Amphotericin B liposomal Side Effects

Brand Names: AmBisome

Please note - some side effects for Amphotericin B liposomal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

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.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, bone pain, dystonia, myalgia, and rigors in 2% to 10% of patients.

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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