Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses Evra. If you are concerned about side effects, discuss the risks and benefits of Evra with your doctor.

The following side effects have been reported by at least 1% of people using Evra. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Acne
• breast discomfort
• changes in skin pigmentation
• Diarrhea
• dizziness
• gas
• gain or loss of body or facial hair
• flu-like illness
• headache (unless it is sudden, severe, or worsening)
• nausea
• painful menstrual periods
• skin irritation, redness, or rash where the patch was applied
• tiredness
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal swelling of arms or legs
• breast lumps
• Headaches or migraines
• muscle pain
• severe pain or a lump in the abdomen
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling of the feet, ankles, or lower leg
• symptoms of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• unexpected vaginal bleeding

Stop using the medication and seek immediate medical attention if any of the following occur:

• convulsions
• loss of vision or change in vision (sudden)
• pains in chest, groin, or leg (especially in calf of leg)
• signs of a blood clot in the lung (e.g., coughing up blood, sudden/unexplained shortness of breath)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Evra.

Each transdermal system sealed within a protective pouch and heat-stamped "EVRA™" contains 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol in the middle layer, releasing approximately 200 µg of norelgestromin and 35 µg of ethinyl estradiol every 24 hours. Nonmedicinal ingredients: backing layer: low-density pigmented polyethylene outer layer and a polyester inner layer; middle layer inactive components: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; release liner: polyethylene terephthalate film with polydimethylsiloxane coating on one side. The EVRA transdermal system does not contain any metal components.

Do not use norelgestromin - ethinyl estradiol if you:

• are allergic to norelgestromin or ethinyl estradiol or any other ingredients of the medication
• are immobilized for prolonged periods
• are known or suspected to be pregnant
• have or have had Blood Clots (in the legs, lungs, eyes, or anywhere else) or have severe or multiple risk factors for them
• have or have had a Stroke or TIA ("mini-stroke")
• have or have had a Heart Attack or chest pain (Angina)
• have or have had valvular heart disease with complications
• have severe high blood pressure (always >160/100 mmHg)
• have Diabetes with blood vessel involvement
• have very High Cholesterol
• have health conditions that increase the risk of blood clots (such as certain inherited blood clotting diseases; talk to your doctor for more information)
• smoke and are over the age of 35
• have active liver disease
• have or have had liver tumours (benign or malignant)
• have or are suspected to have Breast Cancer
• have or are suspected to have cancer of the reproductive organs (e.g., endometrium)
• have undiagnosed abnormal vaginal bleeding
• have yellowing of the skin (jaundice) due to steroids or blocked bile ducts
• have yellowing of the eyes or skin during pregnancy
• have vision problems due to vascular eye disease
• have migraine with focal aura
• have had major surgery associated with an increased risk of blood clots
• are taking the following medication combination used to treat Hepatitis C: paritaprevir, ritonavir, ombitasvir with or without dasabuvir

There may be an interaction between norelgestromin - ethinyl estradiol patch and any of the following:

• Anastrozole
• antibiotics (e.g., ampicillin, Metronidazole, penicillin, rifampin, neomycin, tetracyclines)
• anticonvulsants (e.g., Carbamazepine, , Phenobarbital, Phenytoin, primidone, Topiramate, Lamotrigine)
• Aprepitant
• "azole" antifungals (e.g., fluconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., phenobarbital)
• benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam)
• blood pressure medications (e.g., Metoprolol, , methyldopa)
• Bosentan
• Celecoxib
• Cholestyramine
• Clozapine
• Cobicistat
• Colesevelam
• Colestipol
• corticosteroids (e.g., Dexamethasone, Prednisone)
• Cyclosporine
• dabigatran
• diabetes medications (e.g., Glyburide, Gliclazide, insulin)
• Edoxaban
• folic acid
• grapefruit juice
• Heparin
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir, ritonavir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• Levothyroxine
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor
• mifepristone
• Modafinil
• mycophenolate
• rifabutin
• rifampin
• Rivaroxaban
• Ropinirole
• St. John's wort
• Selegiline
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tizanidine
• Tocilizumab
• tretinoin
• Tranexamic acid
• tretinoin
• Ursodiol
• vitamin B12
• vitamin C (ascorbic acid)
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Evra. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Evra.

The information provided here results from studies of combination oral contraceptives; the patch contraceptive is thought to have similar risks. Oral combination contraceptives increase the risk of the following serious conditions:

• blood clots
• gallbladder disease
• heart attack
• liver tumours
• stroke

The risk of disease or death from these conditions greatly increases if a woman has other risk factors such as high blood pressure, high cholesterol, Obesity, or diabetes.

Smoking while taking oral contraceptives increases the risk of side effects that affect the heart and blood vessels (e.g., blood clots). This risk is greatest for women 35 years and older. You should not take Evra if you smoke and are 35 years or older.

You should stop using the patch immediately if you develop any of the following:

• blood clot disorders and cardiovascular disorders (e.g., inflammation of a vein due to blood clot, blood clot in your lung)
• a condition that makes you immobile for a long period of time (e.g., recovering from major surgery, being bedridden due to a long-term illness)
• vision or eye problems (e.g., double vision, certain eye conditions) – check with your doctor
• severe headache without known cause, or worsening of preexisting migraine

Body weight: For women weighing 90 kg (198 lbs.) or more, the patch may be less effective. Check with your doctor for more information.

Breast self-exam and physical exams: Women taking Evra should do regular breast self-exams and have yearly physical exams done by their doctor.

Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. If you have had clinical depression in the past, you may be more likely to experience it again while taking Evra. If you have depression or a history of depression, discuss with your doctor how Evra may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Evra, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Evra contact your doctor as soon as possible.

Heat sources: Do not expose the patch area to heat sources such as heating pads, electric blankets, saunas, hot tubs, or heat lamps. This may increase the amount of medication that enters your body through the skin.

Sexually transmitted infections: Birth control patches do not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.

Pregnancy: Evra should not be taken during pregnancy. You should stop using Evra if you become pregnant and contact your doctor.

Breast-feeding: Evra passes into breast milk and may affect your baby. Adverse effects on the baby, such as jaundice and breast enlargement, have been reported. Talk to your doctor about whether you should continue breast-feeding.

Children: Evra is not recommended for use before the start of menstruation in puberty.