Elifemme 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 Elifemme.
Applies to ethinyl estradiol / levonorgestrel: transdermal patch extended release. Other dosage forms:
Warning
Transdermal route (Patch, Extended Release)
Warning: Cigarette Smoking and Serious Cardiovascular Events and Contraindicated in Women with BMI greater than or equal to 30 kg/m(2)Cigarette Smoking and Serious Cardiovascular EventsCigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including levonorgestrel/ethinyl estradiol, are contraindicated in women who are over 35 years of age and smoke.Contraindicated in Women with a BMI greater than or equal to 30 kg/m(2)Levonorgestrel/ethinyl estradiol is contraindicated in women with a BMI greater than or equal to 30 kg/m(2). Compared to women with a lower BMI, women with a BMI greater than or equal to 30 kg/m(2) had reduced effectiveness and may have a higher risk for venous thromboembolism events (VTEs).
Serious side effects of Elifemme
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:
Less common
- Difficulty breathing
- pain in the chest, groin, or legs, especially the calves
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- vision changes
Rare
- Bloating
- changes in behavior
- chest pain
- chills
- confusion
- cough
- discouragement
- dizziness
- fast, weak pulse
- feeling sad or empty
- gaseous stomach pain
- indigestion
- irritability
- lack of appetite
- lightheadedness
- loss of interest or pleasure
- nausea
- pale, cold clammy skin
- recurrent fever
- severe cramping
- severe nausea
- severe vomiting
- sneezing
- sore throat
- stomach fullness or pain
- sudden increase in abdominal or shoulder pain
- sweating
- thoughts of killing oneself
- tightness in the chest
- tiredness
- trouble concentrating
- trouble sleeping
- unusual or large amount of vaginal bleeding
- yellow eyes or skin
Other side effects of Elifemme
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:
More common
- Burning, itching, redness, skin rash, swelling, or soreness at the application site
Less common
- Diarrhea
- heavy bleeding
- increased weight
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 Elifemme (ethinyl estradiol / levonorgestrel)
- Check interactions
- Compare alternatives
- Imprints, shape & color data
- Dosage information
- During pregnancy
- Drug class: contraceptives
Patient resources
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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.