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Drug ReportsDiclofenac
Diclofenac
Arthrotec, Cambia, Cataflam, Diclofenac, Flector, Licart, Voltaren, Zipsor, Zorvolex (diclofenac) is a small molecule pharmaceutical. Diclofenac was first approved as Voltaren on 1988-07-28. It is used to treat ankylosing spondylitis, dysmenorrhea, inflammation, juvenile arthritis, and keratosis amongst others in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1. In addition, it is known to target transient receptor potential cation channel subfamily M member 3, peroxisome proliferator-activated receptor gamma, and acid-sensing ion channel 3.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
eye diseasesD005128
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cambia, Cataflam, Diclofenac, Diclofenac potassium, Flector, Licart, Voltaren, Zipsor (discontinued: Cataflam, Diclofenac, Diclofenac potassium, Dyloject, Pennsaid, Solaraze, Voltaren, Zorvolex)
Combinations
Arthrotec, Diclofenac misoprostol (discontinued: Diclofenac misoprostol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diclofenac
Tradename
Company
Number
Date
Products
ZORVOLEXZyla Life SciencesN-204592 DISCN2013-10-18
2 products, RLD
Hide discontinued
Diclofenac sodium
Tradename
Company
Number
Date
Products
VOLTAREN ARTHRITIS PAINGSKN-022122 OTC2007-10-17
1 products, RLD, RS
Show 8 discontinued
Diclofenac sodium
+
Misoprostol
Tradename
Company
Number
Date
Products
ARTHROTECPfizerN-020607 RX1997-12-24
2 products, RLD, RS
Diclofenac potassium
Tradename
Company
Number
Date
Products
ZIPSORAssertio TherapeuticsN-022202 RX2009-06-16
1 products, RLD, RS
CAMBIAAssertio TherapeuticsN-022165 RX2009-06-17
1 products, RLD, RS
Show 1 discontinued
Diclofenac epolamine
Tradename
Company
Number
Date
Products
FLECTORIBSA GroupN-021234 RX2007-01-31
1 products, RLD, RS
LICARTIBSA GroupN-206976 RX2018-12-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
aleve arthritis pain gelANDA2023-11-30
amazon basic care arthritis painANDA2024-05-17
arthritis painANDA2024-12-01
arthritis pain relieverANDA2025-09-08
arthritis pain relievingANDA2025-09-29
arthrotecNew Drug Application2025-08-14
aspercreme arthritisANDA2025-01-28
basic care arthritis painANDA2022-01-06
berkley and jensen arthritis painANDA2023-07-26
calcipotriene 0.005% / diclofenac sodium 3% / hyaluronic acid sodium salt 2% / niacinamide 2%unapproved drug other2019-05-06
Show 83 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
juvenile arthritisEFO_1002007D001171M08
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
photophobia—D020795H53.14
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
dysmenorrhea—D004412N94.6
keratosis—D007642—
Agency Specific
FDA
EMA
Expiration
Code
DICLOFENAC POTASSIUM, ZIPSOR, ASSERTIO
2024-05-25NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Diclofenac Epolamine, Licart, Ibsa Inst Bio
113445202035-02-20U-3393
113511332035-02-20U-3393
Diclofenac Sodium, Pennsaid, Horizon
85464502030-08-09U-1435, U-1436
82170782029-07-10U-1248, U-1477
86181642029-07-10U-1477
87419562029-07-10U-1435
93705012029-07-10U-1614
93754122029-07-10U-1614
94150292029-07-10U-1614
82528382028-04-21DPU-1489
85636132027-10-17DPU-1488
88718092027-10-17U-1614
90669132027-10-17DPU-1488
91015912027-10-17DPU-1488
91321102027-10-17U-1488
91683042027-10-17DP
91683052027-10-17U-1488
92207842027-10-17U-1488
93395512027-10-17U-1488
93395522027-10-17DPU-1488
95393352027-10-17U-1614
Diclofenac, Zorvolex, Zyla
86795442030-04-23DP
89993872030-04-23U-55
90177212030-04-23DP
91738542030-04-23DP
91800952030-04-23U-55
91800962030-04-23DP
91863282030-04-23U-55
Diclofenac Potassium, Zipsor, Assertio
76628582029-02-24U-1035
78840952029-02-24U-1111
79395182029-02-24U-980
81106062029-02-24U-980
86239202029-02-24U-1482
95612002029-02-24U-1482
Diclofenac Sodium, Dyloject, Javelin Pharms Inc
89462922027-03-22U-1659
Diclofenac Potassium, Cambia, Assertio
77593942026-06-16DS, DPU-436
80976512026-06-16DS, DPU-436
89276042026-06-16U-436
98271972026-06-16DP
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AX: Other dermatological preparations in atc
— D11AX18: Diclofenac
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB05: Diclofenac
— M01AB55: Diclofenac, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA15: Diclofenac
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
— S01BC03: Diclofenac
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CC: Antiinflammatory agents, non-steroids and antiinfectives in combination
— S01CC01: Diclofenac and antiinfectives
HCPCS
Code
Description
J1130
Injection, diclofenac sodium, 0.5 mg
Clinical
Clinical Trials
561 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoarthritisD010003EFO_0002506M15-M1951630101877
Postoperative painD010149—G89.184510123060
PainD010146EFO_0003843R52969171758
Knee osteoarthritisD020370EFO_0004616M174141961253
Healthy volunteers/patients———12——2519
Low back painD017116—M54.51256518
Sprains and strainsD013180———2114117
Acute painD059787—R52—373517
Ankle injuriesD016512—S93.4—2101315
Actinic keratosisD055623—L57.01166115
