• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Humira (adalimumab) Injection, Solution For Subcutaneous Use


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Malignancies

ADVERSE REACTIONS

  • Immunogenicity
  • Plaque Psoriasis Clinical Studies

PATIENT COUNSELING INFORMATION

  • Medication Guide

MEDICATION GUIDE (new)

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.