Drug · FAERS side-effect profile with label screen
Isavuconazonium side effects: what 3,648 FDA adverse event reports show
Drug class
Azole antifungal
FDA label, Indications wording of the closest related product
Label matched
Isavuconazonium Sulfate (Cresemba)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,648 reports · 69% serious · 739 with death outcome · 40% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis ( 1.1 ) and Invasive mucormycosis ( 1.2 ) as follows: • CRESEMBA for injection : adults and pediatric patients 1 year of age and older • CRESEMBA capsules : adults.
FDA label, Indications and Usage
What it is
CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder.
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 5Labeled (related wording) 4Reporting / coding artifact 4Lab value / disease marker 5Not in label — unassessed 22
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. 63 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 |
|---|---|---|---|---|---|---|
| Acute myeloid leukaemia | 49 | 18.1 13.7–24.0ROR 18.4 · χ² 774 / p 1e-170 | 18.0 EB05 14.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Febrile neutropenia | 149 | 13.0 11.1–15.2ROR 13.5 · χ² 1,634 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.7 | no trial data cached |
| Leukaemia | 20 | 12.2 7.9–18.9ROR 12.3 · χ² 194 / p 2e-44 | 11.3 EB05 7.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Fungal infection | 52 | 9.0 6.9–11.8ROR 9.1 · χ² 361 / p 8e-81 | 8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Gamma-glutamyltransferase increased | 31 | 8.0 5.7–11.4ROR 8.1 · χ² 184 / p 3e-42 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · 90% clinician | no trial data cached |
| Bacteraemia | 16 | 7.8 4.8–12.8ROR 7.9 · χ² 88 / p 3e-21 | 6.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Cytopenia | 16 | 7.7 4.7–12.6ROR 7.7 · χ² 87 / p 6e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Multiple organ dysfunction syndrome | 37 | 7.6 5.5–10.5ROR 7.7 · χ² 207 / p 4e-47 | 7.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Cytokine release syndrome | 25 | 7.5 5.1–11.2ROR 7.6 · χ² 135 / p 1e-31 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial data cached |
| Hepatic cytolysis | 16 | 7.5 4.6–12.3ROR 7.6 · χ² 84 / p 2e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Nephropathy toxic | 14 | 7.2 4.3–12.2ROR 7.3 · χ² 69 / p 5e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Acute respiratory failure | 24 | 7.2 4.8–10.7ROR 7.3 · χ² 122 / p 1e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Off label use (used outside approved label) | 1,060 | 7.0 6.7–7.4ROR 9.5 · χ² 5,702 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Drug resistance | 31 | 6.9 4.9–9.9ROR 7.0 · χ² 152 / p 4e-35 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · ♀ 17% (drug 40%) · 94% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 22 | 6.8 4.5–10.4ROR 6.9 · χ² 104 / p 1e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 10% (drug 40%) · 95% clinician | no trial data cached |
| Tachypnoea | 16 | 6.8 4.2–11.1ROR 6.8 · χ² 73 / p 6e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Blood alkaline phosphatase increased | 28 | 6.5 4.5–9.4ROR 6.5 · χ² 124 / p 4e-29 | 5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · ♀ 16% (drug 40%) | no trial data cached |
| Mucosal inflammation | 28 | 6.2 4.3–8.9ROR 6.2 · χ² 116 / p 2e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · ♀ 16% (drug 40%) | no trial data cached |
| Bronchospasm (airway tightening) | 15 | 6.0 3.6–10.0ROR 6.0 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Drug level increased | 17 | 5.9 3.7–9.5ROR 5.9 · χ² 64 / p 5e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Hospice care | 10 | 5.8 3.1–10.8ROR 5.9 · χ² 35 / p 1e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Haemoptysis | 27 | 5.6 3.8–8.1ROR 5.6 · χ² 96 / p 5e-23 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Candida infection (yeast infection) | 16 | 5.5 3.4–9.0ROR 5.5 · χ² 55 / p 7e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Liver function test increased | 20 | 5.4 3.5–8.4ROR 5.4 · χ² 67 / p 1e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Septic shock | 39 | 5.2 3.8–7.1ROR 5.2 · χ² 128 / p 6e-30 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 92% clinician | no trial data cached |
| Blood bilirubin increased | 24 | 5.1 3.4–7.6ROR 5.1 · χ² 75 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 · ♀ 5% (drug 40%) | no trial data cached |
| Hepatotoxicity (liver damage) | 18 | 4.7 2.9–7.4ROR 4.7 · χ² 48 / p 2e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Red blood cell count decreased | 23 | 4.6 3.1–6.9ROR 4.6 · χ² 62 / p 2e-15 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Hypoxia (low oxygen) | 28 | 4.6 3.2–6.6ROR 4.6 · χ² 75 / p 2e-18 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 88% (drug 40%) | no trial data cached |
| Central nervous system lesion | 11 | 4.6 2.5–8.3ROR 4.6 · χ² 27 / p 9e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Transaminases increased | 17 | 4.4 2.7–7.1ROR 4.4 · χ² 41 / p 6e-11 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Myelodysplastic syndrome | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Immunodeficiency | 11 | 4.3 2.4–7.7ROR 4.3 · χ² 25 / p 4e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Disease progression | 88 | 4.3 3.5–5.3ROR 4.4 · χ² 220 / p 5e-50 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Encephalopathy | 18 | 4.2 2.7–6.7ROR 4.2 · χ² 41 / p 7e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Pneumothorax | 11 | 4.0 2.2–7.2ROR 4.0 · χ² 22 / p 2e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Neurotoxicity | 12 | 4.0 2.3–7.0ROR 4.0 · χ² 24 / p 5e-7 | 3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Drug-induced liver injury | 21 | 3.9 2.6–6.0ROR 3.9 · χ² 43 / p 3e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 95% clinician | no trial data cached |
| Acute respiratory distress syndrome | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 8e-7 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Blood potassium increased | 11 | 3.9 2.2–7.0ROR 3.9 · χ² 21 / p 2e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Lab value / disease marker | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,060 | 7.0 6.7–7.4ROR 9.5 · χ² 5,702 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Death | 327 | 2.2 2.0–2.4ROR 2.3 · χ² 217 / p 2e-49 | 2.2 EB05 2.0 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.8 | no trial data cached |
| Febrile neutropenia | 149 | 13.0 11.1–15.2ROR 13.5 · χ² 1,634 / p <1e-300 | 12.9 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.7 | no trial data cached |
| Drug interaction | 98 | 3.6 2.9–4.3ROR 3.6 · χ² 178 / p 6e-41 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Disease progression | 88 | 4.3 3.5–5.3ROR 4.4 · χ² 220 / p 5e-50 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 86 | 3.2 2.6–4.0ROR 3.3 · χ² 132 / p 6e-31 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 · ♀ 20% (drug 40%) | no trial data cached |
| Platelet count decreased | 71 | 3.8 3.0–4.8ROR 3.9 · χ² 146 / p 5e-34 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 65 | 2.8 2.2–3.5ROR 2.8 · χ² 72 / p 1e-17 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fungal infection | 52 | 9.0 6.9–11.8ROR 9.1 · χ² 361 / p 8e-81 | 8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| White blood cell count decreased | 51 | 2.7 2.1–3.5ROR 2.7 · χ² 53 / p 1e-13 | 2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Hospitalisation | 49 | 1.8 1.4–2.4ROR 1.9 · χ² 18 / p 9e-6 | 1.8 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Acute myeloid leukaemia | 49 | 18.1 13.7–24.0ROR 18.4 · χ² 774 / p 1e-170 | 18.0 EB05 14.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Respiratory failure | 43 | 3.4 2.5–4.6ROR 3.4 · χ² 70 / p 3e-17 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · ♀ 17% (drug 40%) | no trial data cached |
| Wrong technique in product usage process | 41 | 1.2 0.9–1.6ROR 1.2 · χ² 1 / p 0.182 | 1.2 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Septic shock | 39 | 5.2 3.8–7.1ROR 5.2 · χ² 128 / p 6e-30 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 92% 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.
- Acute myeloid leukaemia — n=49, PRR 18.1
- Leukaemia — n=20, PRR 12.2
- Fungal infection — n=52, PRR 9.0
- Multiple organ dysfunction syndrome — n=37, PRR 7.6
- Cytokine release syndrome — n=25, PRR 7.5
- Haemoptysis — n=27, PRR 5.6
- Liver function test increased — n=20, PRR 5.4
- Septic shock — n=39, PRR 5.2
- Hypoxia — n=28, PRR 4.6
- Drug-induced liver injury — n=21, PRR 3.9
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 Isavuconazonium?
In FDA FAERS, the most frequently co-reported reaction terms for Isavuconazonium are febrile neutropenia, acute kidney injury, platelet count decreased, neutropenia, fungal infection, white blood cell count decreased. 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 Isavuconazonium have an FDA boxed warning?
No. The FDA label retrieved for Isavuconazonium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Isavuconazonium 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 8f7f73b8-586a-4df0-935f-fecd4696c16c, effective 20250425; matched on
openfda.generic_name.exact:"ISAVUCONAZONIUM SULFATE") - 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, 103 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.