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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?

Medication Guides are found within drug labeling - the section is usually located at the end of the drug label although this is not always the case. Note that the links in the Medication Guides database go directly to the first page of the Medication Guide within the drug label. Please check the number of Medication Guide pages before printing.

Drugs@FDA and DailyMed databases also contain medication guides as part of drug labeling.

 

How often are Medication Guides updated?

Medication Guides are updated as they appear in new drug labeling. The newest labeling may contain a Medication Guide, but this is not necessarily reflective of the date of the label.

 

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