US Medical Term · medications
Black-Box Warning
Advertencia de recuadro negro
In 9 languages
| Language | Term |
|---|---|
| English | Black-Box Warning |
| Spanish (Español) | Advertencia de recuadro negro |
| Chinese (中文) | 黑框警告 |
| Korean (한국어) | 블랙박스 경고 |
| Vietnamese (Tiếng Việt) | Cảnh báo hộp đen |
| Filipino (Tagalog) | Babala ng itim na kahon |
| Portuguese (Português) | Aviso de caixa preta |
| Thai (ภาษาไทย) | คำเตือนกล่องดำ |
| Japanese (日本語) | ブラックボックス警告 |
What it means
A black-box warning, also called a boxed warning, is the FDA's strongest safety alert for a prescription drug. It appears surrounded by a bold black border at the top of the drug's official prescribing information and medication guide. The warning highlights serious or life-threatening risks, such as an increased risk of suicidal thoughts, severe liver damage, or dangerous interactions with other drugs. When your doctor prescribes a medication carrying this warning, they have weighed the serious risks against the expected benefits for your specific situation. Ask your doctor and pharmacist to explain the warning, what symptoms to watch for, and when to seek emergency care.
How to say it
Sentences a patient might use with a doctor, nurse, pharmacist, or insurer:
This medication has a black-box warning about liver damage. What should I watch for?
Este medicamento tiene una advertencia de recuadro negro sobre daño hepático. ¿Qué debo vigilar?
My doctor said this drug has a black-box warning but is still the best option for me.
Mi médico dijo que este medicamento tiene una advertencia de recuadro negro pero sigue siendo la mejor opción para mí.
Where can I read the black-box warning for this medication?
¿Dónde puedo leer la advertencia de recuadro negro de este medicamento?
Where you'll see it
Related terms
Sources
Last reviewed: September 2026