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  1. For Patients

Learn About Your Medicines

Patient Information

Patient Package Inserts, Medication Guides. and Instructions for Use

Patient Package Inserts (PPI), Medication Guides (MG), and Instructions for Use (IFU) 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 use the medicine safe and effectively and try to

Prescription Safety

avoid serious adverse events. Not all medicines have patient information and if you have questions about your medicines you should always talk with your Healthcare Provider or Pharmacist. A description of these types of patient labeling are provided below.

Patient Labeling:

  • Patient Package Inserts (PPI) - Patient labeling that is part of the FDA-approved prescription drug labeling. PPIs are developed by the manufacturer, approved by the FDA, and are required to be dispensed with specific products or classes of products (i.e., oral contraceptives and estrogen-containing products) (see, 21 CFR 310.501 and 21 CFR 310.515). Other PPIs are submitted to the FDA voluntarily by the manufacturer and approved by the FDA, but their distribution is not mandated.

  • Instructions for Use (IFU) - Patient labeling that is developed by the manufacturer, approved by the FDA, and dispensed with specific products that have complicated dosing instructions to help the patient use the product properly.

  • Medication Guides (MG)- 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 (see, 21CFR 208) 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 developed by the manufacturer, approved by the FDA, and required to be given to consumers each time the medication is dispensed. To see a complete list of all FDA approved Medication Guides.

You can search the approved Medication Guide list, Drugs@FDA or dailymed for instructions on how to take your medicines safely. To find the currently approved patient information you will need to follow these instructions.

 
Drugs@FDA
Drugs@FDA Webpage

  • You will need to access Drugs@fda.

  • You will need the medicine name.

  • Type in the name of the medicine in the search box and select submit.

  • Choose from the list the type of information you are interested in. For example, "Label Information."

  • There may be various different formulations of the medicine. You will need to click on the correct medicine for more information.

  • The drug details page will come up and you will select either Patient Package Insert, Label, Medication Guide, or Instructions for Use.

-or-

DailyMed
Daily Med Webpage

  •  You will need to access DailyMed.

  • The search allows you to search by any of the following:

  • The search can be accessed on any page of the site by choosing the "Search Tools" link on a desktop/laptop or tablet.

  • The search functionality is also available on the home page and respresented by the magnifying glass icon.

  • On a mobile device, the search tool is accessed by choosing the magnifying glass icon on the top right of the screen.

Drug Trials Snapshot

The FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. In addition to information about who participates in the trial, each Snapshot also includes information on how the study was designed, results of the efficacy and safety studies and, if known, differences in efficacy and side effects among sex, race and age (referred to as subgroups). For more information visit Drug Trials Snapshot webpage.

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