Drug Safety Information for TIMOPTIC-XE (Timolol maleate)

Safety-related Labeling Changes for TIMOPTIC (TIMOLOL MALEATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TIMOPTIC-XE (TIMOLOL MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for TIMOPTIC-XE* (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 TIMOPTIC-XE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective330
2Dizziness268
3Dyspnoea263
4Fatigue250
5Intraocular pressure increased243
6Nausea235
7Asthenia232
8Diarrhoea212
9Headache197
10Fall189
11Vision blurred*188
12Pain*170
13Eye irritation164
14Visual acuity reduced164
15Vomiting156
16Glaucoma151
17Anaemia140
18Hypotension137
19Malaise135
20Eye pain134

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

Top 10 Reasons for Taking TIMOPTIC-XE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Glaucoma4718
2Product used for unknown indication2014
3Intraocular pressure increased571
4Open angle glaucoma*211
5Ocular hypertension185
6Eye disorder141
7Developmental glaucoma136
8Hypertension130
9Cataract95
10Prophylaxis82

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


Types of Adverse Events for TIMOPTIC-XE

Total Reports Filed with FDA: 25326


Number of FDA Adverse Event Reports by Patient Age for TIMOPTIC-XE

Total Reports Filed with FDA: 25326*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Timolol maleate (Timolol, Timolol maleate, Timoptic, Timolol gfs, Timoptic-xe, Blocadren, Timoptic in ocudose, Istalol)

Charts are based on 25326 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 TIMOPTIC-XE 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.

Visit   DrugInformer.com more on TIMOPTIC-XE's side effects.