Sovaldi Side Effects
Generic Name: sofosbuvir
Note: This document contains side effect information about sofosbuvir. Some of the dosage forms listed on this page may not apply to the brand name Sovaldi.
Some side effects of Sovaldi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Applies to sofosbuvir: oral tablet
Sofosbuvir should be used with ribavirin or peginterferon/ribavirin. The prescribing information for these agents should be consulted for side effects.
The most common side effects reported with sofosbuvir (the active ingredient contained in Sovaldi) and ribavirin therapy were fatigue and headache. The most common side effects reported with sofosbuvir, peginterferon, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in 4% of subjects using placebo, 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.
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%)
Very common (10% or more): Headache (up to 36%)
Lipase elevation was isolated and asymptomatic.
Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%)
Common (1% to 10%): Increased lipase (greater than 3 times upper limit of normal [ULN]: up to 2%)
Very common (10% or more): Pruritus (up to 27%), rash (18%)
Very common (10% or more): Insomnia (up to 25%), irritability (up to 13%)
Uncommon (0.1% to 1%): Severe depression (including suicidal ideation, suicide; less than 1%)
Severe depression was reported, particularly in patients with history of psychiatric illness.
Very common (10% or more): Decreased hemoglobin (less than 10 g/dL: up to 23%), anemia (up to 21%), neutropenia (up to 17%), decreased neutrophils (0.5 to less than 0.75 x 10/L: up to 15%)
Common (1% to 10%): Decreased neutrophils (less than 0.5 x 10/L: up to 5%), decreased hemoglobin (less than 8.5 g/dL: up to 2%)
Uncommon (0.1% to 1%): Decreased platelets (25 to less than 50 x 10/L: up to 1%), pancytopenia (less than 1%)
Pancytopenia was reported, particularly in patients using concomitant pegylated interferon.
Very common (10% or more): Decreased appetite (up to 18%)
Creatine kinase elevation was isolated and asymptomatic.
Very common (10% or more): Myalgia (up to 14%)
Common (1% to 10%): Increased creatine kinase (at least 10 times ULN: up to 2%)
Common (1% to 10%): Increased total bilirubin (greater than 1.5 times ULN: up to 3%)
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.
More about Sovaldi (sofosbuvir)
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