Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
- Certain information is necessary to prevent serious adverse effects.
- Patient decision-making should be informed by information about a known serious side effect with a product, or
- Patient adherence to directions for the use of a product are essential to its effectiveness.
There are currently over 300 medications and dosage forms that the FDA requires a Medication Guide be dispensed with.
Available in preformatted PDF or flexible XML with associated stylesheets for display or printing
Mapping available to NDC, RxNorm, and AHFS identifiers
Updated weekly based on new and revised content from the FDA/DailyMed
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