Rubraca: adverse event reports filed with FDA

8,312

reports as suspect product

0% of all reports · about 876 a year

81

reports, 12 months to June 2026

116 in the 12 months before

40.7%

marked serious by the reporter

72.3% across the class

5.5%

record death among outcomes, as reported

455 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Rubraca reports recording the termmedian drug in poly(adp-ribose) polymerase inhibitor

1. Fatiguetiredness30.2%2,507
2. Nauseafeeling sick26.8%2,229
3. Malignant neoplasm progression14%1,162
4. Decreased appetitereduced appetite9.5%790
5. Constipationconstipation9.2%768
6. Diarrhoealoose or frequent stools9.2%764
7. Vomitingbeing sick9.2%762
8. Astheniaweakness or lack of energy8%665
9. Adverse eventan unwanted medical event, type not specified6.9%571
10. Carbohydrate antigen 125 increased6.8%562
11. Dysgeusiaaltered taste6.8%562
12. Product dose omission issuea dose was missed6.6%552
13. Platelet count decreasedlow platelet count6.3%527
14. Anaemialow red blood cells6.1%503
15. Drug ineffectivethe medicine did not work as expected5.9%493
16. Headachehead pain5.2%429
17. Malaisegeneral feeling of being unwell4.9%405
18. Dizzinesslight-headedness or unsteadiness4.9%404
19. Dyspnoeashortness of breath4.7%388
20. Abdominal painstomach or belly pain4.4%367
21. Product dose omissiona dose was missed4.3%361
22. Abdominal pain upperupper stomach pain4.3%355
23. Haemoglobin decreasedlow haemoglobin4.2%353
24. Deaththe patient died; cause not stated by this term4.1%343
25. Abdominal discomfortstomach discomfort4.1%342
26. White blood cell count decreasedlow white cell count3.8%313
27. Weight decreasedweight loss3.5%290
28. Painpain, site not specified3.5%289
29. Red blood cell count decreased3.4%286
30. Taste disorder3.2%270

Top 30 of 781 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the poly(adp-ribose) polymerase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 52,093 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,312 reports.

Drugs most often listed in the same reports

Other products listed in reports where Rubraca is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the poly(adp-ribose) polymerase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Rubraca as a suspect or interacting product; reports listing it only as a concomitant medication (27) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.