Ranitidine may cause liver
injuries ranging from transient, subclinical serum
transaminases increase every 100-1,000 treated patients to cholestatic
hepatitis in less than 1/100,000. Other H2-receptor antagonists are more dangerous: 11
toxic hepatitis cases have been reported as adverse effect after 1 year of marketed
ebrotidine. A 75-year-old male with ischemic cardiopathy history was started on an 8 days treatment of oral
ranitidine due to pirosis, without any other changes of
therapy; 48 h after
drug withdrawal, light-coloured stools, dark urine and icteric scleras developed. On hospital admission, 10 days later, physical examination showed slight
hepatomegaly and severe
jaundice with skin excoriations followed by serum mixed
bilirubin further increase and
aminotransferases activities mild rise. Total
bilirubin peaked at 381.33 mmol/l (5.1-17.1) and progressively returned to normal, after discharge home, in 3 months and now, 1 year later, there is no sign of
liver disease. Ultrasonographic biliary anomalies and the most frequent causes of liver damage were excluded. Liver biopsy confirmed
ranitidine as the most likely cause of liver toxicity since histological and ultramicroscopical study revealed a
drug-induced picture. We report a rare case of
intrahepatic cholestasis jaundice related to
ranitidine, a widely used
drug. Diagnosis would need an ethically unacceptable rechallange test.