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Fayosim Side Effects

Generic Name: ethinyl estradiol / levonorgestrel

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 Fayosim.

For the Consumer

Applies to ethinyl estradiol / levonorgestrel: oral tablet

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

  • Absent, missed, or irregular menstrual periods
  • anxiety
  • bloody stools
  • blurred vision
  • breast tenderness, enlargement, discharge
  • changes in skin color, pain, tenderness, or swelling of the foot or leg
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • confusion
  • cough
  • dark or cloudy urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty in speaking
  • dizziness or lightheadedness
  • double vision
  • dull ache or feeling of pressure or heaviness in the legs
  • fainting
  • fast heartbeat
  • fever
  • fluid-filled skin blisters
  • frequent urge to urinate
  • headache, severe and throbbing
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching of the vagina or outside the genitals
  • itching skin near damaged veins
  • light vaginal bleeding between regular menstrual periods
  • loss of appetite
  • nausea
  • nervousness
  • pain during sexual intercourse
  • pain or discomfort in the arms, jaw, back or neck
  • pelvic pain
  • pounding in the ears
  • sensitivity to the sun
  • skin thinness
  • slow or fast heartbeat
  • slow speech
  • stomach bloating and cramping
  • stomach pain and tenderness
  • stopping of menstrual bleeding
  • sweating
  • swelling
  • swelling, pain, or tenderness in the upper abdominal area
  • swollen feet and ankles
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • troubled breathing
  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

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

  • Acne
  • changes in appetite
  • changes in weight
  • decreased interest in sexual intercourse
  • decreased milk production
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • patchy brown or dark brown discoloration of the skin

For Healthcare Professionals

Applies to ethinyl estradiol / levonorgestrel: oral tablet

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]

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]

References

1. "Product Information. LoSeasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc, St. Laurent, QC.

4. "Product Information. Seasonale (ethinyl estradiol-levonorgestrel)." Barr Pharmaceuticals Inc, Pomona, NY.

5. Cerner Multum, Inc. "Australian Product Information." O 0

6. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

7. "Product Information. Seasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.

8. "Product Information. Quartette (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.

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.

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