Pharmacologic class (EPC) · 3 drug pages

Hepatitis C virus NS5A inhibitor: adverse event reports filed with FDA

35,420 reports list a drug in this class as a suspect or interacting product, 2014–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

35,420
reports across the class: 0.2% of all reports; 312
reports, 12 months to June 2026: 368 in the 12 months before; 42.4%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Hepatitis C virus NS5A inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 35,420 adverse event reports received by FDA, 0.2% of the database, from February 2014 to June 2026.

312 reports arrived in the 12 months to June 2026, down 15% from 368 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 42.4% of the class's reports are marked serious, 5.2% record death among the outcomes and 14.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (20.1%), headache (17.8%) and nausea (7.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
HarvoniLedipasvir and sofosbuvir	brand	18,599	31	38.2%	Fatigue
EpclusaVelpatasvir and sofosbuvir	brand	12,277	281	29%	Fatigue
Ledipasvir and sofosbuvir	generic	4,544	0	95.7%	Headache

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Fatiguetiredness20.1%7,118
Headachehead pain17.8%6,314
Nauseafeeling sick7.3%2,583
Drug ineffectivethe medicine did not work as expected5.4%1,900
Diarrhoealoose or frequent stools4.7%1,668
Insomniadifficulty sleeping4.2%1,505
Hepatitis Chepatitis C infection4.1%1,447
Vomitingbeing sick2.6%925
Dizzinesslight-headedness or unsteadiness2.4%865
Treatment failurethe treatment did not work2.3%824
Drug dose omissiona dose was missed2.1%752
Deaththe patient died; cause not stated by this term2%726
Astheniaweakness or lack of energy2%723
Hepatocellular carcinoma2%717
Rashskin rash1.8%644
Arthralgiajoint pain1.6%556
Painpain, site not specified1.6%550
Constipationconstipation1.5%549
Dyspnoeashortness of breath1.5%548
Pruritusitching1.5%525
Abdominal discomfortstomach discomfort1.5%516
Decreased appetitereduced appetite1.5%516
Depressionlow mood1.4%509
Dyspepsiaindigestion1.4%505
Anaemialow red blood cells1.3%478

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.2%1,844

Life-threatening1.4%483

Hospitalisation (initial or prolonged)14.8%5,251

Disability1.4%482

Congenital anomaly0.1%26

Other serious33.9%12,010

Not serious57.6%20,416

Patient age

Under 20.1%24

2 to 110.1%50

12 to 170.1%30

18 to 4411.3%4,006

45 to 6448%17,012

65 to 7414.4%5,092

75 and over4%1,420

Age not given22%7,786

Who reported

Physician18.8%6,669

Pharmacist28.9%10,252

Other health professional25%8,861

Lawyer0%9

Consumer or non-health professional22%7,803

Not given5.2%1,826

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Hepatitis C virus NS5A inhibitor reports

Which drugs are in the Hepatitis C virus NS5A inhibitor class on this site?

Harvoni, Epclusa and Ledipasvir and sofosbuvir. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

35,420 reports through June 2026, 312 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fatigue (20.1%), headache (17.8%), nausea (7.3%), drug ineffective (5.4%) and diarrhoea (4.7%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.