Gildagia

Last updated on RxList: 7/15/2021
Gildagia Side Effects Center

Last reviewed on RxList 9/14/2017

Gildagia (norethindrone and ethinyl estradiol tablets, 0.4mg/0.035 mg) 28 day regimen is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Gildagia is available in generic form. Common side effects of Gildagia include:

Cigarette smoking increases the risk of serious cardiovascular side effects from use of oral contraceptives such as Gildagia. Women who use oral contraceptives including Gildagia are strongly advised not to smoke.

To achieve maximum contraceptive effectiveness, Gildagia must be taken exactly as directed and at intervals not exceeding 24 hours. The 28 pill pack has 21 “active” peach pills (with hormones) to take for 3 weeks, followed by 1 week of reminder light-green pills (without hormones). Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs. Gildagia may interact with 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. Gildagia is not recommended for use during pregnancy. Small amounts of Gildagia pass into breast milk and may cause adverse reactions in nursing infants. Breastfeeding while using Gildagia is not recommended.

Our Gildagia (norethindrone and ethinyl estradiol tablets, 0.4mg/0.035 mg) 28 Day Regimen 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
Gildagia 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 Gildagia (Norethindrone and Ethinyl Estradiol Tablets, USP)

QUESTION

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

SIDE EFFECTS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS):

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, and secretion
  • Change in weight (increase or decrease)
  • Change in cervical ectropion and secretion
  • Possible 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:

DRUG INTERACTIONS

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.

Concomitant Use With HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Gildagia™ with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, Risk Of Liver Enzyme Elevations With Conomitant Hepatitis C Treatment).

Read the entire FDA prescribing information for Gildagia (Norethindrone and Ethinyl Estradiol Tablets, USP)

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

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