Drug · FAERS side-effect profile with label screen
Darunavir side effects: what 15,030 FDA adverse event reports show
Who reports
15,030 reports · 88% serious · 1,497 with death outcome · 36% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Darunavir, co-administered with ritonavir (darunavir/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 .
FDA label, Indications and Usage
What it is
Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir which has the following chemical name: [(1S,2R)-3-[[(4.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 36
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,043 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Progressive external ophthalmoplegia | 92 | 3,419.4 2,335.6–5,006.3ROR 3,440.5 · χ² 89,200 / p <1e-300 | 814.0 EB05 683.7 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=92 · ♀ 0% (drug 36%) · 95% clinician | no trial arm names this drug |
| Cloacal exstrophy | 32 | 1,629.9 976.8–2,719.5ROR 1,633.4 · χ² 23,099 / p <1e-300 | 515.2 EB05 382.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=32 · 93% clinician | no trial arm names this drug |
| Cd4/cd8 ratio decreased | 97 | 1,282.6 973.1–1,690.7ROR 1,291.0 · χ² 63,613 / p <1e-300 | 586.8 EB05 495.1 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=97 | no trial arm names this drug |
| Bladder agenesis | 32 | 1,047.8 661.7–1,659.1ROR 1,050.0 · χ² 18,404 / p <1e-300 | 438.5 EB05 325.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=32 · 93% clinician | no trial arm names this drug |
| Supernumerary nipple | 25 | 636.7 396.4–1,022.6ROR 637.7 · χ² 10,415 / p <1e-300 | 326.6 EB05 232.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 36%) | no trial arm names this drug |
| Hiv associated nephropathy | 15 | 589.4 322.0–1,078.9ROR 590.0 · χ² 5,762 / p <1e-300 | 270.6 EB05 174.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial arm names this drug |
| Gastrointestinal disorder congenital | 31 | 576.1 378.9–875.9ROR 577.3 · χ² 12,141 / p <1e-300 | 324.8 EB05 239.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=31 · 93% clinician | no trial arm names this drug |
| Hemivertebra | 41 | 440.5 310.0–625.9ROR 441.7 · χ² 13,286 / p <1e-300 | 288.9 EB05 222.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial arm names this drug |
| Aids encephalopathy | 14 | 437.6 239.9–798.3ROR 438.0 · χ² 4,301 / p <1e-300 | 228.8 EB05 144.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Hiv-associated neurocognitive disorder | 26 | 420.7 271.2–652.5ROR 421.4 · χ² 8,017 / p <1e-300 | 260.7 EB05 186.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial arm names this drug |
| Congenital naevus | 30 | 392.9 262.0–589.4ROR 393.7 · χ² 8,819 / p <1e-300 | 256.0 EB05 188.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 36%) | no trial arm names this drug |
| Blood hiv rna | 11 | 378.2 194.1–736.9ROR 378.5 · χ² 2,956 / p <1e-300 | 196.3 EB05 117.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial arm names this drug |
| Caudal regression syndrome | 31 | 341.1 230.2–505.2ROR 341.8 · χ² 8,152 / p <1e-300 | 234.1 EB05 172.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=31 · 93% clinician | no trial arm names this drug |
| Meconium stain | 29 | 319.0 213.1–477.7ROR 319.7 · χ² 7,207 / p <1e-300 | 221.5 EB05 161.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial arm names this drug |
| Acoustic stimulation tests abnormal | 28 | 305.6 203.0–460.1ROR 306.2 · χ² 6,708 / p <1e-300 | 213.9 EB05 155.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 36%) | no trial arm names this drug |
| Genitalia external ambiguous | 31 | 300.2 203.6–442.6ROR 300.8 · χ² 7,345 / p <1e-300 | 214.2 EB05 158.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=31 · 93% clinician | no trial arm names this drug |
| Csf hiv escape syndrome | 24 | 289.5 186.5–449.5ROR 290.0 · χ² 5,464 / p <1e-300 | 201.2 EB05 142.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial arm names this drug |
| Congenital genital malformation | 26 | 266.8 175.4–406.0ROR 267.3 · χ² 5,546 / p <1e-300 | 192.2 EB05 137.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | no trial arm names this drug |
| Cd4 lymphocytes abnormal | 32 | 250.0 171.6–364.3ROR 250.6 · χ² 6,507 / p <1e-300 | 188.1 EB05 139.5 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=31 | no trial arm names this drug |
| Scrotal cyst | 13 | 248.3 137.6–448.1ROR 248.5 · χ² 2,507 / p <1e-300 | 161.1 EB05 100.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Mitochondrial toxicity | 118 | 233.8 192.5–284.0ROR 235.7 · χ² 23,183 / p <1e-300 | 193.8 EB05 166.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=118 · ♀ 5% (drug 36%) | no trial arm names this drug |
| Congenital intestinal malformation | 16 | 220.0 129.8–372.9ROR 220.3 · χ² 2,821 / p <1e-300 | 155.1 EB05 101.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Tethered cord syndrome | 30 | 216.0 147.0–317.3ROR 216.4 · χ² 5,364 / p <1e-300 | 167.1 EB05 122.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial arm names this drug |
| Ectopic kidney | 12 | 206.3 112.5–378.3ROR 206.4 · χ² 1,957 / p <1e-300 | 140.0 EB05 85.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Gastrointestinal malformation | 25 | 186.8 123.1–283.7ROR 187.2 · χ² 3,907 / p <1e-300 | 146.4 EB05 104.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial arm names this drug |
| Congenital pulmonary valve disorder | 12 | 181.3 99.4–331.0ROR 181.5 · χ² 1,745 / p <1e-300 | 128.2 EB05 78.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Lipodystrophy acquired | 244 | 180.2 157.8–205.7ROR 183.2 · χ² 38,292 / p <1e-300 | 157.5 EB05 141.6 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=243 | no trial arm names this drug |
| Congenital musculoskeletal disorder | 10 | 178.6 92.4–345.1ROR 178.7 · χ² 1,410 / p <1e-300 | 122.0 EB05 70.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Ventricular hypoplasia | 27 | 169.5 113.7–252.8ROR 169.8 · χ² 3,879 / p <1e-300 | 136.6 EB05 98.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=27 · 93% clinician | no trial arm names this drug |
| Foetal growth abnormality | 16 | 155.0 92.4–259.8ROR 155.1 · χ² 2,063 / p <1e-300 | 119.8 EB05 78.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Karyotype analysis abnormal | 11 | 154.4 82.8–287.8ROR 154.5 · χ² 1,372 / p 1e-300 | 112.4 EB05 67.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial arm names this drug |
| Congenital anomaly in offspring | 13 | 150.2 84.8–266.3ROR 150.4 · χ² 1,605 / p <1e-300 | 113.4 EB05 70.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Teratogenicity | 28 | 142.1 96.3–209.6ROR 142.4 · χ² 3,429 / p <1e-300 | 118.6 EB05 86.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial arm names this drug |
| Bone demineralisation | 97 | 140.3 113.9–172.8ROR 141.2 · χ² 12,046 / p <1e-300 | 124.3 EB05 104.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=92 | no trial arm names this drug |
| Spine malformation | 32 | 139.7 97.1–200.9ROR 140.0 · χ² 3,875 / p <1e-300 | 118.1 EB05 87.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=32 | no trial arm names this drug |
| Virologic failure | 482 | 136.8 124.8–150.1ROR 141.3 · χ² 59,006 / p <1e-300 | 123.9 EB05 114.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=472 · 97% clinician | no trial arm names this drug |
| Anogenital dysplasia | 13 | 131.5 74.4–232.2ROR 131.6 · χ² 1,419 / p <1e-300 | 102.4 EB05 63.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Plagiocephaly | 43 | 130.8 95.7–178.8ROR 131.2 · χ² 4,941 / p <1e-300 | 113.6 EB05 87.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=43 | no trial arm names this drug |
| Congenital mitral valve incompetence | 11 | 118.2 63.9–218.7ROR 118.3 · χ² 1,071 / p 3e-235 | 92.0 EB05 54.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Laryngomalacia | 26 | 116.1 77.8–173.2ROR 116.3 · χ² 2,630 / p <1e-300 | 99.5 EB05 71.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 36%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Darunavir only as a background or rescue medication (NCT00811954, NCT00042289); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 1,163 | 20.2 19.1–21.4ROR 21.9 · χ² 21,027 / p <1e-300 | 20.0 EB05 19.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.1 | no trial arm names this drug |
| Drug interaction | 987 | 8.7 8.2–9.3ROR 9.3 · χ² 6,750 / p <1e-300 | 8.7 EB05 8.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 93% clinician | no trial arm names this drug |
| Pain | 890 | 2.0 1.9–2.2ROR 2.1 · χ² 470 / p 2e-104 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial arm names this drug |
| Emotional distress | 813 | 9.4 8.8–10.0ROR 9.9 · χ² 6,079 / p <1e-300 | 9.3 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 93% consumer | no trial arm names this drug |
| Anxiety | 812 | 4.0 3.7–4.3ROR 4.1 · χ² 1,827 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial arm names this drug |
| Anhedonia | 705 | 38.1 35.4–41.0ROR 39.9 · χ² 24,789 / p <1e-300 | 37.1 EB05 34.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · 100% consumer | no trial arm names this drug |
| Chronic kidney disease | 571 | 10.5 9.6–11.3ROR 10.8 · χ² 4,857 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial arm names this drug |
| Exposure during pregnancy | 570 | 12.9 11.9–14.0ROR 13.4 · χ² 6,202 / p <1e-300 | 12.8 EB05 11.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 · ♀ 100% (drug 36%) | no trial arm names this drug |
| Maternal exposure during pregnancy | 538 | 8.6 7.9–9.3ROR 8.8 · χ² 3,574 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · ♀ 100% (drug 36%) | no trial arm names this drug |
| Death | 501 | 0.8 0.7–0.9ROR 0.8 · χ² 23 / p 9e-7 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 501 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.032 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial arm names this drug |
| Renal failure (kidney failure) | 498 | 5.2 4.8–5.7ROR 5.4 · χ² 1,693 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 492 | 4.5 4.1–4.9ROR 4.6 · χ² 1,349 / p 1e-295 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 90% clinician | no trial arm names this drug |
| Virologic failure | 482 | 136.8 124.8–150.1ROR 141.3 · χ² 59,006 / p <1e-300 | 123.9 EB05 114.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=472 · 97% clinician | no trial arm names this drug |
| Drug ineffective (drug did not work) | 437 | 0.5 0.4–0.5ROR 0.4 · χ² 290 / p 2e-65 | 0.5 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial arm names this drug |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Progressive external ophthalmoplegia — n=92, PRR 3,419.4
- Cloacal exstrophy — n=32, PRR 1,629.9
- Bladder agenesis — n=32, PRR 1,047.8
- Supernumerary nipple — n=25, PRR 636.7
- Gastrointestinal disorder congenital — n=31, PRR 576.1
- Hemivertebra — n=41, PRR 440.5
- Hiv-associated neurocognitive disorder — n=26, PRR 420.7
- Congenital naevus — n=30, PRR 392.9
- Caudal regression syndrome — n=31, PRR 341.1
- Meconium stain — n=29, PRR 319.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Darunavir?
In FDA FAERS, the most frequently co-reported reaction terms for Darunavir are pain, emotional distress, anxiety, anhedonia, chronic kidney disease, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Darunavir have an FDA boxed warning?
No. The FDA label retrieved for Darunavir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Darunavir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 04a542b3-15ad-4a8a-aab4-ace8e08732f3, effective 20240429; matched on
openfda.generic_name.exact:"DARUNAVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,083 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
DARUNAVIR, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.