Naproxen
Aleve, Anaprox, Naprelan, Naprosyn, Prevacid Naprapac, Treximet, Vimovo (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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| musculoskeletal diseases | D009140 |
| stomatognathic diseases | D009057 |
| respiratory tract diseases | D012140 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| nutritional and metabolic diseases | D009750 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Aleve, Anaprox, Naprelan, Naprosyn (generic drugs available since 1993-12-21)
CombinationsAleve, Treximet, Vimovo (generic drugs available since 1993-12-21, discontinued: Aleve, Prevacid naprapac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diphenhydramine hydrochloride
+
Naproxen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALEVE PM | Bayer | N-205352 OTC | 2014-01-17 | 1 products, RLD, RS |
Esomeprazole magnesium
+
Naproxen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIMOVO | Horizon Pharmaceutical | N-022511 RX | 2010-04-30 | 2 products, RLD |
Lansoprazole
+
Naproxen
Naproxen
Naproxen sodium
Naproxen sodium
+
Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALEVE-D SINUS & COLD | Bayer | N-021076 DISCN | 1999-11-29 | 1 products, RLD |
Hide discontinued
Naproxen sodium
+
Sumatriptan succinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TREXIMET | Currax Pharmaceuticals | N-021926 RX | 2008-04-15 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| anaprox ds ec-naprosyn naprosyn | New Drug Application | 2019-08-01 |
| bayer aleve | New Drug Application | 2023-03-20 |
| naprelan | New Drug Application | 2021-04-01 |
| naprosyn | New Drug Application | 2021-04-30 |
| naproxen sodium | ANDA | 2023-06-13 |
| treximet | New Drug Application | 2021-05-04 |
| vimovo | New Drug Application | 2021-05-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| back pain | HP_0003418 | D001416 | M54 |
| bursitis | EFO_1000941 | D002062 | M71.9 |
| common cold | EFO_0007214 | D003139 | J00 |
| dysmenorrhea | HP_0100607 | D004412 | N94.6 |
| fever | HP_0001945 | D005334 | R50.9 |
| gout | EFO_0004274 | D006073 | M10 |
| headache | HP_0002315 | D006261 | R51 |
| inflammation | MP_0001845 | D007249 | — |
| juvenile arthritis | EFO_0002609 | D001171 | M08 |
Show 3 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Esomeprazole Magnesium / Naproxen, Vimovo, Horizon | |||
| 8945621 | 2031-10-17 | U-1661 | |
| 9220698 | 2031-03-10 | U-1781 | |
| 9393208 | 2029-09-03 | U-1781 | |
| Naproxen Sodium, Naproxen Sodium, Bionpharma Inc | |||
| 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
No data
Clinical
Clinical Trials
277 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 1 | 18 | 7 | 7 | 33 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 7 | 5 | 12 | 2 | 4 | 29 |
| Healthy volunteers/patients | — | 22 | 2 | — | 1 | 1 | 25 | ||
| Pain | D010146 | EFO_0003843 | R52 | 4 | 8 | 5 | 3 | 2 | 22 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 2 | 9 | 3 | 2 | 2 | 18 |
| Postoperative pain | D010149 | G89.18 | — | 1 | 5 | 5 | 1 | 12 | |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 6 | 2 | 4 | — | 11 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | 1 | 5 | — | 8 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | 1 | — | 3 | 2 | 1 | 7 |
| Gout | D006073 | EFO_0004274 | M10 | 1 | 1 | 1 | 2 | — | 5 |
Show 28 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 3 | — | 3 | — | — | 6 |
| Stomach ulcer | D013276 | K25 | 1 | 1 | 4 | — | — | 5 | |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | 1 | 3 | — | — | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | 2 | — | — | 3 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 3 | — | — | 3 |
| Toothache | D014098 | K08.89 | — | — | 1 | — | 2 | 3 | |
| Headache | D006261 | HP_0002315 | R51 | — | — | 2 | — | — | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | 1 | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | 1 | — | — | 1 |
| Immune reconstitution inflammatory syndrome | D054019 | D89.3 | — | 1 | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | 1 | 1 | — | — | — | 2 | |
| Neuralgia | D009437 | EFO_0009430 | — | 1 | — | — | — | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Pharyngitis | D010612 | R07.0 | — | 1 | — | — | — | 1 | |
| Pleural effusion | D010996 | J90 | — | 1 | — | — | — | 1 | |
| Malignant pleural effusion | D016066 | J91.0 | — | 1 | — | — | — | 1 | |
| Dental pins | D003772 | — | 1 | — | — | — | 1 | ||
| Pain management | D059408 | 1 | 1 | — | — | — | 1 | ||
| Pulpitis | D011671 | EFO_1001139 | K04.0 | 1 | 1 | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | — | — | 3 | 3 | ||
| Hemostasis | D006487 | — | — | — | — | 1 | 1 | ||
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | — | — | 1 | 1 | |
| Tendon injuries | D013708 | — | — | — | — | 1 | 1 | ||
| Tooth bleaching | D014073 | — | — | — | — | 1 | 1 | ||
| Cesarean section | D002585 | — | — | — | — | 1 | 1 |
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 |
Target
Agency Approved
PTGS2
PTGS2
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vimovo - Horizon Therapeutics Public
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Naprelan - Elan Corporation
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 17,230 documents
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Safety
Black-box Warning
Black-box warning for: Anaprox ds ec-naprosyn naprosyn, Naprelan, Naprosyn, Treximet, Vimovo
Adverse Events
Top Adverse Reactions
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3,782 adverse events reported
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