Amphotericin B: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Amphotericin B. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Total number of patients | 166% |
| Chills/rigors | 89.7% |
| Chills | 75.9% |
| Hypokalemia | 50.6% |
| Anemia | 47.9% |
| Vomiting | 43.9% |
| Creatinine increased | 42.2% |
| Nausea | 39.7% |
| Bun increased | 31.1% |
| Diarrhea | 30.3% |
| Dyspnea | 29.1% |
| Hyperglycemia | 27.9% |
| Hypomagnesemia | 25.6% |
| Phlebitis | 25.3% |
| Rash | 24.8% |
| Alkaline phosphatase increased | 22.2% |
| Abdominal pain | 21.8% |
| Cough increased | 21.8% |
| Hypotension | 21.5% |
| Tachycardia | 20.9% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ). Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES ). See DOSAGE AND ADMINISTRATION for recommended doses by indication. DESCRIPTION OF CLINICAL STUDIES Eleven clinical studies supporting the efficacy and safety of amphotericin B liposome for injection were conducted. This clinical program included both controlled and uncontrolled studies. These studies, which involved 2,171 patients, included patients with confirmed systemic my…
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