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

Stem definitionDrug idCAS RN
NO2 - derivatives 1952 55-63-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nitroglycerin
  • nitroglycerine
  • nitroglycerol
  • propanetriol trinitrate
  • trinitroglycerin
  • trinitroglycerol
  • glyceryl trinitrate
A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.
  • Molecular weight: 227.09
  • Formula: C3H5N3O9
  • CLOGP: 0.92
  • LIPINSKI: 1
  • HAC: 12
  • HDO: 0
  • TPSA: 165.15
  • ALOGS: -3.05
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O
2.50 mg oral aerosol
2.50 mg SL
5 mg TD

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.64 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance) 194.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.40 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 28, 1981 FDA FOUGERA

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 914.01 10.51 817 63606 88210 50452491
Orthostatic hypotension 549.78 10.51 385 64038 29096 50511605
Sedation complication 471.41 10.51 228 64195 8538 50532163
Creatinine renal clearance decreased 450.05 10.51 244 64179 11637 50529064
Coronary artery disease 423.17 10.51 330 64093 29396 50511305
Cardiac failure congestive 377.54 10.51 500 63923 83882 50456819
Sedation 355.91 10.51 302 64121 30308 50510393
Blood calcium decreased 350.47 10.51 255 64168 20451 50520250
Acute myocardial infarction 348.97 10.51 293 64130 28980 50511721
Angina pectoris 341.17 10.51 276 64147 25912 50514789
Cognitive disorder 300.49 10.51 324 64099 43799 50496902
Balance disorder 277.45 10.51 393 64030 70197 50470504
Depressed level of consciousness 249.56 10.51 319 64104 51634 50489067
Chest pain 246.69 10.51 632 63791 176250 50364451
Hypotension 239.16 10.51 750 63673 234719 50305982
Fall 202.76 10.51 903 63520 334029 50206672
Angina unstable 200.53 10.51 118 64305 6588 50534113
Renal failure 161.02 10.51 393 64030 106240 50434461
Renal injury 141.02 10.51 104 64319 8507 50532194
Coronary arterial stent insertion 137.03 10.51 67 64356 2567 50538134
Drug ineffective 135.33 10.51 562 63861 818771 49721930
Acute coronary syndrome 124.58 10.51 100 64323 9274 50531427
Contraindicated product administered 122.64 10.51 21 64402 148937 50391764
Gastrointestinal haemorrhage 121.20 10.51 280 64143 73041 50467660
Fear 120.96 10.51 119 64304 14430 50526271
Off label use 119.09 10.51 268 64155 474158 50066543
Constipation 114.49 10.51 504 63919 185204 50355497
Systemic lupus erythematosus 113.21 10.51 21 64402 140601 50400100
Mobility decreased 112.57 10.51 287 64136 79661 50461040
Treatment failure 109.85 10.51 21 64402 137616 50403085
Alopecia 108.00 10.51 92 64331 244955 50295746
Hand deformity 106.48 10.51 5 64418 100194 50440507
Glossodynia 102.72 10.51 13 64410 115556 50425145
Maternal exposure during pregnancy 96.94 10.51 41 64382 159737 50380964
Injury 96.93 10.51 201 64222 48724 50491977
Bradycardia 95.63 10.51 236 64187 64190 50476511
Cerebrovascular accident 93.43 10.51 299 64124 94381 50446320
Anhedonia 92.70 10.51 85 64338 9439 50531262
Labile blood pressure 91.71 10.51 44 64379 1616 50539085
Abdominal discomfort 91.46 10.51 96 64327 231545 50309156
Drug intolerance 89.70 10.51 88 64335 219016 50321685
Infusion related reaction 88.63 10.51 53 64370 169504 50371197
Coronary artery occlusion 87.09 10.51 74 64349 7429 50533272
Hyperkalaemia 86.53 10.51 190 64233 47899 50492802
Emotional distress 84.82 10.51 140 64283 28523 50512178
Arthropathy 81.63 10.51 50 64373 157856 50382845
Rheumatoid arthritis 78.76 10.51 85 64338 202465 50338236
Hepatic enzyme increased 76.02 10.51 40 64383 137340 50403361
Myocardial ischaemia 75.02 10.51 83 64340 11530 50529171
Joint swelling 74.95 10.51 123 64300 245163 50295538
Synovitis 73.19 10.51 33 64390 123832 50416869
Peripheral vascular disorder 71.96 10.51 58 64365 5409 50535292
Transient ischaemic attack 71.77 10.51 139 64284 32071 50508630
