Medical Editor: John P. Cunha, DO, FACOEP
What Is Xulane?
Xulane (norelgestromin and ethinyl estradiol transdermal system) is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women who elect to use a transdermal patch.
What Are Side Effects of Xulane?
Common side effects of Xulane include:
- breast tenderness and swelling
- application site reactions where the patch is worn (skin irritation, redness, itching, swelling)
- abdominal pain
- painful menstruation
- menstrual cramps
- vaginal bleeding and menstrual disorders
- mood changes
- vaginal yeast infection
- weight gain
- changes in sex drive, and
- changes in vaginal discharge
Dosage for Xulane
Xulane uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock, or back each week for 3 weeks (21 total days). Week 4 is patch-free.
What Drugs, Substances, or Supplements Interact with Xulane?
Xulane may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort, atorvastatin, rosuvastatin, ascorbic acid, acetaminophen, azole antifungals, grapefruit juice, HIV protease inhibitors, HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, cyclosporine, prednisolone, theophylline, tizanidine, clofibric acid, morphine, salicylic acid, temazepam, lamotrigine, and thyroid hormone. Tell your doctor all medications and supplements you use.
Xulane During Pregnancy and Breastfeeding
Xulane is not recommended for use during pregnancy. Xulane is not recommended for use while breastfeeding. It can decrease milk production.
Our Xulane (norelgestromin and ethinyl estradiol transdermal system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vascular events, including venous and arterial thromboembolic events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by users of combination hormonal contraceptives are:
- Irregular uterine bleeding
- Breast tenderness
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).
The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability.
Adverse drug reactions reported by ≥ 2.5% of norelgestromin and ethinyl estradiol transdermal systemtreated subjects in these trials are shown in Table 3.
Table 3: Adverse Drug Reactions Reported by ≥
2.5% of Norelgestromin and Ethinyl Estradiol Trans dermal System-treated
Subjects in Three Phase 3 Clinical Trials
|System/Organ Class * Adverse reaction||Norelgestromin and Ethinyl Estradiol Transdermal System
(n = 3322)
|Reproductive system and breast disorders|
|Vaginal bleeding and menstrual disorders†||6.4%|
|Nervous system disorders|
|General disorders and administration site conditions|
|Application site disorder†||17.1%|
|Mood, affect and anxiety disorders†||6.3%|
|Skin and subcutaneous tissue disorders|
|Infections and infestations|
|Vaginal yeast infection†||3.9%|
|*MedDRA version 10.0
†Represents a bundle of similar terms
Additional adverse drug reactions that occurred in < 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in the above clinical trials datasets are:
- Gastrointestinal disorders : Abdominal distension
- General disorders and administration site conditions : Fluid retention1, malaise
- Hepatobiliary disorders : Cholecystitis
- Investigations : Blood pressure increased, lipid disorders1
- Musculoskeletal and connective tissue disorders : Muscle spasms
- Psychiatric disorders : Insomnia, libido decreased, libido increased
- Reproductive system and breast disorders : Galactorrhea, genital discharge, premenstrual syndrome, uterine spasm, vaginal discharge, vulvovaginal dryness
- Respiratory, thoracic and mediastinal disorders : Pulmonary embolism
- Skin and subcutaneous tissue disorders : Chloasma, dermatitis contact, erythema, skin irritation
1Represents a bundle of similar terms
The following adverse reactions (Table 4) have been identified during postapproval use of norelgestromin and ethinyl estradiol transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 4: Alphabetical List of Adverse Drug Reactions
Identified During Postmarketing Experience with Norelgestromin and Ethinyl
Estradiol Trans dermal System by System Organ Class*
|System Organ Class||Adverse Drug Reactions|
|Cardiac disorders||Myocardial infarction†|
|Endocrine disorders||Hyperglycemia, insulin resistance|
|Eye disorders||Contact lens intolerance or complication|
|General disorders and administration site conditions||Application site reaction†, edema†|
|Hepatobiliary disorders||Blood cholesterol abnormal, cholelithiasis, cholestasis, hepatic lesion, jaundice cholestatic, low density lipoprotein increased|
|Immune system disorders||Allergic reaction†, urticaria|
|Investigations||Blood glucose abnormal, blood glucose decreased|
|Metabolism and nutrition disorders||Increased appetite|
|Neoplasms benign, malignant and unspecified (Incl. cysts and polyps)||Breast cancer†, cervix carcinoma, hepatic adenoma, hepatic neoplasm|
|Nervous system disorders||Dysgeusia, migraine with aura|
|Psychiatric disorders||Anger, emotional disorder, frustration, irritability|
|Reproductive system and breast disorders||Breast mass, cervical dysplasia, fibroadenoma of breast, menstrual disorder†, suppressed lactation, uterine leiomyoma|
|Skin and subcutaneous tissues disorders||Alopecia, eczema, erythema multiforme, erythema nodosum, photosensitivity reaction, pruritus generalized, rash†, seborrheic dermatitis, skin reaction|
|Vascular disorders||Arterial thrombosis†, cerebrovascular accident†, deep vein thrombosis†, hemorrhage intracranial†, hypertension, hypertensive crisis, pulmonary embolism†, thrombosis†|
|*MedDRA version 10.0
†Represents a bundle of similar terms
Read the entire FDA prescribing information for Xulane (Norelgestromin and Ethinylestradiol Transdermal System)