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 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.

Use Vesanoid (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

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 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.

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 this medicine will affect you. Your reactions could be impaired.