TIMOLOL MALEATE

N/A

Manufactured by Bausch & Lomb Incorporated

16,822 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TIMOLOL MALEATE

TIMOLOL MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch & Lomb Incorporated. The most commonly reported adverse reactions for TIMOLOL MALEATE include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE PAIN, FATIGUE, EYE IRRITATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIMOLOL MALEATE.

Top Adverse Reactions

TREATMENT FAILURE1,011 reports
DRUG INEFFECTIVE677 reports
EYE PAIN512 reports
FATIGUE504 reports
EYE IRRITATION465 reports
DIZZINESS362 reports
DIARRHOEA348 reports
VISION BLURRED339 reports
NAUSEA336 reports
DYSPNOEA321 reports
HEADACHE311 reports
INTRAOCULAR PRESSURE INCREASED310 reports
OCULAR HYPERAEMIA299 reports
OFF LABEL USE284 reports
ASTHENIA272 reports
DEATH270 reports
FALL269 reports
PAIN248 reports
HYPERSENSITIVITY218 reports
GLAUCOMA209 reports
EYE PRURITUS206 reports
VISUAL IMPAIRMENT206 reports
MALAISE202 reports
WEIGHT DECREASED195 reports
VOMITING194 reports
CONSTIPATION187 reports
RASH187 reports
PRURITUS183 reports
CONDITION AGGRAVATED179 reports
ARTHRALGIA176 reports
HYPERTENSION166 reports
PRODUCT DOSE OMISSION ISSUE164 reports
COUGH162 reports
DECREASED APPETITE162 reports
PNEUMONIA162 reports
HYPOTENSION155 reports
LACRIMATION INCREASED155 reports
ANXIETY151 reports
PAIN IN EXTREMITY151 reports
INSOMNIA147 reports
URINARY TRACT INFECTION146 reports
DRUG HYPERSENSITIVITY145 reports
CATARACT143 reports
GAIT DISTURBANCE141 reports
DRY EYE139 reports
ANAEMIA136 reports
BACK PAIN135 reports
SOMNOLENCE135 reports
CONFUSIONAL STATE134 reports
VISUAL ACUITY REDUCED127 reports
CHEST PAIN118 reports
DEPRESSION116 reports
ERYTHEMA116 reports
BRADYCARDIA111 reports
BLOOD PRESSURE INCREASED110 reports
ALOPECIA109 reports
EYE SWELLING109 reports
BLINDNESS106 reports
PYREXIA106 reports
FEELING ABNORMAL102 reports
INCORRECT DOSE ADMINISTERED100 reports
MUSCLE SPASMS99 reports
DRUG INTERACTION98 reports
ABDOMINAL DISCOMFORT97 reports
OEDEMA PERIPHERAL96 reports
ATRIAL FIBRILLATION94 reports
PHOTOPHOBIA93 reports
MYOCARDIAL INFARCTION92 reports
HYPOAESTHESIA91 reports
PRODUCT USE IN UNAPPROVED INDICATION90 reports
BLOOD GLUCOSE INCREASED88 reports
PRODUCT QUALITY ISSUE88 reports
WEIGHT INCREASED88 reports
PERIPHERAL SWELLING87 reports
SYNCOPE87 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS87 reports
DRY MOUTH86 reports
LOSS OF CONSCIOUSNESS86 reports
CEREBROVASCULAR ACCIDENT84 reports
OCULAR DISCOMFORT82 reports
ABDOMINAL PAIN81 reports
RENAL FAILURE81 reports
MYALGIA80 reports
ABDOMINAL PAIN UPPER79 reports
BALANCE DISORDER79 reports
NASOPHARYNGITIS78 reports
DEHYDRATION76 reports
PRODUCT USE ISSUE76 reports
EYE DISORDER75 reports
MUSCULAR WEAKNESS75 reports
PALPITATIONS74 reports
ACUTE KIDNEY INJURY73 reports
FOREIGN BODY SENSATION IN EYES70 reports
COVID 1969 reports
HALLUCINATION69 reports
CARDIAC FAILURE CONGESTIVE68 reports
CONTUSION68 reports
HEART RATE DECREASED67 reports
DYSPHAGIA66 reports
JOINT SWELLING66 reports

Report Outcomes

Out of 9,568 classified reports for TIMOLOL MALEATE:

Serious 50.8%Non-Serious 49.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,426 (59.4%)
Male3,687 (40.4%)
Unknown24 (0.3%)

Reports by Age

Age 77194 reports
Age 73188 reports
Age 76187 reports
Age 72183 reports
Age 80174 reports
Age 78164 reports
Age 68162 reports
Age 70162 reports
Age 71156 reports
Age 75155 reports
Age 74153 reports
Age 81146 reports
Age 79142 reports
Age 84138 reports
Age 64135 reports
Age 82128 reports
Age 83125 reports
Age 65123 reports
Age 85120 reports
Age 69114 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TIMOLOL MALEATE?

This profile reflects 16,822 FDA FAERS reports that mention TIMOLOL MALEATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TIMOLOL MALEATE?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE PAIN, FATIGUE, EYE IRRITATION, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TIMOLOL MALEATE?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with TIMOLOL MALEATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.