Safety Profile
Known Safety Concerns
- Antiplatelet and anticoagulant effect -- interaction with warfarin
- Allergic reactions in pineapple or latex-allergic individuals
- Enhances amoxicillin and tetracycline absorption -- drug interaction
- GI irritation at high doses
Contraindications
- Antiplatelet and anticoagulant effect -- interaction with warfarin
- Allergic reactions in pineapple or latex-allergic individuals
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Bromelain is a proteolytic enzyme complex from pineapple used for inflammation, sinusitis, and sports recovery. Has evidence for modest anti-inflammatory effects. It has antiplatelet and anticoagulant properties — interaction with warfarin and NSAIDs. Allergic reactions occur in individuals allergic to pineapple, latex, or other proteolytic enzymes. May enhance absorption of some antibiotics.
Biological and Chemical Classification
- Scientific Name
- Bromelain (cysteine proteases from Ananas comosus)
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: Metabolic
- Evidence consistency: High consistency across studies (100%)
- Antiplatelet and anticoagulant effect -- interaction with warfarin
- Allergic reactions in pineapple or latex-allergic individuals
- Enhances amoxicillin and tetracycline absorption -- drug interaction
- GI irritation at high doses
The available scientific evidence for Bromelain 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, 09:13
Evidence Distribution
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Observational / other LOW evidence YELLOWEffect of whey protein hydrolysate isolation as a partial replacement of fetal bovine serum on proliferation and differentiation of Hanwoo primary muscle… ↗Lee SH et al.. Effect of whey protein hydrolysate isolation as a partial replacement of fetal bovine serum on proliferation and differentiation of Hanwoo primary muscle cells.. Food Sci Anim Resour. 2026. PMID:41849058.PMID 41849058 ↗Journal Food Sci Anim ResourYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41849058/
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Observational / other LOW evidence YELLOWComparative Effectiveness of Lidocaine- Versus Nifedipine-Based Multimodal Conservative Regimens for Acute Hemorrhoidal Disease: A Multicenter Cohort Study. ↗Schiano di Visconte M et al.. Comparative Effectiveness of Lidocaine- Versus Nifedipine-Based Multimodal Conservative Regimens for Acute Hemorrhoidal Disease: A Multicenter Cohort Study.. J Clin Gastroenterol. 2026. PMID:41837899.PMID 41837899 ↗Journal J Clin GastroenterolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41837899/
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Observational / other LOW evidence YELLOWOptimization, Characterization and Antioxidant Activity of Fish Protein Hydrolysate from Payangka (Ophieleotris aporos) using Papain and Bromelain. ↗Fatimah F et al.. Optimization, Characterization and Antioxidant Activity of Fish Protein Hydrolysate from Payangka (Ophieleotris aporos) using Papain and Bromelain.. Pak J Biol Sci. 2026. PMID:41804243.PMID 41804243 ↗Journal Pak J Biol SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41804243/
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Observational / other LOW evidence YELLOWA magnetic multi-enzyme nanoplatform for high-purity collagen preparation through efficient contaminant protein elimination. ↗Zeng Z et al.. A magnetic multi-enzyme nanoplatform for high-purity collagen preparation through efficient contaminant protein elimination.. J Mater Chem B. 2026. PMID:41778866.PMID 41778866 ↗Journal J Mater Chem BYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41778866/
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Observational / other LOW evidence YELLOWTurning Agricultural Waste Into Enzymatic Treasure: Bromelain Stability in Pineapple Crown and Peel Waste From Subang District, Indonesia. ↗Saptarini NM et al.. Turning Agricultural Waste Into Enzymatic Treasure: Bromelain Stability in Pineapple Crown and Peel Waste From Subang District, Indonesia.. Biochem Res Int. 2026. PMID:41768423.PMID 41768423 ↗Journal Biochem Res IntYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41768423/
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Observational / other LOW evidence YELLOWManagement of mild hand-foot syndrome associated with medical cancer therapies with an alcohol-free moisturizing and reparative gel containing omental lipids, urea, bromelain,… ↗Fattore D et al.. Management of mild hand-foot syndrome associated with medical cancer therapies with an alcohol-free moisturizing and reparative gel containing omental lipids, urea, bromelain, and carnosine: a pilot prospective 12-week study.. Dermatol Reports. 2026. PMID:41755647.PMID 41755647 ↗Journal Dermatol ReportsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41755647/
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Observational / other LOW evidence YELLOWElectrospun nanofibrous scaffolds from waste-derived collagen and cellulose acetate for enhanced wound healing. ↗Munmun SA et al.. Electrospun nanofibrous scaffolds from waste-derived collagen and cellulose acetate for enhanced wound healing.. Int J Biol Macromol. 2026. PMID:41747977.PMID 41747977 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41747977/
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Observational / other LOW evidence YELLOWIdentification of an Anti-inflammatory Peptide from Walnut (Juglans sigillata) Protein and the Effect on DSS-Induced Colitis in Mice. ↗Huan P et al.. Identification of an Anti-inflammatory Peptide from Walnut (Juglans sigillata) Protein and the Effect on DSS-Induced Colitis in Mice.. J Agric Food Chem. 2026. PMID:41741372.PMID 41741372 ↗Journal J Agric Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41741372/
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Observational / other LOW evidence YELLOWEnvironmental Mycotoxins and Brain Health: Protective Role of Bromelain Against Fumonisin B1 in SH-SY5Y Cells. ↗Franco GA et al.. Environmental Mycotoxins and Brain Health: Protective Role of Bromelain Against Fumonisin B1 in SH-SY5Y Cells.. Environ Toxicol. 2026. PMID:41736493.PMID 41736493 ↗Journal Environ ToxicolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41736493/
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Observational / other LOW evidence YELLOWImpact of Plant and Microbial Proteases Treatment on Quality Characteristics of Beef Longissimus Thoracis and Lumborum. ↗Akkaya E et al.. Impact of Plant and Microbial Proteases Treatment on Quality Characteristics of Beef Longissimus Thoracis and Lumborum.. Food Sci Anim Resour. 2025. PMID:41821536.PMID 41821536 ↗Journal Food Sci Anim ResourYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41821536/
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 Bromelain. 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 Bromelain
A score of 3.0 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.