Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1).
One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use.
Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.
Figure 1 Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk;
OR = odds ratio;
HR = hazard ratio.
“ever COC” are females with current or past COC use;
“never COC use” are females that never used COCs.
WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems: Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if a thrombotic event occurs.
Stop at least 4 weeks before through 2 weeks after major surgery.
Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease: Discontinue norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if jaundice occurs ( 5.2 ) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if blood pressure rises significantly.( 5.3 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets.
Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.5 ) Headache: Evaluate significant change in headaches and discontinue norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if indicated ( 5.6 ) Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea ( 5.7 ) 5.1 Thrombotic Disorders and Other Vascular Problems Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
Like all medications, Norethindrone And Ethinyl Estradiol And Ferrous Fumarate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: