No black box warning on record for Ursodiol

As of the latest FDA labeling reviewed, Ursodiol (ursodeoxycholic acid) does not carry a black box warning. Standard warnings and precautions still apply — see the full Ursodiol medicine page for the complete safety profile.

Other warnings & precautions

Gallstone dissolution: Ursodiol is only effective for cholesterol gallstones — not calcium-containing (radiopaque) or pigment stones. Stones must be <20 mm in diameter for best results. Recurrence rate is ~50% within 5 years after dissolution — prophylaxis or eventual cholecystectomy may be needed.
Monitor liver function tests at baseline and periodically during therapy for PBC.
For gallstone dissolution: Obtain abdominal ultrasound at 6-month intervals for the first year to assess stone dissolution and look for calcification.
Worsening of liver disease in PSC: Large trials (e.g., Mayo Clinic trial) showed high-dose ursodiol (28–30 mg/kg/day) for PSC may actually worsen outcomes. Use standard doses only and avoid high-dose ursodiol in PSC.
Pregnancy: Ursodiol is FDA Category B. It is commonly used for intrahepatic cholestasis of pregnancy to reduce pruritus and liver enzyme elevation, with good safety data.

No black box warning on record for Ursodiol

Other warnings & precautions

Gallstone dissolution: Ursodiol is only effective for cholesterol gallstones — not calcium-containing (radiopaque) or pigment stones. Stones must be <20 mm in diameter for best results. Recurrence rate is ~50% within 5 years after dissolution — prophylaxis or eventual cholecystectomy may be needed.
Monitor liver function tests at baseline and periodically during therapy for PBC.
For gallstone dissolution: Obtain abdominal ultrasound at 6-month intervals for the first year to assess stone dissolution and look for calcification.
Worsening of liver disease in PSC: Large trials (e.g., Mayo Clinic trial) showed high-dose ursodiol (28–30 mg/kg/day) for PSC may actually worsen outcomes. Use standard doses only and avoid high-dose ursodiol in PSC.
Pregnancy: Ursodiol is FDA Category B. It is commonly used for intrahepatic cholestasis of pregnancy to reduce pruritus and liver enzyme elevation, with good safety data.

Ursodiol Black Box Warning

No black box warning on record for Ursodiol

Other warnings & precautions

Ursodiol Black Box Warning

No black box warning on record for Ursodiol

Other warnings & precautions