Orlistat (Xenical) in Australia

The Australian Product Information (PI) registers orlistat for adults with a BMI of 30 or more, or 27 or more "in the presence of other risk factors, in conjunction with a mildly hypocaloric diet". It is not recommended under 18.

An April 2025 review in the RACGP's journal (AJGP) says orlistat can be considered for people with cardiovascular disease or high blood pressure when incretin-based medicines, such as semaglutide or tirzepatide, are not tolerated or unaffordable.

It must not be used in pregnancy or breastfeeding, or by people with chronic malabsorption, cholestasis, pancreatic enzyme deficiency, or chronic pancreatitis with major gut surgery.

Each capsule is taken during the meal or up to one hour after it, and skipped if the meal is missed. Doses above 120 mg three times a day give no extra benefit.

The PI diet is mildly reduced in energy, with no more than about 30% of energy from fat (67 g a day on a 2,000 calorie diet), spread over three main meals.

Gut side effects rise with the fat in a meal and mostly occur in the first 3 months, usually as a single episode. In the first year of trials 8.8% stopped orlistat because of side effects, against 4.9% on placebo. The US label, from seven placebo-controlled trials in the same programme, gives year-one rates of oily spotting 26.6% vs 1.3% and faecal incontinence 7.7% vs 0.9%.

PI precautions, then interactions:

No randomised trial has compared orlistat with semaglutide or tirzepatide.

The Australian PI contains no stopping rule: no 12-week check and no minimum weight-loss threshold. The only continuation rule is the RPBS one for DVA card holders. The AJGP review of April 2025 gives a general rule for all weight-loss medicines: consider stopping and trying another if loss is under 5% after 12 weeks on the maximum dose.

The PI says faecal fat returns to pre-treatment levels within 48 to 72 hours of stopping, and says nothing about tapering or weight after stopping. In four trials with a second maintenance year, both groups regained similar amounts and the gap between them held (2007 meta-analysis).

Under the Poisons Standard in force from 1 October 2026, oral orlistat for weight control at 120 mg or less per dose unit is Schedule 3 (Pharmacist Only). No prescription is needed, but a pharmacist must be involved in each sale. Orlistat is not in Appendix H, the list of Schedule 3 medicines that may be advertised, so it cannot be advertised to the public.

Online, Chemist Warehouse requires a call with its pharmacist within 5 business days or the item is removed from the order. Chemist Outlet requires a call within 48 hours unless a script is supplied, and sells one pack per order. Your Discount Chemist labels Xenical "Prescription Only Medicine" and says it must receive a prescription before dispatch, citing government regulations, although the Poisons Standard does not require one.

DVA card holders seeking the RPBS subsidy need a prescription with authority approval.