45/100 · Moderate
Manufactured by Allergan, Inc.
Bimatoprost Adverse Events: Ocular and Mild Systemic Reactions Predominate
44,865 FDA adverse event reports analyzed
Last updated: 2026-05-12
BIMATOPROST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 44,865 FDA adverse event reports, BIMATOPROST has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for BIMATOPROST include DRUG INEFFECTIVE, TREATMENT FAILURE, OCULAR HYPERAEMIA, EYE IRRITATION, MADAROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BIMATOPROST.
Bimatoprost has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 44,865 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Treatment Failure, Ocular Hyperaemia. Of classified reports, 26.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are ocular in nature, with ocular hyperaemia and eye irritation being the most common.
Serious adverse events account for 26.9% of total reports, indicating a moderate risk. The most frequent reactions include ocular hyperaemia, eye irritation, and madarosis, suggesting a notable impact on ocular health.
Patients taking Bimatoprost should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bimatoprost should be used with caution in patients with pre-existing ocular conditions, and its use may interact with other ocular medications. Patients should be advised to follow the prescribed dosing schedule and technique. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bimatoprost received a safety concern score of 45/100 (moderate concern). This is based on a 26.9% serious event ratio across 28,129 classified reports. The score accounts for 44,865 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 19,553, Male: 6,868, Unknown: 42. The most frequently reported age groups are age 70 (346 reports), age 75 (337 reports), age 68 (335 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,129 classified reports for BIMATOPROST:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Bimatoprost should be used with caution in patients with pre-existing ocular conditions, and its use may interact with other ocular medications. Patients should be advised to follow the prescribed dosing schedule and technique.
If you are taking Bimatoprost, here are important things to know. The most commonly reported side effects include drug ineffective, treatment failure, ocular hyperaemia, eye irritation, madarosis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosing schedule and technique to minimize the risk of adverse events. Report any vision changes or ocular discomfort to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Bimatoprost for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 44,865 adverse event reports associated with Bimatoprost. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Bimatoprost include Drug Ineffective, Treatment Failure, Ocular Hyperaemia, Eye Irritation, Madarosis. By volume, the top reported reactions are: Drug Ineffective (4,071 reports), Treatment Failure (3,077 reports), Ocular Hyperaemia (2,333 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bimatoprost.
Out of 28,129 classified reports, 7,576 (26.9%) were classified as serious and 20,553 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Bimatoprost break down by patient sex as follows: Female: 19,553, Male: 6,868, Unknown: 42. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Bimatoprost adverse events are: age 70: 346 reports, age 75: 337 reports, age 68: 335 reports, age 72: 333 reports, age 66: 331 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Bimatoprost adverse event reports is Allergan, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Bimatoprost include: Eye Pruritus, Erythema Of Eyelid, Eye Pain, Hypersensitivity, Vision Blurred. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Bimatoprost to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Bimatoprost has a safety concern score of 45 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are ocular in nature, with ocular hyperaemia and eye irritation being the most common.
Key safety signals identified in Bimatoprost's adverse event data include: Ocular hyperaemia and eye irritation are the most reported reactions, indicating potential ocular irritation.. Serious adverse events such as vision blurring and increased intraocular pressure are reported, though less frequently.. Skin hyperpigmentation and eyelid oedema are also notable, suggesting potential systemic effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bimatoprost should be used with caution in patients with pre-existing ocular conditions, and its use may interact with other ocular medications. Patients should be advised to follow the prescribed dosing schedule and technique. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bimatoprost.
Follow the prescribed dosing schedule and technique to minimize the risk of adverse events. Report any vision changes or ocular discomfort to your healthcare provider promptly.
Bimatoprost has 44,865 adverse event reports on file with the FDA. Serious adverse events account for 26.9% of total reports, indicating a moderate risk. The volume of reports for Bimatoprost reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Bimatoprost for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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