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Acetaminophen

Generic Name
Acetaminophen
Brand Names
Acephen, Acetadryl, Allzital, Apadaz, Arthriten Inflammatory Pain, Bupap, Butapap, Cetafen, Children's Silapap, Coricidin Hbp Cold & Flu, Darvocet-N, Dayquil Sinex, Diphen, Dolofin, Dologen, Dologesic Reformulated Jun 2016, Duralgina, Dvorah, Endocet, Esgic, Exaprin, Excedrin, Excedrin PM Triple Action, Excedrin Tension Headache, Feverall, Fioricet, Fioricet With Codeine, Goody's Back & Body Pain Relief, Goody's Body Pain, Goody's Extra Strength, Goody's Headache Relief Shot, Goody's PM, Hycet, Legatrin PM, Little Fevers, Lorcet, Lortab, Mapap, Mersyndol, Midol Complete, Midol Cramps & Bodyaches, Nalocet, Norco, Orbivan, Pamprin Max Formula, Pamprin Multi-symptom, Panadol, Pediacare Children's Fever Reducer Pain Reliever, Percocet, Percogesic Reformulated Jan 2011, Pharbetol, Premsyn Pms, Prolate, Rivacocet, Robaxacet, Robaxacet-8, Roxicet, Sudafed PE Sinus Headache, Tactinal, Tencon, Trezix, Triatec, Triatec-30, Triatec-8, Tylenol, Tylenol PM, Tylenol With Codeine, Ultracet, Vanatol, Vanatol S, Vanquish, Xodol, Xolox, Zamicet, Zflex, Zydone
Drug Type
Small Molecule
Chemical Formula
C8H9NO2
CAS Number
103-90-2
Unique Ingredient Identifier
362O9ITL9D

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.

Background

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

Published: May 29, 2025

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]

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2023/08/14
Not Applicable
Not yet recruiting
2023/08/03
Phase 4
Completed
2023/08/03
Phase 4
ENROLLING_BY_INVITATION
2023/07/28
Phase 3
Withdrawn
2023/07/05
Phase 4
Completed
2023/06/26
Phase 4
Not yet recruiting
2023/06/09
Phase 2
Recruiting
Benjamin T Diamond, MD
2023/05/26
Phase 4
ENROLLING_BY_INVITATION
2023/05/10
Not Applicable
Completed
2023/05/06
Phase 2
ENROLLING_BY_INVITATION

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
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
Epic Pharma, LLC
42806-111
ORAL
325 mg in 1 1
9/22/2023
Bryant Ranch Prepack
63629-1185
ORAL
300 mg in 1 1
5/19/2023
Bryant Ranch Prepack
71335-1818
ORAL
300 mg in 1 1
5/25/2023
Unit Dose Services
50436-2612
ORAL
325 mg in 1 1
8/15/2017
NuCare Pharmaceuticals, Inc.
68071-3100
ORAL
300 mg in 1 1
2/7/2022
Rebel Distributors Corp
21695-816
ORAL
167 mg in 5 mL
4/24/2009

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
Paracetamol Suppositories
国药准字H42020362
化学药品
栓剂
7/30/2020
Paracetamol Suppositories
国药准字H32023325
化学药品
栓剂
7/7/2020
Paracetamol Suppositories
国药准字H42021668
化学药品
栓剂
8/31/2020
Paracetamol Suppositories
国药准字H44024867
化学药品
栓剂
11/22/2019
Paracetamol Granules
国药准字H19990012
化学药品
颗粒剂
10/13/2020
Paracetamol Granules
国药准字H19990011
化学药品
颗粒剂
10/13/2020
Paracetamol Granules
国药准字H20054795
化学药品
颗粒剂
1/20/2021
Paracetamol Granules
国药准字H10940233
化学药品
颗粒剂
8/17/2020
Paracetamol Granules
国药准字H20054794
化学药品
颗粒剂
6/28/2020
Paracetamol Granules
国药准字H53021822
化学药品
颗粒剂
6/8/2020

PPB Drug Approvals

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