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Ibuprofen

Generic Name
Ibuprofen
Brand Names
Addaprin, Advil, Advil Cold and Sinus, Advil Congestion Relief, Advil PM, Advil Sinus Congestion and Pain, Alivio, Caldolor, Cedaprin, Children's Ibuprofen, Diphen, Duexis, Ibu, Ibutab, Junior Strength Motrin, Motrin, Motrin PM, Neoprofen, Nuprin, Pedea, Proprinal, Reprexain, Sudafed PE Head Congestion Plus Pain, Vicoprofen, Wal-profen Congestion Relief and Pain, Ibuprofen Gen.Orph
Drug Type
Small Molecule
Chemical Formula
C13H18O2
CAS Number
15687-27-1
Unique Ingredient Identifier
WK2XYI10QM

Overview

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin. Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID. On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.

Indication

Ibuprofen is the most commonly used and prescribed NSAID. It is a very common over-the-counter medication widely used as an analgesic, anti-inflammatory and antipyretic. The use of ibuprofen and its enantiomer Dexibuprofen in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder. Due to its activity against prostaglandin and thromboxane synthesis, ibuprofen has been attributed to alteration of platelet function and prolongation of gestation and labour. As ibuprofen is a widely used medication, the main therapeutic indications are:

Associated Conditions

  • Acute Pain
  • Ankylosing Spondylitis (AS)
  • Common Cold
  • Cystic Fibrosis (CF)
  • Fever
  • Gastric Ulcer
  • Gout
  • Headache
  • Insomnia
  • Juvenile Idiopathic Arthritis (JIA)
  • Menstrual Distress (Dysmenorrhea)
  • Migraine
  • Mild pain
  • Nasal Congestion
  • Osteoarthritis (OA)
  • Pain
  • Pain, Inflammatory
  • Patent Ductus Arteriosus (PDA)
  • Pericarditis
  • Primary Dysmenorrhoea
  • Rheumatoid Arthritis
  • Severe Pain
  • Sinus pressure
  • Mild to moderate pain
  • Minor aches and pains
  • Moderate Pain

Research Report

Published: Jul 11, 2025

A Comprehensive Monograph on Ibuprofen (DB01050): From Molecular Mechanisms to Clinical Application and Synthesis

I. Introduction and Historical Context: The Genesis of a Modern Analgesic

Ibuprofen stands as one of the most widely used pharmaceutical agents in modern medicine, a cornerstone of pain and inflammation management available in both prescription and over-the-counter formulations worldwide. Its journey from a laboratory compound to a household name is a compelling narrative of targeted drug discovery, evolving pharmacological understanding, and the perpetual quest for a balance between efficacy and safety. Classified as a non-steroidal anti-inflammatory drug (NSAID), Ibuprofen functions as a non-narcotic analgesic, an anti-inflammatory agent, and an antipyretic.[1] Chemically, it is the prototypical member of the propionic acid class of NSAIDs, a group of compounds that share a common structural and mechanistic heritage.[1]

A. The Quest for a Safer Aspirin

The development of Ibuprofen was not a product of serendipity but of a deliberate and focused research program initiated in 1953 at the Boots Pure Drug Company Ltd. in Nottingham, UK.[4] The project was led by pharmacologist Dr. Stewart Adams, who was tasked with a clear and challenging objective: to discover a novel therapeutic agent for rheumatoid arthritis (RA) that possessed potent anti-inflammatory properties but was devoid of the significant adverse effects associated with the two main therapies of the era—corticosteroids and aspirin.[4]

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2016/01/28
Phase 1
Completed
2016/01/11
Phase 4
Completed
Ajou University School of Medicine
2015/12/14
Phase 1
Completed
2015/11/16
Not Applicable
Completed
2015/11/13
Not Applicable
Recruiting
2015/11/11
Phase 1
Completed
Spherium Biomed
2015/11/01
Phase 2
Completed
Universidad Europea de Madrid
2015/10/27
Not Applicable
Completed
2015/10/22
Phase 4
Completed
Cumberland Pharmaceuticals
2015/10/20
Phase 2
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Direct_Rx
61919-463
ORAL
800 mg in 1 1
4/18/2023
RedPharm Drug, Inc.
67296-1757
ORAL
600 mg in 1 1
3/9/2023
REMEDYREPACK INC.
70518-4341
ORAL
600 mg in 1 1
5/22/2025
Teeter
72036-212
ORAL
200 mg in 1 1
5/20/2025
WR Group, Inc.
69607-8438
ORAL
200 mg in 1 1
3/24/2025
St. Mary's Medical Park Pharmacy
60760-603
ORAL
600 mg in 1 1
2/17/2023
Physicians Total Care, Inc.
54868-4976
ORAL
200 mg in 1 1
10/28/2010
Aphena Pharma Solutions - Tennessee, LLC
71610-547
ORAL
600 mg in 1 1
5/24/2021
St. Mary's Medical Park Pharmacy
60760-596
ORAL
800 mg in 1 1
12/20/2022
Asclemed USA, Inc.
76420-576
ORAL
600 mg in 1 1
10/6/2023

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
Dosage Form
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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
Ibuprofen Tablets
国药准字H13020597
化学药品
片剂
7/9/2021
Ibuprofen Tablets
国药准字H41022398
化学药品
片剂
7/6/2020
Ibuprofen Tablets
国药准字H63020122
化学药品
片剂(糖衣)
4/26/2020
Ibuprofen Tablets
国药准字H20003079
化学药品
片剂(糖衣片)
9/17/2020
Ibuprofen Tablets
国药准字H44021837
化学药品
片剂(糖衣)
11/27/2020
Ibuprofen Tablets
国药准字H32023087
化学药品
片剂
7/14/2020
Ibuprofen Tablets
国药准字H11021353
化学药品
片剂(糖衣)
11/9/2020
Ibuprofen Tablets
国药准字H14021457
化学药品
片剂
4/10/2020
Ibuprofen Tablets
国药准字H22022219
化学药品
片剂
11/25/2020
Ibuprofen Tablets
国药准字H15020583
化学药品
片剂
5/7/2020

PPB Drug Approvals

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Company
Licence No.
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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Sponsor
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Status
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