Mavyret: adverse event reports filed with FDA

10,790

reports as suspect product

0.1% of all reports · about 1,222 a year

227

reports, 12 months to June 2026

257 in the 12 months before

25.3%

marked serious by the reporter

27.5% across the class

2.7%

record death among outcomes, as reported

286 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 Mavyret reports recording the termmedian drug in hepatitis c virus ns3/4a protease inhibitor

1. Fatiguetiredness23.7%2,555
2. Headachehead pain20.4%2,198
3. Nauseafeeling sick10.5%1,129
4. Pruritusitching6.1%658
5. Diarrhoealoose or frequent stools4.4%478
6. Rashskin rash2.9%312
7. Vomitingbeing sick2.9%309
8. Dizzinesslight-headedness or unsteadiness2.1%231
9. Deaththe patient died; cause not stated by this term2.1%224
10. Painpain, site not specified1.9%200
11. Insomniadifficulty sleeping1.8%196
12. Abdominal discomfortstomach discomfort1.8%193
13. Drug ineffectivethe medicine did not work as expected1.6%175
14. Astheniaweakness or lack of energy1.4%156
15. Abdominal pain upperupper stomach pain1.4%147
16. Dyspnoeashortness of breath1.4%146
17. Therapy cessation1.3%145
18. Abdominal painstomach or belly pain1.3%143
19. Constipationconstipation1.3%138
20. Arthralgiajoint pain1.2%133
21. Drug dose omissiona dose was missed1.2%131
22. Product dose omissiona dose was missed1.2%126
23. Feeling abnormalfeeling odd or not right1.1%118
24. Somnolencedrowsiness1.1%116
25. Decreased appetitereduced appetite1%113
26. Peripheral swellingswelling of the arms or legs1%110
27. Depressionlow mood1%105
28. Hospitalisationadmission to hospital1%105
29. Pneumonialung infection0.9%98
30. Hepatic cirrhosis0.9%97

Top 30 of 774 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 hepatitis c virus ns3/4a protease 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 15,916 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. 98.9% 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 10,790 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mavyret 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 hepatitis c virus ns3/4a protease 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 Mavyret as a suspect or interacting product; reports listing it only as a concomitant medication (131) 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.