Brand Names: U.S.
Absorica; Amnesteem; Claravis; Myorisan; Zenatane
Brand Names: Canada
Accutane; Clarus; Epuris
- 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 this drug 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 this drug. If you get pregnant while taking this drug 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 this drug you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.
- This drug is only for patients in the iPLEDGE program.
What is this drug used for?
- It is used to treat pimples (acne).
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
This is not a list of all drugs or health problems that interact with this drug.
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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- If you have an allergy to isotretinoin, vitamin A, or any other part of this drug.
- 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 this drug or for 1 month after you stop this drug.
- If you are taking some antibiotics like tetracycline or doxycycline, products that have vitamin A, products that are like vitamin A, or St John’s wort.
What are some things I need to know or do while I take this drug?
- Tell dentists, surgeons, and other doctors that you use this drug.
- Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you.
- Do not donate blood while using this drug and for 1 month after stopping.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have a bone density test. Talk with your 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 drug 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.
- 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 drug 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 your doctor.
- Lowered night eyesight may happen. Use care when driving or doing other tasks that call for clear eyesight. Keep work space well lit.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- If you are a woman of childbearing age, talk with your doctor about chance of pregnancy when taking this drug. You will also get a written paper talking about the bad effects if you get pregnant.
- You must have 2 pregnancy tests that show you are not pregnant before starting this drug. You will need a pregnancy test every month in order to get more drugs. 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.
- 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.
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 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. These include a fever of 100.4°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
- 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 bruising or bleeding.
- Feeling very tired or weak.
- Not able to pass urine or change in how much urine is passed.
- Back pain.
- Change in eyesight.
- Hearing problems like change in hearing or ringing in the ears may happen. This may clear up after you stop the drug but sometimes it may not go away.
- Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. This could happen at any time during care. Signs of pancreatitis include very bad stomach pain, very bad back pain, or very upset stomach or throwing up. Call your doctor right away if you have any of these signs.
- Very bad bowel problems may happen with this drug (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.
- Swelling in the brain may happen. This can cause long lasting loss of eyesight and sometimes death. Get medical help right away if you have signs like bad headache, dizziness, upset stomach or throwing up, seizures, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, blurred eyesight or other change in eyesight.
- 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.
What are some other side effects of this drug?
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:
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 your national health agency.
- Dry mouth.
- Dry eyes.
- Dry skin.
- Dry lips.
- Nose irritation.
- Change in how contact lenses feel in the eyes.
How is this drug best taken?
Use this drug as ordered by your doctor. Read and follow the dosing on the label 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 this drug.
- Swallow whole. Do not chew, break, or crush.
- Take with a full glass of water.
- Take as you have been told, even if you feel well.
- To gain the most benefit, do not miss doses.
- You will get a month’s supply of this drug 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.
How do I store and/or throw out this drug?
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
General drug facts
- 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.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your 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.
Consumer Information Use and Disclaimer
This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.
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Copyright © 2014 Clinical Drug Information, LLC and Lexi-Comp, Inc.