Applies to amphotericin b liposomal: intravenous powder for solution.

Serious side effects

Along with its needed effects, amphotericin b liposomal 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)

Other side effects

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.

Metabolic

Very common (10% or more): Hypokalemia (51.1%), hyperglycemia (23%), hypomagnesemia (25.9%), hypocalcemia (18.4%), anorexia (14%), hypervolemia (12.2%), hyponatremia (11.6%)

Common (1% to 10%): Hypernatremia, fluid overload, acidosis, hyperchloremia, hyperkalemia, hypermagnesemia, hyperphosphatemia, hypoproteinemia, nonprotein nitrogen (NPN) increased, hyperglycemia^[Ref]

Renal

Very common (10% or more): Creatinine increased (22.4%), BUN increased (21%)

Common (1% to 10%): Abnormal renal function, acute kidney failure, acute renal failure, kidney failure, toxic nephropathy, increased blood urea

Frequency not reported: Renal insufficiency^[Ref]

Hematologic

Very common (10% or more): Anemia (47.9%), leukopenia (15.1%), thrombocytopenia (12.8%)

Common (1% to 10%): Coagulation disorder, ecchymosis, prothrombin decreased, prothrombin increased, thrombocytopenia

Postmarketing reports: Agranulocytosis^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (19.8%), hypotension (14.3%), chest pain (11.1%), phlebitis (10.6%)

Common (1% to 10%): Vasodilatation, arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, cardiomegaly, hemorrhage, postural hypotension, valvular heart disease, vascular disorder^[Ref]

Respiratory

Very common (10% or more): Dyspnea (23%), cough increased (17.8%), lung disorder (17.8%), epistaxis (14.9%), pleural effusion (12.5%), rhinitis (11.1%)

Common (1% to 10%): Hypoxia, hyperventilation, respiratory alkalosis, cough, asthma, atelectasis, hemoptysis, hiccup, hyperventilation, lung edema, pharyngitis, pneumonia, respiratory insufficiency, respiratory failure, sinusitis

Uncommon (0.1% to 1%): Hypoxia

Postmarketing reports: Bronchospasm, cyanosis/hypoventilation, pulmonary edema^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (39.7%), vomiting (31.8%), diarrhea (30.3%), abdominal pain (19.8%), constipation (15.1%)

Common (1% to 10%): Gastrointestinal hemorrhage, dry mouth/nose, dyspepsia, eructation, flatulence, fecal incontinence, hemorrhoids, gum/oral hemorrhage, hematemesis, ileus, mucositis, rectal disorder, stomatitis, ulcerative stomatitis, amylase increased^[Ref]

Other

Very common (10% or more): Fever (89.5%), blood product transfusion reaction (18.4%), peripheral edema (14.6%), edema (14.3%), pain (14%), asthenia (13.1%), chest pain (12%), pyrexia

Common (1% to 10%): Procedural complication, abdomen enlarged, malaise, neck pain, lactate dehydrogenase increased, rigors, influenza-like illness, herpes simplex^[Ref]

Nervous system

Very common (10% or more): Headache (19.8%)

Common (1% to 10%): Dizziness, dystonia, coma, convulsion, dysesthesia, dizziness, paresthesia, somnolence, tremor^[Ref]

Hepatic

Very common (10% or more): Alkaline phosphatase increased (22.2%), bilirubinemia (18.1%), ALT (SGPT) increased (14.6%), AST (SGOT) increased (12.8%), liver function tests abnormal (12.8%)

Common (1% to 10%): Hepatocellular damage, hepatomegaly, veno-occlusive liver disease^[Ref]

Dermatologic

Very common (10% or more): Rash (24.8%), pruritus (10.8%)

Common (1% to 10%): Sweating, cellulitis, face edema, petechia, alopecia, dry skin, maculopapular rash, purpura, skin discoloration, skin disorder, skin ulcer, vesiculobullous rash, flushing

Frequency not reported: Angioneurotic edema

Postmarketing reports: Angioedema, erythema, urticaria^[Ref]

Genitourinary

Very common (10% or more): Hematuria (14%)

Common (1% to 10%): Dysuria, urinary incontinence, vaginal hemorrhage

Postmarketing reports: Hemorrhagic cystitis^[Ref]

Psychiatric

Very common (10% or more): Insomnia (22.1%), anxiety (13.7%), confusion (12.9%)

Common (1% to 10%): Agitation, depression, hallucinations, nervousness, thinking abnormality^[Ref]

Immunologic

Very common (10% or more): Sepsis (14%), infection (12.8%)

Common (1% to 10%): Cell mediated immunologic reaction^[Ref]

Musculoskeletal

Very common (10% or more): Chills (48.1%), back pain (12%)

Common (1% to 10%): Arthralgia, bone pain, myalgia

Postmarketing reports: Rhabdomyolysis^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction

Uncommon (0.1% to 1%): Anaphylactoid reaction

Frequency not reported: Anaphylactic reactions, hypersensitivity^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, dry eyes, eye hemorrhage^[Ref]

Local

Common (1% to 10%): Injection site inflammation^[Ref]