Each vegetable capsule contains: Devil's Claw root extract (harpagophytum procumbens, standardized to contain a minimum of 5% harpagosides) 500 mg • Vitamin C (ascorbyl palmitate) 5 mg.
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Below is general information about the effectiveness of the known ingredients contained in the product Flexosil. 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
Below is general information about the safety of the known ingredients contained in the product Flexosil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately. Devil's claw extract has been used with apparent safety in doses of up to 2400 mg daily for up 12 weeks (6472,8608,14332,14418,47112,47114,47116,47117,47155). There is insufficient reliable information available about the safety of devil's claw when used orally long-term or when used topically.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Anecdotal evidence suggests that devil's claw has oxytocic effects in humans. Also, in vitro research shows that moderate to high doses of devil's claw root extract induce contractions of isolated uterine muscle from pregnant and nonpregnant rats (94689); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Flexosil. 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, devil's claw might increase levels of drugs metabolized by CYP2C19.
 Details
In vitro research shows that devil's claw might inhibit CYP2C19, although this has not been reported in humans (12479).
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Theoretically, devil's claw might increase levels of drugs metabolized by CYP2C9.
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In vitro research shows that devil's claw might inhibit CYP2C9, although this has not been reported in humans (12479).
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Theoretically, devil's claw might increase levels of drugs metabolized by CYP3A4.
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In vitro research shows that devil's claw might inhibit CYP3A4, although this has not been reported in humans (12479).
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Theoretically, devil's claw might decrease the effectiveness of H2-blockers.
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Devil's claw has been reported to increase stomach acid, which might interfere with the effects of H2-blockers (19).
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Theoretically, devil's claw might increase levels of P-glycoprotein substrates.
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Theoretically, devil's claw might decrease the effectiveness of PPIs.
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Devil's claw has been reported to increase stomach acid, which might interfere with the effects of PPIs (19).
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Theoretically, Devil's claw might increase the activity of warfarin.
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In one case report, purpura occurred in a patient taking warfarin and devil's claw concurrently. This might indicate over-anticoagulation (613). It is unclear if this was due to Devil's claw or other contributing factors.
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Below is general information about the adverse effects of the known ingredients contained in the product Flexosil. 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, Devil's claw seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Allergic skin reactions, diarrhea, dyspepsia.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal bleeding.
Cardiovascular ...In one case report, a healthy patient with normal blood pressure presented with hypertension after taking devil's claw 250 mg twice daily for 2 weeks. It gradually resolved after discontinuation of devil's claw (92017). Some animal research shows that devil's claw might have negative chronotropic, as well as positive and negative inotropic, effects (8609). However, these effects have not been documented in humans.
Dermatologic ...Rarely, allergic skin reactions have been reported in patients taking devil's claw (8608,14418).
Endocrine ...In one case report, a 65-year-old female developed psychomotor agitation, nausea, and distress from euvolemic hyponatremia secondary to inappropriate secretion of antidiuretic hormone (SIADH) within 1 month of starting daily treatment with devil's claw. Within 5 days of discontinuing the product and receiving sodium replacement, the symptoms resolved. Two months later, the patient re-initiated devil's claw and again developed euvolemic hyponatremia (96747).
Gastrointestinal ...Gastrointestinal side effects, including mild gastrointestinal upset, diarrhea, anorexia, acid reflux, or loss of taste, have been reported in some individuals receiving devil's claw, especially at high doses (6472,8608,8613,14332,14418,47112,47116,47144,47169). Gastrointestinal complaints have been reported in 9% to 18% of patients taking a specific devil's claw extract (Doloteffin, Ardeypharm) (8608,47169), while diarrhea was reported in about 8% of patients taking devil's claw (Harpadol, Arkopharma) (6472). Several cases of gastrointestinal bleeding have been reported (104977).
Genitourinary ...Dysmenorrhea was reported in one patient taking a specific devil's claw extract (Doloteffin, Ardeypharm) for 8 weeks (8608).
Neurologic/CNS ...In a trial of devil's claw, one patient withdrew after 4 days of therapy due to a throbbing frontal headache, as well as tinnitus, anorexia, and loss of taste (8613). Rarely, dizziness, somnolence, and insomnia have been reported (47116,47169). It is unclear if these symptoms were caused by devil's claw.
Psychiatric ...Rarely, anxiety has been reported in patients taking devil's claw (8608).
