Drug Safety Information for COMBIGAN (Brimonidine tartrate; timolol maleate)

Adverse Drug Reactions for COMBIGAN* (Brimonidine tartrate; timolol maleate)

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 COMBIGAN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Ocular hyperaemia	150
2	Eye irritation	137
3	Vision blurred	112
4	Eye pain	108
5	Dizziness	94
6	Eye pruritus	84
7	Headache	83
8	Fatigue*	82
9	Drug ineffective	63
10	Dyspnoea	58
11	Asthenia	53
12	Diarrhoea	50
13	Intraocular pressure increased	47
14	Nausea	44
15	Visual acuity reduced	43
16	Glaucoma	43
17	Dry mouth	42
18	Visual impairment	40
19	Lacrimation increased	38
20	Fall	37

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

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

	Reason	# of FDA Reports
1	Glaucoma*	1853
2	Product used for unknown indication	722
3	Intraocular pressure increased	306
4	Open angle glaucoma	49
5	Intraocular pressure test	43
6	Eye disorder	33
7	Intraocular lens implant	31
8	Ocular hypertension	29
9	Uveitis	24
10	Retinal disorder	22

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

Types of Adverse Events for COMBIGAN

Total Reports Filed with FDA: 5215

Number of FDA Adverse Event Reports by Patient Age for COMBIGAN

Total Reports Filed with FDA: 5215*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Brimonidine tartrate; timolol maleate (Combigan)

Charts are based on 5215 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.

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.