Applies to estropipate: oral tablet.
Warning
Oral route (Tablet)
Estrogen-Alone TherapyEndometrial CancerThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable DementiaEstrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]- alone, relative to placebo. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg) alone relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable DementiaEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Breast CancerThe WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Serious side effects of Estropipate
Along with its needed effects, estropipate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking estropipate:
Incidence not known
- Acid or sour stomach
- anxiety
- backache
- belching
- breast discharge, swelling, or pain
- change in vaginal discharge
- changes in skin color, pain, tenderness
- chest pain or discomfort
- chills
- clay-colored stools
- confusion
- constipation
- cough
- cramps
- darkened urine
- diarrhea
- difficulty speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- fever
- full or bloated feeling or pressure in the stomach
- headache
- heartburn
- heavy bleeding
- hives, itching, skin rash
- inability to move the arms, legs, or facial muscles
- inability to speak
- indigestion
- itching of the vagina or outside genitals
- loss of appetite
- nausea
- pain during sexual intercourse
- pain or discomfort in the arms, jaw, back, or neck
- pain or feeling of pressure in the pelvis
- pains in stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow speech
- stomach discomfort, upset, or pain
- sudden shortness of breath or troubled breathing
- sweating
- swelling of the abdominal or stomach area
- tightness in the chest
- unpleasant breath odor
- unusual tiredness or weakness
- unusually heavy or unexpected menstrual bleeding
- vaginal yeast infection
- vaginal bleeding or spotting
- vomiting
- vomiting of blood
- yellow eyes or skin
Other side effects of Estropipate
Some side effects of estropipate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Hair loss
- inability to have or keep an erection
- increased hair growth, especially on the face
- loss in sexual ability, desire, drive, or performance
- patchy brown or dark brown discoloration of the skin
- swelling of the breasts or breast soreness in males
- trouble wearing contact lenses
- weight gain or loss
For Healthcare Professionals
Applies to estropipate: oral tablet.
General
The more commonly reported side effects have included headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting.[Ref]
Endocrine
Estrogen and/or Progestin Therapy:
Frequency not reported: Breast tenderness, breast pain, nipple discharge, galactorrhea, fibrocystic breast changes, changes in libido[Ref]
Genitourinary
Estrogen and/or Progestin Therapy:
Frequency not reported: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, endometrial hyperplasia[Ref]
Oncologic
Estrogen and/or Progestin Therapy:
Frequency not reported: Ovarian cancer, Endometrial cancer, Breast cancer[Ref]
Cardiovascular
Estrogen and/or Progestin Therapy:
Frequency not reported: Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increased blood pressure, edema[Ref]
Metabolic
Estrogen and/or Progestin Therapy:
Frequency not reported: Increased and decreased weight, reduced carbohydrate tolerance, elevated triglycerides, hypocalcemia[Ref]
Hypersensitivity
Estrogen and/or Progestin Therapy:
Frequency not reported: Anaphylaxis, anaphylactoid reactions[Ref]
Hepatic
Estrogen and/or Progestin Therapy:
Frequency not reported: Cholestatic jaundice, enlargement of hepatic hemangiomas[Ref]
Gastrointestinal
Estrogen and/or Progestin Therapy:
Frequency not reported: Nausea, vomiting, abdominal cramps, bloating, pancreatitis[Ref]
Psychiatric
Estrogen and/or Progestin Therapy:
Frequency not reported: Mental depression, nervousness, mood disturbances, irritability[Ref]
Dermatologic
Estrogen and/or Progestin Therapy:
Frequency not reported: Chloasma or melasma (may persist following discontinuation), erythema multiforme, erythema nodosum, hemorrhagic eruption, scalp hair loss, hirsutism, pruritus, rash, aggravation of porphyria, angioedema, urticaria[Ref]
Nervous system
Estrogen and/or Progestin Therapy:
Frequency not reported: Headache, migraine, dizziness, exacerbation of epilepsy, chorea, dementia[Ref]
Musculoskeletal
Estrogen and/or Progestin Therapy:
Frequency not reported: Arthralgias, leg cramps[Ref]
Respiratory
Estrogen and/or Progestin Therapy:
Frequency not reported: Exacerbation of asthma
Ocular
Estrogen and/or Progestin Therapy:
Frequency not reported: Retinal vascular thrombosis, steepening of corneal curvature, intolerance to contact lenses[Ref]
