Safety Profile
Known Safety Concerns
- Limited long-term human safety data
- Interacts with antihypertensives
- Inhibits insulin secretion -- diabetic monitoring required
- NMDA receptor modulation -- neurological interactions
Contraindications
- Limited long-term human safety data
- Interacts with antihypertensives
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Agmatine is an endogenous neuromodulator produced by decarboxylation of arginine. Used in sports supplements for vasodilation. Interacts with NMDA receptors and imidazoline receptors. Limited human safety data.
Biological and Chemical Classification
- Scientific Name
- Agmatine sulfate (decarboxylated arginine)
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Metabolic
- Evidence consistency: High consistency across studies (100%)
- Limited long-term human safety data
- Interacts with antihypertensives
- Inhibits insulin secretion -- diabetic monitoring required
- NMDA receptor modulation -- neurological interactions
The available scientific evidence for Agmatine Sulfate indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 25 მარ 2026, 22:48
Evidence Distribution
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Observational / other LOW evidence YELLOWAgmatine augmentation in treatment-resistant obsessive-compulsive disorder: a prospective open-label case series. ↗Salvi JD. Agmatine augmentation in treatment-resistant obsessive-compulsive disorder: a prospective open-label case series.. Front Psychiatry. 2026. PMID:41717561.PMID 41717561 ↗Journal Front PsychiatryYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41717561/
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Observational / other LOW evidence YELLOWInjectable poloxamer-based thermogel as a delivery platform for agmatine and hyaluronic acid in muscle tissue engineering. ↗Qutub M et al.. Injectable poloxamer-based thermogel as a delivery platform for agmatine and hyaluronic acid in muscle tissue engineering.. Eur J Pharm Biopharm. 2026. PMID:41519311.PMID 41519311 ↗Journal Eur J Pharm BiopharmYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41519311/
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Observational / other LOW evidence YELLOWEvidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies. ↗Gilad VH et al.. Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies.. Toxicol Rep. 2024. PMID:39286406.PMID 39286406 ↗Journal Toxicol RepYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39286406/
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Observational / other LOW evidence YELLOWDisclosing Frauds in Herbal Food Supplements Labeling: A Simple LC-MS/MS Approach to Detect Alkaloids and Biogenic Amines. ↗Esposito G et al.. Disclosing Frauds in Herbal Food Supplements Labeling: A Simple LC-MS/MS Approach to Detect Alkaloids and Biogenic Amines.. J Food Prot. 2023. PMID:37640156.PMID 37640156 ↗Journal J Food ProtYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37640156/
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Observational / other LOW evidence YELLOWAnalysis of Regulatory Mechanism of AcrB and CpxR on Colistin Susceptibility Based on Transcriptome and Metabolome of Salmonella Typhimurium. ↗Zhai YJ et al.. Analysis of Regulatory Mechanism of AcrB and CpxR on Colistin Susceptibility Based on Transcriptome and Metabolome of Salmonella Typhimurium.. Microbiol Spectr. 2023. PMID:37358428.PMID 37358428 ↗Journal Microbiol SpectrYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37358428/
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Observational / other LOW evidence YELLOWAgmatine Administration Effects on Equine Gastric Ulceration and Lameness. ↗Taguchi T et al.. Agmatine Administration Effects on Equine Gastric Ulceration and Lameness.. J Clin Med. 2022. PMID:36555900.PMID 36555900 ↗Journal J Clin MedYear 2022Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/36555900/
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Observational / other LOW evidence YELLOWEvidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study. ↗Rosenberg ML et al.. Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study.. Nutrients. 2020. PMID:32102167.PMID 32102167 ↗Journal NutrientsYear 2020Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/32102167/
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Observational / other LOW evidence YELLOWSafety and neurochemical profiles of acute and sub-chronic oral treatment with agmatine sulfate. ↗Bergin DH et al.. Safety and neurochemical profiles of acute and sub-chronic oral treatment with agmatine sulfate.. Sci Rep. 2019. PMID:31481723.PMID 31481723 ↗Journal Sci RepYear 2019Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/31481723/
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Observational / other LOW evidence YELLOWAgmatine for Pain Management in Dogs With Coxofemoral Joint Osteoarthritis: A Pilot Study. ↗Taguchi T et al.. Agmatine for Pain Management in Dogs With Coxofemoral Joint Osteoarthritis: A Pilot Study.. Front Vet Sci. 2018. PMID:30631768.PMID 30631768 ↗Journal Front Vet SciYear 2018Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/30631768/
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Observational / other LOW evidence YELLOWEffect of Agmatine Sulfate on Modulation of Matrix Metalloproteinases via PI3K/Akt-1 in HT1080 Cells. ↗Kim H et al.. Effect of Agmatine Sulfate on Modulation of Matrix Metalloproteinases via PI3K/Akt-1 in HT1080 Cells.. Anticancer Res. 2017. PMID:29061813.PMID 29061813 ↗Journal Anticancer ResYear 2017Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/29061813/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Agmatine Sulfate. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a moderate safety concern. Caution is advised, particularly at high doses or in sensitive populations.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Moderate classification for Agmatine Sulfate
A score of 3.5 places this ingredient in the Moderate band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.