| Ingredients | Active Ingredients: |
|---|---|
|
(Arsenicum album )
(200C)
(Arsenicum album Genus: Arsenicum Species: album Note: 200C )
|
|
|
(1X)
(Avena Note: 1X )
|
|
|
(Bryonia )
(200C)
(Bryonia Genus: Bryonia Note: 200C )
|
|
|
(Capsicum )
(6X)
(Capsicum Genus: Capsicum Note: 6X )
|
|
|
Carbo An
(200C)
(Carbo An Note: 200C )
|
|
|
(Carduus marianus )
(1X)
(Carduus marianus Genus: Carduus Species: marianus Note: 1X )
|
|
|
(Chelidonium maj )
(200C)
(Chelidonium maj Genus: Chelidonium Species: maj Note: 200C )
|
|
|
Hepar Suis
(6X)
(Hepar Suis Note: 6X )
|
|
|
(200C)
(Kali Iod Note: 200C )
|
|
|
Lapis
(200C)
(Lapis Note: 200C )
|
|
|
Radium brom
(200C)
(Radium brom Note: 200C )
|
|
|
(Taraxacum )
(1X)
(Taraxacum Genus: Taraxacum Note: 1X )
|
|
|
(Thuja occidentalis )
(200C)
(Thuja occidentalis Genus: Thuja Species: occidentalis Note: 200C )
|
Glycerin Note: 10%v/v, organic Alcohol Note: 9%v/v, purified Water
On October 9, 2018, U.S. Food and Drug Administration warned that the manufacturer recalled this product due to potential microbial contamination (97578). Advise patients not to use this product.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Party Relief. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of bryonia.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Party Relief. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when organic arsenic is consumed in normal food amounts. Organic forms of arsenic normally found in foods have not been linked to toxicity (7135,16309). ...when arsenic trioxide is used intravenously and appropriately under the guidance of a healthcare provider. Arsenic trioxide (Trisenox) is an FDA-approved prescription drug (15).
LIKELY UNSAFE ...when inorganic arsenic is used orally, especially when used long-term or in high doses. Taking large doses acutely, or in small doses for prolonged periods of time, can cause serious side effects. Chronic intake of 10 mcg/kg daily has been associated with symptomatic arsenicism. Acute doses of 5 mg, or sometimes less, can cause gastrointestinal symptoms. Higher doses can cause severe poisoning and death (7135,16310,16312,16313,16316,102892). Prolonged exposure to inorganic arsenic in drinking water and other sources has been linked to an increased risk of cardiovascular disease, diabetes, cancer, hypertension, and mortality (99824,99827,99829,99830,99832,99834,99835,109108,109110). Inorganic arsenic is classified as a human carcinogen (16312,16316). The maximum permissible level of arsenic in drinking water is 10 mcg/L (16316).
CHILDREN: LIKELY SAFE
when organic arsenic is consumed in food amounts.
Organic forms of arsenic found in a normal diet have not been linked to toxicity (7135,16309).
CHILDREN: LIKELY UNSAFE
when inorganic arsenic is used orally, especially when used long-term or in high doses.
Large doses acutely, or in small doses for prolonged periods of time, can cause serious side effects. Prolonged exposure to inorganic arsenic in drinking water has been linked to reduced scores on intelligence tests, developmental delays, impaired verbal comprehension, decreased memory and attention, and higher blood pressure in children (16319,99826,99828,99836,102898).
PREGNANCY AND LACTATION: LIKELY SAFE
when organic arsenic is consumed in food amounts.
Organic forms of arsenic found in a normal diet have not been linked to toxicity (7135,16309).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when inorganic arsenic is taken orally, especially when used long-term or in high doses.
While exposure to inorganic arsenic in drinking water does not seem to increase the risk of neural tube defects (102897), it has been associated with an increased risk for spontaneous abortion, stillbirth, and neonatal mortality (99833). Exposure to inorganic arsenic in drinking water and other sources while pregnant has also been linked to changes in birth weight, length, and head circumference (102895), with one study showing that higher maternal blood arsenic levels are associated with 44% greater odds of delivering a small for gestational age infant and 103% greater odds of delivering a large for gestational age infant (102895,102896). Avoid arsenic supplements and water contaminated with arsenic during pregnancy or lactation.
LIKELY UNSAFE ...when the root or berries are used orally (2,18). Consuming 40 berries might be fatal (18).
CHILDREN: LIKELY UNSAFE
when the root or berries are used orally (2,18).
Consuming as few as 15 berries can be fatal in children (18).
PREGNANCY: UNSAFE
when the root is used orally.
Bryonia root might have abortifacient effects (2). ...when the berries are used orally (2).
LACTATION: LIKELY UNSAFE
when the root or berries are used orally (2).
LIKELY SAFE ...when used orally in amounts typically found in food. Capsicum has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used topically and appropriately (7038,10650,105345). The active capsicum constituent capsaicin is an FDA-approved ingredient used in certain over-the-counter, topical preparations (272).
POSSIBLY SAFE ...when used orally and appropriately, short-term in medicinal amounts. A specific sustained-release chili extract (Capsifen) has been used safely in doses of up to 200 mg daily, for up to 28 days (105196). ...when used intranasally and appropriately, short-term. Capsicum-containing nasal sprays, suspensions, and swabs seem to be safe when applied multiple times over 24 hours or when applied daily or every other day for up to 14 days. Although no serious side effects have been reported in clinical trials, intranasal application of capsicum-containing products can be very painful (14322,14324,14328,14329,14351,14352,14353,14356,14357) (14358,14359,14360,15016,105204). POSSIBLY UNSAFE when used orally, long-term or in high doses. There is concern that long-term use or use of excessive doses might be linked to hepatic or kidney damage, as well as hypertensive crisis (12404,40569,40606). There is insufficient reliable information available about the safety of capsicum when injected.
CHILDREN: POSSIBLY UNSAFE
when used topically in children under 2 years old (272).
There is insufficient reliable information available about the safety of capsicum when used orally in children.
PREGNANCY: LIKELY SAFE
when used topically and appropriately (272).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term.
Capsicum 5 mg daily has been used for up to 28 days during the latter half of the second trimester and the third trimester (96457).
LACTATION: LIKELY SAFE
when used topically and appropriately (272).
LACTATION: POSSIBLY UNSAFE
when used orally.
Dermatitis can sometimes occur in infants when foods heavily spiced with capsicum peppers are ingested during lactation (739). Also, observational research suggests that intake of raw capsicum peppers during pregnancy is associated with an increased risk of sensitization to inhalant allergens in children by the age of 2 years (41021).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Dandelion has Generally Recognized As Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (12). There is insufficient reliable information available about the safety of dandelion when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those in foods.
