Note: This document contains side effect information about ethinyl estradiol / norgestimate. Some dosage forms listed on this page may not apply to the brand name Tri-Estarylla.

Applies to ethinyl estradiol / norgestimate: oral tablet.

Serious side effects of Tri-Estarylla

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 Tri-Estarylla

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]