Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
diuretics, sulfamoylbenzoic acid derivatives	1433	26807-65-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: metindamide indapamide hemihydrate indapamide flupamid indaflex indamide indamol veroxil (+/-)-Indapamide	A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS. Molecular weight: 365.83 Formula: C16H16ClN3O3S CLOGP: 2.96 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 92.50 ALOGS: -4.03 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

metindamide
indapamide hemihydrate
indapamide
flupamid
indaflex
indamide
indamol
veroxil
(+/-)-Indapamide

A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.

Molecular weight: 365.83
Formula: C16H16ClN3O3S
CLOGP: 2.96
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 92.50
ALOGS: -4.03
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.59 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	7 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.20 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2B,AXL,CAMK2D,CDK5,CDK9,EGFR,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TTK	19
kinase-selectivity-class	AXL,BRAF,CDK9,DDR1,EIF2AK3,GRK2,MAP2K6,MAPKAPK3,PDK1,PDK4,PIK3CD,SIK2,SIK3,STK33,TEK	15
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
July 6, 1983	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
Hyponatraemia	1694.81	13.46	851	30128	132687	90464781
Hypokalaemia	651.76	13.46	457	30522	130659	90466809
Acute kidney injury	399.15	13.46	518	30461	319869	90277599
Inappropriate antidiuretic hormone secretion	269.02	13.46	132	30847	19373	90578095
Drug interaction	188.23	13.46	338	30641	276115	90321353
Hypomagnesaemia	140.14	13.46	108	30871	35480	90561988
Hypochloraemia	120.51	13.46	42	30937	2580	90594888
Conjoined twins	113.33	13.46	28	30951	502	90596966
Lactic acidosis	105.66	13.46	107	30872	50356	90547112
Maternal exposure during pregnancy	96.23	13.46	7	30972	360056	90237412
Confusional state	95.92	13.46	320	30659	385885	90211583
Blood pressure increased	94.09	13.46	208	30771	197009	90400459
Hyponatraemic seizure	89.48	13.46	23	30956	487	90596981
Burning mouth syndrome	85.66	13.46	23	30956	580	90596888
Torsade de pointes	84.83	13.46	57	30922	15125	90582343
Pemphigus	80.23	13.46	9	30970	326855	90270613
Pericarditis	79.19	13.46	3	30976	270148	90327320
Bradycardia	73.56	13.46	115	30864	83732	90513736
Glossodynia	71.56	13.46	12	30967	321767	90275701
Labile hypertension	70.13	13.46	19	30960	496	90596972
Rectal polyp	67.65	13.46	22	30957	1091	90596377
Central nervous system lupus	67.16	13.46	23	30956	1340	90596128
Hypoglycaemia	65.77	13.46	99	30880	69749	90527719
Infusion related reaction	64.39	13.46	31	30948	416749	90180719
Congenital bladder anomaly	63.66	13.46	15	30964	218	90597250
Intestinal malrotation	63.30	13.46	17	30962	429	90597039
Urachal abnormality	63.15	13.46	15	30964	226	90597242
Change of bowel habit	62.46	13.46	25	30954	2258	90595210
Persistent cloaca	62.37	13.46	15	30964	239	90597229
Infection	62.23	13.46	23	30956	362071	90235397
Dehydration	62.05	13.46	176	30803	194271	90403197
Electrocardiogram QT prolonged	61.65	13.46	98	30881	72358	90525110
Rhabdomyolysis	60.60	13.46	81	30898	51175	90546293
Renal artery stenosis	60.12	13.46	24	30955	2153	90595315
Euglycaemic diabetic ketoacidosis	59.73	13.46	33	30946	6168	90591300
Drug ineffective	59.46	13.46	258	30721	1384040	89213428
Alopecia	57.28	13.46	51	30928	495020	90102448
Arthropathy	56.93	13.46	27	30952	366215	90231253
Butterfly rash	56.58	13.46	23	30956	2162	90595306
Hypotension	55.30	13.46	239	30740	325158	90272310
Intestinal haemorrhage	55.11	13.46	28	30951	4419	90593049
Fall	53.03	13.46	313	30666	481497	90115971
Exposure during pregnancy	52.75	13.46	9	30970	238401	90359067
Treatment failure	52.73	13.46	19	30960	303909	90293559
Wound	52.46	13.46	19	30960	302961	90294507
Atrial fibrillation	51.77	13.46	130	30849	133481	90463987
Discomfort	51.38	13.46	15	30964	274320	90323148
Hepatic enzyme increased	51.05	13.46	30	30949	360706	90236762
Off label use	49.98	13.46	201	30778	1102051	89495417
Swelling	49.88	13.46	42	30937	419016	90178452
Urine odour abnormal	49.84	13.46	31	30948	7213	90590255
Impaired healing	49.33	13.46	10	30969	234189	90363279
Left ventricular hypertrophy	49.25	13.46	29	30950	6115	90591353
Osmotic demyelination syndrome	48.88	13.46	17	30962	1037	90596431
Proctalgia	48.75	13.46	32	30947	8166	90589302
Systemic lupus erythematosus	48.57	13.46	32	30947	361864	90235604
Metabolic acidosis	48.32	13.46	76	30903	55600	90541868
Sensitisation	48.02	13.46	25	30954	4150	90593318
Injection site discomfort	47.51	13.46	28	30951	5912	90591556
Blood sodium decreased	46.20	13.46	52	30927	27561	90569907
Dysuria	46.17	13.46	62	30917	39339	90558129
Vessel puncture site haemorrhage	44.44	13.46	10	30969	117	90597351
Furuncle	43.71	13.46	29	30950	7532	90589936
Scleroedema	43.47	13.46	10	30969	130	90597338
Renal impairment	43.41	13.46	105	30874	105316	90492152
Orthostatic hypotension	43.29	13.46	62	30917	41765	90555703
Product packaging confusion	43.29	13.46	11	30968	222	90597246
Blood urea increased	42.14	13.46	52	30927	30361	90567107
Lupus nephritis	41.89	13.46	24	30955	4808	90592660
Polyp	41.03	13.46	28	30951	7616	90589852
Jaundice	40.93	13.46	53	30926	32464	90565004
Protein urine present	40.89	13.46	27	30952	6957	90590511
Contraindicated product administered	40.71	13.46	30	30949	320109	90277359
Duodenal ulcer	39.81	13.46	30	30949	9522	90587946
Oliguria	39.12	13.46	31	30948	10593	90586875
Sprue-like enteropathy	38.98	13.46	14	30965	939	90596529
Spur cell anaemia	38.87	13.46	8	30971	59	90597409
Urine abnormality	38.38	13.46	27	30952	7710	90589758
Urinary incontinence	37.88	13.46	55	30924	37511	90559957
Diabetes mellitus	37.39	13.46	74	30905	64801	90532667
Stomatitis	37.24	13.46	24	30955	274674	90322794
Psoriatic arthropathy	36.76	13.46	16	30963	228319	90369149
Hypertensive angiopathy	36.52	13.46	8	30971	82	90597386
Migraine	36.40	13.46	10	30969	190382	90407086
Nephropathy	36.28	13.46	28	30951	9207	90588261
Failure to suspend medication	36.26	13.46	8	30971	85	90597383
Angioedema	36.19	13.46	73	30906	64803	90532665
Dyslipidaemia	36.16	13.46	29	30950	10078	90587390
Swelling face	35.62	13.46	83	30896	81269	90516199
Frustration tolerance decreased	35.60	13.46	26	30953	7870	90589598
Death	35.15	13.46	64	30915	456487	90140981
Renin increased	34.68	13.46	9	30970	198	90597270
Bladder disorder	34.54	13.46	29	30950	10743	90586725
Heart rate decreased	34.49	13.46	64	30915	53441	90544027
Mass	34.38	13.46	34	30945	15543	90581925
Sinusitis	34.35	13.46	40	30939	343048	90254420
Presyncope	34.18	13.46	48	30931	31757	90565711
Peripheral coldness	33.81	13.46	32	30947	13860	90583608
Needle issue	33.73	13.46	32	30947	13902	90583566
Blood creatinine increased	33.51	13.46	93	30886	101293	90496175
Abdominal discomfort	33.22	13.46	71	30908	477257	90120211
Myalgia	33.12	13.46	133	30846	174992	90422476
Type 2 diabetes mellitus	33.10	13.46	14	30965	203230	90394238
Postoperative wound infection	32.82	13.46	31	30948	13395	90584073
Hyperkalaemia	32.61	13.46	70	30909	64894	90532574
Product dose omission issue	32.57	13.46	31	30948	291656	90305812
Syncope	32.01	13.46	109	30870	132554	90464914
Glomerular filtration rate decreased	32.00	13.46	34	30945	16898	90580570
Circulatory collapse	31.98	13.46	41	30938	24863	90572605
Blood uric acid abnormal	31.84	13.46	8	30971	154	90597314
Hyperlactacidaemia	31.78	13.46	19	30960	4117	90593351
COVID-19 pneumonia	31.73	13.46	35	30944	18142	90579326
Croup infectious	31.55	13.46	11	30968	676	90596792
Injury	31.49	13.46	14	30965	197335	90400133
Disorientation	31.28	13.46	55	30924	44059	90553409
Eosinophilia	30.57	13.46	43	30936	28490	90568978
Electrolyte imbalance	30.35	13.46	39	30940	23706	90573762
Vascular access site haemorrhage	30.09	13.46	8	30971	194	90597274
Blood pressure systolic increased	29.44	13.46	63	30916	58282	90539186
Blood electrolytes abnormal	29.34	13.46	12	30967	1146	90596322
Gait inability	29.32	13.46	7	30972	146449	90451019
Somnolence	29.14	13.46	145	30834	208939	90388529
Thyroid disorder	28.91	13.46	33	30946	17752	90579716
Labelled drug-drug interaction medication error	28.84	13.46	30	30949	14552	90582916
Lower respiratory tract infection	28.73	13.46	26	30953	250633	90346835
Gravitational oedema	28.65	13.46	12	30967	1217	90596251
Therapeutic product effect decreased	28.16	13.46	32	30947	277539	90319929
Ill-defined disorder	28.14	13.46	14	30965	184877	90412591
Drug intolerance	27.60	13.46	71	30908	447520	90149948
Blood creatine phosphokinase increased	27.54	13.46	45	30934	33978	90563490
Retinal detachment	27.49	13.46	21	30958	6801	90590667
Blood pressure inadequately controlled	26.95	13.46	20	30959	6204	90591264
Haematoma	26.80	13.46	48	30931	39000	90558468
Poor dental condition	26.67	13.46	9	30970	501	90596967
Hypersensitivity	26.61	13.46	74	30905	454603	90142865
Diabetic metabolic decompensation	26.24	13.46	13	30966	1944	90595524
Ischaemic stroke	26.15	13.46	35	30944	22131	90575337
Drug hypersensitivity	26.00	13.46	77	30902	463532	90133936
Obesity	25.62	13.46	3	30976	105504	90491964
Vasculitis	25.51	13.46	35	30944	22658	90574810
Urine glucose/creatinine ratio increased	25.40	13.46	7	30972	195	90597273
Bursitis	25	13.46	7	30972	131647	90465821
Psychomotor retardation	24.43	13.46	17	30962	4772	90592696
Platelet dysfunction	24.37	13.46	6	30973	106	90597362
Drug level increased	24.22	13.46	38	30941	27724	90569744
Lethargy	23.99	13.46	61	30918	63078	90534390
Stevens-Johnson syndrome	23.97	13.46	39	30940	29337	90568131
Tubulointerstitial nephritis	23.96	13.46	36	30943	25307	90572161
Mucocutaneous haemorrhage	23.95	13.46	6	30973	114	90597354
Metabolic alkalosis	23.94	13.46	15	30964	3534	90593934
Glycosylated haemoglobin increased	23.83	13.46	28	30951	15534	90581934
Hypouricaemia	23.55	13.46	7	30972	257	90597211
Paramnesia	23.54	13.46	4	30975	8	90597460
Gastrointestinal disorder	23.52	13.46	32	30947	256655	90340813
Convulsive threshold lowered	23.49	13.46	8	30971	458	90597010
Sleep disorder	23.34	13.46	20	30959	198010	90399458
Musculoskeletal stiffness	23.31	13.46	41	30938	296491	90300977
Anuria	23.26	13.46	27	30952	14791	90582677
Depression	23.24	13.46	42	30937	300559	90296909
Blister	23.15	13.46	32	30947	254966	90342502
Transplant dysfunction	22.93	13.46	17	30962	5265	90592203
Therapy non-responder	22.93	13.46	9	30970	136695	90460773
Nail injury	22.74	13.46	9	30970	789	90596679
Glomerular filtration rate increased	22.73	13.46	12	30967	2048	90595420
Dizziness	22.72	13.46	304	30675	588980	90008488
Hypovolaemic shock	22.54	13.46	19	30960	7075	90590393
Sleep disorder due to general medical condition, insomnia type	22.38	13.46	8	30971	128686	90468782
Inflammation	22.35	13.46	17	30962	178575	90418893
Cardiovascular insufficiency	22.34	13.46	11	30968	1624	90595844
Cough	22.29	13.46	208	30771	368754	90228714
Urine albumin/creatinine ratio increased	22.08	13.46	8	30971	550	90596918
Vascular resistance systemic	21.70	13.46	4	30975	15	90597453
Blood urine present	21.49	13.46	28	30951	17250	90580218
Mouth ulceration	21.13	13.46	44	30935	39930	90557538
Blood cholesterol increased	21.07	13.46	24	30955	207988	90389480
Nasal mucosal disorder	21.01	13.46	11	30968	1846	90595622
Cardiac failure	20.56	13.46	83	30896	109413	90488055
Arrhythmia	20.54	13.46	45	30934	42287	90555181
Angina unstable	20.40	13.46	18	30961	7125	90590343
Liver injury	20.38	13.46	17	30962	170550	90426918
Blood pressure abnormal	20.15	13.46	29	30950	19616	90577852
Oedema peripheral	20.13	13.46	154	30825	257761	90339707
Sciatica	19.99	13.46	5	30974	101377	90496091
Gallbladder disorder	19.97	13.46	29	30950	19774	90577694
Hypotonia	19.94	13.46	22	30957	11404	90586064
Urine output decreased	19.84	13.46	23	30956	12580	90584888
Product use issue	19.81	13.46	53	30926	329866	90267602
Rheumatoid arthritis	19.77	13.46	61	30918	362553	90234915
Catheter site thrombosis	19.70	13.46	7	30972	455	90597013
Malaise	19.66	13.46	295	30684	585691	90011777
Lung neoplasm malignant	19.50	13.46	32	30947	24241	90573227
Product use in unapproved indication	19.46	13.46	55	30924	336181	90261287
Rash maculo-papular	19.28	13.46	43	30936	40890	90556578
Adverse event	19.25	13.46	8	30971	117410	90480058
Rash	19.14	13.46	177	30802	795923	89801545
Arteriosclerosis	19.12	13.46	21	30958	10832	90586636
Helicobacter infection	19.09	13.46	30	30949	226820	90370648
Renal failure	19.06	13.46	92	30887	130915	90466553
Impaired work ability	19.05	13.46	28	30951	19298	90578170
Blood glucose decreased	18.98	13.46	31	30948	23398	90574070
Weight increased	18.97	13.46	76	30903	417851	90179617
Peripheral venous disease	18.92	13.46	3	30976	83918	90513550
Prescribed overdose	18.89	13.46	5	30974	97620	90499848
Pharyngeal swelling	18.85	13.46	20	30959	9924	90587544
Food interaction	18.76	13.46	9	30970	1255	90596213
Musculoskeletal discomfort	18.69	13.46	29	30950	20962	90576506
Hypovolaemia	18.43	13.46	22	30957	12409	90585059
Pyelonephritis acute	18.20	13.46	15	30964	5417	90592051
Tinnitus	17.80	13.46	43	30936	43059	90554409
Night sweats	17.78	13.46	11	30968	128755	90468713
Hepatitis D	17.76	13.46	4	30975	47	90597421
Protrusion tongue	17.36	13.46	6	30973	359	90597109
Liver disorder	17.25	13.46	10	30969	121259	90476209
Spinal pain	17.24	13.46	24	30955	15743	90581725
Serratia infection	16.94	13.46	8	30971	1077	90596391
Vulvovaginal inflammation	16.85	13.46	8	30971	1090	90596378
Intracranial haematoma	16.83	13.46	6	30973	394	90597074
Leukocyturia	16.64	13.46	9	30970	1613	90595855
Myocardial ischaemia	16.58	13.46	22	30957	13792	90583676
Inclusion body myositis	16.55	13.46	3	30976	10	90597458
Hypertensive crisis	16.44	13.46	25	30954	17759	90579709
Fear of eating	16.38	13.46	6	30973	426	90597042
Hypocalciuria	16.33	13.46	3	30976	11	90597457
Electrocardiogram ST-T segment abnormal	16.26	13.46	6	30973	435	90597033
Blood glucose increased	16.16	13.46	70	30909	95176	90502292
Chronic gastritis	16.15	13.46	12	30967	3729	90593739
Interstitial lung disease	16.04	13.46	60	30919	76345	90521123
Iron deficiency	15.90	13.46	18	30961	9594	90587874
Iliac artery stenosis	15.87	13.46	4	30975	78	90597390
Injection site erythema	15.69	13.46	7	30972	98495	90498973
Injection site reaction	15.54	13.46	6	30973	92074	90505394
Hyperlipidaemia	15.51	13.46	28	30951	22888	90574580
Lipase increased	15.39	13.46	19	30960	11092	90586376
Pseudogynaecomastia	15.33	13.46	4	30975	90	90597378
Vasoconstriction	15.29	13.46	7	30972	878	90596590
Pain	15.03	13.46	245	30734	996096	89601372
Swollen tongue	15.03	13.46	42	30937	45914	90551554
Hospitalisation	15.02	13.46	13	30966	128087	90469381
Injection site mass	14.96	13.46	27	30952	22063	90575405
Drug reaction with eosinophilia and systemic symptoms	14.90	13.46	40	30939	42718	90554750
Extranodal marginal zone B-cell lymphoma (MALT type)	14.77	13.46	6	30973	563	90596905
Limb discomfort	14.69	13.46	37	30942	38023	90559445
Loss of consciousness	14.66	13.46	90	30889	140148	90457320
Asthenia	14.64	13.46	260	30719	533491	90063977
Hip arthroplasty	14.56	13.46	4	30975	76204	90521264
Angle closure glaucoma	14.50	13.46	10	30969	2765	90594703
Angular cheilitis	14.47	13.46	7	30972	994	90596474
Gastric ulcer haemorrhage	14.41	13.46	13	30966	5298	90592170
Retinopathy hypertensive	14.39	13.46	5	30974	304	90597164
Lip swelling	14.35	13.46	37	30942	38573	90558895
Febrile neutropenia	14.23	13.46	20	30959	158329	90439139
Fatigue	14.21	13.46	294	30685	1153729	89443739
Hypocalcaemia	14.13	13.46	39	30940	42329	90555139
Gingival hypertrophy	14.09	13.46	9	30970	2191	90595277
Neglect of personal appearance	14.08	13.46	4	30975	125	90597343
Nephritis allergic	14.07	13.46	5	30974	325	90597143
Postoperative hypertension	14.05	13.46	3	30976	27	90597441
Acetonaemia	14.04	13.46	5	30974	327	90597141
Proteinuria	13.94	13.46	27	30952	23264	90574204
Haemoglobin decreased	13.94	13.46	99	30880	161857	90435611
Colitis ischaemic	13.81	13.46	19	30960	12327	90585141
Electrocardiogram U-wave abnormality	13.76	13.46	3	30976	30	90597438
Drug ineffective for unapproved indication	13.71	13.46	3	30976	66641	90530827
Ear disorder	13.67	13.46	12	30967	4718	90592750
Intentional product use issue	13.66	13.46	34	30945	216858	90380610
Lymphocytic infiltration	13.63	13.46	7	30972	1129	90596339

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
Hyponatraemia	318.80	13.65	316	20649	101146	42499224
Hypokalaemia	262.25	13.65	243	20722	71478	42528892
Acute kidney injury	164.93	13.65	473	20492	366864	42233506
Drug interaction	86.61	13.65	308	20657	266691	42333679
Death	82.27	13.65	67	20898	471118	42129252
Hypomagnesaemia	78.77	13.65	83	20882	28405	42571965
Bradycardia	57.84	13.65	129	20836	85355	42515015
Syncope	57.43	13.65	141	20824	99265	42501105
Drug ineffective	54.71	13.65	146	20819	630051	41970319
Hyperkalaemia	52.84	13.65	120	20845	80338	42520032
Off label use	52.35	13.65	152	20813	638183	41962187
Dizziness	49.69	13.65	248	20717	249006	42351364
Lactic acidosis	48.57	13.65	83	20882	45178	42555192
Tachyarrhythmia	46.13	13.65	27	20938	3905	42596465
Mucosal dryness	44.59	13.65	20	20945	1658	42598712
Atrial fibrillation	42.53	13.65	158	20807	139435	42460935
Postictal paralysis	42.44	13.65	13	20952	364	42600006
Left atrial dilatation	40.62	13.65	21	20944	2381	42597989
Hypoosmolar state	38.78	13.65	10	20955	146	42600224
Lipoprotein (a) increased	38.64	13.65	12	20953	352	42600018
Drug abuse	37.37	13.65	4	20961	104767	42495603
Angioedema	36.80	13.65	71	20894	42406	42557964
Haematocrit increased	36.52	13.65	20	20945	2547	42597823
Obesity	35.27	13.65	42	20923	16417	42583953
Inappropriate antidiuretic hormone secretion	33.47	13.65	41	20924	16500	42583870
Rhabdomyolysis	33.28	13.65	99	20866	77920	42522450
Hypotension	32.29	13.65	227	20738	257404	42342966
Myalgia	32.00	13.65	112	20853	95968	42504402
Arrhythmia	30.86	13.65	64	20901	40253	42560117
Spinal osteoarthritis	30.83	13.65	29	20936	8657	42591713
Drug dispensed to wrong patient	30.70	13.65	11	20954	506	42599864
Oedema peripheral	30.37	13.65	140	20825	135936	42464434
Presyncope	29.39	13.65	45	20920	22342	42578028
Febrile neutropenia	29.17	13.65	29	20936	185674	42414696
Herbal interaction	28.82	13.65	10	20955	418	42599952
Haemoglobin increased	27.89	13.65	22	20943	5184	42595186
Dyspnoea exertional	26.69	13.65	69	20896	50079	42550291
Lip swelling	26.00	13.65	39	20926	19014	42581356
Endoscopy upper gastrointestinal tract abnormal	25.82	13.65	6	20959	55	42600315
Type 2 diabetes mellitus	25.48	13.65	38	20927	18433	42581937
Carotid arteriosclerosis	24.71	13.65	15	20950	2317	42598053
Glycosylated haemoglobin decreased	24.63	13.65	9	20956	438	42599932
Varicose vein	24.54	13.65	13	20952	1549	42598821
Pancreatic neoplasm	23.95	13.65	11	20954	963	42599407
Consciousness fluctuating	23.70	13.65	12	20953	1303	42599067
Intention tremor	23.47	13.65	9	20956	501	42599869
Diabetic foot	23.27	13.65	16	20949	3057	42597313
Hypovolaemia	22.48	13.65	28	20937	11457	42588913
Tumour invasion	22.28	13.65	8	20957	370	42600000
Skin disorder	22.15	13.65	34	20931	16910	42583460
Electrolyte imbalance	21.92	13.65	34	20931	17067	42583303
Hypochloraemia	21.28	13.65	10	20955	923	42599447
Nail pitting	21.13	13.65	8	20957	430	42599940
Renal artery arteriosclerosis	21.12	13.65	5	20960	50	42600320
Renal artery restenosis	20.93	13.65	4	20961	12	42600358
Product use in unapproved indication	20.61	13.65	37	20928	184419	42415951
Pulse abnormal	20.41	13.65	11	20954	1357	42599013
Peripheral artery haematoma	19.93	13.65	5	20960	65	42600305
Postural tremor	19.91	13.65	8	20957	505	42599865
Onychophagia	19.86	13.65	5	20960	66	42600304
Gastrointestinal ischaemia	19.83	13.65	7	20958	308	42600062
Bundle branch block right	19.57	13.65	22	20943	8084	42592286
Pneumonia	19.37	13.65	125	20840	422024	42178346
Blood bilirubin abnormal	19.00	13.65	9	20956	845	42599525
Renal mass	18.99	13.65	12	20953	1990	42598380
Polyuria	18.95	13.65	24	20941	9987	42590383
Stenosis	18.46	13.65	12	20953	2089	42598281
Angular cheilitis	18.45	13.65	6	20959	205	42600165
Erectile dysfunction	18.42	13.65	39	20926	24874	42575496
Ventricular flutter	18.31	13.65	5	20960	92	42600278
Cholestasis	18.28	13.65	46	20919	32833	42567537
Resting tremor	17.65	13.65	9	20956	992	42599378
Electrocardiogram T wave abnormal	17.58	13.65	11	20954	1793	42598577
Diabetes mellitus inadequate control	17.53	13.65	29	20936	15361	42585009
Blood pressure inadequately controlled	17.29	13.65	13	20952	2855	42597515
Disorientation	17.27	13.65	48	20917	36341	42564029
Hepatic ischaemia	17.27	13.65	7	20958	452	42599918
Hypoparathyroidism	17.24	13.65	8	20957	717	42599653
Metastases to peritoneum	16.79	13.65	12	20953	2437	42597933
Renal pain	16.63	13.65	14	20951	3613	42596757
Apraxia	16.59	13.65	10	20955	1525	42598845
Potentiating drug interaction	16.38	13.65	18	20947	6450	42593920
Arterial stenosis	16.19	13.65	9	20956	1180	42599190
Confusional state	16.13	13.65	139	20826	167458	42432912
Oedema genital	16.11	13.65	7	20958	538	42599832
Respiratory failure	15.89	13.65	24	20941	128108	42472262
Renal failure	15.88	13.65	123	20842	143603	42456767
Wheezing	15.81	13.65	61	20904	54720	42545650
Gingival hypoplasia	15.70	13.65	3	20962	9	42600361
Toxicity to various agents	15.59	13.65	59	20906	229077	42371293
Peripheral arterial occlusive disease	15.56	13.65	18	20947	6820	42593550
Swollen tongue	15.42	13.65	33	20932	21198	42579172
Crepitations	15.33	13.65	13	20952	3388	42596982
External ear pain	15.03	13.65	3	20962	12	42600358
Silent myocardial infarction	14.85	13.65	6	20959	384	42599986
Urinary retention	14.72	13.65	50	20915	42164	42558206
Wrong dose	14.20	13.65	8	20957	1076	42599294
Product prescribing issue	14.04	13.65	17	20948	6756	42593614
Dyslipidaemia	13.89	13.65	20	20945	9398	42590972
Product dose omission issue	13.86	13.65	35	20930	154330	42446040
Ephelides	13.72	13.65	4	20961	94	42600276
Pancytopenia	13.71	13.65	23	20942	117720	42482650
Hyperthyroidism	13.69	13.65	25	20940	14316	42586054

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
Hyponatraemia	1719.13	12.05	1111	47524	216542	110324122
Hypokalaemia	840.04	12.05	672	47963	181776	110358888
Acute kidney injury	505.27	12.05	957	47678	634473	109906191
Drug interaction	250.38	12.05	626	48009	499557	110041107
Inappropriate antidiuretic hormone secretion	242.21	12.05	163	48472	33688	110506976
Hypomagnesaemia	212.72	12.05	191	48444	60179	110480485
Lactic acidosis	137.13	12.05	186	48449	92625	110448039
Bradycardia	123.74	12.05	235	48400	155282	110385382
Hypochloraemia	117.14	12.05	48	48587	3570	110537094
Atrial fibrillation	114.10	12.05	287	48348	229355	110311309
Confusional state	104.19	12.05	445	48190	468235	110072429
Off label use	101.57	12.05	331	48304	1499854	109040810
Maternal exposure during pregnancy	94.88	12.05	4	48631	254879	110285785
Completed suicide	89.57	12.05	4	48631	242377	110298287
Blood pressure increased	85.53	12.05	279	48356	258094	110282570
Drug ineffective	85.52	12.05	362	48273	1520178	109020486
Syncope	84.23	12.05	237	48398	202299	110338365
Death	83.70	12.05	111	48524	698758	109841906
Rhabdomyolysis	81.39	12.05	170	48465	120231	110420433
Pericarditis	79.72	12.05	4	48631	219110	110321554
Hyponatraemic seizure	79.58	12.05	24	48611	715	110539949
Hyperkalaemia	77.36	12.05	179	48456	135617	110405047
Burning mouth syndrome	77.15	12.05	23	48612	658	110540006
Hypotension	76.84	12.05	442	48193	523407	110017257
Treatment failure	71.54	12.05	17	48618	277217	110263447
Torsade de pointes	70.82	12.05	67	48568	22533	110518131
Infusion related reaction	69.06	12.05	41	48594	381121	110159543
Dizziness	64.15	12.05	525	48110	697668	109842996
Presyncope	63.30	12.05	92	48543	48795	110491869
Labile hypertension	62.56	12.05	19	48616	580	110540084
Myalgia	62.11	12.05	227	48408	222154	110318510
Pemphigus	61.99	12.05	10	48625	214560	110326104
Angioedema	61.86	12.05	135	48500	98365	110442299
Central nervous system lupus	61.66	12.05	23	48612	1330	110539334
Hypoglycaemia	58.54	12.05	146	48489	115958	110424706
Folliculitis	58.12	12.05	4	48631	167649	110373015
Duodenal ulcer perforation	56.80	12.05	6	48629	177694	110362970
Swelling	56.55	12.05	43	48592	350998	110189666
Electrocardiogram QT prolonged	55.97	12.05	138	48497	108822	110431842
Osmotic demyelination syndrome	55.52	12.05	24	48611	2039	110538625
Rectal polyp	55.26	12.05	22	48613	1518	110539146
Change of bowel habit	53.93	12.05	26	48609	2843	110537821
Blood sodium decreased	53.86	12.05	75	48560	38244	110502420
Infection	53.84	12.05	48	48587	362152	110178512
Exposure during pregnancy	52.63	12.05	6	48629	167418	110373246
Stomatitis	51.92	12.05	27	48608	270215	110270449
Drug abuse	51.85	12.05	8	48627	177403	110363261
Butterfly rash	51.55	12.05	23	48612	2108	110538556
Glossodynia	50.98	12.05	17	48618	221987	110318677
Impaired healing	50.87	12.05	12	48623	196705	110343959
Renal artery stenosis	50.30	12.05	27	48608	3699	110536965
Fall	50.21	12.05	444	48191	603038	109937626
Wound	48.76	12.05	21	48614	234416	110306248
Dehydration	48.45	12.05	247	48388	279264	110261400
Arrhythmia	47.89	12.05	99	48536	69476	110471188
Electrolyte imbalance	46.94	12.05	69	48566	36959	110503705
Disorientation	46.83	12.05	99	48536	70572	110470092
Alopecia	46.65	12.05	55	48580	364698	110175966
Arthropathy	46.58	12.05	35	48600	287487	110253177
Orthostatic hypotension	46.46	12.05	95	48540	66154	110474510
Rheumatoid factor positive	46.04	12.05	3	48632	131637	110409027
Febrile neutropenia	45.86	12.05	43	48592	316724	110223940
Psoriatic arthropathy	45.30	12.05	15	48620	196746	110343918
Discomfort	45.02	12.05	19	48616	214688	110325976
Metabolic acidosis	44.69	12.05	120	48515	99624	110441040
Sinusitis	44.47	12.05	39	48596	296649	110244015
Muscle injury	44.38	12.05	5	48630	140802	110399862
Hypovolaemia	44.09	12.05	51	48584	21623	110519041
Oedema peripheral	43.42	12.05	270	48365	328390	110212274
Sensitisation	42.26	12.05	25	48610	4126	110536538
Dyslipidaemia	41.96	12.05	43	48592	15922	110524742
Joint range of motion decreased	41.96	12.05	3	48632	121829	110418835
Left ventricular hypertrophy	40.99	12.05	39	48596	13205	110527459
Product use in unapproved indication	40.54	12.05	85	48550	447292	110093372
Migraine	39.66	12.05	13	48622	171639	110369025
Scleroedema	39.21	12.05	10	48625	157	110540507
Blood pressure inadequately controlled	39.07	12.05	30	48605	7603	110533061
Systemic lupus erythematosus	38.64	12.05	33	48602	254305	110286359
Jaundice	38.11	12.05	82	48553	59154	110481510
Intestinal haemorrhage	37.90	12.05	29	48606	7312	110533352
Urine odour abnormal	37.64	12.05	29	48606	7386	110533278
Postictal paralysis	37.49	12.05	13	48622	608	110540056
Injection site discomfort	37.24	12.05	28	48607	6879	110533785
Lupus nephritis	37.18	12.05	24	48611	4621	110536043
Lip swelling	37.13	12.05	74	48561	50593	110490071
Vessel puncture site haemorrhage	36.99	12.05	10	48625	199	110540465
Contraindicated product administered	36.76	12.05	33	48602	248234	110292430
Needle issue	36.32	12.05	42	48593	17798	110522866
Ill-defined disorder	36.03	12.05	12	48623	156841	110383823
Drug hypersensitivity	35.75	12.05	93	48542	453997	110086667
Renin increased	35.63	12.05	11	48624	355	110540309
Blood creatinine increased	35.52	12.05	167	48468	182722	110357942
Hepatic enzyme increased	35.33	12.05	54	48581	320838	110219826
Injury	35.11	12.05	17	48618	177248	110363416
Left atrial dilatation	35.09	12.05	21	48614	3539	110537125
Product packaging confusion	34.97	12.05	11	48624	378	110540286
Therapeutic product effect decreased	34.38	12.05	34	48601	244282	110296382
Hypoosmolar state	34.17	12.05	11	48624	408	110540256
Mucosal dryness	34.06	12.05	22	48613	4241	110536423
Glomerular filtration rate decreased	33.91	12.05	52	48583	28904	110511760
Furuncle	33.66	12.05	29	48606	8639	110532025
Renal failure	33.66	12.05	192	48443	226382	110314282
Hypertensive angiopathy	33.36	12.05	8	48627	96	110540568
C-reactive protein abnormal	33.35	12.05	8	48627	129687	110410977
Renal impairment	32.96	12.05	167	48468	188278	110352386
Tachyarrhythmia	32.82	12.05	28	48607	8233	110532431
Product dose omission issue	32.75	12.05	57	48578	321725	110218939
Proctalgia	31.87	12.05	34	48601	13188	110527476
Euglycaemic diabetic ketoacidosis	31.81	12.05	32	48603	11591	110529073
Glycosylated haemoglobin increased	31.37	12.05	45	48590	23574	110517090
Spur cell anaemia	31.35	12.05	8	48627	126	110540538