POSSIBLY UNSAFE ...when used orally. Greater celandine has been implicated in dozens of cases of liver damage, primarily in European countries including Germany (363,13410,16839,41412,53502,53504,53506,53507,53510). There is insufficient reliable information available about the safety of greater celandine when used topically or when derivatives of greater celandine constituents are used intravenously.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Iodine is safe in amounts that do not exceed the tolerable upper intake level (UL) of 1100 mcg daily (7135,103070). Higher doses can be safely used with appropriate medical monitoring (2197,7080). In some regions of the world, such as Japan, daily dietary intake is estimated to be as high as 5,280-13,800 mcg without adverse outcomes (16747). ...when used topically and appropriately, as a 2% solution. A 2% iodine solution is an FDA-approved prescription product (15).
POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the UL of 1100 mcg daily without proper medical supervision. There is concern that higher intake can increase the risk of side effects such as thyroid dysfunction, as well as thyroiditis, thyroid papillary cancer, thyrotoxicosis, and atrial fibrillation (7135,55962,56013). However, in some regions of the world such as Japan, daily dietary intake is estimated to be as high as 5,280-13,800 mcg without adverse outcomes (16747).
CHILDREN: LIKELY SAFE
when used orally and appropriately (7135).
Iodine is safe in amounts that do not exceed the tolerable upper intake level (UL) of 200 mcg daily for children 1-3 years, 300 mcg daily for children 4-8 years, 600 mcg daily for children 9-13 years, and 900 mcg daily for adolescents (7135). ...when used topically as a 2% solution (15). Iodine is an FDA-approved prescription product.
CHILDREN: POSSIBLY UNSAFE
when used orally in doses exceeding the UL (7135,108709).
Higher intake can cause thyroid dysfunction (7135) and may be associated with a modest reduction in intelligence (108709).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Iodine is safe in amounts that do not exceed the tolerable upper intake level (UL) of 1100 mcg daily in those 18 years and older or 900 mcg daily in those 14-18 years of age (7135,103070). Iodine needs increase during pregnancy and lactation and adequate intakes should begin as soon as a patient is aware of the pregnancy, or earlier in areas of potential deficiency (17920). ...when used topically as a 2% solution (15). Iodine is an FDA-approved prescription product.
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in doses exceeding the UL.
Higher intake can cause thyroid dysfunction (7135). Also, higher intakes during pregnancy cause increased iodine levels in breast milk and infant blood samples. Higher iodine intake during pregnancy has also been associated with an increased risk of congenital hypothyroidism and reduced mental and physical development in the offspring (56089,91390,91394,91395).
LIKELY SAFE ...when used orally and appropriately. A specific milk thistle extract standardized to contain 70% to 80% silymarin (Legalon, Madaus GmbH) has been safely used in doses up to 420 mg daily for up to 4 years (2613,2614,2616,7355,63210,63212,63278,63280,63299,63340)(88154,97626,105792). Higher doses of up to 2100 mg daily have been safely used for up to 48 weeks (63251,96107,101150). Another specific milk thistle extract of silymarin (Livergol, Goldaru Pharmaceutical Company) has been safely used at doses of 140 mg daily for up to 6 months and doses of 420 mg daily for up to 6 weeks (95021,95029,102851,102852,105793,105794,105795,113979). Some isolated milk thistle constituents also appear to be safe. Silibinin (Siliphos, Thorne Research) has been used safely in doses up to 320 mg daily for 28 days (63218). Some combination products containing milk thistle and other ingredients also appear to be safe. A silybin-phosphatidylcholine complex (Silipide, Inverni della Beffa Research and Development Laboratories) has been safely used in doses of 480 mg daily for 7 days (7356) and 240 mg daily for 3 months (63320). Tree turmeric and milk thistle capsules (Berberol, PharmExtracta) standardized to contain 60% to 80% silybin have been safely used twice daily for up to 12 months (95019,96140,96141,96142,97624,101158).
POSSIBLY SAFE ...when used topically and appropriately, short-term. A milk thistle extract cream standardized to silymarin 0.25% (Leviaderm, Madaus GmbH) has been used safely throughout a course of radiotherapy (63239). Another milk thistle extract cream containing silymarin 1.4% has been used with apparent safety twice daily for 3 months (105791,110489). A cream containing milk thistle fruit extract 25% has been used with apparent safety twice daily for up to 12 weeks (111175). A milk thistle extract gel containing silymarin 1% has been used with apparent safety twice daily for 9 weeks (95022). There is insufficient reliable information available about the safety of intravenous formulations of milk thistle or its constituents.
PREGNANCY AND LACTATION:
While research in an animal model shows that taking milk thistle during pregnancy and lactation does not adversely impact infant development (102850), there is insufficient reliable information available about its safety during pregnancy or lactation in humans; avoid using.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
A milk thistle extract 140 mg three times daily has been used with apparent safety for up to 9 months (88154,98452). A specific product containing the milk thistle constituent silybin (Siliphos, Thorne Research Inc.) has been used with apparent safety in doses up to 320 mg daily for up to 4 weeks in children one year of age and older (63218).
LIKELY SAFE ...when used orally and appropriately in food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).
POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Thuja that is thujone-free has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Large doses of thuja have been reported to cause seizures, severe vomiting, organ toxicity, and death in some cases (6002,40888). There is insufficient reliable information available about the safety of thuja when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally due to abortifacient activity (12); avoid using.
LACTATION: LIKELY UNSAFE
when used orally due to toxicity (11); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Party Relief. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Arsenic trioxide can prolong the QT interval.
 Details
Up to 40% of patients treated with prescription arsenic trioxide have a prolonged QT interval on their electrocardiogram (ECG) (15). Theoretically, non-prescription arsenic could have an additive effect when combined with drugs that prolong the QT interval.
|
Theoretically, using topical capsaicin may increase the risk of ACE inhibitor-induced cough.
Details
There is one case report of a topically applied capsaicin cream contributing to the cough reflex in a patient using an ACEI (12414). However, it is unclear if this interaction is clinically significant.
|
Theoretically, capsicum may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that capsicum might increase the effects of antiplatelet drugs (12406,12407). Also, population research shows that capsicum is associated with an increased risk of self-reported bleeding in patients taking warfarin (12405,20348). However, clinical research shows that taking a single dose of capsaicin (Asian Herbex Ltd.), the active ingredient in capsicum, 400-800 mcg orally in combination with aspirin 500 mg does not decrease platelet aggregation when compared with taking aspirin 500 mg alone. Also, there was no notable effect on measures of platelet aggregation with capsaicin (92990). It is unclear whether capsaicin must be used in more than a single dose to affect platelet aggregation.
|
Theoretically, taking capsicum with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Preliminary clinical research shows that consuming capsicum 5 grams along with a glucose drink attenuates the rise in plasma glucose after 30 minutes by 21%, decreases the 2-hour postprandial area under the curve of plasma glucose by 11%, and increases the 2-hour postprandial area under the curve of plasma insulin by 58% in healthy individuals when compared with placebo (40453,40614). Other clinical research shows that taking capsicum 5 mg daily for 28 days significantly reduces postprandial blood glucose and insulin levels, but not fasting blood glucose and insulin levels, in patients with gestational diabetes (96457).
|
Theoretically, taking capsicum with aspirin might reduce the bioavailability of aspirin.
