Daclatasvir Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 24, 2024.

Applies to daclatasvir: oral tablet.

Warning

If you've ever had hepatitis B, it may become active or get worse while using or after you stop using daclatasvir. You may need frequent liver function tests for several months.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Daclatasvir is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
new or worsening liver symptoms--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well.

If you take daclatasvir with sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

very slow heartbeats, chest pain, shortness of breath;
confusion, memory problems; or
weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects may include:

anemia;
headache;
nausea; or
feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to daclatasvir: oral tablet.

General

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]

Other

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]

Dermatologic

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]

Psychiatric

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

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

Hematologic

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]

Respiratory

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]

Gastrointestinal

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]

Musculoskeletal

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

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

Metabolic

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

Cardiovascular

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]

Hepatic

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]