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darunavir

Prezista · ATC code J05AE10

Brand names: Prezista, Darunavir Ratiopharm, Darunasta, Darunavir Al, Darunavir Amarox, Darunavir Beta, Darunavir Heumann, Darunavir Hexal, Darunavir Hormosan, Darunavir Puren, Darunavir Vivanta, Darunavir Zentiva

Key facts
Active substance
darunavir
Drug class
Direct acting antiviral
ATC code
J05AE10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
PREZISTA 100 mg/ml oral suspension · PREZISTA 75 mg film-coated tablets / PREZISTA 150 mg film-coated tablets / PREZISTA 600 mg film-coated tablets · PREZISTA 400 mg film-coated tablets / PREZISTA 800 mg film-coated tablets
Marketing authorisation holder
Janssen-Cilag International NV
Information as of
2026-10-28

Key facts

Darunavir (Prezista) is an HIV protease inhibitor that is always taken with a pharmacokinetic enhancer (ritonavir or cobicistat) and other antiretroviral medicines.

What it is used for

  • Treatment of HIV-1 infection in combination with other antiretrovirals: with low-dose ritonavir in adults and children from 3 years and at least 15 kg; with cobicistat in adults and adolescents aged 12 years and older weighing at least 40 kg.
  • Choice should be guided by treatment history and resistance testing.

Dosing

  • ART-naïve adults: 800 mg once daily with cobicistat 150 mg or ritonavir 100 mg once daily, taken with food.
  • ART-experienced adults: 600 mg twice daily with ritonavir 100 mg twice daily, with food; 800 mg once daily may be used without darunavir resistance-associated mutations, with HIV-1 RNA < 100,000 copies/ml and CD4+ count ≥100 cells x 10⁶/L.
  • The 75 mg, 150 mg and 600 mg tablets are mainly used to build the twice-daily regimen; the oral suspension (100 mg/ml) is for patients unable to swallow tablets.
  • Children from 3 years (at least 15 kg): weight-based dose (e.g. treatment-naïve with ritonavir: 600 mg at 15 to < 30 kg, 675 mg at 30 to < 40 kg, 800 mg at ≥40 kg once daily); see the full text for details.
  • Mild to moderate hepatic impairment: no dose adjustment, but caution. The ritonavir or cobicistat dose should not be altered.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Severe hepatic impairment (Child-Pugh Class C).
  • Co-administration with strong CYP3A inducers such as rifampicin, St John's wort preparations, or lopinavir/ritonavir.
  • Co-administration with substances highly dependent on CYP3A whose elevated levels cause serious events (e.g. alfuzosin, amiodarone, dronedarone, ivabradine, quinidine, ranolazine, colchicine in renal or hepatic impairment); see the full text for the complete list.

Important warnings

  • Regular assessment of virological response; resistance testing if response is lost.
  • Severe skin reactions (0.4%), rarely DRESS and Stevens-Johnson syndrome; discontinue immediately if signs appear. Caution with known sulphonamide allergy.
  • Drug-induced hepatitis (0.5%); liver tests should be monitored and interruption or discontinuation considered if liver injury develops.
  • Once-daily dosing in ART-experienced patients is not for those with resistance mutations, HIV-1 RNA ≥100,000 copies/ml or CD4+ < 100 cells x 10⁶/L.
  • Caution in the elderly because of limited data.

Side effects

  • Most frequent: diarrhoea, nausea, rash, headache and vomiting; 51.3% of treatment-experienced subjects had at least one adverse reaction.
  • Most frequent serious reactions: acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.

Interactions

  • Darunavir/ritonavir inhibits CYP3A, CYP2D6 and P-gp and can raise levels of many medicines; CYP3A inducers can lower darunavir levels.
  • The interaction profile differs depending on the enhancer (ritonavir or cobicistat); see the full text for details.

Pregnancy and breastfeeding

  • Darunavir with ritonavir in pregnancy only if the benefit justifies the risk; darunavir with cobicistat should not be started in pregnancy, and women who become pregnant should be switched to another regimen.
  • Women should be instructed not to breast-feed while taking darunavir.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Darunavir RatiopharmTeva B.V · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • DarunastaTad Pharma Gmbh · 1 register entry
  • Darunavir AlAliud Pharma Gmbh · 1 register entry
  • Darunavir AmaroxAmarox Pharma Gmbh · 1 register entry
  • Darunavir BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Darunavir HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Darunavir HexalHexal Ag · 1 register entry
  • Darunavir HormosanHormosan Pharma Gmbh · 1 register entry
  • Darunavir PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Darunavir RatiopharmRatiopharm Gmbh · 1 register entry
  • Darunavir VivantaVivanta Generics S.R.O. · 1 register entry
  • Darunavir ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • PrezistaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 18 more European countries
Croatia
Darunavir Sandoz
Cyprus
Darunavir Accord, Davarino, Rezavir
Denmark
Darunavir "sandoz", Darunavir "stada", Darunavir Accord, Darunavir Glenmark, Darunavir Medical Valley, Darunavir Stada, Davarino
Estonia
Darunavir Auxilia, Darunavir Sandoz
Finland
Darunavir Accord, Darunavir Medical Valley, Darunavir Sandoz, Darunavir Stada
France
Darunavir Accord, Darunavir Arrow, Darunavir Biogaran, Darunavir Eg, Darunavir Sandoz, Darunavir Teva, Darunavir Zentiva
Greece
Darunavir Accord, Darunavir Vocate, Davarino, Dodefar
Iceland
Darunavir Krka, Darunavir Medical Valley, Darunavir Viatris, Prezista
Ireland
Darunavir Clonmel, Darunavir Rowex
Italy
Darunavir Aurobindo, Darunavir Sandoz, Darunavir Tillomed
Liechtenstein
Darunavir Viatris, Prezista
Netherlands
Darunavir Amarox, Darunavir Glenmark, Darunavir Medicopharm, Darunavir Propylene Glycolate Aurobindo, Darunavir Sandoz, Darunavir Stada, Darunavir Teva, Darunavir Vocate, Darunavir Xiromed
Norway
Darunavir Accord, Darunavir Krka, Darunavir Medical Valley, Darunavir Viatris, Prezista
Poland
Darunavir Aurovitas, Darunavir Sandoz
Portugal
Darunavir Accord, Darunavir Farmoz, Darunavir Generis, Darunavir Sandoz, Darunavir Zentiva
Romania
Darunavir Sandoz, Darunavir Teva
Spain
Darunavir Aurovitas, Darunavir Kern Pharma, Darunavir Sandoz, Darunavir Tarbis, Darunavir Vivanta
Sweden
Darunavir Accord, Darunavir Amarox, Darunavir Glenmark, Darunavir Medical Valley, Darunavir Sandoz, Darunavir Stada

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Prezista – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/prezista-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC J05AE.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.