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Drug ReportsNaproxen
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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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
stomatognathic diseasesD009057
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Aleve, Anaprox, Naprelan, Naprosyn, Naproxen (discontinued: Anaprox, Naprosyn, Naproxen)
Combinations
Aleve, 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
+
Naproxen sodium
Tradename
Company
Number
Date
Products
ALEVE PMBayerN-205352 OTC2014-01-17
1 products, RLD, RS
Naproxen sodium
Tradename
Company
Number
Date
Products
ANAPROX DSAtnahs PharmaN-018164 RX1987-09-30
1 products, RLD, RS
ALEVEBayerN-020204 OTC1994-01-11
1 products, RLD, RS
NAPROXEN SODIUMBionPharmaN-021920 OTC2006-02-17
1 products, RLD, RS
NAPRELANTWi PharmaceuticalsN-020353 RX1996-01-05
3 products, RLD, RS
Show 1 discontinued
Naproxen sodium
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ALEVE-D SINUS & COLDBayerN-021076 DISCN1999-11-29
1 products, RLD
Hide discontinued
Lansoprazole
+
Naproxen
Tradename
Company
Number
Date
Products
PREVACID NAPRAPAC 250 (COPACKAGED)TakedaN-021507 DISCN2003-11-14
1 products, RLD
PREVACID NAPRAPAC 375 (COPACKAGED)TakedaN-021507 DISCN2003-11-14
1 products
PREVACID NAPRAPAC 500 (COPACKAGED)TakedaN-021507 DISCN2003-11-14
1 products
Hide discontinued
Esomeprazole magnesium
+
Naproxen
Tradename
Company
Number
Date
Products
VIMOVOHorizon Therapeutics PublicN-022511 DISCN2010-04-30
2 products, RLD
Hide discontinued
Naproxen sodium
+
Sumatriptan succinate
Tradename
Company
Number
Date
Products
TREXIMETCurrax PharmaceuticalsN-021926 RX2008-04-15
1 products, RLD, RS
Show 1 discontinued
Naproxen
Tradename
Company
Number
Date
Products
NAPROSYNAtnahs PharmaN-017581 RX1982-04-15
1 products, RLD, RS
NAPROSYNAtnahs PharmaN-018965 RX1987-03-23
1 products, RLD
EC-NAPROSYNAtnahs PharmaN-020067 RX1994-10-14
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aleveNew Drug Application2024-12-06
aleve aleve, travel basixNew Drug Application2025-01-06
aleve arthritis pain gelANDA2023-11-30
aleve back and muscle painNew Drug Application2022-09-21
aleve headache painNew Drug Application2024-12-06
aleve liquid gelsANDA2024-05-06
aleve pmNew Drug Application2024-12-06
aleve-d sinus and coldANDA2024-12-06
aleve-d sinus and headacheANDA2024-12-06
alevexC2002632024-12-06
Show 108 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
juvenile arthritisEFO_1002007D001171M08
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
headacheHP_0002315D006261R51
feverHP_0001945D005334R50.9
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
bursitisEFO_1000941D002062M71.9
back painHP_0003418D001416M54
common coldEFO_0007214D003139J00
Show 21 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Naproxen Sodium, Naproxen Sodium, Bionpharma
96939782026-03-03DP
96939792026-03-03DP
100223442026-03-03DPU-1731, U-1732
100289252026-03-03DPU-1731, U-1732
110902802026-03-03DPU-1731, U-1732
Naproxen Sodium / Sumatriptan Succinate, Treximet, Currax
73321832025-10-02DPU-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
366 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MenorrhagiaD008595EFO_0003945N92.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Knee osteoarthritisD020370EFO_0004616M17—11——2
Hip osteoarthritisD015207EFO_1000786M16—11——2
OsteoarthritisD010003EFO_0002506M15-M19—11——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNaproxen
INNnaproxen
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)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Identifiers
PDB—
CAS-ID22204-53-1
RxCUI—
ChEMBL IDCHEMBL154
ChEBI ID7476
PubChem CID156391
DrugBankDB00788
UNII ID57Y76R9ATQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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
Total medical expenditures per year (USD, in millions)
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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
Total medical expenditures per year (USD, in millions)
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Naproxen
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Sumatriptan
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 20,342 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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101,837 adverse events reported
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