Xarelto Side Effects

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Answer the side-effect intent for xarelto without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Xarelto?

Xarelto contains the active ingredient Monohydrate.

• Active ingredient — Monohydrate
• Registration number — 42/8.2/1046
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• Xarelto 10 is used to prevent blood clots in your veins after a major operation on your legs
• For example this could be an operation on your hip or knee
• Your doctor has prescribed Xarelto 10 for you because after an operation you are at an increased risk of getting blood clots
• Xarelto 10 treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs

Common side effects of Xarelto

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.

Frequent side effects

• bleeding in the eye (including bleeding from the whites of the eyes)
• bleeding in tissue (bruising) or deep in (a cavity of) the body (hematoma)-
• bleeding following an operation
• swelling in the limbs
• pain in the limbs
• increase in body temperature (fever)
• pale skin, weakness and breathlesness due to a reduction in red blood cells (anemia)
• stomachache, indigestion, feeling or being sick, constipation, diarrhoea
• impaired function of the kidneys (may be seen in tests performed by your doctor)
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up (hypotension))
• weakness, tiredness, headache, dizziness
• rash, itchy skin
• blood tests may show an increase in some liver enzymes
• coughing up blood

Less frequent side effects

• bleeding in the brain or inside the skull
• bleeding in a joint causing pain and swelling
• oozing of blood or fluid from surgical wound
• feeling unwell
• dry mouth
• allergic reactions, including allergic skin reactions
• itchy, raised rash (hives)
• impaired function of the liver (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
• raised heartbeat
• fainting
• bleeding in the muscle
• collection of blood (hematoma) following complication in a cardiac procedure where a catheter is inserted to treat narrowed coronary arteries (pseudoaneurysm)
• swelling in a particular area
• yellowing of the skin and eyes (jaundice) Not known: frequency cannot be estimated from the available data
• increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome)
• decrease in urine, swelling in limbs, shortness of breath and fatigue after a severe bleeding (kidney failure) The following side effects have been reported since authorisation:
• allergic reaction causing swelling of the face, lips, mouth, tongue or throat (angioedema and allergic edema)
• diarrhoea, trapped gas, stomach cramp, weight loss caused by blocked bile flow (choloestasis), swollen or tender in right side of abdomen, inflamed liver including liver injury (hepatitis)
• low number of platelets, which are cells that help blood to clot (thrombocytopenia)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

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.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
• if you have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or breast-feeding Do not take XARELTO 10 and tell your doctor if any of these apply to you

Use with care, and tell your doctor, if

• if you have an increased risk of bleeding, as could be the case in situations such as:
• moderate or severe kidney disease, since your kidney function may affect the amount of medicine that works in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus)
• a problem with the blood vessels in the back of your eyes (retinopathy)
• a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung
• if you have a prosthetic heart valve
• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed
• if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned. If any of the above apply to you, tell your doctor before you take Xarelto. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation. If you need to have an operation
• it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor
• If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
• it is very important to take Xarelto exactly at the times you have been told by your doctor
• tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary. Children and adolescents XARELTO 10 is not recommended for people under 18 years of age. There is not enough information on its use in children and adolescents

Pregnancy and breastfeeding

• Do not take Xarelto if you are pregnant or breast-feeding
• If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• If you are taking
• some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
• some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
• some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
• anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine to treat abnormal heart beat
• some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)) If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation. If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment
• If you are taking
• some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St John’s Wort (Hypericum perforatum), a herbal product used for depression
• rifampicin, an antibiotic If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be reduced. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

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.

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