Pain and Fever Relief Oral Liquid by Brauer

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alopecia areata. Although there has been interest in using oral aconite for alopecia areata, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Amenorrhea. Although there has been interest in using oral aconite for amenorrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Asthma. Although there has been interest in using oral aconite for asthma, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using injectable aconite for COVID-19, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Diarrhea. Although there has been interest in using oral aconite for diarrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Heart failure. It is unclear if oral aconite is beneficial in patients with left ventricular failure. Details: Preliminary clinical research in patients with left ventricular failure shows that taking heat processed aconite tuber 1000 mg daily for up to 7 months modestly improves heart and kidney function when compared with placebo (30314).
• Pneumonia. Injectable aconite has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Oral aconite has not been evaluated for this use. Details: A meta-analysis of 20 small, low-quality randomized and non-randomized studies in older Chinese adults with severe pneumonia shows that 77% of patients receiving an injection containing aconite extract 0.1 mg/mL and panax ginseng extract 0.8 mg/mL had improvement in symptoms such as fever, cough, and chest tightness when compared with 61% of those who received standard treatment. This combination injection may also modestly reduce disease severity and the risk of mortality when compared with standard treatment. However, these outcomes were not evaluated in all studies, and dosing regimens were heterogenous, with doses ranging from 60-100 mL daily or twice daily for 7-14 days (110472).
• Raynaud syndrome. Although there has been interest in using oral aconite for Raynaud syndrome, there is insufficient reliable information about the clinical effects of aconite for this purpose. More evidence is needed to rate aconite for these uses.

(Read more about ACONITE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Although there is interest in using oral belladonna for asthma, there is insufficient reliable information about the effects of belladonna for this condition.
• Common cold. Although there is interest in using oral belladonna for the common cold, there is insufficient reliable information about the effects of belladonna for this condition.
• Hemorrhoids. Although there is interest in using rectal belladonna for hemorrhoids, there is insufficient reliable information about the effects of belladonna for this condition.
• Irritable bowel syndrome (IBS). It is unclear if oral belladonna is beneficial in patients with IBS. Details: A prescription-only oral combination of belladonna and phenobarbital, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106908). However, preliminary clinical research suggests that taking a combination of belladonna and phenobarbital orally for one month does not improve symptoms of IBS when compared with placebo (34156).
• Kidney stones (nephrolithiasis). It is unclear if rectal belladonna is beneficial in patients with ureteral spasm associated with kidney stones. Details: A prescription-only rectal combination of belladonna and opium, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106909). Clinical trials for this indication have not been published, and clinical data are not included in the package insert.
• Parkinson disease. Although there is interest in using oral belladonna for Parkinson disease, there is insufficient reliable information about the effects of belladonna for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using topical belladonna for RA, there is insufficient reliable information about the effects of belladonna for this condition. More evidence is needed to rate belladonna for these uses.

(Read more about BELLADONNA)

POSSIBLY EFFECTIVE

• Menopausal symptoms. Oral black cohosh seems to modestly improve some physical symptoms of menopause, but it is unclear if black cohosh improves mood-related symptoms. Details: A meta-analysis of 22 studies in adults with menopause shows that taking black cohosh extract alone or in combination with other herbal medicines for 4-52 weeks improves overall menopausal symptoms, hot flashes, and somatic symptoms but not anxiety or depressive symptoms when compared with placebo (111659). Meta-analyses of 20 clinical trials that assessed black cohosh shows that overall black cohosh is not superior to placebo and is inferior to hormonal therapy for reducing hot flash frequency and symptoms of menopause (89467,92661). The most consistent evidence is for a specific isopropanolic extract of black cohosh (Remifemin, Phytopharmica/Enzymatic Therapy). When taken in doses of 40-127 mg daily for up to 12 weeks it reduces menopausal symptoms and hot flash frequency when compared with placebo (9437,13143,13184,14423,15889,35824,35853,35904,35964). It also seems to be comparable to hormonal therapy, including low-dose transdermal estradiol (Estraderm) 25 mcg every 7 days (13184), tibolone 2.5 mg daily (15889,35904), or conjugated equine estrogens (Premarin) 0.625 mg daily (35964). Additionally, the Spanish Menopause Society (AEEM) states that most current evidence shows that this specific black cohosh extract, at a dose of 40 mg daily, is most effective at improving mood and treating vasomotor symptoms such as reducing night sweats and hot flushes, particularly in those with intense hot flushes. In women with natural menopause, taking this extract at a dose of 8-128 mg for 3-6 months treats vasomotor symptoms more effectively than placebo and similarly to low-dose transdermal estrogen or tibolone. Additionally, black cohosh improves depression, anxiety, sleep quality, vaginal atrophy, and bone metabolism but does not seem to clinically impact endometrium thickness, cognitive function, skin, or lipid profiles (111634). Research using other formulations of black cohosh is less consistent. One commercial black cohosh extract CR BNO 1055 (Klimadynon/Menofem, Bionorica AG) 40 mg daily in 1-2 divided doses for 60-90 days does not reduce menopausal symptoms when compared with control groups (10987,13169,35908). Other clinical research shows that taking a different commercial black cohosh extract (Remixin, Mikro-Gen) 40 mg daily for 6 months reduces hot flashes and night sweats when compared with fluoxetine 20 mg daily (35852). However, the high dropout rate and lack of placebo group limit the reliability of these findings. Studies using non-commercial black cohosh extracts have been mostly negative. In one study, taking a black cohosh extract 6.5 mg daily for 12 weeks did not reduce hot flashes or symptom rating scores when compared with placebo; however, a subgroup of patients with at least moderate symptoms appeared to have improvement in some symptoms (14424). In another study, taking black cohosh ethanolic extract 160 mg daily did not reduce frequency of hot flashes or other vasomotor symptoms after 12 months of treatment (15158). Taking another black cohosh extract 128 mg daily for 12 months was significantly less effective than conjugated equine estrogens (Premarin) in reducing hot flashes and night sweats, and was also less effective than placebo at some time points during the study (17091). Black cohosh has also been evaluated in patients with cancer treatment-induced menopausal symptoms. A small observational study in adults with menopausal symptoms secondary to tamoxifen therapy for breast cancer suggests that taking a dry extract of black cohosh 20 mg improves climacteric symptoms when compared with placebo (111635). The validity of these effects is limited by a small sample size and lack of a comparator group. Preliminary clinical trials have also evaluated black cohosh in combination with numerous other herbal ingredients (15037,15893,19552,35853,53707,103269). Several trials have shown a benefit with some combinations when compared with baseline or placebo, but these combinations have not been compared with black cohosh alone. It is unclear whether the effects are due to black cohosh, other ingredients, or the combinations.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there has been interest in using topical black cohosh for acne, there is insufficient reliable information about the clinical effects of black cohosh for this purpose.
• Anxiety. Black cohosh does not appear to be effective for treating anxiety in postmenopausal patients. Details: Preliminary clinical research in postmenopausal patients shows that taking a black cohosh extract, 64 mg daily for 2 weeks, then gradually increasing to 128 mg daily for a total of 12 weeks, does not improve anxiety as measured on the Hamilton Anxiety Rating (HAM-A) scale, when compared with placebo (35897).
• Breast cancer. It is unclear if oral black cohosh is beneficial for breast cancer treatment or prevention. Details: One observational study suggests that the use of black cohosh supplements is associated with a decreased risk of breast cancer (35841); however, other population-based studies found no difference (17412,35896). In females diagnosed with breast cancer, one observational study found that black cohosh extract was associated with prolonged disease-free survival (35845). A small observational study in patients with ductal carcinoma in situ (DCIS) suggests that taking isopropanolic black cohosh extract 20 mg twice daily for 2-6 weeks prior to breast surgery does not impact breast cancer cellular proliferation, tumor volume, invasive disease upgrade rates, or hormone levels including estradiol, and follicle-stimulating hormone when compared to baseline (111714). The validity of these effects is limited by a lack of a comparator group.
• Breast cancer-related hot flashes. Evidence for the use of oral black cohosh for hot flashes associated with breast cancer is conflicting. Details: Preliminary open-label trials show that taking black cohosh extracts can reduce hot flashes in females with a history of breast cancer (13169,14423). However, higher-quality randomized controlled trials show that black cohosh does not reduce hot flashes in these patients (7054,15161).
