Examest Adverse Reactions

The most commonly reported adverse reactions were hot flushes, arthralgia and fatigue. The most commonly reported adverse reactions were hot flushes and nausea. Most adverse reactions can be attributed to the normal pharmacological consequences of estrogen deprivation (e.g., hot flushes).
Metabolism and nutrition disorders: Common: Anorexia.
Psychiatric disorders: Very common: Depression, insomnia.
Nervous system disorders: Very common: Headache, dizziness.
Common: Carpal tunnel syndrome.
Uncommon: Somnolence.
Vascular disorders: Very common: Hot flushes.
Gastrointestinal disorders: Very common: Abdominal pain, nausea.
Common: Vomiting, diarrhea, constipation, dyspepsia.
Hepatobiliary disorders: Very common: Hepatic enzyme increased, blood bilirubin increased, blood alkaline phosphatase increased.
Skin and subcutaneous tissue disorders: Very common: Increased sweating.
Common: Alopecia, rash.
Musculoskeletal and bone disorders: Very common: Joint and musculoskeletal pain (includes: Arthralgia, and less frequently pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness.
General disorders and administration site conditions: Very common: Pain, fatigue.
Common: Oedema peripheral, asthenia.
In patients with advanced breast cancer, an occasional decrease in lymphocytes has been observed in patients receiving Exemestane, particularly in patients with pre-existing lymphopenia. However, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed. Thrombocytopenia and leucopenia have been occasionally reported.
No significant difference was noted for any individual cardiovascular event including hypertension, myocardial infarction and cardiac failure.
In breast cancer, gastric ulcer was observed at a slightly higher frequency in the Exemestane arm compared to Tamoxifen. The majority of patients on Exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.
Post-marketing experience: Immune system disorders: Uncommon: Hypersensitivity.
Nervous system disorders: Common: Paraesthesia.
Hepatobiliary disorders: Rare: Hepatitis, hepatitis cholestatic.
Skin and subcutaneous tissue disorders: Common: Urticaria, pruritus.
Rare: Acute generalised exenthematous pustulosis.