Ledipasvir & Sofosbuvir

BreastfeedingPediatric

FDA APPROVAL DATE: 10/10/2014

CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

Amiodarone, Carbamazepine, Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil, Oxcarbazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Rifapentine, Ritonavir, Rosuvastatin, Simeprevir, St John's Wort, Tenofovir Disoproxil

PREGNANCY CATEGORY: N/A
Insufficient evidence to inform drug-associated risk; contra-indicated in pregnancy when given with ribavirin

Under investigation for treating COVID-19

See adverse reactions attributed to class:

COVID-19 putative drug

See also separate entry for sofosbuvir.

Angioedema 

(2016): Hynicka LM+, Ann Pharmacother 50(6), 516

Edema 

(2017): Latt NL+, World J Gastroenterol 23(26), 47591%

Pruritus 

(2017): Latt NL+, World J Gastroenterol 23(26), 47591%

(2017): Ozono Y+, World J Hepatol 9(36), 1340<10%

(2016): Singh T+, Liver Int 36(6), 802

(2015): Alqahtani SA+, Hepatology 62(1), 25

(2015): Bourliere M+, Lancet Infect Dis 15(4), 397

(2014): Afdhal N+, N Engl J Med 370(20), 18894–5%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<2%

Rash 

(2017): Latt NL+, World J Gastroenterol 23(26), 47593%

(2015): Alqahtani SA+, Hepatology 62(1), 25

(2015): Canadian Agency for Drugs and Technologies in Health, CADTH Rapid Response Reports Jan, Epub [REVIEW]<16%

(2014): Afdhal N+, N Engl J Med 370(16), 14832–6%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<2%

Wound complications 

(2014): Afdhal N+, N Engl J Med 370(16), 14831% (with ribavirin)

Xerosis 

(2014): Afdhal N+, N Engl J Med 370(16), 14833%

Aphthous stomatitis 

(2016): Lim YS+, Hepatol Int 10(6), 947

Nasal congestion 

(2015): Osinusi A+, JAMA 313(12), 123216%

Angina 

(2014): Afdhal N+, N Engl J Med 370(16), 14831%

Atrial fibrillation 

(2017): Hagiwara S+, Oncology 92 Suppl 1, 3

Bradycardia 

(2017): Hagiwara S+, Oncology 92 Suppl 1, 3

(2015): Prescrire Int 24(166), 285 (with amiodarone)

(2015): Fazel Y+, Expert Opin Drug Saf 14(8), 1317 [REVIEW] (with amiodarone)

Cardiac failure 

(2017): Hagiwara S+, Oncology 92 Suppl 1, 3

Chest pain 

(2014): Afdhal N+, N Engl J Med 370(16), 14831%

Hypertension 

(2015): Prescrire Int 24(166), 285

Myopericarditis 

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

QT prolongation 

(2017): Hagiwara S+, Oncology 92 Suppl 1, 3

Anxiety 

(2017): Latt NL+, World J Gastroenterol 23(26), 47591%

Fever (pyrexia) 

(2018): Murray KF+, Hepatology Aug, Epub ahead of print (with ribavirin)

Headache 11–17%

(2018): Ahmed OA+, Infect Drug Resist 11, 2952%

(2018): Asahina Y+, Liver Int Jan, Epub ahead of print

(2018): Isakov V+, Clin Drug Investig 38(3), 23952%

(2018): Modi AA+, Aliment Pharmacol Ther Mar, Epub ahead of print

(2018): Murray KF+, Hepatology Aug, Epub ahead of print (with ribavirin)

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

(2017): Gane EJ+, Gastroenterology 152(6), 136626%

(2017): He X+, World J Hepatol 9(30), 119013%

(2017): Johnson SW+, Int J Antimicrob Agents 49(6), 778

(2017): Latt NL+, World J Gastroenterol 23(26), 475913%

(2017): Liao HT+, Transplant Proc 49(8), 1855 [REVIEW]24%

(2017): Liu CJ+, Gastroenterology Nov, Epub ahead of print

(2017): Mangia A+, Aliment Pharmacol Ther 46(4), 424

(2017): Ozono Y+, World J Hepatol 9(36), 1340<10%

(2017): Rockstroh JK+, Lancet Gastroenterol Hepatol 2(5), 34723%

(2017): Walsh CE+, Haemophilia 23(2), 198

(2017): Zeng QL+, J Hepatol 66(6), 112310%

(2016): Abergel A+, Lancet Infect Dis 16(4), 45927%

(2016): Chuang WL+, J Gastroenterol Hepatol 31(7), 132314%

(2016): Gamal N+, Expert Opin Drug Saf 15(4), 549 [REVIEW]

(2016): Lim YS+, Hepatol Int 10(6), 9478%

(2016): McConachie SM+, Expert Rev Clin Pharmacol 9(2), 287 [REVIEW]>5%

(2016): Saab S+, Hepatology 63(4), 1112>10%

(2016): Saab S+, Hepatology 63(4), 1112>10%

(2016): Singh T+, Liver Int 36(6), 802

(2016): Wilder JM+, Hepatology 63(2), 437

(2015): Prescrire Int 24(166), 285

(2015): Bourliere M+, Lancet Infect Dis 15(4), 397

(2015): Fazel Y+, Expert Opin Drug Saf 14(8), 1317 [REVIEW]

(2015): Gane EJ+, Gastroenterology 149(6), 1454

(2015): Mizokami M+, Lancet Infect Dis 15(6), 6457%

(2015): Reddy KR+, Hepatology 62(1), 7923%

(2015): Smith MA+, Ann Pharmacother 49(3), 343 [REVIEW]

(2015): Smith MA+, Expert Opin Drug Saf 14(11), 1649

(2015): Waheed Y, World J Virol 4(1), 33

(2015): Wyles D+, Hepatology 61(6), 1793 (with ribavirin)

(2014): Afdhal N+, N Engl J Med 370(16), 148323–26%

(2014): Gane EJ+, Gastroenterology 146(3), 736

(2014): Kowdley KV+, N Engl J Med 370(20), 187914–15%

(2014): Lawitz E+, Lancet 383(9916), 515

Insomnia 3–6%

(2018): Ahmed OA+, Infect Drug Resist 11, 2952%

(2018): Modi AA+, Aliment Pharmacol Ther Mar, Epub ahead of print

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

(2017): Latt NL+, World J Gastroenterol 23(26), 47595%

(2017): Ozono Y+, World J Hepatol 9(36), 1340<10%

(2017): Walsh CE+, Haemophilia 23(2), 198

(2016): Gamal N+, Expert Opin Drug Saf 15(4), 549 [REVIEW]

(2016): McConachie SM+, Expert Rev Clin Pharmacol 9(2), 287 [REVIEW]>5%

(2016): Wilder JM+, Hepatology 63(2), 437

(2015): Alqahtani SA+, Hepatology 62(1), 25

(2015): Smith MA+, Ann Pharmacother 49(3), 343

(2015): Smith MA+, Expert Opin Drug Saf 14(11), 1649

(2014): Afdhal N+, N Engl J Med 370(16), 14838–12%

(2014): Kowdley KV+, N Engl J Med 370(20), 18795–7%

Irritability 

(2017): Latt NL+, World J Gastroenterol 23(26), 47591%

(2015): Prescrire Int 24(166), 285

(2015): Alqahtani SA+, Hepatology 62(1), 25

(2014): Afdhal N+, N Engl J Med 370(20), 18895–8%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<4%

Neuropsychiatric disturbances 

(2019): Chen JJ+, J Gastroenterol Hepatol Aug, Epub ahead of print1–3%

Seizures 

(2014): Afdhal N+, N Engl J Med 370(16), 14831%

Sleep related disorder 

(2015): Prescrire Int 24(166), 285

Vertigo (dizziness) 

(2017): Latt NL+, World J Gastroenterol 23(26), 47592%

(2014): Afdhal N+, N Engl J Med 370(16), 14833–6%

(2014): Kowdley KV+, N Engl J Med 370(20), 18793–4%

Acidosis 

(2018): Rosenthal E+, HIV Med 19(3), 22729% (mild)

Creatine phosphokinase increased 

(2014): Osinusi A+, Ann Intern Med 161(9), 634 (grade 3)

Hypercholesterolemia  

(2014): Osinusi A+, Ann Intern Med 161(9), 634 (grade 3)

Hypokalemia 

(2018): Rosenthal E+, HIV Med 19(3), 22713% (mild)

Hypophosphatemia 

(2018): Rosenthal E+, HIV Med 19(3), 22750% (mild)

(2014): Osinusi A+, Ann Intern Med 161(9), 634 (grade 3)

Abdominal pain 

(2018): Isakov V+, Clin Drug Investig 38(3), 23926%

Cholecystitis 

(2014): Afdhal N+, N Engl J Med 370(16), 14831% (with ribavirin)

Constipation 

(2017): Ozono Y+, World J Hepatol 9(36), 1340<10%

(2014): Kowdley KV+, N Engl J Med 370(20), 18794%

Diarrhea 3–7%

(2018): Ahmed OA+, Infect Drug Resist 11, 2951%

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

(2017): He X+, World J Hepatol 9(30), 11903%

(2017): Latt NL+, World J Gastroenterol 23(26), 47592%

(2017): Liao HT+, Transplant Proc 49(8), 1855 [REVIEW]19%

(2017): Walsh CE+, Haemophilia 23(2), 198

(2017): Zeng QL+, J Hepatol 66(6), 112311%

(2016): McConachie SM+, Expert Rev Clin Pharmacol 9(2), 287 [REVIEW]>5%

(2015): Kohli A+, Lancet Infect Dis 15(9), 1049 (2 cases)

(2015): Smith MA+, Ann Pharmacother 49(3), 343 [REVIEW]

(2015): Smith MA+, Expert Opin Drug Saf 14(11), 1649

(2015): Wyles D+, Hepatology 61(6), 1793 (with ribavirin)

(2014): Afdhal N+, N Engl J Med 370(20), 188911%

(2014): Kowdley KV+, N Engl J Med 370(20), 18794–7%

Gastrointestinal bleeding 

(2014): Afdhal N+, N Engl J Med 370(16), 14831%

Gastrointestinal ulceration 

(2017): Ueda Y+, J Gastroenterol 52(8), 986 (3 cases)

Hepatotoxicity 

(2017): Latt NL+, World J Gastroenterol 23(26), 4759 (1 case)

(2015): Prescrire Int 24(166), 285

(2014): Afdhal N+, N Engl J Med 370(16), 14831%

Nausea 6–9%

(2018): Ahmed OA+, Infect Drug Resist 11, 2952%

(2018): Modi AA+, Aliment Pharmacol Ther Mar, Epub ahead of print

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

(2017): Gane EJ+, Gastroenterology 152(6), 136617%

(2017): Latt NL+, World J Gastroenterol 23(26), 47594%

(2017): Liao HT+, Transplant Proc 49(8), 1855 [REVIEW]22%

(2017): Mangia A+, Aliment Pharmacol Ther 46(4), 424

(2017): Walsh CE+, Haemophilia 23(2), 198

(2016): Gamal N+, Expert Opin Drug Saf 15(4), 549 [REVIEW]

(2016): McConachie SM+, Expert Rev Clin Pharmacol 9(2), 287 [REVIEW]>5%

(2016): Singh T+, Liver Int 36(6), 802

(2016): Wilder JM+, Hepatology 63(2), 437

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

(2015): Fazel Y+, Expert Opin Drug Saf 14(8), 1317 [REVIEW]

(2015): Kohli A+, Lancet Infect Dis 15(9), 1049 (2 cases)

(2015): Smith MA+, Ann Pharmacother 49(3), 343 [REVIEW]

(2015): Smith MA+, Expert Opin Drug Saf 14(11), 1649

(2015): Waheed Y, World J Virol 4(1), 33

(2014): Afdhal N+, N Engl J Med 370(20), 188911–13%

(2014): Gane EJ+, Gastroenterology 146(3), 736

(2014): Kowdley KV+, N Engl J Med 370(20), 18797–11%

(2014): Lawitz E+, Lancet 383(9916), 515

Vomiting  

(2016): Singh T+, Liver Int 36(6), 802

Anemia 

(2018): Asahina Y+, Liver Int Jan, Epub ahead of print (with ribavirin)

(2017): Liao HT+, Transplant Proc 49(8), 1855 [REVIEW]42%

(2016): Ciesek S+, Transpl Infect Dis 18(3), 32658% (with ribavirin)

(2015): Canadian Agency for Drugs and Technologies in Health, CADTH Rapid Response Reports Jan, Epub [REVIEW]<1%

(2015): Mizokami M+, Lancet Infect Dis 15(6), 64514% (with ribavirin)

(2014): Afdhal N+, N Engl J Med 370(20), 188910–12% (with ribavirin)

(2014): Kowdley KV+, N Engl J Med 370(20), 18791%

(2014): Lawitz E+, Lancet 383(9916), 515

Bleeding 

(2017): Walsh CE+, Haemophilia 23(2), 198 (1 case)

Hemoglobin decreased 

(2017): Mangia A+, Aliment Pharmacol Ther 46(4), 424

Arthralgia 

(2017): Latt NL+, World J Gastroenterol 23(26), 47594%

(2014): Afdhal N+, N Engl J Med 370(16), 14836%

(2014): Kowdley KV+, N Engl J Med 370(20), 18794–7%

Asthenia (fatigue) 7–18%

(2018): Ahmed OA+, Infect Drug Resist 11, 29518%

(2018): Modi AA+, Aliment Pharmacol Ther Mar, Epub ahead of print

(2018): Pyrsopoulos N+, Eur J Gastroenterol Hepatol Feb, Epub ahead of print

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

(2017): Gane EJ+, Gastroenterology 152(6), 136621%

(2017): He X+, World J Hepatol 9(30), 119010%

(2017): Johnson SW+, Int J Antimicrob Agents 49(6), 778

(2017): Latt NL+, World J Gastroenterol 23(26), 475914%

(2017): Liao HT+, Transplant Proc 49(8), 1855 [REVIEW]39%

(2017): Liu CJ+, Gastroenterology Nov, Epub ahead of print

(2017): Mangia A+, Aliment Pharmacol Ther 46(4), 424

(2017): Rockstroh JK+, Lancet Gastroenterol Hepatol 2(5), 34727%

(2017): Walsh CE+, Haemophilia 23(2), 198

(2017): Zeng QL+, J Hepatol 66(6), 112318%

(2016): Abergel A+, Lancet Infect Dis 16(4), 45939%

(2016): Gamal N+, Expert Opin Drug Saf 15(4), 549 [REVIEW]

(2016): Gane EJ+, Antivir Ther 21(7), 60525%

(2016): Lim YS+, Hepatol Int 10(6), 9476%

(2016): McConachie SM+, Expert Rev Clin Pharmacol 9(2), 287 [REVIEW]>5%

(2016): Saab S+, Hepatology 63(4), 1112>10%

(2016): Saab S+, Hepatology 63(4), 1112>10%

(2016): Wilder JM+, Hepatology 63(2), 437

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

(2015): Prescrire Int 24(166), 285

(2015): Alqahtani SA+, Hepatology 62(1), 25

(2015): Bourliere M+, Lancet Infect Dis 15(4), 397

(2015): Fazel Y+, Expert Opin Drug Saf 14(8), 1317 [REVIEW]

(2015): Gane EJ+, Gastroenterology 149(6), 1454

(2015): Kohli A+, Lancet Infect Dis 15(9), 1049 (3 cases)

(2015): Mizokami M+, Lancet Infect Dis 15(6), 6455%

(2015): Reddy KR+, Hepatology 62(1), 7914–19%

(2015): Smith MA+, Ann Pharmacother 49(3), 343 [REVIEW]

(2015): Smith MA+, Expert Opin Drug Saf 14(11), 1649

(2015): Waheed Y, World J Virol 4(1), 33

(2015): Wyles D+, Hepatology 61(6), 1793 (with ribavirin)

(2014): Afdhal N+, N Engl J Med 370(20), 188921–24%

(2014): Gane EJ+, Gastroenterology 146(3), 736

(2014): Kowdley KV+, N Engl J Med 370(20), 187921–23%

Muscle spasm 

(2014): Afdhal N+, N Engl J Med 370(16), 1483<2%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<3%

Myalgia/Myositis/Myopathy/Myotoxicity 

(2017): Latt NL+, World J Gastroenterol 23(26), 47594%

(2015): Prescrire Int 24(166), 285

(2015): Osinusi A+, JAMA 313(12), 123214%

Nephrotoxicity 

(2017): Latt NL+, World J Gastroenterol 23(26), 4759 (1 case)

(2016): Bunnell KL+, Pharmacotherapy 36(9), e148 (with tenofovir disoproxil)

(2016): Wanchoo R+, Am J Gastroenterol 111(1), 148

Proteinuria 

(2018): Rosenthal E+, HIV Med 19(3), 22754% (mild)

Alveolar hemorrhage (pulmonary) 

(2017): Ueda Y+, J Gastroenterol 52(8), 986 (1 case)

Cough 

(2018): Ahmed OA+, Infect Drug Resist 11, 2951%

(2017): Latt NL+, World J Gastroenterol 23(26), 47592%

(2014): Afdhal N+, N Engl J Med 370(20), 18893–7%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<3%

Dyspnea 

(2015): Prescrire Int 24(166), 285

(2014): Afdhal N+, N Engl J Med 370(16), 14833%

(2014): Kowdley KV+, N Engl J Med 370(20), 1879<1%

Interstitial lung disease 

(2020): Omotani S+, J Pharm Health Care Sci Apr, eCollection (1 case)

Nasopharyngitis 

(2018): Asahina Y+, Liver Int Jan, Epub ahead of print

(2017): Rockstroh JK+, Lancet Gastroenterol Hepatol 2(5), 34727%

(2015): Mizokami M+, Lancet Infect Dis 15(6), 64529%

Pleural effusion 

(2017): Ueda Y+, J Gastroenterol 52(8), 986 (1 case)

Upper respiratory tract infection 

(2017): Liu CJ+, Gastroenterology Nov, Epub ahead of print

(2016): Gane EJ+, Antivir Ther 21(7), 60525%

(2016): Simon TG+, Antivir Ther 21(3), 185

(2015): Gane EJ+, Gastroenterology 149(6), 1454

(2015): Kohli A+, Lancet Infect Dis 15(9), 1049 (2 cases)

(2014): Afdhal N+, N Engl J Med 370(16), 14834–6%

(2014): Lawitz E+, Lancet 383(9916), 515

Adverse effects 

(2019): Buggisch P+, PLoS One 14(4), e02147955% (grade 3–4)

(2019): Chen JJ+, J Gastroenterol Hepatol Aug, Epub ahead of print18%

(2018): Pyrsopoulos N+, Eur J Gastroenterol Hepatol Feb, Epub ahead of print (gastrointestinal)

(2017): Nagao A+, J Acquir Immune Defic Syndr 74(4), 41846%

(2016): Manns M+, Lancet Infect Dis 16(6), 685 (with ribavirin)

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

(2016): Simon TG+, Antivir Ther 21(3), 185 (gastrointestinal)

(2015): Alqahtani SA+, Hepatology 62(1), 2545%

Death 

(2017): Nagao A+, J Acquir Immune Defic Syndr 74(4), 418 (1 case)

Infection 

(2017): Ueda Y+, J Gastroenterol 52(8), 986 (2 cases)

(2016): Gane EJ+, Antivir Ther 21(7), 60563% (viral)



Visit Informa

Click on the DRUG REVIEW ARTICLE tab (above) to see a review of ledipasvir & sofosbuvir 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): 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]

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

(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]

Page last updated 05/07/2020

Drug Eruption Mobile Site

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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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