Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Drug Safety and Availability

Postmarket Drug Safety Information for Patients and Providers

                        
                Index to Drug-Specific Information Home
          Drugs
          Drug Safety and Availability
          Postmarket Drug Safety Information for Patients and ProvidersDrug Safety and Availability Postmarket Drug Safety Information for Patients and Providers
  	
        Share
    Post
    Linkedin

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

Latest Safety Information

Safety Labeling Change Orders
	Index to Drug-Specific Information
	Drug Safety Communications
	News and Events for Human Drugs
	MedWatch Safety Alerts for Human Medical Products
	FDA Drug Safety Podcasts
	Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
	Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
	Postmarketing Drug Safety Evaluations
	Drug Safety Labeling Changes (SLC) DatabaseStudies and Clinical Trials of Approved Products

Postmarket Requirements and Commitments SearchRisk Evaluation and Mitigation Strategies (REMS)

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)
	REMS Integration Initiative
	Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
	Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
	Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
	Template for Proposed REMS and REMS Supporting Document for a REMS that includes Only a Medication Guide and Timetable for Submission of Assessments
	Template for Proposed REMS and REMS Supporting Document for a REMS that includes elements Other Than only a Medication Guide and Timetable for Submission of AssessmentsRegistries and Clinical Trials

ClinicalTrials.govInformation about FDA's Drug Safety Oversight Board (DSB)

Drug Safety Oversight Board Members
	Drug Safety Oversight Board Meetings: Public SummariesGeneral Health Information

MedlinePlus - Health Information from the National Library of MedicineFDA's Response to the Institute of Medicine's 2006 Report

The Future of Drug Safety - Promoting and Protecting the Health of the PublicPrescription Drug Labeling

Drugs@FDA - includes information about drugs, including biological products, approved for human use in the United States (e.g., product information, regulatory history, most recent FDA-approved Prescribing Information and patient labeling, and reviews by FDA staff that evaluate the safety and effectiveness of the product).
	DailyMed - NIH’s labeling tool designed to search over 140,000 labeling documents for prescription drugs (including “small molecules”, therapeutic proteins, vaccines, blood products, cellular and gene therapy products), over-the-counter drugs, homeopathic drugs, animal drugs, and other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods).
	FDALabel - FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results. For the similarities and differences between FDALabel and DailyMed see Slides 42-44 in the Prescription Drug Labeling Updates presentation.
	Medication Guides - Medication Guides are a type of FDA-approved patient labeling for drugs used primarily on an outpatient basis when the FDA determines that it is necessary for patient’s safe and effective use.
	FDA’s Labeling Resources for Human Prescription Drugs webpage with the associated webpages such as the Prescribing Information Resources webpage - provides labeling resources for the Prescribing Information, FDA-approved patient labeling, and/or carton and container labeling for human prescription drugs, including biological productsConsumer Information

Buying and Using Medicines Safely
	How to Dispose of Unused MedicinesRegulations and Guidance Documents

Federal food and drug regulations
	Search all FDA GuidancesResources For You

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)
	Notice: Drug and Biologics Safety Surveillance Best Practice Statement
	Guidance Outlines How FDA Communicates, Prioritizes Drug Safety IssuesBack to Top

                                                                                  Content current as of:
      05/22/2023Postmarket Drug Safety Information for Patients and Providers                
                          

                        Index to Drug-Specific Information
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop