Each liquid capsule contains: Proprietary lend 650 mg: Black Cumin seed Oil , Ginger C02 supercritical extract, Marjoram C02 supercritical extract, Rosemary C02 supercritical extract.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
This product has been discontinued by the manufacturer.
This product has been discontinued by the manufacturer.
Below is general information about the effectiveness of the known ingredients contained in the product Alpha AM Cleanse. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Alpha AM Cleanse. 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 found in foods (6).
POSSIBLY SAFE ...when black seed oil is used orally at doses of up to 5 mL or 5 grams daily for up to 12 weeks (36071,94486,96927,96929,98815,101550,102062,110269,110276). ...when a specific black seed oil formulation containing 5% thymoquinone (BlaQmax) is used in doses of 200 mg daily for 90 days (110264). ...when black seed powder is used orally at doses of up to 2 grams daily for up to 12 months (36239,36244,94478,94479,94485,96928,102061,110268,110271). ...when used topically and appropriately, short-term. There is some clinical evidence that black seed oil can be safely applied as an oil 2 times daily for up to 6 months or 3 times daily for up to 1 month (95981,98814,102064,110262) or as a 30% gel twice daily for approximately 2 months (94483).
CHILDREN: POSSIBLY SAFE
when black seed oil is used orally at doses of 40-80 mg/kg daily for 2-19 months in children ages 4-17 years old (36071,95984).
However, the higher dose of 80 mg/kg daily has been associated with increased adverse effects such as gastrointestinal complaints when taken on an empty stomach (36071).
PREGNANCY: LIKELY UNSAFE
when used orally in amounts exceeding those found in food.
Black seed may decrease or inhibit uterine contractions (241) and may have contraceptive activity (242).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Ginger has been safely used in multiple clinical trials (721,722,723,5343,7048,7084,7085,7400,7623,11346)(12472,13080,13237,13244,17369,17928,17929,89889,89890,89894)(89895,89898,89899,90102,96252,96253,96259,96260,96669) (101760,101761,101762,103359,107903).
POSSIBLY SAFE ...when used topically and appropriately, short-term (89893,89897).
CHILDREN: LIKELY SAFE
when consumed in the amounts typically found in foods.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Ginger powder has been used with apparent safety at a dose of up to 750 mg daily for 4 days in girls aged 14-18 years (96255).
PREGNANCY: LIKELY SAFE
when consumed in the amounts typically found in foods.
Ginger is considered a first-line nonpharmacological treatment option for nausea in pregnancy by the American College of Obstetrics and Gynecology (ACOG) (111601). However, it should not be used long-term or without medical supervision and close monitoring.
PREGNANCY: POSSIBLY SAFE
when used for medicinal purposes.
Despite some early reports of adverse effects (721,7083) and one observational study suggesting that taking dried ginger and other herbal supplements during the first 20 weeks of pregnancy marginally increased the chance of stillbirth (96254), most research shows that ginger is unlikely to cause harm to the baby. The risk for major malformations in infants of parents who took ginger when pregnant does not appear to be higher than the baseline rate of 1% to 3% (721,1922,5343,11346,13071,13080,96254). Also, other research suggests that ginger intake during various trimesters does not significantly affect the risk of spontaneous abortion, congenital malformations, stillbirth, perinatal death, preterm birth, low birth weight, or low Apgar scores (18211,90103). Ginger use has been associated with an increase in non-severe vaginal bleeding, including spotting, after week 17 of pregnancy (18211).
LACTATION: LIKELY SAFE
when consumed in the amounts typically found in foods.
There is insufficient reliable information available about the safety of ginger when used for medicinal purposes; avoid amounts greater than those found in foods.
LIKELY SAFE ...when used in amounts commonly found in foods. Marjoram and its essential oil have Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the leaf is used orally and appropriately in tea, short-term (12,18). ...when marjoram oil is used orally and appropriately, short-term (11).
POSSIBLY UNSAFE ...when the flower, leaf, and oil are used orally, long-term. Marjoram contains arbutin, a hydroquinone glycoside (2,18). Studies in animals suggest that long-term use of hydroquinone can damage the liver and kidneys and might cause cancer (2,76395,95524). There is insufficient reliable information available about the safety of marjoram when used topically.
PREGNANCY: POSSIBLY UNSAFE
when used in medicinal amounts; marjoram has the potential for stimulating menstruation (19,95324).
Avoid amounts greater than those found in foods.
LACTATION:
Insufficient reliable information available; avoid amounts greater than those found in foods.
