AmBisome Side Effects

Generic Name: amphotericin b liposomal

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

Some side effects of AmBisome may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amphotericin b liposomal: intravenous powder for solution

Along with its needed effects, amphotericin b liposomal (the active ingredient contained in AmBisome) 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 liposomal:

More common
  • Chills
  • fever
  • irregular heartbeat
  • muscle cramps or pain
  • unusual tiredness or weakness
Less common
  • Back pain
  • chest pain
  • dark urine
  • difficulty in breathing
  • headache
  • yellowing of eyes or skin
Rare
  • Difficulty in swallowing
  • hives
  • itching, especially of feet or hands
  • reddening of skin, especially around ears
  • swelling of eyes, face, or inside of nose
  • unusual tiredness or weakness (sudden and severe)

Some side effects of amphotericin b liposomal 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
  • Abdominal pain
  • cough
  • diarrhea
  • dizziness
  • nausea
  • vomiting
Less common
  • Skin rash

For Healthcare Professionals

Applies to amphotericin b liposomal: intravenous powder for injection

General

General reactions during amphotericin B liposomal infusions, such as fever and chills/rigors, have been reported. These symptoms usually began within a few minutes of initiation of an amphotericin B liposomal infusion. Slowing the rate of infusion has lessened or controlled symptoms. Severe infusion-related side effects associated with conventional amphotericin B administration have been lessened by pretreatment/treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.

Metabolic

Metabolic side effects have included hypokalemia (4.2% to 51.1%), hypomagnesemia (15.3% to 48.9%), hyperglycemia (8.2% to 23%), hypocalcemia (4.9% to 18.4%), hypervolemia (8.2% to 12.2%), and hyponatremia (2% to 11.6%), hypernatremia (4.1%). Acidosis, increased amylase, hyperchloremia, hyperkalemia, hypermagnesemia, hyperphosphatemia, hypophosphatemia, hypoproteinemia, increased lactate dehydrogenase, increased nonprotein nitrogen, and respiratory alkalosis have been reported in 2% to 10% of patients.

Metabolic changes have occurred less frequently with amphotericin B liposomal than with conventional amphotericin B.

Four patients with invasive fungal infections experienced severe hyperphosphatemia coincident with amphotericin B liposomal therapy. Resolution of the side effect occurred after transition to amphotericin B lipid complex. Hyperphosphatemia may be reported more commonly in patients with mild to moderate renal insufficiency.

Renal

Renal toxicity has been reported less frequently with amphotericin B liposomal than with conventional amphotericin B.

Renal side effects have included increased serum creatinine (5.5% to 47%), BUN (7.4% to 22%), and nephrotoxicity (18.7%). Abnormal renal function (including oliguria and anuria), acute kidney failure, acute renal failure, kidney failure, and toxic nephropathy have been reported in 2% to 10% of patients. Decreased serum concentrations of potassium, magnesium, sodium, and calcium have often accompanied amphotericin-induced nephrotoxicity.

Hematologic

Hematologic side effects have included anemia (2% to 47.9%), leukopenia (15.1% to 17%), and thrombocytopenia (2% to 12.8%). Coagulation defects/disorder, ecchymosis, fluid overload, petechiae, decreased prothrombin, and increased prothrombin have been reported in 2% to 10% of patients. Agranulocytosis has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included hypertension (7.9 to 19.8%), tachycardia (9.4% to 18.5%), hypotension (7.4% to 14.3%), chest pain (8.2% to 12%), and phlebitis (9.3% to 10.6%). Infusion-related effects have included tachycardia (2.3% to 9.9%), hypertension (2.3% to 8.6%), vasodilatation (5.2%), and hypotension (3.5%). Arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, cardiomegaly, hemorrhage, postural hypotension, valvular heart disease, and vasodilatation (flushing) have been reported in 2% to 10% of patients. Cardiac failure and cardiomyopathy have also been reported.

Respiratory

Respiratory side effects have included dyspnea (17.6% to 23%), increased cough (2.1% to 17.8%), lung disorder (13.6% to 17.8%), epistaxis (8.6% to 14.9%), pleural effusion (12.5%), rhinitis (11.1%), and hypoxia (6.2% to 7.6%). Infusion-related reactions have included dyspnea (4.7% to 9.9%), hyperventilation (1.2%), and hypoxia (0.3% to 1.2%). Asthma, atelectasis, hemoptysis, hiccup, hyperventilation, influenza-like symptoms, lung edema, pharyngitis, pneumonia, respiratory insufficiency, respiratory failure, and sinusitis have been reported in 2% to 10% of patients. Bronchospasm, cyanosis/hypoventilation, and pulmonary edema have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (16.3% to 39.7%), vomiting (10.5% to 31.8%), diarrhea (10.5% to 30.3%), constipation (2% to 15.1%), anorexia (2% to 14%), and gastrointestinal hemorrhage (9.9%). Infusion-related reactions have included vomiting (5.9% to 16%) and nausea (8.6% to 14%). Dry mouth/nose, dyspepsia, dysphagia, eructation, fecal incontinence, flatulence, hemorrhoids, gum/oral hemorrhage, hematemesis, ileus, mucositis, rectal disorder, stomatitis, and ulcerative stomatitis have been reported in 2% to 10% of patients. Epigastric pain and cramping have been reported less frequently.

Other

Other side effects have included chills/rigors (40% to 48.1%), chills (47.5%), abdominal pain (7% to 19.8%), blood product transfusion reaction (8.6% to 18.4%), peripheral edema (14.6%), edema (12.3% to 14.3%), pain (14%), sepsis (7.4% to 14%), asthenia (6.2% to 13.1%), infection (11.1% to 12.8%), back pain (12%), and procedural complication (2% to 9.6%). Infusion-related reactions have included chills/rigors (6% to 23.5%) and fever (up to 19.8%). A few cases of flushing, back pain (with or without chest tightness), and chest pain have been reported with amphotericin B liposomal administration, and occasionally this has been severe. Enlarged abdomen, face edema, malaise, and neck pain have been reported in 2% to 10% of patients.

Nervous system

Nervous system side effects have included headache (9.4% to 19.8%), insomnia (17% to 22.1%), confusion (8.6% to 12.9%), dizziness (2% to 8.5%), and peripheral neuropathy. Agitation, coma, convulsion, cough, dysesthesias, paresthesia, tremor, and somnolence have been reported in 2% to 10% of patients.

Hepatic

Hepatic side effects have included elevated alkaline phosphatase (7.1% to 22.2%), bilirubin (5.2% to 18.1%), alanine transaminase (ALT, 8.9% to 14.6%), aspartate transaminase (AST, 7.6% to 12.8%), and abnormal liver function tests (2% to 12.8%). Hepatocellular damage, hepatomegaly, and veno-occlusive liver disease have been reported in 2% to 10% of patients.

Dermatologic

Dermatologic side effects have included rash (4.7% to 24.8%), pruritus (10.8%), sweating (7%), flushing (4.2%). Alopecia, cellulitis, dry skin, herpes simplex, maculopapular rash, purpura, skin discoloration, skin disorder, skin ulcer, urticaria, and vesiculobullous rash have been reported in 2% to 10% of patients. Erythema has been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included hematuria (14%). Dysuria, urinary incontinence, and vaginal hemorrhage have been reported in 2% to 10% of patients. Hemorrhagic cystitis has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety (7.4% to 13.7%). Depression, hallucinations, nervousness, and abnormal thought processes have been reported in 2% to 10% of patients.

Immunologic

Immunologic side effects have included cell mediated immunological reaction and graft versus host disease (2% to 10%). Lysis syndrome has been reported during visceral leishmaniasis therapy.

Ocular

Ocular side effects have included conjunctivitis, dry eyes, and eye hemorrhage in 2% to 10% of patients.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, bone pain, dystonia, myalgia, and rigors in 2% to 10% of patients. Rhabdomyolysis has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (2% to 10%). Hypersensitivity reactions have presented as bronchospasm, wheezing, or anaphylactoid reactions. Angioedema and urticaria have been reported during postmarketing experience.

Local

Local side effects have included inflammation at the injection site in 2% to 10% of patients.

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