Lysodren Side Effects Center

Last updated on RxList: 10/17/2022
Lysodren Side Effects Center

What Is Lysodren?

Lysodren (mitotane) is an antineoplastic (anticancer) medication used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

What Are Side Effects of Lysodren?

Common side effects of Lysodren include:

Tell your doctor if you have serious side effects of Lysodren including:

  • severe dizziness,
  • flushing,
  • fast or pounding heartbeat,
  • shakiness (tremors),
  • unusual or rapid weight loss,
  • change in skin color or thickness,
  • easy bleeding or bruising,
  • breast tenderness or enlargement (males),
  • unwanted facial or body hair (females),
  • mental/mood changes (e.g., depression, irritability, difficulty concentrating, confusion),
  • speech problems,
  • numbness or tingling of hands or feet,
  • unsteadiness,
  • pink urine, or
  • vision problems.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Lysodren

The recommended initial dose of Lysodren is 2 to 6 g per day in divided doses, either three or four times a day. Doses are usually increased incrementally to 9 to 10 g per day.

What Drugs, Substances, or Supplements Interact with Lysodren?

Lysodren may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), blood thinners, or spironolactone. Tell your doctor all medications you use.

Lysodren During Pregnancy and Breastfeeding

During pregnancy, Lysodren should be used only when prescribed. It is unknown if this drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.

Additional Information

Our Lysodren (mitotane) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Lysodren Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blurred or double vision;
  • confusion, problems with speech, balance, or walking;
  • a light-headed feeling, like you might pass out;
  • pelvic pain, vaginal bleeding;
  • easy bruising or bleeding (nosebleeds, bleeding gums); or
  • any bleeding that will not stop.

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • diarrhea;
  • depressed mood;
  • dizziness, spinning sensation; or
  • rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lysodren Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Adrenal Crisis in the Setting of Shock or Severe Trauma [see WARNINGS AND PRECAUTIONS]
  • CNS Toxicity [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Ovarian macrocysts [see WARNINGS AND PRECAUTIONS]

The following adverse reactions associated with the use of LYSODREN were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Common adverse reactions occurring with LYSODREN treatment include:

  • Anorexia, nausea, vomiting, and diarrhea (80%)
  • Depression, dizziness, or vertigo (15%-40%)
  • Rash (15%)
  • Neutropenia
  • Growth retardation, hypothyroidism
  • Confusion, headache, ataxia, mental impairment, weakness, dysarthria
  • Maculopathy
  • Hepatitis, elevation of liver enzymes
  • Gynecomastia
  • Hypercholesterolemia, hypertriglyceridemia
  • Decreased blood androstenedione and decreased blood testosterone in females, increased sex hormone binding globulin in females and males, decreased blood free testosterone in males.

Less common adverse reactions include: visual blurring, diplopia, lens opacity, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, generalized aching, fever and hypogonadism (in males).

DRUG INTERACTIONS

Certain CYP3A Substrates

Mitotane is a strong CYP3A inducer. Concomitant use of LYSODREN may decrease the concentrations of CYP3A substrates, which may reduce the efficacy of these substrates. Avoid the concomitant use of LYSODREN with certain CYP3A4 substrates where minimal concentration changes may lead to therapeutic failure. If concomitant use cannot be avoided, increase the CYP3A substrate dosage in accordance with approved product labeling.

Warfarin

When administering coumarin-type anticoagulants to patients receiving LYSODREN, monitor coagulation tests and adjust the anticoagulant dose as needed.

Read the entire FDA prescribing information for Lysodren (Mitotane)

© Lysodren Patient Information is supplied by Cerner Multum, Inc. and Lysodren Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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