What the label lists and what reports show
Tetrakis copper tetrafluoroborate side effects
Tetrakis copper tetrafluoroborate's FDA label lists its adverse reactions in its own words. FAERS holds 648 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 nausea (49 reports).
- Generic listed
Check it at the source: the tetrakis copper tetrafluoroborate FDA label on DailyMed (effective September 10, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsADVERSE 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 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 Section 5 ). 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 …
Table 2.0 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies*
| Reaction | 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%) |
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, SHINE SPECT USA, LLC, effective September 10, 2026 (SPL set 773b6729-2a74-49e7-9215-ca70da3b854c), via openFDA; the full label on DailyMed
What do FAERS reports show?
648 reports list tetrakis copper tetrafluoroborate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 66 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tetrakis copper tetrafluoroborate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions