Medicines and prescriptions
What Is a Boxed Warning? Black Box Warnings Explained
Boxed warning · say it: BOKST WOR-ningAlso written: black box warning, black-box warning
Short answer
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
What it means
A boxed warning, often called a black box warning, is a safety message printed inside a black border at the top of a US prescription medicine's label. The US Food and Drug Administration (FDA) asks for it when a medicine carries a serious risk that people and prescribers must know about.
The box is there so the most important risk is not missed. It may describe a rare but serious side effect, a group of people who face more risk, or a step that is needed to use the medicine more safely, such as blood tests. Many widely used and helpful medicines carry a boxed warning.
A boxed warning is different from a contraindication. A contraindication says the medicine should not be used in a certain situation. A boxed warning says there is a serious risk to weigh and manage, which is not the same as saying never use it.
Where you may see it
- The very top of US prescribing information, inside a black border
- Medication Guides given with some prescriptions
- Pharmacy printouts and online drug labels
📄 How it looks on a report
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients.
🙅 What it does not mean
- It does not mean the medicine is banned or that you should stop it. Many people take boxed-warning medicines under supervision.
- It does not mean the risk is likely for you. It means the risk is serious enough to highlight.
- Do not stop a prescribed medicine because of the box alone; talk to your prescriber first.
🎯 Check yourself
Which of these is the right meaning of “Boxed warning”?
🗒️ Questions to ask your doctor
🧾 Reports where you will see “Boxed warning”
Paste or upload the report and every line of it is explained, with personal details removed first.
💊 Medicines whose labels mention “Boxed warning”
Plain-English explanations of each medicine, from its official FDA label.
- Alprazolam
a benzodiazepine, a type of central nervous system medicine
- Amitriptyline
An antidepressant of the tricyclic type
- Ampicillin Sodium
a penicillin-type antibacterial medicine
- Apixaban
A factor Xa inhibitor, a blood thinner medicine (anticoagulant)
- Aripiprazole
an atypical antipsychotic medicine
- Bupropion Hydrochloride
an aminoketone antidepressant, a type of medicine used to treat depression
- Carbamazepine
a mood stabilizer, and an anticonvulsant (seizure) medicine, according to the label
- Ciprofloxacin
a fluoroquinolone antibacterial medicine
- Citalopram
a selective serotonin reuptake inhibitor (SSRI), a type of antidepressant medicine
- Clonazepam
a benzodiazepine, a type of medicine that slows activity in the central nervous system
🔗 Read more from trusted sources
- “Boxed warning” on MedlinePlus ↗
US National Library of Medicine
Seeing this word on your own report? Get every line of it explained, free.
Explain my report🧩 Related words
🔎 Look up another word
More words: medicines and prescriptions
General information about a medical word, not advice about your own results. Ask the clinician who ordered the test what it means for you.