Prescription medication · NS5A/NS5B Inhibitor (HCV)

ledipasvir/sofosbuvir

Also sold as Harvoni. Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.

Data updated 2026-05-15

13,424
FDA reports
22
InteractionsSeveral interactions
Rx
Availability

What the data shows

ledipasvir/sofosbuvir (Harvoni) is a prescription NS5A/NS5B Inhibitor (HCV), with 13,424 FDA adverse-event reports on file, with 22 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

ledipasvir/sofosbuvir (Harvoni) is a prescription NS5A/NS5B Inhibitor (HCV). Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.

Harvoni is a medicine that contains ledipasvir and sofosbuvir. It is used to treat chronic hepatitis C virus (HCV) infection in adults and children 3 years and older.

Verify with FDA → · CMS NADAC pricing →

Compare with Another Drug →

What it does

Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.

Common side effects

Feeling tired, Headache, Feeling weak

Key warnings

Harvoni can cause Hepatitis B to become active again if you have had it in the past.

The sections below are summarized in plain English from ledipasvir/sofosbuvir's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Harvoni contains two medicines that stop the hepatitis C virus from multiplying in your body. Ledipasvir blocks a protein called NS5A. Sofosbuvir blocks another protein called NS5B.

Side Effects (from patient reports)

Based on 13,424 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for ledipasvir/sofosbuvir, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Harvoni can cause Hepatitis B to become active again if you have had it in the past. This can cause serious liver problems, including liver failure and death. Your doctor will test you for Hepatitis B before you start Harvoni and monitor you during and after treatment.

Known Drug Interactions

moderate atorvastatin

atorvastatin ↑ atorvastatin Coadministration of HARVONI with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis.

Mechanism: Harvoni can increase the amount of atorvastatin in your system, which may lead to severe muscle problems.

moderate rifampin

( 5.2 , 6.2 , 7.2 ) P-gp inducers (e.g., rifampin, St. P-gp inducers (e.g., rifampin, St. Antimycobacterials: rifabutin rifampin rifapentine ↓ ledipasvir ↓ sofosbuvir Coadministration of HARVONI with rifampin, rifabutin, or rifapentine is not recommended [see Warnings and Precautions (5.3) ].

Mechanism: Rifampin reduces the levels of Harvoni in your body, which can prevent the medicine from treating your infection properly.

moderate amiodarone

7 DRUG INTERACTIONS Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of HARVONI with amiodarone is not recommended. Antiarrhythmics: amiodarone Effect on amiodarone, ledipasvir, and sofosbuvir concentrations unknown Coadministration of amiodarone with HARVONI may result in serious symptomatic bradycardia.

Mechanism: Taking these drugs together can cause your heart rate to drop to a dangerously slow level. While the exact reason is unknown, the combination interferes with your heart's normal rhythm.

moderate rosuvastatin

Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin.

Mechanism: These medications can raise the levels of rosuvastatin in your blood to unsafe levels. This increases your risk of developing serious muscle problems.

moderate rosuvastatin/ezetimibe

Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin.

Mechanism: These medications can cause rosuvastatin to build up in your system, which increases the risk of harmful side effects.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

How long will I need to take Harvoni?
The length of treatment depends on your specific situation, but is usually 12-24 weeks.
Can I take Harvoni if I have kidney problems?
Yes, you can still take Harvoni if you have kidney problems. No dose adjustment is needed.
What should I do if I experience side effects?
Tell your doctor about any side effects you experience while taking Harvoni.
Can I drink alcohol while taking Harvoni?
Talk to your doctor about drinking alcohol while taking Harvoni.
Will Harvoni interact with other medications I am taking?
Harvoni can interact with other medications. Tell your doctor about all the medicines you take.
How will I know if Harvoni is working?
Your doctor will monitor your HCV viral load to see if the treatment is working.
What if I have HIV?
You can still take Harvoni if you have HIV. Follow the dosage recommendations from your doctor.
Can children take Harvoni?
Yes, Harvoni can be used in children 3 years of age and older.
What tests will I need before starting Harvoni?
You will need to be tested for Hepatitis B virus (HBV) infection before starting Harvoni.
What do the tablets look like?
The 90 mg/400 mg tablets are orange and diamond-shaped. The 45 mg/200 mg tablets are white and capsule-shaped.
What are the common side effects of ledipasvir/sofosbuvir?
The registry lists Feeling tired, Headache, Feeling weak, Nausea among the most-reported FAERS reaction terms for ledipasvir/sofosbuvir. The compiled record contains 13,424 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does ledipasvir/sofosbuvir interact with other medications?
The registry has 22 documented interaction rows for ledipasvir/sofosbuvir. Notable source-record pairings include atorvastatin, rifampin, amiodarone. These rows are not a complete medication review.
What drug class is ledipasvir/sofosbuvir?
ledipasvir/sofosbuvir belongs to the NS5A/NS5B Inhibitor (HCV) drug class. It requires a prescription (Rx). Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.
What pregnancy or breastfeeding source fields are listed for ledipasvir/sofosbuvir?
The FDA label for ledipasvir/sofosbuvir contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Related Medications in NS5A/NS5B Inhibitor (HCV)

Other drugs grouped near ledipasvir/sofosbuvir - same-class peers and common alternatives.

acyclovir

Zovirax

Acyclovir is an antiviral medicine.

Compare with ledipasvir/sofosbuvir →

albendazole

Albenza

Albendazole is a medicine that fights parasites.

Compare with ledipasvir/sofosbuvir →

amphotericin B

Ambisome, Fungizone

Amphotericin B liposome is an antifungal medicine.

Compare with ledipasvir/sofosbuvir →

anidulafungin

Eraxis

Eraxis is an antifungal medicine.

Compare with ledipasvir/sofosbuvir →

atovaquone/proguanil

Malarone

Malarone is a drug used to prevent and treat malaria.

Compare with ledipasvir/sofosbuvir →

Compare ledipasvir/sofosbuvir vs acyclovir side-by-side →

Medication Guides

Understanding Drug Interactions

How CYP450 enzymes, inhibitors, and inducers affect your medications

Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

Save on ledipasvir/sofosbuvir

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Check Prices on GoodRx →

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for ledipasvir/sofosbuvir

The FDA label for ledipasvir/sofosbuvir (sold under brand names such as Harvoni) classifies it as a prescription-only medication in the NS5A/NS5B Inhibitor (HCV) class. Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6. Official labeling lists 4 commonly reported side effects, including Feeling tired, Headache, Feeling weak.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 13,424 voluntary reports. The database also lists 22 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: December 26, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page