darunavir
Brand names: Prezista
Darunavir is a medicine used to treat HIV. It belongs to a class of drugs called protease inhibitors and must be taken with ritonavir.
Drug Pricing (NADAC)
Brand Price
$34.91/unit
Generic Price
$1.51/unit
Generic Savings
96%
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Darunavir is used to treat HIV-1 infection in adults and children 3 years and older.
Common side effects
Diarrhea, Nausea, Rash
Key warnings
Darunavir can cause liver problems.
How It Works
Darunavir is a protease inhibitor. It works by blocking an enzyme called protease that HIV needs to make copies of itself. This helps to slow down the spread of HIV in your body.
How to Take It
Take darunavir exactly as your doctor tells you. For adults who have never taken HIV medicine before, the usual dose is 800 mg once a day with 100 mg of ritonavir and food. If you have taken HIV medicine before, the dose may be 600 mg twice a day with 100 mg of ritonavir and food. Always take darunavir with food and ritonavir.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. The recommended dose during pregnancy is 600 mg twice daily with ritonavir 100mg and food. Women with HIV should not breastfeed because HIV can be passed to the baby through breast milk.
Missed Dose
If you miss a dose of darunavir, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store darunavir tablets at room temperature, between 68°F and 77°F. Keep out of reach of children.
Side Effects (from patient reports)
Based on 7,514 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 14,896 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
14,896
Death-Related Reports
1,479
Hospitalization Reports
4,607
Top Indication
Hiv Infection
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FOETAL EXPOSURE DURING PREGNANCY | 1,150 |
| 2 | DRUG INTERACTION | 981 |
| 3 | PAIN | 889 |
| 4 | EMOTIONAL DISTRESS | 812 |
| 5 | ANXIETY | 811 |
| 6 | ANHEDONIA | 704 |
| 7 | CHRONIC KIDNEY DISEASE | 569 |
| 8 | EXPOSURE DURING PREGNANCY | 565 |
| 9 | MATERNAL EXPOSURE DURING PREGNANCY | 535 |
| 10 | DIARRHOEA | 497 |
| 11 | RENAL FAILURE | 497 |
| 12 | DEATH | 496 |
| 13 | ACUTE KIDNEY INJURY | 485 |
| 14 | VIROLOGIC FAILURE | 474 |
| 15 | OSTEOPOROSIS | 436 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Darunavir can cause liver problems. Your doctor should check your liver before you start taking darunavir and during treatment. Tell your doctor right away if you have any signs of liver problems, such as yellowing of the skin or eyes.
Known Drug Interactions
Lipid Modifying Agents: HMG-CoA reductase inhibitors: lovastatin, simvastatin ↑ lovastatin ↑ simvastatin Co-administration is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.
Mechanism: Darunavir raises the level of lovastatin in the blood, which can lead to severe muscle breakdown.
What to do: Do not take these two drugs together because of the risk of serious side effects like muscle damage.
avanafil, sildenafil, tadalafil, vardenafil ↑ PDE-5 inhibitors (only the use of sildenafil at doses used for treatment of erectile dysfunction has been studied with darunavir/ritonavir) Co-administration with darunavir/ritonavir may result in an increase in PDE-5 inhibitor-associated adverse events, including hypotension, syncope, visual disturbances and priapism. Use of PDE-5 inhibitors for pulmonary arterial hypertension (PAH): Co-administration with sildenafil used for PAH is contraindicated due to potential for sildenafil associated adverse reactions (which include visual disturbances, ...
Mechanism: Darunavir increases the amount of sildenafil in your system, which can cause very low blood pressure or fainting.
What to do: Avoid using these drugs together, as the combination can lead to dangerous side effects like vision changes or fainting.
Antipsychotics: lurasidone ↑ lurasidone Co-administration is contraindicated due to potential for serious and/or life-threatening reactions.
Mechanism: Darunavir causes lurasidone to build up in the body to unsafe levels.
What to do: This combination should not be used because it can cause life-threatening reactions.
pimozide ↑ pimozide Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Mechanism: Darunavir increases the level of pimozide in the body, which can cause the heart to beat in a dangerous way.
What to do: Do not take these two medicines together because of the high risk of life-threatening heart rhythm problems.
Sedatives/hypnotics: orally administered midazolam, triazolam ↑ midazolam ↑ triazolam Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression. Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with darunavir may cause large increases in the concentrations of these benzodiazepines.
Mechanism: Darunavir blocks the enzyme that breaks down midazolam, causing the sedative to build up in your body. This can lead to dangerously deep sleep or breathing problems.
What to do: You should not take these two medicines together because the combination can be life-threatening.
Common Questions
Can I take darunavir by itself?
Do I need to take darunavir with food?
What should I do if I have side effects?
Can darunavir cure HIV?
Will darunavir interact with other medicines I am taking?
How often will I see my doctor while taking darunavir?
What tests will my doctor do while I am taking darunavir?
Can I drink alcohol while taking darunavir?
What do the numbers on the pill mean?
Can children take this medicine?
What are the common side effects of darunavir?
Does darunavir interact with other medications?
What drug class is darunavir?
Is there a generic version of darunavir?
Is darunavir safe during pregnancy?
Related Medications in HIV Protease Inhibitor
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amphotericin B
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atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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What the FDA Data Shows for darunavir
The FDA label for darunavir (sold under brand names such as Prezista) classifies it as a prescription-only medication in the HIV Protease Inhibitor class. Darunavir is used to treat HIV-1 infection in adults and children 3 years and older. Official labeling lists 6 commonly reported side effects, including Diarrhea, Nausea, Rash.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,514 voluntary reports. The database also lists 101 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.51 versus $34.91 for the brand — a 96% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 29, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages