| Ingredients | Not Present |
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(root)
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(root)
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(resin)
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Glycerin, Water, Distilled, Grain Alcohol
Below is general information about the effectiveness of the known ingredients contained in the product Oral Care Solution. 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
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 Oral Care Solution. 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 used orally in amounts commonly found in foods. Clove, clove oil, and eugenol have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when clove oil is applied topically (272). A clove oil 1% cream has been applied to the anus with apparent safety for up to 6 weeks (43487). A liposome-based product containing clove oil 45% has been applied to the palms with apparent safety for up to 2 weeks (100596).
LIKELY UNSAFE ...when clove smoke is inhaled. Smoking clove cigarettes can cause respiratory injury (17,43599). ...when clove oil is injected intravenously. This can cause pulmonary edema, hypoxemia, and acute dyspnea (16384). There is insufficient reliable information available about the safety of using clove orally in medicinal amounts.
CHILDREN: LIKELY UNSAFE
when clove oil is taken orally.
Ingesting 5-10 mL of undiluted clove oil has been linked to reports of coagulopathy, liver damage, and other serious side effects in infants and children up to 3 years of age (6,17,43385,43395,43419,43457,43652).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts found in foods (4912).
Clove, clove oil, and eugenol have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of using clove in medicinal amounts during pregnancy and lactation; avoid using.
LIKELY UNSAFE ...when used orally, topically, or intravenously. Total daily silver intake should not exceed 14 mcg/kg daily, or 980 mcg daily for a 70 kg person. Combining colloidal silver supplements with regular dietary intake of silver would likely result in exceeding this amount of silver. Silver accumulates in the body and can lead to an irreversible bluish skin discoloration known as argyria. Neurological deficits and diffuse silver deposition in visceral organs can also occur (5525,8148,8149,10647,10648,12092,92137,92138,92139,102575). In 1999, the US Food and Drug Administration (FDA) ruled that there is no evidence for the safety or effectiveness of colloidal silver products (14255,92137).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally, topically, or intravenously.
Silver appears to cross the placenta (92140). Epidemiological evidence links increased silver levels to developmental anomalies of the ear, face, and neck (5525). Colloidal silver supplements can also lead to silver accumulation and an irreversible bluish skin discoloration known as argyria. Neurological deficits and diffuse silver deposition in visceral organs can also occur (5525,5526,8148,8149,10647,10648,12092,92137,92138,92139).
LIKELY SAFE ...when used orally and appropriately. Ginger has been safely used in multiple clinical trials (721,722,723,5343,7048,7084,7085,7400,7623,11346)(12472,13080,13237,13244,17369,17928,17929,89889,89890,89894)(89895,89898,89899,90102,96252,96253,96259,96260,96669) (101760,101761,101762,103359,107903).
POSSIBLY SAFE ...when used topically and appropriately, short-term (89893,89897).
CHILDREN: LIKELY SAFE
when consumed in the amounts typically found in foods.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Ginger powder has been used with apparent safety at a dose of up to 750 mg daily for 4 days in girls aged 14-18 years (96255).
PREGNANCY: LIKELY SAFE
when consumed in the amounts typically found in foods.
Ginger is considered a first-line nonpharmacological treatment option for nausea in pregnancy by the American College of Obstetrics and Gynecology (ACOG) (111601). However, it should not be used long-term or without medical supervision and close monitoring.
PREGNANCY: POSSIBLY SAFE
when used for medicinal purposes.
Despite some early reports of adverse effects (721,7083) and one observational study suggesting that taking dried ginger and other herbal supplements during the first 20 weeks of pregnancy marginally increased the chance of stillbirth (96254), most research shows that ginger is unlikely to cause harm to the baby. The risk for major malformations in infants of parents who took ginger when pregnant does not appear to be higher than the baseline rate of 1% to 3% (721,1922,5343,11346,13071,13080,96254). Also, other research suggests that ginger intake during various trimesters does not significantly affect the risk of spontaneous abortion, congenital malformations, stillbirth, perinatal death, preterm birth, low birth weight, or low Apgar scores (18211,90103). Ginger use has been associated with an increase in non-severe vaginal bleeding, including spotting, after week 17 of pregnancy (18211).
LACTATION: LIKELY SAFE
when consumed in the amounts typically found in foods.
There is insufficient reliable information available about the safety of ginger when used for medicinal purposes; avoid amounts greater than those found in foods.
POSSIBLY SAFE ...when used orally and appropriately as a single dose (260,261). There is insufficient reliable information available about the safety of goldenseal when used as more than a single dose.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of goldenseal can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
PREGNANCY: LIKELY UNSAFE
when used orally.
Berberine is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to goldenseal (2589).
LACTATION:
LIKELY UNSAFE when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589). Use during lactation can cause kernicterus in the newborn and several resulting fatalities have been reported (2589).
POSSIBLY SAFE ...when neem bark extract is used orally and appropriately, short-term. Neem bark extract has been used safely in clinical research at doses up to 60 mg daily for up to 10 weeks (12822). ...when neem leaf and twig extract is used orally and appropriately, short-term. Neem leaf and twig extract has been used safely in clinical research at doses up to 500 mg twice daily for up to 12 weeks (104181). ...when neem leaf extract gel is used intraorally for up to 6 weeks (12824,64845,64850,94567). ...when neem oil, cream, or face wash is used topically on the skin for up to 2 weeks (64876,64878,64882,102867,107883).
POSSIBLY UNSAFE ...when neem or neem oil is used orally in large amounts or long-term. Preliminary clinical research suggests neem might be toxic to the kidneys or liver with high-dose or chronic use. Cardiac arrest has also been reported (12835,64870,64873).
CHILDREN: POSSIBLY SAFE
when neem extract is used topically.
It has been used with apparent safety as a shampoo, with one or two total applications (97928).
CHILDREN: LIKELY UNSAFE
when neem oil or seeds are used orally.
There are reports of infants who were severely poisoned and died after oral use of neem (3473,3474,3476,64855,64875).
PREGNANCY: LIKELY UNSAFE
when neem oil or leaf is used orally.
Neem oil and leaf have been used as abortifacients (12825,12835,64884,64889).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Oregano leaf and oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of oregano when used orally in amounts greater than those found in food. There is also insufficient reliable information available about the safety of oregano when used topically. Oregano oil in concentrations of greater than 1% may be irritating when applied to mucous membranes (67348,88188).
PREGNANCY: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Oregano is thought to have abortifacient and emmenagogue effects (19,7122,19104).
LACTATION:
There is insufficient reliable information available about the safety of oregano when used in medicinal amounts; avoid amounts greater than those found in food.
LIKELY SAFE ...when peppermint oil is used orally, topically, or rectally in medicinal doses. Peppermint oil has been safely used in multiple clinical trials (3801,3804,6190,6740,6741,10075,12009,13413,14467,17681)(17682,68522,96344,96360,96361,96362,96363,96364,96365,99493).
POSSIBLY SAFE ...when peppermint leaf is used orally and appropriately, short-term. There is some clinical research showing that peppermint leaf can be used safely for up to 8 weeks (12724,13413). The long-term safety of peppermint leaf in medicinal doses is unknown. ...when peppermint oil is used by inhalation as aromatherapy (7107). There is insufficient reliable information available about the safety of using intranasal peppermint oil.
CHILDREN: POSSIBLY SAFE
when used orally for medicinal purposes.
Enteric-coated peppermint oil capsules have been used with apparent safety under medical supervision in children 8 years of age and older (4469).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (96361).
There is insufficient information available about the safety of using peppermint in medicinal amounts during pregnancy or lactation; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Propolis has been used with apparent safety in clinical research at doses of up to 1500 mg daily (95883,99173,102520,102521). ...when used topically. Propolis as a 3% or 10% ointment, 0.5% cream, 30% mouth rinse, or 15% solution has been used with apparent safety in small clinical studies (799,1926,6602,8663,17629,17664,17665,92793,92800,95882)(99171,99173,102519,102521,105785,105786,108516,108523,109985).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY SAFE
when used orally and appropriately during lactation.
Propolis 300 mg daily has been used for 4-10 months in one clinical study with no apparent adverse effects to nursing infants (102518).
Below is general information about the interactions of the known ingredients contained in the product Oral Care Solution. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, clove oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
 Details
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Theoretically, concomitant use of clove extracts with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Clinical and laboratory research suggest that polyphenol extracts from clove flower buds might lower blood glucose levels (100595). Dosing adjustments for insulin or oral hypoglycemic agents may be necessary when taken with clove. Monitor blood glucose levels closely.
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Theoretically, topical application of clove oil with ibuprofen might increase the absorption and side effects of topical ibuprofen.
Details
Laboratory research shows that topical application of clove oil increases the absorption of topical ibuprofen (98854). This interaction has not been reported in humans.
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Ginger may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs. However, research is conflicting.
Details
Laboratory research suggests that ginger inhibits thromboxane synthetase and decreases platelet aggregation (7622,12634,20321,20322,20323,96257). However, this has not been demonstrated unequivocally in humans, with mixed results from clinical trials (96257). Theoretically, excessive amounts of ginger might increase the risk of bleeding when used with anticoagulant/antiplatelet drugs.
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Theoretically, taking ginger with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking ginger with calcium channel blockers might increase the risk of hypotension.
Details
Some animal and in vitro research suggests that ginger has hypotensive and calcium channel-blocking effects (12633). Another animal study shows that concomitant administration of ginger and the calcium channel blocker amlodipine leads to greater reductions in blood pressure when compared with amlodipine alone (107901).
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Theoretically, when taken prior to cyclosporine, ginger might decrease cyclosporine levels.
Details
In an animal model, ginger juice taken 2 hours prior to cyclosporine administration reduced the maximum concentration and area under the curve of cyclosporine by 51% and 40%, respectively. This effect was not observed when ginger juice and cyclosporine were administered at the same time (20401).
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Theoretically, ginger might increase the levels of CYP1A2 substrates.
Details
In vitro research shows that ginger inhibits CYP1A2 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2B6 substrates.
Details
In vitro research shows that ginger inhibits CYP2B6 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2C9 substrates.
Details
In vitro research shows that ginger inhibits CYP2C9 activity (111544). However, this interaction has not been reported in humans.
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Ginger might increase or decrease the levels of CYP3A4 substrates.
Details
In vitro research and some case reports suggest that ginger inhibits CYP3A4 activity (111544,111644). Three case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are CYP3A4 substrates (imatinib, dabrafenib, and crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
Conversely, other in vitro research suggests that ginger induces CYP3A4 activity, leading to reduced levels of CYP3A4 substrates (111404). However, this interaction has not been reported in humans. |
Theoretically, ginger might increase levels of losartan and the risk of hypotension.
Details
In animal research, ginger increased the levels and hypotensive effects of a single dose of losartan (102459). It is not clear if ginger alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.
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Theoretically, ginger might increase levels of metronidazole.
Details
In an animal model, ginger increased the absorption and plasma half-life of metronidazole. In addition, the elimination rate and clearance of metronidazole was significantly reduced (20350).
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Ginger may have antiplatelet effects and increase the risk of bleeding if used with nifedipine.
Details
Clinical research shows that combined treatment with ginger 1 gram plus nifedipine 10 mg significantly inhibits platelet aggregation when compared to nifedipine or ginger alone (20324).
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Ginger might increase the absorption and blood levels of P-glycoprotein (P-gp) substrates.
Details
In vitro research and case reports suggest that ginger inhibits drug efflux by P-gp, potentially increasing absorption and serum levels of P-gp substrates (111544,111644). Two case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are P-gp substrates (trametinib, crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
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Ginger might increase the risk of bleeding with phenprocoumon.
Details
Phenprocoumon, a warfarin-related anticoagulant, might increase the international normalized ratio (INR) when taken with ginger. There is one case report of a 76-year-old woman with a stable INR on phenprocoumon that increased to greater than 10 when she began consuming dried ginger and ginger tea (12880).
