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Ortho Tri-Cyclen

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Ortho Tri-Cyclen / Ortho-Cyclen

Ortho Tri-Cyclen / Ortho-Cyclen

Ortho Tri-Cyclen Side Effects Center

Medical Editor: Omudhome Ogbru, PharmD

Ortho-Tri-Cyclen Lo (ethinyl estradiol, norgestimate) is an oral contraceptive that contains estrogen and progestin. Generic versions are available. Side effects include edema, weakness, breakthrough bleeding, change in weight, headache, nausea, and vomiting. The dose is one active tablet for 21 days and an inert tablet for 7 days, then repeat the cycle. Cigarette smoking increases the risk of cardiovascular adverse effects so women should not smoke when taking hormonal contraceptives. They also may cause deep vein thrombosis and should not be given to women with deep vein thrombosis. Antibiotics, anticonvulsants, protease inhibitors, and st. John's Wort may reduce the effectiveness of oral contraceptives while itraconazole, ketoconazole, or erythromycin increase plasma levels of estrogen. Estrogens increase the levels of blood clotting factors, interfering with the action of warfarin. Estrogens should not be given to pregnant women since they may harm the fetus. Estrogens are secreted into breast milk and may affect the infant. Our Ortho-Tri-Cyclen Lo (ethinyl estradiol, norgestimate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ortho Tri-Cyclen in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);
  • a lump in your breast;
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • mild nausea or vomiting, appetite or weight changes;
  • breast swelling or tenderness;
  • headache, nervousness, dizziness;
  • problems with contact lenses;
  • freckles or darkening of facial skin, loss of scalp hair; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ortho Tri-Cyclen (Norgestimate and Ethinyl Estradiol) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ortho Tri-Cyclen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS Section).

  • Thrombophlebitis and venous thrombosis
  • with or without embolism
  • Arterial thromboembolism
  • Pulmonary embolism
  • Myocardial infarction
  • Cerebral hemorrhage
  • Cerebral thrombosis
  • Hypertension
  • Gallbladder disease
  • Hepatic adenomas or benign
  • liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives:

  • Mesenteric thrombosis
  • Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea
  • Vomiting
  • Gastrointestinal symptoms (such as abdominal cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Edema
  • Melasma which may persist
  • Breast changes: tenderness, enlargement, secretion
  • Change in weight (increase or decrease)
  • Change in cervical erosion and secretion
  • Diminution in lactation when given immediately postpartum
  • Cholestatic jaundice
  • Migraine
  • Allergic reaction, including rash, urticaria, angioedema
  • Mental depression
  • Reduced tolerance to carbohydrates
  • Vaginal candidiasis
  • Change in corneal curvature (steepening)
  • Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:

  • Pre-menstrual syndrome
  • Cataracts
  • Changes in appetite
  • Cystitis-like syndrome
  • Headache
  • Nervousness
  • Dizziness
  • Hirsutism
  • Loss of scalp hair
  • Erythema multiforme
  • Erythema nodosum
  • Hemorrhagic eruption
  • Vaginitis
  • Porphyria
  • Impaired renal function
  • Hemolytic uremic syndrome
  • Acne
  • Changes in libido
  • Colitis
  • Budd-Chiari Syndrome

Read the entire FDA prescribing information for Ortho Tri-Cyclen (Norgestimate and Ethinyl Estradiol) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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