Overview
Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.
Indication
Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain. Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.
Associated Conditions
- Acute Gouty Arthritis
- Acute Migraine
- Ankylosing Spondylitis (AS)
- Back pain
- Bursitis
- Extra-Articular Rheumatism
- Fever
- Flu caused by Influenza
- Headache
- Juvenile Idiopathic Arthritis (JIA)
- Menstrual Distress (Dysmenorrhea)
- Migraine
- Muscle Spasms
- Nasal Congestion
- Osteoarthritis (OA)
- Pain
- Post Traumatic Pain
- Postoperative pain
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Seasonal Allergic Rhinitis
- Sinusitis
- Tendinitis
- Toothache
- Articular inflammation
Research Report
A Comprehensive Monograph on Naproxen (DrugBank ID: DB00788): Pharmacology, Clinical Efficacy, and Comparative Risk-Benefit Analysis
1.0 Executive Summary of Naproxen
Naproxen is a well-established small molecule drug belonging to the propionic acid class of nonsteroidal anti-inflammatory drugs (NSAIDs).[1] First approved for prescription use in 1976 and later for over-the-counter (OTC) access in 1994, it has become a cornerstone therapy for managing pain, inflammation, and fever across a wide spectrum of clinical scenarios.[3] Its therapeutic utility is derived from its core pharmacological mechanism: the non-selective and reversible inhibition of both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes.[1] By blocking these enzymes, naproxen effectively reduces the synthesis of prostaglandins, which are critical mediators in the pathways of pain, inflammation, and pyresis.[1]
Clinically, naproxen is indicated for numerous conditions, including chronic inflammatory disorders like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, as well as acute conditions such as gout, tendinitis, bursitis, and primary dysmenorrhea.[1] Its efficacy in these areas is supported by decades of clinical use and numerous studies. The development of various formulations, including immediate-release, extended-release, and gastro-protective combination products, has further solidified its place in the therapeutic armamentarium.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | Phase 3 | Completed | Zitelli & Brodland Skin Cancer Center | ||
2025/04/08 | Not Applicable | Not yet recruiting | |||
2025/03/31 | Phase 2 | Not yet recruiting | |||
2025/03/06 | Phase 4 | Recruiting | Endeavor Health | ||
2024/08/20 | Phase 4 | Recruiting | |||
2024/07/22 | Phase 1 | Recruiting | |||
2024/07/03 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/05/30 | Phase 1 | ENROLLING_BY_INVITATION | JW Pharmaceutical | ||
2024/05/16 | Phase 1 | Completed | |||
2024/04/03 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0051 | ORAL | 500 mg in 1 1 | 11/10/2022 | |
| Bryant Ranch Prepack | 71335-0255 | ORAL | 375 mg in 1 1 | 10/9/2018 | |
| Biomes Pharmaceuticals | 69150-138 | ORAL | 250 mg in 1 1 | 6/19/2016 | |
| Quality Care Products, LLC | 55700-987 | ORAL | 375 mg in 1 1 | 11/8/2022 | |
| Cardinal Health 110, LLC. dba Leader | 70000-0605 | ORAL | 220 mg in 1 1 | 4/25/2025 | |
| Innovida Phamaceutique Corporation | 71800-901 | ORAL | 500 mg in 1 1 | 12/9/2020 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-189 | ORAL | 375 mg in 1 1 | 5/31/2021 | |
| QPharma Inc | 42708-140 | ORAL | 500 mg in 1 1 | 1/18/2023 | |
| Keltman Pharmaceuticals Inc. | 68387-802 | ORAL | 375 mg in 1 1 | 10/4/2010 | |
| Aidarex Pharmaceuticals LLC | 33261-085 | ORAL | 550 mg in 1 1 | 1/17/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-NAPRO-NA TABLET 275 mg | SIN07136P | TABLET, FILM COATED | 275 mg | 9/23/1992 | |
| PRONAXEN ORAL SUSPENSION 25 MG/ML | SIN16449P | SUSPENSION | 25.00 mg/ml | 3/23/2022 | |
| APO-NAPROXEN TABLET 250 mg | SIN05295P | TABLET | 250 mg | 1/8/1991 | |
| SODEN TABLET 275 mg | SIN08430P | TABLET, FILM COATED | 275 mg | 11/8/1995 | |
| NAPROXEN TABLET 250 mg | SIN05596P | TABLET | 250 mg | 3/27/1991 | |
| SELADIN TABLET 250 mg | SIN08485P | TABLET | 250 mg | 12/21/1995 | |
| SOREN TABLET 275 mg | SIN10626P | TABLET, FILM COATED | 275 mg | 1/7/1999 | |
| APO-NAPROXEN TABLET 375 mg | SIN08425P | TABLET | 375 mg | 10/26/1995 | |
| SUNPROX 275 TABLET 275 mg | SIN07973P | TABLET, FILM COATED | 275 mg | 12/31/1994 | |
| NUPRAFEN TABLET 250 mg | SIN09646P | TABLET | 250 mg | 2/18/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NAPOSIN TABLETS 250MG | N/A | N/A | N/A | 12/9/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NAPROSYN SR 750 naproxen 750 mg sustained release tablets blister pack | 10174 | Medicine | A | 7/19/1991 | |
| INZA 500 naproxen 500 mg tablet bottle | 40929 | Medicine | A | 8/10/1992 | |
| TERRYWHITE CHEMMART PERIOD PAIN RELIEF naproxen sodium 275mg tablet - film coated blister pack | 311152 | Medicine | A | 11/5/2018 | |
| TRUST NAPROXEN naproxen sodium 275mg tablet blister pack | 207745 | Medicine | A | 4/4/2013 | |
| SODEN naproxen sodium 275mg tablet blister pack | 97900 | Medicine | A | 11/3/2003 | |
| CHEMISTS' OWN PERIOD PAIN RELIEF naproxen sodium 275 mg tablet blister pack | 115773 | Medicine | A | 1/18/2005 | |
| APOHEALTH PERIOD PAIN RELIEF naproxen sodium 275 mg tablet blister pack (new formulation) | 453925 | Medicine | A | 6/28/2024 | |
| CHEMISTS’ OWN PERIOD PAIN RELIEF naproxen sodium 275 mg tablet blister pack (new formulation) | 453926 | Medicine | A | 6/28/2024 | |
| PROXEN SR 1000 naproxen 1000 mg sustained release tablet bottle | 47442 | Medicine | A | 2/7/1994 | |
| NAPROSYN naproxen 250 mg tablet blister pack | 65247 | Medicine | A | 9/24/1998 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| WAYMADE-NAPROXEN SODIUM DS | waymade plc | 02463709 | Tablet - Oral | 550 MG | N/A |
| NOVO-NAPROX TAB 125MG | novopharm limited | 00565369 | Tablet - Oral | 125 MG | 12/31/1982 |
| NU-NAPROX EC | nu-pharm inc | 02336553 | Tablet (Enteric-Coated) - Oral | 250 MG | N/A |
| MOTRIMAX 12 HOUR TABLETS | mcneil consumer healthcare division of johnson & johnson inc | 02423790 | Tablet - Oral | 220 MG | N/A |
| NAPROXEN | sanis health inc | 02350769 | Tablet - Oral | 375 MG | 6/15/2010 |
| NAPROXEN EC | sanis health inc | 02350785 | Tablet (Enteric-Coated) - Oral | 250 MG | 6/15/2010 |
| NAPROXEN | sanis health inc | 02350750 | Tablet - Oral | 250 MG | 6/15/2010 |
| NAPROSYN-SR TAB 750MG | syntex inc. | 00788767 | Tablet (Extended-Release) - Oral | 750 MG | 12/31/1989 |
| WAYMADE-NAPROXEN | waymade plc | 02463679 | Tablet (Enteric-Coated) - Oral | 375 MG | N/A |
| TEVA-NAPROXEN SODIUM DS | teva canada limited | 02026600 | Tablet - Oral | 550 MG | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| NAPROXENO NORMON 500 mg COMPRIMIDOS EFG | Laboratorios Normon S.A. | 68435 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| NAPROXENO TEVA-RATIOPHARM 500 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Teva Pharma S.L.U. | 61370 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| VIMOVO 500 mg/20 mg COMPRIMIDOS DE LIBERACION MODIFICADA | Grünenthal Pharma S.A. | 73182 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| NAPROXENO AUROBINDO 500 MG COMPRIMIDOS EFG | Laboratorios Aurobindo S.L.U. | 80806 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LIDET 500 MG COMPRIMIDOS GASTRORRESISTENTES EFG | Aristo Pharma Iberia S.L. | 77727 | COMPRIMIDO GASTRORRESISTENTE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| NAPROSYN 500 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 56267 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| NAPROXENO/ESOMEPRAZOL SANDOZ 500 MG/20 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Sandoz Farmaceutica S.A. | 89990 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LUNDIRAN 250 mg Cápsulas duras | Industria Quimica Y Farmaceutica Vir S.A. | 54246 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| EMOXEN 500 MG/20 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | 89451 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| NAPROXENO AUROVITAS 500 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 85570 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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