Quinolone Antimicrobial side effects compared: 4 drugs, 21,927 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Ofloxacin (Ofloxacin Otic) | 7,170 | 77% | 608 | – | Eye pain; Eye inflammation | Chronic kidney disease; Eye irritation |
| Ofloxacin Otic (Ofloxacin) | 6,940 | 77% | 573 | – | Eye pain; Eye inflammation | Chronic kidney disease; Eye irritation |
| Ofloxacin Otic (Ofloxacin) | 6,850 | 77% | 573 | – | Eye pain; Eye inflammation | Chronic kidney disease; Eye irritation |
| Besifloxacin (Besivance) | 967 | 44% | 67 | – | Eye pain; Vision blurred; Eye irritation | Ocular hyperaemia; Cardiac disorder |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Eye pain | 4/4 | 18.4 | 1,116 | 4/4 members' labels |
| Eye inflammation | 4/4 | 17.1 | 180 | 3/4 members' labels |
| Ocular discomfort | 4/4 | 15.3 | 184 | 0/4 members' labels |
| Photophobia | 4/4 | 13.7 | 290 | 0/4 members' labels |
| Eye infection | 4/4 | 12.7 | 152 | 0/4 members' labels |
| Eye discharge | 4/4 | 10.6 | 127 | 0/4 members' labels |
| Eye irritation | 4/4 | 8.5 | 545 | 1/4 members' labels |
| Lacrimation increased | 4/4 | 7.6 | 243 | 0/4 members' labels |
| Chronic kidney disease | 4/4 | 7.6 | 616 | 0/4 members' labels |
| Ocular hyperaemia | 4/4 | 6.9 | 382 | 0/4 members' labels |
| Eye swelling | 4/4 | 6.6 | 270 | 0/4 members' labels |
| Visual acuity reduced | 4/4 | 5.9 | 214 | 0/4 members' labels |
| Cataract | 4/4 | 5.9 | 376 | 0/4 members' labels |
| Tendonitis | 3/4 | 25.0 | 384 | 0/3 members' labels |
| Toxic epidermal necrolysis | 3/4 | 15.5 | 231 | 0/3 members' labels |
| Tendon rupture | 3/4 | 12.4 | 152 | 0/3 members' labels |
| Vitreous floaters | 3/4 | 10.3 | 99 | 0/3 members' labels |
| Toxic skin eruption | 3/4 | 10.2 | 102 | 0/3 members' labels |
| Hepatic cytolysis | 3/4 | 9.7 | 117 | 0/3 members' labels |
| Cholestasis | 3/4 | 9.0 | 171 | 0/3 members' labels |
| End stage renal disease | 3/4 | 8.7 | 160 | 0/3 members' labels |
| Agranulocytosis | 3/4 | 8.2 | 150 | 0/3 members' labels |
| Neuralgia | 3/4 | 8.1 | 196 | 0/3 members' labels |
| Muscle atrophy | 3/4 | 8.1 | 103 | 0/3 members' labels |
| Conjunctivitis | 3/4 | 7.6 | 141 | 0/3 members' labels |
| Rash maculo-papular | 3/4 | 7.0 | 153 | 0/3 members' labels |
| Eosinophilia | 3/4 | 6.6 | 114 | 0/3 members' labels |
| Blindness unilateral | 3/4 | 6.5 | 93 | 0/3 members' labels |
| Drug reaction with eosinophilia and systemic symptoms | 3/4 | 6.4 | 162 | 0/3 members' labels |
| Hepatocellular injury | 3/4 | 6.4 | 90 | 0/3 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Vision blurred | Besifloxacin | 81 | 12.9 | Labeled (related wording) |
| Cardiac disorder | Besifloxacin | 50 | 11.6 | Not in label — unassessed |
Common questions
Which quinolone antimicrobial has the most FDA adverse event reports?
Ofloxacin has the most FAERS co-reports in this class (7,170), followed by Ofloxacin Otic (6,940). 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 quinolone antimicrobial drugs?
Reaction terms flagged in at least half of the 4 members include eye pain, eye inflammation, ocular discomfort, photophobia, eye infection. 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.