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Note: This document contains side effect information about mitotane. Some of the dosage forms listed on this page may not apply to the brand name Lysodren.
Common side effects of Lysodren include: lethargy and vertigo. See below for a comprehensive list of adverse effects.
Applies to mitotane: oral tablet
Oral route (Tablet)
In patients taking mitotane, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue mitotane until recovery.
Along with its needed effects, mitotane (the active ingredient contained in Lysodren) 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 mitotane:
Incidence not known
Some side effects of mitotane 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:
Applies to mitotane: oral tablet
Very common (10% or more): Adrenal insufficiency, gynecomastia
Frequency not reported: Thyroid impairment, lowered protein-bound iodine (PBI)
Postmarketing reports: Growth retardation, hypothyroidism
Very common (10% or more): CNS effects (up to 40%; primarily depression as manifested by lethargy and somnolence 25%, and dizziness or vertigo 15%), ataxia, paresthesia, sleepiness
Common (1% to 10%): Mental impairment, polyneuropathy, movement disorder, headache
Frequency not reported: Balance disorders, dysgeusia, memory defects, central vestibular syndrome, Parkinson's syndrome, encephalopathy
Postmarketing reports: Neuropsychological disturbance, dysarthria
Very common (10% or more): Prolonged bleeding time (up to 90%), leukopenia/neutropenia (up to 12%)
Common (1% to 10%): Anemia, thrombocytopenia
Very common (10% or more): Elevated liver enzymes (gamma-GT, aminotransferase, alkaline phosphatase)
Common (1% to 10%): Autoimmune hepatitis
Frequency not reported: Liver damage
Postmarketing reports: Hepatitis
Very common (10% or more): GI disturbances (up to 80%; anorexia, nausea, vomiting, diarrhea), mucositis, epigastric discomfort
Frequency not reported: Salivary hypersecretion, dyspepsia
Frequency not reported: Hypertension, orthostatic hypotension, flushing
Very common (10% or more): Skin toxicity/skin rash (up to 25%)
Frequency not reported: Hematuria, hemorrhagic cystitis, albuminuria, proteinuria
Very common (10% or more): Increased plasma cholesterol/hypercholesterolemia, increased plasma triglycerides/hypertriglyceridemia
Postmarketing reports: Decreased blood uric acid/hypouricemia
Very common (10% or more): Myasthenia
Frequency not reported: Blurred vision, diplopia, lens opacity, toxic retinopathy, visual impairment
Postmarketing reports: Maculopathy
Very common (10% or more): Asthenia
Frequency not reported: Generalized aching, hyperpyrexia, opportunistic mycosis
Very common (10% or more): Confusion
Frequency not reported: Aggressiveness