Each tablet (300 mg) contains: Bacopa monnieri Bacopa monnieri Genus: Bacopa Species: monnieri Note: equiv. Bacopa monnieri whole plant (dry) 3 grams 46.0 mg • Convolvulus pluricaulis 46.0 mg • Acorus calamus 46.0 mg • Onosma bracteatum 69.0 mg • Celastrus paniculatus 19.0 mg • Withania somnifera 46.0 mg • Tinospora cordifolia 20.0 mg • Praval pishti 6.0 mg • Mukta pishti 2.0 mg • processed with: Bacopa monnieri Bacopa monnieri Genus: Bacopa Species: monnieri Note: equiv. Bacopa monnieri whole plant (dry) 3 grams • Nardostachys jatamansi • Convolvulus pluricaulis • Rauwolfia serpentina • Tinospora cordifolia . Excipients: Gum acacia, Talcum, Aerosil, Magnesium Stearate, M.C.C.-Q.S.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Divya Mukta Vati. 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
There is insufficient reliable information available about the effectiveness of calamus.
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 Divya Mukta Vati. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Ashwagandha has been used with apparent safety in doses of up to 1250 mg daily for up to 6 months (3710,11301,19271,90649,90652,90653,97292,101816,102682,102683) (102684,102685,102687,103476,105824,109586,109588,109589,109590). ...when used topically. Ashwagandha lotion has been used with apparent safety in concentrations up to 8% for up to 2 months (111538).
PREGNANCY: LIKELY UNSAFE
when used orally.
Ashwagandha has abortifacient effects (12).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Bacopa has been used safely in clinical trials at a dose of up to 600 mg daily for up to 12 weeks (10058,10059,17946,97605).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Clinical research suggests bacopa extract might be safe to use at a dose of 225 mg daily for up to 6 months or 320 mg daily for up to 14 weeks in children aged 6-14 years (33304,97603,109625).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY UNSAFE ...when used orally. The FDA prohibits calamus use in food products due to evidence of carcinogenic effects in animals receiving high doses of a calamus strain high in beta-asarone (93978,94727,94728). However, the beta-asarone content can vary widely among species from 0% to 96% (6); some products may be safer than others. There is insufficient reliable information available about the safety of calamus when used topically.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally; avoid using (4,500).
POSSIBLY UNSAFE ...when used orally. Indian snakeroot contains small amounts of the drugs reserpine and yohimbine. Although most adverse effects to Indian snakeroot appear to be mild, higher doses can cause cardiovascular side effects including bradycardia and hypotension. Prolonged use can cause depression in some people (94330,94331,94332,94438,94440).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
The reserpine alkaloid constituents appear to cross the placenta and are excreted in breast milk (4260).
POSSIBLY SAFE ...when the stem extract is used orally and appropriately, short-term. Tinospora cordifolia aqueous stem extract has been used with apparent safety at a dose of 900 mg daily for up to 8 weeks (15085). Powdered stem extract has also been used with apparent safety at a dose of up to 3 grams daily for up to 2 weeks or a dose of 1500 mg daily for up to 26 weeks (92230,106846,111503). There is insufficient reliable information available about the safety of other parts of Tinospora cordifolia when used orally or when any part of the plant is used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Divya Mukta Vati. 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, taking ashwagandha with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking ashwagandha with antihypertensive drugs might increase the risk of hypotension.
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Animal research suggests that ashwagandha might lower systolic and diastolic blood pressure (19279). Theoretically, ashwagandha might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.
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Theoretically, taking ashwagandha might increase the sedative effects of benzodiazepines.
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There is preliminary evidence that ashwagandha might have an additive effect with diazepam (Valium) and clonazepam (Klonopin) (3710). This may also occur with other benzodiazepines.
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Theoretically, taking ashwagandha might increase the sedative effects of CNS depressants.
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Ashwagandha seems to have sedative effects. Theoretically, this may potentiate the effects of barbiturates, other sedatives, and anxiolytics (3710).
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Theoretically, taking ashwagandha might decrease the effects of immunosuppressants.
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Ashwagandha might increase the effects and adverse effects of thyroid hormone.
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Concomitant use of ashwagandha with thyroid hormones may cause additive therapeutic and adverse effects. Preliminary clinical research and animal studies suggest that ashwagandha boosts thyroid hormone synthesis and secretion (19281,19282,97292). In one clinical study, ashwagandha increased triiodothyronine (T3) and thyroxine (T4) levels by 41.5% and 19.6%, respectively, and reduced serum TSH levels by 17.4% from baseline in adults with subclinical hypothyroidism (97292).
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Theoretically, concurrent use might decrease the effectiveness of both agents.
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Bacopa seems to inhibit acetylcholinesterase and might increase acetylcholine levels, which could counteract the effects of anticholinergic drugs (17946). Similarly, anticholinergic drugs might counteract the cholinergic effects of bacopa.
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Theoretically, bacopa might increase the effects and adverse effects of cevimeline.
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In one case, a 58-year-old female taking cevimeline long-term for Sjogren syndrome experienced hyperhidrosis, malaise, nausea, and tachycardia shortly after taking a single dose of bacopa. Symptoms resolved after two days. Cevimeline is metabolized by cytochrome P450 (CYP) 2D6 and CYP3A4, and researchers theorize that bacopa may have inhibited these isoenzymes (109627). However, it is unclear if bacopa causes clinically significant inhibition of either CYP2D6 or CYP3A4.
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Theoretically, concurrent use of bacopa with other cholinergic drugs might have additive effects.
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Bacopa seems to inhibit acetylcholinesterase and might increase acetylcholine levels (17946). Theoretically, this could result in additive cholinergic effects when used with cholinergic drugs.
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Theoretically, bacopa might increase the levels and adverse effects of CYP1A2 substrates.
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Theoretically, bacopa might increase the levels and adverse effects of CYP2C19 substrates.
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In vitro evidence suggests that bacopa extract can moderately and non-competitively inhibit CYP2C19 enzymes (97606). It is not known whether this is clinically significant.
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Theoretically, bacopa might increase the levels and adverse effects of CYP2C9 substrates.
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Theoretically, bacopa might increase the levels and adverse effects of CYP3A4 substrates.
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Theoretically, bacopa might have additive effects when used with thyroid hormone.
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Animal research suggests that bacopa increases thyroxine (T4) levels in mice by about 40% (33286).
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Theoretically, due to reports that calamus increases stomach acid, calamus might decrease the effectiveness of antacids (19).
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In vitro evidence suggests that calamus can inhibit acetylcholinesterase (AChE) (38418). Theoretically, concurrent use of anticholinergic drugs and calamus might decrease the effectiveness of the anticholinergic drug.
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Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).
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Animal research suggests that calamus can decrease the rate and strength of the heartbeat, which might lower blood pressure (38444). Theoretically, combining calamus with other antihypertensive medications might increase the risk of hypotension; use with caution.
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Some antihypertensive drugs include captopril (Capoten), enalapril (Vasotec), losartan (Cozaar), valsartan (Diovan), diltiazem (Cardizem), Amlodipine (Norvasc), hydrochlorothiazide (HydroDiuril), furosemide (Lasix), and many others.
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In vitro evidence suggests that calamus can inhibit acetylcholinesterase (AChE) (38418). Theoretically, concurrent use of calamus with other cholinergic drugs might have additive effects and increase the risk of cholinergic side effects.
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Cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).
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Theoretically, concomitant use with drugs with sedative properties can cause additive effects and side effects (4,38400,38444).
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In vitro research suggests that calamus extract can inhibit cytochrome P450 2D6 (CYP2D6) (93975). Theoretically, use of calamus with drugs metabolized by CYP2D6 might increase drug levels and potentially increase the risk of adverse effects.
