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  1. Drug Safety and Availability

Medication Guides

Providing information on proper drug use, safety, and storage


What are Medication Guides?

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.


Why do some medicines have Medication Guides?

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.


Where can I find Medication Guides?

See the Medication Guides database.

You can also find Medication Guides by using the Drugs@FDA and the FDALabel databases.


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