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Daklinza Side Effects

Generic name: daclatasvir

Medically reviewed by Drugs.com. Last updated on Feb 21, 2021.

Note: This document contains side effect information about daclatasvir. Some of the dosage forms listed on this page may not apply to the brand name Daklinza.

For the Consumer

Applies to daclatasvir: oral tablet

Warning

  • You will be tested for hepatitis B before starting this drug. In people who have had hepatitis B or carry the virus, the virus has become active again during or after treatment with drugs like this one. This can lead to severe and sometimes deadly liver problems. People with hepatitis B and hepatitis C will be watched closely during and after treatment.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Feeling very tired or weak.
  • Shortness of breath.
  • Dizziness or passing out.
  • Pale skin.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Upset stomach.
  • Diarrhea.
  • Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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]

Genitourinary

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

Ocular

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

Frequently asked questions

References

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.

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.