Duloxetine: Side Effects, Uses & Monitoring
1 INDICATIONS AND USAGE Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [SEE CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder [SEE CLINICAL STUDIES (14.2)] Diabetic
- Data source
- FDA labeling via NIH DailyMed (label afd59273…)
- 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* |
|---|---|
| Nauseac | 23% |
| Nausea | 23% |
| Headache | 14% |
| Decreased weightd | 14% |
| Dry mouth | 13% |
| Dry mouthb | 11% |
| Fatigued | 11% |
| Somnolenceb,f | 11% |
| Somnolence e | 10% |
| Constipationb | 10% |
| Agitationi | 10% |
| Fatigueb,c | 9% |
| Insomnia d | 9% |
| Constipationc | 9% |
| Dizziness c | 9% |
| Diarrhea | 9% |
| Dizziness | 9% |
| Decreased appetiteb | 8% |
| Decreased appetitec | 7% |
| Fatiguec | 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 INDICATIONS AND USAGE Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [SEE CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder [SEE CLINICAL STUDIES (14.2)] Diabetic Peripheral Neuropathy [SEE CLINICAL STUDIES (14.3)] Fibromyalgia [see CLINICAL STUDIES (14.4)] Chronic Musculoskeletal Pain [SEE CLINICAL STUDIES (14.5)]
Conditions associated with Duloxetine in labeling
Anxiety Disorder
A group of mental health conditions characterized by excessive worry, fear, or nervousness that interferes wit...
Depression
A common but serious mood disorder causing persistent sadness, loss of interest, and changes in sleep, appetit...
Fibromyalgia
A chronic disorder characterized by widespread musculoskeletal pain, fatigue, and sleep, memory, and mood dist...
Generalized Anxiety Disorder
Persistent, excessive worry about everyday situations that is difficult to control and interferes with daily l...
Frequently Asked Questions
What is Duloxetine 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 Duloxetine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Duloxetine. Individual risk varies.
Does Duloxetine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Duloxetine.
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.