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Ginger might increase the risk of bleeding with warfarin.
Details
Laboratory research suggests that ginger might inhibit thromboxane synthetase and decrease platelet aggregation (7622,12634,20321,20322,20323). In one case report, ginger increased the INR when taken with phenprocoumon, which has similar pharmacological effects as warfarin (12880). In another case report, ginger increased the INR when taken with a combination of warfarin, hydrochlorothiazide, and acetaminophen (20349). A longitudinal analysis suggests that taking ginger increases the risk of bleeding in patients taking warfarin for at least 4 months (20348). However, research in healthy people suggests that ginger has no effect on INR, or the pharmacokinetics or pharmacodynamics of warfarin (12881,15176). Until more is known, monitor INRs closely in patients taking large amounts of ginger.
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Theoretically, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
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Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.
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Theoretically, goldenseal might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Goldenseal contains berberine. Animal research shows that berberine can have hypotensive effects (33692,34308). Also, an analysis of clinical research shows that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase the sedative effects of CNS depressants.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2C9.
Details
In vitro research shows that goldenseal root extract can modestly inhibit CYP2C9. This effect may be due to its alkaloid constituents, hydrastine and berberine (21117). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP2D6.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2E1.
Details
In vitro research shows that goldenseal root extract can inhibit the activity of CYP2E1 (94140). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP3A4.
Details
Most clinical and in vitro research shows that goldenseal inhibits CYP3A4 enzyme activity and increases serum levels of CYP3A4 substrates, such as midazolam (6450,13536,21117,91740,111725). However, in one small clinical study, goldenseal did not affect the levels of indinavir, a CYP3A4 substrate, in healthy volunteers (10690,93578). This is likely due to the fact that indinavir has a high oral bioavailability, making it an inadequate probe for CYP3A4 interactions (13536,91740) and/or that it is primarily metabolized by hepatic CYP3A, while goldenseal has more potential to inhibit intestinal CYP3A enzyme activity (111725). Both goldenseal extract and its isolated constituents berberine and hydrastine inhibit CYP3A, with hydrastine possibly having more inhibitory potential than berberine (111725).
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Theoretically, goldenseal might increase serum levels of dextromethorphan.
Details
Goldenseal contains berberine. A small clinical study shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).
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Goldenseal might increase serum levels of digoxin, although this effect is unlikely to be clinically significant.
Details
Clinical research shows that goldenseal modestly increases digoxin peak levels by about 14% in healthy volunteers. However, goldenseal does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal does not cause a clinically significant interaction with digoxin. Digoxin is a P-glycoprotein substrate. Some evidence suggests that goldenseal constituents might affect P-glycoprotein; however, it is unclear whether these constituents inhibit or induce P-glycoprotein.
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Theoretically, goldenseal might decrease the conversion of losartan to its active form.
Details
Goldenseal contains berberine. A small clinical study shows that berberine inhibits cytochrome P450 2C9 (CYP2C9) activity and reduces the metabolism of losartan (34279). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might reduce blood levels of metformin.
Details
In vitro research shows that goldenseal extract decreases the bioavailability of metformin, likely by interfering with transport, intestinal permeability, or other processes involved in metformin absorption. It is unclear which, if any, of metformin's transporters are inhibited by goldenseal. Goldenseal does not appear to alter the clearance or half-life of metformin (105764).
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Theoretically, goldenseal might reduce the therapeutic effects of oseltamivir by decreasing its conversion to its active form.
Details
In vitro evidence suggests that goldenseal reduces the formation of the active compound from the prodrug oseltamivir (105765). The mechanism of action and clinical relevance is unclear.
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Theoretically, goldenseal might increase or decrease serum levels of P-glycoprotein (P-gp) substrates.
Details
There is conflicting evidence about the effect of goldenseal on P-gp. In vitro research suggests that berberine, a constituent of goldenseal, modestly inhibits P-gp efflux. Other evidence suggests that berberine induces P-gp. In healthy volunteers, goldenseal modestly increases peak levels of the P-gp substrate digoxin by about 14%. However, it does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal is not a potent inhibitor of P-gp-mediated drug efflux. Until more is known, goldenseal should be used cautiously with P-gp substrates.
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Theoretically, goldenseal might increase the sedative effects of pentobarbital.
Details
Animal research shows that berberine, a constituent of goldenseal, can prolong pentobarbital-induced sleeping time (13519). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase serum levels of tacrolimus.
Details
Goldenseal contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of tacrolimus dosing to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).
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Neem might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, neem leaf extract might increase the levels and clinical effects of CYP2C8 substrates.
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In vitro research shows that neem leaf methanol extract inhibits CYP2C8 enzymes (111593). So far, this reaction has not been reported in humans.
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Theoretically, neem leaf extract might increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro research shows that neem leaf methanol extract inhibits CYP2C9 enzymes (111593). So far, this reaction has not been reported in humans.
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Theoretically, neem leaf extract might increase the levels and clinical effects of CYP3A4 substrates.
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In vitro research shows that neem leaf methanol extract inhibits CYP3A4 enzymes (111593). So far, this reaction has not been reported in humans.
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Theoretically, neem might decrease the effectiveness of immunosuppressants.
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Animal research suggests that neem might have immunostimulant effects (12825).
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Theoretically, neem leaf extract might increase the levels and clinical effects of P-glycoprotein substrates.
Details
In vitro research shows that neem leaf methanol extract inhibits renal P-glycoprotein transport activity (107850). So far, this reaction has not been reported in humans.
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Theoretically, oregano might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
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Theoretically, oregano might increase the risk for hypoglycemia when taken with antidiabetes drugs.
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Theoretically, peppermint oil might increase the levels and adverse effects of cyclosporine.
Details
In animal research, peppermint oil inhibits cyclosporine metabolism and increases cyclosporine levels. Inhibition of cytochrome P450 3A4 (CYP3A4) may be partially responsible for this interaction (11784). An interaction between peppermint oil and cyclosporine has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP1A2 substrates.
