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

Stem definition	Drug id	CAS RN
anti-inflammatory, indometacin derivatives	1440	53-86-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: indomethacin hydrochloride indomethacin HCl indocin indomethacin indometacine indomethacine indometacin indomethacin sodium	A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Additional data needed to determine whether in vitro activity against SARS-CoV-2 corresponds with clinical efficacy in the treatment of COVID-19. Molecular weight: 357.79 Formula: C19H16ClNO4 CLOGP: 4.18 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 68.53 ALOGS: -5.17 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

indomethacin hydrochloride
indomethacin HCl
indocin
indomethacin
indometacine
indomethacine
indometacin
indomethacin sodium

A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Additional data needed to determine whether in vitro activity against SARS-CoV-2 corresponds with clinical efficacy in the treatment of COVID-19.

Molecular weight: 357.79
Formula: C19H16ClNO4
CLOGP: 4.18
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 68.53
ALOGS: -5.17
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
0.10	g	R

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	15 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	7.99 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)	0.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.30 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)	1.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 10, 1965	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
Oligohydramnios	420.57	12.06	134	21589	6232	63461067
Premature delivery	179.68	12.06	118	21605	30163	63437136
Neck deformity	158.19	12.06	49	21674	2072	63465227
Ankylosing spondylitis	150.72	12.06	73	21650	10401	63456898
Neck mass	140.14	12.06	51	21672	3552	63463747
Bone density abnormal	113.46	12.06	43	21680	3355	63463944
Oesophageal spasm	106.01	12.06	40	21683	3083	63464216
Oesophageal pain	95.97	12.06	39	21684	3662	63463637
Exposure during pregnancy	83.31	12.06	172	21551	155375	63311924
Premature baby	81.75	12.06	63	21660	20672	63446627
Disability	72.88	12.06	56	21667	18291	63449008
Premature labour	65.21	12.06	45	21678	12459	63454840
Neonatal disorder	63.25	12.06	18	21705	565	63466734
Lymphoedema	60.79	12.06	42	21681	11650	63455649
Mood swings	60.31	12.06	50	21673	18198	63449101
Maternal exposure during pregnancy	57.78	12.06	186	21537	219876	63247423
Drug hypersensitivity	55.73	12.06	232	21491	310455	63156844
Death	54.77	12.06	30	21693	374351	63092948
Drug ineffective for unapproved indication	53.34	12.06	62	21661	34001	63433298
Drug ineffective	51.19	12.06	563	21160	1044202	62423097
Corneal perforation	46.57	12.06	14	21709	534	63466765
Limb deformity	43.27	12.06	23	21700	3979	63463320
Product use in unapproved indication	42.21	12.06	146	21577	178934	63288365
Glossodynia	39.09	12.06	7	21716	178869	63288430
Hypermobility syndrome	37.10	12.06	13	21710	810	63466489
Low birth weight baby	35.63	12.06	25	21698	7104	63460195
Migraine	35.33	12.06	96	21627	103250	63364049
Maternal drugs affecting foetus	34.95	12.06	22	21701	5220	63462079
Sleep apnoea syndrome	34.34	12.06	46	21677	29087	63438212
Wound	32.37	12.06	8	21715	163255	63304044
Grip strength decreased	32.30	12.06	39	21684	22248	63445051
Bronchopulmonary dysplasia	32.27	12.06	10	21713	423	63466876
Arthralgia	31.93	12.06	316	21407	569394	62897905
Tinnitus	31.39	12.06	49	21674	35579	63431720
Neonatal respiratory distress syndrome	29.91	12.06	16	21707	2802	63464497
Back pain	29.86	12.06	173	21550	263972	63203327
Polyarthritis	29.84	12.06	26	21697	10120	63457179
Pemphigus	29.43	12.06	13	21710	183713	63283586
Musculoskeletal stiffness	29.31	12.06	133	21590	184485	63282814
Joint swelling	29.23	12.06	202	21521	327464	63139835
Serotonin syndrome	28.90	12.06	42	21681	28640	63438659
Joint abscess	28.55	12.06	9	21714	403	63466896
Cellulitis staphylococcal	26.91	12.06	10	21713	738	63466561
Neurodevelopmental disorder	26.16	12.06	7	21716	174	63467125
Joint stiffness	25.61	12.06	49	21674	41820	63425479
Uveitis	25.12	12.06	26	21697	12527	63454772
Vascular rupture	24.91	12.06	12	21711	1688	63465611
Adrenal suppression	24.86	12.06	10	21713	914	63466385
Abdominal discomfort	24.75	12.06	45	21678	320840	63146459
Neuralgia	24.73	12.06	37	21686	25889	63441410
Foetal death	24.27	12.06	24	21699	10956	63456343
Actinomycotic sepsis	24.20	12.06	6	21717	109	63467190
Agitation	24.01	12.06	59	21664	59698	63407601
Preterm premature rupture of membranes	23.89	12.06	11	21712	1398	63465901
Angioedema	23.27	12.06	51	21672	47914	63419385
Medication overuse headache	22.37	12.06	9	21714	823	63466476
Dyspnoea	21.74	12.06	135	21588	661178	62806121
Pulmonary hypertensive crisis	21.72	12.06	7	21716	337	63466962
Foetal exposure during pregnancy	20.28	12.06	38	21685	31924	63435375
Sacroiliitis	20.05	12.06	13	21710	3244	63464055
Serum ferritin decreased	19.88	12.06	11	21712	2059	63465240
Alopecia	19.77	12.06	55	21668	337481	63129818
Therapeutic response unexpected	19.67	12.06	28	21695	18731	63448568
Fibromyalgia	19.29	12.06	66	21657	80354	63386945
Catheter site bruise	19.28	12.06	7	21716	484	63466815
Systemic lupus erythematosus	19.24	12.06	26	21697	208892	63258407
Large intestinal ulcer haemorrhage	19.22	12.06	5	21718	111	63467188
Mycobacterium tuberculosis complex test positive	19.02	12.06	11	21712	2240	63465059
Endothelin increased	18.93	12.06	4	21719	34	63467265
Alpha tumour necrosis factor increased	18.93	12.06	4	21719	34	63467265
Blood pressure diastolic increased	18.72	12.06	20	21703	9990	63457309
Cystitis	18.69	12.06	51	21672	54940	63412359
Oligoarthritis	18.25	12.06	7	21716	564	63466735
Growth retardation	18.25	12.06	9	21714	1332	63465967
Hyperhidrosis	18.08	12.06	79	21644	107757	63359542
Swollen tongue	18.02	12.06	38	21685	34762	63432537
Hydrops foetalis	17.82	12.06	7	21716	601	63466698
Investigation abnormal	17.70	12.06	10	21713	1948	63465351
Atrial fibrillation	17.53	12.06	9	21714	116627	63350672
Tendonitis	17.31	12.06	27	21696	19588	63447711
Hospitalisation	17.19	12.06	4	21719	85077	63382222
Bronchitis	16.91	12.06	86	21637	124849	63342450
Pharyngeal haematoma	16.79	12.06	4	21719	61	63467238
Pharyngitis	16.77	12.06	27	21696	20116	63447183
Impaired work ability	16.75	12.06	25	21698	17450	63449849
Neck pain	16.72	12.06	57	21666	69261	63398038
Oliguria	16.70	12.06	18	21705	9083	63458216
Coccydynia	16.52	12.06	9	21714	1634	63465665
Muscle spasticity	16.51	12.06	28	21695	21766	63445533
Infective myositis	16.50	12.06	4	21719	66	63467233
Ankle fracture	16.35	12.06	25	21698	17830	63449469
Nerve degeneration	16.12	12.06	4	21719	73	63467226
Cerebral vasoconstriction	16.12	12.06	8	21715	1200	63466099
Intervertebral disc protrusion	16.07	12.06	29	21694	23680	63443619
Ear pain	15.95	12.06	37	21686	36081	63431218
Blood pressure fluctuation	15.79	12.06	43	21680	46274	63421025
Fine motor skill dysfunction	15.48	12.06	13	21710	4812	63462487
Benign vaginal neoplasm	15.16	12.06	4	21719	94	63467205
Narcolepsy	15.12	12.06	8	21715	1370	63465929
Pain	15.05	12.06	345	21378	740283	62727016
Hirsutism	15.03	12.06	8	21715	1387	63465912
Skin striae	15.00	12.06	8	21715	1393	63465906
Myoglobin blood increased	14.98	12.06	8	21715	1397	63465902
Visceral leishmaniasis	14.83	12.06	6	21717	557	63466742
Focal nodular hyperplasia	14.74	12.06	6	21717	565	63466734
External ear cellulitis	14.70	12.06	5	21718	285	63467014
Corneal neovascularisation	14.46	12.06	4	21719	113	63467186
Necrotising colitis	14.43	12.06	6	21717	597	63466702
Nephropathy toxic	14.41	12.06	17	21706	9462	63457837
Hypercholesterolaemia	14.34	12.06	26	21697	21308	63445991
Chronic gastritis	14.28	12.06	10	21713	2831	63464468
Mydriasis	14.27	12.06	19	21704	11937	63455362
Arthritis bacterial	14.05	12.06	14	21709	6449	63460850
White blood cell analysis abnormal	14.04	12.06	3	21720	27	63467272
Decreased vibratory sense	13.94	12.06	5	21718	334	63466965
Right ventricular hypertrophy	13.54	12.06	6	21717	697	63466602
Gastroenteritis salmonella	13.51	12.06	6	21717	701	63466598
Alkalosis	13.50	12.06	5	21718	366	63466933
Wheezing	13.46	12.06	8	21715	95587	63371712
Swelling face	13.43	12.06	50	21673	63425	63403874
Apallic syndrome	13.40	12.06	6	21717	715	63466584
Hypopyon	13.31	12.06	6	21717	726	63466573
Hallucination	13.15	12.06	45	21678	54772	63412527
Dysphonia	13.15	12.06	41	21682	47573	63419726
Vision blurred	12.94	12.06	64	21659	91860	63375439
Apgar score low	12.92	12.06	6	21717	778	63466521
Myoclonus	12.84	12.06	21	21702	15847	63451452
Intentional underdose	12.80	12.06	8	21715	1874	63465425
Bradycardia foetal	12.71	12.06	5	21718	431	63466868
Fluid retention	12.62	12.06	47	21676	59639	63407660
Pulmonary valve incompetence	12.33	12.06	7	21716	1376	63465923
Body temperature increased	12.15	12.06	34	21689	37158	63430141

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
Ankylosing spondylitis	155.06	12.89	64	13437	5540	34937890
Ductus arteriosus premature closure	102.01	12.89	23	13478	238	34943192
Gout	54.71	12.89	51	13450	19202	34924228
Sacroiliitis	47.93	12.89	19	13482	1479	34941951
Hepatitis B virus test positive	47.38	12.89	13	13488	314	34943116
Drug ineffective	43.59	12.89	313	13188	456438	34486992
Arthralgia	43.21	12.89	154	13347	169887	34773543
Exostosis	42.29	12.89	25	13476	4698	34938732
Tendon disorder	41.86	12.89	21	13480	2854	34940576
Ankle fracture	40.02	12.89	23	13478	4102	34939328
Premature baby	39.25	12.89	43	13458	19590	34923840
Hypoaldosteronism	38.81	12.89	10	13491	188	34943242
Duodenal perforation	36.71	12.89	15	13486	1263	34942167
Mast cell activation syndrome	36.50	12.89	10	13491	240	34943190
Psoriasis	34.19	12.89	57	13444	38755	34904675
Arthritis	33.07	12.89	50	13451	31296	34912134
Gastrointestinal haemorrhage	32.42	12.89	91	13410	88386	34855044
Joint swelling	31.84	12.89	71	13430	59819	34883611
Chest expansion decreased	31.22	12.89	8	13493	147	34943283
Benign abdominal neoplasm	29.72	12.89	7	13494	89	34943341
Drug hypersensitivity	29.67	12.89	83	13418	80446	34862984
Psoriatic arthropathy	29.02	12.89	37	13464	19761	34923669
Death	28.93	12.89	70	13431	397979	34545451
Synovitis	26.72	12.89	30	13471	14036	34929394
Foot fracture	26.35	12.89	19	13482	4992	34938438
Gouty arthritis	25.36	12.89	11	13490	1075	34942355
Juvenile idiopathic arthritis	25.13	12.89	13	13488	1884	34941546
Gastric haemorrhage	25.03	12.89	25	13476	10236	34933194
Axial spondyloarthritis	24.74	12.89	8	13493	344	34943086
Neonatal disorder	24.73	12.89	10	13491	820	34942610
Xanthelasma	24.26	12.89	6	13495	95	34943335
Foot deformity	23.39	12.89	17	13484	4520	34938910
Osteoarthritis	23.31	12.89	34	13467	20608	34922822
Placental transfusion syndrome	23.05	12.89	4	13497	8	34943422
Coarctation of the aorta	22.39	12.89	8	13493	467	34942963
Back pain	21.81	12.89	99	13402	121690	34821740
Sensitivity to weather change	21.13	12.89	11	13490	1615	34941815
Caesarean section	20.81	12.89	12	13489	2152	34941278
Neonatal respiratory distress syndrome	20.53	12.89	15	13486	4019	34939411
Gastric ulcer	19.47	12.89	27	13474	15623	34927807
Neck pain	19.40	12.89	35	13466	25314	34918116
Water intoxication	19.39	12.89	7	13494	421	34943009
Melaena	18.86	12.89	42	13459	35338	34908092
Enthesopathy	18.75	12.89	15	13486	4598	34938832
Osteopenia	18.09	12.89	15	13486	4834	34938596
Duodenal ulcer	17.87	12.89	21	13480	10311	34933119
Gastric bypass	17.86	12.89	6	13495	291	34943139
Thoracic vertebral fracture	17.73	12.89	10	13491	1720	34941710
Pulmonary sarcoidosis	17.14	12.89	7	13494	589	34942841
Foetal exposure during pregnancy	16.79	12.89	42	13459	38059	34905371
Myofascial pain syndrome	16.46	12.89	6	13495	371	34943059
Erythroblast count increased	16.42	12.89	3	13498	9	34943421
Joint range of motion decreased	16.35	12.89	17	13484	7295	34936135
Stillbirth	16.34	12.89	5	13496	179	34943251
Patent ductus arteriosus	16.01	12.89	12	13489	3342	34940088
Tricuspid valve incompetence	15.51	12.89	19	13482	9741	34933689
Tobacco abuse	15.48	12.89	6	13495	440	34942990
Iridocyclitis	15.46	12.89	9	13492	1643	34941787
Drug tolerance	15.32	12.89	11	13490	2871	34940559
Procedural vomiting	15.26	12.89	5	13496	224	34943206
Gastrointestinal ulcer	15.17	12.89	9	13492	1702	34941728
Musculoskeletal stiffness	15.15	12.89	46	13455	46634	34896796
Spinal deformity	14.87	12.89	6	13495	489	34942941
Oromandibular dystonia	14.80	12.89	6	13495	495	34942935
Sinusitis aspergillus	14.76	12.89	4	13497	92	34943338
Hydrops foetalis	14.62	12.89	7	13494	860	34942570
Pain	14.32	12.89	131	13370	204544	34738886
Intraventricular haemorrhage neonatal	13.73	12.89	5	13496	308	34943122
Neutropenia	13.48	12.89	25	13476	156753	34786677
Faeces discoloured	13.29	12.89	22	13479	14856	34928574
Pain in extremity	13.29	12.89	89	13412	126424	34817006
Adulterated product	13.22	12.89	3	13498	32	34943398
Foetal distress syndrome	13.04	12.89	7	13494	1093	34942337

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
Ankylosing spondylitis	288.77	11.78	123	29245	12082	79702938
Neck deformity	148.81	11.78	46	29322	1791	79713229
Neck mass	119.66	11.78	49	29319	4355	79710665
Oesophageal spasm	109.66	11.78	43	29325	3413	79711607
Bone density abnormal	103.93	11.78	40	29328	3020	79712000
Oesophageal pain	97.48	11.78	42	29326	4237	79710783
Drug ineffective	83.01	11.78	679	28689	1080234	78634786
Sacroiliitis	63.72	11.78	30	29338	3724	79711296
Corneal perforation	61.35	11.78	19	29349	744	79714276
Lymphoedema	60.23	11.78	44	29324	12369	79702651
Arthralgia	58.40	11.78	385	28983	571418	79143602
Back pain	56.71	11.78	242	29126	303938	79411082
Musculoskeletal stiffness	52.86	11.78	163	29205	174845	79540175
Ankle fracture	52.10	11.78	46	29322	16923	79698097
Disability	51.75	11.78	46	29322	17074	79697946
Death	50.33	11.78	82	29286	566432	79148588
Mood swings	49.61	11.78	48	29320	19832	79695188
Joint swelling	48.75	11.78	223	29145	288423	79426597
Drug hypersensitivity	46.15	11.78	225	29143	298691	79416329
Drug ineffective for unapproved indication	46.04	11.78	74	29294	51164	79663856
Sleep apnoea syndrome	44.77	11.78	61	29307	36417	79678603
Hepatitis B virus test positive	42.55	11.78	13	29355	486	79714534
Hypermobility syndrome	41.50	11.78	13	29355	529	79714491
Pain	38.07	11.78	411	28957	703391	79011629
Migraine	36.80	11.78	92	29276	87401	79627619
Limb deformity	35.66	11.78	20	29348	3570	79711450
Gout	32.84	11.78	43	29325	24706	79690314
Hypoaldosteronism	32.68	11.78	10	29358	376	79714644
Tinnitus	30.62	11.78	57	29311	44276	79670744
Neck pain	30.36	11.78	78	29290	75339	79639681
Chest expansion decreased	29.78	11.78	8	29360	187	79714833
Tendon disorder	29.39	11.78	23	29345	7163	79707857
Gastrointestinal haemorrhage	28.62	11.78	119	29249	147600	79567420
Premature delivery	28.43	11.78	39	29329	23428	79691592
Arthritis	28.39	11.78	100	29268	114780	79600240
Gastric haemorrhage	27.92	11.78	31	29337	15019	79700001
Gastric ulcer	27.81	11.78	47	29321	33858	79681162
Right ventricular hypertension	27.63	11.78	4	29364	0	79715020
Psoriatic arthropathy	26.71	11.78	76	29292	77923	79637097
Fibromyalgia	26.37	11.78	67	29301	64273	79650747
Neuralgia	25.70	11.78	45	29323	33339	79681681
Joint abscess	25.48	11.78	9	29359	533	79714487
Investigation abnormal	24.66	11.78	13	29355	2053	79712967
Actinomycotic sepsis	24.19	11.78	6	29362	101	79714919
Duodenal perforation	24.05	11.78	13	29355	2159	79712861
Joint stiffness	23.94	11.78	49	29319	40781	79674239
Large intestinal ulcer	23.26	11.78	17	29351	4780	79710240
Ductus arteriosus premature closure	23.24	11.78	5	29363	43	79714977
Psoriasis	23.01	11.78	79	29289	89508	79625512
Neutropenia	22.48	11.78	45	29323	287665	79427355
Benign abdominal neoplasm	22.48	11.78	7	29361	279	79714741
Dysstasia	22.14	11.78	38	29330	27708	79687312
Uveitis	21.96	11.78	29	29339	16801	79698219
Blood pressure fluctuation	21.62	11.78	64	29304	67081	79647939
Xanthelasma	21.40	11.78	6	29362	165	79714855
Vascular rupture	21.25	11.78	11	29357	1674	79713346
Axial spondyloarthritis	21.12	11.78	8	29360	578	79714442
Intestinal diaphragm disease	21.09	11.78	7	29361	343	79714677
Duodenal ulcer	21.04	11.78	28	29340	16341	79698679
Glossodynia	20.99	11.78	6	29362	103331	79611689
Blood pressure diastolic increased	20.44	11.78	26	29342	14516	79700504
Neonatal disorder	20.15	11.78	4	29364	22	79714998
Gouty arthritis	19.76	11.78	10	29358	1451	79713569
Malignant neoplasm progression	19.57	11.78	13	29355	135977	79579043
Tendonitis	19.49	11.78	33	29335	23797	79691223
Oligoarthritis	19.48	11.78	8	29360	716	79714304
Myocardial infarction	19.32	11.78	125	29243	184004	79531016
Catheter site bruise	19.25	11.78	7	29361	451	79714569
Juvenile idiopathic arthritis	18.95	11.78	15	29353	4748	79710272
Ear pain	18.75	11.78	39	29329	32830	79682190
Right ventricular hypertrophy	18.69	11.78	10	29358	1627	79713393
Osteopenia	18.55	11.78	28	29340	18336	79696684
Wound	18.27	11.78	10	29358	116169	79598851
Alpha tumour necrosis factor increased	17.88	11.78	4	29364	42	79714978
Hyperhidrosis	17.87	11.78	106	29262	151386	79563634
Cystitis	17.68	11.78	51	29317	52681	79662339
Exostosis	17.45	11.78	26	29342	16832	79698188
Large intestinal ulcer haemorrhage	17.45	11.78	6	29362	328	79714692
Adrenal suppression	17.26	11.78	9	29359	1390	79713630
Hypotension	16.98	11.78	94	29274	440223	79274797
Angioedema	16.93	11.78	64	29304	75971	79639049
Fluid retention	16.58	11.78	60	29308	69749	79645271
Febrile neutropenia	16.49	11.78	38	29330	230961	79484059
Bronchitis	16.44	11.78	93	29275	130551	79584469
Hand deformity	16.26	11.78	9	29359	103910	79611110
Gastrointestinal ulcer	16.23	11.78	12	29356	3434	79711586
Mast cell activation syndrome	16.18	11.78	7	29361	713	79714307
Trigger finger	16.10	11.78	13	29355	4232	79710788
Mycobacterium tuberculosis complex test positive	16.10	11.78	11	29357	2781	79712239
Cellulitis staphylococcal	15.78	11.78	8	29360	1165	79713855
Water intoxication	15.69	11.78	7	29361	767	79714253
Muscle spasticity	15.31	11.78	28	29340	21447	79693573
Stress	15.30	11.78	64	29304	79548	79635472
Benign vaginal neoplasm	15.30	11.78	4	29364	84	79714936
Grip strength decreased	14.95	11.78	28	29340	21841	79693179
Exposure during pregnancy	14.77	11.78	75	29293	101057	79613963
Serotonin syndrome	14.57	11.78	43	29325	44984	79670036
Hirsutism	14.55	11.78	8	29360	1374	79713646
Pharyngitis	14.50	11.78	28	29340	22347	79692673
Product dose omission issue	14.43	11.78	45	29323	247492	79467528
Coccydynia	14.18	11.78	9	29359	2012	79713008
Melaena	14.18	11.78	52	29316	60838	79654182
Cerebral vasoconstriction	14.09	11.78	8	29360	1462	79713558
Arthritis bacterial	13.86	11.78	17	29351	9149	79705871
Endothelin increased	13.82	11.78	3	29365	27	79714993
White blood cell analysis abnormal	13.82	11.78	3	29365	27	79714993
Vision blurred	13.73	11.78	76	29292	105822	79609198
Episcleritis	13.63	11.78	7	29361	1048	79713972
Fine motor skill dysfunction	13.49	11.78	13	29355	5344	79709676
Intervertebral disc protrusion	13.44	11.78	28	29340	23593	79691427
Urticaria	13.32	11.78	115	29253	185086	79529934
Pharyngeal haematoma	13.29	11.78	4	29364	142	79714878
Leukopenia	13.24	11.78	14	29354	116499	79598521
Drug intolerance	13.17	11.78	152	29216	263967	79451053
Swollen tongue	13.15	11.78	40	29328	42530	79672490
Facial paresis	13.14	11.78	13	29355	5513	79709507
Premature baby	13.13	11.78	11	29357	3769	79711251
Secondary adrenocortical insufficiency	13.09	11.78	10	29358	3004	79712016
Dizziness	13.07	11.78	269	29099	526172	79188848
Hyponatraemia	12.89	11.78	29	29339	177819	79537201
Treatment failure	12.86	11.78	107	29261	170379	79544641
Corneal neovascularisation	12.83	11.78	4	29364	160	79714860
Focal nodular hyperplasia	12.81	11.78	6	29362	736	79714284
Hypercholesterolaemia	12.70	11.78	27	29341	23068	79691952
Synovitis	12.68	11.78	97	29271	150637	79564383
Infective myositis	12.60	11.78	4	29364	170	79714850
Myoclonus	12.60	11.78	30	29338	27630	79687390
Procedural vomiting	12.44	11.78	6	29362	785	79714235
Prostate cancer recurrent	12.25	11.78	6	29362	812	79714208
Skin striae	12.24	11.78	8	29360	1880	79713140
Wheezing	12.19	11.78	15	29353	116649	79598371
Enthesopathy	12.16	11.78	18	29350	11590	79703430
Alopecia	12.16	11.78	44	29324	231311	79483709
Genital hypoaesthesia	12.03	11.78	4	29364	197	79714823
Oligohydramnios	12	11.78	10	29358	3402	79711618
Neuropathy peripheral	12.00	11.78	21	29347	141284	79573736
Anxiety	11.94	11.78	142	29226	248370	79466650
Pulmonary sarcoidosis	11.88	11.78	7	29361	1370	79713650
Depression	11.83	11.78	127	29241	216663	79498357

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C01EB03	CARDIOVASCULAR SYSTEM CARDIAC THERAPY OTHER CARDIAC PREPARATIONS Other cardiac preparations
ATC	M01AB01	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	M01AB51	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	M02AA23	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	S01BC01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids
ATC	S01CC02	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
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	D002317	Cardiovascular Agents
MeSH PA	D016861	Cyclooxygenase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006074	Gout Suppressants
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D012102	Reproductive Control Agents
MeSH PA	D018689	Sensory System Agents
MeSH PA	D015149	Tocolytic Agents
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35544	cyclooxygenase inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:35845	gout suppressants
CHEBI has role	CHEBI:49103	drug metabolites
CHEBI has role	CHEBI:76206	xenobiotic metabolites
CHEBI has role	CHEBI:78298	environmental contaminants

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

Disease	Relation	SNOMED_ID	DOID
Ankylosing spondylitis	indication	9631008	DOID:7147
Tendinitis	indication	34840004	DOID:971
Tenosynovitis	indication	67801009	DOID:970
Rheumatoid arthritis	indication	69896004	DOID:7148
Patent ductus arteriosus	indication	83330001	DOID:13832
Bursitis	indication	84017003	DOID:2965
Gout	indication	90560007	DOID:13189
Bursitis of shoulder	indication	239961006
Osteoarthritis	indication	396275006
Synovitis	indication	416209007	DOID:2703
Shoulder Tendonitis	indication
Pericarditis	off-label use	3238004	DOID:1787
Premature labor	off-label use	6383007
Renal colic	off-label use	7093002
Pseudoprimary hyperaldosteronism	off-label use	71275003
Nephrogenic diabetes insipidus	off-label use	111395007	DOID:12387
Dysmenorrhea	off-label use	266599000
Fever	off-label use	386661006
Twin reversal arterial perfusion syndrome	off-label use	417006004
Necrotizing enterocolitis in fetus OR newborn	contraindication	2707005
Proctitis	contraindication	3951002	DOID:3127
Acute hemorrhage	contraindication	8573003
Rectal hemorrhage	contraindication	12063002
Hyperkalemia	contraindication	14140009
Myocardial infarction	contraindication	22298006	DOID:5844
Parkinsonism	contraindication	32798002
Dehydration	contraindication	34095006
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Gastrointestinal ulcer	contraindication	40845000
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Gastrointestinal perforation	contraindication	51875005
Stomatitis	contraindication	61170000	DOID:9637
Ulcerative colitis	contraindication	64766004	DOID:8577
Blood coagulation disorder	contraindication	64779008	DOID:1247
Hemorrhoids	contraindication	70153002	DOID:9746
Corneal deposit	contraindication	74460005	DOID:11547
Gastrointestinal hemorrhage	contraindication	74474003
Heart failure	contraindication	84114007	DOID:6000
Epilepsy	contraindication	84757009	DOID:1826
Bacterial infectious disease	contraindication	87628006
Hyponatremia	contraindication	89627008
Kidney disease	contraindication	90708001	DOID:557
Blurring of visual image	contraindication	111516008
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Asthma	contraindication	195967001	DOID:2841
Sepsis of the newborn	contraindication	206376005
Coronary artery bypass graft	contraindication	232717009
Disease of liver	contraindication	235856003	DOID:409
Esophageal dysmotility	contraindication	266434009	DOID:9192
Cerebral hemorrhage	contraindication	274100004
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Malignant tumor of colon	contraindication	363406005	DOID:219
Cardiovascular event risk	contraindication	395112001
Gastric ulcer	contraindication	397825006	DOID:10808
Diverticular disease	contraindication	397881000
Smokes tobacco daily	contraindication	449868002
Psychiatric Disturbance	contraindication
Intraventricular Hemorrhage In Newborn	contraindication
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus	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	4.45	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
20MG	TIVORBEX	GENUS	N204768	Feb. 24, 2014	DISCN	CAPSULE	ORAL	9089471	April 23, 2030	TREATMENT OF PAIN
40MG	TIVORBEX	GENUS	N204768	Feb. 24, 2014	DISCN	CAPSULE	ORAL	9089471	April 23, 2030	TREATMENT OF PAIN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
50MG	INDOMETHACIN	ZYDUS	A216184	Aug. 2, 2023	RX	SUPPOSITORY	RECTAL	Jan. 30, 2024	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	7.21	WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	6.33	WOMBAT-PK	CHEMBL
Multidrug resistance-associated protein 1	Transporter	P33527	MRP1_HUMAN		IC50	4.92	CHEMBL
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		EC50	9.85	CHEMBL
Prostaglandin D2 receptor 2	GPCR	Q9Y5Y4	PD2R2_HUMAN		Ki	6.53	WOMBAT-PK
Dehydrogenase/reductase SDR family member 9	Enzyme	Q9BPW9	DHRS9_HUMAN		IC50	4.85	CHEMBL
Aldose reductase	Enzyme	P15121	ALDR_HUMAN		IC50	5.22	CHEMBL
Aldo-keto reductase family 1 member C2	Enzyme	P52895	AK1C2_HUMAN		IC50	4.44	CHEMBL
Aldo-keto reductase family 1 member C3	Enzyme	P42330	AK1C3_HUMAN		IC50	7	CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	AGONIST	Kd	7.38	IUPHAR
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN		Ki	7.69	PDSP
Lactoylglutathione lyase	Enzyme	Q04760	LGUL_HUMAN		Ki	4.74	CHEMBL
Cytochrome c oxidase subunit 2	Enzyme	P00403	COX2_HUMAN		IC50	6.21	CHEMBL
Interleukin-8	Cytokine	P10145	IL8_HUMAN		IC50	7.30	CHEMBL
Potassium voltage-gated channel subfamily A member 7	Ion channel	Q96RP8	KCNA7_HUMAN		Ki	7.50	WOMBAT-PK
Prostaglandin E synthase	Enzyme	O14684	PTGES_HUMAN		IC50	4.39	CHEMBL
Aldo-keto reductase family 1 member C4	Enzyme	P17516	AK1C4_HUMAN		IC50	4.27	CHEMBL
Nicotinate phosphoribosyltransferase	Enzyme	Q6XQN6	PNCB_HUMAN		Ki	9.82	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	4.49	CHEMBL
Aldose reductase	Enzyme		ALDR_RAT		IC50	5.44	DRUG MATRIX
Prostaglandin G/H synthase 2	Enzyme		PGH2_MOUSE		IC50	8.19	CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_MOUSE		IC50	8.70	CHEMBL
Aldose reductase	Enzyme		ALDR_BOVIN		IC50	5.30	CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_SHEEP		Ki	5.10	CHEMBL
Prostaglandin-H2 D-isomerase	Enzyme		PTGDS_MOUSE		IC50	6.30	CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_RAT		IC50	8.22	CHEMBL
Prostaglandin G/H synthase 2	Enzyme		PGH2_SHEEP		IC50	6.47	CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_BOVIN		IC50	8.39	CHEMBL
Cyclooxygenase	Enzyme		PGH1_BOVIN PGH2_BOVIN		IC50	6.37	CHEMBL
Cyclooxygenase	Enzyme		PGH2_RAT PGH1_RAT		IC50	7	CHEMBL
Prostaglandin G/H synthase (cyclooxygenase)	Enzyme		PGH1_SHEEP PGH2_SHEEP		IC50	6.82	CHEMBL
Nitric oxide synthase, inducible	Enzyme		NOS2_MOUSE		IC50	4.70	CHEMBL
Prostaglandin D2 receptor 2	GPCR		PD2R2_MOUSE	AGONIST	Ki	6	IUPHAR
Prostaglandin G/H synthase 2	Enzyme		PGH2_RAT		IC50	8	CHEMBL

External reference:

ID	Source
D00141	KEGG_DRUG
74252-25-8	SECONDARY_CAS_RN
4017890	VANDF
4017891	VANDF
C0021246	UMLSCUI
CHEBI:49662	CHEBI
IMN	PDB_CHEM_ID
CHEMBL6	ChEMBL_ID
CHEMBL3989410	ChEMBL_ID
DB00328	DRUGBANK_ID
D007213	MESH_DESCRIPTOR_UI
3715	PUBCHEM_CID
1909	IUPHAR_LIGAND_ID
1524	INN_ID
XXE1CET956	UNII
1294612	RXNORM
2387	MMSL
2393	MMSL
4877	MMSL
d00039	MMSL
002373	NDDF
002374	NDDF
373513008	SNOMEDCT_US
60149003	SNOMEDCT_US
783274005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1113	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1113	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
INDOMETHACIN	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0176	SUPPOSITORY	50 mg	RECTAL	ANDA	14 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	10544-083	CAPSULE	50 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	10544-919	CAPSULE, EXTENDED RELEASE	75 mg	ORAL	ANDA	12 sections
Indomethacin	Human Prescription Drug Label	1	10544-935	CAPSULE, EXTENDED RELEASE	75 mg	ORAL	ANDA	24 sections
INDOMETHACIN	HUMAN PRESCRIPTION DRUG LABEL	1	10702-016	CAPSULE, EXTENDED RELEASE	75 mg	ORAL	ANDA	28 sections
INDOMETHACIN ER	HUMAN PRESCRIPTION DRUG LABEL	1	12634-160	CAPSULE	75 mg	ORAL	ANDA	14 sections
INDOMETHACIN ER	HUMAN PRESCRIPTION DRUG LABEL	1	12634-838	CAPSULE	75 mg	ORAL	ANDA	14 sections
INDOMETHACIN	HUMAN PRESCRIPTION DRUG LABEL	1	16590-130	CAPSULE	50 mg	ORAL	ANDA	24 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-522	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-523	CAPSULE	50 mg	ORAL	ANDA	23 sections
Indomethacin	Human Prescription Drug Label	1	31722-542	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	Human Prescription Drug Label	1	31722-542	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	Human Prescription Drug Label	1	31722-543	CAPSULE	50 mg	ORAL	ANDA	27 sections
Indomethacin	Human Prescription Drug Label	1	31722-543	CAPSULE	50 mg	ORAL	ANDA	27 sections
Indomethacin	Human Prescription Drug Label	1	31722-565	CAPSULE, EXTENDED RELEASE	75 mg	ORAL	ANDA	24 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	35356-697	CAPSULE	50 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	35356-697	CAPSULE	50 mg	ORAL	ANDA	27 sections
INDOCIN	HUMAN PRESCRIPTION DRUG LABEL	1	42211-101	SUSPENSION	25 mg	ORAL	NDA	28 sections
INDOCIN	HUMAN PRESCRIPTION DRUG LABEL	1	42211-102	SUPPOSITORY	50 mg	RECTAL	ANDA	29 sections
Tivorbex	HUMAN PRESCRIPTION DRUG LABEL	1	42211-201	CAPSULE	20 mg	ORAL	NDA	28 sections
Tivorbex	HUMAN PRESCRIPTION DRUG LABEL	1	42211-202	CAPSULE	40 mg	ORAL	NDA	28 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	42254-081	CAPSULE	50 mg	ORAL	ANDA	27 sections
INDOMETHACIN	HUMAN PRESCRIPTION DRUG LABEL	1	42254-237	CAPSULE	25 mg	ORAL	ANDA	25 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-368	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-368	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-773	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-773	CAPSULE	25 mg	ORAL	ANDA	27 sections
Indomethacin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-773	CAPSULE	25 mg	ORAL	ANDA	27 sections