Overview
Acetaminophen (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms. Acetaminophen is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.
Indication
In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever. It is available over the counter in various forms, the most common being oral forms. Acetaminophen injection is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics. Specific dosing guidelines should be followed when administering acetaminophen to children.
Associated Conditions
- Acute Gouty Arthritis
- Acute Musculoskeletal Pain
- Allergic Reaction
- Allergy to Tree Pollen
- Ankylosing Spondylitis (AS)
- Chills
- Cold
- Common Cold
- Cough
- Cough caused by Common Cold
- Coughing caused by Flu caused by Influenza
- Dyskinesia of the Biliary Tract
- Dyskinesia of the Urinary Tract
- Febrile Convulsions
- Febrile Illness Acute
- Fever
- Fibromyalgia
- Flu caused by Influenza
- Headache
- Joint dislocations
- Menstrual Distress (Dysmenorrhea)
- Mild pain
- Muscle Inflammation
- Muscle Injuries
- Muscle Spasms
- Musculoskeletal Pain
- Myalgia
- Nasal Congestion
- Neuropathic Pain
- Osteoarthritis (OA)
- Pain
- Postoperative pain
- Premenstrual cramps
- Rheumatoid Arthritis
- Rhinopharyngitis
- Rhinorrhoea
- Severe Pain
- Sinusitis
- Spasms
- Spastic Pain of the Gastrointestinal Tract
- Sprains
- Symptoms Cold
- Tension Headache
- Toothache
- Upper Respiratory Tract Infection
- Whiplash Syndrome
- Acute Torticollis
- Articular inflammation
- Cold or flu syndrome
- Mild to moderate pain
- Minor aches and pains
- Minor pain
- Moderate Pain
- Moderate to severe pain
Research Report
Acetaminophen: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Acetaminophen
1.1. Overview and Therapeutic Class
Acetaminophen, known internationally as paracetamol, is a globally recognized non-opioid analgesic and antipyretic agent.[1] It is widely available both over-the-counter (OTC) and as a prescription medication. The World Health Organization (WHO) recommends acetaminophen as a first-line therapeutic option for the management of mild to moderate pain.[1] Its primary clinical applications are the relief of pain and the reduction of fever, establishing it as a fundamental medication in symptomatic treatment for a diverse range of conditions.[3]
1.2. Chemical Properties and Identifiers
Acetaminophen is classified pharmacologically as a Small Molecule [User Query]. For precise identification in scientific and regulatory contexts, it is assigned the Chemical Abstracts Service (CAS) Number 103-90-2 and the DrugBank Accession Number DB00316 [User Query]. These identifiers are essential for accurate referencing in research, clinical databases, and chemical inventories.
1.3. Significance in Clinical Practice
Acetaminophen is one of the most frequently used medications for pain and fever relief in both the United States and Europe.[1] Its pervasive use is highlighted by its presence as an active ingredient in over 600 different OTC and prescription medicinal products, including standalone analgesics, fever reducers, sleep aids, and various combination formulations for cough, cold, and allergy symptoms.[5] The enduring clinical significance of acetaminophen is founded on its well-established efficacy for common ailments and a generally favorable safety profile when administered according to recommended dosing guidelines. This has solidified its position as an indispensable component of household medicine cabinets worldwide.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/11 | Not Applicable | Not yet recruiting | |||
