AMPHOTERICIN B

N/A

Manufactured by Astellas Pharma US, Inc.

32,295 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMPHOTERICIN B

AMPHOTERICIN B is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. The most commonly reported adverse reactions for AMPHOTERICIN B include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, CONDITION AGGRAVATED, FEBRILE NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMPHOTERICIN B.

Top Adverse Reactions

DRUG INEFFECTIVE3,940 reports
OFF LABEL USE1,911 reports
PYREXIA972 reports
CONDITION AGGRAVATED841 reports
FEBRILE NEUTROPENIA650 reports
ACUTE KIDNEY INJURY625 reports
SEPSIS612 reports
PNEUMONIA576 reports
HYPOKALAEMIA542 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME528 reports
RENAL IMPAIRMENT528 reports
PRODUCT USE IN UNAPPROVED INDICATION521 reports
DEATH515 reports
NEUTROPENIA504 reports
RESPIRATORY FAILURE491 reports
SEPTIC SHOCK486 reports
RENAL FAILURE452 reports
DRUG INTERACTION418 reports
ANAEMIA409 reports
THROMBOCYTOPENIA402 reports
BRONCHOPULMONARY ASPERGILLOSIS401 reports
NAUSEA397 reports
ASPERGILLUS INFECTION394 reports
PANCYTOPENIA394 reports
DIARRHOEA389 reports
VOMITING369 reports
GENERAL PHYSICAL HEALTH DETERIORATION361 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION360 reports
HYPOTENSION355 reports
DYSPNOEA341 reports
DRUG RESISTANCE329 reports
DISEASE PROGRESSION316 reports
FUNGAL INFECTION313 reports
BLOOD CREATININE INCREASED310 reports
MUCORMYCOSIS295 reports
LEUKOPENIA280 reports
INFECTION275 reports
TREATMENT FAILURE252 reports
RASH251 reports
HEADACHE248 reports
MULTI ORGAN FAILURE236 reports
PLEURAL EFFUSION233 reports
PRODUCT USE ISSUE230 reports
PLATELET COUNT DECREASED223 reports
ALANINE AMINOTRANSFERASE INCREASED220 reports
CANDIDA INFECTION214 reports
MUCOSAL INFLAMMATION212 reports
NEPHROPATHY TOXIC206 reports
CARDIAC ARREST202 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME201 reports
ABDOMINAL PAIN193 reports
CYTOMEGALOVIRUS INFECTION193 reports
C REACTIVE PROTEIN INCREASED190 reports
RENAL FAILURE ACUTE190 reports
HAEMOGLOBIN DECREASED188 reports
HYPERTENSION188 reports
TACHYCARDIA184 reports
TOXIC EPIDERMAL NECROLYSIS184 reports
ASPARTATE AMINOTRANSFERASE INCREASED178 reports
CHOLESTASIS174 reports
DISSEMINATED INTRAVASCULAR COAGULATION172 reports
FATIGUE168 reports
TOXICITY TO VARIOUS AGENTS166 reports
WHITE BLOOD CELL COUNT DECREASED166 reports
HEPATIC FUNCTION ABNORMAL165 reports
THERAPY NON RESPONDER165 reports
PAIN161 reports
CHILLS159 reports
MENINGITIS CRYPTOCOCCAL157 reports
BLOOD BILIRUBIN INCREASED155 reports
COUGH155 reports
GRAFT VERSUS HOST DISEASE155 reports
SYSTEMIC CANDIDA155 reports
BONE MARROW FAILURE153 reports
STAPHYLOCOCCAL INFECTION147 reports
OEDEMA PERIPHERAL144 reports
HEPATOTOXICITY143 reports
PATHOGEN RESISTANCE143 reports
ACUTE RESPIRATORY DISTRESS SYNDROME142 reports
DECREASED APPETITE141 reports
PNEUMONIA FUNGAL140 reports
ENCEPHALOPATHY139 reports
HYPONATRAEMIA139 reports
CONFUSIONAL STATE138 reports
METABOLIC ACIDOSIS138 reports
HYPOXIA137 reports
SHOCK131 reports
HYPERBILIRUBINAEMIA130 reports
CARDIAC FAILURE129 reports
ENDOPHTHALMITIS129 reports
HEPATIC FAILURE129 reports
MALAISE128 reports
WEIGHT DECREASED126 reports
PSEUDOMONAS INFECTION125 reports
BACK PAIN124 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED124 reports
LIVER DISORDER124 reports
HYPERKALAEMIA121 reports
BLOOD ALKALINE PHOSPHATASE INCREASED120 reports
ERYTHEMA120 reports

Report Outcomes

Out of 17,512 classified reports for AMPHOTERICIN B:

Serious 94.8%Non-Serious 5.2%

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

Male9,447 (59.0%)
Female6,478 (40.5%)
Unknown89 (0.6%)

Reports by Age

Age 58318 reports
Age 65302 reports
Age 56284 reports
Age 63272 reports
Age 60271 reports
Age 55266 reports
Age 57265 reports
Age 61260 reports
Age 53258 reports
Age 67255 reports
Age 70243 reports
Age 66240 reports
Age 62238 reports
Age 64236 reports
Age 50234 reports
Age 68234 reports
Age 59227 reports
Age 6225 reports
Age 52223 reports
Age 49220 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 AMPHOTERICIN B?

This profile reflects 32,295 FDA FAERS reports that mention AMPHOTERICIN B. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMPHOTERICIN B?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, CONDITION AGGRAVATED, FEBRILE NEUTROPENIA, ACUTE KIDNEY INJURY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMPHOTERICIN B?

Labeling and FAERS entries often list Astellas Pharma US, Inc. in connection with AMPHOTERICIN B. 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.