Lo Loestrin FE
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Lo Loestrin FE
Lo Loestrin FE Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
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. It is not available as a generic currently. Common side effects of Lo Loestrin Fe include irregular uterine bleeding, breast tenderness, headache, acne, and nausea.
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. 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 as advised not to take Lo Loestrin Fe. Many drugs and herbals may interact and make Lo Loestrin Fe less effective so the prescribing physician needs to know what medications the patient is taking before prescribing this drug. 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.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lo Loestrin FE FDA Prescribing Information: Side Effects
(Adverse Reactions)
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
- Nausea
- Breast tenderness
- Headache
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% of all Treated Subjects): The most common adverse reactions reported by at least 2% of the 1,660 women using Lo Loestrin Fe were the following in order of decreasing incidence: nausea/vomiting (7%), headache (7%), bleeding irregularities (including metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage and dysfunctional uterine bleeding) (5%), dysmenorrhea (4%), weight fluctuation (4%), breast tenderness (4%), acne (3%), abdominal pain (3%), anxiety (2%), and depression (2%).
Adverse Reactions Leading to Study Discontinuation: 10.7% of the women discontinued from the clinical trial due to an adverse reaction. Adverse reactions occurring in ≥ 1% of subjects leading to discontinuation of treatment were in decreasing order: menstrual irregularities (including metrorrhagia, irregular menstruation, menorrhagia and vaginal hemorrhage) (4%), headache/migraine (1%), mood disorder (including mood swings, depression, anxiety) (1%), and weight fluctuation (1%).
Serious Adverse Reactions: deep vein thrombosis, ovarian vein thrombosis, cholecystitis
Read the entire FDA prescribing information for Lo Loestrin FE (Norethindrone Acetate and Ethinyl Estradiol, Ethinyl Estradiol Tablets) »
Additional Lo Loestrin 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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