Lebreta

Lebreta Side Effects

letrozole

Manufacturer:

Duopharma HAPI

Distributor:

Duopharma HAPI
Full Prescribing Info
Side Effects
Letrozole is generally well tolerated as first-line and second-line treatment for advanced breast cancer, as adjuvant treatment of early breast cancer and as extended adjuvant treatment in women who have received prior standard tamoxifen therapy.
Generally, the observed adverse reactions are mainly mild or moderate in nature, and most are associated with estrogen deprivation.
The most frequently reported adverse reactions were hot flushes, arthralgia, nausea and fatigue. Many adverse reactions can be attributed to the normal pharmacological consequences of estrogen deprivation (e.g. hot flushes, alopecia and vaginal bleeding).
System Organ Class: Infections and Infestations: Uncommon: Urinary tract Infection.
Benign, Malignant and Unspecified Neoplasms (including cysts and polyps): Uncommon: Tumor pain (metastatic/neoadjuvant).
Blood and Lymphatic System Disorders: Common: Leukopenia.
Metabolism and Nutrition Disorders: Common: Anorexia, increased appetite, hypercholesterolemia.
Uncommon: General oedema.
Psychiatric Disorders: Common: Depression.
Uncommon: Anxiety including nervousness and irritability.
Nervous System Disorders: Common: Headache, dizziness.
Uncommon: Somnolence, memory impairment, dysaesthesia including paraesthesia and hypoesthesia, taste disturbance, cerebrovascular accident.
Eye Disorders: Uncommon: Cataract, eye irritation, blurred vision.
Cardiac Disorders: Uncommon: Palpitations, tachycardia.
Vascular Disorders: Uncommon: Thrombophlebitis including superficial and deep, hypertension, ischaemic cardiac events (the adjuvant setting, irrespective of causality, the following adverse events occurred in the letrozole and tamoxifen groups, respectively: Thromboembolic events, angina pectoris, myocardial infarction and cardiac failure.
Rare: Pulmonary embolism, arterial thrombosis, cerebrovascular infarction.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.
Gastrointestinal Disorders: Common: Nausea, vomiting, dyspepsia, constipation, diarrhoea.
Uncommon: Abdominal pain, stomatitis, dry mouth.
Hepatobiliary Disorders: Uncommon: Increased hepatic enzymes.
Skin and Subcutaneous tissue Disorders: Common: Alopecia increased sweating, rash including erythematous, maculopapular, psoriaform and vesicular rash.
Uncommon: Pruritis, dry skin, urticarial.
Musculoskeletal, Connective Tissue and Bone Disorders: Very common: Arthralgia.
Common: Myalgia, bone pain, osteoporosis, bone fractures, arthritis.
Renal and Urinary Disorders: Uncommon: Increased urinary frequency.
Reproductive System and Breast Disorders: Uncommon: Vaginal bleeding, vaginal discharge, vaginal dryness, breast pain.
General Disorders and Administration Site Conditions: Very common: Hot flushes.
Common: Fatigue including asthenia and malaise, peripheral oedema.
Uncommon: Pyrexia, mucosal dryness, thirst.
Investigations: Common: Increased weight.
Uncommon: Weight loss.
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