Interferes with fungal cytochrome P450 activity (selectively inhibits 14-alpha-lanosterol demethylation), decreasing ergosterol synthesis (principal sterol in fungal cell membrane) and inhibiting fungal cell membrane formation.
Central nervous system: Hallucination (2% to 12%; auditory and/or visual and likely serum concentration-dependent)
Ophthalmic: Visual disturbance (19%)
Renal: Increased serum creatinine (1% to 21%)
2% to 10%:
Cardiovascular: Tachycardia (≤2%)
Central nervous system: Chills (≤4%), headache (≤3%)
Dermatologic: Skin rash (≤7%)
Endocrine & metabolic: Hypokalemia (≤2%)
Gastrointestinal: Nausea (1% to 5%), vomiting (1% to 4%)
Hepatic: Increased serum alkaline phosphatase (4% to 5%), increased serum AST (2% to 4%), increased serum ALT (2% to 3%), cholestatic jaundice (1% to 2%)
Ophthalmic: Photophobia (2%)
Miscellaneous: Fever (≤6%)
<2%, postmarketing, and/or case reports (limited to important or life-threatening): Acute renal failure, adrenocortical insufficiency, agranulocytosis, alopecia, anaphylactoid reaction, anemia (aplastic, hemolytic, macrocytic, megaloblastic, or microcytic), angioedema, anorexia, anuria, arthritis, ascites, ataxia, atrial arrhythmia, atrial fibrillation, atrioventricular block, bacterial infection, bigeminy, blighted ovum, bone marrow depression, bradycardia, brain disease, bundle branch block, cardiac arrest, cardiac failure, cardiomegaly, cardiomyopathy, cellulitis, cerebral edema, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, chest pain, cholecystitis, cholelithiasis, cholestasis, chromatopsia, color blindness, coma, confusion, convulsions, corneal opacity, cyanosis, deafness, deep vein thrombophlebitis, deep vein thrombosis, delirium, dementia, dental fluorosis, depersonalization, depression, diabetes insipidus, diarrhea, discoid lupus erythematosus, disseminated intravascular coagulation, drowsiness, duodenal ulcer (active), duodenitis, dyspnea, eczema, edema, encephalitis, endocarditis, eosinophilia, erythema multiforme, esophageal ulcer, exfoliative dermatitis, extrapyramidal reaction, extrasystoles, fixed drug eruption, fungal infection, gastric ulcer, gastrointestinal hemorrhage, glucose tolerance decreased, graft versus host disease, Guillain-Barre syndrome, hematemesis, hemorrhagic cystitis, hepatic coma, hepatic failure, hepatitis, hepatomegaly, herpes simplex infection, hydronephrosis, hyperbilirubinemia, hypercholesterolemia, hyper-/hypocalcemia, hyper-/hypoglycemia, hyper-/hypomagnesemia, hyper-/hyponatremia, hyper-/hypotension, hyper-/hypothyroidism, hyperkalemia, hypersensitivity reaction, hyperuricemia, hypophosphatemia, hypoxia, impotence, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased susceptibility to infection, intestinal perforation, intracranial hypertension, jaundice, leukopenia, lymphadenopathy, lymphangitis, maculopapular rash, malignant melanoma, melanosis, multiorgan failure, myasthenia, myocardial infarction, myopathy, nephritis, nephrosis, neuropathy, nocturnal amblyopia, nodal arrhythmia, nodule, nystagmus, oculogyric crisis, optic atrophy, optic neuritis, orthostatic hypotension, osteomalacia, osteonecrosis, osteoporosis, otitis externa, palpitations, pancreatitis, pancytopenia, papilledema, paresthesia, perforated duodenal ulcer, periosteal disease, peripheral edema, peritonitis, petechia, pleural effusion, pneumonia, prolonged bleeding time, prolonged QT interval on ECG, pruritus, pseudomembranous colitis, pseudoporphyria, psoriasis, psychosis, pulmonary edema, pulmonary embolism, purpura, rectal hemorrhage, renal insufficiency, renal tubular necrosis, respiratory distress syndrome, respiratory tract infection, retinal hemorrhage, retinitis, seizure, sepsis, skin discoloration, skin photosensitivity, splenomegaly, squamous cell carcinoma, Stevens-Johnson syndrome, subconjunctival hemorrhage, substernal pain, suicidal ideation, supraventricular extrasystole, supraventricular tachycardia, syncope, thrombocytopenia, thrombophlebitis, thrombotic thrombocytopenic purpura, tongue edema, tonic-clonic seizures, torsades de pointes, toxic epidermal necrolysis, uremia, urinary incontinence, urinary retention, urinary tract infection, urticaria, uterine hemorrhage, uveitis, vaginal hemorrhage, vasodilation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, visual field defect
Concerns related to adverse effects:
Concurrent drug therapy issues:
Dosage form specific issues:
– Lactose: Tablets contain lactose; avoid administration in hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
– Sucrose: Suspension contains sucrose; use caution with fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption.