Drug · FAERS side-effect profile with label screen
Bimatoprost side effects: what 28,647 FDA adverse event reports show
Who reports
28,647 reports · 27% serious · 793 with death outcome · 74% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. ( 1 )
FDA label, Indications and Usage
What it is
Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog.
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 40 strongest signals
Labeled adverse reaction 6Labeled (related wording) 12Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 14
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 1,106 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Prostaglandin analogue periorbitopathy | 12 | 1,442.5 541.4–3,843.1ROR 1,443.1 · χ² 5,291 / p <1e-300 | 272.6 EB05 166.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | not reported in cached trials |
| Blepharopachynsis | 20 | 1,311.3 628.4–2,736.5ROR 1,312.2 · χ² 8,832 / p <1e-300 | 322.2 EB05 220.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 74%) · 75% consumer | not reported in cached trials |
| Blepharal pigmentation | 279 | 902.3 757.0–1,075.6ROR 911.2 · χ² 111,190 / p <1e-300 | 390.6 EB05 353.6 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=18 · ♀ 95% (drug 74%) · 82% consumer | not reported in cached trials |
| Periorbital fat atrophy | 22 | 835.1 452.1–1,542.7ROR 835.8 · χ² 8,111 / p <1e-300 | 289.9 EB05 201.8 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | – | not reported in cached trials |
| Iris hyperpigmentation | 99 | 673.6 512.3–885.7ROR 675.9 · χ² 34,033 / p <1e-300 | 326.7 EB05 276.2 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 · 81% consumer | not reported in cached trials |
| Eyelash hyperpigmentation | 24 | 665.8 382.3–1,159.3ROR 666.3 · χ² 7,941 / p <1e-300 | 271.7 EB05 192.1 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | 79% consumer | not reported in cached trials |
| Growth of eyelashes | 297 | 438.0 379.4–505.8ROR 442.6 · χ² 80,302 / p <1e-300 | 268.2 EB05 243.6 · IC025 +7.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=39 · 85% consumer | not reported in cached trials |
| Eyelash changes | 63 | 428.7 313.9–585.4ROR 429.6 · χ² 16,592 / p <1e-300 | 248.9 EB05 201.5 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=6 · ♀ 100% (drug 74%) · 87% consumer | not reported in cached trials |
| Eyelash discolouration | 56 | 247.8 182.9–335.6ROR 248.3 · χ² 10,062 / p <1e-300 | 173.8 EB05 138.9 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | ♀ 100% (drug 74%) | not reported in cached trials |
| Corneal endothelial cell loss | 15 | 204.1 115.1–362.1ROR 204.2 · χ² 2,207 / p <1e-300 | 132.8 EB05 85.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Eyelash thickening | 25 | 189.8 122.2–294.8ROR 190.0 · χ² 3,569 / p <1e-300 | 135.2 EB05 96.3 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | 80% consumer | not reported in cached trials |
| Scleral hyperaemia | 134 | 177.3 146.8–214.1ROR 178.2 · χ² 18,717 / p <1e-300 | 139.7 EB05 121.0 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | 72% consumer | not reported in cached trials |
| Erythema of eyelid | 1,014 | 171.6 160.4–183.6ROR 177.9 · χ² 138,819 / p <1e-300 | 138.4 EB05 131.4 · IC025 +6.9 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · ♀ 96% (drug 74%) | not reported in cached trials |
| Trichiasis | 55 | 158.7 118.5–212.4ROR 159.0 · χ² 6,935 / p <1e-300 | 124.7 EB05 99.4 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 · ♀ 100% (drug 74%) · 85% consumer | not reported in cached trials |
| Enophthalmos | 18 | 156.4 94.0–260.3ROR 156.5 · χ² 2,158 / p <1e-300 | 113.5 EB05 76.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Eyelids pruritus | 530 | 153.4 139.8–168.3ROR 156.3 · χ² 66,052 / p <1e-300 | 126.1 EB05 117.3 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · ♀ 97% (drug 74%) | not reported in cached trials |
| Lid sulcus deepened | 64 | 152.3 116.4–199.4ROR 152.7 · χ² 7,820 / p <1e-300 | 121.5 EB05 98.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=10 · 73% consumer | not reported in cached trials |
