SAFETY AND SIDE EFFECTS OF PREMARIN

WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT PREMARIN?

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using PREMARIN® (conjugated estrogens tablets, USP). Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).

Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.

Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women 65 years of age or older.

You and your healthcare provider should talk regularly about whether you still need treatment.

DO NOT TAKE PREMARIN IF YOU:

  • Have unusual vaginal bleeding
  • Have or had cancer
  • Had a stroke or heart attack
  • Have or had blood clots or liver problems
  • Have a bleeding disorder
  • Are allergic to any of its ingredients
  • Think you may be pregnant

ADDITIONAL IMPORTANT INFORMATION:

  • In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus
  • Estrogens increase the risk of gallbladder disease
  • Discontinue estrogen if loss of vision, pancreatitis, or liver problems occur
  • If you take thyroid medication, consult your healthcare provider, as use of estrogens may change the amount needed

MOST COMMON (≥5%) SIDE EFFECTS:

  • Abdominal pain
  • Asthenia
  • Pain
  • Back pain
  • Headache
  • Flatulence
  • Nausea
  • Depression
  • Insomnia
  • Breast pain
  • Endometrial hyperplasia
  • Leucorrhea
  • Vaginal hemorrhage
  • Vaginitis