- Do not take if you are pregnant or if you may get pregnant. The risk of very bad and sometimes deadly birth defects is very high if you take isotretinoin at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Your doctor will talk about the bad effects before starting you on isotretinoin. If you get pregnant while taking isotretinoin or within 1 month after you stop taking it, call your doctor right away. If you know all the facts and can follow how to take isotretinoin you must sign a patient fact/consent form. Do not sign the form and do not take isotretinoin if you do not know everything on the form.
- You must have 2 pregnancy tests that show you are NOT pregnant before starting isotretinoin. You must have pregnancy tests done while taking isotretinoin. Talk with your doctor.
- Use 2 kinds of birth control that you can trust 1 month before care begins, during care, and for at least 1 month after care ends.
- This medicine is only for patients in the iPLEDGE program.
Uses of Isotretinoin:
What do I need to tell my doctor BEFORE I take Isotretinoin?
- If you have an allergy to isotretinoin or any part of isotretinoin.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are able to get pregnant and are not using 2 kinds of birth control.
- If you are planning to get pregnant within 1 month before care, during care, or within 1 month after care has ended.
- If you are breast-feeding. Do not breast-feed while you take isotretinoin or for 1 month after you stop isotretinoin.
- 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.
This is not a list of all drugs or health problems that interact with isotretinoin.
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 isotretinoin 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 Isotretinoin?
- Tell all of your health care providers that you take isotretinoin. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how isotretinoin affects you.
- Do not donate blood while using isotretinoin and for 1 month after stopping.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
- If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
- Check your blood sugar as you have been told by your doctor.
- Skin may look worse before it looks better.
- Talk with your doctor before you drink alcohol.
- If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
- Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during your care and for at least 6 months after care has ended. The chance of scarring may be raised.
- This medicine may cause weak bones and tendon problems in some people. The chance of bone problems like broken bones may be raised in people who play certain sports. Talk with the doctor.
- Have a bone density test as you have been told by your doctor. Talk with your doctor.
- Lowered night eyesight may happen. Use care at night when driving or doing other tasks that call for clear eyesight. Keep work space well lit.
- Raised pressure in the brain has happened with isotretinoin. 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.
- Very bad bowel problems may happen with isotretinoin (inflammatory bowel disease). Tell your doctor right away if you have signs like very bad loose stools (diarrhea), belly pain, bleeding from the rectum, or rectal pain. This may clear up after you stop the drug but sometimes it may not go away.
- This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- Do not use progestin-only birth control pills (minipills). They may not work well. Talk with your doctor.
- If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.
How is this medicine (Isotretinoin) best taken?
Use isotretinoin as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take isotretinoin.
- Swallow whole. Do not chew, break, or crush.
- Take with a full glass of water.
- Keep taking isotretinoin as you have been told by your doctor or other health care provider, even if you feel well.
- To gain the most benefit, do not miss doses.
- You will get a month's supply of isotretinoin at a time.
What do I do if I miss a dose?
- Never make up a missed dose. Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
See also: Dosage Information (in more detail)
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 low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- Mean actions or thoughts of fighting.
- 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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of esophagus problems like chest pain, trouble swallowing, or new or worse heartburn.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Eye pain.
- Muscle pain or weakness.
- Bone or joint pain.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Not able to pass urine or change in how much urine is passed.
- Back pain.
- Hearing problems like change in hearing or ringing in the ears may happen. This may go away after stopping the drug but sometimes it may not.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with isotretinoin. Call your doctor right away if you have very bad stomach pain, very bad back pain, or very upset stomach or throwing up.
What are some other side effects of Isotretinoin?
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:
- Dry mouth.
- Dry eyes.
- Dry skin.
- Dry lips.
- Nose irritation.
- Change in how contact lenses feel in the eyes.
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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
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 Isotretinoin?
- Store at room temperature.
- Protect from 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.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time isotretinoin is refilled. If you have any questions about isotretinoin, please talk with the doctor, 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.
Disclaimer: This information should not be used to decide whether or not to take isotretinoin or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about isotretinoin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to isotretinoin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using isotretinoin.
Review Date: February 7, 2018
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- Drug class: miscellaneous antineoplastics