Safety Profile
Known Safety Concerns
- Banned by FDA as dietary supplement ingredient since 2004
- Linked to over 155 deaths, heart attacks and strokes
- Severe hypertension and cardiac arrhythmias
- High addiction potential
Contraindications
- Banned by FDA as dietary supplement ingredient since 2004
- Linked to over 155 deaths, heart attacks and strokes
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Ephedra alkaloids were used in weight-loss supplements until the FDA banned them in 2004 following over 155 deaths and thousands of adverse events including heart attacks, strokes, and seizures. Ephedra-containing dietary supplements remain prohibited in the United States.
Biological and Chemical Classification
- Scientific Name
- Ephedra sinica
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: Stimulant
- Evidence consistency: High consistency across studies (100%)
- Banned by FDA as dietary supplement ingredient since 2004
- Linked to over 155 deaths, heart attacks and strokes
- Severe hypertension and cardiac arrhythmias
- High addiction potential
- USA — FDA — Banned
- EU — EC — Banned
- Canada — Health Canada — Banned
The available scientific evidence for Ephedra 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: 06 მარ 2026, 12:01
Evidence Distribution
-
Observational / other LOW evidence YELLOWAn Integrative Workflow Combining Machine Learning and GNPS to Identify Key Anti-Inflammatory Constituents in Honey-Processed Ephedrae Herba (Ephedra sinica Stapf). ↗Li H et al.. An Integrative Workflow Combining Machine Learning and GNPS to Identify Key Anti-Inflammatory Constituents in Honey-Processed Ephedrae Herba (Ephedra sinica Stapf).. Chem Biodivers. 2026. PMID:41779427.PMID 41779427 ↗Journal Chem BiodiversYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41779427/
-
Observational / other LOW evidence YELLOWThe characteristics of metabolites accumulation and their connections with endophytic fungi in roots and stems of Ephedra sinica with different cultivation ages. ↗Wang SS et al.. The characteristics of metabolites accumulation and their connections with endophytic fungi in roots and stems of Ephedra sinica with different cultivation ages.. Fungal Biol. 2026. PMID:41765619.PMID 41765619 ↗Journal Fungal BiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41765619/
-
Observational / other LOW evidence YELLOWTransforming Growth Factor Beta/Smad3/GATA3 Axis Mediates the Therapeutic Effect of Ephedra sinica Stapf Polysaccharide in Allergic Rhinitis. ↗Zhang J et al.. Transforming Growth Factor Beta/Smad3/GATA3 Axis Mediates the Therapeutic Effect of Ephedra sinica Stapf Polysaccharide in Allergic Rhinitis.. J Leukoc Biol. 2026. PMID:41739850.PMID 41739850 ↗Journal J Leukoc BiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41739850/
-
Observational / other LOW evidence YELLOWA reverse network pharmacology and bioinformatics-based approach to exploring medication patterns for polycystic ovary syndrome-related infertility. ↗Wang Y et al.. A reverse network pharmacology and bioinformatics-based approach to exploring medication patterns for polycystic ovary syndrome-related infertility.. Front Med (Lausanne). 2025. PMID:41267865.PMID 41267865 ↗Journal Front Med (Lausanne)Year 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41267865/
-
Observational / other LOW evidence YELLOWComprehensive chemical analysis of polyphenols in the ethyl acetate extract from the roots of Ephedra sinica Stapf and evaluation of its therapeutic… ↗Lv M et al.. Comprehensive chemical analysis of polyphenols in the ethyl acetate extract from the roots of Ephedra sinica Stapf and evaluation of its therapeutic effects on SU5416/hypoxia-induced pulmonary arterial hypertension rats.. Bioresour Bioprocess. 2025. PMID:41160277.PMID 41160277 ↗Journal Bioresour BioprocessYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41160277/
-
Observational / other LOW evidence YELLOWNew 2,3-Methylenedioxy-naphthalene Derivatives With Neuroprotective Activity From the Roots of Ephedra sinica Stapf. ↗Zhang BW et al.. New 2,3-Methylenedioxy-naphthalene Derivatives With Neuroprotective Activity From the Roots of Ephedra sinica Stapf.. Chem Biodivers. 2025. PMID:40991575.PMID 40991575 ↗Journal Chem BiodiversYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40991575/
-
Observational / other LOW evidence YELLOWMulti-level association rule mining and network pharmacology to identify the polypharmacological effects of herbal materials and compounds in traditional medicine. ↗Yu H et al.. Multi-level association rule mining and network pharmacology to identify the polypharmacological effects of herbal materials and compounds in traditional medicine.. Brief Bioinform. 2025. PMID:40622480.PMID 40622480 ↗Journal Brief BioinformYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40622480/
-
Observational / other LOW evidence YELLOWScreening and identification of the H1R antagonists from natural products by BODIPY FL histamine recognition and DPHD-anchored bombardment coupled with target cell… ↗Li X et al.. Screening and identification of the H1R antagonists from natural products by BODIPY FL histamine recognition and DPHD-anchored bombardment coupled with target cell extraction.. Front Pharmacol. 2025. PMID:40520177.PMID 40520177 ↗Journal Front PharmacolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40520177/
-
Animal study LOW evidence YELLOWAnti-obesity potential of selected medicinal plants: A focused study on in vitro inhibitory effects on lipase, u03b1-amylase and u03b1-glucosidase enzymes. ↗Zarei N et al.. Anti-obesity potential of selected medicinal plants: A focused study on in vitro inhibitory effects on lipase, u03b1-amylase and u03b1-glucosidase enzymes.. J Ethnopharmacol. 2025. PMID:40228587.PMID 40228587 ↗Journal J EthnopharmacolYear 2025Study type Animal studyEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40228587/
-
Observational / other LOW evidence YELLOWMaterial basis and mechanism of Ephedra sinica in interfering with wind-chill cold. ↗Wu Y et al.. Material basis and mechanism of Ephedra sinica in interfering with wind-chill cold.. Int Immunopharmacol. 2025. PMID:40058103.PMID 40058103 ↗Journal Int ImmunopharmacolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40058103/
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 Ephedra. 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 critical safety concern. Regulatory restrictions or bans are in place in multiple jurisdictions.
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 Critical classification for Ephedra
A score of 9.0 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.
7 jurisdictions have active restrictions or advisories. Regulatory signals are recorded as Safety Signals and raise the S component.
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.