Lysodren Side Effects

Generic name: mitotane

Medically reviewed by Drugs.com. Last updated on Aug 7, 2023.

Note: This document contains side effect information about mitotane. Some dosage forms listed on this page may not apply to the brand name Lysodren.

Applies to mitotane: oral tablet.

Serious side effects of Lysodren

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

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

Other side effects of Lysodren

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.

General

Common adverse reactions occurring in at least 15% of patients included anorexia, nausea, vomiting, diarrhea, depression, dizziness, vertigo, and rash.

Cardiovascular

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

Dermatologic

Very common (10% or more): Rash (up to 25%)

Frequency not reported: Pruritus^[Ref]

Endocrine

Hypogonadism in males included symptoms such as gynecomastia, decreased libido, erectile dysfunction, and fertility disorders. In pediatric patients, estrogenic-like effects occurred, such as gynecomastia in males, and breast development and/or vaginal bleeding in females.^[Ref]

Very common (10% or more): Adrenal insufficiency (up to 100%)

Common (1% to 10%): Decreased androstenedione, decreased blood testosterone (in females), increased sex hormone binding globulin (in both males and females), decreased blood free testosterone (in males), gynecomastia

Frequency not reported: Hypogonadism (in males), hypothyroidism/thyroid impairment^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 80%), nausea (up to 80%), vomiting (up to 80%), epigastric discomfort (at least 10%), mucositis (at least 10%)

Frequency not reported: Dysgeusia, dyspepsia, salivary hypersecretion^[Ref]

Genitourinary

Frequency not reported: Albuminuria, hematuria, hemorrhagic cystitis, non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding), proteinuria^[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 (at least 10%)

Common (1% to 10%): Autoimmune hepatitis

Frequency not reported: Liver damage^[Ref]

Elevated liver enzymes included gamma-GT, aminotransferase, and alkaline phosphatase.

Liver damage included hepatocellular, cholestatic, and mixed hepatitis.^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Metabolic

Very common (10% or more): Anorexia (up to 80%), increased plasma cholesterol/hypercholesterolemia (at least 10%), increased plasma triglycerides/hypertriglyceridemia (at least 10%)

Frequency not reported: Decreased blood uric acid/hypouricemia^[Ref]

Musculoskeletal

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

Nervous system

Nervous system undesirable effects occurred in approximately 40% of patients, and appeared reversible after cessation of treatment and decrease in plasma levels. Anorexia may constitute the hallmark of initial central nervous system impairment.^[Ref]

Very common (10% or more): Dizziness (up to 40%), vertigo (up to 40%), ataxia (at least 10%), paresthesia (at least 10%), sleepiness (at least 10%)

Common (1% to 10%): Mental impairment, polyneuropathy, movement disorder, headache

Frequency not reported: Balance disorders, memory defects, central vestibular syndrome, dysarthria, Parkinson's syndrome, encephalopathy, neuro-psychological retardation (pediatric)^[Ref]

Ocular

Common (1% to 10%): Maculopathy

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

Other

Common (1% to 10%): Growth retardation

Frequency not reported: Asthenia/weakness, generalized aching, fever, opportunistic mycosis^[Ref]

Psychiatric

Very common (10% or more): Depression (up to 40%), confusion (at least 10%)

Frequency not reported: Aggressiveness^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer