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bimatoprost Side Effects

Also known as: Lumigan

Analysis of 28,128 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

28,128

Death-Related

761

2.7% of reports

Hospitalizations

3,060

10.9% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
4,071
TREATMENT FAILURE
3,077
OCULAR HYPERAEMIA
2,333
EYE IRRITATION
1,841
MADAROSIS
1,386
EYE PRURITUS
1,320
ERYTHEMA OF EYELID
1,012
EYE PAIN
937
HYPERSENSITIVITY
851
VISION BLURRED
834
INTRAOCULAR PRESSURE INCREASED
715
FATIGUE
705
OFF LABEL USE
701
HEADACHE
673
DRY EYE
647
EYE SWELLING
646
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
583
DYSPNOEA
543
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
539
EYELIDS PRURITUS
530

Who Reports Side Effects

Gender Distribution

Female 19,549 (74%)
Male 6,867 (26%)
Unknown 42

Age Distribution

0-17 143 (1%)
18-44 1,252 (10%)
45-64 3,782 (31%)
65-74 3,129 (26%)
75+ 3,962 (32%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 761 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 377
DIARRHOEA 44
PNEUMONIA 44
ASTHENIA 40
FALL 36
CARDIAC FAILURE CONGESTIVE 34
DYSPNOEA 33
FATIGUE 32
ANAEMIA 30
VOMITING 30
PAIN 25
PLEURAL EFFUSION 25
MYOCARDIAL INFARCTION 24
RENAL FAILURE 23
RESPIRATORY FAILURE 23
WEIGHT DECREASED 23
CEREBROVASCULAR ACCIDENT 22
HYPOTENSION 22
ATRIAL FIBRILLATION 21
CARDIAC FAILURE 21

Reactions in Hospitalization Reports

Top reactions in 3,060 reports where hospitalization was an outcome.

Reaction Reports
FALL 276
DYSPNOEA 247
PNEUMONIA 225
ASTHENIA 201
FATIGUE 199
DIARRHOEA 196
NAUSEA 149
DIZZINESS 138
VOMITING 137
ANAEMIA 135
MALAISE 113
WEIGHT DECREASED 113
URINARY TRACT INFECTION 112
HEADACHE 109
PAIN 109
PYREXIA 101
PAIN IN EXTREMITY 100
ATRIAL FIBRILLATION 99
DEHYDRATION 98
CARDIAC FAILURE CONGESTIVE 95

Nearby — Related Medications

Compare bimatoprost vs aflibercept →

What the FAERS Data Reveals About bimatoprost Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 28,128 voluntary reports linked to bimatoprost and its brand equivalents (Lumigan), spanning 2004 through 2025. Of those, 761 (2.7%) listed death as an outcome and 3,060 (10.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 74% were female and 26% male; age distribution skews toward 75+, with 3,962 reports in that bracket. The single most reported reaction is drug ineffective with 4,071 submissions, followed by treatment failure and ocular hyperaemia.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.