FDA Safety Resources

Drug Safety Information for Healthcare Professionals

Postmarket Safety Information for Patients and Providers

In accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) , this FDA website contains links to post marketing drug safety information to improve transparency and communication to patients and healthcare providers.
 

Drug Safety and Availability

Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products.
 

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

FDA Medication Guides

Approved Risk Evaluation and Mitigation Strategies (REMS)

FDA Drug Safety Newsletter

This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
 

FDA > Drugs

FDA's Index to Drug Specific Information

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
 

Medical Product Safety Information

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.
 

FDA Approved Drug Products

FDA Patient Safety News

Medical Product Safety Educational Resources