Amphotericin B Injection
Amphotericin B Injection is a powerful antifungal medicine used intravenously to treat serious, life-threatening fungal infections and visceral leishmaniasis in adults and children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 7 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Amphotericin B injection should only be used for serious, potentially life-threatening fungal infections. It is not appropriate for mild fungal infections like oral thrush or vaginal yeast infections in people with a normal immune system. Giving too much of this medication — even a single excessive dose — can cause a potentially fatal cardiac or cardiopulmonary arrest (the heart or breathing stopping). The daily dose must never exceed the maximum limit. Before every administration, healthcare providers must double-check the product name and the dose, especially when higher amounts are being used.
📖 Amphotericin B Injection: Patient Information Guide
A plain-language walkthrough of Amphotericin B Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Amphotericin B liposome for injection is used intravenously to treat or manage several serious conditions:
- Empirical antifungal therapy: AmBisome (amphotericin B liposome for injection) is used when a fungal infection is suspected (but not yet confirmed) in patients who have fever and severely low white blood cell counts (febrile neutropenia) that have not responded to antibacterial treatment.
- Cryptococcal meningitis in HIV: AmBisome (amphotericin B liposome for injection) treats this serious fungal brain infection in people living with HIV.
- Aspergillus, Candida, and/or Cryptococcus infections: AmBisome (amphotericin B liposome for injection) is used when these infections have not responded to standard amphotericin B, or when kidney problems or serious side effects prevent use of the standard form.
- Visceral leishmaniasis: AmBisome (amphotericin B liposome for injection) treats this parasitic disease; note that relapse rates are high in immunocompromised patients following treatment.
⚙️How it works▾
Amphotericin B works by binding to ergosterol, a substance found in the outer wall of fungal cells. This binding punches tiny channels (pores) in the cell wall, causing essential minerals like potassium and sodium to leak out. Without those minerals, the fungal cell can't survive. Because human cells use cholesterol instead of ergosterol, the drug targets fungi more selectively — though it can still bind to human cell membranes at higher concentrations, which is why side effects occur.
The liposomal form (AmBisome) wraps the drug in tiny fat-like particles called liposomes, which help it reach both the outer and inner forms of fungal organisms while potentially causing fewer side effects than conventional amphotericin B formulations.
💊How it's taken▾
Amphotericin B liposome for injection is given as an intravenous (IV) infusion — it goes directly into a vein and is always administered by a healthcare professional in a clinical setting. It is typically infused once daily over a period of hours. The dose and length of treatment are individualized based on the type of infection, the patient's weight, kidney function, and how well they respond and tolerate the drug.
- The infusion is given slowly to reduce the chance of reactions during administration.
- Doses are not interchangeable between different amphotericin B products — the care team verifies the exact product and dose before every administration.
- Because this drug requires medical supervision, missed doses are managed by the treating healthcare team.
🤒Side effects — in detail▾
Amphotericin B liposome for injection can cause a range of side effects; some are common and manageable, while others require prompt medical attention:
- Chills, rigors (shaking), or fever — especially during the infusion
- Nausea and vomiting
- Diarrhea
- Headache
- Low potassium (hypokalemia) — may cause muscle weakness
- Low magnesium (hypomagnesemia)
- Rising creatinine or BUN — signs of kidney stress
- Rash
- Changes in blood pressure or heart rate during infusion
Seek immediate medical attention for chest pain, severe breathing difficulty, signs of a dangerous drop in blood pressure, or any sign of a severe allergic reaction during or after the infusion. Kidney function and electrolytes are routinely monitored during treatment because of the risk of serious imbalances.
⚠️Warnings & precautions▾
- Overdose risk: Exceeding the maximum allowable dose can cause potentially fatal cardiac or cardiopulmonary arrest. Healthcare providers must verify the product name and dose before every administration.
- For serious infections only: This drug should not be used for mild or superficial fungal infections such as oral thrush or vaginal candidiasis in patients with normal immune function.
- Kidney toxicity: Amphotericin B can significantly stress the kidneys. Kidney function must be monitored throughout treatment, and doses may need to be adjusted.
- Electrolyte imbalances: Low potassium and low magnesium are common and can increase the risk of heart and muscle problems. Blood levels must be monitored and corrected as needed.
- Infusion-related reactions: Fever, chills, nausea, vomiting, and blood pressure changes can occur during infusion and may require treatment with additional medications.
- Visceral leishmaniasis relapse: In immunocompromised patients (including those with HIV/AIDS), relapse after treatment is common; long-term preventive therapy has not been established.
🔀What it interacts with▾
Several medications can interact with amphotericin B injection, making side effects more likely or more serious:
- Cancer (antineoplastic) drugs — increase risk of kidney damage, airway problems, and low blood pressure; use together only with great caution.
- Corticosteroids or ACTH — can worsen potassium loss (hypokalemia), raising the risk of heart rhythm problems; avoid unless necessary to control amphotericin B side effects.
- Digitalis glycosides (e.g., digoxin) — low potassium caused by amphotericin B amplifies the risk of dangerous digitalis toxicity; monitor potassium and heart function closely.
- Flucytosine — combination may increase flucytosine toxicity, possibly by increasing its absorption into cells or reducing kidney excretion.
- Imidazole antifungals (e.g., ketoconazole, fluconazole, miconazole, clotrimazole) — may cause fungi to become resistant to amphotericin B; use with caution, especially in immunocompromised patients.
- Other kidney-toxic drugs (aminoglycosides, cyclosporine, pentamidine) — combination significantly increases the risk of kidney damage; intensive kidney monitoring is required.
- Skeletal muscle relaxants (e.g., tubocurarine) — low potassium from amphotericin B can intensify the muscle-paralyzing effect of these drugs; monitor potassium levels.
- Leukocyte (white blood cell) transfusions — giving these at the same time as an amphotericin B infusion has been linked to serious lung toxicity.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have ever had an allergic reaction to amphotericin B or any ingredient in the product — this is a contraindication unless the benefit clearly outweighs the risk in your specific situation.
- Tell your doctor about any kidney or liver problems, as these can affect how the drug is handled by your body and may increase the risk of side effects.
- Share a full list of all your current medications, especially cancer drugs, steroids, heart medications, antifungals, and antibiotics.
- Inform your care team if you are pregnant or breastfeeding, so the risks and benefits can be carefully weighed.
- If the patient is a child, let the care team know — amphotericin B liposome for injection has been studied and used in pediatric patients, and dosing is weight-based and carefully managed.
- Older adults should ensure their care team has a complete picture of their health status, as kidney function monitoring is especially important.
🚑If you take too much▾
If too much amphotericin B liposome for injection is given, the infusion should be stopped immediately and supportive medical care started right away. Kidney function should be monitored closely after an overdose. Hemodialysis (kidney filtration therapy) and peritoneal dialysis do not appear to remove this drug effectively from the body, so prevention through careful dosing verification is critical.
📡Pharmacodynamics — effects in the body▾
Amphotericin B kills fungal cells by binding to ergosterol in their cell membranes and creating pores that cause essential minerals to leak out. This disruption in cell permeability is lethal to the fungal organism. The drug has a higher affinity for ergosterol (found in fungi) than for cholesterol (found in human cells), but it can still bind to human cell membranes at higher concentrations, which accounts for its toxicity in people.
🔬Pharmacokinetics — how your body processes it▾
After intravenous infusion, amphotericin B from AmBisome (amphotericin B liposome for injection) reaches measurable blood levels quickly, with blood concentrations rising more than proportionally as the dose increases — meaning higher doses produce disproportionately higher drug levels. The drug distributes into tissues and, based on blood levels measured over many weeks after dosing, has a very long final half-life of roughly 100 to 153 hours, likely reflecting slow release from body tissues. Steady-state blood levels are generally reached within about 4 days of daily dosing. How the drug is broken down (metabolized) is not yet fully known, and the pathway by which it leaves the body has not been fully studied.
📦How to store it▾
Prior to reconstitution Amphotericin B for Injection USP should be stored under refrigeration, 2˚ to 8˚C (36˚to 46˚F), protected against exposure to light.
📄 Written from Amphotericin B Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Amphotericin B Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why am I getting this medication instead of something I take by mouth? ▾
Will I feel sick during the infusion? ▾
I heard this drug can harm my kidneys — should I be worried? ▾
Are there medications I should avoid while I'm on this? ▾
How long will I need to be on this medication? ▾
Is this medication safe for children? ▾
Is Amphotericin B Injection available over the counter? ▾
When was Amphotericin B Injection first available? ▾
Who makes Amphotericin B Injection? ▾
💬 Answers drafted from Amphotericin B Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Amphotericin B Injection comes
Amphotericin B Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- AmBisome (amphotericin B liposome for injection) is used to treat suspected fungal infections in patients with fever and very low white blood cell counts (febrile neutropenia)
- AmBisome (amphotericin B liposome for injection) is used to treat cryptococcal meningitis in HIV-infected patients
- AmBisome (amphotericin B liposome for injection) is used for Aspergillus, Candida, and/or Cryptococcus infections that have not responded to other amphotericin B formulations, or in patients who cannot tolerate them due to kidney problems
- AmBisome (amphotericin B liposome for injection) is used to treat visceral leishmaniasis
- AmBisome (amphotericin B liposome for injection) is given as a slow intravenous infusion by a healthcare professional
- AmBisome (amphotericin B liposome for injection) is typically infused once daily; the exact duration of infusion and length of treatment depends on the condition being treated and the patient's response
- AmBisome (amphotericin B liposome for injection) must be prepared correctly before infusion — your care team handles this; do not self-administer
- AmBisome (amphotericin B liposome for injection) dose is individualized based on the type of infection, body weight, kidney function, and how well the patient tolerates the drug
📊 Amphotericin B Injection across the U.S. market
How Amphotericin B Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Amphotericin B Injection is used
A general measure of how commonly Amphotericin B Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Amphotericin B Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Amphotericin B Injection prescribed? Of the 1,596 medications we measure, Amphotericin B Injection ranks #1,264 by Medicaid prescriptions — more than 21% of them.
Utilization by Amphotericin B Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
amphotericin B liposomal 50 MG Injection Most dispensed
Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 967385
amphotericin B 50 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 239240
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amphotericin B Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 10 listed Amphotericin B Injection NDCs with Medicaid activity.
🔍 Compare Amphotericin B Injection products
A representative set of FDA-listed product records for Amphotericin B Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/12.5 mL | Intravenous | Astellas Pharma US, Inc. × 3 listings | NDA | View NDC → |
| 50 mg/12.5 mL | Intravenous | Eugia US LLC × 2 listings | ANDA | View NDC → |
| 50 mg | Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/12.5 mL | — | Jubilant HollisterStier LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 50 mg/12.5 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 50 mg | Intravenous | Sun Pharmaceutical Industries, Inc. × 3 listings | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Amphotericin B Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amphotericin B Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amphotericin B Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Amphotericin B Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 732 8 dose forms · 9 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 2285811In current FDA listingsClinical drug / strength (SCD) liposomal 5 MG/MLRxCUI 834789 -
Dose form (SCDF) Injection RxCUI 1737431In current FDA listingsClinical drug / strength (SCD) liposomal 50 MGRxCUI 96738520 ML amphotericin B lipid complex 5 MG/MLRxCUI 98407850 MGRxCUI 239240 -
Dose form (SCDF) Oral Lozenge RxCUI 374833No current FDA listingClinical drug / strength (SCD) 10 MGRxCUI 199417 -
Dose form (SCDF) Oral Suspension RxCUI 370583No current FDA listingClinical drug / strength (SCD) 100 MG/MLRxCUI 199264 -
Dose form (SCDF) Oral Tablet RxCUI 370894No current FDA listingClinical drug / strength (SCD) 100 MGRxCUI 251350 -
Dose form (SCDF) Topical Cream RxCUI 378973No current FDA listingClinical drug / strength (SCD) 30 MG/MLRxCUI 197367 -
Dose form (SCDF) Topical Lotion RxCUI 377580No current FDA listingClinical drug / strength (SCD) 30 MG/MLRxCUI 197368 -
Dose form (SCDF) Topical Ointment RxCUI 376438No current FDA listing
Look up RxCUI 732 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Amphotericin B Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Amphotericin B Injection belongs to the Polyene Antifungal class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.