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Ocaliva
obeticholic acid
Black Box Warnings .
Hepatic Decompensation and Failure
hepatic decompensation and failure, some fatal or resulting in liver transplant, reported in patients treated with obeticholic acid with or without compensated or decompensated cirrhosis; contraindicated in patients with decompensated cirrhosis, prior decompensation event, or compensated cirrhosis with evidence of portal HTN; permanently D/C in patients who develop hepatic decompensation, evidence of portal HTN with compensated cirrhosis, or clinically significant hepatic adverse reactions
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg
Withdrawn from US Market
- [November 14, 2025]
- Info: voluntarily withdrawn due to reported serious hepatic injury cases and risk/benefit profile; 1-844-782-4278 or www.interceptmedinfo.com/medical-information-requests/ for more info
Peds Dosing .
- Dosage forms: --
Withdrawn from US Market
- [November 14, 2025]
- Info: voluntarily withdrawn due to reported serious hepatic injury cases and risk/benefit profile; 1-844-782-4278 or www.interceptmedinfo.com/medical-information-requests/ for more info