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

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibufenac derivatives	1529	74103-06-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ketorolac ketorolac tromethamine ketorolac trometamol trometamol ketorolac (+/-)-Ketorolac keromin	A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity. Molecular weight: 255.27 Formula: C15H13NO3 CLOGP: 1.62 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 59.30 ALOGS: -2.70 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ketorolac
ketorolac tromethamine
ketorolac trometamol
trometamol ketorolac
(+/-)-Ketorolac
keromin

A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.

Molecular weight: 255.27
Formula: C15H13NO3
CLOGP: 1.62
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 59.30
ALOGS: -2.70
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O
30	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	200 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	58 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	9.79 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.11 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.35 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 30, 1989	FDA

FDA Adverse Event Reporting System (Female)

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
Drug hypersensitivity	475.94	13.22	464	14333	274741	56002529
Punctate keratitis	88.05	13.22	22	14775	545	56276725
Corneal epithelium defect	77.70	13.22	18	14779	320	56276950
Skin papilloma	74.82	13.22	32	14765	4457	56272813
Spinal epidural haematoma	74.27	13.22	22	14775	1045	56276225
Tendon disorder	65.58	13.22	31	14766	5454	56271816
Ulcerative keratitis	56.30	13.22	22	14775	2433	56274837
Eye irritation	54.56	13.22	43	14754	18985	56258285
Renal infarct	52.63	13.22	18	14779	1364	56275906
Anterior chamber cell	50.92	13.22	14	14783	507	56276763
Eye pain	49.12	13.22	50	14747	30797	56246473
Migraine	48.43	13.22	84	14713	86713	56190557
Corneal oedema	48.28	13.22	17	14780	1405	56275865
Retinal pigment epitheliopathy	47.89	13.22	11	14786	188	56277082
Aspirin-exacerbated respiratory disease	47.54	13.22	15	14782	882	56276388
Concussion	45.83	13.22	28	14769	8218	56269052
Tracheal deviation	44.88	13.22	10	14787	148	56277122
Phrenic nerve paralysis	43.00	13.22	10	14787	181	56277089
Purpura fulminans	41.72	13.22	8	14789	53	56277217
Injury	41.61	13.22	64	14733	59787	56217483
Anaphylactic reaction	36.76	13.22	60	14737	58935	56218335
Respiratory tract infection viral	36.16	13.22	15	14782	1936	56275334
Uterine perforation	35.93	13.22	22	14775	6483	56270787
Meniscus injury	35.76	13.22	22	14775	6536	56270734
Emotional distress	34.78	13.22	41	14756	29722	56247548
Corneal disorder	34.19	13.22	14	14783	1748	56275522
Musculoskeletal disorder	32.25	13.22	32	14765	19115	56258155
Systemic lupus erythematosus	31.16	13.22	5	14792	180073	56097197
Treatment failure	31.10	13.22	107	14690	170285	56106985
Ocular hyperaemia	28.58	13.22	32	14765	21947	56255323
Post-traumatic stress disorder	26.74	13.22	16	14781	4522	56272748
Visual acuity reduced	26.65	13.22	30	14767	20696	56256574
Vision blurred	25.71	13.22	63	14734	82880	56194390
Myelomalacia	25.25	13.22	5	14792	40	56277230
Asymptomatic bacteriuria	25.14	13.22	7	14790	266	56277004
Microsporidia infection	24.89	13.22	7	14790	276	56276994
Keratitis	24.36	13.22	13	14784	2954	56274316
Sleep disorder	23.80	13.22	54	14743	67609	56209661
Renal ischaemia	23.69	13.22	8	14789	583	56276687
Fibrosis	23.66	13.22	14	14783	3877	56273393
Foreign body sensation in eyes	23.37	13.22	11	14786	1916	56275354
Intraocular pressure increased	23.04	13.22	16	14781	5825	56271445
Alopecia	22.95	13.22	26	14771	293432	55983838
Hand deformity	22.67	13.22	4	14793	134488	56142782
Immune thrombocytopenia	21.85	13.22	19	14778	9606	56267664
Torsade de pointes	21.34	13.22	21	14776	12419	56264851
Condition aggravated	21.14	13.22	159	14638	344739	55932531
Synovitis	21.10	13.22	8	14789	161297	56115973
Kounis syndrome	20.80	13.22	9	14788	1289	56275981
Corneal thinning	20.79	13.22	5	14792	105	56277165
Corneal abrasion	20.34	13.22	8	14789	900	56276370
Dystonia	19.52	13.22	20	14777	12401	56264869
Pericarditis	18.89	13.22	3	14794	108920	56168350
Myocardial reperfusion injury	18.65	13.22	4	14793	49	56277221
Anxiety	18.63	13.22	100	14697	193072	56084198
Depression	18.58	13.22	95	14702	180022	56097248
Tuberculin test positive	17.67	13.22	11	14786	3336	56273934
Ankylosing spondylitis	17.47	13.22	17	14780	9913	56267357
Renal papillary necrosis	16.99	13.22	5	14792	232	56277038
Photophobia	16.93	13.22	21	14776	16029	56261241
Intervertebral discitis	16.81	13.22	10	14787	2797	56274473
Corneal perforation	16.72	13.22	6	14791	524	56276746
Persistent corneal epithelial defect	16.71	13.22	3	14794	13	56277257
Spinal cord compression	16.43	13.22	11	14786	3773	56273497
Wound	16.37	13.22	8	14789	138796	56138474
Atrophy	16.23	13.22	8	14789	1541	56275729
Abdominal pain	16.23	13.22	120	14677	258685	56018585
Lower respiratory tract infection	16.21	13.22	5	14792	114789	56162481
Small intestinal obstruction	16.15	13.22	21	14776	16804	56260466
Hepatic enzyme increased	15.93	13.22	13	14784	171371	56105899
Swelling	15.91	13.22	24	14773	239747	56037523
Sinusitis	15.60	13.22	97	14700	197484	56079786
Colitis ischaemic	15.51	13.22	16	14781	10004	56267266
Fascial infection	15.50	13.22	3	14794	21	56277249
Opisthotonus	15.33	13.22	5	14792	327	56276943
Paraplegia	15.16	13.22	9	14788	2508	56274762
Hypothyroidism	15.15	13.22	32	14765	38164	56239106
Corneal opacity	15.13	13.22	6	14791	690	56276580
Corneal dystrophy	14.97	13.22	5	14792	352	56276918
Drug-disease interaction	14.49	13.22	5	14792	389	56276881
Laryngeal dyspnoea	14.36	13.22	4	14793	152	56277118
Sacroiliitis	14.36	13.22	9	14788	2763	56274507
Dysentery	14.22	13.22	6	14791	807	56276463
Eye pruritus	14.05	13.22	18	14779	14188	56263082
Product use issue	13.98	13.22	17	14780	186024	56091246
Embedded device	13.72	13.22	9	14788	2984	56274286
Urticaria	13.34	13.22	74	14723	144602	56132668
Atrial fibrillation	13.27	13.22	6	14791	108891	56168379

FDA Adverse Event Reporting System (Male)

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
Victim of child abuse	130.24	17.01	32	7015	880	31689417
Respiratory depression	115.92	17.01	59	6988	14451	31675846
Nightmare	113.70	17.01	55	6992	12082	31678215
Drug dependence	106.74	17.01	65	6982	22514	31667783
Sedation	106.43	17.01	61	6986	18904	31671393
Nephrolithiasis	90.63	17.01	63	6984	27276	31663021
Drug hypersensitivity	89.98	17.01	95	6952	72504	31617793
Product prescribing error	83.84	17.01	53	6994	19589	31670708
Treatment failure	78.31	17.01	68	6979	40724	31649573
Epidural lipomatosis	70.34	17.01	19	7028	765	31689532
Juvenile idiopathic arthritis	55.48	17.01	19	7028	1714	31688583
Anaphylactic reaction	54.15	17.01	48	6999	29505	31660792
Ulcerative keratitis	53.05	17.01	18	7029	1578	31688719
Hyperhidrosis	51.57	17.01	69	6978	67324	31622973
Child abuse	47.73	17.01	12	7035	363	31689934
Product used for unknown indication	46.85	17.01	14	7033	813	31689484
Drug ineffective	44.28	17.01	189	6858	395384	31294913
Cataract	44.27	17.01	39	7008	23768	31666529
Breath sounds abnormal	41.33	17.01	22	7025	5890	31684407
Nausea	34.24	17.01	147	6900	307800	31382497
Heart sounds abnormal	34.20	17.01	11	7036	816	31689481
Asthma-chronic obstructive pulmonary disease overlap syndrome	32.79	17.01	11	7036	931	31689366
Burning feet syndrome	32.63	17.01	7	7040	103	31690194
Periorbital swelling	31.66	17.01	9	7038	438	31689859
Bronchial hyperreactivity	28.20	17.01	11	7036	1434	31688863
Intentional product misuse	27.69	17.01	38	7009	37913	31652384
Angioedema	26.57	17.01	35	7012	33583	31656714
Obesity	26.46	17.01	21	7026	11079	31679218
Corneal thinning	25.31	17.01	6	7041	141	31690156
Drug abuse	23.72	17.01	57	6990	87701	31602596
Strabismus	23.69	17.01	10	7037	1596	31688701
Pulmonary function test abnormal	23.64	17.01	11	7036	2210	31688087
Gastrointestinal motility disorder	22.93	17.01	11	7036	2365	31687932
Eye swelling	21.10	17.01	17	7030	9159	31681138
Urticaria	20.80	17.01	42	7005	57475	31632822
Eye pain	20.58	17.01	19	7028	12285	31678012
Non-infectious endophthalmitis	19.67	17.01	5	7042	158	31690139
Toxicity to various agents	19.48	17.01	8	7039	181479	31508818
Aspirin-exacerbated respiratory disease	19.44	17.01	6	7041	389	31689908
Corneal oedema	19.22	17.01	8	7039	1233	31689064
Urine analysis abnormal	18.97	17.01	9	7038	1888	31688409
Death	18.94	17.01	32	7015	360537	31329760
Neuromuscular block prolonged	18.50	17.01	6	7041	457	31689840
Blood chromogranin A increased	18.08	17.01	5	7042	220	31690077
Carcinoid crisis	17.46	17.01	5	7042	250	31690047
Bone neoplasm	17.01	17.01	5	7042	274	31690023

FDA Adverse Event Reporting System (Geriatric)

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
Drug hypersensitivity	362.83	12.87	388	17746	262071	70648239
Victim of child abuse	124.86	12.87	32	18102	906	70909404
Respiratory depression	121.65	12.87	77	18057	24754	70885556
Punctate keratitis	101.32	12.87	27	18107	893	70909417
Nightmare	89.73	12.87	61	18073	22095	70888215
Corneal epithelium defect	79.38	12.87	21	18113	675	70909635
Anaphylactic reaction	76.39	12.87	95	18039	74879	70835431
Drug dependence	73.22	12.87	67	18067	37254	70873056
Nephrolithiasis	70.41	12.87	73	18061	47250	70863060
Tendon disorder	70.07	12.87	34	18100	6517	70903793
Skin papilloma	69.96	12.87	32	18102	5374	70904936
Spinal epidural haematoma	69.72	12.87	22	18112	1331	70908979
Epidural lipomatosis	63.95	12.87	19	18115	938	70909372
Eye pain	60.69	12.87	58	18076	34044	70876266
Ulcerative keratitis	60.38	12.87	25	18109	3302	70907008
Anterior chamber cell	56.29	12.87	17	18117	888	70909422
Corneal oedema	53.31	12.87	21	18113	2439	70907871
Sedation	52.11	12.87	62	18072	46669	70863641
Aspirin-exacerbated respiratory disease	47.39	12.87	16	18118	1199	70909111
Child abuse	46.12	12.87	12	18122	361	70909949
Tracheal deviation	44.37	12.87	10	18124	161	70910149
Injury	42.91	12.87	67	18067	65178	70845132
Renal infarct	42.48	12.87	18	18116	2519	70907791
Product prescribing error	42.31	12.87	51	18083	38901	70871409
Foreign body sensation in eyes	40.89	12.87	16	18118	1826	70908484
Uterine perforation	38.51	12.87	22	18112	5869	70904441
Phrenic nerve paralysis	37.99	12.87	10	18124	315	70909995
Migraine	36.59	12.87	66	18068	72172	70838138
Drug ineffective	36.43	12.87	383	17751	939369	69970941
Product used for unknown indication	35.41	12.87	14	18120	1642	70908668
Eye irritation	35.00	12.87	32	18102	17756	70892554
Vision blurred	33.93	12.87	75	18059	94909	70815401
Visual acuity reduced	31.03	12.87	37	18097	27893	70882417
Juvenile idiopathic arthritis	30.95	12.87	19	18115	5781	70904529
Ocular hyperaemia	29.64	12.87	34	18100	24605	70885705
Sleep disorder	29.40	12.87	59	18075	69813	70840497
Hyperhidrosis	29.38	12.87	87	18047	131499	70778811
Asthma-chronic obstructive pulmonary disease overlap syndrome	29.22	12.87	12	18122	1552	70908758
Angioedema	28.94	12.87	57	18077	66553	70843757
Concussion	28.80	12.87	21	18113	8488	70901822
Purpura fulminans	28.46	12.87	7	18127	167	70910143
Musculoskeletal disorder	28.25	12.87	30	18104	19941	70890369
Corneal thinning	28.07	12.87	7	18127	177	70910133
Respiratory tract infection viral	28.02	12.87	15	18119	3526	70906784
Burning feet syndrome	27.74	12.87	7	18127	186	70910124
Strabismus	27.50	12.87	13	18121	2351	70907959
Heart sounds abnormal	27.41	12.87	11	18123	1341	70908969
Corneal opacity	27.06	12.87	10	18124	976	70909334
Emotional distress	27.00	12.87	40	18094	37148	70873162
Urticaria	26.69	12.87	97	18037	162952	70747358
Bronchial hyperreactivity	26.20	12.87	13	18121	2613	70907697
Immune thrombocytopenia	25.75	12.87	26	18108	16298	70894012
Meniscus injury	25.01	12.87	17	18117	6150	70904160
Breath sounds abnormal	24.48	12.87	23	18111	13208	70897102
Keratitis	24.48	12.87	14	18120	3743	70906567
Intraocular pressure increased	23.60	12.87	19	18115	8882	70901428
Corneal abrasion	23.26	12.87	9	18125	997	70909313
Post-traumatic stress disorder	22.41	12.87	14	18120	4393	70905917
Corneal disorder	22.37	12.87	11	18123	2168	70908142
Death	21.70	12.87	63	18071	509998	70400312
Drug abuse	21.12	12.87	84	18050	147172	70763138
Pulmonary function test abnormal	20.29	12.87	12	18122	3413	70906897
Myelomalacia	20.18	12.87	5	18129	123	70910187
Back pain	19.30	12.87	127	18007	271025	70639285
Renal ischaemia	19.05	12.87	8	18126	1095	70909215
Abdominal pain	19.03	12.87	151	17983	341976	70568334
Myocardial reperfusion injury	18.77	12.87	4	18130	49	70910261
Sickle cell anaemia with crisis	18.54	12.87	14	18120	5964	70904346
Eye swelling	18.01	12.87	26	18108	23588	70886722
Photophobia	17.97	12.87	23	18111	18627	70891683
Nausea	17.45	12.87	310	17824	851778	70058532
Illness	17.32	12.87	30	18104	31761	70878549
Microsporidia infection	17.15	12.87	7	18127	891	70909419
Torsade de pointes	16.92	12.87	22	18112	18094	70892216
Synovitis	16.82	12.87	6	18128	129222	70781088
Lower respiratory tract infection	16.76	12.87	4	18130	111909	70798401
Neuromuscular block prolonged	16.54	12.87	7	18127	976	70909334
Ischaemic cardiomyopathy	16.41	12.87	14	18120	7090	70903220
Periorbital swelling	16.40	12.87	9	18125	2221	70908089
Fibrosis	16.38	12.87	12	18122	4882	70905428
Tuberculin test positive	15.72	12.87	10	18124	3236	70907074
Non-infectious endophthalmitis	15.60	12.87	5	18129	318	70909992
Procedural pain	15.48	12.87	21	18113	17988	70892322
Asymptomatic bacteriuria	15.29	12.87	5	18129	339	70909971
Interstitial lung disease	15.18	12.87	4	18130	104681	70805629
Diarrhoea	15.12	12.87	128	18006	783213	70127097
Cardiac failure	15.07	12.87	9	18125	143532	70766778
Corneal perforation	15.01	12.87	6	18128	724	70909586
Lip oedema	14.98	12.87	12	18122	5571	70904739
Heparin-induced thrombocytopenia test positive	14.96	12.87	4	18130	134	70910176
Renal papillary necrosis	14.93	12.87	5	18129	365	70909945
Cystoid macular oedema	14.70	12.87	8	18126	1944	70908366
Sinusitis	14.39	12.87	83	18051	169112	70741198
Eyelid oedema	14.37	12.87	17	18117	12710	70897600
Embedded device	14.24	12.87	9	18125	2880	70907430
Blood chromogranin A increased	14.02	12.87	5	18129	441	70909869
Eye pruritus	14.01	12.87	18	18116	14629	70895681
Anxiety	13.78	12.87	100	18034	220230	70690080
Carcinoid crisis	13.36	12.87	5	18129	506	70909804
Pain	13.27	12.87	230	17904	628586	70281724
Cold urticaria	13.21	12.87	3	18131	50	70910260
Condition aggravated	13.17	12.87	167	17967	427468	70482842
Persistent corneal epithelial defect	13.00	12.87	3	18131	54	70910256
Gastrointestinal motility disorder	12.92	12.87	11	18123	5555	70904755
Kounis syndrome	12.88	12.87	9	18125	3402	70906908

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	M01AB15	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	S01BC05	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids
ATC	S01FB51	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Sympathomimetics excl. antiglaucoma preparations
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:50629	COX-2 inhibitor
CHEBI has role	CHEBI:50630	COX-1 inhibitor
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
FDA EPC	N0000175939	Cyclooxygenase Inhibitor
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D000894	Anti-Inflammatory Agents, Non-Steroidal
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D016861	Cyclooxygenase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents

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

Disease	Relation	SNOMED_ID	DOID
Severe pain	indication	76948002
Allergic conjunctivitis	indication	473460002	DOID:11204
Acute postoperative pain	indication	107401000119105
Postoperative Ocular Pain	indication
Post-Op Ocular Inflammation	indication
Post-Op Photophobia	indication
Renal colic	off-label use	7093002
Peptic ulcer	contraindication	13200003	DOID:750
Disorder of cornea	contraindication	15250008	DOID:10124
Acute gastric ulcer with perforation	contraindication	19850005
Myocardial infarction	contraindication	22298006	DOID:5844
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Hypovolemia	contraindication	28560003
Hypertensive disorder	contraindication	38341003	DOID:10763
Gastrointestinal ulcer	contraindication	40845000
Tear film insufficiency	contraindication	46152009
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Corneal erosion	contraindication	50792001
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Acute nephropathy	contraindication	58574008
Blood coagulation disorder	contraindication	64779008	DOID:1247
Rheumatoid arthritis	contraindication	69896004	DOID:7148
Diabetes mellitus	contraindication	73211009	DOID:9351
Gastrointestinal hemorrhage	contraindication	74474003
Hemophilia	contraindication	90935002
Corneal degeneration	contraindication	111521006	DOID:1237
Perioperative care	contraindication	133897009
Asthma	contraindication	195967001	DOID:2841
Impaired renal function disorder	contraindication	197663003
Cerebrovascular accident	contraindication	230690007
Coronary artery bypass graft	contraindication	232717009
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Cerebral hemorrhage	contraindication	274100004
Pregnancy, function	contraindication	289908002
Cardiovascular event risk	contraindication	395112001
Gastric ulcer	contraindication	397825006	DOID:10808
Breastfeeding (mother)	contraindication	413712001
Smokes tobacco daily	contraindication	449868002
Preoperative Pain Management	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.47	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 0.3% BASE;EQ 1% BASE	OMIDRIA	RAYNER SURGICAL	N205388	May 30, 2014	RX	SOLUTION	IRRIGATION	8173707	July 30, 2023	MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
EQ 0.3% BASE;EQ 1% BASE	OMIDRIA	RAYNER SURGICAL	N205388	May 30, 2014	RX	SOLUTION	IRRIGATION	9278101	July 30, 2023	MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8207215	May 28, 2024	A METHOD OF CONTROLLING POSTOPERATIVE OCULAR PAIN AND BURNING/STINGING IN A PATIENT
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8377982	May 28, 2024	A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING/STINGING FOLLOWING CORNEAL SURGERY
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8541463	May 28, 2024	A METHOD OF TREATING OR REDUCING OCULAR PAIN AND BURNING/STINGING
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8906950	May 28, 2024	A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8946281	May 28, 2024	A METHOD OF TREATING OCULAR PAIN
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	9216167	May 28, 2024	A METHOD OF TREATING OCULAR PAIN AND/OR ENHANCING OCULAR COMFORT
0.4%	ACULAR LS	ALLERGAN	N021528	May 30, 2003	RX	SOLUTION/DROPS	OPHTHALMIC	8008338	May 24, 2027	A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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	6.90	WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	9.72	WOMBAT-PK	CHEMBL
Serine/threonine-protein kinase PAK 1	Kinase	Q13153	PAK1_HUMAN		IC50	4.44	CHEMBL
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Ki	4.94	CHEMBL
Aldose reductase	Enzyme		ALDR_RAT		IC50	5.21	DRUG MATRIX
Prostaglandin-H2 D-isomerase	Enzyme		PTGDS_MOUSE		IC50	6.64	CHEMBL

External reference:

ID	Source
4028637	VUID
N0000178380	NUI
D00813	KEGG_DRUG
74103-07-4	SECONDARY_CAS_RN
4019510	VANDF
4028637	VANDF
C0073631	UMLSCUI
CHEBI:6129	CHEBI
KTR	PDB_CHEM_ID
CHEMBL469	ChEMBL_ID
CHEMBL1201124	ChEMBL_ID
DB00465	DRUGBANK_ID
D020910	MESH_DESCRIPTOR_UI
3826	PUBCHEM_CID
6661	IUPHAR_LIGAND_ID
5558	INN_ID
YZI5105V0L	UNII
28200	RXNORM
30341	MMSL
39892	MMSL
4947	MMSL
9780	MMSL
d00273	MMSL
003539	NDDF
004812	NDDF
108512006	SNOMEDCT_US
108513001	SNOMEDCT_US
372501008	SNOMEDCT_US
D020911	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Acular	HUMAN PRESCRIPTION DRUG LABEL	1	0023-2181	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA	23 sections
Acular	HUMAN PRESCRIPTION DRUG LABEL	1	0023-2181	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA	23 sections
ACUVAIL	HUMAN PRESCRIPTION DRUG LABEL	1	0023-3507	SOLUTION/ DROPS	4.50 mg	OPHTHALMIC	NDA	23 sections
ACUVAIL	HUMAN PRESCRIPTION DRUG LABEL	1	0023-3507	SOLUTION/ DROPS	4.50 mg	OPHTHALMIC	NDA	23 sections
ACULAR LS	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9277	SOLUTION/ DROPS	4 mg	OPHTHALMIC	NDA	22 sections
ACULAR LS	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9277	SOLUTION/ DROPS	4 mg	OPHTHALMIC	NDA	22 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0314	TABLET, FILM COATED	10 mg	ORAL	ANDA	27 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0314	TABLET, FILM COATED	10 mg	ORAL	ANDA	27 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0069	INJECTION, SOLUTION	15 mg	INTRAMUSCULAR	ANDA	27 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0072	INJECTION, SOLUTION	30 mg	INTRAMUSCULAR	ANDA	27 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0076	INJECTION, SOLUTION	15 mg	INTRAMUSCULAR	ANDA	27 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1134	TABLET, FILM COATED	10 mg	ORAL	ANDA	19 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9883	INJECTION, SOLUTION	30 mg	INTRAVENOUS	ANDA	15 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9883	INJECTION, SOLUTION	30 mg	INTRAVENOUS	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9884	INJECTION, SOLUTION	30 mg	INTRAMUSCULAR	ANDA	14 sections
KETOROLAC TROMETHAMINE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9952	INJECTION, SOLUTION	15 mg	INTRAVENOUS	ANDA	14 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3793	INJECTION, SOLUTION	15 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3793	INJECTION, SOLUTION	15 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3795	INJECTION, SOLUTION	30 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3795	INJECTION, SOLUTION	30 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3796	INJECTION, SOLUTION	60 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3796	INJECTION, SOLUTION	60 mg	INTRAMUSCULAR	ANDA	15 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0487-6232	INJECTION	30 mg	INTRAMUSCULAR	ANDA	16 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6041	INJECTION	15 mg	INTRAMUSCULAR	ANDA	17 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6042	INJECTION	30 mg	INTRAMUSCULAR	ANDA	17 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6043	INJECTION	30 mg	INTRAMUSCULAR	ANDA	17 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	10544-222	TABLET, FILM COATED	10 mg	ORAL	ANDA	29 sections
Ketorolac Tromethamine	HUMAN PRESCRIPTION DRUG LABEL	1	12634-809	TABLET	10 mg	ORAL	ANDA	13 sections
ACULAR	HUMAN PRESCRIPTION DRUG LABEL	1	16590-002	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA	20 sections
KETOROLAC	HUMAN PRESCRIPTION DRUG LABEL	1	16590-138	TABLET, FILM COATED	10 mg	ORAL	ANDA	15 sections