Lysodren is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

Lysodren may also be used for purposes not listed in this medication guide.

You may need to take steroid medicine, or stop taking Lysodren for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking Lysodren again. Do not change your doses or medication schedule without advice from your doctor.

You must remain under the care of a doctor while taking Lysodren.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if Lysodren is effective.

You may need to take steroid medicine, or stop taking Lysodren for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking this medicine again. Do not change your doses or medication schedule without advice from your doctor.

You must remain under the care of a doctor while taking Lysodren.

Store Lysodren at room temperature away from moisture and heat.

Ask your pharmacist how to safely handle Lysodren tablets. You may need to wear latex gloves when handling this medicine. Do not use a broken tablet.

Tell your doctor if you have ever had:

• recent infection, surgery, or trauma;

• liver disease; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Do not use Lysodren if you are pregnant. This medicine could harm the unborn baby or cause miscarriage or premature birth. Use effective birth control to prevent pregnancy while you are using this medicine.

Do not breastfeed while using this medicine.

Follow your doctor's instructions about how long to avoid pregnancy and breastfeeding after your treatment ends. Lysodren can stay in your bloodstream long after you stop using it.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how Lysodren will affect you. Your reactions could be impaired.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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

Lysodren may cause serious side effects. 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 of Lysodren 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect Lysodren, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.