Metronidazole: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Metronidazole appears in the FDA drug-label database. Marketed as Metronidazole.

Drug class

Nitroimidazole Antimicrobial (FDA established pharmacologic class)

Boxed warning

The FDA label for Metronidazole carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become re…

FDA recalls / enforcement

FDA label via openFDA