Drug · FAERS side-effect profile with label screen
Darunavir combination (4 ingredients) side effects: what 2,717 FDA adverse event reports show
Who reports
2,717 reports · 75% serious · 109 with death outcome · 27% 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 adverse reaction 3Labeled (related wording) 4Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 28
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 22 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 |
|---|---|---|---|---|---|---|
| Bone loss | 601 | 318.0 295.7–341.8ROR 407.9 · χ² 182,106 / p <1e-300 | 302.3 EB05 282.6 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 250.3 · 100% consumer | no trial data cached |
| Skeletal injury | 371 | 283.5 257.4–312.2ROR 328.1 · χ² 100,464 / p <1e-300 | 269.6 EB05 247.3 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 216.1 · 100% consumer | no trial data cached |
| Bone density decreased | 1,056 | 266.0 253.4–279.2ROR 434.3 · χ² 269,547 / p <1e-300 | 255.9 EB05 243.2 · IC025 +7.7 3/3 methods agree | Lab value / disease marker | serious PRR 220.8 · 100% consumer | no trial data cached |
| Multiple fractures | 529 | 254.3 235.2–275.0ROR 315.5 · χ² 129,027 / p <1e-300 | 244.0 EB05 227.0 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 201.2 · 100% consumer | no trial data cached |
| Tooth loss | 557 | 211.4 196.1–227.9ROR 265.6 · χ² 113,390 / p <1e-300 | 204.3 EB05 190.4 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 167.5 · 100% consumer | no trial data cached |
| Osteonecrosis (bone death) | 600 | 142.2 132.4–152.7ROR 182.2 · χ² 82,561 / p <1e-300 | 139.0 EB05 129.9 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 108.0 · 98% consumer | no trial data cached |
| Osteopenia | 245 | 125.9 111.6–142.0ROR 138.2 · χ² 29,754 / p <1e-300 | 122.7 EB05 110.3 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 95.8 | no trial data cached |
| Renal injury | 424 | 110.5 101.2–120.7ROR 130.7 · χ² 45,300 / p <1e-300 | 108.4 EB05 100.0 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 83.9 · 100% consumer | no trial data cached |
| Anhedonia | 317 | 93.4 84.2–103.7ROR 105.6 · χ² 28,574 / p <1e-300 | 91.8 EB05 83.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.0 · 100% consumer | no trial data cached |
| Osteoporosis | 430 | 81.4 74.6–88.8ROR 96.5 · χ² 33,760 / p <1e-300 | 80.2 EB05 74.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 71.5 · 94% consumer | no trial data cached |
| Chronic kidney disease | 578 | 58.6 54.5–63.0ROR 74.1 · χ² 32,532 / p <1e-300 | 58.0 EB05 54.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · 100% consumer | no trial data cached |
| Vitamin d deficiency | 73 | 58.2 46.4–73.0ROR 59.8 · χ² 4,017 / p <1e-300 | 56.9 EB05 46.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 44.0 | no trial data cached |
| Economic problem | 101 | 50.9 42.0–61.6ROR 52.8 · χ² 4,859 / p <1e-300 | 50.1 EB05 42.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 39.9 · 100% consumer | no trial data cached |
| Nephropathy | 58 | 48.0 37.1–61.9ROR 49.0 · χ² 2,604 / p <1e-300 | 47.0 EB05 37.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 39.0 | no trial data cached |
| Fracture | 73 | 29.8 23.8–37.4ROR 30.6 · χ² 2,000 / p <1e-300 | 29.5 EB05 24.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 | no trial data cached |
| Renal failure (kidney failure) | 508 | 29.4 27.2–31.8ROR 35.9 · χ² 13,941 / p <1e-300 | 29.3 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.6 · 86% consumer | no trial data cached |
| Foot fracture | 62 | 25.2 19.7–32.3ROR 25.8 · χ² 1,415 / p <1e-300 | 25.0 EB05 20.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 | no trial data cached |
| Emotional distress | 353 | 22.5 20.4–24.8ROR 25.7 · χ² 7,240 / p <1e-300 | 22.4 EB05 20.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · 100% consumer | no trial data cached |
| Tooth fracture | 30 | 21.0 14.7–30.1ROR 21.3 · χ² 552 / p 3e-122 | 20.7 EB05 15.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Glomerular filtration rate decreased | 25 | 15.9 10.8–23.6ROR 16.1 · χ² 335 / p 4e-75 | 15.6 EB05 10.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 15.1 | no trial data cached |
| Ankle fracture | 30 | 15.0 10.5–21.3ROR 15.1 · χ² 376 / p 4e-84 | 14.6 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Intervertebral disc degeneration | 15 | 12.4 7.5–20.6ROR 12.5 · χ² 146 / p 5e-34 | 11.2 EB05 6.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Wrist fracture | 19 | 12.2 7.8–19.2ROR 12.3 · χ² 185 / p 2e-42 | 11.3 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Bone disorder | 29 | 12.2 8.5–17.5ROR 12.3 · χ² 287 / p 1e-64 | 11.6 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Blood creatinine increased | 103 | 12.2 10.1–14.7ROR 12.6 · χ² 1,045 / p 1e-229 | 12.0 EB05 10.2 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.5 | no trial data cached |
| Renal impairment | 127 | 11.7 9.9–13.9ROR 12.2 · χ² 1,238 / p 2e-271 | 11.6 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| End stage renal disease | 24 | 10.1 6.8–15.0ROR 10.1 · χ² 187 / p 8e-43 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Dental caries | 13 | 9.1 5.3–15.6ROR 9.1 · χ² 86 / p 1e-20 | 7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Anxiety | 334 | 9.0 8.2–10.0ROR 10.2 · χ² 2,410 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 86% consumer | no trial data cached |
| Rib fracture | 23 | 8.6 5.8–13.0ROR 8.7 · χ² 148 / p 2e-34 | 7.7 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Proteinuria | 21 | 8.6 5.6–13.2ROR 8.7 · χ² 133 / p 4e-31 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Hip fracture | 35 | 8.4 6.1–11.7ROR 8.5 · χ² 221 / p 2e-50 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 133 | 6.7 5.7–8.0ROR 7.0 · χ² 649 / p 2e-143 | 6.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Osteoarthritis | 37 | 6.7 4.9–9.3ROR 6.8 · χ² 175 / p 3e-40 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Spinal fracture | 16 | 6.2 3.8–10.1ROR 6.2 · χ² 65 / p 5e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Upper limb fracture | 15 | 5.8 3.5–9.6ROR 5.8 · χ² 55 / p 7e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hip arthroplasty | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 6e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Lower limb fracture | 12 | 4.8 2.8–8.5ROR 4.9 · χ² 33 / p 5e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Pain | 366 | 4.6 4.2–5.0ROR 5.1 · χ² 1,054 / p 1e-231 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 91% consumer | no trial data cached |
| Treatment noncompliance | 30 | 4.3 3.0–6.1ROR 4.3 · χ² 72 / p 1e-17 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Bone density decreased | 1,056 | 266.0 253.4–279.2ROR 434.3 · χ² 269,547 / p <1e-300 | 255.9 EB05 243.2 · IC025 +7.7 3/3 methods agree | Lab value / disease marker | serious PRR 220.8 · 100% consumer | no trial data cached |
| Bone loss | 601 | 318.0 295.7–341.8ROR 407.9 · χ² 182,106 / p <1e-300 | 302.3 EB05 282.6 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 250.3 · 100% consumer | no trial data cached |
| Osteonecrosis (bone death) | 600 | 142.2 132.4–152.7ROR 182.2 · χ² 82,561 / p <1e-300 | 139.0 EB05 129.9 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 108.0 · 98% consumer | no trial data cached |
| Chronic kidney disease | 578 | 58.6 54.5–63.0ROR 74.1 · χ² 32,532 / p <1e-300 | 58.0 EB05 54.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · 100% consumer | no trial data cached |
| Tooth loss | 557 | 211.4 196.1–227.9ROR 265.6 · χ² 113,390 / p <1e-300 | 204.3 EB05 190.4 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 167.5 · 100% consumer | no trial data cached |
| Multiple fractures | 529 | 254.3 235.2–275.0ROR 315.5 · χ² 129,027 / p <1e-300 | 244.0 EB05 227.0 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 201.2 · 100% consumer | no trial data cached |
| Renal failure (kidney failure) | 508 | 29.4 27.2–31.8ROR 35.9 · χ² 13,941 / p <1e-300 | 29.3 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.6 · 86% consumer | no trial data cached |
| Osteoporosis | 430 | 81.4 74.6–88.8ROR 96.5 · χ² 33,760 / p <1e-300 | 80.2 EB05 74.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 71.5 · 94% consumer | no trial data cached |
| Renal injury | 424 | 110.5 101.2–120.7ROR 130.7 · χ² 45,300 / p <1e-300 | 108.4 EB05 100.0 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 83.9 · 100% consumer | no trial data cached |
| Skeletal injury | 371 | 283.5 257.4–312.2ROR 328.1 · χ² 100,464 / p <1e-300 | 269.6 EB05 247.3 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 216.1 · 100% consumer | no trial data cached |
| Pain | 366 | 4.6 4.2–5.0ROR 5.1 · χ² 1,054 / p 1e-231 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 91% consumer | no trial data cached |
| Emotional distress | 353 | 22.5 20.4–24.8ROR 25.7 · χ² 7,240 / p <1e-300 | 22.4 EB05 20.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · 100% consumer | no trial data cached |
| Anxiety | 334 | 9.0 8.2–10.0ROR 10.2 · χ² 2,410 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 86% consumer | no trial data cached |
| Anhedonia | 317 | 93.4 84.2–103.7ROR 105.6 · χ² 28,574 / p <1e-300 | 91.8 EB05 83.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.0 · 100% consumer | no trial data cached |
| Osteopenia | 245 | 125.9 111.6–142.0ROR 138.2 · χ² 29,754 / p <1e-300 | 122.7 EB05 110.3 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 95.8 | no trial data cached |
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.
- Bone loss — n=601, PRR 318.0
- Multiple fractures — n=529, PRR 254.3
- Tooth loss — n=557, PRR 211.4
- Osteopenia — n=245, PRR 125.9
- Anhedonia — n=317, PRR 93.4
- Osteoporosis — n=430, PRR 81.4
- Chronic kidney disease — n=578, PRR 58.6
- Vitamin d deficiency — n=73, PRR 58.2
- Fracture — n=73, PRR 29.8
- Foot fracture — n=62, PRR 25.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 bone density decreased, bone loss, osteonecrosis, chronic kidney disease, tooth loss, multiple fractures. 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, 62 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
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.