Daclatasvir

BreastfeedingPediatric

FDA APPROVAL DATE: 07/24/2015

CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

Amiodarone, Carbamazepine, Dabigatran, Phenytoin, Rifampin, St John's Wort

PREGNANCY CATEGORY: N/A
No data available

Under investigation for treating COVID-19

See adverse reactions attributed to class:

COVID-19 putative drug

Direct-acting antiviral

See also separate entry for sofosbuvir.

DRESS syndrome 

(2015): Suga T+, World J Clin Cases 3(12), 1005 (with asunaprevir)

Pruritus (itching) 

(2018): El-Khayat H+, Aliment Pharmacol Ther Jan, Epub ahead of print

(2017): Cho BW+, Clin Mol Hepatol 23(1), 51 (with asunaprevir)

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]6%

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

Rash 

(2017): Cho BW+, Clin Mol Hepatol 23(1), 51 (with asunaprevir)

(2017): Kutala BK+, Hepat Med 9, 672%

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]5%

Alopecia 

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

Bradyarrhythmia 

(2015): Brainard DM+, N Engl J Med 373(19), 1888

Anorexia 

(2018): Mehta R+, J Clin Exp Hepatol 8(1), 3 (with sofosbuvir)

(2017): Tarao K+, World J Hepatol 9(11), 5446–11% (with asunaprevir)

Fever (pyrexia) 

(2017): Tarao K+, World J Hepatol 9(11), 5444–9% (with asunaprevir)

(2016): Sato A+, Clin J Gastroenterol 9(2), 89 (with asunaprevir)

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

(2014): Kumada H+, Hepatology 59(6), 20839–17% (with asunaprevir)

Headache 14%

(2018): Abdel-Moneim A+, Hepatol Int May, Epub ahead of print (with sofosbuvir)

(2018): El-Khayat H+, Aliment Pharmacol Ther Jan, Epub ahead of print

(2018): Kwo P+, Hepatol Commun 2(4), 35418–31%

(2018): Thiam A+, Drugs Today (Barc) 54(4), 23710% (with asunaprevir and beclabuvir)

(2017): Binda C+, Eur Rev Med Pharmacol Sci 21(1 Suppl), 102

(2017): Kutala BK+, Hepat Med 9, 6728%

(2017): Tarao K+, World J Hepatol 9(11), 5446–7% (with asunaprevir)

(2016): Everson GT+, Liver Int 36(2), 189

(2016): Leroy V+, Hepatology 63(5), 1430 (with ribavirin)

(2016): Mangia A+, Liver Int 36(7), 971

(2016): Manolakopoulos S+, Ann Gastroenterol 29(3), 282 [REVIEW]

(2016): Smith MA+, Ann Pharmacother 50(1), 39 [REVIEW]20%

(2016): Zhu GQ+, Medicine (Baltimore) 95(9), e3004 [REVIEW]

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]19%

(2015): Nelson DR+, Hepatology 61(4), 112720%

(2015): Poordad F+, JAMA 313(17), 1728>10% (with asunaprevir and beclabuvir)

(2015): Wyles DL+, N Engl J Med 373(8), 714

(2014): Everson GT+, Gastroenterology 146(2), 42027% (with asunaprevir and beclabuvir)

(2014): Kumada H+, Hepatology 59(6), 208313–20% (with asunaprevir)

(2014): Lok AS+, J Hepatol 60(3), 490 (with asunaprevir)

(2014): Sulkowski MS+, N Engl J Med 370(3), 211

(2012): Chayama K+, Hepatology 55(3), 742 (with asunaprevir)

Insomnia 

(2018): Kwo P+, Hepatol Commun 2(4), 35412–27%

(2016): Leroy V+, Hepatology 63(5), 1430 (with ribavirin)

(2016): Zhu GQ+, Medicine (Baltimore) 95(9), e3004 [REVIEW]

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]6%

(2015): Nelson DR+, Hepatology 61(4), 11276%

Irritability 

(2017): Kutala BK+, Hepat Med 9, 675%

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]3%

Tremor 

(2018): Kwo P+, Hepatol Commun 2(4), 3543–36%

Vertigo / dizziness 

(2018): Lee BS+, Gut Liver Oct, Epub ahead of print (with asunaprevir)

Alanine aminotransferase (ALT) increased 

(2017): Iio E+, J Gastroenterol 52(1), 94 (with asuaprevir)

(2017): Ogawa E+, Hepatol Res 47(3), e120 (with asunaprevir)

