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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 (see WARNINGS AND PRECAUTIONS). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table:

Table 2.0 - 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, arrhythmia, 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, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent.