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Note: This document contains side effect information about ethinyl estradiol / levonorgestrel. Some of the dosage forms listed on this page may not apply to the brand name Sronyx.
For the ConsumerApplies to ethinyl estradiol / levonorgestrel: oral tablet
Oral route (Tablet)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women older than 35 years, and with the number of cigarettes smoked. Women who use oral contraceptives should be strongly advised not to smoke.
Along with its needed effects, ethinyl estradiol/levonorgestrel 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 / levonorgestrel:
Incidence not known
Some side effects of ethinyl estradiol / levonorgestrel 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 / levonorgestrel: oral tablet
GeneralThe most frequently reported side effects were headache, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changed, anxiety/panic attack, breast pain, and migraines.
GenitourinaryVery common (10% or more): Irregular/heavy uterine bleeding (up to 17%), menorrhagia (up to 11.6%), breast pain (up to 11.2%), dysmenorrhea (up to 11%), breakthrough bleeding/spotting
Common (1% to 10%): Breast tenderness/discomfort, vaginitis, candidiasis, breast enlargement, breast secretion, breast tension, intermenstrual bleeding/metrorrhagia
Uncommon (0.1% to 1%): Breast enlargement, breast hypertrophy, menstrual flow changed
Rare (less than 0.1%): Breast discharge, vaginal discharge, amenorrhea
Frequency not reported: Uterine myoma, temporary infertility, cervical erosion changed, cervical secretion changed, diminution in lactation
Postmarketing reports: Menstrual flow reduced, withdrawal bleeding missed, post pill amenorrhea
CardiovascularUncommon (0.1% to 1%): Blood pressure increased
Rare (less than 0.1%): Venous thromboembolism, arterial thromboembolism
Frequency not reported: Deep vein thrombosis, hypertension, myocardial infarction, varicose veins exacerbated, thrombophlebitis, cerebral vascular disease, mitral valve prolapse
Postmarketing reports: Thrombosis
Nervous systemVery common (10% or more): Headache (up to 33%)
Common (1% to 10%): Migraine, dizziness
Very rare (less than 0.01%): Chorea exacerbated
Frequency not reported: Loss of consciousness, epilepsy, Sydenham's chorea, transient ischemic attack, ischemic stroke, hemorrhagic stroke, stroke, cerebral hemorrhage, cerebral thrombosis
GastrointestinalVery common (10% or more): Nausea/vomiting (up to 11%)
Common (1% to 10%): Abdominal pain/cramps, diarrhea
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Crohn's disease, ulcerative colitis, bloating, mesenteric thrombosis
Postmarketing reports: Abdominal distention
OncologicRare (less than 0.1%): Benign liver tumor, malignant liver tumor, breast cancer
HepaticRare (less than 0.1%): Cholestatic jaundice
Very rare (less than 0.01%): Gallbladder disease, gallbladder disease exacerbated
Frequency not reported: Cholecystitis, cholelithiasis, Budd-Chiari syndrome
Postmarketing reports: Liver function disturbance
HematologicFrequency not reported: Hemolytic uremic syndrome
PsychiatricCommon (1% to 10%): Mood changed, mood swings/alteration/affect lability, depression, anxiety/panic attack, nervousness, libido decreased, libido increased, depression
Frequency not reported: Major depressive disorder, suicide attempt, depressed mood, crying, major depression, affective disorder, depression suicidal, dysthymic disorder
Postmarketing reports: Insomnia
ImmunologicRare (less than 0.1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction
Very rare (less than 0.01%): Systemic lupus erythematosus exacerbated
OcularRare (less than 0.1%): Contact lens intolerance
Very rare (less than 0.01%): Retinal vein thrombosis
Frequency not reported: Cataract, corneal curvature changed/steepening
Postmarketing reports: Optic neuritis
MetabolicCommon (1% to 10%): Appetite increased, fluid retention/edema
Uncommon (0.1% to 1%): Appetite decreased, serum lipid levels changed, hypertriglyceridemia
Rare (less than 0.1%): Glucose tolerance changed
Frequency not reported: Tolerance to carbohydrates reduced
DermatologicCommon (1% to 10%): Acne
Uncommon (0.1% to 1%): Urticaria, rash, chloasma
Rare (less than 0.1%): Erythema nodosum, erythema multiforme, hereditary angioedema exacerbated
Frequency not reported: Herpes gestationis, hirsutism, alopecia, melasma
Postmarketing reports: Alopecia, itching, angioedema
OtherCommon (1% to 10%): Weight gain, weight changed, flu syndrome
Rare (less than 0.1%): Weight decreased
Very rare (less than 0.01%): Porphyria exacerbated
Frequency not reported: Ectopic pregnancy, spontaneous abortion, porphyria, congenital anomaly, cystitis-like syndrome
Postmarketing reports: Chest pain, fatigue, malaise, edema peripheral, pain, serum folate decreased
MusculoskeletalCommon (1% to 10%): Back pain
Frequency not reported: Systemic lupus erythematosus
Postmarketing reports: Muscle spasm, pain in extremity
RenalFrequency not reported: Pulmonary embolism
Postmarketing reports: Pulmonary thrombosis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Sronyx (www.drugs.com/cdi/sronyx.html).
August 4, 2022
August 4, 2022
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