FDA — authorised 1 February 2013
- Application: NDA203284
- Marketing authorisation holder: HORIZON THERAP US
- Status: supplemented
🇺🇸 Glycerol in United States
FDA authorised Glycerol on 1 February 2013 · 1,188 US adverse-event reports
Marketing authorisations
FDA — authorised 2 December 2021
- Application: ANDA205742
- Marketing authorisation holder: PH HEALTH
- 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: 27 March 2025 – 27 March 2026
- Total reports: 1,188
Most-reported reactions
- Constipation — 158 reports (13.3%)
- Fall — 142 reports (11.95%)
- Pain — 125 reports (10.52%)
- Hypotension — 123 reports (10.35%)
- Orthostatic Hypotension — 116 reports (9.76%)
- Blood Calcium Decreased — 107 reports (9.01%)
- Balance Disorder — 106 reports (8.92%)
- Cognitive Disorder — 105 reports (8.84%)
- Creatinine Renal Clearance Decreased — 104 reports (8.75%)
- Mobility Decreased — 102 reports (8.59%)
Other Metabolic approved in United States
Frequently asked questions
Is Glycerol approved in United States?
Yes. FDA authorised it on 1 February 2013; FDA authorised it on 2 December 2021; FDA has authorised it.
Who is the marketing authorisation holder for Glycerol in United States?
HORIZON THERAP US holds the US marketing authorisation.