September 22, 2025

When you take a prescription medicine, safety is the most important factor. The FDA’s Drug Safety-related Labeling Changes (SrLC) database helps doctors, pharmacists, and patients stay updated about new safety warnings, side effects, and precautions for prescription drugs. This blog will explain in simple words what the SrLC database is, why it matters, and how it can protect patients by sharing FDA drug safety updates quickly. Keywords to rank: FDA drug safety database, prescription drug labeling changes, SrLC database FDA, drug warnings and precautions, FDA safety labeling updates.

What is the SrLC Database?

The SrLC database (Drug Safety-related Labeling Changes database) contains updates to safety information for:

  • Prescription drugs approved under NDAs (New Drug Applications)
  • Biological products approved under BLAs (Biologics License Applications)

 Updates have been available since January 2016, making it a trusted source for the most recent FDA drug labeling changes.

Where Do These Updates Come From?

The database collects updates from two main sources:

  1. Company or FDA-initiated updates – through labeling or efficacy supplement approvals.
  2. FDA-required safety labeling changes (SLCs) – under Section 505(o)(4) of the FD&C Act.

Safety Information Covered in the SrLC Database

The database focuses on safety sections of the Prescribing Information, such as:

  • Boxed Warning (black box warning FDA)
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions (side effects FDA updates)
  • Drug Interactions
  • Use in Specific Populations (pregnancy, elderly, children, etc.)
  • Patient Counselling Information (PCI)
  • Patient Information (PI)
  • Medication Guide (MG)

For older drug labels (non-PLR format):

  • Updates in the Warnings section move to Warnings and Precautions
  • Updates in the Precautions section appear under Drug Interactions, Use in Specific Populations, or Patient Counselling Information

What the SrLC Database Does Not Include

It’s important to know what part of this database is not:

  • Labeling for generic drugs (ANDAs)
  • Labeling for vaccines, blood products, allergenic products, and gene therapies
  • Labeling for over the counter (OTC) drugs
  • Non-safety sections like Indications & Usage or Dosage & Administration
  • Safety data before January 2016 (available on MedWatch)

How to Search the SrLC Database

The FDA provides two simple search options:

  1. Search by Drug Name – Look up safety updates for a specific medicine.
  2. Search by Date Range – See all changes made during a selected period.

This makes it easy for doctors, pharmacists, hospitals, and patients to stay informed about new FDA drug safety warnings.

Why the SrLC Database Matters

The SrLC database is important because it ensures:

  • Doctors and pharmacists know the latest risks and warnings.
  • Healthcare systems can integrate updated information into electronic health records.
  • Patients learn about new risks, precautions, and side effects.

By giving faster access to new safety data, the SrLC database helps prevent harmful drug interactions, reduce medical errors, and improve patient safety.