2025/08/15 | Not Applicable | Completed | HITEC-Institute of Medical Sciences | ||
2025/08/05 | Not Applicable | Not yet recruiting | Papa Giovanni XXIII Hospital | ||
2025/08/04 | Not Applicable | Recruiting | |||
2025/08/03 | Not Applicable | Not yet recruiting | |||
2025/07/31 | Not Applicable | Completed | Nanjing Children's Hospital | ||
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/16 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/06/15 | Phase 4 | Recruiting | |||
2025/06/12 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Northwind Pharmaceuticals, LLC | 51655-910 | ORAL | 300 mg in 1 1 | 6/14/2023 | |
| DIRECT RX | 61919-023 | ORAL | 300 mg in 1 1 | 3/29/2023 | |
| Granules Pharmaceuticals Inc. | 70010-670 | ORAL | 325 mg in 1 1 | 3/7/2024 | |
| Physicians Total Care, Inc. | 54868-0378 | ORAL | 120 mg in 5 mL | 11/10/2010 | |
| BI-MART | 37835-525 | ORAL | 650 mg in 30 mL | 5/1/2025 | |
| Akorn | 50383-338 | ORAL | 240 mg in 10 mL | 5/25/2022 | |
| Altura Pharmaceuticals, Inc. | 63874-201 | ORAL | 650 mg in 1 1 | 4/28/2010 | |
| Genexa Inc. | 69676-0089 | ORAL | 160 mg in 5 mL | 5/23/2025 | |
| NUVICARE LLC | 84324-019 | ORAL | 325 mg in 1 1 | 5/20/2025 | |
| Apotheca, Inc. | 12634-537 | ORAL | 650 mg in 1 1 | 3/11/2010 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PARATAB TABLET 500 mg | SIN07062P | TABLET | 500 mg | 6/13/1992 | |
| PANADOL COLD RELIEF PSE CAPLET | Aspen Pharma Pty Ltd | SIN09985P | TABLET | 500 mg | 9/3/1998 |
| PARACETAMOL KABI SOLUTION FOR INFUSION 10MG/ML | SIN15443P | INFUSION, SOLUTION | 10mg/ml | 3/8/2018 | |
| PROGESIC-250 SUSPENSION 250 mg/5 ml | SIN06068P | SUSPENSION | 250 mg/5 ml | 5/20/1991 | |
| PORO Suppository 250mg | SIN13754P | SUPPOSITORY | 250mg | 1/19/2010 | |
| PACOFEN TABLETS | SIN06271P | TABLET | 500 mg | 5/7/1991 | |
| PAMOL 650 TABLET 650MG | SIN15037P | TABLET | 650MG | 6/22/2016 | |
| NAPA 250 SUPPOSITORY 250 mg | SIN10522P | SUPPOSITORY | 250 mg | 12/8/1998 | |
| TYLENOL FILM COATED TABLETS 500MG | SIN15949P | TABLET, FILM COATED | 500MG | 6/6/2020 | |
| CALPOL SUSPENSION 120 mg/5 ml | Aspen Bad Oldesloe GmbH | SIN06062P | SUSPENSION | 120 mg/5 ml | 5/27/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| U-CETOL TAB 500MG | N/A | N/A | N/A | 11/28/1986 | |
| FAST FLU TAB | N/A | N/A | N/A | 10/18/2002 | |
| XYKAA EXTEND PROLONGED RELEASE TABLET 650MG | N/A | N/A | N/A | 9/7/2012 | |
| PANADOL FOR CHILDREN TAB CHEWABLE 120MG | N/A | N/A | N/A | 11/24/1988 | |
| X-COLD CAP | N/A | N/A | N/A | 6/30/2000 | |
| SURE-RELIEF COLD AND COUGH CAP | N/A | N/A | N/A | 6/30/2000 | |
| ACETAMOL TAB 500MG (ORANGE) | N/A | N/A | N/A | 5/25/1979 | |
| PANADOL COLD & FLU HOT REMEDY POWDER | N/A | N/A | N/A | 9/5/1998 | |
| XYKAA RAPID TABLETS 500MG | N/A | N/A | N/A | 1/3/2017 | |
| ANTI-COLD TAB | N/A | N/A | N/A | 9/30/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PANAMAX ELIXIR paracetamol 120mg/5mL oral liquid bottle | 13750 | Medicine | A | 8/30/1991 | |
| DEMAZIN COLD + FLU RELIEF tablet blister pack | 286271 | Medicine | A | 3/1/2017 | |
| Slade's Panadol paracetamol 500mg tablet blister pack | 35805 | A & M Slade Nominees Pty Ltd | Medicine | A | 2/13/1992 |
| AVALLON COLD & FLU DAY + NIGHT RELIEF PE tablet blister pack | 300169 | Medicine | A | 3/1/2018 | |
| CIPLA PAIN RELIEF PARACETAMOL + CODEINE with CALMATIVE tablet blister pack | 140610 | Medicine | A | 6/20/2007 | |
| SOUL PATTINSON PARACETAMOL paracetamol 500mg capsule shaped tablet bister | 82119 | Medicine | A | 5/7/2002 | |
| Paracetamol BNM paracetamol 1000mg/100mL solution for infusion plastic bags | 201870 | Medicine | A | 8/9/2013 | |
| PHARMACY ACTION PARACETAMOL 500mg tablet bottle | 197345 | Medicine | A | 5/10/2012 | |
| FEBRIDOL CO tablets bottle | 196355 | Medicine | A | 4/5/2012 | |
| MEDIX SINUS + PAIN RELIEF PE tablet blister pack | 195426 | Medicine | A | 3/8/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ROBITUSSIN COUGH, COLD & FLU LIQUI-GELS | wyeth consumer healthcare inc. | 02161672 | Capsule - Oral | 250 MG | 12/31/1995 |
| SINUS MEDICATION EXTRA STRENGTH NIGHT TIME | 02246847 | Tablet - Oral | 500 MG | 12/8/2002 | |
| COLD MEDICATION REGULAR NIGHTTIME TABLETS | cellchem pharmaceuticals inc. | N/A | Tablet - Oral | 325 MG | N/A |
| CALMYLIN COUGH AND FLU LIQ | technilab pharma inc. | 01978314 | Liquid - Oral | 325 MG / 15 ML | 12/31/1992 |
| LUPIN-TRAMADOL/ACET | lupin pharma canada limited | 02407981 | Tablet - Oral | 325.00 MG | N/A |
| M-ACETAMINOPHEN 325MG | mantra pharma inc | 02451018 | Tablet - Oral | 325 MG | 5/24/2017 |
| ACETAMINOPHEN CAPLETS | cellchem pharmaceuticals inc. | 02544970 | Tablet - Oral | 500 MG | N/A |
| ACETAMINOPHEN 500MG | jamieson laboratories ltd | N/A | Tablet - Oral | 500 MG | N/A |
| PRACET 30 | laboratoire riva inc. | 02290359 | Tablet - Oral | 300 MG | N/A |
| MUSCLE ACHES & BODY PAIN | perrigo international | 02414449 | Tablet (Extended-Release) - Oral | 650 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TRAMADOL/PARACETAMOL STADA 37,5 MG/325 MG COMPRIMIDOS EFERVESCENTES EFG | Laboratorio Stada S.L. | 79212 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TRAMADOL/PARACETAMOL STADA 37,5 mg / 325 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 74896 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PHARMAGRIP CONGESTION 600 MG/10 MG GRANULADO | Laboratorios Cinfa S.A. | 89542 | GRANULADO | Sin Receta | Not Commercialized |
| GELOCATIL 1 g COMPRIMIDOS | 66204 | COMPRIMIDO | Sin Receta | Commercialized | |
| PARACETAMOL ARISTOGEN 1G COMPRIMIDOS EFERVESCENTES EFG | 83844 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| PARACETAMOL KERN PHARMA 100 mg/ml SOLUCION ORAL EFG | 69429 | SOLUCIÓN ORAL | Sin Receta | Commercialized | |
| YENDOL GRANULADO PARA SUSPENSION ORAL | 47802 | GRANULADO PARA SUSPENSIÓN ORAL | Sin Receta | Commercialized | |
| TRAMADOL/PARACETAMOL BRILL PHARMA 37.5 MG/325 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Brill Pharma S.L. | 78655 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TRAMADOL/PARACETAMOL ANDROMACO 37,5/325 MG COMPRIMIDOS EFERVESCENTES EFG | Andromaco Pharma S.L. | 83693 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TRAMADOL/PARACETAMOL COMBIX 37,5 MG/325 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Combix S.L.U. | 77157 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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