Alcaftadine side effects: what 902 FDA adverse event reports show

Alcaftadine · Lastacaft · 26 reaction terms · 1,121 drug–reaction co-reports · data 2026-09-14

Drug class

Histamine-1 Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Lastacaft

openFDA label

Who reports

902 reports · 15% serious · 5 with death outcome · 79% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LASTACAFT ® is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. LASTACAFT ® is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. ( 1 )

FDA label, Indications and Usage

What it is

LASTACAFT® (alcaftadine ophthalmic solution) is an H1 receptor antagonist, in a sterile ophthalmic solution for topical ophthalmic use. Alcaftadine is a white to yellow powder with an empirical formula of C 19 H 21 N 3 O and a molecular weight of 307.39.

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 18 strongest signals

Labeled adverse reaction 6Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 9

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.
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. 8 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
Ocular hyperaemia	298	149.2 135.9–163.8ROR 222.4 · χ² 43,545 / p <1e-300	146.9 EB05 133.4 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 74.2	no trial data cached
Eye discharge	47	107.4 81.3–142.0ROR 113.3 · χ² 4,830 / p <1e-300	102.6 EB05 80.2 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=5	no trial data cached
Eyelid oedema	42	83.7 62.3–112.5ROR 87.8 · χ² 3,340 / p <1e-300	80.5 EB05 62.0 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4	no trial data cached
Eye pruritus	102	72.1 60.1–86.6ROR 81.2 · χ² 7,074 / p <1e-300	71.0 EB05 60.2 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 92.0	no trial data cached
Eye irritation	170	71.1 62.1–81.4ROR 87.4 · χ² 11,675 / p <1e-300	70.3 EB05 61.9 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 97.5	no trial data cached
Eye inflammation	22	54.3 35.9–82.1ROR 55.7 · χ² 1,097 / p 7e-241	51.9 EB05 36.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eye swelling	83	52.3 42.6–64.2ROR 57.5 · χ² 4,123 / p <1e-300	51.6 EB05 42.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.1	no trial data cached
Conjunctivitis	38	48.2 35.3–65.8ROR 50.2 · χ² 1,706 / p <1e-300	47.0 EB05 35.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 18.3	no trial data cached
Lacrimation increased	57	44.4 34.6–57.1ROR 47.4 · χ² 2,375 / p <1e-300	43.7 EB05 35.0 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 55.3 · 72% consumer	no trial data cached
Eye pain	103	43.4 36.2–52.1ROR 48.9 · χ² 4,231 / p <1e-300	43.0 EB05 36.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 38.0	no trial data cached
Eye infection	13	27.0 15.7–46.3ROR 27.4 · χ² 300 / p 2e-67	26.0 EB05 16.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Ocular discomfort	12	25.7 14.7–45.1ROR 26.0 · χ² 261 / p 6e-59	24.7 EB05 14.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Photophobia (light sensitivity)	13	16.2 9.4–27.8ROR 16.4 · χ² 170 / p 3e-39	15.2 EB05 8.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 23.6	no trial data cached
Dry eye	28	13.4 9.3–19.4ROR 13.8 · χ² 311 / p 8e-70	13.0 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 51.1 · 78% consumer	no trial data cached
Eye disorder	15	10.6 6.4–17.6ROR 10.8 · χ² 122 / p 1e-28	9.3 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Expired product administered	11	7.7 4.3–13.9ROR 7.8 · χ² 58 / p 1e-14	6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Visual acuity reduced	10	6.9 3.7–12.9ROR 7.0 · χ² 45 / p 9e-12	5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Inappropriate schedule of drug administration	17	5.5 3.4–8.8ROR 5.6 · χ² 58 / p 1e-14	4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	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
Ocular hyperaemia	298	149.2 135.9–163.8ROR 222.4 · χ² 43,545 / p <1e-300	146.9 EB05 133.4 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 74.2	no trial data cached
Eye irritation	170	71.1 62.1–81.4ROR 87.4 · χ² 11,675 / p <1e-300	70.3 EB05 61.9 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 97.5	no trial data cached
Eye pain	103	43.4 36.2–52.1ROR 48.9 · χ² 4,231 / p <1e-300	43.0 EB05 36.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 38.0	no trial data cached
Eye pruritus	102	72.1 60.1–86.6ROR 81.2 · χ² 7,074 / p <1e-300	71.0 EB05 60.2 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 92.0	no trial data cached
Eye swelling	83	52.3 42.6–64.2ROR 57.5 · χ² 4,123 / p <1e-300	51.6 EB05 42.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.1	no trial data cached
Lacrimation increased	57	44.4 34.6–57.1ROR 47.4 · χ² 2,375 / p <1e-300	43.7 EB05 35.0 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 55.3 · 72% consumer	no trial data cached
Eye discharge	47	107.4 81.3–142.0ROR 113.3 · χ² 4,830 / p <1e-300	102.6 EB05 80.2 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=5	no trial data cached
Eyelid oedema	42	83.7 62.3–112.5ROR 87.8 · χ² 3,340 / p <1e-300	80.5 EB05 62.0 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4	no trial data cached
Conjunctivitis	38	48.2 35.3–65.8ROR 50.2 · χ² 1,706 / p <1e-300	47.0 EB05 35.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 18.3	no trial data cached
Dry eye	28	13.4 9.3–19.4ROR 13.8 · χ² 311 / p 8e-70	13.0 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 51.1 · 78% consumer	no trial data cached
Eye inflammation	22	54.3 35.9–82.1ROR 55.7 · χ² 1,097 / p 7e-241	51.9 EB05 36.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Inappropriate schedule of drug administration	17	5.5 3.4–8.8ROR 5.6 · χ² 58 / p 1e-14	4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Eye disorder	15	10.6 6.4–17.6ROR 10.8 · χ² 122 / p 1e-28	9.3 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Photophobia (light sensitivity)	13	16.2 9.4–27.8ROR 16.4 · χ² 170 / p 3e-39	15.2 EB05 8.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 23.6	no trial data cached
Eye infection	13	27.0 15.7–46.3ROR 27.4 · χ² 300 / p 2e-67	26.0 EB05 16.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=2	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.

Ocular hyperaemia — n=298, PRR 149.2
Eye inflammation — n=22, PRR 54.3
Eye pain — n=103, PRR 43.4
Dry eye — n=28, PRR 13.4

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 Alcaftadine?

In FDA FAERS, the most frequently co-reported reaction terms for Alcaftadine are ocular hyperaemia, eye irritation, eye pain, eye pruritus, eye swelling, lacrimation 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 Alcaftadine have an FDA boxed warning?

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

Do FAERS signals prove that Alcaftadine 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 17d37e8d-7825-424b-b6ca-0a85d0bf4694, effective 20200601; matched on openfda.generic_name.exact:"ALCAFTADINE")
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, 26 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.