What is fluoxetine used for?

Indications and Usage, quoted from the label by BluePoint Laboratories (ANDA078619). Cross-references to other label sections are left out.

Fluoxetine capsules are indicated for the treatment of:

• Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies].
• Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies].
• Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies].
• Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies].

Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of:

• Acute treatment of depressive episodes associated with Bipolar I Disorder.
• Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).

Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.

Source: DailyMed label, set id f89a5800-6fdb-4938-a28e-3bf1aeb1c21a, version 8, effective October 13, 2026. NDC 68001-399, one of 165 listings for this product.

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA213286). Cross-references to other label sections are left out.

Major Depressive Disorder

Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years. The usefulness of the drug in adult and pediatric patients receiving fluoxetine tablets for extended periods should periodically be re-evaluated.

Obsessive Compulsive Disorder

Fluoxetine tablets are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD). The effectiveness of fluoxetine tablets in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Bulimia Nervosa

Fluoxetine tablets are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa. The physician who elects to use fluoxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Panic Disorder

Fluoxetine tablets are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. The effectiveness of fluoxetine tablets in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Source: DailyMed label, set id 3daecd20-6a59-44d3-8269-4912214c08b4, version 7, effective January 25, 2024. NDC 59651-308, one of 28 listings for this product.

Indications and Usage, quoted from the label by Torrent Pharmaceuticals Limited (ANDA206937). Cross-references to other label sections are left out.

Premenstrual Dysphoric Disorder (PMDD)

Fluoxetine tablets, USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD).

The effectiveness of fluoxetine tablets, USP in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of fluoxetine tablets, USP for extended periods should be periodically re-evaluated for the individual patient.

Source: DailyMed label, set id dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74, version 14, effective October 19, 2026. NDC 13668-443, one of 10 listings for this product.