Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.
Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).
Fluoxetine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Sarafem (fluoxetine)?
Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.
What should I discuss with my healthcare provider before taking Sarafem (fluoxetine)?
Do not use fluoxetine if you are using any of the following drugs:
- pimozide (Orap);
- thioridazine (Mellaril); or
- an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).
Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.Before taking fluoxetine, tell your doctor if you are allergic to any drugs, or if you have:
- cirrhosis of the liver;
- kidney disease;
- diabetes;
- seizures or epilepsy;
- bipolar disorder (manic depression); or
- a history of drug abuse or suicidal thoughts.
If you have any of these conditions, you may not be able to use fluoxetine, or you may need a dosage adjustment or special tests.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor. Fluoxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluoxetine to anyone younger than 18 years old without a doctor’s advice. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression.
How should I take Sarafem (fluoxetine)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from the medication.
Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.Measure the liquid form of fluoxetine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
It may take 4 weeks or longer before you start feeling better. Do not stop using fluoxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor’s instructions.
Store fluoxetine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.
If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a fluoxetine overdose may include nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.
Sarafem (fluoxetine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
- seizure (convulsions);
- tremors, shivering, muscle stiffness or twitching;
- a red, blistering, peeling skin rash;
- problems with balance or coordination; or
- agitation, confusion, sweating, fast heartbeat.
Less serious side effects may include:
- drowsiness, dizziness, weakness;
- runny nose, sore throat, headache, flu symptoms;
- nausea, diarrhea, changes in appetite;
- weight changes;
- decreased sex drive, impotence, or difficulty having an orgasm; or
- dry mouth, increased sweating.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
What other drugs will affect Sarafem (fluoxetine)?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily.
Before taking fluoxetine, tell your doctor if you are using any of the following medicines:
- alprazolam (Xanax);
- clozapine (Clozaril, Fazaclo);
- digitoxin (Crystodigin);
- flecainide (Tambocor);
- haloperidol (Haldol);
- seizure medication such as phenytoin (Dilantin) or carbamazepine (Tegretol);
- tryptophan (also called L-tryptophan);
- vinblastine (Velban);
- a blood thinner such as warfarin (Coumadin);
- almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
- any other antidepressants such as amitriptyline (Elavil), escitalopram (Lexapro), imipramine (Tofranil), sertraline (Zoloft), and others.
This list is not complete and there may be other drugs that can interact with fluoxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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