Frequency of occurrence was calculated from the number of undesirable phenomena, observed in the phase III study in 9,366 women with operable breast cancer in postmenopausal women who received treatment for 5 years, while the frequency of adverse events in the comparison groups and the opinion of the researcher as to the dependence of the undesirable phenomenon on the study drug are not taken into account.
Determination of the frequency of adverse reactions: very often (more than or equal to 10%); often (from 1 to less than 10%); infrequently (from 0.1 to less than 1%); rarely (from 0.01 to less than 0.1%); very rarely (less than 0.01%).
From the side of the vessels: very often - "hot flashes".
From the musculoskeletal and connective tissue: very often - arthralgia / joint stiffness, arthritis, often - bone pain, myalgia, infrequently - trigger finger.
From the genitals and breast: often - dryness of the mucosa the vagina; vaginal bleeding (mainly during the first weeks after the abolition or change of previous hormonal therapy for Arimidex®).
From the skin and subcutaneous tissues: very often skin rash, often thinning of hair (alopecia), allergic reactions, infrequent urticaria, rarely erythema multiforme, anaphylactoid reaction, skin vasculitis (including isolated cases of purpura (Shenllein-Genoch syndrome)), very rarely Stevens syndrome -Johnson, angioedema.
From the gastrointestinal tract: very often - nausea, often - diarrhea, vomiting.
From the liver and biliary tract: often - increased activity of alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, infrequently - increased activity of gamma-glutamyl transferase and bilirubin concentration, hepatitis.
From the nervous system: very often - headache, often - drowsiness,Carpal tunnel syndrome (mainly observed in patients with risk factors of the disease), sensitivity disorders (including paresthesia, loss or perversion of taste sensations).
From the side of metabolism and nutrition: often - anorexia, hypercholesterolemia, infrequently - hypercalcemia (with / without increasing the concentration of parathyroid hormone). Admission of the drug may cause a decrease in bone mineral density due to a decrease in the concentration of circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures.
General disorders: very often - asthenia of mild or moderate severity.
Adverse events noted in clinical trials that are not related to taking Arimidex®: anemia, constipation, dyspepsia, back pain, abdominal pain, increased blood pressure, weight gain, depression, insomnia, dizziness, anxiety, paresthesia.