Is 250mg TUDCA a Good Dose?
250mg TUDCA three times daily (750mg total daily dose, approximately 10mg/kg/day for a 75kg adult) is a reasonable and evidence-supported dose for primary biliary cholangitis, matching the dosing used in clinical trials that demonstrated efficacy comparable to UDCA. 1
Evidence-Based Dosing for TUDCA
Primary Biliary Cholangitis (PBC)
- A multicenter randomized controlled trial in Chinese PBC patients used 250mg TUDCA three times daily (750mg/day total) for 24 weeks, demonstrating that 75.97% of patients achieved >25% reduction in serum alkaline phosphatase. 1
- This dose showed equivalent efficacy to UDCA 250mg three times daily, with both drugs well-tolerated and comparable adverse event rates. 1
- An earlier dose-response study found that approximately 10mg/kg/day of TUDCA was optimal for long-term treatment in PBC patients, with doses of 500mg, 1000mg, or 1500mg daily all showing significant reductions in serum liver enzymes. 2
- TUDCA may provide superior symptom relief compared to UDCA - the proportion of patients with pruritus increased from 1.43% to 10% in the UDCA group, while remaining unchanged in the TUDCA group. 1
Dosing Context and Comparisons
- For reference, UDCA dosing in cholestatic liver diseases is typically 13-15 mg/kg/day for PBC and 15-20 mg/kg/day for primary sclerosing cholangitis. 3
- A single 250mg dose represents approximately 3-4 mg/kg for an average adult, which is subtherapeutic if given once daily, but appropriate when given three times daily (reaching ~10mg/kg/day). 2, 1
Non-Hepatic Applications
Neuroprotective Uses
- For amyotrophic lateral sclerosis (ALS), a much higher dose of 1000mg TUDCA twice daily (2000mg/day total) was used in a pilot study, showing 87% of patients were responders with slower disease progression. 4
- TUDCA acts as a potent anti-apoptotic agent by interfering with mitochondrial pathways, reducing endoplasmic reticulum stress, and stabilizing the unfolded protein response. 5
Renal Protection
- In experimental models, 400mg/kg/day was used to prevent chronic high salt-induced renal injury, though this animal dosing cannot be directly extrapolated to humans. 6
Critical Considerations
Common Pitfall: Taking 250mg as a single daily dose is likely insufficient for therapeutic benefit in cholestatic liver disease. The evidence supports 250mg three times daily (750mg total) as the minimum effective regimen. 2, 1
Safety Profile: TUDCA is well-tolerated with diarrhea being the primary side effect at therapeutic doses. 2 The safety profile is comparable to UDCA, which has been used safely during pregnancy and breastfeeding. 7
Disease-Specific Dosing: The appropriate dose varies significantly by indication - 750mg/day for PBC 1 versus 2000mg/day for neurodegenerative conditions 4, highlighting the importance of matching dose to clinical context.