| Eyelid sensory disorder | 31 | 138.9 94.6–203.9ROR 139.0 · χ² 3,443 / p <1e-300 | 108.9 EB05 80.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 74%) · 77% consumer | not reported in cached trials |
| Eyelid thickening | 44 | 134.5 97.5–185.5ROR 134.7 · χ² 4,801 / p <1e-300 | 108.3 EB05 84.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 74%) · 70% consumer | not reported in cached trials |
| Eyelid irritation | 376 | 132.1 118.4–147.4ROR 133.8 · χ² 41,239 / p <1e-300 | 111.2 EB05 102.1 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=12 · ♀ 96% (drug 74%) | not reported in cached trials |
| Madarosis | 1,393 | 98.9 93.6–104.4ROR 103.9 · χ² 118,660 / p <1e-300 | 87.0 EB05 83.2 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=31 · ♀ 99% (drug 74%) · 74% consumer | not reported in cached trials |
| Intraocular pressure fluctuation | 22 | 96.2 61.6–150.0ROR 96.2 · χ² 1,745 / p <1e-300 | 79.3 EB05 55.2 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=9 · 73% consumer | not reported in cached trials |
| Eyelid exfoliation | 91 | 95.8 77.0–119.2ROR 96.1 · χ² 7,453 / p <1e-300 | 83.3 EB05 69.9 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | ♀ 95% (drug 74%) | not reported in cached trials |
| Trabeculectomy | 10 | 88.0 45.6–169.6ROR 88.0 · χ² 691 / p 2e-152 | 68.7 EB05 39.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Scleral pigmentation | 10 | 84.9 44.1–163.4ROR 84.9 · χ² 668 / p 1e-147 | 66.8 EB05 38.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Trichorrhexis | 281 | 81.9 72.4–92.6ROR 82.7 · χ² 20,092 / p <1e-300 | 73.3 EB05 66.4 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | ♀ 100% (drug 74%) · 79% consumer | not reported in cached trials |
| Conjunctival scar | 12 | 64.6 35.8–116.6ROR 64.6 · χ² 632 / p 8e-140 | 54.5 EB05 33.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Eyelid pain | 148 | 60.4 51.1–71.4ROR 60.7 · χ² 7,925 / p <1e-300 | 55.4 EB05 48.3 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | ♀ 95% (drug 74%) · 74% consumer | not reported in cached trials |
| Iris disorder | 40 | 58.2 42.2–80.3ROR 58.2 · χ² 2,027 / p <1e-300 | 52.6 EB05 40.3 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=7 · 72% consumer | not reported in cached trials |
| Implantation complication | 15 | 57.9 34.2–97.9ROR 57.9 · χ² 724 / p 9e-160 | 50.4 EB05 32.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=6 | not reported in cached trials |
| Eye colour change | 72 | 56.1 44.1–71.3ROR 56.2 · χ² 3,563 / p <1e-300 | 51.4 EB05 42.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=8 · 74% consumer | not reported in cached trials |
| Ocular surface disease | 18 | 53.4 33.1–86.2ROR 53.5 · χ² 814 / p 3e-179 | 47.5 EB05 31.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Eyelid rash | 59 | 48.8 37.5–63.5ROR 48.9 · χ² 2,543 / p <1e-300 | 45.1 EB05 36.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | ♀ 100% (drug 74%) | not reported in cached trials |
| Intraocular pressure decreased | 33 | 48.4 34.0–68.8ROR 48.4 · χ² 1,391 / p <1e-300 | 44.3 EB05 33.0 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Intraocular pressure increased (raised eye pressure) | 724 | 43.7 40.6–47.1ROR 44.8 · χ² 28,461 / p <1e-300 | 41.2 EB05 38.8 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 60.1 | not reported in cached trials |
| Skin hyperpigmentation | 481 | 43.5 39.7–47.6ROR 44.2 · χ² 18,795 / p <1e-300 | 41.0 EB05 38.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 · ♀ 95% (drug 74%) · 81% consumer | not reported in cached trials |
| Eyelid skin dryness | 63 | 41.6 32.3–53.7ROR 41.7 · χ² 2,325 / p <1e-300 | 39.0 EB05 31.6 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | 76% consumer | not reported in cached trials |
| Dark circles under eyes | 79 | 41.4 33.0–52.0ROR 41.5 · χ² 2,910 / p <1e-300 | 38.9 EB05 32.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=7 · ♀ 100% (drug 74%) · 79% consumer | not reported in cached trials |
| Periorbital disorder | 11 | 40.9 22.3–75.1ROR 40.9 · χ² 368 / p 2e-82 | 36.5 EB05 21.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Ocular hyperaemia | 2,350 | 38.7 37.2–40.3ROR 42.1 · χ² 82,134 / p <1e-300 | 36.8 EB05 35.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Bimatoprost as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01646151 — A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocula (N=2580, phase n/a; 2 AE terms posted; arms: Bimatoprost)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 4,105 | 2.3 2.2–2.4ROR 2.5 · χ² 3,157 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 80% consumer | not reported in cached trials |
| Treatment failure | 3,079 | 28.5 27.5–29.5ROR 31.8 · χ² 78,874 / p <1e-300 | 27.4 EB05 26.6 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 81% consumer | not reported in cached trials |
| Ocular hyperaemia | 2,350 | 38.7 37.2–40.3ROR 42.1 · χ² 82,134 / p <1e-300 | 36.8 EB05 35.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | not reported in cached trials |
| Eye irritation | 1,861 | 25.3 24.1–26.4ROR 26.9 · χ² 41,965 / p <1e-300 | 24.4 EB05 23.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.7 | NCT01646151: 158/2,580 (6.1%) on Bimatoprost |
| Madarosis | 1,393 | 98.9 93.6–104.4ROR 103.9 · χ² 118,660 / p <1e-300 | 87.0 EB05 83.2 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=31 · ♀ 99% (drug 74%) · 74% consumer | not reported in cached trials |
| Eye pruritus | 1,334 | 30.8 29.2–32.5ROR 32.3 · χ² 36,960 / p <1e-300 | 29.6 EB05 28.3 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | not reported in cached trials |
| Erythema of eyelid | 1,014 | 171.6 160.4–183.6ROR 177.9 · χ² 138,819 / p <1e-300 | 138.4 EB05 131.4 · IC025 +6.9 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · ♀ 96% (drug 74%) | not reported in cached trials |
| Eye pain | 954 | 12.8 12.1–13.7ROR 13.3 · χ² 10,258 / p <1e-300 | 12.6 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · 73% consumer | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 854 | 3.4 3.2–3.6ROR 3.5 · χ² 1,437 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Vision blurred (blurred vision) | 846 | 4.6 4.3–4.9ROR 4.7 · χ² 2,344 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | not reported in cached trials |
| Off label use (used outside approved label) | 730 | 0.6 0.6–0.7ROR 0.6 · χ² 183 / p 7e-42 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Intraocular pressure increased (raised eye pressure) | 724 | 43.7 40.6–47.1ROR 44.8 · χ² 28,461 / p <1e-300 | 41.2 EB05 38.8 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 60.1 | not reported in cached trials |
| Fatigue (tiredness) | 721 | 0.7 0.6–0.7ROR 0.7 · χ² 113 / p 1e-26 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.6 | not reported in cached trials |
| Headache | 688 | 0.8 0.7–0.9ROR 0.8 · χ² 34 / p 3e-9 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Dry eye | 657 | 10.0 9.3–10.8ROR 10.3 · χ² 5,283 / p <1e-300 | 9.9 EB05 9.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 75% consumer | not reported in cached trials |
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.
- Blepharopachynsis — n=20, PRR 1,311.3
- Blepharal pigmentation — n=279, PRR 902.3
- Scleral hyperaemia — n=134, PRR 177.3
- Lid sulcus deepened — n=64, PRR 152.3
- Eyelid sensory disorder — n=31, PRR 138.9
- Eyelid thickening — n=44, PRR 134.5
- Eye colour change — n=72, PRR 56.1
- Dark circles under eyes — n=79, PRR 41.4
- Ocular hyperaemia — n=2,350, PRR 38.7
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 Bimatoprost?
In FDA FAERS, the most frequently co-reported reaction terms for Bimatoprost are ocular hyperaemia, eye irritation, madarosis, eye pruritus, erythema of eyelid, eye pain. 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 Bimatoprost have an FDA boxed warning?
No. The FDA label retrieved for Bimatoprost has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bimatoprost 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 27bef7e1-750a-4ac1-ab5f-e4c0121ffcbc, effective 20230831; matched on
openfda.generic_name.exact:"BIMATOPROST") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,146 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 - ClinicalTrials.gov API v2 (query
BIMATOPROST, results-bearing studies sorted by enrollment)
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.