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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 sections
This 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) drugs
This 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 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
- 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