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Mitotane may cause a serious, life-threatening condition that can occur when not enough hormone (cortisol) is produced by the adrenal glands in your body. Tell your doctor if you have or develop a severe infection, illness, or injury, or if you are having surgery, including dental surgery. Your doctor will probably tell you not to take mitotane. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; weakness; lightheadedness; dizziness; decreased consciousness; feeling irritable or depressed; confusion; lower back or leg pain; nausea, vomiting, or diarrhea; stomach pain; weight loss; changes in skin color; hair loss; or craving for salt.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mitotane and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risk(s) of taking mitotane.
WHY is this medicine prescribed?
Mitotane is used to treat cancer of the adrenal gland that can not be treated with surgery. Mitotane is in a class of medications called antineoplastic agents. It works by slowing growth or reducing the size of the tumor.
HOW should this medicine be used?
Mitotane comes as a tablet to take by mouth. It is usually taken three to four times a day with a high-fat meal or snack. Ask your doctor for examples of foods that you can eat when you take mitotane. Your doctor will tell you how often you will receive mitotane. The schedule depends on the condition you have and on how your body responds to the medication. Take mitotane at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mitotane exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not open, chew, or crush them. Do not take tablets that are broken or crushed. If any of the tablets are broken or crushed, do not touch them with your bare hands. You should wear rubber or latex gloves when you handle broken or crushed tablets so that your skin does not come into contact with the medication. If the broken or crushed tablets touch your skin, wash the area well with soap and water right away. If you are a caregiver, you should wear rubber or latex gloves when handling mitotane tablets.
If you vomit after taking mitotane, do not take another dose. Continue your regular dosing schedule.
Your doctor will start you on a low dose of mitotane and gradually increase your dose depending on how well the medication works for you and the side effects you experience.
Your doctor may need to decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with mitotane.
Continue to take mitotane even if you feel well. Do not stop taking mitotane without talking to your doctor.
Are there OTHER USES for this medication?
Mitotane is also sometimes used to treat Cushing's syndrome (condition where the body produces too much of the hormone cortisol). Talk to your doctor about the risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking mitotane,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Mitotane may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately:
Mitotane may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests, such as blood tests before, during, and after your treatment to check your body's response to mitotane.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mitotane.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: October 20, 2024.