Glutamine side effects: what 4,408 FDA adverse event reports show
Drug class
Amino Acid
Brand names
Endari
Who reports
4,408 reports · 62% serious · 127 with death outcome · 58% female
Used for
Endari 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. ( 1 )
What it is
Endari (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.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 35 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 1,615 | 542.4 520.0–565.8ROR 855.6 · χ² 782,492 / p <1e-300 | 483.5 EB05 464.1 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious PRR 590.2 · 95% consumer | no trial data cached |
| Product dose omission | 272 | 19.6 17.5–22.0ROR 20.8 · χ² 4,783 / p <1e-300 | 19.5 EB05 17.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.4 · 98% consumer | no trial data cached |
| Product dose omission issue | 652 | 10.9 10.2–11.7ROR 12.6 · χ² 5,932 / p <1e-300 | 10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 26.2 · 99% consumer | no trial data cached |
| Transfusion | 21 | 9.5 6.2–14.6ROR 9.6 · χ² 151 / p 4e-35 | 8.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Treatment noncompliance | 77 | 6.8 5.4–8.4ROR 6.9 · χ² 372 / p 4e-83 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 97% consumer | no trial data cached |
| Hospitalisation | 185 | 5.8 5.0–6.7ROR 6.0 · χ² 731 / p 2e-161 | 5.7 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 90% consumer | no trial data cached |
| Underdose | 85 | 5.5 4.5–6.8ROR 5.6 · χ² 312 / p 3e-70 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 · 98% consumer | no trial data cached |
| Product use complaint | 18 | 5.5 3.5–8.8ROR 5.5 · χ² 62 / p 1e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Insurance issue | 17 | 5.4 3.4–8.8ROR 5.5 · χ² 57 / p 2e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Therapy cessation | 56 | 5.2 4.0–6.8ROR 5.3 · χ² 187 / p 7e-43 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 96% consumer | no trial data cached |
| Product dose omission in error | 29 | 5.1 3.6–7.4ROR 5.2 · χ² 93 / p 3e-22 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · 97% consumer | no trial data cached |
| Product availability issue | 21 | 4.5 2.9–6.8ROR 4.5 · χ² 53 / p 2e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 100% consumer | no trial data cached |
| Adverse event | 86 | 4.4 3.6–5.5ROR 4.5 · χ² 227 / p 1e-51 | 4.3 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · 96% consumer | no trial data cached |
| Therapy interrupted | 58 | 4.0 3.1–5.2ROR 4.0 · χ² 128 / p 6e-30 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 75% consumer | no trial data cached |
| Drug dose omission | 132 | 3.7 3.2–4.4ROR 3.8 · χ² 265 / p 7e-60 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 95% consumer | no trial data cached |
| Abdominal pain upper | 159 | 3.7 3.2–4.3ROR 3.8 · χ² 311 / p 6e-70 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 · 93% consumer | no trial data cached |
| Osteonecrosis (bone death) | 25 | 3.6 2.4–5.3ROR 3.6 · χ² 44 / p 1e-11 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 96% consumer | no trial data cached |
| Red blood cell count decreased | 21 | 3.5 2.3–5.4ROR 3.5 · χ² 35 / p 2e-9 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 · 76% consumer | no trial data cached |
| Gastroenteritis viral | 13 | 3.4 2.0–5.9ROR 3.4 · χ² 20 / p 4e-6 | 3.1 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Constipation | 149 | 3.3 2.8–3.8ROR 3.4 · χ² 236 / p 2e-53 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 90% consumer | no trial data cached |
| Hip arthroplasty | 10 | 3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Adverse drug reaction | 56 | 3.0 2.3–3.9ROR 3.0 · χ² 72 / p 1e-17 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 85% consumer | no trial data cached |
| Intentional dose omission | 17 | 3.0 1.8–4.8ROR 3.0 · χ² 20 / p 4e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Back pain | 122 | 2.5 2.1–3.0ROR 2.5 · χ² 109 / p 7e-26 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 92% consumer | no trial data cached |
| Medication error | 28 | 2.4 1.7–3.5ROR 2.4 · χ² 22 / p 2e-6 | 2.3 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.2 · 89% consumer | no trial data cached |
| Skin ulcer | 13 | 2.4 1.4–4.1ROR 2.4 · χ² 9 / p 0.001 | 2.3 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Abdominal discomfort | 80 | 2.3 1.8–2.8ROR 2.3 · χ² 57 / p 3e-14 | 2.3 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 · 94% consumer | no trial data cached |
| Pain | 271 | 2.1 1.9–2.4ROR 2.2 · χ² 159 / p 1e-36 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 · 92% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 1,615 | 542.4 520.0–565.8ROR 855.6 · χ² 782,492 / p <1e-300 | 483.5 EB05 464.1 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious PRR 590.2 · 95% consumer | no trial data cached |
| Product dose omission issue | 652 | 10.9 10.2–11.7ROR 12.6 · χ² 5,932 / p <1e-300 | 10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 26.2 · 99% consumer | no trial data cached |
| Product dose omission | 272 | 19.6 17.5–22.0ROR 20.8 · χ² 4,783 / p <1e-300 | 19.5 EB05 17.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.4 · 98% consumer | no trial data cached |
| Pain | 271 | 2.1 1.9–2.4ROR 2.2 · χ² 159 / p 1e-36 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 · 92% consumer | no trial data cached |
| Hospitalisation | 185 | 5.8 5.0–6.7ROR 6.0 · χ² 731 / p 2e-161 | 5.7 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 90% consumer | no trial data cached |
| Abdominal pain upper | 159 | 3.7 3.2–4.3ROR 3.8 · χ² 311 / p 6e-70 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 · 93% consumer | no trial data cached |
| Constipation | 149 | 3.3 2.8–3.8ROR 3.4 · χ² 236 / p 2e-53 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 90% consumer | no trial data cached |
| Drug dose omission | 132 | 3.7 3.2–4.4ROR 3.8 · χ² 265 / p 7e-60 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 95% consumer | no trial data cached |
| Back pain | 122 | 2.5 2.1–3.0ROR 2.5 · χ² 109 / p 7e-26 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 92% consumer | no trial data cached |
| Adverse event | 86 | 4.4 3.6–5.5ROR 4.5 · χ² 227 / p 1e-51 | 4.3 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · 96% consumer | no trial data cached |
| Underdose | 85 | 5.5 4.5–6.8ROR 5.6 · χ² 312 / p 3e-70 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 · 98% consumer | no trial data cached |
| Abdominal discomfort | 80 | 2.3 1.8–2.8ROR 2.3 · χ² 57 / p 3e-14 | 2.3 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 · 94% consumer | no trial data cached |
| Treatment noncompliance | 77 | 6.8 5.4–8.4ROR 6.9 · χ² 372 / p 4e-83 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 97% consumer | no trial data cached |
| Therapy interrupted | 58 | 4.0 3.1–5.2ROR 4.0 · χ² 128 / p 6e-30 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 75% consumer | no trial data cached |
| Adverse drug reaction | 56 | 3.0 2.3–3.9ROR 3.0 · χ² 72 / p 1e-17 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 85% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sickle cell anaemia with crisis — n=1,615, PRR 542.4
- Transfusion — n=21, PRR 9.5
- Osteonecrosis — n=25, PRR 3.6
- Abdominal discomfort — n=80, PRR 2.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Glutamine?
In FDA FAERS, the most frequently co-reported reaction terms for Glutamine are sickle cell anaemia with crisis, pain, abdominal pain upper, constipation, back pain, abdominal discomfort. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Glutamine have an FDA boxed warning?
No. The FDA label retrieved for Glutamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glutamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID d5a783f4-12ef-4326-8faa-40018e45ba3b, effective 20250620; matched on
openfda.generic_name.exact:"GLUTAMINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 63 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.