Safety Profile
Known Safety Concerns
- No established UL for oral supplementation
- Very rare anaphylaxis documented with IV administration only
- No significant drug interactions at supplement doses
- Oral bioavailability is lower than fat-soluble benfotiamine form
Contraindications
- No established UL for oral supplementation
- Very rare anaphylaxis documented with IV administration only
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Thiamine hydrochloride is the most water-soluble form of vitamin B1 and the standard pharmaceutical grade used in clinical and nutritional applications. Excellent safety profile with no established UL. It is the active form used in intravenous Wernicke encephalopathy treatment. At oral supplement doses it is extremely safe.
Biological and Chemical Classification
- Scientific Name
- Thiamine hydrochloride
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: Vitamin
- Evidence consistency: High consistency across studies (100%)
- No established UL for oral supplementation
- Very rare anaphylaxis documented with IV administration only
- No significant drug interactions at supplement doses
- Oral bioavailability is lower than fat-soluble benfotiamine form
The available scientific evidence for Vitamin B1 (Thiamine Hydrochloride) 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: 24 მარ 2026, 07:56
Evidence Distribution
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Observational / other LOW evidence YELLOWAnalysis of the Use of Carrots, Cauliflower and Broccoli Waste Materials as a Matrix for Thiamine. ↗Szymandera-Buszka KE et al.. Analysis of the Use of Carrots, Cauliflower and Broccoli Waste Materials as a Matrix for Thiamine.. Foods. 2026. PMID:41829074.PMID 41829074 ↗Journal FoodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829074/
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Observational / other LOW evidence YELLOWHydroxocobalamin, thiamine, and pyridoxine as an adjunct to standard treatment in chronic low back pain: a randomized clinical trial. ↗Reyes-Alvarez MT et al.. Hydroxocobalamin, thiamine, and pyridoxine as an adjunct to standard treatment in chronic low back pain: a randomized clinical trial.. Med Clin (Barc). 2026. PMID:41604864.PMID 41604864 ↗Journal Med Clin (Barc)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41604864/
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Observational / other LOW evidence YELLOWClinical and Etiopathological Perspective of Vitamin B1 Hypersensitivity and an Example of a Desensitization Protocol. ↗Lis K. Clinical and Etiopathological Perspective of Vitamin B1 Hypersensitivity and an Example of a Desensitization Protocol.. Life (Basel). 2025. PMID:41598206.PMID 41598206 ↗Journal Life (Basel)Year 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41598206/
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Observational / other LOW evidence YELLOWSolid-Phase Removal of Vitamin B(1) (Thiamine Hydrochloride) from Aqueous Media Using Sugarcane (Saccharum officinarum) Bagasse as an Eco-friendly Biosorbent. ↗Ali S et al.. Solid-Phase Removal of Vitamin B(1) (Thiamine Hydrochloride) from Aqueous Media Using Sugarcane (Saccharum officinarum) Bagasse as an Eco-friendly Biosorbent.. ACS Omega. 2025. PMID:41487170.PMID 41487170 ↗Journal ACS OmegaYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41487170/
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Observational / other LOW evidence YELLOWLooking beyond Benzoin: Thiamine-Mediated Efficient Aroylation of Cyclic Vinamidinium Salt with Aldehydes. ↗Chauhan D et al.. Looking beyond Benzoin: Thiamine-Mediated Efficient Aroylation of Cyclic Vinamidinium Salt with Aldehydes.. J Org Chem. 2025. PMID:41181900.PMID 41181900 ↗Journal J Org ChemYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41181900/
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Observational / other LOW evidence YELLOWAssessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B(1)) for all animal species for the renewal of… ↗Villa RE et al.. Assessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B(1)) for all animal species for the renewal of their authorisation (Kaesler Nutrition GmbH).. EFSA J. 2025. PMID:40297191.PMID 40297191 ↗Journal EFSA JYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40297191/
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Observational / other LOW evidence YELLOWThiamine hydrochloride (VB(1)) in aqueous media catalyzed the synthesis of polysubstituted quinolines via a one-pot strategy: a combined experimental and theoretical investigation. ↗Hajipour M et al.. Thiamine hydrochloride (VB(1)) in aqueous media catalyzed the synthesis of polysubstituted quinolines via a one-pot strategy: a combined experimental and theoretical investigation.. RSC Adv. 2025. PMID:40275868.PMID 40275868 ↗Journal RSC AdvYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40275868/
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Observational / other LOW evidence YELLOWThiamine hydrochloride, riboflavin, pyridoxine hydrochloride, and biotin hard gelatin capsules prepared in advance and stored for the treatment of pediatric metabolic diseases:… ↗Bonino M et al.. Thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, and biotin hard gelatin capsules prepared in advance and stored for the treatment of pediatric metabolic diseases: a safer alternative.. PLoS One. 2025. PMID:40258084.PMID 40258084 ↗Journal PLoS OneYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40258084/
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Observational / other LOW evidence YELLOWAssessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B(1)) for all animal species for the renewal of… ↗Villa RE et al.. Assessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B(1)) for all animal species for the renewal of their authorisation (DSM Nutritional Products Ltd. and Orffa Additives BV).. EFSA J. 2025. PMID:40206139.PMID 40206139 ↗Journal EFSA JYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40206139/
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Observational / other LOW evidence YELLOWIn Vitro Mucoadhesive Features of Gliadin Nanoparticles Containing Thiamine Hydrochloride. ↗Voci S et al.. In Vitro Mucoadhesive Features of Gliadin Nanoparticles Containing Thiamine Hydrochloride.. Pharmaceutics. 2024. PMID:39458625.PMID 39458625 ↗Journal PharmaceuticsYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39458625/
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 Vitamin B1 (Thiamine Hydrochloride). 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 low safety concern under normal conditions of use.
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 Low classification for Vitamin B1 (Thiamine Hydrochloride)
A score of 1.5 places this ingredient in the Low 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.