Drug side effects
darunavir Side Effects
The reactions most often reported to the FDA for darunavir (also sold as Prezista), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 14,896
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2006 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of darunavir come from 14,896 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 14,896 reports to the FDA Adverse Event Reporting System (FAERS) for darunavir (Prezista): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
14,896
Reports Mentioning Death
1,479
9.9% of reports — not proof the medicine caused the death
Hospitalizations
4,607
30.9% of reports
Top Indication
Hiv Infection
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,479 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 493 |
| FOETAL EXPOSURE DURING PREGNANCY | 177 |
| TREATMENT FAILURE | 112 |
| DRUG RESISTANCE | 98 |
| CD4/CD8 RATIO DECREASED | 96 |
| CD4 LYMPHOCYTES DECREASED | 84 |
| CARDIAC ARREST | 59 |
| DRUG INTERACTION | 54 |
| PNEUMONIA | 54 |
| DIARRHOEA | 53 |
| RENAL FAILURE | 50 |
| ANAEMIA | 42 |
| COMPLETED SUICIDE | 42 |
| HEART DISEASE CONGENITAL | 40 |
| RESPIRATORY FAILURE | 40 |
| HYPOTENSION | 39 |
| ANXIETY | 38 |
| TOXICITY TO VARIOUS AGENTS | 37 |
| ACUTE KIDNEY INJURY | 36 |
Reactions in Hospitalization Reports
Top reactions in 4,607 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 385 |
| ACUTE KIDNEY INJURY | 318 |
| PAIN | 260 |
| ANXIETY | 235 |
| RENAL FAILURE | 234 |
| EMOTIONAL DISTRESS | 229 |
| PYREXIA | 225 |
| DIARRHOEA | 217 |
| ANHEDONIA | 202 |
| NAUSEA | 180 |
| ANAEMIA | 171 |
| CHRONIC KIDNEY DISEASE | 168 |
| RENAL IMPAIRMENT | 151 |
| RASH | 137 |
| VOMITING | 137 |
| ASTHENIA | 135 |
| HOSPITALISATION | 133 |
| PNEUMONIA | 132 |
| IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME | 131 |
Nearby, Related Medications
What the FAERS Data Reveals About darunavir Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 14,896 voluntary reports linked to darunavir and its brand equivalents (Prezista), spanning 2006 through 2025. Of those, 1,479 (9.9%) listed death as an outcome and 4,607 (30.9%) involved hospitalization. The most common indication reported alongside adverse events was Hiv Infection.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 36% were female and 63% male; age distribution skews toward 45-64, with 4,091 reports in that bracket. The single most reported reaction is foetal exposure during pregnancy with 1,150 submissions, followed by drug interaction and pain.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to darunavir's 14,896.
Read our methodology - how this data is sourced, computed, and verified.