Skip to Content

Demulen 1 / 50 Side Effects

Generic Name: ethinyl estradiol / ethynodiol

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

For the Consumer

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.

Side effects requiring immediate medical attention

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

  • Absent, missed, or irregular menstrual periods
  • anxiety
  • bloody stools
  • blurred vision
  • breast tenderness, enlargement, discharge
  • changes in skin color, pain, tenderness, or swelling of the foot or leg
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • confusion
  • cough
  • dark or cloudy urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty in speaking
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • fever
  • headache, severe and throbbing
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching of the vagina or outside the genitals
  • loss of appetite
  • nausea
  • nervousness
  • pain during sexual intercourse
  • pain or discomfort in the arms, jaw, back or neck
  • pounding in the ears
  • slow or fast heartbeat
  • slow speech
  • stomach pain and tenderness
  • stopping of menstrual bleeding
  • sweating
  • swelling
  • swelling, pain, or tenderness in the upper abdominal area
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • troubled breathing
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Side effects not requiring immediate medical attention

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

  • Acne
  • changes in appetite
  • changes in weight
  • decreased interest in sexual intercourse
  • decreased milk production
  • light vaginal bleeding between regular menstrual periods
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • patchy brown or dark brown discoloration of the skin

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

2. "Oral contraceptives and neoplasia. WHO Scientific Group." World Health Organ Tech Rep Ser 817 (1992): 1-46

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

4. 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 80 (1992): 708-14

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

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

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

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

9. 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 79 (1992): 529-33

10. 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 85 (1993): 142-7

11. Burkman RT Jr "Benefits and risk of oral contraceptives. A reassessment." J Reprod Med 36 (1991): 217-8

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

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

14. Derman RJ "Oral contraceptives and cardiovascular risk. Taking a safe course of action." Postgrad Med 88 (1990): 119-22

15. Lidegaard O "Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study." BMJ 306 (1993): 956-63

16. 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 348 (1996): 505-10

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

18. Derman R "Oral contraceptives: a reassessment." Obstet Gynecol Surv 44 (1989): 662-8

19. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85

20. Thorogood M "Risk of stroke in users of oral contraceptives." JAMA 281 (1999): 1255-6

21. Piegsa K, Guillebaud J "Oral contraceptives and the risk of DVT." Practitioner 240 (1996): 544

22. 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 348 (1996): 498-505

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

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

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

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

27. Thorneycroft IH "Oral contraceptives and myocardial infarction." Am J Obstet Gynecol 163 (1990): 1393-7

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

29. Farmer R, Lewis M "Oral contraceptives and mortality from venous thromboembolism." Lancet 348 (1996): 1095

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

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

32. Williams RS "Benefits and risks of oral contraceptive use." Postgrad Med 92 (1992): 155-7

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

34. 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 103 (1996): 261-7

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

36. "Product Information. Ortho-Novum (oral contraceptive combination pill)." Ortho Pharmaceutical Corporation, Raritan, NJ.

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

38. Waltimo J "Geographic tongue during a year of oral contraceptive cycles." Br Dent J 171 (1991): 94-6

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

40. 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 51 (1989): 71-4

41. 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 40 (1989): 553-61

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

43. Hannaford PC, Kay CR "Oral contraceptives and diabetes mellitus." BMJ 299 (1989): 1315-6

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

45. 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 271 (1994): 1099-102

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

47. Stubblefield PG "Choosing the best oral contraceptive." Clin Obstet Gynecol 32 (1989): 316-28

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

49. 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 156 (1992): 33-8

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

51. Tao LC "Oral contraceptive-associated liver cell adenoma and hepatocellular carcinoma." Cancer 68 (1991): 341-7

52. 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

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

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

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

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

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

58. 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 16 (1992): 982-7

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

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

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

62. 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 54 (suppl (1996): s1-106

63. Turnquest MA "Oral contraceptive use and incidence of cervical intraepithelial neoplasia." Am J Obstet Gynecol 168 (1993): 1895-6

64. Thomas DB "Oral contraceptives and breast cancer: review of the epidemiologic literature." Contraception 43 (1991): 597-642

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

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 129 (1989): 269-80

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

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

69. 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 70 (1991): 143-8

70. Schlesselman JJ "Oral contraceptives and breast cancer." Am J Obstet Gynecol 163 (1990): 1379-87

71. 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 81 (1989): 1000-4

72. Brinton LA "Oral contraceptives and cervical neoplasia." Contraception 43 (1991): 581-95

73. 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 71 (1992): 368-76

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

75. 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 60 (1995): 163-7

76. 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 81 (1989): 1313-21

77. 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 136 (1992): 1437-44

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

79. Ewertz M "Oral contraceptives and breast cancer risk in Denmark." Eur J Cancer 28A (1992): 1176-81

80. 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 73 (1996): 1291-7

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.