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In rare casesdanazol can cause a condition that results in the breakdown of skeletal muscle tissueleading to kidney failureCall your doctor right away if you have unexplained muscle paintendernessor weakness especially if you also have feverunusual tirednessand dark colored urine.

Since hepatic dysfunction manifested by modest increases in serum transaminase levels has been reported in patients treated with Danazolperiodic liver function tests should be performedsee WARNINGS and ADVERSE REACTIONS

There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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