Loestrin Fe

Last reviewed on RxList: 9/8/2016
Loestrin Fe Side Effects Center

Last reviewed on RxList 11/18/2016

Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol and ferrous sulfate) contains a combination of female hormones that prevent ovulation, along with the mineral iron, used as contraception to prevent pregnancy. Loestrin 24 Fe is also used to treat severe acne. Loestrin 24 Fe may be available in generic form. Common side effects of Loestrin 24 Fe include:

  • nausea (especially when you first start taking Loestrin 24 Fe),
  • vomiting,
  • headache,
  • stomach cramping,
  • bloating,
  • dizziness,
  • vaginal discomfort/irritation/itching,
  • increased vaginal fluids/discharge,
  • breast tenderness/enlargement,
  • nipple discharge,
  • freckles or darkening of facial skin,
  • increased hair growth,
  • loss of scalp hair,
  • changes in weight or appetite,
  • problems with contact lenses, or
  • decreased sex drive.

Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular menstrual periods may occur, especially during the first few months of use of Loestrin 24 Fe.

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 breastfeeding.

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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Loestrin Fe Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • breakthrough bleeding;
  • headache; or
  • problems with contact lenses.

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)

QUESTION

Which of the following are methods for contraception? See Answer
Loestrin Fe Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

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.

The safety of LOESTRIN 24 Fe was evaluated in 743 subjects who participated in an open-label, randomized, active-controlled, multicenter clinical trial of LOESTRIN 24 Fe for contraception. This trial examined healthy, non-pregnant volunteers aged 18 to 45 years, who were sexually active and had a body mass index of ≤ 35 kg/m². Subjects were followed for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure.

Common Adverse Reactions ( ≥ 2% of all subjects): The most common adverse reactions reported by at least 2% of the 743 women using LOESTRIN 24 Fe 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%), mood changes (including mood swings (2.2%) and depression (1.1%)), bacterial vaginitis (3.1%), acne (2.7%), and weight gain (2.0%).

Adverse Reactions Leading to Study Discontinuation: Among the 743 women using LOESTRIN 24 Fe, 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%), mood changes (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of LOESTRIN 24 Fe. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Cardiovascular: chest pain, palpitations, tachycardia, angina pectoris, myocardial infarction.

Endocrine disorders: hypothyroidism, hyperthyroidism.

Eye disorders: blurred vision, visual impairment, transient blindness, corneal thinning, change in corneal curvature (steepening).

GI disorders: nausea, vomiting, abdominal pain, constipation, pancreatitis.

Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver.

Immune system disorders: anaphylactic reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

Infections: vaginal infection.

Metabolism and nutrition disorders: change in weight or appetite (increase or decrease). hypoglycemia, diabetes mellitus, anemia.

Musculoskeletal and connective tissue disorders: myalgia.

Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration, night sweats, swelling face or lips, hirsutism, skin burning sensation, erythema multiforme, erythema nodosum, hemorrhagic eruption.

Nervous system disorders: headache, dizziness, migraine, hyperesthesia, paraesthesia, hypoaesthesia, somnolence, loss of consciousness, sensory disturbance.

Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido, bipolar disorder, dissociation, homicidal ideation.

Renal and urinary disorders: pollakiuria, dysuria, cystitis-like syndrome.

Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, ovarian cyst, pelvic pain, ovarian cyst ruptured, pelvic fluid collection.

Vascular disorders: hot flush, thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein), migraine, transient ischemic attack, ischemic stroke.

Read the entire FDA prescribing information for Loestrin Fe (Norethindrone Acetate and Ethinyl Estradiol)

© Loestrin Fe Patient Information is supplied by Cerner Multum, Inc. and Loestrin Fe Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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