Drug · FAERS side-effect profile with label screen
Ofloxacin Otic Solution side effects: what 6,850 FDA adverse event reports show
Brand names
Ofloxacin
openFDA label
Who reports
6,850 reports · 77% serious · 573 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus .
FDA label, Indications and Usage
What it is
DESCRIPTION Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 32
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 386 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Tendonitis | 126 | 25.0 21.0–29.7ROR 25.4 · χ² 2,856 / p <1e-300 | 24.7 EB05 21.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 | no trial data cached |
| Eye pain | 331 | 18.4 16.6–20.5ROR 19.3 · χ² 5,426 / p <1e-300 | 18.3 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 74% consumer | no trial data cached |
| Eye inflammation | 51 | 16.6 12.6–21.9ROR 16.7 · χ² 730 / p 5e-161 | 16.4 EB05 12.9 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=43 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 77 | 15.7 12.6–19.6ROR 15.9 · χ² 1,041 / p 1e-228 | 15.5 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 97% clinician | no trial data cached |
| Ocular discomfort | 54 | 15.3 11.7–20.0ROR 15.4 · χ² 704 / p 2e-155 | 15.1 EB05 11.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 · 75% consumer | no trial data cached |
| Photophobia (light sensitivity) | 83 | 13.7 11.0–16.9ROR 13.8 · χ² 958 / p 1e-210 | 13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 72% consumer | no trial data cached |
| Tendon rupture (torn tendon) | 50 | 12.4 9.4–16.4ROR 12.5 · χ² 511 / p 2e-113 | 12.1 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Eye infection | 44 | 12.0 9.0–16.2ROR 12.1 · χ² 433 / p 2e-96 | 11.7 EB05 8.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=24 | no trial data cached |
| Eye discharge | 35 | 10.5 7.6–14.6ROR 10.6 · χ² 291 / p 1e-65 | 9.9 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Toxic skin eruption | 34 | 10.3 7.4–14.4ROR 10.4 · χ² 276 / p 2e-62 | 9.7 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 100% clinician | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 42 | 10.0 7.4–13.6ROR 10.1 · χ² 332 / p 2e-74 | 9.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Hepatic cytolysis | 39 | 9.8 7.2–13.4ROR 9.8 · χ² 298 / p 4e-67 | 9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Vitreous floaters | 31 | 9.8 6.9–13.9ROR 9.8 · χ² 235 / p 3e-53 | 9.1 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Cholestasis (bile flow blockage) | 57 | 9.2 7.1–11.9ROR 9.2 · χ² 405 / p 2e-90 | 8.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 94% clinician | no trial data cached |
| End stage renal disease | 53 | 8.8 6.7–11.5ROR 8.9 · χ² 359 / p 2e-80 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 50 | 8.3 6.3–10.9ROR 8.4 · χ² 313 / p 2e-70 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Neuralgia | 64 | 8.1 6.3–10.3ROR 8.2 · χ² 390 / p 4e-87 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 32% (drug 54%) | no trial data cached |
| Eye irritation | 147 | 8.1 6.9–9.5ROR 8.2 · χ² 906 / p 2e-199 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 76% consumer | no trial data cached |
| Muscle atrophy | 33 | 8.0 5.7–11.3ROR 8.1 · χ² 196 / p 7e-45 | 7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 30% (drug 54%) | no trial data cached |
| Chronic kidney disease | 190 | 7.6 6.6–8.7ROR 7.8 · χ² 1,084 / p 5e-238 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Lacrimation increased | 74 | 7.6 6.1–9.5ROR 7.7 · χ² 417 / p 6e-93 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 76% consumer | no trial data cached |
| Conjunctivitis | 44 | 7.3 5.5–9.9ROR 7.4 · χ² 234 / p 3e-53 | 6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Drug resistance | 60 | 7.2 5.6–9.2ROR 7.2 · χ² 312 / p 5e-70 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 97% clinician | no trial data cached |
| Rash maculo-papular | 51 | 7.1 5.4–9.3ROR 7.1 · χ² 259 / p 2e-58 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Ocular hyperaemia | 104 | 6.8 5.6–8.3ROR 6.9 · χ² 511 / p 2e-113 | 6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Eosinophilia | 38 | 6.7 4.9–9.2ROR 6.7 · χ² 177 / p 1e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 100% clinician | no trial data cached |
| Blindness unilateral | 30 | 6.5 4.6–9.3ROR 6.6 · χ² 135 / p 2e-31 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 54 | 6.5 5.0–8.5ROR 6.5 · χ² 245 / p 2e-55 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 29% (drug 54%) · 100% clinician | no trial data cached |
| Hepatocellular injury | 30 | 6.5 4.5–9.2ROR 6.5 · χ² 133 / p 4e-31 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 22% (drug 54%) · 90% clinician | no trial data cached |
| Eye swelling | 78 | 6.5 5.2–8.1ROR 6.5 · χ² 355 / p 2e-79 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 78% consumer | no trial data cached |
| International normalised ratio increased | 60 | 6.4 5.0–8.2ROR 6.4 · χ² 267 / p 2e-60 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Encephalopathy | 50 | 6.3 4.7–8.3ROR 6.3 · χ² 215 / p 4e-49 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 96% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 45 | 6.2 4.6–8.3ROR 6.2 · χ² 191 / p 1e-43 | 5.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 100% clinician | no trial data cached |
| Ear infection | 53 | 6.1 4.7–8.0ROR 6.2 · χ² 222 / p 2e-50 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 | no trial data cached |
| Cataract | 112 | 5.8 4.8–7.0ROR 5.9 · χ² 439 / p 8e-98 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Visual acuity reduced | 63 | 5.8 4.5–7.4ROR 5.8 · χ² 243 / p 4e-55 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 96% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 24 | 5.7 3.8–8.4ROR 5.7 · χ² 87 / p 5e-21 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 25% (drug 54%) | no trial data cached |
| Tubulointerstitial nephritis | 34 | 5.6 4.0–7.8ROR 5.6 · χ² 123 / p 8e-29 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Anhedonia | 48 | 5.6 4.2–7.4ROR 5.6 · χ² 175 / p 4e-40 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 26% (drug 54%) | no trial data cached |
| Product administration error | 36 | 5.5 4.0–7.7ROR 5.6 · χ² 129 / p 4e-30 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 78% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye pain | 331 | 18.4 16.6–20.5ROR 19.3 · χ² 5,426 / p <1e-300 | 18.3 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 74% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 241 | 4.8 4.3–5.5ROR 5.0 · χ² 737 / p 2e-162 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 92% clinician | no trial data cached |
| Arthralgia (joint pain) | 239 | 1.8 1.6–2.0ROR 1.8 · χ² 80 / p 2e-19 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Renal failure (kidney failure) | 205 | 4.7 4.1–5.4ROR 4.8 · χ² 595 / p 8e-132 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Anxiety | 199 | 2.1 1.9–2.4ROR 2.2 · χ² 121 / p 2e-28 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Chronic kidney disease | 190 | 7.6 6.6–8.7ROR 7.8 · χ² 1,084 / p 5e-238 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Condition aggravated | 172 | 1.7 1.5–2.0ROR 1.8 · χ² 55 / p 8e-14 | 1.7 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Drug interaction | 148 | 2.9 2.4–3.3ROR 2.9 · χ² 178 / p 7e-41 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 90% clinician | no trial data cached |
| Eye irritation | 147 | 8.1 6.9–9.5ROR 8.2 · χ² 906 / p 2e-199 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 76% consumer | no trial data cached |
| Vision blurred (blurred vision) | 146 | 3.3 2.8–3.8ROR 3.3 · χ² 229 / p 4e-52 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Anaemia (low red blood cells) | 144 | 2.3 2.0–2.7ROR 2.3 · χ² 107 / p 3e-25 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · 90% clinician | no trial data cached |
| Product dose omission issue | 139 | 1.5 1.3–1.8ROR 1.5 · χ² 23 / p 1e-6 | 1.5 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.2 · 75% consumer | no trial data cached |
| Myalgia (muscle pain) | 138 | 2.5 2.1–2.9ROR 2.5 · χ² 122 / p 1e-28 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Pain in extremity | 137 | 1.4 1.2–1.7ROR 1.4 · χ² 17 / p 2e-5 | 1.4 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Insomnia (trouble sleeping) | 137 | 1.6 1.3–1.9ROR 1.6 · χ² 28 / p 5e-8 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Tendonitis — n=126, PRR 25.0
- Toxic epidermal necrolysis — n=77, PRR 15.7
- Ocular discomfort — n=54, PRR 15.3
- Photophobia — n=83, PRR 13.7
- Tendon rupture — n=50, PRR 12.4
- Eye discharge — n=35, PRR 10.5
- Toxic skin eruption — n=34, PRR 10.3
- Hepatic cytolysis — n=39, PRR 9.8
- Vitreous floaters — n=31, PRR 9.8
- Cholestasis — n=57, PRR 9.2
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ofloxacin Otic?
In FDA FAERS, the most frequently co-reported reaction terms for Ofloxacin Otic are eye pain, acute kidney injury, arthralgia, renal failure, anxiety, chronic kidney disease. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ofloxacin Otic have an FDA boxed warning?
No. The FDA label retrieved for Ofloxacin Otic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ofloxacin Otic causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2bb61a24-87a6-4e74-a319-fc5e7c483bbb, effective 20241216; matched on
openfda.generic_name.exact:"OFLOXACIN OTIC") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 426 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.