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Aranelle

  • Generic Name: norethindrone and ethinyl estradiol kit
  • Brand Name: Aranelle
  • Drug Class: Contraceptives, Oral

Aranelle (Norethindrone and Ethinyl Estradiol Kit) side effects drug center

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    PROFESSIONAL

    CONSUMER

    SIDE EFFECTS

     

    Aranelle Side Effects Center

    What Is Aranelle?

    Aranelle (norethindrone and ethinyl estradiol kit) is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

    What Are Side Effects of Aranelle?

    Side effects of Aranelle include:

    Dosage for Aranelle

    The dose of Aranelle is 1 light yellow tablet is taken for 7 days, then 1 white tablet for 9 days, then 1 light yellow tablet for 5 days, then 1 peach tablet (inert) for 7 days, whether bleeding has stopped or not. One tablet is taken each day at the same time for 28 days. After all 28 tablets are taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day.

    Aranelle In Children

    Safety and efficacy of Aranelle have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of the product before menarche is not indicated.

    What Drugs, Substances, or Supplements Interact with Aranelle?

    Aranelle may interact with other medicines such as:

    • rifampin,
    • barbiturates,
    • phenylbutazone,
    • phenytoin sodium,
    • griseofulvin,
    • ampicillin,
    • tetracyclines, and
    • HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

    Tell your doctor all medications and supplements you use.

    Aranelle During Pregnancy and Breastfeeding

    Aranelle is not recommended for use during pregnancy as it is intended to prevent pregnancy. Small amounts of oral contraceptive steroids 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, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. A breastfeeding woman is advised to use other forms of contraception until she has completely weaned her child.

    Additional Information

    Our Aranelle (norethindrone and ethinyl estradiol kit) 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.

     

    Aranelle 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 Aranelle (Norethindrone and Ethinyl Estradiol Kit)

     

    Aranelle Professional Information

    SIDE EFFECTS

    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, carcinomas or benign liver tumors

    There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

    • 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 cramps and bloating)
    • Breakthrough bleeding
    • Spotting
    • Change in menstrual flow
    • Amenorrhea
    • Temporary infertility after discontinuation of treatment
    • Edema
    • Melasma which may persist
    • Breast changes: tenderness, enlargement, secretion
    • Change in weight (increase or decrease)
    • Change in cervical erosion and secretion
    • Diminution in lactation when given immediately postpartum
    • Cholestatic jaundice
    • Migraine
    • Rash (allergic)
    • Mental depression
    • Reduced tolerance to carbohydrates
    • Vaginal candidiasis
    • Change in corneal curvature (steepening)
    • Intolerance to contact lenses

    The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

    • Pre-menstrual syndrome
    • Cataracts
    • Changes in appetite
    • Cystitis-like syndrome
    • Headache
    • Nervousness
    • Dizziness
    • Hirsutism
    • Loss of scalp hair
    • Erythema multiforme
    • Erythema nodosum
    • Hemorrhagic eruption
    • Vaginitis
    • Porphyria
    • Impaired renal function
    • Hemolytic uremic syndrome
    • Budd-Chiari syndrome
    • Acne
    • Changes in libido
    • Colitis

    Read the entire FDA prescribing information for Aranelle (Norethindrone and Ethinyl Estradiol Kit)

    &Copy; Aranelle Patient Information is supplied by Cerner Multum, Inc. and Aranelle Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.