What the label lists and what reports show
Latanoprost side effects
Latanoprost's FDA label: “Most common ocular adverse reactions (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.” FAERS holds 50,627 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 eye irritation (2,399 reports).
- Generic listed
Check it at the source: the latanoprost FDA label on DailyMed (effective December 18, 2025, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of IYUZEH?IYUZEH may cause serious side effects including: changes in the color of your eye (iris). Your iris may become more brown in color while using IYUZEH. This color change may not go away when you stop using IYUZEH. If IYUZEH is used in 1 eye only, the color of that eye may always be a different color from the color of your other eye. darkening of the color of the skin around your eye (eyelid). These skin changes usually go away when you stop using IYUZEH. increasing the length, thickness, color, or number of your eyelashes. These eyelash changes usually go away when you stop using IYUZEH. hair growth on your eyelids. This hair growth usually goes away when you stop using IYUZEH. […]
Source: FDA drug label (IYUZEH), Thea Pharma Inc., effective July 30, 2024 (SPL set 192fc081-cc38-4e83-b779-9592e060b915), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common ocular adverse reactions (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| System Organ Class/ Preferred Term | XELPROS (N = 448) |
|---|---|
| Eye disorders | 325 (73%) |
| Eye pain / stinging | 246 (55%) |
| Ocular hyperemia | 185 (41%) |
| Conjunctival hyperemia | 65 (15%) |
| Eye discharge | 53 (12%) |
| Growth of eyelashes | 47 (11%) |
| Eyelash thickening | 35 (8%) |
| Ocular Itching | 20 (5%) |
| Visual acuity reduced | 16 (4%) |
| Dry eye | 13 (3%) |
| Erythema of eyelid | 14 (3%) |
| Foreign body sensation in eyes | 9 (2%) |
| Eyelid edema | 7 (2%) |
| Punctate keratitis | 6 (1%) |
| Eyelash discoloration | 5 (1%) |
| Conjunctival edema | 5 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common ocular adverse reactions (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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 studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Across multiple clinical trials conducted with XELPROS (latanoprost ophthalmic emulsion) 0.005%, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia, reported in 55% and 41% of XELPROS treated patients, respectively (Table 1). Less than 1% of patients discontinued therapy because of intolerance to the eye pain/stinging or to the ocular hyperemia. Table 1.
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective December 18, 2025 (SPL set 34ad5cf6-4df0-4104-bddd-4c7631133ded), via openFDA; the full label on DailyMed
What do FAERS reports show?
50,627 reports list latanoprost among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,181 are coded as a death and 10,454 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. Reports rose sharply in 2020 (9,002, against a median of 2,701 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 7 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?
- Latanoprost: 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