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
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]
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/03 | Phase 4 | Recruiting | |||
2024/12/12 | Phase 3 | Completed | |||
2024/11/13 | Phase 3 | Active, not recruiting | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III | ||
2024/11/04 | Phase 4 | Recruiting | |||
2024/09/19 | Not Applicable | Active, not recruiting | Arooj Khan | ||
2024/09/13 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2024/08/28 | Not Applicable | Completed | |||
2024/08/20 | Phase 4 | Completed | Ankara Etlik City Hospital | ||
2024/08/06 | N/A | Recruiting | |||
2024/08/01 | Phase 3 | Recruiting |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RedPharm Drug, Inc. | 67296-1581 | ORAL | 600 mg in 1 1 | 1/13/2021 | |
| QPharma Inc | 42708-175 | ORAL | 600 mg in 1 1 | 6/7/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4908 | ORAL | 400 mg in 1 1 | 2/18/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4305 | ORAL | 600 mg in 1 1 | 2/16/2021 | |
| RedPharm Drug, Inc. | 67296-1217 | ORAL | 400 mg in 1 1 | 1/20/2022 | |
| A-S Medication Solutions | 50090-6886 | ORAL | 800 mg in 1 1 | 5/10/2021 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-130 | ORAL | 400 mg in 1 1 | 1/14/2021 | |
| Dolgencorp Inc | 55910-897 | ORAL | 100 mg in 5 mL | 4/28/2025 | |
| Horizon Therapeutics USA, Inc. | 75987-010 | ORAL | 800 mg in 1 1 | 5/6/2021 | |
| Legacy Pharmaceutical Packaging, LLC | 68645-562 | ORAL | 600 mg in 1 1 | 12/13/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML | SIN16467P | INFUSION, SOLUTION | 4mg/ml | 4/4/2022 | |
| NUROFEN EXPRESS LIQUID CAPSULE 400mg | SIN14561P | CAPSULE, LIQUID FILLED | 400mg | 6/19/2014 | |
| YSP IBUPROFEN FILM COATED TABLET 400 mg | SIN07892P | TABLET, FILM COATED | 400 mg | 10/24/1994 | |
| PEROFEN 200 TABLET 200 mg | SIN06793P | TABLET, SUGAR COATED | 200 mg | 1/21/1992 | |
| NUROFEN EXPRESS CAPLETS 342MG | SIN14366P | TABLET, FILM COATED | 342mg | 6/14/2013 | |
| Spedifen Film Coated Tablet 400mg | SIN14169P | TABLET, FILM COATED | 400mg | 6/21/2012 | |
| APO-IBUPROFEN-FC TABLET 200 mg | SIN06016P | TABLET, FILM COATED | 200 mg | 6/3/1991 | |
| NUROFEN FOR CHILDREN 100mg/5ml (PROFESSIONAL PACK) | SIN15309P | SYRUP | 100mg/5ml | 7/31/2017 | |
| BRUFEN TABLET 200 mg | SIN05722P | TABLET, SUGAR COATED | 200 mg | 4/8/1991 | |
| BRAVEX PAEDIATRIC SUSPENSION 100MG/5ML | SIN15828P | SUSPENSION | 100mg/5ml | 10/9/2019 |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MEDIX IBUPROFEN 200 mg tablet blister pack | 314244 | Medicine | A | 2/14/2019 | |
| CHEMISTS’ OWN IBUPROFEN TABLETS 200mg blister pack (new formulation) | 339258 | Medicine | A | 7/9/2020 | |
| AROFEN 12 HOUR EXTENDED RELEASE TABLET ibuprofen 600 mg blister pack | 406177 | Medicine | A | 3/14/2023 | |
| PHARMACY CHOICE IBUPROFEN DOUBLE STRENGTH ibuprofen 400 mg film-coated tablet blister pack | 397975 | Medicine | A | 10/18/2022 | |
| APOHEALTH IBUPROFEN DOUBLE STRENGTH 400 ibuprofen 400 mg film-coated tablet blister pack | 396910 | Medicine | A | 10/4/2022 | |
| IBUFOUND COLD & FLU film-coated tablet blister pack | 450785 | Medicine | A | 6/4/2024 | |
| BUGESIC ORAL SUSPENSION ibuprofen 20mg/mL oral liquid bottle | 80886 | Medicine | A | 11/15/2001 | |
| ADVIL INFANT 3 MONTHS - 2 YEARS PAIN & FEVER RELIEF ibuprofen 40 mg/mL oral liquid suspension bottle | 178432 | Medicine | A | 12/15/2010 | |
| GOFEX 200 CLEARCAP ibuprofen 200 mg soft capsule blister pack | 185416 | Medicine | A | 6/16/2011 | |
| ZENIFEN ibuprofen 200mg tablet blister pack | 346883 | Medicine | A | 10/30/2020 |
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| IBUPROFEN CAPSULES, 200 MG | 02489759 | Capsule - Oral | 200 MG | N/A | |
| IBUPROFEN | perrigo international | 02263777 | Tablet - Oral | 400 MG | N/A |
| IBUPROFEN | 02309459 | Tablet - Oral | 400 MG | N/A | |
| IBUPROFEN | angita pharma inc. | 02498200 | Tablet - Oral | 200 MG | N/A |
| IBUPROFEN TABLETS | vita health products inc | 02368072 | Tablet - Oral | 200 MG | 1/26/2017 |
| ADVIL PEDIATRIC DROPS | glaxosmithkline consumer healthcare ulc | 02242522 | Drops - Oral | 40 MG / ML | 10/23/2000 |
| ANALGESIC AND MUSCLE RELAXANT | 02377462 | Tablet - Oral | 400 MG | 3/20/2012 | |
| ADVIL COLD AND SINUS NIGHTTIME | haleon canada ulc | 02267632 | Tablet - Oral | 200 MG | 8/4/2006 |
| REGULAR IBUPROFEN | teva canada limited | 02420120 | Tablet - Oral | 200 MG | N/A |
| MOTRIN 300MG | mcneil consumer healthcare division of johnson & johnson inc | 02242632 | Tablet - Oral | 300 MG | 5/15/2002 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IBUPROFENO BRIL 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Brill Pharma S.L. | 79552 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUPROFENO KABI 400 MG SOLUCION PARA PERFUSION | Fresenius Kabi España, S.A.U. | 85580 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| IBUPROFENO ARISTOGEN 400 COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 85028 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| NEOBRUFEN 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 70031 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| NIDOL 400 mg/30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Cantabria Pharma S.L. | 70442 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUPROFENO KERN PHARMA 600 mg GRANULADO EFERVESCENTE EFG | 67918 | GRANULADO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| IBUPROFENO DERMOGEN 400 mg SUSPENSION ORAL | Dermogen-Farma S.A. | 66330 | SUSPENSIÓN ORAL | Sin Receta | Not Commercialized |
| IBUPROFENO SANDOZ 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 66326 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO PENSA 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 88684 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO PHARMA COMBIX 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Combix S.L.U. | 90046 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.