What the label lists and what reports show
Rolapitant side effects
Rolapitant's FDA label: “Most common adverse reactions (≥3%) are: Cisplatin Based Highly Emetogenic Chemotherapy: neutropenia, hiccups and abdominal pain.” FAERS holds 538 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (51 reports).
- No generic listed
Check it at the source: the rolapitant FDA label on DailyMed (effective August 19, 2020, TerSera Therapeutics LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VARUBI?VARUBI may cause serious side effects, including: Change in the level of some medicines in your blood. Serious or life-threatening reactions, including heart rhythm changes, may occur if VARUBI is used with certain other medicines. You should not take VARUBI if you take thioridazine or pimozide. The most common side effects of VARUBI in people who take VARUBI and receive Cisplatin chemotherapy medicine include: low white blood cell count, hiccups, and stomach (abdominal) pain. The most common side effects of VARUBI in people who take VARUBI and receive Anthracycline and Cyclophosphamide chemotherapy medicines include: decreased appetite, low white blood cell count, dizziness, indigestion, urinary tract infection, mouth sores, and low red blood cell count. These are not all the possible side effects of VARUBI. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, TerSera Therapeutics LLC, effective August 19, 2020 (SPL set a52896cd-4a98-49b8-82db-bf1985a64d97), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥3%) are: Cisplatin Based Highly Emetogenic Chemotherapy: neutropenia, hiccups and abdominal pain.
Table 3: Most Common Adverse Reactions in Patients Receiving Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide (Cycle 1)*
| Reaction | VARUBI Regimen (VARUBI, Dexamethasone, and 5-HT 3 Receptor Antagonist) N = 670 | Control (Placebo, Dexamethasone, and 5-HT 3 Receptor Antagonist) N = 674 |
|---|---|---|
| Decreased appetite | 9% | 7% |
| Neutropenia | 7% | 6% |
| Dizziness | 6% | 4% |
| Dyspepsia | 4% | 2% |
| Urinary tract infection | 4% | 3% |
| Stomatitis | 4% | 2% |
| Anemia | 3% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Interaction with CYP2D6 Substrates [see Contraindications (4), Warnings and Precautions (5.1) ] Most common adverse reactions (≥3%) are: Cisplatin Based Highly Emetogenic Chemotherapy: neutropenia, hiccups and abdominal pain. ( 6.1 ) Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide: decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TerSera Therapeutics at 1-844-334-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 4 controlled clinical trials in patients receiving emetogenic cancer chemotherapy, VARUBI was given in combination with a 5-HT 3 receptor antagonist and dexamethasone. On Day 1 of Cycle 1 of chemotherapy, 1567 patients were treated with VARUBI and 1198 of these patients continued into the optional multiple cycle extension for up to 6 cycles of chemotherapy. …
Source: FDA drug label, TerSera Therapeutics LLC, effective August 19, 2020 (SPL set a52896cd-4a98-49b8-82db-bf1985a64d97), via openFDA; the full label on DailyMed
What do FAERS reports show?
538 reports list rolapitant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 163 are coded as a death and 115 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rolapitant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions