MICAFUNGIN SODIUM

N/A

Manufactured by Fresenius Kabi USA, LLC

15,554 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MICAFUNGIN SODIUM

MICAFUNGIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for MICAFUNGIN SODIUM include OFF LABEL USE, DRUG INEFFECTIVE, FEBRILE NEUTROPENIA, PYREXIA, PRODUCT USE IN UNAPPROVED INDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MICAFUNGIN SODIUM.

Top Adverse Reactions

OFF LABEL USE1,166 reports
DRUG INEFFECTIVE1,106 reports
FEBRILE NEUTROPENIA531 reports
PYREXIA513 reports
PRODUCT USE IN UNAPPROVED INDICATION387 reports
SEPSIS342 reports
PNEUMONIA325 reports
DEATH308 reports
DIARRHOEA292 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME266 reports
NEUTROPENIA262 reports
ACUTE KIDNEY INJURY253 reports
RESPIRATORY FAILURE252 reports
SEPTIC SHOCK232 reports
APLASTIC ANAEMIA228 reports
FUNGAL INFECTION220 reports
ANAEMIA206 reports
CONDITION AGGRAVATED196 reports
INFECTION193 reports
RENAL FAILURE190 reports
BRONCHOPULMONARY ASPERGILLOSIS180 reports
NAUSEA170 reports
MUCOSAL INFLAMMATION169 reports
CANDIDA INFECTION168 reports
PRODUCT USE ISSUE157 reports
ASPERGILLUS INFECTION156 reports
HYPOTENSION155 reports
THROMBOCYTOPENIA153 reports
PLATELET COUNT DECREASED150 reports
RENAL IMPAIRMENT149 reports
VOMITING148 reports
DRUG INTERACTION147 reports
ASPARTATE AMINOTRANSFERASE INCREASED145 reports
DYSPNOEA144 reports
ALANINE AMINOTRANSFERASE INCREASED143 reports
PANCYTOPENIA139 reports
PLEURAL EFFUSION136 reports
ABDOMINAL PAIN128 reports
RASH126 reports
BACTERIAL INFECTION123 reports
CYTOMEGALOVIRUS VIRAEMIA123 reports
WHITE BLOOD CELL COUNT DECREASED122 reports
HYPOKALAEMIA119 reports
CYTOKINE RELEASE SYNDROME114 reports
CELLULITIS113 reports
CLOSTRIDIUM DIFFICILE COLITIS110 reports
DISSEMINATED INTRAVASCULAR COAGULATION110 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION110 reports
DRUG RESISTANCE110 reports
HYPERTENSION109 reports
CYTOMEGALOVIRUS INFECTION108 reports
DISEASE PROGRESSION105 reports
HEPATIC FUNCTION ABNORMAL99 reports
HYPOXIA99 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN97 reports
LYMPHOPENIA94 reports
ACUTE GRAFT VERSUS HOST DISEASE92 reports
DISSEMINATED ASPERGILLOSIS92 reports
LEUKOPENIA91 reports
MULTI ORGAN FAILURE91 reports
CARDIAC ARREST89 reports
SYSTEMIC CANDIDA88 reports
GRAFT VERSUS HOST DISEASE87 reports
MUCORMYCOSIS87 reports
BLOOD BILIRUBIN INCREASED86 reports
GASTROINTESTINAL HAEMORRHAGE85 reports
LYMPHOID TISSUE HYPOPLASIA84 reports
PNEUMONIA FUNGAL84 reports
HAEMOGLOBIN DECREASED83 reports
ACUTE MYELOID LEUKAEMIA82 reports
STAPHYLOCOCCAL INFECTION82 reports
THYMUS HYPOPLASIA82 reports
ACUTE RESPIRATORY DISTRESS SYNDROME81 reports
BACTERAEMIA80 reports
BLOOD CREATININE INCREASED80 reports
VENOOCCLUSIVE LIVER DISEASE79 reports
ENTEROCOCCAL INFECTION78 reports
FUNGAEMIA78 reports
ATRIAL FIBRILLATION77 reports
TACHYCARDIA77 reports
NEUTROPHIL COUNT DECREASED76 reports
ACUTE RESPIRATORY FAILURE73 reports
THROMBOTIC MICROANGIOPATHY73 reports
ASTHENIA72 reports
DRUG INDUCED LIVER INJURY69 reports
HEPATIC FAILURE69 reports
LIVER DISORDER69 reports
PAIN69 reports
C REACTIVE PROTEIN INCREASED68 reports
CARDIAC FAILURE68 reports
HEADACHE68 reports
STOMATITIS68 reports
FATIGUE67 reports
HUMAN HERPESVIRUS 6 INFECTION66 reports
RESPIRATORY DISTRESS63 reports
TUMOUR LYSIS SYNDROME63 reports
DECREASED APPETITE61 reports
INTERSTITIAL LUNG DISEASE61 reports
WHITE BLOOD CELL COUNT INCREASED61 reports
PANCREATITIS ACUTE59 reports

Report Outcomes

Out of 8,120 classified reports for MICAFUNGIN SODIUM:

Serious 89.5%Non-Serious 10.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male4,499 (60.3%)
Female2,926 (39.2%)
Unknown34 (0.5%)

Reports by Age

Age 44139 reports
Age 57139 reports
Age 58134 reports
Age 70128 reports
Age 71126 reports
Age 67124 reports
Age 62123 reports
Age 65115 reports
Age 59114 reports
Age 72114 reports
Age 10111 reports
Age 8108 reports
Age 56107 reports
Age 55106 reports
Age 6104 reports
Age 64104 reports
Age 16102 reports
Age 48101 reports
Age 66101 reports
Age 63100 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MICAFUNGIN SODIUM?

This profile reflects 15,554 FDA FAERS reports that mention MICAFUNGIN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MICAFUNGIN SODIUM?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, FEBRILE NEUTROPENIA, PYREXIA, PRODUCT USE IN UNAPPROVED INDICATION, SEPSIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MICAFUNGIN SODIUM?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with MICAFUNGIN SODIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.