Darunavir

Darunavir is an HIV-1 antiviral drug [see Microbiology ( 12.4 )] .

• Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 )]. Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.ICD-10: B20

• Co-administration of darunavir/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see Drug Interactions ( 7.3 )] .contraindicated

Testing: In treatment-experienced patients, treatment history genotypic and/or phenotypic testing is recommended prior to initiation of therapy with darunavir/ritonavir to assess drug susceptibility of the HIV-1 virus ( 2.1 , 12.4 ) Monitor serum liver chemistry tests before and during therapy with darunavir/ritonavir. ( 2.1 , 2.2 , 5.2 ) Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (one 800 mg tablet) taken with ritonavir 100 mg once daily and with food. ( 2.3 ) Treatment-experienced adult patients with at least one darunavir resistance associated substitution: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. ( 2.3 ) Pregnant patients: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. ( 2.4 ) Pediatric patients (3 to less than 18 years of age and weighing at least 10 kg): dosage of darunavir and ritonavir is based on body weight and should not exceed the adult dose. Darunavir should be taken with ritonavir and with food. ( 2.5 ) Darunavir/ritonavir is not recommended for use in patients with severe hepatic impairment. ( 2.6 ) 2.1 Testing Prior to Initiation of Darunavir/ritonavir In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus [see Microbiology ( 12.4 )]. Refer to Dosage and Administration ( 2.3 ), ( 2.4 ) and ( 2.5 ) for dosing recommendations.

Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis or in patients who have pre-treatment elevations of transaminases. Post-marketing cases of liver injury, including some fatalities, have been reported. ( 5.2 ) Skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis, have been reported. Discontinue treatment if severe reaction develops. ( 5.3 ) Use with caution in patients with a known sulfonamide allergy. ( 5.4 ) Patients may develop new onset diabetes mellitus or hyperglycemia. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. ( 5.6 ) Patients may develop redistribution/accumulation of body fat or immune reconstitution syndrome. ( 5.7 , 5.8 ) Patients with hemophilia may develop increased bleeding events. ( 5.9 ) Darunavir/ritonavir is not recommended in pediatric patients below 3 years of age in view of toxicity and mortality observed in juvenile rats dosed with darunavir up to days 23 to 26 of age. ( 5.10 ) 5.1 Importance of Co-administration with Ritonavir Darunavir must be co-administered with ritonavir and food to achieve the desired antiviral effect. Failure to administer darunavir with ritonavir and food may result in a loss of efficacy of darunavir.

The following adverse reactions are discussed in other sections of labeling: Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Severe Skin Reactions [see Warnings and Precautions ( 5.3 )] Diabetes Mellitus/Hyperglycemia [see Warnings and Precautions ( 5.6 )] Fat Redistribution [see Warnings and Precautions ( 5.7 )] Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.8 )] Hemophilia [see Warnings and Precautions ( 5.9 )] Due to the need for co-administration of darunavir with ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions. The most common clinical adverse drug reactions to darunavir/ritonavir (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Treatment Naïve-Adults: TMC114-C211 The safety assessment is based on all safety data from the Phase 3 trial TMC114-C211 comparing darunavir/ritonavir 800/100 mg once daily versus lopinavir/ritonavir 800/200 mg per day in 689 antiretroviral treatment-naïve HIV-1-infected adult subjects.

Pregnancy: Total darunavir exposures were generally lower during pregnancy compared to postpartum period. The reduction in darunavir exposures during pregnancy were greater for once daily dosing compared to the twice daily dosing regimen. ( 8.1 , 12.3 ) Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. ( 8.2 ) Pediatrics: Not recommended for patients less than 3 years of age. ( 8.4 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to darunavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263. Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage. Available limited data from the APR show no statistically significant difference in the overall risk of major birth defects for darunavir compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) [see Data]. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%.

Human experience of acute overdose with darunavir/ritonavir is limited. No specific antidote is available for overdose with darunavir. Treatment of overdose with darunavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Since darunavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.

• Jun 23, 2006NDANDA021976Janssen Prods
• Dec 16, 2011NDANDA202895Janssen Prods
• Jan 29, 2015NDANDA205395Janssen Prods
• Jul 17, 2018NDANDA210455Janssen Prods
• Sep 29, 2022ANDAANDA202073Lupin
• Sep 14, 2023ANDAANDA202083Hetero Labs Ltd Iii
• Nov 28, 2023ANDAANDA206288Cipla
• Nov 28, 2023ANDAANDA210677Aurobindo Pharma Ltd

1. 1Bone Density Decreased1,4157.5%
2. 2Pain1,3787.3%
3. 3Emotional Distress1,2716.7%
4. 4Anxiety1,2606.7%
5. 5Chronic Kidney Disease1,2206.4%
6. 6Foetal Exposure During Pregnancy1,2086.4%
7. 7Anhedonia1,1205.9%
8. 8Drug Interaction1,0685.6%
9. 9Renal Failure1,0505.5%
10. 10Osteoporosis9274.9%
11. 11Osteonecrosis8384.4%
12. 12Bone Loss7163.8%
13. 13Multiple Fractures6783.6%
14. 14Tooth Loss6723.6%
15. 15Acute Kidney Injury6603.5%

Recent PubMed references pinned to Darunavir as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The protease inhibitor darunavir prevents esophagitis and impairments in esophageal barrier function in a mouse model of GERD.
  American journal of physiology. Gastrointestinal and liver physiology · 2026 · Sales TMAL, Daniel AML, Silva LMGD, et al.
  PMID 42013031DOI 10.1152/ajpgi.00058.2025
• The dolutegravir failure cohort: A multi-country longitudinal cohort with a randomised clinical trial of continued dolutegravir versus switch to darunavir in people with viraemia while on dolutegravir in Sub-Saharan Africa (The Ndovu Study) protocol.
  PloS one · 2026 · Ombajo LA, Nkuranga J, Penner J, et al.
  PMID 41824511DOI 10.1371/journal.pone.0330792
• Dolutegravir restores gut microbiota in late-stage HIV-1 unlike darunavir: an open-label, randomized clinical trial.
  Nature communications · 2026 · Català-Moll F, Blázquez-Bondia C, Farré-Badia J, et al.
  PMID 41781390DOI 10.1038/s41467-026-69846-7
• Dosing of ritonavir-boosted darunavir for treatment of HIV in pregnancy.
  AIDS (London, England) · 2026 · Sconza R, Taylor GP, Ene L, et al.
  PMID 41670404DOI 10.1097/QAD.0000000000004461
• Virological outcomes with Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) in people previously treated with darunavir-based antiretroviral therapy.
  HIV medicine · 2026 · Sheridan R, Osei-Kuffour Ekert Y, Campbell L, et al.
  PMID 41622121DOI 10.1111/hiv.70204
• Coadministration of a crystalline drug compromises supersaturation and membrane transport of an amorphous drug.
  International journal of pharmaceutics · 2026 · Alkalla N, Alhalaweh A, Bergström CAS, et al.
  PMID 41241164DOI 10.1016/j.ijpharm.2025.126388
• Repurposing HIV-Protease Inhibitor Precursors as Anticancer Agents: The Synthetic Molecule RDD-142 Delays Cell Cycle Progression and Induces Autophagy in HepG2 Cells with Enhanced Efficacy via Liposomal Formulation.
  International journal of molecular sciences · 2025 · Crispo F, Vassallo A, Faraone I, et al.
  PMID 41226346DOI 10.3390/ijms262110305
• Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial.
  Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2026 · Miro JM, Torres F, Manzardo C, et al.
  PMID 41083105DOI 10.1016/j.cmi.2025.09.026

The 10 most recently updated of 279 ClinicalTrials.gov registrations naming Darunavir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
  Recruiting · Phase 4 · Interventional · 350 enrolled · Gilead Sciences
  NCT06337032updated 2026-06-10
• Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV
  Active not recruiting · Phase 2 · Interventional · 40 enrolled · Federal University of São Paulo
  NCT06799650updated 2026-06-01
• Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
  Active not recruiting · Phase 3 · Interventional · 600 enrolled · Gilead Sciences
  NCT06630299updated 2026-05-29
• A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
  Active not recruiting · Phase 2 · Interventional · 83 enrolled · Gilead Sciences
  NCT05729568updated 2026-04-27
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 133 enrolled · Gilead Sciences
  NCT02016924updated 2026-04-21
• Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
  Completed · Phase 3 · Interventional · 640 enrolled · ANRS, Emerging Infectious Diseases
  NCT03256422updated 2026-04-13
• Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
  Terminated · Phase 2 · Interventional · 93 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06005610updated 2026-04-08
• Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors
  Completed · Phase 2 · Interventional · 91 enrolled · ANRS, Emerging Infectious Diseases
  NCT02738502updated 2026-04-07
• Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136
  Completed · Phase 3 · Interventional · 225 enrolled · French National Agency for Research on AIDS and Viral Hepatitis
  NCT00421551updated 2026-04-07
• National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection
  Completed · Phase 3 · Interventional · 101 enrolled · ANRS, Emerging Infectious Diseases
  NCT02987530updated 2026-04-07

Frequently asked questions

How does Darunavir work?

Darunavir is an HIV-1 antiviral drug [see Microbiology ( 12.4 )] .

What is Darunavir used for?

According to FDA labeling, Darunavir carries indications including: Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 )]. Darunavir is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Darunavir?

Darunavir is classified as Protease inhibitors, Protease Inhibitor, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A Inhibitors, HIV Protease Inhibitors, Decreased Protein Synthesis.

What are the brand names for Darunavir?

Darunavir is marketed under brand names including Prezcobix, Prezista, Symtuza.

What are the contraindications for Darunavir?

Darunavir labeling lists contraindications including: Co-administration of darunavir/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see Drug Interactions ( 7.3 )] .. Always consult the full prescribing information and a clinician.