Nateran Adverse Reactions

The most commonly reported adverse reactions were hot flushes, arthralgia, fatigue and nausea. Most adverse reactions can be attributed to the normal pharmacological consequences of estrogen deprivation (e.g., hot flushes).
The reported adverse reactions are listed as follows by MedDRA System Organ Class and by frequency. Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000).
Metabolism and nutrition disorders: Common: Anorexia.
Psychiatric disorders: Very common: Depression, Insomnia.
Nervous system disorders: Very common: Headache, dizziness.
Common: Carpal tunnel syndrome.
Vascular disorders: Very common: Hot flushes.
Gastrointestinal disorders: Very common: Abdominal pain, nausea.
Common: Vomiting, diarrhoea, 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*.
Common: Fracture, osteoporosis.
General disorders and administration site conditions: Very common: Pain, fatigue.
Common: Oedema peripheral, asthenia.
*Include arthralgia, and less frequent pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness.
In patients with advanced breast cancer, an occasional decrease in lymphocyte has been observed 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.
The frequency of ischemic cardiac events in the exemestane and tamoxifen treatment arms respectively. No significant difference was noted for any individual cardiovascular event including hypertension, myocardial infarction and cardiac failure.
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 exanthematous pustulosis.