All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
	1497	54-85-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: isoniazid 4-Pyridinecarboxylic hydrazide armazid isoniazide isonicotinohydrazide	Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis. Molecular weight: 137.14 Formula: C6H7N3O CLOGP: -0.67 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 68.01 ALOGS: -0.59 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.30	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	140 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	7 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	72.92 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.82 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	7.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Sept. 29, 1952	FDA	SANDOZ

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 reaction with eosinophilia and systemic symptoms	641.63	13.88	285	21411	33551	63433775
Drug-induced liver injury	498.99	13.88	253	21443	39969	63427357
Paradoxical drug reaction	463.63	13.88	131	21565	4021	63463305
Acute hepatic failure	342.72	13.88	153	21543	18174	63449152
Drug resistance	277.63	13.88	142	21554	22791	63444535
Hepatitis	255.99	13.88	163	21533	39625	63427701
Hepatotoxicity	238.92	13.88	152	21544	36889	63430437
Tuberculoma of central nervous system	222.41	13.88	45	21651	302	63467024
Tuberculosis	217.26	13.88	96	21600	11115	63456211
Jaundice	211.26	13.88	129	21567	29122	63438204
Hepatic encephalopathy	194.41	13.88	89	21607	11193	63456133
Immune reconstitution inflammatory syndrome	192.54	13.88	74	21622	6010	63461316
Immune reconstitution inflammatory syndrome associated tuberculosis	178.97	13.88	38	21658	332	63466994
Pulmonary tuberculosis	164.91	13.88	61	21635	4456	63462870
Drug interaction	161.19	13.88	284	21412	228847	63238479
Loss of employment	159.70	13.88	50	21646	2194	63465132
Pyrexia	113.14	13.88	385	21311	470093	62997233
Hepatic failure	112.44	13.88	95	21601	35561	63431765
Exposure during pregnancy	99.28	13.88	185	21511	155362	63311964
Encephalopathy	98.04	13.88	91	21605	38529	63428797
Hepatic steatosis	97.66	13.88	80	21616	28689	63438637
Hepatic function abnormal	97.17	13.88	89	21607	37053	63430273
Disseminated tuberculosis	94.75	13.88	36	21660	2831	63464495
Cerebellar ataxia	94.09	13.88	27	21669	875	63466451
Transaminases increased	83.68	13.88	76	21620	31291	63436035
Liver injury	81.60	13.88	102	21594	60418	63406908
Alanine aminotransferase increased	78.50	13.88	133	21563	103637	63363689
Myocarditis	78.27	13.88	47	21649	10278	63457048
Aspartate aminotransferase increased	76.78	13.88	122	21574	90155	63377171
Pancreatitis haemorrhagic	74.17	13.88	20	21676	513	63466813
Lymphadenopathy	74.15	13.88	78	21618	38380	63428946
Eosinophilia	72.49	13.88	61	21635	22695	63444631
Gastric disorder	67.12	13.88	73	21623	37296	63430030
Liver disorder	66.87	13.88	87	21609	53600	63413726
Lymph node tuberculosis	66.16	13.88	20	21676	779	63466547
Fatigue	65.69	13.88	128	21568	887900	62579426
Pain	63.63	13.88	97	21599	740531	62726795
Pneumocystis jirovecii pneumonia	59.43	13.88	48	21648	16866	63450460
Multiple organ dysfunction syndrome	58.62	13.88	84	21612	56668	63410658
Congestive hepatopathy	56.36	13.88	25	21671	2917	63464409
Generalised tonic-clonic seizure	54.42	13.88	58	21638	28958	63438368
Meningitis tuberculous	54.11	13.88	16	21680	577	63466749
Face oedema	53.95	13.88	49	21647	20163	63447163
Tuberculosis gastrointestinal	51.92	13.88	14	21682	359	63466967
Distributive shock	51.67	13.88	19	21677	1364	63465962
Arthropathy	49.53	13.88	10	21686	234782	63232544
Glossodynia	49.16	13.88	3	21693	178873	63288453
Tuberculin test positive	49.11	13.88	24	21672	3487	63463839
Hepatitis toxic	47.81	13.88	23	21673	3230	63464096
Mycobacterium tuberculosis complex test positive	45.94	13.88	20	21676	2231	63465095
Hand deformity	42.85	13.88	3	21693	159454	63307872
Alopecia	42.48	13.88	32	21664	337504	63129822
Liver transplant	42.39	13.88	19	21677	2272	63465054
Glomerulonephritis minimal lesion	42.31	13.88	11	21685	244	63467082
Oedematous pancreatitis	41.56	13.88	13	21683	568	63466758
Wound	41.31	13.88	4	21692	163259	63304067
Hepatitis fulminant	40.59	13.88	21	21675	3443	63463883
Latent tuberculosis	39.90	13.88	19	21677	2608	63464718
Oedematous kidney	39.56	13.88	9	21687	111	63467215
Synovitis	39.33	13.88	8	21688	186910	63280416
Swelling	38.82	13.88	23	21673	275355	63191971
Hepatocellular injury	38.25	13.88	47	21649	27334	63439992
Aspergillus infection	37.30	13.88	27	21669	8066	63459260
Pleural effusion	36.46	13.88	91	21605	93119	63374207
Hepatic necrosis	35.79	13.88	23	21673	5664	63461662
Hepatic haematoma	35.59	13.88	11	21685	462	63466864
Product dose omission issue	35.30	13.88	18	21678	234295	63233031
Focal dyscognitive seizures	35.06	13.88	18	21678	2903	63464423
Coagulopathy	34.92	13.88	39	21657	20505	63446821
Cardiac failure	34.84	13.88	87	21609	89055	63378271
Hepatosplenomegaly	33.98	13.88	17	21679	2597	63464729
Disseminated intravascular coagulation	33.82	13.88	37	21659	19014	63448312
Mycoplasma genitalium infection	33.58	13.88	6	21690	18	63467308
Discomfort	33.52	13.88	8	21688	167366	63299960
Serotonin syndrome	33.42	13.88	45	21651	28637	63438689
Systemic lupus erythematosus	33.06	13.88	15	21681	208903	63258423
Rash maculo-papular	32.62	13.88	47	21649	31849	63435477
Sinusitis	31.83	13.88	19	21677	226634	63240692
Drug level decreased	31.10	13.88	24	21672	7895	63459431
Treatment noncompliance	31.09	13.88	50	21646	37275	63430051
Jarisch-Herxheimer reaction	29.35	13.88	9	21687	368	63466958
Hemianopia heteronymous	29.19	13.88	6	21690	44	63467282
Joint swelling	28.90	13.88	42	21654	327624	63139702
Fall	28.46	13.88	57	21639	392277	63075049
Bovine tuberculosis	28.40	13.88	6	21690	51	63467275
Cholestatic liver injury	28.23	13.88	15	21681	2595	63464731
Tuberculous pleurisy	28.20	13.88	9	21687	420	63466906
Hypertransaminasaemia	28.09	13.88	21	21675	6588	63460738
Multiple-drug resistance	27.90	13.88	19	21677	5151	63462175
Peritoneal tuberculosis	26.92	13.88	9	21687	487	63466839
Pathogen resistance	26.46	13.88	20	21676	6378	63460948
Gamma-glutamyltransferase increased	26.20	13.88	44	21652	33987	63433339
Ocular icterus	26.05	13.88	16	21680	3640	63463686
Pericardial effusion	26.05	13.88	41	21655	30017	63437309
Cardiac failure congestive	25.98	13.88	80	21616	92353	63374973
Liver function test abnormal	25.46	13.88	53	21643	48128	63419198
Hepatitis B core antibody positive	25.10	13.88	7	21689	204	63467122
Immune system disorder	24.61	13.88	23	21673	9811	63457515
Abdominal pain upper	23.91	13.88	136	21560	206308	63261018
Seizure	23.74	13.88	99	21597	132535	63334791
Interstitial lung disease	23.74	13.88	60	21636	61848	63405478
Pancreatitis acute	23.46	13.88	37	21659	27129	63440197
Contusion	23.38	13.88	11	21685	150033	63317293
Acute respiratory distress syndrome	23.07	13.88	34	21662	23500	63443826
Microcytic anaemia	21.90	13.88	14	21682	3415	63463911
Mastitis bacterial	21.88	13.88	5	21691	63	63467263
Neurotoxicity	21.87	13.88	28	21668	16962	63450364
Bilirubin conjugated increased	21.73	13.88	13	21683	2821	63464505
Trichophytosis	21.67	13.88	5	21691	66	63467260
Helicobacter infection	21.65	13.88	3	21693	92782	63374544
Peripheral swelling	21.61	13.88	36	21660	265906	63201420
Cytomegalovirus infection	21.60	13.88	31	21665	20921	63446405
Maternal exposure during breast feeding	21.51	13.88	15	21681	4226	63463100
Toxic optic neuropathy	21.07	13.88	6	21690	189	63467137
Blood bilirubin increased	20.97	13.88	42	21654	37098	63430228
Pericarditis tuberculous	20.94	13.88	4	21692	19	63467307
Liver transplant rejection	20.64	13.88	10	21686	1425	63465901
Pseudomembranous colitis	20.61	13.88	13	21683	3099	63464227
Electrocardiogram ST segment elevation	20.18	13.88	14	21682	3913	63463413
Blood beta-D-glucan increased	20.17	13.88	6	21690	221	63467105
Pericarditis	19.96	13.88	10	21686	131569	63335757
Intentional overdose	19.75	13.88	63	21633	74089	63393237
Infectious pleural effusion	19.71	13.88	10	21686	1573	63465753
Oral candidiasis	19.62	13.88	31	21665	22767	63444559
Infection	19.58	13.88	30	21666	229143	63238183
Hyperinsulinaemia	19.40	13.88	5	21691	107	63467219
Stillbirth	19.27	13.88	17	21679	6733	63460593
Hypersensitivity	19.15	13.88	45	21651	292640	63174686
Central venous pressure increased	19.14	13.88	5	21691	113	63467213
Hepatic cyst	18.90	13.88	15	21681	5139	63462187
Joint tuberculosis	18.82	13.88	5	21691	121	63467205
Mobility decreased	18.69	13.88	9	21687	121150	63346176
Lower respiratory tract infection	18.69	13.88	11	21685	132296	63335030
Cytomegalovirus chorioretinitis	18.54	13.88	10	21686	1783	63465543
Pneumonia lipoid	18.44	13.88	5	21691	131	63467195
Anxiety	18.09	13.88	29	21667	217512	63249814
Status epilepticus	17.89	13.88	24	21672	15209	63452117
Optic neuritis	17.86	13.88	18	21678	8417	63458909
Nephrotic syndrome	17.86	13.88	15	21681	5561	63461765
Fibromyalgia	17.85	13.88	3	21693	80417	63386909
Substance-induced psychotic disorder	17.75	13.88	10	21686	1941	63465385
Shock	17.61	13.88	30	21666	23433	63443893
Vaginal flatulence	17.53	13.88	12	21684	3281	63464045
Feeling abnormal	17.47	13.88	15	21681	148377	63318949
Granuloma	17.43	13.88	15	21681	5746	63461580
Interferon gamma release assay positive	17.39	13.88	4	21692	52	63467274
Optic neuropathy	17.37	13.88	10	21686	2022	63465304
Memory impairment	17.26	13.88	7	21689	104251	63363075
Encephalitis	17.09	13.88	18	21678	8862	63458464
AIDS related complication	17.05	13.88	3	21693	8	63467318
Death	17.04	13.88	68	21628	374313	63093013
Intraventricular haemorrhage neonatal	17.03	13.88	5	21691	176	63467150
Drug level increased	16.98	13.88	29	21667	22707	63444619
Muscle spasms	16.95	13.88	17	21679	156133	63311193
Impaired healing	16.79	13.88	7	21689	102535	63364791
Cerebrovascular accident	16.70	13.88	8	21688	108016	63359310
Vaginal discharge	16.56	13.88	18	21678	9180	63458146
Cardiac arrest	16.49	13.88	69	21627	92476	63374850
Nicotinic acid deficiency	16.39	13.88	4	21692	68	63467258
Lupus-like syndrome	16.31	13.88	23	21673	15272	63452054
Renal transplant failure	16.30	13.88	7	21689	755	63466571
Ill-defined disorder	16.18	13.88	4	21692	81751	63385575
Ascites	16.16	13.88	40	21656	40688	63426638
Acid fast bacilli infection	15.83	13.88	4	21692	79	63467247
Insomnia	15.81	13.88	31	21665	215221	63252105
Organising pneumonia	15.40	13.88	14	21682	5762	63461564
Hospitalisation	15.29	13.88	5	21691	85076	63382250
Lymphadenitis	15.26	13.88	11	21685	3264	63464062
Nasopharyngitis	15.14	13.88	41	21655	254216	63213110
Rash morbilliform	15.11	13.88	11	21685	3314	63464012
Dry mouth	15.04	13.88	4	21692	77859	63389467
Liver palpable	14.98	13.88	3	21693	19	63467307
Thalassaemia	14.71	13.88	4	21692	106	63467220
Metabolic acidosis	14.56	13.88	41	21655	45028	63422298
Respiratory failure	14.45	13.88	71	21625	101787	63365539
Hydrocephalus	14.44	13.88	13	21683	5287	63462039
