Drug · FAERS side-effect profile with label screen
Micafungin Sodium side effects: what 6,382 FDA adverse event reports show
Who reports
6,382 reports · 96% serious · 2,365 with death outcome · 40% 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 (related wording) 1Likely indication confounding 4Lab value / disease marker 4Not in label — unassessed 31
What the badges mean
- 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. 970 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 |
|---|---|---|---|---|---|---|
| Anti factor v antibody | 14 | 4,294.4 1,802.0–10,234.1ROR 4,301.5 · χ² 20,318 / p <1e-300 | 496.7 EB05 314.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Lymphoid tissue hypoplasia | 84 | 3,271.9 2,361.8–4,532.8ROR 3,304.8 · χ² 116,320 / p <1e-300 | 1,060.8 EB05 883.6 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Pre-engraftment immune reaction | 44 | 3,085.0 1,980.1–4,806.4ROR 3,101.1 · χ² 58,739 / p <1e-300 | 854.8 EB05 663.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 71% (drug 40%) · 100% clinician | no trial data cached |
| Thymus hypoplasia | 82 | 2,286.6 1,693.8–3,086.9ROR 2,309.1 · χ² 95,796 / p <1e-300 | 926.1 EB05 769.7 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Disseminated aspergillosis | 96 | 641.9 513.3–802.8ROR 649.3 · χ² 48,188 / p <1e-300 | 461.9 EB05 389.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=24 · 92% clinician | no trial data cached |
| Corynebacterium bacteraemia | 17 | 641.8 376.4–1,094.2ROR 643.1 · χ² 8,121 / p <1e-300 | 323.5 EB05 213.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Herpes simplex oesophagitis | 28 | 455.0 304.2–680.7ROR 456.5 · χ² 10,321 / p <1e-300 | 304.2 EB05 220.9 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | – | no trial data cached |
| Geotrichum infection | 30 | 409.0 278.0–601.6ROR 410.4 · χ² 10,119 / p <1e-300 | 286.6 EB05 210.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Cerebral ventricle collapse | 10 | 377.5 194.1–734.4ROR 378.0 · χ² 2,936 / p <1e-300 | 201.8 EB05 117.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mycotic endophthalmitis | 21 | 312.3 198.4–491.6ROR 313.1 · χ² 5,508 / p <1e-300 | 221.5 EB05 152.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Gastrointestinal mucormycosis | 17 | 298.0 180.2–492.7ROR 298.6 · χ² 4,226 / p <1e-300 | 204.9 EB05 135.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Trichosporon infection | 39 | 271.9 195.4–378.2ROR 273.1 · χ² 9,234 / p <1e-300 | 218.7 EB05 166.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | no trial data cached |
| Pulmonary mucormycosis | 44 | 232.2 170.6–316.1ROR 233.4 · χ² 9,044 / p <1e-300 | 194.4 EB05 150.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 69% (drug 40%) · 100% clinician | no trial data cached |
| Disseminated mucormycosis | 32 | 223.7 155.9–321.1ROR 224.6 · χ² 6,300 / p <1e-300 | 182.9 EB05 135.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 10% (drug 40%) · 100% clinician | no trial data cached |
| Engraft failure | 20 | 187.3 118.9–295.0ROR 187.8 · χ² 3,273 / p <1e-300 | 149.5 EB05 102.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 65% (drug 40%) · 100% clinician | no trial data cached |
| Fungal endocarditis | 20 | 181.8 115.5–286.1ROR 182.2 · χ² 3,181 / p <1e-300 | 146.0 EB05 99.8 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Cerebral aspergillosis | 40 | 173.4 125.9–238.8ROR 174.2 · χ² 6,245 / p <1e-300 | 150.5 EB05 115.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=40 | no trial data cached |
| Blood beta-d-glucan increased | 20 | 173.4 110.2–272.8ROR 173.8 · χ² 3,043 / p <1e-300 | 140.6 EB05 96.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Cystitis viral | 22 | 152.5 99.2–234.5ROR 152.9 · χ² 2,976 / p <1e-300 | 127.9 EB05 89.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% clinician | no trial data cached |
| Fungaemia | 82 | 137.6 110.3–171.7ROR 139.0 · χ² 10,404 / p <1e-300 | 126.6 EB05 105.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=76 · 93% clinician | no trial data cached |
| Idiopathic pneumonia syndrome | 15 | 131.9 78.5–221.7ROR 132.2 · χ² 1,727 / p <1e-300 | 108.4 EB05 69.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Fusarium infection | 34 | 130.2 92.3–183.7ROR 130.7 · χ² 4,017 / p <1e-300 | 115.8 EB05 86.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 19% (drug 40%) · 100% clinician | no trial data cached |
| Rhinocerebral mucormycosis | 17 | 130.0 79.8–211.6ROR 130.2 · χ² 1,945 / p <1e-300 | 108.7 EB05 71.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Scedosporium infection | 34 | 128.4 91.0–181.1ROR 128.9 · χ² 3,963 / p <1e-300 | 114.3 EB05 85.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Nasal abscess | 11 | 126.1 68.8–231.1ROR 126.3 · χ² 1,183 / p 2e-259 | 99.8 EB05 59.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Systemic mycosis | 56 | 125.4 95.9–163.9ROR 126.2 · χ² 6,457 / p <1e-300 | 114.8 EB05 91.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=52 | no trial data cached |
