Gilotrif: adverse event reports filed with FDA

5,308

reports as suspect product

0% of all reports · about 414 a year

39

reports, 12 months to June 2026

67 in the 12 months before

84.5%

marked serious by the reporter

70.8% across the class

21.7%

record death among outcomes, as reported

1,150 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 Gilotrif reports recording the termmedian drug in kinase inhibitor

1. Diarrhoealoose or frequent stools34.6%1,838
2. Malignant neoplasm progression26.5%1,409
3. Rashskin rash14.5%768
4. Stomatitissore mouth8.5%449
5. Deaththe patient died; cause not stated by this term7.9%418
6. Nauseafeeling sick7.3%389
7. Decreased appetitereduced appetite7.2%382
8. Vomitingbeing sick6.3%333
9. Paronychia5.9%311
10. Dehydrationdehydration5.3%282
11. Metastases to central nervous system4.2%222
12. Off label useused for a purpose or in a way not on the label4%214
13. Fatiguetiredness4%212
14. Astheniaweakness or lack of energy3.8%201
15. Dry skindry skin3.5%185
16. Weight decreasedweight loss3.4%181
17. Dyspnoeashortness of breath3%159
18. Acneacne2.9%156
19. Drug ineffectivethe medicine did not work as expected2.9%156
20. Pneumonialung infection2.8%147
21. Pruritusitching2.7%141
22. Interstitial lung diseasescarring or inflammation of lung tissue2.5%134
23. Epistaxisnosebleed2.4%125
24. Pleural effusionfluid around the lung2.3%124
25. Dermatitis acneiform2.3%121
26. Pyrexiafever2.2%116
27. Alopeciahair loss2.1%114
28. Disease progressionthe disease advanced2%106
29. Malaisegeneral feeling of being unwell1.8%93
30. Dizzinesslight-headedness or unsteadiness1.7%92

Top 30 of 665 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. 38% 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 5,308 reports.

Drugs most often listed in the same reports

Other products listed in reports where Gilotrif 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 Gilotrif as a suspect or interacting product; reports listing it only as a concomitant medication (110) 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.