granisetron Side Effects
Also known as: Kytril
Analysis of 10,198 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
10,198
Death-Related
1,855
18.2% of reports
Hospitalizations
4,892
48.0% 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 1,855 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 601 |
| NAUSEA | 186 |
| DIARRHOEA | 167 |
| PNEUMONIA | 155 |
| VOMITING | 143 |
| OFF LABEL USE | 142 |
| FATIGUE | 140 |
| PYREXIA | 135 |
| SEPSIS | 131 |
| DYSPNOEA | 113 |
| FEBRILE NEUTROPENIA | 109 |
| ANAEMIA | 103 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 100 |
| MALIGNANT NEOPLASM PROGRESSION | 100 |
| DISEASE PROGRESSION | 96 |
| DECREASED APPETITE | 92 |
| NEUTROPENIA | 92 |
| THROMBOCYTOPENIA | 88 |
| ASTHENIA | 87 |
| DEHYDRATION | 79 |
Reactions in Hospitalization Reports
Top reactions in 4,892 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FEBRILE NEUTROPENIA | 591 |
| NAUSEA | 562 |
| PYREXIA | 501 |
| DIARRHOEA | 447 |
| VOMITING | 433 |
| DYSPNOEA | 315 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 312 |
| ANAEMIA | 305 |
| PNEUMONIA | 283 |
| NEUTROPENIA | 261 |
| FATIGUE | 248 |
| SEPSIS | 196 |
| DECREASED APPETITE | 194 |
| ABDOMINAL PAIN | 190 |
| THROMBOCYTOPENIA | 185 |
| DEHYDRATION | 177 |
| ASTHENIA | 171 |
| PLATELET COUNT DECREASED | 170 |
| CONSTIPATION | 161 |
| HYPOTENSION | 159 |
Nearby — Related Medications
What the FAERS Data Reveals About granisetron Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 10,198 voluntary reports linked to granisetron and its brand equivalents (Kytril), spanning 2003 through 2025. Of those, 1,855 (18.2%) listed death as an outcome and 4,892 (48.0%) 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, 54% were female and 46% male; age distribution skews toward 45-64, with 2,620 reports in that bracket. The single most reported reaction is nausea with 1,305 submissions, followed by vomiting and febrile neutropenia.
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.