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
- Abnormal uterine bleeding/spotting.
- Dysmenorrhea or pelvic pain.
- Increase in size of uterine leiomyomata.
- Vaginitis, including vaginal candidiasis.
- Change in amount of cervical secretion.
- Change in cervical ectropion.
- Ovarian cancer.
- Endometrial hyperplasia.
- Endometrial cancer.
Breasts
- Tenderness, enlargement, pain, discharge, galactorrhea.
- Fibrocystic breast changes.
- Breast cancer.
Cardiovascular
- Deep and superficial venous thrombosis.
- Pulmonary embolism.
- Thrombophlebitis.
- Myocardial infarction.
- Stroke.
- Increase in blood pressure.
Gastrointestinal
- Nausea, vomiting.
- Abdominal cramps, bloating.
- Cholestatic jaundice.
- Increased incidence of gallbladder disease.
- Pancreatitis.
- Enlargement of hepatic hemangiomas.
- Ischemic colitis.
Skin
- Chloasma or melasma that may persist when drug is discontinued.
- Erythema multiforme.
- Erythema nodosum.
- Hemorrhagic eruption.
- Loss of scalp hair.
- Hirsutism.
- Pruritis.
- Rash.
Eyes
- Retinal vascular thrombosis.
- Intolerance to contact lenses.
Central Nervous System
- Headache.
- Migraine.
- Dizziness.
- Mental depression.
- Exacerbation of chorea.
- Nervousness.
- Exacerbation of epilepsy.
- Dementia.
- Possible growth potentiation of benign meningioma.
Miscellaneous
- Increase or decrease in weight.
- Glucose intolerance.
- Aggravation of porphyria.
- Edema.
- Arthralgia.
- Leg cramps.
- Changes in libido.
- Urticaria.
- Hypocalcemia (preexisting condition).
- Injection site pain.
- Injection site edema.
- Phlebitis (injection site).
- Exacerbation of asthma.
- Increased triglycerides.