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Some drugs metabolized by CYP2D6 include amitriptyline (Elavil), codeine, desipramine (Norpramin), flecainide (Tambocor), haloperidol (Haldol), imipramine (Tofranil), metoprolol (Lopressor, Toprol XL), ondansetron (Zofran), paroxetine (Paxil), risperidone (Risperdal), tramadol (Ultram), venlafaxine (Effexor), and others.
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In vitro research suggests that calamus inhibits cytochrome P450 3A4 (CYP3A4) (93975). Theoretically, use of calamus with drugs metabolized by CYP3A4 might increase drug levels and potentially increase the risk of adverse effects.
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Some drugs metabolized by CYP3A4 include lovastatin (Mevacor), clarithromycin (Biaxin), indinavir (Crixivan), sildenafil (Viagra), triazolam (Halcion), and numerous others.
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Theoretically, due to reports that calamus increases stomach acid, calamus might decrease the effectiveness of H2-blockers (19). The H2 blockers include cimetidine (Tagamet), ranitidine (Zantac), nizatidine (Axid), and famotidine (Pepcid).
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Theoretically, calamus might potentiate the effects and adverse effects of monoamine oxidase inhibitor drugs (4).
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Theoretically, due to reports that calamus increases stomach acid, calamus might decrease the effectiveness of PPIs (19). PPIs include omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esomeprazole (Nexium).
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Theoretically, taking Indian snakeroot might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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Theoretically, concomitant use of Indian snakeroot with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, concomitant use of Indian snakeroot and antihypertensive drugs might increase the risk of hypotension.
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Theoretically, concomitant use might increase the risk of adverse effects.
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Theoretically, taking Indian snakeroot with beta-blockers might increase the risk of bradycardia and/or hypotension.
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Indian snakeroot contains small amounts of reserpine. Reserpine causes catecholamine-depletion (15). Concomitant use of Indian snakeroot and beta-blockers might increase the risk or bradycardia and/or hypotension.
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Theoretically, taking Indian snakeroot might cause additive sedative effects.
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Theoretically, Indian snakeroot might inhibit CYP2D6 enzymes and reduce the metabolism of CYP2D6 substrates.
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Indian snakeroot contains small amounts of the drug yohimbine. In vitro research shows that yohimbine inhibits CYP2D6 enzyme activity (23117).
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Theoretically, taking Indian snakeroot with digoxin might increase the risk of bradycardia.
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Theoretically, taking Indian snakeroot with ephedrine might alter the effects and side effects of ephedrine.
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Theoretically, taking Indian snakeroot with levodopa may reduce the effectiveness of levodopa.
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Theoretically, taking Indian snakeroot with MAOIs might cause additive effects.
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Theoretically, concomitant use might cause additive effects.
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Theoretically, concomitant use might alter the effects of Indian snakeroot and increase the risk of adverse effects.
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A small clinical study in patients taking TCAs for at least 4 weeks shows that receiving doses of intravenous yohimbine, a constituent of Indian snakeroot, 2.5-20 mg daily for up to 7 days precipitates severe anxiety, agitation, and tremor (105881). Also, concomitant use of TCAs with Indian snakeroot may decrease the effects of other rauwolfia alkaloids (15).
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Theoretically, Tinospora cordifolia might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP1A2.
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In vitro research shows that Tinospora cordifolia extract inhibits CYP1A2 at high concentrations (98225). However, this interaction has not been reported in humans.
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Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2C19.
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In vitro research shows that Tinospora cordifolia extract inhibits CYP2C19 at high concentrations (98225). However, this interaction has not been reported in humans.
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Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2C9.
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In vitro research shows that Tinospora cordifolia extract inhibits CYP2C9. Animal research shows that Tinospora cordifolia extract 400 mg/kg twice daily for 14 days reduces the clearance and increases plasma levels of glyburide, a CYP2C9 substrate (98225). However, this interaction has not been reported in humans.
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Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2D6.
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In vitro research shows that Tinospora cordifolia extract inhibits CYP2D6 at high concentrations (98225). However, this interaction has not been reported in humans.
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Theoretically, Tinospora cordifolia might reduce the effectiveness of immunosuppressants.
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Below is general information about the adverse effects of the known ingredients contained in the product Divya Mukta Vati. 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, ashwagandha seems to be well-tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, nausea, and vomiting. However, these adverse effects do not commonly occur with typical doses.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about acute liver failure, hepatic encephalopathy, and the need for liver transplantation with ashwagandha treatment.
Dermatologic ...Orally, dermatitis has been reported in three of 42 patients in a clinical trial (19276).
Endocrine ...A case report describes a 73-year-old female who had taken an ashwagandha root extract (unspecified dose) for 2 years to treat hypothyroidism which had been previously managed with levothyroxine. The patient was diagnosed with hyperthyroidism after presenting with supraventricular tachycardia, chest pain, tremor, dizziness, fatigue, irritability, hair thinning, and low thyroid stimulating hormone (TSH) levels. Hyperthyroidism resolved after discontinuing ashwagandha (108745).
Gastrointestinal ...Orally, large doses may cause gastrointestinal upset, diarrhea, and vomiting secondary to irritation of the mucous and serous membranes (3710). When taken orally, nausea and abdominal pain (19276,110490) and gastritis and flatulence (90651) have been reported.
Genitourinary ...In one case report, a 28-year-old male with a decrease in libido who was taking ashwagandha 5 grams daily over 10 days subsequently experienced burning, itching, and skin and mucous membrane discoloration of the penis, as well as an oval, dusky, eroded plaque (3 cm) with erythema on the glans penis and prepuce (32537).
Hepatic ...Orally, ashwagandha in doses of 154-1350 mg daily has played a role in several case reports of liver injury. In most of these cases, other causes of liver injury were excluded, and liver failure did not occur. Symptoms included jaundice, pruritus, malaise, fatigue, lethargy, weight loss, nausea, diarrhea, abdominal pain, stool discoloration, and dark urine. Symptom onset was typically 5-180 days from first intake, although in some cases onset occurred after more than 12 months of use (102686,107372,110490,110491,111533,111535,112111). Laboratory findings include elevated aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, and serum bilirubin (112111). In most cases, liver enzymes normalized within 1-5 months after discontinuation of ashwagandha (102686,107372,110491,111535,112111). However, treatment with corticosteroids, lactulose, ornithine, ursodeoxycholic acid, and plasmapheresis, among other interventions, was required in one case (111533). Rarely, use of oral ashwagandha has been reported to cause hepatic encephalopathy and liver failure requiring liver transplantation (110490).
Neurologic/CNS ...Orally, ashwagandha has been reported to cause drowsiness (110492). Headache, neck pain, and blurry vision have been reported in a 47-year-old female taking ashwagandha, cannabis, and venlafaxine. Imaging over the course of multiple years and hospital admissions indicated numerous instances of intracranial hemorrhage and multifocal stenosis of intracranial arteries, likely secondary to reversible cerebral vasoconstriction syndrome (RCVS) (112113). It is unclear whether the RCVS and subsequent intracranial hemorrhages were precipitated by ashwagandha, cannabis, or venlafaxine.
General
...Orally, bacopa is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal cramps, diarrhea, dry mouth, headache, nausea.
Cardiovascular ...Orally, bacopa has been reported to cause palpitations (10058).
Gastrointestinal ...Orally, bacopa has been reported to cause abdominal cramps, abdominal pain, bloating, decreased appetite, diarrhea, dry mouth, excessive thirst, flatulence, indigestion, nausea, and increased stool frequency. Rates of adverse gastrointestinal events have ranged from 12% to 30% (10058,17946,33295,97605,109623,111520).
Musculoskeletal ...Orally, bacopa has been reported to cause arthralgia, muscle fatigue, and myopathy (10058,109623,111522). In one case, a 21-year-old male experienced progressive proximal weakness, muscle atrophy, weight loss, dark urine, and elevated serum markers of myopathy, with muscle biopsy showing immune-mediated necrotizing myopathy, after taking a supplement containing bacopa for 5 years (111522).
