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Ortho Tri-Cyclen Lo

Last reviewed on RxList: 10/14/2016
Ortho Tri-Cyclen Lo Side Effects Center

Last reviewed on RxList 9/28/2016

Ortho Tri-Cyclen Lo (norgestimate, ethinyl estradiol) contains a combination of female hormones used as contraception to prevent pregnancy. Ortho Tri-Cyclen Lo is also used to treat severe acne. Ortho Tri-Cyclen Lo is available in generic form. Common side effects of Ortho Tri-Cyclen Lo include:

  • nausea (especially when you first start taking Ortho Tri-Cyclen Lo),
  • vomiting,
  • headache,
  • stomach cramping/bloating,
  • dizziness,
  • vaginal itching or discharge,
  • increased vaginal fluids,
  • breast tenderness or swelling,
  • nipple discharge,
  • freckles or darkening of facial skin,
  • increased hair growth,
  • loss of scalp hair,
  • changes in weight or appetite,
  • problems with contact lenses, or
  • decreased sex drive.
  • Acne may improve or get worse.
  • Vaginal bleeding between periods (spotting) or missed/irregular menstrual periods may occur, especially during the first few months of use of Ortho Tri-Cyclen Lo.

The dosage of Ortho Tri-Cyclen Lo is one white, light blue or dark blue "active" tablet taken daily from day 1 through day 21 of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one dark green "reminder" tablet daily for 7 days. Take tablets without interruption for 28 days, and start a new course the next day. Ortho Tri-Cyclen Lo may interact with phenylbutazone, St. John's wort, antibiotics, seizure medicines, barbiturates, or HIV medicines. Tell your doctor all medications you use. Ortho Tri-Cyclen Lo must not be used during pregnancy. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, consult your doctor about birth control, and find out when it is safe to use birth control containing estrogen, such as this medication. This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Ortho Tri-Cyclen Lo (norgestimate, ethinyl estradiol) 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 Lo 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 Lo (Norgestimate, Ethinyl Estradiol)

QUESTION

Which of the following are methods for contraception? See Answer
Ortho Tri-Cyclen Lo 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.

The safety of ORTHO TRI-CYCLEN Lo was evaluated in 1,723 subjects who participated in a randomized, partially blinded, multicenter, active-controlled clinical trial of ORTHO TRI-CYCLEN Lo for contraception. This trial examined healthy, nonpregnant, volunteers aged 18-45 (nonsmoker if 35-45 years of age), who were sexually active with regular coitus. Subjects were followed for up to 13 28-day cycles.

Common Adverse Reactions ( ≥ 2% of subjects)

The most common adverse reactions reported by at least 2% of the 1,723 women using the 28-day regimen were the following in order of decreasing incidence: headache/migraine (30.5%), nausea/vomiting (16.3%); breast issues (including tenderness, pain, enlargement, swelling, discharge, discomfort, cyst, and nipple pain) (10.3%), abdominal pain (9.2%), menstrual disorders (including dysmenorrhea, menstrual discomfort, menstrual disorder) (9.2%), mood disorders (including depression, mood altered, mood swings and depressed mood) (7.6%); acne (5.1%), vulvovaginal infection (3.5%), abdominal distension (2.8%), weight increased (2.4%) , fatigue (2.1%).

Adverse Reactions Leading To Study Discontinuation

In the clinical trial of ORTHO TRI-CYCLEN Lo 4% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions leading to discontinuation were headache/migraine (1.2%), nausea/vomiting (0.7%), cervical dysplasia (0.7%), abdominal pain (0.4%), ovarian cyst (0.3%), acne (0.2%), flatulence (0.2%) and depression (0.2%).

Serious Adverse Reactions

carcinoma of the cervix in situ (1 subject) and cervical dysplasia (1 subject).

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 (Including 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 Lo (Norgestimate, Ethinyl Estradiol)

Related Resources for Ortho Tri-Cyclen Lo

Read the Ortho Tri-Cyclen Lo User Reviews »

© Ortho Tri-Cyclen Lo Patient Information is supplied by Cerner Multum, Inc. and Ortho Tri-Cyclen Lo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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