Topical Tacrolimus Added to the PBS

From October 1 2026, tacrolimus 0.1% ointment will be available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of atopic dermatitis. Eligible patients must be at least 16 years of age and have moderate to severe disease.

Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and cytokine production. It also inhibits the release of inflammatory mediators from skin mast cells and basophils. Although topical corticosteroids remain the cornerstone of drug treatment for atopic dermatitis, non-steroid options may be appropriate for some patients.

A large meta-analysis comparing topical treatments for atopic dermatitis found tacrolimus 0.1% ointment to be among the most effective of the therapies evaluated for reducing itch severity and preventing flare-ups. Comparative studies have also shown tacrolimus to be more effective than pimecrolimus cream, with a faster onset of action. However, pimecrolimus remains an effective alternative, and some patients may prefer its cream formulation.

Tacrolimus may be used for the short-term treatment of acute flares. Intermittent long-term use may be considered in select patients to reduce recurrence and prolong flare-free periods. The most common adverse effects are application-site reactions such as burning, stinging, itching, and warmth. These effects are usually mild to moderate and tend to lessen as skin inflammation improves. Alcohol intolerance, which may present as facial flushing or skin irritation after alcohol consumption, has also been reported. Unlike topical corticosteroids, tacrolimus does not cause skin atrophy, striae, or telangiectasia, making it particularly useful for delicate skin areas and for patients requiring repeated courses of treatment.