Safety

Zometa (zoledronic acid) for injection

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

March 2016

Summary View

ADVERSE REACTIONS

Postmarketing Experience

Osteonecrosis of the Jaw

  • Cases of osteonecrosis (primarily involving the jaw but also of other anatomical sites including hip, femur and external auditory canal) have been reported predominantly in cancer patients treated with intravenous bisphosphonates including Zometa. Many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ.

 

June 2015

Summary View

WARNINGS AND PRECAUTIONS

  • The risk of ONJ may increase with duration of exposure to bisphosphonates.

ADVERSE REACTIONS

  • Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have also been reported.

 

January 2015

Summary View

WARNINGS AND PRECAUTIONS

  • Hypocalcemia: Caution is advised when Zometa is administered with drugs known to cause hypocalcemia, as severe hypocalcemia may develop. Serum calcium should be measured and hypocalcemia must be corrected before initiating Zometa.

 

November 2012

Summary View

ADVERSE REACTIONS

Clinical Studies Experience
Postmarketing Experience
  • Acute Phase Reaction - Within three days after Zometa administration, an acute phase reaction has been reported, with symptoms including pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness; these symptoms usually resolve within three days of onset, but resolution could take up to 7 to 14 days. However, some of these symptoms have been reported to persist for a longer duration.
Hypersensitivity Reactions
  • bronchospasms, interstitial lung disease (ILD) with positive re-challenge

 

March 2012

Summary View

WARNINGS AND PRECAUTIONS

Atypical subtrochanteric and diaphyseal femoral fractures
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including Zometa. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to just above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. These fractures occur after minimal or no trauma. Patients may experience thigh or groin pain weeks to months before presenting with a completed femoral fracture….

ADVERSE REACTIONS

Postmarketing Experience

Atypical subtrochanteric and diaphyseal femoral fractures

  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, including Zometa
      

February 2011

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • ...pyrexia, asthenia, fatigue, or malaise persisting for greater than 30 days has been observed

 

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