Risk assessment for coenzyme Q10 (Ubiquinone)
Abstract
Coenzyme Q10 (CoQ10) widely occurs in organisms and tissues, and is produced and used as both a drug and dietary supplement. Increasing evidence of health benefits of orally administered CoQ10 are leading to daily consumption in larger amounts, and this increase justifies research and risk assessment to evaluate the safety. A large number of clinical trials have been conducted using a range of CoQ10 doses. Reports of nausea and other adverse gastrointestinal effects of CoQ10 cannot be causally related to the active ingredient because there is no dose-response relationship: the adverse effects are no more common at daily intakes of 1200 mg than at a 60 mg. Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 1200 mg/day, and this level is identified as the OSL. Much higher levels have been tested without adverse effects and may be safe, but the data for intakes above 1200 mg/day are not sufficient for a confident conclusion of safety.
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Some concerns result from the randomisation process in two studies because allocation is claimed to be random but is not described in detail.
“Some concerns result from the randomisation process in two studies, as the allocation of participants is claimed to be random but is not described in detail.(33,42)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
Two trials do not report medication intake.
“While one trial did not exclude respective patients but reports the intake of pain medication as part of the study characteristics,(43) two other trials do not report medication intake.(33,42)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
All selected trials investigate the impact of daily oral CoQ10 supplementation on muscle pain under statin therapy.
“All selected trials investigate the impact of a daily oral CoQ10 supplementation on muscle pain under statin therapy.(33,34,39–43)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
Because medication intake was investigated in only four studies, effects of the intervention on the intensity of muscle pain might be underestimated in the remaining trials.
“As medication intake was only investigated in four studies,(34,39–41) effects of the intervention on the intensity of muscle pain might be underestimated in the remaining trials.(33,42,43)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
CoQ10 supplementation is generally considered safe with no remarkable side effects even up to high doses of 1200 mg/d.
“A CoQ10 supplementation is generally considered safe with no remarkable side effects even up to high doses of 1200 mg/d, thus a supplementation of CoQ10 could be used to prevent a CoQ10 deficiency especially additionally to statin treatment.(59)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [59]
Additional supplementation with n-3 FA and selenium in the studies of Tóth et al. and Fedacko et al. may have influenced the results.
“Despite strict inclusion criteria, additional supplementation with n-3 FA and selenium in the studies of Tóth et al.(33) and Fedacko et al.,(42) respectively, may have influenced the results.(33,42)”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
Inclusion of patients with and without SAMS in some studies may have contributed to underestimation of the effectiveness of CoQ10 supplementation in this meta-analysis.
“The fact that some studies included patients with and without SAMS(33,39,40) could further have contributed to underestimation of the effectiveness of CoQ10 supplementation in this meta-analysis.”
From Effects of coenzyme Q10 supplementation on myopathy in statin-treated patients: a systematic review and meta-analysis (2025) · cites this paper as [33]
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KATERE SO PRILAGODITVENE REAKCIJE NA TELESNO
Eiken, O. (2008)
- Authors
- Hathcock, J. N., & Shao, A.
- Corresponding author
- Hathcock, John N.
- ORCID
- Shao, Andrew
- Venue
- Regulatory Toxicology and Pharmacology
- Publisher
- Elsevier BV
- Published
- 2006-08
- Volume
- 45
- Issue
- 3
- Pages
- 282-288
- ISSN
- 0273-2300 (ISSN-L)
- OpenAlex
- W2097278486
- Cited by
- 114
- References
- 91
- Citations by year
- 2026: 1 · 2025: 12 · 2024: 4 · 2023: 6 · 2022: 9 · 2021: 7 · 2020: 6 · 2019: 5 · 2018: 6 · 2017: 6 · 2016: 1 · 2015: 4 · 2014: 7 · 2013: 8 · 2012: 7
- FWCI
- 0.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Regulatory Toxicology and Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Coenzyme Q10 studies and effects
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutrition and Health Studies
- Keywords
- coenzyme Q10, dietary supplements, risk assessment, safety assessment, dose-response relationship, gastrointestinal adverse effects, nausea, oral intake
- MeSH terms
- Coenzymes, Double-Blind Method, Drug Administration Schedule, Humans, Placebos, Safety, Ubiquinone, Randomized Controlled Trials as Topic, Risk Assessment, No-Observed-Adverse-Effect Level
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