| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | FUNGIZONE | AMPHOTERICIN B | SUSPENSION;ORAL | 100MG/ML | No | No |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050341-003 | FUNGIZONE | AMPHOTERICIN B | 100MG/ML | SUSPENSION / ORAL | Approved before 1982 |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amphotericin B | AMPHOTERICIN B | Sun Pharmaceutical Industries, Inc. | 02aadef1-390b-4270-b56d-33452eb89dde | 2026-04-20 | Warnings, Adverse reactions | |
| Amphotericin B | AMPHOTERICIN B | Sun Pharmaceutical Industries, Inc. | 593cffa0-c305-48b6-8ec7-331e0ff91d2b | 2026-04-20 | Warnings, Adverse reactions | |
| Amphotericin B | AMPHOTERICIN B | Eugia US LLC | 6f24975c-5191-4fc2-a8da-e57358f8e154 | 2025-06-12 | Warnings, Adverse reactions | |
| Amphotericin B | AMPHOTERICIN B | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2b2f3ff5-9d62-4ad2-8eac-1181e5911513 | 2025-06-03 | Warnings, Adverse reactions | |
| Amphotericin B | AMPHOTERICIN B | XGen Pharmaceuticals DJB, Inc. | a0a54943-9ce4-4f3e-b681-a1a9144c16ce | 2022-01-03 | Boxed warning, Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including amphotericin B liposome for injection. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of amphotericin B liposome for injection.
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ADVERSE REACTIONS The following adverse events are based on the experience of 592 adult patients (295 treated with amphotericin B liposome for injection and 297 treated with amphotericin B deoxycholate) and 95 pediatric patients (48 treated with amphotericin B liposome for injection and 47 treated with amphotericin B deoxycholate) in Study 94-0-002, a randomized double-blind, multicenter study in febrile, neutropenic patients. Amphotericin B liposome for injection and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 10% or greater) occurring with amphotericin B liposome for injection compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: Empirical Therapy Study 94-0-002 Common Adverse Events Adverse Event by Body System Amphotericin B Liposome for Injection N=343 % Amphotericin B N=344 % Body as a Whole Abdominal pain 19.8 21.8 Asthenia 13.1 10.8 Back pain 12 7.3 Blood product transfusion reaction 18.4 18.6 Chills 47.5 75.9 Infection 11.1 9.3 Pain 14 12.8 Sepsis 14 11.3 Cardiovascular System Chest pain 12 11.6 Hypertension 7.9 16.3 Hypotension 14.3 21.5 Tachycardia 13.4 20.9 Digestive System Diarrhea 30.3 27.3 Gastrointestinal hemorrhage 9.9 11.3 Nausea 39.7 38.7 Vomiting 31.8 43.9 Metabolic and Nutritional Disorders Alkaline phosphatase increased 22.2 19.2 ALT (SGPT) increased 14.6 14 AST (SGOT) increased 12.8 12.8 Bilirubinemia 18.1 19.2 BUN increased 21 31.1 Creatinine increased 22.4 42.2 Edema 14.3 14.8 Hyperglycemia 23 27.9 Hypernatremia 4.1 11 Hypervolemia 12.2 15.4 Hypocalcemia 18.4 20.9 Hypokalemia 42.9 50.6 Hypomagnesemia 20.4 25.6 Peripheral edema 14.6 17.2 Nervous System Anxiety 13.7 11 Confusion 11.4 13.4 Headache 19.8 20.9 Insomnia 17.2 14.2 Respiratory System Cough increased 17.8 21.8 Dyspnea 23 29.1 Epistaxis 14.9 20.1 Hypoxia 7.6 14.8 Lung disorder 17.8 17.4 Pleural effusion 12.5 9.6 Rhinitis 11.1 11 Skin and Appendages Pruritus 10.8 10.2 Rash 24.8 24.4 Sweating 7 10.8 Urogenital System Hematuria 14 14 Amphotericin B liposome for injection was well tolerated. Amphotericin B liposome for injection had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. In pediatric patients (16 years of age or les...
Adverse Event by Body SystemAmphotericin B Liposome for Injection N=343 %Amphotericin B N=344 %Body as a WholeAbdominal pain19.821.8Asthenia13.110.8Back pain127.3Blood product transfusion reaction18.418.6Chills47.575.9Infection11.19.3Pain1412.8Sepsis1411.3Cardiovascular SystemChest pain1211.6Hypertension7.916.3Hypotension14.321.5Tachycardia13.420.9 Digestive SystemDiarrhea30.327.3Gastrointestinal hemorrhage9.911.3Nausea39.738.7Vomiting31.843.9Metabolic and Nutritional DisordersAlkaline phosphatase increased22.219.2ALT (SGPT) increased14.614AST (SGOT) increased12.812.8Bilirubinemia18.119.2BUN increased2131.1Creatinine increased22.442.2Edema14.314.8Hyperglycemia2327.9Hypernatremia4.111Hypervolemia12.215.4Hypocalcemia18.420.9Hypokalemia42.950.6Hypomagnesemia20.425.6Peripheral edema14.617.2Nervous SystemAnxiety13.711Confusion11.413.4Headache19.820.9Insomnia17.214.2Respiratory SystemCough increased17.821.8Dyspnea2329.1Epistaxis14.920.1Hypoxia7.614.8Lung disorder17.817.4Pleural effusion12.59.6Rhinitis11.111 Skin and AppendagesPruritus10.810.2Rash24.824.4Sweating710.8 Urogenital SystemHematuria1414