Norgestrel

Norgestrel is an over the counter (OTC) progestin-only oral contraceptive indicated to prevent pregnancy.

• Norgestrel is available under the following different brand names: Opill

Common side effects of Norgestrel include:

• headache
• dizziness
• nausea
• increased appetite
• abdominal pain
• cramps
• bloating
• fatigue
• vaginal discharge
• painful menstrual periods
• nervousness
• backache
• breast discomfort
• acne
• ovarian cysts
• and menstrual irregularities (changes in menstrual flow, breakthrough bleeding/spotting, missed menstrual periods, prolonged bleeding)

Serious side effects of Norgestrel include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• depression
• unwanted facial or body hair
• swelling of the ankles or feet
• severe stomach or pelvic pain
• lumps in the breast
• unusual tiredness
• dark urine
• yellowing of the eyes or skin (jaundice)
• sudden shortness of breath
• chest, jaw, and left arm pain
• confusion
• coughing up blood
• sudden dizziness
• fainting
• pain, swelling, or warmth in the groin or calf
• tingling, weakness, or numbness in the arms or legs
• headaches with or without vision changes
• lack of coordination
• existing migraines becoming worse
• sudden or very severe headache
• trouble speaking
• weakness on one side of the body
• vision problems or changes

Rare side effects of Norgestrel 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, loss of coordination, feeling 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, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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 and pediatric dosage

Tablet

• 0.075 mg in 28-day calendar packs
• All tablets contain active drug

Contraception

• 1 tablet (0.075 mg) orally at the same time every day
• Administration is continuous with no interruption between pill packs

Starting norgestrel

• Start the first pack on any day
• If switching from another oral contraceptive, vaginal ring, or patch, start taking the day after stopping the other method
• Use a condom (or another barrier method) for each intercourse during the first 2 days after initiating

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, healthcare provider, or pharmacist first.

• Norgestrel has severe interactions with no other drugs.
• Norgestrel has serious interactions with the following drugs:
  • apalutamide
  • carbamazepine
  • enzalutamide
  • fosphenytoin
  • mifepristone
  • phenobarbital
  • phenytoin
  • primidone
  • rifampin
  • St John's wort
• Norgestrel has moderate interactions with at least 98 drugs.
• Norgestrel has minor interactions with no 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 of 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, or if you have health questions, concerns.

Contraindications

• Known or suspected pregnancy
• Known or suspected breast cancer
• Undiagnosed abnormal genital bleeding
• Hypersensitivity to norgestrel or excipients
• Benign or malignant liver tumors
• Acute liver disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Norgestrel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Norgestrel?”

Cautions

• Cigarette smoking greatly increases the risk for suffering heart attacks and strokes; advise women who use oral contraceptives not to smoke
• Risks including, but not limited to, an increased risk for serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism
• Remain alert to the earliest manifestation of symptoms of any serious disease and discontinue therapy when appropriate
• Alert patients of the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives
• If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle
• Irregular menstrual patterns are common among women using progestin-only oral contraceptives; if bleeding is suggestive of infection, malignancy, or other abnormal conditions, such nonpharmacologic causes should be ruled out; if prolonged amenorrhea occurs, evaluate if the patient is pregnant
• Increased relative risk of developing breast cancer, particularly at a younger age and apparently related to the duration of use, has been reported; women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined
• Benign hepatic adenomas are associated with combined oral contraceptive use
• Allergic reactions
  • Contains FD&C yellow No.5 (tartrazine) as a color additive
  • People allergic to aspirin often have a tartrazine allergy too
  • Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin erythema, rash, or blisters
  • Discontinue if an allergic reaction occurs and promptly seek medical attention
• Drug interaction overview
• Norgestrel is a major CYP3A4 substrate
  • Strong or moderate CYP3A4 inhibitors
  • Caution/monitor
  • Strong or moderate CYP3A4 inhibitors may increase the systemic concentration of norgestrel, which may increase the risk for adverse effects
  • Strong CYP3A4 inducers
  • Consider therapy modification
  • Strong CYP3A4 inducers: Contraceptive failure is possible owing to decreased serum concentration of norgestrel
  • Advise patients to use an alternative method of contraception or a backup method during coadministration and to continue backup contraception for 28 days after discontinuing the strong CYP3A4 inducer to ensure contraceptive reliability
  • Moderate CYP3A4 inducers may decrease progestin concentration; consider the use of additional barrier methods
• Laboratory tests
  • The following endocrine tests may be affected by progestin-only oral contraceptive use:
  • Sex hormone–binding globulin concentrations may be decreased
  • Thyroxine concentrations may be decreased owing to a decrease in thyroid-binding globulin

Pregnancy and Lactation

• Contraindicated for known or suspected pregnancy
• Advise patients on the importance of ruling out suspected pregnancy before initiating any hormonal contraceptive use
• Limited available data indicate a rapid return of normal ovulation and fertility following the discontinuation of progestin-only oral contraceptives
• Many studies have reported no effects on fetal development associated with long-term use of contraceptive doses of oral progestins
• Few studies on infant growth and development that have been conducted have not reported significant adverse effects
• Lactation
  • Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1%-6% of the levels of maternal plasma
  • According to the LactMed database, progestin-only contraceptives (eg, norgestrel) are considered the hormonal contraceptives of choice during lactation
  • Very rarely, adverse effects in the infant/child have been reported, including jaundice