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Note: This document contains side effect information about ethinyl estradiol / norethindrone. Some of the dosage forms listed on this page may not apply to the brand name Larin Fe 1 / 20.
For the ConsumerApplies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable
Other dosage forms:
Oral route (Tablet)
Junel®, Loestrin®, Microgestin®, Tri-Legest®: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.Femhrt®: Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen alone and with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible.
Along with its needed effects, ethinyl estradiol/norethindrone 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 / norethindrone:
Incidence not known
Some side effects of ethinyl estradiol / norethindrone 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 / norethindrone: oral capsule, oral tablet, oral tablet chewable
GeneralThe most frequently reported side effects were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, abdominal pain, mood changes, bacterial vaginitis, acne, irregular uterine bleeding, and weight gain.
GenitourinaryCommon (1% to 10%): Vaginal candidiasis, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal/irregular bleeding, metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage, breast pain, dysmenorrhea, vaginal hemorrhage, dysfunctional uterine bleeding
Frequency not reported: Ovarian vein thrombosis, vaginitis, amenorrhea, breakthrough bleeding, breast enlargement, breast secretion, cervical erosion changed, cervical secretion, menstrual flow changed, diminution in lactation, spotting, temporary infertility after discontinuation of treatment, premenstrual syndrome, uterine fibroid disease exacerbated
Postmarketing reports: Vaginal infection, pollakiuria, dysuria, ovarian cyst, pelvic pain, ovarian cyst rupture, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement
CardiovascularUncommon (0.1% to 1%): Blood pressure increased
Frequency not reported: Deep vein thrombosis, myocardial infarction, hypertension, arterial thromboembolism, thrombophlebitis
Postmarketing reports: Coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, heart rate irregular
GastrointestinalCommon (1% to 10%): Nausea/vomiting, abdominal pain
Frequency not reported: Abdominal cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn's disease, ulcerative colitis, mesenteric thrombosis
Postmarketing reports: Constipation, pancreatitis
Nervous systemCommon (1% to 10%): Headache
Frequency not reported: Migraine, dizziness, cerebral hemorrhage, cerebral thrombosis
Postmarketing reports: Loss of consciousness, hyperesthesia, paresthesia, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, epilepsy exacerbated, dementia, hemiparesis
OncologicFrequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor
Postmarketing reports: Hemangioma of liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer
EndocrinePostmarketing reports: Hypothyroidism, hyperthyroidism
PsychiatricCommon (1% to 10%): Mood swing, depression, mood changed, anxiety
Frequency not reported: Nervousness
Postmarketing reports: Insomnia, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability
DermatologicCommon (1% to 10%): Acne
Frequency not reported: Hirsutism, loss of scalp hair, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus
Postmarketing reports: Alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema
HepaticFrequency not reported: Liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome
Postmarketing reports: Cholelithiasis, cholecystitis
HematologicFrequency not reported: Hemolytic uremic syndrome
Postmarketing reports: Anemia
ImmunologicPostmarketing reports: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction
OcularFrequency not reported: Corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis
Postmarketing reports: Vision blurred, vision impaired, corneal thinning, fungal infection, transient blindness
RespiratoryFrequency not reported: Pulmonary embolism
Postmarketing reports: Asthma exacerbated, dyspnea
MusculoskeletalFrequency not reported: Leg cramp, backache
Postmarketing reports: Myalgia, arthralgia, back pain
MetabolicCommon (1% to 10%): Weight fluctuation
Frequency not reported: Tolerance to carbohydrates reduced
Postmarketing reports: Appetite increased, appetite decreased, diabetes mellitus, hypoglycemia, hypocalcemia, triglycerides increased, blood glucose abnormal
OtherCommon (1% to 10%): Cervical smear abnormal, weight gain, edema
Frequency not reported: Fatigue, porphyria, Vitamin B6 deficient
Postmarketing reports: Weight decreased, peripheral edema, malaise, chest pain
RenalFrequency not reported: Renal function impaired
Postmarketing reports: Cystitis-like syndrome
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Larin Fe 1/20 (www.drugs.com/cdi/larin-fe-1-20.html).
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