Drug Safety Information for AZOPT (Brinzolamide)

FDA Safety-related Labeling Changes for AZOPT (BRINZOLAMIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AZOPT* (Brinzolamide)

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 AZOPT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	123
2	Intraocular pressure increased	121
3	Drug ineffective	94
4	Asthenia	86
5	Fatigue*	85
6	Headache*	81
7	Nausea*	79
8	Visual acuity reduced	78
9	Dizziness*	75
10	Vision blurred*	74
11	Fall	69
12	Glaucoma	69
13	Eye irritation	62
14	Cataract	59
15	Malaise*	59
16	Diarrhoea	59
17	Eye pain	56
18	Confusional state	56
19	Arthralgia	50
20	Ocular hyperaemia	49

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

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

	Reason	# of FDA Reports
1	Glaucoma*	1945
2	Product used for unknown indication	756
3	Intraocular pressure increased	284
4	Developmental glaucoma	88
5	Open angle glaucoma	87
6	Ocular hypertension	55
7	Cataract	48
8	Intraocular pressure test	33
9	Uveitis	32
10	Macular degeneration	29

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

Types of Adverse Events for AZOPT

Total Reports Filed with FDA: 8208

Number of FDA Adverse Event Reports by Patient Age for AZOPT

Total Reports Filed with FDA: 8208*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Brinzolamide (Azopt)

Charts are based on 8208 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.