isosorbide mononitrate ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
NO2 - derivatives 1506 16051-77-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • isosorbide mononitrate
  • isosorbide 5-mononitrate
  • isosorbide 5-nitrate
  • monosorbitrate
  • isosorbide-5-mononitrate
for prevention of angina pectoris; structure given in first source; a Russian drug
  • Molecular weight: 191.14
  • Formula: C6H9NO6
  • CLOGP: -0.81
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 93.74
  • ALOGS: -0.53
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 8.97 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 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) 4.10 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKDC,STK33,SYK,TEK,ZAP70 33
kinase-selectivity-class AXL,CDK9,GRK2,MAP2K6,TEK 5
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1991 FDA

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
Myocardial infarction 524.13 14.09 382 33587 105590 90488888
Cardiospasm 323.35 14.09 97 33872 3349 90591129
Palmoplantar keratoderma 321.67 14.09 97 33872 3410 90591068
Pruritus genital 300.69 14.09 98 33871 4460 90590018
Cardiac failure congestive 300.50 14.09 268 33701 98426 90496052
Sleep terror 286.48 14.09 94 33875 4370 90590108
Subarachnoid haemorrhage 280.17 14.09 136 33833 17768 90576710
Atrial tachycardia 278.23 14.09 99 33870 5891 90588587
Carotid artery occlusion 268.98 14.09 98 33871 6244 90588234
Tension headache 249.32 14.09 97 33872 7412 90587066
Anosmia 217.37 14.09 95 33874 9753 90584725
Immunisation 215.02 14.09 64 33905 2149 90592329
Ventricular tachycardia 207.17 14.09 124 33845 24584 90569894
Acute myocardial infarction 200.49 14.09 138 33831 34752 90559726
Facial pain 190.91 14.09 95 33874 13087 90581391
Pain of skin 178.65 14.09 97 33872 15985 90578493
Vasculitis 172.58 14.09 107 33862 22586 90571892
Coronary artery disease 172.30 14.09 124 33845 33499 90560979
Angina pectoris 166.25 14.09 129 33840 39031 90555447
Lip swelling 163.50 14.09 127 33842 38483 90555995
Chest pain 162.31 14.09 365 33604 319280 90275198
Hypoglycaemia 154.26 14.09 159 33810 69689 90524789
Blindness 147.73 14.09 103 33866 26465 90568013
Diplopia 142.80 14.09 104 33865 28610 90565868
Muscle twitching 139.67 14.09 96 33873 24106 90570372
Eye pruritus 139.53 14.09 103 33866 28924 90565554
Transient ischaemic attack 138.78 14.09 121 33848 43055 90551423
Tinnitus 136.94 14.09 120 33849 42982 90551496
Cognitive disorder 130.34 14.09 145 33824 69262 90525216
Angioedema 126.09 14.09 138 33831 64738 90529740
Parkinsonism 118.96 14.09 71 33898 13994 90580484
Hyponatraemia 117.83 14.09 193 33776 133345 90461133
Dementia 115.43 14.09 85 33884 23776 90570702
Hallucination 114.00 14.09 132 33837 65827 90528651
Systemic lupus erythematosus 111.18 14.09 6 33963 361890 90232588
Infusion related reaction 108.74 14.09 14 33955 416766 90177712
Disturbance in attention 103.56 14.09 107 33862 47002 90547476
Melaena 102.83 14.09 93 33876 34704 90559774
Synovitis 102.77 14.09 5 33964 329747 90264731
Drug ineffective 102.16 14.09 231 33738 1384067 89210411
Blood cholesterol decreased 101.49 14.09 35 33934 1896 90592582
Acute kidney injury 100.82 14.09 306 33663 320081 90274397
Drug interaction 96.49 14.09 274 33695 276179 90318299
Blood glucose increased 94.11 14.09 145 33824 95101 90499377
Glossodynia 93.87 14.09 7 33962 321772 90272706
Contraindicated product administered 93.29 14.09 7 33962 320132 90274346
Peripheral circulatory failure 91.84 14.09 31 33938 1573 90592905
Maternal exposure during pregnancy 91.76 14.09 13 33956 360050 90234428
Arthropathy 91.54 14.09 14 33955 366228 90228250
Mucosal erosion 91.41 14.09 32 33937 1813 90592665
Atrial fibrillation 90.53 14.09 172 33797 133439 90461039
Wound 90.09 14.09 6 33963 302974 90291504
Rheumatoid arthritis 85.90 14.09 16 33953 362598 90231880
Hyperkalaemia 84.91 14.09 113 33856 64851 90529627
Rash papular 84.08 14.09 66 33903 20289 90574189
Hypotension 82.70 14.09 289 33680 325108 90269370
Atrioventricular block first degree 82.65 14.09 47 33922 8464 90586014
Cardiac failure 80.48 14.09 146 33823 109350 90485128
Angina unstable 79.09 14.09 43 33926 7100 90587378
Drug intolerance 78.17 14.09 35 33934 447556 90146922
Neuroglycopenia 77.71 14.09 25 33944 1090 90593388
Stomatitis 77.28 14.09 7 33962 274691 90319787
Intentional product misuse 76.97 14.09 128 33841 89476 90505002
Dehydration 76.03 14.09 201 33768 194246 90400232
Palpitations 74.73 14.09 161 33808 136567 90457911
Multiple drug therapy 74.30 14.09 41 33928 6968 90587510
Joint swelling 72.54 14.09 50 33919 503250 90091228
Hepatic enzyme increased 69.90 14.09 24 33945 360712 90233766
Rhabdomyolysis 69.82 14.09 91 33878 51165 90543313
Gastric polyps 68.61 14.09 34 33935 4638 90589840
Toxic epidermal necrolysis 68.11 14.09 72 33897 32456 90562022
Coronary arterial stent insertion 67.92 14.09 29 33940 2811 90591667
Dry skin 66.71 14.09 119 33850 87954 90506524
Blood urea increased 66.69 14.09 69 33900 30344 90564134
Stupor 66.30 14.09 35 33934 5447 90589031
Impaired healing 65.78 14.09 6 33963 234193 90360285
Syncope 65.49 14.09 150 33819 132513 90461965
Dizziness 65.02 14.09 410 33559 588874 90005604
Fall 64.63 14.09 353 33616 481457 90113021
Bradycardia 64.42 14.09 114 33855 83733 90510745
Swelling 63.94 14.09 39 33930 419019 90175459
Blood creatine increased 63.72 14.09 37 33932 6930 90587548
Diabetes mellitus inadequate control 61.30 14.09 53 33916 18631 90575847
Sinusitis 61.19 14.09 26 33943 343062 90251416
Therapeutic product effect decreased 60.10 14.09 15 33954 277556 90316922
Nasopharyngitis 59.22 14.09 40 33929 407064 90187414
Cardiorenal syndrome 57.84 14.09 20 33949 1092 90593386
Feeling abnormal 56.57 14.09 164 33805 167071 90427407
Drug dependence 56.29 14.09 62 33907 29265 90565213
Fibromyalgia 56.05 14.09 6 33963 206263 90388215
Psoriatic arthropathy 54.20 14.09 10 33959 228325 90366153
Muscle injury 53.99 14.09 3 33966 176651 90417827
Discomfort 53.56 14.09 18 33951 274317 90320161
Irritable bowel syndrome 51.63 14.09 8 33961 207440 90387038
Initial insomnia 51.52 14.09 36 33933 9274 90585204
Musculoskeletal stiffness 50.47 14.09 24 33945 296508 90297970
Hypersensitivity 50.09 14.09 58 33911 454619 90139859
Medication error 50.09 14.09 103 33866 84549 90509929
Urinary retention 49.84 14.09 66 33903 37678 90556800
Blood cholesterol increased 49.61 14.09 9 33960 208003 90386475
Bradykinesia 49.06 14.09 31 33938 6757 90587721
Fear of eating 48.60 14.09 14 33955 418 90594060
Exposure during pregnancy 47.67 14.09 15 33954 238395 90356083
Visual impairment 45.91 14.09 131 33838 132234 90462244
Amnesia 45.29 14.09 115 33854 108390 90486088
Myocardial ischaemia 44.94 14.09 39 33930 13775 90580703
Gastrointestinal haemorrhage 44.48 14.09 102 33867 90146 90504332
Dermatitis exfoliative 44.36 14.09 27 33942 5509 90588969
Renal impairment 44.28 14.09 112 33857 105309 90489169
Ill-defined disorder 44.08 14.09 8 33961 184883 90409595
Genital erosion 43.29 14.09 13 33956 450 90594028
Hyperhidrosis 42.60 14.09 130 33839 136175 90458303
Cerebrovascular accident 42.58 14.09 122 33847 123411 90471067
Tachycardia 42.56 14.09 143 33826 157530 90436948
Hiatus hernia 42.54 14.09 50 33919 25311 90569167
Heart rate increased 42.37 14.09 115 33854 112787 90481691
Blood potassium increased 41.79 14.09 45 33924 20704 90573774
Liver injury 41.50 14.09 7 33962 170560 90423918
Urticaria 40.01 14.09 35 33934 312699 90281779
Chronic kidney disease 39.52 14.09 69 33900 50122 90544356
Therapeutic product effect incomplete 39.12 14.09 12 33957 193884 90400594
Chronic obstructive pulmonary disease 38.11 14.09 85 33884 73744 90520734
Hypomagnesaemia 37.71 14.09 56 33913 35532 90558946
Iron deficiency anaemia 36.97 14.09 45 33924 23617 90570861
Joint range of motion decreased 36.70 14.09 4 33965 135639 90458839
COVID-19 36.14 14.09 142 33827 168701 90425777
Anti-neutrophil cytoplasmic antibody positive vasculitis 35.97 14.09 21 33948 3972 90590506
Sodium retention 35.73 14.09 9 33960 159 90594319
Intestinal ischaemia 34.96 14.09 28 33941 8855 90585623
Infection 34.91 14.09 51 33918 362043 90232435
Hypotonia 34.66 14.09 31 33938 11395 90583083
Anxiety disorder 34.38 14.09 22 33947 4900 90589578
Muscle rigidity 34.17 14.09 34 33935 14275 90580203
Sleep disorder 33.72 14.09 16 33953 198014 90396464
Drug hypersensitivity 33.43 14.09 78 33891 463531 90130947
Hyperthyroidism 32.21 14.09 37 33932 18273 90576205
Injury 32.02 14.09 17 33952 197332 90397146
Upper gastrointestinal haemorrhage 31.61 14.09 41 33928 22935 90571543
Gastroenteritis bacterial 31.60 14.09 10 33959 413 90594065
Dyspnoea 31.24 14.09 483 33486 880472 89714006
International normalised ratio increased 30.89 14.09 60 33909 47256 90547222
Memory impairment 30.86 14.09 151 33818 197093 90397385
Dysuria 30.80 14.09 54 33915 39347 90555131
Gastrointestinal tract mucosal pigmentation 30.22 14.09 11 33958 698 90593780
Acute coronary syndrome 30.18 14.09 28 33941 10785 90583693
Blood creatinine increased 30.09 14.09 95 33874 101291 90493187
Product administration error 30.06 14.09 43 33926 26380 90568098
Wheezing 30.02 14.09 27 33942 238053 90356425
Cholecystitis 29.25 14.09 34 33935 17006 90577472
Motor dysfunction 29.12 14.09 36 33933 19194 90575284
Incorrect product administration duration 28.98 14.09 36 33933 19286 90575192
Osteoarthritis 28.74 14.09 19 33950 195711 90398767
Product use issue 28.46 14.09 50 33919 329869 90264609
Blood pressure decreased 27.80 14.09 76 33893 74819 90519659
Peptic ulcer 27.59 14.09 20 33949 5455 90589023
Metastatic neoplasm 27.54 14.09 19 33950 4796 90589682
Micturition disorder 27.51 14.09 16 33953 3004 90591474
Dialysis 27.20 14.09 27 33942 11302 90583176
General physical health deterioration 27.01 14.09 58 33911 355057 90239421
Arteriospasm coronary 26.72 14.09 19 33950 5031 90589447
Weight increased 26.51 14.09 75 33894 417852 90176626
Osteoporosis 26.44 14.09 88 33881 96443 90498035
Arthritis 26.29 14.09 15 33954 167300 90427178
Inflammation 25.33 14.09 18 33951 178574 90415904
Hypoaesthesia 25.00 14.09 50 33919 314160 90280318
Off label use 24.49 14.09 280 33689 1101972 89492506
Lung disorder 24.18 14.09 13 33956 149870 90444608
Sinus arrest 23.98 14.09 13 33956 2133 90592345
Prescribed overdose 23.75 14.09 4 33965 97621 90496857
Febrile neutropenia 23.75 14.09 15 33954 158334 90436144
Intentional overdose 23.47 14.09 83 33886 93751 90500727
Electrolyte imbalance 23.22 14.09 36 33933 23709 90570769
Vasodilatation 22.94 14.09 14 33955 2870 90591608
Cardiac failure acute 22.51 14.09 25 33944 11904 90582574
Cardiac disorder 22.40 14.09 59 33910 56813 90537665
Pain 22.15 14.09 253 33716 996088 89598390
Abdominal pain upper 21.71 14.09 205 33764 332469 90262009
Muscular weakness 21.58 14.09 142 33827 206524 90387954
Orthostatic hypotension 21.40 14.09 48 33921 41779 90552699
Conjunctivitis 21.39 14.09 37 33932 26669 90567809
Type 2 diabetes mellitus 21.21 14.09 27 33942 203217 90391261
Knee arthroplasty 21.17 14.09 3 33966 83179 90511299
Pulmonary oedema 21.08 14.09 61 33908 62019 90532459
Night sweats 21.02 14.09 11 33958 128755 90465723
Tachyphylaxis 20.91 14.09 7 33962 346 90594132
Wound infection 20.72 14.09 7 33962 106395 90488083
Labelled drug-drug interaction issue 20.67 14.09 12 33957 2246 90592232
Vitamin D deficiency 20.60 14.09 29 33940 17527 90576951
Cardiac failure chronic 20.54 14.09 17 33952 5629 90588849
Blood loss anaemia 20.44 14.09 22 33947 10118 90584360
Neutropenia 20.39 14.09 33 33936 224871 90369607
Pruritus 20.33 14.09 300 33669 541225 90053253
Mitral valve stenosis 20.28 14.09 10 33959 1349 90593129
Coronary artery bypass 20.23 14.09 12 33957 2337 90592141
Product residue present 20.10 14.09 15 33954 4276 90590202
Arteriosclerosis coronary artery 19.64 14.09 21 33948 9582 90584896
Road traffic accident 19.41 14.09 8 33961 107618 90486860
Shock 19.40 14.09 37 33932 28741 90565737
Conjunctival discolouration 19.12 14.09 5 33964 103 90594375
Autoimmune disorder 18.99 14.09 3 33966 76741 90517737
Liver disorder 18.86 14.09 11 33958 121258 90473220
Hip arthroplasty 18.81 14.09 3 33966 76205 90518273
Hyperparathyroidism 18.69 14.09 13 33956 3324 90591154
Lethargy 18.58 14.09 59 33910 63080 90531398
Electrocardiogram QRS complex prolonged 18.55 14.09 18 33951 7330 90587148
Renal failure 18.17 14.09 97 33872 130910 90463568
Back pain 18.05 14.09 190 33779 316985 90277493
C-reactive protein increased 18.00 14.09 25 33944 181364 90413114
Corneal abrasion 17.63 14.09 9 33960 1307 90593171
Liver function test increased 17.57 14.09 5 33964 84850 90509628
Sciatica 17.55 14.09 8 33961 101374 90493104
Nodal rhythm 17.54 14.09 10 33959 1808 90592670
Eosinophilic granulomatosis with polyangiitis 16.91 14.09 11 33958 2519 90591959
Acid base balance abnormal 16.90 14.09 6 33963 354 90594124
Gait inability 16.84 14.09 18 33951 146438 90448040
Tuberculosis of central nervous system 16.84 14.09 6 33963 358 90594120
Circulatory collapse 16.77 14.09 32 33937 24872 90569606
Mitral valve incompetence 16.49 14.09 30 33939 22494 90571984
Cerebral infarction 16.48 14.09 33 33936 26563 90567915
Prescribed underdose 16.33 14.09 4 33965 75015 90519463
Lupus myocarditis 16.02 14.09 4 33965 68 90594410
Haematoma 15.88 14.09 41 33928 39007 90555471
Post procedural haemorrhage 15.85 14.09 18 33951 8780 90585698
Musculoskeletal pain 15.64 14.09 25 33944 171226 90423252
Upper respiratory tract infection 15.64 14.09 15 33954 128303 90466175
Colitis microscopic 15.48 14.09 20 33949 11139 90583339
Cardiac arrest 15.45 14.09 79 33890 104856 90489622
Joint stiffness 15.43 14.09 5 33964 78037 90516441
Haemorrhoids 15.21 14.09 32 33937 26670 90567808
Disease progression 15.13 14.09 22 33947 156593 90437885
Restlessness 15.04 14.09 38 33931 35682 90558796
Gastrointestinal tract mucosal discolouration 14.98 14.09 3 33966 17 90594461
Glomerulonephritis rapidly progressive 14.93 14.09 8 33961 1282 90593196
Haemorrhage intracranial 14.84 14.09 23 33946 15139 90579339
Cutaneous lupus erythematosus 14.83 14.09 11 33958 3107 90591371
Procedural haemorrhage 14.81 14.09 11 33958 3113 90591365
Glomerular filtration rate abnormal 14.62 14.09 8 33961 1337 90593141
Device programming error 14.62 14.09 5 33964 264 90594214
Anal haemorrhage 14.53 14.09 10 33959 2514 90591964
Hypercholesterolaemia 14.53 14.09 10 33959 100882 90493596
Lower limb fracture 14.26 14.09 7 33962 85006 90509472

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
Myocardial infarction 375.25 13.61 481 34012 123528 42463314
Cardiac failure congestive 318.81 13.61 369 34124 85233 42501609
Cardiospasm 225.69 13.61 77 34416 1830 42585012
Angina pectoris 210.41 13.61 190 34303 32706 42554136
Palmoplantar keratoderma 205.63 13.61 75 34418 2179 42584663
Pruritus genital 197.68 13.61 76 34417 2563 42584279
Acute myocardial infarction 195.30 13.61 238 34255 57927 42528915
Chest pain 187.81 13.61 374 34119 139156 42447686
Sleep terror 186.60 13.61 75 34418 2851 42583991
Tension headache 185.40 13.61 78 34415 3336 42583506
Atrial tachycardia 170.95 13.61 78 34415 4062 42582780
Carotid artery occlusion 169.98 13.61 78 34415 4116 42582726
Facial pain 159.51 13.61 75 34418 4185 42582657
Coronary artery disease 158.33 13.61 206 34287 53514 42533328
Immunisation 149.66 13.61 51 34442 1207 42585635
Anosmia 148.53 13.61 76 34417 5100 42581742
Drug ineffective 134.91 13.61 189 34304 630008 41956834
Pain of skin 124.46 13.61 79 34414 8001 42578841
Lip swelling 115.82 13.61 107 34386 18946 42567896
Ventricular tachycardia 113.69 13.61 131 34362 30029 42556813
Muscle twitching 110.58 13.61 85 34408 11695 42575147
Angina unstable 110.53 13.61 84 34409 11364 42575478
Dizziness 109.67 13.61 445 34048 248809 42338033
Subarachnoid haemorrhage 103.29 13.61 89 34404 14383 42572459
Hypotension 102.46 13.61 446 34047 257185 42329657
Pericarditis 96.60 13.61 83 34410 13361 42573481
Eye pruritus 95.60 13.61 77 34416 11335 42575507
Off label use 85.46 13.61 251 34242 638084 41948758
Hallucination 83.07 13.61 159 34334 57348 42529494
Cardiac failure 76.91 13.61 225 34268 106631 42480211
Vasculitis 76.31 13.61 84 34409 18310 42568532
Blindness 76.15 13.61 83 34410 17895 42568947
Rash papular 71.13 13.61 66 34427 11745 42575097
Transient ischaemic attack 69.29 13.61 109 34384 33630 42553212
Cognitive disorder 68.25 13.61 109 34384 34063 42552779
Diplopia 66.27 13.61 82 34411 20234 42566608
Presyncope 64.57 13.61 85 34408 22302 42564540
Syncope 62.80 13.61 200 34293 99206 42487636
Amnesia 62.78 13.61 95 34398 28342 42558500
Blood glucose increased 55.71 13.61 158 34335 73541 42513301
Disturbance in attention 55.21 13.61 92 34401 29774 42557068
Febrile neutropenia 54.91 13.61 42 34451 185661 42401181
Product use in unapproved indication 54.18 13.61 42 34451 184414 42402428
Dyspnoea 54.12 13.61 571 33922 442050 42144792
Myocardial ischaemia 52.09 13.61 68 34425 17694 42569148
Anti-neutrophil cytoplasmic antibody positive vasculitis 51.41 13.61 25 34468 1503 42585339
Bradycardia 51.27 13.61 169 34324 85315 42501527
Angioedema 51.24 13.61 109 34384 42368 42544474
Migraine 50.65 13.61 81 34412 25333 42561509
Visual impairment 50.14 13.61 109 34384 43004 42543838
Tinnitus 49.34 13.61 86 34407 28852 42557990
Coronary arterial stent insertion 49.32 13.61 34 34459 3951 42582891
Palpitations 47.62 13.61 118 34375 50679 42536163
Alopecia 46.06 13.61 84 34409 29192 42557650
Blood potassium increased 42.44 13.61 63 34430 18473 42568369
International normalised ratio increased 42.13 13.61 109 34384 48059 42538783
Ventricular dysfunction 41.18 13.61 32 34461 4471 42582371
Left atrial dilatation 40.81 13.61 25 34468 2377 42584465
Drug abuse 40.54 13.61 17 34476 104754 42482088
Memory impairment 40.23 13.61 110 34383 50112 42536730
Dry skin 39.85 13.61 107 34386 48231 42538611
Venous pressure jugular increased 39.79 13.61 17 34476 755 42586087
Muscular weakness 38.90 13.61 152 34341 83346 42503496
Peripheral swelling 38.60 13.61 160 34333 90110 42496732
Orthostatic hypotension 37.50 13.61 79 34414 30491 42556351
Haematocrit increased 36.81 13.61 24 34469 2543 42584299
Gastrointestinal haemorrhage 36.27 13.61 166 34327 97560 42489282
Atrial fibrillation 35.83 13.61 214 34279 139379 42447463
Arteriospasm coronary 35.56 13.61 30 34463 4708 42582134
Mucosal dryness 35.16 13.61 20 34473 1658 42585184
Dehydration 34.91 13.61 215 34278 141552 42445290
Chest discomfort 33.10 13.61 120 34373 63496 42523346
Malignant neoplasm progression 32.68 13.61 24 34469 108376 42478466
Feeling abnormal 32.46 13.61 127 34366 69659 42517183
Malaise 32.34 13.61 287 34206 211869 42374973
Upper gastrointestinal haemorrhage 32.29 13.61 74 34419 30225 42556617
Heart rate increased 31.65 13.61 105 34388 53150 42533692
Neutropenia 31.40 13.61 72 34421 199359 42387483
Pulmonary oedema 30.75 13.61 104 34389 53168 42533674
Drug interaction 29.97 13.61 339 34154 266660 42320182
Venous pressure jugular decreased 29.69 13.61 7 34486 39 42586803
Hyperhidrosis 27.34 13.61 145 34348 90367 42496475
Lupus pneumonitis 27.08 13.61 7 34486 60 42586782
Acute kidney injury 27.01 13.61 432 34061 366905 42219937
Mast cell activation syndrome 26.26 13.61 10 34483 328 42586514
Hypovolaemia 26.24 13.61 39 34454 11446 42575396
Condition aggravated 25.15 13.61 117 34376 260637 42326205
Mucosal inflammation 24.58 13.61 5 34488 49369 42537473
Oedema peripheral 23.30 13.61 189 34304 135887 42450955
Abdominal pain upper 22.70 13.61 129 34364 82480 42504362
Cardiac failure chronic 22.51 13.61 33 34460 9568 42577274
Pancytopenia 22.40 13.61 38 34455 117705 42469137
Therapeutic product effect incomplete 22.30 13.61 15 34478 70924 42515918
Glomerular filtration rate decreased 22.11 13.61 44 34449 16307 42570535
Haemoglobin increased 21.98 13.61 24 34469 5182 42581660
Linear IgA disease 21.56 13.61 16 34477 2087 42584755
Drug reaction with eosinophilia and systemic symptoms 21.50 13.61 4 34489 42071 42544771
Contusion 20.82 13.61 78 34415 41907 42544935
General physical health deterioration 20.40 13.61 59 34434 151187 42435655
Abdominal discomfort 20.34 13.61 117 34376 75138 42511704
Disease progression 20.15 13.61 55 34438 143601 42443241
Coronary artery bypass 20 13.61 22 34471 4788 42582054
Wrong patient received product 19.62 13.61 19 34474 3564 42583278
Nodal arrhythmia 19.61 13.61 11 34482 888 42585954
Rhabdomyolysis 19.60 13.61 119 34374 77900 42508942
Arrhythmia 19.25 13.61 74 34419 40243 42546599
Gravitational oedema 19.17 13.61 10 34483 698 42586144
Excessive cerumen production 19.14 13.61 8 34485 336 42586506
Fluid retention 18.48 13.61 62 34431 31557 42555285
Melaena 18.40 13.61 71 34422 38675 42548167
Tachycardia 18.17 13.61 142 34351 100945 42485897
Stent placement 18.06 13.61 22 34471 5338 42581504
Infection 17.99 13.61 40 34453 112028 42474814
Pterygium 17.89 13.61 6 34487 135 42586707
Prinzmetal angina 17.80 13.61 12 34481 1345 42585497
Ischaemic cardiomyopathy 17.63 13.61 24 34469 6498 42580344
Faeces discoloured 17.52 13.61 41 34452 16973 42569869
Loss of control of legs 17.47 13.61 10 34483 839 42586003
Pyrexia 17.37 13.61 220 34273 393822 42193020
Drug intolerance 17.17 13.61 24 34469 80400 42506442
Hirsutism 17.15 13.61 7 34486 277 42586565
Drug ineffective for unapproved indication 17.04 13.61 8 34485 46155 42540687
Rash 16.97 13.61 143 34350 276811 42310031
Nitritoid reaction 16.86 13.61 4 34489 23 42586819
Myalgia 16.73 13.61 134 34359 95946 42490896
Toxicity to various agents 16.54 13.61 113 34380 229023 42357819
Cardiac failure acute 16.45 13.61 35 34458 13598 42573244
Blood pressure systolic decreased 16.05 13.61 20 34473 4967 42581875
Nasal crusting 16.04 13.61 8 34485 508 42586334
Injection site pain 15.90 13.61 14 34479 57784 42529058
Septic arthritis staphylococcal 15.85 13.61 8 34485 521 42586321
Infusion related reaction 15.25 13.61 16 34477 60790 42526052
Treatment failure 15.13 13.61 17 34476 62607 42524235
Oral mucosal blistering 15.10 13.61 14 34479 2487 42584355
Myelosuppression 14.95 13.61 7 34486 40454 42546388
Seizure 14.86 13.61 49 34444 120512 42466330
Electrocardiogram ST segment elevation 14.78 13.61 21 34472 5918 42580924
Rheumatoid arthritis 14.70 13.61 8 34485 42432 42544410
Neutrophil count decreased 14.48 13.61 18 34475 63397 42523445
Product use issue 14.38 13.61 25 34468 76726 42510116
Drug dependence 14.37 13.61 3 34490 29091 42557751
Sprue-like enteropathy 14.34 13.61 8 34485 639 42586203
Coronary artery stenosis 14.12 13.61 28 34465 10351 42576491
Cardiac disorder 13.82 13.61 77 34416 48855 42537987
Pulmonary embolism 13.80 13.61 50 34443 119562 42467280

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
Myocardial infarction 906.54 12.68 796 61318 191287 110335898
Cardiac failure congestive 604.60 12.68 571 61543 150429 110376756
Cardiospasm 515.28 12.68 166 61948 4801 110522384
Palmoplantar keratoderma 494.04 12.68 164 61950 5223 110521962
Pruritus genital 470.94 12.68 166 61948 6356 110520829
Sleep terror 449.83 12.68 161 61953 6449 110520736
Atrial tachycardia 426.17 12.68 169 61945 9009 110518176
Carotid artery occlusion 415.96 12.68 168 61946 9397 110517788
Tension headache 408.19 12.68 166 61948 9452 110517733
Acute myocardial infarction 400.11 12.68 350 61764 83427 110443758
Anosmia 357.18 12.68 163 61951 12309 110514876
Subarachnoid haemorrhage 349.04 12.68 214 61900 29488 110497697
Immunisation 336.80 12.68 108 62006 3075 110524110
Facial pain 325.06 12.68 163 61951 15176 110512009
Angina pectoris 319.20 12.68 271 61843 62024 110465161
Coronary artery disease 305.68 12.68 281 61833 71409 110455776
Ventricular tachycardia 299.03 12.68 238 61876 49771 110477414
Pain of skin 297.66 12.68 168 61946 19861 110507324
Chest pain 289.68 12.68 647 61467 375728 110151457
Lip swelling 271.07 12.68 226 61888 50441 110476744
Muscle twitching 247.29 12.68 173 61941 29762 110497423
Vasculitis 234.52 12.68 180 61934 35693 110491492
Eye pruritus 224.28 12.68 169 61945 32606 110494579
Blindness 215.12 12.68 172 61942 36187 110490998
Diplopia 205.90 12.68 178 61936 41716 110485469
Hallucination 202.77 12.68 267 61847 101165 110426020
Angina unstable 202.29 12.68 122 61992 16310 110510875
Transient ischaemic attack 196.91 12.68 210 61904 63772 110463413
Cognitive disorder 194.81 12.68 243 61871 87268 110439917
Hypotension 192.75 12.68 689 61425 523160 110004025
Drug ineffective 191.20 12.68 353 61761 1520187 109006998
Tinnitus 169.39 12.68 189 61925 60351 110466834
Disturbance in attention 160.66 12.68 186 61928 61809 110465376
Angioedema 159.04 12.68 234 61880 98266 110428919
Rash papular 153.45 12.68 126 61988 27513 110499672
Acute kidney injury 150.41 12.68 730 61384 634700 109892485
Dizziness 146.29 12.68 775 61339 697418 109829767
Blood glucose increased 141.21 12.68 261 61853 132235 110394950
Cardiac failure 141.19 12.68 320 61794 187306 110339879
Infusion related reaction 131.46 12.68 27 62087 381135 110146050
Atrial fibrillation 130.78 12.68 352 61762 229290 110297895
Coronary arterial stent insertion 128.68 12.68 64 62050 5851 110521334
Synovitis 128.66 12.68 6 62108 274086 110253099
Syncope 127.14 12.68 322 61792 202214 110324971
Bradycardia 125.73 12.68 273 61841 155244 110371941
Drug intolerance 124.28 12.68 37 62077 406475 110120710
Drug interaction 119.92 12.68 577 61537 499606 110027579
Rheumatoid arthritis 117.21 12.68 15 62099 299598 110227587
Dehydration 115.98 12.68 383 61731 279128 110248057
Hypoglycaemia 115.37 12.68 222 61892 115882 110411303
Palpitations 114.74 12.68 267 61847 158945 110368240
Dry skin 109.62 12.68 208 61906 107445 110419740
Melaena 109.03 12.68 162 61952 68595 110458590
Arthropathy 108.67 12.68 16 62098 287506 110239679
Systemic lupus erythematosus 106.40 12.68 10 62104 254328 110272857
Hyperkalaemia 102.55 12.68 232 61882 135564 110391621
Gastrointestinal haemorrhage 100.59 12.68 260 61854 165258 110361927
Sinusitis 100.26 12.68 22 62092 296666 110230519
Maternal exposure during pregnancy 99.11 12.68 13 62101 254870 110272315
Treatment failure 99.03 12.68 18 62096 277216 110249969
Wound 98.65 12.68 9 62105 234428 110292757
Stomatitis 97.71 12.68 17 62097 270225 110256960
Off label use 97.60 12.68 473 61641 1499712 109027473
Rhabdomyolysis 95.75 12.68 210 61904 120191 110406994
Feeling abnormal 91.03 12.68 265 61849 180446 110346739
Amnesia 89.72 12.68 189 61925 105219 110421966
Contraindicated product administered 88.92 12.68 16 62098 248251 110278934
Mucosal erosion 87.49 12.68 39 62075 2785 110524400
Hyponatraemia 87.36 12.68 295 61819 217358 110309827
Blood potassium increased 86.53 12.68 100 62014 33149 110494036
Joint swelling 86.49 12.68 73 62041 442772 110084413
Pemphigus 85.72 12.68 10 62104 214560 110312625
Helicobacter infection 85.27 12.68 4 62110 181873 110345312
Glossodynia 84.70 12.68 12 62102 221992 110305193
Visual impairment 84.60 12.68 214 61900 134214 110392971
Myocardial ischaemia 84.58 12.68 89 62025 26595 110500590
Fibromyalgia 82.67 12.68 3 62111 170906 110356279
Anti-neutrophil cytoplasmic antibody positive vasculitis 81.99 12.68 46 62068 5371 110521814
Psoriatic arthropathy 81.59 12.68 8 62106 196753 110330432
Dementia 80.32 12.68 94 62020 31579 110495606
Peripheral circulatory failure 79.25 12.68 32 62082 1787 110525398
Impaired healing 76.55 12.68 10 62104 196707 110330478
Blood cholesterol decreased 76.19 12.68 35 62079 2681 110524504
Nasopharyngitis 75.78 12.68 66 62048 394295 110132890
Hyperhidrosis 75.27 12.68 254 61860 187044 110340141
Swelling 74.71 12.68 53 62061 350988 110176197
Therapeutic product effect decreased 73.25 12.68 23 62091 244293 110282892
Intentional product misuse 72.87 12.68 201 61913 132703 110394482
Irritable bowel syndrome 72.72 12.68 5 62109 164210 110362975
Dyspnoea 71.99 12.68 942 61172 1105930 109421255
Atrioventricular block first degree 68.98 12.68 60 62054 14165 110513020
Gastric polyps 67.96 12.68 41 62073 5482 110521703
Neuroglycopenia 67.56 12.68 25 62089 1101 110526084
International normalised ratio increased 67.45 12.68 150 61964 86622 110440563
Febrile neutropenia 67.17 12.68 48 62066 316719 110210466
Heart rate increased 66.81 12.68 205 61909 143629 110383556
Upper gastrointestinal haemorrhage 66.80 12.68 109 62005 49987 110477198
Muscle injury 66.32 12.68 3 62111 140804 110386381
Hepatic enzyme increased 64.98 12.68 51 62063 320841 110206344
Musculoskeletal stiffness 62.54 12.68 40 62074 279782 110247403
Therapeutic product effect incomplete 62.05 12.68 24 62090 223781 110303404
Presyncope 62.01 12.68 104 62010 48783 110478402
Parkinsonism 61.58 12.68 69 62045 22118 110505067
Infection 61.07 12.68 68 62046 362132 110165053
Blood creatine increased 58.72 12.68 50 62064 11471 110515714
Multiple drug therapy 58.56 12.68 43 62071 7971 110519214
Tachycardia 58.23 12.68 267 61847 226378 110300807
Orthostatic hypotension 57.78 12.68 120 61994 66129 110461056
Product use in unapproved indication 56.60 12.68 103 62011 447274 110079911
Hypersensitivity 55.71 12.68 88 62026 403910 110123275
Blood urea increased 55.69 12.68 106 62008 54851 110472334
Exposure during pregnancy 55.37 12.68 13 62101 167411 110359774
Osteoarthritis 55.08 12.68 17 62097 182606 110344579
Discomfort 54.77 12.68 26 62088 214681 110312504
Pulmonary oedema 53.95 12.68 151 61963 100508 110426677
Memory impairment 52.82 12.68 235 61879 196709 110330476
Fear of eating 52.13 12.68 17 62097 511 110526674
Arteriospasm coronary 51.58 12.68 42 62072 9058 110518127
Ill-defined disorder 50.27 12.68 13 62101 156840 110370345
Inflammation 49.91 12.68 23 62091 193215 110333970
Muscular weakness 49.89 12.68 273 61841 248195 110278990
General physical health deterioration 49.38 12.68 103 62011 425192 110101993
Cardiac failure chronic 49.09 12.68 49 62065 13762 110513423
Joint range of motion decreased 47.86 12.68 6 62108 121826 110405359
Sleep disorder 46.32 12.68 27 62087 198617 110328568
Coronary artery bypass 45.46 12.68 33 62081 6009 110521176
Renal impairment 45.46 12.68 218 61896 188227 110338958
Ventricular dysfunction 45.41 12.68 36 62078 7475 110519710
Urticaria 45.34 12.68 68 62046 318789 110208396
Left atrial dilatation 45.28 12.68 27 62087 3533 110523652
Blood cholesterol increased 44.70 12.68 24 62090 184761 110342424
Stupor 44.45 12.68 37 62077 8228 110518957
Arthritis 43.19 12.68 20 62094 167566 110359619
Blood pressure decreased 40.97 12.68 150 61964 114941 110412244
Neutropenia 40.78 12.68 94 62020 374526 110152659
Condition aggravated 40.18 12.68 245 61869 734591 109792594
Product use issue 39.18 12.68 72 62042 311623 110215562
Cerebrovascular accident 38.97 12.68 203 61911 181081 110346104
Fall 38.79 12.68 513 61601 602969 109924216
Diabetes mellitus inadequate control 38.63 12.68 64 62050 29711 110497474
Cardiac failure acute 38.54 12.68 57 62057 24021 110503164
Dermatitis exfoliative 38.03 12.68 39 62075 11308 110515877
Weight increased 37.58 12.68 116 61998 419528 110107657
Cardiorenal syndrome 36.61 12.68 19 62095 1899 110525286
Venous pressure jugular increased 36.61 12.68 17 62097 1335 110525850
Injury 36.08 12.68 28 62086 177237 110349948
Initial insomnia 35.35 12.68 36 62078 10353 110516832
Drug abuse 34.89 12.68 29 62085 177382 110349803
Acute coronary syndrome 34.55 12.68 53 62061 23059 110504126
Liver injury 34.28 12.68 21 62093 150392 110376793
Drug hypersensitivity 34.28 12.68 135 61979 453955 110073230
Wheezing 33.85 12.68 57 62057 255173 110272012
Ischaemic cardiomyopathy 33.34 12.68 31 62083 7980 110519205
Glomerular filtration rate decreased 33.31 12.68 59 62055 28897 110498288
Hiatus hernia 32.73 12.68 57 62057 27549 110499636
Mucosal inflammation 32.72 12.68 7 62107 96134 110431051
Arteriosclerosis coronary artery 32.60 12.68 54 62060 25064 110502121
Lung disorder 32.34 12.68 32 62082 180015 110347170
Toxic epidermal necrolysis 32.28 12.68 87 62027 56640 110470545
Blood creatinine increased 31.51 12.68 193 61921 182696 110344489
Grip strength decreased 31.36 12.68 4 62110 80170 110447015
Gastrointestinal tract mucosal pigmentation 31.33 12.68 15 62099 1262 110525923
Paraesthesia 31.21 12.68 68 62046 276453 110250732
Peripheral venous disease 31.03 12.68 5 62109 84112 110443073
Genital erosion 31.02 12.68 13 62101 798 110526387
Prinzmetal angina 30.94 12.68 18 62096 2251 110524934
Night sweats 30.13 12.68 19 62095 133964 110393221
Lymphorrhoea 30.05 12.68 9 62105 203 110526982
Drug reaction with eosinophilia and systemic symptoms 30.02 12.68 5 62109 82090 110445095
C-reactive protein increased 29.51 12.68 48 62066 217871 110309314
Hypoaesthesia 29.45 12.68 85 62029 314138 110213047
Malignant neoplasm progression 29.15 12.68 33 62081 174534 110352651
Wound infection 29.04 12.68 9 62105 96456 110430729
Liver function test abnormal 29 12.68 95 62019 68855 110458330
Bradykinesia 29.00 12.68 33 62081 10755 110516430
Sciatica 28.95 12.68 8 62106 92391 110434794
Hypomagnesaemia 28.91 12.68 87 62027 60283 110466902
Sodium retention 28.73 12.68 9 62105 237 110526948
Gravitational oedema 28.41 12.68 16 62098 1882 110525303
Haematocrit increased 28.35 12.68 23 62091 4936 110522249
COVID-19 27.89 12.68 234 61880 244826 110282359
Injection site reaction 27.38 12.68 8 62106 89062 110438123
Venous pressure jugular decreased 27.19 12.68 7 62107 88 110527097
Arrhythmia 26.74 12.68 93 62021 69482 110457703
Renal failure 26.67 12.68 218 61896 226356 110300829
Rash 26.63 12.68 314 61800 820650 109706535
Migraine 26.39 12.68 176 61938 171476 110355709
Haemoglobin increased 26.33 12.68 29 62085 9118 110518067
Autoimmune disorder 26.27 12.68 3 62111 65480 110461705
Malaise 26.23 12.68 526 61588 671293 109855892
Injection site pain 26.20 12.68 37 62077 177885 110349300
Road traffic accident 25.89 12.68 14 62100 107384 110419801
Gastroenteritis bacterial 25.76 12.68 10 62104 503 110526682
Lower gastrointestinal haemorrhage 25.70 12.68 41 62073 18445 110508740
Atrioventricular block 25.65 12.68 39 62075 16838 110510347
Faeces discoloured 25.60 12.68 58 62056 33890 110493295
Prescribed overdose 24.92 12.68 9 62105 87572 110439613
Mucosal dryness 24.85 12.68 20 62094 4243 110522942
Lupus pneumonitis 24.75 12.68 7 62107 128 110527057
Asthma 24.72 12.68 66 62048 250225 110276960