• Cardiovascular disease (CVD). It is unclear if oral black cohosh reduces the risk of CVD. Details: Preliminary clinical research in postmenopausal adults shows that taking a specific black cohosh extract called CR BNO 1055 (Klimadynon Uno, Bionorica) 40 mg daily, in conjunction with endurance exercise, for 10 weeks does not reduce cardiovascular disease risk measured by the Framingham Risk score when compared with endurance exercise or light exercise alone (35908).
• Cognitive function. It is unclear if oral black cohosh is beneficial for improving cognitive function in postmenopausal patients. Details: In one preliminary clinical trial, taking a black cohosh extract 128 mg daily for 12 months did not significantly improve performance on memory and attention tests when compared with placebo in postmenopausal patients (19553).
• Cough. Although there has been interest in using oral black cohosh for cough, there is insufficient reliable information about the clinical effects of black cohosh for this purpose.
• Dysmenorrhea. Although there has been interest in using oral black cohosh for dysmenorrhea, there is insufficient reliable information about the clinical effects of black cohosh for this purpose.
• Infertility. It is unclear if oral black cohosh is beneficial for female infertility. Details: One small clinical study in patients with unexplained infertility shows that taking black cohosh rhizome dry extract (Klimadynon, Bionorica) 120 mg on days 1-12 of the menstrual cycle, plus clomiphene citrate 150 mg daily on days 3-7, increases the pregnancy rate by 23% when compared with clomiphene citrate alone (35858). Another small clinical study in patients with unexplained infertility shows that taking black cohosh (Klimadynon, Bionorica) 120 mg plus clomiphene citrate 150 mg results in similar pregnancy rates when compared with ethinyl estradiol 100 mcg plus clomiphene citrate (35902).
• Insect repellent. Although there has been interest in using topical black cohosh as an insect repellent, there is insufficient reliable information about the clinical effects of black cohosh for this purpose.
• Migraine headache. Oral black cohosh has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In one preliminary clinical trial, taking one tablet of a phytoestrogen formulation containing black cohosh extract 25 mg, soy extract 75 mg, and dong quai extract 50 mg twice daily for 24 weeks reduced the frequency of menstrual migraines when compared with placebo (35797).
• Osteoarthritis. Oral black cohosh has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific combination product containing black cohosh 35 mg per tablet, with white willow bark, sarsaparilla, poplar bark, and guaiacum resin (Reumalex, Gerard House Ltd.), two tablets daily for 2 months improves pain when compared with placebo in patients with osteoarthritis. However, no improvement in joint function was found (35946).
• Osteoporosis. There is contradictory evidence on the benefit of black cohosh for osteoporosis treatment or prevention. Details: In one preliminary clinical trial, postmenopausal patients taking specific black cohosh products (Klimadynon/Menofem, Bionorica AG; Remifemin, Schaper & Brümmer) 40 mg daily for 12 weeks had increased levels of bone-specific alkaline phosphatase (bALP), which is a marker of bone formation (14330,35865). However, in another clinical trial, bone mineral density was no different in patients taking a specific black cohosh extract (Klimadynon/Klimadynon Uno/Menofem, Bionorica) 40 mg daily for 12 months when compared with two control groups (35908). It is not known if these black cohosh products can decrease the risk of fracture.
• Parturition. It is unclear whether oral black cohosh is beneficial or safe for labor induction. Details: It has been reported that as many as 45% of nurse-midwives have used black cohosh to induce labor in pregnant adults at term (1122). However, there is no reliable clinical evidence that black cohosh is safe or effective for this use (15035).
• Polycystic ovary syndrome (PCOS). It is unclear if oral black cohosh is beneficial for improving fertility in patients with PCOS. Details: A small clinical study in patients with PCOS and a history of infertility shows that taking black cohosh 10 mg twice daily for 10 days along with clomiphene citrate 50 mg twice daily for 5 days, both starting on the second day of the menstrual cycle, does not increase endometrial thickness or the size or number of mature follicles when compared with clomiphene citrate alone (107905). Pregnancy and live birth rates were not evaluated in this study.
• Premenstrual syndrome (PMS). Although there has been interest in using oral black cohosh for PMS, there is insufficient reliable information about the clinical effects of black cohosh for this purpose.
• Rheumatoid arthritis (RA). Oral black cohosh has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with RA shows that taking a specific combination product containing black cohosh 35 mg per tablet, with white willow bark, sarsaparilla, poplar bark, and guaiacum resin (Reumalex, Gerard House Ltd.) two tablets daily for 2 months improves pain when compared with placebo. However, no improvement in joint function was observed (35946).
• Sexual dysfunction. It is unclear if oral black cohosh is beneficial for improving sexual dysfunction. Details: A small observational study in adults with breast cancer on tamoxifen suggests that taking a dry extract of black cohosh 20 mg is associated with improvements in sexual response scores, which include sexual parameters such as desire, lubrication, orgasm, satisfaction, and pain but not arousal when compared to baseline (111635). The validity of these effects is limited by a small sample size and the lack of a comparator group.
• Warts. Although there has been interest in using topical black cohosh for warts, there is insufficient reliable information about the clinical effects of black cohosh for this purpose. More evidence is needed to rate black cohosh for these uses.

(Read more about BLACK COHOSH)

There is insufficient reliable information available about the effectiveness of gelsemium.

(Read more about GELSEMIUM)

There is insufficient reliable information available about the effectiveness of pulsatilla.

(Read more about PULSATILLA)

UNSAFE ...when used orally or topically. Aconite root contains toxic alkaloids that are strong, fast-acting poisons that affect the heart and central nervous system, causing severe arrhythmias, reduced consciousness, and death (15499,19669,30294,30300,30301,30303,30309,30334,30335,30336,92276,104514,106706). All species of this plant are dangerous. Severe poisoning has been reported after ingestion of 0.2-2 mg of aconitine, 1 gram of the raw plant, or 6 grams of processed and cured aconite (3490,104514). Even when a processed product is used, aconite can cause toxicity including nausea, vomiting, dizziness, muscle spasms, hypothermia, paralysis of the respiratory system, and heart rhythm disorders (15499). Aconite can also be absorbed through the skin and cause significant toxicity (12).

PREGNANCY AND LACTATION: UNSAFE
when used orally or topically (15499).

(Read more about ACONITE)

POSSIBLY UNSAFE ...when used rectally. It is not known whether significant amounts of the toxic alkaloids are absorbed from the rectum (106909). ...when used topically. It is not known whether significant amounts of the toxic alkaloids are absorbed through the skin (106909).

LIKELY UNSAFE ...when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

CHILDREN: LIKELY UNSAFE
when used orally. Fatalities in children may occur at doses of belladonna providing atropine 0.2 mg/kg (34168). Two belladonna berries, which contain 2 mg atropine per fruit, may be lethal for a small child (34144). Severe adverse effects and fatalities have been reported in infants treated with topical homeopathic teething products containing belladonna (17493,34142,34146,93537).

PREGNANCY: LIKELY UNSAFE
when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

LACTATION: LIKELY UNSAFE
when used orally. Belladonna can reduce milk production and is secreted into breast milk (15).

(Read more about BELLADONNA)

POSSIBLY SAFE ...when used orally and appropriately. Black cohosh has been safely used in some studies lasting up to a year (15036,15158,17091,19553,35908); however, most studies have lasted only up to 6 months (141,4614,4620,7054,9437,9494,13143,13184,14330,14423)(14424,15037,15889,15893,35824,35852,35853,35858,35865,35897)(35902,35904,35946,35964,95525,103269). There is concern that black cohosh might cause liver damage in some patients. Several case reports link black cohosh to liver failure or autoimmune hepatitis (4383,10692,11906,12006,13144,14469,15160,16721,16722,16723)(16724,16725,16726,16727,35857,107906). However, the evidence that black cohosh causes liver damage is not conclusive (17085). Until more is known, monitor liver function in patients who take black cohosh.

PREGNANCY: POSSIBLY UNSAFE
when used orally in pregnant patients who are not at term. Black cohosh might have hormonal effects and menstrual and uterine stimulant effects (15035). Theoretically, this might increase the risk of miscarriage; avoid using during pregnancy. There is insufficient reliable information available about the safety of black cohosh when used to induce labor.

LACTATION: POSSIBLY UNSAFE
when used orally. Black cohosh might have hormonal effects. Theoretically, maternal intake of black cohosh might adversely affect a nursing child (15035). Until more is known, nursing patients should avoid taking black cohosh.

(Read more about BLACK COHOSH)

UNSAFE ...when the rhizome or root are used orally. All parts of the plant contain toxic alkaloids. The adult lethal dose is 2-3 grams or 4 mL of the fluid extract (18).

CHILDREN: UNSAFE
when used orally. The lethal dose is 500 mg (18).

PREGNANCY AND LACTATION: UNSAFE
when used orally due to toxicity (6).

(Read more about GELSEMIUM)

LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.

PREGNANCY: LIKELY UNSAFE
when used orally. The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.

LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19). There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.

(Read more about PULSATILLA)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.  Details Higenamine, a constituent of aconite, is thought to have antiplatelet and antithrombotic effects. In an animal model of thrombosis, higenamine inhibited platelet aggregation and reduced the size of thrombus formation (92282).

STIMULANT DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other stimulant drugs might alter the effects of the stimulant drug or increase the risk of cardiovascular toxicity.  Details Aconite and its constituents have stimulant effects due to agonist activity at beta-2-adrenoreceptors. In cardiac muscle, aconite appears to have a positive inotropic effect and increases heart rate and blood pressure (2634,15499,30296,92282). However, some constituents of aconite can reduce heart rate and blood pressure (15499,30343).

(Read more about ACONITE)

ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.  Details Belladonna has anticholinergic activity and increases the activity of anticholinergic drugs (2,12).

CISAPRIDE (Propulsid) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, belladonna might reduce the effects of cisapride.  Details Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).

(Read more about BELLADONNA)

ATORVASTATIN (Lipitor) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Taking black cohosh with atorvastatin might increase the risk for elevated liver function tests.  Details In one case report, a patient taking atorvastatin (Lipitor) developed significantly elevated liver function enzymes after starting black cohosh 100 mg four times daily. Liver enzymes returned to normal when black cohosh was discontinued (16725). It is unclear whether the elevated liver enzymes were due to black cohosh itself or an interaction between atorvastatin and black cohosh.

CISPLATIN (Platinol-AQ) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, black cohosh may reduce the clinical effects of cisplatin.  Details Animal research suggests that black cohosh might decrease the cytotoxic effect of cisplatin on breast cancer cells (13101).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Some research suggests that black cohosh might inhibit CYP2D6, but there is conflicting evidence.  Details Some clinical research suggests that black cohosh might modestly inhibit CYP2D6 and increase levels of drugs metabolized by this enzyme (13536). However, contradictory clinical research shows a specific black cohosh product (Remifemin, Enzymatic Therapy) 40 mg twice daily does not significantly inhibit metabolism of a CYP2D6 substrate in healthy study volunteers (16848). Until more is known, use black cohosh cautiously in patients taking drugs metabolized by CYP2D6.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black cohosh may alter the effects of estrogen therapy.  Details Some research suggests that black cohosh has estrogenic effects (4618,12064,15035,35831). This may enhance or inhibit the effects of estrogen therapy.

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking black cohosh with hepatotoxic drugs may increase the risk of liver damage.  Details There is concern that black cohosh might be linked to cases of liver failure and autoimmune hepatitis (4383,10692,11906,11909,12006,13144,14469,15160,107906).

ORGANIC ANION-TRANSPORTING POLYPEPTIDE SUBSTRATES (OATP) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Black cohosh may inhibit one form of OATP, OATP2B1, which could reduce the bioavailability and clinical effects of OATP2B1 substrates.  Details In vitro research shows that black cohosh modestly inhibits OATP2B1 (35450). 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.

(Read more about BLACK COHOSH)

(Read more about GELSEMIUM)

(Read more about PULSATILLA)

General ...Orally and topically, aconite is generally regarded as unsafe for use. Any benefits of therapy might not outweigh the risk of toxicity.
Most Common Adverse Effects:
All routes of administration: Serious neurologic, cardiovascular, gastrointestinal, and respiratory adverse effects have been reported.

Cardiovascular ...Orally and topically, aconite can cause hypotension, palpitations, chest tightness, pulmonary edema, arrhythmia, bradycardia, tachycardia, sustained or bidirectional ventricular tachycardia, ventricular fibrillation, and Torsade de pointes (558,559,561,562,563,3490,15499,15650,30294,30295)(30300,30305,30323,30336,92276,92277,92278,104514,106706,110473)(112901). Cardioversion has been reported to be ineffective for the reversal of aconite-induced dysrhythmia, but the use of agents such as amiodarone, lidocaine, and magnesium have been successful in some cases (2634,3490,106706,112901).

Gastrointestinal ...Orally, aconite can cause nausea, vomiting, diarrhea, and gastric pain (563,30297,30341,92277,92278). Topically, aconite can cause nausea and vomiting (92276).

Neurologic/CNS ...Orally, aconite can cause weakness, sweating, restlessness, dizziness, numbness, paresthesia, seizures, and reduced consciousness (558,559,561,562,563,3490,15499,15650,30335,30336,30341,92277,92278,104513). Topically, aconite can cause generalized paresthesia, fatigue, sweating, dizziness and tongue numbness (92276).

Ocular/Otic ...Orally, aconite has been reported to cause visual blurring and yellow-green vision with pupil dilation (30319).

Pulmonary/Respiratory ...Orally, aconite overdose can lead to respiratory failure (104513).

Renal ...Orally and topically, aconite can cause hypokalemia and metabolic and/or respiratory acidosis (558,559,561,562,563,3490,15499,15650).

Other ...Orally and topically, aconite has been reported to cause death in both adults and children (559,3490,3491,30301,30334,30341,92276,92278). In one case report, topical application of aconite to an infant led to cardiogenic shock with multi-organ failure and death (92276). Poisoning has been reported in 15 patients after consuming a homemade liquor containing aconite. Patients presented with tongue or extremity numbness, vomiting, dizziness, or heart palpitations, and 5 died (110471). Death has also been reported in individuals who cooked aconite tubers as vegetables or for health purposes (92278).
The first symptoms of aconite poisoning after oral ingestion of the leaves or root usually occur within 10-90 minutes, although toxicity may be delayed until a second or third dose (559,15499,104513,110471). Recovery time from aconite poisoning ranges from 1.5-2 days for mild intoxication to 7-9 days for patients with cardiovascular complications; fatalities in treated patients are about 5% (15499). Treatment of aconite toxicity is typically supportive, although charcoal hemoperfusion has aided in detoxification (15499,106706).

(Read more about ACONITE)

General ...Orally, belladonna can cause anticholinergic side effects even at low doses, and is considered poisonous.
Most Common Adverse Effects:
Orally: Anticholinergic side effects, including blurred vision, constipation, delirium, dilated pupils, dizziness, dry mouth, fever, headache, hypertension, muscle rigidity and tremor, psychosis, respiratory failure, and slurred speech.

Cardiovascular ...Orally, belladonna can cause anticholinergic side effects such as hypertension, hypotension, tachycardia, and ventricular premature beats (553,34168,34180).

Dermatologic ...Orally, belladonna can cause anticholinergic side effects such as dry, red skin and decreased perspiration (553,34146,34152). One case of rash and another case of hives have been reported in patients taking belladonna with phenobarbital and ergotamine orally; it is unclear if the adverse effects were due to belladonna or the other ingredients (34154).
Topically, belladonna plaster (Cuxon Gerrard) can cause contact dermatitis (34152).

Gastrointestinal ...Orally, belladonna can cause anticholinergic side effects such as dry mouth and constipation (553,34162,34163,34176,34180,34181).

Genitourinary ...Orally, belladonna can cause anticholinergic side effects such as urinary retention (553,34145,34150,34163).

Neurologic/CNS ...Orally, belladonna can cause anticholinergic side effects such as memory and attention impairment, headache, and confusion (553,34163,34180).

Ocular/Otic ...Orally and topically, belladonna can cause anticholinergic side effects such as dilation of pupils and blurred vision (553,34157,34168,34169,34180). A case report describes anisocoria (unequal pupil sizes) in a 70-year-old female who used homeopathic pink eye relief drops (Similasan) containing belladonna, eyebright, and hepar sulphuris (calcium sulfide) in one eye for 3 days. The pupil dilation lasted more than 2 weeks and did not respond to bright light or pilocarpine (106907). Another report describes a case of acute angle closure glaucoma, requiring referral to an ophthalmologist, in a 55-year-old female who used these eye drops for 2 days (106906).

(Read more about BELLADONNA)

General ...Orally, black cohosh is generally well tolerated when used in typical doses.
Most Common Adverse Effects:
Orally: Breast tenderness, dizziness, gastrointestinal upset, headache, irritability, rash, tiredness.
Serious Adverse Effects (Rare):
Orally: Endometrial hyperplasia and hepatotoxicity, although data are conflicting for both.

Cardiovascular ...A single case of reversible bradycardia has been reported for a 59-year-old female who took one tablet of a specific black cohosh product (Remifemin, Schaper & Brümmer) daily for 2 weeks. The adverse event was considered probably related to black cohosh use, although the exact mechanism by which black cohosh exerted this effect was unclear (35920).
There has been concern that, if black cohosh has estrogen-like effects, it could also potentially cause estrogen-like side effects including increased risk for thromboembolism and cardiovascular disease. These outcomes have not been specifically assessed in long-term trials; however, some research shows that a specific black cohosh extract (CimiPure, PureWorld) does not significantly affect surrogate markers for thromboembolism and cardiovascular risk such as fibrinogen, cholesterol, triglycerides, glucose, or insulin levels compared to placebo (16850).

Dermatologic ...Black cohosh has been associated with skin irritation and rashes (7054,10987,14330,15889,35853). A case report describes a patient who developed cutaneous pseudolymphoma 6 months after starting a specific black cohosh extract (Remifemin). Symptoms resolved within 12 weeks of discontinuing black cohosh (15890).

Gastrointestinal ...Orally, black cohosh can commonly cause gastrointestinal upset (4383,4615,4616,10988,13184,35824,35853,35965,103269,111714). Constipation and indigestion have also been reported (7054,35852).

Genitourinary ...Orally, black cohosh, including the specific black cohosh product Remifemin, may cause vaginal bleeding and breast tenderness in some postmenopausal patients (15889,35824). However, the frequency of these events seems to be less than that of tibolone, a prescription hormone medication used to treat symptoms of menopause (15889,35904).
Due to the potential estrogen-like effects, there is concern that black cohosh might increase the risk of endometrial hyperplasia. However, a specific black cohosh extract CR BNO 1055 (Klimadynon/Menofem, Bionorica AG) does not appear to cause endometrial hyperplasia. Clinical research in postmenopausal adults shows that taking 40 mg daily of this extract for 12 weeks does not significantly increase superficial cells when compared with placebo, and causes significantly fewer superficial cells when compared with conjugated estrogens (Premarin) (14330). Additional clinical research shows that taking 40 mg daily of this extract for a year does not increase the risk of endometrial hyperplasia or endometrial thickening in postmenopausal adults (15036). Another specific combination product containing black cohosh extract plus St. John's wort (Gynoplus, Jin-Yang Pharm) also does not significantly increase superficial cells compared to placebo after 12 weeks of treatment (15893). Some patients taking tamoxifen plus black cohosh have experienced endometrial hyperplasia and vaginal bleeding. However, these effects are more likely due to tamoxifen than black cohosh (7054).

