Paracetamol Side Effects

Home › Medicine Side Effects › paracetamol

Answer the side-effect intent for paracetamol 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 paracetamol?

Paracetamol contains the active ingredient Paracetamol.

• Active ingredient — Paracetamol
• Registration number — 47/2.7/0570
• Registration holder — Equity Pharmaceuticals (Pty) Ltd

It is approved for:

• INTRAMOL is a solution for intravenous infusion and used for the short-term treatment of mild to moderate pain and/or fever, when the oral route is unsuitable

Common side effects of paracetamol

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

• allergic reactions with symptoms such as swelling of the face, eyelids, throat and lips and/or itchiness of the skin
• liver problems presented with the following symptoms: pain in the stomach area, nausea, vomiting, tiredness and sweating
• severe pain in the kidneys (lower back area) These are all very serious side effects
• If you have them, you may have had a serious allergic reaction to INTRAMOL. You may need urgent medical attention. Other side effects may occur, please tell your doctor as soon as possible. The following side effects have been reported less frequently
• skin irritations
• signs of recurrent infections such as fever or sore throat
• low blood pressure or e.g. feeling dizzy when moving from sitting to standing position
• bleeding from the nose or gums which may indicate low levels of blood platelets
• rapid heart beating
• general unwell feeling
• pain or burning sensation at the injection site
• inflammation of the liver characterised by poor appetite, yellowing of skin, whites of the eyes and mucous membranes These are all serious side effects
• You may need urgent medical attention. Tell your doctor if you notice any of the following
• nausea and diarrhoea Side effects with unknown frequency
• serious skin conditions (Stevens-Johnson Syndrome) with symptoms like a rash, fever, or other flu-like symptoms such as fever, sore throat, and fatigue. Within a few days, a painful rash appears on the skin, often starting on the face and spreading to other parts of the body after starting a new medication or during an illness; severe skin condition with rash that is more widespread. Large areas of the skin may detach and peel off, resembling a severe burn or major skin injury (Toxic Epidermal Necrolysis (TEN)
• Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug induced hypersensitivity syndrome (DIHS), which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs. See also section 2
• an acute pustular eruption characterised by the sudden onset of numerous small pus-filled blisters on reddened skin, which can occur all over the body or in specific areas (AGEP). Symptoms such as fever, skin peeling, itchiness, face and extremity swelling, nail/hair changes and mucous membrane involvement may occur
• development of one or more red or pinkish circular or oval-shaped areas (flat or with defined borders) on the skin as a result of systemic exposure to a medicine (FDE)

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

• you are allergic or hypersensitive to paracetamol or any other ingredient used in the INTRAMOL formulation Read this entire leaflet carefully before INTRAMOL is administered to you
• Keep this leaflet
• You may need to read it again
• If you have further questions, please ask your doctor or pharmacist
• INTRAMOL has been prescribed for you personally and you should not share medicine with other people. It may harm them, even if their symptoms are the same as yours. S3
• you have severe liver problems, including alcoholic hepatitis
• if you weigh less than 33 kg (approximately 11 years old)

Use with care, and tell your doctor, if

• you have severe kidney problems

Pregnancy and breastfeeding

• No unwanted reactions have been reported in pregnant women or in the unborn foetus with oral preparations of paracetamol
• Clinical experience with the intravenous preparations of paracetamol such as in INTRAMOL is limited
• If you are pregnant or breastfeeding your baby while INTRAMOL is administered to you, please inform your doctor, pharmacist or other health care professional

Interactions and medicines to check

The approved leaflet names these interactions.

• you are using alcohol daily (3 or more alcoholic drinks every day)
• you are dehydrated e.g. after vomiting and/or diarrhoea
• you are suffering from eating disorders such as anorexia, bulimia or cachexia
• you are in shock (which results in a decreased blood volume)
• you suffer from glucose-6-phosphate dehydrogenase deficiency. It is a hereditary disease characterised by abnormally low levels of glucose-6-phosphate dehydrogenase, a metabolic enzyme. If any of these apply to you, tell your doctor. Serious skin reactions like toxic epidermal necrolysis (TEN), Steven-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/drug-induced hypersensitivity syndrome, and fixed drug eruptions have been observed in patients receiving paracetamol-containing medicines such as INTRAMOL. Stop using INTRAMOL and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 5. Dosages in excess of those recommended may cause severe liver damage. Signs and symptoms of overdose are usually seen first after two days with a maximum usually after 4 to 6 days. Treatment of an overdose should be started as soon as possible. Your doctor will switch to suitable pain treatment taken by mouth as soon as you are able swallow. INTRAMOL contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately. Special caution is advised in patients with kidney function impairment. Prolonged administration of INTRAMOL can cause damage to your kidneys. You are at an increased risk of developing a paracetamol overdose if you are currently on medicines that are hazardous to your liver or that affect your liver enzymes. If you are suffering from alcoholism, any liver disease, or condition that results from eating a diet in which certain nutrients are lacking (nutritional problems), you are at risk of liver damage. INTRAMOL should not be administered in excessive quantities to you. Using INTRAMOL with food and drink INTRAMOL can be used with or without food

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

• diclofenac side effects

← Back to more medicine side effects.