Ogestrel 0.5 / 50 Side Effects
Generic Name: ethinyl estradiol / norgestrel
Note: This page contains side effects data for the generic drug ethinyl estradiol / norgestrel. It is possible that some of the dosage forms included below may not apply to the brand name Ogestrel 0.5 / 50.
For the Consumer
Applies to ethinyl estradiol / norgestrel: tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking ethinyl estradiol / norgestrel:
Acne; breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; mild hair loss; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes (eg, sudden vision loss, double vision); yellowing of the skin or eyes (with or without fever).
For Healthcare Professionals
Applies to ethinyl estradiol / norgestrel: oral tablet
A number of studies have suggested that use of oral contraceptives decreases the risk of ovarian cancer. Specifically, the risk of epithelial ovarian cancers is decreased by 40%. The protection against ovarian cancer may last for 10 to 15 years after discontinuation of oral contraceptives. After long term use (12 years), the risk of ovarian cancer is decreased by as much as 80%.
The risk of endometrial cancer is decreased by approximately 50%. Protection may last for 15 years after discontinuation and may be greatest for nulliparous women who may be at higher risk for endometrial carcinoma than other women.
The incidence of hospitalization for pelvic inflammatory disease is approximately 50% lower in women taking oral contraceptives. The reason for the decrease in the frequency (or severity) of pelvic inflammatory disease in women taking oral contraceptives has not been fully elucidated.
Some recent studies have suggested that the decrease in frequency of functional ovarian cysts reported with some older formulations may not occur in women taking newer low dose formulations.
One recent study (The Nurses' Health Study) has suggested that long term use of oral contraceptives is safe and does not adversely affect long term risk for mortality.[Ref]
A relatively common gastrointestinal side effect is nausea, which occurs in approximately 10% of treated women and may be more frequent during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease.[Ref]
Oral contraceptive combinations have been studied extensively for oncologic side effects. 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."[Ref]
Cardiovascular side effects of the estrogen component of this combination drug may be significant and include hypertension. However, significant blood pressure increases generally occur only in women receiving high-dose estrogen products (50 mcg or more of ethinyl estradiol or equivalent daily). Estrogens have also been associated with edema. In addition, exogenous estrogens may exert cardio-protective effects by causing favorable changes in lipid profiles. These beneficial effects, however, may be partially or completely offset by alterations in lipid profiles induced by exogenous progestins.[Ref]
All the progestins which occur in commercially available oral contraceptive combinations have adverse effects on lipid profiles. Specifically, these progestins exert antiestrogen and androgen effects and decrease HDL (and HDL2) cholesterol levels and increase LDL cholesterol levels. However, the estrogens in oral contraceptive combinations exert opposing effects. Consequently, alterations in lipid profiles are related to the relative amount and potency of the specific estrogen and progestin in a given product. (Norgestrel exerts potent progestin, antiestrogen and androgen effects.)
A number of investigations have suggested that oral contraceptive combinations may decrease glucose tolerance. However, some recent studies with low dose preparations have suggested that decreases in glucose tolerance due to oral contraceptive combinations are generally minimal.
Despite the potentially adverse effects of oral contraceptives on lipid levels and glucose tolerance, some investigators have suggested that young diabetic women without existing vascular disease or severe lipidemias may be candidates for low dose oral contraceptive combinations provided that they receive close monitoring for adverse metabolic effects.[Ref]
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]
A hematologic concern is the risk of thromboembolism that is associated with the use of exogenous estrogens. However, because the dose of exogenous estrogens is low in most commercially available preparations, the risk of thromboembolism is minimal for most women (except women who are over age 35 and smoke and women with a history of previous thrombotic diseases).[Ref]
A common genitourinary side effect is breakthrough bleeding and spotting, especially during the first several cycles of oral contraceptive use. Non-hormonal causes of such bleeding should be excluded.[Ref]
Nervous system side effects include chorea, which has been reported once in association with oral contraceptives.[Ref]
1. Colditz GA "Oral contraceptive use and mortality during 12 years of follow-up: the Nurses' Health Study." Ann Intern Med 120 (1994): 821-6
2. Steinberg WM "Oral contraception: risks and benefits." Adv Contracept 5 (1989): 219-28
3. Peterson HB, Lee NC "Long-term health risks and benefits of oral contraceptive use." Obstet Gynecol Clin North Am 17 (1990): 775-88
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 79 (1992): 529-33
5. "Oral contraceptives and neoplasia. WHO Scientific Group." World Health Organ Tech Rep Ser 817 (1992): 1-46
6. 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
7. 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
8. Lanes SF, Birmann B, Walker AM, Singer S "Oral contraceptive type and functional ovarian cysts." Am J Obstet Gynecol 166 (1992): 956-61
9. Burkman RT Jr "Benefits and risk of oral contraceptives. A reassessment." J Reprod Med 36 (1991): 217-8
10. 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
11. Grimes DA "The safety of oral contraceptives: epidemiologic insights from the first 30 years." Am J Obstet Gynecol 166 (1992): 1950-4
12. 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
13. Oren R, Fich A "Oral contraceptive-induced esophageal ulcer. Two cases and literature review." Dig Dis Sci 36 (1991): 1489-90
14. Waltimo J "Geographic tongue during a year of oral contraceptive cycles." Br Dent J 171 (1991): 94-6
15. "Product Information. Ortho-Novum (oral contraceptive combination pill)." Ortho Pharmaceutical Corporation, Raritan, NJ.
16. Shoupe D "Multicenter randomized comparative trial of two low-dose triphasic combined oral contraceptives containing desogestrel or norethindrone." Obstet Gynecol 83 (1994): 679-85
17. 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
18. Ewertz M "Oral contraceptives and breast cancer risk in Denmark." Eur J Cancer 28A (1992): 1176-81
19. Rettig BA, Lemon HM "Cancers related to contraceptive use." Br J Cancer 74 (1996): 1509-10
20. 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
21. 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
22. 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
23. Brinton LA "Oral contraceptives and cervical neoplasia." Contraception 43 (1991): 581-95
24. 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
25. Kaunitz AM "Oral contraceptives and gynecologic cancer: an update for the 1990s." Am J Obstet Gynecol 167 (1992): 1171-6
26. 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
27. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85
28. Thomas DB "Oral contraceptives and breast cancer: review of the epidemiologic literature." Contraception 43 (1991): 597-642
29. Turnquest MA "Oral contraceptive use and incidence of cervical intraepithelial neoplasia." Am J Obstet Gynecol 168 (1993): 1895-6
30. Murray PP, Stadel BV, Schlesselman JJ "Oral contraceptive use in women with a family history of breast cancer." Obstet Gynecol 73 (1989): 977-83
31. 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
32. 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
33. 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
34. 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
35. Schlesselman JJ "Oral contraceptives and breast cancer." Am J Obstet Gynecol 163 (1990): 1379-87
36. Lund E "Oral contraceptives and breast cancer. A review with some comments on mathematical models." Acta Oncol 31 (1992): 183-6
37. 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
38. Derman RJ "Oral contraceptives and cardiovascular risk. Taking a safe course of action." Postgrad Med 88 (1990): 119-22
39. 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
40. Derman R "Oral contraceptives: a reassessment." Obstet Gynecol Surv 44 (1989): 662-8
41. Thorogood M "Risk of stroke in users of oral contraceptives." JAMA 281 (1999): 1255-6
42. 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
43. Rosenberg L, Palmer JR, Lesko SM, Shapiro S "Oral contraceptive use and the risk of myocardial infarction." Am J Epidemiol 131 (1990): 1009-16
44. Williams RS "Benefits and risks of oral contraceptive use." Postgrad Med 92 (1992): 155-7
45. Lidegaard O "Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study." BMJ 306 (1993): 956-63
46. 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
47. Thorneycroft IH "Oral contraceptives and myocardial infarction." Am J Obstet Gynecol 163 (1990): 1393-7
48. 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
49. Farmer R, Lewis M "Oral contraceptives and mortality from venous thromboembolism." Lancet 348 (1996): 1095
50. 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
51. 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
52. 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
53. Speroff L "Oral contraceptives and venous thromboembolism." Int J Gynaecol Obstet 54 (1996): 45-50
54. Piegsa K, Guillebaud J "Oral contraceptives and the risk of DVT." Practitioner 240 (1996): 544
55. Vandenbroucke JP, Bloemenkamp KWM, Helmerhorst FM, Rosendaal FR "Oral contraceptives and mortality from venous thromboembolism - reply." Lancet 348 (1996): 1096-7
56. 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
57. Martinelli I, Rosendaal FR, Vandenbroucke JP, Mannucci PM "Oral contraceptives are a risk factor for cerebral vein thrombosis." Thromb Haemost 76 (1996): 477-8
58. 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
59. 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
60. 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
61. Hannaford PC, Kay CR "Oral contraceptives and diabetes mellitus." BMJ 299 (1989): 1315-6
62. Bracken MB, Hellenbrand KG, Holford TR "Conception delay after oral contraceptive use: the effect of estrogen dose." Fertil Steril 53 (1990): 21-7
63. Kjaer K, Hagen C, Sando SH, Eshoj O "Contraception in women with IDDM. An epidemiological study." Diabetes Care 15 (1992): 1585-90
64. 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
65. 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
66. Stubblefield PG "Choosing the best oral contraceptive." Clin Obstet Gynecol 32 (1989): 316-28
67. Miwa LJ, Edmunds AL, Shaefer MS, Raynor SC "Idiopathic thromboembolism associated with triphasic oral contraceptives." DICP 23 (1989): 773-5
68. Mooney MJ, Nyreen MR, Hall RA, Carter PL "Hepatic adenoma presenting as a right lower quadrant mass." Am Surg 59 (1993): 229-31
69. Mathieu D, Zafrani ES, Anglade MC, Dhumeaux D "Association of focal nodular hyperplasia and hepatic hemangioma." Gastroenterology 97 (1989): 154-7
70. Weden M, Glaumann H, Einarsson K "Protracted cholestasis probably induced by oral contraceptive." J Intern Med 231 (1992): 561-5
71. 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
72. 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
73. 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
74. Conter RL, Longmire WP Jr "Recurrent hepatic hemangiomas. Possible association with estrogen therapy." Ann Surg 207 (1988): 115-9
75. 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
76. 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
77. Tao LC "Oral contraceptive-associated liver cell adenoma and hepatocellular carcinoma." Cancer 68 (1991): 341-7
78. Beaumont V, Lemort N, Beaumont JL "Oral contraceptives, sex steroid-induced antibodies and vascular thrombosis: results from 1318 cases." Eur Heart J 12 (1991): 1219-24
79. Lidegaard O "Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease." Br J Obstet Gynaecol 102 (1995): 153-9
80. Key JD, Hammill WW, Everett L "Pulmonary embolus in an adolescent on oral contraceptives." J Adolesc Health 13 (1992): 713-5
81. Omdal R, Roalso S "Chorea gravidarum and chorea associated with oral contraceptives-- diseases due to antiphospholipid antibodies?" Acta Neurol Scand 86 (1992): 219-20
It is possible that some side effects of Ogestrel 0.5 / 50 may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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