Details
In vitro and animal research shows that peppermint oil and peppermint leaf inhibit CYP1A2 (12479,12734). However, in clinical research, peppermint tea did not significantly affect the metabolism of caffeine, a CYP1A2 substrate. It is possible that the 6-day duration of treatment may have been too short to identify a difference (96359).
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Theoretically, peppermint might increase the levels of CYP2C19 substrates.
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In vitro research shows that peppermint oil inhibits CYP2C19 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP2C9 substrates.
Details
In vitro research shows that peppermint oil inhibits CYP2C9 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP3A4 substrates.
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Theoretically, propolis might increase the risk of bleeding when taken with antiplatelet or anticoagulant drugs.
Details
In vitro research shows that propolis water extract and the propolis constituent, caffeic acid phenethyl ester, can inhibit platelet aggregation (50794,95885). Additionally, evidence from an animal model shows that taking propolis in addition to warfarin decreases INR, suggesting that propolis can decrease the effectiveness of warfarin (95874).
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Theoretically, high doses of propolis might increase blood levels of drugs metabolized by CYP1A2.
Details
In vitro research shows that propolis extract can inhibit CYP1A2 (92797,92799). However, animal research shows that propolis extract does not significantly affect CYP1A2 activity when administered to rats at doses up to 250 mg/kg. It is postulated that the constituents of propolis that inhibit CYP1A2 in vitro do not have significant effects in vivo due to low bioavailability and hepatic first-pass effect (92797). This effect has not been reported in humans.
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Theoretically, high doses of propolis might increase blood levels of drugs metabolized by CYP2C19.
Details
In vitro research shows that propolis extract can inhibit CYP2C19 (92797,92799). However, animal research shows that propolis extract does not significantly affect CYP2C19 activity when administered to rats at doses up to 250 mg/kg. It is postulated that the constituents of propolis that inhibit CYP2C19 in vitro do not have significant effects in vivo due to low bioavailability and hepatic first-pass effect (92797). This effect has not been reported in humans.
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Theoretically, high doses of propolis might increase blood levels of drugs metabolized by CYP2C9.
Details
In vitro research shows that propolis extract can inhibit CYP2C9 (92797,92799). However, animal research shows that propolis extract does not significantly affect CYP2C9 activity when administered to rats at doses up to 250 mg/kg. It is postulated that the constituents of propolis that inhibit CYP2C9 in vitro do not have significant effects in vivo due to low bioavailability and hepatic first-pass effect (92797). This effect has not been reported in humans.
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Theoretically, high doses of propolis might increase blood levels of drugs metabolized by CYP2D6.
Details
In vitro research shows that propolis extract can inhibit CYP2D6 (92797,92799). However, animal research shows that propolis extract does not significantly affect CYP2D6 activity when administered to rats at doses up to 250 mg/kg. It is postulated that the constituents of propolis that inhibit CYP2D6 in vitro do not have significant effects in vivo due to low bioavailability and hepatic first-pass effect (92797). This effect has not been reported in humans.
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Theoretically, propolis might increase levels of drugs metabolized by CYP2E1.
Details
In vitro research shows that propolis can inhibit CYP2E1 (92799). This effect has not been reported in humans.
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Theoretically, high doses of propolis might increase blood levels of drugs metabolized by CYP3A4.
Details
Some in vitro research shows that propolis extract can inhibit CYP3A4 (92797); however, other in vitro research shows that propolis has no effect on CYP3A4 activity (92799). Furthermore, animal research shows that propolis extract does not significantly affect CYP3A4 activity when administered to rats at doses up to 250 mg/kg. It is postulated that the constituents of propolis that might in inhibit CYP3A4 in vitro do not have significant effects in vivo due to low bioavailability and hepatic first-pass effect (92797). This effect has not been reported in humans.
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Theoretically, propolis might decrease the effectiveness of warfarin.
Details
Animal research shows that taking propolis in addition to warfarin decreases the international normalized ratio (INR) (95874). This effect has not been reported in humans.
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Below is general information about the adverse effects of the known ingredients contained in the product Oral Care Solution. 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, clove is well tolerated when consumed as a spice; however, clove oil in doses of only 5-10 mL can be toxic in children.
Topically, clove is generally well tolerated. When inhaled or used intravenously, clove may be unsafe.
Most Common Adverse Effects:
Topically: Burning, contact dermatitis, dental decay, itching, mucous membrane irritation, tingling, ulcers.
Inhaled: Dental decay, hypertension, itching, tachycardia.
Serious Adverse Effects (Rare):
Orally: Liver failure, respiratory distress.
Inhaled: Pneumonitis, pulmonary edema, respiratory distress.
Cardiovascular ...Smoking clove cigarettes increases heart rate and systolic blood pressure (12892).
Dental ...Population research has found that the risk of dental decay is increased in clove cigarette smokers (43332). Repeated topical application of clove in the mouth can cause gingival damage and skin and mucous membrane irritation (4,272,512). Eugenol, a constituent of clove and a material commonly found in dentistry, has been associated with side effects including gum inflammation and irritation (43365,43373,43522).
Dermatologic ...The American Dental Association has accepted clove for professional use, but not nonprescription use, due to potential damage to soft tissue that may be induced by clove application. In clinical research, small aphthous-like ulcers appeared in the area of the mouth where clove gel was applied in four participants (43448). Skin irritation and stinging have been reported with clove oil application (43338,43626). In a 24-year-old, exposure to a clove oil spill resulted in permanent local anesthesia and anhidrosis, or lack of sweating, at the affected area (43626).
Endocrine ...A case of hypoglycemia and metabolic acidosis have been reported after administration of one teaspoon of clove oil to a seven-month-old infant (43457). A case of electrolyte imbalance following accidental ingestion by a seven-month-old has also been reported (6).
Hematologic ...A case of disseminated intravascular coagulation has been reported in a 2-year-old patient after consuming between 5-10 mL of clove oil. The patient was treated with heparin, fresh frozen plasma, protein C, factor VII, and antithrombin III. On the fifth day, the patient started to improve and made a full recovery (43652).
Hepatic ...There are three cases of hepatic failure occurring in children after ingestion of 5-10 mL of clove oil (43395,43419,43652). Liver injury also occurred in a 3-year-old male (96949). These patients were successfully treated with N-acetylcysteine. The course of liver injury seems to be milder and shorter with early N-acetylcysteine treatment (43395,43419,96949). Another patient, who also presented with disseminated intravascular coagulation, was successfully treated with heparin, fresh frozen plasma, protein C, factor VII, and antithrombin III (43652).
Immunologic ...Contact dermatitis and urticaria has been reported following topical exposure to clove oil or eugenol, a constituent of clove oil (12635,43339,43606,43346).
Neurologic/CNS ...CNS depression has been reported in a 7-month-old who was given one teaspoon of clove oil accidentally in place of mineral oil for diarrhea. The patient was successfully treated with supportive care and gastric lavage (43457). A case of confusion and inability to speak has been reported secondary to oral exposure to clove oil and alcohol. The patient required intubation and was successfully treated with thiamine and normal saline (43580). Seizure and coma have been reported in a two-year-old male after ingesting 5-10 mL of clove oil (43652).
Pulmonary/Respiratory
...Clove cigarettes have been associated with throat and chest tightness (43337), pulmonary edema (43618), and fatal aspiration pneumonitis (43599).
The causative factor may be clove alone or clove along with other substances found in cigarettes. Clove cigarettes contain significant amounts of nicotine, tar, and carbon monoxide and increase plasma levels of nicotine and exhaled carbon monoxide, which might cause long-term health effects similar to tobacco smoking (12892). According to the American Medical Association, inhaling clove cigarette smoke has been associated with severe lung injury in a few susceptible individuals with prodromal respiratory infection. Also, some individuals with normal respiratory tracts have apparently suffered aspiration pneumonitis as the result of a diminished gag reflex induced by a local anesthetic action of eugenol, which is volatilized into the smoke (43602).
Intravenous injection of clove oil in a 32-year-old female resulted in hypoxia, acute dyspnea, interstitial and alveolar infiltrates, and non-cardiogenic pulmonary edema. The patient was managed with supplemental oxygen and recovered over the next seven days (16384).
Occupational exposure to eugenol, a constituent of clove, has also been reported to cause asthma and rhinitis (43492).
Renal ...Proteinuria and other urinary abnormalities were observed in a seven-month-old infant given one teaspoon of clove oil accidentally in place of mineral oil for diarrhea. The patient was successfully treated with supportive care and gastric lavage (43457).
General
...Orally, topically, or via inhalation, colloidal silver can cause serious adverse effects.
Most Common Adverse Effects:
All routes of administration: An irreversible deposition of silver in the skin and mucous membranes with chronic use or high doses can cause a grey-blue discoloration known as argyria. Colloidal silver has also been associated with vision loss and organ damage.
Dermatologic ...Orally, topically, or via inhalation, long-term use of colloidal silver can lead to an irreversible deposition of silver compounds in the mucous membranes, skin, and nails. This condition, which is known as argyria, has been described in numerous case reports (5525,8148,8149,10647,10648,12092,44474,44493,44498,44501)(44514,44523,44528,44538,44540,44547,44593,44638,44649,44726)(44788,44825,44815,92137,92138,92139,96760,102571,102572,102573)(102575,112289). Argyria is characterized by a blueish-gray discoloration which occurs when the silver compounds from colloidal silver are reduced to elemental silver (44474,92139). Since sunlight catalyzes the reduction of silver compounds to elemental silver, sun exposed regions are usually most affected (92138,92139). The blueish-gray discoloration also occurs because colloidal silver can stimulate melanin production in skin (92139). Argyria typically first appears in the gingiva with a slate-blue silver line (5525). It can also occur in the fingernails, where it may be an early sign of silver ingestion and is also known as azure lunula (8149,10648,112289). Argyria usually occurs after ingestion of 4-5 grams of colloidal silver (92138). Although the blueish-gray discoloration associated with argyria is permanent, laser treatment may be used to lighten the skin (92139).
Hematologic ...Intravenously, severe anemia and leukopenia with elevated serum ferritin have been reported in various patients given colloidal silver. In one case, a 30‐year‐old female experienced severe anemia after receiving 48 infusions with a specific colloidal silver marketed for oral use (Argentyn 23). The infusions provided silver 883 mg and were administered over 3 months. The patient was treated for anemia with oral copper, as well as four apheresis treatments. Similar symptoms occurred in other females who were treated with oral copper and repeated blood transfusions. The anemia associated with colloidal silver is related to a decline in serum levels of copper, which is needed for the production of hemoglobin (102570).
Hepatic ...Orally and intravenously, hepatotoxicity has been reported. A 64-year-old male experienced cholelithiasis with acute encephalopathy after repeated oral dosing with colloidal silver providing 2838 ppm of silver over 4 hours (102572). Intravenously, elevated liver enzymes, up to 150 times normal, have been reported in a 30‐year‐old female who received 48 infusions with a specific colloidal silver marketed for oral use (Argentyn 23) providing silver 883 mg over 3 months (102570).
Neurologic/CNS ...At least two cases of myoclonic seizures have been reported after the use of homemade colloidal silver preparations (44485,44649). In one case, myoclonic status epilepticus and coma occurred secondary to consumption of a homemade colloidal silver drink (Schaffer's Health Center Ltd., Unity). The patient had consumed at least one ounce daily for 4 months. The seizures did not respond to benzodiazepines, valproate, phenytoin, phenobarbital, or propofol. The patient required mechanical ventilation and remained in a coma in the intensive care unit for 50 days (44485). In another case, myoclonic seizures and aspiration pneumonia occurred in a 75-year-old male who ingested "several spoons" of homemade colloidal silver up to 4 times daily whenever he "felt a cold coming on" for 4 years. The seizures were treated with clonazepam, and after being hospitalized for 2 months, he was discharged to a nursing home (44649). A more recent case report describes a 70-year-old male hospitalized after exhibiting expressive aphasia, focal seizure followed by generalized seizure, hypertension, encephalopathy, and an abnormal electroencephalogram. The patient had been self-medicating with colloidal silver 1 ounce daily, and blood tests revealed silver levels nearly 16 times that of normal. Extensive tests could not identify any other probable cause other than the silver use. The patient recovered and was discharged on levetiracetam, which was well tolerated at 2 months follow-up. The colloidal silver was a home-made electrolysis preparation using direct current, silver anodes, and steam distilled water (112290).
