Naproxen
/ Naproxen, Aleve, Anaprox, Naprelan, Naprosyn, Naproxen, Naproxen /, Prevacid Naprapac, Treximet (naproxen) is a small molecule pharmaceutical. Naproxen was first approved as Naprosyn on 1982-01-01. It is used to treat ankylosing spondylitis, back pain, bursitis, common cold, and dysmenorrhea amongst others in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Aleve, Anaprox, Naprelan, Naprosyn, Naproxen (discontinued: Anaprox, Naprosyn, Naproxen)
CombinationsAleve, Naproxen diphenhydramine, Naproxen esomeprazole magnesium, Naproxen pseudoephedrine, Sumatriptan naproxen, Treximet (discontinued: Aleve, Naproxen diphenhydramine, Naproxen esomeprazole magnesium, Prevacid naprapac, Treximet, Vimovo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diphenhydramine hydrochloride
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Naproxen sodium
Naproxen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ANAPROX DS | Atnahs Pharma | N-018164 RX | 1987-09-30 | 1 products, RLD, RS |
| ALEVE | Bayer | N-020204 OTC | 1994-01-11 | 1 products, RLD, RS |
| NAPROXEN SODIUM | BionPharma | N-021920 OTC | 2006-02-17 | 1 products, RLD, RS |
| NAPRELAN | TWi Pharmaceuticals | N-020353 RX | 1996-01-05 | 3 products, RLD, RS |
Show 1 discontinued
Naproxen sodium
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Pseudoephedrine hydrochloride
Lansoprazole
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Naproxen
Esomeprazole magnesium
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Naproxen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIMOVO | Horizon Therapeutics Public | N-022511 DISCN | 2010-04-30 | 2 products, RLD |
Hide discontinued
Naproxen sodium
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Sumatriptan succinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TREXIMET | Currax Pharmaceuticals | N-021926 RX | 2008-04-15 | 1 products, RLD, RS |
Show 1 discontinued
Naproxen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NAPROSYN | Atnahs Pharma | N-017581 RX | 1982-04-15 | 1 products, RLD, RS |
| NAPROSYN | Atnahs Pharma | N-018965 RX | 1987-03-23 | 1 products, RLD |
| EC-NAPROSYN | Atnahs Pharma | N-020067 RX | 1994-10-14 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aleve | New Drug Application | 2023-12-05 |
| aleve aleve, travel basix | New Drug Application | 2023-10-03 |
| aleve arthritis pain gel | ANDA | 2023-11-30 |
| aleve back and muscle pain | New Drug Application | 2022-09-21 |
| aleve headache pain | New Drug Application | 2022-10-04 |
| aleve liquid gels | ANDA | 2024-05-06 |
| aleve pm | New Drug Application | 2022-11-15 |
| aleve-d sinus and cold | ANDA | 2023-11-30 |
| aleve-d sinus and headache | ANDA | 2023-11-30 |
| alevex | C200263 | 2023-11-30 |
Show 109 more
Indications
FDA
EMA
Show 21 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Naproxen Sodium, Naproxen Sodium, Bionpharma | |||
| 9693978 | 2026-03-03 | DP | |
| 9693979 | 2026-03-03 | DP | |
| 10022344 | 2026-03-03 | DP | U-1731, U-1732 |
| 10028925 | 2026-03-03 | DP | U-1731, U-1732 |
| 11090280 | 2026-03-03 | DP | U-1731, U-1732 |
| Naproxen Sodium / Sumatriptan Succinate, Treximet, Currax | |||
| 7332183 | 2025-10-02 | DP | U-867, U-1719 |
ATC Codes
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CC: Antiinflammatory products for vaginal administration
— G02CC02: Naproxen
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE02: Naproxen
— M01AE52: Naproxen and esomeprazole
— M01AE56: Naproxen and misoprostol
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA12: Naproxen
HCPCS
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Clinical
Clinical Trials
364 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 9 | 21 | 20 | 7 | 10 | 65 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 2 | 1 | 19 | 12 | 10 | 43 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 2 | 16 | 11 | 4 | 6 | 38 |
| Healthy volunteers/patients | — | — | — | 29 | 2 | — | 2 | 1 | 33 |
| Pain | D010146 | EFO_0003843 | R52 | 6 | 8 | 7 | 4 | 4 | 29 |
| Postoperative pain | D010149 | — | G89.18 | — | 5 | 10 | 9 | 5 | 28 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 5 | 1 | 8 | 8 | 3 | 25 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 7 | 4 | 6 | 4 | 20 |
| Back pain | D001416 | HP_0003418 | M54 | — | 6 | 5 | 7 | 3 | 20 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | 1 | 6 | 3 | 12 |
Show 57 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Toothache | D014098 | — | K08.89 | — | 2 | 5 | — | 2 | 9 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | 2 | 6 | — | — | 7 |
| Stomach ulcer | D013276 | — | K25 | 1 | 2 | 6 | — | — | 7 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | 3 | — | 2 | 6 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 3 | — | 2 | 5 |
| Spondylarthritis | D025241 | — | — | — | 1 | 2 | — | 2 | 5 |
| Syndrome | D013577 | — | — | 1 | 2 | 1 | — | 2 | 5 |
| Chronic pain | D059350 | HP_0012532 | — | — | 3 | 1 | — | — | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | 2 | — | 1 | 4 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | 1 | — | 2 | 4 |
Show 26 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | — | — | — | 2 |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | 1 | 1 | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | — | 1 |
| Mastodynia | D059373 | EFO_1001366 | N64.4 | — | 1 | — | — | — | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | — | — | — | 1 |
| Pharyngitis | D010612 | — | R07.0 | — | 1 | — | — | — | 1 |
| Tonsillitis | D014069 | HP_0011110 | J03 | — | 1 | — | — | — | 1 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 4 | — | — | — | — | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 4 | — | — | — | — | 4 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | — | 3 |
| Hyperuricemia | D033461 | HP_0002149 | — | 1 | — | — | — | — | 1 |
| Essential hypertension | D000075222 | — | I10 | 1 | — | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | — | — | — | — | 3 | 3 |
| Rib fractures | D012253 | — | — | — | — | — | — | 2 | 2 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | — | — | — | 1 | 1 |
| Shoulder pain | D020069 | HP_0030834 | M25.51 | — | — | — | — | 1 | 1 |
| Flail chest | D005409 | — | S22.5 | — | — | — | — | 1 | 1 |
| Knee injuries | D007718 | — | — | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Naproxen |
| INN | naproxen |
| Description | Naproxen is a methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes. It has a role as a non-steroidal anti-inflammatory drug, an antipyretic, a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a non-narcotic analgesic, a gout suppressant, a xenobiotic, an environmental contaminant and a drug allergen. It is a monocarboxylic acid and a methoxynaphthalene. It is a conjugate acid of a naproxen(1-). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2cc([C@H](C)C(=O)O)ccc2c1 |
Identifiers
| PDB | — |
| CAS-ID | 22204-53-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL154 |
| ChEBI ID | 7476 |
| PubChem CID | 156391 |
| DrugBank | DB00788 |
| UNII ID | 57Y76R9ATQ (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Naprelan – Elan Corporation
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Vimovo – Horizon Therapeutics Public
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Estimated US medical usage
Naproxen
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Esomeprazole
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Naproxen
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Lansoprazole
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Naproxen
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Naproxen
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Pseudoephedrine
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Naproxen
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Sumatriptan
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Trends
PubMed Central
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Additional graphs summarizing 19,970 documents
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Safety
Black-box Warning
Black-box warning for: Anaprox, Anaprox ds ec-naprosyn naprosyn, Ec-naproxen, Ec-naproxen naproxen naproxen sodium ds, Ec-naproxen naproxen naproxen sodium naproxen sodium ds, Naprelan, Naprosyn, Naprotin, Naproxen, Naproxen and esomeprazole magnesium, Naproxen naproxen sodium, Naproxen oral suspension, Naproxen sodium naproxen sodium, Sallus pain relief collection with naproxen, Sumatriptan and naproxen sodium, Sumatriptan succinate and naproxen sodium, Theraproxen, Treximet, Vimovo
Adverse Events
Top Adverse Reactions
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98,986 adverse events reported
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