Evigrade

Thiocolchicoside

AEMPS

Centrally acting muscle relaxant

ATC code: M03BX05

Updated · Methodology

Indications

C

Acute painful muscle spasm

Adjunct

Add-on therapy for acute painful skeletal muscle spasm in adults over 16, alongside analgesics. Per the 2014 decision, oral courses are limited to 7 days (8 mg twice daily) and IM courses to 5 days (4 mg twice daily). Evidence versus other muscle relaxants is weak; placebo advantage is modest (Tüzün 2016 meta-analysis).

Adults over 16 only, maximum 5–7 days.

ICD-10: M62.8 · ICD-11: MB47.3

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.

F

Anti-aging and longevity

Not recommended

Thiocolchicoside is a centrally acting muscle relaxant, an agonist at GABA-A and glycine receptors. It is prescribed in short courses for acute painful muscle spasm associated with spinal or muscular pathology (AEMPS Ficha Técnica, maximum 5–7 days). In anti-aging regimens, thiocolchicoside is used long-term for muscle relaxation in healthy adults. Long-term use is not justified: in 2014 the restricted thiocolchicoside to short courses for acute muscle spasm after evidence of genotoxicity of the active metabolite (DNA damage risk and potential carcinogenicity). The drug is not approved in the US ( has not approved it). Specific risks: diarrhea, allergic reactions, and seizures (especially with dose exceedance or in those predisposed to epilepsy). If thiocolchicoside was prescribed for chronic use in muscle tension, consider seeking a second opinion.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A semisynthetic colchicoside derivative with agonist action on GABA-A and glycine receptors in the spinal cord. Reduces reflex muscle spasm by inhibiting motor neurons. The SL18.0740 metabolite showed aneugenic activity in in vitro and in vivo studies – chromosomal damage with mutagenic potential for germ cells and the fetus. Based on these findings, in 2014 restricted indications and shortened course length.

Safety

Contraindications

  • Hypersensitivity to thiocolchicoside or colchicine
  • Pregnancy and lactation
  • Women of reproductive age without reliable contraception
  • Age under 16
  • Flaccid paralysis and muscle hypotonia
  • Epilepsy or history of seizures

Serious adverse effects

  • Seizures (particularly with overdose)
  • Anaphylactic reactions
  • Severe gastrointestinal disturbance
  • Potential mutagenicity and teratogenicity per EMA

Common adverse effects

  • Nausea, vomiting
  • Diarrhea
  • Abdominal pain
  • Drowsiness
  • Allergic skin reactions

Pregnancy: can you take Thiocolchicoside?

Absolute contraindication throughout pregnancy. The SL18.0740 metabolite is potentially mutagenic and teratogenic. Reliable contraception is mandatory in women of reproductive age on therapy.

Breastfeeding: can you take Thiocolchicoside?

Thiocolchicoside and its metabolites pass into milk. Breastfeeding is contraindicated during therapy.

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

Practical notes

Evidence

In 2014, reassessed thiocolchicoside's safety profile and substantially restricted its use. The drug's metabolite showed aneugenic potential – the ability to cause structural chromosomal damage. On this basis, it is banned in children under 16, in pregnancy and lactation, and in women of reproductive age without reliable contraception. Course is limited to 5–7 days. Long courses and chronic use that were previously common in Spain, Italy, France, and Greece are no longer recommended.

Common myths

Myth: «thiocolchicoside is natural and has no side effects.» Fact: the molecule comes from colchicoids – a class with known toxicity when doses are exceeded. The aneugenic metabolite restricts use in reproductively relevant groups. Myth: «after a back injury, a month-long course relaxes the muscles.» Fact: in acute back pain the course is no longer than 7 days, used only alongside analgesics and continued activity; routine «muscle relaxation» courses have no evidence base and carry risk without benefit.

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Frequently asked

What is Thiocolchicoside used for?

Thiocolchicoside is evaluated for the following indications with varying evidence strength: Acute painful muscle spasm (evidence tier C), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Thiocolchicoside?

Common side effects of Thiocolchicoside (≥ 1 in 100): Nausea, vomiting, Diarrhea, Abdominal pain, Drowsiness, Allergic skin reactions. See the Safety section for uncommon and serious reactions.

Is Thiocolchicoside safe during pregnancy?

Absolute contraindication throughout pregnancy. The SL18.0740 metabolite is potentially mutagenic and teratogenic. Reliable contraception is mandatory in women of reproductive age on therapy.

Is Thiocolchicoside compatible with breastfeeding?

Thiocolchicoside and its metabolites pass into milk. Breastfeeding is contraindicated during therapy.

Who should not take Thiocolchicoside?

Thiocolchicoside is contraindicated in: Hypersensitivity to thiocolchicoside or colchicine; Pregnancy and lactation; Women of reproductive age without reliable contraception; Age under 16; Flaccid paralysis and muscle hypotonia. Full list in the Safety section.

Official sources

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