Avapritinib: adverse event reports filed with FDA

543

reports as suspect product

0% of all reports · about 97 a year

148

reports, 12 months to June 2026

148 in the 12 months before

42.2%

marked serious by the reporter

70.8% across the class

10.9%

record death among outcomes, as reported

59 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 Avapritinib reports recording the termmedian drug in kinase inhibitor

1. Off label useused for a purpose or in a way not on the label19.7%107
2. Drug ineffectivethe medicine did not work as expected8.1%44
3. Periorbital oedema7.6%41
4. Disease progressionthe disease advanced5.2%28
5. Fatiguetiredness5%27
6. Astheniaweakness or lack of energy4.4%24
7. Face oedemaswelling of the face4.1%22
8. Nauseafeeling sick4.1%22
9. Anaemialow red blood cells3.7%20
10. Diarrhoealoose or frequent stools3.5%19
11. Memory impairmentmemory problems3.3%18
12. Confusional stateconfusion3.1%17
13. Thrombocytopenialow platelets3.1%17
14. Deaththe patient died; cause not stated by this term2.9%16
15. Hair colour changes2.9%16
16. Eyelid oedemaa swollen eyelid2.6%14
17. Cognitive disorderproblems with thinking or memory2.4%13
18. Weight increasedweight gain2.4%13
19. Dysphagiadifficulty swallowing2.2%12
20. Headachehead pain2.2%12
21. Parkinsonism2.2%12
22. Blood bilirubin increased2%11
23. Insomniadifficulty sleeping2%11
24. Oedemaswelling from fluid2%11
25. Condition aggravatedthe condition being treated got worse1.8%10
26. Hyperbilirubinaemia1.8%10
27. Lacrimation increasedwatery eyes1.8%10
28. Salivary hypersecretion1.8%10
29. Oedema peripheralswelling of the legs, ankles or hands1.7%9
30. Swelling facea swollen face1.7%9

Top 30 of 131 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 100 drugs in the kinase 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 849,161 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. 10.1% 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 543 reports.

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 kinase 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 Avapritinib as a suspect or interacting product; reports listing it only as a concomitant medication (30) 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.