Ingredients | Amount Per Serving |
---|---|
Total Carbohydrates
|
<1 Gram(s) |
(Olea europaea )
(leaf)
|
30 mg |
(Ocimum sanctum )
(leaf)
|
12 mg |
Respiratory Vitality Extract Blend
(Each capsule contains 1,600 mg dry herb equivalent.)
(Respiratory Vitality Extract Blend Note: Each capsule contains 1,600 mg dry herb equivalent. )
|
425 mg |
(leaf)
|
|
(Althaea officinalis )
(root)
|
|
(leaf)
|
|
(Inula helenium )
(root)
(organic)
|
|
(floral buds & tops)
|
|
(Ceanothus americanus )
(root)
|
|
(berry)
|
|
(Schisandra chinensis )
(berry)
|
Vegetable Glycerin, Sunflower Lecithin, Water, Hypromellose, Olive Oil
Below is general information about the effectiveness of the known ingredients contained in the product Mighty Lungs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of Asian water plantain.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of buckhorn plantain.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of gumweed.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of New Jersey tea.
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 Mighty Lungs. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the safety of Asian water plantain.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally with appropriate fluid intake, short-term (12,272). Black psyllium has been used with apparent safety in doses of 15-30 grams daily for up to 6 months (19156,10091,93215,102826). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a claim of reducing the risk of coronary heart disease (93217,93218).
LIKELY UNSAFE ...when black psyllium is used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (2,18,93218). ...when granular dosage forms containing black psyllium are used as over-the-counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective (GRASE) as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally with appropriate fluid intake (272).
POSSIBLY SAFE ...when used orally and appropriately (2). ...when used topically (2).
PREGNANCY: LIKELY UNSAFE
when used orally or topically.
Some evidence suggests buckhorn plantain affects muscle tone of the uterus (4275).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (12).
POSSIBLY UNSAFE ...when used orally in large amounts. Elecampane can cause gastrointestinal upset and symptoms of paralysis (12).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (12); avoid using.
POSSIBLY SAFE ...when great plantain seed is used orally, short-term. Great plantain seed has been used with apparent safety at doses up to 3600 mg daily for up to 8 weeks and 2000 mg daily for up to 12 weeks (106644,106645). ...when used topically, short-term. Topical great plantain 10% has been used with apparent safety for up to 2 weeks (106643,110088,110090). There is insufficient reliable information available about the safety of great plantain leaf or leaf extract when used orally.
PREGNANCY: LIKELY UNSAFE
when used orally because it can increase uterine tone (4).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately (2,12). There is insufficient reliable information available about the safety of gumweed when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Hawthorn preparations in doses of up to 1800 mg daily seem to be safe when used for up to 16 weeks. Although hawthorn might be safe for long-term use, current studies have not evaluated safety past 16 weeks (8279,8280,8281,10144,17203,104689). There is insufficient reliable information available about the safety of hawthorn when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally, short-term. Holy basil leaf extract has been used with apparent safety at a dose of 500 mg daily for 60-90 days (12242,18107,19575,91571,96944). ...when used topically in the mouth, short-term. Holy basil has been used with apparent safety as a 4% mouthwash solution for up to 30 days (91570,103621).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in high doses during pregnancy or when trying to conceive.
Animal research suggests that relatively high doses of holy basil extract (200 mg/kg) may reduce implantation rate when used for one week, while long-term use of higher doses (2-4 grams/kg) may decrease the number of full-term pregnancies (55040,91569). There is insufficient reliable information available regarding the safety of holy basil 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.
There is insufficient reliable information available about the safety of New Jersey tea.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.
POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.
PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.
POSSIBLY SAFE ...when used orally and appropriately. Schisandra extract up to 1 gram daily has been used for up to 12 weeks with apparent safety (12,96632,105562,105563,112887).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Some evidence suggests schisandra fruit is a uterine stimulant (11).
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Mighty Lungs. 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, black psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.
Theoretically, black psyllium might reduce carbamazepine absorption. A preliminary study using blond psyllium reported decreased carbamazepine bioavailability due to binding of the drug to psyllium, as well as reduction of available fluid in the gut for dissolution of the drug (539). This interaction may also occur with black psyllium.
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Theoretically, taking black psyllium at the same time as digoxin might reduce digoxin absorption and decrease digoxin levels.
