FDA — authorised 9 December 1983
- Application: NDA018685
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: GAVISCON
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
🇺🇸 Alginate in United States
FDA authorised Alginate on 9 December 1983 · 1,600 US adverse-event reports
Marketing authorisations
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: 27 March 2025 – 27 March 2026
- Total reports: 1,600
Most-reported reactions
- Fatigue — 182 reports (11.38%)
- Off Label Use — 177 reports (11.06%)
- Pyrexia — 177 reports (11.06%)
- Nausea — 176 reports (11%)
- Diarrhoea — 174 reports (10.88%)
- Rash — 157 reports (9.81%)
- Headache — 148 reports (9.25%)
- Vomiting — 147 reports (9.19%)
- Dyspnoea — 132 reports (8.25%)
- Pain — 130 reports (8.12%)
Other Other approved in United States
Frequently asked questions
Is Alginate approved in United States?
Yes. FDA authorised it on 9 December 1983; FDA has authorised it.
Who is the marketing authorisation holder for Alginate in United States?
CHATTEM SANOFI holds the US marketing authorisation.