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Sofosbuvir Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 23, 2024.

Applies to sofosbuvir: oral packet, oral tablet.

Warning

Oral route (Tablet)

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Serious side effects of Sofosbuvir

Along with its needed effects, sofosbuvir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sofosbuvir:

More common

Rare

Incidence not known

Other side effects of Sofosbuvir

Some side effects of sofosbuvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to sofosbuvir: oral pellet, oral tablet.

General

When this drug is used with ribavirin or peginterferon alfa/ribavirin, the respective manufacturer product information should be consulted for associated side effects.

The most common side effects reported with sofosbuvir and ribavirin therapy were fatigue and headache. The most common side effects reported with sofosbuvir, peginterferon alfa, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in up to 4% of subjects using placebo, up to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2% of subjects using sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks.[Ref]

Other

Very common (10% or more): Fatigue (up to 59%), asthenia (up to 21%), pyrexia (up to 18%), chills (up to 17%), influenza-like illness (up to 16%), pain

Common (1% to 10%): Chest pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 36%), dizziness

Common (1% to 10%): Disturbance in attention, migraine, memory impairment[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%), vomiting

Common (1% to 10%): Increased lipase, abdominal discomfort, constipation, dyspepsia, dry mouth, gastroesophageal reflux[Ref]

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in up to 2% of patients. Lipase elevation was isolated and asymptomatic.[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 32.5%), anemia (up to 21%), neutropenia (up to 17%), decreased neutrophils (up to 15%), decreased lymphocyte count, decreased platelet count

Uncommon (0.1% to 1%): Pancytopenia[Ref]

Decreased hemoglobin (less than 10 g/dL: up to 23%; less than 8.5 g/dL: up to 2%), decreased neutrophils (0.5 to less than 0.75 x 10[9]/L: up to 15%; less than 0.5 x 10[9]/L: up to 5%), and decreased platelets (25 to less than 50 x 10[9]/L: up to 1%) have been reported.

In a study in liver transplant recipients, decreased hemoglobin was very common during therapy. Hemoglobin decreased to less than 10 g/dL in 13 of 40 patients (32.5%); hemoglobin decreased to less than 8.5 g/dL in 1 of those patients. Epoetin and/or a blood product was used in 8 patients (20%); 5 patients (12.5%) discontinued, modified, or interrupted therapy due to side effects.

Pancytopenia was reported, particularly in patients using concomitant pegylated interferon.[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 27%), rash (18%)

Common (1% to 10%): Alopecia, dry skin

Frequency not reported: Stevens-Johnson syndrome

Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]

Psychiatric

Severe depression was reported, particularly in patients with history of psychiatric illness.[Ref]

Very common (10% or more): Insomnia (up to 25%), irritability (up to 13%)

Common (1% to 10%): Depression, anxiety, agitation

Uncommon (0.1% to 1%): Severe depression (including suicidal ideation, suicide)[Ref]

Cardiovascular

Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with amiodarone and/or other agents that lower heart rate.

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

Frequency not reported: Severe bradycardia, heart block

Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 18%)

Common (1% to 10%): Decreased weight[Ref]

Musculoskeletal

Increased creatine kinase (at least 10 x ULN) was reported in up to 2% of patients. Creatine kinase elevation was isolated and asymptomatic.[Ref]

Very common (10% or more): Myalgia (up to 14%), arthralgia

Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms[Ref]

Respiratory

Very common (10% or more): Dyspnea, cough

Common (1% to 10%): Nasopharyngitis, exertional dyspnea[Ref]

Hepatic

Increased total bilirubin (greater than 1.5 x ULN) was reported in up to 3% of patients. Bilirubin levels peaked during the first 1 to 2 weeks of therapy then decreased and returned to baseline levels by 4 weeks after therapy. These bilirubin elevations were not associated with transaminase elevations.[Ref]

Common (1% to 10%): Increased total bilirubin

Postmarketing reports: Hepatitis B reactivation[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Frequently asked questions

References

1. Product Information. Sovaldi (sofosbuvir). Gilead Sciences. 2013.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

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. ht 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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