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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

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[Ref]

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[Ref]

Hematologic

Very common (10% or more): Prolonged bleeding time (up to 90%), leukopenia/neutropenia (up to 12%)
Common (1% to 10%): Anemia, thrombocytopenia[Ref]

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[Ref]

Gastrointestinal

Very common (10% or more): GI disturbances (up to 80%; anorexia, nausea, vomiting, diarrhea), mucositis, epigastric discomfort
Frequency not reported: Salivary hypersecretion, dyspepsia[Ref]

Cardiovascular

Frequency not reported: Hypertension, orthostatic hypotension, flushing[Ref]

Dermatologic

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

Genitourinary

Frequency not reported: Hematuria, hemorrhagic cystitis, albuminuria, proteinuria[Ref]

Metabolic

Very common (10% or more): Increased plasma cholesterol/hypercholesterolemia, increased plasma triglycerides/hypertriglyceridemia
Postmarketing reports: Decreased blood uric acid/hypouricemia[Ref]

Musculoskeletal

Very common (10% or more): Myasthenia[Ref]

Ocular

Frequency not reported: Blurred vision, diplopia, lens opacity, toxic retinopathy, visual impairment
Postmarketing reports: Maculopathy[Ref]

Other

Very common (10% or more): Asthenia
Frequency not reported: Generalized aching, hyperpyrexia, opportunistic mycosis[Ref]

Psychiatric

Very common (10% or more): Confusion
Frequency not reported: Aggressiveness[Ref]

References

1. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb, Princeton, NJ.

Some side effects of mitotane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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