Meldonium

Metabolic agents (local classification). Russian and Latvian development.

ATC code: C01EB-MELDONIUM (Meldonium (Mildronate) – local code)

Brand names

Mildronate, Quaterine

Mechanism of action

Meldonium (3-(2,2,2-trimethylhydrazinium) propionate, trade name Mildronate) is a structural analogue of gamma-butyrobetaine and an inhibitor of gamma-butyrobetaine hydroxylase. It reduces endogenous carnitine biosynthesis and shifts myocardial energy metabolism from long-chain fatty acid oxidation toward glucose oxidation, which is theoretically more oxygen-efficient under ischaemia. The molecule was developed at the Latvian Institute of Organic Synthesis in the 1970s. Meldonium is registered as a prescription drug only in Russia, Latvia and several other former Soviet states. It is not approved by the , or MHRA. The World Anti-Doping Agency added meldonium to the Prohibited List effective 1 January 2016 after surveillance data documented widespread use among elite athletes for ergogenic purposes.

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Athletic endurance

Not recommended

Evidence tier F (and prohibited). WADA added meldonium to the Prohibited List on 1 January 2016 after pre-listing surveillance found the drug in samples from more than 180 athletes at the 2015 European Games and in numerous post-Soviet competitors across endurance sports. A high-profile sanction followed: tennis player Maria Sharapova received a provisional ban in March 2016. The drug is not approved as an ergogenic aid by any regulator. Independent RCTs in healthy athletes are absent. Use of meldonium by competitive athletes triggers anti-doping sanctions regardless of intent.

Sources

Chronic cerebrovascular insufficiency

Not recommended

Evidence tier F. The diagnostic category "chronic cerebrovascular insufficiency" used to justify meldonium prescribing in Russian outpatient care is absent from ICD-11 and from international neurology. Meldonium is not listed in any international vascular cognitive impairment or stroke prevention guideline. In patients with prior stroke or TIA, evidence-based secondary prevention is antiplatelet therapy (or anticoagulation for atrial fibrillation), high-intensity statin, blood pressure control to under 130/80 mmHg in most adults and diabetes management.

Sources

Coronary artery disease

Not recommended

Evidence tier D. International cardiology guidelines ( 2024 chronic coronary syndromes, 2023 chronic CAD) do not list meldonium. Available trials are predominantly Russian-language, single-centre, with surrogate endpoints (exercise tolerance, anginal frequency by diary) rather than hard outcomes (cardiovascular mortality, myocardial infarction). Independent meta-analysis with low risk of bias has not been published. Evidence-based stable angina therapy is beta-blockers or calcium channel blockers for symptom control, antiplatelet therapy and high-intensity statin for prognosis, plus revascularisation in selected anatomy.

Sources

Practical notes

Russian practice note

Meldonium is supplied as 250 mg and 500 mg capsules and as a 100 mg/mL injection. The manufacturer Grindeks is a Latvian company; its primary market is Russia, Belarus, Kazakhstan, and Georgia. The drug is not registered in the US, EU, or UK. In athletes after 2016, meldonium is a class S4 doping agent (hormones and metabolic modulators). Urine clearance can take several months after discontinuation, which complicates the boundary between «residual concentration» and active use.

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Safety

Contraindications

Pregnancy and breastfeeding
Age under 18
Raised intracranial pressure
Intracranial tumours, venous outflow disorders
Hypersensitivity

Serious adverse effects

Hypotension (rare)
Eosinophilia (post-marketing reports)

Common adverse effects

Allergic reactions (pruritus, rash, swelling)
Tachycardia
Agitation, sleep disturbance
Dyspepsia

PregnancyFDA N

Contraindicated in pregnancy per label.

Breastfeeding

Contraindicated during breastfeeding per label.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Meldonium used for?

Meldonium is evaluated for the following indications with varying evidence strength: Chronic cerebrovascular insufficiency (evidence tier F), Coronary artery disease (evidence tier F), Athletic endurance (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Meldonium?

Common side effects of Meldonium (≥ 1 in 100): Allergic reactions (pruritus, rash, swelling), Tachycardia, Agitation, sleep disturbance, Dyspepsia. See the Safety section for uncommon and serious reactions.

Is Meldonium safe during pregnancy?

FDA category N. Contraindicated in pregnancy per label.

Is Meldonium compatible with breastfeeding?

Contraindicated during breastfeeding per label.

Who should not take Meldonium?

Meldonium is contraindicated in: Pregnancy and breastfeeding; Age under 18; Raised intracranial pressure; Intracranial tumours, venous outflow disorders; Hypersensitivity. Full list in the Safety section.