Simpesse Side Effects

Generic name: ethinyl estradiol / levonorgestrel

Medically reviewed by Drugs.com. Last updated on Feb 1, 2025.

Note: This document provides detailed information about Simpesse Side Effects associated with ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply specifically to the brand name Simpesse.

Applies to ethinyl estradiol / levonorgestrel: transdermal patch extended release.

Other dosage forms:

• oral tablet, oral tablet chewable
• oral tablet

Common side effects of Simpesse

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:

Serious side effects of Simpesse

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:

For healthcare professionals

Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable, transdermal film.

General adverse events

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]

Further information

Simpesse side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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