Drug Safety Information for ALPHAGAN P (Brimonidine tartrate)

FDA Safety-related Labeling Changes for SIMBRINZA (BRIMONIDINE TARTRATE; BRINZOLAMIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for MIRVASO (BRIMONIDINE TARTRATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for ALPHAGAN P* (Brimonidine tartrate)

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 ALPHAGAN P
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Erythema667
2Condition aggravated473
3Flushing382
4Drug ineffective334
5Eye irritation252
6Ocular hyperaemia*242
7Dyspnoea234
8Fatigue224
9Feeling hot220
10Skin burning sensation218
11Inappropriate schedule of drug administration214
12Intraocular pressure increased211
13Dizziness207
14Vision blurred*204
15Off label use196
16Rebound effect185
17Asthenia170
18Headache168
19Nausea168
20Eye pain162

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

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

Reason # of FDA Reports
1Glaucoma*3908
2Rosacea3121
3Product used for unknown indication1737
4Intraocular pressure increased607
5Erythema431
6Open angle glaucoma*255
7Ocular hypertension*132
8Developmental glaucoma104
9Eye disorder101
10Flushing85

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


Types of Adverse Events for ALPHAGAN P

Total Reports Filed with FDA: 24015


Number of FDA Adverse Event Reports by Patient Age for ALPHAGAN P

Total Reports Filed with FDA: 24015*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Brimonidine tartrate (Brimonidine, Qoliana, Mirvaso, Alphagan, Alphagan p, Brimonidine tartrate)

Charts are based on 24015 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 ALPHAGAN P Reviews and Review Summary .

Historical 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.