Your Side Effects May IncludeA boxed warning is the strongest warning the FDA requires on a prescription drug's label. It appears at the very top of the prescribing information, set inside a box, which is why people often call it a "black box warning." It flags a risk that is serious or life-threatening, or a precaution that's essential for using the drug safely.
Real examples from the quiz
Boxed warnings are more common than most people expect, and they show up on very familiar drugs:
- Cipro, an everyday antibiotic, has a boxed warning that includes tendon rupture.
- Ozempic has one about thyroid tumors, which were seen in rats and mice. It isn't known whether this happens in people.
- Singulair, an asthma and allergy pill, has one about mood and behavior changes.
- Celebrex carries the warning shared by NSAID pain relievers about heart attack, stroke and stomach bleeding.
- Botox has one about the toxin spreading beyond the injection site.
- Warfarin, a blood thinner, has one about serious bleeding.
What a boxed warning means
- It's about a serious risk. The risk may be rare, but when it happens it can be severe.
- It often comes with instructions. Many boxed warnings say what to avoid, what to watch for or what tests are needed. Those instructions are the most useful part.
- It can change. The FDA adds, changes and occasionally removes boxed warnings as new information comes in.
What it doesn't mean
- It doesn't mean the drug is unsafe for you. Doctors prescribe drugs with boxed warnings every day because, for many people, the benefits outweigh the risks.
- It doesn't mean you should stop taking it. Stopping some medicines suddenly is risky in itself. If a boxed warning worries you, ask your doctor or pharmacist how it applies to you.
Questions to ask
- Does this boxed warning apply to someone like me?
- What signs should I watch for, and what should I do if I notice them?
- Are there tests I need while I take this?
- Are there other medicines, foods or activities I should avoid?
You can read any drug's boxed warning at the top of its label on DailyMed.
Sources
This article is general information, not medical advice. Talk to your doctor or pharmacist about your own medicines.