FDA label
What is fluvoxamine used for?
The FDA-approved uses of fluvoxamine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for fluvoxamine maleate (capsule, extended release) lists this use: Obsessive Compulsive Disorder.
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Fluvoxamine Maleate, capsule, extended release
Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA091476). Cross-references to other label sections are left out.
Obsessive Compulsive Disorder
Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES [14.1, 14.3] ).
The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see CLINICAL STUDIES [14.2] ). The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION [2.4] ).
Source: DailyMed label, set id d492230c-f56a-4759-ba86-7090b9f44063, version 27, effective June 24, 2026. NDC 10370-175, one of 18 listings for this product.
Fluvoxamine Maleate, tablet
Indications and Usage, quoted from the label by Apotex Corp (ANDA075902). Cross-references to other label sections are left out.
Obsessive-Compulsive Disorder
Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults.
Source: DailyMed label, set id 6eeb14df-6fcf-a737-5359-5744eb4accea, version 16, effective September 11, 2026. NDC 60505-0164, one of 14 listings for this product.
Fluvoxamine Maleate, tablet, film coated
Indications and Usage, quoted from the label by Bionpharma Inc. (ANDA217917). Cross-references to other label sections are left out.
Obsessive-Compulsive Disorder
Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 years to 17 years), and one maintenance trial in adults.
Source: DailyMed label, set id 191912e6-b3c8-be1a-e063-6394a90a8dd4, version 2, effective March 5, 2025. NDC 69452-287, one of 5 listings for this product.
Questions
What is fluvoxamine used for?
The FDA label for fluvoxamine maleate (capsule, extended release) lists this use: Obsessive Compulsive Disorder.
What drug class is fluvoxamine?
FDA lists fluvoxamine in the Serotonin Reuptake Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.