What the label lists and what reports show
Bimatoprost side effects
Bimatoprost's FDA label: “Most common adverse reaction (31%) is conjunctival hyperemia.” FAERS holds 28,651 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 (2,350 reports).
- Generic listed
Check it at the source: the bimatoprost FDA label on DailyMed (effective June 22, 2024, Allergan, 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 LATISSE ® ?The most common side effects after using LATISSE ® solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE ® solution may cause other less common side effects which typically occur on the skin close to where LATISSE ® is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids. If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your physician’s advice concerning the continued use of LATISSE ® solution. What happens if I stop using LATISSE ® ? If you stop using LATISSE ® , your eyelashes are expected to return to their previous appearance over several weeks to months. […]
Source: FDA drug label (LATISSE), Allergan, Inc., effective July 1, 2024 (SPL set 34f83d9d-2c64-463e-8a90-9a460fedfead), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (31%) is conjunctival hyperemia.
From the label: adverse reactions, continuedThe following adverse reactions are described elsewhere in the labeling: Pigmentation including blepharal pigmentation and iris hyperpigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Intraocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4) ] Most common adverse reaction (31%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s 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 practice. In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia.
Source: FDA drug label, NDA022184 (Abbvie), as published by Allergan, Inc., effective June 22, 2024 (SPL set a5e67c75-db88-4372-bb07-c8dd15c97631), via openFDA; the full label on DailyMed
What do FAERS reports show?
28,651 reports list bimatoprost among the medicines taken, each a report of something that happened, not proof the medicine caused it; 793 are coded as a death and 3,141 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 19 reactions below, 12 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?
- Bimatoprost: 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