Pediatric Medication


  • This drug may cause an unsafe and sometimes deadly heartbeat that is not normal. Sudden deaths have happened in people taking this drug. Do not give this drug if your child has low potassium or magnesium levels or a history of long QT on ECG. Your child’s heartbeat will be watched often with an ECG. Talk with the doctor.
  • This drug must only be used when other drugs cannot be used or have not worked. Talk with your child’s doctor to be sure that the benefits of this drug are more than the risks.
  • There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.

What is this drug used for?

  • It is used to treat schizophrenia.
  • 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 has heart problems.
  • If your child has ever had a heartbeat that does not feel normal.
  • If your child is very sleepy.
  • If your child has recently drunk a lot of alcohol or taken a big amount of drugs that may slow your child’s actions like phenobarbital or some pain drugs like oxycodone.
  • If your child is taking any of these drugs: Fluoxetine, fluvoxamine, paroxetine, pindolol, or propranolol.
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 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.
  • To lower the chance of feeling dizzy or passing out, have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell the doctor if your child has ever had a low white blood cell count. Call the doctor right away if your child has signs of infection like fever, chills, or sore throat. Talk with the doctor.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • This drug may cause seizures in some patients. Talk with the doctor.
  • Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
  • This drug may cause the results of some pregnancy tests to be wrong. Talk with the doctor.

If your child is pregnant or breast-feeding a baby:

  • Taking this drug in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • Shakiness, trouble moving around, or stiffness.
  • Feeling confused.
  • Mood changes.
  • Seizures.
  • Swelling in the arms or legs.
  • Change in eyesight.
  • Any unexplained bruising or bleeding.
  • Very nervous and excitable.
  • Not able to pass urine.
  • Feeling very tired or weak.
  • Restlessness.
  • Enlarged breasts.
  • Nipple discharge.
  • Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. The risk may be greater in older adults, mostly women. The chance that this will happen or that it will never go away is greater in people who take this drug in higher doses or for a long time. Muscle problems may also occur after short-term use with low doses. Call your child’s doctor right away if your child has trouble controlling body movements or if your child has muscle problems with his/her tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your child’s doctor right away if your child has any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or is sweating a lot.

If your child has menstrual periods:

  • For females, no period.

If your child is or may be sexually active:

  • Change in sex ability.

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:
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dry mouth.
  • Feeling sleepy.
  • Stuffy nose.
  • Upset stomach or throwing up.
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.
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • 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.

What do I do if my child misses a dose?

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next 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.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. 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 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.

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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