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Resources » Food and Drug Administration (FDA) » Medication/Med Guides

News and Announcements Consumer Publications Medication Guides
Pregnancy Exposure Registries    

This web page may not contain a complete listing of all available medication guides. To see if a drug has a Medication Guide, please view the labeling found in Drugs@FDA.

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
Listed by Drug Name
*biologic or drug/biologic combination
Listed by Active Ingredient
*biologic or drug/biologic combination

 








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