Chenodal Side Effects

Generic name: chenodeoxycholic acid

Note: This document contains side effect information about chenodeoxycholic acid. Some of the dosage forms listed on this page may not apply to the brand name Chenodal.

Some side effects of Chenodal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to chenodeoxycholic acid: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking chenodeoxycholic acid (the active ingredient contained in Chenodal) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using chenodiol and call your doctor at once if you have a serious side effect such as:

• worsening or no improvement of your gallstone symptoms;

• diarrhea; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of chenodeoxycholic acid may include:

• heartburn, upset stomach, gas;

• mild stomach cramps; or

• vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to chenodeoxycholic acid: oral tablet

Hepatic

Hepatic side effects have included dose-related serum aminotransferase (mainly SGPT) elevations, usually not accompanied by
rises in alkaline phosphatase or bilirubin, occurring in 30% or more of patients treated with the recommended dose of chenodeoxycholic acid (the active ingredient contained in Chenodal) In most cases, these elevations were minor (1½ to 3 times the upper limit of laboratory normal) and
transient, returning to within the normal range within six months despite continued administration of the drug.

Morphologic studies of liver biopsies taken before and after 9 and 24 months of treatment with chenodeoxycholic acid have shown that 63% of the patients prior to chenodiol treatment had evidence of intrahepatic cholestasis. Almost all pretreatment patients had electron microscopic abnormalities. By the ninth month of treatment, reexamination of two-thirds of the patients showed an 89% incidence of the signs of intrahepatic cholestasis. Two of 89 patients at the ninth month had lithocholate-like lesions in the canalicular membrane, although there were not clinical enzyme abnormalities in the face of continued treatment and no change in Type 2 light microscopic parameters.

Gastrointestinal

Gastrointestinal side effects have included diarrhea in 30% to 40% of patients and may occur at any time during treatment, but is most commonly encountered when treatment is initiated. Usually, the diarrhea is mild, translucent, well-tolerated and does not
interfere with therapy. Other less frequent, gastrointestinal side effects reported include urgency, cramps, heartburn, constipation, nausea and vomiting, anorexia, epigastric distress, dyspepsia, flatulence and nonspecific abdominal pain.

Hematologic

Hematologic side effects have included decreases in white cell count but the drug was continued in all patients without incident.

Metabolic

Metabolic side effects have included serum total cholesterol and low-density lipoprotein (LDL) cholesterol increases of 10% or more during drug administration; no change has been seen in the high-density lipoprotein (HDL) fraction; small decreases in serum triglyceride levels for females have been reported.

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