Diclofenac Side Effects

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

Part of otc pharmacy medicine side effects side effects.

What is diclofenac?

Diclofenac contains the active ingredient Diclofenac potassium.

• Active ingredient — Diclofenac potassium
• Registration number — 56/3.1/0559
• Registration holder — Unicorn Pharmaceuticals (Pty) Ltd

It is approved for:

• Diclofenac potassium, the active ingredient in Diclofenac 50 Unicorn, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs reduce pain and inflammation
• Diclofenac 50 Unicorn is for the emergency treatment of short-term (acute) gout attacks, for a maximum period of 5 days

Common side effects of diclofenac

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

• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo, nervousness
• Skin rash, spots or any other skin reactions
• If you have a blood test and levels of liver enzymes in the blood are raised

Less frequent side effects

• Fast or irregular heartbeat (palpitations), chest pain, heart disorders, including heart attack or breathlessness, difficulty breathing when lying down, or swelling of the feet or legs (signs of heart failure), especially if you have been taking a higher dose (150 mg per day) for a long period of time
• Stomach ulcers or bleeding (there have been less frequent reported cases resulting in death, particularly in the elderly)
• Gastritis (inflammation, irritation or swelling of the stomach lining), vomiting blood, diarrhoea with blood in it or bleeding from the back passage, black, tarry faeces or stools
• Drowsiness, tiredness
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice
• Asthma (symptoms may include wheezing, breathlessness, coughing and a tightness across the chest)
• Inflammation of the lining of the brain (meningitis), tingling or numbness in the fingers, tremor, visual disturbances such as blurred or double vision, taste changes, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, irritability, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck
• Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease), inflammation of the pancreas
• Hypertension (high blood pressure), hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), blood disorders (including anaemia)
• Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine
• Facial swelling, serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight
• Hair loss
• Impotence

Frequency unknown side effects

• Throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation
• Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke

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 think you may be allergic to diclofenac potassium, or any other NSAID (for example aspirin or ibuprofen) or to any of the other ingredients of Diclofenac 50 Unicorn (listed in section 6)
• signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction
• if you have now, or have ever had, a stomach (gastric) or intestinal ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
• if you have had stomach or bowel problems after you have taken other NSAIDs
• if you have heart, kidney or liver failure
• if you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you are more than six months pregnant or breastfeeding

Use with care, and tell your doctor, if

• if you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease (types of inflammatory bowel diseases), hiatus hernia, gastro- oesophageal reflux disease, and/or angiodysplasia (abnormality with the blood vessels in the gastrointestinal tract)
• if you have kidney or liver problems, or are you elderly
• if you have a condition called porphyria
• if you suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets
• if you ever had asthma
• if you are breastfeeding
• if you have angina, blood clots, high blood pressure, abnormally high levels of fat in your blood (raised cholesterol or raised triglycerides)
• if you have heart problems, or have you had a stroke, or you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol or are a smoker)
• if you have Lupus (SLE) (an autoimmune disease) or any similar condition
• You should take the lowest dose of Diclofenac 50 Unicorn for the shortest possible time, particularly if you are underweight or elderly
• Tell your doctor if you experience skin rash, itching, painful red areas, peeling or blistering of the skin or any other allergic reaction while taking Diclofenac 50 Unicorn. Signs of an allergic reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction
• There is a small increased risk of heart attack or stroke when you are taking Diclofenac 50 Unicorn. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for
• If at any time while taking Diclofenac 50 Unicorn you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately
• Whilst you are taking Diclofenac 50 Unicorn your doctor may want to give you a check-up from time to time
• If you have a history of stomach problems when you are taking NSAID, including Diclofenac 50 Unicorn, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms
• Because it is an anti-inflammatory medicine, Diclofenac 50 Unicorn may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac 50 Unicorn
• Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking Diclofenac 50 Unicorn, as Diclofenac 50 Unicorn can sometimes worsen wound healing in your gut after surgery

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Diclofenac 50 Unicorn
• • If you pregnant or planning to become pregnant, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy
• You should not take Diclofenac 50 Unicorn during the last 3 months of pregnancy as it may affect the baby’s circulation
• • If you are breastfeeding do not take Diclofenac 50 Unicorn
• • If you are you trying for a baby, do not take Diclofenac 50 Unicorn

Interactions and medicines to check

The approved leaflet names these interactions.

• Lithium (used to treat some mental problems)
• Cardiac glycosides (for example digoxin), used to treat heart problems
• Diuretics (water tablets)
• Medicines used to treat heart conditions or high blood pressure, for example beta- blockers or ACE inhibitors
• Anticoagulants (blood thinning tablets like warfarin)
• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen
• Oral steroids (an anti-inflammatory drug)
• Medicines known as SSRIs used to treat depression
• Medicines to treat diabetes
• Methotrexate (for some inflammatory diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants) Trimethoprim (a medicine used to prevent or treat urinary tract infections)
• Quinolone antibiotics (for infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestyramine (used to lower cholesterol)
• Mifepristone (a medicine used to terminate pregnancy)
• Voriconazole (a medicine used to treat fungal infections)

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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