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Label Changes for:

Rebetol (ribavirin) Capsules and Oral Solution

May 2015

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

May 2015


Usage Safeguards
  • added to significant adverse reactions caused by REBETOL/INTRON A...homicidal ideation


May 2013


What is the most important information I should know about REBETOL?

  • If you or your female sexual partner becomes pregnant while taking REBETOL or within 6 months after you stop taking REBETOL, tell your health care provider right away. You or your health care provider should contact the REBETOL pregnancy registry by calling 1-800-593-2214. The REBETOL pregnancy registry collects information... 


October 2010


Concomitant administration of Azathioprine
  • Pancytopenia (marked decreases in red blood cells, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine. In this limited number of patients (n=8), myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of both HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone. PegIntron, Rebetol and azathioprine should be discontinued for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine.