Lysodren Side Effects

Generic name: mitotane

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.

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

For the Consumer

Applies to mitotane: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking mitotane (the active ingredient contained in Lysodren) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• fast or pounding heartbeats;

• warmth, redness, or tingly feeling under your skin;

• sweating, cold or clammy skin;

• high fever, chills, uncontrolled shaking;

• blurred or double vision;

• confusion, problems with speech, balance, or walking;

• pain or burning when you urinate;

• blood in your urine; or

• unexpected weight loss.

Less serious side effects of mitotane may include:

• dizziness, spinning sensation;

• drowsiness, tired feeling;

• depressed mood;

• mild skin rash;

• nausea, vomiting, diarrhea; or

• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to mitotane: oral tablet

General

In general, 80% of patients experience at least one side effect from mitotane (the active ingredient contained in Lysodren) Toxicity is usually reversible upon reduction of dosage or discontinuation of therapy.

Gastrointestinal

Gastrointestinal side effects occur in approximately 80% of patients, and include anorexia in 24% to 36%, nausea in 39% to 65%, vomiting in 40%, and diarrhea in 13% to 49% of patients. Rarely, hypersialorrhea has been reported.

Nervous system

Nervous system toxicity occurs in up to 50% of patients, and includes lethargy and somnolence in 25% to 44%, dizziness or vertigo in 18%, weakness in 12% to 23%, muscle tremors in 3%, headache in 5%, confusion in 3%, and irritability in 1% of patients. Prolonged administration may result in permanent brain damage. Frank encephalopathy, hallucinations, speech or memory impairment and ataxia have been rarely reported.

Formal neuropsychiatric testing of patients taking mitotane for up to two years has revealed evidence of impairment, particularly in visual-spatial tasks, oral language, and memory. The incidence of impairment has been associated with serum mitotane levels exceeding 15 mg/L. Above this level, most patients develop cerebellar ataxia. The effects do not appear to be permanent, and often remit at serum levels below 5 to 15 mg/L.

Dermatologic

The main dermatologic side effect is a transient maculopapular rash which appears in approximately 18% of patients. Rare side effects include urticaria, hyperpigmentation, facial swelling, and alopecia.

Therapy can usually be continued despite the transient maculopapular rash.

Hepatic

Mild elevations in hepatic enzymes have been reported in up to 23% of patients in some studies. Severe hepatotoxicity is rare. Limited data (using antipyrine clearance) have shown that mitotane (the active ingredient contained in Lysodren) can induce hepatic microsomal enzymes leading to enhanced steroid degradation.

Ocular

Ocular side effects are rare, and include visual blurring, diplopia, lens opacity/cataracts, toxic retinopathy with papilledema, or retinal hemorrhage in 3% of patients.

Genitourinary

Genitourinary side effects are rare, and include hematuria, hemorrhagic cystitis, or albuminuria in 2% of patients. The use of mitotane (the active ingredient contained in Lysodren) has rarely been associated with (reversible) primary hypogonadism and impotence in males.

Endocrine

Many patients require exogenous steroid replacement during mitotane (the active ingredient contained in Lysodren) therapy. The adequacy of corticosteroid replacement may be assessed by monitoring levels of adrenal corticotropic hormone [ACTH].

Endocrine side effects are expected because of the effect of mitotane on the adrenal cortex. Reversible primary testicular dysfunction/hypogonadism has been associated with the use of mitotane in males. The use of mitotane has been associated with increases in both serum total cholesterol and triglycerides.

Cardiovascular

Cardiovascular side effects are rare, and include hypertension, orthostatic hypotension, or flushing in 2% of patients.

Hematologic

Hematologic side effects including prolonged bleeding times due to mitotane-induced platelet dysfunction have rarely been reported. Thrombocytopenia and leukopenia have also been noted.

Data have revealed an aspirin-like ability of mitotane to inhibit platelet aggregation.

Other

Other side effects found in 8% or less of patients include generalized aching, hyperpyrexia, and decreased protein bound iodine.

Respiratory

Respiratory side effects including wheezing and dyspnea have rarely been reported.

Renal

Renal side effects including increased excretion of urate have rarely been reported.

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