Blisovi Fe 1/20: Package Insert and Label Information (Page 4 of 7)


  1. Back DJ, Breckenridge AM, Crawford FE, McIver M, Orme ML’E, Rowe PH and Smith E: Kinetics of norethindrone in women II. Single-dose kinetics. Clin Pharmacol Ther 1978; 24:448-453.
  2. Hümpel M, Nieuweboer B, Wendt H and Speck U: Investigations of pharmacokinetics of ethinyloestradiol to specific consideration of a possible first-pass effect in women. Contraception 1979; 19:421-432.
  3. Back DJ, Breckenridge AM, Crawford FE, McIver M, Orme ML’E, Rowe PH and Watts MJ. An investigation of the pharmacokinetics of ethinyl estradiol in women using radioimmunoassay. Contraception 1979;20:263-273.
  4. Hammond GL, Lähteenmaki PLA, Lähteenmaki P and Luukkainen T. Distribution and percentages of non-protein bound contraceptive steroids in human serum. J Steriod Biochem 1982;17:375-380.
  5. Fotherby K. Pharmacokinetics and metabolism of progestins in humans, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994; 99-126.
  6. Goldzieher JW. Pharmacokinetics and metabolism of ethynyl estrogens, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press Ltd., New York, 1994; 127-151.
  7. Hatcher RA, et al. 1998. Contraceptive Technology, Seventeenth Edition. New York: Irvington Publishers.
  8. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 1). New England Journal of Medicine , 305:612-618, 1981.
  9. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 2). New England Journal of Medicine , 305:672-677, 1981.
  10. Adam, S.A., and M. Thorogood: Oral contraception and myocardial infarction revisited: The effects of new preparations and prescribing patterns. Brit. J. Obstet. and Gynec. , 88:838-845, 1981.
  11. Mann, J.I., and W.H. Inman: Oral contraceptives and death from myocardial infarction. Brit. Med. J. , 2(5965):245-248, 1975.
  12. Mann, J.I., M.P. Vessey, M. Thorogood, and R. Doll: Myocardial infarction in young women with special reference to oral contraceptive practice. Brit. Med. J. , 2(5956):241-245, 1975.
  13. Royal College of General Practitioners’ Oral Contraception Study: Further analyses of mortality in oral contraceptive users. Lancet , 1:541-546, 1981.
  14. Slone, D., S. Shapiro, D.W. Kaufman, L. Rosenberg, O.S. Miettinen, and P.D. Stolley: Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives. N.E.J.M. , 305:420-424, 1981.
  15. Vessey, M.P.: Female hormones and vascular disease: An epidemiological overview. Brit. J. Fam. Plann. , 6:1-12, 1980.
  16. Russell-Briefel, R.G., T.M. Ezzati, R. Fulwood, J.A. Perlman, and R.S. Murphy: Cardiovascular risk status and oral contraceptive use, United States, 1976-80. Preventive Medicine , 15:352-362, 1986.
  17. Goldbaum, G.M., J.S. Kendrick, G.C. Hogelin, and E.M. Gentry: The relative impact of smoking and oral contraceptive use on women in the United States. J.A.M.A. , 258:1339-1342, 1987.
  18. Layde, P.M., and V. Beral: Further analyses of mortality in oral contraceptive users: Royal College General Practitioners’ Oral Contraception Study. (Table 5) Lancet , 1:541-546, 1981.
  19. Knopp, R.H.: Arteriosclerosis risk: The roles of oral contraceptives and postmenopausal estrogens. J. of Reprod. Med. , 31(9) (Supplement): 913-921, 1986.
  20. Krauss, R.M., S. Roy, D.R. Mishell, J. Casagrande, and M.C. Pike: Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses. Am. J. Obstet. Gyn. , 145:446-452, 1983.
  21. Wahl, P., C. Walden, R. Knopp, J. Hoover, R. Wallace, G. Heiss, and B. Rifkind: Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N.E.J.M. , 308:862-867, 1983.
  22. Wynn, V., and R. Niththyananthan: The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins. Am. J. Obstet. and Gyn. , 142:766-771, 1982.
  23. Wynn, V., and I. Godsland: Effects of oral contraceptives on carbohydrate metabolism. J. Reprod. Medicine , 31 (9)(Supplement):892-897, 1986.
  24. LaRosa, J.C.: Atherosclerotic risk factors in cardiovascular disease. J. Reprod. Med. , 31(9)(Supplement): 906-912, 1986.
  25. Inman, W.H., and M.P. Vessey: Investigations of death from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. Brit. Med. J. , 2(5599): 193-199, 1968.
  26. Maguire, M.G., J. Tonascia, P.E. Sartwell, P.D. Stolley, and M.S. Tockman: Increased risk of thrombosis due to oral contraceptives: A further report. Am. J. Epidemiology , 110(2): 188-195, 1979.
  27. Pettiti, D.B., J. Wingerd, F. Pellegrin, and S. Ramacharan: Risk of vascular disease in women: Smoking, oral contraceptives, noncontraceptive estrogens, and other factors. J.A.M.A. , 242:1150-1154, 1979.
  28. Vessey, M.P., and R. Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease. Brit. Med. J.,2(5599): 199-205, 1968.
  29. Vessey, M.P., and R. Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease: A further report. Brit. Med. J. , 2(5658): 651-657, 1969.
  30. Porter, J.B., J.R. Hunter, D.A. Danielson, H. Jick, and A. Stergachis: Oral contraceptives and non-fatal vascular disease: Recent experience. Obstet. and Gyn. , 59(3):299-302, 1982.
  31. Vessey, M., R. Doll, R. Peto, B. Johnson, and P. Wiggins: A long-term follow-up study of women using different methods of contraception: An interim report. J. Biosocial. Sci. , 8:375-427, 1976.
  32. Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose veins. J. of Royal College of General Practitioners , 28:393-399, 1978.
  33. Collaborative Group for the study of stroke in young women: Oral contraception and increased risk of cerebral ischemia or thrombosis. N.E.J.M. , 288:871-878, 1973.
  34. Petitti, D.B., and J. Wingerd: Use of oral contraceptives, cigarette smoking, and risk of subarachnoid hemorrhage. Lancet , 2:234-236, 1978.
  35. Inman, W.H.: Oral contraceptives and fatal subarachnoid hemorrhage. Brit. Med. J. , 2(6203): 1468-70, 1979.
  36. Collaborative Group for the study of stroke in young women: Oral contraceptives and stroke in young women: Associated risk factors. J.A.M.A. , 231:718-722, 1975.
  37. Inman, W.H., M.P. Vessey, B. Westerholm, and A. Engelund: Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs. Brit. Med. J. , 2:203-209, 1970.
  38. Meade, T.W., G. Greenberg, and S.G. Thompson: Progestogens and cardiovascular reactions associated with oral contraceptives and a comparison of the safety of 50- and 35- mcg oestrogen preparations. Brit. Med. J. , 280(6224): 1157-1161, 1980.
  39. Kay, C.R.: Progestogens and arterial disease: Evidence from the Royal College of General Practitioners’ study. Amer. J. Obstet. Gyn. , 142:762-765, 1982.
  40. Royal College of General Practitioners: Incidence of arterial disease among oral contraceptive users. J. Coll. Gen. Pract. , 33:75-82, 1983.
  41. Ory, H.W.: Mortality associated with fertility and fertility control:1983. Family Planning Perspectives , 15:50-56, 1983.
  42. Ory, H., Z. Naib, S.B. Conger, R.A. Hatcher, and C.W. Tyler: Contraceptive choice and prevalence of cervical dysplasia and carcinoma in situ. Am. J. Obstet. Gynec., 124:573-577, 1976.
  43. Vessey, M.P., M. Lawless, K. McPherson, D. Yeates: Neoplasia of the cervix uteri and contraception: A possible adverse effect of the pill. Lancet, 2:930, 1983.
  44. Brinton, L.A., G.R. Huggins, H.F. Lehman, K. Malli, D.A. Savitz, E. Trapido, J. Rosenthal, and R. Hoover: Long-term use of oral contraceptives and risk of invasive cervical cancer. Int. J. Cancer, 38:339-344, 1986.
  45. WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Invasive cervical cancer and combined oral contraceptives. Brit. Med. J., 290:961-965, 1985.
  46. Rooks, J.B., H.W. Ory, K.G. Ishak, L.T. Strauss, J.R. Greenspan, A.P. Hill, and C.W. Tyler: Epidemiology of hepatocellular adenoma: The role of oral contraceptive use. J.A.M.A., 242:644-648, 1979.
  47. Bein, N.N., and H.S. Goldsmith: Recurrent massive hemorrhage from benign hepatic tumors secondary to oral contraceptives. Brit. J. Surg., 64:433-435, 1977.
  48. Klatskin, G.: Hepatic tumors: Possible relationship to use of oral contraceptives. Gastroenterology, 73:386-394, 1977.
  49. Henderson, B.E., S. Preston-Martin, H.A. Edmondson, R.L. Peters, and M.C. Pike: Hepatocellular carcinoma and oral contraceptives. Brit. J. Cancer, 48:437-440, 1983.
  50. Neuberger, J., D. Forman, R. Doll, and R. Williams: Oral contraceptives and hepatocellular carcinoma. Brit. Med. J., 292:1355-1357, 1986.
  51. Forman, D., T.J. Vincent, and R. Doll: Cancer of the liver and oral contraceptives. Brit. Med. J., 292: 1357-1361, 1986.
  52. Harlap, S., and J. Eldor: Births following oral contraceptive failures. Obstet. Gynec., 55:447-452, 1980.
  53. Savolainen, E., E. Saksela, and L. Saxen: Teratogenic hazards of oral contraceptives analyzed in a national malformation register. Amer. J. Obstet. Gynec., 140:521-524, 1981.
  54. Janerich, D.T., J.M. Piper, and D.M. Glebatis: Oral contraceptives and birth defects. Am. J. Epidemiology, 112:73-79, 1980.
  55. Ferencz, C., G.M. Matanoski, P.D. Wilson, J.D. Rubin, C.A. Neill, and R. Gutberlet: Maternal hormone therapy and congenital heart disease. Teratology, 21:225-239, 1980.
  56. Rothman, K.J., D.C. Fyler, A. Goldbatt, and M.B. Kreidberg: Exogenous hormones and other drug exposures of children with congenital heart disease. Am. J. Epidemiology, 109:433-439, 1979.
  57. Boston Collaborative Drug Surveillance Program: Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumors. Lancet, 1:1399-1404, 1973.
  58. Royal College of General Practitioners: Oral Contraceptives and Health. New York, Pittman, 1974, 100p.
  59. Layde, P.M., M.P. Vessey, and D. Yeates: Risk of gallbladder disease: A cohort study of young women attending family planning clinics. J. of Epidemiol. and Comm. Health, 36: 274-278, 1982.
  60. Rome Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO): Prevalence of gallstone disease in an Italian adult female population. Am. J. Epidemiol., 119:796-805, 1984.
  61. Strom, B.L., R.T. Tamragouri, M.L. Morse, E.L. Lazar, S.L. West, P. D. Stolley, and J.K. Jones: Oral contraceptives and other risk factors for gallbladder disease. Clin. Pharmacol. Ther., 39:335-341, 1986.
  62. Wynn, V., P.W. Adams, I.F. Godsland, J. Melrose, R. Niththyananthan, N.W. Oakley, and A. Seedj: Comparison of effects of different combined oral-contraceptive formulations on carbohydrate and lipid metabolism. Lancet, 1:1045-1049, 1979.
  63. Wynn, V.: Effect of progesterone and progestins on carbohydrate metabolism. In Progesterone and Progestin. Edited by C.W. Bardin, E. Milgrom, P. Mauvis-Jarvis. New York, Raven Press, pp. 395-410, 1983.
  64. Perlman, J.A., R. G. Roussell-Briefel, T.M. Ezzati, and G. Lieberknecht: Oral glucose tolerance and the potency of oral contraceptive progestogens. J. Chronic Dis., 38:857¬864, 1985.
  65. Royal College of General Practitioners’ Oral Contraception Study: Effect on hypertension and benign breast disease of progestogen component in combined oral contraceptives. Lancet, 1:624, 1977.
  66. Fisch, I.R., and J. Frank: Oral contraceptives and blood pressure. J.A.M.A., 237:2499¬2503, 1977.
  67. Laragh, A.J.: Oral contraceptive induced hypertension: Nine years later. Amer. J. Obstet. Gynecol., 126:141-147, 1976.
  68. Ramcharan, S., E. Peritz, F.A. Pellegrin, and W.T. Williams: Incidence of hypertension in the Walnut Creek Contraceptive Drug Study cohort. In Pharmacology of Steroid Contraceptive Drugs. Edited by S. Garattini and H.W. Berendes. New York, Raven Press, pp. 277-288, 1977. (Monographs of the Mario Negri Institute for Pharmacological Research, Milan.)
  69. Back DJ, Orme ML’E. Drug interactions, in Pharmacology of the contraceptive steroids. Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994, 407-425.
  70. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med. 2002;346(26):2025-2032.
  71. Dumeaux V, Fournier A, Lund E, Clavel-Chapelon F. Previous oral contraceptive use and breast cancer risk according to hormone replacement therapy use among postmenopausal women. Cancer Causes Control. 2005;16(5):537-544.
  72. Dorjgochoo T, Shu XO, Li HL, et al. Use of oral contraceptives, intrauterine devices and tubal sterilization and cancer risk in a large prospective study, from 1996 to 2006. Int J Cancer. 2009;124(10):2442-2449.
  73. Hunter DJ, Colditz GA, Hankinson SE, et al. Oral contraceptive use and breast cancer: a prospective study of young women. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2010;19(10):2496-2502.
  74. Vessey M, Yeates D. Oral contraceptive use and cancer. Final report from the Oxford-Family Planning Association contraceptive study. Contraception. 2013; 88(6): 678-683.
  75. Morch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard O. Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med. 2017;377(23):2228-2239.
  76. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Oral contraceptive use and the risk of ovarian cancer. J.A.M.A., 249:1596-1599, 1983.
  77. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Combination oral contraceptive use and the risk of endometrial cancer. J.A.M.A., 257:796-800, 1987.
  78. Ory, H.W.: Functional ovarian cysts and oral contraceptives: Negative association confirmed surgically. J.A.M.A., 228:68-69, 1974.
  79. Ory, H.W., P. Cole, B. Macmahon, and R. Hoover: Oral contraceptives and reduced risk of benign breast disease. N.E.J.M., 294:41-422, 1976.
  80. Ory, H.W.: The noncontraceptive health benefits from oral contraceptive use. Fam. Plann. Perspectives, 14:182-184, 1982.
  81. Ory, H.W., J.D. Forrest, and R. Lincoln: Making Choices: Evaluating the health risks and benefits of birth control methods. New York, The Alan Guttmacher Institute, p.1, 1983.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775


Revised: March 2023

Blisovi™ Fe 1/20

(norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*)

1 mg/0.02 mg

*Ferrous fumarate tablets are not USP for dissolution

The patient labeling for oral contraceptive drug products is set forth below:

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections.


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 are strongly advised not to smoke.

Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

  • Smoke
  • Have high blood pressure, diabetes, high cholesterol
  • Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast, jaundice, or malignant or benign liver tumors.

You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding may subside within the first three months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1 Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.

2 Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.

3 High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness.

There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. Some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill.

Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and your healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your healthcare provider.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted infections such as chlamydia , genital herpes , genital warts , gonorrhea , hepatitis B and syphilis. provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

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