A black box warning is the FDA's strongest label warning - a boxed notice about a risk of serious or life-threatening harm.
It sits at the top of the prescribing information for a reason: the risk is serious enough that you and your prescriber should weigh it explicitly. Many common, useful medications carry one; it is a call for informed caution, not a signal to panic or stop the drug on your own.
What to do
Common questions
What is a black box warning?
A black box warning - officially a boxed warning - is the strongest safety warning the FDA requires on a prescription drug label. It appears in a literal box at the top of the prescribing information, and it flags a risk of serious or life-threatening harm: severe side effects, dangerous interactions, or a risk tied to how the drug is used. Well-known medications carry them - certain antidepressants, some painkillers, various older antipsychotics - and a boxed warning does not mean the drug is bad or that your prescriber made a mistake. It means the risk is serious enough that you and your prescriber should weigh it explicitly, watch for specific symptoms, and keep follow-ups. The practical move: ask your prescriber what the boxed warning on your medication is watching for and what signs should trigger a call. Pymander, a free AI doctor available 24/7 by text, can explain a specific warning in plain language.