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Note: This document contains side effect information about ethinyl estradiol / norgestimate. Some of the dosage forms listed on this page may not apply to the brand name Tri-Previfem.
For the ConsumerApplies to ethinyl estradiol / norgestimate: oral tablet
Oral route (Tablet)
Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. This risk increases with age and the number of cigarettes smoked and is quite marked in women over 35 years of age. Use of combination oral contraceptives is contraindicated in women over the age of 35 who smoke
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
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
GeneralThe 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).
GenitourinaryVery 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
Some women experience oligomenorrhea and amenorrhea following termination or oral contraceptive use.
GastrointestinalVery 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
Nervous systemVery 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
CardiovascularUncommon (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
RespiratoryUncommon (0.1% to 1%): Dyspnea
Frequency not reported: Pulmonary embolism
DermatologicCommon (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
MetabolicCommon (1% to 10%): Weight fluctuation, fluid retention
Rare (less than 0.1%): Appetite disorder
Frequency not reported: Dyslipidemia
MusculoskeletalCommon (1% to 10%): Muscle spasms, pain in extremity, back pain
Uncommon (0.1% to 1%): Myalgia
OncologicUncommon (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
HepaticRare (less than 0.1%): Hepatitis
PsychiatricCommon (1% to 10%): Depression, mood altered, mood disorder, nervousness, insomnia
Uncommon (0.1% to 1%): Anxiety, libido disorder
Frequency not reported: Irritability, mood swing
ImmunologicCommon (1% to 10%): Hypersensitivity
OtherCommon (1% to 10%): Weight increased, weight decreased, fatigue, chest pain, asthenic conditions, edema
OcularUncommon (0.1% to 1%): Vision impaired, dry eye
Frequency not reported: Contact lens intolerance, retinal vascular thrombosis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Tri-previfem (www.drugs.com/cdi/tri-previfem.html).
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