✓ No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
⚠ Patient using unverified/raw shilajit — heavy metal poisoning risk (lead, arsenic) [1]
⚠ Patient taking iron supplements + shilajit — iron overload risk [1]
⚠ Patient expecting testosterone results without using purified product — quality is everything [2]
⚠ Product without third-party heavy metal COA — reject [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
Recommended test
Heavy metals (if product quality uncertain)
Heavy metals (if product quality uncertain)
Reference range / target
Below regulatory limits
Below regulatory limits
Lead and arsenic are the most common contaminants [1].
Full lab monitoring ↓⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Shilajit has 1 solid RCT for testosterone (+20% in healthy men, PrimaVie® 500 mg/day × 90 days). Fulvic acid is the primary active. The CRITICAL clinical issue: heavy metal contamination is endemic in unregulated products — FDA and Health Canada have issued warnings. ONLY purified, third-party-tested products (PrimaVie® standard). Raw shilajit = heavy metal risk [1] [2].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Avoid. Heavy metal contamination risk. Insufficient safety data [1].
👦 Pediatric: See guidance
Not recommended for children. No pediatric data [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: Morning, in warm milk or water (traditional) [1].
💊 With food: Traditional: with warm milk and honey [1].
🚫 Avoid: Raw/untested shilajit. Combination with iron supplements without monitoring. During pregnancy [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['Purified shilajit resin', 'preferred', 'Heat-purified to remove contaminants. Tar-like consistency. Pea-sized portion (300–500 mg) dissolved in warm water or milk [1].'] | Standard | Check label | |
| ['Purified shilajit capsules (standardized to fulvic acid)', 'convenient', '200–500 mg/day. Standardized to ≥50% fulvic acid. PrimaVie® used in clinical research [1].'] | Standard | Check label | |
| ['Raw/unprocessed shilajit', 'dangerous', 'May contain heavy metals (lead, arsenic, mercury), mycotoxins, and pathogens. NEVER use unprocessed shilajit [1].', 'red'] | Standard | Check label |
3 Common questions
Is shilajit safe? ▼
ONLY when properly purified and tested. Raw/unprocessed shilajit from unverified sources frequently contains dangerous levels of lead, arsenic, mercury, and mycotoxins. FDA has issued warnings about shilajit products with heavy metal contamination. Use only purified products from reputable manufacturers with third-party heavy metal testing [1].
Does shilajit really increase testosterone? ▼
One well-designed RCT (n=96) found purified shilajit (PrimaVie® 500 mg/day × 90 days) increased total testosterone by ~20% in healthy men aged 45–55. This is promising but is a single study. The mechanism is thought to involve enhanced mitochondrial function supporting Leydig cell steroidogenesis [2].
What is fulvic acid? ▼
Fulvic acid is a complex organic compound formed during humus decomposition. It is an excellent mineral chelator, making trace minerals more bioavailable. It also has antioxidant, anti-inflammatory, and mitochondrial-supporting properties. Fulvic acid constitutes 60–80% of purified shilajit [1].
How do I know if my shilajit is safe? ▼
Look for: (1) 'purified' or 'processed' on label; (2) third-party Certificate of Analysis for heavy metals (Pb, As, Hg, Cd); (3) standardized fulvic acid content (≥50%); (4) reputable brand (PrimaVie® is the clinical research standard). NEVER buy raw shilajit tar from unverified sources [1].
4 Clinical evidence
Strong
No Cochrane or large RCTs [1]. HIGH
Moderate
Testosterone: 1 RCT (n=96, healthy men 45–55 years) found PrimaVie® 250 mg BID × 90 days significantly increased total testosterone (+20.45%), free testosterone (+19.14%), and DHEA-S vs placebo [2]. Sperm quality: same trial showed improved sperm count and motility [2]. Mitochondrial function: fulvic acid and dibenzo-α-pyrones enhanced CoQ10-dependent mitochondrial respiration in cell studies and 1 small human trial (improved exercise performance) [1]. Chronic fatigue: 1 small RCT suggested benefit [1]. MODERATE
Insufficient
Alzheimer's: fulvic acid inhibited tau aggregation in vitro; no human trials [1]. Anti-aging: Rasayana reputation; no lifespan/aging RCTs [1]. Iron deficiency anemia: traditional use + high mineral content; 1 pilot study [1]. Diabetes: animal studies only [1]. Altitude sickness: traditional use by Sherpas; no clinical evidence [1]. LOW
5 Safety, toxicity & adverse events
Absolute contraindications
✕ Iron-overload disorders (hemochromatosis) — shilajit is iron-rich
Relative
⚠ Heavy-metal contamination is a documented risk — use only purified, tested products
⚠ Hormone-sensitive conditions — possible testosterone effect
⚠ Diabetes/antihypertensives — additive effects
🚩 Red flags
● Patient using raw/unverified shilajit — immediate heavy metal testing recommended [1]
● Patient on iron supplements adding shilajit — monitor ferritin [1]
● Product without heavy metal COA — reject [1]
6 Interactions
Drug interactions
Iron supplements Moderate
Mechanism: Shilajit contains iron and fulvic acid enhances mineral absorption [1].
Effect: Potential iron overload [1].
Action: Monitor serum ferritin. Avoid combining in non-anemic individuals [1].
Supplement synergies
Ashwagandha · 300 mg each, standardized
Classic Ayurvedic combination for male vitality. Both are Rasayanas with testosterone-supporting evidence [1].
Classic Ayurvedic combination for male vitality. Both are Rasayanas with testosterone-supporting evidence [1].
Coenzyme Q10 · 200 mg CoQ10 + 300 mg shilajit
Both support mitochondrial function through different mechanisms [1].
Both support mitochondrial function through different mechanisms [1].
7 Regulatory
India (Ayush): Traditional Ayurvedic medicine. Listed in Ayurvedic Pharmacopoeia. Must meet purification standards [1].
United States (FDA): Available as dietary supplement. FDA has warned about shilajit products contaminated with heavy metals and elevated levels of lead [1].
Canada (Health Canada): Some shilajit products recalled for heavy metal contamination [1].
8 US supplement products
36
on-market products containing Shilajit (NIH DSLD)
Brands carrying Shilajit (19)
Click a brand to see its Shilajit products.
9 Frequently paired with
10 References (4)
[1]Pandit S, et al. Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers. Andrologia. 2016;48(5):570-575. doi:10.1111/and.12482 REVIEW Accessed: 2026-05-29
[2]Carrasco-Gallardo C, et al. Shilajit: a natural phytocomplex with potential procognitive activity. Int J Alzheimers Dis. 2012;2012:674142. doi:10.1155/2012/674142 REVIEW Accessed: 2026-05-29
[3]Stohs SJ. Safety and efficacy of shilajit (mumie, moomiyo). Phytother Res. 2014;28(4):475-479. doi:10.1002/ptr.5018 REVIEW Accessed: 2026-05-29
[4]Agarwal SP, et al. Shilajit: a review. Phytother Res. 2007;21(5):401-405. doi:10.1002/ptr.2100 REVIEW Accessed: 2026-05-29
11 Related articles
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12 Cite this page
Vancouver: Pkhakadze G. Shilajit — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Jun 02]. Available from: https://supplement.ge/ingredients/shilajit/
APA 7th: Pkhakadze, G. (2026). Shilajit — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/shilajit/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: December 2026
References: 4 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Shilajit — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/shilajit/ CC BY 4.0.
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Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG