Safety assessment of coenzyme Q₁₀ (CoQ₁₀)

Abstract

Coenzyme Q10 (CoQ10) is a naturally occurring component present in living cells. Its physiological function is to act as an essential cofactor for ATP production, and to perform important antioxidant activities in the body. In most countries, CoQ10 has been widely used as a dietary supplement for more than 20 years. Recently, the use of CoQ10 as a dietary supplement has grown with a corresponding increase in daily dosage. The present review describes the safety profile of CoQ10 on the basis of animal and human data. The published reports concerning safety studies indicate that CoQ10 has low toxicity and does not induce serious adverse effects in humans. The acceptable daily intake (ADI) is 12mg/kg/day, calculated from the no-observed-adverse-effect level (NOAEL) of 1200 mg/kg/day derived from a 52-week chronic toxicity study in rats, i.e., 720 mg/day for a person weighing 60 kg. Risk assessment for CoQ10 based on various clinical trial data indicates that the observed safety level (OSL) for CoQ10 is 1200 mg/day/person. Evidence from pharmacokinetic studies suggest that exogenous CoQ10 does not influence the biosynthesis of endogenous CoQ9/CoQ10 nor does it accumulate into plasma or tissues after cessation of supplementation. Overall, these data from preclinical and clinical studies indicate that CoQ10 is highly safe for use as a dietary supplement. Additionally, analysis of CoQ10 bioavailability or its pharmacokinetics provides the pertinent safety evaluation for CoQ10.

Nanomicellar formulation of coenzyme Q10 (Ubisol-Q10) effectively blocks ongoing neurodegeneration in the mouse 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine model: potential use as an adjuvant treatment in Parkinson's disease

“…This concentration was consistent with previous report on in vivo CoQ 10 testing Cleren et al, 2008) as well as with CoQ 10 dosing of PD patients in clinical trial (Shults et al, , 2002. However, although at this concentration Ubisol-Q 10 was well tolerated, the delivered dose of CoQ 10 was well above the acceptable daily intake (ADI) of 12 mg/kg/day (Hidaka et al, 2008). Therefore, in the next set of experiments, we proceeded to test Ubisol-Q 10 at 5× and 10× lower doses, that is, 6 mg/kg/day and 3 mg/kg/day, well within the ADI value.…”

Support of drug therapy using functional foods and dietary supplements: focus on statin therapy

“…CoQ 10 is widely recognised as safe with no reported toxicity (123) . It has been shown that CoQ 10 supplementation (100 mg/d) in HC patients treated with atorvastatin (10 mg/d) did not have an effect on statin-induced reductions in total or LDL-cholesterol, or TAG levels (124) .…”

Packaging of the Coenzyme Q₁₀ into a Liposome for Mitochondrial Delivery and the Intracellular Observation in Patient Derived Mitochondrial Disease Cells

“…2) In 1961, the important role of CoQ 10 as an electron carrier in the electron transport pathway was first proposed by Peter Mitchell, making it a subject of interest to medical and pharmaceutical researchers. 3) Since then, substantial amounts of laboratory and animal data on CoQ 10 have been published.…”

“…3) Since then, substantial amounts of laboratory and animal data on CoQ 10 have been published. These findings indicate that, in addition to its function as an electron carrier, CoQ 10 acts as an antioxidant and can prevent damage to cellular components caused by free radicals and can also stabilize cell membranes.…”