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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Generic drug name: levonorgestrel and ethinyl estradiol [oral contraceptive] (LEE voh nor jes trel and ETH in il es tra DYE ole)
Brand name(s): ALESSE 28, ALTAVERA, AVIANE, ENPRESSE, JOLESSA, LESSINA, LEVLITE, LEVORA, LOSEASONIQUE, LYBREL, NORDETTE, ORSYTHIA, PORTIA, QUARTETTE, QUASENSE, SEASONALE, SEASONIQUE, SRONYX, TRIPHASIL, TRIVORA-28
GENERIC: available FAMILY: Second Generation Oral Contraceptives
Find the drug label by searching at DailyMed.

Generic drug name: norethindrone and ethinyl estradiol (nor eth IN drone and ETH in il es tra DYE ole)
Brand name(s): COMBI PATCH, LOESTRIN FE 1/20, NEOCON 1/35, ORTHO-NOVUM 7/7/7, OVCON 35
GENERIC: available FAMILY: Second Generation Oral Contraceptives
Find the drug label by searching at DailyMed.

Generic drug name: norgestimate and ethinyl estradiol (nor JES ti mate and ETH in il es tra DYE ole)
Brand name(s): ESTARYLLA, ORTHO TRI-CYCLEN, ORTHO TRI-CYCLEN LO, ORTHO-CYCLEN, TRI-MILI, TRINESSA
GENERIC: available FAMILY: Second Generation Oral Contraceptives
Find the drug label by searching at DailyMed.

Generic drug name: norgestrel and ethinyl estradiol (nor JES trel and ETH in il es tra DYE ole)
Brand name(s): LO/OVRAL 28, LOW-OGESTREL
GENERIC: available FAMILY: Second Generation Oral Contraceptives
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

These drugs should not be used if you are pregnant or are thinking of becoming pregnant. The risk of use of these drugs in pregnant women clearly outweighs any possible benefit.

Breast-feeding Warning

Oral contraceptive steroids are excreted in breast milk and have caused adverse effects in nursing infants, including jaundice and breast enlargement. These drugs may also decrease the amount and quality of breast milk. Use another form of birth control until the infant is completely weaned.

Safety Warnings For This Drug [top]

FDA-APPROVED BLACK-BOX WARNING

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular adverse effects from combination oral contraceptive (COC) use. The risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over age 35 and smoke.

Facts About This Drug [top]

Are birth control pills the safest contraceptive option for you? There are many issues to consider, and like every other decision concerning your health, this is a highly individual one. Unfortunately, you will not be able to base your decision on assurances of absolute safety. In fact, even after more than 40 years of studying the pill, much about its long-term effects on human physiology is still unknown.

Although the convenience of the pill is obvious from the start, its acute problems...

Are birth control pills the safest contraceptive option for you? There are many issues to consider, and like every other decision concerning your health, this is a highly individual one. Unfortunately, you will not be able to base your decision on assurances of absolute safety. In fact, even after more than 40 years of studying the pill, much about its long-term effects on human physiology is still unknown.

Although the convenience of the pill is obvious from the start, its acute problems may quickly become evident. Many women suffer from headaches, bloating, nausea, irregular bleeding, breast tenderness, weight gain or optical (visual) changes. The use of oral contraceptives also is associated with increased risk of several very serious conditions, including heart attack, blood clots, stroke, liver tumors and gallbladder disease.

We have long been concerned about the pill’s relationship to the risk of breast cancer.[1] The best evidence indicates that women who are currently using a combined oral contraceptive or have done so within the last 10 years are at slightly increased risk of being diagnosed with breast cancer.[2]

Oral contraceptives have been suspected of being associated with cervical cancer. There is now compelling evidence of this link. Women who have taken oral contraceptives for five to nine years were almost three times more likely than nonusers to develop cervical cancer. Those who used the pill for more than 10 years were four times more likely than nonusers to develop the disease.[3]

Oral contraceptives have come a long way since the early days — the 1960s and 1970s — when women were first given hormone doses so potent that heart attacks and strokes were not unusual among pill users. With hormone levels in the pill now much lower, the number of women suffering from heart attacks and strokes also appears to have dropped.