Ocular/Otic ...Chronic ingestion or inhalation of colloidal silver may cause silver deposition in the eye. This condition is known as ocular argyrosis, which is characterized by a blueish-gray discoloration of the eye (44514,102571). In one case report, chronic use of oral colloidal silver over 9 years resulted in a 2-week history of loss of vision in one eye (102571). Topically, use of eye drops containing colloidal silver can also cause this condition (44821). In one report, a case of ocular argyrosis reportedly occurred in a patient with long-standing herpetic keratitis after only one treatment with eye drops consisting of a 1% solution of colloidal silver (44822).
Oncologic ...Orally, chronic intake of colloidal silver over a 10-year period may have caused bone marrow damage, possibly contributing to the diagnosis of acute myeloid leukemia in a 72-year-old male. The patient died of respiratory failure related to recurrent pneumonia (102574).
Renal ...Orally, glomerulonephritis has been reported in a 47-year-old female who took colloidal silver to treat her T-cell lymphoma. She was treated with hemodialysis, intravenous methylprednisolone, and intravenous cyclophosphamide (102575).
General
...Orally, ginger is generally well tolerated.
However, higher doses of 5 grams per day increase the risk of side effects and reduce tolerability. Topically, ginger seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, burping, diarrhea, heartburn, and a pepper-like irritant effect in the mouth and throat. However, some of these mild symptoms may be reduced by ingesting encapsulated ginger in place of powdered ginger.
Topically: Dermatitis in sensitive individuals.
Cardiovascular ...Orally, use of ginger resulted in mild arrhythmia in one patient in a clinical trial (16306).
Dermatologic
...Orally, ginger can cause hives (17933), as well as bruising and flushing (20316) or rash (20316).
Topically, ginger can cause dermatitis in sensitive individuals (12635,46902).
Gastrointestinal
...Orally, common side effects of ginger include nausea (17933,22602,89898,101761), belching (10380,103359), dry mouth (103359), dry retching (10380), vomiting (10380), burning sensation (10380), oral numbness (22602), abdominal discomfort (5343,89898,96253), heartburn (5343,7624,12472,16306,20316,51845,89894,89895,89898,89899)(101760,101761,101762,111543), diarrhea (5343,101760), constipation (89898,101760,101761), or a transient burning or "chilly hot" sensation of the tongue and throat (52076).
Orally, Number Ten, a specific product composed of rhubarb, ginger, astragalus, red sage, and turmeric, can increase the incidence of loose stools (20346).
Four cases of small bowel obstruction due to ginger bolus have been reported following the ingestion of raw ginger without sufficient mastication (chewing). In each case, the bolus was removed by enterotomy. Ginger is composed of cellulose and therefore is resistant to digestion. It can absorb water, which may cause it to swell and become lodged in narrow areas of the digestive tract (52115).
Genitourinary ...In one clinical trial, some patients reported increased menstrual bleeding while taking a specific ginger extract (Zintoma, Goldaru) 250 mg four times daily orally for 3 days (17931). An "intense" urge to urinate after 30 minutes was reported in two of eight patients given 0.5-1 gram of ginger (7624). However, this effect has not been corroborated elsewhere. Dysuria, flank pain, perineal pain, and urinary stream interruption have been reported in a 43-year-old male who drank ginger tea, containing 2-3 teaspoons of dry ginger, daily over 15 years. The adverse effects persisted for 4 years and were not associated with increases in urinary frequency or urgency. Upon discontinuing ginger, the patient's symptoms began to improve within one week and completely resolved after eight weeks, with no relapses six months later (107902).
Immunologic ...In one case report, a 59-year-old Japanese female with multiple allergic sensitivities developed pruritus and then anaphylactic shock after taking an oral ginger-containing herbal supplement for motion sickness (Keimei Gashinsan, Keimeido). The patient had used this supplement previously for over 20 years with no allergic reaction. The authors theorized the development of a cross-reactivity to ginger after the use of an oral supplement containing zedoary and turmeric, which are also in the Zingiberaceae family (102463).
Neurologic/CNS ...Orally, ginger may cause sedation, drowsiness, or dizziness (16306,17933,51845).
General
...There is limited reliable information available about the safety of goldenseal when used in more than a single dose.
Berberine, a constituent of goldenseal, is generally well tolerated when used orally.
Most Common Adverse Effects:
Orally: Berberine, a constituent of goldenseal, can cause abdominal distension, abdominal pain, bitter taste, constipation, diarrhea, flatulence, headache, nausea, and vomiting.
Dermatologic ...Orally, berberine, a constituent of goldenseal, may cause rash. However, this appears to be rare (34285). A case of photosensitivity characterized by pruritic, erythematous rash on sun-exposed skin has been reported in a 32-year-old female taking a combination product containing goldenseal, ginseng, bee pollen, and other ingredients. The rash resolved following discontinuation of the supplement and treatment with corticosteroids (33954). It is not clear if this adverse effect is due to goldenseal, other ingredients, or the combination.
Endocrine ...A case of severe, reversible hypernatremia has been reported in an 11-year-old female with new-onset type 1 diabetes and diabetic ketoacidosis who took a goldenseal supplement (52592).
Gastrointestinal ...Orally, berberine, a constituent of goldenseal, may cause diarrhea, constipation, flatulence, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953). Theoretically, these effects may occur in patients taking goldenseal. However, this hasn't been reported in clinical research or case reports.
Neurologic/CNS ...Orally, berberine, a constituent of goldenseal, may cause headache when taken in a dose of 5 mg/kg daily (33648). Theoretically, this may occur with goldenseal, but this hasn't been reported in clinical research or case reports.
General
...Orally, neem extracts seem to be well tolerated in adults.
However, high-quality assessment of safety has not been conducted. In children, oral use of neem oil can cause serious adverse effects. Topically, neem seems to be well tolerated in children and adults.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Cardiac arrest, nephrotoxicity, and ventricular fibrillation with neem leaf in adults. Encephalopathy, hematologic abnormalities, hepatotoxicity, and nephrotoxicity with neem oil in infants and young children.
Cardiovascular ...Orally, neem leaf has been reported to cause ventricular fibrillation and cardiac arrest after ingestion in humans (64873,64870).
Dental ...Topically, use of neem twigs to brush teeth, which is a traditional dental hygiene practice in India, has been associated with vitiligo of the lips. The limonoid constituents in neem, which have been shown to inhibit melanogenesis and have cytotoxic effects, combined with repeated, local trauma from this dental hygiene practice are thought to cause this leucodermic reaction. In a case series of seven patients experiencing vitiligo of the lips from neem twigs, use of toothpaste and topical tacrolimus along with avoidance of neem stopped the progression of depigmentation in all patients. Repigmentation was reported in four of the seven patients 12 months after discontinuing neem-based dental hygiene practices (100958).
Dermatologic ...Topically, neem products have been associated with dermatologic reactions. Some case reports have associated the use of topical neem oil with contact dermatitis (64851,94568,102867). In one case series, the topical application of neem seed extract shampoo was associated with skin irritation, red spots, and a burning feeling of the scalp (64848). Use of neem twigs to brush teeth, which is a traditional dental hygiene practice in India, has been associated with vitiligo of the lips. The limonoid constituents in neem, which have been shown to inhibit melanogenesis and have cytotoxic effects, combined with repeated, local trauma from this dental hygiene practice are thought to cause this leucodermic reaction. In a case series of seven patients experiencing vitiligo of the lips from neem twigs, use of toothpaste and topical tacrolimus along with avoidance of neem stopped the progression of depigmentation in all patients. Repigmentation was reported in four of the seven patients 12 months after discontinuing neem-based dental hygiene practices (100958).
Gastrointestinal ...Orally, neem oil has been reported to cause vomiting and loose stools in infants and small children (3473,3474,3476,64865).
Genitourinary ...Orally, neem leaf has been reported to cause oliguria and anuria in adults (12833,12834). After a single intrauterine instillation, purified neem oil has been reported to cause endometritis in healthy, tubectomised females (64886).
Hematologic
...Orally, neem leaf has been reported to cause hemolysis in adults (12835).
In one case report, a 35-year-old male with diabetes and glucose-6-phosphate dehydrogenase (G6PD) deficiency developed hemolytic anemia and jaundice after drinking several liters of neem tea daily for 3 weeks. All symptoms resolved after discontinuation and supportive treatment (94571). Orally, neem oil has been reported to cause metabolic acidosis, anemia, and polymorphonuclear leukocytosis in infants and young children (3473,3474,3476,64865).
A single intrauterine instillation of purified neem oil has been reported to cause mild transient eosinophilia in healthy, tubectomised females (64886).
Hepatic ...Orally, neem oil has been associated with reports of hepatotoxicity in infants and children. These adverse effects occurred after single doses of neem oil ranging from a few drops to 60 mL. Pathologic findings on liver biopsy reports have been consistent with Reye-like syndrome (3473,3474,3475).
Immunologic ...Topically, a case of aggravated bullous pemphigoid requiring hospitalization is reported in a 47-year-old patient with this autoimmune condition after application of neem oil to blisters for an unknown duration (111715).
Neurologic/CNS ...Orally, single doses of neem oil ranging from a few drops to 60 mL have been associated with reports of encephalopathy in infants and small children. Symptoms include drowsiness, seizure, loss of consciousness, coma, cerebral edema, Reye-like syndrome, and death within hours of ingestion (3473,3474,3476,3476,64855,94750). There is also at least one case report of neurotoxicity in an adult after ingestion of a neem-based pesticide. A 35-year-old female experienced neurotoxicity requiring intensive medical care and ventilation after ingestion of a pesticide containing azadirachtin, a constituent of neem oil (64858).
Ocular/Otic ...In one case report, a 35-year-old female developed toxic optic neuropathy and vision loss in both eyes lasting for two days after consuming 150 mL of neem oil in a suicide attempt five days earlier (64856).
Renal ...Orally, neem leaf has been reported to cause oliguria, anuria, acute tubular necrosis, and nephrotoxicity in adults (12833,12834). There are some case reports of children developing Reye-like syndrome after ingestion of neem oil. Pathologic findings on renal biopsy reports have been consistent with Reye syndrome (3473,3474,3475).
General
...Orally, oregano is well tolerated when used in amounts typically found in foods.
There is currently a limited amount of information available about the safety of oregano when used in larger amounts as medicine.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Topically: Dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Systemic allergic reactions, including anaphylaxis, in sensitive individuals.
Dermatologic ...Oregano has been reported to cause allergic contact dermatitis (46902). Topically, oregano oil in concentrations of greater than 1% has been reported to cause irritation when applied to mucous membranes (67348,88188).
Gastrointestinal ...Orally, large amounts of oregano can cause gastrointestinal upset. Concentrated, non-emulsified oil of oregano can cause localized irritation of the gastrointestinal tract (6878).
Immunologic ...Systemic allergic reactions have been reported with oregano. A 45-year-old male developed pruritus, respiratory difficulty, hypotension, swelling of the lips and tongue, and facial edema after ingesting pizza seasoned with oregano. He had 2 similar episodes after ingesting foods seasoned with thyme, another member of the Lamiaceae family. He did not react to similar foods without the seasoning, and he had positive skin tests to plants of the Lamiaceae family (3705).
General
...Orally, topically, or rectally, peppermint oil is generally well tolerated.
Inhaled,
peppermint oil seems to be well tolerated. Intranasally, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted. Orally, peppermint leaf seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, anal burning, belching, diarrhea, dry mouth, heartburn, nausea, and vomiting.
Topically: Burning, dermatitis, irritation, and redness.
Dermatologic
...Topically, peppermint oil can cause skin irritation, burning, erythema, and contact dermatitis (3802,11781,31528,43338,68473,68457,68509,96361,96362).
Also, a case of severe mucosal injury has been reported for a patient who misused an undiluted over the counter mouthwash that contained peppermint and arnica oil in 70% alcohol (19106).
In large amounts, peppermint oil may cause chemical burns when used topically or orally. A case of multiple burns in the oral cavity and pharynx, along with edema of the lips, tongue, uvula, and soft palate, has been reported for a 49-year-old female who ingested 40 drops of pure peppermint oil. Following treatment with intravenous steroids and antibiotics, the patient's symptoms resolved over the course of 2 weeks (68432). Also, a case of chemical burns on the skin and skin necrosis has been reported for a 35-year-old male who spilled undiluted peppermint oil on a previous skin graft (68572). Oral peppermint oil has also been associated with burning mouth syndrome and chronic mouth ulceration in people with contact sensitivity to peppermint (6743). Also, excessive consumption of mint candies containing peppermint oil has been linked to cases of stomatitis (13114).
Gastrointestinal ...Orally, peppermint oil can cause heartburn, nausea and vomiting, anal or perianal burning, abdominal pain, belching, dry mouth, diarrhea, and increased appetite (3803,6740,6741,6742,10075,11779,11789,17682,68497,68514)(68532,68544,96344,96360,102602,104219,107955). Enteric-coated capsules might help to reduce the incidence of heartburn (3802,4469,6740,11777). However, in one clinical study, a specific enteric-coated formulation of peppermint oil (Pepogest; Nature's Way) taken as 180 mg three times daily was associated with a higher rate of adverse effects when compared with placebo (48% versus 31%, respectively). Specifically, of the patients consuming this product, 11% experienced belching and 26% experienced heartburn, compared to 2% and 12%, respectively, in the placebo group (107955). A meta-analysis of eight small clinical studies in patients with irritable bowel syndrome shows that taking enteric-coated formulations of peppermint oil increases the risk of gastroesophageal reflux symptoms by 67% when compared with a control group (109980). Enteric-coated capsules can also cause anal burning in people with reduced bowel transit time (11782,11789).
Genitourinary ...Orally, a sensitive urethra has been reported rarely (102602).
Hepatic ...One case of hepatocellular liver injury has been reported following the oral use of peppermint. Symptoms included elevated liver enzymes, fatigue, jaundice, dark urine, and signs of hypersensitivity. Details on the dosage and type of peppermint consumed were unavailable (96358).
Immunologic ...One case of IgE-mediated anaphylaxis, characterized by sudden onset of lip and tongue swelling, tightness of throat, and shortness of breath, has been reported in a 69-year-old male who consumed peppermint candy (89479). An allergic reaction after use of peppermint oil in combination with caraway oil has been reported in a patient with a history of bronchial asthma (96344). It is not clear if this reaction occurred in response to the peppermint or caraway components.
Neurologic/CNS ...Orally, headache has been reported rarely (102602).
Ocular/Otic ...Orally, peppermint has been reported to cause blurry vision (3803).
General
...Orally and topically, propolis seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache.
Topically: Contact cheilitis and contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions in sensitive individuals.
Dermatologic
...Propolis can cause allergic reactions and acute oral mucositis with ulceration from the use of the propolis-containing lozenges (2632).
Topically, propolis-containing products, including some cosmetics, can cause eczematous contact dermatitis, erythema multiforme-like contact dermatitis, or allergic contact cheilitis (2632,15647,92796,92798,95878,95882,102517).
Patients allergic to bees or bee products may be more likely to experience allergic reactions to propolis.
Genitourinary ...Vulvar eczema caused by propolis sensitization after topical therapy has been reported (70067).
Hepatic ...Orally, propolis may cause an increase in liver enzymes when used long-term at high doses. In one case, a 30-year-old male presented with persistent abnormal liver enzymes for six months. With other causes ruled out, the patient disclosed using more than 10 propolis lozenges per day for several months to treat a sore throat. Upon discontinuation of the propolis lozenges, liver enzymes returned to normal (105788). Despite concerns presented in this case, analyses of small clinical studies suggest that propolis may have hepatoprotective effects when used at doses of 500-1000 mg daily for up to one year (108521,108522).
Immunologic
...In one case report, a 36-year-old female developed severe erythematous papules and patches with edema of the face, neck, arms, abdomen, and thighs after consuming propolis solution for a few weeks.
After symptom resolution, a patch test showed an extreme positive reaction to propolis (106443). In another case, laryngeal edema and severe anaphylactic reaction has been reported in a patient who used topical propolis for the treatment of acute pharyngitis. The patient died due to complications of hypoxia that resulted from the allergic reaction (70063).
Topically, propolis-containing products can cause allergic contact dermatitis, including cheilitis, when used on or near the lips or mouth (15647,92796,92798,102517). Propolis-containing lozenges can cause allergic reactions as well as acute oral mucositis with ulceration (2632).
Patients allergic to bees or bee products may be more likely to experience allergic reactions to propolis.
Neurologic/CNS ...Orally, propolis may cause headache in some patients. In one clinical trial, around 7% of patients taking propolis 250 mg twice daily for 4 months reported mild headache (105786).
Renal ...In one case report, a 59-year-old male with cholangiocarcinoma developed acute kidney failure requiring hemodialysis after taking a Brazilian preparation of propolis 5 mL three times daily for 2 weeks. Renal function improved when propolis was discontinued. The patient restarted taking propolis and symptoms developed again and the patient again required hemodialysis. Symptoms of renal failure improved when propolis was finally discontinued. This product was not screened for contaminants; however, family members of this patient used the same product without apparent adverse effects (14300).
