Cardiolite Side Effects

Please note - some side effects for Cardiolite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Cardiolite Side Effects - for the Professional

Cardiolite

Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient’s genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred. Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table:

Table 9
Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium
Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies*
Body System Breast Studies Cardiac Studies
Women
n = 673
Women
n = 685
Men
n = 2361
Total
n = 3046
Body as a Whole    21 (3.1%)   6 (0.9%)   17 (0.7%)   23 (0.8%)
  Headache    11 (1.6%)   2 (0.3%)     4 (0.2%)    6 (0.2%)
Cardiovascular      9 (1.3%) 24 (3.5%)   75 (3.2%)   99 (3.3%)
  Chest Pain/Angina         0 (0%) 18 (2.6%)   46 (1.9%)   64 (2.1%)
  ST segment changes         0 (0%) 11 (1.6%)   29 (1.2%)   40 (1.3%)
Digestive System      8 (1.2%)   4 (0.6%)     9 (0.4%)   13 (0.4%)
  Nausea      4 (0.6%)   1 (0.1%)     2 (0.1%)     3 (0.1%)
Special Senses 132 (19.6%) 62 (9.1%) 160 (6.8%) 222 (7.3%)
  Taste Perversion 129 (19.2%) 60 (8.8%) 157 (6.6%) 217 (7.1%)
  Parosmia      8 (1.2%)   6 (0.9%)   10 (0.4%)   16 (0.5%)
*Excludes the 22 patients whose gender were not recorded.

In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.

The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent.

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