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tafluprost Side Effects

Also known as: Zioptan

Analysis of 2,845 adverse event reports submitted to the FDA from 2010 to 2025.

Total Reports

2,845

Death-Related

326

11.5% of reports

Hospitalizations

275

9.7% of reports

Top Indication

Glaucoma

Most Reported Adverse Reactions

OCULAR HYPERAEMIA
459
EYE IRRITATION
416
EYE PAIN
288
EYE PRURITUS
227
DRUG INEFFECTIVE
206
DEATH
197
VISION BLURRED
167
HEADACHE
164
EYE SWELLING
122
DRY EYE
107
INTRAOCULAR PRESSURE INCREASED
95
PHOTOPHOBIA
85
LACRIMATION INCREASED
74
DIZZINESS
69
DYSPNOEA
69
HYPERSENSITIVITY
64
OFF LABEL USE
63
FATIGUE
56
PRURITUS
56
COUGH
51

Who Reports Side Effects

Gender Distribution

Female 1,877 (70%)
Male 795 (29%)
Unknown 27

Age Distribution

0-17 7 (1%)
18-44 28 (2%)
45-64 236 (18%)
65-74 381 (29%)
75+ 683 (51%)

Reporting Trend by Year

2010 2025

Reactions in Death Reports

Top reactions reported in 326 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 193
CEREBROVASCULAR ACCIDENT 14
MYOCARDIAL INFARCTION 11
CARDIAC FAILURE CONGESTIVE 10
CORONAVIRUS INFECTION 10
PARKINSON^S DISEASE 8
NEOPLASM MALIGNANT 7
CARDIAC FAILURE 6
DIABETES MELLITUS 6
HYPERTENSION 6
COVID-19 5
DEMENTIA 5
FALL 5
LUNG NEOPLASM MALIGNANT 5
PNEUMONIA 5
RENAL FAILURE 5
BLADDER CANCER 4
CONFUSIONAL STATE 3
DRUG INEFFECTIVE 3
DYSPHAGIA 3

Reactions in Hospitalization Reports

Top reactions in 275 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 16
FALL 16
DRUG INEFFECTIVE 15
SYNCOPE 15
DIZZINESS 11
ARRHYTHMIA 10
ATRIOVENTRICULAR BLOCK SECOND DEGREE 10
DRUG INTERACTION 10
ATRIAL FIBRILLATION 9
CARDIOVASCULAR INSUFFICIENCY 9
GOITRE 9
HEADACHE 9
HOSPITALISATION 9
OFF LABEL USE 9
ACUTE KIDNEY INJURY 8
ATRIOVENTRICULAR BLOCK 8
BRADYCARDIA 8
CONSTIPATION 8
EMPHYSEMA 8
NAUSEA 8

Nearby — Related Medications

Compare tafluprost vs aflibercept →

What the FAERS Data Reveals About tafluprost Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,845 voluntary reports linked to tafluprost and its brand equivalents (Zioptan), spanning 2010 through 2025. Of those, 326 (11.5%) listed death as an outcome and 275 (9.7%) involved hospitalization. The most common indication reported alongside adverse events was Glaucoma.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 70% were female and 29% male; age distribution skews toward 75+, with 683 reports in that bracket. The single most reported reaction is ocular hyperaemia with 459 submissions, followed by eye irritation and eye pain.

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.