FDA — authorised 31 December 1985
- Application: NDA018735
- Marketing authorisation holder: BRACCO
- Local brand name: ISOVUE-250
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Isovue 250 in United States
FDA authorised Isovue 250 on 31 December 1985 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 12 October 1994
- Application: NDA020327
- Marketing authorisation holder: BRACCO
- Local brand name: ISOVUE-250
- Indication: INJECTABLE — INJECTION
- 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: 22 April 2025 – 22 April 2026
- Total reports: 10
Most-reported reactions
- Anaphylactic Reaction — 1 report (10%)
- Asthenia — 1 report (10%)
- Cerebrovascular Accident — 1 report (10%)
- Death — 1 report (10%)
- Dehydration — 1 report (10%)
- Electrocardiogram St Segment Elevation — 1 report (10%)
- Electrocardiogram T Wave Inversion — 1 report (10%)
- Faecal Incontinence — 1 report (10%)
- Feeling Hot — 1 report (10%)
- Hyperhidrosis — 1 report (10%)
Other Diagnostic Imaging approved in United States
Frequently asked questions
Is Isovue 250 approved in United States?
Yes. FDA authorised it on 31 December 1985; FDA authorised it on 12 October 1994.
Who is the marketing authorisation holder for Isovue 250 in United States?
BRACCO holds the US marketing authorisation.