Drug · FAERS side-effect profile with label screen
Ketotifen side effects: what 6,490 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Ketotifen Fumarate (Ketotifen Fumarate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,490 reports · 17% serious · 48 with death outcome · 74% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
FDA label, Indications and Usage
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
Reporting / coding artifact 2No label text to screen 38
What the badges mean
- 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.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 116 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 2,496 | 101.3 98.2–104.6ROR 164.0 · χ² 241,184 / p <1e-300 | 98.2 EB05 95.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 80% consumer | no trial data cached |
| Eye irritation | 637 | 37.3 34.7–40.2ROR 41.3 · χ² 22,289 / p <1e-300 | 36.9 EB05 34.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 97% consumer | no trial data cached |
| Eye pruritus | 214 | 21.1 18.5–24.1ROR 21.8 · χ² 4,058 / p <1e-300 | 20.9 EB05 18.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.5 · 91% consumer | no trial data cached |
| Eye pain | 276 | 16.2 14.5–18.2ROR 16.9 · χ² 3,918 / p <1e-300 | 16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · 95% consumer | no trial data cached |
| Ocular hyperaemia | 226 | 15.7 13.8–17.9ROR 16.2 · χ² 3,088 / p <1e-300 | 15.6 EB05 14.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · 92% consumer | no trial data cached |
| Eye discharge | 44 | 14.0 10.4–18.8ROR 14.1 · χ² 515 / p 3e-114 | 13.7 EB05 10.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 88% consumer | no trial data cached |
| Eye inflammation | 35 | 12.0 8.6–16.7ROR 12.1 · χ² 342 / p 1e-76 | 11.6 EB05 8.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 | no trial data cached |
| Eyelid oedema | 40 | 11.1 8.1–15.1ROR 11.1 · χ² 356 / p 1e-79 | 10.6 EB05 7.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | 95% consumer | no trial data cached |
| Tenderness | 34 | 10.6 7.5–14.8ROR 10.6 · χ² 284 / p 6e-64 | 10.0 EB05 7.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 | no trial data cached |
| Photophobia (light sensitivity) | 52 | 9.0 6.9–11.8ROR 9.1 · χ² 362 / p 5e-81 | 8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 | no trial data cached |
| Lacrimation increased | 83 | 9.0 7.3–11.1ROR 9.1 · χ² 581 / p 1e-128 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 90% consumer | no trial data cached |
| Skin reaction | 39 | 9.0 6.6–12.3ROR 9.0 · χ² 268 / p 2e-60 | 8.4 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.5 | no trial data cached |
| Ocular discomfort | 30 | 8.9 6.3–12.8ROR 9.0 · χ² 203 / p 2e-46 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 93% consumer | no trial data cached |
| Eye swelling | 101 | 8.8 7.3–10.7ROR 9.0 · χ² 694 / p 2e-153 | 8.6 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · 95% consumer | no trial data cached |
| Hereditary angioedema | 25 | 7.7 5.2–11.4ROR 7.7 · χ² 139 / p 2e-32 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.6 | no trial data cached |
| Foot deformity | 26 | 7.6 5.2–11.1ROR 7.6 · χ² 142 / p 5e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.6 · ♀ 0% (drug 74%) | no trial data cached |
| Dry eye | 111 | 7.4 6.2–8.9ROR 7.5 · χ² 610 / p 6e-135 | 7.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 · 73% consumer | no trial data cached |
| Scratch | 23 | 7.2 4.8–10.8ROR 7.2 · χ² 116 / p 2e-27 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 95% (drug 74%) | no trial data cached |
| Ankle fracture | 29 | 6.1 4.2–8.7ROR 6.1 · χ² 117 / p 1e-27 | 5.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.7 · ♀ 7% (drug 74%) | no trial data cached |
| Seasonal allergy | 26 | 6.0 4.1–8.7ROR 6.0 · χ² 102 / p 2e-24 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 · ♀ 96% (drug 74%) · 88% consumer | no trial data cached |
| Paraesthesia oral | 26 | 5.9 4.0–8.6ROR 5.9 · χ² 100 / p 9e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.5 · ♀ 100% (drug 74%) | no trial data cached |
| Ear pain | 35 | 5.8 4.2–8.1ROR 5.9 · χ² 135 / p 2e-31 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.7 · ♀ 100% (drug 74%) | no trial data cached |
| Sneezing | 39 | 5.6 4.1–7.7ROR 5.7 · χ² 144 / p 2e-33 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.6 · ♀ 95% (drug 74%) | no trial data cached |
| Synovitis | 28 | 5.0 3.5–7.3ROR 5.0 · χ² 86 / p 9e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 · ♀ 0% (drug 74%) | no trial data cached |
| Paralysis | 22 | 5.0 3.3–7.5ROR 5.0 · χ² 65 / p 3e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 100% (drug 74%) | no trial data cached |
| Foot fracture | 29 | 4.9 3.4–7.1ROR 5.0 · χ² 87 / p 5e-21 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.4 · ♀ 11% (drug 74%) | no trial data cached |
| Osteoarthritis | 64 | 4.9 3.8–6.2ROR 4.9 · χ² 193 / p 3e-44 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.4 | no trial data cached |
| Muscle tightness | 24 | 4.8 3.2–7.2ROR 4.8 · χ² 68 / p 7e-17 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 | no trial data cached |
| Pharyngeal swelling | 14 | 4.7 2.8–8.0ROR 4.7 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Thinking abnormal | 27 | 4.7 3.2–6.8ROR 4.7 · χ² 74 / p 4e-18 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.3 · ♀ 100% (drug 74%) | no trial data cached |
| Oral pain | 32 | 4.6 3.3–6.5ROR 4.6 · χ² 87 / p 6e-21 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.4 · ♀ 100% (drug 74%) | no trial data cached |
| Eye disorder | 42 | 4.1 3.1–5.6ROR 4.2 · χ² 97 / p 3e-23 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 80% consumer | no trial data cached |
| Expired product administered | 41 | 4.0 2.9–5.4ROR 4.0 · χ² 89 / p 2e-21 | 3.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | 93% consumer | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 66 | 3.9 3.1–4.9ROR 3.9 · χ² 139 / p 2e-32 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.8 | no trial data cached |
| Temperature intolerance | 12 | 3.8 2.2–6.7ROR 3.8 · χ² 22 / p 1e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 51 | 3.7 2.8–4.9ROR 3.8 · χ² 100 / p 9e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 | no trial data cached |
| Conjunctivitis | 21 | 3.7 2.4–5.7ROR 3.7 · χ² 39 / p 3e-10 | 3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Obesity | 18 | 3.6 2.3–5.8ROR 3.7 · χ² 32 / p 8e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Eye infection | 12 | 3.5 2.0–6.1ROR 3.5 · χ² 19 / p 8e-6 | 3.1 EB05 1.9 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious n=2 | no trial data cached |
| Vision blurred (blurred vision) | 146 | 3.5 2.9–4.1ROR 3.5 · χ² 254 / p 2e-57 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 85% 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 2,496 | 101.3 98.2–104.6ROR 164.0 · χ² 241,184 / p <1e-300 | 98.2 EB05 95.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 80% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 915 | 2.2 2.1–2.4ROR 2.5 · χ² 673 / p 1e-148 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 86% consumer | no trial data cached |
| Eye irritation | 637 | 37.3 34.7–40.2ROR 41.3 · χ² 22,289 / p <1e-300 | 36.9 EB05 34.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 97% consumer | no trial data cached |
| Eye pain | 276 | 16.2 14.5–18.2ROR 16.9 · χ² 3,918 / p <1e-300 | 16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · 95% consumer | no trial data cached |
| Ocular hyperaemia | 226 | 15.7 13.8–17.9ROR 16.2 · χ² 3,088 / p <1e-300 | 15.6 EB05 14.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · 92% consumer | no trial data cached |
| Pruritus (itching) | 218 | 1.9 1.6–2.1ROR 1.9 · χ² 88 / p 3e-21 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 11.6 | no trial data cached |
| Eye pruritus | 214 | 21.1 18.5–24.1ROR 21.8 · χ² 4,058 / p <1e-300 | 20.9 EB05 18.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.5 · 91% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 174 | 3.0 2.6–3.5ROR 3.1 · χ² 237 / p 8e-54 | 3.0 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.6 | no trial data cached |
| Vision blurred (blurred vision) | 146 | 3.5 2.9–4.1ROR 3.5 · χ² 254 / p 2e-57 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 85% consumer | no trial data cached |
| Urticaria (hives) | 134 | 2.6 2.2–3.1ROR 2.6 · χ² 132 / p 9e-31 | 2.6 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial data cached |
| Drug hypersensitivity | 126 | 2.1 1.8–2.5ROR 2.1 · χ² 72 / p 1e-17 | 2.1 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Dry eye | 111 | 7.4 6.2–8.9ROR 7.5 · χ² 610 / p 6e-135 | 7.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 · 73% consumer | no trial data cached |
| Eye swelling | 101 | 8.8 7.3–10.7ROR 9.0 · χ² 694 / p 2e-153 | 8.6 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · 95% consumer | no trial data cached |
| Erythema (skin redness) | 99 | 1.6 1.3–1.9ROR 1.6 · χ² 19 / p 5e-6 | 1.6 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Inappropriate schedule of product administration | 98 | 1.8 1.5–2.2ROR 1.8 · χ² 34 / p 3e-9 | 1.8 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 10.2 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Ketotifen?
In FDA FAERS, the most frequently co-reported reaction terms for Ketotifen are eye irritation, eye pain, ocular hyperaemia, pruritus, eye pruritus, hypersensitivity. 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 Ketotifen have an FDA boxed warning?
No. The FDA label retrieved for Ketotifen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ketotifen 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 1234de19-257c-422c-8706-1239381a2706, effective 20230511; matched on
openfda.generic_name.exact:"KETOTIFEN FUMARATE") - 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, 156 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.