Hypovolaemia 24.72 12.68 44 62070 21630 110505555
Myelosuppression 24.71 12.68 11 62103 94329 110432856
Lower limb fracture 24.61 12.68 6 62108 75342 110451843
Gastritis erosive 24.59 12.68 32 62082 11968 110515217
Electrocardiogram ST segment elevation 24.59 12.68 28 62086 9132 110518053
Back pain 24.47 12.68 317 61797 370679 110156506
Upper respiratory tract infection 23.98 12.68 23 62091 131305 110395880
Incorrect product administration duration 23.88 12.68 42 62072 20456 110506729
Abdominal pain upper 23.74 12.68 300 61814 348811 110178374
Blood loss anaemia 23.73 12.68 39 62075 17986 110509199
Knee arthroplasty 23.65 12.68 4 62110 64944 110462241
Dry mouth 23.54 12.68 48 62066 199900 110327285
Coronary artery occlusion 23.34 12.68 36 62078 15736 110511449
Bundle branch block left 22.81 12.68 32 62082 12856 110514329
Oedema peripheral 22.59 12.68 283 61831 328377 110198808
Drug ineffective for unapproved indication 22.55 12.68 15 62099 102823 110424362
Myalgia 22.53 12.68 207 61907 222174 110305011
Pruritus 22.25 12.68 454 61660 581106 109946079
Type 2 diabetes mellitus 22.20 12.68 41 62073 177191 110349994
Cytokine release syndrome 22.19 12.68 6 62108 70300 110456885
Chest discomfort 21.95 12.68 170 61944 173678 110353507
Chronic obstructive pulmonary disease 21.92 12.68 120 61994 109038 110418147
Sinus bradycardia 21.82 12.68 50 62064 29433 110497752
Taste disorder 21.76 12.68 5 62109 65382 110461803
Cholecystitis 21.53 12.68 46 62068 25836 110501349
Disease progression 21.44 12.68 68 62046 243966 110283219
Medication error 21.28 12.68 116 61998 105250 110421935
Coronary artery stenosis 21.20 12.68 32 62082 13726 110513459
Frequent bowel movements 20.89 12.68 7 62107 71383 110455802
Chronic kidney disease 20.41 12.68 91 62023 76200 110450985
Colitis ulcerative 20.29 12.68 9 62105 77354 110449831
Urinary retention 20.08 12.68 85 62029 69598 110457587
Mitral valve incompetence 19.86 12.68 52 62062 33277 110493908
Cardiac disorder 19.66 12.68 90 62024 76190 110450995
Neoplasm progression 19.49 12.68 6 62108 64589 110462596
Obesity 19.39 12.68 21 62093 113330 110413855
Weight decreased 19.29 12.68 169 61945 467888 110059297
Stent placement 19.23 12.68 22 62092 7212 110519973
Hip arthroplasty 19.12 12.68 4 62110 55809 110471376
Joint stiffness 18.98 12.68 7 62107 67236 110459949
Wrong patient received product 18.94 12.68 21 62093 6653 110520532
Mitral valve stenosis 18.79 12.68 11 62103 1391 110525794
Pain 18.59 12.68 402 61712 954553 109572632
Gastrointestinal disorder 18.19 12.68 72 62042 241880 110285305
Ventricular hypertrophy 18.01 12.68 21 62093 7024 110520161
Cardiac arrest 17.88 12.68 179 61935 196574 110330611
Injection site erythema 17.78 12.68 16 62098 94160 110433025
Red blood cell sedimentation rate increased 17.74 12.68 11 62103 78291 110448894
Liver disorder 17.73 12.68 33 62081 142210 110384975
Peripheral swelling 17.67 12.68 322 61792 403712 110123473
Dialysis 17.64 12.68 36 62078 19583 110507602
Nitritoid reaction 17.64 12.68 4 62110 28 110527157
Shock 17.53 12.68 68 62046 53520 110473665
Therapeutic response decreased 17.50 12.68 17 62097 96482 110430703
Cerebral hypoperfusion 17.29 12.68 9 62105 905 110526280
Vascular stent thrombosis 17.12 12.68 16 62098 4145 110523040
Back injury 17.08 12.68 3 62111 47396 110479789
Myopathy 17.02 12.68 41 62073 24919 110502266
Excessive cerumen production 16.89 12.68 9 62105 949 110526236
Drug dependence 16.80 12.68 64 62050 49956 110477229
Hypotonia 16.73 12.68 31 62083 15714 110511471
Tachyphylaxis 16.73 12.68 7 62107 428 110526757
Vasodilatation 16.58 12.68 15 62099 3729 110523456
Oxygen saturation decreased 16.57 12.68 40 62074 156942 110370243
Motor dysfunction 16.55 12.68 40 62074 24366 110502819
Linear IgA disease 16.39 12.68 16 62098 4373 110522812
Ventricular extrasystoles 16.32 12.68 38 62076 22603 110504582
Conjunctival discolouration 16.24 12.68 5 62109 124 110527061
Corneal abrasion 16.16 12.68 10 62104 1399 110525786
Intestinal ischaemia 16.13 12.68 31 62083 16148 110511037
Circulatory collapse 16.11 12.68 57 62057 42936 110484249
Musculoskeletal pain 16.07 12.68 51 62063 182972 110344213
Incorrect route of product administration 15.96 12.68 8 62106 64053 110463132
Atrioventricular block complete 15.92 12.68 35 62079 20047 110507138
Nodal rhythm 15.72 12.68 14 62100 3409 110523776
Glomerular filtration rate abnormal 15.66 12.68 12 62102 2371 110524814
Micturition disorder 15.48 12.68 16 62098 4682 110522503
Duodenal ulcer 15.46 12.68 34 62080 19480 110507705
Labelled drug-drug interaction issue 15.41 12.68 15 62099 4086 110523099
Hypercholesterolaemia 15.35 12.68 17 62097 90820 110436365
Peptic ulcer 15.12 12.68 20 62094 7599 110519586
Anxiety 15.08 12.68 275 61839 344803 110182382
Bronchitis 15.06 12.68 42 62072 156990 110370195
Rectal haemorrhage 15.02 12.68 117 61997 119716 110407469
Nasal crusting 14.93 12.68 8 62106 853 110526332
Hyperthyroidism 14.80 12.68 43 62071 29218 110497967
Sudden cardiac death 14.74 12.68 17 62097 5620 110521565
Adverse event 14.69 12.68 24 62090 108785 110418400
Laryngitis 14.61 12.68 3 62111 42408 110484777
Insomnia 14.60 12.68 284 61830 360306 110166879
Septic arthritis staphylococcal 14.59 12.68 8 62106 893 110526292
Loss of personal independence in daily activities 14.48 12.68 40 62074 149980 110377205
Blood creatine phosphokinase increased 14.45 12.68 80 62034 72997 110454188
Nodal arrhythmia 14.36 12.68 11 62103 2173 110525012
Electrocardiogram QRS complex prolonged 14.29 12.68 26 62088 12995 110514190
Neutrophil count decreased 14.26 12.68 29 62085 120912 110406273
Oliguria 14.21 12.68 32 62082 18625 110508560
Pancytopenia 14.14 12.68 65 62049 209548 110317637
Ventricular fibrillation 13.99 12.68 53 62061 41260 110485925
Ear infection 13.96 12.68 9 62105 62723 110464462
Muscle rigidity 13.81 12.68 37 62077 23994 110503191
Therapy non-responder 13.70 12.68 44 62070 157263 110369922
Stress 13.52 12.68 24 62090 105324 110421861
Lymphopenia 13.51 12.68 3 62111 40167 110487018
Peripheral arterial occlusive disease 13.48 12.68 21 62093 9259 110517926
Gait inability 13.43 12.68 36 62078 136340 110390845
Leukopenia 13.39 12.68 41 62073 148750 110378435
Nail disorder 13.32 12.68 8 62106 57927 110469258
Sideroblastic anaemia 13.27 12.68 6 62108 443 110526742
Osteoporosis 13.17 12.68 89 62025 87063 110440122
Lupus myocarditis 13.16 12.68 4 62110 95 110527090
Acid base balance abnormal 12.87 12.68 6 62108 475 110526710
Gastritis 12.85 12.68 62 62052 53637 110473548
Left ventricular failure 12.83 12.68 23 62091 11366 110515819
Product administration error 12.81 12.68 48 62066 37169 110490016
Epilepsy 12.71 12.68 23 62091 100186 110426999
Pneumonectomy 12.71 12.68 4 62110 107 110527078

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01DA14 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
VASODILATORS USED IN CARDIAC DISEASES
Organic nitrates
FDA CS M0014874 Nitrates
FDA PE N0000009909 Vasodilation
FDA EPC N0000175415 Nitrate Vasodilator
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
MeSH PA D020030 Nitric Oxide Donors
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50566 nitric oxide donor

Related Drugs by ATC class:

C01DA Organic nitrates 7 drugs

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

DiseaseRelationSNOMED_IDDOID
Angina pectoris indication 194828000
Angina Pectoris Prevention indication
Chronic heart failure off-label use 48447003
Prevention of Bleeding Esophageal Varices off-label use
Myocardial infarction contraindication 22298006 DOID:5844
Hyperthyroidism contraindication 34486009 DOID:7998
Low blood pressure contraindication 45007003
Injury of head contraindication 82271004
Increased intestinal motility contraindication 102624003
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Malabsorption States contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Soluble guanylate cyclase Enzyme ACTIVATOR CHEMBL CHEMBL
Atrial natriuretic peptide receptor 1 Enzyme WOMBAT-PK

External reference:

IDSource
4020224 VUID
N0000179163 NUI
D00630 KEGG_DRUG
4020224 VANDF
C0064079 UMLSCUI
CHEBI:6062 CHEBI
CHEMBL1311 ChEMBL_ID
DB01020 DRUGBANK_ID
27661 PUBCHEM_CID
7052 IUPHAR_LIGAND_ID
C030397 MESH_SUPPLEMENTAL_RECORD_UI
5177 INN_ID
LX1OH63030 UNII
28004 RXNORM
4935 MMSL
6257 MMSL
d00269 MMSL
003639 NDDF
108484003 SNOMEDCT_US
386854005 SNOMEDCT_US
LX1OH63030 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 0228-2620 TABLET 20 mg ORAL ANDA 21 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 0228-2631 TABLET 10 mg ORAL ANDA 21 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0615-7767 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0615-7768 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6449 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6450 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 10544-243 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 21 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-104 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-105 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 12 sections
ISOSORBIDE MONONITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-106 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 12 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 16729-396 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 16729-397 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 16729-398 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 21695-575 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 21695-777 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 21695-837 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 23 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 23155-178 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 12 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 23155-519 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 12 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 23155-628 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 12 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 42677-305 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 11 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 42677-306 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 11 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 42677-307 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 11 sections
Isosorbide Mononitrate Human Prescription Drug Label 1 42799-958 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 20 sections
Isosorbide Mononitrate Human Prescription Drug Label 1 42799-959 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 20 sections
Isosorbide Mononitrate Human Prescription Drug Label 1 42799-960 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 20 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 43353-917 TABLET, EXTENDED RELEASE 120 mg ORAL ANDA 23 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0787 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 23 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1963 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 25 sections
isosorbide mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2077 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 23 sections
Isosorbide Mononitrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2554 TABLET, EXTENDED RELEASE 30 mg ORAL ANDA 25 sections