Duloxetine (APO-Duloxetine)
What to know about Duloxetine — also sold as APO-Duloxetine, Duloxetine Sandoz 60, Tixol 60, DYTREX 60, Duloxetine Sandoz and 6 more: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Duloxetine (brand names: APO-Duloxetine, Duloxetine Sandoz 60, Tixol 60, DYTREX 60, Duloxetine Sandoz and 6 more) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. SNRI antidepressant with moderate sedation and potential interaction risks affecting work performance.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
- Serotonergic: Risk of serotonin syndrome when combined with other serotonergic drugs
- PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
SNRI antidepressant with moderate sedation and potential interaction risks affecting work performance.
How Duloxetine is regulated
Duloxetine is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.
United Kingdom NICE / MHRA / FPM
NICE guidelines recommend certain antidepressants (amitriptyline, duloxetine) for chronic pain management. For personal injury claims, antidepressant prescribing should be assessed for injury relatedness.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 )
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.