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 |
---|---|---|---|---|---|
2023/10/31 | Phase 4 | Completed | |||
2023/10/11 | Phase 4 | Completed | Ayah Mohammed Khalil | ||
2023/09/29 | Phase 4 | Completed | |||
2023/09/21 | Phase 2 | Recruiting | |||
2023/08/31 | Phase 4 | Completed | |||
2023/08/24 | Phase 2 | Suspended | |||
2023/08/22 | Phase 1 | Recruiting | |||
2023/08/16 | Phase 1 | Completed | |||
2023/08/14 | Not Applicable | Not yet recruiting | |||
2023/08/03 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
RxChange Co. | 33358-001 | ORAL | 300 mg in 1 1 | 11/5/2014 | |
Bryant Ranch Prepack | 71335-1271 | ORAL | 325 mg in 1 1 | 9/3/2020 | |
Cardinal Health 107, LLC | 55154-7147 | ORAL | 325 mg in 1 1 | 4/21/2021 | |
CVS | 51316-662 | ORAL | 650 mg in 20 mL | 5/2/2025 | |
CHAIN DRUG MARKETING ASSOCIATION INC | 63868-485 | ORAL | 250 mg in 1 1 | 8/13/2025 | |
Quality Care products LLC | 49999-852 | ORAL | 325 mg in 1 1 | 8/10/2022 | |
NuCare Pharmaceuticals, Inc. | 68071-3061 | ORAL | 300 mg in 1 1 | 2/10/2021 | |
Epic Pharma, LLC | 42806-116 | ORAL | 325 mg in 1 1 | 9/22/2023 | |
STAT Rx USA LLC | 42549-553 | ORAL | 325 mg in 1 1 | 3/29/2012 | |
Keltman Pharmaceuticals Inc. | 68387-497 | ORAL | 325 mg in 1 1 | 7/20/2010 |
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 |
---|---|---|---|---|---|
UPHAMOL TABLET 500MG | SIN15456P | TABLET | 500mg | 3/19/2018 | |
Poro Suspension 250mg/5ml | SIN13340P | SUSPENSION | 50.0 mg/ml | 8/27/2007 | |
SETAMOL TABLET 500 mg | SIN06220P | TABLET, FILM COATED | 500 mg | 5/31/1991 | |
AI KAN SHAN FEVER POWDER 500 mg/sachet | SIN06353P | POWDER | 500mg | 7/4/1991 | |
CHLORNAMOL SUSPENSION | SIN03141P | SUSPENSION | 250 mg/5 ml | 6/8/1989 | |
PANAMOL FORTE SUSPENSION 250 mg/5 ml | SIN05559P | SUSPENSION | 250 mg/5 ml | 3/7/1991 | |
PARACETAMOL TABLET 500 mg | SIN06402P | TABLET | 500 mg | 7/8/1991 | |
BEAFLU PLUS TABLET | SIN11457P | TABLET | 500 mg | 2/23/2001 | |
PANADOL COLD & FLU HOT REMEDY | SMITHKLINE BEECHAM S.A. | SIN11609P | POWDER | 750 mg | 8/3/2001 |
FLUCOL CAPSULE | SIN08881P | CAPSULE | 250 mg | 8/28/1996 |
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 |
---|---|---|---|---|---|
FAST-ACT COLD AND COUGH CAP | N/A | N/A | N/A | 9/11/2006 | |
MEGA POWER COLD & FLU TAB | N/A | N/A | N/A | 9/30/2002 | |
PARCEMOL PLAIN TAB 500MG (WHITE) | N/A | N/A | N/A | 1/3/2017 | |
PARACETAMOL TAB 500MG (ORANGE) | N/A | N/A | N/A | 4/27/1979 | |
MANGA TABLETS | N/A | N/A | N/A | 12/1/2017 | |
U-G TAB 500MG | N/A | N/A | N/A | 6/11/1990 | |
PROFESIN COLD CAP | N/A | N/A | N/A | 3/28/2001 | |
NICE-COLD CAP | N/A | N/A | N/A | 11/2/2004 | |
U-C SYRUP 250MG/5ML | N/A | N/A | N/A | 6/11/1990 | |
U-COLCAP TAB | N/A | N/A | N/A | 10/28/2002 |
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
TRIACET | laboratoires trianon inc. | 02485141 | Capsule - Oral | 500 MG | N/A |
ACETAMINOPHEN HEADACHE ULTRA RELIEF | 02290901 | Tablet - Oral | 500 MG | 9/26/2008 | |
RELIEF 325MG TABLETS | pendopharm division of pharmascience inc | 00374148 | Tablet - Oral | 325 MG | 12/31/1982 |
PMS-ACETAMINOPHEN TAB 500MG | 00892505 | Tablet - Oral | 500 MG | 12/31/1991 | |
REGULAR ACETAMINOPHEN | teva canada limited | 02417081 | Tablet - Oral | 325 MG | N/A |
REGULAR STRENGTH TYLENOL COLD DAYTIME | mcneil consumer healthcare division of johnson & johnson inc | 00743283 | Tablet - Oral | 325 MG | 12/31/1987 |
REGULAR STRENGTH SINUS MEDICATION | wes pak products ltd. | 02229371 | Tablet - Oral | 325 MG / TAB | 11/18/1996 |
TAMICODE TABLETS | 02439220 | Tablet - Oral | 500 MG | N/A | |
NIGHTTIME EXTRA STRENGTH CONTAC COLD & SORE THROAT | valeant canada lp / valeant canada s.e.c. | 02276216 | Tablet - Oral | 500 MG | 7/3/2007 |
NIGHT TIME RELIEF | pharma strides canada corporation | 02248905 | Capsule - Oral | 250 MG | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DOLOCATIL CODEINA 325/15 mg COMPRIMIDOS | 61757 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
DOLOMIDINA 500/25MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 80485 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized | |
APIRETAL 100 mg/ml SOLUCION ORAL | Laboratorios Ern S.A. | 49302 | SOLUCIÓN ORAL | Sin Receta | Commercialized |
PHARMAGRIP TOS Y CONGESTIÓN POLVO PARA SOLUCION ORAL | Laboratorios Cinfa S.A. | 75762 | POLVO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized |
VEGALGRIP GRANULADO PARA SOLUCION ORAL | Vegal Farmaceutica S.L. | 82548 | GRANULADO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
KERNGRIP JUNIOR POLVO PARA SOLUCION ORAL | 84855 | POLVO PARA SOLUCIÓN ORAL | Sin Receta | Not Commercialized | |
DOLOCATIL 650 mg COMPRIMIDOS EFG | 66012 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
COUGHGRIP 300MG/15MG/2MG POLVO PARA SOLUCION ORAL | Tecnimede España Industria Farmaceutica S.A. | 98999 | POLVO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized |
PARACETAMOL/IBUPROFENO WINADOL 500 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Nutra Essential Otc S.L. | 87955 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
SARIDON 250 mg/150 mg/50 mg COMPRIMIDOS | Bayer Hispania S.L. | 4384 | COMPRIMIDO | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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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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