Tretinoin is used to cause remission of acute promyelocytic leukemia (APL), a type of blood cancer. Tretinoin is used only for remission of APL and not for continued (maintenance) treatment.

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

Tretinoin can cause severe birth defects, miscarriage, or premature birth. Tell your doctor if you are pregnant or plan to become pregnant. You will need frequent pregnancy testing before and during treatment with tretinoin.

Some people taking tretinoin develop a life-threatening condition called retinoic acid-APL syndrome. Tell your doctor right away if you have early symptoms of this syndrome: fever, shortness of breath, feeling light-headed, and/or weight gain.

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

Tretinoin comes as a capsule to take by mouth. It is usually taken twice a day for up to 90 days. Take tretinoin 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 tretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take tretinoin even if you feel well. Do not stop taking tretinoin without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You will need frequent medical tests.

Tretinoin is usually given until you have been in remission for 30 days, or after a total of 90 days (whichever comes first). Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture, heat, and light.

Tretinoin taken in any amount (even for a short time) can cause severe birth defects, miscarriage, or premature birth. Tell your doctor if you are pregnant or plan to become pregnant. You will need frequent pregnancy testing before and during treatment with tretinoin.

Use 2 effective forms of birth control beginning 1 month before you start taking tretinoin and continuing for at least 1 month after your last dose.

You must use birth control unless you've had a hysterectomy and no longer have a uterus. Use birth control even if you think you cannot become pregnant or have gone through menopause. Tell your doctor right away if you miss a period or think you might be pregnant.

Ask your doctor about the best birth control methods to use. Tretinoin can make certain birth control pills less effective.

You should not use tretinoin if you are allergic to it or to other retinoids (such as Accutane, Retin-A, Renova).

Tell your doctor if you have ever had:

• high cholesterol or triglycerides;

• liver disease; or

• a blood clot or stroke.

Do not breastfeed while taking tretinoin.

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.

Overdose symptoms may include headache, dizziness, weakness, warmth or tingling in your face, stomach pain, and dry or cracked lips.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Do not use vitamin A supplements or multivitamins that contain vitamin A while you are taking tretinoin.

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

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

Some people taking tretinoin develop a life-threatening condition called retinoic acid-APL (RA-APL) syndrome. This syndrome can progress and cause failure of many organs in your body, such as the lungs, liver, or kidneys. Tell your doctor right away if you have early symptoms of RA-APL syndrome: fever, shortness of breath, feeling light-headed, and/or weight gain. RA-APL is treatable, but you may need to stop taking tretinoin for a short time. Follow your doctor's instructions carefully.

Tretinoin may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• mouth and throat ulcers, red or swollen gums, burning mouth pain, trouble swallowing;

• increased pressure inside the skull--severe headaches, ringing in your ears, nausea, vision problems, pain behind your eyes;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• lung problems--pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down);

• signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;

• signs of infection--fever, chills, flu symptoms, easy bruising or bleeding, new or worsening cough, stabbing chest pain, wheezing, rapid and shallow breathing; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of tretinoin may include:

• headache, weakness, tiredness;

• fever, chills, infections, not feeling well;

• bleeding;

• swelling in your hands or feet;

• abnormal liver function tests;

• flushing (sudden warmth, redness, or tingly feeling);

• dry mouth, nose, or throat;

• stomach pain, nausea, vomiting, diarrhea;

• bone pain;

• rash; or

• mouth sores.

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.

Tell your doctor about all your other medicines, especially:

• aminocaproic acid;

• aprotinin;

• tranexamic acid; or

• an antibiotic--doxycycline, demeclocycline, minocycline, tetracycline.

This list is not complete. Other drugs may affect tretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist if you have any questions about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.