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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
2022/08/02
Phase 3
Completed
2022/07/29
Not Applicable
UNKNOWN
Yuzuncu Yıl University
2022/06/23
Phase 1
Completed
2022/06/02
Not Applicable
Completed
2022/05/13
Phase 4
Recruiting
University Hospital, Akershus
2022/05/02
N/A
Completed
Nuria Llorach-Perucho
2022/04/22
Phase 1
UNKNOWN
2022/04/22
Phase 2
Recruiting
2022/04/15
Phase 1
Completed
2022/04/13
Phase 4
Recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Aurohealth LLC
58602-893
ORAL
125 mg in 1 1
7/3/2025
Ascend Laboratories, LLC
67877-626
ORAL
800 mg in 1 1
11/24/2021
Northwind Pharmaceuticals, LLC
51655-851
ORAL
800 mg in 1 1
1/16/2024
Aphena Pharma Solutions - Tennessee, LLC
71610-387
ORAL
800 mg in 1 1
1/22/2020
Lake Erie Medical DBA Quality Care Products LLC
49999-042
ORAL
800 mg in 1 1
3/20/2019
RPK Pharmaceuticals, Inc.
53002-3010
ORAL
600 mg in 1 1
4/18/2019
REMEDYREPACK INC.
70518-0761
ORAL
600 mg in 1 1
4/28/2025
Bryant Ranch Prepack
71335-0690
ORAL
400 mg in 1 1
3/16/2021
NuCare Pharmaceuticals,Inc.
68071-2815
ORAL
800 mg in 1 1
8/19/2022
Prasco Laboratories
66993-490
INTRAVENOUS
10 mg in 1 mL
10/31/2023

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-IBUPROFEN
00839264
Tablet - Oral
600 MG
7/9/2008
ROBAX PLATINUM
glaxosmithkline consumer healthcare ulc
02247147
Tablet - Oral
200 MG
7/2/2003
SUPER STRENGTH MOTRIN IB LIQUID GELS
mcneil consumer healthcare division of johnson & johnson inc
02317850
Capsule - Oral
400 MG
7/6/2009
IBUPROFEN 200 MG
pendopharm division of pharmascience inc
02291932
Tablet - Oral
200 MG
6/1/2007
IBUPROFEN LIQUID FILLED CAPSULES
02281384
Capsule - Oral
200 MG
11/7/2006
IBUPROFEN TABLETS
02314754
Tablet - Oral
200 MG
3/5/2010
IBUPROFEN DAYTIME
vita health products inc
02434466
Capsule - Oral
200 MG
N/A
APO-IBUPROFEN
00506052
Tablet - Oral
400 MG
12/31/1983
CHILDREN'S MOTRIN CHEWABLE TABLETS
mcneil consumer healthcare division of johnson & johnson inc
02247343
Tablet (Chewable) - Oral
50 MG
5/14/2003
COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME
vita health products inc
02388030
Tablet ,  Kit - Oral
200 MG
5/23/2014

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
IBUPROFENO AUROVITAS PHARMA 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Aurovitas Spain, S.A.U.
86554
COMPRIMIDO RECUBIERTO CON PELÍCULA
Sin Receta
Commercialized
IBUPROFENO ZENTIVA KS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
85948
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
IBUPROFENO PHARMA COMBIX 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Laboratorios Combix S.L.U.
74207
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
IBUPROFENO CODRAMOL 200 MG POLVO ORAL
Farmalider S.A.
79595
POLVO ORAL
Sin Receta
Commercialized
IBUDOL RAPID 400 mg GRANULADO PARA SOLUCION ORAL
72763
GRANULADO PARA SOLUCIÓN ORAL
Sin Receta
Commercialized
PHARMAFREN 200 MG/30 MG CAPSULAS DURAS
Laboratorios Cinfa S.A.
83605
CÁPSULA DURA
Sin Receta
Commercialized
PARACETAMOL/IBUPROFENO WINADOL 500 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Nutra Essential Otc S.L.
87955
COMPRIMIDO RECUBIERTO CON PELÍCULA
Sin Receta
Not Commercialized
NOVIDOL 50 mg/g GEL
Menarini Consumer Healthcare S.A.U.
67207
GEL
Sin Receta
Commercialized
NEOBRUFEN 600 mg GRANULADO EFERVESCENTE
61610
GRANULADO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
IBUPROFENO BRIL 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Brill Pharma S.L.
79553
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

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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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MA Number
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