What the label lists and what reports show
Amphotericin b side effects
Amphotericin b's FDA label lists its adverse reactions in its own words. FAERS holds 14,762 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (795 reports).
- Generic listed
Check it at the source: the amphotericin b FDA label on DailyMed (effective June 3, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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, multi-center study in febrile, neutropenic patients. Amphotericin B liposome for injection and amphotericin B were infused over two hours.
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 % |
|---|---|---|
| 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 |
| Chest pain | 12 | 11.6 |
| Hypertension | 7.9 | 16.3 |
| Hypotension | 14.3 | 21.5 |
| Tachycardia | 13.4 | 20.9 |
| Diarrhea | 30.3 | 27.3 |
| Gastrointestinal hemorrhage | 9.9 | 11.3 |
| Nausea | 39.7 | 38.7 |
| Vomiting | 31.8 | 43.9 |
| 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective June 3, 2025 (SPL set 2b2f3ff5-9d62-4ad2-8eac-1181e5911513), via openFDA; the full label on DailyMed
What do FAERS reports show?
14,762 reports list amphotericin b among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,701 are coded as a death and 6,302 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amphotericin b: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions