Standard Care | Low Risk

Vortioxetine Hydrobromide (BRINTELLIX vortioxetine (as hydrobromide) 10 mg film-coated tablet blister pack)

What to know about Vortioxetine Hydrobromide — also sold as BRINTELLIX vortioxetine (as hydrobromide) 10 mg film-coated tablet blister pack, BRINTELLIX vortioxetine (as hydrobromide) 20 mg film-coated tablet blister pack, BRINTELLIX vortioxetine (as hydrobromide) 15 mg film-coated tablet blister pack: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.

Vortioxetine Hydrobromide (brand names: BRINTELLIX vortioxetine (as hydrobromide) 10 mg film-coated tablet blister pack, BRINTELLIX vortioxetine (as hydrobromide) 20 mg film-coated tablet blister pack, BRINTELLIX vortioxetine (as hydrobromide) 15 mg film-coated tablet blister pack) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Multimodal antidepressant with serotonergic effects and moderate sedation potential.

Key Takeaways

  • TGA Schedule: S4 in Australia
  • Risk level: Low (2 points)
  • CNS depressant: May cause sedation, impair driving, and affect work capacity
  • Serotonergic: Risk of serotonin syndrome when combined with other serotonergic drugs

Scheduling and Classification

Jurisdiction Classification Status
Australia (TGA) S4 Not PBS listed

Risk Profile

Risk Level Low
Risk Points 2
CNS Depressant Yes
Respiratory Risk No

Multimodal antidepressant with serotonergic effects and moderate sedation potential.

How Vortioxetine Hydrobromide is regulated

Vortioxetine Hydrobromide 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.

Work capacity impact: As a CNS depressant, Vortioxetine Hydrobromide may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.

Australia TGA / PBS / State Schemes

Classified as S4 under the Therapeutic Goods Administration (TGA).

WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for all S8 opioids. WorkCover QLD Pain Intervention Guidelines recommend multimodal pain management with opioids as a last resort.

United Kingdom NICE / MHRA / FPM

NICE NG193 (Chronic Pain) recommends against initiating opioids for chronic primary pain. The Faculty of Pain Medicine (FPM) Opioids Aware resource recommends structured opioid prescribing with regular review, dose limits, and documented tapering plans.

For personal injury claims in the UK, opioid prescribing duration and dose should be reviewed against NICE and FPM guidelines. Costs may be recoverable as a disbursement in high-value PI claims.

NICE guidelines recommend certain antidepressants (amitriptyline, duloxetine) for chronic pain management. For personal injury claims, antidepressant prescribing should be assessed for injury relatedness.

UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.

United States FDA / CDC / State WC

The CDC Clinical Practice Guideline for Prescribing Opioids (2022) recommends non-opioid therapies as first-line treatment for pain. When opioids are prescribed, the lowest effective dose should be used for the shortest duration needed.

For workers compensation claims, many states require prior authorization for opioids beyond initial acute prescribing. State drug formularies (e.g. California MTUS, Texas, New York) may restrict or require step therapy before opioid approval.

New Zealand ACC / BPAC NZ / Medsafe

BPAC NZ recommends reassessing opioid therapy at regular intervals and limiting duration. The NZ Opioid Prescribing B-QuiCK Guide provides structured prescribing and tapering protocols.

ACC (Accident Compensation Corporation) covers treatment-related medications for accepted claims. Opioid prescribing beyond guidelines may require ACC clinical review and approval.

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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.