No black box warning on record for Metronidazole

As of the latest FDA labeling reviewed, Metronidazole (metronidazole) does not carry a black box warning. Standard warnings and precautions still apply — see the full Metronidazole medicine page for the complete safety profile.

Other warnings & precautions

Alcohol Interaction: The disulfiram-like reaction with alcohol is severe and can be dangerous. Patients must not consume ANY alcohol — including in food sauces, mouthwash, cough medicines — during metronidazole therapy and for at least 48 hours after the last dose. The reaction includes flushing, vomiting, palpitations, hypotension, and in severe cases, respiratory depression.
Peripheral Neuropathy: Prolonged or high-dose use is associated with peripheral neuropathy that may be irreversible. Monitor for symptoms (numbness, tingling, pain in extremities) and discontinue if neurological symptoms appear.
CNS Toxicity: High doses or prolonged use, particularly IV, can cause encephalopathy, ataxia, and seizures. Use lowest effective dose and shortest course.
Carcinogenicity: Metronidazole has been shown to be carcinogenic in mice and rats with prolonged high-dose use. Avoid unnecessary prolonged use in humans, although clinical carcinogenicity at therapeutic doses has not been established.
C. difficile Guidelines: While metronidazole was historically first-line for C. diff, current IDSA guidelines prefer oral vancomycin or fidaxomicin for most cases due to superior cure rates and lower recurrence.

No black box warning on record for Metronidazole

Other warnings & precautions

Alcohol Interaction: The disulfiram-like reaction with alcohol is severe and can be dangerous. Patients must not consume ANY alcohol — including in food sauces, mouthwash, cough medicines — during metronidazole therapy and for at least 48 hours after the last dose. The reaction includes flushing, vomiting, palpitations, hypotension, and in severe cases, respiratory depression.
Peripheral Neuropathy: Prolonged or high-dose use is associated with peripheral neuropathy that may be irreversible. Monitor for symptoms (numbness, tingling, pain in extremities) and discontinue if neurological symptoms appear.
CNS Toxicity: High doses or prolonged use, particularly IV, can cause encephalopathy, ataxia, and seizures. Use lowest effective dose and shortest course.
Carcinogenicity: Metronidazole has been shown to be carcinogenic in mice and rats with prolonged high-dose use. Avoid unnecessary prolonged use in humans, although clinical carcinogenicity at therapeutic doses has not been established.
C. difficile Guidelines: While metronidazole was historically first-line for C. diff, current IDSA guidelines prefer oral vancomycin or fidaxomicin for most cases due to superior cure rates and lower recurrence.

Metronidazole Black Box Warning

No black box warning on record for Metronidazole

Other warnings & precautions

Metronidazole Black Box Warning

No black box warning on record for Metronidazole

Other warnings & precautions