Drug · FAERS side-effect profile with label screen
Gatifloxacin side effects: what 1,774 FDA adverse event reports show
Drug class
Quinolone antimicrobial
FDA label, Indications wording
Who reports
1,774 reports · 81% serious · 105 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: • Aerobic gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus m.
FDA label, Indications and Usage
What it is
Gatifloxacin ophthalmic solution is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis.
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 35 strongest signals
Labeled adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 6Not in label — unassessed 19
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 26 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 44 | 40.6 30.3–54.4ROR 41.6 · χ² 1,657 / p <1e-300 | 39.9 EB05 30.9 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 37.9 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 151 | 36.9 31.7–43.0ROR 40.2 · χ² 5,231 / p <1e-300 | 36.6 EB05 32.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 100% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 96 | 31.3 25.8–38.1ROR 33.1 · χ² 2,785 / p <1e-300 | 31.1 EB05 26.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 100% clinician | no trial data cached |
| Eye inflammation | 21 | 26.4 17.2–40.4ROR 26.7 · χ² 487 / p 4e-108 | 25.8 EB05 17.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 85 | 18.3 14.9–22.5ROR 19.2 · χ² 1,376 / p <1e-300 | 18.2 EB05 15.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · ♀ 97% (drug 42%) · 99% clinician | no trial data cached |
| Visual acuity reduced | 43 | 15.2 11.3–20.4ROR 15.5 · χ² 556 / p 3e-123 | 15.0 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.6 | no trial data cached |
| Eye pain | 67 | 14.4 11.3–18.2ROR 14.9 · χ² 820 / p 1e-180 | 14.2 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 65% (drug 42%) | no trial data cached |
| End stage renal disease | 21 | 13.5 8.8–20.6ROR 13.6 · χ² 230 / p 2e-52 | 12.8 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| International normalised ratio increased | 31 | 12.7 9.0–18.1ROR 12.9 · χ² 324 / p 1e-72 | 12.3 EB05 8.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 · ♀ 14% (drug 42%) · 100% clinician | no trial data cached |
| Eye infection | 11 | 11.6 6.4–20.9ROR 11.7 · χ² 96 / p 5e-23 | 9.7 EB05 5.2 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=7 | no trial data cached |
| Mental status changes | 27 | 11.5 7.9–16.7ROR 11.7 · χ² 248 / p 3e-56 | 10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Electrolyte imbalance | 11 | 11.3 6.3–20.4ROR 11.4 · χ² 93 / p 2e-22 | 9.4 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Anorexia | 12 | 10.9 6.2–19.1ROR 10.9 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Drug intolerance | 83 | 10.2 8.3–12.6ROR 10.7 · χ² 682 / p 1e-150 | 10.0 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 100% (drug 42%) · 96% clinician | no trial data cached |
| Drug prescribing error | 16 | 9.7 6.0–15.8ROR 9.8 · χ² 117 / p 2e-27 | 8.4 EB05 5.2 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Eye irritation | 42 | 8.9 6.6–12.0ROR 9.1 · χ² 288 / p 8e-65 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · ♀ 66% (drug 42%) | no trial data cached |
| Cataract | 44 | 8.8 6.6–11.7ROR 9.0 · χ² 296 / p 1e-66 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 67% (drug 42%) | no trial data cached |
| Renal failure acute | 30 | 8.2 5.8–11.8ROR 8.4 · χ² 184 / p 3e-42 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 21% (drug 42%) · 96% clinician | no trial data cached |
| Photophobia (light sensitivity) | 13 | 8.2 4.8–14.2ROR 8.3 · χ² 76 / p 2e-18 | 6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Electrocardiogram qt prolonged | 25 | 8.2 5.6–12.1ROR 8.3 · χ² 151 / p 4e-35 | 7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 100% clinician | no trial data cached |
| Haematocrit decreased | 13 | 7.7 4.5–13.2ROR 7.8 · χ² 69 / p 4e-17 | 6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Blood glucose decreased | 30 | 7.4 5.2–10.5ROR 7.5 · χ² 159 / p 1e-36 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · ♀ 20% (drug 42%) · 100% clinician | no trial data cached |
| Chronic kidney disease | 47 | 7.3 5.5–9.6ROR 7.4 · χ² 248 / p 4e-56 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Ocular hyperaemia | 26 | 6.6 4.5–9.6ROR 6.7 · χ² 118 / p 1e-27 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 64% (drug 42%) | no trial data cached |
| Tubulointerstitial nephritis | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 40 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Post procedural complication | 10 | 6.1 3.3–11.4ROR 6.2 · χ² 38 / p 3e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Anaphylactic shock | 13 | 6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Lacrimation increased | 15 | 5.9 3.6–9.8ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Renal injury | 15 | 5.9 3.6–9.8ROR 6.0 · χ² 56 / p 3e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Glycosylated haemoglobin increased | 11 | 5.2 2.9–9.3ROR 5.2 · χ² 33 / p 5e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Cerebral infarction | 10 | 4.8 2.6–9.0ROR 4.9 · χ² 27 / p 1e-7 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Coma | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 1e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Convulsion (seizure) | 20 | 4.1 2.6–6.3ROR 4.1 · χ² 44 / p 2e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Eye pruritus | 10 | 3.6 1.9–6.7ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Blood glucose increased | 46 | 2.9 2.2–3.8ROR 2.9 · χ² 55 / p 6e-14 | 2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · ♀ 21% (drug 42%) · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 151 | 36.9 31.7–43.0ROR 40.2 · χ² 5,231 / p <1e-300 | 36.6 EB05 32.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 100% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 96 | 31.3 25.8–38.1ROR 33.1 · χ² 2,785 / p <1e-300 | 31.1 EB05 26.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 85 | 18.3 14.9–22.5ROR 19.2 · χ² 1,376 / p <1e-300 | 18.2 EB05 15.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · ♀ 97% (drug 42%) · 99% clinician | no trial data cached |
| Drug intolerance | 83 | 10.2 8.3–12.6ROR 10.7 · χ² 682 / p 1e-150 | 10.0 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 100% (drug 42%) · 96% clinician | no trial data cached |
| Eye pain | 67 | 14.4 11.3–18.2ROR 14.9 · χ² 820 / p 1e-180 | 14.2 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 65% (drug 42%) | no trial data cached |
| Chronic kidney disease | 47 | 7.3 5.5–9.6ROR 7.4 · χ² 248 / p 4e-56 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Blood glucose increased | 46 | 2.9 2.2–3.8ROR 2.9 · χ² 55 / p 6e-14 | 2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · ♀ 21% (drug 42%) · 95% clinician | no trial data cached |
| Cataract | 44 | 8.8 6.6–11.7ROR 9.0 · χ² 296 / p 1e-66 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 67% (drug 42%) | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 44 | 40.6 30.3–54.4ROR 41.6 · χ² 1,657 / p <1e-300 | 39.9 EB05 30.9 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 37.9 | no trial data cached |
| Visual acuity reduced | 43 | 15.2 11.3–20.4ROR 15.5 · χ² 556 / p 3e-123 | 15.0 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.6 | no trial data cached |
| Eye irritation | 42 | 8.9 6.6–12.0ROR 9.1 · χ² 288 / p 8e-65 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · ♀ 66% (drug 42%) | no trial data cached |
| International normalised ratio increased | 31 | 12.7 9.0–18.1ROR 12.9 · χ² 324 / p 1e-72 | 12.3 EB05 8.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 · ♀ 14% (drug 42%) · 100% clinician | no trial data cached |
| Blood glucose decreased | 30 | 7.4 5.2–10.5ROR 7.5 · χ² 159 / p 1e-36 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · ♀ 20% (drug 42%) · 100% clinician | no trial data cached |
| Renal failure acute | 30 | 8.2 5.8–11.8ROR 8.4 · χ² 184 / p 3e-42 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 21% (drug 42%) · 96% clinician | no trial data cached |
| Mental status changes | 27 | 11.5 7.9–16.7ROR 11.7 · χ² 248 / p 3e-56 | 10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | 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.
- Hypoglycaemia — n=151, PRR 36.9
- Hyperglycaemia — n=96, PRR 31.3
- Eye inflammation — n=21, PRR 26.4
- End stage renal disease — n=21, PRR 13.5
- Mental status changes — n=27, PRR 11.5
- Cataract — n=44, PRR 8.8
- Renal failure acute — n=30, PRR 8.2
- Electrocardiogram qt prolonged — n=25, PRR 8.2
- Chronic kidney disease — n=47, PRR 7.3
- Ocular hyperaemia — n=26, PRR 6.6
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 Gatifloxacin?
In FDA FAERS, the most frequently co-reported reaction terms for Gatifloxacin are hypoglycaemia, hyperglycaemia, anaphylactic reaction, eye pain, chronic kidney disease, blood glucose increased. 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 Gatifloxacin have an FDA boxed warning?
No. The FDA label retrieved for Gatifloxacin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Gatifloxacin 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 9e6fcd14-1fee-493f-811c-e18cbfbee65b, effective 20250215; matched on
openfda.generic_name.exact:"GATIFLOXACIN") - 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, 61 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.