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Patients receiving anastrozole had an increase in the incidence of all fractures (specifically fractures of spine, hip and wrist) [315 (10%)] compared with patients receiving tamoxifen [209 (7%)]. Patients receiving anastrozole had a decrease in hot flashes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events and ischemic cerebrovascular events compared with patients receiving tamoxifen. Patients receiving tamoxifen had a decrease in hypercholesterolemia (108 [3. Angina pectoris was reported in 71 [2, propionate 100 cena. Results from the adjuvant trial bone substudy, at 12 and 24 months demonstrated that patients receiving anastrozole had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Ductal Carcinoma in Situ (DCIS): The type and frequency of adverse events in the NSABP B-24 trial were consistent with those observed in the other adjuvant trials conducted with tamoxifen. Reduction in Breast Cancer Incidence in High Risk Women: In the NSABP P-1 trial, there was an increase in five serious adverse effects in the tamoxifen group: endometrial cancer (33 cases in the tamoxifen group vs. The following table presents the adverse events observed in NSABP P-1 by treatment arm. Only adverse events more common on tamoxifen than placebo are shown. NSABP P-1 Trial: All Adverse Events. In the NSABP P-1 trial, 15. The following are the medical reasons for withdrawing from tamoxifen and placebo therapy, respectively: hot flashes (3. In the NSABP P-1 trial, 8. On the NSABP P-1 trial, hot flashes of any severity occurred in 68% of women on placebo and in 80% of women on tamoxifen. Severe hot flashes occurred in 28% of women on placebo and 45% of women on tamoxifen. Vaginal discharge occurred in 35% and 55% of women on placebo and tamoxifen respectively; and was severe in 4. There was no difference in the incidence of vaginal bleeding between treatment arms. Mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study. A causal relationship has not been established; however, as an increase in the incidence of endometrial adenocarcinoma and uterine sarcoma has been noted in adults treated with tamoxifen (see BOXED WARNING ), continued monitoring of McCune-Albright patients treated with tamoxifen for long-term effects is recommended. The safety and efficacy of tamoxifen for girls aged 2 to 10 years with McCune-Albright s yndrome and precocious puberty have not been studied beyond 1 year of treatment. The long-term effects of tamoxifen therapy in girls have not been established. Postmarketing Experience: Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash and headaches. Usually these have not been of sufficient severity to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, interstitial pneumonitis, and rare reports of hypersensitivity reactions including angioedema have been reported with tamoxifen therapy.
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If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention. Check with your doctor as soon as possible if any of the following side effects occur: blurred vision or vision changes cough and shortness of breath increased pain or growth of tumour numbness or tingling of the skin pain or feeling of pressure in the pelvis severe nausea or vomiting signs of anemia (low red blood cells; e. Stop taking the medication and seek immediate medical attention if any of the following occur: blistering, peeling, or loosening of the skin or mucous membranes hives signs of a severe allergic reaction (e. Check with your doctor if you notice any symptom that worries you while you are taking this medication. Are there any other precautions or warnings for this medication? Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication. Blood clots: Tamoxifen may increase the chance of developing blood clots in the lungs or legs. This chance may be further increased if tamoxifen is given with other forms of chemotherapy. 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