Lo Loestrin FE
"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
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. Common side effects of Lo Loestrin Fe include vaginal bleeding between periods (spotting) or missed/irregular periods, breast tenderness, headache, acne, nausea, vomiting, bloating, swelling of the ankles or feet (fluid retention), or weight changes.
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 Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lo Loestrin FE Overview - Patient Information: Side Effects
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)
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
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:
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%).
Read the entire FDA prescribing information for Lo Loestrin FE (Norethindrone Acetate and Ethinyl Estradiol, Ethinyl Estradiol Tablets)
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