(2017): Sezaki H+, Liver Int 37(9), 1325 (with asunaprevir)

(2017): Tarao K+, World J Hepatol 9(11), 54425–38% (with asunaprevir)

(2016): Suda G+, J Gastroenterol 51(7), 733 (with asunaprevir)

(2015): Jensen D+, J Hepatol 63(1), 303% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

(2015): Muir AJ+, JAMA 313(17), 1736 (grade 3 or 4) (with asunaprevir and beclabuvir)

(2015): Poordad F+, JAMA 313(17), 1728<1% (grade 4) (with asunaprevir and beclabuvir)

(2014): Kumada H+, Hepatology 59(6), 208313–18% (with asunaprevir)

(2014): Manns M+, Lancet 384(9954), 1597<2% (grade 3 or 4) (with asunaprevir)

Aspartate aminotransferase (AST) increased 

(2017): Tarao K+, World J Hepatol 9(11), 54427–39% (with asunaprevir)

(2015): Jensen D+, J Hepatol 63(1), 303% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

(2014): Kumada H+, Hepatology 59(6), 208312–13% (with asunaprevir)

(2014): Manns M+, Lancet 384(9954), 1597<2% (grade 3 or 4) (with asunaprevir)

Hyperbilirubinemia 

(2018): Cheng PN+, J Formos Med Assoc Oct, Epub ahead of print (with sofosbuvir and ribavirin)

(2017): Tarao K+, World J Hepatol 9(11), 5444–9% (with asunaprevir)

Hypertransaminasemia (transaminitis) 

(2019): Jang ES+, J Med Virol Aug, Epub ahead of print8% (with asunaprevir)

Serum creatinine increased 

(2017): Tarao K+, World J Hepatol 9(11), 5449–14% (with asunaprevir)

Abdominal pain 

(2018): Kwo P+, Hepatol Commun 2(4), 35412–18%

(2015): Nelson DR+, Hepatology 61(4), 11275%

(2014): Everson GT+, Gastroenterology 146(2), 42011% (with asunaprevir and beclabuvir)

Cholecystitis 

(2016): Miyashima Y+, Intern Med 55(24), 3595 (with asunaprevir)

Diarrhea 5%

(2018): Kwo P+, Hepatol Commun 2(4), 35418–19%

(2018): Thiam A+, Drugs Today (Barc) 54(4), 23710% (with asunaprevir and beclabuvir)

(2017): Sperl J+, Ther Clin Risk Manag 13, 733 (1 case)

(2017): Tarao K+, World J Hepatol 9(11), 5444–5% (with asunaprevir)

(2016): Everson GT+, Liver Int 36(2), 189 (with asunaprevir and beclabuvir)

(2016): Miyazaki R+, Ther Apher Dial 20(5), 462 (2 cases) (with asunaprevir)

(2015): Poordad F+, JAMA 313(17), 1728>10% (with asunaprevir and beclabuvir)

(2014): Everson GT+, Gastroenterology 146(2), 42017% (with asunaprevir and beclavbuvir)

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

(2014): Kumada H+, Hepatology 59(6), 20839–12% (with asunaprevir)

(2014): Lok AS+, J Hepatol 60(3), 490 (with asunaprevir)

(2012): Chayama K+, Hepatology 55(3), 742 (with asunaprevir)

Hepatotoxicity 

(2018): Kwo P+, Hepatol Commun 2(4), 3549–45%

(2016): Miyashima Y+, Intern Med 55(24), 3595 (with asunaprevir)

Nausea 8%

(2018): Abdel-Moneim A+, Hepatol Int May, Epub ahead of print (with sofosbuvir)

(2018): Kwo P+, Hepatol Commun 2(4), 35426–27%

(2018): Mehta R+, J Clin Exp Hepatol 8(1), 3 (with sofosbuvir)

(2018): Thiam A+, Drugs Today (Barc) 54(4), 23710% (with asunaprevir and beclabuvir)

(2017): Binda C+, Eur Rev Med Pharmacol Sci 21(1 Suppl), 102

(2017): Kutala BK+, Hepat Med 9, 6724%

(2016): Everson GT+, Liver Int 36(2), 189 (with asunaprevir and beclabuvir)

(2016): Mangia A+, Liver Int 36(7), 971

(2016): Manolakopoulos S+, Ann Gastroenterol 29(3), 282

(2016): Miyazaki R+, Ther Apher Dial 20(5), 462 (1 case) (with asunaprevir)

(2016): Smith MA+, Ann Pharmacother 50(1), 39 [REVIEW]12%

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]14%

(2015): Nelson DR+, Hepatology 61(4), 112712%

(2015): Poordad F+, JAMA 313(17), 1728>10% (with asunaprevir and beclabuvir)

(2015): Wyles DL+, N Engl J Med 37(8), 714

(2014): Everson GT+, Gastroenterology 146 (2), 42014% (with asunaprevir and beclabuvir)

(2014): Sulkowski MS+, N Engl J Med 370(3), 211

Vomiting  

(2018): Kwo P+, Hepatol Commun 2(4), 3549–18%

(2018): Mehta R+, J Clin Exp Hepatol 8(1), 3 (with sofosbuvir)

Anemia 

(2018): El-Khayat H+, Aliment Pharmacol Ther Jan, Epub ahead of print

(2017): Kutala BK+, Hepat Med 9, 672%

(2017): Liao H+, Clin Res Hepatol Gastroenterol 41(3), 262 [REVIEW]32%

(2016): Coilly A+, J Hepatol 65(4), 71118%

(2015): Herzer K+, Digestion 91(4), 326 (with ribavirin and simeprevir)

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]6%

(2015): Jensen D+, J Hepatol 63(1), 306% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

Coagulopathy 

(2016): Miyashima Y+, Intern Med 55(24), 3595 (with asunaprevir)

Hemoglobin decreased 

(2018): Cheng PN+, J Formos Med Assoc Oct, Epub ahead of print (with sofosbuvir and ribavirin)

(2017): Tarao K+, World J Hepatol 9(11), 5448–14% (with asunaprevir)

Lymphocytosis 

(2014): Kumada H+, Hepatology 59(6), 2083<4% (grade 3 or 4) (with asunaprevir)

Lymphopenia (lymphocytopenia) 

(2015): Jensen D+, J Hepatol 63(1), 3016% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

Neutropenia 

(2018): Lee BS+, Gut Liver Oct, Epub ahead of print (with asunaprevir )

(2017): Liao H+, Clin Res Hepatol Gastroenterol 41(3), 262 [REVIEW]23%

(2015): Jensen D+, J Hepatol 63(1), 3022% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

(2014): Izumi N+, Antivir Ther 19(5), 501 (with PEG-interferon and ribavirin)

Platelets increased 

(2014): Kumada H+, Hepatology 59(6), 20832% (grade 3 or 4) (with asunaprevir)

Thrombocytopenia 

(2017): Liao H+, Clin Res Hepatol Gastroenterol 41(3), 262 [REVIEW]21%

(2015): Jensen D+, J Hepatol 63(1), 304% (grade 3 or 4) (with asunaprevir, PEG-interferon and ribavirin)

Arthralgia 

(2018): Kwo P+, Hepatol Commun 2(4), 354<12%

(2015): Nelson DR+, Hepatology 61(4), 11275%

Asthenia / fatigue 14%

(2018): Abdel-Moneim A+, Hepatol Int May, Epub ahead of print (with sofosbuvir)

(2018): El-Khayat H+, Aliment Pharmacol Ther Jan, Epub ahead of print

(2018): Kwo P+, Hepatol Commun 2(4), 35412–36%

(2018): Thiam A+, Drugs Today (Barc) 54(4), 23710% (with asunaprevir and beclabuvir)

(2017): Binda C+, Eur Rev Med Pharmacol Sci 21(1 Suppl), 102

(2017): Kutala BK+, Hepat Med 9, 6734%

(2017): Tarao K+, World J Hepatol 9(11), 5446–13% (with asunaprevir)

(2016): Everson GT+, Liver Int 36(2), 189 (with asunaprevir and beclabuvir)

(2016): Leroy V+, Hepatology 63(5), 1430 (with ribavirin)

(2016): Mangia A+, Liver Int 36(7), 971

(2016): Manolakopoulos S+, Ann Gastroenterol 29(3), 282 [REVIEW]

(2016): Smith MA+, Ann Pharmacother 50(1), 39 [REVIEW]19%

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]29%

(2015): Nelson DR+, Hepatology 61(4), 112719%

(2015): Poordad F+, JAMA 313(17), 1728>10% (with asunaprevir and beclabuvir)

(2015): Wyles DL+, N Engl J Med 373(8), 714

(2014): Everson GT+, Gastroenterology 146(2), 42017% (with asunaprevir and beclabuvir)

(2014): Lok AS+, J Hepatol 60(3), 490 (with asunaprevir)

