Prescription medication · Polyene Antifungal
amphotericin B
Also sold as Ambisome, Fungizone. This medicine treats fungal infections like aspergillosis, candidiasis, and cryptococcosis.
Data updated 2026-05-15
- 17,512
- FDA reportsModerately reported
- 12
- InteractionsSeveral interactions
- In shortage
- FDA status
What the data shows
amphotericin B (Ambisome) is a prescription Polyene Antifungal, reported at a middle-of-the-pack volume (17,512 FDA reports), with 12 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
amphotericin B (Ambisome) is a prescription Polyene Antifungal. This medicine treats fungal infections like aspergillosis, candidiasis, and cryptococcosis.
Amphotericin B liposome is an antifungal medicine. It fights serious fungal infections in your body.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from amphotericin B's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 17,512 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for amphotericin B, by number of reports
- Pyrexia
Pyrexia
972 reports
- Condition Aggravated
Condition Aggravated
841 reports
- Febrile Neutropenia
Febrile Neutropenia
650 reports
- Acute Kidney Injury
Acute Kidney Injury
625 reports
- Sepsis
Sepsis
613 reports
- Pneumonia
Pneumonia
576 reports
- Hypokalaemia
Hypokalaemia
542 reports
- Multiple Organ Dysfunction Syndrome
Multiple Organ Dysfunction Syndrome
528 reports
- Renal Impairment
Renal Impairment
528 reports
- Death
Death
516 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for amphotericin B each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where amphotericin B sits
amphotericin B has more FDA adverse-event reports than 52% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is amphotericin B; the line is the median (50th percentile).
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
Reports Mentioning Death
6,407
36.6% of reports — not proof of cause
Hospitalization Reports
7,521
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 13 | DEATH | 516 |
| 14 | NEUTROPENIA | 504 |
| 15 | RESPIRATORY FAILURE | 491 |
| 16 | SEPTIC SHOCK | 486 |
| 17 | RENAL FAILURE | 452 |
| 18 | DRUG INTERACTION | 419 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for amphotericin B?
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
Acyclovir is an antiviral medicine.
Compare with amphotericin B →
albendazole
Albenza
Albendazole is a medicine that fights parasites.
Compare with amphotericin B →
anidulafungin
Eraxis
Eraxis is an antifungal medicine.
Compare with amphotericin B →
atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
Compare with amphotericin B →
baloxavir marboxil
Xofluza
Xofluza is an antiviral medicine that can treat the flu.
Compare with amphotericin B →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for amphotericin B: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 17,512.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 36.59%.
- micafungin Δ 0.76 pts · 4,779 reports · Echinocandin Antifungal 35.82%death share
- dobutamine Δ 1.71 pts · 3,554 reports · Inotropic Agent (Beta-1 Agonist) 38.29%death share
- vasopressin Δ 2.91 pts · 4,135 reports · Vasopressin Receptor Agonist 39.49%death share
- pseudoephedrine Δ 3.19 pts · 9,450 reports · Decongestant 33.40%death share
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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 17,512 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 21, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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