Medication Guide June 14, 2019

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. 

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 updated as they appear in new drug labeling.  Please note that we link directly into the drug label to the first page of the medication guide. 

Medication Guides may or may not be at the end of the label.  Before printing check the number of pages of the Medication Guide.

The newest labeling may contain a Medication Guide, but this is not necessarily reflective of the date of the label.

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

Related Information

• Medication Guides for Certain Prescription Products
• Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
• Drug Info Rounds Video: Medication Guides
• Approved Risk Evaluation and Mitigation Strategies (REMS)