Details
Animal research shows that acute or chronic intake of capsicum pepper reduces oral aspirin bioavailability (22617). This has not been shown in humans.
|
Theoretically, taking capsicum with ciprofloxacin might increase levels and adverse effects of ciprofloxacin.
Details
Animal research shows that concomitant use of capsaicin, the active constituent of capsicum, and ciprofloxacin increases the bioavailability of ciprofloxacin by up to 70% (22613).
|
Theoretically, taking capsicum with theophylline might increase the levels and adverse effects of theophylline.
Details
|
Theoretically, taking dandelion root along with anticoagulant or antiplatelet drugs might increase the risk of bruising and bleeding.
Details
In vitro research suggests that dandelion root inhibits platelet aggregation (18291).
|
Theoretically, dandelion might increase the risk for hypoglycemia when used with antidiabetes drugs.
Details
Laboratory research suggests that dandelion extract may have moderate alpha-glucosidase inhibitor activity and might also increase insulin secretion (13474,90926). Also, in a case report, a 58-year-old woman with type 2 diabetes who was being treated with insulin developed hypoglycemia 2 weeks after beginning to eat salads containing dandelion (46960).
|
Theoretically, dandelion might increase levels of drugs metabolized by CYP1A2.
Details
Laboratory research suggests that dandelion might inhibit CYP1A2 (12734). So far, this interaction has not been reported in humans. However, until more is known, watch for an increase in the levels of drugs metabolized by CYP1A2 in patients taking dandelion.
|
Theoretically, dandelion might increase the clearance of drugs that are UDP-glucuronosyltransferase substrates.
Details
There is some preliminary evidence that dandelion might induce UDP-glucuronosyltransferase, a phase II enzyme (12734).
|
Theoretically, through diuretic effects, dandelion might reduce excretion and increase levels of lithium.
Details
Animal research suggests that dandelion has diuretic properties (13475). As diuretics can increase serum lithium levels, the dose of lithium might need to be decreased when taken with dandelion.
|
Theoretically, dandelion might increase the risk of hyperkalemia when taken with potassium-sparing diuretics.
Details
Dandelion contains significant amounts of potassium (13465).
|
Theoretically, dandelion might lower fluoroquinolone levels.
Details
Animal research shows that dandelion reduces absorption of ciprofloxacin and can lower levels by 73% (13477). However, this effect has not been reported in humans.
|
Research in vitro shows that chelidonine, a constituent of greater celandine, inhibits cytochrome P450 2D6 (CYP2D6) enzyme activity (99455). Theoretically, greater celandine might increase levels of drugs metabolized by CYP2D6.
Details
Some drugs metabolized by CYP2D6 include amitriptyline (Elavil), clozapine (Clozaril), codeine, desipramine (Norpramin), donepezil (Aricept), fentanyl (Duragesic), flecainide (Tambocor), fluoxetine (Prozac), meperidine (Demerol), methadone (Dolophine), metoprolol (Lopressor, Toprol XL), olanzapine (Zyprexa), ondansetron (Zofran), tramadol (Ultram), trazodone (Desyrel), and many others.
|
There is some concern that greater celandine can adversely affect the liver. Greater celandine has been linked to many cases of hepatotoxicity (363,13410,16839,41412,53502,53504,53506,53507,53510). Theoretically, concomitant use with other potentially hepatotoxic drugs might increase the risk of developing liver damage. Some of these drugs include acarbose (Precose, Prandase), amiodarone (Cordarone), atorvastatin (Lipitor), azathioprine (Imuran), carbamazepine (Tegretol), cerivastatin (Baycol), diclofenac (Voltaren), felbamate (Felbatol), fenofibrate (TriCor), fluvastatin (Lescol), gemfibrozil (Lopid), isoniazid, itraconazole, (Sporanox), ketoconazole (Nizoral), leflunomide (Arava), lovastatin (Mevacor), methotrexate (Rheumatrex), nevirapine (Viramune), niacin, nitrofurantoin (Macrodantin), pioglitazone (Actos), pravastatin (Pravachol), pyrazinamide, rifampin (Rifadin), ritonavir (Norvir), rosiglitazone (Avandia), simvastatin (Zocor), tacrine (Cognex), tamoxifen, terbinafine (Lamisil), valproic acid, and zileuton (Zyflo).
|
Preliminary clinical research suggests that taking a specific semi-synthetic derivative of the greater celandine constituent chelidonine (Ukrain; not available in North America) might stimulate immune responses in cancer patients (53473,53497). Theoretically, taking greater celandine might decrease the effects of immunosuppressive therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), and other corticosteroids (glucocorticoids).
|
Theoretically taking monoamine oxidase inhibitors (MAOIs) with greater celandine might increase the risk of serotonergic side effects including serotonin syndrome. In vitro research shows that chelerythrine, an isoquinoline alkaloid in greater celandine, strongly, selectively, and reversibly inhibits an isoform of recombinant human monoamine oxidase-A (MAO-A). It was also a weak but selective inhibitor of monoamine oxidase-B (MAO-B) (99454). Some MAOIs include phenelzine (Nardil), tranylcypromine (Parnate), and others.
|
Combining iodine with amiodarone might cause excessively high iodine levels.
Details
|
Iodine might alter the effects of antithyroid drugs.
Details
|
Combining iodine with lithium might have additive hypothyroid effects.
Details
Lithium can inhibit thyroid function. Several case reports suggest that concomitant use of lithium and potassium iodide can reduce thyroid function in otherwise healthy adults (17574). Monitor thyroid function.
|
Taking milk thistle with antidiabetes drugs may increase the risk of hypoglycemia.
Details
Clinical research shows that milk thistle extract, alone or along with tree turmeric extract, can lower blood glucose levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, including those already taking antidiabetes drugs (15102,63190,63314,63318,95019,96140,96141,97624,97626,113987).
|
Theoretically, milk thistle might inhibit CYP2B6.
Details
An in vitro study shows that silybin, a constituent of milk thistle, binds to and noncompetitively inhibits CYP2B6. Additionally, silybin might downregulate the expression of CYP2B6 by decreasing mRNA and protein levels (112229).
|
It is unclear if milk thistle inhibits CYP2C9; research is conflicting.
Details
In vitro research suggests that milk thistle might inhibit CYP2C9 (7089,17973,17976). Additionally, 3 case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are CYP2C9 substrates, including imatinib and capecitabine (111644). However, contradictory clinical research shows that milk thistle extract does not inhibit CYP2C9 or significantly affect levels of the CYP2C9 substrate tolbutamide (13712,95026). Differences in results could be due to differences in dosages or formulations utilized (95026).
|
It is unclear if milk thistle inhibits CYP3A4; research is conflicting.
Details
While laboratory research shows conflicting results (7318,17973,17975,17976), pharmacokinetic research shows that taking milk thistle extract 420-1350 mg daily does not significantly affect the metabolism of the CYP3A4 substrates irinotecan, midazolam, or indinavir (8234,17974,93578,95026). However, 8 case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are CYP3A4 substrates, including gefitinib, sorafenib, doxorubicin, and vincristine (111644).
|
Theoretically, milk thistle might interfere with estrogen therapy through competition for estrogen receptors.
Details
|
Theoretically, milk thistle might affect the clearance of drugs that undergo glucuronidation.
Details
Laboratory research shows that milk thistle constituents inhibit uridine diphosphoglucuronosyl transferase (UGT), the major phase 2 enzyme that is responsible for glucuronidation (7318,17973). Theoretically, this could decrease the clearance and increase levels of glucuronidated drugs. Other laboratory research suggests that a milk thistle extract of silymarin might inhibit beta-glucuronidase (7354), although the significance of this effect is unclear.
|
Theoretically, milk thistle might interfere with statin therapy by decreasing the activity of organic anion transporting polypeptide 1B1 (OATB1B1) and inhibiting breast cancer resistance protein (BCRP).
Details
Preliminary evidence suggests that a milk thistle extract of silymarin can decrease the activity of the OATP1B1, which transports HMG-CoA reductase inhibitors into the liver to their site of action, and animal research shows this increases the maximum plasma concentration of pitavastatin and pravastatin (113975). The silibinin component also inhibits BCRP, which transports statins from the liver into the bile for excretion. However, in a preliminary study in healthy males, silymarin 140 mg three times daily had no effect on the pharmacokinetics of a single 10 mg dose of rosuvastatin (16408).
|
Theoretically, milk thistle may induce cytochrome P450 3A4 (CYP3A4) enzymes and increase the metabolism of indinavir; however, results are conflicting.
Details
One pharmacokinetic study shows that taking milk thistle (Standardized Milk Thistle, General Nutrition Corp.) 175 mg three times daily in combination with multiple doses of indinavir 800 mg every 8 hours decreases the mean trough levels of indinavir by 25% (8234). However, results from the same pharmacokinetic study show that milk thistle does not affect the overall exposure to indinavir (8234). Furthermore, two other pharmacokinetic studies show that taking specific milk thistle extract (Legalon, Rottapharm Madaus; Thisilyn, Nature's Way) 160-450 mg every 8 hours in combination with multiple doses of indinavir 800 mg every 8 hours does not reduce levels of indinavir (93578).
|
Theoretically, milk thistle might increase the levels and clinical effects of ledipasvir.
Details
Animal research in rats shows that milk thistle increases the area under the curve (AUC) for ledipasvir and slows its elimination (109505).
|
Theoretically, concomitant use of milk thistle with morphine might affect serum levels of morphine and either increase or decrease its effects.
Details
Animal research shows that milk thistle reduces serum levels of morphine by up to 66% (101161). In contrast, laboratory research shows that milk thistle constituents inhibit uridine diphosphoglucuronosyl transferase (UGT), the major phase 2 enzyme that is responsible for glucuronidation (7318,17973). Theoretically, this could decrease the clearance and increase morphine levels. The effect of taking milk thistle on morphine metabolism in humans is not known.
|
Milk thistle may inhibit one form of OATP, OATP-B1, which could reduce the bioavailability and clinical effects of OATP-B1 substrates.
Details
In vitro research shows that milk thistle inhibits OATP-B1. Two case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are OATP substrates, including sorafenib and methotrexate (111644). OATPs are expressed in the small intestine and liver and are responsible for the uptake of drugs and other compounds into the body. Inhibition of OATP may reduce the bioavailability of oral drugs that are substrates of OATP.
|
Theoretically, milk thistle might increase the absorption of P-glycoprotein substrates. However, this effect does not seem to be clinically significant.
Details
In vitro research shows that milk thistle can inhibit P-glycoprotein activity (95019,111644) and 1 case report from the World Health Organization (WHO) adverse drug reaction database describes increased abdominal pain in a patient taking milk thistle and the cancer medication vincristine, a P-glycoprotein substrate, though this patient was also taking methotrexate (111644). However, a small pharmacokinetic study in healthy volunteers shows that taking milk thistle (Enzymatic Therapy Inc.) 900 mg, standardized to 80% silymarin, in 3 divided doses daily for 14 days does not affect absorption of digoxin, a P-glycoprotein substrate (35825).
|
Theoretically, milk thistle might decrease the clearance and increase levels of raloxifene.
Details
Laboratory research suggests that the milk thistle constituents silibinin and silymarin inhibit the glucuronidation of raloxifene in the intestines (93024).
|
Milk thistle might decrease the clearance of sirolimus.
Details
Pharmacokinetic research shows that a milk thistle extract of silymarin decreases the apparent clearance of sirolimus in hepatically impaired renal transplant patients (19876). It is unclear if this interaction occurs in patients without hepatic impairment.
|
Theoretically, milk thistle might decrease the levels and clinical effects of sofosbuvir.
Details
Animal research in rats shows that milk thistle reduces the metabolism of sofosbuvir, as well as the hepatic uptake of its active metabolite (109505).
|
Theoretically, the milk thistle constituent silibinin might increase tamoxifen levels and interfere with its conversion to an active metabolite.
Details
Animal research suggests that the milk thistle constituent silibinin might increase plasma levels of tamoxifen and alter its conversion to an active metabolite. The mechanism appears to involve inhibition of pre-systemic metabolism of tamoxifen by cytochrome P450 (CYP) 2C9 and CYP3A4, and inhibition of P-glycoprotein-mediated efflux of tamoxifen into the intestine for excretion (17101). Whether this interaction occurs in humans is not known.
|
Theoretically, milk thistle might increase the effects of warfarin.
Details
In one case report, a man stabilized on warfarin experienced an increase in INR from 2.64 to 4.12 after taking a combination product containing milk thistle 200 mg daily, as well as dandelion, wild yam, niacinamide, and vitamin B12. Levels returned to normal after stopping the supplement (101159). Although a direct correlation between milk thistle and the change in INR cannot be confirmed, some in vitro research suggests that milk thistle might inhibit cytochrome P450 2C9 (CYP2C9), an enzyme involved in the metabolism of various drugs, including warfarin (7089,17973,17976).
|
Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.
Details
|
Concomitant use of oats and insulin might increase the risk of hypoglycemia.
Details
In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).
|
Thuja products can contain thujone, which might lower the seizure threshold (1304). Theoretically, this could decrease the effectiveness of anticonvulsants drugs.
|
Thuja might stimulate immune function (1305). Theoretically, taking thuja might decrease the effects of immunosuppressive therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), and other corticosteroids (glucocorticoids).
|
Thuja products can contains significant amounts of thujone, a neurotoxin (1304). Theoretically, patients taking drugs that lower the seizure threshold might be at greater risk of seizure if they also take thuja. Advise patients taking these drugs to avoid thuja products. Some drugs that lower the seizure threshold include anesthetics (propofol, others), antiarrhythmics (mexiletine), antibiotics (amphotericin, penicillin, cephalosporins, imipenem), antidepressants (bupropion, others), antihistamines (cyproheptadine, others), immunosuppressants (cyclosporine), narcotics (fentanyl, others), stimulants (methylphenidate), theophylline, and others.
|
Below is general information about the adverse effects of the known ingredients contained in the product Party Relief. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, organic forms of arsenic found in the diet are well tolerated, with no clear links to adverse effects.
However, high doses or chronic intake of inorganic arsenic is associated with potentially serious adverse effects.
Serious Adverse Effects (Rare):
Orally: With the acute ingestion of inorganic arsenic, anemia, arrhythmias, bruising, gastrointestinal irritation or damage, hepatotoxicity, and peripheral neuropathy.
With chronic intake of inorganic arsenic, arsenicism can occur, including anorexia, cancer, skin hyperpigmentation and hyperkeratosis, and toxicity of the cardiovascular and neurological systems.
Cardiovascular
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause hematopoietic depression including anemia, arrhythmias, and blood vessel damage leading to bruising (7135,16309,16312).
Acute ingestion of inorganic arsenic 10 mg/kg daily or more causes vasodilation and myocardial depression leading to myocardial injury, shock, and circulatory failure (17,7135,16313,16316,102892). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by cardiomyopathy and arrhythmias (17,7135,16309,16310,16316). Prolonged exposure to inorganic arsenic in drinking water at levels greater than or equal to 20 mcg/L has been linked, in a dose-dependent manner, to a 9% to 43% greater risk of cardiovascular disease, 11% to 55% greater risk of coronary heart disease, and 16% to 90% greater risk of cardiovascular-related death (99827). Also, each interquartile increase in urinary inorganic arsenic levels is associated with an increased risk of both cardiovascular and all-cause mortality in a specific area of the US (109110). A metabolite of arsenic, monomethylarsonic acid, has also been positively linked to stroke risk (99831). Increased exposure to inorganic arsenic has also been linked to the development of left ventricular hypertrophy (99835). The cardiovascular adverse effects of inorganic arsenic appear to be more profound in males with hypertension (99829).
The association between arsenic exposure and hypertension has also been investigated. A meta-analysis of observational research has found that the odds of having hypertension and risk of hypertension were increased by 14% and 30%, respectively, in those with the highest arsenic exposure when compared with the lowest. Exposure was determined based on intake of rice and rice products, as well as exposure in water, or levels in urine, hair, or toenails (109108). Additionally, increased exposure to inorganic arsenic in drinking water has been linked to higher blood pressure in children (102898).
Dermatologic ...Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by skin hyperpigmentation, hyperkeratosis, alopecia, and occlusive peripheral vascular disease leading to gangrene (17,7135,16309,16310,16316,102894). In one case, chronic intake of inorganic arsenic 30 ng daily has reportedly caused eczema of the hands, arms, and legs (102893).
Endocrine ...Orally, prolonged exposure to inorganic arsenic in drinking water has been associated with a 23% to 75% increase in the risk for diabetes (99830,99834). For every 100 mcg/L increase in inorganic arsenic levels in drinking water, the associated risk for diabetes increases by 13% (99834). A small meta-analysis has found that overall exposure to arsenic, including organic and inorganic arsenic, is associated with an increased risk of developing gestational diabetes (106539).
Gastrointestinal ...Orally, acute ingestion of inorganic arsenic 5 mg, or sometimes less, can cause vomiting, diarrhea, stomach cramps, and flatulence (16316,102893). These effects usually resolve in about 12 hours without treatment (16316). Doses of inorganic arsenic 1 mg/kg daily can cause gastrointestinal irritation (7135,16309,16312). Acute ingestion of inorganic arsenic 10 mg/kg daily or more causes severe gastrointestinal symptoms including bloody rice-water diarrhea (17,7135,16313,16316,102892). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by anorexia and gastrointestinal disturbances (17,7135,16309,16310,16316).
Genitourinary ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused irregular menstruation (102893). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from genitourinary diseases (106541).
Hematologic ...Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by anemia, leukopenia, and occlusive peripheral vascular disease (17,7135,16309,16310,16316).
Hepatic
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause hepatotoxicity (7135,16309,16312).
The homeopathic remedy, arsenicum album, has been associated with three cases of acute liver injury. In one case, a 70-year-old male with pre-existing non-alcoholic steatohepatitis (NASH) cirrhosis died following the acute liver injury associated with use of this compound for about 12 weeks. High levels of arsenic were found in his hair and nail samples. Symptoms in the two other individuals resolved upon discontinuation of homeopathic arsenic and use of corticosteroids (109114).
Musculoskeletal ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused leg cramps in one patient (102893).
Neurologic/CNS
...Orally, doses of inorganic arsenic 1 mg/kg daily can cause peripheral neuropathy and encephalopathy (7135,16309,16312).
In one case, chronic intake of inorganic arsenic 30 ng daily has reportedly caused headache, dizziness, and difficulty concentrating (102893). Acute ingestion of inorganic arsenic 10 mg/kg daily or more can cause cerebral edema, leading to encephalopathy, convulsions, coma, and death (17,7135,16313,16316). Chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, characterized in part by sensory disturbances, peripheral neuropathy, encephalopathy, confusion, and memory loss (17,7135,16309,16310,16316). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from nervous system diseases (106541).
In children, prolonged exposure to inorganic arsenic in drinking water has been linked to reduced scores on intelligence tests, developmental delays, impaired verbal comprehension, and decreased memory and attention (16319,99826,99828,99836).
Ocular/Otic ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused conjunctivitis in one patient (102893). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from traffic accidents. This is suggested to be related to a higher prevalence of visual field narrowing due to macular degeneration, as well as motor or sensory dysfunction, in those exposed to arsenic during infancy (106541).
Oncologic ...Inorganic arsenic is classified as a human carcinogen (16312,16316). Orally, chronic intake of 10 mcg/kg daily of inorganic arsenic produces arsenicism, which can result in cancers of the skin, lungs, liver, kidneys, and bladder (17,7135,16309,16310,16316). Chronic ingestion of lower doses of inorganic arsenic, as a contaminant in well water, has also been linked to cancers of the skin, bladder, kidneys, and lungs (7135,99824,99832,106540). More specifically, levels of inorganic arsenic greater than 200 mcg/L in drinking water have been linked to lung cancer (99824). Levels of inorganic arsenic greater than 10 mcg/L in drinking water are also dose-dependently linked to an increased risk for bladder and kidney cancers (99832). A meta-analysis of observational research has found that arsenic exposure, especially from water and soil, is associated with prostate cancer risk (109109). A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from liver cancer (106541).
Psychiatric ...Orally, chronic intake of inorganic arsenic 30 ng daily has reportedly caused insomnia and anxiety in one patient (102893).
Pulmonary/Respiratory ...A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased mortality from respiratory diseases (106541).
Other
...Orally, high doses of inorganic arsenic can cause death.
In one case, a 24-year-old female receiving a combination of arsenic trioxide, realgar, and mung bean flour from an illegal medical provider died within days of taking the compounded preparation. Laboratory analysis revealed the amount of arsenic consumed to be around 1.1 grams on day 1 and 0.9 grams on day 4. Researchers concluded that arsenic as the source of poisoning was clear based on the amount of arsenic ingested and the patient's clinical presentation prior to death, which included vomiting, diarrhea, reduced urine output, liver and kidney abnormalities, and myocardial injury (102892).
A long-term observational study in adults has found that exposure to inorganic arsenic from consumption of contaminated milk powder during infancy is associated with increased all-cause mortality (106541).
General
...Orally, bryonia root can cause dizziness, vomiting, convulsions, colic, bloody diarrhea, abortion, nervous excitement, and kidney damage.
Large doses of bryonia can cause anuria, collapse, paralysis, and death (2). Bryonia berries can be fatal when taken orally; 40 berries can be fatal in adults, and 15 berries can be fatal in children (18).
Topically, skin contact with fresh bryonia may cause irritation (19).
Dermatologic ...Topically, skin contact with fresh bryonia may cause irritation (19).
Gastrointestinal ...Orally, bryonia root can cause vomiting, colic, and bloody diarrhea (2).
Genitourinary ...Orally, bryonia root can cause abortion (2). Large doses of bryonia can cause anuria and death (2).
Musculoskeletal ...Orally, large doses of bryonia can cause paralysis and death (2).
Neurologic/CNS ...Orally, bryonia root can cause dizziness, convulsions, and nervous excitement (2). Large doses of bryonia can cause paralysis and death (2).
Renal ...Orally, bryonia root can cause kidney damage (2). Large doses of bryonia can cause anuria and death (2).
Other ...Orally, bryonia berries can be fatal. Consuming 40 berries can be fatal in adults and as few as 15 berries can be fatal in children (18).
General
...Orally, capsicum is generally well tolerated in amounts typically found in food or when the extract is used in doses of up to 200 mg daily.
Topically and intranasally, capsaicin, a constituent of capsicum, is generally well tolerated.
Most Common Adverse Effects:
Orally: Belching, bloating, burning, diarrhea, dyspepsia, gas, headache, mild constipation, nausea, rhinorrhea, skin flushing, and sweating.
Serious Adverse Effects (Rare):
Orally: Cases of myocardial infarction and hypertensive crisis have been reported.
Cardiovascular
...Orally, palpitation was reported in one clinical trial (105196).
One case of myocardial infarction has been reported in a 41-year-old male without cardiovascular risk factors; the event was attributed to the use of an oral capsicum pepper pill that the patient had been taking for weight loss (40768). Another case of coronary vasospasm and acute myocardial infarction has been reported for a healthy 29-year-old male; the event was attributed to the use of a topical capsicum-containing patch that the patient had been applying to the middle of the back for 6 days (40658). Two cases of arterial hypertensive crisis have been reported for individuals who ingested a large amount of peppers and chili peppers the day before. One of the patients also had an acute myocardial infarction, and the other had high levels of thyroid stimulating hormone (40569,40606).
Dermatologic
...Orally, capsicum or its constituent capsaicin may cause urticaria and skin wheals in rare cases (96457,105203).
Topically, capsicum can cause a prickling sensation, itching, pain, burning, edema, stinging, irritation, rash, and erythema. About 1 in 10 patients who use capsaicin topically discontinue treatment because of adverse effects. These effects seem to occur more often with topical formulations containing higher concentrations of capsaicin, the active constituent of capsicum. Side effects tend to diminish with continued use (12401,15260,15261,40358,40439,40483,40547,40676,40682,40719)(40784,40847,92979,92983,92984,96453,105193,105197,105202,111514). In one case, application of a capsaicin 8% patch (Qutenza) for 60 minutes caused a second-degree burn, characterized by burning, erythema, severe pain, and blistering at the administration site. The burn was treated with topical corticosteroids, but 9 months later neuropathic pain persisted, resulting in limited mobility. It is unclear whether the mobility sequalae were caused by topical capsaicin or the patient's pre-existing neurological disorders (111514). Skin contact with fresh capsicum fruit can also cause irritation or contact dermatitis (12408).
Intranasally, capsaicin can cause nasal burning and pain in most patients. It also often causes lacrimation, sneezing, and excessive nasal secretion; however, these side effects appear to diminish with repeat applications (14323,14329,14358). In some cases, the burning sensation disappears after 5-8 applications (14351,14358). In some cases, patients are pretreated with intranasal lidocaine to decrease the pain of intranasal capsaicin treatment. However, even with lidocaine pretreatment, patients seem to experience significant pain (14324).
Gastrointestinal
...Orally, capsicum can cause upper abdominal discomfort, including irritation, fullness, dyspepsia, gas, bloating, nausea, epigastric pain and burning, anal burning, diarrhea, mild constipation, and belching (12403,12410,40338,40427,40456,40503,40560,40584,40605,40665)(40718,40725,40745,40808,40828,96456,96457,105194,105196).
There is a case report of a 3-year-old female who experienced a burning and swollen mouth and lips after touching the arm of a parent that had been treated with a capsaicin patch and then placing the fingers in the mouth (105199). Excessive amounts of capsaicin can lead to gastroenteritis and hepatic necrosis (12404). In a case report, a 40-year-old male with diabetes consumed white wine daily and chewed cayenne which was thought to result in black teeth stains and loss of enamel (40809). Some preliminary research links ingestion of capsaicin with stomach and gallbladder cancer; however the link may be due to contamination of capsaicin products with carcinogens (40771).
Topically, capsaicin can cause diarrhea and vomiting (105202).
Immunologic ...In a case report, a 34-year-old female had anaphylaxis involving difficulty breathing and stupor and also urticaria after consuming a red bell pepper, which is in the capsicum genus. The causal chemical was theorized to be 1,3-beta-glucanase (92978). In another case report, a 33-year-old female experienced angioedema, difficulty breathing and swallowing, and urticaria after ingesting raw green and red peppers (92982).
Neurologic/CNS ...Orally, capsicum can cause sweating and flushing of the head and neck, lacrimation, headache, faintness, and rhinorrhea (7005,12410,105196,105203). Topically, applying capsaicin can cause headache (96450,105202). Injection of capsaicin into the intermetatarsal space has also been associated with headache (96454).
Ocular/Otic
...Topically, capsicum can be extremely irritating to the eyes and mucous membranes.
Capsicum oleoresin, an oily extract in pepper self-defense sprays, causes intense eye pain. It can also cause erythema, blepharospasm, tearing, shortness of breath, and blurred vision. In rare cases, corneal abrasions have occurred (12408,12409,40345,40348,40383,40720,40857).
Inhalation of capsicum can cause eye irritation, and allergic alveolitis (5885). In a case report, a 38-year-old female had acute anterior uveitis that developed about 12 hours after using a specific patch (Isola Capsicum N Plus) that contained capsaicin 1.5 mg per patch and methyl salicylate 132 mg per patch for neck pain. The uveitis was controlled with topical steroids and did not recur (92977).
Oncologic ...Population research suggests that moderate to high intake of capsaicin, the active constituent of capsicum, is associated with an increased risk of gastric cancer, while low intake is associated with a decreased risk. It is not clear from the study what amount of capsaicin is considered high versus low intake (92988). Additionally, some research suggests that any link may be due to contamination of capsaicin products with carcinogens (40771).
Pulmonary/Respiratory
...Orally, difficulty breathing was reported in a clinical trial (105196).
Topically, nasopharyngitis related to the use of a cream containing capsaicin has been reported (105202).
Inhalation of capsicum and exposure to capsicum oleoresin spray can cause cough, dyspnea, pain in the nasal passages, sneezing, rhinitis, and nasal congestion (5885,15016,40522,40546,40647). In rare cases, inhalation of the capsicum oleoresin or pepper spray has caused cyanosis, apnea, respiratory arrest and death in people. Death was caused by asphyxiation probably due to acute laryngeal edema and bronchoconstriction from inhalation of the capsicum oleoresin spray (40546,40672,40837,40879).
In a case report, a 47-year-old female who was exposed to capsaicin gas for more than 20 minutes experienced acute cough, shortness of breath, short-term chest pain, wheezing, and difficulty breathing for months afterwards (92980). In rare cases, exposure to capsicum oleoresin spray resulted in apnea, pulmonary injury, cyanosis, and even respiratory arrest (40383,40546).
General
...Orally, dandelion seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, heartburn, and stomach discomfort.
Topically: Dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.
Cardiovascular ...In one report, a 39-year-old obese woman developed palpitations and syncope after taking a weight loss supplement containing a combination of dandelion, bladderwrack, and boldo for 3 weeks. The patient was found to have prolonged QT-interval on ECG and frequent episodes of sustained polymorphic ventricular tachycardia (14321). It is not clear whether dandelion, another ingredient, or the combination of ingredients is responsible for this adverse effect. The product was not analyzed to determine the presence of any potential toxic contaminants.
Dermatologic ...Topically, dandelion can cause contact dermatitis and erythema multiforme in sensitive individuals. Dandelion can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family (13478,13481,42893,46945,46977). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
Endocrine ...In one report, a 56-year-old man with renal impairment developed hyperoxalaemia and peripheral gangrene after ingesting large amounts of dandelion tea (10 to 15 cups daily for 6 months). The adverse effect was attributed to the high oxalate content of dandelion tea (258 mcmol/L) and reduced renal oxalate clearance caused by renal impairment (90639). In another report, a 58-year-old woman with type 2 diabetes who was being treated with insulin developed hypoglycemic symptoms 2 weeks after beginning to eat salads containing dandelion (46960). The hypoglycemic effect was attributed to the potential alpha-glucosidase inhibitory activity of dandelion.
Gastrointestinal ...Gastrointestinal symptoms, including stomach discomfort, diarrhea, and heartburn, have been reported following oral use of dandelion (19146,36931). A case of intestinal blockage has been reported for a patient who ingested a large amount of dandelion greens three weeks after undergoing a stomach operation (46981). Also, a case of hemorrhagic cystitis has been reported for a 33-year-old woman who took a specific herbal product (Slim-Kombu, Balestra and Mech, Vicenza, Italy) containing 20 herbal extracts, including dandelion extract. Symptoms resolved after the patient discontinued using the product, and symptoms resumed when the patient began taking the supplement again four months later. While various ingredients in the supplement may have contributed to the symptoms, it is possible that dandelion extract may have contributed to the effect due to its diuretic, laxative, cholagogue, and antirheumatic properties (46959).
Other ...Orally, products containing dandelion pollen can cause allergic reactions, including anaphylaxis (13479,13480). Also, rhinoconjunctivitis and asthma have been reported after handling products such as bird feed containing dandelion and other herbs, with reported positive skin tests for dandelion hypersensitivity (46948). Dandelion pollen may cause pollinosis, such as allergic rhinitis and conjunctivitis (18065,46951,46964,46966,46972).
General
...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510).
Greater celandine can also cause rash (13410). Greater celandine extract has caused a single case of hemolytic anemia (53508).
Topically, greater celandine can cause contact dermatitis (13411).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, increased body temperature, general burning sensations, and bleeding (13409,53460).
Dermatologic ...Orally, greater celandine can cause rash (13410). Topically, greater celandine can cause contact dermatitis (13411).
Gastrointestinal ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, including obstipation, nausea, and diarrhea (13409,53460).
Hematologic
...Orally, greater celandine extract has caused a single case of hemolytic anemia.
This resulted in thrombocytopenia, destruction of liver cells, and kidney failure, requiring treatment (53508).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause bleeding (13409,53460).
Hepatic ...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510). The cause is unknown, but appears to be idiopathic. It seems to be independent of dose, and the amount of time before development of liver disease is generally long and variable (363,53506). The main symptom is usually jaundice (53506). Liver enzymes are elevated at least two-fold in all cases where measurements were completed (53506). Although other causes of liver toxicity cannot be ruled out in some cases, many reported cases of hepatotoxicity are probably or likely associated with the use of greater celandine. Recurrence of hepatitis with unintentional re-exposure has also been reported (53506,94282). Discontinuation of greater celandine usually results in a fairly rapid recovery although liver enzymes need months to return to normal (53506,94282). Death has occurred in one patient with hepatitis due to bleeding associated with colonic diverticulitis. Causality was described as possible, not probable, in this case (53506).
Neurologic/CNS ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause increased body temperature and general burning sensations (13409).
General
...Orally, iodine is well tolerated when taken in amounts that do not exceed the tolerable upper intake level (UL) or when used therapeutically with appropriate medical monitoring (2197,7080,7135).
Most Common Adverse Effects:
Orally: Abdominal upset, diarrhea, goiter, headache, hyperthyroidism, hypothyroidism, metallic taste, nausea, rhinorrhea, thyroid adenoma.
Topically: Burns, dermatitis, irritation.
Serious Adverse Effects (Rare):
All ROAs: Hypersensitivity reactions such as anaphylaxis and angioedema.
Dermatologic
...Orally, taking iodine chronically or in large amounts has been reported to cause acneform skin lesions called iododerma (2138).
In one case, a patient developed iododerma after consuming a specific product (Hoxsey's Brown Tonic) containing an unspecified quantity of potassium iodide. After several months of consumption, the patient developed acneform skin lesions on the nose, cheeks, and upper back and presented with a urine iodine level of 7,455,647 ug/L (reference range: 34-523 ug/L). After discontinuation of potassium iodide, the lesions resolved gradually over the course of several weeks (95431).
Topically, iodine may stain skin, irritate tissues, and cause sensitization in some individuals (15,56106). Iodine burns are associated with application of 7% hydroalcoholic solution (15). Povidone-iodine may cause contact dermatitis or irritant reactions in some people. However, patch testing with potassium iodide is usually negative in these patients, indicating that contact dermatitis caused by topical iodine does not indicate a propensity for reaction to oral potassium iodide (93001).
Endocrine
...Prolonged use and/or large oral doses of iodine intake can cause thyroid gland hyperplasia, thyroid adenoma, goiter, and hypothyroidism (15,56013,56089,91397,91398,99793,99795).
