Drug · FAERS side-effect profile with label screen
Micafungin side effects: what 5,004 FDA adverse event reports show
Who reports
5,004 reports · 95% serious · 1,776 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Micafungin for injection is indicated for: • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.1 ) and Use in Specific Populat.
FDA label, Indications and Usage
What it is
Micafungin for Injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899.
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) 3Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 21
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. 164 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 |
|---|---|---|---|---|---|---|
| Candida infection (yeast infection) | 151 | 38.2 32.7–44.8ROR 39.4 · χ² 5,395 / p <1e-300 | 37.7 EB05 33.0 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 32.4 | no trial data cached |
| Multiple organ dysfunction syndrome | 227 | 34.3 30.2–39.0ROR 35.9 · χ² 7,266 / p <1e-300 | 34.0 EB05 30.4 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.7 | no trial data cached |
| Cytokine release syndrome | 100 | 22.1 18.2–26.8ROR 22.5 · χ² 1,984 / p <1e-300 | 21.9 EB05 18.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 96% clinician | no trial data cached |
| Nephropathy toxic | 51 | 19.3 14.7–25.3ROR 19.5 · χ² 861 / p 1e-189 | 19.1 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 10% (drug 39%) | no trial data cached |
| Bacteraemia | 52 | 18.6 14.2–24.4ROR 18.8 · χ² 844 / p 6e-186 | 18.4 EB05 14.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Hyperbilirubinaemia | 44 | 18.0 13.4–24.1ROR 18.1 · χ² 685 / p 2e-151 | 17.7 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 18% (drug 39%) · 90% clinician | no trial data cached |
| Septic shock | 180 | 17.5 15.2–20.2ROR 18.1 · χ² 2,780 / p <1e-300 | 17.4 EB05 15.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Febrile neutropenia | 263 | 16.7 14.8–18.8ROR 17.6 · χ² 3,862 / p <1e-300 | 16.6 EB05 15.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 91% clinician | no trial data cached |
| Disseminated intravascular coagulation | 55 | 16.4 12.6–21.3ROR 16.5 · χ² 776 / p 4e-171 | 16.2 EB05 12.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Cytomegalovirus infection | 64 | 16.2 12.7–20.6ROR 16.4 · χ² 893 / p 1e-196 | 16.0 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 92% clinician | no trial data cached |
| Acute respiratory distress syndrome | 64 | 15.2 11.9–19.4ROR 15.4 · χ² 833 / p 2e-183 | 15.0 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 95% clinician | no trial data cached |
| Drug resistance | 92 | 15.1 12.3–18.4ROR 15.3 · χ² 1,190 / p 4e-261 | 14.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 | no trial data cached |
| Fungal infection | 101 | 12.7 10.5–15.5ROR 13.0 · χ² 1,079 / p 5e-237 | 12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 93% clinician | no trial data cached |
| Mucosal inflammation | 76 | 12.2 9.8–15.3ROR 12.4 · χ² 772 / p 3e-170 | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 97% clinician | no trial data cached |
| Respiratory failure | 202 | 11.6 10.2–13.3ROR 12.1 · χ² 1,952 / p <1e-300 | 11.5 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Acute respiratory failure | 52 | 11.4 8.7–15.0ROR 11.5 · χ² 482 / p 3e-107 | 11.1 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 · 92% clinician | no trial data cached |
| Multi-organ failure | 46 | 11.0 8.3–14.7ROR 11.1 · χ² 408 / p 5e-91 | 10.6 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Thrombotic microangiopathy | 24 | 10.4 7.0–15.5ROR 10.4 · χ² 194 / p 2e-44 | 9.5 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 64% (drug 39%) · 91% clinician | no trial data cached |
| Pulmonary mass | 36 | 10.2 7.3–14.1ROR 10.2 · χ² 288 / p 8e-65 | 9.6 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 18% (drug 39%) | no trial data cached |
| Vasculitis | 28 | 10.1 7.0–14.6ROR 10.1 · χ² 220 / p 5e-50 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 0% (drug 39%) | no trial data cached |
| Acute myeloid leukaemia | 37 | 10.0 7.2–13.8ROR 10.0 · χ² 289 / p 3e-65 | 9.4 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hypoxia (low oxygen) | 79 | 9.5 7.6–11.8ROR 9.6 · χ² 588 / p 3e-130 | 9.2 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 92% clinician | no trial data cached |
| Device related infection | 34 | 9.2 6.6–12.9ROR 9.3 · χ² 242 / p 9e-55 | 8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 22 | 9.2 6.1–14.0ROR 9.3 · χ² 153 / p 2e-35 | 8.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 95% clinician | no trial data cached |
| Encephalopathy | 52 | 8.9 6.8–11.7ROR 9.0 · χ² 357 / p 7e-80 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Oesophagitis | 23 | 8.8 5.9–13.3ROR 8.9 · χ² 152 / p 4e-35 | 7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.9 · 100% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 20 | 8.8 5.7–13.7ROR 8.8 · χ² 131 / p 1e-30 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Brain oedema | 25 | 8.3 5.6–12.3ROR 8.3 · χ² 153 / p 2e-35 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 92% clinician | no trial data cached |
