Note: This document contains side effect information about amphotericin b lipid complex. Some dosage forms listed on this page may not apply to the brand name Abelcet.

Applies to amphotericin b lipid complex: suspension.

Serious side effects of Abelcet

Along with its needed effects, amphotericin b lipid complex (the active ingredient contained in Abelcet) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking amphotericin b lipid complex:

More common

• Chills and fever
• headache
• nausea and vomiting

Less common

• Difficulty in breathing
• sore throat and fever
• unusual bleeding or bruising
• unusual tiredness and weakness

Rare

• Increased or decreased urination

Other side effects of Abelcet

Some side effects of amphotericin b lipid complex may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• loss of appetite
• stomach pain

For Healthcare Professionals

Applies to amphotericin b lipid complex: intravenous suspension.

General

The most common clinical side effects in clinical trials were chills, increased creatinine, pyrexia, hypokalemia, nausea, and vomiting.^[Ref]

Other

Very common (10% or more): Chills (up to 18%), fever/pyrexia (up to 14%), multiple organ failure (11%)

Common (1% to 10%): Sepsis, infection, pain, chest pain, increased alkaline phosphatase

Frequency not reported: Malaise, weight loss, increased lactate dehydrogenase, shivering, generalized edema, asthenia, peripheral edema

Renal

Very common (10% or more): Increased serum creatinine (up to 13%)

Common (1% to 10%): Renal failure, renal impairment, increased BUN/urea

Frequency not reported: Decreased renal function, abnormal kidney function

Postmarketing reports: Renal tubular acidosis (including hyposthenuria, electrolyte imbalance [e.g., increased potassium, decreased magnesium]), nephrogenic diabetes insipidus^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, electrolyte imbalance (including increased blood potassium, decreased blood magnesium)

Frequency not reported: Anorexia, hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia, acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypernatremia, hyponatremia, hyperchloremia

Postmarketing reports: Hyperammonemia^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, gastrointestinal hemorrhage, abdominal pain, nausea and vomiting

Frequency not reported: Melena, dyspepsia, epigastric pain, cramping, constipation

Postmarketing reports: Peritonitis^[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia, leukopenia, anemia

Frequency not reported: Coagulation defects, blood dyscrasias (including eosinophilia), leukocytosis, decreased thromboplastin

Postmarketing reports: Pancytopenia^[Ref]

Nervous system

Common (1% to 10%): Headache, tremor

Uncommon (0.1% to 1%): Convulsions, neuropathy

Frequency not reported: Peripheral neuropathy, deafness, hearing loss, tinnitus, transient vertigo, cerebral vascular accident, extrapyramidal syndrome, other neurologic symptoms, somnolence

Postmarketing reports: Encephalopathy, stupor^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic response

Frequency not reported: Anaphylaxis, allergic reactions (including bronchospasm, wheezing, asthma), anaphylactoid reactions, infusion hypersensitivity reactions (including abdominal pain, nausea, vomiting, myalgia, pruritus, maculopapular rash, fever, hypotension, shock, bronchospasm, respiratory failure)^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, cardiac arrest, hypertension, tachycardia, cardiac arrhythmias

Uncommon (0.1% to 1%): Shock

Frequency not reported: Cardiac failure, myocardial infarction, thrombophlebitis, cardiomyopathy, arrhythmias, ventricular fibrillation, atrial fibrillation, phlebitis, supraventricular tachycardia, abnormal ECG, cyanosis

Postmarketing reports: Asystole, bradycardia, hemorrhage, vasodilation^[Ref]

Respiratory

Common (1% to 10%): Respiratory failure, dyspnea, pneumonia, respiratory disorder, asthma

Frequency not reported: Wheezing, pulmonary edema, hemoptysis, tachypnea, pulmonary embolus, pleural effusion, hypoxia, lung disorder, pneumonia, hyperventilation, increased cough, pharyngitis, apnea

Postmarketing reports: Bronchospasm^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus

Frequency not reported: Maculopapular rash, erythema multiforme, skin ulcer, exanthema

Postmarketing reports: Exfoliative dermatitis^[Ref]

Local

Uncommon (0.1% to 1%): Injection site reaction

Frequency not reported: Injection site inflammation, injection site hypersensitivity^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myalgia

Frequency not reported: Myasthenia, bone pain, joint pain, muscle pain^[Ref]

Hepatic

Common (1% to 10%): Hyperbilirubinemia, abnormal liver function tests

Frequency not reported: Acute liver failure, jaundice, hepatitis, increased AST, increased ALT, veno-occlusive liver disease, hepatomegaly, cholangitis, cholecystitis, bilirubinemia^[Ref]

Genitourinary

Frequency not reported: Oliguria, anuria, impotence, dysuria, hematuria, urinary tract infection, pyuria, urinary tract disorder

Postmarketing reports: Hyposthenuria, incontinence^[Ref]

Ocular

Frequency not reported: Visual impairment, diplopia

Psychiatric

Frequency not reported: Confusion, insomnia, anxiety

Postmarketing reports: Agitation