Fluoxetine: Side Effects, Uses & Monitoring
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 Studi
- Data source
- FDA labeling via NIH DailyMed (label 62e08a06…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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…
Conditions associated with Fluoxetine in labeling
Anxiety and Panic
Persistent anxiety and panic symptoms that affect daily function and well-being....
Depression
A common but serious mood disorder causing persistent sadness, loss of interest, and changes in sleep, appetit...
Obsessive Compulsive Disorder
A condition characterized by unwanted intrusive thoughts (obsessions) and repetitive behaviors (compulsions)....
Panic Disorder
A condition marked by recurrent, unexpected panic attacks with intense fear and physical symptoms such as palp...
Frequently Asked Questions
What is Fluoxetine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Fluoxetine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Fluoxetine. Individual risk varies.
Does Fluoxetine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Fluoxetine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.