Ma Huang (Ephedra) 50 mg as a standardized extract 1:10 (equivalent to 500 mg Ma Huang) with 4 mg of total Ephedrines • Wild Horehound leaf 150 mg • Thyme herb extract (1:4) 100 mg (equivalent to 400 mg of Thyme) • Coltsfoot leaf 50 mg • Mullein leaf 50 mg • Cayenne 1.125 mg • Marshmallow root 9 mg • Slippery Elm bark 9 mg. Other Ingredients: Gelatin , Water.
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 Herbal Decongestant Expectorant Capsules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of coltsfoot.
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 Herbal Decongestant Expectorant Capsules. 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 typically found in food. Capsicum has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used topically and appropriately (7038,10650,105345). The active capsicum constituent capsaicin is an FDA-approved ingredient used in certain over-the-counter, topical preparations (272).
POSSIBLY SAFE ...when used orally and appropriately, short-term in medicinal amounts. A specific sustained-release chili extract (Capsifen) has been used safely in doses of up to 200 mg daily, for up to 28 days (105196). ...when used intranasally and appropriately, short-term. Capsicum-containing nasal sprays, suspensions, and swabs seem to be safe when applied multiple times over 24 hours or when applied daily or every other day for up to 14 days. Although no serious side effects have been reported in clinical trials, intranasal application of capsicum-containing products can be very painful (14322,14324,14328,14329,14351,14352,14353,14356,14357) (14358,14359,14360,15016,105204). POSSIBLY UNSAFE when used orally, long-term or in high doses. There is concern that long-term use or use of excessive doses might be linked to hepatic or kidney damage, as well as hypertensive crisis (12404,40569,40606). There is insufficient reliable information available about the safety of capsicum when injected.
CHILDREN: POSSIBLY UNSAFE
when used topically in children under 2 years old (272).
There is insufficient reliable information available about the safety of capsicum when used orally in children.
PREGNANCY: LIKELY SAFE
when used topically and appropriately (272).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term.
Capsicum 5 mg daily has been used for up to 28 days during the latter half of the second trimester and the third trimester (96457).
LACTATION: LIKELY SAFE
when used topically and appropriately (272).
LACTATION: POSSIBLY UNSAFE
when used orally.
Dermatitis can sometimes occur in infants when foods heavily spiced with capsicum peppers are ingested during lactation (739). Also, observational research suggests that intake of raw capsicum peppers during pregnancy is associated with an increased risk of sensitization to inhalant allergens in children by the age of 2 years (41021).
LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Dietary supplement products sold in the US are not required to include the amount of PAs they may contain; therefore, all preparations used orally containing coltsfoot should be considered potentially unsafe (3484). Tell patients not to use coltsfoot preparations that are not certified and labeled as hepatotoxic PA-free.
PREGNANCY: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally.
Coltsfoot preparations containing hepatotoxic pyrrolizidine alkaloid (PA) constituents might be teratogenic and hepatotoxic (575,12841,12842). There is one case report of fatal hepatic veno-occlusive disease in a neonate associated with regular maternal consumption during pregnancy of an herb tea containing several pyrrolizidine alkaloid herbs, including coltsfoot (575). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during pregnancy; avoid using.
LACTATION: LIKELY UNSAFE
when used orally.
Hepatotoxic pyrrolizidine alkaloid (PA) constituents in coltsfoot are excreted in milk (12841,12842). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during lactation; avoid using.
LIKELY UNSAFE ...when used orally. Ephedra can cause severe life-threatening or disabling adverse effects in some people. Ephedra is banned in the US. Several case reports have linked ephedra to serious side effects including hypertension, myocardial infarction (MI), seizure, stroke, psychosis, and others (1276,2729,6486,6998,9167,10689). Prolonged use or use of high doses might increase the risk of serious adverse effects (2729). Some suggest that ephedra is only harmful when used inappropriately in excessive doses or for prolonged periods. However, there are several cases of significant adverse events in patients who used ephedra short-term in relatively low doses ranging from 20-60 mg of ephedra alkaloids (2729,6486). There is some evidence that people who take doses greater than 32 mg per day might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage (9167). It is not possible to determine who is at the greatest risk. However, people with pre-existing conditions such as cardiovascular disease or those using ephedra products in combination with other stimulants such as caffeine, might be at increased risk.
CHILDREN: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (6486).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (1276,2729,6486,6998,9167,10689).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Gelatin has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term . A specific type of gelatin from donkey hide, called colla corii asini, has been safely used in doses of 6-10 grams orally daily for 6-8 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and oral ulcers (97634,107011). Since gelatin is often derived from bovine bones and skin, there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated gelatin preparations.
CHILDREN: POSSIBLY SAFE
when gelatin tannate is used orally and appropriately in medicinal amounts, short-term.
In children under 15 kg or under 3 years of age, gelatin tannate has been used with apparent safety at doses up to 250 mg four times daily for up to 5 days. In children over 15 kg or over 3 years of age, it has been used with apparent safety at doses up to 500 mg four times daily for up to 5 days (103296). There is insufficient reliable information available about the safety of other forms of gelatin in children.
PREGNANCY: LIKELY SAFE
when used orally in the amounts commonly found in foods.
PREGNANCY: POSSIBLY SAFE
when a specific type of gelatin from donkey hide, called colla corii asini, is used orally in doses of 10 grams daily for 6 weeks.
Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and ulcers in the oral cavity (97634).
There is insufficient reliable information available about the safety of other types of gelatin when used during pregnancy in medicinal amounts.
LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
There is insufficient reliable information available about the safety of using larger amounts of gelatin during lactation; avoid using.
LIKELY SAFE ...when marshmallow root and leaf are used in amounts commonly found in foods. Marshmallow root has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when marshmallow root and leaf are used orally in medicinal amounts (4,12). ...when used topically (4,62020). There is insufficient reliable information available about the safety of marshmallow flower.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
POSSIBLY SAFE ...when used orally and appropriately (4,12,272,512,1740).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Slippery elm bark has historically been inserted into the cervix to induce abortion. As a result, slippery elm has been reported in some sources to have abortifacient activity. However, there is no reliable information available about whether slippery elm has abortifacient activity when taken orally.
LIKELY SAFE ...when used in amounts commonly found in foods. Thyme has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when thyme is used orally and appropriately in supplemental amounts. Orally, thyme, in combination with other herbs, has been used safely for up to 23 days (13557,49219,49223,78133). ...when diluted thyme oil is used topically, short-term. Diluted thyme oil has been used with apparent safety for up to 7 months (5177). There is insufficient reliable information available about the safety of thyme oil when used orally or when inhaled.
CHILDREN: LIKELY SAFE
when used in amounts commonly found in foods.
Thyme has Generally Recognized as Safe (GRAS) status in the US (4912).
CHILDREN: POSSIBLY SAFE
when thyme is used orally in medicinal amounts in combination with English ivy.
Thyme has been used with apparent safety in combination with English ivy for up to 10 days (78181).
There is insufficient reliable information available about the safety of thyme oil when used orally or topically in children.
PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts commonly found in foods.
Thyme has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of thyme when used in medicinal amounts during pregnancy and breast-feeding; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. White horehound has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately (2,12).
POSSIBLY UNSAFE ...when used orally in excessive amounts; white horehound may have a purgative effects (4,12). There is insufficient reliable information available about the safety of the topical use of white horehound.
PREGNANCY: LIKELY UNSAFE
when used orally; white horehound might have abortifacient effect (19), or stimulate menstrual flow and the uterus (12).
There is insufficient reliable information available about the safety of topical use during pregnancy; avoid using.
LACTATION:
There is insufficient reliable information available about the safety of oral use during lactation; avoid amounts greater than those commonly found in foods.
There is insufficient reliable information available about the safety of topical use during lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Herbal Decongestant Expectorant Capsules. 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, using topical capsaicin may increase the risk of ACE inhibitor-induced cough.
Details
There is one case report of a topically applied capsaicin cream contributing to the cough reflex in a patient using an ACEI (12414). However, it is unclear if this interaction is clinically significant.
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Theoretically, capsicum may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that capsicum might increase the effects of antiplatelet drugs (12406,12407). Also, population research shows that capsicum is associated with an increased risk of self-reported bleeding in patients taking warfarin (12405,20348). However, clinical research shows that taking a single dose of capsaicin (Asian Herbex Ltd.), the active ingredient in capsicum, 400-800 mcg orally in combination with aspirin 500 mg does not decrease platelet aggregation when compared with taking aspirin 500 mg alone. Also, there was no notable effect on measures of platelet aggregation with capsaicin (92990). It is unclear whether capsaicin must be used in more than a single dose to affect platelet aggregation.
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Theoretically, taking capsicum with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Preliminary clinical research shows that consuming capsicum 5 grams along with a glucose drink attenuates the rise in plasma glucose after 30 minutes by 21%, decreases the 2-hour postprandial area under the curve of plasma glucose by 11%, and increases the 2-hour postprandial area under the curve of plasma insulin by 58% in healthy individuals when compared with placebo (40453,40614). Other clinical research shows that taking capsicum 5 mg daily for 28 days significantly reduces postprandial blood glucose and insulin levels, but not fasting blood glucose and insulin levels, in patients with gestational diabetes (96457).
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Theoretically, taking capsicum with aspirin might reduce the bioavailability of aspirin.
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Animal research shows that acute or chronic intake of capsicum pepper reduces oral aspirin bioavailability (22617). This has not been shown in humans.
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Theoretically, taking capsicum with ciprofloxacin might increase levels and adverse effects of ciprofloxacin.
Details
Animal research shows that concomitant use of capsaicin, the active constituent of capsicum, and ciprofloxacin increases the bioavailability of ciprofloxacin by up to 70% (22613).
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Theoretically, taking capsicum with theophylline might increase the levels and adverse effects of theophylline.
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Concomitant use might increase the risk of bleeding due to decreased platelet aggregation. Coltsfoot has been reported to inhibit platelet aggregation (12864); avoid concomitant use. Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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Theoretically, excessive doses of coltsfoot may interfere with antihypertensive or cardiovascular therapy (12858).
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Hepatotoxic pyrrolizidine alkaloids (PA) are substrates of cytochrome P450 3A4 (CYP3A4) (12841,12860). Theoretically, drugs that induce CYP3A4 might increase the conversion of PAs to toxic metabolites. Some drugs that induce CYP3A4 include carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin, rifabutin (Mycobutin), and others.
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Theoretically, ephedra may reduce the effects of anticonvulsants.
Details
Ephedra has been associated with reports of seizure (13304).
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Theoretically, taking ephedra with antidiabetes drugs might interfere with blood glucose control.
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One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose levels and might decrease the effectiveness of drug therapy (3719,12857,48810). Monitor blood glucose concentrations closely.
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Theoretically, large amounts of ephedra might increase the cardiac inotropic effects of beta-agonists.
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Theoretically, ephedra might decrease levels of drugs metabolized by CYP1A2.
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Some animal research suggests that ephedra induces CYP1A2 and increases the clearance of CYP1A2 substrates such as caffeine (91808).
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Theoretically, concomitant use might reduce the levels and clinical effects of dexamethasone.
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Theoretically, concomitant use might increase the risk of hypertension.
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The ephedrine contained in ephedra might cause excessive vasoconstriction and hypertension when used in combination with ergot derivatives (6009).
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Theoretically, concomitant use might have additive adverse hepatotoxic effects.
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Concomitant use might increase the risk of serious adverse effects.
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Use of ephedra with caffeine or other methylxanthines such as theophylline might increase the risk of stimulatory adverse effects (8641,24180). There is also some evidence that using ephedra with caffeine might increase the risk of serious life-threatening or debilitating adverse effects such as hypertension, myocardial infarction (MI), stroke, seizures, and death (1275,6486,10307,48751,54423,54429).
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Theoretically, concomitant use might increase the risk of serious adverse effects.
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Theoretically, ephedra might have an additive effect with drugs that prolong the QT interval.
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Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions have been reported with ingestion of recommended doses of ephedra (11135,11708). Ephedra may have an additive effect with drugs that prolong the QT interval. This may increase the risk of ventricular arrhythmias (11355,48765).
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Theoretically, concomitant use might increase the risk for serious adverse effects.
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Theoretically, marshmallow flower might have antiplatelet effects.
Details
Animal research suggests that marshmallow flower extract has antiplatelet effects (92846). However, the root and leaf of marshmallow, not the flower, are the plant parts most commonly found in dietary supplements. Theoretically, use of marshmallow flower with anticoagulant/antiplatelet drugs can have additive effects, and might increase the risk for bleeding in some patients.
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Theoretically, due to potential diuretic effects, marshmallow might reduce excretion and increase levels of lithium.
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Marshmallow is thought to have diuretic properties. To avoid lithium toxicity, the dose of lithium might need to be decreased when used with marshmallow.
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Theoretically, mucilage in marshmallow might impair absorption of oral drugs.
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Theoretically, slippery elm may slow the absorption and reduce serum levels of oral drugs.
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Slippery elm inner bark contains mucilage, which may interfere with the absorption of orally administered drugs (19).
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Theoretically, concurrent use of anticholinergic drugs and thyme essential oil might reduce the effects of anticholinergic drugs.
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In vitro evidence suggests that thyme essential oil and specific essential oil constituents like thymohydroquinone and carvacrol can inhibit acetylcholinesterase (AChE) (78155). However, this effect has not been observed in humans.
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Theoretically, thyme leaf extract might have additive effects with anticoagulant or antiplatelet drugs.
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Theoretically, concurrent use of cholinergic drugs and thyme essential oil might cause additive cholinergic effects.
Details
In vitro evidence suggests that thyme essential oil and specific essential oil constituents like thymohydroquinone and carvacrol can inhibit acetylcholinesterase (AChE) (78155). However, this effect has not been observed in humans.
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Theoretically, thyme might competitively inhibit the effects of estrogen replacement therapy.
Details
In vitro research shows that thyme has estrogen receptor-binding activity and phytoestrogen content (3701). However, this effect has not been observed in humans.
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Evidence from animal research suggests that white horehound might lower blood glucose (23603,26149). However, preliminary clinical research suggests that white horehound only slightly lowers blood glucose when taken in combination with antidiabetic agents, suggesting that the effect may not be clinically significant (86369). Until more is known, use with caution. Theoretically, white horehound may have additive effects when used by patients taking antidiabetic drugs. The dose of diabetes medications might need to be adjusted. Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.
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Evidence from animal research suggests that taking white horehound extract lowers blood pressure (49408,86367). Theoretically, taking white horehound with antihypertensive drugs might enhance therapeutic effects and increase the risk of hypotension. 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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Below is general information about the adverse effects of the known ingredients contained in the product Herbal Decongestant Expectorant Capsules. 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, capsicum is generally well tolerated in amounts typically found in food or when the extract is used in doses of up to 200 mg daily.
Topically and intranasally, capsaicin, a constituent of capsicum, is generally well tolerated.
Most Common Adverse Effects:
Orally: Belching, bloating, burning, diarrhea, dyspepsia, gas, headache, mild constipation, nausea, rhinorrhea, skin flushing, and sweating.
Serious Adverse Effects (Rare):
Orally: Cases of myocardial infarction and hypertensive crisis have been reported.
Cardiovascular
...Orally, palpitation was reported in one clinical trial (105196).
One case of myocardial infarction has been reported in a 41-year-old male without cardiovascular risk factors; the event was attributed to the use of an oral capsicum pepper pill that the patient had been taking for weight loss (40768). Another case of coronary vasospasm and acute myocardial infarction has been reported for a healthy 29-year-old male; the event was attributed to the use of a topical capsicum-containing patch that the patient had been applying to the middle of the back for 6 days (40658). Two cases of arterial hypertensive crisis have been reported for individuals who ingested a large amount of peppers and chili peppers the day before. One of the patients also had an acute myocardial infarction, and the other had high levels of thyroid stimulating hormone (40569,40606).
Dermatologic
...Orally, capsicum or its constituent capsaicin may cause urticaria and skin wheals in rare cases (96457,105203).
Topically, capsicum can cause a prickling sensation, itching, pain, burning, edema, stinging, irritation, rash, and erythema. About 1 in 10 patients who use capsaicin topically discontinue treatment because of adverse effects. These effects seem to occur more often with topical formulations containing higher concentrations of capsaicin, the active constituent of capsicum. Side effects tend to diminish with continued use (12401,15260,15261,40358,40439,40483,40547,40676,40682,40719)(40784,40847,92979,92983,92984,96453,105193,105197,105202,111514). In one case, application of a capsaicin 8% patch (Qutenza) for 60 minutes caused a second-degree burn, characterized by burning, erythema, severe pain, and blistering at the administration site. The burn was treated with topical corticosteroids, but 9 months later neuropathic pain persisted, resulting in limited mobility. It is unclear whether the mobility sequalae were caused by topical capsaicin or the patient's pre-existing neurological disorders (111514). Skin contact with fresh capsicum fruit can also cause irritation or contact dermatitis (12408).
Intranasally, capsaicin can cause nasal burning and pain in most patients. It also often causes lacrimation, sneezing, and excessive nasal secretion; however, these side effects appear to diminish with repeat applications (14323,14329,14358). In some cases, the burning sensation disappears after 5-8 applications (14351,14358). In some cases, patients are pretreated with intranasal lidocaine to decrease the pain of intranasal capsaicin treatment. However, even with lidocaine pretreatment, patients seem to experience significant pain (14324).
Gastrointestinal
...Orally, capsicum can cause upper abdominal discomfort, including irritation, fullness, dyspepsia, gas, bloating, nausea, epigastric pain and burning, anal burning, diarrhea, mild constipation, and belching (12403,12410,40338,40427,40456,40503,40560,40584,40605,40665)(40718,40725,40745,40808,40828,96456,96457,105194,105196).
There is a case report of a 3-year-old female who experienced a burning and swollen mouth and lips after touching the arm of a parent that had been treated with a capsaicin patch and then placing the fingers in the mouth (105199). Excessive amounts of capsaicin can lead to gastroenteritis and hepatic necrosis (12404). In a case report, a 40-year-old male with diabetes consumed white wine daily and chewed cayenne which was thought to result in black teeth stains and loss of enamel (40809). Some preliminary research links ingestion of capsaicin with stomach and gallbladder cancer; however the link may be due to contamination of capsaicin products with carcinogens (40771).
Topically, capsaicin can cause diarrhea and vomiting (105202).
Immunologic ...In a case report, a 34-year-old female had anaphylaxis involving difficulty breathing and stupor and also urticaria after consuming a red bell pepper, which is in the capsicum genus. The causal chemical was theorized to be 1,3-beta-glucanase (92978). In another case report, a 33-year-old female experienced angioedema, difficulty breathing and swallowing, and urticaria after ingesting raw green and red peppers (92982).
Neurologic/CNS ...Orally, capsicum can cause sweating and flushing of the head and neck, lacrimation, headache, faintness, and rhinorrhea (7005,12410,105196,105203). Topically, applying capsaicin can cause headache (96450,105202). Injection of capsaicin into the intermetatarsal space has also been associated with headache (96454).
Ocular/Otic
...Topically, capsicum can be extremely irritating to the eyes and mucous membranes.
Capsicum oleoresin, an oily extract in pepper self-defense sprays, causes intense eye pain. It can also cause erythema, blepharospasm, tearing, shortness of breath, and blurred vision. In rare cases, corneal abrasions have occurred (12408,12409,40345,40348,40383,40720,40857).
Inhalation of capsicum can cause eye irritation, and allergic alveolitis (5885). In a case report, a 38-year-old female had acute anterior uveitis that developed about 12 hours after using a specific patch (Isola Capsicum N Plus) that contained capsaicin 1.5 mg per patch and methyl salicylate 132 mg per patch for neck pain. The uveitis was controlled with topical steroids and did not recur (92977).
Oncologic ...Population research suggests that moderate to high intake of capsaicin, the active constituent of capsicum, is associated with an increased risk of gastric cancer, while low intake is associated with a decreased risk. It is not clear from the study what amount of capsaicin is considered high versus low intake (92988). Additionally, some research suggests that any link may be due to contamination of capsaicin products with carcinogens (40771).
Pulmonary/Respiratory
...Orally, difficulty breathing was reported in a clinical trial (105196).
Topically, nasopharyngitis related to the use of a cream containing capsaicin has been reported (105202).
Inhalation of capsicum and exposure to capsicum oleoresin spray can cause cough, dyspnea, pain in the nasal passages, sneezing, rhinitis, and nasal congestion (5885,15016,40522,40546,40647). In rare cases, inhalation of the capsicum oleoresin or pepper spray has caused cyanosis, apnea, respiratory arrest and death in people. Death was caused by asphyxiation probably due to acute laryngeal edema and bronchoconstriction from inhalation of the capsicum oleoresin spray (40546,40672,40837,40879).
In a case report, a 47-year-old female who was exposed to capsaicin gas for more than 20 minutes experienced acute cough, shortness of breath, short-term chest pain, wheezing, and difficulty breathing for months afterwards (92980). In rare cases, exposure to capsicum oleoresin spray resulted in apnea, pulmonary injury, cyanosis, and even respiratory arrest (40383,40546).
General ...Orally, the major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These alkaloids can cause liver and lung injury (12841,12842). Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with hepatic veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842). Deep vein thrombosis (DVT) and pulmonary embolus (PE) thought to be associated with coltsfoot have been reported (18242). Coltsfoot products containing PAs should be avoided. There is currently a limited amount of information available about the adverse effects of PA-free coltsfoot.
Cardiovascular ...Orally, a single case report associates coltsfoot and its PA content with deep vein thrombosis (DVT) and pulmonary embolus (PE). A 27-year-old man with no history of coagulation disorders developed a DVT and several PE after consuming unknown quantities of coltsfoot and several other herbs. However, he also had other risk factors for thrombosis, including smoking and recent bed rest (18242).
Hepatic ...Orally, coltsfoot might cause liver damage. Coltsfoot contains hepatotoxic pyrrolizidine alkaloids (PAs) (12841,12842). Chronic exposure to other plants containing hepatotoxic PAs is associated with veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842).
Pulmonary/Respiratory ...Orally, coltsfoot might cause lung damage. The major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These constituents can cause lung damage with pulmonary-arterial hypertension (12841,12842).
General
...Orally, ephedra is frequently associated with adverse reactions and is banned in the US.
In some cases, adverse effects can be severe or life-threatening. Large studies looking at the safety of ephedra have not been performed. Since most of the adverse effect data are from case reports, it is impossible to determine the overall incidence of these adverse effects. It is also difficult to determine which patient groups might be most likely to experience an adverse event.
Most Common Adverse Effects:
Orally: Anorexia, anxiety, difficulty concentrating, difficulty urinating, dizziness, dry mouth, flushing, headache, heartburn, hyperthermia, hypertension, insomnia, irritability, nausea, personality changes, polydipsia, restlessness, tachycardia, tingling, and vomiting.
Serious Adverse Effects (Rare):
Orally: Cardiac arrest, cardiac arrhythmia, cardiomyopathy, heart failure, hepatotoxicity, myocardial infarction, myopathies, psychosis, seizure, stroke, and sudden death.
Cardiovascular
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally, ephedra use has been associated with cardiomyopathy (1270,48801), hypersensitivity myocarditis (1271,6487,48738,48739), chest tightness, myocardial infarction (6486), cardiac arrest and sudden death (1274,6486), hypertension, tachycardia, and cardiac arrhythmias (6009,8643,35749,35750,37689,48736,48737,48805,48847,48870,48872). Ephedrine abuse has led to heart failure (48813). Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions can occur with ingestion of recommended doses of ephedra containing products (11135,11708). In a review of 926 cases reported to the FDA of possible adverse effects of ephedra, 37 patients had serious or fatal adverse reactions. Ephedra use was temporally related to 16 strokes, 10 myocardial infarctions, and 11 sudden deaths. These effects occurred in people aged 30-56 years. There is some evidence that people who take doses greater than 32 mg daily might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage, when compared with those taking doses of less than 32 mg daily (9167,48771).
Ephedrine, the primary active ingredient in ephedra, has been associated with coronary artery spasm, myocardial injury with pulmonary edema, and cardiovascular collapse (48867,48872,48783). However, several clinical trials evaluating ephedrine-caffeine combinations for weight loss reported no differences in mean heart rate or blood pressure when compared to placebo (37617,48792,48865,48882). Other preliminary clinical research showed that ephedrine and caffeine use by prescription did not result in increased risk of adverse cardiovascular outcomes (48806).
Endocrine ...One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose and insulin levels (3719,12857,48810).
