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.
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.
This is a plain-language summary of amphotericin B's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of amphotericin B's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Call your doctor right away if you miss an appointment to receive your dose. They will tell you when to reschedule.
This is a plain-language summary of amphotericin B's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store the medicine in its original packaging until you are ready to use it.
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
- Fever
Fever
974 reports
- Condition got worse
Condition got worse
842 reports
- Fever with low white blood cell count
Fever with low white blood cell count
650 reports
- Sudden kidney damage
Sudden kidney damage
625 reports
- Blood infection
Blood infection
612 reports
- Lung infection
Lung infection
578 reports
- Low potassium
Low potassium
541 reports
- Failure of multiple organs
Failure of multiple organs
528 reports
- Kidney damage
Kidney damage
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) 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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
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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 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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