PROzac; PROzac Weekly; Sarafem
Apo-Fluoxetine; Ava-Fluoxetine; CO Fluoxetine; Dom-Fluoxetine; Fluoxetine Capsules BP; FXT 40; Gen-Fluoxetine; JAMP-Fluoxetine; Mint-Fluoxetine; Mylan-Fluoxetine; Novo-Fluoxetine; Nu-Fluoxetine; PHL-Fluoxetine; PMS-Fluoxetine; PRO-Fluoxetine; Prozac; Q-Fluoxetine; ratio-Fluoxetine; Riva-Fluoxetine; Sandoz-Fluoxetine; Teva-Fluoxetine; ZYM-Fluoxetine
- 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.
- It is used to treat low mood (depression).
- It is used to treat obsessive-compulsive problems.
- It is used to treat mood problems caused by monthly periods.
- It is used to treat eating problems.
- It is used to treat panic attacks.
- 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 is taking any of these drugs: Linezolid or methylene blue.
- If your child is taking any of these drugs: Pimozide or thioridazine.
- 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.
- 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.
- 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.
- 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.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- It may take several weeks to see the full effects.
- 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.
- Use with care in children. Talk with the doctor.
- 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 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.
- 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 sodium levels like headache, trouble focusing, memory problems, change in thinking clearly and with logic, weakness, seizures, or change in balance.
- 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.
- If your child is planning to harm him/herself. If the want to harm him/herself gets worse.
- Change in the way your child acts.
- Very bad dizziness or passing out.
- A big weight gain or loss.
- 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.
- 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.
- 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.
If your child is or may be sexually active:
- Change in sex ability.
- Lowered interest in sex.
- Nervous and excitable.
- Upset stomach.
- Dry mouth.
- Not hungry.
- Loose stools (diarrhea).
- Not able to sleep.
- Feeling sleepy.
- Bad dreams.
- Feeling tired or weak.
- Sweating a lot.
- Flu-like signs.
- 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 swallow whole. Do not let your child chew, break, or crush.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, get an oral syringe, a dropper, a spoon, or a cup (only for older children) from your pharmacist.
- 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.
- Store at room temperature. Do not freeze.
- 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.
- 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, 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.