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Daclatasvir Side Effects

For the Consumer

Applies to daclatasvir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by daclatasvir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking daclatasvir:

Incidence not known:
  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • slow or irregular heartbeat
  • unusual tiredness

Minor Side Effects

Some of the side effects that can occur with daclatasvir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Headache
  • nausea
Less common:
  • Diarrhea

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

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

Psychiatric

Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)
Common (1% to 10%): Depression, anxiety[Ref]

Hematologic

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]

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]

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

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]

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]

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 sofosbuvir in combination with another HCV direct-acting antiviral (including this drug). 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

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]

Genitourinary

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

Ocular

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb, Princeton, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Not all side effects for daclatasvir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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