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Medication Guides

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.

Note: This page links to PDF files which require the free Adobe Acrobat Reader.

Medication Guides are available for these products:

Listed by Drug Name

*biologic or drug/biologic combination

Listed by Active Ingredient

*biologic or drug/biologic combination

 

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Date created: May 30, 2006, updated August 19, 2008