Lysodren Side Effects

Generic name: mitotane

Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.

Note: This document provides detailed information about Lysodren Side Effects associated with mitotane. Some dosage forms listed on this page may not apply specifically to the brand name Lysodren.

Applies to mitotane: oral tablet.

Precautions

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for as long as this medicine is detected in your blood. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you get a serious injury, infection, or illness of any kind. This medicine may weaken your body's defenses against infection or inflammation.

Adrenal insufficiency may develop in patients using this medicine. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

This medicine may cause cysts in the ovaries in premenopausal women (have menstrual cycles). Tell your doctor if you have bloating, sudden or severe pelvic pain, or vaginal bleeding.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to mitotane: oral tablet.

General adverse events

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

• 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]

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]

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

• 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]

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]

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]

See also:

Further information

Lysodren side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer