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
- slow or irregular heartbeat
- trouble breathing
- 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:
- lack or loss of strength
- muscle pain
- trouble sleeping
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- trouble concentrating
For Healthcare Professionals
Applies to ledipasvir / sofosbuvir: oral tablet
The most common side effects reported with this drug were fatigue, headache, asthenia, and nausea. 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.
Among 174 liver transplant recipients with compensated liver disease using this drug with ribavirin for 12 weeks, 1% permanently discontinued this drug due to a side effect.
Among 162 patients with decompensated liver disease (pretransplant or posttransplant) using this drug with ribavirin for 12 weeks, 4% died, 2% had a liver transplantation, and less than 1% had a liver transplantation and died during therapy or within 30 days after stopping therapy. Due to the advanced liver disease in these patients (who had increased risk of disease progression leading to liver failure and death), the contribution of drug effect to outcomes could not be reliably assessed. This drug was permanently discontinued due to a side effect in 2% of patients.
If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.[Ref]
Decreased hemoglobin (less than 10 g/dL: up to 39%; less than 8.5 g/dL: up to 13%) has been reported in liver transplant recipients and/or patients with decompensated liver disease using this drug with ribavirin for 12 or 24 weeks. Ribavirin was permanently discontinued in up to 19% of patients. Immunosuppressive agents were modified in up to 10% of liver transplant recipients (modified dose due to improved organ function in at least 7%).
Very common (10% or more): Decreased hemoglobin (up to 39%)
Very common (10% or more): Asthenia (up to 36%), fatigue (up to 18%)[Ref]
Very common (10% or more): Headache (up to 29%)
Common (1% to 10%): Dizziness[Ref]
Very common (10% or more): Cough (up to 11%)
Common (1% to 10%): Dyspnea
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 patients using this drug for 8, 12, and 24 weeks, respectively. Increased lipase (greater than 3 x ULN) was reported in 1%, 3%, and 9% of patients with compensated cirrhosis using placebo, this drug plus ribavirin for 12 weeks, and this drug for 24 weeks, respectively. Lipase elevation was transient and asymptomatic.[Ref]
Depression (especially in patients with history of psychiatric illness) was reported in patients using sofosbuvir-containing regimens. Suicidal ideation and suicide have been reported in less than 1% of patients using sofosbuvir with ribavirin or pegylated interferon/ribavirin in other clinical trials.[Ref]
Common (1% to 10%): Insomnia, irritability
Frequency not reported: Depression
-Frequency not reported: Depression, suicidal ideation, suicide[Ref]
Common (1% to 10%): Rash
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema
Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, less than 1%, and 2% of patients using this drug for 8, 12, and 24 weeks, respectively. Increased bilirubin (greater than 1.5 x ULN) was reported in 3%, 11%, and 3% of patients with compensated cirrhosis using placebo, this drug plus ribavirin for 12 weeks, and this drug for 24 weeks, respectively.[Ref]
Common (1% to 10%): Increased bilirubin
Postmarketing reports: Hepatitis B reactivation[Ref]
Frequency not reported: Severe bradycardia, heart block
Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]
Severe bradycardia and heart block have been reported when this drug was used with concomitant amiodarone and/or other agents that lower heart rate.
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with this drug.[Ref]
Common (1% to 10%): Myalgia, elevated creatine kinase
-Frequency not reported: Elevated creatine kinase[Ref]
Creatine kinase was not evaluated in some phase 3 clinical trials for this drug, but was evaluated in at least 1 trial. Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in 1% of patients using this drug for 12 weeks; such elevations were previously reported in patients using sofosbuvir with ribavirin or peginterferon/ribavirin in other clinical trials.[Ref]
1. "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences, Foster City, CA.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. 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.
More about Harvoni (ledipasvir / sofosbuvir)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 302 Reviews – Add your own review/rating
- Drug class: antiviral combinations
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