What Are the Side Effects of Mitopure?

November 21, 2025 •

2 min read

Clinical studies and reviews have reported that Mitopure, a proprietary form of Urolithin A, is generally well-tolerated and has a favorable safety profile in healthy adults. This article explores what the side effects of Mitopure are, providing a comprehensive guide to potential adverse effects, important precautions, and the clinical evidence supporting its safety.

Quick Summary

Clinical evidence suggests Mitopure is safe for most healthy adults, with no serious adverse effects reported in trials. Mild effects sometimes occur but are often unrelated to supplementation.

Key Points

Low Risk of Serious Side Effects: Clinical trials have consistently found no serious adverse events directly related to Mitopure supplementation in healthy adults.
Mild and Infrequent Effects: Reported mild side effects, such as headache, muscle aches, and limb discomfort, are rare and often deemed unrelated to the supplement.
Rare Allergic Potential: Very rare allergic reactions can occur in sensitive individuals due to inactive ingredients like rice fiber or annatto, though the risk is low.
Precaution for Drug Interactions: A theoretical risk of interaction with medications metabolized by the cytochrome P450 system exists, warranting caution and medical consultation.
Limited Long-Term Safety Data: While short-term trials show safety, limited long-term safety data in humans is available, so continued monitoring and research are needed.
Consult a Doctor for High-Risk Groups: Individuals who are pregnant, breastfeeding, or have pre-existing liver, kidney, or metabolic conditions should consult a healthcare provider before using Mitopure.
Importance of Clinically Tested Product: Opting for the clinically tested Mitopure brand over unverified Urolithin A products ensures higher quality, purity, and adherence to safety standards.

The Safety Profile of Mitopure: What Clinical Research Shows

Mitopure is a proprietary form of Urolithin A derived from precursors found in foods like pomegranates. Research indicates it is safe and well-tolerated in healthy adults, with no serious adverse events reported in clinical trials,. A study in Cell Reports Medicine noted its safety over four months of daily use. The FDA has granted it Generally Recognized As Safe (GRAS) status,.

Mild and Infrequent Adverse Effects

Some mild side effects have been reported in clinical studies and by users, though they are often not considered directly related to Mitopure,. These infrequent effects may include headaches, muscle aches (myalgia), and general limb discomfort. Mild gastrointestinal issues have also been anecdotally reported.

Allergic Reactions to Inactive Ingredients

Rare allergic reactions to inactive ingredients are possible but unlikely for most people as the products are free from common allergens. Potential allergens in some products include rice fiber (in powder), sunflower lecithin, palm kernel MCT oil (in softgels), and annatto (in capsules).

Drug Interactions and Important Contraindications

While direct research is lacking, a theoretical risk of interaction with certain prescription medications exists because Urolithin A precursors in pomegranate juice interact with the liver's cytochrome P450 system,. Consult a doctor before use, especially if taking ACE inhibitors, blood pressure medications, statins, or warfarin. Limited safety data means caution is needed for pregnant or breastfeeding women, and those with liver or kidney disease or pre-existing metabolic or cardiovascular conditions.

Mitopure vs. Other Longevity Supplements

Comparing Mitopure to other supplements helps understand its safety profile. Here's a brief comparison:


Feature	Mitopure (Urolithin A)	Nicotinamide Mononucleotide (NMN)	Coenzyme Q10 (CoQ10)
Known Side Effects	Mild, infrequent effects reported in trials, often deemed unrelated. Rare allergic potential from inactive ingredients.	Generally well-tolerated. Some anecdotal reports of mild effects like nausea or digestive upset.	Usually very safe. Possible mild side effects include digestive upset, insomnia, or skin rashes.
Long-Term Safety Data	Limited long-term human safety data available.	More long-term data needed.	More extensively studied long-term safety profile.
Clinical Testing	Proprietary form (Timeline's Mitopure) extensively tested,.	Varied testing between manufacturers.	Broad range of testing.
Regulatory Status	FDA GRAS status and NSF Certified for Sport (for specific products).	Varies, recent regulatory scrutiny.	Regulated as a dietary supplement.
Mechanism of Action	Activates mitophagy and promotes mitochondrial biogenesis,.	Precursor to NAD+.	Antioxidant, involved in energy production.

Conclusion: Navigating Potential Side Effects with Mitopure

Mitopure is generally safe and well-tolerated with no serious adverse effects in trials. Mild side effects are infrequent and often unrelated, and allergic reactions to inactive ingredients are rare. However, caution and medical consultation are advised for those who are pregnant, breastfeeding, have pre-existing conditions, or are taking prescription medications due to limited data and potential theoretical interactions. Consulting a physician and choosing a clinically tested product can help ensure safe use.

Frequently Asked Questions

No, clinical trials involving Mitopure have reported no serious adverse events directly attributed to the supplement. It is generally considered safe for healthy adults.

Common side effects are not typical. However, some clinical trial participants reported mild, infrequent issues such as headaches, muscle aches (myalgia), and limb discomfort, which were often considered unrelated to the supplement.

While allergic reactions are rare, they are possible due to inactive ingredients in the softgels or powder, such as annatto, sunflower lecithin, or rice fiber. Those with known sensitivities should review the full ingredient list.

There is a theoretical concern about potential interactions with drugs metabolized by the cytochrome P450 system. It is important to consult a healthcare provider before taking Mitopure if you are on any prescription medication, including statins, blood pressure drugs, or warfarin,.

Mitopure has been shown to be safe and well-tolerated in clinical studies lasting up to four months. However, long-term safety data beyond these trial periods is limited and ongoing research is necessary.

Individuals who are pregnant or breastfeeding, or those with liver or kidney disease, should exercise caution and consult a doctor before use, as safety data for these specific populations is limited.

No, dietary supplements like Mitopure do not receive FDA approval in the same way as prescription drugs. However, the ingredient received a 'Generally Recognized As Safe' (GRAS) notice from the FDA, and the product is manufactured under stringent quality standards.