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Daclatasvir Side Effects

Medically reviewed by Last updated on Jun 18, 2023.

Applies to daclatasvir: oral tablet.


In clinical trials, this drug was used in combination with sofosbuvir (with or without ribavirin), with peginterferon alfa/ribavirin, with asunaprevir, or with asunaprevir/peginterferon alfa/ribavirin. Fatigue, headache, and nausea were reported most often when used with sofosbuvir. Headache, anemia, fatigue, and nausea were reported most often when used with sofosbuvir and ribavirin. Fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anemia, pyrexia, cough, dyspnea, neutropenia, diarrhea, and arthralgia were reported most often when used with peginterferon alfa/ribavirin; the most common side effects of at least grade 3 severity were neutropenia, anemia, thrombocytopenia, and lymphopenia. The side effects and laboratory abnormalities reported with this drug in combination with peginterferon alfa/ribavirin was similar to those reported with peginterferon alfa/ribavirin alone, including in patients with cirrhosis. Headache, fatigue, diarrhea, nasopharyngitis, and nausea were reported most often when used with asunaprevir. Fatigue, headache, pruritus, asthenia, influenza-like illness, insomnia, rash, anemia, cough, dry skin, diarrhea, nausea, alopecia, irritability, pyrexia, and myalgia were reported most often when used with asunaprevir/peginterferon alfa/ribavirin.

The manufacturer product information for coadministered hepatitis C virus (HCV) antiviral drugs should be consulted.[Ref]


Very common (10% or more): Fatigue (up to 41.5%), asthenia (up to 24.1%), influenza-like illness (up to 22.4%), pyrexia (up to 16.1%)

Common (1% to 10%): Hot flush, pain, weight decreased[Ref]

Nervous system

Very common (10% or more): Headache (up to 31.2%)

Common (1% to 10%): Dizziness, migraine, somnolence[Ref]


Very common (10% or more): Pruritus (up to 26.1%), rash (up to 20.6%), dry skin (up to 17.8%), alopecia (up to 16.1%)

Postmarketing reports: Erythema multiforme[Ref]

Erythema multiforme has been reported with this drug as part of an asunaprevir regimen.[Ref]


Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)

Common (1% to 10%): Depression, anxiety[Ref]


Of the patients reporting anemia, 43% received ribavirin in addition to this drug and sofosbuvir. During the study, anemia was not reported in the ribavirin-free treatment groups.

In trials of this drug with sofosbuvir (with or without ribavirin), grade 3 decreased hemoglobin was reported in 2% of patients; all of these patients received this drug with sofosbuvir and ribavirin.[Ref]

Very common (10% or more): Anemia (up to 20%), neutropenia (up to 14.8%)

Common (1% to 10%): Thrombocytopenia, decreased hemoglobin

Frequency not reported: Eosinophilia[Ref]


Very common (10% or more): Cough (up to 18.3%), nasopharyngitis (up to 13.7%), dyspnea (up to 12.3%)

Common (1% to 10%): Exertional dyspnea, nasal congestion, upper respiratory tract infection[Ref]


Elevated lipase (at least 3.1 times the upper limit of normal [3.1 x ULN]) was reported in up to 4% of patients using this drug with sofosbuvir (with or without ribavirin).[Ref]

Very common (10% or more): Diarrhea (up to 17.6%), nausea (up to 16.6%)

Common (1% to 10%): Upper abdominal pain, abdominal pain, constipation, flatulence, gastroesophageal reflux disease, dry mouth, vomiting, elevated lipase[Ref]


Very common (10% or more): Myalgia (up to 15.3%), arthralgia (up to 10.1%)

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


Very common (10% or more): Decreased appetite (up to 11.8%)[Ref]


Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir. Cases of severe bradycardia and heart block have been reported with this drug in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate.[Ref]

Postmarketing reports: Symptomatic bradycardia, heart block, cardiac arrhythmias[Ref]


Common (1% to 10%): Increased ALT, increased AST, increased total bilirubin

Postmarketing reports: Hepatitis B reactivation[Ref]

Increased ALT (at least 5.1 x ULN), AST (at least 5.1 x ULN), and total bilirubin (at least 2.6 x ULN) were reported in up to 4%, up to 3%, and up to 8% of patients, respectively.

Grade 3/4 increased total bilirubin was reported in 5% of patients; all of these patients were coinfected with HIV and using concomitant atazanavir, had Child-Pugh A, B, or C cirrhosis, or were post-liver transplant.[Ref]


Common (1% to 10%): Urinary tract infection


Common (1% to 10%): Dry eye[Ref]

Frequently asked questions


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

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Daklinza (daclatasvir). Bristol-Myers Squibb. 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.