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Oesclim Side Effects

Generic Name: estradiol

Note: This page contains side effects data for the generic drug estradiol. It is possible that some of the dosage forms included below may not apply to the brand name Oesclim.

For the Consumer

Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet

As well as its needed effects, estradiol (the active ingredient contained in Oesclim) may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking estradiol, check with your doctor immediately:

Less common:
  • Vaginal yeast infection
Incidence not known:
  • Change in vaginal discharge
  • clear or bloody discharge from the nipple
  • decrease in the amount of urine
  • dimpling of the breast skin
  • fast heartbeat
  • fever
  • hives, itching, or rash
  • hoarseness
  • inverted nipple
  • irritation
  • joint pain, stiffness, or swelling
  • lump in the breast or under the arm
  • noisy, rattling breathing
  • pain or feeling of pressure in the pelvis
  • pain, redness, or swelling in the arm or leg
  • persistent crusting or scaling of the nipple
  • redness of the skin
  • redness or swelling of the breast
  • sore on the skin of the breast that does not heal
  • swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
  • tightness in the chest
  • troubled breathing at rest
  • troubled breathing or swallowing
  • vaginal bleeding

If any of the following symptoms of overdose occur while taking estradiol, get emergency help immediately:

Symptoms of overdose:
  • Abdominal or stomach pain
  • dizziness
  • drowsiness
  • nausea or vomiting
  • tenderness of the breasts
  • unusual tiredness or weakness

Severity: Minor

Some estradiol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Back pain
  • headache
  • itching or pain of the vagina or genital area
  • thick, white vaginal discharge with mild or no odor
  • weight gain
Less common:
  • Body aches or pain
  • chills
  • cough
  • diarrhea
  • ear congestion
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
Incidence not known:
  • Feeling sad or empty
  • headache, severe and throbbing
  • irritability
  • lack of appetite
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • welts

For Healthcare Professionals

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

Gastrointestinal

Cases of oral pigmentation and ischemic colitis have been reported rarely.[Ref]

Cardiovascular

The reported effects of estrogens on cardiovascular activity are variable. Alterations in lipid profiles in treated women are thought to be responsible for reducing cardiovascular risks. Data suggest estrogen use may increase blood pressure, particularly in patients receiving high doses, decrease blood pressure, or result in no change. In addition, noncontraceptive use of estrogens in young women (particularly smokers) may substantially increase the risk of nonfatal myocardial infarction. Other studies have concluded that no increased risk of myocardial infarction exists.[Ref]

Endocrine

Endocrine side effects have included increased levels of thyroxin-binding globulin which led to increased total thyroid serum levels and a decreased in resin uptake of T3. Free thyroid hormone levels remained unchanged. Other endocrine effects have included decreased fasting plasma glucose.[Ref]

Hepatic

Hepatic side effects have included reports of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas, and well-differentiated hepatocellular carcinomas. Aggravation of porphyria has been reported. Postmarketing side effects with Vivelle-Dot include abnormal liver function tests.[Ref]

References

1. "Product Information. Estrace (estradiol)." Bristol-Myers Squibb, Princeton, NJ.

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

3. 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

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

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

6. 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

7. 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

8. 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

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

10. 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

11. 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

12. 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 90 (2002): 82-5

13. Belchetz PE "Hormonal treatment of postmenopausal women." N Engl J Med 330 (1994): 1062-71

14. 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

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

16. 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

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

18. 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 60 (1999): 534-47

19. Malini S, Smith EO, Goldzieher JW "Measurement of breast volume by ultrasound during normal menstrual cycles and with oral contraceptive use." Obstet Gynecol 66 (1985): 538-41

20. Molitch ME, Oill P, Odell WD "Massive hyperlipemia during estrogen therapy." JAMA 227 (1974): 522-5

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

22. 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

It is possible that some side effects of Oesclim may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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