Drug · FAERS side-effect profile with label screen
Darunavir Ethanolate and Cobicistat side effects: what 1,753 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Prezcobix, Prezcobix Ped
openFDA label
Who reports
1,753 reports · 66% serious · 135 with death outcome · 25% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weig.
FDA label, Indications and Usage
What it is
PREZCOBIX and PREZCOBIX PED are fixed-dose combination products containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.
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 4Labeled (related wording) 5Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 26
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. 42 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 |
|---|---|---|---|---|---|---|
| Anhedonia | 377 | 172.6 157.7–188.9ROR 219.6 · χ² 63,310 / p <1e-300 | 168.7 EB05 154.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 159.4 · 98% consumer | no trial data cached |
| Economic problem | 138 | 108.0 92.0–126.9ROR 117.1 · χ² 14,402 / p <1e-300 | 105.5 EB05 91.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 97.4 · 95% consumer | no trial data cached |
| Osteopenia | 111 | 87.6 73.1–105.0ROR 93.5 · χ² 9,355 / p <1e-300 | 85.7 EB05 73.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 81.9 | no trial data cached |
| Bone density decreased | 170 | 64.5 55.9–74.4ROR 71.3 · χ² 10,522 / p <1e-300 | 63.7 EB05 56.1 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 64.5 · 93% consumer | no trial data cached |
| End stage renal disease | 89 | 58.0 47.4–71.1ROR 61.1 · χ² 4,912 / p <1e-300 | 57.1 EB05 47.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.6 | no trial data cached |
| Osteoporosis | 181 | 52.8 46.0–60.6ROR 58.7 · χ² 9,118 / p <1e-300 | 52.3 EB05 46.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 53.3 | no trial data cached |
| Multiple fractures | 72 | 52.2 41.6–65.4ROR 54.3 · χ² 3,549 / p <1e-300 | 51.3 EB05 42.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 48.5 | no trial data cached |
| Emotional distress | 426 | 42.1 38.7–45.7ROR 55.2 · χ² 17,073 / p <1e-300 | 41.8 EB05 38.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 40.1 · 98% consumer | no trial data cached |
| Chronic kidney disease | 256 | 40.1 35.8–44.9ROR 46.7 · χ² 9,713 / p <1e-300 | 39.8 EB05 35.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 · 84% consumer | no trial data cached |
| Decreased activity | 32 | 35.8 25.4–50.5ROR 36.5 · χ² 1,046 / p 1e-229 | 35.0 EB05 26.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.2 | no trial data cached |
| Bone loss | 42 | 33.2 24.6–44.7ROR 33.9 · χ² 1,275 / p 1e-279 | 32.6 EB05 25.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 30.9 | no trial data cached |
| Nephropathy | 25 | 31.9 21.6–47.1ROR 32.4 · χ² 717 / p 3e-158 | 31.2 EB05 22.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.6 | no trial data cached |
| Quality of life decreased | 35 | 31.2 22.5–43.4ROR 31.8 · χ² 992 / p 5e-218 | 30.7 EB05 23.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 | no trial data cached |
| Brain injury | 26 | 31.0 21.2–45.5ROR 31.5 · χ² 725 / p 6e-160 | 30.4 EB05 21.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 | no trial data cached |
| Tooth loss | 48 | 27.5 20.8–36.4ROR 28.3 · χ² 1,200 / p 3e-263 | 27.2 EB05 21.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 | no trial data cached |
| Vitamin d deficiency | 20 | 24.6 15.9–38.0ROR 24.8 · χ² 428 / p 2e-95 | 24.0 EB05 16.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Osteonecrosis (bone death) | 60 | 21.7 16.9–27.8ROR 22.4 · χ² 1,162 / p 4e-255 | 21.5 EB05 17.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 | no trial data cached |
| Foot fracture | 34 | 21.4 15.3–29.9ROR 21.8 · χ² 641 / p 1e-141 | 21.1 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Loss of personal independence in daily activities | 80 | 20.1 16.3–25.0ROR 21.1 · χ² 1,437 / p <1e-300 | 20.0 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 | no trial data cached |
| Proteinuria | 31 | 19.7 13.9–27.9ROR 20.0 · χ² 531 / p 9e-118 | 19.4 EB05 14.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 | no trial data cached |
| Skeletal injury | 16 | 18.3 11.2–29.8ROR 18.5 · χ² 244 / p 2e-55 | 17.7 EB05 11.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 | no trial data cached |
| Blood creatinine increased | 95 | 17.4 14.3–21.1ROR 18.3 · χ² 1,453 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.5 | no trial data cached |
| Anxiety | 404 | 17.0 15.6–18.5ROR 21.7 · χ² 6,123 / p <1e-300 | 16.9 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · 86% consumer | no trial data cached |
| Renal failure (kidney failure) | 170 | 15.2 13.2–17.5ROR 16.7 · χ² 2,254 / p <1e-300 | 15.2 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 · 70% consumer | no trial data cached |
| Dysstasia | 37 | 15.1 11.0–20.8ROR 15.4 · χ² 474 / p 2e-105 | 14.9 EB05 11.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Drug resistance | 32 | 14.9 10.6–21.0ROR 15.2 · χ² 401 / p 1e-89 | 14.6 EB05 10.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 | no trial data cached |
| Renal impairment | 104 | 14.9 12.3–17.9ROR 15.8 · χ² 1,336 / p 9e-293 | 14.8 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Glomerular filtration rate decreased | 15 | 14.8 8.9–24.5ROR 14.9 · χ² 180 / p 3e-41 | 13.9 EB05 8.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 13.9 | no trial data cached |
| Rib fracture | 24 | 14.0 9.4–20.8ROR 14.2 · χ² 277 / p 2e-62 | 13.5 EB05 9.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Renal injury | 35 | 14.0 10.0–19.4ROR 14.2 · χ² 408 / p 5e-91 | 13.6 EB05 10.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.3 | no trial data cached |
| Ankle fracture | 17 | 13.1 8.2–21.1ROR 13.2 · χ² 178 / p 5e-41 | 12.2 EB05 7.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Wrist fracture | 13 | 13.0 7.5–22.3ROR 13.1 · χ² 132 / p 8e-31 | 11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Nephropathy toxic | 11 | 11.8 6.6–21.3ROR 11.9 · χ² 98 / p 2e-23 | 10.0 EB05 5.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Foetal exposure during pregnancy | 74 | 10.9 8.7–13.6ROR 11.3 · χ² 657 / p 3e-145 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 · ♀ 57% (drug 25%) | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 131 | 10.3 8.7–12.1ROR 11.0 · χ² 1,097 / p 9e-241 | 10.1 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 | no trial data cached |
| Coronary artery occlusion | 11 | 9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Fracture | 14 | 8.8 5.2–14.9ROR 8.9 · χ² 90 / p 1e-21 | 7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Pollakiuria (frequent urination) | 30 | 8.6 6.0–12.3ROR 8.8 · χ² 195 / p 1e-44 | 7.9 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Pain | 440 | 8.6 7.9–9.3ROR 11.1 · χ² 3,014 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 · 88% consumer | no trial data cached |
| Hyperkalaemia (high potassium) | 24 | 8.2 5.5–12.2ROR 8.3 · χ² 145 / p 9e-34 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | 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 |
|---|---|---|---|---|---|---|
| Pain | 440 | 8.6 7.9–9.3ROR 11.1 · χ² 3,014 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 · 88% consumer | no trial data cached |
| Emotional distress | 426 | 42.1 38.7–45.7ROR 55.2 · χ² 17,073 / p <1e-300 | 41.8 EB05 38.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 40.1 · 98% consumer | no trial data cached |
| Anxiety | 404 | 17.0 15.6–18.5ROR 21.7 · χ² 6,123 / p <1e-300 | 16.9 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · 86% consumer | no trial data cached |
| Anhedonia | 377 | 172.6 157.7–188.9ROR 219.6 · χ² 63,310 / p <1e-300 | 168.7 EB05 154.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 159.4 · 98% consumer | no trial data cached |
| Chronic kidney disease | 256 | 40.1 35.8–44.9ROR 46.7 · χ² 9,713 / p <1e-300 | 39.8 EB05 35.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 · 84% consumer | no trial data cached |
| Osteoporosis | 181 | 52.8 46.0–60.6ROR 58.7 · χ² 9,118 / p <1e-300 | 52.3 EB05 46.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 53.3 | no trial data cached |
| Renal failure (kidney failure) | 170 | 15.2 13.2–17.5ROR 16.7 · χ² 2,254 / p <1e-300 | 15.2 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 · 70% consumer | no trial data cached |
| Bone density decreased | 170 | 64.5 55.9–74.4ROR 71.3 · χ² 10,522 / p <1e-300 | 63.7 EB05 56.1 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 64.5 · 93% consumer | no trial data cached |
| Depression | 147 | 7.7 6.6–9.0ROR 8.3 · χ² 858 / p 6e-189 | 7.6 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 84% consumer | no trial data cached |
| Economic problem | 138 | 108.0 92.0–126.9ROR 117.1 · χ² 14,402 / p <1e-300 | 105.5 EB05 91.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 97.4 · 95% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 131 | 10.3 8.7–12.1ROR 11.0 · χ² 1,097 / p 9e-241 | 10.1 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 | no trial data cached |
| Osteopenia | 111 | 87.6 73.1–105.0ROR 93.5 · χ² 9,355 / p <1e-300 | 85.7 EB05 73.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 81.9 | no trial data cached |
| Renal impairment | 104 | 14.9 12.3–17.9ROR 15.8 · χ² 1,336 / p 9e-293 | 14.8 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Blood creatinine increased | 95 | 17.4 14.3–21.1ROR 18.3 · χ² 1,453 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.5 | no trial data cached |
| End stage renal disease | 89 | 58.0 47.4–71.1ROR 61.1 · χ² 4,912 / p <1e-300 | 57.1 EB05 47.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.6 | 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.
- Anhedonia — n=377, PRR 172.6
- Osteopenia — n=111, PRR 87.6
- End stage renal disease — n=89, PRR 58.0
- Osteoporosis — n=181, PRR 52.8
- Multiple fractures — n=72, PRR 52.2
- Emotional distress — n=426, PRR 42.1
- Chronic kidney disease — n=256, PRR 40.1
- Decreased activity — n=32, PRR 35.8
- Bone loss — n=42, PRR 33.2
- Quality of life decreased — n=35, PRR 31.2
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 Ethanolate and Cobicistat?
In FDA FAERS, the most frequently co-reported reaction terms for Darunavir Ethanolate and Cobicistat are pain, emotional distress, anxiety, anhedonia, chronic kidney disease, osteoporosis. 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 Ethanolate and Cobicistat have an FDA boxed warning?
No. The FDA label retrieved for Darunavir Ethanolate and Cobicistat has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Darunavir Ethanolate and Cobicistat 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 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f, effective 20260201; matched on
openfda.generic_name.exact:"DARUNAVIR ETHANOLATE AND COBICISTAT") - 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, 82 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.