- 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.
- It is used to treat bipolar problems.
- It is used to treat schizophrenia.
- It may be given to your child for other reasons. Talk with the doctor.
- 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 ever had a long QT on ECG or other heartbeat that is not normal.
- If your child has had a recent heart attack.
- If your child has any of these health problems: Low potassium levels, low magnesium levels, or a weak heart (heart failure).
- If your child is taking any of these drugs: Amiodarone, arsenic, chlorpromazine, disopyramide, dofetilide, dolasetron, dronedarone, droperidol, gatifloxacin, halofantrine, ibutilide, levomethadyl, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, tacrolimus, or thioridazine.
- If your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking 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.
- High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
- Have your child’s blood sugar checked as you have been told by your child’s doctor.
- 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 rise slowly if your child has been sitting or lying down. Have your child be careful going up and down 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.
- Dizziness, sleepiness, and feeling less stable may happen with this drug. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
- 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.
- A very bad and sometimes deadly reaction has happened with this drug. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
- Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this drug is stopped. Sometimes, signs may lessen or go away over time after this drug is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer your child takes this drug or with higher doses. 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.
- Call your child’s doctor right away if your child gets a painful erection (hard penis) or gets an erection that lasts for longer than 4 hours. If this is not treated right away, it may lead to lasting sex problems and your child may not be able to have sex in the future.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- 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.
- 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 high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- 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 a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- If your child is planning to harm him/herself. If the want to harm him/herself gets worse.
- Very bad dizziness or passing out.
- Fast or slow heartbeat.
- Change in the way your child acts.
- Mood changes.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Not able to focus.
- Change in eyesight.
- Enlarged breasts.
- Nipple discharge.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- 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.
- An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. This may raise the chance of sudden death. Talk with the doctor.
If your child has menstrual periods:
- For females, no period.
If your child is or may be sexually active:
- Not able to get or keep an erection.
- Very bad irritation where the shot was given.
- Feeling sleepy.
- Feeling tired or weak.
- Upset stomach or throwing up.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Dry mouth.
- Runny nose.
- Weight gain.
- Irritation where this drug is given.
- It may take several weeks to see the full effects.
- Give this drug with food.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- To gain the most benefit, do not miss giving your child doses.
- 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.
- It is given as a shot into a muscle.
- Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
- Have blood work checked as you have been told by the doctor. 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.
- 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.
- Call your child’s doctor to find out what to do.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- 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.
- 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.