Drug · FAERS side-effect profile with label screen
Caspofungin side effects: what 4,684 FDA adverse event reports show
Drug class
Echinocandin antifungal
FDA label, Indications wording of the closest related product
Label matched
Caspofungin Acetate (Caspofungin Acetate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,684 reports · 94% serious · 1,668 with death outcome · 41% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. ( 1 ) Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) Treatment of esophageal candidiasis.
FDA label, Indications and Usage
What it is
Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis.
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) 5Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 18
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. 161 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 |
|---|---|---|---|---|---|---|
| Toxic skin eruption | 62 | 27.6 21.6–35.4ROR 28.0 · χ² 1,556 / p <1e-300 | 27.3 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Hyperbilirubinaemia | 63 | 27.5 21.5–35.2ROR 27.9 · χ² 1,576 / p <1e-300 | 27.2 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 | no trial data cached |
| Multi-organ failure | 107 | 27.5 22.8–33.1ROR 28.1 · χ² 2,688 / p <1e-300 | 27.2 EB05 23.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 93% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 91 | 27.2 22.2–33.3ROR 27.7 · χ² 2,256 / p <1e-300 | 26.9 EB05 22.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 | no trial data cached |
| Cholestasis (bile flow blockage) | 110 | 25.9 21.5–31.2ROR 26.5 · χ² 2,599 / p <1e-300 | 25.7 EB05 21.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · 92% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 145 | 23.4 19.9–27.5ROR 24.1 · χ² 3,072 / p <1e-300 | 23.2 EB05 20.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 115 | 20.2 16.9–24.2ROR 20.7 · χ² 2,076 / p <1e-300 | 20.1 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 94% clinician | no trial data cached |
| Septic shock | 193 | 20.1 17.5–23.1ROR 20.9 · χ² 3,471 / p <1e-300 | 20.0 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 79 | 19.2 15.4–23.9ROR 19.5 · χ² 1,341 / p 8e-294 | 19.0 EB05 15.8 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.8 · 95% clinician | no trial data cached |
| Drug resistance | 108 | 18.9 15.7–22.8ROR 19.3 · χ² 1,807 / p <1e-300 | 18.8 EB05 16.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 · 91% clinician | no trial data cached |
| Candida infection (yeast infection) | 67 | 18.0 14.2–22.9ROR 18.3 · χ² 1,058 / p 2e-232 | 17.9 EB05 14.6 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.9 | no trial data cached |
| Hepatocellular injury | 55 | 17.4 13.4–22.6ROR 17.6 · χ² 830 / p 8e-183 | 17.2 EB05 13.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 62% (drug 41%) | no trial data cached |
| Fungal infection | 123 | 16.6 13.9–19.8ROR 17.0 · χ² 1,783 / p <1e-300 | 16.5 EB05 14.2 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.4 · 92% clinician | no trial data cached |
| Neutrophil count increased | 36 | 15.7 11.4–21.8ROR 15.8 · χ² 480 / p 8e-107 | 15.5 EB05 11.5 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Disseminated intravascular coagulation | 44 | 14.0 10.4–18.8ROR 14.1 · χ² 516 / p 1e-114 | 13.7 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 90% clinician | no trial data cached |
| Lymphocyte count decreased | 54 | 13.7 10.5–17.9ROR 13.9 · χ² 622 / p 1e-137 | 13.5 EB05 10.6 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 · 100% clinician | no trial data cached |
| Bacteraemia | 35 | 13.3 9.6–18.6ROR 13.4 · χ² 387 / p 2e-86 | 13.0 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Hypomagnesaemia | 41 | 13.3 9.8–18.0ROR 13.4 · χ² 452 / p 2e-100 | 13.0 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 95% clinician | no trial data cached |
| Acute respiratory distress syndrome | 52 | 13.2 10.1–17.3ROR 13.3 · χ² 573 / p 7e-127 | 12.9 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 · 100% clinician | no trial data cached |
| Bone marrow failure | 60 | 13.2 10.2–16.9ROR 13.3 · χ² 661 / p 5e-146 | 13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Eosinophilia | 50 | 12.8 9.7–16.9ROR 13.0 · χ² 533 / p 3e-118 | 12.6 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 94% clinician | no trial data cached |
| Rash maculo-papular | 58 | 11.7 9.1–15.2ROR 11.9 · χ² 559 / p 8e-124 | 11.5 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Clostridium difficile colitis | 27 | 11.4 7.8–16.6ROR 11.5 · χ² 246 / p 1e-55 | 10.7 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 96% clinician | no trial data cached |
| Febrile neutropenia | 168 | 11.4 9.8–13.2ROR 11.8 · χ² 1,582 / p <1e-300 | 11.3 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Acute myeloid leukaemia | 39 | 11.2 8.2–15.4ROR 11.3 · χ² 353 / p 5e-79 | 10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Encephalopathy | 61 | 11.2 8.7–14.3ROR 11.3 · χ² 554 / p 8e-123 | 10.9 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 91% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 61 | 11.0 8.6–14.1ROR 11.1 · χ² 544 / p 1e-120 | 10.7 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 96% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 39 | 11.0 8.0–15.0ROR 11.1 · χ² 343 / p 7e-77 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 · 92% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 110 | 10.8 8.9–12.9ROR 11.0 · χ² 963 / p 9e-212 | 10.6 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 52 | 10.5 8.0–13.7ROR 10.6 · χ² 435 / p 5e-97 | 10.1 EB05 7.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 62% (drug 41%) | no trial data cached |
| Gamma-glutamyltransferase increased | 51 | 10.3 7.8–13.6ROR 10.4 · χ² 419 / p 2e-93 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Cytomegalovirus infection | 38 | 10.2 7.5–14.1ROR 10.3 · χ² 307 / p 4e-69 | 9.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Blood bilirubin increased | 60 | 9.9 7.7–12.8ROR 10.1 · χ² 473 / p 4e-105 | 9.6 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · 92% clinician | no trial data cached |
| Blood urea increased | 36 | 9.6 6.9–13.3ROR 9.7 · χ² 268 / p 1e-60 | 9.0 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 94% clinician | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 35 | 9.5 6.9–13.3ROR 9.6 · χ² 259 / p 2e-58 | 8.9 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 0% (drug 41%) · 97% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 20 | 9.4 6.1–14.6ROR 9.5 · χ² 142 / p 5e-33 | 8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 95% clinician | no trial data cached |
| Hepatic failure | 62 | 9.2 7.2–11.8ROR 9.3 · χ² 445 / p 5e-99 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Hepatic function abnormal | 74 | 9.0 7.1–11.2ROR 9.1 · χ² 515 / p 3e-114 | 8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Bacterial infection | 37 | 8.9 6.5–12.3ROR 9.0 · χ² 253 / p 4e-57 | 8.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 62% (drug 41%) | no trial data cached |
| Oral candidiasis (oral thrush) | 25 | 8.6 5.8–12.7ROR 8.7 · χ² 161 / p 4e-37 | 7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 670 | 2.3 2.1–2.4ROR 2.5 · χ² 511 / p 2e-113 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 93% clinician | no trial data cached |
| Death | 226 | 1.2 1.0–1.3ROR 1.2 · χ² 6 / p 0.007 | 1.2 EB05 1.1 · IC025 +0.0 | Outcome field, not a reaction | serious PRR 0.7 | no trial data cached |
| Product use in unapproved indication | 209 | 3.8 3.4–4.4ROR 4.0 · χ² 439 / p 7e-98 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 95% clinician | no trial data cached |
| Pneumonia (lung infection) | 202 | 2.8 2.4–3.2ROR 2.9 · χ² 235 / p 2e-53 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 · 90% clinician | no trial data cached |
| Septic shock | 193 | 20.1 17.5–23.1ROR 20.9 · χ² 3,471 / p <1e-300 | 20.0 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Sepsis (blood infection) | 192 | 7.7 6.7–8.9ROR 8.0 · χ² 1,119 / p 1e-245 | 7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Febrile neutropenia | 168 | 11.4 9.8–13.2ROR 11.8 · χ² 1,582 / p <1e-300 | 11.3 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Multiple organ dysfunction syndrome | 145 | 23.4 19.9–27.5ROR 24.1 · χ² 3,072 / p <1e-300 | 23.2 EB05 20.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 | no trial data cached |
| Respiratory failure | 131 | 8.0 6.8–9.5ROR 8.3 · χ² 803 / p 6e-177 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Renal failure (kidney failure) | 125 | 4.2 3.5–5.0ROR 4.3 · χ² 302 / p 7e-68 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Drug interaction | 123 | 3.5 2.9–4.1ROR 3.5 · χ² 216 / p 4e-49 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 95% clinician | no trial data cached |
| Fungal infection | 123 | 16.6 13.9–19.8ROR 17.0 · χ² 1,783 / p <1e-300 | 16.5 EB05 14.2 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.4 · 92% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 117 | 4.7 3.9–5.6ROR 4.8 · χ² 339 / p 6e-76 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 115 | 20.2 16.9–24.2ROR 20.7 · χ² 2,076 / p <1e-300 | 20.1 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 94% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 114 | 3.4 2.8–4.0ROR 3.4 · χ² 187 / p 7e-43 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · 90% 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.
- Toxic skin eruption — n=62, PRR 27.6
- Hyperbilirubinaemia — n=63, PRR 27.5
- Multi-organ failure — n=107, PRR 27.5
- Cholestasis — n=110, PRR 25.9
- Drug reaction with eosinophilia and systemic symptoms — n=115, PRR 20.2
- Septic shock — n=193, PRR 20.1
- Hepatocellular injury — n=55, PRR 17.4
- Disseminated intravascular coagulation — n=44, PRR 14.0
- Hypomagnesaemia — n=41, PRR 13.3
- Eosinophilia — n=50, PRR 12.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Caspofungin?
In FDA FAERS, the most frequently co-reported reaction terms for Caspofungin are pneumonia, septic shock, sepsis, febrile neutropenia, multiple organ dysfunction syndrome, 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 Caspofungin have an FDA boxed warning?
No. The FDA label retrieved for Caspofungin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Caspofungin 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 2b9bf716-9d4b-4264-985b-6fe98f5e729d, effective 20251008; matched on
openfda.generic_name.exact:"CASPOFUNGIN ACETATE") - 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, 201 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.