amphotericin B
Brand names: Ambisome, Fungizone
Amphotericin B liposome is an antifungal medicine. It fights serious fungal infections in your body.
Drug Shortage Alert
amphotericin B is currently listed as to be discontinued by the FDA. Affected manufacturer: Leadiant Biosciences, Inc..
View all drug shortages →What it does
This medicine treats fungal infections like aspergillosis, candidiasis, and cryptococcosis.
Common side effects
Abdominal pain, Weakness, Back pain
Key warnings
This medicine is not interchangeable with other amphotericin B products.
How It Works
Amphotericin B liposome belongs to a class of drugs called polyene antifungals. It works by binding to the membrane of the fungal cells. This binding disrupts the fungal cell membrane, causing the cell to die.
How to Take It
This medicine is given through an IV into your vein over about 2 hours. Your doctor will decide the right dose for you based on your infection. The usual dose is 3 to 6 mg/kg per day, depending on the infection being treated. The IV line should be flushed with a special solution before use.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Talk to your doctor about the risks and benefits of using this medicine during pregnancy or while breastfeeding.
Missed Dose
Call your doctor right away if you miss an appointment to receive your dose. They will tell you when to reschedule.
Storage
Store the medicine in its original packaging until you are ready to use it.
Side Effects (from patient reports)
Based on 11,200 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 17,512 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.
Total Reports
17,512
Death-Related Reports
6,407
Hospitalization Reports
7,521
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 3,940 |
| 2 | OFF LABEL USE | 1,911 |
| 3 | PYREXIA | 972 |
| 4 | CONDITION AGGRAVATED | 841 |
| 5 | FEBRILE NEUTROPENIA | 650 |
| 6 | ACUTE KIDNEY INJURY | 625 |
| 7 | SEPSIS | 613 |
| 8 | PNEUMONIA | 576 |
| 9 | HYPOKALAEMIA | 542 |
| 10 | MULTIPLE ORGAN DYSFUNCTION SYNDROME | 528 |
| 11 | RENAL IMPAIRMENT | 528 |
| 12 | PRODUCT USE IN UNAPPROVED INDICATION | 521 |
| 13 | DEATH | 516 |
| 14 | NEUTROPENIA | 504 |
| 15 | RESPIRATORY FAILURE | 491 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine is not interchangeable with other amphotericin B products. Different versions of amphotericin B act differently in the body. Make sure you always get the correct medicine.
Known Drug Interactions
Nephrotoxic agents Concomitant administration of cidofovir injection and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated.
Mechanism: Both drugs can cause damage to the kidneys. Combining them makes kidney injury much more likely.
What to do: This drug combination should be avoided. Your doctor will need to use a different medicine that is safer for your kidneys.
Cyclosporine or amphotericin B Unknown Monitor renal function when Ganciclovir Injection is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions (5.2)]. (7) Cyclosporine or amphotericin B: When coadministered with ganciclovir, the risk of nephrotoxicity may be increased.
Mechanism: Both of these medications can be toxic to the kidneys when used at the same time. This combination may lead to a rise in serum creatinine levels, indicating kidney stress.
What to do: Your doctor will need to check your kidney function frequently while you are on both drugs. Ensure you stay hydrated and follow all scheduled lab work.
Cyclosporine or amphotericin B Unknown Monitor renal function when valganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions (5.2)]. ( 7 ) Cyclosporine or amphotericin B: When coadministered with valganciclovir, the risk of nephrotoxicity may be increased.
Mechanism: Both of these drugs can be hard on the kidneys, and using them at the same time increases the chance of kidney injury.
What to do: Your doctor should check your kidney function frequently to ensure the organs are working properly during treatment.
Azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B.
Mechanism: Using these two antifungal medicines together might make the fungus harder to kill and resistant to the treatment.
What to do: Your doctor will monitor your progress closely to ensure the infection is being treated effectively.
7.5 Amphotericin B Liposome for Injection Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B [see Clinical Pharmacology (12.3) ] .
Mechanism: These medications do not interfere with each other's levels in the body. They do not change how the body processes the medicine.
What to do: No dose adjustment is required when taking these two medications together.
Common Questions
Can I switch to a different brand of amphotericin B?
How long will I need to take this medicine?
What should I do if I feel sick during the infusion?
Can I take other medicines with this one?
Will this medicine affect my kidneys?
Can this medicine cause an allergic reaction?
How will I know if the medicine is working?
What if I have a reaction to the blood transfusion?
Can this medicine cause low potassium?
How is this medicine given?
What are the common side effects of amphotericin B?
Does amphotericin B interact with other medications?
What drug class is amphotericin B?
Is amphotericin B safe during pregnancy?
Has amphotericin B been recalled?
Is amphotericin B currently in shortage?
Active Recalls
Out of specification for assay
SUN PHARMACEUTICAL INDUSTRIES INC
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Franck's Lab Inc dba Trinity Care Solutions
Related Medications in Polyene Antifungal
Other drugs grouped near amphotericin B — same-class peers and common alternatives.
acyclovir
Zovirax
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albendazole
Albenza
Albendazole is a medicine that fights parasites.
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anidulafungin
Eraxis
Eraxis is an antifungal medicine.
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atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
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baloxavir marboxil
Xofluza
Xofluza is an antiviral medicine that can treat the flu.
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What the FDA Data Shows for amphotericin B
The FDA label for amphotericin B (sold under brand names such as Ambisome, Fungizone) classifies it as a prescription-only medication in the Polyene Antifungal class. This medicine treats fungal infections like aspergillosis, candidiasis, and cryptococcosis. Official labeling lists 24 commonly reported side effects, including Abdominal pain, Weakness, Back pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 11,200 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 21, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages