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

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:

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
Rare
  • Shortness of breath
  • wheezing
Incidence not known
  • 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
  • lower abdominal cramping
  • nervousness
  • painful urination
  • pounding in the ears
  • redness of the face, neck, arms, and occasionally, upper chest
  • slow or fast heartbeat
  • 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
  • stomach pain, fullness, or discomfort
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
  • Aching muscles
  • flushing or redness of the skin
  • muscle twitching

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. Postmarketing nervous system side effects including neuropsychological disturbance, dysarthria, headache, ataxia, and mental impairment have been 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 side effects are rare, and include visual blurring, diplopia, lens opacity/cataracts, toxic retinopathy with papilledema, or retinal hemorrhage in 3% of patients. Postmarketing hepatic side effects including hepatitis and elevation of liver enzymes have been reported.

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. Postmarketing ocular side effects including maculopathy have been reported.

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. Postmarketing genitourinary side effects including gynecomastia have been reported.

Endocrine

Endocrine side effects are expected because of the effect of mitotane (the active ingredient contained in Lysodren) 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. Postmarketing endocrine side effects including growth retardation and hypothyroidism have been reported.

Many patients require exogenous steroid replacement during mitotane therapy. The adequacy of corticosteroid replacement may be assessed by monitoring levels of adrenal corticotropic hormone [ACTH].

Cardiovascular

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

Hematologic

Data have revealed an aspirin-like ability of mitotane (the active ingredient contained in Lysodren) to inhibit platelet aggregation.

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

Other

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

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.

Psychiatric

Postmarketing psychiatric side effects including confusional state have been reported.

Metabolic

Postmarketing metabolic side effects including decreased blood uric acid, increased blood cholesterol, and increased blood triglycerides have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Advanced Breast Cancer: Learn about treatments to improve quality of life. Click Here

Close
Hide
(web4)