Antidepressant_other | Low Risk

Mirtazapine (MIRTANZA ODT)

Mirtazapine risk profile, scheduling, and guidance for claims professionals and care workers . Also known as MIRTANZA ODT, Avanza, Axit 30, Mirtazapine Sandoz, MIRTANZA and 6 more.

Source: PBS, TGA Updated April 2026

Mirtazapine (brand names: MIRTANZA ODT, Avanza, Axit 30, Mirtazapine Sandoz, MIRTANZA and 6 more) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Sedating antidepressant with CNS depression and impairment 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
  • PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme

Scheduling and Classification

Jurisdiction Classification Status
Australia (TGA) S4 PBS listed

Risk Profile

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

Sedating antidepressant with CNS depression and impairment potential.

Regulatory and Compliance Guidance

When Mirtazapine appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.

Work capacity impact: As a CNS depressant, Mirtazapine 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).

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.

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.

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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.