cilostazol Side Effects
Also known as: Pletal
Analysis of 5,992 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
5,992
Death-Related
956
16.0% of reports
Hospitalizations
2,791
46.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 956 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 217 |
| PNEUMONIA | 88 |
| CARDIAC ARREST | 46 |
| FALL | 44 |
| RENAL FAILURE | 43 |
| ACUTE KIDNEY INJURY | 41 |
| CHRONIC KIDNEY DISEASE | 41 |
| SEPSIS | 41 |
| DIARRHOEA | 40 |
| ANAEMIA | 37 |
| CARDIO-RESPIRATORY ARREST | 36 |
| HYPOTENSION | 36 |
| CARDIAC FAILURE | 34 |
| DYSPNOEA | 34 |
| MYOCARDIAL INFARCTION | 34 |
| SEPTIC SHOCK | 34 |
| ASTHENIA | 33 |
| DECREASED APPETITE | 32 |
| INTERSTITIAL LUNG DISEASE | 31 |
| RESPIRATORY FAILURE | 31 |
Reactions in Hospitalization Reports
Top reactions in 2,791 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PNEUMONIA | 176 |
| FALL | 145 |
| ANAEMIA | 129 |
| DIARRHOEA | 128 |
| ASTHENIA | 114 |
| DYSPNOEA | 110 |
| GASTROINTESTINAL HAEMORRHAGE | 110 |
| NAUSEA | 105 |
| DECREASED APPETITE | 95 |
| VOMITING | 94 |
| PYREXIA | 93 |
| ACUTE KIDNEY INJURY | 84 |
| MALAISE | 82 |
| OFF LABEL USE | 82 |
| DRUG INTERACTION | 80 |
| DIZZINESS | 78 |
| DRUG INEFFECTIVE | 77 |
| DEHYDRATION | 76 |
| CEREBRAL INFARCTION | 75 |
| RENAL FAILURE | 75 |
Nearby — Related Medications
What the FAERS Data Reveals About cilostazol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 5,992 voluntary reports linked to cilostazol and its brand equivalents (Pletal), spanning 2004 through 2025. Of those, 956 (16.0%) listed death as an outcome and 2,791 (46.6%) 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, 41% were female and 59% male; age distribution skews toward 75+, with 1,865 reports in that bracket. The single most reported reaction is diarrhoea with 302 submissions, followed by fall and pneumonia.
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.
Read our methodology — how this data is sourced, computed, and verified.