General Rarely, hypersensitivity reactions (including urticaria and anaphylaxis ) have been reported in patients receiving ZOLADEX. As with other endocrine therapies, hypercalcemia (increased calcium ) has rarely been reported in cancer patients with bone metastases following initiation of treatment with ZOLADEX or other LHRH agonists. ZOLADEX has been found to be generally well tolerated in clinical trials . Adverse reactions reported in these trials were rarely severe enough to result in the patients' withdrawal from ZOLADEX treatment. As seen with other hormonal therapies, the most commonly observed adverse events during ZOLADEX therapy were due to the expected physiological effects from decreased testosterone levels. These included hot flashes , sexual dysfunction and decreased erections. Initially, ZOLADEX, like other LHRH agonists, causes transient increases in serum levels of testosterone. A small percentage of patients experienced a temporary worsening of signs and symptoms (see WARNINGS section), usually manifested by an increase in cancer-related pain which was managed symptomatically. Isolated cases of exacerbation of disease symptoms, either ureteral obstruction or spinal cord compression , occurred at similar rates in controlled clinical trials with both ZOLADEX and orchiectomy . The relationship of these events to therapy is uncertain. There have been post-marketing reports of osteoporosis , decreased bone mineral density and bony fracture in men treated with ZO
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