Daklinza Side Effects
Generic Name: daclatasvir
Note: This page contains information about the side effects of daclatasvir. Some of the dosage forms included on this document may not apply to the brand name Daklinza.
For the Consumer
Applies to daclatasvir: oral tablet
In addition to its needed effects, some unwanted effects may be caused by daclatasvir (the active ingredient contained in Daklinza). 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
- shortness of breath
- 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:
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. 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 drugs should be consulted.[Ref]
Very common (10% or more): Fatigue (up to 41.5%), asthenia (up to 22.4%), 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%)
Common (1% to 10%): Dizziness, migraine[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%)[Ref]
Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)
Common (1% to 10%): Depression, anxiety[Ref]
Very common (10% or more): Anemia (up to 19.3%), neutropenia (up to 14.8%)
Common (1% to 10%): Thrombocytopenia
Frequency not reported: Decreased hemoglobin, 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.
Grade 3 decreased hemoglobin was reported in 1 patient in a ribavirin treatment group.[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]
Very common (10% or more): Diarrhea (up to 17.6%), nausea (up to 16.6%)
Common (1% to 10%): Upper abdominal pain, constipation, flatulence, gastroesophageal reflux disease, dry mouth, vomiting, elevated lipase[Ref]
Transient, asymptomatic elevated lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in 2% of patients using this drug with sofosbuvir.[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 sofosbuvir in combination with another hepatitis C virus 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]
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 1% of patients, respectively.[Ref]
Common (1% to 10%): Increased ALT, increased AST
Uncommon (0.1% to 1%): Increased total bilirubin[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. "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb, Princeton, NJ.
3. Cerner Multum, Inc. "Australian Product Information." O 0
Not all side effects for Daklinza may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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