ADVERSE REACTIONS
See BOX WARNINGS, WARNINGS, and PRECAUTIONS.
Systemic absorption may occur with the use of Premarin Vaginal Cream. Warnings, precautions, and adverse reactions associated with oral Premarin treatment should be taken into account.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
- Genitourinary system: Breakthrough bleeding, spotting, change in menstrual flow; dysmenorrhea; premenstrual-like syndrome; amenorrhea during and after treatment; increase in size of uterine fibromyomata; vaginitis, including vaginal candidiasis; change in cervical erosion and in degree of cervical secretion; cystitis-like syndrome; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer; precocious puberty.
- Breasts: Tenderness, pain, enlargement, secretion; breast cancer; fibrocystic breast changes.
- Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism, myocardial infarction, stroke; increase in blood pressure.
- Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating; cholestatic jaundice; pancreatitis; increased incidence of gallbladder disease; enlargement of hepatic hemangiomas.
- Skin: Chloasma or melasma which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritis; rash; urticaria.
- Eyes: Retinal vascular thrombosis; intolerance to contact lenses.
- Central Nervous System: Headache; migraine; dizziness; nervousness; mood disturbances; irritability; mental depression; chorea; exacerbation of epilepsy; dementia.
- Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; glucose intolerance; aggravation of porphyria; edema; changes in libido; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; angioedema; hypersensitivity; increased triglycerides; arthralgias; leg cramps.
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