Nitroimidazole Antimicrobial side effects compared: 4 drugs, 111,569 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Metronidazole | 63,491 | 84% | 6,851 | boxed | Toxic encephalopathy; Proctitis; Cerebellar syndrome | Macular degeneration; Anal fistula |
| Metronidazole Topical (Metronidazole) | 47,359 | 87% | 5,345 | – | – | – |
| Tinidazole | 438 | 72% | 20 | boxed | – | – |
| Secnidazole (Solosec) | 281 | 23% | 3 | – | – | – |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Vaginal flatulence | 2/4 | 1,717.5 | 495 | 0/2 members' labels |
| Appendicolith | 2/4 | 1,187.0 | 568 | 0/2 members' labels |
| Congenital hiatus hernia | 2/4 | 115.5 | 102 | 0/2 members' labels |
| Female genital tract fistula | 2/4 | 80.8 | 601 | 0/2 members' labels |
| Toxic encephalopathy | 2/4 | 57.7 | 1,288 | 1/2 members' labels |
| Dysmetria | 2/4 | 47.4 | 133 | 0/2 members' labels |
| Radiculopathy | 2/4 | 44.4 | 547 | 0/2 members' labels |
| Proctitis | 2/4 | 44.1 | 578 | 1/2 members' labels |
| Cerebellar ataxia | 2/4 | 42.6 | 193 | 1/2 members' labels |
| Bloody discharge | 2/4 | 39.8 | 217 | 0/2 members' labels |
| Pseudomembranous colitis | 2/4 | 39.5 | 424 | 0/2 members' labels |
| Cerebellar syndrome | 2/4 | 39.2 | 411 | 1/2 members' labels |
| Chronic sinusitis | 2/4 | 33.7 | 605 | 0/2 members' labels |
| Pouchitis | 2/4 | 33.2 | 141 | 0/2 members' labels |
| Hyperphosphataemia | 2/4 | 33.1 | 336 | 0/2 members' labels |
| Megacolon | 2/4 | 30.5 | 231 | 0/2 members' labels |
| Macular degeneration | 2/4 | 29.9 | 1,715 | 0/2 members' labels |
| Abortion incomplete | 2/4 | 28.5 | 262 | 0/2 members' labels |
| Bronchopulmonary aspergillosis allergic | 2/4 | 28.0 | 124 | 0/2 members' labels |
| Fistula discharge | 2/4 | 26.8 | 171 | 0/2 members' labels |
| Clostridium difficile colitis | 2/4 | 26.6 | 1,403 | 0/2 members' labels |
| Dysbiosis | 2/4 | 25.3 | 99 | 0/2 members' labels |
| Chronic kidney disease-mineral and bone disorder | 2/4 | 24.2 | 128 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Pelvic abscess | Metronidazole | 80 | 24.8 | Likely indication confounding |
| Clostridium colitis | Metronidazole | 84 | 24.3 | Likely indication confounding |
| Enterocutaneous fistula | Metronidazole | 60 | 24.2 | Not in label — unassessed |
| Linear iga disease | Metronidazole Topical | 84 | 23.5 | No label text to screen |
| Fixed eruption | Metronidazole Topical | 85 | 23.3 | No label text to screen |
| Acinetobacter infection | Metronidazole Topical | 51 | 21.8 | No label text to screen |
| Total lung capacity decreased | Metronidazole Topical | 74 | 21.4 | No label text to screen |
| Perirectal abscess | Metronidazole | 68 | 21.4 | Likely indication confounding |
| Hyperparathyroidism secondary | Metronidazole Topical | 114 | 20.8 | No label text to screen |
| Anal fistula | Metronidazole | 316 | 20.7 | Not in label — unassessed |
| Rectal abscess | Metronidazole | 99 | 20.6 | Likely indication confounding |
| Bacterial vaginosis | Metronidazole | 89 | 20.1 | Likely indication confounding |
| Clostridium difficile infection | Metronidazole | 1,167 | 18.7 | Likely 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.