Celebrex Side Effects

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

What is Celebrex?

Celebrex contains the active ingredient Celecoxib.

• Active ingredient — Celecoxib
• Registration number — 50/3.1/9029; 50/3.1/9030
• Registration holder — Forrester Pharma (Pty) Ltd

It is approved for:

• CELEXII belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors
• Your body makes substances called prostaglandins
• Some prostaglandins may cause pain and inflammation
• In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these

Common side effects of Celebrex

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

• Infections of the airways such as sinusitis (swelling and redness of the nasal sinuses) or bronchitis (inflammation of the mucous membranes of the airways)
• Worsening of existing allergies
• Weight gain
• Trouble sleeping
• Dizziness, abnormal muscle tension
• Headache
• High blood pressure, worsening of existing high blood pressure. (You may not know that you have high blood pressure unless you have your blood pressure tested)
• Runny nose, sore throat, shortness of breath
• Nausea (feeling sick), vomiting (being sick)
• Indigestion, windiness, pain on stomach
• Problem swallowing
• Sore teeth
• Skin rash, itching skin
• Accidental injury
• Flu-like illness
• Keeping fluid back in the body tissues, with swollen ankles, legs and/or hands

Less frequent side effects

• Inflammation or infection of the inner ear (dizziness or feeling that everything is spinning around you)
• Infection of the gums
• Blood disorders, such as anaemia (too few red blood cells or their haemoglobin content is too low), leukopenia (a lowered white blood cell count) or thrombocytopenia (deficiency of platelets in the blood)*
• You will only know that you have these disorders if your doctor orders blood tests. See your doctor if you are pale and tired, get more infections than usual or have problems to stop bleeding, or if you have unexpected bruising
• Increased sodium in blood, increased potassium in blood (determined by blood tests)
• Feeling tired, confused
• Feeling anxious or depressed
• Seeing or hearing things that do not exist (hallucinations)
• Blurred vision, eye inflammation and bloodshot eyes, vitreous floaters (seeing spots or strings that move when you move your eyes), bleeding in an eye, painful eyes
• Ringing in the ears, above normal hearing sense, voice disorder
• Irregular heart rhythm, increased heart rate
• Flushing, inflammation of a blood vessel (you may feel unwell with fever, sweats and tiredness)
• Tightness in the chest with coughing and wheezing (bronchospasm)
• Shortness of breath, cough, fatigue (inflammation of the lung tissues – pneumonitis)
• Abdominal pain, cramping, bloating, constipation
• Mouth ulcers, numbness, burning sensation in the mouth (stomatitis)
• Hair loss
• Muscle spasms (leg cramps), muscle pain
• Lower limb fracture
• Kidney function disorders (shown by laboratory tests)
• Frequent urination during the night (nocturia)
• Menstrual disorders
• Swollen face
• Chest pain

Frequency unknown side effects

• Sleepiness
• Abnormal skin sensations (tingling or tickling or itching or burning)
• Problems with coordination and speech (ataxia)
• No sense of smell or taste, or taste affected
• Worsening of existing epilepsy (seizure disorder)
• Female fertility decreased
• Vaginal bleeding
• Tender breasts
• 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 hypersensitive (allergic) to celecoxib or any of the ingredients of CELEXII
• If you have had an allergic reaction to a group of medicines called “sulphonamides” (medicines that prevent the growth of bacteria)
• If you have severe liver disease
• If you have severe kidney disease
• If you have had allergic reactions such as asthma, nose polyps, severe nasal congestion, or an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing from aspirin or other NSAIDs (anti-inflammatory and pain- relieving medicines, such as diclofenac, ibuprofen)
• If you have established ischaemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or blockages of blood vessels to the heart or brain
• If you are about to have coronary artery bypass graft surgery
• If you currently have an ulcer in your stomach or intestines, or if you are bleeding in your stomach or intestines (you may notice that you have black sticky stools or bloody diarrhoea)
• If you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn’s disease
• if you are pregnant or it is possible that you could become pregnant
• if you are breastfeeding

Use with care, and tell your doctor, if

• If you smoke, have diabetes, high blood pressure or high blood cholesterol
• If you have had a serious allergic reaction or a serious skin reaction to any medicines
• If you have previously had an ulcer or bleeding in your stomach or intestines. (Do not take CELEXII if you currently have an ulcer or bleeding in your stomach or intestine)
• If you are taking corticosteroid medicines (for example prednisone)
• If you are taking aspirin (even at low dose for heart protective purposes)
• If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban)
• If you are taking CELEXII at the same time as other non-aspirin NSAIDs such as ibuprofen or diclofenac. The use of these medicines together should be avoided
• If you have fluid retention (such as swollen ankles and feet)
• If you have heart failure or other heart problems
• If you have high blood pressure
• If your liver or kidneys are not working well, as your doctor may want to keep a regular check on you
• 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 CELEXII
• If you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (medicines used to get rid of excess fluid in the body)
• If you feel ill due to an infection, or think you have an infection, as CELEXII may mask a fever or other signs of infection and inflammation
• If you are above 65 years of age your doctor will want to monitor you regularly. The consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems. CELEXII may lead to an increase in blood pressure. Your doctor may want to monitor your blood pressure on a regular basis. Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start 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 CELEXII
• Pregnancy CELEXII 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 CELEXII you should discontinue the treatment and contact your doctor for alternative treatment
• Breastfeeding CELEXII must not be used during breastfeeding
• Fertility NSAIDs, including CELEXII, may make it more difficult to become pregnant
• You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant

Interactions and medicines to check

The approved leaflet names these interactions.

• Warfarin (used to prevent blood from clotting)
• ACE inhibitors, angiotensin II receptor antagonists, beta blockers (used for high blood pressure and heart failure)
• Diuretics (used to treat fluid retention)
• Ciclosporin and tacrolimus (used for immune system suppression e.g., after transplants)
• Aspirin (used for pain and fever). CELEXII can be taken with low dose aspirin (75 mg or less daily). Ask your doctor for advice before taking both medicines together. CELEXII has no antiplatelet effect and is therefore not a substitute for aspirin for prevention of thrombosis
• Neuroleptics (used to treat some mental disorders)
• Medicines for anxiety (diazepam) or to treat depression (citalopram, imipramine)
• Medicines to treat an irregular heartbeat (amiodarone, quinidine)
• Dextromethorphan (used to treat coughs)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• Lithium (used to treat some types of depression)
• Oral contraceptives
• Glibenclamide, tolbutamide (medicines used in the management of type 2 diabetes)
• Phenytoin, a medicine used in epilepsy (seizure disorder)
• Fluconazole (used to treat fungal infection)
• Rifampicin (used to treat bacterial infections)
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• Ketoconazole (an antifungal medicine)
• Antacids (used for heartburn)

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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