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Ortho Tri-Cyclen

Last reviewed on RxList: 7/14/2020
Ortho Tri-Cyclen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ortho Tri-Cyclen?

Ortho Tri-Cyclen (ethinyl estradiol, norgestimate) is an oral contraceptive that contains estrogen and progestin. Generic versions of Ortho-Tri-Cyclen are available.

What Are Side Effects of Ortho Tri-Cyclen?

Side effects of Ortho-Tri-Cyclen include:

  • nausea (especially when you first start taking Ortho-Tri-Cyclen),
  • weakness,
  • breakthrough bleeding,
  • changes in your menstrual periods or spotting between periods,
  • changes in weight or appetite,
  • headache,
  • depression,
  • rash,
  • vomiting,
  • bloating,
  • stomach cramps,
  • breast tenderness or swelling,
  • nipple discharge,
  • freckles or darkening of facial skin,
  • increased hair growth,
  • loss of scalp hair,
  • problems with contact lenses,
  • vaginal itching or discharge, or
  • decreased sex drive.

Dosage for Ortho Tri-Cyclen

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.

What Drugs, Substances, or Supplements Interact with Ortho Tri-Cyclen?

Ortho-Tri-Cyclen may interact with bosentan, antibiotics, tuberculosis medications, drugs to treat hepatitis C or HIV/AIDS, phenobarbital and other barbiturates, St. John's wort, seizure medications, dantrolene, lamotrigine, tizanidine, or tranexamic acid. Tell your doctor all medications and supplements you use.

Ortho Tri-Cyclen During Pregnancy and Breastfeeding

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. Breastfeeding while taking Ortho-Tri-Cyclen is not recommended.

Additional Information

Our Ortho-Tri-Cyclen (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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Ortho Tri-Cyclen Consumer Information

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

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe headache, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • changes in the pattern or severity of migraine headaches;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • stomach pain, gas, nausea, vomiting;
  • breast tenderness;
  • acne, darkening of facial skin;
  • headache, nervousness, mood changes;
  • problems with contact lenses;
  • changes in weight;
  • breakthrough bleeding;
  • vaginal itching or discharge; or
  • rash.

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)

QUESTION

Which of the following are methods for contraception? See Answer
Ortho Tri-Cyclen Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:

Adverse reactions commonly reported by COC users are:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

ORTHO-CYCLEN

The safety of ORTHO-CYCLEN was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of ORTHO-CYCLEN for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles.

Common Adverse Reactions ( ≥ 2% of subjects)

The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5.0%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%).

Adverse Reactions Leading to Study Discontinuation

Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions ( ≥ 1%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5.0%), headache (4.1%), mood disorders (including depression and mood altered) (2.4%), premenstrual syndrome (1.7%), hypertension (1.4%), breast pain (1.4%), nervousness (1.3%), amenorrhea (1.1%), dysmenorrhea (1.1%), weight increased (1.1%), and flatulence (1.1%).

Serious Adverse Reactions

breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).

ORTHO TRI-CYCLEN

The safety of ORTHO TRI-CYCLEN was evaluated in 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of ORTHO TRI-CYCLEN for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles.

Common Adverse Reactions ( ≥ 2% of subjects)

The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8.0%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight (including weight fluctuation, increased or decreased) (2.5%).

Adverse Reactions Leading to Study Discontinuation

Over the trials, between 9 to 27% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions ( ≥ 1%) leading to discontinuation were: metrorrhagia (4.3%), nausea/vomiting (2.8%), headache/migraine (2.4%), mood disorders (including depression and mood altered) (1.1%), and weight increased (1.1%).

Serious Adverse Reactions

breast cancer (1 subject), carcinoma of the cervix in situ (1 subject), hypertension (1 subject), and migraine (2 subjects).

Postmarketing Experience

The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: Urinary tract infection;

Neoplasms Benign, Malignant and Unspecified (Incl. Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst;

Immune System Disorders: Hypersensitivity;

Metabolism and Nutrition Disorders: Dyslipidemia;

Psychiatric Disorders: Anxiety, insomnia;

Nervous System Disorders: Syncope, convulsion, paresthesia, dizziness;

Eye Disorders: Visual impairment, dry eye, contact lens intolerance;

Ear and Labyrinth Disorders: Vertigo;

Cardiac Disorders: Tachycardia, palpitations;

Vascular Events: Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush;

Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident;

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea;

Gastrointestinal Disorders: Pancreatitis, abdominal distension, diarrhea, constipation;

Hepatobiliary Disorders: Hepatitis;

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne;

Musculoskeletal, Connective Tissue, and Bone Disorders: Muscle spasms, pain in extremity, myalgia, back pain;

Reproductive System and Breast Disorders: Ovarian cyst, suppressed lactation, vulvovaginal dryness;

General Disorders and Administration Site Conditions: Chest pain, asthenic conditions.

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

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