DO NOT USE — This ingredient is banned, prohibited, or linked to serious harm

This substance is prohibited in dietary supplements in one or more major jurisdictions, has been withdrawn from the market, or is an unapproved drug. Do not consume without direct supervision from a qualified medical professional.

Global Ingredient Risk Index

Tianeptine

Tianeptine sodium / sulfate

Also known as: Neptune's Fix, ZaZa Red, Tianna, TD Red

23 მარ 2026

CRITICAL RISK 9.5/10 How?

This ingredient is classified as unclassified risk (GIRI score: 9.5/10).

Known Safety Concerns

Unapproved drug — marketed illegally as a supplement in the US
Opioid-like dependence and severe withdrawal syndrome
Fatal overdoses documented — often combined with other substances
Banned in Alabama, Georgia, Indiana, Michigan, Minnesota, Mississippi, Ohio, and others
FDA import alert and safety warnings issued

Contraindications

Unapproved drug — marketed illegally as a supplement in the US
Opioid-like dependence and severe withdrawal syndrome

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Information not yet available for this ingredient profile.

Tianeptine is an atypical antidepressant with opioid agonist activity at mu-opioid receptors, marketed in the US as a dietary supplement despite being unapproved as a drug. At high doses it produces opioid-like euphoria, rapid tolerance, severe physical dependence, and a withdrawal syndrome indistinguishable from opioid withdrawal. Multiple US states have banned it. The FDA has issued warnings and import alerts. Overdose fatalities have been documented.

Scientific Name: Tianeptine sodium / sulfate

Information not yet available for this ingredient profile.

SETI Score 50/100

Risk Level High risk

Scientific Confidence Low

Evidence Strength Limited

Key Safety Concern Unapproved drug — marketed illegally as a supplement in the US

Evidence Reviewed 10 PubMed studies

Scientific Confidence Low

Based on study quality, consistency, and recency

Executive Summary — Ingredient Assessment

SETI Score 50/100

Risk Level High risk

Evidence Strength Limited

Main Safety Concern Unapproved drug — marketed illegally as a supplement in the US

Ingredient Tianeptine

Scientific name Tianeptine sodium / sulfate

Scientific Evidence Overview

10 studies reviewed
0 high-quality studies (meta-analysis or RCT)
Evidence consistency: High consistency across studies (100%)

Safety Signals

Unapproved drug — marketed illegally as a supplement in the US
Opioid-like dependence and severe withdrawal syndrome
Fatal overdoses documented — often combined with other substances
Banned in Alabama, Georgia, Indiana, Michigan, Minnesota, Mississippi, Ohio, and others
FDA import alert and safety warnings issued

Evidence Strength Limited

Final Scientific Assessment

The available scientific evidence for Tianeptine indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.

Ingredient Tianeptine

Evidence reviewed 10 peer-reviewed studies (last 10 years)

Scientific name Tianeptine sodium / sulfate

50 /100

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: 23 მარ 2026, 14:49

Evidence Distribution

10 Other / unclassified

Observational / other LOW evidence YELLOW
Improving Cognition in Bipolar Disorder: A Systematic Review of Current Pharmacological and Nutraceutical Approaches. ↗

PMID 41843701 ↗

Journal Neuropsychobiology

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41843701/

Yalin N et al.. Improving Cognition in Bipolar Disorder: A Systematic Review of Current Pharmacological and Nutraceutical Approaches.. Neuropsychobiology. 2026. PMID:41843701.
Observational / other LOW evidence YELLOW
Differential inhibition of the diverse behavioural effects of mu-opioid receptor agonists by progressive receptor depletion. ↗

PMID 41796936 ↗

Journal Neuropharmacology

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41796936/

Brown L et al.. Differential inhibition of the diverse behavioural effects of mu-opioid receptor agonists by progressive receptor depletion.. Neuropharmacology. 2026. PMID:41796936.
Observational / other LOW evidence YELLOW
u03bc Opioid Modulation of Sensorimotor Functional Connectivity in Autism: Insights From a Pharmacological Neuroimaging Investigation Using Tianeptine. ↗

PMID 41630828 ↗

Journal Biol Psychiatry Glob Open Sci

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41630828/

Dimitrov M et al.. u03bc Opioid Modulation of Sensorimotor Functional Connectivity in Autism: Insights From a Pharmacological Neuroimaging Investigation Using Tianeptine.. Biol Psychiatry Glob Open Sci. 2026. PMID:41630828.
Observational / other LOW evidence YELLOW
Prediction of 12-Week Remission in Patients With Depressive Disorder Using Reasoning-Based Large Language Models: Model Development and Validation Study. ↗

PMID 41576265 ↗

Journal JMIR Ment Health

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41576265/

Park JH et al.. Prediction of 12-Week Remission in Patients With Depressive Disorder Using Reasoning-Based Large Language Models: Model Development and Validation Study.. JMIR Ment Health. 2026. PMID:41576265.
Observational / other LOW evidence YELLOW
Emerging Substances and Perinatal Health: A Narrative Review. ↗

PMID 41166713 ↗

Journal Obstet Gynecol

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41166713/

Jones CW et al.. Emerging Substances and Perinatal Health: A Narrative Review.. Obstet Gynecol. 2026. PMID:41166713.
Observational / other LOW evidence YELLOW
Targeting Cend1-Atp5f1b interaction rescues mitochondrial dysfunction and ameliorates ischemic brain injury. ↗

PMID 41469760 ↗

Journal Commun Biol

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41469760/

Li H et al.. Targeting Cend1-Atp5f1b interaction rescues mitochondrial dysfunction and ameliorates ischemic brain injury.. Commun Biol. 2025. PMID:41469760.
Observational / other LOW evidence YELLOW
Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols. ↗

PMID 41376187 ↗

Journal Brain Behav

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41376187/

Park HY et al.. Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols.. Brain Behav. 2025. PMID:41376187.
Observational / other LOW evidence YELLOW
Gas station heroin- tianeptine and its impact: a systematic review and exploratory analysis. ↗

PMID 41136982 ↗

Journal BMC Public Health

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41136982/

Parnia S et al.. Gas station heroin- tianeptine and its impact: a systematic review and exploratory analysis.. BMC Public Health. 2025. PMID:41136982.
Observational / other LOW evidence YELLOW
Gas Station Heroin: A Case Report of Tianeptine Use Disorder and a Literature Review. ↗

PMID 41132482 ↗

Journal Cureus

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41132482/

Kandra K et al.. Gas Station Heroin: A Case Report of Tianeptine Use Disorder and a Literature Review.. Cureus. 2025. PMID:41132482.
Observational / other LOW evidence YELLOW
Concomitant Tianeptine and Alcohol Use Disorders: Diagnosis and Treatment with Buprenorphine-Naloxone. ↗

PMID 41127130 ↗

Journal Kans J Med

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41127130/

Krause Q et al.. Concomitant Tianeptine and Alcohol Use Disorders: Diagnosis and Treatment with Buprenorphine-Naloxone.. Kans J Med. 2025. PMID:41127130.

Q × L × D × S × 10 = 9.5 / 10

The GIRI Score is the product of four independently computed evidence components, each normalised to 0–1, then scaled to 0–10. Every component is derived exclusively from peer-reviewed references and regulatory data — no editorial judgement is applied.

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)

50%

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.

Benefit

Risk

50%

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.

50%

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.

0Q × 5L × 5D × 5S = 9.5 / 10

Final GIRI Score for Tianeptine. 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.

CRITICAL RISK 9.5/10

Based on available regulatory signals and scientific evidence, this ingredient presents a critical safety concern. Regulatory restrictions or bans are in place in multiple jurisdictions.

LOW
0–3.0

MODERATE
3.0–5.5

HIGH
5.5–7.5

CRITICAL
7.5–10

9.5

The score pin shows exactly where this ingredient falls on the fixed risk scale.

What drove the Critical classification for Tianeptine

A score of 9.5 places this ingredient in the Critical 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.

← Back to Ingredient Database

Tianeptine

Safety Profile

Known Safety Concerns

Contraindications

Interactions

Evidence and Scientific Findings

Ingredient Overview

Biological and Chemical Classification

Mechanism of Action

Clinical Evidence of Effectiveness

Pharmacokinetics

Recommended Dosage

SETI — Scientific Evidence Transparency Index

Executive Summary — Ingredient Assessment

Evidence Summary

Evidence Policy

Evidence Distribution

Score Transparency

Risk Level Classification

What drove the Critical classification for Tianeptine

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