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
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/04/28 | Phase 4 | Terminated | |||
2023/04/14 | N/A | Completed | |||
2023/03/13 | Phase 2 | Completed | |||
2023/03/09 | Phase 3 | Completed | Johnson & Johnson Consumer Inc. (J&JCI) | ||
2023/02/10 | Phase 4 | Recruiting | |||
2023/02/10 | Phase 2 | Recruiting | |||
2023/01/30 | Phase 2 | Recruiting | |||
2023/01/18 | Not Applicable | Completed | Ho Chi Minh City Hospital of Dermato-Venereology | ||
2023/01/10 | Phase 4 | Recruiting | |||
2022/12/12 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Unit Dose Services | 50436-4856 | ORAL | 325 mg in 1 1 | 8/12/2011 | |
Bryant Ranch Prepack | 71335-1444 | ORAL | 325 mg in 1 1 | 3/10/2021 | |
PAI Holdings, LLC | 0121-0772 | ORAL | 325 mg in 15 mL | 7/6/2023 | |
Bryant Ranch Prepack | 72162-2510 | ORAL | 325 mg in 1 1 | 5/23/2025 | |
Quality Care Products, LLC | 49999-060 | ORAL | 300 mg in 1 1 | 4/21/2022 | |
Preferred Pharmaceuticals Inc. | 68788-8585 | ORAL | 500 mg in 1 1 | 5/7/2025 | |
Bryant Ranch Prepack | 72162-2271 | ORAL | 325 mg in 1 1 | 3/18/2024 | |
RedPharm Drug Inc. | 67296-0544 | ORAL | 300 mg in 1 1 | 5/23/2011 | |
McKesson Medical-Surgical, Inc. | 68599-4679 | ORAL | 325 mg in 1 1 | 9/9/2025 | |
SpecGx LLC | 0406-0123 | ORAL | 325 mg in 1 1 | 1/3/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
RICOFLU COLDS AND FLU RELIEF TABLETS | SIN09235P | TABLET | 400 mg | 3/5/1997 | |
HORGESIC TABLET 35MG/450MG | SIN16415P | TABLET | 450 mg | 1/7/2022 | |
UNIFLU COLDS & FLU TABLETS | SIN07102P | TABLET | 400 mg | 7/7/1992 | |
NORPHEN TABLET | ATLANTIC LABORATORIES CORPN LTD | SIN12142P | TABLET | 450 mg | 12/5/2002 |
ULTRADOL F.C. TABLETS 37.5MG/325MG | SIN16498P | TABLET, FILM COATED | 325mg | 5/19/2022 | |
CAMGESIC TABLET | SIN09867P | TABLET | 450 mg | 7/2/1998 | |
Panadol Cold Relief PE Caplet | Aspen Pharma Pty Ltd. | SIN13878P | TABLET | 500 mg | 10/27/2010 |
NORGESIC TABLET | SIN05552P | TABLET | 450 mg | 3/20/1991 | |
PANADOL MENSTRUAL CAPLET | STERLING DRUG (M) SDN BHD | SIN11051P | TABLET, FILM COATED | 500 mg | 7/28/1999 |
Panadol Sinus MAX Caplet 500mg/5mg | Aspen Pharma Pty Ltd. | SIN13877P | TABLET | 500 mg | 10/27/2010 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ENZACOV CAP | N/A | N/A | N/A | 6/30/2000 | |
PARCEMOL SYRUP FORTE 250MG/5ML (RED) | N/A | N/A | N/A | 9/19/1985 | |
CARECTAL TAB | N/A | N/A | N/A | 5/17/2000 | |
PARCEMOL SYRUP (FORTE) 250MG/5ML(ORANGE) | N/A | N/A | N/A | 4/26/1979 | |
PARCEMOL SYRUP | N/A | N/A | N/A | 3/31/1979 | |
PARCEMOL PLAIN TAB 500MG (BLUE) | N/A | N/A | N/A | 1/3/2017 | |
PARACETAMOL TAB 500MG | N/A | N/A | N/A | 8/18/2000 | |
U-J TAB 300MG | N/A | N/A | N/A | 6/11/1990 | |
PANADOL ACTIFAST TAB 500MG | N/A | N/A | N/A | 4/17/2002 | |
RACEFINE TAB | N/A | N/A | N/A | 5/17/2000 |
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PDP-ACETAMINOPHEN SOLUTION 80MG/ML | pendopharm division of pharmascience inc | 00887587 | Drops - Oral | 80 MG / ML | 12/31/1990 |
PAT-TRAMADOL/ACET | 02389274 | Tablet - Oral | 325 MG | 8/14/2012 | |
MEDICAMENT POUR LES SINUS, EXTRA-FORT | laboratoire riva inc. | 02240563 | Tablet - Oral | 500 MG | 4/19/2000 |
PEDIAPHEN | euro-pharm international canada inc | 02241478 | Tablet - Oral | 80 MG | 12/23/1999 |
MEDICAMENT POUR LES SINUS, REGULIER | laboratoire riva inc. | 02240562 | Tablet - Oral | 325 MG | 4/19/2000 |
MIDOL MULTI-SYMPTOM CAPLETS EXTRA STRENGTH | bayer inc consumer care | 02150484 | Tablet - Oral | 500 MG / TAB | 12/31/1995 |
MIDOL ONE | Bayer Inc | 02273438 | Tablet - Oral | 325 MG | N/A |
MUSCLE AND BACK PAIN RELIEF | teva canada limited | 02237995 | Tablet - Oral | 325 MG | 7/30/1999 |
NITETIME COLD MEDICINE LIQ | 01900501 | Liquid - Oral | 650 MG / 30 ML | 12/31/1992 | |
HOT LEMON NIGHT TIME TOTAL EXTRA STRENGTH | cellchem pharmaceuticals inc. | 02338416 | Powder For Solution - Oral | 650 MG / SACHET | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
TRAMADOL/PARACETAMOL ARISTO 75 MG/650 MG COMPRIMIDOS EFERVESCENTES | Aristo Pharma Iberia S.L. | 86603 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
TRAMADOL/PARACETAMOL APOTEX 37,5 MG/325 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Apotex Europe B.V. | 77374 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
TRACIMOL 37,5 MG / 325 MG COMPRIMIDOS EFG | Acino Ag | 77342 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
PARACETAMOL SERRACLINICS 10 mg/ml SOLUCION PARA PERFUSION | Laboratorios Serra Pamies S.A. | 68475 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
NORMOGRIP ANTITUSIVO GRANULADO PARA SOLUCION ORAL | Laboratorios Normon S.A. | 88698 | GRANULADO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized |
COD-EFFERALGAN 500 mg/ 30 mg comprimidos efervescentes | Upsa S.A.S. | 60748 | COMPRIMIDO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
GELOCATIL GRIPE FORTE CON FENILEFRINA POLVO PARA SOLUCION ORAL | 66302 | POLVO PARA SOLUCIÓN ORAL | Sin Receta | Not Commercialized | |
PARACETAMOL EDIGEN 500 MG COMPRIMIDOS EFERVESCENTES EFG | 83845 | COMPRIMIDO EFERVESCENTE | Sin Receta | Not Commercialized | |
PARACETAMOL/FENILEFRINA/CLORFENAMINA GOBENS 500 MG/10 MG/4 MG CAPSULAS DURAS | Laboratorios Normon S.A. | 82756 | CÁPSULA DURA | Sin Receta | Not Commercialized |
TRAMADOL/PARACETAMOL SANDOZ 37,5 mg/325 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 74080 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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