Today’s pill is clearly safer in many respects. When used properly, it prevents pregnancy more than 98% of the time, and its unwanted clotting properties have been significantly reduced.

Ortho Tri-Cyclen, which contains the progestin norgestimate, is included with the second-generation oral contraceptives because it is rapidly converted to norgestrel in the body.[4] Ortho Tri-Cyclen also is approved for the treatment of acne in women over age 15 who have no contraindications to oral contraceptives, wish to use an oral contraceptive, have achieved menarche and are unresponsive to topical antiacne medications.[5]

Since oral contraceptive pills were first introduced onto the market, there have been a number of new preparations that have emerged.

Seasonale is the first “extended-cycle" oral contraceptive pill. It contains a combination of ethinyl estradiol and levonorgestrel and is taken for 84 consecutive days. This results in bleeding only four times a year compared with bleeding 13 times a year with ‘traditional’ oral contraceptive pills. In a randomized controlled one-year trial, Seasonale was found to be at least as effective as Nordette (which contains the same drug combination but is taken on a 28-day cycle). Seasonale was found to be associated with more unscheduled bleeding or spotting; however, the frequency and duration decreased after the first few months. The increased risks of adverse effects such as thromboembolism that may result from longer exposure to the hormones have not been established.[6]

The first chewable oral contraceptive, Ovcon 35, was approved by the Food and Drug Administration (FDA) in November 2003. Ovcon 35 is a spearmint-flavored tablet that can be chewed or swallowed whole. It contains a combination of norethindrone and ethinyl estradiol. The product label warnings are similar to those of all birth control pills. Risks include blood clots, heart attacks, stroke and an increased risk of cardiovascular adverse effects associated with cigarette smoking.[7]

In March 2014 the Medicines and Healthcare products Regulatory Agency (MHRA, an agency in the U.K. similar to the FDA) issued a drug safety update that St. John’s wort, when used with hormonal contraceptives, reduces the effectiveness of the contraceptives and increases the risk of unplanned pregnancy.[8]

Regulatory actions:

2012: In June and July, the FDA issued advisory information concerning the use of combined hormonal contraceptives and the drug lamotrigine (which is used for seizure control). The FDA reported that coadministration of these medications may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.[9]

2013: The FDA issued an advisory for women with a history of hypertension, hypertension-related disease or renal disease who use hormonal oral contraceptives. These women should be closely monitored for a persistent increase in blood pressure.[10]

2017: In March, the labeling for the seizure drug valproate (DEPAKENE) was revised to warn that using hormonal contraceptives containing estrogen with valproate may cause an increased rate of seizures.[11]

2019: The FDA updated the drug product labels of estrogen-containing oral contraceptives to warn that symptoms of angioedema may be brought on or made worse in patients with hereditary angioedema, a potentially life-threatening condition that can cause swelling in the skin, lips, mouth and throat.[12]

In August, the FDA updated the drug product labels of oral contraceptive drugs containing ethinyl estradiol to warn that they should not be taken by patients who are taking the multidrug hepatitis C regimen of ombitasvir, paritaprevir and ritonavir, with or without dasabuvir. Evidence from clinical trials showed that this drug combination is associated with an increased risk of liver damage.[13]

Before You Use This Drug [top]

Do not use if you have or have had:

  • cancer of the breast, known or suspected
  • abnormal mammogram (breast X-ray)
  • cancer of the cervix or endometrium (lining of the uterus)
  • unexplained vaginal bleeding
  • jaundice (yellowing of the skin or eyeballs) during previous pregnancy or with prior use of birth control pills
  • liver disease, including tumors or cancer of the liver
  • pregnancy or are breast-feeding
  • blood clots in legs, lungs, or eyes
  • heart attack or stroke
  • chest pain
  • uncontrolled high blood pressure
  • plans to have surgery requiring bed rest
  • heart valve or heart rhythm disorders
  • headaches with neurological symptoms
  • heart disease

Tell your doctor if you have or have had:

  • migraine headache
  • mental depression
  • diabetes
  • epilepsy
  • gallbladder disease
  • history of irregular menstrual periods
  • high blood pressure
  • strong family history of breast cancer
  • elevated cholesterol or triglycerides
  • liver disease

Tell your doctor about any other drugs you take, including aspirin, herbs (including St. John’s wort), vitamins, and nonprescription products, and whether you smoke.

When You Use This Drug [top]

  • You should receive regular checkups by your doctor at least every 6 to 12 months.
  • You should examine your breasts every month (ask your doctor to show you how), and your doctor should check your breasts at least every year.
  • Tell any doctor, dentist, emergency medical technician, pharmacist, or surgeon you see that you take oral contraceptives.
  • Use an additional birth control method when you are using ampicillin, penicillin V, ritonavir, tetracyclines, or hepatic enzyme inducers.
  • Stop medication immediately and check with your doctor if you think you may be pregnant. Contact your doctor immediately if you miss two periods.
  • Call your doctor if vaginal bleeding occurs.
  • Have your dentist clean your teeth regularly. Ask about any swelling, tenderness, or bleeding of gums.

How to Use This Drug [top]

  • If you miss taking a pill, follow the directions in the FDA-approved patient information leaflet that you should receive from your pharmacist each time you get a prescription for birth control pills. This information will tell you what to do and when to use a backup method of contraception.
  • Do not share your medication with others.
  • Take the drug at the same time each day.
  • Do not break, chew, or crush this drug.
  • Your pharmacist is required to dispense an FDA-approved patient information leaflet each time you receive a prescription for an oral contraceptive. Since the many different brands of oral contraceptives vary in the number of tablets taken per month and the colors of the pills, consult this information for the drug you receive before starting to take your pills. Make sure you are receiving the FDA-approved information for the brand of birth control pills you are taking and not just the printout from the pharmacist’s computer system.
  • Try to keep an extra month’s supply available.
  • Store at room temperature. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

carbamazepine, DILANTIN, EVISTA, FULVICIN, GRIFULVIN V, GRIS-PEG, GRISACTIN, griseofulvin, LUMINAL, nelfinavir, NORVIR, phenobarbital, phenytoin, raloxifene, RIFADIN, rifampin, RIMACTANE, ritonavir, SOLFOTON, ST. JOHN’S WORT, TEGRETOL, TOPAMAX, topiramate, VIRACEPT.

Other antibiotics, drugs used for seizures, and drugs used for HIV/AIDS may also interact with birth control pills.

You may need to use additional forms of contraception when you take these drugs.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • sharp chest pain
  • crushing chest pain or heaviness
  • coughing up blood
  • sudden loss of coordination
  • lumps in breast
  • mood changes
  • pain in the calf or groin
  • sudden partial or complete loss of vision
  • severe pain or tenderness in the stomach area
  • severe and sudden headache, vomiting, dizziness, fainting
  • sudden slurring of speech
  • sudden shortness of breath
  • weakness, or numbness in arms or legs
  • yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light brown–colored bowel movements
  • changes in menstrual bleeding
  • depression
  • fainting, nausea, pale or sweating skin (if you have diabetes)
  • increased blood pressure
  • insomnia (difficulty sleeping)
  • worsening migraines
  • vaginal infection such as a yeast infection
  • stoppage of menstrual bleeding over several months
  • breakthrough bleeding
  • prolonged or very light bleeding

Signs of overdose:

  • irregular bleeding cycle
  • nausea or vomiting
  • withdrawal bleeding

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Call your doctor if these symptoms continue:

  • abdominal cramping or bloating
  • acne
  • breast pain, tenderness, or swelling
  • dizziness or fainting
  • swelling of ankles or feet
  • unusual tiredness or weakness
  • nausea or vomiting
  • brown, blotchy spots on skin
  • gain or loss of body or facial hair
  • weight gain or loss
  • increased sensitivity to the sun
  • sexual interest decrease or increase

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • blood pressure
  • liver function tests
  • Pap smear
  • breast exams
  • glucose (sugar), lipid (cholesterol), and lipoprotein serum levels
  • FSH levels (if you are close to menopause)

last reviewed June 30, 2021