Fluoxetine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Fluoxetine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Insomnia | 33% |
| Nausea | 29% |
| Asthenia | 21% |
| Headache | 21% |
| Diarrhea | 18% |
| Anorexia | 17% |
| Somnolence | 17% |
| Anxiety | 15% |
| Nervousness | 15% |
| Tremor | 13% |
| Dry mouth | 12% |
| Libido decreased | 11% |
| Pharyngitis | 11% |
| Yawn | 11% |
| Flu syndrome | 10% |
| Dyspepsia | 10% |
| Dizziness | 9% |
| Sweating | 8% |
| Impotence | 7% |
| Abnormal ejaculation | 7% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
1.1 Major Depressive Disorder Fluoxetine capsules, USP are 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)]. 1.2 Obsessive Compulsive Disorder Fluoxetine capsules, USP 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) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine capsules, USP 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 capsules, USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. 1.3 Bulimia Nervosa Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of binge-eating and vomitin…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.