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U.S. Department of Health and Human Services

Safety

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Zometa (zoledronic acid) Injection, 4 mg/100 mL single-use, ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate

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

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.10 Hypocalcemia
  • Hypocalcemia has been reported in patients treated with Zometa. Cardiac arrhythmias and neurologic adverse events (seizures, tetany, and numbness) have been reported secondary to cases of severe hypocalcemia. In some instances, hypocalcemia may be life-threatening. Hypocalcemia must be corrected before initiating Zometa. Adequately supplement patients with calcium and vitamin D.

6 ADVERSE REACTIONS

6.2 Post-marketing Experience
  • acute phase reaction: added .....arthritis with subsequent joint swelling