Amphotericin B
Active ingredient · 4 therapeutic classes
Sold as AMBISOME · FUNGIZONE
- Drug class
- Antibiotics
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 8
- FDA reports (12 mo)
- 1,326
Overview
Plain-language summary, compiled from the cited regulatory records
Amphotericin B is an anti-infective medication used for local oral treatment [1]. It belongs to the drug class of Antiinfectives And Antiseptics For Local Oral Treatment (A01AB) [1].
This medication is approved for empirical therapy in febrile, neutropenic patients with presumed fungal infections [1]. It is also indicated for the treatment of Cryptococcal Meningitis in patients with HIV [1]. Additionally, Amphotericin B is used to treat infections caused by Aspergillus species, Candida species, and/or Cryptococcus species in patients whose infections are refractory to amphotericin B deoxycholate, or in patients where other treatments are not suitable [1].
In the past 12 months, there have been 1326 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include "Drug Ineffective," "Off Label Use," "Condition Aggravated," "Acute Kidney Injury," and "Product Use In Unapproved Indication" [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 4 | March 22, 2025 |
| GB United Kingdom | MHRA | 3 | May 15, 2026 |
| US United States | FDA | 1 | April 20, 2026 |
CACanada· Health Canada
4 products
Uses
AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATION.................................................................................................................
5 WARNINGS ................................................................................................................................... 5 PRECAUTIONS .............................................................................................................................
5 ADVERSE REACTIONS............................................................................................................... 8 SYMPTOMS AND TREATMENT OF OVERDOSAGE ............................................................. 9 DOSAGE AND ADMINISTRATION ...........................................................................................
9 PHARMACEUTICAL INFORMATION ..................................................................................... 12 AVAILABILITY OF DOSAGE FORMS .................................................................................... 13 MICROBIOLOGY .......................................................................................................................
GBUnited Kingdom· MHRA
3 products
Uses
Amphotericin B Gilead liposomal is indicated in adults and children aged 1 month to 18 years old for: • the treatment of severe systemic and/or deep mycoses • the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children • the empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause.
Infections successfully treated with Amphotericin B Gilead liposomal include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis. Amphotericin B Gilead liposomal should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.
USUnited States· FDA
1 product
Uses
INDICATIONS AND USAGE
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) . Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES) .
See DOSAGE AND ADMINISTRATION for recommended doses by indication.
Drug interactions
Known interactions involving Amphotericin B. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 316. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 00029149 · revised March 22, 2025
- [2]MHRA (UK) · PL168070001 · revised February 14, 2025
- [3]FDA DailyMed · 02aadef1-390b-42… · revised April 20, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.