In another case report, an infant presented with reversible hypothyroidism at birth because the mother had consumed excessive seaweed soup during and after pregnancy, which resulted in excessive iodine consumption (99795). Iodine has also been linked to rare cases of adverse events. In one case report, a 56-year-old male developed thyrotoxic hypokalemic paralysis thought to be related to excessive intake of iodine (91401).
Topically, using povidone-iodine (PI) 1% solution as a gargle and nasal spray, in addition to intranasal application of PI 10% ointment over 5 days, can precipitate subclinical hypothyroidism, with elevated thyroid stimulating hormone (TSH) and normal thyroid hormone levels. TSH levels seem to normalize about 7-12 days after stopping topical PI application (105877).
Gastrointestinal
...Orally, the commonly reported adverse effects of a saturated solution of potassium iodide (SSKI) are nausea (14%), abdominal pain (14%), metallic taste (4%), and diarrhea (4%) (17561).
These side effects can be minimized by avoiding quick dosage increases (17574). Taking iodine chronically or in large amounts has also been reported to cause soreness in teeth and gums, burning in mouth and throat, increased salivation, swelling of parotid and submaxillary glands, inflammation of the respiratory tract, gastric upset, and diarrhea (15,2138).
Intranasally, applying povidone-iodine 1% solution along with a 10% ointment can cause unpleasant nasal tingling (105877).
Immunologic ...People who are allergic to iodine-containing foods or drugs are sometimes stated to have "iodine allergy", but the actual allergen is another agent such as seafood proteins or radiocontrast media (93001). However, some people can be hypersensitive to iodine when used orally. Symptoms of hypersensitivity can include angioedema, cutaneous and mucosal hemorrhage, fever, arthralgia, lymph node enlargement, eosinophilia, urticaria, erythema, and thrombotic thrombocytopenic purpura (15,17561). Other reported side effects include potassium toxicity, metabolic acidosis, pustular psoriasis, and vasculitis (17574). However, such sensitivity is very rare (93001). Orally, iodine hypersensitivity can cause fatal periarteritis (15).
Neurologic/CNS
...Orally, common side effects of a saturated solution of potassium iodide (SSKI) have included headache (7%) (17561).
Side effects can be minimized by avoiding quick dosage increases (17574).
High intake of iodine may be associated with adverse cognitive outcomes in children. Observational research in children aged 7-14 years has found that those consuming drinking water with iodine concentrations above 900 mcg/L daily, which exceeds the tolerable upper intake level, is associated with a 1.6-point reduction in intelligence level when compared with those consuming water with iodine concentrations below 300 mcg/L (108709).
Ocular/Otic ...Orally, taking iodine chronically or in large amounts has been reported to cause eye irritation and eyelid swelling (15,2138).
Pulmonary/Respiratory ...Orally, common side effects of a saturated solution of potassium iodide (SSKI) included rhinorrhea (11%) (17561). Side effects can be minimized by avoiding quick dosage increases (17574). Taking iodine chronically or in large amounts has also been reported to cause coryza, sneezing, cough, and pulmonary edema (15,2138). Ophthalmically, povidone-iodine 5% solution 3 drops administered in each eye has been reported to slow respiration by about 18 seconds (range 4 to 96 seconds) when compared with saline control in children ages 2-17 years undergoing strabismus surgery (103077).
Renal ...When povidone-iodine was used in renal pelvic instillation sclerotherapy, one patient (2%) had significant flank pain during treatment (55970).
General
...Orally, milk thistle is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal bloating, diarrhea, dyspepsia, flatulence, and nausea. However, these adverse effects do not typically occur at a greater frequency than with placebo.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including anaphylaxis, have been reported.
Dermatologic ...Orally, milk thistle may cause allergic reactions including urticaria, eczema, skin rash, and anaphylaxis in some people (6879,7355,8956,63210,63212,63238,63251,63315,63325,95029). Allergic reactions may be more likely to occur in patients sensitive to the Asteraceae/Compositae family (6879,8956). A case report describes a 49-year-old female who developed clinical, serologic, and immunopathologic features of bullous pemphigoid after taking milk thistle orally for 6 weeks. Symptoms resolved after treatment with prednisone and methotrexate (107376). Topically, milk thistle can cause erythema (110489).
Gastrointestinal ...Mild gastrointestinal symptoms have been reported, including nausea, vomiting, bloating, diarrhea, epigastric pain, abdominal colic or discomfort, dyspepsia, dysgeusia, flatulence, constipation, and loss of appetite (2616,6879,8956,13170,63140,63146,63160,63210,63218,63219)(63221,63244,63247,63250,63251,63320,63321,63323,63324,63325)(63327,63328,95024,95029,107374). There is one report of a 57-year-old female with sweating, nausea, colicky abdominal pain, diarrhea, vomiting, weakness, and collapse after ingesting milk thistle; symptoms subsided after 24-48 hours without medical treatment and recurred with re-challenge (63329).
Musculoskeletal ...In one clinical study three patients taking milk thistle 200 mg orally three times daily experienced tremor; the incidence of this adverse effect was similar for patients treated with fluoxetine 10 mg three times daily (63219).
General
...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.
Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).
Gastrointestinal
...When consumed orally, oats provide fiber.
Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).
Immunologic ...In a case report, a 45-year-old male developed acute generalized urticaria, facial angioedema, and dyspnea immediately after consuming oat flour. The reaction resolved after emergency care for anaphylaxis. Further investigation revealed an IgE-mediated hypersensitivity reaction to oat proteins (113490).
General ...Orally, large doses of thuja have been reported to cause toxicity involving headache, nervous agitation, seizures, gastric irritation, vomiting, abdominal pain, and diarrhea. Thuja toxicity has also been reported to cause liver damage, renal toxicity, and death in some cases (6002,40888).
Dermatologic
...Contact dermatitis, presenting as an itchy papular squamous eruption on the hands, developed in a 46-year-old female who handled thuja plants while gardening.
It resolved when contact with thuja was avoided. The causative ingredient of thuja was identified as limonene (113415).
In one case report, a 5-year-old female presented with a papillary eccrine adenoma. In an effort to avoid excisional biopsy, an ointment containing thuja was applied to the lesion for 6 months, resulting in peripheral extension and central necrosis of the lesion, eventually necessitating complete excision (106048).
Gastrointestinal ...Orally, large doses of thuja have been reported to cause toxicity involving gastric irritation, vomiting, abdominal pain, and diarrhea (6002,40888).
Hepatic ...Orally, large doses of thuja have been reported to cause toxicity involving liver damage and death (6002,40888). In one case report, a healthy 40-year-old female taking thuja and black cohosh for 1 month presented with 3 days of severe abdominal pain and AST and ALT levels exceeding 5 times the upper limit of normal. Symptoms improved within 5 days of supplement discontinuation and levels normalized within 2 weeks (106047). It is unclear if this reaction was due to thuja, black cohosh, or other factors.
Neurologic/CNS ...Orally, large doses of thuja have been reported to cause toxicity involving nervous agitation, seizures, and death (6002,40888).
Renal ...Orally, large doses of thuja have been reported to cause toxicity involving renal toxicity and death (6002,40888).