| Aspergillus test positive | 14 | 118.5 69.3–202.5ROR 118.7 · χ² 1,445 / p <1e-300 | 98.3 EB05 62.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Encephalitis viral | 55 | 118.4 90.4–155.0ROR 119.2 · χ² 5,996 / p <1e-300 | 108.8 EB05 86.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 67% (drug 40%) · 100% clinician | no trial data cached |
| Enterococcus test positive | 29 | 115.7 79.8–167.8ROR 116.1 · χ² 3,041 / p <1e-300 | 103.2 EB05 75.4 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Aplastic anaemia | 228 | 113.1 99.2–128.9ROR 116.2 · χ² 24,115 / p <1e-300 | 107.2 EB05 96.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | no trial data cached |
| Periostitis | 19 | 112.9 71.3–178.7ROR 113.1 · χ² 1,909 / p <1e-300 | 97.6 EB05 66.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Adenoviral hepatitis | 10 | 112.1 59.5–211.1ROR 112.2 · χ² 949 / p 1e-208 | 89.4 EB05 51.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Human herpesvirus 6 encephalitis | 12 | 109.5 61.4–195.1ROR 109.6 · χ² 1,133 / p 1e-248 | 90.2 EB05 55.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Enterococcal sepsis | 34 | 108.1 76.7–152.3ROR 108.5 · χ² 3,353 / p <1e-300 | 98.0 EB05 73.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 62% (drug 40%) | no trial data cached |
| Gastrointestinal fungal infection | 21 | 106.5 68.8–164.7ROR 106.7 · χ² 2,003 / p <1e-300 | 93.6 EB05 64.6 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=21 · 90% clinician | no trial data cached |
| Acute graft versus host disease in intestine | 54 | 99.6 75.9–130.6ROR 100.2 · χ² 4,969 / p <1e-300 | 92.7 EB05 73.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=54 · 100% clinician | no trial data cached |
| Mucormycosis | 99 | 99.5 81.5–121.5ROR 100.7 · χ² 9,183 / p <1e-300 | 94.0 EB05 79.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=96 · 96% clinician | no trial data cached |
| Acute graft versus host disease in liver | 27 | 96.7 65.9–142.0ROR 97.0 · χ² 2,370 / p <1e-300 | 87.5 EB05 63.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 17% (drug 40%) · 100% clinician | no trial data cached |
| Systemic candida | 91 | 95.2 77.3–117.3ROR 96.3 · χ² 8,078 / p <1e-300 | 90.0 EB05 75.5 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=81 | no trial data cached |
| Acute graft versus host disease in skin | 98 | 91.6 74.9–111.9ROR 92.6 · χ² 8,378 / p <1e-300 | 86.9 EB05 73.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=98 · 99% clinician | 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) | 1,222 | 3.5 3.3–3.7ROR 3.9 · χ² 2,278 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Drug ineffective (drug did not work) | 1,139 | 2.2 2.0–2.3ROR 2.3 · χ² 749 / p 4e-165 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Febrile neutropenia | 552 | 20.9 19.3–22.7ROR 22.3 · χ² 10,386 / p <1e-300 | 20.7 EB05 19.3 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 94% clinician | no trial data cached |
| Pyrexia (fever) | 535 | 3.8 3.5–4.2ROR 4.0 · χ² 1,142 / p 1e-250 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Product use in unapproved indication | 398 | 4.1 3.7–4.5ROR 4.2 · χ² 923 / p 4e-203 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 361 | 8.1 7.3–8.9ROR 8.4 · χ² 2,234 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Pneumonia (lung infection) | 343 | 2.6 2.4–2.9ROR 2.7 · χ² 353 / p 4e-79 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Death | 317 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.058 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.4 | no trial data cached |
| Diarrhoea (diarrhea) | 303 | 1.2 1.0–1.3ROR 1.2 · χ² 8 / p 0.003 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 287 | 5.3 4.7–5.9ROR 5.4 · χ² 995 / p 9e-219 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Multiple organ dysfunction syndrome | 281 | 25.3 22.5–28.4ROR 26.1 · χ² 6,475 / p <1e-300 | 25.0 EB05 22.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.6 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 273 | 4.5 4.0–5.0ROR 4.6 · χ² 735 / p 4e-162 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 92% clinician | no trial data cached |
| Respiratory failure | 263 | 9.0 8.0–10.1ROR 9.3 · χ² 1,860 / p <1e-300 | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Septic shock | 246 | 14.2 12.6–16.1ROR 14.6 · χ² 3,003 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Aplastic anaemia | 228 | 113.1 99.2–128.9ROR 116.2 · χ² 24,115 / p <1e-300 | 107.2 EB05 96.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% 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.
- Lymphoid tissue hypoplasia — n=84, PRR 3,271.9
- Pre-engraftment immune reaction — n=44, PRR 3,085.0
- Thymus hypoplasia — n=82, PRR 2,286.6
- Disseminated aspergillosis — n=96, PRR 641.9
- Geotrichum infection — n=30, PRR 409.0
- Mycotic endophthalmitis — n=21, PRR 312.3
- Trichosporon infection — n=39, PRR 271.9
- Pulmonary mucormycosis — n=44, PRR 232.2
- Disseminated mucormycosis — n=32, PRR 223.7
- Engraft failure — n=20, PRR 187.3
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 febrile neutropenia, pyrexia, sepsis, pneumonia, diarrhoea, neutropenia. 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, 1,010 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.