Medical Editor: John P. Cunha, DO, FACOEP
Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol/ferrous fumarate) is a combination of female hormones and the mineral iron used as an oral contraceptive to prevent pregnancy. Minastrin 24 Fe is available in generic form. Common side effects of Minastrin 24 Fe are:
- vaginal candidiasis,
- menstrual cramps,
- breast tenderness,
- bacterial vaginitis,
- abnormal cervical smear,
- mood swings, and
- weight gain.
The dosage of Minastrin 24 Fe is one yellow Minastrin 24 Fe capsule daily, beginning on day one of the menstrual cycle (the first day of menstruation is day one), for 24 consecutive days, followed by one maroon capsule daily on days 25 through 28. Minastrin 24 Fe must be taken as directed and at intervals not exceeding 24 hours. Minastrin 24 Fe may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John's wort, ascorbic acid, acetaminophen, itraconazole, ketoconazole, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors (NNRTIs), antibiotics, lamotrigine, and thyroid hormone replacement therapy. Tell your doctor all medications and supplements you use. There is no reason for pregnant women to use Minastrin 24 Fe. Minastrin 24 Fe passes into breast milk and may reduce milk production. Women should use other forms of contraception until they have weaned their child. Consult your doctor before breastfeeding.
Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol/ferrous fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke [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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data presented in Section 6.1 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Minastrin 24 Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
Common Adverse Reactions ( ≥ 2% of all Treated Subjects): The most common adverse reactions reported by at least 2% of the 743 women using norethindrone acetate/ethinyl estradiol tablets were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), bacterial vaginitis (3.1%), abnormal cervical smear (3.1%), acne (2.7%), mood swings (2.2%), and weight gain (2.0%).
Adverse Reactions Leading to Study Discontinuation: Among the 743 women using norethindrone acetate/ethinyl estradiol tablets, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal or irregular bleeding (1.3%), nausea (0.8%), menstrual cramps (0.5%), and increased blood pressure (0.4%).
The following adverse reactions have been identified during post approval use of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes.
Immune system disorders: hypersensitivity reaction.
GI disorders: nausea, vomiting, abdominal pain.
Musculoskeletal and connective tissue disorders: myalgia.
Eye disorders: blurred vision, visual impairment, corneal thinning, change in corneal curvature (steepening).
Infections and infestations: fungal infection, vaginal infection.
Nervous system disorders: headache, dizziness, migraine, loss of consciousness.
Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido.
Renal and urinary disorders: cystitis-like syndrome.
Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, dysmenorrhea.
Read the entire FDA prescribing information for Minastrin 24 Fe (Norethindrone Acetate and Ethinyl Estradiol/Ferrous Fumarate Capsules)