SIDE EFFECTS: Dizziness, drowsiness, nausea/vomiting, diarrhea, loss of appetite, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual/rapid weight loss, mental/mood changes (such as depression, confusion), vision changes (such as blurred vision, double vision), change in skin color, fainting, easy bleeding/bruising, bloody urine, signs of an ovarian cyst (such as unusual vaginal bleeding, pelvic pain). Mitotane can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before taking mitotane, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mitotane. Mitotane may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control while using this medication and for some time after stopping treatment. Your doctor will do blood tests to decide when you can stop using birth control. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. This medication passes into breast milk and may harm a nursing infant. Breast-feeding is not recommended while using this drug and for some time after stopping this drug. Your doctor will do blood tests to see when you can start breast-feeding. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include naldemedine, ranolazine, certain products used to treat hepatitis C (such as asunaprevir, daclatasvir, ombitasvir/paritaprevir/ritonavir), among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.