Synthetic Conjugated Estrogens A Side Effects

Generic Name: conjugated estrogens topical

Note: This page contains side effects data for the generic drug conjugated estrogens topical. It is possible that some of the dosage forms included below may not apply to the brand name Synthetic Conjugated Estrogens A.

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

For the Consumer

Applies to conjugated estrogens topical: vaginal cream

As well as its needed effects, conjugated estrogens topical (the active ingredient contained in Synthetic Conjugated Estrogens A) may cause unwanted side effects that require medical attention.

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

More common
  • Breast pain
  • change in vaginal discharge
  • cough or hoarseness
  • fever or chills
  • increased clear or white vaginal discharge
  • itching of the vagina or genital area
  • lower back or side pain
  • pain during sexual intercourse
  • pain or feeling of pressure in the pelvis
  • painful or difficult urination
  • thick, white vaginal discharge with no odor or with a mild odor
  • vaginal bleeding
Less common
  • Feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • sweating
Incidence not known
  • Abdominal or stomach bloating
  • abnormal uterine bleeding or spotting
  • acne
  • anxiety
  • bloody or cloudy urine
  • breast tenderness, enlargement, pain, or discharge
  • chest pain or discomfort
  • decreased vision or other changes in vision
  • difficulty with swallowing
  • enlargement of the penis or testes
  • fast heartbeat
  • frequent urge to urinate
  • growth of pubic hair
  • hives
  • itching
  • itching of the vagina or outside genitals
  • nausea
  • pain during sexual intercourse
  • pain or discomfort in the arms, jaw, back, or neck
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid increase in height
  • shortness of breath
  • stomach pain
  • sudden shortness of breath or troubled breathing
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing

Some conjugated estrogens topical 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
  • Abdominal or stomach pain
  • back pain
  • diarrhea
  • headache
  • lack or loss of strength
Less common
  • Body aches or pain
  • congestion
  • increased dryness or soreness of the throat
  • runny nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes
Incidence not known
  • Abdominal or stomach cramps
  • changes in weight
  • decreased or increased interest in sexual intercourse
  • depression
  • difficulty with moving
  • headache, severe and throbbing
  • heavy bleeding
  • inability to have or keep an erection
  • increased hair growth, especially on the face
  • irritability
  • itching of the vagina or genitals
  • leg cramps
  • loss of scalp hair
  • loss or increase in sexual ability, desire, drive, or performance
  • mood changes
  • muscle pain or stiffness
  • nervousness
  • pain
  • pain in the joints
  • patchy brown or dark brown discoloration of the skin
  • poor insight and judgment
  • problems with memory or speech
  • swelling of the breasts or breast soreness in both females and males
  • trouble recognizing objects
  • trouble thinking and planning
  • weakness

For Healthcare Professionals

Applies to conjugated estrogens topical: vaginal cream with applicator

Oncologic

Oncologic side effects have included an increased risks of endometrial carcinoma, ovarian cancer, and breast cancer.[Ref]

Cardiovascular

Cardiovascular side effects have included deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, increase in blood pressure, and myocardial infarction.[Ref]

The manufacturer recommends close observation if conjugated estrogens must be used in patients who may be particularly sensitive to fluid retention because of underlying asthma, epilepsy, migraine, heart disease, and renal dysfunction.[Ref]

Genitourinary

Genitourinary side effects have included breakthrough bleeding, spotting, changes in vaginal bleeding pattern, abnormal withdrawal bleeding or flow, dysmenorrhea, increase the size of preexisting uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis like syndrome, application site reactions of vulvovaginal discomfort including burning and irritation, genital pruritus, ovarian cancer, endometrial hyperplasia, and precocious puberty. Additional side effects have included breast enlargement, breast pain, dysuria, leukorrhea, metrorrhagia, urinary frequency, urinary tract infection, urinary urgency, vaginal hemorrhage, vaginal moniliasis, vaginitis, and vulvovaginal disorder.[Ref]

Metabolic

Metabolic side effects have included increased serum triglyceride levels and reduced carbohydrate tolerance. Aggravation of porphyria has been reported.[Ref]

General

General side effects have included reports of fluid retention, and increase or decrease in weight.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, pancreatitis, and increased incidence of gallbladder disease. Ischemic colitis has also been reported.[Ref]

Hematologic

Hematologic side effects have included hypercoagulability. Several cases of the hemolytic uremic syndrome have also been associated with conjugated estrogen therapy.[Ref]

Hepatic

Many of the reports of hepatic tumors have occurred in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.[Ref]

Hepatic side effects have included enlargement of hepatic hemangiomas and rare cases of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas and well differentiated hepatocellular carcinomas.[Ref]

Nervous system

Nervous system side effects have included migraine, dizziness, nervousness, mood disturbances, irritability, chorea, exacerbation of epilepsy, dementia, and mental depression. Possible growth potentiation of benign meningioma has also been reported.[Ref]

Other

Other side effects have included breast tenderness, pain, enlargement, secretion, and fibrocystic breast changes. Postmarketing experience has included reports of gynecomastia in males.[Ref]

Psychiatric

Psychiatric side effects have included reports of rapid mood cycling in patients with severe depression.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported in postmarketing experience.