(2014): Sulkowski MS+, N Engl J Med 370(3), 211

Renal failure 

(2018): Kwo P+, Hepatol Commun 2(4), 3549–12%

(2017): Liao H+, Clin Res Hepatol Gastroenterol 41(3), 262 [REVIEW]8%

Cough 

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]9%

Dyspnea 

(2018): Lee BS+, Gut Liver Oct, Epub ahead of print (with asunaprevir)

(2017): Kutala BK+, Hepat Med 9, 671%

Influenza 

(2015): Jafri SM+, Expert Opin Drug Saf 14(11), 1787 [REVIEW]2%

Nasopharyngitis 

(2017): Tarao K+, World J Hepatol 9(11), 5444–9% (with asunaprevir)

(2014): Kumada H+, Hepatology 59(6), 208330–31% (with asunaprevir)

Pulmonary toxicity 

(2016): Kamada T+, Respir Investig 54(3), 207 (with asunaprevir)

Adverse effects 

(2019): Jang ES+, J Med Virol Aug, Epub ahead of print35% (with asunaprevir)

(2019): Klimova EA+, Ter Arkh (Russian) 91(8), 67-7443% (with narlaprevir and ritonavir)

(2017): Hezode C+, Clin Infect Dis 64(11), 1615 (with ribavirin, simeprevir and sofosbuvir)

(2016): Hagiwara S+, Dig Dis 34(6), 620 (with asunaprevir)

(2016): Kumada H+, J Gastroenterol Hepatol 31(1), 1414% (grade 3 or 4) (with asunaprevir)

(2016): Patel P+, J Cutan Med Surg 20(1), 58 [REVIEW] (cutaneous)

(2015): Jensen D+, J Hepatol 63(1), 306% (serious) (with asunaprevir, PEG-interferon and ribavirin)

(2015): Muir AJ+, JAMA 313(17), 1736 (with asunaprevir and beclabuvir)

(2015): Piroth L+, Clin Infect Dis 61(5), 81728% (serious) (with asunaprevir, PEG-interferon and ribavirin)

(2014): Kumada H+, Hepatology 59(6), 20836–7% (serious) (with asunaprevir)

Infection 

(2017): Liao H+, Clin Res Hepatol Gastroenterol 41(3), 262 [REVIEW]26%



Visit Informa

Click on the DRUG REVIEW ARTICLE tab (above) to see a review of daclatasvir in the Taylor & Francis journal Expert Opinion on Drug Safety. (Note that non-subscribers to the journal will only be able to see an abstract of the article.)

Adverse reactions attributed to entire drug class COVID-19 putative drug

Cutaneous adverse reaction  

(2020): Tursen U+, Dermatol Ther May, Epub ahead of print [REVIEW]

Cardiovascular adverse effect 

(2020): Carpenter A+, Front Cardiovasc Med 7, 85 [REVIEW]

(2020): Giudicessi JR+, Mayo Clin Proc May, Online ahead of print [REVIEW]

(2020): Naksuk N+, Eur Heart J Acute Cardiovasc Care May, Epub ahead of print [REVIEW]

(2020): Sarayani A+, Res Social Adm Pharm Apr, Epub ahead of print [REVIEW]

(2020): Zhang D+, Zhongguo Zhong Yao Za Zhi (Chinese) 45(10), 2275-2286 [REVIEW]

Neuropsychiatric disturbances 

(2020): García CAC+, Gen Hosp Psychiatry Jun, Online ahead of print [REVIEW]

Gastrointestinal disorder 

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print23%

Hepatic disorder 

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print14%

Thrombocytopenia 

(2020): Nham E+, Infect Chemother Apr, Epub ahead of print

Adverse effects 

(2020): Favilli A+, J Matern Fetal Neonatal Med Jun, Online ahead of print [REVIEW]

(2020): Griffiths G+, Trials 21(1), 544

(2020): Patil VM+, Life Sci May, Epub ahead of print [REVIEW]

(2020): Rhodes NJ+, medRxiv Jun, Preprint

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print38%

(2020): Svensson M, Lakartidningen (Swedish) Apr, 117

(2020): Wen CY+, Zhonghua Nei Ke Za Zhi (Chinese) May, Epub ahead of print

(2020): Zhong H+, Pharmacol Res Apr, Epub ahead of print [REVIEW]

Adverse reactions attributed to entire drug class Direct-acting antiviral

Anemia 

(2019): Ridruejo E+, Nefrologia Jun, Epub ahead of print

Adverse effects 

(2019): Ridruejo E+, Nefrologia Jun, Epub ahead of print30%

Page last updated 07/01/2020

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric
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