FDA — authorised 7 July 2017
- Application: NDA208587
- Marketing authorisation holder: EMMAUS MEDCL
- Local brand name: ENDARI
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 L-glutamine in United States
FDA authorised L-glutamine on 7 July 2017 · 468 US adverse-event reports
Marketing authorisations
FDA — authorised 8 July 2024
- Application: ANDA215647
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: L-GLUTAMINE
- Indication: FOR SOLUTION — ORAL
- 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: 468
Most-reported reactions
- Nausea — 68 reports (14.53%)
- Fatigue — 59 reports (12.61%)
- Pain — 53 reports (11.32%)
- Arthralgia — 45 reports (9.62%)
- Diarrhoea — 43 reports (9.19%)
- Headache — 43 reports (9.19%)
- Drug Ineffective — 41 reports (8.76%)
- Dizziness — 39 reports (8.33%)
- Sickle Cell Anaemia With Crisis — 39 reports (8.33%)
- Weight Decreased — 38 reports (8.12%)
L-glutamine 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 L-glutamine approved in United States?
Yes. FDA authorised it on 7 July 2017; FDA authorised it on 8 July 2024; FDA has authorised it.
Who is the marketing authorisation holder for L-glutamine in United States?
EMMAUS MEDCL holds the US marketing authorisation.