Fayosim Side Effects
Generic name: ethinyl estradiol / levonorgestrel
Medically reviewed by Drugs.com. Last updated on Jun 30, 2024.
Note: This document contains side effect information about ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply to the brand name Fayosim.
Applies to ethinyl estradiol / levonorgestrel: oral tablet. Other dosage forms:
Warning
Oral route (Kit)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. The 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 Fayosim
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:
More common
- Cramps
- headache
- heavy bleeding
- pain
Less common
- Absent, missed, or irregular menstrual periods
- breast pain
- change in the color, amount, or odor of vaginal discharge
Incidence not known
- Anxiety
- chest pain
- cough
- diarrhea
- difficult or labored breathing
- dizziness or lightheadedness
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- fever
- headache, severe and throbbing
- heavy non-menstrual vaginal bleeding
- joint or muscle pain
- longer or heavier menstrual periods
- nausea
- numbness or tingling of the face, hands, or feet
- pain, redness, or swelling in the arm or leg
- redness and soreness of the eyes
- redness of the face, neck, arms, and occasionally, the upper chest
- skin rash
- sores in the mouth
- stomach pain
- sudden sweating
- swelling of the feet or lower legs
- tightness in the chest
- troubled breathing
- vomiting
Other side effects of Fayosim
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:
Less common
- Acne
- crying
- delusions of persecution, mistrust, suspiciousness, or combativeness
- discouragement
- false or unusual sense of well-being
- feeling of unreality
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- quick to react or overreact emotionally
- rapidly changing moods
- sense of detachment from self or body
- tiredness
- trouble concentrating
- trouble sleeping
Incidence not known
- Back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty in moving
- headache
- injury
- muscle pain, spasm, or stiffness
- pain in the arms, legs, or joints
- sleepiness or unusual drowsiness
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- weight decreased
For Healthcare Professionals
Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable, transdermal film.
General
The 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.[Ref]
Genitourinary
Very 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[Ref]
Cardiovascular
Uncommon (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[Ref]
Nervous system
Very 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[Ref]
Local
Common (1% to 10%): Application site disorder (transdermal system)
Gastrointestinal
Very 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[Ref]
Oncologic
Rare (less than 0.1%): Benign liver tumor, malignant liver tumor, breast cancer[Ref]
Hepatic
Rare (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[Ref]
Hematologic
Frequency not reported: Hemolytic uremic syndrome[Ref]
Psychiatric
Common (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[Ref]
Immunologic
Rare (less than 0.1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction
Very rare (less than 0.01%): Systemic lupus erythematosus exacerbated[Ref]
Ocular
Rare (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[Ref]
Metabolic
Common (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[Ref]
Dermatologic
Common (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[Ref]
Other
Common (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[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Frequency not reported: Systemic lupus erythematosus
Postmarketing reports: Muscle spasm, pain in extremity[Ref]
Renal
Frequency not reported: Pulmonary embolism
Postmarketing reports: Pulmonary thrombosis[Ref]
More about Fayosim (ethinyl estradiol / levonorgestrel)
- Check interactions
- Compare alternatives
- Imprints, shape & color data
- Dosage information
- During pregnancy
- Drug class: contraceptives
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References
1. (2001) "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. (2017) "Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc
5. (2017) "Product Information. Quartette (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA
6. (2017) "Product Information. LoSeasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA
7. (2017) "Product Information. Seasonale (ethinyl estradiol-levonorgestrel)." Barr Pharmaceuticals Inc
8. (2017) "Product Information. Seasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA
9. (2021) "Product Information. Twirla (ethinyl estradiol-levonorgestrel)." Agile Therapeutics, Inc.
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.