Darunavir
Pronunciation: da-ROO-na-veer.
- Generic name
- darunavir
- Brand names
- Daruvir, Prezista, Darunavir, Daruviren
- Drug class
- HIV-1 Protease Inhibitor
Availability and supply rules vary by country
Trade names by country: Canada
Australia: · Full directory
What darunavir is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how darunavir works
Darunavir is a nonpeptidic HIV-1 protease inhibitor. It binds to the active site of the HIV-1 protease enzyme, preventing the cleavage of viral polyproteins into functional proteins required for viral maturation. This results in the production of immature, noninfectious viral particles, thereby reducing viral replication. (1)
What darunavir is used for
HIV infection
Darunavir, always co-administered with ritonavir or cobicistat and other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older. (2)
Before taking darunavir
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to darunavir or excipients, and in those taking drugs highly dependent on CYP3A for clearance. (Contraindication) (2)
Tell your clinician about
(2)How to take darunavir
- General Instructions: Take darunavir exactly as prescribed by your healthcare provider. It is usually taken once or twice daily with food, and always in combination with a boosting agent (ritonavir or cobicistat) and other antiretroviral drugs.. Adult Dosing: For treatment-naïve adults: 800 mg once daily with 100 mg ritonavir or 150 mg cobicistat, taken with food. For treatment-experienced adults: 600 mg twice daily with 100 mg ritonavir, taken with food.. Pediatric Dosing: Dosing in children (aged 3 years and older) is based on body weight and should be determined by a pediatric HIV specialist. Always use the oral suspension or tablet formulation as directed.. Administration: Swallow tablets whole with food. Do not crush or chew. Oral suspension should be shaken well before use and measured with the provided dosing syringe.. When To Stop: Do not stop taking darunavir without consulting your healthcare provider, as this may cause the virus to become resistant. Discontinue only if directed by your doctor due to severe side effects or laboratory abnormalities.. Storage: Store tablets at room temperature (68°F to 77°F or 20°C to 25°C). Keep in the original container and protect from moisture. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember with food. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or contact a Poison Control Center immediately. There is no specific antidote; treatment is supportive and symptomatic. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Diarrhea
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Nausea
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Rash
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Headache
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Abdominal pain
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Vomiting
Incidence: Common (>=5%, moderate intensity or higher, per FDA label)
Signs of severe skin reaction (widespread rash, blistering, peeling skin, mouth sores)
Incidence: Uncommon but serious
Signs of liver problems (yellowing of skin or eyes, dark urine, unusual tiredness, abdominal pain)
Incidence: Uncommon but serious
Serious warnings
May cause severe skin reactions, including Stevens-Johnson syndrome — serious
Symptoms: May cause severe skin reactions, including Stevens-Johnson syndrome. Can cause liver problems, especially in patients with pre-existing liver disease. May interact with many other medications; always inform your healthcare provider of all drugs you take. Risk of immune reconstitution syndrome as the immune system recovers. Not recommended for use in patients with severe hepatic impairment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to darunavir or excipients, and in those taking drugs highly dependent on CYP3A for clearance. Use with caution in patients with hepatic impairment, hemophilia, or a history of sulfonamide allergy. Monitor for skin reactions and liver toxicity.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Darunavir is metabolized by CYP3A4 and has significant drug-drug interactions. It should not be used with drugs that are highly dependent on CYP3A for clearance or with strong CYP3A inducers (e.g., rifampin, St. John’s wort). It may increase levels of certain statins, antiarrhythmics, and sedatives, and decrease effectiveness of hormonal contraceptives. Always review all medications with your healthcare provider before starting darunavir. | (1) |
| Alfuzosin, ergot derivatives, cisapride, pimozide, oral midazolam, triazolam, St. John's Wort, lovastatin, simvastatin, rifampin, sildenafil (when used for pulmonary arterial hypertension) | Co-administration with darunavir/ritonavir is contraindicated per FDA labelling due to the potential for serious or life-threatening reactions or loss of therapeutic effect. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Pregnancy Category C: darunavir should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Discuss individual risk and benefit with your healthcare provider. (2)
Breastfeeding
Mothers taking darunavir are instructed not to breastfeed, because of the potential for HIV transmission through breast milk and the potential for serious adverse reactions in a nursing infant. (2)
Children
Frequency: Once daily. Weight Based: Children aged 3 years and older: 8 mg/kg (up to a maximum of 800 mg) once daily with food when used in combination with a ritonavir booster.. Max Daily Dose: 800 mg. Max Single Dose: 800 mg. Age Restrictions: Not recommended for pediatric use in children under 3 years of age. Safety not established in children under this age. (2)
Renal_impairment
Hepatic impairment: no dose adjustment is needed for mild or moderate hepatic impairment; darunavir is not recommended for patients with severe hepatic impairment because it has not been studied in this group. Renal impairment: no dose adjustment is needed; darunavir pharmacokinetics have not been significantly affected by moderate renal impairment in available studies, but caution is advised as darunavir has not been studied in severe renal impairment or dialysis. (2)
Hepatic_impairment
Hepatic impairment: no dose adjustment is needed for mild or moderate hepatic impairment; darunavir is not recommended for patients with severe hepatic impairment because it has not been studied in this group. Renal impairment: no dose adjustment is needed; darunavir pharmacokinetics have not been significantly affected by moderate renal impairment in available studies, but caution is advised as darunavir has not been studied in severe renal impairment or dialysis. (2)
Monitoring
(2)Storage
Store tablets at room temperature, 68°F to 77°F (20°C to 25°C). Keep in the original container and protect from moisture. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: HIV infection
Dose summary: 800 mg once daily with food when used in combination with a ritonavir booster.
