Uses of Tretinoin:

• It is used to treat a type of leukemia.

What do I need to tell my doctor BEFORE I take Tretinoin?

• If you have an allergy to tretinoin, vitamin A, or any other part of tretinoin (systemic).
• If you are allergic to tretinoin (systemic); any part of tretinoin (systemic); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Demeclocycline, doxycycline, minocycline, tetracycline, a product that has vitamin A in it, a product that is like vitamin A, or St. John's wort.
• If you are breast-feeding. Do not breast-feed while you take tretinoin (systemic).

This is not a list of all drugs or health problems that interact with tretinoin (systemic).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tretinoin (systemic) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tretinoin?

• Tell all of your health care providers that you take tretinoin (systemic). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how tretinoin (systemic) affects you.
• Treatment with tretinoin (systemic) may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Constipation, diarrhea, throwing up, and upset stomach are common with tretinoin (systemic). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.
• Blood clots have happened with tretinoin (systemic). Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• Raised pressure in the brain has happened with tretinoin (systemic). This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight.
• Use with care in children. Talk with the doctor.
• Do not use progestin-only birth control pills (minipills). They may not work well. Talk with your doctor.
• If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.

How is this medicine (Tretinoin) best taken?

Use tretinoin (systemic) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking tretinoin (systemic) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in hearing.
• Hearing loss.
• Swelling of belly.
• A heartbeat that does not feel normal.
• A burning, numbness, or tingling feeling that is not normal.
• Low mood (depression).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Pale skin.

What are some other side effects of Tretinoin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Flushing.
• Headache.
• Stomach pain.
• Bone pain.
• Skin irritation.
• Feeling tired or weak.
• Dry mouth, eyes, skin, or lips.
• Sweating a lot.
• Mouth irritation or mouth sores.
• Anxiety.
• Trouble sleeping.
• Dizziness.
• Earache.
• Weight gain or loss.
• Not hungry.
• Muscle pain.
• Pain in side.
• Shivering.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tretinoin?

• Store at room temperature.
• Protect from heat and light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tretinoin (systemic), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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