Neurologic/CNS ...Orally, bacopa has been reported to cause drowsiness, headache, insomnia, and vivid dreams (10058,10059,17946,109623).
Other ...Orally, bacopa has been reported to cause flu like symptoms and fatigue (10058,97605,111520).
General ...Orally, nausea, vomiting, and intestinal paralysis have been reported with calamus use (33310,38458,93980). Tachycardia has also been reported (93980).
Cardiovascular ...Tachycardia has been reported as a toxic effect related to oral use of calamus oil (93980).
Gastrointestinal ...A case of gastrointestinal toxicity has been reported in a 19-year-old male who appeared to use calamus root for its euphoric effects. The man ingested a large amount of the root with water and later presented at the emergency department with continuous vomiting, paleness, and sweating. He was treated intravenously with saline and promethazine (38458). Both nausea and vomiting have been reported in patients using calamus oil orally (93980). Intestinal paralysis has also been reported with calamus use in children (33310).
General
...Orally, Indian snakeroot may be unsafe, particularly at high doses.
Most adverse effects are thought to be from the constituents reserpine and yohimbine.
Most Common Adverse Effects:
Orally: Abdominal pain, bradycardia, congestion, diarrhea, hypotension, increased appetite, nightmares, sedation, weight gain.
Serious Adverse Effects (Rare):
Orally: Atrial fibrillation, convulsions, depression, myocardial infarction.
Cardiovascular ...Orally, Indian snakeroot has been associated with reports of bradycardia and mild hypotension. These adverse effects are thought to be related to the constituent reserpine (94331,94440). Adverse reactions to reserpine also include angina-like symptoms (94328). At high doses, adverse effects related to yohimbine, another constituent of Indian snakeroot, include hypertension, tachycardia, palpitations, myocardial infarction, and atrial fibrillation (3312,17465,86801,91521). A supplement containing Indian snakeroot and several other ingredients (Carditone, Ayush Herbs) has been associated with reduction in blood pressure and increase in serum potassium levels (102838).
Dermatologic ...Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. Orally, reserpine can cause facial flushing, skin rash, and itching (94328). Yohimbine may cause rash, erythrodermic skin eruption, and exanthema (3312,3971,86878,86896).
Endocrine ...Indian snakeroot contains small amounts of reserpine and may theoretically cause some of the adverse effects associated with this constituent. Orally, reserpine can cause galactorrhea and breast enlargement (275,94328).
Gastrointestinal ...Orally, Indian snakeroot has been associated with increased or decreased appetite, diarrhea, nausea, vomiting, and abdominal pain (94332,94438,94440). Yohimbine, a constituent of Indian snakeroot, has been associated with nausea, vomiting, increased salivation, diarrhea, and gastrointestinal distress (3970,17465,86780,86786,86804,86827,86896). Reserpine, another constituent of Indian snakeroot, may cause gastrointestinal irritation and activation of peptic ulcers (15,19).
Genitourinary ...Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. Yohimbine may cause dartos contraction or decreased libido in some patients (86786,86882).
Hematologic ...Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. A case of drug-induced agranulocytosis has been reported following prolonged use of oral yohimbine (86877). Reserpine may cause thrombocytopenia (275).
Immunologic ...There is one report of a hypersensitivity reaction to yohimbine, a constituent of Indian snakeroot. Symptoms included fever, chills, malaise, itchy, scaly skin, progressive kidney failure, and a lupus-like syndrome (6169).
Musculoskeletal ...Orally, Indian snakeroot has been associated with muscle aches and cramps (94438).
Neurologic/CNS ...Orally, Indian snakeroot may cause headaches, feeling cold, dizziness, drowsiness, nightmares, and mild sedation (94331,94332,94438,94440). Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. Doses of reserpine of greater than 0.5 mg daily can increase the risk of side effects. In extremely large amounts, Parkinson-like symptoms, extrapyramidal reactions, and convulsions may occur (15,94328,94332). Orally, yohimbine has been associated with reports of tremulousness, head twitching, seizures, loss of consciousness, decreased energy, dizziness, vertigo, headache, feeling cold, flushing, diaphoresis, and paralysis (11,18,3312,3971,17465,86786,86801,86804,86827,86896).
Oncologic ...Indian snakeroot contains small amounts of reserpine and may theoretically cause some of the adverse effects associated with this constituent. Some preliminary research suggests a link between reserpine and an increased risk of breast cancer; but this has not been confirmed in further research (94328).
Psychiatric
...Orally, Indian snakeroot can cause emotional upset or depression, especially in people with prior episodes.
This appears to be related to the constituent reserpine (94332,94438). One study shows the rate of depressive episodes is similar for patients taking Indian snakeroot and those taking reserpine (94438). Some research suggests that the risk of depression might increase with dose or the length of use. When taken for less than 40 days, depression did not occur in patients taking Indian snakeroot or reserpine (94330).
Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. Orally, yohimbine may increase anxiety and impulsivity (17465,86784,86810).
Pulmonary/Respiratory ...Orally, Indian snakeroot can cause nasal stuffiness or congestion and shortness of breath (94330,94332,94438,94440). One study shows that Indian snakeroot may increase the risk for nasal congestion more than the constituent reserpine. (94438). Reserpine is also associated with rare reports of allergic reactions that can precipitate asthma (15,94328). Another constituent of Indian snakeroot, yohimbine, may cause bronchospasm, tachypnea, cough, sinusitis, and rhinorrhea (17465,86825,86850,94112). Excessive doses of yohimbine can cause respiratory depression (1118).
Renal
...Orally, Indian snakeroot may cause increased urination (94332).
Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. A case of acute kidney failure related to yohimbine-induced systemic lupus erythematosus has been reported (6169).
Other ...Orally, Indian snakeroot has been associated with reports of weight gain (94438).
General
...Orally, Tinospora cordifolia seems to be well tolerated.
Topically, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Headache and nasal pain.
Topically: Burning, erythema, and pruritus.
Serious Adverse Effects (Rare):
Orally: Liver injury has been reported.
Dermatologic ...Topically, Tinospora cordifolia has been reported to cause pruritus, erythema, and burning (92220).
Hepatic
...Orally, liver injury is reported after consumption of Tinospora cordifolia.
In 2 case series, autoimmune hepatitis, acute hepatitis, worsening of chronic liver disease, or acute liver failure is reported in 49 patients after consuming various forms and doses of Tinospora cordifolia alone or in combination with other ingredients for a median of 42-90 days. Of these patients, 2 required a liver transplant and 4 died (110533,110534).
Liver injury is also reported in patients taking combination supplements containing Tinospora cordifolia. One case reports a 50-year-old female who presented with a 2-week history of constant right upper quadrant abdominal pain, nausea, loss of appetite, and fatigue, along with severely elevated alanine transaminase (ALT) and aspartate aminotransferase (AST), after taking a specific combination product containing Tinospora cordifolia 900 mg, stinging nettle 600 mg, and quercetin 600 mg (HistaEze) daily for 4 to 5 weeks (112404). Another case reports a 54-year-old female who developed acute hepatitis with elevated ALT, AST, alkaline phosphatase, gamma-glutamyl transferase, and bilirubin after consuming a multi-ingredient product containing approximately 1900 mg of Tinospora cordifolia and 11 other Ayurvedic herbals daily for 2.5 months (112405). In both cases, liver function returned to normal within 3 months of discontinuing the supplement (112404,112405). It is unclear whether the liver injury in these cases is due to Tinospora cordifolia, other ingredients, or the combination.
Neurologic/CNS ...Orally, Tinospora cordifolia has been reported to cause headache in a clinical trial (15085).
Pulmonary/Respiratory ...Orally, Tinospora cordifolia extract has been reported to cause nasal pain in a clinical trial (15085).