Erivedge: adverse event reports filed with FDA

7,857

reports as suspect product

0% of all reports · about 555 a year

282

reports, 12 months to June 2026

452 in the 12 months before

36.9%

marked serious by the reporter

42.3% across the class

10.7%

record death among outcomes, as reported

841 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 Erivedge reports recording the termmedian drug in hedgehog pathway inhibitor

1. Muscle spasmsmuscle cramps24.8%1,946
2. Alopeciahair loss16.7%1,314
3. Ageusialoss of taste12.7%995
4. Fatiguetiredness11.4%896
5. Deaththe patient died; cause not stated by this term8.8%695
6. Weight decreasedweight loss8.7%682
7. Dysgeusiaaltered taste8.5%669
8. Nauseafeeling sick8.3%653
9. Decreased appetitereduced appetite8.3%652
10. Diarrhoealoose or frequent stools5.5%433
11. Constipationconstipation4.6%363
12. Off label useused for a purpose or in a way not on the label4.3%340
13. Astheniaweakness or lack of energy3.4%271
14. Arthralgiajoint pain3.4%269
15. No adverse eventno adverse event was reported3.3%256
16. Taste disorder3%236
17. Painpain, site not specified2.8%220
18. Vomitingbeing sick2.6%204
19. Myalgiamuscle pain2.5%195
20. Drug ineffectivethe medicine did not work as expected2.1%164
21. Headachehead pain2.1%164
22. Malaisegeneral feeling of being unwell2%154
23. Basal cell carcinoma1.6%128
24. Falla fall1.6%127
25. Rashskin rash1.6%127
26. Abdominal pain upperupper stomach pain1.5%118
27. Dizzinesslight-headedness or unsteadiness1.4%113
28. Insomniadifficulty sleeping1.3%101
29. Intentional product use issuedeliberate use not as intended1.3%101
30. Pruritusitching1.2%93

Top 30 of 487 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 3 drugs in the hedgehog pathway 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 9,739 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. 93.5% 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 7,857 reports.

Drugs most often listed in the same reports

Other products listed in reports where Erivedge 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 hedgehog pathway 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 Erivedge as a suspect or interacting product; reports listing it only as a concomitant medication (106) 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.