l-glutamine
Pharmaranks rates L-Glutamine 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. L-Glutamine is a medication supplied as a powder, for solution.
Generic · by Novitium Pharma
Generic of Endari
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- L-Glutamine
- Form
- Powder
- Strength
- L-GLUTAMINE 5GM/PACKET
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Novitium Pharma
- FDA application
- ANDA215647
What is L-Glutamine?
From the FDA label:L-glutamine is an amino acid. L-glutamine is designated chemically as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, or (S)-2,5-diamino-5-oxopentanoic acid. The molecular formula is C 5 H 10 N 2 O 3 with the molecular weight of 146.15 g/mol and the following structural formula: L-glutamine Oral Powder is formulated as a white to off-white colored powder and is packaged as 5 grams in a foil-plastic laminate packet for oral administration. structure
How to use
2 DOSAGE & ADMINISTRATION 5 grams to 15 grams orally, twice daily based on body weight. (2) Each dose of L-glutamine should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion. (2) 2.1 Dosage Administer L-glutamine orally, twice per day at the dose based on body weight according to Table 1. Table 1. Recommended Dosing Weight in kilograms Weight in pounds Per dose in grams Per day in grams Packets per dose Packets per day less than 30 less than 66 5 10 1 2 30 to 65 66 to 143 10 20 2 4 greater than 65 greater than 143 15 30 3 6 2.2 Preparation of Product Mix L-glutamine immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete dissolution is not required prior to administration.
Side effects
Most common adverse reactions (incidence > 10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to L-glutamine in 187 patients, including 136 exposed for 6 months and 109 exposed for ≥1 year. L-glutamine was studied in 2 placebo-controlled clinical trials (a phase 3 study, n=230 and a phase 2 study, n=70). In these trials, patients with sickle cell anemia or sickle β 0 -thalassemia were randomized to receive L-glutamine (n=187) or placebo (n=111) orally twice daily for 48 weeks followed by 3 weeks of tapering. Both studies included pediatric and adult patients (5-58 years of age) and 54% were female. The majority of patients were black (97.3%), had a diagnosis of sickle cell anemia (89.9%) and were receiving hydroxyurea at baseline (63.4%). Treatment discontinuation due to adverse reactions was reported in 2.7% (n=5) of patients receiving L-glutamine.…
Who should not take L-Glutamine
None None (4)
Overdose — what happens if you take too much
Single oral doses of L-glutamine at about 20 g/kg to 22 g/kg, 8 g/kg to 11 g/kg, and 19 g/kg were lethal in mice, rats, and rabbits, respectively. Supportive measures should be undertaken in the event of overdose of L-glutamine.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- How is L-Glutamine rated?
- pharmaranks gives L-Glutamine a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for L-Glutamine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell L-Glutamine. To pay less, L-Glutamine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes L-Glutamine?
- L-Glutamine is marketed by Novitium Pharma. You can see Novitium Pharma's full profile, rating, and other products on pharmaranks.
- Is L-Glutamine a brand-name or generic drug?
- L-Glutamine is a generic medication; its active ingredient is L-Glutamine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is L-Glutamine available over the counter?
- No. L-Glutamine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does L-Glutamine come in?
- L-Glutamine is currently marketed as powder, per the FDA's National Drug Code Directory.
- Is L-Glutamine FDA-registered?
- L-Glutamine is on record with the U.S. FDA under application number ANDA215647. You can verify this on its official FDA label.
- Has L-Glutamine been recalled by the FDA?
- L-Glutamine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is L-Glutamine safe?
- There's no single safe-or-not verdict. pharmaranks gives L-Glutamine a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of L-Glutamine?
- L-Glutamine's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (incidence > 10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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l-glutamine
70/100