Hepatomegaly	14.38	13.88	19	21677	11870	63455456
Congenital skin dimples	14.30	13.88	4	21692	118	63467208
Lymph node abscess	14.25	13.88	3	21693	25	63467301
Transplant rejection	14.24	13.88	18	21678	10762	63456564
Aplasia pure red cell	14.23	13.88	12	21684	4475	63462851
Antipsychotic drug level above therapeutic	14.20	13.88	7	21689	1036	63466290
C-reactive protein increased	14.14	13.88	67	21629	94640	63372686
Methylobacterium infection	14.05	13.88	3	21693	27	63467299
Computerised tomogram abnormal	14.03	13.88	9	21687	2208	63465118
Back pain	13.99	13.88	45	21651	264100	63203226
Pain in extremity	13.97	13.88	62	21634	331424	63135902
Dysdiadochokinesis	13.96	13.88	4	21692	129	63467197
Haemodilution	13.96	13.88	4	21692	129	63467197
Paraparesis	13.92	13.88	9	21687	2239	63465087
Arachnoiditis	13.90	13.88	5	21691	337	63466989

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
Paradoxical drug reaction	865.35	14.66	229	20136	3122	34933444
Drug-induced liver injury	503.82	14.66	272	20093	28560	34908006
Immune reconstitution inflammatory syndrome	456.54	14.66	177	20188	8582	34927984
Drug reaction with eosinophilia and systemic symptoms	391.29	14.66	242	20123	32770	34903796
Hepatotoxicity	356.55	14.66	196	20169	21289	34915277
Jaundice	294.70	14.66	200	20165	31682	34904884
Drug resistance	286.79	14.66	182	20183	25745	34910821
Immune reconstitution inflammatory syndrome associated tuberculosis	254.48	14.66	58	20307	400	34936166
Tuberculosis	229.18	14.66	108	20257	8469	34928097
Tuberculoma of central nervous system	188.21	14.66	41	20324	223	34936343
Hepatitis	185.94	14.66	135	20230	23769	34912797
Pulmonary tuberculosis	178.62	14.66	76	20289	4678	34931888
Drug interaction	112.49	14.66	337	20028	225609	34710957
Pyrexia	94.25	14.66	413	19952	332600	34603966
Immune system disorder	91.23	14.66	49	20316	5066	34931500
Meningitis tuberculous	87.21	14.66	27	20338	658	34935908
Disseminated tuberculosis	81.99	14.66	35	20330	2170	34934396
Hydrocephalus	81.94	14.66	46	20319	5186	34931380
Acute hepatic failure	77.85	14.66	65	20300	14009	34922557
Alanine aminotransferase increased	77.06	14.66	155	20210	80660	34855906
Hepatic function abnormal	75.34	14.66	110	20255	44253	34892313
Death	70.60	14.66	77	20288	397972	34538594
Granuloma	69.01	14.66	35	20330	3216	34933350
Optic neuritis	68.72	14.66	36	20329	3538	34933028
Liver function test abnormal	67.80	14.66	87	20278	30987	34905579
Tuberculosis of central nervous system	67.25	14.66	17	20348	190	34936376
Drug level decreased	67.15	14.66	47	20318	7799	34928767
Hepatic enzyme increased	65.05	14.66	96	20269	38984	34897582
Hepatitis toxic	61.68	14.66	29	20336	2258	34934308
Lymphadenopathy	57.91	14.66	77	20288	28386	34908180
Lymph node tuberculosis	57.81	14.66	18	20347	447	34936119
Mycobacterial infection	57.62	14.66	28	20337	2346	34934220
Tubulointerstitial nephritis	57.48	14.66	66	20299	20958	34915608
Optic neuropathy	56.36	14.66	26	20339	1939	34934627
Hepatic failure	54.85	14.66	83	20282	34448	34902118
Aspartate aminotransferase increased	54.15	14.66	121	20244	67662	34868904
Fall	53.04	14.66	26	20339	202859	34733707
Transaminases increased	50.67	14.66	70	20295	26753	34909813
Tuberculous pleurisy	48.16	14.66	15	20350	373	34936193
Tuberculosis of eye	48.03	14.66	10	20355	42	34936524
Bone tuberculosis	47.45	14.66	15	20350	392	34936174
Skin disorder	46.56	14.66	48	20317	13507	34923059
Tuberculosis gastrointestinal	45.85	14.66	13	20352	231	34936335
Granulomatous liver disease	45.10	14.66	16	20349	601	34935965
Pyelonephritis fungal	43.49	14.66	10	20355	72	34936494
Latent tuberculosis	42.13	14.66	19	20346	1344	34935222
Thalamic infarction	41.42	14.66	16	20349	765	34935801
Liver disorder	41.06	14.66	71	20294	32926	34903640
Hepatitis fulminant	40.35	14.66	27	20338	4163	34932403
Complications of transplanted kidney	40.35	14.66	28	20337	4581	34931985
Central nervous system vasculitis	40.27	14.66	14	20351	495	34936071
Multiple-drug resistance	39.36	14.66	29	20336	5210	34931356
Toxic epidermal necrolysis	38.66	14.66	55	20310	21591	34914975
Diaphragmatic injury	38.46	14.66	10	20355	126	34936440
Demodicidosis	38.06	14.66	11	20354	210	34936356
Blood bilirubin increased	35.91	14.66	73	20292	38223	34898343
Splenic embolism	34.69	14.66	10	20355	189	34936377
Type III immune complex mediated reaction	34.35	14.66	11	20354	300	34936266
Drug eruption	33.26	14.66	49	20316	19849	34916717
Mycobacterium tuberculosis complex test positive	33.20	14.66	16	20349	1316	34935250
Strongyloidiasis	32.36	14.66	20	20345	2691	34933875
Optic atrophy	32.31	14.66	14	20351	900	34935666
Tuberculin test positive	32.09	14.66	15	20350	1152	34935414
Sideroblastic anaemia	32.09	14.66	10	20355	249	34936317
Vitamin B1 decreased	29.48	14.66	10	20355	328	34936238
Product dose omission issue	28.81	14.66	17	20348	119694	34816872
Peritoneal tuberculosis	28.62	14.66	10	20355	359	34936207
Pain	28.61	14.66	47	20318	204628	34731938
Atrial fibrillation	28.60	14.66	18	20347	122375	34814191
Colour blindness	27.95	14.66	9	20356	250	34936316
Eosinophilia	27.01	14.66	52	20313	26170	34910396
Mycobacterium fortuitum infection	26.65	14.66	8	20357	175	34936391
Condition aggravated	26.45	14.66	197	20168	191999	34744567
Pathogen resistance	26.30	14.66	30	20335	9452	34927114
Lichenoid keratosis	26.19	14.66	17	20348	2491	34934075
Marrow hyperplasia	26.09	14.66	13	20352	1150	34935416
Encephalopathy	25.91	14.66	61	20304	35258	34901308
Diarrhoea	25.40	14.66	129	20236	389783	34546783
Liver injury	25.39	14.66	37	20328	14841	34921725
Rash maculo-papular	25.22	14.66	53	20312	28398	34908168
Hypotension	24.83	14.66	58	20307	221591	34714975
Ocular toxicity	24.58	14.66	8	20357	230	34936336
Splenic abscess	24.52	14.66	9	20356	373	34936193
Pancytopenia	24.44	14.66	115	20250	95042	34841524
Dyspnoea	24.34	14.66	125	20240	376657	34559909
Myocardial infarction	24.16	14.66	21	20344	121064	34815502
Encephalitis	23.61	14.66	25	20340	7252	34929314
Completed suicide	23.53	14.66	14	20351	98154	34838412
Oral candidiasis	23.45	14.66	32	20333	12078	34924488
Malignant neoplasm progression	23.40	14.66	11	20354	88035	34848531
Hepatic encephalopathy	22.88	14.66	35	20330	14650	34921916
Urinary tract inflammation	22.67	14.66	7	20358	169	34936397
Mitochondrial neurogastrointestinal encephalopathy	22.55	14.66	4	20361	5	34936561
Feeling abnormal	21.88	14.66	5	20360	63230	34873336
Hyperuricaemia	21.56	14.66	25	20340	8018	34928548
Constipation	21.51	14.66	29	20336	136953	34799613
Bovine tuberculosis	21.36	14.66	6	20359	103	34936463
Genitourinary tract infection	21.30	14.66	6	20359	104	34936462
Pulmonary sequestration	21.28	14.66	5	20360	40	34936526
Autoimmune haemolytic anaemia	21.28	14.66	19	20346	4477	34932089
Liver transplant	21.26	14.66	15	20350	2519	34934047
Disseminated intravascular coagulation	20.93	14.66	42	20323	21774	34914792
Papule	20.60	14.66	18	20347	4121	34932445
Pulmonary granuloma	20.09	14.66	12	20353	1518	34935048
Granulomatous lymphadenitis	20	14.66	6	20359	131	34936435
Hepatic necrosis	19.90	14.66	17	20348	3777	34932789
Urogenital infection bacterial	19.77	14.66	5	20360	56	34936510
Chronic allograft nephropathy	19.54	14.66	11	20354	1246	34935320
Dilatation intrahepatic duct acquired	19.45	14.66	5	20360	60	34936506
Tuberculoid leprosy	19.38	14.66	5	20360	61	34936505
Papilloma	19.33	14.66	7	20358	279	34936287
Hereditary optic atrophy	19.17	14.66	4	20361	17	34936549
Brain oedema	18.86	14.66	31	20334	13790	34922776
Liver transplant rejection	18.84	14.66	13	20352	2106	34934460
Conductive deafness	18.78	14.66	7	20358	303	34936263
Febrile neutropenia	18.57	14.66	32	20333	136817	34799749
Herpes zoster meningoencephalitis	18.50	14.66	7	20358	316	34936250
Implant site infection	18.20	14.66	10	20355	1080	34935486
Nasopharyngitis	18.19	14.66	9	20356	69959	34866607
Past-pointing	18.17	14.66	4	20361	23	34936543
Bilirubin conjugated increased	17.86	14.66	15	20350	3256	34933310
Protrusion tongue	17.80	14.66	6	20359	193	34936373
Vasculitis	17.71	14.66	27	20338	11269	34925297
Lymphopenia	17.57	14.66	33	20332	16302	34920264
Trisomy 21	17.56	14.66	8	20357	579	34935987
Renal atrophy	17.42	14.66	10	20355	1175	34935391
Insomnia	17.34	14.66	21	20344	103886	34832680
Psoas abscess	17.24	14.66	8	20357	604	34935962
Cardiac failure congestive	17.14	14.66	14	20351	83256	34853310
Spermatozoa progressive motility abnormal	17.14	14.66	4	20361	31	34936535
Testicular mass	17.13	14.66	5	20360	99	34936467
Generalised tonic-clonic seizure	17.11	14.66	38	20327	21136	34915430
Neuropsychiatric symptoms	17.09	14.66	9	20356	893	34935673
Cachexia	17.06	14.66	21	20344	7165	34929401
Erythrodermic psoriasis	17.05	14.66	9	20356	898	34935668
Unmasking of previously unidentified disease	16.98	14.66	9	20356	905	34935661
Hemianopia heteronymous	16.81	14.66	4	20361	34	34936532
Splenic infarction	16.76	14.66	12	20353	2063	34934503
Dermatitis exfoliative	16.74	14.66	20	20345	6619	34929947
Leprosy	16.72	14.66	5	20360	108	34936458
Delayed graft function	16.02	14.66	12	20353	2209	34934357
COVID-19	16.01	14.66	13	20352	77537	34859029
Cross sensitivity reaction	15.90	14.66	10	20355	1387	34935179
Coma hepatic	15.89	14.66	7	20358	468	34936098
Disease progression	15.85	14.66	24	20341	108053	34828513
Spermatozoa progressive motility decreased	15.80	14.66	5	20360	131	34936435
Optic disc hyperaemia	15.74	14.66	3	20362	7	34936559
Peripheral swelling	15.59	14.66	13	20352	76528	34860038
Myxoedema coma	15.59	14.66	6	20359	284	34936282
Splenomegaly	15.59	14.66	30	20335	15087	34921479
Thrombosis	15.55	14.66	5	20360	50453	34886113
Hepatitis cholestatic	15.39	14.66	21	20344	7926	34928640
Renal transplant failure	15.38	14.66	9	20356	1097	34935469
Ototoxicity	15.28	14.66	11	20354	1906	34934660
Transplant rejection	15.26	14.66	24	20341	10287	34926279
Cryptococcosis	15.11	14.66	12	20353	2407	34934159
Fatigue	14.98	14.66	141	20224	370512	34566054
Trichoglossia	14.87	14.66	6	20359	322	34936244
Hepatocellular injury	14.83	14.66	37	20328	22174	34914392
Chronic obstructive pulmonary disease	14.81	14.66	5	20360	48913	34887653
Adrenocortical insufficiency acute	14.66	14.66	10	20355	1590	34934976

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
Paradoxical drug reaction	1263.69	12.59	348	37824	6837	79699379
Drug reaction with eosinophilia and systemic symptoms	981.55	12.59	519	37653	63725	79642491
Drug-induced liver injury	950.70	12.59	513	37659	65604	79640612
Immune reconstitution inflammatory syndrome	625.28	12.59	239	37933	13602	79692614
Hepatotoxicity	524.39	12.59	319	37853	51033	79655183
Jaundice	510.63	12.59	318	37854	53031	79653185
Drug resistance	493.03	12.59	286	37886	41927	79664289
Immune reconstitution inflammatory syndrome associated tuberculosis	436.11	12.59	97	38075	739	79705477
Acute hepatic failure	411.02	12.59	226	37946	29887	79676329
Tuberculosis	386.02	12.59	174	37998	15024	79691192
Tuberculoma of central nervous system	366.84	12.59	79	38093	508	79705708
Hepatitis	350.29	12.59	256	37916	55471	79650745
Pulmonary tuberculosis	334.41	12.59	130	38042	7735	79698481
Drug interaction	246.20	12.59	584	37588	414599	79291617
Pyrexia	195.49	12.59	739	37433	677970	79028246
Hepatic encephalopathy	170.10	12.59	119	38053	24047	79682169
Disseminated tuberculosis	149.46	12.59	61	38111	4122	79702094
Hepatic function abnormal	146.80	12.59	178	37994	72929	79633287
Meningitis tuberculous	138.69	12.59	42	38130	1163	79705053
Loss of employment	136.18	12.59	50	38122	2537	79703679
Hepatic failure	134.38	12.59	156	38016	61056	79645160
Lymphadenopathy	127.57	12.59	142	38030	53105	79653111
Alanine aminotransferase increased	124.70	12.59	254	37918	162316	79543900
Lymph node tuberculosis	119.53	12.59	36	38136	978	79705238
Immune system disorder	116.26	12.59	70	38102	10959	79695257
Transaminases increased	112.11	12.59	131	38041	51612	79654604
Drug level decreased	108.59	12.59	74	38098	14328	79691888
Hepatitis toxic	103.01	12.59	50	38122	5097	79701119
Aspartate aminotransferase increased	102.03	12.59	213	37959	138428	79567788
Liver injury	97.95	12.59	128	38044	56486	79649730
Hydrocephalus	95.14	12.59	57	38115	8843	79697373
Pain	92.61	12.59	121	38051	703681	79002535
Eosinophilia	85.49	12.59	107	38065	45238	79660978
Tuberculosis gastrointestinal	83.56	12.59	24	38148	550	79705666
Fall	81.91	12.59	68	38104	487561	79218655
Encephalopathy	80.79	12.59	128	38044	67269	79638947
Optic neuropathy	79.36	12.59	37	38135	3447	79702769
Liver function test abnormal	78.04	12.59	123	38049	64352	79641864
Tuberculosis of central nervous system	78.01	12.59	22	38150	471	79705745
Optic neuritis	74.35	12.59	50	38122	9470	79696746
Liver disorder	72.68	12.59	127	38045	72290	79633926
Hepatitis fulminant	71.18	12.59	44	38128	7218	79698998
Latent tuberculosis	68.39	12.59	33	38139	3320	79702896
Generalised tonic-clonic seizure	67.89	12.59	94	38078	43816	79662400
Granuloma	65.81	12.59	44	38128	8253	79697963
Drug abuse	65.18	12.59	3	38169	162688	79543528
Peritoneal tuberculosis	63.73	12.59	19	38153	498	79705718
Pancreatitis haemorrhagic	62.72	12.59	21	38151	809	79705407
Mycobacterial infection	62.66	12.59	32	38140	3636	79702580
Fatigue	60.56	12.59	235	37937	929492	78776724
Liver transplant	59.76	12.59	33	38139	4390	79701826
Multiple-drug resistance	58.78	12.59	42	38130	8766	79697450
Death	57.85	12.59	115	38057	566399	79139817
Bone tuberculosis	57.38	12.59	18	38154	562	79705654
Face oedema	57.24	12.59	69	38103	28067	79678149
Complications of transplanted kidney	55.96	12.59	36	38136	6330	79699886
Rash maculo-papular	55.82	12.59	98	38074	55980	79650236
Tuberculous pleurisy	55.44	12.59	18	38154	629	79705587
Product dose omission issue	54.71	12.59	25	38147	247512	79458704
Hepatic necrosis	53.07	12.59	40	38132	9060	79697156
Blood bilirubin increased	52.51	12.59	105	38067	66127	79640089
Granulomatous liver disease	49.54	12.59	20	38152	1313	79704903
Bovine tuberculosis	48.15	12.59	12	38160	156	79706060
Strongyloidiasis	47.02	12.59	27	38145	3871	79702345
Hepatocellular injury	45.85	12.59	82	38090	47511	79658705
Hepatic steatosis	45.66	12.59	72	38100	37666	79668550
Disseminated intravascular coagulation	45.62	12.59	70	38102	35772	79670444
Tuberculin test positive	44.88	12.59	25	38147	3383	79702833
Pathogen resistance	44.62	12.59	44	38128	14298	79691918
Synovitis	44.47	12.59	9	38163	150725	79555491
Arthropathy	43.86	12.59	15	38157	177096	79529120
Hemianopia heteronymous	43.67	12.59	10	38162	88	79706128
Sinusitis	42.79	12.59	20	38152	195481	79510735
Wound	41.12	12.59	4	38168	116175	79590041
Tubulointerstitial nephritis	40.90	12.59	69	38103	38166	79668050
Liver transplant rejection	40.53	12.59	23	38149	3225	79702991
Diaphragmatic injury	40.41	12.59	10	38162	126	79706090
Thalamic infarction	39.77	12.59	17	38155	1290	79704926
Demodicidosis	39.53	12.59	11	38161	224	79705992
Distributive shock	38.94	12.59	21	38151	2666	79703550
Skin disorder	38.65	12.59	63	38109	33880	79672336
Central nervous system vasculitis	38.55	12.59	17	38155	1391	79704825
Mycobacterium tuberculosis complex test positive	38.19	12.59	21	38151	2771	79703445
Peripheral swelling	37.81	12.59	44	38128	269573	79436643
Sideroblastic anaemia	37.58	12.59	11	38161	270	79705946
Pleural effusion	37.29	12.59	153	38019	145109	79561107
Coagulopathy	37.23	12.59	64	38108	35942	79670274
Glomerulonephritis minimal lesion	36.99	12.59	14	38158	773	79705443
Joint swelling	36.44	12.59	51	38121	288595	79417621
Encephalitis	36.43	12.59	40	38132	14720	79691496
Nasopharyngitis	36.06	12.59	41	38131	253840	79452376
Discomfort	36.03	12.59	8	38164	125609	79580607
Splenic embolism	36.01	12.59	10	38162	202	79706014
Toxic epidermal necrolysis	35.72	12.59	71	38101	44510	79661706
Lower respiratory tract infection	35.54	12.59	9	38163	129211	79577005
Oral candidiasis	35.11	12.59	56	38116	29572	79676644
Neuropathy peripheral	34.83	12.59	147	38025	141158	79565058
Pyelonephritis fungal	34.82	12.59	10	38162	229	79705987
Diarrhoea	34.77	12.59	263	37909	880226	78825990
Malignant neoplasm progression	34.58	12.59	11	38161	135979	79570237
Tuberculosis of eye	34.02	12.59	8	38164	80	79706136
Bilirubin conjugated increased	33.75	12.59	25	38147	5514	79700702
Feeling abnormal	33.75	12.59	17	38155	159182	79547034
Transplant rejection	33.68	12.59	44	38128	19393	79686823
Renal transplant failure	33.63	12.59	17	38155	1890	79704326
Insomnia	33.32	12.59	41	38131	245129	79461087
Infection	33.29	12.59	40	38132	241672	79464544
Hand deformity	33.28	12.59	5	38167	103914	79602302
Gastric disorder	32.91	12.59	62	38110	37371	79668845
Drug eruption	32.86	12.59	68	38104	43867	79662349
Ocular toxicity	31.99	12.59	13	38159	868	79705348
Cholestatic liver injury	31.69	12.59	23	38149	4918	79701298
Mycoplasma genitalium infection	31.56	12.59	6	38166	18	79706198
Pemphigus	31.42	12.59	5	38167	99577	79606639
Contusion	31.37	12.59	16	38156	148760	79557456
Pneumocystis jirovecii pneumonia	31.30	12.59	56	38116	32452	79673764
Oedematous kidney	31.26	12.59	9	38163	208	79706008
Hepatic enzyme increased	31.25	12.59	171	38001	182439	79523777
Alopecia	31.11	12.59	39	38133	231316	79474900
Jarisch-Herxheimer reaction	30.95	12.59	13	38159	944	79705272
Swelling	30.77	12.59	35	38137	216676	79489540
Splenic abscess	29.46	12.59	11	38161	585	79705631
Myocardial infarction	29.25	12.59	27	38145	184102	79522114
Coma hepatic	29.07	12.59	13	38159	1100	79705116
Cachexia	29.04	12.59	31	38141	11052	79695164
Febrile neutropenia	28.96	12.59	41	38131	230958	79475258
Hypertransaminasaemia	28.88	12.59	32	38140	11892	79694324
Lichenoid keratosis	28.59	12.59	20	38152	4037	79702179
Cerebrovascular accident	28.12	12.59	20	38152	155272	79550944
Optic atrophy	27.71	12.59	15	38157	1918	79704298
Hypotension	27.45	12.59	113	38059	440204	79266012
Ocular icterus	27.34	12.59	22	38150	5478	79700738
Muscle spasms	27.30	12.59	26	38146	174704	79531512
Immunosuppressant drug level decreased	27.21	12.59	15	38157	1989	79704227
Hepatomegaly	27.08	12.59	39	38133	18835	79687381
Mycobacterium fortuitum infection	26.75	12.59	8	38164	212	79706004
Constipation	26.69	12.59	60	38112	282990	79423226
Congestive hepatopathy	26.54	12.59	20	38152	4527	79701689
Pulmonary granuloma	26.41	12.59	15	38157	2106	79704110
Vitamin B1 decreased	26.41	12.59	10	38162	553	79705663
Focal dyscognitive seizures	26.36	12.59	18	38154	3494	79702722
Pancreatitis acute	26.27	12.59	67	38105	49537	79656679
Aplasia pure red cell	26.25	12.59	25	38147	7785	79698431
Pericardial effusion	26.11	12.59	64	38108	46173	79660043
Hyperuricaemia	25.75	12.59	30	38142	11769	79694447
Myocarditis	25.65	12.59	41	38131	21692	79684524
Toxic optic neuropathy	25.51	12.59	12	38160	1141	79705075
Oedematous pancreatitis	25.36	12.59	12	38160	1156	79705060
Colour blindness	25.21	12.59	9	38163	421	79705795
Back pain	25.15	12.59	69	38103	304111	79402105
Completed suicide	24.92	12.59	50	38122	245717	79460499
Type III immune complex mediated reaction	24.61	12.59	10	38162	668	79705548
Substance-induced psychotic disorder	24.57	12.59	17	38155	3372	79702844
Granulomatous lymphadenitis	24.49	12.59	8	38164	285	79705931
Haemolytic anaemia	24.38	12.59	36	38136	17784	79688432
Marrow hyperplasia	24.22	12.59	13	38159	1635	79704581
COVID-19	24.01	12.59	24	38148	157650	79548566
Anxiety	23.99	12.59	52	38120	248460	79457756
Pulmonary sequestration	23.80	12.59	5	38167	28	79706188
Psoas abscess	23.78	12.59	11	38161	1006	79705210
Papule	23.56	12.59	23	38149	7384	79698832
Dyspnoea	23.52	12.59	280	37892	856745	78849471
Epistaxis	23.49	12.59	12	38160	111503	79594713
Herpes zoster meningoencephalitis	23.49	12.59	10	38162	751	79705465
Hepatosplenomegaly	23.45	12.59	21	38151	6048	79700168
Lupus-like syndrome	23.44	12.59	31	38141	13826	79692390
Nicotinic acid deficiency	23.42	12.59	7	38165	185	79706031
Cytomegalovirus infection	23	12.59	58	38114	42586	79663630
Stevens-Johnson syndrome	22.96	12.59	55	38117	39111	79667105
HIV infection	22.71	12.59	11	38161	1116	79705100
Dry mouth	22.59	12.59	7	38165	88012	79618204
Urogenital infection bacterial	22.52	12.59	6	38166	103	79706113
Hereditary optic atrophy	22.48	12.59	5	38167	38	79706178
Pancytopenia	22.44	12.59	146	38026	165599	79540617
Impaired healing	22.44	12.59	7	38165	87648	79618568
Aspergillus infection	22.41	12.59	36	38136	19125	79687091
Brain oedema	22.40	12.59	42	38130	25221	79680995
Cerebellar ataxia	22.36	12.59	13	38159	1908	79704308
Gastrooesophageal reflux disease	22.29	12.59	11	38161	104235	79601981
Treatment noncompliance	22.10	12.59	65	38107	52203	79654013
Depression	22.07	12.59	44	38128	216746	79489470
Metabolic acidosis	22.02	12.59	88	38084	82441	79623775
Lymphadenitis	21.84	12.59	18	38154	4637	79701579
Chromaturia	21.83	12.59	42	38130	25704	79680512
Balance disorder	21.80	12.59	10	38162	98847	79607369
Conductive deafness	21.74	12.59	7	38165	238	79705978
Splenomegaly	21.60	12.59	37	38135	20717	79685499
Adrenocortical insufficiency acute	21.44	12.59	15	38157	3028	79703188
Systemic lupus erythematosus	21.41	12.59	16	38156	121133	79585083
Bradycardia	21.38	12.59	20	38152	135537	79570679
Seizure	21.25	12.59	159	38013	188675	79517541
Gamma-glutamyltransferase increased	21.24	12.59	66	38106	54614	79651602
Thrombosis	21.03	12.59	7	38165	84093	79622123
Dizziness	20.83	12.59	157	38015	526284	79179932
Mitochondrial neurogastrointestinal encephalopathy	20.80	12.59	4	38168	13	79706203
Memory impairment	20.74	12.59	14	38158	111720	79594496
Lymph node abscess	20.66	12.59	5	38167	57	79706159
Choroiditis	20.59	12.59	11	38161	1370	79704846
Stomatitis	20.50	12.59	24	38148	146733	79559483
Ototoxicity	20.45	12.59	15	38157	3259	79702957
Blood alkaline phosphatase increased	20.40	12.59	72	38100	63592	79642624
Mastitis bacterial	20.21	12.59	5	38167	63	79706153
Injury	20.18	12.59	6	38166	77490	79628726
Joint tuberculosis	20.06	12.59	6	38166	159	79706057
Pulmonary embolism	20.02	12.59	32	38140	171622	79534594
Weight increased	20.01	12.59	67	38105	277319	79428897
Pulmonary tuberculoma	19.94	12.59	3	38169	0	79706216
Ascites	19.70	12.59	80	38092	75482	79630734
Lymphocyte stimulation test positive	19.69	12.59	10	38162	1123	79705093
Acid fast bacilli infection	19.68	12.59	6	38166	170	79706046
Pseudomembranous colitis	19.60	12.59	18	38154	5356	79700860
Testicular mass	19.59	12.59	5	38167	72	79706144
Cryptococcosis	19.59	12.59	15	38157	3478	79702738
Hepatitis B core antibody positive	19.48	12.59	8	38164	549	79705667
Cholestasis	19.41	12.59	62	38110	52047	79654169
Thrombocytopenia	19.30	12.59	203	37969	265056	79441160
Mycobacterium abscessus infection	18.97	12.59	10	38162	1212	79705004
Lung infiltration	18.97	12.59	37	38135	22875	79683341
Papilloma	18.84	12.59	7	38165	367	79705849
Wrong technique in product usage process	18.73	12.59	6	38166	73869	79632347
Hyperinsulinaemia	18.72	12.59	6	38166	201	79706015
Infectious pleural effusion	18.66	12.59	15	38157	3729	79702487
Wheezing	18.65	12.59	17	38155	116647	79589569
Disseminated mycobacterium avium complex infection	18.44	12.59	6	38166	211	79706005
Chronic allograft nephropathy	18.39	12.59	11	38161	1700	79704516
Pain in extremity	18.34	12.59	101	38071	364437	79341779
Extrapulmonary tuberculosis	18.30	12.59	7	38165	398	79705818
Central nervous system lesion	18.28	12.59	27	38145	13341	79692875
Intestinal tuberculosis	18.20	12.59	6	38166	220	79705996
Mobility decreased	18.14	12.59	19	38153	122156	79584060
Nasal congestion	18.07	12.59	7	38165	76545	79629671
Subacute hepatic failure	17.92	12.59	6	38166	231	79705985
Spermatozoa progressive motility abnormal	17.92	12.59	4	38168	31	79706185
Pericarditis tuberculous	17.78	12.59	5	38167	106	79706110
Tuberculoid leprosy	17.73	12.59	5	38167	107	79706109
Multiple organ dysfunction syndrome	17.56	12.59	108	38064	120138	79586078
Hilar lymphadenopathy	17.55	12.59	11	38161	1848	79704368
Urinary tract inflammation	17.38	12.59	6	38166	254	79705962
Delayed graft function	17.38	12.59	14	38158	3493	79702723
Coronary artery disease	17.17	12.59	5	38167	65469	79640747
Fluid retention	17.12	12.59	6	38166	69803	79636413
Lymphopenia	16.94	12.59	42	38130	30515	79675701
Arachnoiditis	16.86	12.59	8	38164	775	79705441
Genitourinary tract infection	16.84	12.59	6	38166	279	79705937
Rebound effect	16.83	12.59	19	38153	7207	79699009
Chronic obstructive pulmonary disease	16.82	12.59	10	38162	85409	79620807
Vaginal flatulence	16.54	12.59	12	38160	2563	79703653
Unmasking of previously unidentified disease	16.53	12.59	11	38161	2046	79704170
Central venous pressure increased	16.49	12.59	5	38167	139	79706077
Injection site pain	16.31	12.59	23	38149	129815	79576401
Oesophageal candidiasis	16.18	12.59	21	38151	9197	79697019
Hepatitis cholestatic	16.16	12.59	26	38146	13826	79692390
Hepatic haematoma	16.14	12.59	8	38164	853	79705363
Syncope	16.13	12.59	39	38133	179410	79526806
Henoch-Schonlein purpura	16.00	12.59	12	38160	2698	79703518
Blood pressure increased	15.97	12.59	50	38122	211310	79494906
Hospitalisation	15.95	12.59	13	38159	94223	79611993
Transient ischaemic attack	15.84	12.59	3	38169	52692	79653524
Skin lesion	15.78	12.59	50	38122	41794	79664422
Rash morbilliform	15.76	12.59	17	38155	6133	79700083
Leprosy	15.73	12.59	5	38167	163	79706053
Infusion related reaction	15.67	12.59	57	38115	230180	79476036
Erythrodermic psoriasis	15.59	12.59	10	38162	1748	79704468
Ill-defined disorder	15.59	12.59	6	38166	65869	79640347
Sedation	15.51	12.59	3	38169	51892	79654324
Spermatozoa progressive motility decreased	15.46	12.59	4	38168	61	79706155
Rheumatoid arthritis	15.27	12.59	50	38122	208420	79497796
Renal atrophy	15.25	12.59	10	38162	1815	79704401
Hepatitis acute	15.25	12.59	27	38145	15515	79690701
Hypermetabolism	15.19	12.59	6	38166	372	79705844
Bone pain	15.10	12.59	4	38168	55738	79650478
Implant site infection	15.05	12.59	10	38162	1855	79704361
Intentional product misuse	15.05	12.59	14	38158	95151	79611065
Hyperbilirubinaemia	14.99	12.59	35	38137	24483	79681733
Neuropsychiatric symptoms	14.96	12.59	9	38163	1406	79704810
Spleen palpable	14.92	12.59	3	38169	13	79706203
Injection site reaction	14.71	12.59	4	38168	54781	79651435
Vaginal discharge	14.68	12.59	18	38154	7445	79698771
Shock	14.60	12.59	50	38122	43498	79662718
Autoimmune haemolytic anaemia	14.57	12.59	19	38153	8361	79697855
Amnesia	14.50	12.59	6	38166	63051	79643165
Optic disc hyperaemia	14.41	12.59	3	38169	16	79706200
Visual pathway disorder	14.35	12.59	4	38168	82	79706134
Disseminated Bacillus Calmette-Guerin infection	14.34	12.59	5	38167	218	79705998
Chest pain	14.31	12.59	78	38094	282226	79423990
Pneumonia cryptococcal	14.28	12.59	9	38163	1526	79704690
Haemophagocytic lymphohistiocytosis	14.26	12.59	32	38140	21805	79684411
CD4 lymphocytes	14.25	12.59	3	38169	17	79706199
Cutaneous tuberculosis	14.13	12.59	5	38167	228	79705988
Hypersensitivity vasculitis	14.07	12.59	17	38155	6926	79699290
Dysphagia	14.02	12.59	23	38149	122113	79584103
Cardiac disorder	13.96	12.59	7	38165	65750	79640466
Chylothorax	13.93	12.59	7	38165	768	79705448
Drug level fluctuating	13.90	12.59	7	38165	772	79705444
Vomiting	13.66	12.59	416	37756	665412	79040804
Pancreatitis	13.65	12.59	67	38105	68508	79637708
Acinetobacter infection	13.58	12.59	11	38161	2766	79703450
Oligohydramnios	13.57	12.59	12	38160	3400	79702816
Musculoskeletal stiffness	13.50	12.59	41	38131	174967	79531249
Orthostatic hypotension	13.48	12.59	5	38167	56159	79650057
Dehydration	13.46	12.59	67	38105	248120	79458096
Atrial fibrillation	13.45	12.59	49	38123	197837	79508379
Food interaction	13.44	12.59	9	38163	1693	79704523
Nocardiosis	13.34	12.59	15	38157	5664	79700552
Interstitial lung disease	13.34	12.59	96	38076	112504	79593712
Urinary tract infection	13.29	12.59	77	38095	274435	79431781
Illness	13.26	12.59	3	38169	46508	79659708
Nephrotic syndrome	13.07	12.59	21	38151	11153	79695063
Methylobacterium infection	13.04	12.59	3	38169	27	79706189
Hypersensitivity	12.99	12.59	73	38099	262166	79444050
Intentional product use issue	12.94	12.59	34	38138	152078	79554138
Pleurisy	12.69	12.59	20	38152	10455	79695761

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J04AC01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Hydrazides
ATC	J04AC51	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Hydrazides
ATC	J04AM01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
FDA EPC	N0000175483	Antimycobacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000995	Antitubercular Agents
MeSH PA	D054872	Fatty Acid Synthesis Inhibitors
MeSH PA	D000960	Hypolipidemic Agents
CHEBI has role	CHEBI:33231	antitubercular agents
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Inactive tuberculosis	indication	11999007
Acute tuberculosis	indication	25629007
Pulmonary tuberculosis	indication	154283005	DOID:2957
Tuberculosis of meninges	off-label use	58437007
Atypical mycobacterial infection	off-label use	111812000
Nutritional disorder	contraindication	2492009	DOID:374
Alcoholism	contraindication	7200002
Jaundice	contraindication	18165001
Acute hepatitis	contraindication	37871000
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Diabetes mellitus	contraindication	73211009	DOID:9351
Gout	contraindication	90560007	DOID:13189
Anemia due to enzyme deficiency	contraindication	111577008
Acute hepatic failure	contraindication	197270009
Disease of liver	contraindication	235856003	DOID:409
Diabetic - poor control	contraindication	268519009
Peripheral nerve disease	contraindication	302226006
Porphyria	contraindication	418470004
Diabetic peripheral neuropathy	contraindication	424736006
Slow acetylator due to N-acetyltransferase enzyme variant	contraindication	425079005
Prolonged-Severe Nausea and Vomiting	contraindication
Chronic Hepatic Disease	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	10.98	acidic
pKa2	3.79	Basic
pKa3	1.94	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Cytochrome P450 3A5	Enzyme	P20815	CP3A5_HUMAN		IC50	4.96		WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		IC50	5.31		WOMBAT-PK
Myeloperoxidase	Enzyme	P05164	PERM_HUMAN		IC50	5.33		CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH]	Enzyme		INHA_MYCTU	INHIBITOR	IC50	5.08		CHEMBL	CHEMBL
Catalase-peroxidase	Enzyme		KATG_MYCTO					WOMBAT-PK
Dihydrofolate reductase	Enzyme		DYR_MYCTU		Ki	9		CHEMBL

External reference:

ID	Source
4017505	VUID
N0000145890	NUI
D00346	KEGG_DRUG
4017505	VANDF
C0022209	UMLSCUI
CHEBI:6030	CHEBI
ISZ	PDB_CHEM_ID
CHEMBL64	ChEMBL_ID
DB00951	DRUGBANK_ID
D007538	MESH_DESCRIPTOR_UI
3767	PUBCHEM_CID
4188	INN_ID
12761	IUPHAR_LIGAND_ID
V83O1VOZ8L	UNII
6038	RXNORM
2955	MMSL
4929	MMSL
d00101	MMSL
002844	NDDF
387472004	SNOMEDCT_US
81335000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0440-1655	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0440-7655	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1109	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0066	TABLET	100 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0071	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3056	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	ANDA	25 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3056	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	ANDA	25 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10135-584	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10544-087	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10544-121	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10544-218	TABLET	300 mg	ORAL	ANDA	22 sections
ISONIAZID	HUMAN PRESCRIPTION DRUG LABEL	1	16590-984	TABLET	300 mg	ORAL	ANDA	13 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	21695-627	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	43063-463	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	43063-463	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	46287-009	SOLUTION	50 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0370	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0370	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0370	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0410	TABLET	100 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0410	TABLET	100 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1490	SOLUTION	50 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	51079-083	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	51655-391	TABLET	300 mg	ORAL	ANDA	10 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	52959-145	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	53002-2920	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	53002-2920	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	53808-1041	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	54868-2304	TABLET	100 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	54868-2416	TABLET	300 mg	ORAL	ANDA	24 sections