Sofosbuvir Side Effects
Medically reviewed by Drugs.com. Last updated on March 24, 2020.
For the Consumer
Applies to sofosbuvir: oral tablet
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.
Side effects requiring immediate medical attention
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:
- lower back or side pain
- pale skin
- ulcers, sores, or white spots in the mouth
- unusual tiredness or weakness
- Changes in behavior
- feeling sad or empty
- loss of interest or pleasure
- thoughts of killing oneself
- trouble concentrating
Incidence not known
- Chest pain or discomfort
- lightheadedness, dizziness, or fainting
- shortness of breath
- slow or irregular heartbeat
- unusual tiredness
Side effects not requiring immediate medical attention
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:
- Decreased appetite
- difficulty with moving
- lack or loss of strength
- muscle aching or cramping
- muscle pains or stiffness
- rash or itching skin
- trouble sleeping
For Healthcare Professionals
Applies to sofosbuvir: oral pellet, oral tablet
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]
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]
Very common (10% or more): Headache (up to 36%), dizziness
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]
Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%), vomiting
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/L: up to 15%; less than 0.5 x 10/L: up to 5%), and decreased platelets (25 to less than 50 x 10/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.
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]
Very common (10% or more): Pruritus (up to 27%), rash (18%)
Frequency not reported: Stevens-Johnson syndrome
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]
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]
Very common (10% or more): Decreased appetite (up to 18%)
Common (1% to 10%): Decreased weight[Ref]
Very common (10% or more): Myalgia (up to 14%), arthralgia
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): Dyspnea, cough
Common (1% to 10%): Nasopharyngitis, exertional dyspnea[Ref]
Common (1% to 10%): Increased total bilirubin
Postmarketing reports: Hepatitis B reactivation[Ref]
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%): Blurred vision[Ref]
1. "Product Information. Sovaldi (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]):
Frequently asked questions
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More about sofosbuvir
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 49 Reviews
- Drug class: miscellaneous antivirals
- FDA Alerts (2)
- Other brands
Related treatment guides
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.