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Ursodeoxycholic Acid

Bile acid / gallstone dissolution agent / hepatoprotective · Hepatoprotective

Also known as UDCA, Ursodiol, Ursodeoxycholate

START
8-10 mg/kg/day divided for gallstones; 13-15 mg/kg/day for PBC; take with meals
TYPICAL MAX
15 mg/kg/day (20 mg/kg in CF)
STOP IF
No response after 6-12 months (gallstones), worsening liver function, severe diarrhea
WATCH
LFTs monthly for first 3 months then 6-monthly (PBC), ultrasound at 6-12 months (gallstones), check gallbladder function
CDSCO approvedSchedule HJan AushadhiATC A05AA02
Dose laddermg/d
300start450titrate1.2kceiling
Renal dose adjustmenteGFR mL/min/1.73m²
FULLNo renal adjustment needed; minimal renal excretion090

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
30minONSET2hPEAK4d1dDURATION
ONSET
30min · absorption onset
PEAK
2h · Peak plasma concentration
4d · Very long half-life (enterohepatic circulation)
DURATION
1d · 24-hour coverage with divided doses
EXCRETION
Fecal (major); renal (<1%)
route + CYP
INTERACTIONS
2 major
SEVERE in our sources
PREGNANCY
Not recommended in pregnancy; limited data - weigh benefits vs risks
FDA category + note
Top interactionssee all 12
  • ColesevelamSevereDatabase
  • ColestipolSevereDatabase
Available in India

748 branded formulations and 29 fixed-dose combinations. Look up specific brands in the Drugs workspace.

Jan Aushadhi — generic available at GoI pharmacies

Mechanism

Reduces cholesterol absorption in intestine and secretion into bile; displaces cholesterol from bile acid micelles, promoting cholesterol solubilization; cytoprotective effect on hepatocytes via anti-apoptotic and membrane-stabilizing actions

Indications

Dissolution of cholesterol gallstonesPrimary biliary cholangitis (PBC)Primary sclerosing cholangitis (off-label)Drug-induced cholestasisNon-alcoholic fatty liver disease (off-label)

Dosing

Adult
Gallstones: 8-10 mg/kg/day in 2-3 divided doses (typically 300 mg BD-TDS); PBC: 13-15 mg/kg/day in 2-4 divided doses
Pediatric
PBC in children: 10-15 mg/kg/day in 2-3 divided doses; CF-related liver disease: 20-30 mg/kg/day
Renal adjustment
No specific adjustment needed; minimal renal excretion
Hepatic adjustment
No dose reduction needed in liver disease; primary indication is liver disease
Geriatric
No specific adjustment; standard weight-based dosing
Max dose
15 mg/kg/day (usual); up to 20 mg/kg/day in CF-related liver disease

Pharmacokinetics

Onset
Weeks to months (for gallstone dissolution)
Peak effect
1-3 hours (Tmax)
Duration
24 hours
Half-life
3.5-5.8 days (long half-life due to enterohepatic circulation)
Bioavailability
~90%
Protein binding
96-99%
Metabolism
Hepatic conjugation to taurine and glycine; extensive enterohepatic recirculation
Excretion
Fecal (major); renal (<1%)

Contraindications

  • Radiopaque (calcified) gallstones
  • Non-functioning gallbladder
  • Acute cholecystitis
  • Biliary-gastrointestinal fistula
  • Hypersensitivity to UDCA

Side effects

Common
Diarrhea (dose-related)NauseaPruritusConstipationAbdominal painHeadache
Serious
  • Severe right upper quadrant pain (biliary colic during stone dissolution)
  • Hepatic decompensation in late-stage PBC (rare)
  • Urticaria
  • Worsening of liver function in advanced cirrhosis

Pregnancy & lactation

Pregnancy

Not recommended in pregnancy; limited data - weigh benefits vs risks

Lactation

Excreted in breast milk in small amounts; compatible with breastfeeding per WHO

Drug interactions

Colesevelam
Severe
Database

Decreased efficacy of ursodeoxycholic acid.

Administer ursodeoxycholic acid at least 2 hours before or 4-6 hours after colesevelam. Monitor for therapeutic effect.

Colestipol
Severe
Database

Decreased efficacy of ursodeoxycholic acid.

Administer ursodeoxycholic acid at least 2 hours before or 4-6 hours after colestipol. Monitor for therapeutic effect.

Aluminum Hydroxide
Moderate
Database

Decreased therapeutic effect of ursodeoxycholic acid.

Administer ursodeoxycholic acid at least 2 hours before or after aluminum hydroxide (or other aluminum-containing antacids).

Source: DDInter

Aluminum Containing Antacids
Moderate
Database

Decreased efficacy of ursodeoxycholic acid.

Administer ursodeoxycholic acid at least 2 hours before or after aluminum-containing antacids. Monitor for therapeutic effect.

Cholestyramine
Moderate
Database

Bile acid sequestrants bind UDCA in gut, reducing absorption by ~50%

Take UDCA at least 2 hours before or 4 hours after cholestyramine

Source: Kimi deep-research + Cla

Clofibrate
Moderate
Database

Reduced efficacy of ursodeoxycholic acid in dissolving gallstones.

Avoid concomitant use if ursodeoxycholic acid is used for gallstone dissolution. If used for other indications, monitor for reduced efficacy.

Estrogens
Moderate
Database

Reduced efficacy of ursodeoxycholic acid in dissolving gallstones.

Avoid concomitant use if ursodeoxycholic acid is used for gallstone dissolution. If used for other indications, monitor for reduced efficacy.

Ethinyl Estradiol
Moderate
Database

Reduced efficacy of ursodeoxycholic acid, especially for gallstone dissolution.

Avoid concomitant use if possible, particularly when ursodeoxycholic acid is used for gallstone dissolution. Consider alternative contraception.

Oral Contraceptives
Moderate
Database

Reduced efficacy of ursodeoxycholic acid in dissolving gallstones.

Avoid concomitant use if ursodeoxycholic acid is used for gallstone dissolution. If used for other indications, monitor for reduced efficacy.

Rifampicin
Moderate
Database

Decreased plasma concentrations and reduced therapeutic efficacy of ursodeoxycholic acid.

Avoid concomitant use if possible. If unavoidable, monitor UDCA efficacy and consider dose adjustment.

Ciclosporin
Moderate
Database

UDCA may increase ciclosporin absorption

Monitor ciclosporin levels when co-prescribing

Source: Kimi deep-research + Cla

Ciprofloxacin
Moderate
Database

Reduced absorption of fluoroquinolones due to chelation

Take fluoroquinolones 2 hours before or 6 hours after UDCA

Source: Kimi deep-research + Cla

Related guidelines

Ask House about Ursodeoxycholic Acid

Continue into a citation-backed clinical answer with the drug context already attached.

Sources: Goodman & Gilman 14e, Katzung, BNF, Nelson·Verified: 2026-05-19 · House clinical team·Cockpit curated: 2026-05-19