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Drug Notebook

Generic Name: fluoxetine

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An SSRI antidepressant - treats Obsessive Compulsive Disorder, Premenstrual Dysphoric Disorder, Depr... more

FDA Alerts

Suicidality

Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Fluoxetine is not approved for use in pediatric patients except for patients with major depressive disorder or obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on fluoxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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Fluoxetine Hydrochloride
G / FL 10 10 mg	barr 10 mg / 876 10 mg	93 7198 / 93 7198 40 mg	GG 575 / GG 575 10 mg
b / 201 10 10 mg	M inside a box 0663 20 mg	G / FL 20 20 mg	E85 / E85 20 mg
93 42 / 93 42 10 mg	M 0661 10 mg	93 43 / 93 43 20 mg	MYLAN 4210 / MYLAN 4210 10 mg
barr 20 mg / 877 20 mg	MYLAN 4220 / MYLAN 4220 20 mg	GG 550 / GG 550 20 mg	GG 540 / GG 540 40 mg
9 3 / 7188 10 mg
Prozac
DISTA 3107 / PROZAC 40mg 40 mg	DISTA 3105 / PROZAC 20 mg 20 mg	PROZAC 10 10 mg	DISTA 3104 / PROZAC 10 mg 10 mg

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(floo OX e teen)

What is the most important information I should know about 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 is fluoxetine?

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 should I discuss with my healthcare provider before taking 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.

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