Fungizone (Amphotericin B) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Although some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance, often at less than the full therapeutic dose.

Tolerance may be improved by treatment with aspirin, antipyretics (e.g., acetaminophen), antihistamines, or antiemetics. Meperidine (25 to 50 mg IV) has been shown in some patients to decrease the duration of shaking chills and fever that may accompany the infusion of amphotericin B.

Administration of amphotericin B on alternate days may decrease anorexia and phlebitis.

Intravenous administration of small doses of adrenal corticosteroids just prior to or during the amphotericin B infusion may help decrease febrile reactions. Dosage and duration of such corticosteroid therapy should be kept to a minimum (see PRECAUTIONS: Drug Interactions).

Addition of heparin (1000 units per infusion), and the use of pediatric scalp-vein needle may lessen the incidence of thrombophlebitis. Extravasation may cause chemical irritation.

The adverse reactions most commonly observed are:

General (body as a whole): fever (sometimes accompanied by shaking chills usually occurring within 15 to 20 minutes after initiation of treatment); malaise; weight loss.

Cardiopulmonary: hypotension; tachypnea.

Gastrointestinal: anorexia; nausea; vomiting; diarrhea; dyspepsia; cramping epigastric pain.

Hematologic: normochromic, normocytic anemia.

Local: pain at the injection site with or without phlebitis or thrombophlebitis.

Musculoskeletal: generalized pain, including muscle and joint pains.

Neurologic: headache.

Renal: decreased renal function and renal function abnormalities including: azotemia, hypokalemia, hyposthenuria, renal tubular acidosis; and nephrocalcinosis. These usually improve with interruption of therapy. However, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5 g) of amphotericin B or receiving other nephrotoxic agents. In some patients hydration and sodium repletion prior to amphotericin B administration may reduce the risk of developing nephrotoxicity. Supplemental alkali medication may decrease renal tubular acidosis.

The following adverse reactions have also been reported:

General (body as a whole): flushing.

Allergic: anaphylactoid and other allergic reactions; bronchospasm; wheezing.

Cardiopulmonary: cardiac arrest; shock; cardiac failure; pulmonary edema; hypersensitivity pneumonitis; arrhythmias, including ventricular fibrillation; dyspnea; hypertension.

Dermatologic: rash, in particular maculopapular; pruritus. Skin exfoliation, toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported during post-marketing surveillance.

Gastrointestinal: acute liver failure; hepatitis; jaundice; hemorrhagic gastroenteritis; melena.

Hematologic: agranulocytosis; coagulation defects; thrombocytopenia; leukopenia; eosinophilia; leukocytosis.

Neurologic: convulsions; hearing loss; tinnitus; transient vertigo; visual impairment; diplopia; peripheral neuropathy; encephalopathy (see PRECAUTIONS); other neurologic symptoms.

Renal: acute renal failure; anuria; oliguria. Nephrogenic diabetes insipidus has been reported during post-marketing surveillance.

Altered Laboratory Findings

Serum Electrolytes: Hypomagnesemia; hypo- and hyperkalemia; hypocalcemia.

Liver Function Tests: Elevations of AST, ALT, GGT, bilirubin, and alkaline phosphatase.

Renal Function Tests: Elevations of BUN and serum creatinine.

REPORTS OF SUSPECTED FUNGIZONE SIDE EFFECTS / ADVERSE REACTIONS

Possible Fungizone side effects / adverse reactions in 44 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-02

Patient: 44 year old female

Reactions: Hyperventilation, Chest Discomfort, Tetany, Malaise, Monoplegia, Dizziness, Tremor

Adverse event resulted in: hospitalization

Suspect drug(s):
Ambroxol
    Dosage: unk
    Indication: Bronchitis
    Start date: 2011-10-04
    End date: 2011-10-04

Moxifloxacin HCL
    Dosage: 1 df, once
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-10-04
    End date: 2011-10-04

Fungizone
    Indication: Oral Fungal Infection

Other drugs received by patient: Lercanidipine; Levonorgestrel; Innovar

Possible Fungizone side effects / adverse reactions in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-12-30

Patient: 38 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Adverse event resulted in: hospitalization

Suspect drug(s):
Klipal (Codeine Phosphate, Paracetamol) (500 Milligram, Tablets)
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-10
    End date: 2008-12-31

Fungizone
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-22

Efferalgan Codeine (Codeine Phosphate, Paracetamol) (Tablets)
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-10
    End date: 2008-12-31

Propofan (Caffeine, Carbasalate Calcium, Chlorphenamine Maleate, Dextr
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-10
    End date: 2008-12-31

Fosfomycin (Fosfomycin Trometamol) (Granulate)
    Dosage: (3 gm, once), oral
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2008-12-21
    End date: 2008-12-21

Pyostacine (Pristinamycin)
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-01
    End date: 2008-12-10

Ketoprofen
    Dosage: oral
    Administration route: Oral
    Indication: Paronychia
    Start date: 2008-12-10
    End date: 2008-12-31

Possible Fungizone side effects / adverse reactions in 36 year old male

Reported by a physician from Korea, Republic of on 2012-01-09

Patient: 36 year old male

Reactions: Oesophageal Candidiasis, Chest Discomfort, Febrile Neutropenia, Cholestasis, Depression, Blood Pressure Decreased, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Kaletra
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-31
    End date: 2010-04-02

Fungizone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Avelox; Ursa; Ursa; Metformin HCL; Lanston; Armodafinil; Lanston; Humulin R; 3tc/azt; Apidra Solostar; Surfolase; Gadin; Famotidine; Ganciclovir Sodium; Gadin; Jeil Pethidine HCL Inj. 25mg/0.5ml; Famotidine