What the label lists and what reports show
Rucaparib camsylate side effects
Rucaparib camsylate's FDA label: “Most common adverse reactions (≥10%) among patients with ovarian cancer were nausea, fatigue (including asthenia), anemia, ALT/AST increased, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, blood creatinine increased …” FAERS holds 8,779 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 (2,551 reports).
- No generic listed
Check it at the source: the rucaparib camsylate FDA label on DailyMed (effective December 31, 2025, pharmaand GmbH); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What is the most important information I should know about Rubraca?Rubraca may cause serious side effects including: Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca. Symptoms of low blood cell counts are common during treatment with Rubraca, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca: weakness weight loss fever frequent infections blood in urine or stool shortness of breath feeling very tired bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: before treatment with Rubraca. every month during treatment with Rubraca. weekly if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve. See "What are possible side effects of Rubraca?" for more information about side effects.
Source: FDA drug label, pharmaand GmbH, effective December 31, 2025 (SPL set 0295d202-1cfe-7659-e063-6294a90a476e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) among patients with ovarian cancer were nausea, fatigue (including asthenia), anemia, ALT/AST increased, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, blood creatinine increased, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia.
Table 4. Adverse Reactions in ≥ 10% of Patients with BRCA-mutated mCRPC in TRITON3
| Reaction | Grades 1-4 a (%) | Grades 3-4 (%) | Grades 1-4 a (%) | Grades 3-4 (%) |
|---|---|---|---|---|
| Fatigue/Asthenia | 61 | 7 | 65 | 10 |
| Edema b | 18 | 0 | 20 | 0 |
| Musculoskeletal pain b | 53 | 7 | 57 | 8 |
| Nausea | 51 | 2 | 22 | 1 |
| Diarrhea | 31 | 2 | 29 | 1 |
| Constipation | 31 | 2 | 17 | 1 |
| Vomiting | 25 | 1 | 10 | 1 |
| Abdominal pain b | 17 | 1 | 10 | 1 |
| Decreased appetite | 34 | 1 | 20 | 2 |
| Dyspnea b | 19 | 1 | 13 | 1 |
| Dysgeusia b | 18 | 0 | 12 | 0 |
| Dizziness b | 16 | 1 | 9 | 0 |
| Headache b | 12 | 0 | 9 | 0 |
| Peripheral neuropathy b | 12 | 1 | 26 | 1 |
| Weight decreased | 16 | 1 | 13 | 0 |
| Rash b | 13 | 1 | 6 | 0 |
| Photosensitivity reaction b | 12 | 1 | 0 | 0 |
| Urinary tract infection b | 10 | 3 | 4 | 1 |
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 serious adverse reactions are discussed elsewhere in the labeling: Myelodysplastic Syndrome/Acute Myeloid Leukemia [see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (≥10%) among patients with ovarian cancer were nausea, fatigue (including asthenia), anemia, ALT/AST increased, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, blood creatinine increased, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia. ( 6.1 ) Most common adverse reactions (≥10%) among patients with BRCA -mutated mCRPC were fatigue/asthenia, musculoskeletal pain, nausea, anemia, decreased appetite, increased ALT/AST, constipation, diarrhea, vomiting, thrombocytopenia, dyspnea, increased blood creatinine, edema, dizziness, weight decreased, abdominal pain, dysgeusia, rash, neuropathy peripheral, urinary tract infection, cough, headache, hemorrhage, neutropenia, and photosensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact pharmaand agent at 1-800-506-8501 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 practice.
Source: FDA drug label, pharmaand GmbH, effective December 31, 2025 (SPL set 0295d202-1cfe-7659-e063-6294a90a476e), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,779 reports list rucaparib camsylate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 505 are coded as a death and 1,469 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 21 reactions below, 15 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?
- Rucaparib camsylate: 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