Medication Guides

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

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.

Please note: All links in the table below go to documents in PDF format.

 

      Medication Guides are available for these products:

*biologic or drug/biologic combination