ISOtretinoin (Systemic)

Pediatric Medication

Brand Names: US

Absorica; Amnesteem; Claravis; Myorisan; Zenatane

Brand Names: Canada

Accutane; Clarus; Epuris

Warning

  • Do not give this drug to your child if she is pregnant or if she may get pregnant. The risk of very bad and sometimes deadly birth defects is very high if your child takes this drug at any time during pregnancy. 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. The doctor will talk about the bad effects before starting your child on this drug. If your child gets pregnant while taking this drug or within 1 month after stopping it, call the doctor right away. If you and your child know all the facts and your child can follow how to take this drug, a patient fact/consent form must be signed. The form must not be signed and your child must not take this drug if you and your child do not know everything on the form.
  • Your child must have 2 pregnancy tests that show she is not pregnant before starting this drug. She will need a pregnancy test every month in order to get more of this drug. Talk with the doctor.
  • Be sure your child uses 2 kinds of birth control to prevent pregnancy 1 month before care begins, during care, and for at least 1 month after care ends.
  • You may only get this drug through a special program. Talk with your doctor.

What is this drug used for?

  • It is used to treat pimples (acne).
  • It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is able to get pregnant and is not using 2 kinds of birth control.
  • If your child is planning to get pregnant within 1 month before care, during care, or within 1 month after care has ended.
  • If your child is 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 your child is breast-feeding a baby:

  • Be sure your child does not breast-feed a baby while taking this drug and for 1 month after stopping this drug.

This is not a list of all drugs or health problems that interact with this drug.

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

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness or clear eyesight until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Lowered night eyesight may happen. This may be sudden. This may clear up after your child stops the drug but sometimes it may not go away. Have your child use care when doing tasks that call for clear eyesight.
  • Be sure your child does not donate blood while using this drug and for 1 month after stopping.
  • This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
  • High blood sugar has happened with this drug. This includes diabetes that is new or worse. Talk with the doctor.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
  • Skin may look worse before it looks better.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is allergic to tartrazine, talk with your child’s doctor. Some products have tartrazine.
  • Have your child avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during 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 the doctor.
  • Your child may need to have a bone density test. Talk with the doctor.
  • Raised pressure in the brain has happened with this drug. This can cause long lasting loss of eyesight and sometimes death. Call the doctor right away if your child has a bad headache, dizziness, upset stomach or throwing up, or seizures. Call the doctor right away if your child has a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, or blurred eyesight or other change in eyesight.
  • Very bad bowel problems may happen with this drug (inflammatory bowel disease). Tell the doctor right away if your child has signs like very bad loose stools (diarrhea), belly pain, bleeding from the rectum, or rectal pain. This may clear up after your child stops the drug but sometimes it may not go away.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

If your child is or may be sexually active:

  • Do not have your child use progestin-only birth control pills (minipills). They may not work well. Talk with the doctor.
  • If your child has sex without using 2 kinds of birth control, if you think your child may be pregnant, or if your child misses her period, call the doctor right away.

What are some side effects that I need to call my child’s 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 child’s doctor or get medical help right away if your child has 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.
  • If your child shows signs of low mood (depression), thoughts of killing him/herself, 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 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.
  • Swelling.
  • Swollen gland.
  • A heartbeat that does not feel normal.
  • 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.
  • Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. This could happen at any time during care. Call the doctor right away if your child has signs of pancreatitis like very bad stomach pain, very bad back pain, or very upset stomach or throwing up.
  • 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 your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Low white blood cell counts have happened with this drug. This may lead to a higher chance of getting an infection. Call your child’s doctor right away if your child has signs of infection like fever, chills, or sore throat.

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 child’s doctor or get medical help if any of these side effects or any other side effects bother your child 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 child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

  • Some drugs may need to be given with food or on an empty stomach. For some drugs, it does not matter. Check with your pharmacist about how to give this drug to your child.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Give this drug with a full glass of water.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • To gain the most benefit, do not miss giving your child doses.
  • You will get a month’s supply of this drug at a time.

What do I do if my child misses a dose?

  • Skip the missed dose and go back to your child’s normal time.
  • Do not give 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 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.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child 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 child’s 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.

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.

Last Reviewed Date

2018-09-10

Copyright

© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated