Epinastine side effects: what 1,128 FDA adverse event reports show
Drug class
H 1 histamine receptor antagonist
Label matched
Epinastine Hydrochloride (Epinastine Hydrochloride)
Who reports
1,128 reports · 65% serious · 106 with death outcome · 54% female
Used for
Epinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
What it is
Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.
Boxed warning
None in the current label
Causality screen of the 13 strongest signals
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.
- 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. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Treatment failure | 317 | 72.1 65.7–79.2ROR 100.0 · χ² 22,166 / p <1e-300 | 71.6 EB05 65.2 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | 80% consumer | no trial data cached |
| Drug eruption | 26 | 27.5 18.8–40.2ROR 28.1 · χ² 637 / p 8e-141 | 27.0 EB05 19.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Blood lactate dehydrogenase increased | 14 | 16.3 9.7–27.5ROR 16.5 · χ² 187 / p 9e-43 | 15.5 EB05 9.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 15.4 | no trial data cached |
| Hepatic function abnormal | 32 | 16.1 11.4–22.6ROR 16.5 · χ² 438 / p 2e-97 | 15.8 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 97% clinician | no trial data cached |
| Toxic skin eruption | 6 | 11.1 5.0–24.6ROR 11.1 · χ² 45 / p 9e-12 | 7.6 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Erythema multiforme | 5 | 10.0 4.2–23.9ROR 10.0 · χ² 32 / p 8e-9 | 6.3 EB05 2.7 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Altered state of consciousness | 11 | 9.5 5.3–17.1ROR 9.6 · χ² 75 / p 2e-18 | 7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Face oedema | 8 | 8.8 4.4–17.5ROR 8.8 · χ² 48 / p 2e-12 | 6.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Melaena (black stool) | 9 | 7.6 4.0–14.6ROR 7.6 · χ² 45 / p 9e-12 | 5.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Interstitial lung disease | 19 | 7.3 4.7–11.4ROR 7.4 · χ² 98 / p 3e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Cytomegalovirus infection | 5 | 5.6 2.3–13.4ROR 5.6 · χ² 15 / p 7e-5 | 3.9 EB05 1.9 · IC025 +0.4 | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Peritonitis | 5 | 4.5 1.9–10.8ROR 4.5 · χ² 10 / p 7e-4 | 3.4 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 5 | 3.6 1.5–8.7ROR 3.7 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 317 | 72.1 65.7–79.2ROR 100.0 · χ² 22,166 / p <1e-300 | 71.6 EB05 65.2 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | 80% consumer | no trial data cached |
| Hepatic function abnormal | 32 | 16.1 11.4–22.6ROR 16.5 · χ² 438 / p 2e-97 | 15.8 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 97% clinician | no trial data cached |
| Drug eruption | 26 | 27.5 18.8–40.2ROR 28.1 · χ² 637 / p 8e-141 | 27.0 EB05 19.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Interstitial lung disease | 19 | 7.3 4.7–11.4ROR 7.4 · χ² 98 / p 3e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Blood lactate dehydrogenase increased | 14 | 16.3 9.7–27.5ROR 16.5 · χ² 187 / p 9e-43 | 15.5 EB05 9.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 15.4 | no trial data cached |
| Altered state of consciousness | 11 | 9.5 5.3–17.1ROR 9.6 · χ² 75 / p 2e-18 | 7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Melaena (black stool) | 9 | 7.6 4.0–14.6ROR 7.6 · χ² 45 / p 9e-12 | 5.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Face oedema | 8 | 8.8 4.4–17.5ROR 8.8 · χ² 48 / p 2e-12 | 6.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Toxic skin eruption | 6 | 11.1 5.0–24.6ROR 11.1 · χ² 45 / p 9e-12 | 7.6 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 5 | 3.6 1.5–8.7ROR 3.7 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Peritonitis | 5 | 4.5 1.9–10.8ROR 4.5 · χ² 10 / p 7e-4 | 3.4 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Cytomegalovirus infection | 5 | 5.6 2.3–13.4ROR 5.6 · χ² 15 / p 7e-5 | 3.9 EB05 1.9 · IC025 +0.4 | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Erythema multiforme | 5 | 10.0 4.2–23.9ROR 10.0 · χ² 32 / p 8e-9 | 6.3 EB05 2.7 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Gastric cancer | 4 | 2.9 1.1–7.7ROR 2.9 · χ² 3 / p 0.035 | 2.4 EB05 1.1 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Pregnancy | 4 | 3.7 1.4–9.8ROR 3.7 · χ² 5 / p 0.010 | 2.8 EB05 1.3 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 4.8 | 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.
- Drug eruption — n=26, PRR 27.5
- Hepatic function abnormal — n=32, PRR 16.1
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 Epinastine?
In FDA FAERS, the most frequently co-reported reaction terms for Epinastine are hepatic function abnormal, drug eruption, interstitial lung disease, blood lactate dehydrogenase increased, altered state of consciousness, melaena. 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 Epinastine have an FDA boxed warning?
No. The FDA label retrieved for Epinastine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Epinastine 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 0d4ee45c-e58f-4b7c-b389-898f5c27f54d, effective 20250322; matched on
openfda.generic_name.exact:"EPINASTINE HYDROCHLORIDE") - 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, 20 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.