LIKELY SAFE ...when used orally in amounts typically found in foods. Rosemary has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the leaf is used orally and appropriately in medicinal amounts (18). Powdered rosemary leaf has been used with apparent safety as a single dose of up to 1.5 grams (18246,91731) or at a dose of 1-4 grams daily for up to 8 weeks (91727,98536,105327,109561). ...when the essential oil is used topically and appropriately for up to 7 months (5177,91729,109560). ...when the essential oil is used by inhalation as aromatherapy, short-term (7107,18323,105324,109559).
LIKELY UNSAFE ...when the essential oil or very large quantities of rosemary leaf are used orally. Ingestion of undiluted rosemary oil or very large quantities of rosemary leaf can cause serious adverse effects (18,515).
PREGNANCY: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Rosemary might have uterine and menstrual flow stimulant effects (4,12,18), and might increase metabolism of estradiol and estrone (18331); avoid using. There is insufficient reliable information available about the safety of rosemary when used topically during pregnancy.
LACTATION:
There is insufficient reliable information available about the safety of using rosemary in medicinal amounts during lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Alpha AM Cleanse. 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 seed may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, taking black seed with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking black seed with antihypertensive drugs might increase the risk of hypotension.
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Clinical research suggests that black seed powder and oil might reduce blood pressure by 2-3 mmHg (16437,94489). In animal research, black seed modestly reduces blood pressure and concomitant use of black seed and amlodipine (Norvasc) or metoprolol (Lopressor) increased the blood pressure lowering effects of these drugs (101559,108703).
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Theoretically, black seed may increase the risk of bleeding if used with clopidogrel.
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Animal research shows that taking black seed extract daily for 2 weeks prior to a single dose of clopidogrel increases maximum concentrations of clopidogrel by approximately 31% and modestly decreases oral clearance. Furthermore, bleeding time was increased by 12% (108701). This has not been shown in humans.
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Theoretically, concomitant use with drugs that have sedative properties may cause additive effects.
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Animal research suggests that black seed may have CNS depressant effects (36064).
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Theoretically taking black seed might reduce the levels and clinical effects of cyclosporine.
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In animal research, black seed extract decreased the maximal levels of cyclosporine in the blood by 35.5% (94474). This has not been shown in humans.
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Theoretically, black seed might increase levels of drugs metabolized by CYP2C9.
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In vitro research suggests that thymoquinone, a constituent of black seed, can decrease the metabolism of phenytoin by a mechanism possibly related to the inhibition of CYP2C9 (110281). The effect of black seed on CYP2C9 is unclear. This has not been shown in humans.
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Theoretically, taking black seed with diuretic drugs might increase potassium loss and the risk of hypokalemia.
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Black seed extract has shown diuretic effects in animals, which could theoretically increase potassium loss (36026). This has not been shown in humans.
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Theoretically, black seed might interfere with immunosuppressive therapy.
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Theoretically, black seed might increase levels and adverse effects of phenytoin.
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In vitro research suggests that thymoquinone, a constituent of black seed, can decrease the metabolism of phenytoin (110281). This effect may be due to inhibition of cytochrome P450 2C9 (CYP2C9). The effect of black seed on phenytoin metabolism is unclear. This has not been shown in humans.
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Theoretically, combining serotonergic drugs with black seed might increase the risk of serotonergic side effects, including serotonin syndrome and cerebral vasoconstrictive disorders.
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Animal research suggests that black seed can increase brain serotonin levels (36180,94488). In one case report, a 35-year-old man undergoing endoscopic surgery experienced immediate postoperative serotonin syndrome that was likely associated with the use of black seed oil 600 mg daily starting 4 days before surgery, and precipitated by the use of serotonergic pain medications, including fentanyl and oxycodone (101558). Monitor patients for signs of serotonin syndrome and other serotonergic side effects if using black seed with serotonergic drugs.
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Theoretically, black seed might increase levels of warfarin and increase the risk of bleeding.
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In vitro research suggests that thymoquinone, a constituent of black seed, can decrease the metabolism of warfarin (110280). This effect may be due to inhibition of cytochrome P450 2C9 (CYP2C9). The effect of black seed on warfarin metabolism is unclear. This has not been shown in humans.
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Ginger may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs. However, research is conflicting.
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Laboratory research suggests that ginger inhibits thromboxane synthetase and decreases platelet aggregation (7622,12634,20321,20322,20323,96257). However, this has not been demonstrated unequivocally in humans, with mixed results from clinical trials (96257). Theoretically, excessive amounts of ginger might increase the risk of bleeding when used with anticoagulant/antiplatelet drugs.
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Theoretically, taking ginger with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking ginger with calcium channel blockers might increase the risk of hypotension.
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Some animal and in vitro research suggests that ginger has hypotensive and calcium channel-blocking effects (12633). Another animal study shows that concomitant administration of ginger and the calcium channel blocker amlodipine leads to greater reductions in blood pressure when compared with amlodipine alone (107901).
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Theoretically, when taken prior to cyclosporine, ginger might decrease cyclosporine levels.
Details
In an animal model, ginger juice taken 2 hours prior to cyclosporine administration reduced the maximum concentration and area under the curve of cyclosporine by 51% and 40%, respectively. This effect was not observed when ginger juice and cyclosporine were administered at the same time (20401).
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Theoretically, ginger might increase the levels of CYP1A2 substrates.
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In vitro research shows that ginger inhibits CYP1A2 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2B6 substrates.
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In vitro research shows that ginger inhibits CYP2B6 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2C9 substrates.
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In vitro research shows that ginger inhibits CYP2C9 activity (111544). However, this interaction has not been reported in humans.
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Ginger might increase or decrease the levels of CYP3A4 substrates.
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In vitro research and some case reports suggest that ginger inhibits CYP3A4 activity (111544,111644). Three case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are CYP3A4 substrates (imatinib, dabrafenib, and crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
Conversely, other in vitro research suggests that ginger induces CYP3A4 activity, leading to reduced levels of CYP3A4 substrates (111404). However, this interaction has not been reported in humans. |
Theoretically, ginger might increase levels of losartan and the risk of hypotension.
Details
In animal research, ginger increased the levels and hypotensive effects of a single dose of losartan (102459). It is not clear if ginger alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.
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Theoretically, ginger might increase levels of metronidazole.
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In an animal model, ginger increased the absorption and plasma half-life of metronidazole. In addition, the elimination rate and clearance of metronidazole was significantly reduced (20350).
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Ginger may have antiplatelet effects and increase the risk of bleeding if used with nifedipine.
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Clinical research shows that combined treatment with ginger 1 gram plus nifedipine 10 mg significantly inhibits platelet aggregation when compared to nifedipine or ginger alone (20324).
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Ginger might increase the absorption and blood levels of P-glycoprotein (P-gp) substrates.
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In vitro research and case reports suggest that ginger inhibits drug efflux by P-gp, potentially increasing absorption and serum levels of P-gp substrates (111544,111644). Two case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are P-gp substrates (trametinib, crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
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Ginger might increase the risk of bleeding with phenprocoumon.
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Phenprocoumon, a warfarin-related anticoagulant, might increase the international normalized ratio (INR) when taken with ginger. There is one case report of a 76-year-old woman with a stable INR on phenprocoumon that increased to greater than 10 when she began consuming dried ginger and ginger tea (12880).
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Ginger might increase the risk of bleeding with warfarin.
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Laboratory research suggests that ginger might inhibit thromboxane synthetase and decrease platelet aggregation (7622,12634,20321,20322,20323). In one case report, ginger increased the INR when taken with phenprocoumon, which has similar pharmacological effects as warfarin (12880). In another case report, ginger increased the INR when taken with a combination of warfarin, hydrochlorothiazide, and acetaminophen (20349). A longitudinal analysis suggests that taking ginger increases the risk of bleeding in patients taking warfarin for at least 4 months (20348). However, research in healthy people suggests that ginger has no effect on INR, or the pharmacokinetics or pharmacodynamics of warfarin (12881,15176). Until more is known, monitor INRs closely in patients taking large amounts of ginger.
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In vitro research suggests that marjoram extract can inhibit acetylcholinesterase activity (31438,76912). Theoretically, using marjoram in medicinal amounts along with anticholinergic drugs might decrease the effectiveness of marjoram or the anticholinergic agent.
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Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).
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In vitro research suggests that marjoram extract inhibits platelet aggregation and adhesion (76932). Theoretically, marjoram might increase the risk of bleeding when used in medicinal amounts along with antiplatelet or anticoagulant drugs.
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Some anticoagulant or antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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In vitro research suggests that marjoram extract can inhibit acetylcholinesterase activity (31438,76912). Theoretically, using marjoram in medicinal amounts along with 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, rosemary may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, taking rosemary with antidiabetes drugs might increase the risk of hypoglycemia.
