When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to tretinoin, isotretinoin, vitamin A, or parabens (preservatives used in some medicines). Do not use this medicine if you are pregnant or plan to become pregnant.

How to Use This Medicine:
Liquid Filled Capsule

• A nurse or other trained health professional will give you this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine is not for long-term use.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other medicines that you should not use together with tretinoin. This includes nonprescription (over-the-counter) medicines, vitamins, and herbal supplements. Make sure your doctor knows about all other medicines you use.
• Make sure your doctor knows if you also use aminocaproic acid, cimetidine, ketoconazole, Amicar®, Nizoral®, or Tagamet®. Tell you doctor if you use erythromycin, tetracycline, or verapamil.
• Make sure your doctor knows if you use cyclosporine, diltiazem, phenobarbital, rifampin, Neoral®, or Sandimmune®. Tell your doctor if you also use a steroid medicine such as dexamethasone, prednisolone, prednisone, or Medrol®.
• If you are using birth control pills, ask your doctor if your pills are the right kind to use. Some kinds of birth control pills ("minipills") will not work as well.

Warnings While Using This Medicine:

• For women: Using this medicine while you are pregnant can cause very serious birth defects. You must use two forms of birth control for the entire time that you are being treated with this medicine, and for 1 month after you take your last dose of this medicine. Even if you have been unable to become pregnant in the past, or have been through menopause, you should still use birth control unless you have had a hysterectomy. You will need to have a negative pregnancy test to be sure that you are not pregnant before you start using this medicine. You also might need to have pregnancy tests during treatment, depending on your situation. If you think you have become pregnant while using this medicine, tell your doctor right away.
• Women using this medicine should not breast feed a child.
• Make sure your doctor knows if you have liver disease, high cholesterol, or high triglycerides (fat in the blood). Tell your doctor if you have a history of heart disease or blood clots.
• Some people who use this medicine may develop a condition called "retinoic acid-APL (RA-APL) syndrome." You should call your doctor right away if you have a fever, breathing problems, rapid weight gain, or swelling in your hands, ankles, or feet when using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in your urine, trouble urinating, discomfort when urinating, or a change in how much or how often you urinate.
• Bone pain.
• Chest pain, pressure, or tightness, or an uneven heartbeat.
• Confusion, seizures, or fainting.
• Dark-colored urine or pale stools.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• New or worsening coughing, or coughing up blood.
• New trouble with speaking, walking, or balance.
• Numbness or weakness in your arm or leg, or in one side of your body.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain in your lower leg (calf).
• Skin rash.
• Swelling in your abdomen.
• Tarry, bloody, or unusually dark colored stools.
• Unusual bleeding or bruising.
• Vision problems, severe headache.
• Wheezing, shortness of breath, or other breathing problems.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, or upset stomach.
• Dizziness or light-headedness.
• Dry mouth, dry skin, or nasal dryness.
• Earache, or changes in hearing.
• Feeling anxious, depressed, weak, or unusually tired.
• Hair loss.
• Loss of appetite, weight loss.
• Mild headache, fever, or body aches.
• Shivering.
• Sweating more than usual.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088