FDA — authorised 2 August 2017
- Application: ANDA206961
- Marketing authorisation holder: NEXUS
- Status: approved
🇺🇸 ISOPROTERENOL in United States
FDA authorised ISOPROTERENOL on 2 August 2017 · 411 US adverse-event reports
Marketing authorisations
FDA — authorised 17 October 2018
- Application: ANDA210576
- Marketing authorisation holder: AMNEAL
- Status: supplemented
FDA — authorised 9 February 2021
- Application: ANDA211864
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 16 February 2021
- Application: ANDA210845
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 19 May 2021
- Application: ANDA211237
- Marketing authorisation holder: AMRING PHARMS
- Status: approved
FDA — authorised 3 October 2024
- Application: ANDA217648
- Marketing authorisation holder: GLAND
- Status: approved
FDA
- Application: NDA017366
- Marketing authorisation holder: MEAD JOHNSON
- Local brand name: MUCOMYST W/ ISOPROTERENOL
- Indication: SOLUTION — INHALATION
- 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: 411
Most-reported reactions
- Drug Ineffective — 134 reports (32.6%)
- Torsade De Pointes — 47 reports (11.44%)
- Off Label Use — 44 reports (10.71%)
- Ventricular Tachycardia — 34 reports (8.27%)
- Electrocardiogram Qt Prolonged — 31 reports (7.54%)
- Cardiogenic Shock — 25 reports (6.08%)
- Drug Interaction — 25 reports (6.08%)
- Toxicity To Various Agents — 24 reports (5.84%)
- Ventricular Fibrillation — 24 reports (5.84%)
- Hypotension — 23 reports (5.6%)
ISOPROTERENOL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is ISOPROTERENOL approved in United States?
Yes. FDA authorised it on 2 August 2017; FDA authorised it on 17 October 2018; FDA authorised it on 9 February 2021.
Who is the marketing authorisation holder for ISOPROTERENOL in United States?
NEXUS holds the US marketing authorisation.