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Theoretically, taking black psyllium at the same time as ethinyl estradiol might alter levels of estradiol.
Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. This is unlikely to be clinically significant (12421).
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Theoretically, taking black psyllium at the same time as lithium might reduce lithium absorption.
The fiber in black psyllium might reduce lithium absorption and plasma levels. Some case reports describe a reduction in plasma lithium levels with concomitant administration of blond psyllium. This was reversed when psyllium was stopped (540,92194). This interaction may also occur with black psyllium.
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Theoretically, black psyllium might increase the therapeutic and adverse effects of metformin.
Animal research shows that concurrent consumption of blond psyllium with metformin slows and increases the absorption of metformin (99433). This interaction may also occur with black psyllium. To avoid changes in absorption, take psyllium 30-60 minutes after metformin.
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Theoretically, taking black psyllium at the same time as olanzapine might reduce olanzapine absorption.
The fiber in black psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was concomitantly administered with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).
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Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.
Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940). Although many of these studies evaluated blond psyllium, the fiber content in black psyllium may have similar effects.
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Theoretically, elecampane may cause additive sedative effects when taken with CNS depressants.
Elecampane might have sedative effects (4).
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Theoretically, consuming large amounts of great plantain leaves, which contain vitamin K, might decrease the clinical effects of warfarin.
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Theoretically, hawthorn may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
In vitro and animal research shows that hawthorn can inhibit platelet aggregation (95528,95529,95530,95531). However, its effect in humans is unclear. One observational study shows that patients taking hawthorn shortly before undergoing coronary artery bypass graft (CABG) surgery or valve replacement surgery have a 10% incidence of postoperative bleeding, compared with 1% in those who never consumed hawthorn extract (95527). However, clinical research shows that taking a specific preparation of dried hawthorn leaves and flowers (Crataesor, Soria Natural Lab) 800 mg three times daily for 15 days does not affect platelet aggregation or levels of thromboxane B2, the metabolite of thromboxane A2, in healthy humans (54664).
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Theoretically, concomitant use might cause additive effects on blood pressure and heart rate.
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Theoretically, concomitant use might cause additive coronary vasodilation and hypotensive effects.
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Theoretically, hawthorn might potentiate the effects and adverse effects of digoxin.
Hawthorn appears to improve cardiac output (12595); however, hawthorn does not appear to affect digoxin pharmacokinetics (19249). Case reports suggest that at least one species of hawthorn root extract (Crataegus mexicana) may produce adverse effects similar to digoxin and can cross-react with digoxin assays, leading to falsely elevated plasma digoxin levels (113112,113113).
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Theoretically, concomitant use might cause additive coronary vasodilatory effects.
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Theoretically, concomitant use might result in additive vasodilation and hypotension.
Hawthorn might inhibit PDE-5 and cause vasodilation (12595).
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Theoretically, holy basil seed oil might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
Animal research shows that holy basil seed oil can prolong bleeding time, possibly due to inhibition of platelet aggregation (13251). However, it is not known if this occurs in humans.
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Theoretically, holy basil might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, holy basil seed oil might increase the sedative effects of pentobarbital.
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Theoretically, marshmallow flower might have antiplatelet effects.
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.
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, schisandra might increase the levels and clinical effects of cyclophosphamide.
In vitro research shows that schisandra increases the concentration of cyclophosphamide, likely through inhibition of cytochrome P450 3A4. After multiple doses of the schisandra constituents schisandrin A and schisantherin A, the maximum concentration of cyclophosphamide was increased by 7% and 75%, respectively, while the overall exposure to cyclophosphamide was increased by 29% and 301%, respectively (109636).
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Schisandra can increase the levels and clinical effects of cyclosporine.
A small observational study in children with aplastic anemia found that taking schisandra with cyclosporine increased cyclosporine trough levels by 93% without increasing the risk of adverse events. However, the dose of cyclosporine was reduced in 9% of children to maintain appropriate cyclosporine blood concentrations (109637).
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Theoretically, schisandra might increase the levels and clinical effects of CYP2C19 substrates.
In vitro research shows that schisandra inhibits CYP2C19, and animal research shows that schisandra increases the concentration of voriconazole, a CYP2C19 substrate (105566). Theoretically, schisandra may also inhibit the metabolism of other CYP2C19 substrates. This effect has not been reported in humans.
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Theoretically, schisandra might decrease the levels and clinical effects of CYP2C9 substrates.
In vitro and animal research suggests that schisandra induces CYP2C9 enzymes (14441). This effect has not been reported in humans.
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Schisandra can increase the levels and clinical effects of drugs metabolized by CYP3A4.
Most clinical and laboratory research shows that schisandra, administered either as a single dose or up to twice daily for 14 days, inhibits CYP3A4 and increases the concentration of CYP3A4 substrates such as cyclophosphamide, midazolam, tacrolimus, and talinolol (13220,17414,23717,91386,91388,91387,96631,105564,109636,109638,109639,109640,109641). Although one in vitro and animal study shows that schisandra may induce CYP3A4 metabolism (14441), this effect appears to be overpowered by schisandra's CYP3A4 inhibitory activity and has not been reported in humans.
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Schisandra can increase the levels and clinical effects of midazolam.
A small pharmacokinetic study in healthy adults shows that taking schisandra extract (Hezheng Pharmaceutical Co.) containing deoxyschizandrin 33.75 mg twice daily for 8 days and a single dose of midazolam 15 mg on day 8 increases the overall exposure to midazolam by about 119%, increases the peak plasma level of midazolam by 86%, and decreases midazolam clearance by about 52%. This effect has been attributed to inhibition of CYP3A4 by schisandra (91388).
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Schisandra might increase the levels and clinical effects of P-glycoprotein substrates.
In vitro research shows that schisandra extracts and constituents such as schisandrin B inhibit P-glycoprotein mediated efflux in intestinal cells and in P-glycoprotein over-expressing cell lines (17414,105643,105644). Additionally, a small clinical study shows that schisandra increases the peak concentration and overall exposure to talinolol, a P-glycoprotein probe substrate (91386). Theoretically, schisandra might inhibit the efflux of other P-glycoprotein substrates.
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Schisandra can increase the levels and clinical effects of sirolimus.
A small pharmacokinetic study in healthy volunteers shows that taking 3 capsules of schisandra (Hezheng Pharmaceutical Company) containing a total of 33.75 mg deoxyschizandrin twice daily for 13 days and then taking a single dose of sirolimus 2 mg increases the overall exposure and peak level of sirolimus by two-fold. This effect is thought to be due to inhibition of cytochrome P450 3A4 by schisandra, as well as possible inhibition of the P-glycoprotein drug transporter (105643).
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Schisandra can increase the levels and clinical effects of tacrolimus.
Clinical research in healthy children and adults, transplant patients, and patients with nephrotic syndrome and various rheumatic immunologic disorders shows that taking schisandra with tacrolimus increases tacrolimus peak levels by 183% to 268%, prolongs or delays time to peak tacrolimus concentrations, increases overall exposure to tacrolimus by 126% to 343%, and decreases tacrolimus clearance by 19% to 73% (17414,91387,15570,96631,105623,109638,109639,109640,109641,112889)(112890,112972,112973,112974). This effect is thought to be due to inhibition of P-glycoprotein drug transporter and CYP3A4 and CYP3A5 by schisandra (17414,96631,105623,105643,105644,112974). Some clinical and observational studies suggest that schisandra increases tacrolimus levels similarly in both expressors and non-expressors of CYP3A5, while other studies suggest it does so to a greater degree in CYP3A5 expressors than non-expressors (105623,109638,109639,109640,112889,112890,112973,112974). Animal research suggests that the greatest increase in tacrolimus levels occurs when schisandra is taken either concomitantly or up to 2 hours before tacrolimus (105564), and clinical and observational research in humans suggests that schisandra may increase whole blood levels of tacrolimus and decrease clearance of tacrolimus in a dose-dependent manner (109639,109640,112972).
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Schisandra can increase the levels and clinical effects of talinolol.
A small pharmacokinetic study in healthy volunteers shows that taking schisandra extract 300 mg twice daily for 14 days with a single dose of talinolol 100 mg on day 14 increases the peak talinolol level by 51% and the overall exposure to talinolol by 47%. This effect is thought to be due to the possible inhibition of cytochrome P450 3A4 and P-glycoprotein by schisandra (91386).
tly.
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Theoretically, schisandra might increase the levels and clinical effects of voriconazole.
Animal research shows that oral schisandra given daily for 1 or 14 days increases levels of intravenously administered voriconazole, a cytochrome P450 (CYP) 2C19 substrate. This effect is thought to be due to inhibition of CYP2C19 by schisandra (105566). However, this interaction has not been reported in humans.
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Theoretically, schisandra might decrease the levels and clinical effects of warfarin.
Animal research suggests that oral schisandra extract, given daily for 6 days, reduces levels of intravenously administered warfarin. This effect might be due to the induction of cytochrome P450 (CYP) 2C9 metabolism by schisandra (14441). However, this interaction has not been reported in humans.
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Below is general information about the adverse effects of the known ingredients contained in the product Mighty Lungs. 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 ...There is limited information available about the potential adverse effects of Asian water plantain. Orally, it has been used as a part of Traditional Chinese Medicine (TCM) with apparent safety; there have been no reported adverse effects in most patients. However, one case of hepatotoxicity and nephrotoxicity has been reported with the use of a combination TCM product containing Asian water plantain (99434).
Hepatic ...One case report of drug-induced systemic toxicity, including hepatotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He presented with gum bleed and petechiae, and his admission lab values indicated fulminant liver failure. His condition progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).
Renal ...One case report of drug-induced systemic toxicity, including nephrotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He initially presented with hepatic failure, which progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).
General
...Orally, black psyllium is generally well tolerated when taken with adequate fluids.
Most Common Adverse Effects:
Orally: Bloating, flatulence.
Serious Adverse Effects (Rare):
Orally: Bowel obstruction, esophageal obstruction.
Gastrointestinal ...Black psyllium can cause flatulence and bloating. These effects are generally transient and can be reduced by increasing the daily dose gradually (93214). Taking black psyllium with too little fluid can lead to esophageal or intestinal obstruction (18,93217,93218).
Immunologic ...Several psyllium species have been associated with sensitization and allergic reactions, especially in people exposed to airborne psyllium dust, such as nurses preparing doses of psyllium powder, and workers in psyllium processing plants (93214). Symptoms of occupational exposure include rhinitis, conjunctivitis, wheezing, asthma, and urticarial rashes (18,93214). Severe anaphylactic reactions have been reported in individuals with occupational exposure who then ingest psyllium products (2329,8079,9246).
General ...Orally, topically, or by inhalation, buckhorn plantain can cause allergic reactions (3901,98010).
Dermatologic ...There are case reports of phototoxic reactions on sun-exposed skin after oral ingestion of buckhorn plantain, or skin contact with the plant. An erythematous, burning rash develops, with vesicles and bullae, followed by necrotic crusting (98010).
Immunologic ...Buckhorn plantain can cause allergic reactions after oral ingestion, skin contact, or inhalation of pollen (3901,98010).
General
...There is a limited amount of information available about the adverse effects of elecampane.
Most Common Adverse Effects:
Topically: Allergic contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Diarrhea, vomiting, spasms, and symptoms of paralysis at high doses.
Gastrointestinal ...Orally, large doses of elecampane may cause vomiting and diarrhea (12).
Immunologic ...Topically, elecampane can cause allergic contact dermatitis (6958,48729,48731), especially in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
Musculoskeletal ...Orally, large doses of elecampane may cause spasms and symptoms of paralysis (12).
General
...Orally and topically, great plantain seems to be well tolerated.
However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Dermatologic ...Topically, application can cause allergic contact dermatitis in some individuals (4).
Gastrointestinal ...Theoretically, great plantain may have laxative effects when used orally in excessive amounts (4).
General ...Orally, gumweed seems to be well tolerated. It can cause gastric mucosal irritation (2,12), diarrhea (18), and kidney irritation (12).
Gastrointestinal ...Orally, gumweed can cause gastric mucosal irritation (2,12) and diarrhea (18).
Renal ...Orally, gumweed can cause kidney irritation (12).
General
...Orally, hawthorn seems to be well tolerated when used appropriately.
Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Multiorgan hypersensitivity reactions resulting in acute renal failure have been reported rarely.
Cardiovascular
...Orally, tachycardia (with facial pains) of uncertain relationship to hawthorn was reported in a multicenter clinical trial (54640).
Palpitations (19244) were reported in three patients in a large surveillance trial of 3,664 patients with cardiac failure (54692) and in 11 patients with congestive heart failure (CHF) in a literature review of 5,577 patients (19247). Circulation failure has been reported in two patients with CHF in a literature review of 5,577 patients (19247). Incidences of hospitalization, hospitalization due to CHF, worsening of CHF, angina, and atrial fibrillation have also been reported with the use of hawthorn extract WS 1442 (Crataegutt forte), although it is unclear if these events are related to hawthorn supplementation or existing CHF (19222). In clinical trials, chest pain (8281), short-term increases in blood pressure (19240), and other non-specific heart problems (17203) have also been reported following the use of various hawthorn preparations (e.g. WS 1442, Korodin).
Orally, severe bradycardia, bradypnea, and Mobitz type 1 second degree heart block have been reported in a 16-year-old female who consumed Hawthorn root extract. Blood tests indicated plasma digoxin levels in the therapeutic range, despite no history of digoxin use. Medical treatment for digoxin cardiotoxicity did not improve symptoms. Symptoms gradually normalized over 3 days after discontinuation of the product (113112). Similarly, a 40-year-old female presented with bradycardia and elevated plasma digoxin levels after taking hawthorn root extract 196 mg daily for 2 days with no history of digoxin use. Symptoms resolved within 24 hours (113113).
Dermatologic ...Orally, erythematous rash has been reported in patients with CHF in a literature review of 5,577 patients (19247). Non-specific rashes and itching (19222,19243) as well as toxiderma from the fruits of hawthorn (54670) have also been reported.
Gastrointestinal ...Orally, rare abdominal discomfort of uncertain relationship to hawthorn has been reported in a large clinical trial, surveillance study, case reports, and a literature review (19247,54640,54692,113112). Digestive intolerance (19241), diarrhea (19243,113112), flatulence (8281), gastroenteritis (8281), increased bowel movements (19243), obstipation (8281), mild and rare nausea (10144,19247,19244), vomiting (113112), nutritional and metabolic problems (17203), and other non-specific gastrointestinal effects (19222), have also been reported. Furthermore, gastrointestinal hemorrhage has been reported in two patients with CHF in a literature review of 5,577 patients (19247).
Musculoskeletal ...In clinical trials, arthritis (8281), back pain (8281), weakness (19243), and other non-specific musculoskeletal effects (19222) have been reported following the use of various hawthorn preparations g. WS 1442, CKBM-A01). Additionally, in a case report, myalgia has been reported following use of hawthorn root extract (113113).
Neurologic/CNS ...Orally, headache and dizziness/vertigo were reported in 2 patients in a large surveillance trial of 3,664 patients with cardiac failure (54692), in 15 patients with CHF as reported in a literature review of 5,577 patients (19247), in a varying number of clinical trial participants (8281,19222,19244), and in case reports (113112,113113). Incidences of fainting (19222), fever (17203), and infrequent, mild and transient sleepiness have also been reported (19221,54692).
Psychiatric ...Orally, agitation was reported in a large surveillance trial of 3,664 patients with cardiac failure (54692).
Pulmonary/Respiratory ...Orally, bronchitis has been reported following the use of hawthorn extract WS 1442 (8281), and bradypnea has been reported following the use of hawthorn root extract (113112).
Renal ...A case of multiorgan hypersensitivity reaction and acute renal failure following the consumption of C. orientalis has been reported (54654).
Other ...Flu-like syndrome (8281) and other non-specific infections have been reported following the use of the hawthorn extract WS 1442 (17203,19222). Hawthorn has also been reported to cause nosebleeds (8281,10144).
General
...Orally and topically, holy basil extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Loose stools and nausea.
Topically: Bitter taste with oral application.
Gastrointestinal
...Orally, two out of 24 participants taking capsules containing holy basil extract in one clinical study experienced nausea or loose stools (55037).
Topically, holy basil mouthwash has been reported to cause a bitter taste in clinical trials (55038).
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 ...None reported; however, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, olive fruit is well tolerated when used in typical food amounts.
Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.
Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).
Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).
Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).
Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).
Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).
General
...Orally, schisandra seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Decreased appetite, heartburn, stomach upset, and urticaria.
Dermatologic ...Orally, schisandra can cause urticaria in some patients (11).
Gastrointestinal ...Orally, schisandra can cause heartburn, decreased appetite, and stomach upset (11).