Cometriq: adverse event reports filed with FDA

2,578

reports as suspect product

0% of all reports · about 191 a year

42

reports, 12 months to June 2026

55 in the 12 months before

37.5%

marked serious by the reporter

70.8% across the class

12.8%

record death among outcomes, as reported

329 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 Cometriq reports recording the termmedian drug in kinase inhibitor

1. Off label useused for a purpose or in a way not on the label34.7%894
2. Diarrhoealoose or frequent stools26.4%680
3. Fatiguetiredness20.1%518
4. Nauseafeeling sick13.5%347
5. Decreased appetitereduced appetite11.1%285
6. Stomatitissore mouth9%232
7. Weight decreasedweight loss8.7%224
8. Malignant neoplasm progression8.1%209
9. Pain in extremitypain in an arm or leg7.8%202
10. Astheniaweakness or lack of energy7.5%193
11. Blistera blister6.9%178
12. Vomitingbeing sick6.5%167
13. Deaththe patient died; cause not stated by this term6.1%158
14. Oral pain5.8%149
15. Palmar-plantar erythrodysaesthesia syndrome5.4%140
16. Constipationconstipation5.1%132
17. Dysphoniaa hoarse voice5.1%131
18. Rashskin rash5.1%131
19. Dysgeusiaaltered taste5%128
20. Blood pressure increaseda raised blood pressure reading4.9%127
21. Painpain, site not specified4.9%126
22. Malaisegeneral feeling of being unwell4.8%125
23. Dizzinesslight-headedness or unsteadiness4.5%116
24. Dry mouthdry mouth4.4%113
25. Dehydrationdehydration3.8%97
26. Hypertensionhigh blood pressure3.8%97
27. Oropharyngeal painsore throat3.6%94
28. Dry skindry skin3.4%88
29. Headachehead pain3.4%88
30. Dyspnoeashortness of breath3.4%87

Top 30 of 452 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. 93.8% 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 2,578 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cometriq 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 Cometriq as a suspect or interacting product; reports listing it only as a concomitant medication (15) 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.