Amphotericin B

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

• Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES) .ICD-10: B20

• Amphotericin B liposome for injection is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.contraindicated

Amphotericin B liposome for injection is not interchangeable or substitutable on a mg per mg basis with other amphotericin B products. Different amphotericin B products are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing. Amphotericin B liposome for injection should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes. An in-line membrane filter may be used for the intravenous infusion of amphotericin B liposome for injection, provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1.0 MICRON. NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of amphotericin B liposome for injection. If this is not feasible, amphotericin B liposome for injection must be administered through a separate line. Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended initial dose of amphotericin B liposome for injection for each indication for adult and pediatric patients is as follows: Indication Dose (mg/kg/day) Empirical therapy 3 Systemic fungal infections: Aspergillus Candida Cryptococcus 3 to 5 Cryptococcal meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ) 6 Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.

Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including amphotericin B liposome for injection. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of amphotericin B liposome for injection.

The following adverse events are based on the experience of 592 adult patients (295 treated with amphotericin B liposome for injection and 297 treated with amphotericin B deoxycholate) and 95 pediatric patients (48 treated with amphotericin B liposome for injection and 47 treated with amphotericin B deoxycholate) in Study 94-0-002, a randomized double-blind, multicenter study in febrile, neutropenic patients. Amphotericin B liposome for injection and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 10% or greater) occurring with amphotericin B liposome for injection compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: Empirical Therapy Study 94-0-002 Common Adverse Events Adverse Event by Body System Amphotericin B Liposome for Injection N=343 % Amphotericin B N=344 % Body as a Whole Abdominal pain 19.8 21.8 Asthenia 13.1 10.8 Back pain 12 7.3 Blood product transfusion reaction 18.4 18.6 Chills 47.5 75.9 Infection 11.1 9.3 Pain 14 12.8 Sepsis 14 11.3 Cardiovascular System Chest pain 12 11.6 Hypertension 7.9 16.3 Hypotension 14.3 21.5 Tachycardia 13.4 20.9 Digestive System Diarrhea 30.3 27.3 Gastrointestinal hemorrhage 9.9 11.3 Nausea 39.7 38.7 Vomiting 31.8 43.9 Metabolic and Nutritional Disorders Alkaline phosphatase increased 22.2 19.2 ALT (SGPT) increased 14.6 14 AST (SGOT) increased 12.8 12.8 Bilirubinemia 18.1 19.2 BUN increased 21 31.1 Creatinine increased 22.4 42.2 Edema 14.3 14.8 Hyperglycemia 23 27.9 Hypernatremia 4.1 11 Hypervolemia 12.2 15.4 Hypocalcemia…

Pregnancy There have been no adequate and well-controlled studies of amphotericin B liposome for injection in pregnant women. Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small. Segment II studies in both rats and rabbits have concluded that amphotericin B liposome for injection had no teratogenic potential in these species. In rats, the maternal non-toxic dose of amphotericin B liposome for injection was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 mg/kg to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction. Rabbits receiving the higher doses, (equivalent to 0.5 to 2 times the recommended human dose) of amphotericin B liposome for injection experienced a higher rate of spontaneous abortions than did the control groups. Amphotericin B liposome for injection should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks involved.

The toxicity of amphotericin B liposome for injection due to overdose has not been defined. Repeated daily doses up to 10 mg/kg in pediatric patients and 15 mg/kg in adult patients have been administered in clinical trials with no reported dose-related toxicity. Management If overdosage should occur, cease administration immediately. Symptomatic supportive measures should be instituted. Particular attention should be given to monitoring renal function. Hemodialysis or peritoneal dialysis do not appear to significantly affect the elimination of amphotericin B liposome for injection.

• Apr 29, 1992ANDAANDA063206Xgen Pharms
• Aug 11, 1997NDANDA050740Astellas
• Dec 14, 2021ANDAANDA212514Spil
• Nov 17, 2022ANDAANDA214010Eugia Pharma
• Jun 2, 2025ANDAANDA215354Avet Lifesciences
• Jun 30, 2025ANDAANDA212967Mylan Labs Ltd

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Abelcet, Injection, 5 mg/1 mL; 3.4 mg/1 mL; 1.5 mg/1 mL (NDC 57665-101-41)To be discontinued
  Sponsor: Leadiant Biosciences, Inc.
  Updated Aug 8, 2025

1. 1Drug Ineffective5,08425%
2. 2Off Label Use2,35012%
3. 3Pyrexia1,0665.3%
4. 4Condition Aggravated9064.5%
5. 5Acute Kidney Injury7373.6%
6. 6Febrile Neutropenia6953.4%
7. 7Sepsis6503.2%
8. 8Hypokalaemia6363.1%
9. 9Death6343.1%
10. 10Pneumonia6263.1%
11. 11Multiple Organ Dysfunction Syndrome6073.0%
12. 12Renal Impairment6053.0%
13. 13Product Use In Unapproved Indication5842.9%
14. 14Neutropenia5522.7%
15. 15Respiratory Failure5452.7%

Recent PubMed references pinned to Amphotericin B as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Nebulized amphotericin B deoxycholate in management of chronic pulmonary aspergillosis: experience from a tertiary care centre in North India.
  The Journal of antimicrobial chemotherapy · 2026 · Sehgal IS, Agarwal R, Muthu V, et al.
  PMID 42253040DOI 10.1093/jac/dkag200
• Low-intensity pulsed ultrasound combined with microbubbles enhances amphotericin B delivery across the blood-brain barrier for improved therapy of cryptococcal meningitis.
  Drug delivery · 2026 · Liu J, Li Z, Li D, et al.
  PMID 42241274DOI 10.1080/10717544.2026.2677305
• Real-World Efficacy and Safety of Liposomal Amphotericin B for Invasive Fungal Disease in Patients with Hematologic Malignancies: A Multicenter Retrospective Study.
  Drug design, development and therapy · 2026 · Lu T, Zhang J, Liu D, et al.
  PMID 42226752DOI 10.2147/DDDT.S605938
• Microneedle-based injection of Fungizone/Amphotericin B: an effective treatment for American cutaneous leishmaniasis in mice.
  Drug delivery · 2026 · Huston RH, Cox B, Verma C, et al.
  PMID 42083326DOI 10.1080/10717544.2026.2665882
• A 3D-printed diffusion cell for nail permeation testing.
  International journal of pharmaceutics · 2026 · Maisonneuve S, Vrignaud S, Pihet M, et al.
  PMID 42082059DOI 10.1016/j.ijpharm.2026.126898
• Eudragit E100/silk fibroin hybrid nanoparticles for the controlled oral delivery of amphotericin B.
  Therapeutic delivery · 2026 · Pham DT, Loan PTT, Ha PTM, et al.
  PMID 42059406DOI 10.1080/20415990.2026.2665555
• A step toward defining optimal liposomal amphotericin B treatment duration in pulmonary mucormycosis: results from emulated trials.
  Antimicrobial agents and chemotherapy · 2026 · Coste A, Paccoud O, Danion F, et al.
  PMID 42053464DOI 10.1128/aac.01523-25
• De-centering the drug: Violet light and amphotericin B enhance antileishmanial activity through additive and host-directed effects.
  Experimental parasitology · 2026 · Diniz BP, Pereira CL, Melo TS, et al.
  PMID 42031056DOI 10.1016/j.exppara.2026.109136

The 10 most recently updated of 198 ClinicalTrials.gov registrations naming Amphotericin B as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
  Recruiting · Phase 2 · Interventional · 60 enrolled · Elion Therapeutics, Inc.
  NCT07215273updated 2026-06-09
• Human Bioequivalence Study of Liposomal Amphotericin B for Injection
  Completed · Interventional · 58 enrolled · Sichuan Huiyu Pharmaceutical Co., Ltd
  NCT06983665updated 2026-05-27
• Amphotericin Versus Posaconazole for Pulmonary Mucormycosis
  Completed · Phase 2 · Interventional · 82 enrolled · Post Graduate Institute of Medical Education and Research, Chandigarh
  NCT05468372updated 2026-05-22
• Human Bioequivalence Study of Amphotericin B Liposome for Injection
  Completed · Interventional · 42 enrolled · Sichuan Huiyu Pharmaceutical Co., Ltd
  NCT06977490updated 2026-05-22
• Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
  Not yet recruiting · Phase 3 · Interventional · 664 enrolled · University of Minnesota
  NCT07261150updated 2026-05-08
• Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients
  Not yet recruiting · Interventional · 15 enrolled · Peking University People's Hospital
  NCT07559032updated 2026-04-30
• A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
  Completed · Phase 2 · Interventional · 101 enrolled · Drugs for Neglected Diseases
  NCT05593666updated 2026-04-30
• Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
  Recruiting · Phase 2 · Phase 3 · Interventional · 356 enrolled · Makerere University
  NCT03945448updated 2026-04-28
• Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
  Not yet recruiting · Phase 3 · Interventional · 428 enrolled · Duke University
  NCT06525389updated 2026-04-23
• Study on the Pharmacokinetic Characteristics of Liposomal Amphotericin B in Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
  Not yet recruiting · Observational · 10 enrolled · Institute of Hematology & Blood Diseases Hospital, China
  NCT07532850updated 2026-04-16

Frequently asked questions

How does Amphotericin B work?

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

What is Amphotericin B used for?

According to FDA labeling, Amphotericin B carries indications including: Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Amphotericin B?

Amphotericin B is classified as Antibiotics, Antiinfectives and antiseptics for local oral treatment, Lipid-based Polyene Antifungal, Polyene Antifungal, Ergosterol Synthesis Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Amphotericin B?

Amphotericin B is marketed under brand names including Abelcet, AmBisome.

What are the contraindications for Amphotericin B?

Amphotericin B labeling lists contraindications including: Amphotericin B liposome for injection is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.. Always consult the full prescribing information and a clinician.