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Climodien Side Effects

Generic name: estradiol

Medically reviewed by Drugs.com. Last updated on Jan 5, 2024.

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

For Healthcare Professionals

Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring.

Genitourinary

Very common (10% or more): Breast pain (29%)

Common (1% to 10%): Vulvovaginal pruritus, leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia, metrorrhagia, endometrial hyperplasia

Uncommon (0.1% to 1%): Urinary problems

Rare (less than 0.1%): Galactorrhea

Postmarketing reports: Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain, breast tenderness, vaginal ulceration, uterine fibroids[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (16%),

Common (1% to 10%): Flatulence, nausea, diarrhea

Uncommon (0.1% to 1%): Vomiting

Postmarketing reports: Abdominal distension[Ref]

Musculoskeletal

Very common (10% or more): Back pain (11%), arthralgia (11%)

Common (1% to 10%): Leg cramps[Ref]

Cardiovascular

Common (1% to 10%): Varicose veins, cardiac symptoms (e.g. palpitations)

Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease

Rare (less than 0.1%): Arterial hypertension

Postmarketing reports: Deep vein thrombosis, changes in blood pressure[Ref]

Nervous system

Very common (10% or more): Headache (18%)

Uncommon (0.1% to 1%): Vertigo, migraine

Rare (less than 0.1%): Aggravation of epilepsy

Postmarketing reports: Migraine aggravated, paresthesia, dizziness[Ref]

Oncologic

Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma

Postmarketing reports: Endometrial cancer, breast cancer[Ref]

Other

Very common (10% or more): Pain (11%)

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Weight increased, asthenia

Postmarketing reports: Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema[Ref]

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Sleep disorders, nervousness, mood swings

Rare (less than 0.1%): Change in libido

Postmarketing reports: Vaginismus, insomnia, anxiety, irritability[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Skin discoloration, acne

Postmarketing reports: Urticaria, erythematous or pruritic rash, alopecia, hyperhidrosis, night sweats, contact dermatitis, eczema[Ref]

Ocular

Uncommon (0.1% to 1%): Vision abnormal NOS

Postmarketing reports: Visual disturbances, contact lens intolerance[Ref]

Hepatic

Rare (less than 0.1%): Liver function tests abnormalities

Postmarketing reports: Cholestatic jaundice[Ref]

Metabolic

Rare (less than 0.1%): Glucose intolerance

Postmarketing reports: Fluid retention[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)

Postmarketing reports: Anaphylactic reactions, hypersensitivity[Ref]

Immunologic

Very common (10% or more): Upper respiratory tract infection (17%)

Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis, rhinitis, sinusitis, moniliasis genital

Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis[Ref]

Local

Common (1% to 10%): Skin irritation (topical gel)

Postmarketing reports: Application site reaction[Ref]

References

1. Auerbach R, Mittal K, Schwartz PE. Estrogen and progestin receptors in an ovarian ependymoma. Obstet Gynecol. 1988;71:1043-5.

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

3. Product Information. Climara (estradiol). Berlex Laboratories. 2001;PROD.

4. Product Information. Estrace (estradiol). Warner Chilcott Laboratories. 2001;PROD.

5. Nash HA, AlvarezSanchez F, Mishell DR, Fraser IS, Maruo T, Harmon TM. Estradiol-delivering vaginal rings for hormone replacement therapy. Am J Obstet Gynecol. 1999;181:1400-6.

6. Cerner Multum, Inc. Australian Product Information.

7. Product Information. Yuvafem (estradiol topical). AvKare Inc. 2017.

8. Product Information. Estradiol Vaginal Insert (estradiol topical). Teva Pharmaceuticals USA. 2017.

9. 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.

10. 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.

11. Crane MG, Harris JJ, Winsor W 3d. Hypertension, oral contraceptive agents, and conjugated estrogens. Ann Intern Med. 1971;74:13-21.

12. 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.

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

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

15. Belchetz PE. Hormonal treatment of postmenopausal women. N Engl J Med. 1994;330:1062-71.

16. 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.

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

18. 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.

19. 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.

20. 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.

21. 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.

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

23. Bui MN, Arai AE, Hathaway L, Waclawiw MA, Csako G, Cannon RO 3rd. Effect of hormone replacement therapy on carotid arterial compliance in healthy postmenopausal women. Am J Cardiol. 2002;90:82-5.

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

25. Cohen L, Coxwell WL, Melchione T, Koltun W, Gibson E, Gupta N, Roberts M. Low-dose 17-beta estradiol matrix transdermal system in the treatment of moderate-to-severe hot flushes in postmenopausal women. Curr Ther Res Clin Exp. 1999;60:534-47.

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

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

32. 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.

33. 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.

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

35. 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.

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

37. 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.

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

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

40. 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.

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

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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