What the label lists and what reports show
Alcaftadine side effects
Alcaftadine's FDA label: “The most common ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT ® , were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus.” FAERS holds 902 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ocular hyperaemia (298 reports).
- Generic approved
Check it at the source: the alcaftadine FDA label on DailyMed (effective June 1, 2020, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT ® , were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus.
From the label: adverse reactions, continuedThe most common ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT ® , were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most frequent ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT ® , were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus. The most frequent non-ocular adverse reactions, occurring in less than 3% of subjects with eyes treated with LASTACAFT ® , were nasopharyngitis and headache. Some of these events were similar to the underlying disease being studied. 6. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of LASTACAFT ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Source: FDA drug label, NDA022134 (Abbvie), as published by Allergan, Inc., effective June 1, 2020 (SPL set 17d37e8d-7825-424b-b6ca-0a85d0bf4694), via openFDA; the full label on DailyMed
What do FAERS reports show?
902 reports list alcaftadine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 37 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alcaftadine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions