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These highlights do not include all the information needed to use FLUOXETINE TABLETS, USP safely and effectively. See full prescribing information for FLUOXETINE TABLETS, USP. FLUOXETINE tablets, USP for oral use Initial U.S. Approval: 1987
Medication labelWhy this: Advisory · dailymed-prescription
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)]. Fluoxetine is 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) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine 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 for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. Fluoxetine is indicated for the acute and maintenance treatment of binge‑eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)]. Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)]. The effectiveness of fluoxetine 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 for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].
- generic_name
- fluoxetine hydrochloride
- product_names
- fluoxetine hydrochloride
- ndc
- 72162-1495, 49884-336, 72162-1495-1, 72162-1495-3
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en