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Animal research shows that rosemary extract can decrease blood glucose levels in diabetic models (71821,71923). However, research in humans is conflicting. Although rosemary powder decreased blood glucose levels in healthy adults (105327), no change in blood glucose levels was seen in adults with type 2 diabetes, most of whom were taking antidiabetes drugs (105323,105327).
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Theoretically, rosemary might have additive effects with salicylate-containing drugs such as aspirin.
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Rosemary is reported to contain salicylates (18330).
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Theoretically, rosemary might have additive effects with salicylate-containing drugs such as choline magnesium trisalicylate.
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Rosemary is reported to contain salicylate (18330).
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Theoretically, rosemary might decrease the levels and clinical effects of CYP1A1 substrates.
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Theoretically, rosemary might decrease the levels and clinical effects of CYP1A2 substrates.
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Theoretically, rosemary might have additive effects with salicylate-containing drugs such as salsalate.
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Rosemary is reported to contain salicylate (18330).
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Below is general information about the adverse effects of the known ingredients contained in the product Alpha AM Cleanse. 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 and topically, black seed seems to be well tolerated.
Most Common Adverse Effects:
Orally: Constipation, gastric burning or discomfort, nausea, and vomiting.
Dermatologic ...Orally, black seed can cause itching, but this adverse effect is rare (94481). It has also been reported to cause bullous drug eruption and maculopapular eruption (94480,100324). Topically, black seed and its oil have been reported to cause allergic contact dermatitis (36053,36296,36297,100324). Rarely, topical use of the oil has been reported to cause a rash related to drug reaction with eosinophilia and systemic symptoms (DRESS) (110277).
Gastrointestinal ...In a clinical trial, unspecified gastrointestinal complaints occurred in 20% of patients taking black seed oil orally (36071). Gastrointestinal complaints occurred rarely in another clinical trial; however, one patient in this study was hospitalized for nausea and vomiting thought to be associated with black seed oil (110267). Gastrointestinal adverse effects to black seed have included constipation (36180), burning sensation (94487), epigastric discomfort (94479), vomiting (94491), or mild nausea (94481,94489,94491,96927,96929). Gastrointestinal adverse effects to a specific black seed oil formulation containing 5% thymoquinone (BlaQmax) have included mild cases of bloating, burping and mild diarrhea (110264).
Genitourinary ...Orally, relatively severe menstrual bleeding has occurred in one clinical trial (104661).
Hepatic ...While intake of black seed has been associated with hepatotoxicity in some animal research, other animal research has not confirmed this finding (245,95982). Hepatotoxicity has not been reported in humans.
Immunologic ...Orally, black seed has been reported to cause bullous drug eruption and maculopapular eruption (94480,100324). Topically, black seed and its oil can cause allergic contact dermatitis (6,36053,36296,36297,100324,110266). One case of bullous drug eruption with skin detachment has been reported for a 54-year-old woman who used black seed oil orally. The eruptions resolved following treatment with clobetasol propionate 0.05%. Although this patient showed a positive skin prick test for undiluted black seed oil, the tests were negative when the oil was diluted to 10% and 1% (94480). A 28-year-old woman developed a rash following topical use of black seed oil. She was diagnosed with drug reaction with eosinophilia and systemic symptoms (DRESS), including enlarged lymph nodes, and required systemic corticosteroid treatment. This diagnosis was confirmed six months later following confirmation with a patch test (110277). In another case report, a 58-year-old woman developed eczematous lesions on the lower and upper eyelids after topical application of an oil containing black seed. This reaction was followed by the development of a diffuse maculopapular eruption after taking two oral capsules containing black seed oil. It is theorized that the topical application of black seed oil led to systemic sensitization prior to the use of oral black seed in this patient (100324).
Renal ...Orally, black seed might cause renal dysfunction. A case of acute renal failure thought to be related to use of black seed tablets 2-2.5 grams daily has been reported for a 62 year-old patient with diabetes (94477).
General
...Orally, ginger is generally well tolerated.
However, higher doses of 5 grams per day increase the risk of side effects and reduce tolerability. Topically, ginger seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, burping, diarrhea, heartburn, and a pepper-like irritant effect in the mouth and throat. However, some of these mild symptoms may be reduced by ingesting encapsulated ginger in place of powdered ginger.
Topically: Dermatitis in sensitive individuals.
Cardiovascular ...Orally, use of ginger resulted in mild arrhythmia in one patient in a clinical trial (16306).
