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

Drug Safety and Availability

                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections Home
          Drugs
          Drug Safety and Availability
          Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug LabelingDrug Safety and Availability Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug Labeling
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Contact FDA**

Toll Free
(855) 543-3784, or
(301) 796-3400druginfo@fda.hhs.gov

**Human Drug Information**Division of Drug Information (CDER)
Office of CommunicationsFeedback Form
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

The *Drug Safety-related Labeling Changes* (SrLC) database includes updates to safety information in labeling for human prescription drugs regulated under NDAs and human prescription biological products regulated under BLAs.  Updates are available since January 2016.  This database includes labeling changes:

From labeling and efficacy supplement approvals (changes initiated by the company or FDA) and
	Required by the FDA under Section 505(o)(4) of the FD&C Act [safety labeling changes (SLCs)].  See the guidance for industry: *Safety Labeling Changes - Implementation of Section 505(o)(4) of the FD&C Act*(June 2013).This database includes changes to safety information in the:

Prescribing Information (i.e., BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DRUG INTERACTIONS, USE IN SPECIFIC POPULATIONS, and PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide) sections).  For presentation purposes for this database, prescription drugs with “old” format labeling (also known as non-Physician Labeling Rule format labeling):
	Safety changes in the WARNINGS section will appear under the WARNINGS AND PRECAUTIONS section
		Safety changes in the PRECAUTIONS section will generally appear under the WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, USE IN SPECIFIC POPULATIONS, and/or PATIENT COUNSELING INFORMATION sectionsThis database has two searches: A ***Search Labeling by Drug Name****,* and a ***Search Labeling by Date Range***

This website provides these safety information to the public, including health care vendors who integrate these important prescription drug labeling updates into systems frequently accessed by health care practitioners and/or patients.  Ultimately, the FDA expects that prompt access to these vital new safety data by health care practitioners and patients will better promote patient health.

This SrLC database was renamed to clarify to users that the data from these labeling searches include SLCs that were required by FDA as well as updates to safety information in the labeling recommended by the FDA or initiated by companies.

This database does **not** include updates to safety information in:

Other sections of the Prescribing Information (e.g., INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).  For the most recent FDA-approved labeling, please see Drugs@FDA.
	Labeling for generic drugs regulated under ANDAs.
	Labeling for FDA-approved prescription products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
	Labeling for nonprescription (e.g., over-the-counter) drugsThis database also does **not** include safety information from approved Prescribing Information under original NDAs and BLAs (see Drugs@FDA) or safety data prior to January 2016.  Data prior to January 2016 are available on the MedWatch website.

**Search the Drug Safety-related Labeling Changes (SrLC) database**
Search approved safety-related labeling changes by drug name, active ingredient, date range or labeling section.

Resources For You

Updates to Safety Information in FDA-Approved Prescription Drug Labeling
	From January 2016 to current
		Before January 2016
	Drugs@FDA
	Postmarket Drug Safety Information for Patients and Providers
	Information for Healthcare Professionals (Drugs)
	Prescription Drug Labeling Resources - Provides resources for the Prescribing Information, FDA-approved patient labeling, and carton and container labeling for human prescription drugs

                                                                                  Content current as of:
      03/18/2021
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
 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