ADVERSE REACTIONS
See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.
Premarin Intravenous for injection is indicated for short-term use. However, the warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into account.
The following adverse reactions have been identified during post-approval use of oral or intravenous Premarin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary system
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- Abnormal uterine bleeding/spotting.
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- Dysmenorrhea or pelvic pain.
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- Increase in size of uterine leiomyomata.
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- Vaginitis, including vaginal candidiasis.
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- Change in amount of cervical secretion.
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- Change in cervical ectropion.
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- Ovarian cancer.
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- Endometrial hyperplasia.
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- Endometrial cancer.
Breasts
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- Tenderness, enlargement, pain, discharge, galactorrhea.
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- Fibrocystic breast changes.
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- Breast cancer.
Cardiovascular
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- Deep and superficial venous thrombosis.
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- Pulmonary embolism.
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- Thrombophlebitis.
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- Myocardial infarction.
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- Stroke.
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- Increase in blood pressure.
Gastrointestinal
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- Nausea, vomiting.
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- Abdominal cramps, bloating.
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- Cholestatic jaundice.
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- Increased incidence of gallbladder disease.
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- Pancreatitis.
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- Enlargement of hepatic hemangiomas.
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- Ischemic colitis.
Skin
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- Chloasma or melasma that may persist when drug is discontinued.
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- Erythema multiforme.
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- Erythema nodosum.
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- Hemorrhagic eruption.
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- Loss of scalp hair.
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- Hirsutism.
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- Pruritis.
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- Rash.
Eyes
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- Retinal vascular thrombosis.
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- Intolerance to contact lenses.
Central Nervous System
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- Headache.
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- Migraine.
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- Dizziness.
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- Mental depression.
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- Exacerbation of chorea.
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- Nervousness.
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- Exacerbation of epilepsy.
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- Dementia.
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- Possible growth potentiation of benign meningioma.
Miscellaneous
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- Increase or decrease in weight.
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- Glucose intolerance.
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- Aggravation of porphyria.
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- Edema.
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- Arthralgia.
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- Leg cramps.
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- Changes in libido.
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- Urticaria.
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- Hypocalcemia (preexisting condition).
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- Injection site pain.
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- Injection site edema.
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- Phlebitis (injection site).
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- Exacerbation of asthma.
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- Increased triglycerides.