MID-VOLUME · HOSP-HEAVY
darunavir Side Effects
darunavir (also sold as Prezista) sits MID-VOLUME #274 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 30.9% mention hospitalization (4,607 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 14,896
- FAERS reports
FDA Adverse Event Reporting System extract for darunavir. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
darunavir: 30.9% mention hospitalization (4,607 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #274 of 524 by FAERS report count.
Mid-book FAERS page for darunavir (Prezista) (14,896 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2006–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FOETAL EXPOSURE DURING PREGNANCY leads 1,150 of 14,896 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (4,091 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,479 reports, 9.9%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization is HEAVY (4,607, 30.9% of the book). Top reactions in those rows:
| 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 |
How to read darunavir FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 14,896 voluntary reports linked to darunavir (Prezista), 2006-2025. Death is listed on 1,479 (9.9%). Hospitalization appears on 4,607 (30.9%). Top co-reported indication: Hiv Infection.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 30.9% mention hospitalization (4,607 reports).
Read with darunavir
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 14,954 FAERS cases (Δ 58 heavier vs darunavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 14,997 FAERS cases (Δ 101 heavier vs darunavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 15,113 FAERS cases (Δ 217 heavier vs darunavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 14,664 FAERS cases (Δ 232 lighter vs darunavir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.2 pp vs darunavir's DEATH-HEAVY): CASELOAD · HOSP-MID.
darunavir stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.