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Insurance, rules and care

Boxed warning

A boxed warning is the FDA's most prominent safety alert, shown in a black-bordered box at the top of a drug's prescribing information.

Updated Insurance, rules and care
DefinitionA boxed warning is the FDA's most prominent safety alert, shown in a black-bordered box at the top of a drug's prescribing information.

What it means

The FDA uses boxed warnings for serious or life-threatening risks that prescribers and patients need to see first.

Ozempic, Wegovy, Mounjaro, Zepbound, Victoza, Saxenda, Trulicity and Rybelsus carry a boxed warning about thyroid C-cell tumors. It says these tumors occurred in rodents, that human relevance is unknown, and that the drugs are contraindicated in people with a personal or family history of MTC or MEN 2.

A boxed warning does not mean a drug is unsafe for everyone. It means a specific risk must be weighed and discussed before treatment.

You can find the full text of a drug's boxed warning at the top of its prescribing information on DailyMed. The patient Medication Guide repeats the key points in simpler language.

Why it matters

Every drug page on Sunny Weigh summarizes the boxed warning in plain language next to the label facts.

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