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Ogen Side Effects

Generic Name: estropipate

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

For the Consumer

Applies to estropipate: oral tablet

Warning

  • Estrogens may raise the chance of uterine cancer. Progestins may lower this chance. A warning sign for cancer of the uterus is vaginal bleeding. Report any vaginal bleeding to the doctor.
  • Do not use estrogens to prevent heart disease or dementia. Using estrogens may raise the chances of having a heart attack, a stroke, breast cancer, ovarian cancer, a blood clot, or dementia.
  • Use estrogens with or without progestin for the shortest time needed at the lowest useful dose.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Dizziness or passing out.
  • Change in eyesight.
  • Loss of eyesight.
  • Bulging eyes.
  • Change in how contact lenses feel in the eyes.
  • A lump in the breast, breast soreness, or nipple discharge.
  • Breast pain.
  • Vaginal itching or discharge.
  • Vaginal bleeding that is not normal.
  • Low mood (depression).
  • Mood changes.
  • Memory problems or loss.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Hair loss.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • Bloating.
  • Tender breasts.
  • Vaginal bleeding or spotting.
  • Feeling nervous and excitable.
  • Weight gain or loss.
  • Joint pain.
  • Lowered interest in sex.
  • This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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]

Nervous system

Estrogen and/or Progestin Therapy:

Frequency not reported: Headache, migraine, dizziness, exacerbation of epilepsy, chorea, dementia[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]

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, Raritan, NJ.

2. Julian TM "Pseudoincontinence secondary to unopposed estrogen replacement in the surgically castrate premenopausal female." Obstet Gynecol 70 (1987): 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 64 (1971): 1143-9

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

5. 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 134 (1991): 1375-85

6. 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 332 (1995): 1589-93

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

8. Gray LA Sr, Christopherson WM, Hoover RN "Estrogens and endometrial carcinoma." Obstet Gynecol 49 (1977): 385-9

9. 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 300 (1979): 9-13

10. 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 321 (1989): 293-7

11. 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 114 (1981): 497-506

12. 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 69 (1982): 1017-25

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

14. 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 274 (1995): 137-42

15. 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 281 (1999): 2091-7

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

17. 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 298 (1989): 147-51

18. 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 134 (1991): 1386-95

19. Jick H, Dinan B, Rothman KJ "Noncontraceptive estrogens and nonfatal myocardial infarction." JAMA 239 (1978): 1407-8

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

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

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

23. Barrett-Connor E, Bush TL "Estrogen and coronary heart disease in women." JAMA 265 (1991): 1861-7

24. 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 276 (1978): 33-55

25. 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 273 (1995): 199-208

26. Wren BG, Routledge DA "Blood pressure changes: oestrogens in climacteric women." Med J Aust 2 (1981): 528-31

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

28. 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 325 (1991): 756-62

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

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

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

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

33. Molitch ME, Oill P, Odell WD "Massive hyperlipemia during estrogen therapy." JAMA 227 (1974): 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 60 (1981): 27-31

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

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

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

38. Steiger MJ, Quinn NP "Hormone replacement therapy induced chorea." BMJ 302 (1991): 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.

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