Ogen 0.625 Side Effects

Generic name: estropipate

Medically reviewed by Drugs.com. Last updated on Dec 6, 2023.

Note: This document contains side effect information about estropipate. Some dosage forms listed on this page may not apply to the brand name Ogen 0.625.

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 Ogen 0.625

Along with its needed effects, estropipate (the active ingredient contained in Ogen 0.625) 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 Ogen 0.625

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]