Skip to main content

Kelnor 1/50 Side Effects

Generic name: ethinyl estradiol / ethynodiol

Medically reviewed by Drugs.com. Last updated on May 25, 2023.

Note: This document contains side effect information about ethinyl estradiol / ethynodiol. Some dosage forms listed on this page may not apply to the brand name Kelnor 1/50.

Applies to ethinyl estradiol / ethynodiol: oral tablet.

Warning

Oral route (Tablet)

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Serious side effects of Kelnor 1/50

Along with its needed effects, ethinyl estradiol/ethynodiol 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 ethinyl estradiol / ethynodiol:

Incidence not known

Other side effects of Kelnor 1/50

Some side effects of ethinyl estradiol / ethynodiol 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 ethinyl estradiol / ethynodiol: oral tablet.

General

The more commonly reported adverse events with combined oral contraceptives include nausea, vomiting, and headache.[Ref]

Cardiovascular

Combined Oral Contraceptives:

Frequency not reported: Increased risk of thrombophlebitis, thrombosis, arterial thromboembolism, myocardial infarction and coronary thrombosis; hypertension, edema[Ref]

Nervous system

Combined Oral Contraceptives:

Frequency not reported: Migraine, headache, dizziness, cerebral hemorrhage, cerebral thrombosis[Ref]

Genitourinary

Combined Oral Contraceptives:

Frequency not reported: Breakthrough bleeding and spotting, especially during the first several cycles; change in menstrual flow; amenorrhea during or after use; vaginal candidiasis; cystitis-like syndrome; vaginitis; hemolytic uremic syndrome; changes in cervical erosion or secretion; oligomenorrhea and amenorrhea following termination of oral contraceptive use[Ref]

Gastrointestinal

Combined Oral Contraceptives:

Frequency not reported: Nausea, vomiting abdominal cramps, bloating, mesenteric thrombosis, colitis, gallbladder disease[Ref]

Respiratory

Combined Oral Contraceptives:

Frequency not reported: Pulmonary embolism,

Endocrine

Combined Oral Contraceptives:

Frequency not reported: Temporary infertility after discontinuation of use; breast changes including tenderness, enlargement, and secretion; premenstrual syndrome; diminution in lactation when given immediately postpartum[Ref]

Hepatic

Combined Oral Contraceptives:

Frequency not reported: Benign and malignant liver tumors, and other hepatic lesions; cholestatic jaundice, Budd-Chiari syndrome[Ref]

Dermatologic

Combined Oral Contraceptives:

Frequency not reported: Chloasma or melasma (which may persist), rash (allergic), hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, acne, porphyria, hemorrhagic eruption

Psychiatric

Combined Oral Contraceptives:

Frequency not reported: Nervousness, mental depression, changes in libido[Ref]

Oncologic

Combined Oral Contraceptives:

Frequency not reported: Breast cancer, hepatocellular carcinoma, endocervical hyperplasia[Ref]

A number of studies have examined a possible relationship between the use of oral contraceptives and the development of breast cancer. Many of the studies have reported conflicting results. A committee of the World Health Organization evaluated these studies and the risks of breast cancer and concluded that: "Numerous studies have found no overall association between oral contraceptive use and risk of breast cancer." In addition, the same committee also examined a possible relationship between oral contraceptive use and neoplasms of the uterine cervix and concluded that: "There are insufficient data to draw any firm conclusions regarding the effects of combined oral contraceptives on the risk of cervical adenocarcinoma."

The World Health Organization committee also noted that some studies "have found a weak association between long-term use of oral contraceptives and breast cancer diagnosed before the age of 36, and perhaps up to the age 45....It is unclear whether this observed association is attributable to bias, the development of new cases of cancer, or accelerated growth of existing cancers."

The World Health Organization committee further concluded that there is no increased risk of breast cancer in women over the age of 45 who have previously taken oral contraceptives. In addition, studies suggest that use of oral contraceptives does not place specific groups of women (like those with a family history of breast cancer) at higher or lower risk, and variations in the hormonal content of oral contraceptives do not influence the risk of breast cancer.

In general, studies evaluating the potential risk of cervical cancer in patients taking oral contraceptives have been complicated by the large number of confounding factors which make investigations into the epidemiology of this neoplasm difficult. Some studies have suggested that women taking oral contraceptives are at increased risk of dysplasia, epidermoid carcinoma, and adenocarcinoma of the cervix. However, other studies have not found such an association.

The rate of death due to hepatocellular carcinoma in the United States has not changed during the last 25 years (a time during which use of oral contraceptive hormones has increased dramatically).

A committee of the World Health Organization has reported that in developing countries where hepatitis B virus infection and hepatocellular carcinoma are common, "short term use of oral contraceptives does not appear to be associated with an increased risk. Data on the effects of long term use are scarce."

A recent Italian case-control study of women with hepatocellular carcinoma has suggested that the relative risk of hepatocellular carcinoma is 2.2 for oral contraceptive users compared to women who never used oral contraceptives.

A similar American case-control study from 1989 also reported a strong association between oral contraceptive use and hepatocellular carcinoma but concluded that: "If this observed association is causal, the actual number of cases of liver cancer in the United States attributable to oral contraceptive use is small. Therefore, these findings do not have public health importance in the United States and other Western nations."[Ref]

Ocular

Combined Oral Contraceptives:

Frequency not reported: Retinal thrombosis, optic neuritis, changes in contact lens tolerance, cataracts, change in corneal curvature (steepening), ectropion[Ref]

Metabolic

Combined Oral Contraceptives:

Frequency not reported: Changes in appetite, increased/decreased weight, reduced tolerance to carbohydrates

Renal

Combined Oral Contraceptives:

Frequency not reported: Impaired renal function

References

1. Grimes DA. The safety of oral contraceptives: epidemiologic insights from the first 30 years. Am J Obstet Gynecol. 1992;166:1950-4.

2. Lanes SF, Birmann B, Walker AM, Singer S. Oral contraceptive type and functional ovarian cysts. Am J Obstet Gynecol. 1992;166:956-61.

3. John EM, Whittemore AS, Harris R, Itnyre J. Characteristics relating to ovarian cancer risk: collaborative analysis of seven U.S. case-control studies. Epithelial ovarian cancer in black women. Collaborative Ovarian Cancer Group. J Natl Cancer Inst. 1993;85:142-7.

4. Holt VL, Daling JR, McKnight B, Moore D, Stergachis A, Weiss NS. Functional ovarian cysts in relation to the use of monophasic and triphasic oral contraceptives. Obstet Gynecol. 1992;79:529-33.

5. Gross TP, Schlesselman JJ. The estimated effect of oral contraceptive use on the cumulative risk of epithelial ovarian cancer. Obstet Gynecol. 1994;83:419-24.

6. Hankinson SE, Colditz GA, Hunter DJ, Spencer TL, Rosner B, Stampfer MJ. A quantitative assessment of oral contraceptive use and risk of ovarian cancer. Obstet Gynecol. 1992;80:708-14.

7. Steinberg WM. Oral contraception: risks and benefits. Adv Contracept. 1989;5:219-28.

8. Friedman AJ, Wheeler JM. Incidence of ovarian cyst formation in women taking ethynodiol diacetate, 1mg, with ethinyl estradiol, 35 micrograms. J Reprod Med. 1991;36:345-9.

9. Burkman RT Jr. Benefits and risk of oral contraceptives. A reassessment. J Reprod Med. 1991;36:217-8.

10. Peterson HB, Lee NC. Long-term health risks and benefits of oral contraceptive use. Obstet Gynecol Clin North Am. 1990;17:775-88.

11. Oral contraceptives and neoplasia. WHO Scientific Group. World Health Organ Tech Rep Ser. 1992;817:1-46.

12. Colditz GA. Oral contraceptive use and mortality during 12 years of follow-up: the Nurses' Health Study. Ann Intern Med. 1994;120:821-6.

13. Williams RS. Benefits and risks of oral contraceptive use. Postgrad Med. 1992;92:155-7.

14. Rosenberg L, Palmer JR, Lesko SM, Shapiro S. Oral contraceptive use and the risk of myocardial infarction. Am J Epidemiol. 1990;131:1009-16.

15. Thorogood M, Mann J, Murphy M, Vessey M. Fatal stroke and use of oral contraceptives: findings from a case- control study. Am J Epidemiol. 1992;136:35-45.

16. Leaf DA, Bland D, Schaad D, Neighbor WE, Scott CS. Oral contraceptive use and coronary risk factors in women. Am J Med Sci. 1991;301:365-8.

17. Thorneycroft IH. Oral contraceptives and myocardial infarction. Am J Obstet Gynecol. 1990;163:1393-7.

18. Lidegaard O. Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study. BMJ. 1993;306:956-63.

19. Derman RJ. Oral contraceptives and cardiovascular risk. Taking a safe course of action. Postgrad Med. 1990;88:119-22.

20. Hannaford PC, Croft PR, Kay CR. Oral contraception and stroke. Evidence from the Royal College of General Practitioners' Oral Contraception Study. Stroke. 1994;25:935-42.

21. Derman R. Oral contraceptives: a reassessment. Obstet Gynecol Surv. 1989;44:662-8.

22. Mishell DR. Contraception. N Engl J Med. 1989;320:777-85.

23. Norris LA, Bonnar J. The effect of oestrogen dose and progestogen type on haemostatic changes in women taking low dose oral contraceptives. Br J Obstet Gynaecol. 1996;103:261-7.

24. Levine AB, Teppa J, Mcgough B, Cowchock FS. Evaluation of the prethrombotic state in pregnancy and in women using oral contraceptives. Contraception. 1996;53:255-7.

25. Petitti DB, Sidney S, Bernstein A, Wolf S, Quesenberry C, Ziel HK. Stroke in users of low-dose oral contraceptives. N Engl J Med. 1996;335:8-15.

26. Speroff L. Oral contraceptives and venous thromboembolism. Int J Gynaecol Obstet. 1996;54:45-50.

27. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG, Debertribeiro M, Medina E, Artigas J, Shen H, Zhong YH, Zhang DW,. Ischaemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study. Lancet. 1996;348:498-505.

28. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG. Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre, case-control study. Lancet. 1996;348:505-10.

29. Piegsa K, Guillebaud J. Oral contraceptives and the risk of DVT. Practitioner. 1996;240:544.

30. Martinelli I, Rosendaal FR, Vandenbroucke JP, Mannucci PM. Oral contraceptives are a risk factor for cerebral vein thrombosis. Thromb Haemost. 1996;76:477-8.

31. Farmer R, Lewis M. Oral contraceptives and mortality from venous thromboembolism. Lancet. 1996;348:1095.

32. Vandenbroucke JP, Bloemenkamp KWM, Helmerhorst FM, Rosendaal FR. Oral contraceptives and mortality from venous thromboembolism - reply. Lancet. 1996;348:1096-7.

33. Farley TMM, Meirik O, Poulter NR, Chang CL, Marmot MG. Oral contraceptives and thrombotic diseases: impact of new epidemiological studies. Contraception. 1996;54:193-5.

34. Thorogood M. Risk of stroke in users of oral contraceptives. JAMA. 1999;281:1255-6.

35. Omdal R, Roalso S. Chorea gravidarum and chorea associated with oral contraceptives-- diseases due to antiphospholipid antibodies? Acta Neurol Scand. 1992;86:219-20.

36. Product Information. Ortho-Novum 1/35 (ethinyl estradiol-norethindrone). Ortho McNeil Pharmaceutical.

37. Oren R, Fich A. Oral contraceptive-induced esophageal ulcer. Two cases and literature review. Dig Dis Sci. 1991;36:1489-90.

38. Shoupe D. Multicenter randomized comparative trial of two low-dose triphasic combined oral contraceptives containing desogestrel or norethindrone. Obstet Gynecol. 1994;83:679-85.

39. Waltimo J. Geographic tongue during a year of oral contraceptive cycles. Br Dent J. 1991;171:94-6.

40. Garg SK, Chase HP, Marshall G, Hoops SL, Holmes DL, Jackson WE. Oral contraceptives and renal and retinal complications in young women with insulin-dependent diabetes mellitus. JAMA. 1994;271:1099-102.

41. Janaud A, Rouffy J, Upmalis D, Dain MP. A comparison study of lipid and androgen metabolism with triphasic oral contraceptive formulations containing norgestimate or levonorgestrel. Acta Obstet Gynecol Scand Suppl. 1992;156:33-8.

42. Hannaford PC, Kay CR. Oral contraceptives and diabetes mellitus. BMJ. 1989;299:1315-6.

43. Stubblefield PG. Choosing the best oral contraceptive. Clin Obstet Gynecol. 1989;32:316-28.

44. Bracken MB, Hellenbrand KG, Holford TR. Conception delay after oral contraceptive use: the effect of estrogen dose. Fertil Steril. 1990;53:21-7.

45. Spellacy WN, Ellingson AB, Tsibris JC. The effects of two triphasic oral contraceptives on carbohydrate metabolism in women during 1 year of use. Fertil Steril. 1989;51:71-4.

46. Burkman RT, Zacur HA, Kimball AW, Kwiterovich P, Bell WR. Oral contraceptives and lipids and lipoproteins: Part I--Variations in mean levels by oral contraceptive type. Contraception. 1989;40:553-61.

47. Miwa LJ, Edmunds AL, Shaefer MS, Raynor SC. Idiopathic thromboembolism associated with triphasic oral contraceptives. DICP. 1989;23:773-5.

48. Kjaer K, Hagen C, Sando SH, Eshoj O. Contraception in women with IDDM. An epidemiological study. Diabetes Care. 1992;15:1585-90.

49. Godsland IF, Crook D. Update on the metabolic effects of steroidal contraceptives and their relationship to cardiovascular disease risk. Am J Obstet Gynecol. 1994;170:1528-36.

50. Tao LC. Oral contraceptive-associated liver cell adenoma and hepatocellular carcinoma. Cancer. 1991;68:341-7.

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

52. 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.

53. Palmer JR, Rosenberg L, Kaufman DW, Warshauer ME, Stolley P, Shapiro S. Oral contraceptive use and liver cancer. Am J Epidemiol. 1989;130:878-82.

54. Mooney MJ, Nyreen MR, Hall RA, Carter PL. Hepatic adenoma presenting as a right lower quadrant mass. Am Surg. 1993;59:229-31.

55. Gyorffy EJ, Bredfeldt JE, Black WC. Transformation of hepatic cell adenoma to hepatocellular carcinoma due to oral contraceptive use. Ann Intern Med. 1989;110:489-90.

56. Tavani A, Negri E, Parazzini F, Franceschi S, La Vecchia C. Female hormone utilisation and risk of hepatocellular carcinoma. Br J Cancer. 1993;67:635-7.

57. Mathieu D, Zafrani ES, Anglade MC, Dhumeaux D. Association of focal nodular hyperplasia and hepatic hemangioma. Gastroenterology. 1989;97:154-7.

58. Weden M, Glaumann H, Einarsson K. Protracted cholestasis probably induced by oral contraceptive. J Intern Med. 1992;231:561-5.

59. Le Bail B, Jouhanole H, Deugnier Y, Salame G, Pellegrin JL, Saric J, Balabaud C, Bioulac-Sage P. Liver adenomatosis with granulomas in two patients on long-term oral contraceptives. Am J Surg Pathol. 1992;16:982-7.

60. Ushiroyama T, Okamoto Y, Toyoda K, Sugimoto O. A case of panic disorder induced by oral contraceptive. Acta Obstet Gynecol Scand. 1992;71:78-80.