Dermatologic
...Orally, ginger can cause hives (17933), as well as bruising and flushing (20316) or rash (20316).
Topically, ginger can cause dermatitis in sensitive individuals (12635,46902).
Gastrointestinal
...Orally, common side effects of ginger include nausea (17933,22602,89898,101761), belching (10380,103359), dry mouth (103359), dry retching (10380), vomiting (10380), burning sensation (10380), oral numbness (22602), abdominal discomfort (5343,89898,96253), heartburn (5343,7624,12472,16306,20316,51845,89894,89895,89898,89899)(101760,101761,101762,111543), diarrhea (5343,101760), constipation (89898,101760,101761), or a transient burning or "chilly hot" sensation of the tongue and throat (52076).
Orally, Number Ten, a specific product composed of rhubarb, ginger, astragalus, red sage, and turmeric, can increase the incidence of loose stools (20346).
Four cases of small bowel obstruction due to ginger bolus have been reported following the ingestion of raw ginger without sufficient mastication (chewing). In each case, the bolus was removed by enterotomy. Ginger is composed of cellulose and therefore is resistant to digestion. It can absorb water, which may cause it to swell and become lodged in narrow areas of the digestive tract (52115).
Genitourinary ...In one clinical trial, some patients reported increased menstrual bleeding while taking a specific ginger extract (Zintoma, Goldaru) 250 mg four times daily orally for 3 days (17931). An "intense" urge to urinate after 30 minutes was reported in two of eight patients given 0.5-1 gram of ginger (7624). However, this effect has not been corroborated elsewhere. Dysuria, flank pain, perineal pain, and urinary stream interruption have been reported in a 43-year-old male who drank ginger tea, containing 2-3 teaspoons of dry ginger, daily over 15 years. The adverse effects persisted for 4 years and were not associated with increases in urinary frequency or urgency. Upon discontinuing ginger, the patient's symptoms began to improve within one week and completely resolved after eight weeks, with no relapses six months later (107902).
Immunologic ...In one case report, a 59-year-old Japanese female with multiple allergic sensitivities developed pruritus and then anaphylactic shock after taking an oral ginger-containing herbal supplement for motion sickness (Keimei Gashinsan, Keimeido). The patient had used this supplement previously for over 20 years with no allergic reaction. The authors theorized the development of a cross-reactivity to ginger after the use of an oral supplement containing zedoary and turmeric, which are also in the Zingiberaceae family (102463).
Neurologic/CNS ...Orally, ginger may cause sedation, drowsiness, or dizziness (16306,17933,51845).
General
...Orally, marjoram and its essential oil are well tolerated in amounts commonly found in foods (4912).
Marjoram leaf and marjoram oil seem to be well tolerated when used appropriately for medicinal purposes (2,11,12,18). However, marjoram flower, leaf, and oil should not be used long-term due to the arbutin content (2,76395,95524).
Topically, there are rare reports of allergic skin reactions with marjoram use (33865,58049).
Immunologic ...Possible allergic contact dermatitis in children with pre-existing childhood atopic eczema was observed in a randomized clinical trial employing extended use of essential oils, including sweet marjoram essential oil (58049). A case report describes a 38-year old woman who had an exacerbation of perioral dermatitis after eating food seasoned with marjoram. The dermatitis resolved within 3 weeks on a marjoram-free diet, but reappeared when she was rechallenged with marjoram (33865).
General ...Orally, rosemary seems to be well tolerated when used in appropriate medicinal amounts. Undiluted rosemary oil or very large quantities of rosemary leaf should not be consumed. Topically and as aromatherapy, rosemary seems to be well tolerated.
Dermatologic ...Topically, rosemary use can lead to photosensitivity, erythema, dermatitis, and cheilitis in hypersensitive individuals (4,6).
Immunologic
...Topically, allergic reactions can occur.
When used in the mouth, lip and gum edema have occurred (101173). When used on the skin, allergic contact dermatitis has occurred, likely due to the constituent carnosol (71715,71924,71926).
Rosemary might also cause occupational asthma. A case of occupational asthma caused by several aromatic herbs including thyme, rosemary, bay leaf, and garlic has been reported. The diagnosis was confirmed by inhalation challenges. Although all of the herbs caused immediate skin reactivity, a radioallergosorbent test (RAST) showed that garlic was the most potent allergen by weight, with rosemary and the other herbs showing less reactivity (783).
Neurologic/CNS ...Orally, the undiluted oil, as well as the camphor constituent of rosemary, might cause seizures (4,5,6,12868).