TIMOLOL MALEATE FDA MedWatch Direct Reports Summary

These tables and charts are created from 329 voluntary U.S. reports for TIMOLOL MALEATE (TIMOLOL MALEATE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS TIMOLOL MALEATE Report.

Top Adverse Effects Associated with TIMOLOL MALEATE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	PRODUCT SUBSTITUTION ISSUE	27
2	VISION BLURRED	22
3	DIZZINESS	21
4	FATIGUE	21
5	EYE IRRITATION	19
6	HEADACHE	18
7	DRUG INEFFECTIVE	14
8	NAUSEA	14
9	ITCHING	14
10	EYE PAIN	13
11	HYPERSENSITIVITY	13
12	LACK OF STRENGTH AND ENERGY (ASTHENIA)	12
13	INTRAOCULAR PRESSURE INCREASED	12
14	ITCHY EYES	11
15	PAIN	11
16	VOMITING	11
17	DEATH	10
18	DIARRHEA	10
19	SHORTNESS OF BREATH	10
20	EYE RED	10
21	FALL	8
22	INSTILLATION SITE PAIN	8
23	PRODUCT QUALITY ISSUE	8
24	THERAPY CESSATION	8
25	VISUAL IMPAIRMENT	8

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TIMOLOL MALEATE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
129	168	32	329

Medwatch Reporter Type	Count
Consumer	187
Physician	17
Pharmacist	37
Other Health Professional	28

Top Indications

Product used for unknown indication
Glaucoma
Ocular hypertension
Intraocular pressure test
Intraocular pressure increased

Type of Outcome Reported
Serious: 200
Not Serious: 129
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 329
Concomitant Drugs: 228
Note: A single MedWatch report can list more than one drug. This summary includes TIMOLOL MALEATE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

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

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

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

Have experience (good or bad) with TIMOPTIC-XE? Rate TIMOPTIC-XE at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.