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Generess Fe Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Generess Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. Currently, there are no generic versions of Generess Fe available. Common side effects can include nausea/vomiting, headaches/migraine, depression/mood complaints, dysmenorrhea, acne, anxiety symptoms, breast pain/tenderness, and increased weight.
Generess FE is available in blister packs. Each blister pack (28 tablets) contains in the following order and strength: 24 tablets containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol and 4 other tablets containing 75 mg ferrous fumarate. The ferrous fumarate chewable tablets do not serve any therapeutic purpose. For maximum contraceptive effectiveness, Generess Fe must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. If feasible, stop Generess Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Generess Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. Women who currently have or have had breast cancer should not use Generess Fe. Discontinue Generess Fe if jaundice develops. An increase in frequency or severity of migraine during use of Generess Fe (which may be the beginning phase of a cerebrovascular event) may be a reason for immediate discontinuation. Women with a history of depression should be carefully observed and Generess Fe discontinued if depression recurs to a serious degree. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates, St. John's wort, topiramate, some HIV medications, and antibiotics. Patients should consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. There is little or no increased risk of birth defects in women who inadvertently use Generess Fe during early pregnancy. When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Women who do not breastfeed may start Generess Fe no earlier than four weeks postpartum. Use of this product in pediatric patients before menarche is not indicated.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Generess Fe FDA Prescribing Information: Side Effects
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and smoking [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
- Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Breast tenderness
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A phase 3 clinical trial evaluated the safety and efficacy of GENERESS Fe for pregnancy prevention. The study was a multicenter, non-comparative, openlabel study with a treatment duration of 12 months (thirteen 28-day cycles). A total of 1,677 women aged 18-46 were enrolled and took at least one dose of GENERESS Fe.
Adverse Reactions Leading to Study Discontinuation: 8.5% of the women discontinued from the clinical trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were nausea (1.0%), weight increase (0.8%), acne (0.8%), metrorrhagia (0.7%), altered mood (0.4%), hypertension (0.4%), irritability (0.3%), migraine (0.3%), decreased libido (0.3%) and mood swings (0.3%).
Common Adverse Reactions ( ≥ 2% of all treated subjects): nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%).
Read the entire FDA prescribing information for Generess Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate) »
Additional Generess Fe Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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