Evra patch Side Effects

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Answer side-effect and tolerability questions around evra patch, including expected changes, warning signs and safe escalation guidance.

Part of contraceptive patch side effects.

What is Evra patch?

Evra-Patch contains the active ingredient Norelgestromin, ethinyloestradiol.

• Active ingredient — Norelgestromin, ethinyloestradiol
• Registration number — 36/18.7/0491
• Registration holder — Acino Pharma (Pty) Ltd

It is approved for:

• EVRA is a combination transdermal contraceptive patch used to prevent pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines for HIV infection (such as ritonavir, nevirapine, nelfinavir), or medicines given in combination with HIV/AIDS medicines (e.g. cobicistat)
• Medicines for infection (such as rifampicin, rifabutin and griseofulvin)
• Medicines for epilepsy (such as topiramate, barbiturates, phenytoin sodium, carbamazepine, primidone, oxcarbamazepine, eslicarbazine acetate, rufinamide and felbamate)
• (fos)aprepitant (a medicine to treat nausea)
• Medicines for high blood pressure in the blood vessels in the lung (bosentan)
• St. John’s Wort – an herbal remedy used for depression
• A mood enhancing substance called modafinil. If you use any of these medicines, you may need to use another method of birth control (such as a condom, diaphragm or foam). The interfering effect of some of these medicines can last for up to 28 days after you have stopped taking them. Blood levels of oestrogen from EVRA may be increased if you use certain medicines or drink grapefruit juice
• Paracetamol
• Ascorbic acid (Vitamin C)
• Certain anti-fungal medicines, such as itraconazole, ketoconazole, voriconazole and fluconazole
• Etoricoxib (an anti-inflammatory medicine)
• Certain cholesterol lowering medicines, such as atorvastatin and rosuvastatin
• Some HIV medicines such as etravirine, atazanavir and indinavir are some examples. EVRA may make other medicines less effective, such as:
• Medicines containing:
• Ciclosporin, omeprazole, prednisolone, prednisone, selegiline, tizanidine, voriconazole and theophylline (the levels of these medicines may be increased)
• Paracetamol, clofibric acid, morphine, salicylic acid and temazepam (the levels of these medicines may be decreased)
• The anti-epileptic lamotrigine. This can increase the risk of fits (seizures). Ask your doctor or pharmacist for advice before taking any medicine. Healthcare providers are advised to consult the package inserts of concurrently-used medicines to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations and the possible need to adjust dosages. Laboratory tests: If you are having any blood or urinary test, tell your health care professional that you are using EVRA as it may affect the results of some tests

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• You are allergic (hypersensitive) to norelgestromin, ethinyloestradiol or any of the other ingredients in EVRA
• You have ever had a heart attack or a type of chest pain called “angina”
• You have ever had a stroke or signs which may lead to stroke. This includes a slight, temporary stroke, without any after effects
• You have high blood pressure (160/100 mm Hg or above)
• You have diabetes with damaged blood vessels
• You have bad headaches with neurological symptoms such as changes in vision or numbness in any part of your body (migraine with focal aura)
• You have ever a blood clot (thrombosis) in your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism) or another part of your body
• You have an illness which runs in your family which affects the clotting of your blood (such as “protein C deficiency” or “protein S deficiency”)
• You have very high fat levels in your blood (cholesterol or triglycerides)
• You have an illness which runs in your family which affects fat levels in your blood (called dyslipoproteinaemia)
• You have ever had liver tumours or any problem with your liver
• You have ever been told you might have breast cancer or cancer of the womb, cervix or vagina
• You have unexplained vaginal bleeding
• You have a blood problem called porphyria
• You are pregnant or think you might be pregnant
• You have certain types of jaundice (yellowing of the skin and whites of the eye)
• You have had pemphigus gestationis (a rare skin blistering disorder that occurs in women of childbearing age. It usually presents in pregnancy but can also recur in women who subsequently use oral contraceptive therapy or with menstruation. It usually starts with an itchy rash that develops into blisters. It is commonest during mid to late pregnancy (the second and third trimesters))
• You take any medicines with paritaprevir/ritonavir, ombitasvir, and/or dasabuvir

Use with care, and tell your doctor, if

• That you are on treatment for depression
• That you have had depression with previous use of hormonal contraceptives
• That you have a substance abuse problem
• You have underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder
• That you have a family history of mental disorders
• That you have a history of physical or sexual abuse Hormonal contraceptives including EVRA, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behavior (eg. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression contact your doctor for advice. Medical-check-ups Before using EVRA you will need to see your doctor for a medical check-up. Check with your doctor or pharmacist before using EVRA if you have any of the following or they happen to get worse while using EVRA:
• You weigh 90 kg or more
• You, or any of your family, have high fat levels in the blood (triglycerides or cholesterol)
• You have high blood pressure or your blood pressure gets higher
• You have an immune system problem called “SLE” (systemic lupus erythematosus)
• You have a blood problem which causes kidney damage called “HUS” (haemolytic uraemic syndrome)
• You have a hearing loss
• You have epilepsy or any other problem that can cause fits (convulsions)
• You have a problem of the nervous system involving sudden movements of the body called “Sydenham’s chorea”
• You have diabetes
• You have depression of a history of this condition
• You have gallstones
• You have liver problems, including yellowing of the skin and whites of the eyes (jaundice)
• You have an inflammatory illness of your gut (Crohn’s disease or ulcerative colitis)
• You have “pregnancy spots”
• These are yellowish-brown patches or spots, especially on your face (called “chloasma”)
• Smoking and age: Cigarette smoking increases the risk of serious cardiovascular events from EVRA use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, EVRA should not be used by women who are over 35 years of age and smoke. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using EVRA. Potentially serious conditions: The following information is based on information about combined birth control pills. As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks. All combined birth control pills have risks, which potentially could lead to disability or death. Thrombosis (Blood Clots) Using combined hormonal contraceptives, including EVRA, increases the chances of getting a thrombosis (blood clots). It is possible that the risk of blood clots in the legs and/or lungs with EVRA is more than the risk with combined birth control pills. The risk of developing blood clots is not affected by how long you use EVRA. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more. The risk returns to normal, a few months after you stop using EVRA. Blood clots can cause blockage in a vein or artery and this may make you permanently disabled or even cause death
• Blood clots can form in a vein in your leg (deep vein thrombosis or DVT) and travel to the lungs. This can cause chest pain and make you breathless or collapse
• This is called a “pulmonary embolism” or PE
• Blood clots can form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke)
• Blood clots can happen in other places such as the liver, gut, kidney or eye. Blood clots in the eye may cause loss of eyesight or double vision
• Tell your doctor immediately if you notice any possible signs of a blood clot, such as: o Pain or swelling in either leg o Pain in the chest, which may spread to the arm o Sudden shortness of breath or sudden coughing o Unusual, severe or long-lasting headache o Vision problems o Difficulty speaking o Feeling dizzy or fainting spells o Feeling weak or numb on one side or one part of the body o Difficulty walking or holding things o Sudden stomach pain If you think you might have any of these, talk to your doctor immediately. Your chances of getting a blood clot increases: o As you get older o If blood clots in blood vessels (veins or arteries) runs in the family o If you smoke, especially if you are over 35 years of age o If you stay in bed for many days o If you are very overweight o If you have just had a baby, miscarriage or abortion o If you have had a serious injury, particularly of the leg or hip o If you have had or are going to have a major operation or need to have bed rest for a long time. Normally you should not use EVRA for two weeks before or two weeks after surgery o If you have ever had blood clots before o If you have problems with your blood fats (cholesterol or triglycerides) o If you have high blood pressure o If you have heart problems (problems with heart valves, abnormal heart rhythm). Cancer Breast cancer Breast cancer has been found more often in women who use combined hormonal contraceptives, such as EVRA. The increased risk gradually goes down after stopping the combined hormonal contraceptives, such as EVRA. After ten years, the risk is the same as for people who have never used the combined hormonal contraceptive. Cervical cancer Cervical cancer also has been found more often in women taking combined hormonal contraceptives, such as EVRA. Liver cancer Liver tumours have been found in women taking combined hormonal contraceptives, such as EVRA. This can cause bleeding inside the body with severe pain in the stomach area. If this happens, talk to your doctor immediately

Pregnancy and breastfeeding

• o Do not use EVRA if you are pregnant or if you think you are pregnant o Do not use EVRA if you are breastfeeding or planning to breastfeed your baby
• EVRA should not be taken together with any medicines with paritaprevir/ritonavir, ombitasvir, and/or dasabuvir
• This may increase levels of the liver enzyme ‘alanine aminotransferase’ (ALT) in the blood
• Driving or using machines: You can drive or operate machinery while wearing EVRA
• Children and adolescents EVRA has not been studied in children and adolescents under 18 years of age
• EVRA must not be used in children and adolescents who have not yet had their first menstrual period

Common side effects of Evra patch

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• headache
• feeling sick (nausea)
• breast tenderness
• vaginal yeast infection, sometimes called thrush
• mood problems such as depression, change in mood or mood swings
• feeling dizzy
• migraine
• stomach pain or bloating
• being sick (vomiting) or diarrhoea
• acne, skin itching or skin irritation
• muscle spasms
• breast pain or enlargement
• uterine cramps, painful or heavy periods, bleeding between periods or vaginal discharge
• problems where the patch has been on the skin (such as redness, irritation, itching or rash)
• feeling tired or generally unwell
• weight gain. Less frequent side effects:
• swelling due to water retention in the body
• high levels of fats in the blood (such as cholesterol and triglycerides)
• uncontrollable emotions
• anxiety
• problems sleeping (insomnia)
• less interest in sex or increased interest in sex
• skin rash, redness of the skin
• swelling of the breast, lumps in the breast or abnormal breast milk production
• premenstrual syndrome
• vaginal bleeding or dryness
• problems where the patch has been on the skin (such as swelling, discoloured skin, pain, spots, blisters or the skin feeling oversensitive)
• swelling
• rise in blood pressure
• increased appetite
• abnormal crying
• blood clot in the lung
• inflammation of the gall bladder
• yellow-brown pigment spots on the face
• irregular periods
• a bumpy rash (hives) where the patch has been on the skin
• rise in cholesterol levels
• aggression
• having more periods than normal Other side effects include:
• other problems where the patch has been on the skin, skin reactions or allergic reactions
• A severe allergic reaction that may include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• non-cancerous (benign) tumours in your breast or liver
• breast, cervical or liver cancer
• fibroids in the womb (uterus)
• Abnormal blood sugar, cholesterol or insulin levels
• blood clots, blocked arteries, heart attack or stroke
• problems when wearing contact lenses
• high blood pressure
• inflammation of the colon
• gallstones or blockage of the bile duct
• abnormal taste
• yellowing of the skin and whites of the eyes
• hair loss
• sensitivity to sunlight
• less frequent, light or no periods
• anger, feeling irritable or frustrated
• suicidal thoughts/behavior and suicide If you have an upset stomach
• The amount of hormones you get from EVRA should not be affected by being sick (vomiting) or diarrhoea
• You do not need to use extra contraception if you have an upset stomach. You may have spotting or light bleeding or breast tenderness or may feel sick during the first three cycles. The problem will usually go away but if it does not, check with your doctor or pharmacist. Not all side effects reported for EVRA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EVRA, please consult your doctor, pharmacist or other healthcare professional for advice

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with Evra patch makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

Serious side effects and warning signs

The leaflet lists these as serious side effects needing immediate attention.

Frequent

• headache
• feeling sick (nausea)
• breast tenderness
• vaginal yeast infection, sometimes called thrush
• mood problems such as depression, change in mood or mood swings
• feeling dizzy
• migraine
• stomach pain or bloating
• being sick (vomiting) or diarrhoea
• acne, skin itching or skin irritation
• muscle spasms
• breast pain or enlargement
• uterine cramps, painful or heavy periods, bleeding between periods or vaginal discharge
• problems where the patch has been on the skin (such as redness, irritation, itching or rash)
• feeling tired or generally unwell
• weight gain

Less frequent

• swelling due to water retention in the body
• high levels of fats in the blood (such as cholesterol and triglycerides)
• uncontrollable emotions
• anxiety
• problems sleeping (insomnia)
• less interest in sex or increased interest in sex
• skin rash, redness of the skin
• swelling of the breast, lumps in the breast or abnormal breast milk production
• premenstrual syndrome
• vaginal bleeding or dryness
• problems where the patch has been on the skin (such as swelling, discoloured skin, pain, spots, blisters or the skin feeling oversensitive)
• swelling
• rise in blood pressure
• increased appetite
• abnormal crying
• blood clot in the lung
• inflammation of the gall bladder
• yellow-brown pigment spots on the face
• irregular periods
• a bumpy rash (hives) where the patch has been on the skin
• rise in cholesterol levels
• aggression
• having more periods than normal

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

What happens after stopping or changing the method?

What happens after stopping or changing Evra patch depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• contraceptive patch side effects

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