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Drug reference

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 excretion0≥90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
30minONSET2hPEAK4dt½1dDURATION
ONSET
30min · absorption onset
PEAK
2h · Peak plasma concentration
t½
4d · Very long half-life (enterohepatic circulation)
DURATION
1d · 24-hour coverage with divided doses
EXCRETION
Fecal (major); renal (<1%)
route + CYP
INTERACTIONS
—
none in our sources
PREGNANCY
Not recommended in pregnancy; limited data - weigh benefits vs risks
FDA category + note
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

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

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

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

8 additional unreviewed or low-confidence interactions hidden because their provenance or source detail is insufficient.

Related guidelines

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Textbook-sourced·Sources: Goodman & Gilman 14e, Katzung, BNF, Nelson·Updated: 2026-05-19·Cockpit curated: 2026-05-19