| Shock | 45 | 8.3 6.2–11.1ROR 8.3 · χ² 280 / p 3e-63 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 98% clinician | no trial data cached |
| Lung infection | 31 | 8.3 5.8–11.7ROR 8.3 · χ² 190 / p 1e-43 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Pancytopenia (all blood cells low) | 108 | 8.1 6.7–9.8ROR 8.3 · χ² 669 / p 9e-148 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Cytopenia | 23 | 8.1 5.4–12.1ROR 8.1 · χ² 135 / p 1e-31 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 96% clinician | no trial data cached |
| Malnutrition | 21 | 7.9 5.2–12.2ROR 8.0 · χ² 120 / p 3e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 71% (drug 39%) · 90% clinician | no trial data cached |
| Respiratory distress | 52 | 7.9 6.0–10.4ROR 8.0 · χ² 306 / p 7e-69 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Staphylococcal infection | 61 | 7.7 6.0–9.9ROR 7.8 · χ² 351 / p 2e-78 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Blood bilirubin increased | 49 | 7.6 5.7–10.0ROR 7.7 · χ² 274 / p 9e-62 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Drug ineffective for unapproved indication | 100 | 7.5 6.2–9.1ROR 7.7 · χ² 560 / p 4e-124 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 91% clinician | no trial data cached |
| Sepsis (blood infection) | 200 | 7.5 6.6–8.6ROR 7.8 · χ² 1,128 / p 2e-247 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Neurotoxicity | 31 | 7.5 5.3–10.6ROR 7.5 · χ² 168 / p 1e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 97% clinician | no trial data cached |
| Drug-induced liver injury | 55 | 7.5 5.8–9.7ROR 7.6 · χ² 302 / p 5e-68 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | 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) | 1,015 | 3.2 3.1–3.4ROR 3.8 · χ² 1,665 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Off label use (used outside approved label) | 592 | 2.9 2.7–3.1ROR 3.1 · χ² 744 / p 4e-164 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Pyrexia (fever) | 289 | 3.5 3.1–3.9ROR 3.7 · χ² 521 / p 1e-115 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Product use in unapproved indication | 286 | 4.9 4.4–5.5ROR 5.1 · χ² 896 / p 4e-197 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 97% clinician | no trial data cached |
| Febrile neutropenia | 263 | 16.7 14.8–18.8ROR 17.6 · χ² 3,862 / p <1e-300 | 16.6 EB05 15.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 91% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 227 | 34.3 30.2–39.0ROR 35.9 · χ² 7,266 / p <1e-300 | 34.0 EB05 30.4 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 219 | 6.0 5.3–6.9ROR 6.3 · χ² 919 / p 3e-202 | 6.0 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 93% clinician | no trial data cached |
| Respiratory failure | 202 | 11.6 10.2–13.3ROR 12.1 · χ² 1,952 / p <1e-300 | 11.5 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Sepsis (blood infection) | 200 | 7.5 6.6–8.6ROR 7.8 · χ² 1,128 / p 2e-247 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Pneumonia (lung infection) | 199 | 2.6 2.3–3.0ROR 2.6 · χ² 194 / p 2e-44 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 196 | 6.1 5.3–7.0ROR 6.3 · χ² 829 / p 2e-182 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Septic shock | 180 | 17.5 15.2–20.2ROR 18.1 · χ² 2,780 / p <1e-300 | 17.4 EB05 15.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Condition aggravated | 170 | 2.4 2.0–2.7ROR 2.4 · χ² 134 / p 3e-31 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Candida infection (yeast infection) | 151 | 38.2 32.7–44.8ROR 39.4 · χ² 5,395 / p <1e-300 | 37.7 EB05 33.0 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 32.4 | no trial data cached |
| Hypotension (low blood pressure) | 128 | 2.7 2.3–3.2ROR 2.7 · χ² 134 / p 3e-31 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | 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.
- Cytokine release syndrome — n=100, PRR 22.1
- Nephropathy toxic — n=51, PRR 19.3
- Bacteraemia — n=52, PRR 18.6
- Hyperbilirubinaemia — n=44, PRR 18.0
- Septic shock — n=180, PRR 17.5
- Cytomegalovirus infection — n=64, PRR 16.2
- Fungal infection — n=101, PRR 12.7
- Multi-organ failure — n=46, PRR 11.0
- Thrombotic microangiopathy — n=24, PRR 10.4
- Pulmonary mass — n=36, PRR 10.2
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 Micafungin?
In FDA FAERS, the most frequently co-reported reaction terms for Micafungin are pyrexia, febrile neutropenia, multiple organ dysfunction syndrome, acute kidney injury, respiratory failure, sepsis. 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 Micafungin have an FDA boxed warning?
No. The FDA label retrieved for Micafungin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Micafungin 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 31e74606-bccd-4276-bb20-a1933ce4ca25, effective 20250909; matched on
openfda.generic_name.exact:"MICAFUNGIN") - 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, 204 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.