Xulane Side Effects

Generic name: ethinyl estradiol / norelgestromin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 21, 2024.

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

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

Important warnings This medicine can cause some serious health issues

Transdermal route (patch, extended release)

Cardiovascular Risk Associated with Smoking, Risk of Venous Thromboembolism, and Pharmacokinetic Profile of Ethinyl Estradiol. Women over 35 years old who smoke should not use norelgestromin and ethinyl estradiol transdermal system.Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptives (CHC) use.There may be an increased risk of venous thromboembolism (VTE) among women who use the norelgestromin and ethinyl estradiol transdermal system compared to women who used certain oral contraceptives.The pharmacokinetic (PK) profile of ethinyl estradiol (EE) for the norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral contraceptives in that it has a higher areas under the time-concentration curve, steady state concentrations and lower peak concentrations.

Serious side effects of Xulane

Along with its needed effects, ethinyl estradiol / norelgestromin 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 / norelgestromin:

More common

• body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Incidence not known

• anxiety
• changes in skin color
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness
• eye pain
• fainting
• inability to speak
• itching
• lack or loss of appetite
• light-colored stools
• lightheadedness
• nausea
• numbness in the hands
• pain in the stomach
• pain in the chest, groin, or legs, especially the calves
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pounding in the ears
• rash
• seizures
• slow or fast heartbeat
• slurred speech
• sudden headache
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg on one side of the body
• sweating
• swelling, pain, or tenderness in the upper abdominal or stomach area
• temporary blindness
• unpleasant breath odor
• vision changes
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / norelgestromin:

Symptoms of overdose

• unusual vaginal bleeding in women
• vomiting

Other side effects of Xulane

Some side effects of ethinyl estradiol / norelgestromin 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, or redness of the skin
• menstrual cramps
• pain, soreness, swelling, or discharge from the breast or breasts
• swelling or soreness at the patch site

Incidence not known

• absent, missed, or irregular menstrual periods
• bloody vaginal discharge
• brown, blotchy spots on exposed skin
• change in amount of vaginal discharge
• change in menstrual flow
• decreased amount of breast milk
• discouragement
• dry mouth
• feeling sad or empty
• increase or decrease in weight
• increased hunger or thirst
• increased urination
• irritability
• itching of the vagina or outside of the genitals
• light vaginal bleeding between periods and after sexual intercourse
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps or bloating
• stopping of menstrual bleeding
• swelling
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble concentrating
• trouble sleeping

For healthcare professionals

Applies to ethinyl estradiol / norelgestromin: transdermal film extended release.

General

The most frequently reported side effects were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood affect and anxiety disorders.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (16.6%)
• Common (1% to 10%): Abdominal pain, vomiting, diarrhea, abdominal distention
• Postmarketing reports: Colitis^[Ref]

Nervous system

• Very common (10% or more): Headache (21%)
• Common (1% to 10%): Dizziness, migraine
• Rare (less than 0.1%): Cerebrovascular accident
• Frequency not reported: Stroke
• Postmarketing reports: Dysgeusia, migraine with aura, hemorrhage intracranial, cerebral hemorrhage, abnormal taste^[Ref]

Respiratory

• Rare (less than 0.1%): Pulmonary embolism
• Postmarketing reports: Pulmonary artery thrombosis^[Ref]

Genitourinary

• Very common (10% or more): Breast symptoms (22.4%), breast tenderness
• Common (1% to 10%): Dysmenorrhea, vaginal bleeding/menstrual disorder, vaginal yeast infection/candidiasis, vulvovaginal infection, uterine spasm, vaginal discharge
• Uncommon (0.1% to 1%): Galactorrhea, premenstrual syndrome, vulvovaginal dryness
• Rare (less than 0.1%): Genital discharge
• Frequency not reported: Uterine bleeding irregular
• Postmarketing reports: Lactation suppressed, menstrual disorder^[Ref]

Local

• Very common (10% or more): Application site disorder (17.1%)
• Common (1% to 10%): Application site reaction
• Rare (less than 0.1%): Application site pustule
• Postmarketing reports: Erosion, abscess^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Hypertension, blood pressure increased
• Rare (less than 0.1%): Arterial thromboembolism
• Postmarketing reports: Myocardial infarction, arterial thrombosis, cerebrovascular accident, deep vein thrombosis, hypertension, hypertensive crisis, thrombosis, venous thromboembolism^[Ref]

Psychiatric

• Common (1% to 10%): Mood disorder, affect disorder, anxiety
• Uncommon (0.1% to 1%): Insomnia, libido decreased
• Rare (less than 0.1%): Libido increased
• Postmarketing reports: Anger, emotional disorder, frustration, irritability^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Hypercholesterolemia, fluid retention, appetite increase, lipid disorder
• Postmarketing reports: Hyperglycemia, insulin resistance, blood glucose decreased, blood glucose increased, blood cholesterol abnormal, low density lipoprotein increased, blood glucose abnormal^[Ref]

Dermatologic

• Common (1% to 10%): Acne, pruritus, rash, skin reaction, skin irritation
• Uncommon (0.1% to 1%): Alopecia, allergic dermatitis, eczema, urticaria, photosensitivity, contact dermatitis, erythema
• Frequency not reported: Chloasma
• Postmarketing reports: Erythema multiforme, erythema nodosum, seborrheic dermatitis, pustular rash, angioedema, exfoliative rash^[Ref]

Hepatic

• Rare (less than 0.1%): Cholecystitis, cholelithiasis
• Postmarketing reports: Cholestasis, hepatic lesion, cholestatic jaundice^[Ref]

Other

• Common (1% to 10%): Fatigue, weight increased, malaise
• Uncommon (0.1% to 1%): Edema, peripheral edema
• Rare (less than 0.1%): Swelling
• Postmarketing reports: Face edema, pitting edema, localized edema^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasm^[Ref]

Oncologic

• Rare (less than 0.1%): Fibroadenoma of breast, uterine leiomyoma
• Postmarketing reports: Breast cancer, cervix carcinoma, hepatic adenoma, hepatic neoplasm, breast mass, cervical dysplasia^[Ref]

Ocular

• Postmarketing reports: Contact lens intolerance/complication^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Hypersensitivity
• Postmarketing reports: Allergic reaction^[Ref]

Frequently asked questions

• Twirla vs Xulane: How do they compare?
• Can you start the Xulane patch anytime?
• Should I stop using Xulane if I get a rash?
• Can you get pregnant on the Xulane patch?
• How does the Xulane patch work?
• Where do you place the Xulane patch?

Further information

Xulane 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer