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
- 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?
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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.
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The Apr 2008 label not available at this site.
