FDA — authorised 21 December 1990
- Application: NDA019785
- Marketing authorisation holder: SHINE
- Local brand name: CARDIOLITE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Sestamibi in United States
FDA authorised Sestamibi on 21 December 1990 · 523 US adverse-event reports
Marketing authorisations
FDA — authorised 22 September 2008
- Application: ANDA078098
- Marketing authorisation holder: CURIUM
- Status: supplemented
FDA — authorised 28 April 2009
- Application: ANDA078809
- Marketing authorisation holder: CARDINAL HEALTH 414
- Status: approved
FDA — authorised 29 April 2009
- Application: ANDA078806
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Status: supplemented
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 523
Most-reported reactions
- Drug Ineffective — 281 reports (53.73%)
- Scan Myocardial Perfusion Abnormal — 44 reports (8.41%)
- Nausea — 32 reports (6.12%)
- Dizziness — 30 reports (5.74%)
- Headache — 29 reports (5.54%)
- Dyspnoea — 24 reports (4.59%)
- Off Label Use — 24 reports (4.59%)
- Product Preparation Error — 23 reports (4.4%)
- Vomiting — 19 reports (3.63%)
- Tremor — 17 reports (3.25%)
Sestamibi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Sestamibi approved in United States?
Yes. FDA authorised it on 21 December 1990; FDA authorised it on 22 September 2008; FDA authorised it on 28 April 2009.
Who is the marketing authorisation holder for Sestamibi in United States?
SHINE holds the US marketing authorisation.