Compral Side Effects

Home › Medicine Side Effects › Compral

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

What is Compral?

Compral contains the active ingredient Aspirin , Caffeine and Paracetamol.

• Active ingredient — Aspirin , Caffeine and Paracetamol
• Registration number — 36/2.8/0009
• Registration holder — Adcock Ingram Limited

It is approved for:

• COMPRAL PAIN POWDERS belongs to a group of medicines called analgesic combinations
• COMPRAL PAIN POWDERS is used for the symptomatic relief of mild to moderate pain such as headaches, dysmenorrhoea (painful menstrual period), pain in muscles and joints, dental pain and inflammation, pain associated with colds or flu and fever

Common side effects of Compral

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.

Less frequent side effects

• Blood related reactions including low blood platelet count, lack of white blood cells, and a type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number
• Pyroglutamic aciduria (an inherited disorder of amino acid metabolism)
• Hearing loss
• Skin rashes and other allergic reactions such as itching, or wheezing, coughing or difficulty breathing, or swelling of the lips, tongue and face. The rash may be red or itchy with swelling but sometimes may be more serious and accompanied by fever and ulcers or abscesses
• Liver problems (yellow eyes and skin, nausea, stomach pain)

Frequency unknown side effects

• Drug-induced hypersensitivity syndrome (severe reaction usually characterized by fever, rash, and multiorgan failure)
• Kidney problems
• High blood pressure
• Inflammation of the pancreas
• Fixed drug eruptions (these are dermatological manifestations of medicine reactions that often occur in the same location upon re-exposure to a medicine). Aspirin
• Blood and lymphatic system disorders: Prolonged bleeding time, anaemia
• Immune system disorders: Hypersensitivity reactions
• Metabolism and nutrition disorders: Sodium retention and fluid retention
• Ear and labyrinth disorders: Temporary hearing loss
• Nervous system disorders: Dizziness, aseptic meningitis (inflammation of the tissues surrounding the brain and spinal cord), and headache
• Cardiovascular: Swelling, high blood pressure, heart failure
• Respiratory, thoracic, and mediastinal disorders: Difficulty in breathing or wheezing, worsening of asthma
• Gastrointestinal: Ulcers in stomach or duodenum, gastrointestinal bleeding, which can sometimes cause death. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, faeces containing digested blood, vomiting blood, mouth ulcers and cold sores, worsening of inflammation of the colon and inflammatory disease which affects the stomach and intestinal tract, inflammation of the stomach
• Hepatobiliary: Raised liver enzymes, Reye’s syndrome (in children and adolescents under the age of 18 years of age), which can be fatal that causes brain and liver damage. Usually occurs in children who have had a recent viral infection, such as chickenpox or the flu
• Skin reactions: Raised bumps which contain fluid, including Stevens-Johnson syndrome (rare skin disorder) and severe skin reaction
• Kidney and Urinary Disorders: Kidney problems, increased uric acid in urine. Prolonged use of high doses may lead to renal papillary necrosis (a type of damage that occurs in your kidneys). Caffeine
• Gastrointestinal disorders: Nausea, increased stomach secretions and stomach ulcers
• Cardiac disorders: Palpitations, tachycardia (abnormally fast heartbeat)
• Psychiatric disorders: Difficulty sleeping, restlessness, anxiety, irritability, and nervousness
• Nervous system disorders: Dizziness, headache, convulsions (uncontrollable shaking that is rapid and rhythmic, with the muscles contracting and relaxing repeatedly), excitement, loss of one or more types of sensory perception and muscle tremor (involuntary movements)
• Vertigo (sensation of spinning or swaying)
• Tinnitus (ringing in the ears)
• Increased urination

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 or ever had a problem of your blood not clotting properly, have severe liver function problems or if you are taking medicines to reduce blood clotting
• If you are hypersensitive (allergic) to aspirin or other NSAIDs, paracetamol, caffeine or to any of the other ingredients of COMPRAL PAIN POWDERS (listed in section 6)
• If you have a history of asthma, bronchospasm (sudden constrictions of the muscles of the passage ways by which air passes through the nose to the air sacs of the lungs), angioedema (painless swelling of the tissue layer under the skin), rhinitis (irritation and inflammation of the mucous membranes inside the nose), urticaria (hives), when you take aspirin or NSAIDsS. (NSAIDs-class of medicines which aspirin belongs to)
• If you have or ever had a stomach ulcer, damage or bleeding of the stomach related to previous use of aspirin and other NSAID’s (class of medicines which aspirin belongs to) including COMPRAL PAIN POWDERS
• If you have kidney failure, liver failure or heart failure
• If you have or ever had gout
• If you are pregnant, do not use NSAIDs at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby
• If your child is under the age of 18 years

Use with care, and tell your doctor, if

• To not exceed the recommended daily dose as it may cause serious harm to your liver
• COMPRAL PAIN POWDERS contains paracetamol. Do not take COMPRAL PAIN POWDERS if you are taking any other prescription or nonprescription medicines containing paracetamol due to the possibility of paracetamol overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death
• To not give it to children and adolescents under the age of 18 years of age
• If your symptoms do not improve within 10 days of continuous use, please consult your doctor
• If no relief is obtained with the recommended dosage, consult your doctor. Excessive and prolonged use of COMPRAL PAIN POWDERS may be dangerous
• Seek medical advice if cough persists, or if it is accompanied by high fever, skin rash or persistent headache
• If you suffer from liver or kidney disease, you should take COMPRAL PAIN POWDERS under medical supervision
• If you have existing liver disease as it increases the risk of paracetamol-related liver damage
• If you are pregnant or plan to become pregnant, tell your doctor or health care provider. Taking NSAIDs at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs around 30 weeks of pregnancy or later
• Do not take NSAIDs such as COMPRAL PAIN POWDERS regularly during the third trimester of pregnancy. This may result in premature closure of the foetal ductus arteriosus in utero (closure before desirable time, of the unborn baby’s blood vessel which is part of the vessels connecting the lungs and heart), and possibly, in persistent pulmonary hypertension (high blood pressure in blood vessels of the lungs) of the new-born. The onset of labour may be delayed, and its duration increased
• Avoid use of COMPRAL PAIN POWDERS with other systemic NSAID’s (non-steroidal antiinflammatory medicines, the class to which aspirin belongs) including cyclooxygenase- 2(COX-2) selective inhibitors (e.g., piroxicam), due to the potential for additive undesirable effects. Serious hypersensitivity (allergic) reactions can occur and bronchospasm (sudden constrictions of the muscles of the passage ways by which air passes through the nose to the air sacs of the lungs) may suddenly occur in patients suffering from or with previous history of asthma, allergic disease or nasal polyps (sac like growths of inflamed tissue lining the nose or sinuses). See Other medicines and COMPRAL PAIN POWDERS
• if you suffer from or have a previous history of asthma, allergic disease, or nasal polyps (sac like growths of inflamed tissue lining the nose or sinuses)
• If you are scheduled to undergo any surgical procedures as the use of COMPRAL PAIN POWDERS should be stopped several days before any scheduled surgical procedures
• Aspirin, as in COMPRAL PAIN POWDERS, prevents blood cells called platelets from clumping together to form a clot, thereby increasing bleeding time. You should report any unusual bleeding symptoms to your doctor
• If you suffer from G-6-PD deficiency (a hereditary condition leading to low red blood cell counts), you should consult your doctor, pharmacist, or healthcare professional. Taking high doses of Aspirin, as in COMPRAL PAIN POWDERS, more than 1g daily, may worsen acute haemolytic anaemia (increased red blood cell breakdown)
• Paracetamol, as in COMPRAL PAIN POWDERS, can cause serious skin reactions known as severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE). You can identify these reactions by severe skin peeling, painful blisters, extremely serious allergic skin reactions accompanied by fever or flu-like symptoms, facial swelling, and painful blisters, abdominal pains, abdominal heartbeat. If you experience any of these skin reactions, stop taking COMPRAL PAIN POWDERS and consult your doctor immediately. Aspirin may cause Reye’s syndrome. Reye’s syndrome is a rare but serious illness, in children and teenagers with chickenpox or influenza. Consult a doctor before using aspirin in such patients. For this reason, do not give COMPRAL PAIN POWDERS to children under 18 years of age unless prescribed by a doctor. If the child changes in behaviour with nausea and vomiting, consult your doctor because these symptoms could be an early sign of Reye’s syndrome. Check with your doctor before taking COMPRAL PAIN POWDERS if you:
• have a history of high blood pressure or heart disease, as you may experience water retention and swelling. Heart failure may suddenly occur
• are an elderly, as you may experience an increased frequency of side effects especially having an ulcer, stomach, and intestinal bleeding, which may cause death. Your risk of experiencing these side effects is higher with increasing doses of COMPRAL PAIN POWDERS
• have a history of ulcers, because your risk of having an ulcer, stomach and intestinal bleeding is higher, with increasing doses of COMPRAL PAIN POWDERS
• have a history of:
• ulcerative colitis
• stomach and intestinal diseases e.g. Crohn’s disease (inflammatory disease of the stomach and intestine)
• hiatus hernia (stomach pushing up into the chest)
• gastro-oesophageal reflux disease (digestive disorder which affects the lower gut sphincter)
• angiodysplasia (vascular malformation of the gut). These conditions may worsen. Check with your doctor before taking COMPRAL PAIN POWDERS if you have:
• uncontrolled hypertension
• liver or kidney problems
• heart problems
• dyspepsia (a persistent or recurrent pain or discomfort in the upper abdomen)
• anaemia (deficiency of blood components that transport oxygen)
• dehydration (significantly lost body fluids)
• diabetes mellitus (a chronic disease associated with abnormally high levels of the sugar glucose in the blood)
• You may need to avoid using COMPRAL PAIN POWDERS altogether or limit the amount you take as prolonged use of high doses may lead to metabolic acidosis (a condition in which acids build up in your body), anaemia, blood disorders, stomach and intestinal bleeding, peptic ulceration and renal papillary necrosis (death of kidney papillae, that is, areas where the openings of the collecting ducts enter the kidney and where urine flows into the ureters). Cases of liver failure have been reported in patients with depleted glutathione (a protein) levels, such as those:
• who are severely malnourished (lacking sufficient nutrients in the body) – anorexic (lacking appetite)
• severely underweight
• are chronic heavy users of alcohol
• have sepsis (severe infection) In patients with glutathione (a protein) depleted states, the use of COMPRAL PAIN POWDERS may increase the risk of metabolic acidosis. Signs of metabolic acidosis include:
• deep, rapid difficult breathing
• feeling sick (nausea), being sick (vomiting)
• loss of appetite Contact a doctor immediately if you get a combination of these symptoms. Avoid excess intake of caffeine (e.g. tea, coffee and some canned drinks) while taking COMPRAL PAIN POWDERS as it contains caffeine. Children and adolescents Do not give COMPRAL PAIN POWDERS to children under 18 years of age unless prescribed by a doctor

Pregnancy and breastfeeding

• The use of COMPRAL PAIN POWDERS during pregnancy and breastfeeding is not recommended
• If you are pregnant, or breast-feeding, 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 COMPRAL PAIN POWDERS
• COMPRAL PAIN POWDERS is not to be taken during the first and third trimesters of pregnancy, except under the advice and supervision of a medical doctor
• Regular use of NSAIDs such as COMPRAL PAIN POWDERS during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born
• The onset of labour may be delayed, and its duration increased, with increased risk of bleeding tendency in both the mother and child
• If the expected benefit to the mother is greater than the possible risk to the foetus, the lowest effective dose and the shortest duration of treatment should be considered

Interactions and medicines to check

The approved leaflet names these interactions.

• Sulphonamides (group of antibiotics): Possible enhanced activity of sulphonamides
• Sulphonylureas (medicines used to lower blood sugar levels). e.g. glibenclamide. Aspirin, as in COMPRAL PAIN POWDERS, may enhance the effects of anti-diabetic medicines
• Uricosurics (medicine used to treat gout such as probenecid and sulphinpyrazone): Aspirin, as in COMPRAL PAIN POWDERS, can reduce the effect of uricosurics while probenecid can increase the amount of aspirin circulating in the body
• Barbiturates and other sedatives: May mask the respiratory symptoms (associated with the body’s breathing system) of aspirin overdosage and have been reported to enhance its toxicity
• Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Use of two or more NSAIDs concomitantly could result in an increase in side effects
• Antiepileptics (for seizures) such as carbamazepine, phenobarbital, phenytoin or primidone: Possible decrease in desirable effects of paracetamol, as in COMPRAL PAIN POWDERS
• Lamotrigine: (mainly used to treat seizures) Paracetamol, as in COMPRAL PAIN POWDERS, affects the metabolic disposition (fate of the medicine after it is taken into the body) of lamotrigine. The percentage of lamotrigine recovered in the urine increases and is reduced in the blood thus making it less effective
• Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (PUBs)
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding
• Anticoagulants and Platelet Aggregation Inhibitors (medicines used to thin blood): Aspirin and paracetamol, as in COMPRAL PAIN POWDERS, may enhance the effects of anticoagulants such as coumarins (e.g. warfarin) and heparin, and of platelet aggregation inhibitors such as ticlopidine, clopidogrel cilostazol as there is an increased risk of bleeding. Your doctor may monitor your bleeding time and blood-thinning therapy. Thrombolytics (used to break the clots): There is an increased risk of bleeding when taken together with COMPRAL PAIN POWDERS. Concomitant use is therefore not recommended
• Loop Diuretics (medicines that result in high water loss e.g. furosemide): Aspirin, as in COMPRAL PAIN POWDERS, may reduce their activity. NSAIDs can cause acute kidney failure, especially if you are dehydrated. If you take a diuretic with aspirin, it is necessary to ensure you take enough water and to have your kidney function and blood pressure monitored by the doctor, particularly when starting diuretic treatment
• Phenytoin: Aspirin, as in COMPRAL PAIN POWDERS, increases serum levels of phenytoin (amount of phenytoin present in your blood at the time of testing); serum phenytoin should be well monitored by your doctor
• Valproate: Aspirin, as in COMPRAL PAIN POWDERS, interferes with the breakdown of valproate and hence could increase valproate’s toxicity; valproate levels should be well monitored by your doctor
• Methotrexate (≤15 mg/ week): The toxicity of methotrexate may be enhanced by use together with aspirin, as in COMPRAL PAIN POWDERS. In case you take it together with aspirin, your doctor will monitor your kidney
• Alcohol: Use together with aspirin, as in COMPRAL PAIN POWDERS, increases the risk of stomach and intestinal bleeding
• Diuretics and antihypertensive agents (medicines used to reduce water levels in your body and blood pressure e.g. beta blockers, angiotensin converting enzyme (ACE) inhibitors): Antihypertensive effect may be decreased. Therefore, take caution when using them together with COMPRAL PAIN POWDERS. You should have your blood pressure periodically monitored, especially if you are an elderly. You should take adequate water and check with your doctor for consideration of monitoring kidney function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity (damage to the kidneys)
• Potassium-sparing medicines: Treatment together with aspirin, as in COMPRAL PAIN POWDERS, may be associated with increased serum potassium levels (amount of potassium in the blood at the time of testing). Serum potassium levels should be monitored frequently. Antacids: May increase removal of aspirin, as in COMPRAL PAIN POWDERS, from the body by alkalinisation of urine
• Gold compounds (medicines used in rheumatoid arthritis): Risk of aspirin, as in COMPRAL PAIN POWDERS, induced liver damage may be increased
• Dipyridamole (medicine used to prevent clot formation): Aspirin, as in COMPRAL PAIN POWDERS, side effects may be increased
• Metoprolol (medicine used to treat heart attacks and high blood pressure): Aspirin, as in COMPRAL PAIN POWDERS, side effects may be increased
• Carbonic anhydrase inhibitors (medicines used to treat glaucoma e.g. acetazolamide): Risk of aspirin, as in COMPRAL PAIN POWDERS, toxicity may be increased
• Metoclopramide and domperidone (medicines used for nausea and vomiting): Increased absorption of paracetamol, as in COMPRAL PAIN POWDERS
• Cholestyramine (medicine used to reduce high cholesterol and to treat itching caused by partial blockage of the bile): Absorption of paracetamol, as in COMPRAL PAIN POWDERS, is reduced if given within one hour of cholestyramine
• Antibacterials such as: (i) Isoniazid or Rifampicin (medicine for treatment of an infectious disease mainly of the lungs called tuberculosis) chronic use may increase the risk of liver damage when combined with paracetamol, as in COMPRAL PAIN POWDERS, at recommended doses. (ii) Flucloxacillin (medicine used to treat skin, wound, chest and bone infections) caution is advised when taken together with paracetamol, as in COMPRAL PAIN POWDERS, as this may result in:
• pyroglutamic aciduria (a condition that prevents production of glutathione, a chemical involved in important processes in the body e.g. processing medication)
• high anion gap metabolic acidosis (condition that occurs when there is too much acid in the body, characterised by a high difference between the negatively charged and positively charged electrolytes in the blood)
• Antivirals such as Zidovudine (used to treat infection caused by HIV): Paracetamol, as in COMPRAL PAIN POWDERS, may delay the metabolism of zidovudine and cause severe toxic damage to the liver
• Probenecid: Pre-treatment with probenecid can decrease COMPRAL PAIN POWDERS clearance and increase its plasma half-life. NSAIDS: Prolonged concurrent use of COMPRAL PAIN POWDERS with NSAIDS increases the risk of kidney problems
• Alcohol: Reduces the liver’s capacity to deal with paracetamol, as in COMPRAL PAIN POWDERS
• Chloramphenicol: Use of chloramphenicol with paracetamol, as in in COMPRAL PAIN POWDERS, may enhance effect of chloramphenicol
• Antibacterials: elimination half-life of caffeine, as in COMPRAL PAIN POWDERS, increases and clearance decreases when co-administered with ciprofloxacin, enoxacin and pipemidic acid. Enoxacin had the greatest inhibitory effect on the clearance
• Antidepressants: Fluvoxamine has been reported to significantly enhance the effects of caffeine, as in COMPRAL PAIN POWDERS
• Antiepileptics: The effect of caffeine, as in COMPRAL PAIN POWDERS, may be enhanced. Carbamazepine or valproic acid has no effect on caffeine, as in COMPRAL PAIN POWDERS
• Methoxsalen (used to treat psoriasis): Can reduce removal of caffeine, as in COMPRAL PAIN POWDERS, from your body
• Sex hormones: The clearance of caffeine has been reported to be reduced and its effects are enhanced in women taking oral contraceptives. This effect was also reported in postmenopausal women taking oestrogens for hormone replacement therapy
• Sympathomimetics: Giving caffeine with ephedrine has been reported to produce significant cardiovascular, metabolic, and hormonal responses, including increased systolic blood pressure and heart rate, and raised fasting glucose and insulin
• Lithium: Caffeine, as in COMPRAL PAIN POWDERS, can increase the elimination of lithium from the body. This can enhance the effects of lithium. Therefore, concomitant use is not recommended
• Allopurinol (medicine used to treat gout): Allopurinol has been reported to enhance the effects of caffeine, as in COMPRAL PAIN POWDERS
• Cimetidine (medicine used for heartburn, ulcers, increased acid production and other associated symptoms): Cimetidine has been reported to enhance the effects of caffeine, as in COMPRAL PAIN POWDERS. COMPRAL PAIN POWDERS with food, drink and alcohol Avoid excessive intake of caffeine (e.g. coffee, tea and some canned drinks) while taking COMPRAL PAIN POWDERS. If you take aspirin with alcohol, it could increase the risk of stomach and intestinal 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.

Related pages

• minoxidil side effects

← Back to more medicine side effects.