Prescription medicine
Glutamine Brand names: Endari
Glutamine (Endari) is a prescription medicine. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the glutamine FDA label on DailyMed (effective June 20, 2025); every glutamine label on DailyMed.
Highlights of the record
FDA label of June 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEndari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
Forms and strengths
- 5 g
Powder for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 10, 2018; 3 more by firms not listed as its makers
- FAERS reports
- 4,739 through July 30, 2026
What is glutamine used for?
From the label: indications and usageEndari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
FDA pharmacologic class: Amino Acid.
Source: FDA drug label (Endari), Emmaus Medical, Inc., effective June 20, 2025 (SPL set d5a783f4-12ef-4326-8faa-40018e45ba3b), via openFDA; the full label on DailyMed
Is there a generic for glutamine (Endari)?
No generic glutamine is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists glutamine from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has glutamine been recalled?
The FDA's Enforcement Report lists 4 recalls naming glutamine since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of glutamine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 10, 2018 | Class II | Pharm D Solutions, LLC | Lack of Assurance of Sterility |
| September 27, 2017 | Class II | United Pharmacy not a listed maker | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed |
| November 17, 2016 | Class II | Tri-Coast Pharmacy not a listed maker | Lack of Assurance of Sterility |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glutamine label say about other medicines?
The glutamine label names no other medicine on this site. The labels of 2 other medicines name glutamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name glutamine
Source: FDA drug label (Endari), Emmaus Medical, Inc., effective June 20, 2025 (SPL set d5a783f4-12ef-4326-8faa-40018e45ba3b), via openFDA; the full label on DailyMed
What do FAERS reports show for glutamine?
The FDA Adverse Event Reporting System holds 4,739 reports that list glutamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 142 are coded as a death and 1,787 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other amino acids
- the pharmacologic class, with prices and generics
- Glutamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other