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 |
---|---|---|---|---|---|
2024/07/17 | Phase 4 | Not yet recruiting | |||
2024/07/12 | Phase 1 | Recruiting | |||
2024/07/03 | Early Phase 1 | Completed | United States Naval Medical Center, San Diego | ||
2024/06/28 | Phase 4 | Recruiting | |||
2024/06/27 | Phase 4 | Completed | |||
2024/06/21 | Phase 1 | Recruiting | |||
2024/06/14 | Phase 1 | Completed | |||
2024/05/30 | Phase 4 | Recruiting | |||
2024/05/28 | Not Applicable | Not yet recruiting | |||
2024/05/16 | Phase 2 | Recruiting | Kasr El Aini Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
NuCare Pharmaceuticals,Inc. | 68071-5201 | ORAL | 325 mg in 1 1 | 2/7/2022 | |
Unit Dose Services | 50436-3918 | ORAL | 325 mg in 1 1 | 8/7/2018 | |
Bryant Ranch Prepack | 63629-2293 | ORAL | 325 mg in 1 1 | 3/19/2021 | |
Rebel Distributors Corp. | 21695-271 | ORAL | 750 mg in 1 1 | 2/10/2010 | |
A-S Medication Solutions | 50090-3011 | ORAL | 300 mg in 1 1 | 12/28/2023 | |
AvPAK | 50268-553 | ORAL | 325 mg in 1 1 | 8/29/2022 | |
ATLANTIC BIOLOGICALS CORP. | 17856-1122 | ORAL | 160 mg in 5 mL | 5/12/2025 | |
A-S Medication Solutions | 50090-0919 | ORAL | 325 mg in 1 1 | 11/28/2019 | |
Bryant Ranch Prepack | 63629-2190 | ORAL | 325 mg in 1 1 | 4/26/2019 | |
Graviti Pharmaceuticals Private Limited | 69844-049 | ORAL | 325 mg in 1 1 | 7/15/2020 |
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 |
---|---|---|---|---|---|
COLDSOFT DAY SOFT GELATIN CAPSULE | SIN13321P | CAPSULE, GELATIN COATED | 275.00MG | 7/31/2007 | |
PANADOL WITH OPTIZORB CAPLET 500MG | Sterling Drug (Malaya) Sdn Bhd, Granules India Limited (Granulate) | SIN14699P | TABLET, FILM COATED | 500 mg | 12/17/2014 |
PARACETAMOL B. BRAUN SOLUTION FOR INFUSION 10MG/ML | SIN14786P | INFUSION, SOLUTION | 1.00g/100ml | 5/19/2015 | |
PANADOL TABLET 500 mg | STERLING DRUG (MALAYA) SDN BHD | SIN05919P | TABLET | 500 mg | 5/23/1991 |
SUNNY PARACETAMOL TABLET 500 mg | SIN06174P | TABLET | 500mg | 5/8/1991 | |
PARMOL 250 SUSPENSION 250 mg/5 ml | SIN05565P | SUSPENSION | 250 mg/5 ml | 3/20/1991 | |
PORO SUSPENSION (ORANGE FLAVOUR) 250MG/5ML | SIN16140P | SUSPENSION | 250mg/5ml | 3/29/2021 | |
ACET 325 SUPPOSITORIES 325 mg | SIN10641P | SUPPOSITORY | 325 mg | 1/7/1999 | |
DOLO TABLETS 500 mg | SIN11052P | TABLET | 500 mg | 7/29/1999 | |
WATSONS PAIN & FEVER RELIEF TABLET 500MG | SIN16262P | TABLET | 500 mg | 7/5/2021 |
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 |
---|---|---|---|---|---|
NEW COLD STOP FLU & COUGH CAP | N/A | N/A | N/A | 8/5/2007 | |
CAD-FORTE CAP | N/A | N/A | N/A | 6/17/2004 | |
COLDSCAP CAP | N/A | N/A | N/A | 2/8/2002 | |
POURKE CAP | N/A | N/A | N/A | 6/9/2006 | |
UNI-PAINGETEX TABLET | N/A | synco (h.k.) limited | N/A | N/A | 1/16/2014 |
FLUCOL COLD RELIEF CAP | N/A | N/A | N/A | 12/11/1986 | |
U-NORCETOL TAB | N/A | synco (h.k.) limited | N/A | N/A | 4/13/1987 |
GREAT WALL BRAND JINGZHI YINQIAO JIEDU PIAN TABLETS | N/A | N/A | N/A | 5/4/2021 | |
FIRMBO CAP | N/A | N/A | N/A | 6/9/2006 | |
DETROLI CAP | N/A | N/A | N/A | 9/5/2007 |
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
COLD AND FLU MEDICINE - NIGHT TIME FORMULA | pharmetics (2011) inc | 02271672 | Capsule - Oral | 325 MG | 4/10/2006 |
DAY & NIGHT COMBO PACK | the winning combination inc. | 02380331 | Kit
,
Powder For Solution - Oral | 500 MG / 4.6 G | N/A |
CHILDREN'S TYLENOL COLD AND COUGH | mcneil consumer healthcare division of johnson & johnson inc | 00870455 | Tablet - Oral | 80 MG | 12/31/1990 |
COLD STIX | laboratoire riva inc. | 02377861 | Powder For Solution - Oral | 325 MG / SACHET | 10/10/2013 |
DAY & NIGHT COMBO PACK | the winning combination inc. | 02380331 | Kit
,
Powder For Solution - Oral | 650 MG / 5 G | N/A |
CHILDREN'S TYLENOL ALLERGY-D SUSPENSION | mcneil consumer healthcare division of johnson & johnson inc | 02241043 | Suspension - Oral | 160 MG / 5 ML | 6/15/2000 |
ACETAMINOPHEN 500MG | zakaria pharmaceutical group inc. | 02238806 | Tablet - Oral | 500 MG / TAB | 3/3/1999 |
HOT LEMON RELIEF POWDER EXTRA STRENGTH | 02248704 | Powder - Oral | 650 MG / 22 G | N/A | |
ACETAMINOPHEN CAPLETS EXTRA STRENGTH | tanta pharmaceuticals inc | 01962353 | Tablet - Oral | 500 MG | 12/31/1993 |
HOT LEMON ULTRA STRENGTH TOTAL FLU NIGHT | cellchem pharmaceuticals inc. | 02504812 | Powder For Solution - Oral | 1000 MG / SACHET | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
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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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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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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