Etynodiol-Ethinyl Estradiol

Etynodiol-Ethinyl Estradiol is a combination of female hormones and is used as contraception to prevent pregnancy.

• Etynodiol-Ethinyl Estradiol is available under the following different brand names: Kelnor, Zovia

Common side effects of Etynodiol-Ethinyl Estradiol include:

• nausea
• vomiting 
• headache 
• stomach cramping/bloating 
• dizziness
• vaginal discomfort/irritation
• increased vaginal fluids or discharge 
• breast tenderness/enlargement
• mood changes
• weight gain
• 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

Serious side effects of Etynodiol-Ethinyl Estradiol include:

• heart attack: chest pain, stomach discomfort, sweating, nausea, dizziness
• stroke: sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, difficulty walking
• deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
• pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
• liver problems: yellowing of the skin or the whites of the eyes, tiredness, stomach pain

Rare side effects of Etynodiol-Ethinyl Estradiol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 0.035 mg/1 mg
• 0.05 mg/1 mg

Oral contraceptive (OCP)

Adult dosage

• 1 hormonally active tab for 21 days followed by an inert tab (or tablet-free) for 7 days; repeat cycle

Initiating after-pregnancy

Adult dosage

• Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
• CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
• Initiating after vaginal birth: Wait at least 3 weeks
• Initiating after cesarean section birth: Wait at least 6 weeks
• Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Etynodiol-Ethinyl Estradiol has severe interactions with the following drugs:
  • fezolinetant
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
• tranexamic acid oral
• Etynodiol-Ethinyl Estradiol has serious interactions with at least 63 other drugs
• Etynodiol-Ethinyl Estradiol has moderate interactions with at least 101 other drugs
• Etynodiol-Ethinyl Estradiol has minor interactions with at least 31 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease (stroke, myocardial infarction), thrombophlebitis, deep vein thrombosis (DVT)/pulmonary embolism (PE), thrombogenic valvular disease
• Estrogen-dependent neoplasia, liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension (HTN)
• Diabetes mellitus (DM) with vascular involvement
• Jaundice with prior OCP use

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Etynodiol-Ethinyl Estradiol?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Etynodiol-Ethinyl Estradiol?"

Cautions

• Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, systemic lupus erythematosus; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk for thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• Some studies link OCP use with an increased risk for breast cancer, whereas other studies have not reported a change in risk
• Woman's risk depends on conditions where naturally high hormone levels persist for long periods including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity
• Increased risk for cervical cancer with OCP use; however, HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Increased risk for liver cancer with OCP use; risk increases with longer duration of OCP use
• CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to reduce the risk for VTE before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

Pregnancy and Lactation

• Do not use during pregnancy
• Lactation
  • Small amounts of steroids are excreted in breast milk; estrogens may reduce the quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)