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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

In addition to its needed effects, some unwanted effects may be caused by mitotane. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with mitotane may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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


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]


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


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]


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


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


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


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


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


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


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


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


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


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

Not all side effects for mitotane may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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