61. Deci PA, Lydiard RB, Santos AB, Arana GW. Oral contraceptives and panic disorder. J Clin Psychiatry. 1992;53:163-5.

62. Ewertz M. Oral contraceptives and breast cancer risk in Denmark. Eur J Cancer. 1992;28A:1176-81.

63. Delgado-Rodriguez M, Sillero-Arenas M, Martin-Moreno JM, Galvez-Vargas R. Oral contraceptives and cancer of the cervix uteri. A meta-analysis. Acta Obstet Gynecol Scand. 1992;71:368-76.

64. Sillero-Arenas M, Rodriguez-Contreras R, Delgado-Rodriguez M, Bueno-Cavanillas A, Galvez-Vargas R. Patterns of research. Oral contraceptives and cervical cancer. Acta Obstet Gynecol Scand. 1991;70:143-8.

65. Lund E. Oral contraceptives and breast cancer. A review with some comments on mathematical models. Acta Oncol. 1992;31:183-6.

66. Miller DR, Rosenberg L, Kaufman DW, Stolley P, Warshauer ME, Shapiro S. Breast cancer before age 45 and oral contraceptive use: new findings. Am J Epidemiol. 1989;129:269-80.

67. Rosenberg L, Palmer JR, Clarke EA, Shapiro S. A case-control study of the risk of breast cancer in relation to oral contraceptive use. Am J Epidemiol. 1992;136:1437-44.

68. Schlesselman JJ. Oral contraceptives and breast cancer. Am J Obstet Gynecol. 1990;163:1379-87.

69. Turnquest MA. Oral contraceptive use and incidence of cervical intraepithelial neoplasia. Am J Obstet Gynecol. 1993;168:1895-6.

70. Kaunitz AM. Oral contraceptives and gynecologic cancer: an update for the 1990s. Am J Obstet Gynecol. 1992;167:1171-6.

71. Romieu I, Willett WC, Colditz GA, Stampfer MJ, Rosner B, Hennekens CH, Speizer FE. Prospective study of oral contraceptive use and risk of breast cancer in women. J Natl Cancer Inst. 1989;81:1313-21.

72. Olsson H, Moller TR, Ranstam J. Early oral contraceptive use and breast cancer among premenopausal women: final report from a study in southern Sweden. J Natl Cancer Inst. 1989;81:1000-4.

73. Jones MW, Silverberg SG. Cervical adenocarcinoma in young women: possible relationship to microglandular hyperplasia and use of oral contraceptives. Obstet Gynecol. 1989;73:984-9.

74. Murray PP, Stadel BV, Schlesselman JJ. Oral contraceptive use in women with a family history of breast cancer. Obstet Gynecol. 1989;73:977-83.

75. Thomas DB. Oral contraceptives and breast cancer: review of the epidemiologic literature. Contraception. 1991;43:597-642.

76. Brinton LA. Oral contraceptives and cervical neoplasia. Contraception. 1991;43:581-95.

77. Lavecchia C, Negri E, Franceschi S, Talamini R, Amadori D, Filiberti R, Conti E, Montella M, Veronesi A, Parazzini F, Ferraroni M. Oral contraceptives and breast cancer: a cooperative italian study. Int J Cancer. 1995;60:163-7.

78. Zondervan KT, Carpenter LM, Painter R, Vessey MP. Oral contraceptives and cervical cancer - further findings from the oxford family planning association contraceptive study. Br J Cancer. 1996;73:1291-7.

79. Calle EE, Heath CW, Miraclemcmahill HL, Coates RJ, Liff JM, Franceschi S, Talamini R, Chantarakul N, Koetsawang S, Rachawat D. Breast cancer and hormonal contraceptives: further results. Contraception. 1996;54 (suppl:s1-106.

80. Rettig BA, Lemon HM. Cancers related to contraceptive use. Br J Cancer. 1996;74:1509-10.

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.