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Amena

Amena Adverse Reactions

tibolone

Manufacturer:

BIOFEMME, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Adverse Reactions
Gastrointestinal: Abdominal pain (upper and lower), gastrointestinal upset, cholestatic jaundice, gall bladder disease.
Skin and Subcutaneous Tissue Disorders: Abnormal hair growth, acne, rash, pruritus, seborrheic dermatitis, itching, facial hypertrichosis, chloasma, erythema multiforme, erythema nodosum, vascular purpura.
Reproductive System and Breast Disorder: Vaginal discharge, leucorrhea, vaginal hemorrhage/bleeding, vaginal candidiasis, vaginal mycosis, endometrial wall thickening/hyperplasia, postmenopausal hemorrhage, breast tenderness, genital pruritus, pelvic pain, cervical dysplasia, genital discharge, vulvovaginitis, breast discomfort, fungal infection, nipple pain.
Estrogen-dependent neoplasms: Endometrial cancer, breast cancer.
Investigations: Weight increase, abnormal cervical smear (the majority consisted of benign changes), changes in liver function parameters.
Central Nervous System Disorders: Dizziness, headache, migraine, depression, probable dementia.
Cardiovascular System Disorders: Venous thromboembolism (i.e., deep leg or pelvic venous thrombosis and pulmonary embolism), myocardial infarction, stroke/ischemic stroke.
Musculoskeletal Disorders: Arthralgia, myalgia.
Others: Visual disturbances, (including blurred vision), edema, thromboembolism.
Adverse reactions reported in association with estrogen-progesterone treatment: Estrogen-dependent neoplasms both benign and malignant (i.e., endometrial cancer), venous thromboembolism (deep leg or pelvic venous thrombosis and pulmonary embolism) is more frequent among HRT users than among non-users (see Contraindications and Precautions), myocardial infarction, gall bladder disease, skin and subcutaneous disorders (i.e., chloasma, erythema multiforme, erthema nodosum, vascular purpura), and probable dementia.
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