Ovral (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 like 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 work 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 during regular visits 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 have missed a menstrual period.
• You have 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 get pregnant in the future.

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

This medicine will not protect you from HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner start having sexual intercourse with other people, or if you or your partner tests positive for a sexually transmitted disease. Discuss any concerns 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 continues for 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. Smoking while using ethinyl estradiol and norgestrel combination increases your risk of a blood clot, heart attack, or stroke. Your risk is even higher if you are over 35, 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 for weight and cholesterol management.

Using this medicine may increase your risk of blood clotting problems. Contact your doctor right away if you have pain in the chest, groin, or legs, especially in 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 raise your risk of breast cancer or cancer of 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 stomach pain or tenderness, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellowing of the 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 specialist (ophthalmologist) to examine your eyes.

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

Make sure any doctor or dentist treating you knows that you are using this medicine. The results of 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 products (e.g., St. John's wort) or vitamin supplements.

In deciding to use this medicine, you and your doctor need to consider the risks and the benefits. The following points should be taken into account:

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 provider know about any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

There have not been any appropriate studies to determine the effects of ethinyl estradiol and norgestrel combination in children. However, there are no expected problems that would limit the use of this medicine for birth control in teenage females, but it should not be used before menstruation begins.

Geriatric

There have not been any appropriate studies to determine the effects of ethinyl estradiol and norgestrel combination in elderly patients. This medicine is not intended for use in older women.

Breast Feeding

Research has shown harmful effects to infants in breastfeeding women. You should either stop breastfeeding or your doctor should prescribe an alternative to this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If necessary, your doctor may adjust your dose or take other precautions. When taking this medicine, it's crucial for your healthcare professional to know if you are using any of the medicines listed below. The following interactions are significant, but this list may not include all possible interactions.

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

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following is generally not recommended, but might be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both.

• 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 may increase the risk of certain side effects, but using both may be necessary for treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both.

• 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

Some medicines should not be taken with food or certain foods because interactions may happen. Drinking alcohol or using tobacco with some medicines can also cause interactions. The following interactions are significant, but this list may not cover all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If both are used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor about any other medical conditions, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, or history of or
• Diabetes with damage to kidneys, eyes, nerves, or blood vessels or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, 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 immobilization or
• Migraine headaches or
• Stroke, history of or
• Known or suspected tumors (estrogen-dependent)—This medicine should not be used in these situations.

• History of depression or
• History of epilepsy or
• History of gallbladder disease or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease—These conditions may worsen with this medicine.

• 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 occur, 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.