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Ogen 1.25 Side Effects

Generic name: estropipate

Medically reviewed by Drugs.com. Last updated on Oct 22, 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 1.25.

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 1.25

Along with its needed effects, estropipate (the active ingredient contained in Ogen 1.25) 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

Other side effects of Ogen 1.25

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

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]

References

1. Product Information. Ortho-Est (estropipate). Ortho McNeil Pharmaceutical. 2001.

2. Julian TM. Pseudoincontinence secondary to unopposed estrogen replacement in the surgically castrate premenopausal female. Obstet Gynecol. 1987;70:382-3.

3. Lozman H, Barlow AL, Levitt DG. Piperazine estrone sulfate and conjugated estrogens equine in the treatment of the menopausal syndrome. South Med J. 1971;64:1143-9.

4. Obrink A, Bunne G, Collen J, Tjernberg B. Endometrial cancer and exogenous estrogens. Acta Obstet Gynecol Scand. 1979;58:123.

5. Palmer JR, Rosenberg L, Clarke EA, Miller DR, Shapiro S. Breast cancer risk after estrogen replacement therapy: results from the Toronto Breast Cancer Study. Am J Epidemiol. 1991;134:1386-95.

6. Kaufman DW, Palmer JR, de Mouzon J, Rosenberg L, Stolley PD, Warshauer ME, Zauber AG, Shapiro S. Estrogen replacement therapy and the risk of breast cancer: results from the case-control surveillance study. Am J Epidemiol. 1991;134:1375-85.

7. Spengler RF, Clarke EA, Woolever CA, Newman AM, Osborn RW. Exogenous estrogens and endometrial cancer: a case-control study and assessment of potential biases. Am J Epidemiol. 1981;114:497-506.

8. Persson I, Adami HO, Bergkvist L, Lindgren A, Pettersson B, Hoover R, Schairer C. Risk of endometrial cancer after treatment with oestrogens alone or in conjunction with progestogens: results of a prospective study. BMJ. 1989;298:147-51.

9. Thomas DB, Persing JP, Hutchinson WB. Exogenous estrogens and other risk factors for breast cancer in women with benign breast diseases. J Natl Cancer Inst. 1982;69:1017-25.

10. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R. Endometrial cancer and estrogen use. Report of a large case-control study. N Engl J Med. 1979;300:9-13.

11. Gordon J, Reagan JW, Finkle WD, Ziel HK. Estrogen and endometrial carcinoma. An independent pathology review supporting original risk estimate. N Engl J Med. 1977;297:570-1.

12. Bergkvist L, Adami HO, Persson I, Hoover R, Schairer C. The risk of breast cancer after estrogen and estrogen-progestin replacement. N Engl J Med. 1989;321:293-7.

13. Gray LA Sr, Christopherson WM, Hoover RN. Estrogens and endometrial carcinoma. Obstet Gynecol. 1977;49:385-9.

14. Boston Collaborative Drug Surveilance Program. Surgically confirmed gallbladder disease, venous thromboembolism, and breast tumors in relation to postmenopausal estrogen therapy. N Engl J Med. 1974;290:15-9.

15. Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med. 1995;332:1589-93.

16. Stanford JL, Weiss NS, Voigt LF, Daling JR, Habel LA, Rossing MA. Combined estrogen and progestin hormone replacement therapy in relation to risk of breast cancer in middle-aged women. JAMA. 1995;274:137-42.

17. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. JAMA. 1996;275:370-5.

18. Gapstur SM, Morrow M, Sellers TA. Hormone replacement therapy and risk of breast cancer with a favorable histology: results of the Iowa women's health study. JAMA. 1999;281:2091-7.

19. Crane MG, Harris JJ. Estrogens and hypertension: effect of discontinuing estrogens on blood pressure, exchangeable sodium, and the renin-aldosterone system. Am J Med Sci. 1978;276:33-55.

20. Rosenberg L, Slone D, Shapiro S, Kaufman D, Stolley PD, Miettinen OS. Noncontraceptive estrogens and myocardial infarction in young women. JAMA. 1980;244:339-42.

21. Jick H, Dinan B, Rothman KJ. Noncontraceptive estrogens and nonfatal myocardial infarction. JAMA. 1978;239:1407-8.

22. Wren BG, Routledge DA. Blood pressure changes: oestrogens in climacteric women. Med J Aust. 1981;2:528-31.

23. Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen and cardiovascular disease. Ten-year follow-up from the Nurses' Health Study. N Engl J Med. 1991;325:756-62.

24. Devor M, Barrett-Connor E, Renvall M, Feigal D, Ramsdell J. Estrogen replacement therapy and the risk of venous thrombosis. Am J Med. 1992;92:275-81.

25. Barrett-Connor E, Bush TL. Estrogen and coronary heart disease in women. JAMA. 1991;265:1861-7.

26. Grady D, Rubin SM, Petiti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992;117:1016-36.

27. Barrett-Connor E, Wingard DL, Criqui MH. Postmenopausal estrogen use and heart disease risk factors in the 1980s. Rancho Bernardo, Calif, revisited. JAMA. 1989;261:1095-2100.

28. Schwartz J, Freeman R, Frishman W. Clinical pharmacology of estrogens: cardiovascular actions and cardioprotective benefits of replacement therapy in postmenopausal women. J Clin Pharmacol. 1995;35:1-16.

29. The Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1995;273:199-208.

30. Collins P, Beale CM, Rosano GMC. Oestrogen as a calcium channel blocker. Eur Heart J. 1996;17 ( Suppl:27-31.

31. Bagdade JD, Subbaiah PV. Effects of estropipate treatment on plasma lipids and lipoprotein lipid composition in postmenopausal women. J Clin Endocrinol Metab. 1991;72:283-6.

32. Isaacs AJ, Havard CW. Effect of piperazine oestrone sulphate on serum lipids and lipoproteins in menopausal women. Acta Endocrinol (Copenh). 1977;85:143-50.

33. Molitch ME, Oill P, Odell WD. Massive hyperlipemia during estrogen therapy. JAMA. 1974;227:522-5.

34. Lagrelius A, Johnson P, Lunell NO, Samsioe G. Treatment with oral estrone sulphate in the female climacteric. I. Influence on lipids. Acta Obstet Gynecol Scand. 1981;60:27-31.

35. Conter RL, Longmire WP Jr. Recurrent hepatic hemangiomas. Possible association with estrogen therapy. Ann Surg. 1988;207:115-9.

36. Aldinger K, Ben-Menachem Y, Whalen G. Focal nodular hyperplasia of the liver associated with high-dosage estrogens. Arch Intern Med. 1977;137:357-9.

37. Oppenheim G. A case of rapid mood cycling with estrogen: implications for therapy. J Clin Psychiatry. 1984;45:34-5.

38. Steiger MJ, Quinn NP. Hormone replacement therapy induced chorea. BMJ. 1991;302:762.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.