What is a black box warning?
Last updated September 3, 2026.
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
- Ask what it is watching for. Your prescriber can name the specific risk and which symptoms should trigger an immediate call.
- Do not stop on your own. Many drugs with boxed warnings are dangerous to quit abruptly - decide any change with your prescriber.
- Keep the monitoring schedule. Boxed warnings often come with required lab checks or follow-ups; they are part of the safety plan.
- Report new symptoms. If something serious appears, contact your prescriber and report it to FDA MedWatch.
Related questions
- How do I report a medication side effect?
- What do I do if my medication is recalled?
- Do medications really expire?
- Why does my pill look different than last refill?