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dorzolamide Side Effects

Also known as: Trusopt

Analysis of 7,422 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

7,422

Death-Related

381

5.1% of reports

Hospitalizations

1,356

18.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

TREATMENT FAILURE
1,369
DRUG INEFFECTIVE
704
OFF LABEL USE
475
FATIGUE
444
HEADACHE
356
PAIN
321
EYE PAIN
292
EYE IRRITATION
281
HYPERSENSITIVITY
265
RASH
252
PAIN IN EXTREMITY
251
WEIGHT DECREASED
242
CONDITION AGGRAVATED
241
DYSPNOEA
238
DIZZINESS
234
CONFUSIONAL STATE
233
DIARRHOEA
221
DEATH
215
INTRAOCULAR PRESSURE INCREASED
215
VISION BLURRED
213

Who Reports Side Effects

Gender Distribution

Female 3,755 (55%)
Male 3,077 (45%)
Unknown 14

Age Distribution

0-17 70 (2%)
18-44 184 (5%)
45-64 688 (19%)
65-74 978 (26%)
75+ 1,776 (48%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 381 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 215
PNEUMONIA 23
RENAL FAILURE 19
ASTHENIA 18
RESPIRATORY FAILURE 17
FALL 16
OFF LABEL USE 16
FATIGUE 15
CHRONIC KIDNEY DISEASE 13
DYSPNOEA 13
CONFUSIONAL STATE 11
ACUTE RESPIRATORY DISTRESS SYNDROME 10
DIZZINESS 10
GASTROINTESTINAL HAEMORRHAGE 10
HAEMORRHAGE INTRACRANIAL 10
SEPSIS 10
TOXIC EPIDERMAL NECROLYSIS 10
VOMITING 10
WEIGHT DECREASED 10
DECREASED APPETITE 9

Reactions in Hospitalization Reports

Top reactions in 1,356 reports where hospitalization was an outcome.

Reaction Reports
FALL 103
PNEUMONIA 91
OFF LABEL USE 89
DYSPNOEA 83
FATIGUE 75
ACUTE KIDNEY INJURY 74
DIARRHOEA 69
ASTHENIA 65
DIZZINESS 64
PAIN 64
DEHYDRATION 59
DRUG INEFFECTIVE 54
WEIGHT DECREASED 54
CONSTIPATION 53
CONFUSIONAL STATE 51
NAUSEA 49
VOMITING 48
HEADACHE 47
MALAISE 40
URINARY TRACT INFECTION 40

Nearby — Related Medications

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What the FAERS Data Reveals About dorzolamide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 7,422 voluntary reports linked to dorzolamide and its brand equivalents (Trusopt), spanning 2004 through 2025. Of those, 381 (5.1%) listed death as an outcome and 1,356 (18.3%) 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, 55% were female and 45% male; age distribution skews toward 75+, with 1,776 reports in that bracket. The single most reported reaction is treatment failure with 1,369 submissions, followed by drug ineffective and off label use.

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.