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 |
|---|---|---|---|---|---|
2018/02/28 | Phase 1 | Completed | |||
2018/02/28 | Phase 4 | Completed | |||
2018/02/26 | Phase 4 | Completed | |||
2018/02/19 | Not Applicable | Terminated | |||
2018/02/19 | Not Applicable | Completed | |||
2018/02/09 | Phase 4 | Completed | |||
2018/02/07 | Phase 4 | UNKNOWN | |||
2018/01/30 | Phase 4 | Completed | |||
2018/01/30 | Phase 1 | Completed | |||
2018/01/29 | Not Applicable | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-3858 | ORAL | 325 mg in 1 1 | 4/2/2024 | |
| Unit Dose Services | 50436-2605 | ORAL | 325 mg in 1 1 | 8/15/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-2800 | ORAL | 300 mg in 1 1 | 7/19/2022 | |
| RedPharm Drug, Inc. | 67296-1794 | ORAL | 325 mg in 1 1 | 1/21/2022 | |
| Preferred Pharmaceuticals Inc. | 68788-8375 | ORAL | 500 mg in 15 mL | 5/7/2025 | |
| Sun Pharmaceutical Industries, Inc. | 57664-537 | ORAL | 325 mg in 1 1 | 1/15/2024 | |
| GAVIS Pharmaceuticals, LLC | 43386-670 | ORAL | 650 mg in 1 1 | 7/12/2011 | |
| A-S Medication Solutions | 50090-3705 | ORAL | 325 mg in 1 1 | 11/30/2018 | |
| Rebel Distributors Corp. | 21695-272 | ORAL | 325 mg in 1 1 | 2/10/2010 | |
| Keltman Pharmaceuticals Inc. | 68387-520 | ORAL | 500 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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Paracetamol Tablets | 国药准字H11020019 | 化学药品 | 片剂 | 11/6/2020 | |
| Paracetamol Tablets | 国药准字H32025066 | 化学药品 | 片剂 | 7/7/2020 | |
| Paracetamol Tablets | 国药准字H32023276 | 化学药品 | 片剂 | 6/22/2020 | |
| Paracetamol Tablets | 国药准字H34020235 | 化学药品 | 片剂 | 6/28/2020 | |
| Paracetamol Tablets | 国药准字H23020023 | 化学药品 | 片剂 | 3/21/2020 | |
| Paracetamol Tablets | 国药准字H52020020 | 化学药品 | 片剂 | 8/10/2020 | |
| Paracetamol Tablets | 国药准字H34023936 | 化学药品 | 片剂 | 5/19/2020 | |
| Paracetamol Tablets | 国药准字H22022007 | 化学药品 | 片剂 | 3/5/2020 | |
| Paracetamol Tablets | 国药准字H53020133 | 化学药品 | 片剂 | 5/4/2020 | |
| Paracetamol Tablets | 国药准字H32022408 | 化学药品 | 片剂 | 6/15/2020 |
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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