Prescription medication · HIV Protease Inhibitor
darunavir
Also sold as Prezista. Darunavir is used to treat HIV-1 infection in adults and children 3 years and older.
Data updated 2026-05-15
- 14,896
- FDA reportsModerately reported
- 101
- InteractionsMany interactions
- 96% less
- Generic vs brandHuge savings
- $34.91
- Brand price (NADAC)
What the data shows
darunavir (Prezista) is a prescription HIV Protease Inhibitor, reported less often than most tracked drugs (14,896 FDA reports), whose generic costs a fraction of the brand (about 96% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
darunavir (Prezista) is a prescription HIV Protease Inhibitor. Darunavir is used to treat HIV-1 infection in adults and children 3 years and older.
Darunavir is a medicine used to treat HIV. It belongs to a class of drugs called protease inhibitors and must be taken with ritonavir.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from darunavir's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 14,896 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for darunavir, by number of reports
- Foetal Exposure During Pregnancy
Foetal Exposure During Pregnancy
1,150 reports
- Drug Interaction
Drug Interaction
981 reports
- Pain
Pain
889 reports
- Emotional Distress
Emotional Distress
812 reports
- Anxiety
Anxiety
811 reports
- Anhedonia
Anhedonia
704 reports
- Chronic Kidney Disease
Chronic Kidney Disease
569 reports
- Exposure During Pregnancy
Exposure During Pregnancy
565 reports
- Maternal Exposure During Pregnancy
Maternal Exposure During Pregnancy
535 reports
- Diarrhoea
Diarrhoea
497 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for darunavir each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where darunavir sits
darunavir has more FDA adverse-event reports than 48% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is darunavir; the line is the median (50th percentile).
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
Reports Mentioning Death
1,479
9.9% of reports — not proof of cause
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for darunavir?
Related Medications in HIV Protease Inhibitor
Other drugs grouped near darunavir - same-class peers and common alternatives.
acyclovir
Zovirax
Acyclovir is an antiviral medicine.
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albendazole
Albenza
Albendazole is a medicine that fights parasites.
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amphotericin B
Ambisome, Fungizone
Amphotericin B liposome is an antifungal medicine.
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anidulafungin
Eraxis
Eraxis is an antifungal medicine.
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atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for darunavir: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 14,896.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.93%.
- naproxen Δ 0.01 pts · 75,912 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 9.92%death share
- eplerenone Δ 0.02 pts · 12,113 reports · Aldosterone Antagonist 9.91%death share
- doxycycline hyclate Δ 0.03 pts · 63,762 reports · Tetracycline Antibiotic (Antimalarial) 9.90%death share
- famciclovir Δ 0.03 pts · 2,678 reports · Antiviral (Nucleoside Analog) 9.90%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 14,896 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 29, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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