Drug Safety Information for DORZOLAMIDE HYDROCHLORIDE (Dorzolamide hydrochloride)

Safety-related Labeling Changes for TRUSOPT (DORZOLAMIDE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for COSOPT (DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for DORZOLAMIDE HYDROCHLORIDE* (Dorzolamide hydrochloride)

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 DORZOLAMIDE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Intraocular pressure increased142
2Drug ineffective133
3Dyspnoea*99
4Eye irritation90
5Visual acuity reduced90
6Dizziness*87
7Fatigue84
8Headache81
9Diarrhoea75
10Vision blurred74
11Glaucoma72
12Eye pain*71
13Nausea69
14Fall62
15Asthenia59
16Ocular hyperaemia59
17Cataract52
18Confusional state47
19Anaemia46
20Malaise45

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

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

Reason # of FDA Reports
1Glaucoma*1682
2Product used for unknown indication802
3Intraocular pressure increased302
4Open angle glaucoma*156
5Ocular hypertension70
6Eye disorder48
7Behcet's syndrome47
8Intraocular pressure test abnormal43
9Prophylaxis24
10Cataract21

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


Types of Adverse Events for DORZOLAMIDE HYDROCHLORIDE

Total Reports Filed with FDA: 8766


Number of FDA Adverse Event Reports by Patient Age for DORZOLAMIDE HYDROCHLORIDE

Total Reports Filed with FDA: 8766*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dorzolamide hydrochloride (Dorzolamide hcl, Dorzolamide, Trusopt)

Charts are based on 8766 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.

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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.