This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
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, for topical ophthalmic use is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions 6.2) ]. Hypersensitivity
Concurrent administration of Bimatoprost ophthalmic solution, for topical ophthalmic use and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2, 5.3 ) 5.1 Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, bimatoprost ophthalmic solution 0.03% lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution 0.03% may interfere with the desired reduc...
The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [see Warnings and Precautions (5.1)] Iris Pigmentation [see Warnings and Precautions (5.2)] Lid Pigmentation [see Warnings and Precautions (5.3)] Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)] Intraocular Inflammation [see Warnings and Precautions (5.5)] Macular Edema [see Warnings and Precautions (5.6)] Hypersensitivity [see Contraindications (4)] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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. The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel...
Source: FDA SPL label for bimatoprost (Alembic Pharmaceuticals Limited), effective 20230719. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 1,768 | 4,440 | 2,504 | 1,106 | 1,297 | 949 | 948 | 494 |
1,617 reports blaming this drug for every million Medicare prescriptions filled, which is 0.6× the typical drug on this site. (2,387 reports in 2024–2026, against 1,476,293 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 10/2019 | Class III | Sandoz Inc | Labeling: Incorrect or missing package insert. |
| 10/2017 | Class III | Allergan Sales, LLC | Failed Impurities/Degradation Specifications. |
| 03/2017 | Class III | Allergan Sales, LLC | Failed Impurities/Degradation Specifications |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $2,249,158 in payments to US physicians and hospitals tied to this drug across 40,901 transactions (Durysta $1,458,282, Lumigan $783,789, Latisse $7,086).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Lumigan | 1,407,999 | $460 |
| Bimatoprost | 67,911 | $106 |
| Durysta | 383 | $3,483 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.