Drug Safety Information for BETIMOL (Timolol)

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

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

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

Adverse Drug Reactions for BETIMOL* (Timolol)

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 BETIMOL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Intraocular pressure increased	24
2	Fall	21
3	Dizziness	20
4	Hypertension	19
5	Nausea	19
6	Cataract	17
7	Diarrhoea	17
8	Drug ineffective	17
9	Vomiting	16
10	Glaucoma	16
11	Pyrexia	16
12	Headache	16
13	Visual acuity reduced	16
14	Death	15
15	Pain*	15
16	Condition aggravated	14
17	Dyspnoea	14
18	Eye irritation	14
19	Myocardial infarction	13
20	Rash	11

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

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

	Reason	# of FDA Reports
1	Glaucoma	357
2	Product used for unknown indication	173
3	Intraocular pressure increased	80
4	Ocular hypertension	48
5	Eye operation	39
6	Ill-defined disorder	18
7	Intraocular pressure test abnormal	18
8	Eye disorder	15
9	Cataract	11
10	Hypertonia	7

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

Types of Adverse Events for BETIMOL

Total Reports Filed with FDA: 1838

Number of FDA Adverse Event Reports by Patient Age for BETIMOL

Total Reports Filed with FDA: 1838*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Timolol (Timacar, Optimol, Betimol, Timoptol)

Charts are based on 1838 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.