Skip to Content

Harvoni Side Effects

Generic Name: ledipasvir / sofosbuvir

Note: This page contains information about the side effects of ledipasvir / sofosbuvir. Some of the dosage forms included on this document may not apply to the brand name Harvoni.

For the Consumer

Applies to ledipasvir / sofosbuvir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ledipasvir / sofosbuvir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking ledipasvir / sofosbuvir:

Incidence not known:
  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • shortness of breath
  • slow or irregular heartbeat
  • unusual tiredness

Minor Side Effects

Some of the side effects that can occur with ledipasvir / sofosbuvir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Cough
  • diarrhea
  • headache
  • irritability
  • lack or loss of strength
  • muscle pain
  • nausea
  • trouble breathing
  • trouble sleeping
  • unusual tiredness or weakness
Less common:
  • Discouragement
  • dizziness
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • trouble concentrating

For Healthcare Professionals

Applies to ledipasvir / sofosbuvir: oral tablet

General

The most common side effects reported with this drug were fatigue and headache. When this drug was studied with ribavirin, the most common side effects to this combination were consistent with known ribavirin side effects; frequency and severity of the expected side effects were not increased. Therapy was permanently discontinued due to side effects in 0%, less than 1%, and 1% of patients using this drug for 8, 12, and 24 weeks, respectively, and less than 1%, 0%, and 2% for patients using this drug with ribavirin for 8, 12, and 24 weeks, respectively.

The manufacturer product information for ribavirin should be consulted, if applicable.[Ref]

Other

Very common (10% or more): Fatigue (up to 18%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, increased lipase[Ref]

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in less than 1%, 2%, and 3% of subjects using this drug for 8, 12, and 24 weeks, respectively. Lipase elevation was transient and asymptomatic.[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Hepatic

Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, less than 1%, and 2% of subjects using this drug for 8, 12, and 24 weeks, respectively.[Ref]

Common (1% to 10%): Increased bilirubin[Ref]

Cardiovascular

Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with this drug.[Ref]

Musculoskeletal

Frequency not reported: Increased creatine kinase[Ref]

Creatine kinase was not evaluated in clinical trials for this drug. Isolated, asymptomatic creatine kinase elevations (grade 3 or 4) were reported with sofosbuvir in combination with ribavirin or peginterferon alfa/ribavirin in other clinical trials.[Ref]

References

1. "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences, Foster City, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. FDA. U.S. Food and Drug Administration "FDA Drug Safety Communicaation: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug. Ava" ([2015 Mar 24]):

Not all side effects for Harvoni may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide