Drug · FAERS side-effect profile with label screen
Anidulafungin side effects: what 1,600 FDA adverse event reports show
Brand names
Eraxis
openFDA label
Who reports
1,600 reports · 97% serious · 688 with death outcome · 41% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1.
FDA label, Indications and Usage
What it is
ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans .
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 10Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 17
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.
- 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. 49 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 |
|---|---|---|---|---|---|---|
| Multiple organ dysfunction syndrome | 173 | 81.8 71.0–94.2ROR 91.6 · χ² 13,659 / p <1e-300 | 80.6 EB05 71.0 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 48.0 | no trial data cached |
| Candida infection (yeast infection) | 92 | 72.7 59.6–88.7ROR 77.1 · χ² 6,404 / p <1e-300 | 71.3 EB05 59.9 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 61.4 | no trial data cached |
| Disseminated intravascular coagulation | 46 | 42.9 32.2–57.0ROR 44.1 · χ² 1,834 / p <1e-300 | 42.0 EB05 32.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 15% (drug 41%) | no trial data cached |
| Bacteraemia | 36 | 40.2 29.1–55.6ROR 41.1 · χ² 1,335 / p 2e-292 | 39.3 EB05 29.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.9 · ♀ 70% (drug 41%) | no trial data cached |
| Septic shock | 128 | 39.0 33.0–46.0ROR 42.3 · χ² 4,691 / p <1e-300 | 38.6 EB05 33.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 · 95% clinician | no trial data cached |
| Covid-19 pneumonia | 34 | 37.6 27.0–52.5ROR 38.4 · χ² 1,172 / p 3e-257 | 36.8 EB05 27.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.5 · ♀ 4% (drug 41%) | no trial data cached |
| Drug resistance | 70 | 35.8 28.5–45.1ROR 37.4 · χ² 2,332 / p <1e-300 | 35.4 EB05 29.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 23.8 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 33 | 28.8 20.5–40.3ROR 29.3 · χ² 855 / p 3e-188 | 28.3 EB05 21.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 · ♀ 69% (drug 41%) | no trial data cached |
| Vasculitis | 21 | 23.7 15.5–36.2ROR 24.0 · χ² 433 / p 2e-96 | 23.2 EB05 15.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Bacterial infection | 31 | 21.9 15.5–31.1ROR 22.3 · χ² 598 / p 3e-132 | 21.6 EB05 15.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · ♀ 77% (drug 41%) · 90% clinician | no trial data cached |
| Brain oedema | 21 | 21.8 14.3–33.4ROR 22.1 · χ² 397 / p 1e-88 | 21.4 EB05 14.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 71% (drug 41%) | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 31 | 18.3 12.9–25.9ROR 18.6 · χ² 489 / p 1e-108 | 18.0 EB05 13.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 73% (drug 41%) | no trial data cached |
| Hyperbilirubinaemia | 14 | 17.8 10.6–30.1ROR 18.0 · χ² 206 / p 6e-47 | 17.1 EB05 10.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Cytokine release syndrome | 23 | 15.8 10.6–23.8ROR 16.1 · χ² 305 / p 1e-68 | 15.4 EB05 10.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 100% clinician | no trial data cached |
| Fungal infection | 40 | 15.8 11.6–21.4ROR 16.1 · χ² 539 / p 2e-119 | 15.6 EB05 11.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.0 | no trial data cached |
| Generalised oedema | 14 | 14.9 8.9–25.1ROR 15.0 · χ² 168 / p 1e-38 | 13.9 EB05 8.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 | no trial data cached |
| Contraindicated product administered | 34 | 14.8 10.6–20.6ROR 15.1 · χ² 424 / p 2e-94 | 14.5 EB05 10.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · ♀ 0% (drug 41%) | no trial data cached |
| Drug level decreased | 11 | 14.1 7.8–25.4ROR 14.2 · χ² 121 / p 2e-28 | 12.5 EB05 6.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 | no trial data cached |
| Hemiparesis | 18 | 13.9 8.8–21.9ROR 14.0 · χ² 202 / p 4e-46 | 13.1 EB05 8.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Sepsis (blood infection) | 116 | 13.6 11.4–16.3ROR 14.6 · χ² 1,352 / p 2e-296 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 95% clinician | no trial data cached |
| Multi-organ failure | 18 | 13.5 8.5–21.3ROR 13.6 · χ² 195 / p 1e-44 | 12.6 EB05 7.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 | no trial data cached |
| Hypothermia | 10 | 12.9 7.0–24.0ROR 13.0 · χ² 99 / p 2e-23 | 11.0 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Acute respiratory distress syndrome | 17 | 12.6 7.9–20.2ROR 12.7 · χ² 170 / p 3e-39 | 11.6 EB05 7.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | no trial data cached |
| Splenomegaly | 11 | 12.3 6.8–22.2ROR 12.4 · χ² 103 / p 1e-24 | 10.5 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Coagulopathy | 15 | 11.8 7.2–19.6ROR 12.0 · χ² 138 / p 3e-32 | 10.6 EB05 6.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Pancytopenia (all blood cells low) | 50 | 11.8 9.0–15.5ROR 12.1 · χ² 483 / p 2e-107 | 11.5 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 98% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 15 | 11.7 7.0–19.3ROR 11.8 · χ² 136 / p 1e-31 | 10.4 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Metabolic acidosis | 28 | 11.6 8.0–16.8ROR 11.8 · χ² 261 / p 5e-59 | 11.0 EB05 7.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · ♀ 81% (drug 41%) · 100% clinician | no trial data cached |
| Respiratory failure | 63 | 11.3 8.9–14.4ROR 11.8 · χ² 585 / p 2e-129 | 11.1 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Hepatotoxicity (liver damage) | 19 | 11.2 7.2–17.6ROR 11.4 · χ² 167 / p 1e-38 | 10.2 EB05 6.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Shock | 19 | 10.9 7.0–17.1ROR 11.0 · χ² 162 / p 3e-37 | 9.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Nervous system disorder | 26 | 10.9 7.4–16.0ROR 11.1 · χ² 224 / p 6e-51 | 10.2 EB05 7.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · ♀ 12% (drug 41%) | no trial data cached |
| Pneumothorax | 13 | 10.8 6.3–18.5ROR 10.8 · χ² 106 / p 5e-25 | 9.2 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Acute hepatic failure | 11 | 10.6 5.9–19.1ROR 10.7 · χ² 86 / p 7e-21 | 8.7 EB05 4.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | no trial data cached |
| Hepatic failure | 23 | 10.0 6.7–15.0ROR 10.1 · χ² 177 / p 1e-40 | 9.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 91% clinician | no trial data cached |
| Febrile neutropenia | 49 | 9.7 7.4–12.8ROR 10.0 · χ² 375 / p 7e-84 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 98% clinician | no trial data cached |
| Oral herpes | 14 | 9.4 5.6–15.9ROR 9.5 · χ² 97 / p 3e-23 | 8.0 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Blood urea increased | 12 | 9.4 5.3–16.4ROR 9.4 · χ² 81 / p 9e-20 | 7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 | no trial data cached |
| Leukopenia (low white blood cells) | 35 | 9.2 6.6–12.8ROR 9.4 · χ² 248 / p 3e-56 | 8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Drug ineffective for unapproved indication | 36 | 8.5 6.1–11.7ROR 8.6 · χ² 230 / p 2e-52 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · ♀ 21% (drug 41%) | 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 |
|---|---|---|---|---|---|---|
| Multiple organ dysfunction syndrome | 173 | 81.8 71.0–94.2ROR 91.6 · χ² 13,659 / p <1e-300 | 80.6 EB05 71.0 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 48.0 | no trial data cached |
| Septic shock | 128 | 39.0 33.0–46.0ROR 42.3 · χ² 4,691 / p <1e-300 | 38.6 EB05 33.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 116 | 13.6 11.4–16.3ROR 14.6 · χ² 1,352 / p 2e-296 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 95% clinician | no trial data cached |
| Candida infection (yeast infection) | 92 | 72.7 59.6–88.7ROR 77.1 · χ² 6,404 / p <1e-300 | 71.3 EB05 59.9 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 61.4 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 82 | 7.9 6.4–9.8ROR 8.3 · χ² 493 / p 1e-109 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Drug resistance | 70 | 35.8 28.5–45.1ROR 37.4 · χ² 2,332 / p <1e-300 | 35.4 EB05 29.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 23.8 | no trial data cached |
| Respiratory failure | 63 | 11.3 8.9–14.4ROR 11.8 · χ² 585 / p 2e-129 | 11.1 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Thrombocytopenia (low platelets) | 57 | 6.7 5.2–8.7ROR 6.9 · χ² 272 / p 2e-61 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 61% (drug 41%) · 98% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 50 | 11.8 9.0–15.5ROR 12.1 · χ² 483 / p 2e-107 | 11.5 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 98% clinician | no trial data cached |
| Febrile neutropenia | 49 | 9.7 7.4–12.8ROR 10.0 · χ² 375 / p 7e-84 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 98% clinician | no trial data cached |
| Disseminated intravascular coagulation | 46 | 42.9 32.2–57.0ROR 44.1 · χ² 1,834 / p <1e-300 | 42.0 EB05 32.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 15% (drug 41%) | no trial data cached |
| Disease progression | 43 | 4.8 3.6–6.4ROR 4.9 · χ² 126 / p 2e-29 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 98% clinician | no trial data cached |
| Fungal infection | 40 | 15.8 11.6–21.4ROR 16.1 · χ² 539 / p 2e-119 | 15.6 EB05 11.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.0 | no trial data cached |
| Drug ineffective for unapproved indication | 36 | 8.5 6.1–11.7ROR 8.6 · χ² 230 / p 2e-52 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · ♀ 21% (drug 41%) | no trial data cached |
| Bacteraemia | 36 | 40.2 29.1–55.6ROR 41.1 · χ² 1,335 / p 2e-292 | 39.3 EB05 29.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.9 · ♀ 70% (drug 41%) | 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.
- Disseminated intravascular coagulation — n=46, PRR 42.9
- Septic shock — n=128, PRR 39.0
- Covid-19 pneumonia — n=34, PRR 37.6
- Toxic epidermal necrolysis — n=33, PRR 28.8
- Vasculitis — n=21, PRR 23.7
- Bacterial infection — n=31, PRR 21.9
- Brain oedema — n=21, PRR 21.8
- Stevens-johnson syndrome — n=31, PRR 18.3
- Cytokine release syndrome — n=23, PRR 15.8
- Sepsis — n=116, PRR 13.6
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 Anidulafungin?
In FDA FAERS, the most frequently co-reported reaction terms for Anidulafungin are multiple organ dysfunction syndrome, septic shock, sepsis, candida infection, neutropenia, respiratory failure. 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 Anidulafungin have an FDA boxed warning?
No. The FDA label retrieved for Anidulafungin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Anidulafungin 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 a88d9010-55fb-4a02-baff-042cd27688ea, effective 20250819; matched on
openfda.generic_name.exact:"ANIDULAFUNGIN") - 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, 89 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.