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Mitotane

Generic Name: mitotane (MYE toe tane)
Brand Name: Lysodren
Physician reviewed mitotane patient information - includes mitotane description, dosage and directions.
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Drug Information:
Mitotane is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma). Mitotane may also be used for purposes not listed in this medication guide. You may need to stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking mitotane again. You may need to take steroid medication along with mitotane, especially if you have a serious injury or medical emergency. Do not change your doses or medication schedule without advice from your doctor. Learn more

Mitotane Side Effects

Mitotane Side Effects

In Summary

Commonly reported side effects of mitotane include: lethargy and vertigo. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mitotane: oral tablet

Warning

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 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:

More common

  • Darkening of the skin
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • loss of appetite
  • mental depression
  • nausea or vomiting
  • skin rash
  • unusual tiredness or weakness

Less common

  • Blood in the urine
  • blurred vision
  • double vision

Incidence not known

  • Bloating
  • chills
  • cloudy urine
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • feeling of warmth
  • fever
  • frequent urination
  • headache
  • pelvic cramping, discomfort, pain, or heaviness
  • nervousness
  • painful urination
  • pounding in the ears
  • redness of the face, neck, arms, and occasionally, upper chest
  • slow or fast heartbeat
  • vaginal bleeding
  • vision changes
  • white area over the eye

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:

More common

  • Feeling of constant movement of self or surroundings
  • indigestion
  • passing of gas
  • sensation of spinning
  • sleepiness

Less common

  • Aching muscles
  • flushing or redness of the skin
  • muscle twitching

For Healthcare Professionals

Applies to mitotane: oral tablet

Endocrine

Very common (10% or more): Adrenal insufficiency, gynecomastia

Frequency not reported: Thyroid impairment, lowered protein-bound iodine (PBI)

Postmarketing reports: Growth retardation, hypothyroidism

Nervous system

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

Hematologic

Very common (10% or more): Prolonged bleeding time (up to 90%), leukopenia/neutropenia (up to 12%)

Common (1% to 10%): Anemia, thrombocytopenia

Hepatic

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

Gastrointestinal

Very common (10% or more): GI disturbances (up to 80%; anorexia, nausea, vomiting, diarrhea), mucositis, epigastric discomfort

Frequency not reported: Salivary hypersecretion, dyspepsia

Cardiovascular

Frequency not reported: Hypertension, orthostatic hypotension, flushing

Dermatologic

Very common (10% or more): Skin toxicity/skin rash (up to 25%)

Genitourinary

Frequency not reported: Hematuria, hemorrhagic cystitis, albuminuria, proteinuria

Metabolic

Very common (10% or more): Increased plasma cholesterol/hypercholesterolemia, increased plasma triglycerides/hypertriglyceridemia

Postmarketing reports: Decreased blood uric acid/hypouricemia

Musculoskeletal

Very common (10% or more): Myasthenia

Ocular

Frequency not reported: Blurred vision, diplopia, lens opacity, toxic retinopathy, visual impairment

Postmarketing reports: Maculopathy

Other

Very common (10% or more): Asthenia

Frequency not reported: Generalized aching, hyperpyrexia, opportunistic mycosis

Psychiatric

Very common (10% or more): Confusion

Frequency not reported: Aggressiveness

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Mitotane (www.drugs.com/mtm/mitotane.html).