Xulane Side Effects Center

Last updated on RxList: 11/10/2020
Xulane Side Effects Center

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:

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.

Additional Information

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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Xulane Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or pain in an arm or leg;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • severe headache, pounding in your neck or ears;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • breast pain or swelling;
  • nausea;
  • menstrual cramps, breakthrough bleeding;
  • headache, anxiety, mood changes; or
  • skin reactions where a patch was worn--redness, irritation, itching, rash, pain, or swelling.

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.

Read the entire detailed patient monograph for Xulane (Norelgestromin and Ethinylestradiol Transdermal System)

QUESTION

Which of the following are methods for contraception? See Answer
Xulane Professional Information

SIDE EFFECTS

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 BOX 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
  • Nausea
  • Breast tenderness
  • Headache

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 system-treated subjects in these trials are shown in Table 2.

Table 2: Adverse Drug Reactions Reported by ≥ 2.5% of Norelgestromin and Ethinyl Estradiol Transdermal 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
Breast symptoms22.4%
Dysmenorrhea7.8%
Vaginal bleeding and menstrual disorders6.4%
Gastrointestinal disorders
Nausea16.6%
Abdominal pain8.1%
Vomiting5.1%
Diarrhea4.2%
Nervous system disorders
Headache21.0%
Dizziness3.3%
Migraine2.7%
General disorders and administration site conditions
Application site disorder17.1%
Fatigue2.6%
Psychiatric disorders
Mood, affect and anxiety disorders6.3%
Skin and subcutaneous tissue disorders
Acne2.9%
Pruritus2.5%
Infections and infestations
Vaginal yeast infection3.9%
Investigations
Weight increased2.7%
*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

Postmarketing Experience

The following adverse reactions (Table 3) 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 3: Alphabetical List of Adverse Drug Reactions Identified During Postmarketing Experience with Norelgestromin and Ethinyl Estradiol Transdermal System by System Organ Class*

System Organ ClassAdverse Drug Reactions
Cardiac disordersMyocardial infarction
Endocrine disordersHyperglycemia, insulin resistance
Eye disordersContact lens intolerance or complication
Gastrointestinal disordersColitis
General disorders and administration site conditionsApplication site reaction, edema
Hepatobiliary disordersBlood cholesterol abnormal, cholelithiasis, cholestasis, hepatic lesion, jaundice cholestatic, low density lipoprotein increased
Immune system disordersAllergic reaction, urticaria
InvestigationsBlood glucose abnormal, blood glucose decreased
Metabolism and nutrition disordersIncreased appetite
Neoplasms benign, malignant and unspecified (Incl. cysts and polyps)Breast cancer, cervix carcinoma, hepatic adenoma, hepatic neoplasm
Nervous system disordersDysgeusia, migraine with aura
Psychiatric disordersAnger, emotional disorder, frustration, irritability
Reproductive system and breast disordersBreast mass, cervical dysplasia, fibroadenoma of breast, menstrual disorder, suppressed lactation, uterine leiomyoma
Skin and subcutaneous tissues disordersAlopecia, eczema, erythema multiforme, erythema nodosum, photosensitivity reaction, pruritus generalized, rash, seborrheic dermatitis, skin reaction
Vascular disordersArterial 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)

© Xulane Patient Information is supplied by Cerner Multum, Inc. and Xulane Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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