Scroll

diclofenac 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibufenac derivatives	865	15307-86-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: diclofenac calcium diclofenac diethylamine diclofenac hydroxyethylpyrrolidine diclofenac diclofenamic acid diclofenac sodium diclofenac potassium diclofenac epolamine	A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt. Molecular weight: 296.15 Formula: C14H11Cl2NO2 CLOGP: 4.58 LIPINSKI: 0 HAC: 3 HDO: 2 TPSA: 49.33 ALOGS: -4.82 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

diclofenac calcium
diclofenac diethylamine
diclofenac hydroxyethylpyrrolidine
diclofenac
diclofenamic acid
diclofenac sodium
diclofenac potassium
diclofenac epolamine

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

Molecular weight: 296.15
Formula: C14H11Cl2NO2
CLOGP: 4.58
LIPINSKI: 0
HAC: 3
HDO: 2
TPSA: 49.33
ALOGS: -4.82
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O
0.10	g	P
0.10	g	R
0.10	g	O

ADMET properties:

Show entries

Search:

Property	Value	Reference
BA (Bioavailability)	54 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	3.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	10.85 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	1.40 hours	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ

Showing 1 to 9 of 9 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
July 28, 1988	FDA
March 23, 2021	PMDA	Hisamitsu Pharmaceutical Co., Inc

FDA Adverse Event Reporting System (Female)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigus	2381.73	10.33	3623	302102	180103	63003194
Glossodynia	2254.49	10.33	3482	302243	175394	63007903
Systemic lupus erythematosus	2111.72	10.33	3681	302044	205237	62978060
Rheumatoid arthritis	2032.61	10.33	4046	301679	249773	62933524
Hand deformity	1975.04	10.33	3080	302645	156377	63026920
Wound	1775.56	10.33	2973	302752	160290	63023007
Pericarditis	1665.55	10.33	2568	303157	129011	63054286
Abdominal discomfort	1599.13	10.33	4242	301483	316643	62866654
Discomfort	1595.59	10.33	2876	302849	164498	63018799
Arthropathy	1521.51	10.33	3435	302290	231357	62951940

Showing 1 to 10 of 830 entries

Previous1 2 3 4 5…83Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Embolia cutis medicamentosa	277.83	10.36	72	82325	167	34874367
Ankylosing spondylitis	264.98	10.36	165	82232	5439	34869095
Death	252.26	10.36	343	82054	397706	34476828
Melaena	225.86	10.36	343	82054	35037	34839497
Gastric ulcer	208.17	10.36	219	82178	15431	34859103
Duodenal ulcer	165.67	10.36	160	82237	10172	34864362
Off label use	150.73	10.36	498	81899	419026	34455508
Kounis syndrome	131.46	10.36	79	82318	2439	34872095
Onychoclasis	129.71	10.36	71	82326	1829	34872705
Febrile neutropenia	124.55	10.36	85	82312	136764	34737770

Showing 1 to 10 of 405 entries

Previous1 2 3 4 5…41Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigus	1666.89	9.92	1928	287244	97654	79357562
Systemic lupus erythematosus	1473.39	9.92	1999	287173	119150	79336066
Glossodynia	1461.71	9.92	1837	287335	101500	79353716
Hand deformity	1436.04	9.92	1826	287346	102093	79353123
Pericarditis	1345.57	9.92	1771	287401	102465	79352751
Anti-cyclic citrullinated peptide antibody positive	1254.36	9.92	1527	287645	81616	79373600
Wound	1222.58	9.92	1789	287383	114390	79340826
Discomfort	1148.63	9.92	1812	287360	123805	79331411
Duodenal ulcer perforation	1114.22	9.92	1286	287886	64925	79390291
Rheumatoid arthritis	1106.63	9.92	2377	286795	206093	79249123

Showing 1 to 10 of 834 entries

Previous1 2 3 4 5…84Next

FDA Adverse Event Reporting System (Pediatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Right ventricular hypertrophy	36.53	33.34	8	116	15	89653

Showing 1 to 1 of 1 entries

Previous1Next

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	D11AX18	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals
ATC	M01AB05	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	M01AB55	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	M02AA15	MUSCULO-SKELETAL SYSTEM TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN Antiinflammatory preparations, non-steroids for topical use
ATC	S01BC03	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids
ATC	S01CC01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Antiinflammatory agents, non-steroids and antiinfectives in combination
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35493	anti-pyretic
CHEBI has role	CHEBI:35544	cyclooxygenase inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic

Showing 1 to 10 of 25 entries

Previous1 2 3Next

Drug Use | Suggest Off label Use Form| |View source of the data|

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Ankylosing spondylitis	indication	9631008	DOID:7147
Pain	indication	22253000
Tenosynovitis	indication	67801009	DOID:970
Rheumatoid arthritis	indication	69896004	DOID:7148
Actinic keratosis	indication	201101007	DOID:8866
Dysmenorrhea	indication	266599000
Lumbago	indication	279039007
Osteoarthritis	indication	396275006
Adhesive capsulitis of shoulder	indication	399114005	DOID:14188
Post-Op Photophobia	indication

Showing 1 to 10 of 66 entries

Previous1 2 3 4 5 6 7Next

🐶 Veterinary Drug Use

Species	Use	Relation
Horses	Pain and inflammation associated with osteoarthritis	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Surpass Topical Anti-Inflammatory Cream	Boehringer lngelheim Animal Health USA Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.22	acidic
pKa2	0.55	Basic

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1.3%	LICART	IBSA INST BIO	N206976	Dec. 19, 2018	RX	SYSTEM	TOPICAL	11344520	Feb. 20, 2035	METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED
1.3%	LICART	IBSA INST BIO	N206976	Dec. 19, 2018	RX	SYSTEM	TOPICAL	11351133	Feb. 20, 2035	METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PENNSAID	NUVO PHARMS INC	N020947	Nov. 4, 2009	DISCN	SOLUTION	TOPICAL	8217078	July 10, 2029	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PENNSAID	NUVO PHARMS INC	N020947	Nov. 4, 2009	DISCN	SOLUTION	TOPICAL	8618164	July 10, 2029	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PENNSAID	NUVO PHARMS INC	N020947	Nov. 4, 2009	DISCN	SOLUTION	TOPICAL	8741956	July 10, 2029	COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PENNSAID	NUVO PHARMS INC	N020947	Nov. 4, 2009	DISCN	SOLUTION	TOPICAL	8546450	Aug. 9, 2030	COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PENNSAID	NUVO PHARMS INC	N020947	Nov. 4, 2009	DISCN	SOLUTION	TOPICAL	8546450	Aug. 9, 2030	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
18MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZORVOLEX	ZYLA	N204592	Oct. 18, 2013	DISCN	CAPSULE	ORAL	8999387	April 23, 2030	TREATMENT OF PAIN
18MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZORVOLEX	ZYLA	N204592	Oct. 18, 2013	DISCN	CAPSULE	ORAL	9180095	April 23, 2030	TREATMENT OF PAIN
18MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ZORVOLEX	ZYLA	N204592	Oct. 18, 2013	DISCN	CAPSULE	ORAL	9186328	April 23, 2030	TREATMENT OF PAIN

Showing 1 to 10 of 42 entries

Previous1 2 3 4 5Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
25MG	ZIPSOR	ASSERTIO	N022202	June 16, 2009	RX	CAPSULE	ORAL	May 25, 2024	NEW PATIENT POPULATION

Showing 1 to 1 of 1 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	7.70	WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	7.52	WOMBAT-PK	CHEMBL
Transthyretin	Secreted	P02766	TTHY_HUMAN		Kd	6	CHEMBL
Aldo-keto reductase family 1 member C3	Enzyme	P42330	AK1C3_HUMAN		IC50	5.59	CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	ANTAGONIST	Ki	6.20	IUPHAR
Cytochrome c oxidase subunit 2	Enzyme	P00403	COX2_HUMAN		IC50	5	CHEMBL
Interleukin-8	Cytokine	P10145	IL8_HUMAN		IC50	8.10	CHEMBL
Transient receptor potential cation channel subfamily A member 1	Ion channel	O75762	TRPA1_HUMAN		EC50	4.25	CHEMBL
Aldo-keto reductase family 1 member B10	Enzyme	O60218	AK1BA_HUMAN		IC50	5.72	CHEMBL
Acid-sensing ion channel 3	Ion channel	Q9UHC3	ASIC3_HUMAN	BLOCKER	IC50	4	IUPHAR

Showing 1 to 10 of 22 entries

Previous1 2 3Next

External reference:

Show entries

Search:

ID	Source
DIF	PDB_CHEM_ID
002391	NDDF
004409	NDDF
004410	NDDF
005170	NDDF
006237	NDDF
108515008	SNOMEDCT_US
11838	MMSL
119623-66-4	SECONDARY_CAS_RN
144O8QL0L1	UNII

Showing 1 to 10 of 48 entries

Previous1 2 3 4 5Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Aleve Arthritis Pain Gel	HUMAN OTC DRUG LABEL	1	0280-0039	GEL	1 mg	TOPICAL	ANDA	17 sections
Aleve Arthritis Pain Gel	HUMAN OTC DRUG LABEL	1	0280-0039	GEL	1 mg	TOPICAL	ANDA	17 sections
arthritis pain relieving	HUMAN OTC DRUG LABEL	1	0363-5123	GEL	10 mg	TOPICAL	ANDA	17 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1411	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1411	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1411	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1421	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1421	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1421	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections
diclofenac epolamine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3225	PATCH	0.01 g	TOPICAL	NDA authorized generic	30 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next