Qinlock: adverse event reports filed with FDA

5,104

reports as suspect product

0% of all reports · about 828 a year

1,059

reports, 12 months to June 2026

859 in the 12 months before

42.4%

marked serious by the reporter

70.8% across the class

9.1%

record death among outcomes, as reported

465 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 Qinlock reports recording the termmedian drug in kinase inhibitor

1. Fatiguetiredness13.3%679
2. Alopeciahair loss11.5%589
3. Deaththe patient died; cause not stated by this term7.3%372
4. Underdoseless than the intended dose7.2%370
5. Extra dose administered6.9%353
6. Nauseafeeling sick6.5%330
7. Hospitalisationadmission to hospital6.2%318
8. Drug ineffectivethe medicine did not work as expected6.2%317
9. Painpain, site not specified5.7%292
10. Constipationconstipation5.7%289
11. Inappropriate schedule of product administrationthe product was taken at the wrong times5.3%273
12. Disease progressionthe disease advanced5.3%268
13. Diarrhoealoose or frequent stools5.2%266
14. Product use in unapproved indicationused for a purpose not on the label5.2%265
15. Neoplasm progression5.1%262
16. Muscle spasmsmuscle cramps5.1%258
17. Astheniaweakness or lack of energy4.8%243
18. Product dose omission issuea dose was missed4.6%233
19. Decreased appetitereduced appetite4.3%220
20. Malignant neoplasm progression4.3%218
21. Dry skindry skin4.3%217
22. Pain in extremitypain in an arm or leg4.3%217
23. Adverse eventan unwanted medical event, type not specified4.2%216
24. Hypertensionhigh blood pressure4%205
25. Myalgiamuscle pain3.9%200
26. Pruritusitching3.5%181
27. Palmar-plantar erythrodysaesthesia syndrome3.5%178
28. Vomitingbeing sick3.3%168
29. Arthralgiajoint pain3.2%165
30. Abdominal pain upperupper stomach pain3.2%164

Top 30 of 598 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. 95.4% 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 5,104 reports.

Drugs most often listed in the same reports

Other products listed in reports where Qinlock 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 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 Qinlock as a suspect or interacting product; reports listing it only as a concomitant medication (17) 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.