What warnings have been issued by the FDA regarding the use of zoledronic acid (Reclast) for the treatment of osteoporosis?

Updated: Sep 26, 2019
  • Author: Monique Bethel, MD; Chief Editor: Herbert S Diamond, MD  more...
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Answer

In November 2012, the FDA made safety labeling changes for zoledronic acid to warn against the following adverse reactions [137] :

  • Acute phase reaction within 3 days of zoledronic acid administration: symptoms include pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness; symptoms usually resolve within 3 days of onset but can take 7-14 days to resolve, and some symptoms may persist for a longer duration

  • Hypersensitivity reactions presenting as bronchospasms; interstitial lung disease (ILD) with positive re-challenge


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