Safety Profile
Information not yet available for this ingredient profile.
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Graviola (soursop) leaf extract is marketed for immune support and has been studied in cancer research. However, it contains annonacin, a neurotoxin associated with an atypical form of Parkinson’s disease (atypical parkinsonism) in populations with high soursop consumption. Annonacin accumulates in the brain and may damage dopaminergic neurons. The risk of neurological harm is the primary safety concern. It may also cause hypotension and interact with antihypertensive medications. Use is strongly discouraged without medical guidance.
Biological and Chemical Classification
- Scientific Name
- Annona muricata
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: Botanical
- Evidence consistency: High consistency across studies (100%)
- No significant safety signals identified in the reviewed literature.
The available scientific evidence for Graviola Leaf Extract 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: 26 მარ 2026, 14:21
Evidence Distribution
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Observational / other LOW evidence YELLOWDevelopment of Polyphenol-Rich Extract from Annona muricata L. Leaves and Its Application in Acne-Reducing Gels. ↗Thy LTM et al.. Development of Polyphenol-Rich Extract from Annona muricata L. Leaves and Its Application in Acne-Reducing Gels.. Chem Biodivers. 2026. PMID:41852103.PMID 41852103 ↗Journal Chem BiodiversYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41852103/
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Observational / other LOW evidence YELLOWMoisture absorption isotherm of soursop tea (Annona muricata L.) and kinetic models of moisture absorption, color changes, degradation of bioactive compounds and… ↗Vu ND et al.. Moisture absorption isotherm of soursop tea (Annona muricata L.) and kinetic models of moisture absorption, color changes, degradation of bioactive compounds and antioxidant activities under storage conditions.. Food Chem. 2026. PMID:41850101.PMID 41850101 ↗Journal Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41850101/
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Observational / other LOW evidence YELLOWBioactive Natural Products Targeting Androgen Receptor Signaling in Prostate Cancer: A Systematic Review. ↗Pratama F et al.. Bioactive Natural Products Targeting Androgen Receptor Signaling in Prostate Cancer: A Systematic Review.. Cancers (Basel). 2026. PMID:41827723.PMID 41827723 ↗Journal Cancers (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41827723/
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Observational / other LOW evidence YELLOWEffects of graviola oil extract on fattening performance and circadian rhythms of adipokine, cardiac and mitochondrial function markers in lambs. ↗Kotan GC et al.. Effects of graviola oil extract on fattening performance and circadian rhythms of adipokine, cardiac and mitochondrial function markers in lambs.. BMC Vet Res. 2026. PMID:41803858.PMID 41803858 ↗Journal BMC Vet ResYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41803858/
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Observational / other LOW evidence YELLOWSynergistic Anticancer Activity of Annona muricata Leaf Extract and Cisplatin in 4T1 Triple-Negative Breast Cancer Cells. ↗Kouki O et al.. Synergistic Anticancer Activity of Annona muricata Leaf Extract and Cisplatin in 4T1 Triple-Negative Breast Cancer Cells.. Cells. 2026. PMID:41677580.PMID 41677580 ↗Journal CellsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41677580/
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Observational / other LOW evidence YELLOWComputer-Aided Identification and Molecular Interaction Analyses of Annona muricata Acetogenins Against LuxS. ↗Adewusi T et al.. Computer-Aided Identification and Molecular Interaction Analyses of Annona muricata Acetogenins Against LuxS.. Biotechnol Appl Biochem. 2026. PMID:41618984.PMID 41618984 ↗Journal Biotechnol Appl BiochemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41618984/
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Observational / other LOW evidence YELLOWTherapeutic efficacy of Annona muricata in counteracting nephrolithiasis-induced electrolyte imbalance and antioxidant disruption in ethylene glycol-treated rats. ↗Rahman SA et al.. Therapeutic efficacy of Annona muricata in counteracting nephrolithiasis-induced electrolyte imbalance and antioxidant disruption in ethylene glycol-treated rats.. Sci Rep. 2026. PMID:41530387.PMID 41530387 ↗Journal Sci RepYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41530387/
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Observational / other LOW evidence YELLOWPhenolic Profile and Bioactive Prospects of Wild Annona Species From Angola. ↗Rangel J et al.. Phenolic Profile and Bioactive Prospects of Wild Annona Species From Angola.. Chem Biodivers. 2026. PMID:41370287.PMID 41370287 ↗Journal Chem BiodiversYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41370287/
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Observational / other LOW evidence YELLOWComparative analysis of four different solvent extracts of Annona muricata bark based on bioactive compounds and antibacterial effectiveness. ↗Dey SS et al.. Comparative analysis of four different solvent extracts of Annona muricata bark based on bioactive compounds and antibacterial effectiveness.. Heliyon. 2025. PMID:41477502.PMID 41477502 ↗Journal HeliyonYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41477502/
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Observational / other LOW evidence YELLOWExploring the anticancer potential of traditional herbs from Tamil Nadu: a narrative review of ethnomedicinal insights and scientific evidence. ↗Nair PMK et al.. Exploring the anticancer potential of traditional herbs from Tamil Nadu: a narrative review of ethnomedicinal insights and scientific evidence.. Front Immunol. 2025. PMID:41346617.PMID 41346617 ↗Journal Front ImmunolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41346617/
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 Graviola Leaf Extract. 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 high safety concern. Its use in dietary supplements is associated with documented adverse events.
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 High classification for Graviola Leaf Extract
A score of 6.5 places this ingredient in the High 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.