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
Canadian National PDA Treatment Study	2020/04/15	NCT04347720	N/A	Completed	IWK Health Centre
The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electrodiagnostic Testing	2020/04/08	NCT04337814	Not Applicable	Completed	Aga Khan University Hospital, Pakistan
LIBERATE Trial in COVID-19	2020/04/06	NCT04334629	Phase 4	Withdrawn	King's College London
Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.	2020/03/31	NCT04328805	Phase 4	Completed	Universidad Europea de Madrid
Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis	2020/02/25	NCT04282941	Phase 3	UNKNOWN	Instituto de Investigación Hospital Universitario La Paz
Control of Fever in Septic Patients	2020/01/13	NCT04227652	Not Applicable	Completed	University Hospital Ostrava
Probiotic Intervention After Surgical Removal of Mandibular Third Molars	2019/12/18	NCT04203771	Not Applicable	Completed	AB Biotics, SA
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions	2019/12/17	NCT04202224	Not Applicable	Completed	Lithuanian University of Health Sciences
Evaluation of Methylprednisolone or Ibuprofen on Efficacy of Nerve Blocks With Symptomatic Irreversible Pulpitis	2019/11/08	NCT04157036	Phase 3	Terminated	Walter Reed National Military Medical Center
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma	2019/10/21	NCT04133623	Phase 3	Completed	IRCCS Burlo Garofolo

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ibuprofen	A-S Medication Solutions	50090-5445	ORAL	800 mg in 1 1	5/10/2021
Ibuprofen	Preferred Pharmaceuticals Inc.	68788-7080	ORAL	800 mg in 1 1	7/13/2023
IBUPROFEN	Northwind Pharmaceuticals	51655-275	ORAL	800 mg in 1 1	1/1/2023
Ibuprofen	A-S Medication Solutions	50090-5446	ORAL	800 mg in 1 1	5/10/2021
Ibuprofen	Proficient Rx LP	63187-980	ORAL	600 mg in 1 1	5/1/2022
Ibuprofen	A-S Medication Solutions	50090-3007	ORAL	400 mg in 1 1	3/16/2021
IBU	A-S Medication Solutions	50090-4339	ORAL	800 mg in 1 1	4/18/2019
Ibuprofen	Cardinal Health 107, LLC	55154-0741	ORAL	600 mg in 1 1	8/25/2019
Ibuprofen	A-S Medication Solutions	50090-5819	ORAL	400 mg in 1 1	10/10/2022
Otis Clapp Ultraprin	Unifirst First Aid Corporation	47682-702	ORAL	200 mg in 1 1	9/9/2025

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
No NMPA approvals found for this drug.

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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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APOHEALTH IBUPROFEN SOFT GEL CAPSULES 200 mg blister pack	279997	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	9/7/2016
WOOLWORTHS ESSENTIALS IBUPROFEN 200 mg film coated tablet blister pack (new formulation)	308741	Probiotec Pharma Pty Limited	Medicine	A	8/29/2018
PHARMACY HEALTH IBUPROFEN 200 MG film-coated tablet bottle (reformulation)	358391	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	3/31/2021
PRICELINE IBUPROFEN 200 MG film-coated tablet bottle (reformulation)	358392	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	3/31/2021
CALDOLOR ibuprofen 800mg/8mL concentrated solution for injection vial	175191	Phebra Pty Ltd	Medicine	A	12/12/2012
APOHEALTH IBUPROFEN LONG LASTING 600 ibuprofen 600 mg modified release tablet bottle	341759	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/18/2020
IBUPROFEN CODEINE-DWRN tablet blister pack	422472	GM Pharma International Pty Ltd	Medicine	A	12/7/2023
NUROFEN FOR CHILDREN BABY 3+ MONTHS STRAWBERRY FLAVOUR ibuprofen 40 mg/mL oral suspension (formulation 2)	167732	Reckitt Benckiser Pty Ltd	Medicine	A	12/22/2009
NUROFEN COLD & FLU WITH DECONGESTANT tablet blister pack	65640	Reckitt Benckiser Pty Ltd	Medicine	A	8/24/1998
MEDI CHOICE IBUPROFEN 200mg sugar coated tablet blister pack	175689	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	9/10/2010

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
IBUPROFEN NIGHTTIME	vita health products inc	02430770	Capsule - Oral	200 MG	1/27/2015
DIMETAPP COLD AND SINUS CAPLETS	whitehall-robins inc.	02036320	Tablet - Oral	200 MG	9/10/2002
JUNIOR STRENGTH MOTRIN CAPLETS	mcneil consumer healthcare division of johnson & johnson inc	02240527	Tablet - Oral	100 MG	9/20/1999
ADVIL ARTHRITIS PAIN	haleon canada ulc	02415623	Capsule - Oral	400 MG	7/7/2014
IBUPROFEN CAPLETS	marcan pharmaceuticals inc	02394731	Tablet - Oral	200 MG	N/A
IBUPROFEN CAPSULES, 400 MG	Catalent Ontario Limited	02489767	Capsule - Oral	400 MG	N/A
IBUPROFEN MENSTRUAL PAIN RELIEF	Apotex Inc	02317982	Tablet - Oral	400 MG	3/3/2009
SUMMIT ULTRA	pendopharm division of pharmascience inc	02360357	Tablet - Oral	400 MG	2/21/2012
COLD + SINUS CAPLETS	vita health products inc	02279851	Tablet - Oral	200 MG	12/8/2006
COLD & SINUS RELIEF CAPSULES	Apotex Inc	02407779	Capsule - Oral	200 MG	3/20/2014

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
IBUPROFENO GEISER 50 MG/G GEL	Geiser Pharma S.L.	86188	GEL	Sin Receta	Not Commercialized
BISOLFREN 200 MG/30 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA	Opella Healthcare Spain S.L.	76389	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Not Commercialized
PIREXIN 20 mg/ml SUSPENSION ORAL	Laboratorios Ern S.A.	65147	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
IBUPROFENO VEGAL 600 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Vegal Farmaceutica S.L.	66456	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
IBUPROFENO TEVA 400 mg CAPSULAS BLANDAS	Teva Pharma S.L.U.	71436	CÁPSULA BLANDA	Sin Receta	Commercialized
ALGIASDIN RETARD 600 mg COMPRIMIDOS DE LIBERACIÓN PROLONGADA	Isdin S.A.	61609	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
EUDORLIN 40 MG/ML SUSPENSION ORAL EFG	Berlin-Chemie Ag	80140	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ASTEFOR 400/30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Farmasierra Laboratorios S.L.	68541	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
IBUPROFENO CODRAMOL 200 MG SUSPENSION ORAL	Nutra Essential Otc S.L.	82403	SUSPENSIÓN ORAL	Sin Receta	Commercialized
JUNIFEN 40 mg/ml SUSPENSION ORAL SABOR NARANJA	Reckitt Benckiser Healthcare S.A.	73047	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized

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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