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timolol Side Effects

Also known as: Timoptic

Analysis of 11,690 adverse event reports submitted to the FDA from 2003 to 2025.

Total Reports

11,690

Death-Related

550

4.7% of reports

Hospitalizations

2,304

19.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

TREATMENT FAILURE
3,042
DRUG INEFFECTIVE
783
FATIGUE
470
HYPERSENSITIVITY
456
DIZZINESS
401
DIARRHOEA
396
OFF LABEL USE
395
DYSPNOEA
363
NAUSEA
347
EYE IRRITATION
327
FALL
317
HEADACHE
301
EYE PAIN
279
VISION BLURRED
274
INTRAOCULAR PRESSURE INCREASED
272
ASTHENIA
256
PAIN
256
DEATH
240
GLAUCOMA
230
MALAISE
212

Who Reports Side Effects

Gender Distribution

Female 6,465 (59%)
Male 4,547 (41%)
Unknown 28

Age Distribution

0-17 130 (2%)
18-44 267 (5%)
45-64 1,109 (20%)
65-74 1,547 (28%)
75+ 2,527 (45%)

Reporting Trend by Year

2003 2025

Reactions in Death Reports

Top reactions reported in 550 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 239
DIARRHOEA 35
FALL 31
PNEUMONIA 28
RENAL FAILURE 26
SEPSIS 23
RESPIRATORY FAILURE 22
ACUTE KIDNEY INJURY 21
ASTHENIA 21
OFF LABEL USE 21
ANAEMIA 20
CHRONIC KIDNEY DISEASE 20
DYSPNOEA 19
FATIGUE 19
CARDIO-RESPIRATORY ARREST 18
THROMBOCYTOPENIA 17
CARDIAC FAILURE CONGESTIVE 16
CEREBRAL HAEMORRHAGE 15
MYALGIA 15
SEPTIC SHOCK 15

Reactions in Hospitalization Reports

Top reactions in 2,304 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 178
DIARRHOEA 161
FALL 157
FATIGUE 141
PNEUMONIA 137
ACUTE KIDNEY INJURY 132
ANAEMIA 104
BRADYCARDIA 104
DIZZINESS 103
ASTHENIA 101
PYREXIA 99
CONFUSIONAL STATE 95
DRUG INEFFECTIVE 95
PAIN 94
NAUSEA 93
URINARY TRACT INFECTION 92
DEHYDRATION 87
VOMITING 80
MALAISE 77
GASTROINTESTINAL HAEMORRHAGE 76

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What the FAERS Data Reveals About timolol Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 11,690 voluntary reports linked to timolol and its brand equivalents (Timoptic), spanning 2003 through 2025. Of those, 550 (4.7%) listed death as an outcome and 2,304 (19.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 41% male; age distribution skews toward 75+, with 2,527 reports in that bracket. The single most reported reaction is treatment failure with 3,042 submissions, followed by drug ineffective and fatigue.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.