Darunavir Brand names: Prezista

What is darunavir used for?

From the label: indications and usage

PREZISTA, co-administered with ritonavir (PREZISTA/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) ]. PREZISTA 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. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.

Conditions named in the indications of darunavir's FDA labels, with every medicine labeled for each:

• HIV

FDA pharmacologic class: Protease Inhibitor.

What does the patient leaflet for darunavir say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about PREZISTA?

Ask your healthcare provider or pharmacist about medicines that should not be taken with PREZISTA. For more information, see " Who should not take PREZISTA? " and " What should I tell my healthcare provider before taking PREZISTA? " PREZISTA may cause liver problems. Some people taking PREZISTA in combination with ritonavir have developed liver problems, which may be life-threatening. Your healthcare provider should do blood tests before and during your PREZISTA and ritonavir combination treatment. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider if you have any of the below signs and symptoms of liver problems. dark (tea colored) urine yellowing of your skin or whites of your eyes pale colored stools (bowel movements) nausea vomiting pain or tenderness on your right side below your ribs loss of appetite tiredness PREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. Tell your healthcare provider right away if you develop a rash. Stop taking PREZISTA and ritonavir combination treatment and tell your healthcare provider right away if you have any skin changes with symptoms below: fever tiredness muscle or joint pain blisters or skin lesions mouth sores or ulcers red or inflamed eyes, like "pink eye" (conjunctivitis) Rash occurred more often in people taking PREZISTA and raltegravir together than with either drug separately, but was generally mild. See " What are the possible side effects of PREZISTA? " for more information about side effects.

From the patient leaflet: How should I store PREZISTA?

Store PREZISTA oral suspension and tablets at room temperature 77°F (25°C). Do not refrigerate or freeze PREZISTA oral suspension. Keep PREZISTA oral suspension away from high heat. PREZISTA oral suspension should be stored in the original container. Keep PREZISTA and all medicines out of the reach of children.

Is there a generic for darunavir (Prezista)?

The FDA approved the first generic darunavir on November 21, 2017. 11 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 8 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists darunavir from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 1 patent for Prezista tablets: the compound patent runs to December 26, 2026 (pediatric exclusivity to June 26, 2027). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for darunavir (Prezista)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.16 per Darunavir 600 mg tablet, down 4% from $1.21 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has darunavir been recalled?

The FDA's Enforcement Report lists 1 recall naming darunavir since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of darunavir and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

What does the darunavir label say about other medicines?

The darunavir label names 130 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name darunavir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Every other medicine the darunavir label names

Other labels that name darunavir

• Cobicistat
• Deferasirox
• Ethinyl estradiol and etonogestrel
• Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
• Ethinyl estradiol and ferrous fumarate and levonorgestrel
• Ethinyl estradiol and levonorgestrel
• Ethinyl estradiol and norelgestromin
• Ethinyl estradiol and norgestimate
• Ethinyl estradiol and segesterone
• Ledipasvir and sofosbuvir

Check darunavir against other medicines

What do FAERS reports show for darunavir?

The FDA Adverse Event Reporting System holds 15,039 reports that list darunavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,497 are coded as a death and 4,650 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 1,295
• 982
• 1,200
• 1,174
• 1,304
• 927
• 853
• 595
• 522
• 324
• 137

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Foetal Exposure During Pregnancy (a use or a product term, not a reaction)1,163
• Drug Interaction (a use or a product term, not a reaction)986
• Pain890
• Emotional Distress813
• Anxiety812
• Anhedonia705
• Chronic Kidney Disease571
• Exposure During Pregnancy (a use or a product term, not a reaction)570

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as darunavir?

42 other medicines are given the same way (oral) and in the same FDA class as darunavir or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as darunavir

How does darunavir compare with medicines for the same use?

1 side-by-side page set darunavir beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

• Atazanavir

What next?

Alternatives to darunavir

42 medicines for the same use

Other protease inhibitors

the pharmacologic class, with prices and generics

Darunavir side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other