Drug Safety Information for Healthcare Professionals
Postmarket 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.
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