Meloxicam Side Effects

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

What is meloxicam?

Meloxicam contains the active ingredient Meloxicam.

• Active ingredient — Meloxicam
• Registration number — 58/3.1/0236; 58/3.1/0237
• Registration holder — Unimed Healthcare (Pty) Ltd

It is approved for:

• rheumatoid arthritis (inflammation in the joints)
• painful osteoarthritis (pain and stiffness)
• ankylosing spondylitis (a form of spinal arthritis)
• episodes of acute sciatica (any pain stemming from the irritation of the sciatic/hip nerve)

Common side effects of meloxicam

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

• diarrhoea, stomach pain, feeling sick or being sick, indigestion, heartburn
• unusual tiredness or weakness

Less frequent side effects

• anaemia (you may feel weak and look pale)
• headache, dizziness, light headedness
• ringing in the ears
• swelling of your lower legs, hands, arms, feet, ankles and legs
• drowsiness
• visual disturbances, blurred vision or other eye problems
• vertigo (feeling unbalanced / spinning head), ringing or buzzing in the ears
• skin rashes or other skin conditions, itching
• flushing
• high blood pressure (headaches, vision problems, blurred vision, irregular heart beat)
• inflammation or soreness of the mouth or gullet, stomach or intestinal ulcer, colitis (inflammation of the colon or Crohn’s disease), which may be worsened
• gastrointestinal bleeding, inflammation of the stomach, constipation, flatulence, gastrointestinal perforation (a hole in the all of the GI tract)
• abnormalities in tests of liver function, hepatitis
• sodium and water retention, high potassium levels, abnormal renal function tests, urination problems, renal failure
• ovulation delay

Frequency not known side effects

• increased sensitivity of the skin to sunlight
• allergic shock with reactions such as difficulty breathing, rash, swelling of the throat, lips or tongue
• confusion
• sleep disturbances, nightmares
• cardiac failure (disease of the heart with shortness of breath and swelling of face, feet or lower legs due to fluid build-up)
• pancreatitis
• infertility in women

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 meloxicam, or to any of the ingredients of MELOXICAM UNIMED
• if you previously suffered from any of the following after taking aspirin or any other pain medication:
• asthma (wheezing, chest tightness, breathlessness)
• skin hives (skin rashes/raised red patches on the skin with severe itching)
• nasal polyps (nasal blockage due to swellings in the lining in your nose)
• angioedema (swelling under the skin)
• if you have experienced heart failure
• if you have or had a stomach ulcer
• if you suffer from severe liver disease
• if you suffer from kidney disease and are not undergoing dialysis
• if you are pregnant or breastfeeding your baby
• if you have a history of bleeding in your stomach or intestines, recent or a history of stomach or bleeding ulcers
• if you have been diagnosed with Crohn’s disease or ulcerative colitis (an inflammatory bowel disease with symptoms such as abdominal pain and cramping, rectal pain or bleeding, often bloody diarrhoea)
• if you suffer from any bleeding disorders
• if you have recently undergone heart surgery (for narrowed or blocked arteries)
• if you are a child below the age of 12 years

Use with care, and tell your doctor, if

• if you have a history of peptic ulcer (stomach ulcer), in particular with bleeding, you should be cured before starting treatment with MELOXICAM UNIMED. Gastrointestinal bleeding or ulcer can occur at any time during treatment, with or without warning symptoms. Tell your doctor if you have ever suffered from oesophagitis (inflammation of the gullet) or gastritis (inflammation of the stomach) or any other gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastroesophageal reflux disease or angiodysplasia (a small malformation of some blood vessels in the gut)
• if you are an elderly patient, you may be more likely to experience the side effects of MELOXICAM UNIMED, especially gastrointestinal disorders, stomach ulcer or perforation (which may be fatal) or bleeding disorders
• if you have a history of stomach ulcers/ bleeding, your doctor may prescribe the lowest dose of MELOXICAM UNIMED as well an additional medicine to reduce the amount of acid produced in your stomach and to protect the lining of your stomach. Should the symptoms of either stomach ulcer or bleeding occur whilst taking MELOXICAM UNIMED, you should stop taking it immediately
• if you are receiving heparin or taking warfarin (used to thin your blood), aspirin or any other pain medication (non-steroidal anti-inflammatory medicines – NSAIDs)
• MELOXICAM UNIMED may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke. The risk is more likely with prolonged treatment. Do not exceed the recommended duration of treatment
• if any of the following risk factors apply to you, notify your doctor: high blood pressure, increased cholesterol levels, diabetes and smoking, as these may increase the risk of heart attack or stroke
• If you have abnormal heart function, high blood pressure or any other conditions that may be worsened by fluid retention (excessive build-up of fluid in the body), notify your doctor
• If you have heart disease caused by narrowing and/or blocking of blood vessels by cholesterol, stroke, and peripheral arterial disease which is a common circulation problem in which blood flow is reduced to the limbs because of narrowed arteries
• if you notice a skin rash, or any abnormalities of the skin, you should stop taking MELOXICAM UNIMED. Serious skin reactions, which can be fatal, may occur
• if you suffer from kidney or liver problems or are taking diuretic medicines (water tablets), antihypertensive medicines or if you are dehydrated, your kidney function should be carefully monitored
• if you have been diagnosed with high levels of potassium in your blood
• if you are diabetic, your potassium levels should be monitored regularly
• if you have kidney problems and are taking a medicine called pemetrexed (used in the treatment of cancer), please notify your doctor so that the dose of MELOXICAM UNIMED can be adjusted
• if you are taking lithium (a mood stabilizer)
• MELOXICAM UNIMED may hide the symptoms of an infection (e.g. fever)
• If you are experiencing difficulty conceiving, you should consider stopping treatment with MELOXICAM UNIMED
• the regular use of MELOXICAM UNIMED in the last three months of pregnancy may cause abnormally high blood pressure in the blood vessels of the baby’s lungs which may delay or lengthen labour in the mother

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care professional for advice before using MELOXICAM UNIMED
• Pregnancy: You should not take MELOXICAM UNIMED during pregnancy
• It may harm your unborn baby and interfere with normal labour/delivery
• Breast-feeding MELOXICAM UNIMED must not be used during breast-feeding
• Fertility MELOXICAM UNIMED 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.

• Aspirin and other anti-inflammatory medication: may increase the risk of stomach ulceration and/or bleeding
• Medicines which prevent blood clotting or “blood-thinning” medicines, such as warfarin, clopidogrel, ticlopidine or heparin, and medicines which break down blood clots (thrombolytics / anti-platelet medicines), as these may increase the risk of bleeding
• Selective serotonin re-uptake inhibitors used in the treatment of depression may increase the risk of bleeding
• Lithium (psychiatric medicine used to treat mood disorders), as MELOXICAM UNIMED 7,5 mg / 15 mg may affect how your medicine works
• Methotrexate (used in the treatment of tumours, severe skin conditions and active rheumatoid arthritis), as FELOXOCAM may increase the effect of this medicine
• Medicines used to treat high blood pressure, including diuretics (water tablets), beta-blockers (eg. atenolol), ACE-inhibitors (eg. enalapril), Angiotensin II receptor blockers (eg. losartan) as MELOXICAM UNIMED may reduce the effect of these medicines and your doctor may need to monitor your kidney function
• Cholestyramine (used to lower cholesterol levels) may reduce the effect of MELOXICAM UNIMED
• Ciclosporin or tacrolimus (used after organ transplants or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome) may affect the way your kidneys work
• Deferasirox (used to treat high levels of iron in the blood) may increase the risk of bleeding and stomach ulcers
• Pemetrexed (used in the treatment of cancer), as your dose schedule of MELOXICAM UNIMED may need to be adjusted
• Oral anti-diabetic medicines, such as sulphonealureas and nateglinide
• Corticosteroids (used to treat various inflammatory or skin conditions) may increase the risk of stomach ulcer and bleeding. Taking MELOXICAM UNIMED with alcohol Simultaneous intake of alcohol increases the risk of bleeding

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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