Swelling face	30.78	12.05	100	48535	92221	110448443
Myelosuppression	30.62	12.05	3	48632	94337	110446327
Dysuria	30.62	12.05	76	48559	60155	110480509
Urine abnormality	30.49	12.05	28	48607	9068	110531596
Hypersensitivity	30.09	12.05	85	48550	403913	110136751
Therapy non-responder	29.78	12.05	16	48619	157291	110383373
Lower respiratory tract infection	29.65	12.05	38	48597	243068	110297596
Nephropathy	29.62	12.05	33	48602	13434	110527230
Angular cheilitis	29.60	12.05	13	48622	1148	110539516
Frustration tolerance decreased	29.51	12.05	27	48608	8704	110531960
Lethargy	29.09	12.05	99	48536	93477	110447187
Pain	28.75	12.05	275	48360	954680	109585984
Ischaemic stroke	28.73	12.05	59	48576	41204	110499460
Metabolic alkalosis	28.66	12.05	22	48613	5573	110535091
Injection site reaction	28.48	12.05	3	48632	89067	110451597
Polyp	28.28	12.05	28	48607	9952	110530712
Diabetes mellitus	28.19	12.05	102	48533	99279	110441385
Bursitis	28.03	12.05	11	48624	129907	110410757
Drug dispensed to wrong patient	27.92	12.05	11	48624	738	110539926
Sprue-like enteropathy	27.80	12.05	14	48621	1682	110538982
Blood urea increased	27.57	12.05	69	48566	54888	110485776
Tubulointerstitial nephritis	27.07	12.05	68	48567	54216	110486448
Haematocrit increased	26.50	12.05	20	48615	4939	110535725
Herbal interaction	26.20	12.05	10	48625	616	110540048
Vascular access site haemorrhage	26.07	12.05	8	48627	253	110540411
Product use issue	25.94	12.05	62	48573	311633	110229031
Circulatory collapse	25.94	12.05	58	48577	42935	110497729
Blood pressure abnormal	25.88	12.05	40	48595	22384	110518280
Endoscopy upper gastrointestinal tract abnormal	25.84	12.05	6	48629	62	110540602
Bladder disorder	25.72	12.05	28	48607	11109	110529555
Mass	25.49	12.05	37	48598	19593	110521071
Musculoskeletal stiffness	25.47	12.05	53	48582	279769	110260895
Swollen tongue	25.42	12.05	71	48564	60291	110480373
Cholestasis	25.33	12.05	74	48561	64444	110476220
Diabetic foot	25.24	12.05	18	48617	4077	110536587
Thyroid disorder	25.03	12.05	34	48601	16935	110523729
Protein urine present	25.01	12.05	28	48607	11456	110529208
Dyspnoea exertional	24.75	12.05	101	48534	103959	110436705
Helicobacter test positive	24.65	12.05	12	48623	1341	110539323
Blood cholesterol increased	24.54	12.05	27	48608	184758	110355906
Sleep disorder due to general medical condition, insomnia type	24.40	12.05	8	48627	105635	110435029
Croup infectious	24.34	12.05	11	48624	1039	110539625
Oliguria	23.98	12.05	35	48600	18622	110522042
Blood glucose decreased	23.97	12.05	45	48590	29443	110511221
Hypotonia	23.91	12.05	32	48603	15713	110524951
Cardiovascular insufficiency	23.91	12.05	16	48619	3272	110537392
Adverse event	23.83	12.05	9	48626	108800	110431864
Hypocalcaemia	23.80	12.05	73	48562	65293	110475371
Diabetic metabolic decompensation	23.75	12.05	17	48618	3872	110536792
Pneumonia	23.68	12.05	259	48376	876455	109664209
Nocturia	23.50	12.05	33	48602	16957	110523707
Malaise	23.35	12.05	420	48215	671399	109869265
Road traffic accident	23.33	12.05	9	48626	107389	110433275
Glomerular filtration rate increased	23.23	12.05	13	48622	1932	110538732
Retinopathy hypertensive	23.21	12.05	9	48626	579	110540085
Drug intolerance	23.16	12.05	96	48539	406416	110134248
Potentiating drug interaction	23.02	12.05	27	48608	11616	110529048
Lower limb fracture	22.94	12.05	3	48632	75345	110465319
Postoperative wound infection	22.39	12.05	31	48604	15722	110524942
Rheumatoid arthritis	22.33	12.05	63	48572	299550	110241114
Eosinophilia	22.32	12.05	66	48569	57870	110482794
Pharyngeal swelling	22.30	12.05	27	48608	12005	110528659
Peripheral venous disease	22.00	12.05	5	48630	84112	110456552
Blood uric acid abnormal	21.86	12.05	8	48627	438	110540226
Poor dental condition	21.85	12.05	9	48626	678	110539986
Abdominal discomfort	21.82	12.05	94	48541	393764	110146900
Inflammation	21.76	12.05	32	48603	193206	110347458
Gait inability	21.56	12.05	17	48618	136359	110404305
Disease progression	21.55	12.05	47	48588	243987	110296677
Loss of consciousness	21.51	12.05	154	48481	196152	110344512
Renal artery restenosis	21.38	12.05	4	48631	12	110540652
Urinary incontinence	21.30	12.05	58	48577	48529	110492135
Peripheral coldness	21.30	12.05	33	48602	18507	110522157
Failure to suspend medication	21.19	12.05	8	48627	478	110540186
Nail pitting	21.16	12.05	8	48627	480	110540184
Haemoglobin increased	21.13	12.05	23	48612	9124	110531540
Gravitational oedema	20.82	12.05	12	48623	1886	110538778
Bundle branch block left	20.82	12.05	27	48608	12861	110527803
Atrioventricular block	20.74	12.05	31	48604	16846	110523818
Retinal detachment	20.72	12.05	25	48610	11075	110529589
Vascular resistance systemic	20.69	12.05	4	48631	15	110540649
Nail injury	20.39	12.05	9	48626	804	110539860
Gastrointestinal ischaemia	20.36	12.05	8	48627	533	110540131
Injection site erythema	20.27	12.05	8	48627	94168	110446496
Toxicity to various agents	20.25	12.05	126	48509	480429	110060235
Diabetes mellitus inadequate control	20.05	12.05	42	48593	29733	110510931
Duodenal ulcer	20.03	12.05	33	48602	19481	110521183
Erectile dysfunction	19.89	12.05	32	48603	18524	110522140
Tumour invasion	19.81	12.05	8	48627	573	110540091
Pemphigoid	19.79	12.05	33	48602	19674	110520990
Glycosylated haemoglobin decreased	19.79	12.05	9	48626	863	110539801
Hypovolaemic shock	19.69	12.05	28	48607	14555	110526109
Blood electrolytes abnormal	19.66	12.05	12	48623	2096	110538568
Prescribed overdose	19.59	12.05	7	48628	87574	110453090
Intention tremor	19.57	12.05	9	48626	885	110539779
Nasopharyngitis	19.55	12.05	98	48537	394263	110146401
Pyrexia	19.50	12.05	278	48357	897987	109642677
Heart rate decreased	19.42	12.05	80	48555	82676	110457988
Transplant dysfunction	19.34	12.05	21	48614	8307	110532357
Blood pressure systolic increased	19.30	12.05	80	48555	82911	110457753
Rash maculo-papular	19.23	12.05	74	48561	74148	110466516
Consciousness fluctuating	19.20	12.05	12	48623	2184	110538480
Cough	19.10	12.05	297	48338	461344	110079320
Mental status changes	18.98	12.05	5	48630	76117	110464547
Ventricular extrasystoles	18.96	12.05	35	48600	22606	110518058
Psychomotor retardation	18.71	12.05	20	48615	7772	110532892
Depressed mood	18.61	12.05	64	48571	60745	110479919
Pancreatic neoplasm	18.58	12.05	11	48624	1818	110538846
Hypertensive crisis	18.34	12.05	36	48599	24336	110516328
Haematoma	18.29	12.05	62	48573	58414	110482250
Nasal mucosal disorder	18.28	12.05	11	48624	1872	110538792
Paramnesia	18.14	12.05	4	48631	32	110540632
Drug level increased	18.03	12.05	54	48581	47665	110492999
Ventricular flutter	18.02	12.05	5	48630	110	110540554
Product prescribing issue	17.95	12.05	25	48610	12747	110527917
Gingival hypertrophy	17.86	12.05	15	48620	4316	110536348
Helicobacter infection	17.79	12.05	33	48602	181844	110358820
Proteinuria	17.77	12.05	48	48587	39970	110500694
Sleep disorder	17.75	12.05	38	48597	198606	110342058
Hyperlactacidaemia	17.70	12.05	20	48615	8266	110532398
Urine albumin/creatinine ratio increased	17.70	12.05	9	48626	1104	110539560
Stevens-Johnson syndrome	17.66	12.05	53	48582	46848	110493816
Peripheral artery haematoma	17.57	12.05	5	48630	121	110540543
Carotid artery stenosis	17.52	12.05	21	48614	9242	110531422
Mucocutaneous haemorrhage	17.21	12.05	6	48629	285	110540379
Bundle branch block right	17.19	12.05	24	48611	12267	110528397
Arterial stenosis	17.14	12.05	10	48625	1609	110539055
Labelled drug-drug interaction medication error	17.08	12.05	39	48596	29263	110511401
Blood glucose increased	16.94	12.05	108	48527	132388	110408276
Food interaction	16.93	12.05	11	48624	2141	110538523
Anaemia megaloblastic	16.89	12.05	8	48627	841	110539823
Chronic gastritis	16.87	12.05	16	48619	5395	110535269
Urinary retention	16.86	12.05	68	48567	69615	110471049
Liver injury	16.84	12.05	25	48610	150388	110390276
Fatigue	16.82	12.05	407	48228	1215551	109325113
Urine glucose/creatinine ratio increased	16.81	12.05	5	48630	142	110540522
Stenosis	16.78	12.05	13	48622	3338	110537326
Platelet count decreased	16.76	12.05	49	48586	230394	110310270
Hospitalisation	16.63	12.05	23	48612	142470	110398194
Sciatica	16.62	12.05	10	48625	92389	110448275
Vertigo	16.62	12.05	79	48556	86791	110453873
Liver disorder	16.56	12.05	23	48612	142220	110398444
Melaena	16.56	12.05	67	48568	68690	110471974
Renal pain	16.54	12.05	21	48614	9796	110530868
Hypouricaemia	16.46	12.05	7	48628	571	110540093
Incorrect route of product administration	16.37	12.05	4	48631	64057	110476607
Hyperhidrosis	16.14	12.05	139	48496	187159	110353505
Heart rate irregular	16.12	12.05	42	48593	34232	110506432
Gingival hypoplasia	16.03	12.05	3	48632	9	110540655
Spinal pain	15.98	12.05	29	48606	18486	110522178
Colitis ulcerative	15.96	12.05	7	48628	77356	110463308
Periorbital oedema	15.92	12.05	21	48614	10171	110530493
Renal mass	15.85	12.05	13	48622	3622	110537042
Catheter site thrombosis	15.84	12.05	7	48628	627	110540037
Oedema genital	15.76	12.05	7	48628	635	110540029
Depression	15.64	12.05	79	48556	317256	110223408
Thrombocytosis	15.52	12.05	21	48614	10423	110530241
Polydipsia	15.48	12.05	18	48617	7670	110532994
Lung neoplasm malignant	15.44	12.05	41	48594	33801	110506863
Postural tremor	15.34	12.05	8	48627	1034	110539630
Convulsive threshold lowered	15.31	12.05	8	48627	1038	110539626
Renal artery arteriosclerosis	15.23	12.05	4	48631	71	110540593
Ejection fraction decreased	15.20	12.05	46	48589	40834	110499830
Congenital methaemoglobinaemia	15.17	12.05	4	48631	72	110540592
Blood creatine phosphokinase increased	15.12	12.05	68	48567	73009	110467655
Mouth ulceration	15.02	12.05	51	48584	48087	110492577
COVID-19 pneumonia	14.96	12.05	43	48592	37100	110503564
Product monitoring error	14.89	12.05	19	48616	8908	110531756
Anuria	14.86	12.05	33	48602	24308	110516356
Skin wound	14.60	12.05	10	48625	2124	110538540
Urine output decreased	14.52	12.05	29	48606	19847	110520817
Musculoskeletal discomfort	14.47	12.05	32	48603	23506	110517158
Polyuria	14.33	12.05	27	48608	17711	110522953
Pseudogynaecomastia	14.21	12.05	4	48631	93	110540571
Protrusion tongue	14.20	12.05	6	48629	482	110540182
Therapeutic response decreased	14.07	12.05	13	48622	96486	110444178
Ear infection	14.05	12.05	5	48630	62727	110477937
Resting tremor	14.03	12.05	9	48626	1714	110538950
Vision blurred	14	12.05	101	48534	128921	110411743
Blood lactic acid increased	13.94	12.05	25	48610	15796	110524868
Frequent bowel movements	13.90	12.05	7	48628	71383	110469281
Platelet dysfunction	13.84	12.05	6	48629	513	110540151
Blood urine present	13.84	12.05	32	48603	24213	110516451
Weight increased	13.82	12.05	118	48517	419526	110121138
Fear of eating	13.74	12.05	6	48629	522	110540142
Angina pectoris	13.67	12.05	59	48576	62236	110478428
Osteoporosis	13.60	12.05	11	48624	87141	110453523
Hepatitis D	13.60	12.05	4	48631	109	110540555
Pancytopenia	13.54	12.05	47	48588	209566	110331098
Blood bilirubin abnormal	13.45	12.05	9	48626	1841	110538823
Pregnancy	13.42	12.05	3	48632	51064	110489600
Gallbladder disorder	13.40	12.05	29	48606	21000	110519664
Arteriosclerosis	13.38	12.05	32	48603	24735	110515929
Night sweats	13.38	12.05	24	48611	133959	110406705
Blood potassium decreased	13.24	12.05	53	48582	54061	110486603
Pancreatitis acute	13.16	12.05	57	48578	60217	110480447
Gastric ulcer	13.14	12.05	43	48592	39784	110500880
Multiple sclerosis relapse	13.11	12.05	3	48632	50237	110490427
External ear pain	13.10	12.05	3	48632	29	110540635
Wound infection	12.91	12.05	14	48621	96451	110444213
Hyperuricaemia	12.85	12.05	23	48612	14508	110526156
Thirst	12.77	12.05	29	48606	21678	110518986
Blister	12.75	12.05	54	48581	227322	110313342
Coronary artery occlusion	12.73	12.05	24	48611	15748	110524916
Gastrointestinal disorder	12.64	12.05	59	48576	241893	110298771
Postoperative hypertension	12.59	12.05	3	48632	35	110540629
Cardiac failure	12.56	12.05	132	48503	187494	110353170
Ear disorder	12.54	12.05	13	48622	4876	110535788
Plasma cell myeloma	12.51	12.05	6	48629	62930	110477734
Hypoparathyroidism	12.48	12.05	8	48627	1522	110539142
Drug level above therapeutic	12.44	12.05	20	48615	11568	110529096
Hypocalciuria	12.44	12.05	3	48632	37	110540627
Acute myocardial infarction	12.43	12.05	71	48564	83706	110456958
Epistaxis	12.43	12.05	99	48536	130273	110410391
Ephelides	12.41	12.05	4	48631	149	110540515
Parkinsonian gait	12.36	12.05	7	48628	1065	110539599
Ventricular tachycardia	12.25	12.05	49	48586	49960	110490704
Lipase increased	12.18	12.05	26	48609	18646	110522018
Angle closure glaucoma	12.18	12.05	11	48624	3488	110537176
Brain stem haematoma	12.14	12.05	4	48631	160	110540504
Vasoconstriction	12.13	12.05	7	48628	1103	110539561
Injection site swelling	12.12	12.05	6	48629	61784	110478880
Hyperlipidaemia	12.10	12.05	39	48596	35809	110504855

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C03BA11	CARDIOVASCULAR SYSTEM DIURETICS LOW-CEILING DIURETICS, EXCL. THIAZIDES Sulfonamides, plain
ATC	C09BX01	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors, other combinations
ATC	C09BX06	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors, other combinations
ATC	C09DX09	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C10BX13	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
FDA PE	N0000175359	Increased Diuresis
FDA EPC	N0000175420	Thiazide-like Diuretic
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004232	Diuretics
MeSH PA	D045283	Natriuretic Agents
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D049993	Sodium Chloride Symporter Inhibitors
CHEBI has role	CHEBI:35498	diuretic
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:35674	antihypertensive agent
CHEBI has role	CHEBI:35705	immunosuppressive agent

Related Drugs by ATC class:

C03BA Sulfonamides, plain 10 drugs

chlortalidone clofenamide clopamide clorexolone fenquizone mefruside meticrane metolazone quinethazone xipamide

C09BX ACE inhibitors, other combinations 7 drugs

amlodipine bisoprolol hydrochlorothiazide nebivolol perindopril ramipril zofenopril

C09DX Angiotensin II receptor blockers (ARBs), other combinations 10 drugs

aliskiren amlodipine candesartan cilexetil hydrochlorothiazide irbesartan nebivolol olmesartan medoxomil sacubitril telmisartan valsartan

C10BX Lipid modifying agents in combination with other drugs 14 drugs

acetylsalicylic acid amlodipine atorvastatin candesartan cilexetil fimasartan lisinopril nebivolol perindopril pravastatin ramipril rosuvastatin simvastatin show all 14 →

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Edema	indication	267038008
Anuria	contraindication	2472002	DOID:2983
Dehydration	contraindication	34095006
Hyperuricemia	contraindication	35885006	DOID:1920
Hypokalemia	contraindication	43339004
Sympathectomy	contraindication	57071006
Acute nephropathy	contraindication	58574008
Hyperparathyroidism	contraindication	66999008	DOID:13543
Diabetes mellitus	contraindication	73211009	DOID:9351
Oliguria	contraindication	83128009
Hyponatremia	contraindication	89627008
Gout	contraindication	90560007	DOID:13189
Disease of liver	contraindication	235856003	DOID:409

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.53	acidic
pKa2	9.54	acidic
pKa3	5.52	Basic

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 2.5MG BASE;1.25MG;20MG	WIDAPLIK	AZURITY	N219423	June 5, 2025	DISCN	TABLET	ORAL	10799487	Jan. 23, 2038	A METHOD OF TREATING HYPERTENSION

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 1.25MG BASE;0.625MG;10MG	WIDAPLIK	AZURITY	N219423	June 5, 2025	DISCN	TABLET	ORAL	June 5, 2028	NEW PRODUCT
EQ 2.5MG BASE;1.25MG;20MG	WIDAPLIK	AZURITY	N219423	June 5, 2025	DISCN	TABLET	ORAL	June 5, 2028	NEW PRODUCT
EQ 5MG BASE;2.5MG;40MG	WIDAPLIK	AZURITY	N219423	June 5, 2025	DISCN	TABLET	ORAL	June 5, 2028	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Solute carrier family 12 member 3	Transporter	P55017	S12A3_HUMAN	INHIBITOR	A2	7.54	WOMBAT-PK	CHEMBL
Carbonic anhydrase 2	Enzyme	P00918	CAH2_HUMAN		Kd	6.70	CHEMBL
Carbonic anhydrase 1	Enzyme	P00915	CAH1_HUMAN		Kd	5	CHEMBL
Carbonic anhydrase 4	Enzyme	P22748	CAH4_HUMAN		Ki	6.67	CHEMBL
Carbonic anhydrase 9	Enzyme	Q16790	CAH9_HUMAN		Ki	7.44	CHEMBL
Carbonic anhydrase 12	Enzyme	O43570	CAH12_HUMAN		Ki	8	CHEMBL
Potassium voltage-gated channel subfamily KQT member 1	Ion channel	P51787	KCNQ1_HUMAN				WOMBAT-PK
Carbonic anhydrase 5A, mitochondrial	Enzyme	P35218	CAH5A_HUMAN		Ki	6.05	CHEMBL
Carbonic anhydrase 5B, mitochondrial	Enzyme	Q9Y2D0	CAH5B_HUMAN		Ki	6.56	CHEMBL
Carbonic anhydrase 7	Enzyme	P43166	CAH7_HUMAN		Ki	9.64	CHEMBL
Carbonic anhydrase 6	Enzyme	P23280	CAH6_HUMAN		Kd	6.60	CHEMBL
Carbonic anhydrase 14	Enzyme	Q9ULX7	CAH14_HUMAN		Ki	5.31	CHEMBL
Carbonic anhydrase 13	Enzyme	Q8N1Q1	CAH13_HUMAN		Kd	7	CHEMBL
Carbonic anhydrase 3	Enzyme	P07451	CAH3_HUMAN		Kd	4.96	CHEMBL
N-acyl-phosphatidylethanolamine-hydrolyzing phospholipase D	Enzyme	Q6IQ20	NAPEP_HUMAN	ALLOSTERIC MODULATOR	Kd	6.24	IUPHAR
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.54	DRUG MATRIX
Carbonic anhydrase 13	Enzyme		CAH13_MOUSE		Ki	7.89	CHEMBL

External reference:

ID	Source
4018746	VUID
N0000147050	NUI
D00345	KEGG_DRUG
180004-24-4	SECONDARY_CAS_RN
4018746	VANDF
C0021186	UMLSCUI
CHEBI:5893	CHEBI
BL1	PDB_CHEM_ID
CHEMBL406	ChEMBL_ID
DB00808	DRUGBANK_ID
D007190	MESH_DESCRIPTOR_UI
3702	PUBCHEM_CID
7203	IUPHAR_LIGAND_ID
3333	INN_ID
F089I0511L	UNII
5764	RXNORM
2360	MMSL
4873	MMSL
d00260	MMSL
002313	NDDF
387419003	SNOMEDCT_US
725661001	SNOMEDCT_US
74213004	SNOMEDCT_US
F089I0511L	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2571	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2571	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2597	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2597	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	Human Prescription Drug Label	1	16571-875	TABLET	1.25 mg	ORAL	ANDA	18 sections
Indapamide	Human Prescription Drug Label	1	16571-876	TABLET	2.50 mg	ORAL	ANDA	18 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	21695-576	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	20 sections
WIDAPLIK	Human Prescription Drug Label	3	24338-001	TABLET	0.63 mg	ORAL	NDA	27 sections
WIDAPLIK	Human Prescription Drug Label	3	24338-002	TABLET	1.25 mg	ORAL	NDA	27 sections
WIDAPLIK	Human Prescription Drug Label	3	24338-003	TABLET	2.50 mg	ORAL	NDA	27 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	50090-7826	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	50090-7828	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	51407-024	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	51407-025	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	62559-510	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	62559-511	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1953	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1953	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1954	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1954	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	68151-1294	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	20 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	68788-7247	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	71335-1541	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	72162-1766	TABLET, FILM COATED	1.25 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	72162-1767	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	19 sections
Indapamide	HUMAN PRESCRIPTION DRUG LABEL	1	72189-591	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	12 sections

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indapamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: