Safety Profile
Known Safety Concerns
- Bright yellow urine discoloration -- harmless but may alarm users
- No established UL -- oral toxicity not documented
- More expensive than standard riboflavin with limited additional benefit in most individuals
- May cause photosensitivity in very rare cases
Contraindications
- Bright yellow urine discoloration -- harmless but may alarm users
- No established UL -- oral toxicity not documented
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Riboflavin-5-phosphate (R5P) is the active coenzyme form of vitamin B2, already phosphorylated and ready for metabolic use without requiring hepatic conversion. It has higher bioavailability in certain individuals with impaired riboflavin conversion. Safety profile is identical to standard riboflavin — excellent with no established UL. Causes the same harmless bright yellow urine discoloration.
Biological and Chemical Classification
- Scientific Name
- Riboflavin-5-phosphate sodium
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
- 6 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Vitamin
- Evidence consistency: High consistency across studies (100%)
- Bright yellow urine discoloration -- harmless but may alarm users
- No established UL -- oral toxicity not documented
- More expensive than standard riboflavin with limited additional benefit in most individuals
- May cause photosensitivity in very rare cases
The available scientific evidence for Vitamin B2 (Riboflavin-5-Phosphate) 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 | 6/40 |
| Evidence consistency | 20/20 |
| Safety signals | 8/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 6 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 6 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
-
Observational / other LOW evidence YELLOWOptimizing riboflavin delivery with co-crystal and in situ hydrogel formulations for management of keratoconus: A comprehensive investigation with in vitro, ex vivo… ↗Aytekin E et al.. Optimizing riboflavin delivery with co-crystal and in situ hydrogel formulations for management of keratoconus: A comprehensive investigation with in vitro, ex vivo and in vivo studies.. Int J Pharm. 2025. PMID:40058739.PMID 40058739 ↗Journal Int J PharmYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40058739/
-
Observational / other LOW evidence YELLOWPolydeoxynucleotide-Loaded Visible Light Photo-Crosslinked Gelatin Methacrylate Hydrogel: Approach to Accelerating Cartilage Regeneration. ↗Park S et al.. Polydeoxynucleotide-Loaded Visible Light Photo-Crosslinked Gelatin Methacrylate Hydrogel: Approach to Accelerating Cartilage Regeneration.. Gels. 2025. PMID:39852013.PMID 39852013 ↗Journal GelsYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/39852013/
-
Observational / other LOW evidence YELLOWDevelopment of graphitic carbon nitride quantum dots-based oxygen self-sufficient platforms for enhanced corneal crosslinking. ↗Yang M et al.. Development of graphitic carbon nitride quantum dots-based oxygen self-sufficient platforms for enhanced corneal crosslinking.. Nat Commun. 2024. PMID:38951161.PMID 38951161 ↗Journal Nat CommunYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38951161/
-
Observational / other LOW evidence YELLOWRiboflavin alleviates fluoride-induced ferroptosis by IL-17A-independent system Xc(-)/GPX4 pathway and iron metabolism in testicular Leydig cells. ↗Li X et al.. Riboflavin alleviates fluoride-induced ferroptosis by IL-17A-independent system Xc(-)/GPX4 pathway and iron metabolism in testicular Leydig cells.. Environ Pollut. 2024. PMID:38199481.PMID 38199481 ↗Journal Environ PollutYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38199481/
-
Observational / other LOW evidence YELLOWDesign of ocular drug delivery platforms and in vitro - in vivo evaluation of riboflavin to the cornea by non-interventional (epi-on) technique… ↗Aytekin E et al.. Design of ocular drug delivery platforms and in vitro - in vivo evaluation of riboflavin to the cornea by non-interventional (epi-on) technique for keratoconus treatment.. J Control Release. 2020. PMID:32413453.PMID 32413453 ↗Journal J Control ReleaseYear 2020Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/32413453/
-
Observational / other LOW evidence YELLOWOn-line dynamic detection in the column chromatography separation based on an optical fiber surface plasmon resonance sensor. ↗Cao J et al.. On-line dynamic detection in the column chromatography separation based on an optical fiber surface plasmon resonance sensor.. Appl Opt. 2019. PMID:31503880.PMID 31503880 ↗Journal Appl OptYear 2019Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/31503880/
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 B2 (Riboflavin-5-Phosphate). 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 B2 (Riboflavin-5-Phosphate)
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.