US Medical Term · medicines
Off-Label Drug Use
Uso de Medicamentos Fuera de Indicación
In 9 languages
| Language | Term |
|---|---|
| English | Off-Label Drug Use |
| Spanish (Español) | Uso de Medicamentos Fuera de Indicación |
| Chinese (中文) | 超适应症用药 |
| Korean (한국어) | 허가 외 약물 사용 |
| Vietnamese (Tiếng Việt) | Sử dụng thuốc ngoài nhãn |
| Filipino (Tagalog) | Off-Label na Paggamit ng Gamot |
| Portuguese (Português) | Uso Off-Label de Medicamentos |
| Thai (ภาษาไทย) | การใช้ยานอกข้อบ่งชี้ |
| Japanese (日本語) | 適応外使用 |
What it means
Off-label drug use refers to prescribing an FDA-approved medication for a purpose, patient population, dosage, or route of administration not included in the FDA-approved labeling. This is legal and common in medical practice — estimates suggest 20–60% of prescriptions in certain specialties are off-label. Physicians may prescribe off-label based on clinical evidence, published studies, or expert consensus. However, insurers may deny coverage for off-label uses unless prior authorization is obtained with supporting clinical justification.
Related terms
Related guide
→ US Guide: prescriptions generics and discount programsSources
Last reviewed: September 2026