Nordette-28 Side Effects Center

Last updated on RxList: 9/29/2021
Nordette-28 Side Effects Center

What Is Nordette-28?

Nordette-28 (levonorgestrel and ethinyl estradiol) is a combination of two female hormones used as contraception to prevent pregnancy. Nordette-28 is available in generic form.

What Are Side Effects of Nordette-28?

Common side effects of Nordette-28 include:

  • nausea,
  • vomiting,
  • headache,
  • stomach cramping,
  • bloating,
  • dizziness,
  • vaginal discomfort/irritation,
  • increased vaginal fluids, or
  • breast tenderness/enlargement

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.

Dosage for Nordette-28

The dosage of Nordette-28 is one light-orange tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to the prescribed schedule.

What Drugs, Substances, or Supplements Interact with Nordette-28?

Nordette-28 may interact with rifampin, epilepsy medications, barbiturates, primidone, topiramate, phenylbutazone, HIV/AIDS drugs, modafinil, antibiotics, lamotrigine, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, and topiramate. Tell your doctor all medications and supplements you use.

Nordette-28 During Pregnancy or Breastfeeding

Nordette-28 must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This drug passes into breast milk and may reduce the quantity and quality of the milk. Consult your doctor before breastfeeding.

Additional Information

Our Nordette-28 (levonorgestrel and ethinyl estradiol) tablets, 0.15mg/0.03mg 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
Nordette-28 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 birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
  • 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, fever, 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;
  • changes 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 (especially when you first start taking this medicine);
  • breast tenderness;
  • breakthrough bleeding;
  • acne, darkening of facial skin;
  • weight gain; 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 Nordette-28 (Levonorgestrel and Ethinyl Estradiol Tablets)

QUESTION

Which of the following are methods for contraception? See Answer
Nordette-28 Professional Information

SIDE EFFECTS

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

  • Serious cardiovascular adverse events [see BOXED WARNING and WARNINGS]
  • Vascular events [see WARNINGS]
  • Liver disease [see WARNINGS]
  • Hypertension [see WARNINGS]
  • Gallbladder disease [see WARNINGS]
  • Carbohydrate and lipid effects [see WARNINGS]
  • Headache [see WARNINGS]
  • Carcinoma of the cervix [see WARNINGS]

Adverse reactions reported by COC users and described elsewhere in the labeling are:

  • Bleeding irregularities and amenorrhea [see WARNINGS]
  • Mood changes, including depression [see WARNINGS]
  • Melasma/chloasma which may persist [see WARNINGS]
  • Edema/fluid retention [see PRECAUTIONS]
  • Diminution in lactation when given immediately postpartum [see PRECAUTIONS]

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; 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 the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.

DRUG INTERACTIONS

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.

Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.

No drug-drug interaction studies were conducted with NORDETTE-28.

Effects Of Other Drugs On Combined Oral Contraceptives

Substances Decreasing The Plasma Concentrations Of COCs And Potentially Diminishing The Efficacy Of COCs

Table 1 includes substances that demonstrated an important drug interaction with NORDETTE 28.

Table 1: Significant Drug Interactions Involving Substances That Affect COCs

Metabolic Enzyme Inducers
Clinical effect
  • Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs.
  • Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding.
Prevention or management
  • Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs.
  • Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability.
Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s worta, and certain protease inhibitors (see separate section on protease inhibitors below).
Colesevelam
Clinical effect
  • Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol.
  • Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC.
Prevention or management Administer 4 or more hours apart to attenuate this drug interaction.
a Induction potency of St. John’s wort may vary widely based on preparation.

Substances Increasing The Systemic Exposure Of COCs

Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of7 conjugation. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs.

Human Immunodeficiency Virus (HIV)/hepatitis C Virus (HCV) Protease Inhibitors And Nonnucleoside Reverse Transcriptase Inhibitors

Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).

In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).

Effects Of Combined Oral Contraceptives On Other Drugs

Table 2 provides significant drug interaction information for drugs co-administered with NORDETTE-28.

Table 2: Significant Drug Interaction Information for Drugs Co-Administered With COCs

Lamotrigine
Clinical effect
  • Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation.
  • Decreased systemic exposure of lamotrigine may reduce seizure control.
Prevention or management Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine.
Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy
Clinical effect Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin (see Warnings, EFFECT ON BINDING GLOBULINS).
Prevention or management The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use (see Warnings, EFFECT ON BINDING GLOBULINS).
Other Drugs
Clinical effect Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole).
Prevention or management The dosage of drugs that can be affected by this interaction may need to be increased. Consult the approved product labeling for the concomitantly used drug.

Effect On Laboratory Tests

The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Read the entire FDA prescribing information for Nordette-28 (Levonorgestrel and Ethinyl Estradiol Tablets)

© Nordette-28 Patient Information is supplied by Cerner Multum, Inc. and Nordette-28 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors