Side Effects of Actigall (Ursodiol)
Actigall (ursodiol) is generally well-tolerated with gastrointestinal symptoms being the most common side effects, occurring in approximately 25-45% of patients, while serious adverse events are rare. 1
Common Gastrointestinal Side Effects
The most frequently reported adverse effects involve the digestive system 1:
- Abdominal pain occurs in 43.2% of patients receiving ursodiol for gallstone dissolution and 6.2% for gallstone prevention 1
- Diarrhea affects 25-27% of patients 1
- Nausea occurs in 14-17% of patients 1
- Dyspepsia (indigestion) affects approximately 17% of patients 1
- Constipation occurs in 9.7-26.4% of patients depending on indication 1
- Flatulence affects 4.7-7.7% of patients 1
- Vomiting occurs in 9.7-13.7% of patients 1
Musculoskeletal and Neurological Effects
Less common but notable side effects include 1:
- Headache in 18-25% of patients 1
- Back pain in 7.1-11.8% of patients 1
- Arthralgia (joint pain) in 7.7% of patients 1
- Dizziness in 12.9-16.5% of patients 1
Dermatologic Effects
- Alopecia (hair loss) occurs in 5.3% of patients receiving ursodiol for gallstone prevention 1
Respiratory and Infectious Complications
Upper respiratory symptoms are common 1:
- Upper respiratory tract infections in 12.4-15.5% of patients 1
- Sinusitis in 5.3-11% of patients 1
- Viral infections in 9% of patients 1
Serious but Rare Adverse Events
Post-marketing surveillance has identified 1:
- Enteroliths (bezoars) - rare but documented complication 1
Important Clinical Context
Ursodiol demonstrates an excellent safety profile with less than 1% of patients experiencing adverse effects severe enough to require treatment discontinuation 2. The drug is virtually free of hepatotoxicity, and liver function tests typically remain normal during therapy 2. This contrasts favorably with chenodiol (chenodeoxycholic acid), which causes more frequent and severe adverse effects 3.
Dosing Considerations and Tolerability
For primary sclerosing cholangitis, while ursodiol at standard doses (13-15 mg/kg/day) improves liver function tests, doses should not exceed 20 mg/kg/day, as higher doses (28-30 mg/kg/day) have been associated with significantly worse outcomes despite biochemical improvement 4.
Most adverse effects are mild, self-limited, and do not require discontinuation of therapy 2. The transient diarrhea that occurs in less than 1% of patients typically resolves without intervention 2.