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 |
---|---|---|---|---|---|
2018/04/02 | Phase 3 | Completed | |||
2018/03/29 | Not Applicable | Completed | Yeditepe University Hospital | ||
2018/03/29 | N/A | Completed | |||
2018/03/23 | Early Phase 1 | Completed | Spectrum Health - Lakeland | ||
2018/03/21 | Phase 4 | Withdrawn | Spectrum Health - Lakeland | ||
2018/03/21 | Phase 4 | Completed | |||
2018/03/19 | Phase 4 | Completed | |||
2018/03/19 | Phase 4 | Completed | Minerva A Romero Arenas | ||
2018/03/01 | Not Applicable | Completed | |||
2018/02/28 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
RedPharm Drug, Inc. | 67296-0355 | ORAL | 325 mg in 1 1 | 2/21/2024 | |
Rhodes Pharmaceuticals L.P. | 42858-202 | ORAL | 325 mg in 1 1 | 1/2/2024 | |
FH2 Pharma LLC | 72887-683 | ORAL | 300 mg in 1 1 | 4/27/2023 | |
Eugia US LLC | 55150-307 | INTRAVENOUS | 10 mg in 1 mL | 8/3/2023 | |
Eywa Pharma Inc | 71930-044 | ORAL | 300 mg in 1 1 | 6/17/2019 | |
Advanced Rx of Tennessee, LLC | 80425-0528 | ORAL | 300 mg in 1 1 | 6/2/2025 | |
Bryant Ranch Prepack | 63629-1186 | ORAL | 300 mg in 1 1 | 5/20/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-2856 | ORAL | 325 mg in 1 1 | 10/24/2022 | |
Major Pharmaceuticals | 0904-6826 | ORAL | 325 mg in 1 1 | 1/31/2022 | |
Redpharm Drug | 67296-0836 | ORAL | 325 mg in 1 1 | 8/28/2025 |
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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---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
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---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ACETAMINOPHEN TAB 500MG EXT STRENGTH | pharmel inc | 00718866 | Tablet - Oral | 500 MG | 12/31/1987 |
ACETAB TAB 325MG | laboratoire romilo | 00422061 | Tablet - Oral | 325 MG / TAB | 4/2/1980 |
WAMPOLE-ACETAMINOPHEN/CODEINE/CAFFEINE | 02453703 | Tablet - Oral | 300 MG | 12/23/2016 | |
PAIN & FEVER + DECONGESTANT | accudial pharmaceutical inc | 02367262 | Suspension - Oral | 160 MG / 5 ML | N/A |
ACETAMINOPHEN ARTHRITIS PAIN | perrigo international | 02272482 | Tablet (Extended-Release) - Oral | 650 MG | 8/28/2006 |
ACETAMINOPHEN TABLETS USP 500 MG | genvion corporation | 02383667 | Tablet - Oral | 500 MG | N/A |
ACETAMINOPHEN TABLETS EXTRA STRENGTH | tanta pharmaceuticals inc | 01904132 | Tablet - Oral | 500 MG | 12/31/1991 |
ACETAMINOPHEN ULTRA RELIEF EXTRA STRENGTH | 02286807 | Tablet - Oral | 500 MG | N/A | |
ACETAMINOPHEN TABLETS 325MG | westcan pharmaceuticals ltd. | 00793264 | Tablet - Oral | 325 MG / TAB | 2/20/1997 |
TYLENOL COMPLETE COLD, COUGH & FLU PLUS MUCUS RELIEF | mcneil consumer healthcare division of johnson & johnson inc | 02295326 | Capsule - Oral | 250 MG | 8/18/2009 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
PARACETAMOL FARMALID 650 MG COMPRIMIDOS EFG | Dermogen-Farma S.A. | 86643 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
PARACETAMOL ONEDOSE 1 G COMPRIMIDOS EFG | Laboratorios Bluepharma, S.L. | 73492 | COMPRIMIDO | Sin Receta | Not Commercialized |
PARACETAMOL NORMON 10 mg/ml SOLUCION PARA PERFUSION EFG | Laboratorios Normon S.A. | 71530 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
CUPANOL NIÑOS 250 mg COMPRIMIDOS | Laboratorios Ern S.A. | 56815 | COMPRIMIDO | Sin Receta | Not Commercialized |
PARACETAMOL SANDOZ 1 g COMPRIMIDOS EFG | Sandoz Farmaceutica S.A. | 70311 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ALERJUVENTUS EXPECTORANTE JARABE | Laboratorios Ern S.A. | 46599 | JARABE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
GELOGRIP POLVO PARA SOLUCION ORAL | 70287 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
GELOCATIL PEDIATRICO 250 mg granulado | 72344 | GRANULADO | Sin Receta | Not Commercialized | |
GRIPALNORM GRANULADO PARA SOLUCION ORAL | Laboratorios Normon S.A. | 82096 | GRANULADO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
TRAMADOL/PARACETAMOL DAVUR 75 MG/650 MG COMPRIMIDOS | Laboratorios Davur, S.L.U. | 83142 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
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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