medicines
Off-Label Drug Use
適応外使用 (tekiōgai shiyō)
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.
Off-label prescribing is distinct from prescribing unapproved drugs; the drug itself is FDA-approved, only its specific use differs from the labeling.
In 9 languages
| Language | Term |
|---|---|
| English | Off-Label Drug Use |
| Japanese (日本語) | 適応外使用 |
| Chinese (中文) | 超适应症用药 |
| Korean (한국어) | 허가 외 약물 사용 |
| Portuguese | Uso Off-Label de Medicamentos |
| Spanish | Uso de Medicamentos Fuera de Indicación |
| Filipino | Off-Label na Paggamit ng Gamot |
| Thai | การใช้ยานอกข้อบ่งชี้ |
| Vietnamese | Sử dụng thuốc ngoài nhãn |
| Romanization | tekiōgai shiyō |
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Browse US healthcare guides →Last reviewed: September 2026