Ortho Tri-Cyclen Side Effects

Generic name: ethinyl estradiol / norgestimate

Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.

Note: This document provides detailed information about Ortho Tri-Cyclen Side Effects associated with ethinyl estradiol / norgestimate. Some dosage forms listed on this page may not apply specifically to the brand name Ortho Tri-Cyclen.

Applies to ethinyl estradiol / norgestimate: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Cigarette Smoking and Serious Cardiovascular Events. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

For this reason, COCs are contraindicated in women who are over 35 years of age and smoke

Serious side effects of Ortho Tri-Cyclen

Along with its needed effects, ethinyl estradiol/norgestimate 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 while taking ethinyl estradiol/norgestimate:

Incidence not known

• absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sudden trouble breathing
• sweating
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Other side effects of Ortho Tri-Cyclen

Some side effects of ethinyl estradiol / norgestimate 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

• bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

For healthcare professionals

Applies to ethinyl estradiol / norgestimate: oral tablet.

General

The most frequently reported side effects were headache/migraine, nausea/vomiting, gastrointestinal disorder, diarrhea, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding, mood disorders (including depression and mood altered), flatulence, nervousness, rash, and changes in weight (including weight increased or decreased).^[Ref]

Genitourinary

• Very common (10% or more): Breast issues (10.3%), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding
• Common (1% to 10%): Vaginal infection, genital discharge, breast tenderness, breast pain, breast enlargement, breast swelling, breast discharge, breast discomfort, nipple pain, menstrual discomfort, menstrual disorder, vulvovaginal infection, urinary tract infection, amenorrhea, premenstrual syndrome
• Uncommon (0.1% to 1%): Ovarian cyst, vulvovaginal dryness
• Rare (less than 0.1%): Vaginal discharge
• Frequency not reported: Suppressed lactation^[Ref]

Some women experience oligomenorrhea and amenorrhea following termination or oral contraceptive use.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea/vomiting (16.3%), gastrointestinal disorder, diarrhea
• Common (1% to 10%): Abdominal/gastrointestinal pain, flatulence, abdominal distention, constipation
• Rare (less than 0.1%): Pancreatitis^[Ref]

Nervous system

• Very common (10% or more): Headache/migraine (up to 33.6%)
• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Syncope, paresthesia
• Frequency not reported: Convulsion, cerebrovascular accident^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Palpitation, thrombosis, hypertension, hot flush
• Rare (less than 0.1%): Tachycardia, arterial thromboembolism
• Frequency not reported: Myocardial infarction, venous thromboembolic event, deep vein thrombosis^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Dyspnea
• Frequency not reported: Pulmonary embolism^[Ref]

Dermatologic

• Common (1% to 10%): Rash, acne
• Uncommon (0.1% to 1%): Alopecia, hirsutism, urticaria, pruritus, erythema, skin discoloration
• Rare (less than 0.1%): Hyperhidrosis, photosensitivity reaction
• Frequency not reported: Angioedema, erythema nodosum, night sweats^[Ref]

Metabolic

• Common (1% to 10%): Weight fluctuation, fluid retention
• Rare (less than 0.1%): Appetite disorder
• Frequency not reported: Dyslipidemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasms, pain in extremity, back pain
• Uncommon (0.1% to 1%): Myalgia^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Cervical dysplasia
• Rare (less than 0.1%): Breast cyst
• Frequency not reported: Breast cancer, carcinoma of the cervix in situ, hepatic adenoma, breast cancer, benign breast neoplasm, focal nodular hyperplasia, fibroadenoma of breast^[Ref]

Hepatic

• Rare (less than 0.1%): Hepatitis^[Ref]

Psychiatric

• Common (1% to 10%): Depression, mood altered, mood disorder, nervousness, insomnia
• Uncommon (0.1% to 1%): Anxiety, libido disorder
• Frequency not reported: Irritability, mood swing^[Ref]

Immunologic

• Common (1% to 10%): Hypersensitivity^[Ref]

Other

• Common (1% to 10%): Weight increased, weight decreased, fatigue, chest pain, asthenic conditions, edema^[Ref]

Ocular

• Uncommon (0.1% to 1%): Vision impaired, dry eye
• Frequency not reported: Contact lens intolerance, retinal vascular thrombosis^[Ref]

Further information

Ortho Tri-Cyclen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer