FDA — authorised 3 June 1986
- Application: NDA019445
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEXTROSE 50%
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Dextrose 50 in United States
FDA authorised Dextrose 50 on 3 June 1986 · 78 US adverse-event reports
Marketing authorisations
FDA — authorised 26 March 2021
- Application: ANDA203451
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: DEXTROSE 50%
- Indication: INJECTABLE — INJECTION
- Status: approved
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: 78
Most-reported reactions
- Pyrexia — 12 reports (15.38%)
- Pneumonia — 10 reports (12.82%)
- Drug Ineffective — 9 reports (11.54%)
- Hypotension — 9 reports (11.54%)
- Respiratory Failure — 9 reports (11.54%)
- Chills — 6 reports (7.69%)
- Hyperkalaemia — 6 reports (7.69%)
- Pleural Effusion — 6 reports (7.69%)
- Urinary Tract Infection — 6 reports (7.69%)
- Asthenia — 5 reports (6.41%)
Dextrose 50 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Dextrose 50 approved in United States?
Yes. FDA authorised it on 3 June 1986; FDA authorised it on 26 March 2021; FDA has authorised it.
Who is the marketing authorisation holder for Dextrose 50 in United States?
HOSPIRA holds the US marketing authorisation.