Etoricoxib Side Effects

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

What is etoricoxib?

Etoricoxib contains the active ingredient Etoricoxib.

• Active ingredient — Etoricoxib
• Registration number — 50/3.1/0586; 50/3.1/0587; 50/3.1/0588
• Registration holder — Biotech Laboratories (Pty) Ltd

It is approved for:

• ankylosing spondylitis (a form of arthritis that primarily affects the spine; inflammation of the spinal joints)
• short term relief of acute pain (treatment limited to a maximum period of 8 days)
• acute pain after dental surgery
• menstrual pain

Common side effects of etoricoxib

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

• dry socket (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• increased blood pressure
• stomach pain, wind (excessive gas), heartburn, diarrhoea, indigestion (dyspepsia), stomach discomfort, nausea
• bruising
• weakness and fatigue, flu-like illness
• changes in blood tests related to your liver

Less frequent side effects

• gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection
• appetite increases or decreases, weight gain
• anxiety, depression, decreases in mental sharpness
• inability to sleep, numbness or tingling
• eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while remaining still)
• inflammation of the blood vessels
• cough, breathlessness, nosebleed
• stomach or bowel bloating, acid reflux, changes in your bowel habits, constipation, gastritis (inflammation of the lining of the stomach), being sick (vomiting)
• dry mouth, stomach ulcer, irritable bowel syndrome, inflammation of the pancreas
• inflammation of the oesophagus, mouth ulcers
• swelling of the face, skin rash or itchy skin, redness of the skin
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, serious kidney problems
• low blood levels of sodium The frequency of the following side effects is unknown:
• hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention)
• confusion, restlessness
• feeling or hearing things that are not there (hallucinations)
• taste alteration, sleepiness
• blurred vision
• inflammation of the stomach lining that can become serious and may lead to bleeding
• severe skin reactions

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 hypersensitive (allergic) to etoricoxib or any of the other ingredients of ETORICOXIB BIOTECH (listed in section 6)
• if you have a stomach ulcer or are bleeding from the stomach or intestines
• if you have serious liver disease
• if you have serious kidney disease
• if you are allergic to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs) including COX-2 inhibitors such as ETORICOXIB BIOTECH or experienced any signs of allergy while using these medicines such as difficulty breathing, runny nose or itching
• if you have high blood pressure which is not under control
• if you are pregnant or breastfeeding your baby
• if you are under the age of 16 years
• if you have inflammatory bowel disease
• if you have congestive heart failure
• if you have heart disease or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries) or had any kind of stroke (including mini-stroke or transient ischaemic attack)
• if you have to undergo bypass surgery
• if you are currently being treated with lithium (treatment of bipolar disorders)
• if you are currently being treated with digoxin (treatment of heart failure)

Use with care, and tell your doctor, if

• You have any history of liver or kidney disease
• You are dehydrated, for example by a prolonged vomiting or diarrhoea
• You have swelling due to fluid retention
• You have a history of heart failure, or any other form of heart disease
• You have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart complications
• You have a history of high blood pressure. ETORICOXIB BIOTECH can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time
• You have a history of any medicine allergy. You might be at higher risk for serious skin reactions
• You have a history of stomach bleeding or ulcers
• You are being treated for an infection. ETORICOXIB BIOTECH can mask or hide a fever, which is a sign of infection
• You are a woman trying to become pregnant
• You are over 65 years of age
• You are on warfarin or any other anticoagulant treatment. Your doctor will monitor your bleeding time
• You develop flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). If you have experienced any hypersensitivity (allergic) reaction to aspirin, you should avoid taking ETORICOXIB BIOTECH

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 ETORICOXIB BIOTECH
• ETORICOXIB BIOTECH should not be taken during pregnancy or if you are breastfeeding your baby
• Women who are trying to get pregnant should not take ETORICOXIB BIOTECH

Interactions and medicines to check

The approved leaflet names these interactions.

• ciclosporin or tacrolimus (drugs used for suppressing the immune system)
• medicines that thin your blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used for suppressing the immune system, and often used in rheumatoid arthritis)
• diuretics (water tablets)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• lithium (a medicine used to treat some types of depression)
• birth control pills (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• digoxin (a medicine for heart failure and irregular heart rhythm)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for asthma)
• aspirin, the risk of stomach ulcers is greater if you take ETORICOXIB BIOTECH with aspirin. Aspirin for prevention of heart attacks or stroke: ETORICOXIB BIOTECH can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor. Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): Do not take high dose aspirin or other anti-inflammatory medicines while taking ETORICOXIB BIOTECH. ETORICOXIB BIOTECH with food and drink ETORICOXIB BIOTECH may be taken with or after 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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