Tamoxen Adverse Reactions

Tabulated list of adverse reactions: Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal women patients with operable breast cancer treated for 5 years and unless specified, no account was taken of the frequency within the comparative treatment group or whether the investigator considered it to be related to study medication.
Adverse drug reactions (ADRs) can be classified as either due to the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge and pruritus vulvae, or as more general ADRs e.g. nausea, fluid retention and skin rash. When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease.
This adverse drug reaction was not reported in the Tamoxifen arm (n=3094) of the previously mentioned study; however, it has been reported in other trials or from other sources. (See table.)

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