Drug · FAERS side-effect profile with label screen
Posaconazole Delayed-Release side effects: what 10,915 FDA adverse event reports show
Brand names
Posaconazole
openFDA label
Who reports
10,915 reports · 92% serious · 2,744 with death outcome · 40% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Posaconazole delayed-release tablets is an azole antifungal agent indicated as follows: ( 1 ) Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of deve.
FDA label, Indications and Usage
What it is
Posaconazole is an azole antifungal agent. Posaconazole is available as delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3 R ,5 .
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 1Labeled (related wording) 3Likely indication confounding 4Lab value / disease marker 1Not in label — unassessed 31
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 986 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 |
|---|---|---|---|---|---|---|
| Npm1 gene mutation | 11 | 10,418.6 2,309.5–46,999.4ROR 10,429.1 · χ² 16,061 / p <1e-300 | 422.2 EB05 251.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Protothecosis | 34 | 1,091.6 716.1–1,664.1ROR 1,095.0 · χ² 22,816 / p <1e-300 | 497.8 EB05 372.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 40%) | no trial data cached |
| Pseudoaldosteronism | 65 | 961.9 714.1–1,295.8ROR 967.7 · χ² 40,747 / p <1e-300 | 536.9 EB05 436.0 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=63 · 95% clinician | no trial data cached |
| Left atrial hypertrophy | 11 | 534.3 273.7–1,042.9ROR 534.8 · χ² 4,160 / p <1e-300 | 242.1 EB05 144.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Demodicidosis | 19 | 499.9 301.6–828.4ROR 500.7 · χ² 7,095 / p <1e-300 | 283.0 EB05 191.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Fusarium infection | 102 | 337.2 273.4–415.9ROR 340.4 · χ² 28,740 / p <1e-300 | 271.8 EB05 230.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=101 | no trial data cached |
| Microsporidia infection | 50 | 314.7 233.4–424.2ROR 316.1 · χ² 13,139 / p <1e-300 | 244.8 EB05 192.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Adenovirus reactivation | 19 | 305.0 188.0–495.0ROR 305.5 · χ² 4,700 / p <1e-300 | 208.1 EB05 140.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Geotrichum infection | 29 | 303.5 205.2–449.0ROR 304.3 · χ² 7,278 / p <1e-300 | 223.3 EB05 163.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Chimerism | 11 | 270.6 143.9–508.9ROR 270.9 · χ² 2,355 / p <1e-300 | 168.3 EB05 100.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acanthamoeba infection | 23 | 264.1 170.8–408.3ROR 264.6 · χ² 5,061 / p <1e-300 | 194.6 EB05 136.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 40%) · 96% clinician | no trial data cached |
| Scedosporium infection | 79 | 247.4 195.8–312.5ROR 249.1 · χ² 16,928 / p <1e-300 | 207.9 EB05 172.2 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=79 | no trial data cached |
| Encephalitis fungal | 10 | 242.9 125.8–469.0ROR 243.1 · χ² 1,926 / p <1e-300 | 153.1 EB05 88.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Bronchiolitis obliterans syndrome | 18 | 228.8 140.4–373.1ROR 229.2 · χ² 3,443 / p <1e-300 | 168.2 EB05 112.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Allogenic stem cell transplantation | 16 | 219.6 130.9–368.4ROR 219.9 · χ² 2,927 / p <1e-300 | 159.7 EB05 104.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Disseminated toxoplasmosis | 11 | 202.3 108.7–376.6ROR 202.5 · χ² 1,813 / p <1e-300 | 139.3 EB05 83.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Central nervous system fungal infection | 19 | 186.5 116.4–298.6ROR 186.8 · χ² 3,024 / p <1e-300 | 145.3 EB05 98.3 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Chronic graft versus host disease in lung | 14 | 173.3 100.3–299.5ROR 173.6 · χ² 2,043 / p <1e-300 | 130.9 EB05 82.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Differentiation syndrome | 53 | 153.7 116.3–203.3ROR 154.5 · χ² 7,299 / p <1e-300 | 135.4 EB05 107.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=53 | no trial data cached |
| Pulmonary mucormycosis | 37 | 148.5 106.3–207.4ROR 149.0 · χ² 4,891 / p <1e-300 | 128.8 EB05 97.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | no trial data cached |
| Acute myeloid leukaemia refractory | 12 | 147.6 82.1–265.5ROR 147.8 · χ² 1,488 / p <1e-300 | 112.9 EB05 68.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Disseminated coccidioidomycosis | 10 | 144.6 76.0–275.0ROR 144.7 · χ² 1,195 / p 4e-262 | 107.5 EB05 62.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Adenoviral hepatitis | 16 | 142.3 85.6–236.4ROR 142.5 · χ² 1,959 / p <1e-300 | 114.7 EB05 74.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Eye infection fungal | 26 | 141.5 95.1–210.7ROR 141.9 · χ² 3,246 / p <1e-300 | 120.3 EB05 86.3 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=26 · ♀ 9% (drug 40%) | no trial data cached |
| Mucormycosis | 169 | 135.0 115.6–157.6ROR 137.1 · χ² 20,855 / p <1e-300 | 124.3 EB05 109.4 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=169 · 93% clinician | no trial data cached |
| Lip squamous cell carcinoma | 11 | 134.4 73.0–247.7ROR 134.6 · χ² 1,239 / p 1e-271 | 103.6 EB05 61.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Rhinocerebral mucormycosis | 22 | 131.9 85.6–203.1ROR 132.1 · χ² 2,551 / p <1e-300 | 111.6 EB05 77.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Mycotic endophthalmitis | 12 | 130.6 72.8–234.4ROR 130.8 · χ² 1,325 / p 2e-290 | 102.8 EB05 62.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Phaeohyphomycosis | 29 | 129.6 89.0–188.6ROR 129.9 · χ² 3,343 / p <1e-300 | 112.5 EB05 82.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Cutaneous mucormycosis | 11 | 126.3 68.6–232.4ROR 126.4 · χ² 1,167 / p 5e-256 | 98.7 EB05 58.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acute myeloid leukaemia recurrent | 131 | 125.8 105.5–150.0ROR 127.4 · χ² 15,098 / p <1e-300 | 116.1 EB05 100.3 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=131 · 90% clinician | no trial data cached |
| Primary adrenal insufficiency | 18 | 123.5 76.7–198.9ROR 123.7 · χ² 1,940 / p <1e-300 | 103.6 EB05 69.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Cerebral aspergillosis | 35 | 116.1 82.6–163.3ROR 116.5 · χ² 3,656 / p <1e-300 | 103.4 EB05 77.7 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=35 · ♀ 0% (drug 40%) · 91% clinician | no trial data cached |
| Chronic graft versus host disease in eye | 11 | 113.2 61.7–208.0ROR 113.4 · χ² 1,051 / p 7e-231 | 90.6 EB05 54.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=11 | no trial data cached |
| Congenital aplasia | 16 | 112.3 67.8–185.8ROR 112.4 · χ² 1,562 / p <1e-300 | 94.4 EB05 61.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Systemic mycosis | 62 | 107.7 83.5–139.1ROR 108.4 · χ² 6,104 / p <1e-300 | 99.0 EB05 80.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=62 · 95% clinician | no trial data cached |
| Neutrophil pelger-huet anomaly present | 10 | 107.0 56.6–202.3ROR 107.1 · χ² 896 / p 3e-197 | 85.4 EB05 49.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Electrocardiogram pr shortened | 11 | 105.8 57.6–194.1ROR 105.9 · χ² 984 / p 2e-216 | 85.8 EB05 51.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Cystitis viral | 18 | 95.2 59.3–152.9ROR 95.4 · χ² 1,510 / p <1e-300 | 83.0 EB05 55.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Disseminated mucormycosis | 16 | 82.6 50.1–136.2ROR 82.7 · χ² 1,159 / p 3e-254 | 72.6 EB05 47.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,312 | 1.9 1.8–2.0ROR 2.0 · χ² 610 / p 5e-135 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Off label use (used outside approved label) | 1,216 | 2.7 2.6–2.8ROR 2.9 · χ² 1,347 / p 3e-295 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Febrile neutropenia | 894 | 26.3 24.7–28.0ROR 28.5 · χ² 21,479 / p <1e-300 | 25.9 EB05 24.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 · 94% clinician | no trial data cached |
| Drug interaction | 817 | 9.9 9.3–10.6ROR 10.7 · χ² 6,572 / p <1e-300 | 9.9 EB05 9.3 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 656 | 9.3 8.7–10.1ROR 9.9 · χ² 4,885 / p <1e-300 | 9.3 EB05 8.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 · 91% clinician | no trial data cached |
| Pyrexia (fever) | 653 | 3.6 3.4–3.9ROR 3.8 · χ² 1,259 / p 6e-276 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Death | 581 | 1.3 1.2–1.4ROR 1.3 · χ² 41 / p 9e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Product use in unapproved indication | 563 | 4.4 4.1–4.8ROR 4.6 · χ² 1,508 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 93% clinician | no trial data cached |
| Pneumonia (lung infection) | 488 | 2.9 2.7–3.2ROR 3.0 · χ² 615 / p 4e-136 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 421 | 7.3 6.6–8.0ROR 7.5 · χ² 2,276 / p <1e-300 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 94% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 389 | 1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.001 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Septic shock | 364 | 16.3 14.7–18.0ROR 16.8 · χ² 5,180 / p <1e-300 | 16.2 EB05 14.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 92% clinician | no trial data cached |
| Nausea | 348 | 0.8 0.8–0.9ROR 0.8 · χ² 10 / p 9e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Condition aggravated | 342 | 2.2 2.0–2.4ROR 2.2 · χ² 219 / p 7e-50 | 2.2 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 334 | 4.2 3.8–4.7ROR 4.3 · χ² 821 / p 7e-181 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 · 95% clinician | 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.
- Protothecosis — n=34, PRR 1,091.6
- Fusarium infection — n=102, PRR 337.2
- Microsporidia infection — n=50, PRR 314.7
- Geotrichum infection — n=29, PRR 303.5
- Acanthamoeba infection — n=23, PRR 264.1
- Scedosporium infection — n=79, PRR 247.4
- Differentiation syndrome — n=53, PRR 153.7
- Pulmonary mucormycosis — n=37, PRR 148.5
- Mucormycosis — n=169, PRR 135.0
- Rhinocerebral mucormycosis — n=22, PRR 131.9
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 Posaconazole Delayed-Release?
In FDA FAERS, the most frequently co-reported reaction terms for Posaconazole Delayed-Release are febrile neutropenia, neutropenia, pyrexia, pneumonia, thrombocytopenia, 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 Posaconazole Delayed-Release have an FDA boxed warning?
No. The FDA label retrieved for Posaconazole Delayed-Release has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Posaconazole Delayed-Release 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 f2baa339-75ff-4c03-8334-a88648f701f7, effective 20221220; matched on
openfda.generic_name.exact:"POSACONAZOLE DELAYED-RELEASE") - 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, 1,026 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.