Show 123 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—312—28
Rotator cuff injuriesD000070636—M75.1—22—24
Dental pinsD003772———12——3
ToothacheD014098—K08.89—12——3
TendinopathyD052256EFO_1001434M77.9—11—23
RadiculopathyD011843—M54.1——1—23
ContusionsD003288—T14.8——3——3
Anterior cruciate ligament injuriesD000070598————1—23
BursitisD002062EFO_1000941M71.9—21—13
SciaticaD012585—M54.3——1—23
Show 31 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——11——45
Diabetic retinopathyD003930EFO_0003770——1——34
Skin neoplasmsD012878EFO_0004198C44—3———3
AnalgesiaD000698——11——23
Hand-foot syndromeD060831EFO_1001893——1——23
GoutD006073EFO_0004274M10—1——12
Gouty arthritisD015210———2———2
PeriodontitisD010518EFO_0000649K05.321———2
Renal insufficiencyD051437—N1911———2
Multiple myelomaD009101—C90.0—1———1
Show 25 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EdemaD004487—R60.91———23
Bone fracturesD050723EFO_0003931T14.81———23
UveitisD014605EFO_1001231H20.91———12
Therapeutic equivalencyD013810——2————2
NecrosisD009336——2————2
AlcoholismD000437EFO_0003829F10.12————2
Alcohol drinkingD000428EFO_0004329—2————2
AgingD000375GO_0007568R41.811————1
Carpal tunnel syndromeD002349EFO_0004143G56.01————1
Median neuropathyD020423——1————1
Show 18 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25————33
Pathologic dilatationD004108——————33
KeratoconusD007640EFO_0004223H18.6————33
RegenerationD012038——————33
Retinal diseasesD012164—H35.9————33
Intervertebral disc displacementD007405EFO_1001800—————33
UreterolithiasisD053039EFO_1001228N20.1————33
ObesityD009765EFO_0001073E66.9————22
HerniaD006547—K40-K46————22
Rib fracturesD012253——————22
Show 99 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDiclofenac
INNdiclofenac
Description
Diclofenac is a monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. It has a role as a non-narcotic analgesic, an antipyretic, an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, a xenobiotic, an environmental contaminant, a drug allergen and a non-steroidal anti-inflammatory drug. It is a secondary amino compound, an amino acid, a dichlorobenzene, an aromatic amine and a monocarboxylic acid. It is functionally related to a phenylacetic acid and a diphenylamine. It is a conjugate acid of a diclofenac(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (acetic acid derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Identifiers
PDB—
CAS-ID15307-86-5
RxCUI—
ChEMBL IDCHEMBL139
ChEBI ID47381
PubChem CID3033
DrugBankDB00586
UNII ID144O8QL0L1 (ChemIDplus, GSRS)
Target
Agency Approved
PTGS2
PTGS2
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
5743
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
Q16876
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
TRPM3
TRPM3
PPARG
PPARG
ASIC3
ASIC3
Organism
Homo sapiens
Gene name
TRPM3
Gene synonyms
KIAA1616, LTRPC3
NCBI Gene ID
80036
Protein name
transient receptor potential cation channel subfamily M member 3
Protein synonyms
Long transient receptor potential channel 3, LTrpC-3, LTrpC3, Melastatin-2, MLSN2
Uniprot ID
Q9HCF6
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zipsor – Assertio Therapeutics
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Zipsor – Assertio Therapeutics
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Arthrotec – Pfizer
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Lidocaine – Amneal Pharmaceuticals
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Lidocaine – Amphastar Pharmaceuticals
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Diclofenac – Amneal Pharmaceuticals
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Diclofenac – Novartis
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Cambia – Assertio Therapeutics
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Cambia – Assertio Therapeutics
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Tabular view
Estimated US medical usage
Diclofenac
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Diclofenac
+
Misoprostol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 41,087 documents
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Safety
Black-box Warning
Black-box warning for: Arthrotec, Cambia, Capsinac, Clofenax, Diclofenac, Diclofenac epolamine, Diclofenac potassium, Diclofenac potassium for oral solution, Diclofenac sodium 1.5%, Diclofenac sodium and misoprostol, Diclofenac sodium d/r, Diclofenac sodium delayed release, Diclofenac sodium diclofenac sodium, Diclofenac sodium extended-release, Diclofenac sodium gel, Diclofenac sodium misoprostol, Diclofenac sodium topical sol, Diclofenac sodium topical solution, Diclofenac sodium/misoprostol, Diclogen, Diclosaicin, Diclostream, Diclotral pak, Diclovix m, Diclozor, Dimentho, Fenovar, Flector, Flexipak, Iclofenac cp, Inflatherm, Lefluniclo, Lextol, Licart, Lixofen, Lofena, Orthaphen, Pennsaid, Profinac, Varophen, Venngel ii, Venngel one, Ziclopro, Zipsor, Zorvolex
Adverse Events
Top Adverse Reactions
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110,477 adverse events reported
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