Label Changes for:

Actonel (risedronate sodium) Tablets

April 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


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

  • Upper Gastrointestinal Adverse Reactions
  • Musculoskeletal Pain

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Treatment of Postmenopausal Osteoporosis
    • Daily Dosing
      • Table 1
      • Gastrointestinal Adverse Events
      • Musculoskeletal Adverse Events
      • Laboratory Test Findings
    • Once-a-week Dosing
      • Gastrointestinal Adverse Events
    • Monthly Dosing
      • Two Consecutive Days per Month
      • Acute Phase Reactions
      • Gastrointestinal Adverse Events
      • Ocular Adverse Events
      • Laboratory Test Findings
    • Once a Month
      • Acute Phase Reactions
      • Gastrointestinal Adverse Events
      • Ocular Adverse Events
      • Laboratory Test Findings
    • Prevention of Postmenopausal Osteoporosis
      • Daily Dosing
      • Once-a-week Dosing
    • Treatment and Prevention of Glucocorticoid-induced Osteoporosis
    • Treatment of Paget's Disease
      • Table 2
  • Postmarketing Experience
    • Gastrointestinal Adverse Events

PATIENT COUNSELING INFORMATION

  • If the dose of Actonel 150 mg once a month is missed...

PATIENT PACKAGE INSERT

  • How should I take Actonel?
  • What is my Actonel schedule?
  • What should I avoid while taking Actonel?
  • What are the possible side effects of Actonel?
  • Other possible side effects may include...
  • Call you doctor for medical advice about side effects.
  • How should I store Actonel?

WARNINGS AND PRECAUTIONS

Upper Gastrointestinal Adverse Reactions

...Patients should discontinue use if new or worsening symptoms occur...

Musculoskeletal Pain

...Consider discontinuing use if severe symptoms develop.

The Apr 2008 label not available at this site. 

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