Daclatasvir Side Effects
For the Consumer
Applies to daclatasvir: oral tablet
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with daclatasvir. 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 management for HBV infection as clinically indicated .
Along with its needed effects, daclatasvir 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 daclatasvir:
Incidence Not Known
- Chest pain or discomfort
- lightheadedness, dizziness, or fainting
- slow or irregular heartbeat
- unusual tiredness
Some side effects of daclatasvir 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:
For Healthcare Professionals
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]
Very common (10% or more): Headache (up to 31.2%)
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]
Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)
Very common (10% or more): Anemia (up to 20%), neutropenia (up to 14.8%)
Common (1% to 10%): Thrombocytopenia, decreased hemoglobin
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): Cough (up to 18.3%), nasopharyngitis (up to 13.7%), dyspnea (up to 12.3%)
Very common (10% or more): Diarrhea (up to 17.6%), nausea (up to 16.6%)
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): Myalgia (up to 15.3%), arthralgia (up to 10.1%)
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]
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%): Increased ALT, increased AST, increased total bilirubin
Postmarketing reports: Hepatitis B reactivation[Ref]
Common (1% to 10%): Urinary tract infection
Common (1% to 10%): Dry eye[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb, Princeton, NJ.
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.
More about daclatasvir
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 10 Reviews
- Drug class: NS5A inhibitors
- FDA Alerts (1)
Other brands: Daklinza