Blisovi 24 Fe

Last updated on RxList: 4/16/2020
Blisovi 24 Fe Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Blisovi 24 Fe?

Blisovi 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is a combined oral contraceptive (COC) plus iron used to prevent pregnancy in women who elect to use oral contraceptives as a method of contraception.

What Are Side Effects of Blisovi 24 Fe?

Side effects of Blisovi 24 Fe include:

Dosage for Blisovi 24 Fe

To achieve maximum contraceptive effectiveness, Blisovi 24 Fe should be taken exactly as directed and at intervals not exceeding 24 hours. Blisovi 24 Fe tablets may be administered without regard to meals.

Blisovi 24 Fe In Children

Safety and efficacy of Blisovi 24 Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in post-pubertal adolescents under the age of 16 years and in users age 16 years and older. Use of this product before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Blisovi 24 Fe?

Blisovi 24 Fe may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Blisovi 24 Fe During Pregnancy and Breastfeeding

Blisovi 24 Fe is not recommended for use during pregnancy. Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. breastfeeding is not recommended while using Blisovi 24 Fe. Nursing mothers are advised to use other forms of contraception until the child has been completely weaned.

Additional Information

Our Blisovi 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 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.

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
Blisovi 24 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 Blisovi 24 Fe (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Tablets)

QUESTION

Which of the following are methods for contraception? See Answer
Blisovi 24 Fe Professional Information

SIDE EFFECTS

The most common adverse events reported by 2 to 6% of the 743 women using Blisovi 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 Blisovi 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%), 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 Blisovi 24 Fe (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Tablets)

© Blisovi 24 Fe Patient Information is supplied by Cerner Multum, Inc. and Blisovi 24 Fe Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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