Gastrointestinal ...The use of ephedra causes a 2. 2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally and intravenously, ephedra and ephedrine most commonly cause dry mouth, anorexia, nausea, vomiting, heartburn, abdominal discomfort, and changes in stool consistency (1276,3719,6008,6486,8647,10004,10382,37831,48817,48837). One case of ischemic colitis and symptoms of abdominal pain and bloody diarrhea associated with the use of a weight loss supplement containing ephedra has been reported (48803).
Hepatic ...Cases of hepatotoxicity such as acute hepatitis and liver failure from ephedra-containing supplements have been reported. Some cases of hepatotoxicity resolved after discontinuation of ephedra, while others required liver transplantation. In obese patients using ephedra for weight loss, it is possible that ephedra exacerbated pre-existing liver disease. Onset of liver injury seems to occur an average of 3 months after ephedra ingestion, suggesting an idiosyncratic mechanism of liver injury (1273,48747,48800,94875,94876,94877,81600,98441). Previously, it was thought that the cause of ephedra hepatotoxicity was an immune reaction or a contamination. However, since the majority of evidence suggests that hepatotoxicity is idiosyncratic, these prior postulations have since been dismissed (1273,48747,81600,98441).
Musculoskeletal ...Orally, ephedra has been reported to cause myopathies, including myalgia, rhabdomyolysis, and eosinophilia-myalgia syndrome (1270,16054,48791).
Neurologic/CNS
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes dizziness, restlessness, anxiety, irritability, personality changes, difficulty concentrating, insomnia, and headache (1276,3719,6008,6486,8647,10004,10382).
Ephedra can cause seizures in otherwise healthy people, as well as in people with underlying seizure disorders (10307,48870). Of 33 seizures linked to dietary supplement use that were reported to the FDA over 7 years, 27 involved ephedra (13304). Other adverse events reported with ephedra use include sudden hearing loss, stroke, transient ischemic attack, cerebral hemorrhage, and loss of consciousness (1275,1381,2729,6486,8643,9167,10005,48746,48862). In one case-control study, doses of ephedra above 32 mg daily have been associated with an increased risk for hemorrhagic stroke (9167). A case of encephalopathy syndrome with multi-organ failure and transient cortical blindness after ingestion of a performance-enhancing ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788).
Ocular/Otic ...A case of encephalopathy syndrome with transient cortical blindness after ingestion of an ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788). A case of sudden hearing loss following the use of ephedra has also been reported (48761).
Psychiatric
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes anxiety, irritability, personality changes, difficulty concentrating, and insomnia (1276,3719,6008,6486,8647,10004,10382).
Cases of ephedrine-induced psychiatric complications (6998) include mania (48855), psychosis (1276,6998,10689,48751,48841,48843), and hallucinations (48857). In some cases psychosis can be prolonged for several months after discontinuation (1276,6998,10689). A case of a suicide attempt and mood disorder associated with the use of a diet pill containing ephedra has also been reported (48752).
Long-term use of ephedra or use in high doses has been associated with dependence and tolerance (1381).
Renal ...Orally, ephedra has been reported to cause nephrolithiasis (1272,48877), diuresis, urinary retention, and dysuria (16054,48791).
General
...Orally, gelatin seems to be well tolerated.
Most Common Adverse Effects:
Oral: Belching, bloating, and dyspepsia.
Serious Adverse Effects (Rare):
Injection: IgE-mediated allergic reactions, Kounis syndrome.
Gastrointestinal ...Orally, gelatin can cause unpleasant taste, sensation of heaviness in the stomach, bloating, dyspepsia, and belching (7704).
Immunologic
...Gelatin can cause allergic reactions.
Gelatin in foods can cause initial sensitization (7703). Gelatin-containing medicines including oral medications, suppositories, vaccines, and injectable products can cause IgE-mediated allergic reactions, including urticaria, angioedema, wheezing, hypotension, and anaphylaxis (7708,7709,7710,97633,111345). In the US, gelatin is used as a stabilizer in some vaccines such as measles, mumps, and rubella (MMR), and diphtheria, pertussis, tetanus (DPT) (7711). In one case report, a 73-year-old male experienced anaphylactic symptoms within 10 minutes of receiving gelatin lysate as a plasma expander during a routine surgery. The patient proceeded to develop heart, respiratory, and kidney failure and died 76 days after receiving the gelatin infusion (97633). At least 12 case reports describe life-threatening anaphylaxis after administration of gelatin-containing hemostatic agents during surgery. In these cases, hypotension, tachycardia, and increased airway pressure occurred shortly after injection of the agent into the pedicle tract (111345).
There are at least two cases of Kounis syndrome, an acute coronary syndrome related to a massive mast cell activation, after the use of a gelatin infusion during general anesthesia. In one case, immediate symptoms included bradycardia and hypotension, followed by myocardial ischemia and coronary vasospasm (97631).
Other ...Since gelatin is sometimes produced from bovine bones and skin, there is some concern about the potential risk of contamination with diseased animals and transmission of bovine spongiform encephalopathy (BSE, mad cow disease) and other diseases (1825). So far, there are no reports of BSE or other disease transmission to humans from gelatin products.
General ...Orally and topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General ...Information regarding the adverse effects of mullein is limited. A thorough evaluation of safety outcomes has not been conducted.
Dermatologic ...Two case reports have described dermatitis, with positive patch tests, after topical exposure to the whole plant, or by occupational inhalation of plant dust (92839,97316). In the case of topical exposure, the patient also had positive patch tests to other plants.
General ...Orally, slippery elm seems to be well tolerated. A thorough evaluation of safety outcomes with topical use of slippery elm has not been conducted.
Dermatologic ...Topically, slippery elm extracts can cause contact dermatitis. The pollen is an allergen (6). Contact dermatitis and urticaria have been reported after exposure to slippery elm or an oleoresin contained in the slippery elm bark (75131).
General
...Orally, thyme is well tolerated when used in food and seems to be well tolerated when used medicinally.
Topically, thyme seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Allergic reactions, diarrhea, dizziness, headache, heartburn, nausea, or vomiting.
Topically: Contact dermatitis and skin irritation.
Dermatologic ...Topically, thyme, thyme oil, or the constituent thymol can cause contact dermatitis and skin irritation (13463,78252,78362,78384,77982,78154,78310,78313,78384). In one study of 100 patients with contact allergies, 5% were attributed to thyme oil as an allergen contained in wound dressings (78362). Toothpastes containing thymol have been associated with cheilitis and glossitis (13463).
Gastrointestinal
...Orally, thyme and thyme oil may cause heartburn, nausea, vomiting, stomach upset, or diarrhea (13557,94033).
In a clinical study, two patients using extracts of thyme herb and ivy leaves experienced temporary stomach ache and mild nausea (78181).
Intravaginally, cream containing thyme and garlic has been associated with reports of nausea and vomiting in one clinical study (88387). It is not clear if these adverse effects were associated with thyme, garlic, or the combination.
Genitourinary ...Intravaginally, cream containing thyme and garlic has been associated with reports of vaginal dryness and vaginal irritation in one clinical study (88387). It is not clear if these adverse effects were associated with thyme, garlic, or the combination.
Immunologic ...Orally, thyme can cause allergic reactions; however, this is uncommon (13463). Allergic reactions to thyme might be more common in people who are also allergic to oregano and other Lamiaceae species (3808).
Neurologic/CNS ...Orally, thyme may case headache or dizziness (94033).
Pulmonary/Respiratory ...By inhalation, occupational exposure to thyme dust can cause acute airway obstruction (783,13463,13464,77982,78098).
General
...Orally, white horehound may cause nausea, dry mouth, excessive salivation, loss of appetite, and dizziness in some patients (86369).
Large amounts of white horehound (exact dose is unclear) may cause purgative effects (4,12).
Topically, skin contact with the plant juice may cause contact dermatitis (4).
Dermatologic ...Topically, skin contact with the plant juice may cause contact dermatitis (4).
Gastrointestinal ...Orally, clinical research shows that drinking one cup of tea prepared with white horehound 1 gram three times daily for 3 weeks may cause nausea, dry mouth, excessive salivation, and loss of appetite in some patients (86369). Intake of large amounts of white horehound (exact dose is unclear) may cause purgative effects (4,12).
Neurologic/CNS ...Orally, clinical research shows that drinking one cup of tea prepared with white horehound 1 gram three times daily for 3 weeks may cause dizziness in some patients (86369).