Aspirin Side Effects

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Answer the side-effect intent for aspirin 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 aspirin?

Aspirin contains the active ingredient Aspirin.

• Active ingredient — Aspirin
• Registration number — E/2.7/104
• Registration holder — Unimed Healthcare (Pty) Ltd

It is approved for:

• The active ingredient aspirin has analgesic (reduces pain), antipyretic (reduces fever) and anti-inflammatory (reduces inflammation) actions
• ASPIRIN 300 UNIMED is indicated for the relief of mild to moderate pain and fever

Common side effects of aspirin

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.

Reported side effects

• you have an allergic reaction. The signs may include a skin rash, swallowing or breathing problems, wheezing, worsening of asthma, swelling of your lips, face, throat or tongue
• you get blistering, peeling, bleeding, scaling or fluid filled patches on any part of your skin. You may have a serious skin problem
• you have a fever and yellowing of the skin or whites of the eyes, feel tired, weak or generally unwell, loss of appetite (anorexia), feeling sick (nausea), being sick (vomiting). These may be early signs of liver problems
• stomach ulcers or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling or being sick)
• if you develop flu-like symptoms with a high body temperature, widespread rash, swollen glands, facial swelling and abnormal blood results (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• These are all very serious side effects. If you have them, you may have had a serious reaction to ASPIRIN 300 UNIMED. You may need urgent medical attention or hospitalisation. Other side effects include:
• longer bleeding time
• blood does not clot well, which may result in easy bruising or bleeding
• dizziness
• swelling
• high blood pressure and heart failure
• stomach ulcers
• bleeding from the gastrointestinal tract
• nausea (feeling sick), vomiting (being sick), diarrhoea
• indigestion, constipation, stomach pain
• vomiting blood or blood in your stool
• worsening of inflammatory bowel diseases
• liver problems
• itchy skin rash caused by allergic reaction, pale or red irregular raised patches with severe itching (hives)
• blistering, peeling, bleeding, scaling or fluid filled patches on any part of the skin
• runny nose
• difficulty breathing or wheezing, worsening of asthma

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 have stomach ulcers
• if you have a bleeding disorder such as haemophilia
• if you suffer from severe kidney impairment
• if you are taking oral anti-coagulant medicines (medicines that prevent the blood from clotting)
• if you have an intolerance or are hypersensitive (allergic) to aspirin or to any of the other ingredients in ASPIRIN 300 UNIMED (listed in section 6)
• if you have or have had severe heart problems
• if you have a history of stomach or intestinal perforation, ulcers or bleeding due to previous NSAIDs use, including ASPIRIN 300 UNIMED
• if you suffer from or have suffered from a recurring ulcer, bleeding or perforation
• if you are pregnant or breastfeeding your infant
• if you are under 12 years of age

Use with care, and tell your doctor, if

• when given to children or teenagers ASPIRIN 300 UNIMED may cause Reye’s syndrome. Reye’s syndrome is a rare but serious illness in children and teenagers with chickenpox and flu. For this reason, ASPIRIN 300 UNIMED should not be given to children aged under the age of 12 years and teenagers, unless on the advice of a doctor
• if you continue to take large amounts of ASPIRIN 300 UNIMED it may cause anaemia, abnormal conditions or diseases of the blood, gastrointestinal bleeding, stomach ulcers and kidney damage
• if you develop serious skin reactions, skin rash, chest tightness, wheezing or difficulty breathing, you should stop taking ASPIRIN 300 UNIMED immediately. Tell your doctor or pharmacist before taking ASIPRIN 300 UNIMED:
• if you have high blood pressure and/or suffer from heart problems. ASPIRIN 300 UNIMED may be associated with a small increased risk of heart failure
• if you are elderly, as you may be more susceptible to the side effects of ASPIRIN 300 UNIMED
• if you have a history of stomach ulcers or are of advanced age, the risk of internal bleeding of the stomach or intestines or ulcers is higher if you take large amounts of ASPIRIN 300 UNIMED
• if you suspect that you have an ulcer, treatment with ASPIRIN 300 UNIMED should be stopped and you should consult your doctor
• if you have a history of stomach and intestinal diseases e.g. inflammatory disease of the stomach and intestine, stomach pushing up into the chest, digestive disorder which affects the lower gut sphincter and vascular malformation of the gut, as these conditions may worsen
• if you are scheduled for a surgical procedure. You must stop using ASPIRIN 300 UNIMED several days before your surgery
• if you have a history of allergic reactions to NSAIDs, including attacks of asthma, swelling of your face, lips and tongue, hives, itchy skin or runny nose
• if you have other allergies or asthma
• if you suffer from kidney problems
• if you suffer from indigestion
• if you have anaemia or suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
• if you are dehydrated (you may feel thirsty and have a headache, dry mouth and lips)
• if you develop symptoms such as a high body temperature, widespread rash, swollen glands or facial swelling. This reaction can also include kidneys, liver, and heart dysfunction as well as abnormal blood test results (for example an abnormal increase in the number of disease-fighting white blood cells

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 health care provider for advice before taking ASPIRIN 300 UNIMED
• You should not take ASPIRIN 300 UNIMED during pregnancy or while you are breastfeeding your baby
• Taking ASPIRIN 300 UNIMED while you are 20 weeks or more than 20 weeks pregnant, may cause serious kidney problems in your unborn baby
• This may cause a delay in your baby’s lung development, as well as result in limb disabilities
• Regular use of ASPIRIN 300 UNIMED may result in increased blood pressure in your baby’s lungs
• The onset of labour may be delayed and its duration increased

Interactions and medicines to check

The approved leaflet names these interactions.

• other non-steroidal anti-inflammatory drugs – NSAIDs (such as ibuprofen, naproxen, fenbufen, indomethacin and piroxicam)
• corticosteroids (to suppress the immune system)
• SSRIs such as sertraline or paroxetine (medicines to treat depression)
• medicines used to prevent blood clotting such as warfarin
• oral antidiabetic medicines (medicine you take by mouth for the treatment of diabetes)
• sulphonamides (medicine used to treat infections)
• methotrexate (to treat some cancers, psoriasis and rheumatic disease)
• phenytoin or sodium valproate (to treat epilepsy)
• zarfirlukast (to treat asthma)
• medicines used to treat gout such as probenecid and sulfinpyrazone
• barbiturates and other sedatives (medicines to induce sleep)
• medicines which make your urine more alkaline such as antacids
• mifepristone (to induce abortion)
• dipyridamole (medicine used to treat heart or blood conditions)
• metoclopramide (medicines used for nausea and vomiting)
• metoprolol (to treat angina)
• acetazolamide (to treat glaucoma). ASPIRIN 300 UNIMED may interfere with some blood and urine tests. If you need to have blood and urine tests, tell your doctor you are taking ASPIRIN 300 UNIMED. ASPIRIN 300 UNIMED with food, drink and alcohol You should not drink alcohol while you are taking ASPIRIN 300 UNIMED

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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