Lynparza: adverse event reports filed with FDA

14,399

reports as suspect product

0.1% of all reports · about 895 a year

968

reports, 12 months to June 2026

1,828 in the 12 months before

89.4%

marked serious by the reporter

72.3% across the class

32.6%

record death among outcomes, as reported

4,695 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 Lynparza reports recording the termmedian drug in poly(adp-ribose) polymerase inhibitor

1. Deaththe patient died; cause not stated by this term27.4%3,952
2. Malignant neoplasm progression10.6%1,522
3. Nauseafeeling sick8.4%1,207
4. Anaemialow red blood cells7.8%1,126
5. Fatiguetiredness7%1,010
6. Off label useused for a purpose or in a way not on the label4.1%584
7. Drug ineffectivethe medicine did not work as expected3.1%453
8. Vomitingbeing sick3.1%451
9. Diarrhoealoose or frequent stools2.6%368
10. Astheniaweakness or lack of energy2.5%353
11. Decreased appetitereduced appetite2.4%351
12. Interstitial lung diseasescarring or inflammation of lung tissue2.2%321
13. Haemoglobin decreasedlow haemoglobin2.2%319
14. Malaisegeneral feeling of being unwell2.2%316
15. Ovarian cancer recurrent2.1%302
16. Myelodysplastic syndrome2.1%301
17. Platelet count decreasedlow platelet count2.1%299
18. Headachehead pain1.8%265
19. Carbohydrate antigen 125 increased1.8%259
20. Dyspnoeashortness of breath1.8%255
21. Dizzinesslight-headedness or unsteadiness1.8%253
22. Myelosuppression1.8%252
23. Product dose omission issuea dose was missed1.7%247
24. Painpain, site not specified1.7%241
25. Disease progressionthe disease advanced1.7%238
26. Constipationconstipation1.6%227
27. Renal impairmentreduced kidney function1.6%227
28. Acute myeloid leukaemia1.6%226
29. White blood cell count decreasedlow white cell count1.5%223
30. Product use issuea problem in how the product was used1.5%220

Top 30 of 983 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. 56% 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 14,399 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lynparza 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 Lynparza as a suspect or interacting product; reports listing it only as a concomitant medication (363) 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.