Renal context: No dose adjustment is needed for renal impairment; darunavir pharmacokinetics have not been significantly affected by moderate renal impairment. Darunavir has not been studied in severe renal impairment or in patients on dialysis, so caution and clinician oversight are advised in that group. (1) (2)
Frequently asked questions
What is darunavir used for?
Darunavir is used to treat HIV-1 infection in adults and children aged 3 years and older, always in combination with other antiretroviral medicines.
How should I take darunavir?
Take darunavir exactly as prescribed, with food, and always with a boosting agent (ritonavir or cobicistat). Do not skip doses.
What are the most common side effects?
Common side effects include diarrhea, nausea, headache, abdominal pain, and rash. Most are mild and temporary.
Can I take darunavir if I have liver problems?
Darunavir should be used with caution in patients with mild to moderate liver disease and is not recommended in severe hepatic impairment.
Are there any serious risks with darunavir?
Serious risks include severe skin reactions, liver toxicity, and drug interactions. Seek medical help if you notice signs of allergic reaction or liver problems.
Can I stop taking darunavir if I feel better?
No, do not stop taking darunavir without your doctor’s advice. Stopping can lead to drug resistance and treatment failure.
Does darunavir cure HIV?
No, darunavir does not cure HIV. It helps control the virus and improve immune function when taken as part of combination therapy.
What happens if I take too much Darunavir?
Taking too much Darunavir may lead to an exacerbation of side effects, though specific overdose symptoms are not well-defined. If you suspect an overdose, it is crucial to seek immediate emergency medical attention. Contact your local poison control center or emergency services without delay for guidance and treatment.
Can I drink alcohol while taking Darunavir?
While there are no specific contraindications against moderate alcohol consumption with Darunavir, it is generally advisable to limit alcohol intake. Alcohol can potentially increase the risk of liver-related side effects, which can also be a concern with some HIV medications. Always discuss alcohol consumption with your healthcare provider.
Is Darunavir safe during pregnancy?
Darunavir's safety during pregnancy falls under a category that requires careful consideration. It is essential for pregnant individuals or those planning pregnancy to consult their doctor. Your healthcare provider will weigh the potential benefits of treatment against any potential risks to the fetus and determine the most appropriate course of action for your specific situation.
What is the mechanism of action of darunavir?
Darunavir is a nonpeptidic HIV-1 protease inhibitor. It binds to the active site of the HIV-1 protease enzyme, preventing the cleavage of viral polyproteins into functional proteins required for viral maturation. This results in the production of immature, noninfectious viral particles, thereby reducing viral replication. (1)
What is the generic name of Darunavir?
The generic name is darunavir. It is sold under brand names including Daruvir, Prezista, Darunavir, Daruviren.
What class of drug is darunavir?
Darunavir is classed as: HIV-1 Protease Inhibitor.
References
- Darunavir clinician-authored medicine recordMedGuideGlobal · Global · accessed 2026-08-06 · source 1
- PREZISTA (darunavir) tablets, film coated — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- SYMTUZA (DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS LP] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Darunavir — FDA approval record (Drugs@FDA ANDA214085)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- darunavir — RxNorm normalized drug concept (RXCUI 2637854)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient darunavir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
Canada
- PREZISTA