Hepatic ...There is concern that black cohosh might cause liver disease, hepatotoxicity, or hepatitis. Adverse effects on the liver have not been documented in clinical studies. However, multiple case reports of liver toxicity, hepatitis, and abnormal liver function have been described in females taking black cohosh products alone or in combination with other herbs or drugs. In some cases, patients developed liver failure and required immediate liver transplantation (4383,10692,11909,12006,13144,14469,15160,16721,16722,16723) (16724,16727,35883,35888,35890,35895,89465,101592,107906). In one case, a female developed autoimmune hepatitis after 3 weeks of taking black cohosh. Symptoms resolved 2 weeks after discontinuing black cohosh (11906). In at least three cases, females have developed elevated liver enzymes and symptoms of hepatotoxicity after taking black cohosh products. Symptoms resolved and liver enzymes normalized within a week of discontinuing black cohosh (16725,16726). Analysis of two liver biopsies suggests that hepatotoxicity associated with black cohosh use results from the accumulation of 4HNE protein adducts in the cytoplasm of liver cells, which promotes the migration of lymphocytes to the affected area and induces an autoimmune response leading to troxis necrosis (89469).
However, many of these cases are poorly documented. Causality is possible based on some reports; however, other reports do not indicate that black cohosh is the probable cause of the events (15891,15892,16722,16723,16727,89465). Hepatitis can occur with no identifiable cause, raising the possibility that black cohosh and hepatitis might have been coincidental in some cases. Also, plant misidentification can occur, resulting in accidental substitution of a hepatotoxic plant (11910). Therefore, some experts argue that these cases do not provide conclusive evidence that black cohosh is responsible for liver disease (17085,35882,111634). Nonetheless, some countries require cautionary labeling on black cohosh products suggesting a risk of liver toxicity. The United States Pharmacopeia also recommends cautionary labeling on black cohosh products (16722). Until more is known about this potential risk, consider monitoring liver function in patients who take black cohosh.

Musculoskeletal ...One patient treated with black cohosh in a clinical trial discontinued treatment due to edema and arthralgia (35897).
Black cohosh has been linked to asthenia and muscle damage in one case. A 54-year-old female experienced asthenia with elevated creatinine phosphokinase (CPK) and lactate dehydrogenase (LDH) levels while taking black cohosh. The patient had taken a specific black cohosh extract (Remifemin) for 1 year, discontinued it for 2 months, restarted it, and then experienced symptoms 2 months later. Symptoms began to resolve 10 days after discontinuing black cohosh (14299).

Neurologic/CNS ...Orally, black cohosh may cause headache, dizziness, or tiredness (35852,35886). There is one case report of seizures in a female who used black cohosh, evening primrose oil, and chasteberry (10988).
Also, there has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.
In another case report, orobuccolingual dyskinesia, including tongue-biting, eating difficulties, and speech problems, was reported in a 46-year-old female who took two tablets containing black cohosh 20 mg and Panax ginseng 50 mg daily for 15 months. The patient's condition improved after stopping treatment with the herbs and taking clonazepam 2 mg daily with baclofen 40 mg daily (89735).

Ocular/Otic ...There is some concern that black cohosh might increase the risk of retinal vein thrombosis due to its estrogenic activity. In one case, a patient with protein S deficiency and systemic lupus erythematosus (SLE) experienced retinal vein thrombosis 3 days after taking a combination product containing black cohosh 250 mg, red clover 250 mg, dong quai 100 mg, and wild yam 276 mg (13155). It is unclear if this event was due to black cohosh, other ingredients, the combination, or another factor.

Oncologic ...There is some concern that black cohosh may affect hormone-sensitive cancers, such as some types of breast or uterine cancer, due to its potential estrogenic effects. However, evidence from a cohort study suggests that regular use of black cohosh is not associated with the risk of breast or endometrial cancer (17412,111634).

Psychiatric ...A 36-year-old female with a 15-year history of depression developed mania with psychotic and mixed features after taking a black cohosh extract 40 mg daily. The patient gradually recovered after stopping black cohosh and receiving treatment with antipsychotics (104517).

Pulmonary/Respiratory ...There has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.

Renal ...There has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.

Other ...While rare, weight gain has been reported in some patients taking black cohosh. However, in most cases the causality could not be established. A review of the literature, including published case reports, spontaneous reports to adverse event databases, and clinical trials, suggests that black cohosh does not cause weight gain (107907).

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General ...Orally, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).

Neurologic/CNS ...Orally, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).

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General ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19). It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).

Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).

Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).

Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).

Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).

Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).

Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).

Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).

(Read more about PULSATILLA)