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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/17 | Phase 4 | Not yet recruiting | |||
2024/07/11 | Phase 4 | Recruiting | Cape Fear Valley Health System | ||
2024/07/11 | Phase 2 | Not yet recruiting | |||
2024/07/03 | Early Phase 1 | Completed | United States Naval Medical Center, San Diego | ||
2024/06/27 | Phase 4 | Completed | |||
2024/05/30 | Phase 4 | Recruiting | |||
2024/05/10 | Not Applicable | Recruiting | Bruno Minotti | ||
2024/05/03 | Phase 4 | Not yet recruiting | |||
2024/03/19 | Phase 3 | Completed | Lahore Medical Research Center, LLP | ||
2024/02/08 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| DISCOUNT DRUG MART, INC. | 53943-212 | ORAL | 200 mg in 1 1 | 5/27/2025 | |
| L. Perrigo Company | 0113-0897 | ORAL | 100 mg in 5 mL | 4/30/2025 | |
| PharmPak, Inc. | 54348-830 | ORAL | 600 mg in 1 1 | 10/9/2022 | |
| REMEDYREPACK INC. | 70518-3313 | ORAL | 600 mg in 1 1 | 3/15/2024 | |
| Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-768 | ORAL | 200 mg in 1 1 | 7/31/2025 | |
| Redpharm Drug, Inc. | 67296-1518 | ORAL | 400 mg in 1 1 | 2/7/2023 | |
| Polygen Pharmaceuticals LLC | 52605-123 | ORAL | 800 mg in 1 1 | 10/20/2011 | |
| Preferred Pharmaceuticals, Inc. | 68788-9110 | ORAL | 400 mg in 1 1 | 7/12/2023 | |
| Haleon US Holdings LLC | 0573-0196 | ORAL | 200 mg in 1 1 | 4/9/2025 | |
| Walgreen Company | 0363-1521 | ORAL | 100 mg in 1 1 | 5/7/2025 |
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 |
|---|---|---|---|---|---|
| BIFEN SUSPENSION 100 mg/5 ml | SIN08932P | SUSPENSION | 100 mg/5 ml | 9/20/1996 | |
| YSP IBUPROFEN SUSPENSION 20MG/ML | SIN14161P | SUSPENSION | 20.0mg | 6/18/2012 | |
| SPEDIFEN 400 SACHET 400 mg /sachet | SIN10707P | GRANULE, FOR SOLUTION | 400 mg/sachet | 1/25/1999 | |
| IBUFEN TABLETS 200 mg | SIN05464P | TABLET, FILM COATED | 200 mg | 2/19/1991 | |
| MAXIGESIC PE FILM-COATED TABLET | SIN16703P | TABLET, FILM COATED | 150.0mg | 2/21/2023 | |
| NUROMOL FILM COATED TABLET 200mg/500mg | SIN15200P | TABLET, FILM COATED | 200mg | 3/28/2017 | |
| MAXIGESIC TABLET 500MG/150MG | SIN14648P | TABLET, FILM COATED | 150 MG | 10/23/2014 | |
| NUROFEN EXPRESS CAPLETS 684MG | SIN14367P | TABLET, FILM COATED | 684MG | 6/14/2013 |
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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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ADVIL EXTRA STRENGTH LIQUI-GELS | haleon canada ulc | 02248231 | Capsule - Oral | 400 MG | 6/21/2004 |
| ADVIL MUSCLE AND JOINT | haleon canada ulc | 02355701 | Tablet - Oral | 400 MG | 11/7/2011 |
| MOTRIN TABLETS 300MG | mcneil consumer healthcare division of johnson & johnson inc | 00327794 | Tablet - Oral | 300 MG | 12/31/1975 |
| MOTRIN IB CAPLETS 200MG | upjohn consumer products company | 01994352 | Tablet - Oral | 200 MG / TAB | 12/31/1993 |
| IBUPROFEN CAPSULES 200 MG | auro pharma inc | 02554585 | Capsule - Oral | 200 MG | N/A |
| EXTRA STRENGTH IBUPROFEN | vita health products inc | 02246055 | Tablet - Oral | 400 MG | 11/22/2002 |
| CHILDREN'S IBUPROFEN SUSPENSION | perrigo international | 02280175 | Suspension - Oral | 100 MG / 5 ML | 8/30/2007 |
| CODOFEN | paladin pharma inc. | 02309785 | Tablet - Oral | 200 MG | N/A |
| PAMPRIN IBUPROFEN FORMULA | 02293013 | Tablet - Oral | 400 MG | 6/22/2007 | |
| ADVIL COLD & SINUS EXTRA STRENGTH LIQUI-GELS | glaxosmithkline consumer healthcare ulc | 02552930 | Capsule - Oral | 400 MG | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IBUFÉN XPRESS 400 MG GRANULADO PARA SOLUCIÓN ORAL | Laboratorios Cinfa S.A. | 67938 | GRANULADO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized |
| IBUPROFENO NORMON 40 mg/ml SUSPENSION ORAL EFG | Laboratorios Normon S.A. | 75244 | SUSPENSIÓN ORAL | Sin Receta | Commercialized |
| SALVARINA CAPSULAS DURAS | Laboratorios Salvat S.A. | 59120 | CÁPSULA DURA | Sin Receta | Not Commercialized |
| IBUFARMALID 600 mg SUSPENSION ORAL | Farmalider S.A. | 67931 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO CODRAMOL 20 mg / ml SUSPENSION ORAL EFG | Farmalider S.A. | 74672 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO NORMON 20 mg/ml SUSPENSION ORAL EFG | Laboratorios Normon S.A. | 65920 | SUSPENSIÓN ORAL | Sin Receta | Commercialized |
| IBUPROFENO CINFA 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 70039 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO B. BRAUN 600 MG SOLUCION PARA PERFUSION | B Braun Medical S.A. | 80720 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| IBUPROFENO LIDERFARM 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Farmalider S.A. | 77526 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUPROFENO FARMASIERRA 20 mg/ml SUSPENSION ORAL | Farmasierra Laboratorios S.L. | 68027 | SUSPENSIÓN ORAL | Sin Receta | Not Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No UK EMC drug information found for this drug. | |||||
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