Ogestrel (Oral)

Ethinyl estradiol and norgestrel combination is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm, and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress regularly to ensure this medicine is working properly and does not cause unwanted effects. Your doctor may also want to check your blood pressure while you are using this medicine.

Even though you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you might be pregnant while using this medicine, tell your doctor right away.

You may be pregnant if:

• You do not take the pills regularly and missed a menstrual period.
• You missed 2 menstrual periods.

If you think you may be pregnant, stop using this medicine and contact your doctor immediately. You may have a higher risk of an ectopic pregnancy if you become pregnant while using this medicine. An ectopic pregnancy can be serious and life-threatening. It can also cause issues that may make it harder for you to become pregnant in the future.

Do not use this medicine with any medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Inform your doctor if you or your partner start having sexual intercourse with other people, or if you or your partner test positive for a sexually transmitted disease. If this is a concern for you, discuss it with your doctor.

You might experience light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or if the bleeding lasts more than a few days in a row, contact your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Contact your doctor immediately if you have pain in the chest, groin, or legs, especially the calves, difficulty breathing, a sudden severe headache, slurred speech, sudden unexplained shortness of breath, sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (e.g., endometrium, ovaries, cervix). Discuss this risk with your doctor. Contact your doctor immediately if you experience abnormal vaginal bleeding.

Contact your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver problem.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

This medicine may increase your risk of developing gallbladder disease. Contact your doctor if you start having stomach pains, nausea, and vomiting.

Make sure any doctor or dentist who treats you knows that you are using this medicine. Some medical tests may be affected by this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research on the effects of ethinyl estradiol and norgestrel combination in children has not been conducted. However, there are no expected pediatric-specific issues that would limit the usefulness of this medicine for teenagers. This medicine may be used for birth control in teenage females, but it should not be used before menstruation begins.

Geriatric

Research on the effects of ethinyl estradiol and norgestrel combination in older adults has not been conducted. This medicine is not intended for use in elderly women.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should be given an alternative to this medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could occur. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may modify your other medications.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in certain situations. If both medications are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Aprobarbital
• Armodafinil
• Artemether
• Bacampicillin
• Barbital
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Eterobarb
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Heptabarbital
• Hexobarbital
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may change the dose or frequency of one or both medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at the same time as food or certain foods because of possible interactions. Alcohol or tobacco may also cause interactions with some medicines. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine, or give you special instructions about using food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical conditions, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (such as deep vein thrombosis or pulmonary embolism), or history of or
• Breast cancer, or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (such as coronary artery disease or heart valve problems), or history of or
• Uncontrolled hypertension (high blood pressure) or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver disease, including tumors or cancer or
• Major surgery planned in the near future, with long periods of immobility or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—This medicine should not be used in patients with these conditions.

• Depression, history of or
• Epilepsy, history of or
• Gallbladder disease, history of or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease—These conditions may worsen.

• Diarrhea or
• Vomiting—These may reduce the absorption of ethinyl estradiol and norgestrel combination in the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• backache
• belching
• bleeding between periods
• blurred vision
• breast tenderness, pain, enlargement, or secretion
• change in the amount of bleeding during periods
• change in the pattern of monthly periods
• changes in skin color, pain, tenderness, swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• clear or bloody discharge from the nipple
• cough
• dark urine
• diarrhea
• difficulty swallowing
• dimpling of the breast skin
• dizziness
• dull ache or feeling of pressure or heaviness in the legs
• fast heartbeat
• fever
• full or bloated feeling or pressure in the stomach
• headache
• headache, severe and throbbing
• heartburn
• hives
• inability to speak
• indigestion
• inverted nipple
• itching of the vagina or genital area
• itching skin near damaged veins
• light vaginal bleeding between periods and after intercourse
• loss of appetite
• lump in the breast or under the arm
• nausea and vomiting
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• persistent crusting or scaling of the nipple
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or swelling of the breast
• seizures
• severe or sudden headache
• slow or fast heartbeat
• slurred speech
• sore on the skin of the breast that does not heal
• stomach discomfort, upset, or pain
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• temporary blindness
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual stopping of menstrual bleeding
• unusual tiredness or weakness
• vomiting of blood
• weakness in the arm or leg on one side of the body, sudden and severe
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne
• changes in weight or appetite
• decreased interest in sexual intercourse
• inability to have or keep an erection
• increased hair growth, especially on the face
• intolerance to contact lenses
• loss in sexual ability, desire, drive, or performance
• loss of hair on the scalp

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cryselle
• Lo/Ovral
• Low-Ogestrel
• Ogestrel
• Ovral

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive

Pharmacologic Class: Estrogen

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may begin taking the pills on the first day of your menstrual period, or on the first Sunday after your period begins.

You should use a second form of birth control (eg, condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.

It is very important that you take this medicine on time every day. Birth control pills work best when there is no more than 24 hours between doses.

You could have light bleeding or spotting 3 days after you stop taking a white tablet, or when you switch to ethinyl estradiol and norgestrel combination from another birth control pill or implant, or injection.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For prevention of pregnancy:For oral dosage form (tablets): Adults—One white tablet each day for 21 days. Then one peach tablet per day for 7 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss one white pill, take it as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss two white pills in a row during Week 1 or 2, take two pills as soon as you can. Take two more pills on the next day. Then go back to your regular schedule of taking one pill every day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on Day 1 of your period and you miss two white pills in a row during Week 3, throw out the rest of your pills and start a new pack the same day. If you miss three or more white pills in a row during any week, throw out the rest of your pills and start a new pack the same day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss two white pills in a row during Week 3, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss three or more white pills in a row during any week, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period two months in a row, because you may be pregnant.

You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.