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Nitroimidazole Antimicrobial side effects compared: 4 drugs, 111,569 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Metronidazole63,49184%6,851boxedToxic encephalopathy; Proctitis; Cerebellar syndromeMacular degeneration; Anal fistula
Metronidazole Topical (Metronidazole)47,35987%5,345–––
Tinidazole43872%20boxed––
Secnidazole (Solosec)28123%3–––

Class-wide signals (flagged in at least 2 of 4 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Vaginal flatulence2/41,717.54950/2 members' labels
Appendicolith2/41,187.05680/2 members' labels
Congenital hiatus hernia2/4115.51020/2 members' labels
Female genital tract fistula2/480.86010/2 members' labels
Toxic encephalopathy2/457.71,2881/2 members' labels
Dysmetria2/447.41330/2 members' labels
Radiculopathy2/444.45470/2 members' labels
Proctitis2/444.15781/2 members' labels
Cerebellar ataxia2/442.61931/2 members' labels
Bloody discharge2/439.82170/2 members' labels
Pseudomembranous colitis2/439.54240/2 members' labels
Cerebellar syndrome2/439.24111/2 members' labels
Chronic sinusitis2/433.76050/2 members' labels
Pouchitis2/433.21410/2 members' labels
Hyperphosphataemia2/433.13360/2 members' labels
Megacolon2/430.52310/2 members' labels
Macular degeneration2/429.91,7150/2 members' labels
Abortion incomplete2/428.52620/2 members' labels
Bronchopulmonary aspergillosis allergic2/428.01240/2 members' labels
Fistula discharge2/426.81710/2 members' labels
Clostridium difficile colitis2/426.61,4030/2 members' labels
Dysbiosis2/425.3990/2 members' labels
Chronic kidney disease-mineral and bone disorder2/424.21280/2 members' labels

Member-specific signals (flagged in exactly one drug)

ReactionDrugReportsPRRLabel screen
Pelvic abscessMetronidazole8024.8Likely indication confounding
Clostridium colitisMetronidazole8424.3Likely indication confounding
Enterocutaneous fistulaMetronidazole6024.2Not in label — unassessed
Linear iga diseaseMetronidazole Topical8423.5No label text to screen
Fixed eruptionMetronidazole Topical8523.3No label text to screen
Acinetobacter infectionMetronidazole Topical5121.8No label text to screen
Total lung capacity decreasedMetronidazole Topical7421.4No label text to screen
Perirectal abscessMetronidazole6821.4Likely indication confounding
Hyperparathyroidism secondaryMetronidazole Topical11420.8No label text to screen
Anal fistulaMetronidazole31620.7Not in label — unassessed
Rectal abscessMetronidazole9920.6Likely indication confounding
Bacterial vaginosisMetronidazole8920.1Likely indication confounding
Clostridium difficile infectionMetronidazole1,16718.7Likely indication confounding

Common questions

Which nitroimidazole antimicrobial has the most FDA adverse event reports?

Metronidazole has the most FAERS co-reports in this class (63,491), followed by Metronidazole Topical (47,359). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across nitroimidazole antimicrobial drugs?

Reaction terms flagged in at least half of the 4 members include vaginal flatulence, appendicolith, congenital hiatus hernia, female genital tract fistula, toxic encephalopathy. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.