Medical Editor: John P. Cunha, DO, FACOEP
What Is Lo Loestrin Fe?
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) is a packet of two combination drugs and two placebo tablets used for prevention of pregnancy in women.
What Are Side Effects of Lo Loestrin Fe?
Common side effects of Lo Loestrin Fe include:
- breast tenderness,
- swelling of the ankles or feet (fluid retention), or
- weight changes.
- Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
Serious side effects of Lo Loestrin Fe are:
- vascular problems (deep venous thrombosis),
- liver disease, and
- cholecystitis, which can be exacerbated by smoking tobacco.
- Women over 35 who smoke are advised not to take Lo Loestrin Fe.
Dosage for Lo Loestrin Fe
Lo Loestrin Fe is available in single packets (blister packets) containing 28 tablets with the following concentrations: 24 tablets each containing 1 mg norethindrone acetate and 10 meg ethinyl estradiol, two tablets each containing 10 meg ethinyl estradiol, and two tablets each containing 75 mg ferrous fumarate. To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth 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.
What Drugs, Substances, or Supplements Interact with Lo Loestrin Fe?
Lo Loestrin Fe may interact with aromatase inhibitors, ospemifene, tamoxifen, tizanidine, tranexamic acid, drugs to treat chronic hepatitic C, griseofulvin, modafinil, rifamycins, St. John's wort, drugs used to treat seizures, and HIV drugs. Tell your doctor all medications and supplements you use.
Lo Loestrin Fe During Pregnancy and Breastfeeding
Women who currently have or have had breast cancer should not use Lo Loestrin Fe. This drug should be discontinued if the patient becomes pregnant. Lo Loestrin Fe may decrease breast milk production. A small amount of Lo Loestrin Fe passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Our Lo Loestrin Fe 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.
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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 Lo Loestrin FE (Norethindrone Acetate and Ethinyl Estradiol, Ethinyl Estradiol Tablets)
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and smoking [see BOX 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.
A multicenter phase 3 clinical trial evaluated the safety and efficacy of Lo Loestrin Fe for pregnancy prevention. The study was a one year, open-label, single-arm, uncontrolled study. A total of 1,660 women aged 18 to 45 were enrolled and took at least one dose of Lo Loestrin Fe [see Clinical Studies].
Common Adverse Reactions (≥ 2 percent Of All Treated Subjects)
The most common adverse reactions reported by at least 2 percent of the 1,660 women using Lo Loestrin Fe were the following in order of decreasing incidence: nausea/vomiting (7 percent), headache (7 percent), bleeding irregularities (including metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage and dysfunctional uterine bleeding) (5 percent), dysmenorrhea (4 percent), weight fluctuation (4 percent), breast tenderness (4 percent), acne (3 percent), abdominal pain (3 percent), anxiety (2 percent), and depression (2 percent).
Adverse Reactions Leading To Study Discontinuation
10.7 percent of the women discontinued from the clinical trial due to an adverse reaction. Adverse reactions occurring in ≥1 percent of subjects leading to discontinuation of treatment were in decreasing order: menstrual irregularities (including metrorrhagia, irregular menstruation, menorrhagia and vaginal hemorrhage) (4 percent), headache/migraine (1 percent), mood disorder (including mood swings, depression, anxiety) (1 percent), and weight fluctuation (1 percent).
Serious Adverse Reactions
Read the entire FDA prescribing information for Lo Loestrin FE (Norethindrone Acetate and Ethinyl Estradiol, Ethinyl Estradiol Tablets)
© Lo Loestrin FE Patient Information is supplied by Cerner Multum, Inc. and Lo Loestrin FE Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.