Brand Names: U.S.
- Children and teens who take this drug may be at a greater risk of having thoughts or actions of suicide. Adults may also be at risk. The risk may be greater in people who have had these thoughts or actions in the past. Watch people who take this drug closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
- This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child.
- 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 low mood (depression).
What do I need to tell the doctor BEFORE my child takes 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 their drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking 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 is taking any of these drugs: Linezolid or methylene blue.
- If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure. Talk with your child’s doctor.
- If your child is taking any of these drugs: Pimozide or thioridazine.
- If your child is taking another drug that has the same drug in it.
What are some things I need to know or do while my child takes this drug?
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- 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.
- Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
- If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
- Have your child’s blood sugar checked as you have been told by your child’s doctor.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- This drug may cause weight gain. Your child’s weight may need to be checked often.
- Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
- This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
- Some people may have a higher chance of eye problems with this drug. The doctor may want your child to have an eye exam to see if your child has a higher chance of these eye problems. Call the doctor right away if your child has eye pain, change in eyesight, or swelling or redness in or around the eye.
- Alcohol may interact with this drug. Be sure your child does not drink beer, wine, or mixed drinks.
- Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
- 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.
If your child is pregnant or breast-feeding a baby:
- 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.
- Signs of infection. These include a fever of 100.5°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 bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- 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 low sodium levels like headache, trouble focusing, memory problems, change in thinking clearly and with logic, weakness, seizures, or change in balance.
- If your child is planning to harm him/herself. If the want to harm him/herself gets worse.
- Shortness of breath.
- Very bad dizziness or passing out.
- Feeling very tired or weak.
- Swelling in the arms or legs.
- Enlarged breasts.
- Nipple discharge.
- Not sweating during activities or in warm temperatures.
- Trouble passing urine.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with certain other drugs. Call your child’s doctor right away if your child has dizziness, a very bad headache, agitation, hallucinations, fever, a fast heartbeat, a heartbeat that does not feel normal, flushing, seizures, shakiness, is sweating a lot, a change in balance, a change in thinking clearly and with logic, a very bad upset stomach and throwing up, or very bad loose stools.
- 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.
- Very bad and sometimes deadly reactions along with a rash have rarely happened with this drug. Lung, kidney, or liver problems have also happened. Call the doctor right away if your child has a change in the amount of urine passed, dark urine, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, yellow skin or eyes, or shortness of breath.
- 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.
If your child has menstrual periods:
If your child is or may be sexually active:
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:
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.
- Dry mouth.
- Feeling tired or weak.
- Feeling sleepy.
- More hungry.
- Weight gain.
How is this drug best given?
Give this drug as ordered by your child’s doctor. Read and follow the dosing on the label closely.
- Give in the evening.
- To gain the most benefit, do not miss giving your child doses.
- Give as you have been told, even if your child feels well.
- Give this drug with or without food.
- Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
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.
- 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 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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Last updated: August 15, 2014