Food and Drug Administration Safety Resources

• Drug Safety Information for Health Care Professionals

  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 health care providers.

  Postmarket Drug Safety Information for Patients and 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.

  Drug Safety and Availability

• 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)

  Approved Risk Evaluation and Mitigation Strategies (REMS)

• FDA Drug Safety Newsletter

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

  FDA Drug Safety Newsletter

• FDA > Drugs

  The FDA’s Drug section provides safety information, news about approvals and clearances and other resources for patients and health care professionals.

  FDA > Drugs

• FDA's Index to Drug Specific Information

  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.

  MedWatch: The FDA Safety Information and Adverse Event Reporting Program

• 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 health care professional and patient.

  Medical Product Safety Information

• FDA Approved Drug Products

  FDA Approved Drug Products

• FDA Patient Safety News

  FDA Patient Safety News

• Medical Product Safety Educational Resources

  Medical Product Safety Educational Resources