isoniazid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1497 54-85-3

Description:

MoleculeDescription

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:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
Sept. 29, 1952 FDA SANDOZ

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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
Interstitial lung disease 23.74 13.88 60 21636 61848 63405478
Seizure 23.74 13.88 99 21597 132535 63334791
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
Lower respiratory tract infection 18.69 13.88 11 21685 132296 63335030
Mobility decreased 18.69 13.88 9 21687 121150 63346176
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
Nephrotic syndrome 17.86 13.88 15 21681 5561 63461765
Optic neuritis 17.86 13.88 18 21678 8417 63458909
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cytochrome P450 3A5 Enzyme IC50 4.96 WOMBAT-PK
Cytochrome P450 3A4 Enzyme IC50 5.31 WOMBAT-PK
Myeloperoxidase Enzyme IC50 5.33 CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH] Enzyme INHIBITOR IC50 5.08 CHEMBL CHEMBL
Catalase-peroxidase Enzyme WOMBAT-PK
Dihydrofolate reductase Enzyme Ki 9 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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