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Estarylla Side Effects

Generic name: ethinyl estradiol / norgestimate

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

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 Estarylla.

Applies to ethinyl estradiol / norgestimate: oral tablet.

Warning

Oral route (Tablet)

Cigarette Smoking and Serious Cardiovascular EventsCigarette 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 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

Other side effects of 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

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]

References

1. Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate). Ortho McNeil Pharmaceutical. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Product Information. Ortho Tri-Cyclen Lo (ethinyl estradiol-norgestimate). Ortho McNeil Pharmaceutical. 2017.

Further information

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.