rolapitant Side Effects
Also known as: Varubi
Analysis of 531 adverse event reports submitted to the FDA from 2013 to 2025.
Total Reports
531
Death-Related
161
30.3% of reports
Hospitalizations
114
21.5% of reports
Top Indication
Nausea
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 161 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 141 |
| ACUTE INTERSTITIAL PNEUMONITIS | 9 |
| RESPIRATORY SYMPTOM | 9 |
| NAUSEA | 5 |
| PNEUMONIA | 4 |
| THROMBOCYTOPENIA | 4 |
| ANAEMIA | 3 |
| HOSPITALISATION | 3 |
| NEOPLASM MALIGNANT | 3 |
| CONSTIPATION | 2 |
| DECREASED APPETITE | 2 |
| DEHYDRATION | 2 |
| DISEASE PROGRESSION | 2 |
| FATIGUE | 2 |
| HAEMOGLOBIN DECREASED | 2 |
| HEADACHE | 2 |
| HYPERKALAEMIA | 2 |
| MALAISE | 2 |
| PRODUCT USE ISSUE | 2 |
| WEIGHT DECREASED | 2 |
Reactions in Hospitalization Reports
Top reactions in 114 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 18 |
| DECREASED APPETITE | 12 |
| HOSPITALISATION | 12 |
| FATIGUE | 10 |
| DEATH | 9 |
| DIARRHOEA | 9 |
| THROMBOCYTOPENIA | 9 |
| DISEASE PROGRESSION | 7 |
| DYSPNOEA | 7 |
| MALAISE | 7 |
| PNEUMONIA | 7 |
| ASTHENIA | 6 |
| CHEST PAIN | 6 |
| CONSTIPATION | 6 |
| DEHYDRATION | 6 |
| PLASMA CELL MYELOMA | 6 |
| ANAEMIA | 5 |
| ARTHRALGIA | 5 |
| BLOOD COUNT ABNORMAL | 5 |
| CARDIAC FAILURE | 5 |
Nearby — Related Medications
What the FAERS Data Reveals About rolapitant Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 531 voluntary reports linked to rolapitant and its brand equivalents (Varubi), spanning 2013 through 2025. Of those, 161 (30.3%) listed death as an outcome and 114 (21.5%) involved hospitalization. The most common indication reported alongside adverse events was Nausea.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 43% male; age distribution skews toward 45-64, with 120 reports in that bracket. The single most reported reaction is death with 141 submissions, followed by nausea 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.
Read our methodology — how this data is sourced, computed, and verified.