Darunavir

BreastfeedingPediatric
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

Abacavir, Alfuzosin, Almotriptan, Alosetron, Alprazolam, Amiodarone, Antifungals, Apixaban, Artemether/Lumefantrine, Astemizole, Atorvastatin, Bortezomib, Brinzolamide, Calcium channel blockers, Captopril, Carbamazepine, Ciclesonide, Cisapride, Clarithromycin, Colchicine, Conivaptan, Cyclosporine, CYP2D6 substrates, CYP3A4 inhibitors, inducers and substrates, Dabigatran, Dasatinib, Deferasirox, Delavirdine, Didanosine, Dienogest, Digoxin, Dihydroergotamine, Dronedarone, Duloxetine, Dutasteride, Efavirenz, Elbasvir & Grazoprevir, Enfuvirtide, Eplerenone, Ergotamine, Estrogens, Etravirine, Everolimus, Fentanyl, Fesoterodine, Food, Fusidic Acid, Glecaprevir & Pibrentasvir, Guanfacine, Halofantrine, HMG-CoA reductase inhibitors, Indinavir, Inhaled corticosteroids, Ixabepilone, Ketoconazole, Lidocaine, Lopinavir, Lovastatin, Maraviroc, Meperidine, Methadone, Methylprednisolone, Midazolam, Mifepristone, Mometasone, Nefazodone, Nilotinib, Nisoldipine, Olaparib, P-glycoprotein substrates, Paricalcitol, Paroxetine Hydrochloride, Pazopanib, Phenobarbital, Phenytoin, Pimecrolimus, Pimozide, Prasugrel, Pravastatin, Protease inhibitors, Quetiapine, Quinidine, Quinine, Ranolazine, Rifabutin, Rifampin, Rilpivirine, Rivaroxaban, Romidepsin, Rosuvastatin, Salmeterol, Saquinavir, Saxagliptin, Sertraline, Sildenafil, Silodosin, Simeprevir, Simvastatin, Sirolimus, Sorafenib, St John's Wort, Tacrolimus, Tadalafil, Tamsulosin, Telaprevir, Temsirolimus, Tenofovir Disoproxil, Terfenadine, Theophylline, Tolvaptan, Topotecan, Trazodone, Triazolam, Tricyclic antidepressants, Vardenafil, Voriconazole, Warfarin, Zidovudine

PREGNANCY CATEGORY: C

Under investigation for treating COVID-19

See adverse reactions attributed to class:

Antiretroviral

COVID-19 putative drug

HIV-1 protease inhibitor

Darunavir is a sulfonamide and can be absorbed systemically. Sulfonamides can produce severe, possibly fatal, reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome.

Prezcobix is darunavir and cobicistat.

Angioedema <2%

(package insert)

DRESS syndrome 

(2014): Almudimeegh A+, Br J Dermatol 171(4), 895 (with adiazine, levetiracetam, pyrimethamine and HAART)

Hypersensitivity <2%

(2017): Eyer-Silva WA+, Rev Soc Bras Med Trop 50(4), 575 (with raltegravir)

(2015): Sanchez-Olivas MA+, Rev Alerg Mex (Spanish) 62(2), 142 [REVIEW]

Lipodystrophy 

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

Pruritus <2%

(package insert)

Rash 6–10%

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

(2014): Kakuda TN+, J Clin Pharmacol 54(8), 949 (with cobicistat)

(2014): Lin KY+, J Infect Chemother 20(8), 465

(2014): Nishijima T+, J Infect Chemother 20(4), 28511% (generally mild)

(2014): Santini-Oliveira M+, Expert Opin Drug Saf 13(12), 1623 [REVIEW]

(2012): Santos JR+, PLoS One 7(5), e37442

(2012): Smith KY+, J Natl Med Assoc 104(7-8), 366

(2010): Currier J+, Ann Intern Med 153(6), 349

(2008): Borras-Blasco J+, J Antimicrob Chemother 62(5), 879

Stevens-Johnson syndrome <2%

(package insert)

Toxic epidermal necrolysis Life threatening

(2009): Pahk R+, Clin Exp Dermatol 34(8), e775 (with abacavir)

Urticaria <2%

(package insert)

Abnormal dreams <2%

(package insert)

Anorexia 2%

(package insert)

Headache 7%

(2016): Fatkenheuer G+, HIV Med 17(6), 453

(2015): Molina JM+, Lancet HIV 2(4), e1275%

(2014): Clotet B+, Lancet 383(9936), 222210%

(2014): Kakuda TN+, J Clin Pharmacol 54(8), 949 (with cobicistat)

(2014): Moshkovich GF+, Ter Arkh (Russian) 86(11), 29

(2009): Arasteh K+, Antivir Ther 14(6), 8592%

Neuropsychiatric disturbances 

(2019): Vizcarra P+, Antivir Ther June, Epub ahead of print (3 cases) (with dolutegravir boosted with cobicistat and ritonavir)

Neurotoxicity 

(2010): Winston A+, HIV Clin Trials 11(3), 16316%

Peripheral neuropathy 

(2013): Lorber M, J Int Assoc Provid AIDS Care 12(3), 162 [REVIEW]

Cushing's syndrome 

(2013): Hall JJ+, Int J STD AIDS 24(9), 748 (with triamcinolone)

Diabetes mellitus 2%

(new onset or exacebated) (package insert)

Hyperbilirubinemia 

(2013): Mora-Peris B+, J Antimicrob Chemother 68(6), 1348 (with maraviroc)

Hyperlipidemia  

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

Abdominal distension 2%

(package insert)

Abdominal pain 6%

(package insert)

Diarrhea 9–14%

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

(2015): Molina JM+, Lancet HIV 2(4), e12724%

(2014): Clotet B+, Lancet 383(9936), 222229%

(2014): Moshkovich GF+, Ter Arkh (Russian) 86(11), 29

(2013): Orkin C+, HIV Med 14(1), 495%

(2012): Banhegyi D+, Curr HIV Res 10(2), 171

(2012): Smith KY+, J Natl Med Assoc 104(7-8), 366

(2011): Phung BC+, Expert Rev Anti Infect Ther 9(6), 631 [REVIEW]

(2010): Currier J+, Ann Intern Med 153(6), 349

(2009): Arasteh K+, Antivir Ther 14(6), 8593%

Dyspepsia <3%

(package insert)

Flatulence <2%

(package insert)

Gastrointestinal disorder 

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

(2014): Zorrilla CD+, HIV Med 15(1), 5025%

(2012): Santos JR+, PLoS One 7(5), e37442

Hepatotoxicity <2%

(2016): Antinori A+, Drug Des Devel Ther 10, 1589

(2010): Ortu F+, Eur J Med Res 15(2), 81

(2008): AIDS Read 18(7), 348

(2008): AIDS Read 18(5), 235

(2008): AIDS Patient Care STDS. 22(4), 346

(2008): Vispo E, AIDS Rev 10(1), 63

Nausea 4–7%

(2015): Molina JM+, Lancet HIV 2(4), e12714%

(2014): Clotet B+, Lancet 383(9936), 222218%

(2014): Moshkovich GF+, Ter Arkh (Russian) 86(11), 29

(2012): Smith KY+, J Natl Med Assoc 104(7-8), 366

(2010): Currier J+, Ann Intern Med 153(6), 349

(2009): Arasteh K+, Antivir Ther 14(6), 8592%

Pancreatitis <2%

(package insert)

Vomiting  2–5%

(2009): Arasteh K+, Antivir Ther 14(6), 8593%

Asthenia (fatigue) 2–3%

(package insert)

Osteonecrosis <2%

(package insert)

Nephrolithiasis 

(2014): Izzedine H+, Clin Kidney J 7(2), 121 [REVIEW]

Adverse effects 

(2016): EPPICC Study Group, Antivir Ther 21(4), 353 (serious / 1 case)Pediatric

(2014): Gazzola L+, HIV Clin Trials 15(4), 1406% (with etravirine)

(2014): Kakuda TN+, J Clin Pharmacol 54(8), 949 (gastrointestinal / with cobicistat)

(2014): Macias J+, HIV Med 15(7), 417 (with maraviroc)

(2014): Podzamczer D+, J Antimicrob Chemother 69(9), 253610% (with abacavir and lamivudine)

(2011): Elgadi MM+, Drugs R D 11(4), 29525%

Death 

(2008): AIDS Read 18(5), 235

Infection 

(2014): Zorrilla CD+, HIV Med 15(1), 5044%



Adverse reactions attributed to entire drug class Antiretroviral

Hematological adverse effect 

(2019): Oumar AA+, Int J Basic Clin Pharmacol 8(5), 83115%

Optic neuropathy 

(2013): Wang MY+, J Neuroophthalmol 33(2), 172 [REVIEW]

Adverse effects 

(2019): Oumar AA+, Int J Basic Clin Pharmacol 8(5), 83142%

(2014): Lorio M+, J Int Assoc Provid AIDS Care 13(5), 4666%

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]

Adverse reactions attributed to entire drug class HIV-1 protease inhibitor

Eczema 

(2015): Descamps V+, Br J Dermatol 173(1), 311

Xerosis 

(2015): Descamps V+, Br J Dermatol 173(1), 311

Page last updated 05/07/2020

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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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