Ortho-Cyclen

Generic Name: norgestimate and ethinyl estradiol (nor-JES-ti-mate/ETH-i-nil ES-tra-DYE-ol)
Brand Name: Examples include Ortho-Cyclen and Tri-Sprintec

Cigarette smoking increases the risk of serious heart problems associated with use of Ortho-Cyclen. This risk increases with age and with heavy smoking. Women who are older than 35 years old have a greater risk. Women who are older than 35 years old and smoke should not use Ortho-Cyclen.


Ortho-Cyclen is used for:

Preventing pregnancy. It may also be used to treat acne in certain patients. It may also be used for other conditions as determined by your doctor.

Ortho-Cyclen is an estrogen and progestin combination. It works by preventing ovulation. It may also change the cervical mucus to prevent the sperm from reaching the egg and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus.

Do NOT use Ortho-Cyclen if:

  • you are allergic to any ingredient in Ortho-Cyclen
  • you are pregnant or think you may be pregnant
  • you have blood clots (eg, in the legs, lungs, eyes) or a history of blood clots or blood clotting problems
  • you have chest pain caused by angina or a history of heart or brain blood vessel problems, heart attack, or stroke
  • you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
  • you have a history of breast cancer
  • you have abnormal vaginal bleeding of an unknown cause
  • you have certain heart valve problems, diabetes that affects circulation, uncontrolled high blood pressure, liver disease, or liver tumor or cancer, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use
  • you have certain types of headaches or migraines with aura
  • you have had surgery and are or will be confined to a bed or a chair for an extended period of time
  • you are older than 35 years old and you smoke

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using Ortho-Cyclen:

Some medical conditions may interact with Ortho-Cyclen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of porphyria, diabetes or high blood sugar, gallbladder problems, heart problems (eg, angina), high blood pressure, high cholesterol or triglycerides, high blood calcium levels, kidney or liver problems, mental or mood problems (eg, depression), migraines or headaches, pancreas problems, or seizures
  • if you have endometriosis, growths in the uterus, an abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
  • if a family member has a history of high blood triglyceride levels
  • if you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride)
  • if you smoke, are very overweight, or have fluid retention or swelling problems

Some MEDICINES MAY INTERACT with Ortho-Cyclen. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Atorvastatin, azole antifungals (eg, ketoconazole), nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, etravirine, nevirapine), protease inhibitors (eg, boceprevir, ritonavir), or rosuvastatin because they may decrease Ortho-Cyclen's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of Ortho-Cyclen's side effects
  • Acitretin, aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, colesevelam, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, oxcarbazepine, rifamycins (eg, rifampin), rufinamide, St. John's wort, topiramate, or troglitazone because they may decrease Ortho-Cyclen's effectiveness
  • Cyclosporine, prednisolone, theophylline, tizanidine, or voriconazole because the risk of their side effects may be increased by Ortho-Cyclen
  • Clofibric acid, lamotrigine, morphine, temazepam, thyroid hormones (eg, levothyroxine), or valproic acid because their effectiveness may be decreased by Ortho-Cyclen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ortho-Cyclen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ortho-Cyclen:

Use Ortho-Cyclen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Ortho-Cyclen. Talk to your pharmacist if you have questions about this information.
  • Take Ortho-Cyclen by mouth with or without food.
  • Eating grapefruit or drinking grapefruit juice while you are taking Ortho-Cyclen may increase the amount of Ortho-Cyclen in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • If you also take colesevelam, take it 4 hours before or after you take Ortho-Cyclen.
  • Talk with your doctor about how you should start to take your first pack of Ortho-Cyclen. Take Ortho-Cyclen at the same time each day. Take the tablets in the order directed on the blister pack. After taking the last pill in the pack, start taking the first pill from the new pack the very next day.
  • Ortho-Cyclen may not be effective for up to 7 days after you begin taking the first cycle of pills. Use a back-up method of birth control for the first 7 days after you start Ortho-Cyclen.
  • For Ortho-Cyclen to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
  • Severe vomiting or diarrhea may decrease Ortho-Cyclen's effectiveness. Use a back-up method of birth control until you check with your doctor.
  • If you miss a dose of Ortho-Cyclen, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Ortho-Cyclen, read the extra patient information leaflet that comes with Ortho-Cyclen or contact you doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of Ortho-Cyclen. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Ortho-Cyclen.

Important safety information:

  • Ortho-Cyclen may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke. Do not smoke or use other tobacco products while taking Ortho-Cyclen.
  • Bleeding or spotting may occur while you are taking Ortho-Cyclen, especially during the first 3 months. Do not stop taking Ortho-Cyclen if this occurs. If bleeding or spotting is persistent or if it occurs after menstrual cycles that were previously regular, contact your doctor.
  • If you miss more than 2 periods in a row or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur.
  • You should usually not take Ortho-Cyclen within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking Ortho-Cyclen in these instances.
  • Follow your doctor's instructions to examine your breasts, and report any lumps to your doctor immediately.
  • Tell your doctor or dentist that you take Ortho-Cyclen before you receive any medical or dental care, emergency care, or surgery. If possible, Ortho-Cyclen should be stopped at least 4 weeks before through 2 weeks after surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, lengthy illness).
  • Ortho-Cyclen does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • You may experience a delay in being able to become pregnant after stopping Ortho-Cyclen. This effect may be greater in patients who had irregular periods before starting Ortho-Cyclen. Discuss any concerns with your doctor or pharmacist.
  • Certain antibiotics, anticonvulsants, and other medicines may decrease the effectiveness of Ortho-Cyclen. Ask your pharmacist if you have questions about which medicines may decrease Ortho-Cyclen's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information.
  • If you wear contact lenses and you develop problems with them or other vision changes, contact your doctor.
  • Ortho-Cyclen may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
  • Diabetes patients - Ortho-Cyclen may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Ortho-Cyclen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ortho-Cyclen.
  • Lab tests, including breast exams, PAP tests, physicals, and blood pressure, may be performed while you use Ortho-Cyclen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ortho-Cyclen should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Ortho-Cyclen if you are pregnant. If you think you may be pregnant, contact your doctor right away. Ortho-Cyclen is found in breast milk. If you are or will be breast-feeding while you use Ortho-Cyclen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ortho-Cyclen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness; bleeding or spotting between menstrual periods; headache; nausea; stomach cramps and bloating; vomiting; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps, pain, or discharge; bulging eyes; calf or leg pain, swelling, redness, or tenderness; changes in vision (eg, double vision, vision loss); change in the amount of urine produced; chest pain or pressure; coughing up blood; fainting; fever; mental or mood changes (eg, depression); severe stomach pain or tenderness; severe or persistent dizziness or headache; shortness of breath; sudden, severe nausea or vomiting; swelling of fingers, hands, legs, or ankles; symptoms of liver problems (eg, dark urine, fever, loss of appetite, pale stools, unusual tiredness, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual sweating; unusual or severe vaginal bleeding; vaginal irritation or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ortho-Cyclen:

Store Ortho-Cyclen at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ortho-Cyclen out of the reach of children and away from pets.

General information:

  • If you have any questions about Ortho-Cyclen, please talk with your doctor, pharmacist, or other health care provider.
  • Ortho-Cyclen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ortho-Cyclen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ortho-Cyclen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ortho-Cyclen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Ortho-Cyclen.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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