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.

Click here for an example of medication guides.

The information provided in this website is aimed at helping people become empowered through knowledge to help protect themselves from medication related harm. You should consult with your physicians before making any changes to your prescription regimen, including herbal, supplement and over the counter products recommended by your physician(s). Increased awareness about the medications and products you are taking will help you have an effective problem solving discussion with your physician(s) and care managers.