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What the label lists and what reports show

Technetium tc 99m sestamibi side effects

Technetium tc 99m sestamibi's FDA label lists its adverse reactions in its own words. FAERS holds 281 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is product with quality issue administered (12 reports).

  • Generic listed

Check it at the source: the technetium tc 99m sestamibi FDA label on DailyMed (effective September 8, 2025); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

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 patients’ 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 ( 5 ) ]. Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc 99m Sestamibi administration are shown in the following table: Table 2 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc 99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose genders were not recorded. …

Table 2 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc 99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose genders were not recorded.

ReactionWomen n = 673Women n = 685Men n = 2361Total n = 3046
Body as a Whole21 (3.1%)6 (0.9%)17 (0.7%)23 (0.8%)
Headache11 (1.6%)2 (0.3%)4 (0.2%)6 (0.2%)
Cardiovascular9 (1.3%)24 (3.5%)75 (3.2%)99 (3.3%)
Chest Pain/Angina0 (0%)18 (2.6%)46 (1.9%)64 (2.1%)
ST segment changes0 (0%)11 (1.6%)29 (1.2%)40 (1.3%)
Digestive System8 (1.2%)4 (0.6%)9 (0.4%)13 (0.4%)
Nausea4 (0.6%)1 (0.1%)2 (0.1%)3 (0.1%)
Special Senses132 (19.6%)62 (9.1%)160 (6.8%)222 (7.3%)
Taste Perversion129 (19.2%)60 (8.8%)157 (6.6%)217 (7.1%)
Parosmia8 (1.2%)6 (0.9%)10 (0.4%)16 (0.5%)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Cardinal Health 414, LLC, effective September 8, 2025 (SPL set 8626e756-767a-4a14-9188-658b58185254), via openFDA; the full label on DailyMed

What do FAERS reports show?

281 reports list technetium tc 99m sestamibi among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 9 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)196
  • Off Label Use (a use or a product term, not a reaction)15
  • Product With Quality Issue Administered12
  • Dizziness (named in the label)11
  • Product Preparation Error10
  • Radioisotope Uptake Increased10
  • Rash (named in the label)9
  • Urticaria (named in the label)9
  • Malaise8
  • Nausea (named in the label)8
  • Chest Pain (named in the label)7
  • Headache (named in the label)7
  • Dyspnoea (named in the label)6
  • Fatigue (named in the label)5
  • Feeling Abnormal5
  • Paraesthesia Oral5
  • Pruritus (named in the label)5
  • Vomiting (named in the label)5
  • Angioedema (named in the label)4
  • Anxiety4
  • Diarrhoea4
  • Feeling Hot4
  • Hyperhidrosis4
  • Hypoaesthesia4
  • Swollen Tongue4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Technetium tc 99m sestamibi: the full record
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Side effects hub
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