Ledipasvir and sofosbuvir: adverse event reports filed with FDA

4,544

reports as suspect product

0% of all reports · about 387 a year

0

reports, 12 months to June 2026

1 in the 12 months before

95.7%

marked serious by the reporter

42.4% across the class

12.3%

record death among outcomes, as reported

557 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

Reactions recorded in the reports

share of Ledipasvir and sofosbuvir reports recording the termmedian drug in hepatitis c virus ns5a inhibitor

1. Headachehead pain10.1%459
2. Fatiguetiredness10%455
3. Deaththe patient died; cause not stated by this term5.8%263
4. Drug ineffectivethe medicine did not work as expected5.7%260
5. Nauseafeeling sick5.1%230
6. Astheniaweakness or lack of energy4.7%215
7. Hepatocellular carcinoma4.7%213
8. Vomitingbeing sick4%184
9. Hepatitis Chepatitis C infection4%183
10. Insomniadifficulty sleeping4%181
11. Dizzinesslight-headedness or unsteadiness3.6%164
12. Hepatic cirrhosis3.6%162
13. Malaisegeneral feeling of being unwell3.4%153
14. Diarrhoealoose or frequent stools3.3%148
15. Dyspnoeashortness of breath3.1%140
16. Ascitesfluid in the abdomen2.9%133
17. Drug dose omissiona dose was missed2.8%128
18. Treatment failurethe treatment did not work2.8%125
19. Acute kidney injurysudden loss of kidney function2.7%124
20. Anaemialow red blood cells2.4%108
21. Pneumonialung infection2.3%105
22. Painpain, site not specified2.3%104
23. Decreased appetitereduced appetite2.2%99
24. Hypertensionhigh blood pressure2.1%96
25. Depressionlow mood2.1%95
26. Hepatic cancer2.1%94
27. Feeling abnormalfeeling odd or not right2%92
28. Weight decreasedweight loss2%90
29. Abdominal painstomach or belly pain1.8%81
30. Arthralgiajoint pain1.8%81

Top 30 of 765 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 ns5a 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 35,420 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. 62.4% 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 4,544 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ledipasvir and sofosbuvir 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 ns5a 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 Ledipasvir and sofosbuvir 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.