Off-label use.

Medicines are licensed for specific uses – for botulinum toxin in aesthetics, for example, frown lines, crow's feet and forehead, medically for underarm sweating or migraine. Any use outside this list – such as chin, neck, masseter or bunny lines – is off-label.

Off-label use is permitted in Germany and everyday in medicine; the physician carries increased responsibility. Requirements are scientific experience with the use, a careful benefit-risk assessment and explicit information that the use is outside the licence.

For patients this does not mean 'unsafe': many off-label uses have been established for decades and are described in guidelines. It means the manufacturer takes no liability for this indication and the decision is made consciously together.

This lexicon entry is general information and does not replace the medical consultation required under German law (§ 630e BGB).