Drug Safety Information for LUMIGAN (Bimatoprost)

Safety-related Labeling Changes for LUMIGAN (BIMATOPROST) Rx Drug: FDA Link

Adverse Drug Reactions for LUMIGAN* (Bimatoprost)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LUMIGAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective1469
2Ocular hyperaemia1183
4Wrong technique in drug usage process807
5Eye irritation786
6Eye pruritus742
7Erythema of eyelid723
8Inappropriate schedule of drug administration474
9Eyelids pruritus451
10Incorrect dose administered437
11Eyelid oedema434
12Vision blurred400
14Skin hyperpigmentation378
15Eye pain*353
17Dry eye*279
19Eye swelling271
20Therapeutic response decreased255

* This side effect also appears in "Top 10 Side Effects of LUMIGAN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LUMIGAN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Growth of eyelashes10201
3Product used for unknown indication4347
5Intraocular pressure increased618
6Open angle glaucoma234
7Hair growth abnormal226
9Intraocular pressure test106
10Eye disorder86

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for LUMIGAN

Total Reports Filed with FDA: 32251

Number of FDA Adverse Event Reports by Patient Age for LUMIGAN

Total Reports Filed with FDA: 32251*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bimatoprost (Latisse, Lumigan, Bimatoprost)

Charts are based on 32251 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LUMIGAN Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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