Aurovela

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/1/2021
Aurovela Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Aurovela?

Aurovela 1.5/30 (norethindrone acetate and ethinyl estradiol tablets) is a combination of female hormones indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

What Are Side Effects of Aurovela?

Common side effects of Aurovela 1.5/30 include:

  • nausea,
  • vomiting,
  • abdominal cramps,
  • bloating,
  • breakthrough bleeding,
  • spotting, changes in menstrual flow,
  • missed menstrual periods,
  • temporary infertility after discontinuation of treatment,
  • fluid retention (edema),
  • skin discoloration which may persist breast changes (tenderness, enlargement, nipple discharge),
  • changes in weight,
  • diminished milk production in lactating women when given immediately postpartum,
  • cholestatic jaundice,
  • migraine,
  • rash (allergic),
  • depression,
  • reduced tolerance to carbohydrates,
  • vaginal yeast infection, and
  • problems with contact lenses

Dosage for Aurovela

Aurovela 1.5/30 provides the patient with a convenient tablet schedule of 3 weeks on -1 week off. To achieve maximum contraceptive effectiveness, Aurovela 1.5/30 must be taken exactly as directed and at intervals not exceeding 24 hours.

What Drugs, Substances, or Supplements Interact with Aurovela?

Aurovela 1.5/30 may interact with cyclosporine, prednisolone, theophylline, acetaminophen, temazepam, salicylic acid, morphine, and clofibric acid. Tell your doctor all medications and supplements you use.

Aurovela During Pregnancy or Breastfeeding

Aurovela 1.5/30 is not recommended for use during pregnancy; it may harm a fetus. Aurovela 1.5/30 passes into breast milk. Nursing mothers are advised not to use oral contraceptives such as Aurovela 1.5/30, but to use other forms of contraception until they have completely weaned their child. Consult your doctor before breastfeeding.

Additional Information

Our Aurovela 1.5/30 (norethindrone acetate and ethinyl estradiol 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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Aurovela 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 Aurovela (Norethindrone Acetate and Ethinyl Estradiol Tablets)

QUESTION

Which of the following are methods for contraception? See Answer
Aurovela 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 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 Aurovela (Norethindrone Acetate and Ethinyl Estradiol Tablets)

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

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