Medical Editor: John P. Cunha, DO, FACOEP
Generess Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is an oral contraceptive regimen indicated for use by women to prevent pregnancy. Common side effects can include nausea, vomiting, headaches, migraine, depression, mood complaints, abdominal cramps, bloating, acne, anxiety, breast pain and tenderness, weight gain, swelling of the ankles/feet (fluid retention), vaginal bleeding between periods (spotting), or missed/irregular periods.
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.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Generess Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate)
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)