Harvoniledipasvir + sofosbuvir

Name: HARVONI (ledipasvir + sofosbuvir) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

19,106 adverse event reports submitted to the FDA (2010–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Harvoni in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

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Fatigue 4,130 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Headache 3,706 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Nausea 1,242 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
Drug Ineffective 1,137 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →
Diarrhoea 913 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →
Hepatitis C 884 reports
Insomnia 835 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →
Vomiting 442 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Dizziness 439 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
Drug Dose Omission 436 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →
Hepatocellular Carcinoma 401 reports
Treatment Failure 374 reports
A report that the treatment did not produce the expected result. Similar to drug ineffective, it reflects that someone felt the treatment was not working.
Full definition in the glossary →
Rash 361 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Asthenia 337 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Arthralgia 330 reports
Joint pain.
Full definition in the glossary → See all drugs reporting this event →

Browse the full glossary →

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

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Harvoni adverse event reports by reporter sex
Sex	Reports
Male	10,647
Female	7,925
Unknown	1

By Age Group

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Harvoni adverse event reports by reporter age group
Age group	Reports
0-17	98
18-34	786
35-49	2,001
50-64	8,885
65-74	2,801
75+	845

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Harvoni. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

View outcome data as a table

Harvoni adverse event reports by reported outcome
Outcome	Reports
Non-Serious	11,663
Other Serious	5,905
Hospitalization	2,708
Death	776
Life-Threatening	326
Disability	246

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Harvoni. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

Harvoni adverse event reports by year
Year	Reports
2010	1
2013	1
2014	125
2015	4,134
2016	5,147
2017	4,537
2018	2,885
2019	1,344
2020	414
2021	221
2022	160
2023	68
2024	34
2025	24
2026 (partial)	11

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Medications commonly reported with Harvoni

In FDA adverse event reports that mention Harvoni, these medications appeared most often in the same report.

Ribavirin (1,187 reports)
Furosemide (505 reports)
Omeprazole (452 reports)
Lisinopril (369 reports)
Spironolactone (369 reports)

This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026