What is the indication for acetaminophen (paracetamol)?

From the Guidelines

Paracetamol is primarily used to treat mild to moderate pain and reduce fever, with a standard adult dose of 500-1000mg every 4-6 hours as needed, not exceeding 4000mg in 24 hours, as it is a safer alternative to NSAIDs with a lower risk of gastrointestinal and cardiovascular side effects 1.

Indications for Use

• Mild to moderate pain such as headaches, toothaches, muscle aches, backaches, menstrual cramps
• Reducing fever associated with colds and flu

Dosage and Administration

• Standard adult dose: 500-1000mg every 4-6 hours as needed, not exceeding 4000mg in 24 hours
• Dosing for children is based on weight and age

Safety Profile

• Generally well-tolerated when taken as directed
• Overdosing can cause serious liver damage
• Safer alternative to NSAIDs with a lower risk of gastrointestinal and cardiovascular side effects 1

Comparison to Other Analgesics

• Less effective than NSAIDs for pain relief, but with a more favorable safety profile and low cost 1
• May be used as a first-line option for treatment of acute or chronic low back pain due to its safety profile and low cost 1

From the FDA Drug Label

Warnings Liver warning This product contains acetaminophen Severe liver damage may occur if: an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount a child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen taken with 3 or more alcoholic drinks every day while using this product Allergy Acetaminophen may cause severe skin reactions Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do Not Use with any other drug containing acetaminophen (prescription or nonprescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of his product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present If pregnant or breastfeeding, ask a health professional before use. Keep Out Of Reach Of Children Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. The primary use of paracetamol is for:

• Pain relief: for more than 10 days unless directed by a doctor
• Fever reduction: for more than 3 days unless directed by a doctor 2

From the Research

What is Paracetamol Used For

• Paracetamol is used for the management of fever and mild-to-moderate pain in infants and children, and it is considered as first-line therapy for the treatment of both according to international guidelines and recommendations 3.
• It is also used for the treatment of mild to moderate acute pain in adults, especially those with liver, kidney, or cardiovascular disease, gastrointestinal disorders, asthma, or who are older 4.
• Paracetamol is used to treat fever or pain in children younger than 2 years, although ibuprofen may be more effective in reducing temperature and pain within the first 24 hours of treatment 5.
• It is also used to treat the pain and fever symptoms associated with common cold and flu, and is considered safe and effective in over-the-counter (OTC) doses 6.

Comparison with Other Medications

• Paracetamol is as effective as aspirin and ibuprofen for the indications normally treated with over-the-counter (OTC) medications, but has a lower risk of gastrointestinal toxicity compared to aspirin 7.
• Ibuprofen may be more effective than paracetamol in reducing temperature and pain within the first 24 hours of treatment in children younger than 2 years, but both medications have similar serious adverse event profiles 5.
• Paracetamol is well tolerated and effective in treating mild to moderate pain, but there is growing concern about a possible risk of gastrointestinal toxicity and a possible link with asthma in children 7.

Dosage and Safety

• The correct dose of paracetamol is paramount to maximize efficacy and avoid delays in effect, and the recommended dose is 15 mg/kg for fever and pain management in children 3.
• Paracetamol is generally well tolerated at recommended doses (≤4 g/day) in healthy adults, but dosing for adults who are older and/or have decompensated cirrhosis, advanced kidney failure, or analgesic-induced asthma should be individualized in consultation with their physician 4.
• Paracetamol has a lower risk of adverse events compared to non-steroidal anti-inflammatory drugs (NSAIDs) when used at repetitive doses for consecutive days 3.