Applies to amphotericin b: powder for solution.

Serious side effects of Amphotericin b

Along with its needed effects, amphotericin b 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 immediately if any of the following side effects occur while taking amphotericin b:

More common

With intravenous injection

• Fever and chills
• headache
• increased or decreased urination
• irregular heartbeat
• muscle cramps or pain
• nausea
• pain at the place of injection
• unusual tiredness or weakness
• vomiting

Less common or rare

With intravenous injection

• Blurred or double vision
• convulsions (seizures)
• numbness, tingling, pain, or weakness in hands or feet
• shortness of breath, troubled breathing, wheezing, or tightness in chest
• skin rash or itching
• sore throat and fever
• unusual bleeding or bruising

With spinal injection

• Blurred vision or any change in vision
• difficult urination
• numbness, tingling, pain, or weakness

Other side effects of Amphotericin b

Some side effects of amphotericin b 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

With intravenous injection

• Diarrhea
• headache
• indigestion
• loss of appetite
• nausea or vomiting
• stomach pain

Less common

With spinal injection

• Back, leg, or neck pain
• dizziness or lightheadedness
• headache
• nausea or vomiting

For Healthcare Professionals

Applies to amphotericin b: compounding powder, compounding powder for reconstitution, intravenous powder for injection, oral suspension.

General

Oral amphotericin B is not appreciably absorbed, even at high dosage, and systemic adverse effects have not been noted.

Intravenous amphotericin B will lead to some intolerance in most patients, even at less than the full therapeutic dose. Tolerance can be improved by treatment with antipyretics, antihistamines, or antiemetics. Meperidine may decrease the duration of chills and fever that accompany infusion. Small doses of IV adrenal corticosteroids just prior to or during infusion may decrease febrile reactions. Heparin and use of a pediatric scalp-vein needle may lessen thrombophlebitis incidence.^[Ref]

Renal

Very common (10% or more): Renal function test abnormalities (including azotemia, hyposthenuria, renal tubular acidosis, and nephrocalcinosis), blood creatinine increased

Common (1% to 10%): Renal failure acute

Uncommon (0.1% to 1%): Renal impairment

Rare (less than 0.1%): Nephrogenic diabetes insipidus^[Ref]

Renal function test abnormalities usually improve upon interruption of therapy, however some permanent impairment often occurs, especially in patients receiving large cumulative doses (over 5 grams). Concomitant diuretic use may predispose patient for renal impairment, whereas sodium repletion/supplementation may reduce nephrotoxicity occurrence.^[Ref]

Metabolic

Very common (10% or more): Hypokalemia

Common (1% to 10%): Hypomagnesemia, decreased appetite

Rare (less than 0.1%): Hyperkalemia

Frequency not reported: Hypocalcemia^[Ref]

Gastrointestinal

Common (1% to 10%): Mild gastrointestinal distress, nausea, vomiting, diarrhea

Uncommon (0.1% to 1%): Abdominal pain upper

Rare (less than 0.1%): Dyspepsia, hemorrhagic gastroenteritis, melena

Frequency not reported: Transient yellowing of the teeth (oral route), cramping, epigastric pain^[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Agranulocytosis, leukopenia, thrombocytopenia

Rare (less than 0.1%): Coagulopathy, eosinophilia, leukocytosis

Frequency not reported: Normochromic normocytic anemia^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Neuropathy peripheral

Rare (less than 0.1%): Encephalopathy, convulsion, tinnitus, vertigo^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactoid/anaphylactic reactions^[Ref]

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included hypotension, tachypnea, cardiac arrest, shock, cardiac failure, pulmonary edema, arrhythmia, including ventricular fibrillation, dyspnea, hypertension, and transient asystole. Thrombophlebitis has occurred in many patients because of the long duration of intravenous therapy usually required.^[Ref]

Musculoskeletal

Very common (10% or more): Chills

Uncommon (0.1% to 1%): Myalgia

Rare (less than 0.1%): Arthralgia^[Ref]

Chills usually occur within 15 to 20 minutes after initiation of infusion^[Ref]

Respiratory

Very common (10% or more): Dyspnea

Uncommon (0.1% to 1%): Bronchospasm

Frequency not reported: Tachypnea, wheezing, pulmonary edema, hypersensitivity pneumonitis^[Ref]

Hepatic

Common (1% to 10%): Liver function test abnormalities, hepatic function abnormal

Uncommon (0.1% to 1%): Jaundice

Rare (less than 0.1%): Acute hepatic failure^[Ref]

Other

Very common (10% or more): Pyrexia

Rare (less than 0.1%): Deafness, pain and malaise, weight decreased

Frequency not reported: Hearing loss^[Ref]

Dermatologic

Common (1% to 10%): Rash

Rare (less than 0.1%): Urticaria, angioedema, rash maculopapular, pruritus, skin exfoliation, Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Local

Common (1% to 10%): Injection site pain (with or without phlebitis or thrombophlebitis)^[Ref]

Ocular

Rare (less than 0.1%): Vision blurred, diplopia

Frequency not reported: Visual impairment^[Ref]

Genitourinary

Rare (less than 0.1%): Anuria, oliguria^[Ref]