Loestrin Fe
Medical Group: Sell the Pill Without Prescription »
"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).
Whether t"...
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Loestrin 24 Fe
Loestrin Fe Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol and ferrous sulfate) is used as contraception to prevent pregnancy. It is also used to treat severe acne. It contains a combination of female hormones that prevent ovulation. It also contains iron. This medication may be available in generic form. Common side effects include nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
The dose of Loestrin 24 Fe is one white hormone tablet taken daily for 24 consecutive days followed by one brown iron tablet daily for 4 consecutive days. Withdrawal bleeding usually occurs within three days following discontinuation of white tablets and may not have finished before the next pack is started. Follow package or physician instructions. Loestrin 24 Fe may interact with acetaminophen, ascorbic acid (vitamin C), prednisolone, theophylline, St. John's wort, antibiotics, seizure medications, barbiturates, or HIV or AIDS medications. Tell your doctor all medications and supplements you use. Loestrin 24 Fe must not be used during pregnancy. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, consult your doctor about birth control, and find out when it is safe to use birth control containing estrogen, such as this medication. This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. Our Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol) 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 in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Loestrin Fe in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in the pattern or severity of migraine headaches;
- pain in your upper stomach, jaundice (yellowing of the skin or eyes);
- a lump in your breast;
- swelling in your hands, ankles, or feet; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
- mild nausea or vomiting, appetite or weight changes;
- breast swelling or tenderness;
- headache, nervousness, dizziness;
- problems with contact lenses;
- freckles or darkening of facial skin, loss of scalp hair; or
- vaginal itching or discharge.
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.
Read the entire detailed patient monograph for Loestrin Fe (Norethindrone Acetate and Ethinyl Estradiol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
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.
Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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 Loestrin Fe (Norethindrone Acetate and Ethinyl Estradiol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Loestrin Fe FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The most common adverse events reported by 2 - 6% of the 743 women using Loestrin 24 Fe were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.
Among the 743 women using Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol) , 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 bleeding (0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
- Thrombophlebitis
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:
- Nausea
- Vomiting
- Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Temporary infertility after discontinuation of treatment
- Edema/fluid retention
- Melasma/chloasma which may persist
- Breast changes: tenderness, pain, enlargement, and secretion
- Change in weight or appetite (increase or decrease)
- Change in cervical ectropion and secretion
- Possible diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine headache
- Rash (allergic)
- Mood changes, including depression
- Vaginitis, including candidiasis
- Change in corneal curvature (steepening)
- Intolerance to contact lenses
- Decrease in serum folate levels
- Exacerbation of systemic lupus erythematosus
- Exacerbation of porphyria
- Exacerbation of chorea
- Aggravation of varicose veins
- Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
The following adverse reactions have been reported in users of oral contraceptives, and a causal association has been neither confirmed nor refuted:
- Acne
- Budd-Chiari syndrome
- Cataracts
- Colitis
- Changes in libido
- Cystitis-like syndrome
- Dizziness
- Dysmenorrhea
- Erythema multiforme
- Erythema nodosum
- Headache
- Hemorrhagic eruption
- Hemolytic uremic syndrome
- Hirsutism
- Impaired renal function
- Loss of scalp hair
- Nervousness
- Optic neuritis, which may lead to partial or complete loss of vision
- Pancreatitis
- Premenstrual syndrome
Read the entire FDA prescribing information for Loestrin Fe (Norethindrone Acetate and Ethinyl Estradiol) »
Additional Loestrin 24 Fe Information
Loestrin 24 Fe - User Reviews
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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