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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.
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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.
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
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