Respiratory

Respiratory side effects have included pulmonary embolism, exacerbation of asthma, and rare cases of exacerbations of pulmonary lymphangioleiomyomatosis. In addition, combinations of high-dose conjugated estrogens and progestin have been reported to increase ventilation and increase the hypoxic ventilatory response.[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma, which did not always resolve following discontinuation of estrogen therapy, scalp hair loss, hirsutism, erythema multiforme, erythema nodosum, rash, pruritus, and hemorrhagic eruptions. Acne and erythema have also been reported.[Ref]

Endocrine

Endocrine side effects have included increased levels of thyroxin-binding globulin, leading to an increase in total thyroid serum levels and a decrease in resin uptake of T3. Free thyroid hormone levels remain unchanged. Other endocrine effects include decreased fasting plasma glucose.[Ref]

Ocular

Ocular side effects have included retinal vascular thrombosis and intolerance to contact lenses.[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscle cramps.

References

1. 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

2. Woodruff JD, Pickar JH "Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone." Am J Obstet Gynecol 170 (1994): 1213-23

3. Buring JE, Bain CJ, Ehrmann RL "Conjugated estrogen use and risk of endometrial cancer." Am J Epidemiol 124 (1986): 434-41

4. 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

5. 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

6. 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

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 114 (1981): 497-506

8. 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

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. Shapiro S, Kelly JP, Rosenberg L, Kaufman DW, Helmrich SP, Rosenshein NB, Lewis JL Jr, Knapp RC, Stolley PD, Schottenfeld D "Risk of localized and widespread endometrial cancer in relation to recent and discontinued use of conjugated estrogens." N Engl J Med 313 (1985): 969-72

11. 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

12. 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

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

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

15. Hoover R, Glass A, Finkle WD, Azevedo D, Milne K "Conjugated estrogens and breast cancer risk in women." J Natl Cancer Inst 67 (1981): 815-20

16. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

17. 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

18. 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

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

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

21. 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

22. 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

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 325 (1991): 756-62

24. 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

25. 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

26. Pripp U, Hall G, Csemiczky G, Eksborg S, Landgren BM, SchenckGustafsson K "A randomized trial on effects of hormone therapy on ambulatory blood pressure and lipoprotein levels in women with coronary artery disease." J Hypertens 17 (1999): 1379-86

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

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

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

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

32. Julian TM "Pseudoincontinence secondary to unopposed estrogen replacement in the surgically castrate premenopausal female." Obstet Gynecol 70 (1987): 382-3

33. McClennan BL "Ischemic colitis secondary to Premarin: report of a case." Dis Colon Rectum 19 (1976): 618-20

34. 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

35. Ashouri OS, Marbury TC, Fuller TJ, Gaffney E, Grubb WG, Cade JR "Hemolytic uremic syndrome in two postmenopausal women taking a conjugated estrogen preparation." Clin Nephrol 17 (1982): 212-5

36. 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

37. Boschetti C, Cortellaro M, Nencioni T, Bertolli V, Della Volpe A, Zanussi C "Short- and long-term effects of hormone replacement therapy (transdermal estradiol vs oral conjugated equine estrogens, combined with medroxyprogesterone acetate) on blood coagulation factors in postmenopausal women." Thromb Res 62 (1991): 1-8

38. 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

39. MacLennan AH, MacLennan A, O'Neill S, Kirkgard Y, Wenzel S, Chambers HM "Oestrogen and cyclical progestogen in postmenopausal hormone replacement therapy." Med J Aust 157 (1992): 167-70

40. Steiger MJ, Quinn NP "Hormone replacement therapy induced chorea." BMJ 302 (1991): 762

41. Jick SS, Walker AM, Jick H "Conjugated estrogens and fibrocystic breast disease." Am J Epidemiol 124 (1986): 746-51

42. Pastides H, Najjar MA, Kelsey JL "Estrogen replacement therapy and fibrocystic breast disease." Am J Prev Med 3 (1987): 282-6

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

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