Sovaldi Side Effects

Generic Name: sofosbuvir

Note: This page contains side effects data for the generic drug sofosbuvir. It is possible that some of the dosage forms included below may not apply to the brand name Sovaldi.

It is possible that some side effects of Sovaldi may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sofosbuvir: oral tablet

As well as its needed effects, sofosbuvir (the active ingredient contained in Sovaldi) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sofosbuvir, check with your doctor immediately:

More common
  • chills
  • fever
  • lower back or side pain
  • pale skin
  • ulcers, sores, or white spots in the mouth
  • unusual tiredness or weakness
Rare
  • Changes in behavior
  • discouragement
  • feeling sad or empty
  • loss of interest or pleasure
  • thoughts of killing oneself
  • trouble concentrating

Some sofosbuvir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Decreased appetite
  • diarrhea
  • difficulty with moving
  • fatigue
  • headache
  • irritability
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • rash or itching skin
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir: oral tablet

General

This drug should be used with ribavirin or peginterferon alfa/ribavirin. The manufacturer product 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 alfa, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in 1.4% to 4% of subjects using placebo, 0.5% to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11.1% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2.4% of subjects using sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks.

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

Nervous system

Very common (10% or more): Headache (up to 36%), dizziness
Common (1% to 10%): Disturbance in attention, migraine, memory impairment

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

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

Dermatologic

Very common (10% or more): Pruritus (up to 27%), rash (18%)
Common (1% to 10%): Alopecia, dry skin

Psychiatric

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)

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

Hematologic

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.

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

Very common (10% or more): Decreased hemoglobin (up to 23%), 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

Metabolic

Very common (10% or more): Decreased appetite (up to 18%)
Common (1% to 10%): Decreased weight

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), arthralgia
Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms

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

Respiratory

Very common (10% or more): Dyspnea, cough
Common (1% to 10%): Nasopharyngitis, exertional dyspnea

Hepatic

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

Increased total bilirubin (greater than 1.5 times 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.

Ocular

Common (1% to 10%): Blurred vision

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