Zejula: adverse event reports filed with FDA

15,540

reports as suspect product

0.1% of all reports · about 1,252 a year

499

reports, 12 months to June 2026

1,072 in the 12 months before

59.5%

marked serious by the reporter

72.3% across the class

5.5%

record death among outcomes, as reported

849 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 Zejula reports recording the termmedian drug in poly(adp-ribose) polymerase inhibitor

1. Nauseafeeling sick24.7%3,838
2. Fatiguetiredness21.4%3,323
3. Platelet count decreasedlow platelet count18.3%2,843
4. Constipationconstipation16.2%2,519
5. Insomniadifficulty sleeping11.9%1,845
6. Headachehead pain10.1%1,568
7. Blood pressure increaseda raised blood pressure reading9.4%1,459
8. Vomitingbeing sick8.5%1,319
9. Carbohydrate antigen 125 increased8%1,250
10. Astheniaweakness or lack of energy7.5%1,169
11. Haemoglobin decreasedlow haemoglobin7.3%1,138
12. Decreased appetitereduced appetite7.2%1,126
13. Off label useused for a purpose or in a way not on the label6.9%1,070
14. Product dose omission issuea dose was missed6.8%1,058
15. Dizzinesslight-headedness or unsteadiness6.5%1,015
16. White blood cell count decreasedlow white cell count6.2%960
17. Anaemialow red blood cells5.9%923
18. Dyspnoeashortness of breath5.9%919
19. Red blood cell count decreased5.7%889
20. Heart rate increaseda fast heart rate reading5.1%789
21. Malaisegeneral feeling of being unwell5.1%789
22. Drug ineffectivethe medicine did not work as expected5%779
23. Malignant neoplasm progression5%779
24. Hypertensionhigh blood pressure5%770
25. Arthralgiajoint pain4.9%761
26. Disease progressionthe disease advanced4.5%699
27. Painpain, site not specified4.4%686
28. Diarrhoealoose or frequent stools4.3%671
29. Neuropathy peripheralnerve damage in hands or feet4%619
30. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine4%618

Top 30 of 1,353 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. 77.7% 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 15,540 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zejula 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 Zejula as a suspect or interacting product; reports listing it only as a concomitant medication (74) 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.