Glossary · Regulation
Off-label use
In short
Off-label means an authorized medicine is used outside its marketing authorization — for a different disease, a different age group or in a different form. Doctors may do this, but it is not covered by the authorization.
In Germany, doctors may prescribe off-label as part of their therapeutic freedom, but then bear greater responsibility for informing the patient and for liability. Statutory health insurance generally does not pay; the Federal Joint Committee (G-BA) sets exceptions for individual substances and uses.
Off-label does not mean unproven: some uses are well studied and were simply never submitted for authorization, for example because patent protection had expired. Others rest only on small studies. Which applies is stated on the respective topic page.
Off-label means “not tested and authorized for this purpose” — not automatically “forbidden” or “ineffective”.
Where this comes up in the fact checks
- Low-Dose Naltrexone – Every use in fibromyalgia, long COVID or autoimmune diseases is off-label.
- Ketamine and esketamine – The esketamine nasal spray is authorized for treatment-resistant depression; ketamine infusions are off-label for it.
- Rapamycin – Authorized in transplant medicine; off-label use for longevity runs ahead of the evidence.
Sources
Related terms: Marketing authorization (EMA, FDA, BfArM) · Compounded medicine (pharmacy preparation) · § 3a HWG (German Medicinal Products Advertising Act)
Information only, not medical advice. The BK-Score is a subjective assessment according to disclosed rules – not a scientific evaluation. Scoring rules