Arcoxia Side Effects

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

What is Arcoxia?

Arcoxia contains the active ingredient Etoricoxib.

• Active ingredient — Etoricoxib
• Registration number — 50/3.1/0087; 50/3.1/0088; 50/3.1/0089
• Registration holder — Forrester Pharma (Pty) Ltd

It is approved for:

• Relief of symptoms of rheumatoid arthritis
• Treatment of ankylosing spondylitis
• Treatment of gout attacks
• Short term relief of acute pain, treatment limited to a maximum period of 8 days
• Treatment of acute pain after dental surgery
• Treatment of menstrual pain. EXXIB does not cure arthritis

Common side effects of Arcoxia

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

• Swelling of the legs and/or feet due to fluid retention (oedema)
• Dizziness, headache
• High blood pressure
• Stomach pain, flatulence, heartburn, diarrhoea, abdominal discomfort, nausea
• Increase in liver enzymes (ALT and AST)
• Discolouration of the skin
• Unusual tiredness or weakness, flu-like symptoms

Less frequent side effects

• Blood disorder (low level of red blood cells, an abnormally low amount of platelets)
• Increased or decreased appetite, weight gain
• Anxiety, depression, mental impairment
• Sleeping problems, numbness or tingling sensation, a decreased ability for physical sensation
• Eye inflammation or infection
• Ringing sound in the ears, spinning sensation (vertigo)
• Hot flushes, very high blood pressure that became worse
• Coughing, shortness of breath, nose bleeds
• Stomach swelling, reflux, changes in bowel movement pattern, constipation, dry mouth, small intestine ulcers, irritable bowel syndrome, inflammation of the oesophagus, mouth ulcers, vomiting, inflammation of the stomach
• Swelling of the face, skin rash or itchy skin, redness of the skin
• Muscle cramp/spasm, muscle pain/stiffness
• Presence of protein in the urine
• Chest pain
• Changes in blood tests (increased blood urea, increased creatine phosphokinase, decreased haematocrit, decreased haemoglobin, increased potassium levels, increased serum creatinine, increased uric acid, decreased blood sodium

Frequency unknown side effects

• Decreased level of platelets
• Confusion, hallucinations (seeing or hearing things that do not exist), restlessness
• Drowsiness, taste alteration
• Blurred vision
• Swelling of the arms, hands and legs (peripheral oedema)
• Pinkish, itchy swellings on the skin, also called hives, lesions on the skin
• Low levels of potassium in the blood (hypokalaemia)

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 (hypersensitive) to etoricoxib, or any of the inactive ingredients of EXXIB
• If you have an active stomach ulcer or bleeding in the stomach or intestines
• If you have a serious liver disorder
• If you have a serious kidney disorder
• If you have previously experienced any of the following after taking aspirin or other nonsteroidal anti-inflammatory medicines: asthma (wheezing or inability to breathe easily), nasal irritation, nasal polyps (overgrowths in the nose) or allergic symptoms such as swelling of the face, lips, tongue or throat and/or itching skin rash
• If you have high blood pressure which has not been adequately controlled by treatment
• If you are pregnant or breastfeeding
• If you are under 16 years of age
• If you have inflammatory bowel disease (characterised by inflammation of the bowel)
• If your doctor has diagnosed heart problems including heart failure (moderate or severe), chest pain (angina) or if you have had a heart attack, bypass surgery, narrow or blocked arteries of the extremities (peripheral arterial disease), or any kind of stroke (including mini-stroke or transient ischaemic attack). EXXIB may increase your risk of a heart attack and stroke and therefore it should not be taken if you have already had heart problems or a stroke
• If you are having heart bypass surgery
• If you are using lithium, a medicine used to treat depression
• If you are using digoxin, a medicine used to treat various heart conditions

Use with care, and tell your doctor, if

• If you have a history of stomach bleeding or ulcers (blood in your stools)
• If you are dehydrated, for example by a prolonged period of vomiting or diarrhoea
• If you have a history of heart failure, heart attack, or any other form of heart disease
• If you have narrow or blocked arteries of the extremities
• If you have a history of stroke or mini-stroke
• If you have a history of high blood pressure
• If you have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease
• If you have a history of kidney disease
• Dangerously low levels of potassium (hypokalaemia) and high levels of acid in the blood (renal tubular acidosis – caused by the kidneys not removing acids from the blood into the urine as they should) have been reported when other NSAIDs medicines (such as ibuprofen) have been used for long periods of time at higher than recommended doses. Caution is advised with the use of EXXIB
• If you have swelling due to fluid retention
• If you have a history of liver disease
• Serious skin reactions may occur with the treatment of EXXIB
• If you are being treated for an infection. EXXIB can mask or hide a fever, which is a sign of infection
• If you are elderly (over 65 years of age)
• If you are a woman trying to become pregnant. There appears to be a higher risk of cardiovascular events with higher doses and longer duration of treatment

Pregnancy and breastfeeding

• 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 EXXIB
• Pregnancy EXXIB must not be used by women who are pregnant or can become pregnant (i.e
• women of childbearing potential who are not using adequate contraception) during ongoing treatment
• If you become pregnant during treatment with EXXIB you should discontinue the treatment and contact your doctor for alternative treatment
• Breastfeeding DO NOT take EXXIB if you are breastfeeding your baby
• EXXIB may cross the placenta and be distributed into breast milk

Interactions and medicines to check

The approved leaflet names these interactions.

• Warfarin (used for the prevention of blood clots)
• Diuretics (water pills, used for the treatment of high blood pressure)
• ACE inhibitors and angiotensin receptor blockers (used to treat high blood pressure and heart failure)
• Aspirin (in low doses used as a blood thinner). EXXIB can be taken with low dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor
• Aspirin (in high doses used to treat pain, fever and inflammation). Do not take high doses of aspirin or other anti-inflammatory medicines while taking EXXIB
• Ciclosporin or tacrolimus (used for suppressing the immune system)
• Lithium (used to treat depression)
• Methotrexate (used for suppressing the immune system, and often used in rheumatoid arthritis)
• Oral contraceptive pills (used to prevent unplanned pregnancies)
• Hormone replacement therapy
• Digoxin (used for heart failure and irregular heart rhythm)
• Minoxidil (used to treat high blood pressure)
• Salbutamol (used to treat asthma)
• Ketoconazole (used for the treatment of fungal infections)
• Rifampicin (used for the treatment of tuberculosis (TB)). EXXIB with food and drink: EXXIB may be taken with or without food

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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