Olaparib: adverse event reports filed with FDA

5,674

reports as suspect product

0% of all reports · about 394 a year

1,636

reports, 12 months to June 2026

1,457 in the 12 months before

96.8%

marked serious by the reporter

72.3% across the class

20.3%

record death among outcomes, as reported

1,152 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 Olaparib reports recording the termmedian drug in poly(adp-ribose) polymerase inhibitor

1. Deaththe patient died; cause not stated by this term12.9%733
2. Fatiguetiredness11.4%648
3. Nauseafeeling sick9.9%564
4. Malignant neoplasm progression8.4%479
5. Anaemialow red blood cells8%455
6. Neuropathy peripheralnerve damage in hands or feet7%399
7. Off label useused for a purpose or in a way not on the label4.7%268
8. Disease progressionthe disease advanced4.3%245
9. Vomitingbeing sick4.3%242
10. Astheniaweakness or lack of energy3.9%222
11. Diarrhoealoose or frequent stools3.6%207
12. Drug ineffectivethe medicine did not work as expected3.2%181
13. Myelodysplastic syndrome3.1%175
14. Constipationconstipation3%173
15. Myelosuppression3%168
16. Decreased appetitereduced appetite2.9%166
17. Thrombocytopenialow platelets2.8%161
18. Product dose omission issuea dose was missed2.4%136
19. Renal impairmentreduced kidney function2.3%133
20. Arthralgiajoint pain2.3%130
21. Painpain, site not specified2.3%128
22. Dyspnoeashortness of breath2.1%121
23. Headachehead pain2%114
24. Acute myeloid leukaemia1.9%109
25. Haemoglobin decreasedlow haemoglobin1.9%106
26. Toxicity to various agentspoisoning or toxic effect of one or more substances1.8%103
27. Neutropenialow neutrophils, a type of white blood cell1.7%99
28. Pancytopenialow counts of all blood cells1.6%91
29. Dizzinesslight-headedness or unsteadiness1.5%87
30. Product use in unapproved indicationused for a purpose not on the label1.5%86

Top 30 of 762 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. 52% 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 5,674 reports.

Drugs most often listed in the same reports

Other products listed in reports where Olaparib 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 Olaparib as a suspect or interacting product; reports listing it only as a concomitant medication (393) 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.