Bepotastine Besilate side effects: what 641 FDA adverse event reports show

Bepotastine Besilate · 14 reaction terms · 128 drug–reaction co-reports · data 2026-09-14

Drug class

Histamine h 1 receptor antagonist

FDA label, Indications wording

Who reports

641 reports · 56% serious · 38 with death outcome · 67% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bepotastine besilate ophthalmic solution, 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )

FDA label, Indications and Usage

What it is

Bepotastine besilate ophthalmic solution, 1.5% is a sterile, topically administered drug for ophthalmic 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 9 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 5

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.
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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Erythema multiforme	8	28.1 14.1–55.9ROR 28.4 · χ² 183 / p 6e-42	26.2 EB05 13.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 29.8	no trial data cached
Obstructive airways disorder	7	20.5 9.8–42.9ROR 20.7 · χ² 111 / p 3e-26	18.2 EB05 7.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.9	no trial data cached
Conjunctivitis	11	19.6 10.9–35.2ROR 19.9 · χ² 176 / p 2e-40	18.5 EB05 10.3 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 27.2	no trial data cached
Eye pruritus	19	18.9 12.1–29.4ROR 19.4 · χ² 304 / p 2e-68	18.4 EB05 12.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.7	no trial data cached
Eye irritation	32	18.8 13.4–26.3ROR 19.7 · χ² 522 / p 7e-116	18.6 EB05 13.7 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.0 · 89% consumer	no trial data cached
Product taste abnormal	6	14.6 6.6–32.4ROR 14.7 · χ² 63 / p 1e-15	11.0 EB05 4.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Rotator cuff syndrome	5	12.7 5.3–30.4ROR 12.8 · χ² 43 / p 3e-11	8.4 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.1	no trial data cached
Ocular hyperaemia	18	12.6 8.0–19.9ROR 12.9 · χ² 181 / p 1e-41	11.7 EB05 7.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Blood count abnormal	5	10.6 4.4–25.5ROR 10.7 · χ² 35 / p 2e-9	6.8 EB05 2.8 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	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 irritation	32	18.8 13.4–26.3ROR 19.7 · χ² 522 / p 7e-116	18.6 EB05 13.7 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.0 · 89% consumer	no trial data cached
Eye pruritus	19	18.9 12.1–29.4ROR 19.4 · χ² 304 / p 2e-68	18.4 EB05 12.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.7	no trial data cached
Ocular hyperaemia	18	12.6 8.0–19.9ROR 12.9 · χ² 181 / p 1e-41	11.7 EB05 7.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Conjunctivitis	11	19.6 10.9–35.2ROR 19.9 · χ² 176 / p 2e-40	18.5 EB05 10.3 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 27.2	no trial data cached
Erythema multiforme	8	28.1 14.1–55.9ROR 28.4 · χ² 183 / p 6e-42	26.2 EB05 13.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 29.8	no trial data cached
Obstructive airways disorder	7	20.5 9.8–42.9ROR 20.7 · χ² 111 / p 3e-26	18.2 EB05 7.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.9	no trial data cached
Product taste abnormal	6	14.6 6.6–32.4ROR 14.7 · χ² 63 / p 1e-15	11.0 EB05 4.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Blood count abnormal	5	10.6 4.4–25.5ROR 10.7 · χ² 35 / p 2e-9	6.8 EB05 2.8 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	no trial data cached
Rotator cuff syndrome	5	12.7 5.3–30.4ROR 12.8 · χ² 43 / p 3e-11	8.4 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.1	no trial data cached
Ocular discomfort	4	12.1 4.5–32.0ROR 12.1 · χ² 30 / p 2e-8	7.1 EB05 2.5 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Toxic skin eruption	4	13.0 4.9–34.4ROR 13.0 · χ² 33 / p 5e-9	7.7 EB05 2.7 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.3	no trial data cached
Gastric cancer	3	3.8 1.2–11.8ROR 3.8 · χ² 4 / p 0.026	2.7 EB05 1.1 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 3.9	no trial data cached
Breast cancer metastatic	3	9.1 3.0–28.3ROR 9.2 · χ² 14 / p 7e-5	4.7 EB05 1.7 · IC025 +0.0	Not in label — unassessed	serious PRR 9.6	no trial data cached
Eye inflammation	3	10.4 3.4–32.2ROR 10.4 · χ² 17 / p 2e-5	5.3 EB05 1.8 · IC025 +0.1	Not in label — unassessed	serious n=1	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.

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 Bepotastine Besilate?

In FDA FAERS, the most frequently co-reported reaction terms for Bepotastine Besilate are eye irritation, eye pruritus, ocular hyperaemia, conjunctivitis, erythema multiforme, obstructive airways disorder. 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 Bepotastine Besilate have an FDA boxed warning?

No. The FDA label retrieved for Bepotastine Besilate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bepotastine Besilate 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 75178670-aa57-45f9-94d5-efcf8305e683, effective 20180320; matched on openfda.generic_name.exact:"BEPOTASTINE BESILATE")
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, field patient.drug.openfda.generic_name.exact, 14 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.