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Daclatasvir Side Effects

The most commonly reported side effects of daclatasvir include fatigue, hepatocellular carcinoma, and headache, based on 6,246 FDA adverse event reports from 2011 to 2025. 6.3% of reports found the drug to be ineffective.

Daclatasvir side effects

Percentages show how often each reaction appears relative to total reports for daclatasvir.

1
Fatigue8.9%556
2
Hepatocellular Carcinoma7.3%454
3
Headache7.1%441
4
Hepatitis C6.7%420
5
Drug Ineffective6.3%396
6
Treatment Failure5.1%316
7
Nausea4.8%302
8
Anaemia4.6%287
9
Ascites3.7%228
10
Off Label Use3.5%221
11
Insomnia3.3%207
12
Diarrhoea3.1%196
13
Hepatic Failure3.1%191
14
Acute Kidney Injury3.0%185
15
Hepatic Encephalopathy2.8%173

These are voluntary reports and do not establish that daclatasvir caused these reactions.

Report severity

83.6%Serious5,219 reports
29.3%Hospitalizations1,833 reports
10.6%Fatal661 reports

Seriousness is determined by the reporter, not by OpenClaim.

Daclatasvir drug interactions

Other drugs that appear in adverse event reports alongside daclatasvir. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sofosbuvir62.4%3,897
2
Ribavirin27.9%1,745
3
Simeprevir-sodium4.6%287
4
Tenofovir1.7%108
5
Peginterferon1.5%95
6
Ritonavir1.5%95
7
Ledipasvir1.5%92
8
Raltegravir-potassium1.2%74
9
Emtricitabine1.2%73
10
Tacrolimus1.1%71
11
Velpatasvir0.9%57
12
Mycophenolate0.9%55
13
Metoprolol0.7%42
14
Lamivudine0.7%41
15
Amlodipine0.6%40

Taken alongside

1
Sofosbuvir7.3%453
2
Spironolactone4.6%290
3
Ribavirin4.6%287
4
Furosemide4.3%268
5
Omeprazole3.4%214
6
Lactulose2.6%161
7
Pantoprazole-sodium2.5%159
8
Insulin2.5%155
9
Amlodipine2.5%154
10
Aspirin2.4%150
11
Tacrolimus2.3%144
12
Mycophenolate2.1%129
13
Propranolol-hydrochloride2.0%126
14
Methadone-hydrochloride1.9%117
15
Acetaminophen1.8%110

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports daclatasvir side effects

32.2% of daclatasvir adverse event reports involve female patients and 50.5% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female32.2%
Male50.5%
Unknown17.3%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6476.6%
65+23.3%

What is daclatasvir used for

Conditions and purposes for which patients were taking daclatasvir when the adverse event was reported.

Acute Hepatitis CAcute Lymphocytic Leukaemia RefractoryAntiviral ProphylaxisAntiviral TreatmentAnxiety DisorderAcute Hepatitis CAntiviral TreatmentBipolar DisorderChild-pugh-turcotte Score IncreasedChronic HepatitisChronic Hepatitis BChronic Hepatitis CChronic Kidney DiseaseChronic Myeloid LeukaemiaCirrhosis Alcoholic

Showing 15 of 67 indications

Daclatasvir brand names and reporting trend

Daclatasvir is sold under the brand name Daklinza.

Brand names

Daklinza3,531

Quarterly reports (20112025)

20112016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking daclatasvir with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.