Atrial fibrillation 64.78 10.51 279 64144 101466 50439235
Discomfort 63.83 10.51 29 64394 108351 50432350
Therapeutic product effect decreased 62.45 10.51 49 64374 136001 50404700
Product use issue 62.33 10.51 59 64364 149416 50391285
Swelling 61.08 10.51 101 64322 200771 50339930
Syncope 59.21 10.51 274 64149 102728 50437973
Cardiac disorder 59.12 10.51 153 64270 42826 50497875
Renal impairment 57.32 10.51 219 64204 75442 50465259
Febrile neutropenia 54.67 10.51 28 64395 97639 50443062
Unevaluable event 54.37 10.51 155 64268 45911 50494790
Neutropenia 54.33 10.51 65 64358 147900 50392801
Cardiac failure 54.28 10.51 216 64207 75824 50464877
Pyrexia 53.89 10.51 275 64148 379928 50160773
Pericarditis 53.08 10.51 17 64406 78672 50462029
Ischaemic cardiomyopathy 52.14 10.51 34 64389 2278 50538423
Chronic obstructive pulmonary disease 50.19 10.51 166 64257 53269 50487432
Rash 50.01 10.51 339 64084 437132 50103569
Coronary artery bypass 49.96 10.51 33 64390 2260 50538441
Hepatic ischaemia 49.19 10.51 21 64402 584 50540117
Infection 48.90 10.51 91 64332 172863 50367838
Acute kidney injury 47.96 10.51 472 63951 227586 50313115
Drug abuse 45.92 10.51 10 64413 59836 50480865
Arthralgia 45.27 10.51 350 64073 438352 50102349
Condition aggravated 44.27 10.51 211 64212 296847 50243854
Helicobacter infection 43.17 10.51 6 64417 49696 50491005
Troponin increased 42.37 10.51 52 64371 8066 50532635
Hyponatraemia 41.45 10.51 236 64187 95903 50444798
Hypersensitivity 41.45 10.51 138 64285 215023 50325678
Cardiac arrest 41.24 10.51 213 64210 83438 50457263
Duodenal ulcer perforation 40.83 10.51 5 64418 45606 50495095
Pulmonary oedema 39.00 10.51 144 64279 48794 50491907
Abortion spontaneous 38.85 10.51 4 64419 41768 50498933
Hepatorenal syndrome 37.77 10.51 25 64398 1718 50538983
Hypoglycaemia 37.26 10.51 151 64272 53430 50487271
Arteriospasm coronary 36.34 10.51 32 64391 3370 50537331
Muscle relaxant therapy 35.99 10.51 12 64411 164 50540537
Nasopharyngitis 35.62 10.51 126 64297 192801 50347900
Coronary artery stenosis 35.49 10.51 35 64388 4254 50536447
Injection site pain 35.44 10.51 54 64369 110970 50429731
White blood cell count decreased 35.16 10.51 59 64364 116663 50424038
Intentional overdose 34.85 10.51 18 64405 62486 50478215
Angioplasty 34.70 10.51 21 64402 1234 50539467
Haematemesis 34.39 10.51 95 64328 27630 50513071
Wound 34.21 10.51 51 64372 105743 50434958
Prinzmetal angina 33.90 10.51 17 64406 688 50540013
Exposure during pregnancy 33.90 10.51 64 64359 120951 50419750
Stress 33.82 10.51 147 64276 53646 50487055
Cardiac murmur 33.69 10.51 54 64369 10730 50529971
Arteriosclerosis coronary artery 33.69 10.51 45 64378 7591 50533110
Sinus arrest 33.55 10.51 23 64400 1675 50539026
Fatigue 33.20 10.51 669 63754 706932 49833769
Sinusitis 33.10 10.51 109 64314 170449 50370252
Product solubility abnormal 32.82 10.51 17 64406 737 50539964
Heart sounds 32.70 10.51 16 64407 614 50540087
Bursitis infective 32.46 10.51 20 64403 1214 50539487
Sinus node dysfunction 32.22 10.51 32 64391 3923 50536778
Hypovolaemia 31.80 10.51 49 64374 9416 50531285
Prolonged expiration 30.65 10.51 16 64407 705 50539996
Dyspnoea 29.98 10.51 910 63513 546698 49994003
Haemorrhage 29.83 10.51 141 64282 53300 50487401
Product use in unapproved indication 29.26 10.51 65 64358 115754 50424947
Oesophageal pain 29.22 10.51 26 64397 2776 50537925
Hyperkeratosis 29.15 10.51 34 64389 5001 50535700
International normalised ratio increased 28.73 10.51 120 64303 43032 50497669
Anxiety 28.72 10.51 349 64074 177257 50363444
Suicide attempt 28.69 10.51 15 64408 51717 50488984
Cardiomegaly 28.67 10.51 63 64360 15882 50524819
Injection site pruritus 28.57 10.51 8 64415 40403 50500298
Injection site reaction 28.50 10.51 14 64409 50018 50490683
Injection site erythema 28.48 10.51 32 64391 74904 50465797
Malignant neoplasm progression 28.25 10.51 27 64396 68097 50472604
Lower gastrointestinal haemorrhage 28.02 10.51 39 64384 6840 50533861
Musculoskeletal stiffness 27.86 10.51 78 64345 128403 50412298
Drug interaction 26.74 10.51 379 64044 199242 50341459
Left ventricular dysfunction 26.72 10.51 48 64375 10458 50530243
Disease progression 26.58 10.51 51 64372 95815 50444886
Intentional product use issue 25.93 10.51 36 64387 76882 50463819
Blood loss anaemia 25.76 10.51 41 64382 8098 50532603
Vascular pseudoaneurysm 25.60 10.51 18 64405 1366 50539335
Product dose omission issue 25.39 10.51 134 64289 183704 50356997
Sputum discoloured 25.31 10.51 54 64369 13341 50527360
Fear of eating 25.02 10.51 11 64412 329 50540372
Melaena 24.81 10.51 83 64340 26781 50513920
Mucosal inflammation 24.80 10.51 10 64413 40132 50500569
Pregnancy 24.69 10.51 4 64419 29573 50511128
Dyspnoea exertional 24.23 10.51 129 64294 51104 50489597
Oedema peripheral 24.07 10.51 307 64116 157654 50383047
Hyperlipidaemia 23.77 10.51 62 64361 17428 50523273
Post procedural haemorrhage 23.53 10.51 37 64386 7233 50533468
Neutrophil count decreased 23.17 10.51 15 64408 46011 50494690
Psoriatic arthropathy 22.78 10.51 16 64407 47016 50493685
Pruritus 22.73 10.51 241 64182 283327 50257374
Coronary artery dissection 22.28 10.51 13 64410 714 50539987
Arterial occlusive disease 22.24 10.51 29 64394 4779 50535922
Toxicity to various agents 22.20 10.51 387 64036 212112 50328589
Acute pulmonary oedema 22.17 10.51 36 64387 7231 50533470
Rales 22.14 10.51 43 64380 9935 50530766
Total lung capacity decreased 22.06 10.51 16 64407 1275 50539426
Irritable bowel syndrome 21.78 10.51 20 64403 51421 50489280
Presyncope 21.67 10.51 74 64349 24124 50516577
Dermatitis bullous 21.16 10.51 35 64388 7138 50533563
Silent myocardial infarction 21 10.51 10 64413 361 50540340
Stomatitis 20.89 10.51 63 64360 101281 50439420
Mitral valve incompetence 20.81 10.51 59 64364 17412 50523289
Cerebral mass effect 20.80 10.51 13 64410 809 50539892
Knee arthroplasty 20.46 10.51 10 64413 35836 50504865
Hallucination 20.40 10.51 115 64308 46542 50494159
Sinus bradycardia 20.29 10.51 49 64374 13134 50527567
Percutaneous coronary intervention 19.84 10.51 8 64415 192 50540509
Pituitary apoplexy 19.81 10.51 7 64416 115 50540586
Atrioventricular block 19.64 10.51 32 64391 6446 50534255
Diarrhoea 19.43 10.51 586 63837 587890 49952811
Completed suicide 19.42 10.51 94 64329 131795 50408906
Ventricular extrasystoles 19.42 10.51 42 64381 10474 50530227
Ventricular tachycardia 19.41 10.51 54 64369 15767 50524934
Chronic kidney disease 19.40 10.51 101 64322 39670 50501031
Ill-defined disorder 19.00 10.51 25 64398 54629 50486072
Autonomic dysreflexia 18.98 10.51 9 64414 322 50540379
C-reactive protein increased 18.74 10.51 35 64388 66439 50474262
Subdural haematoma 18.74 10.51 47 64376 12900 50527801
Laryngospasm 18.73 10.51 20 64403 2668 50538033
Red blood cell sedimentation rate increased 18.72 10.51 7 64416 29409 50511292
Leukopenia 18.65 10.51 36 64387 67492 50473209
Peripheral swelling 18.59 10.51 170 64253 205766 50334935
Coronary artery reocclusion 18.51 10.51 5 64418 31 50540670
Coronary artery restenosis 18.33 10.51 9 64414 348 50540353
Colitis microscopic 18.15 10.51 31 64392 6489 50534212
Hip arthroplasty 18.13 10.51 8 64415 30421 50510280
Laryngotracheal oedema 17.99 10.51 5 64418 35 50540666
Bundle branch block left 17.85 10.51 30 64393 6200 50534501
Impaired healing 17.75 10.51 39 64384 69747 50470954
Electrocardiogram ST segment elevation 17.73 10.51 22 64401 3451 50537250
Blister 17.68 10.51 53 64370 85365 50455336
Multiple organ dysfunction syndrome 16.94 10.51 116 64307 50221 50490480
Bone marrow failure 16.87 10.51 7 64416 27617 50513084
Lip swelling 16.63 10.51 69 64354 24667 50516034
Bronchopulmonary aspergillosis allergic 16.45 10.51 13 64410 1178 50539523
Swollen tongue 16.31 10.51 76 64347 28554 50512147
Herpes zoster 16.07 10.51 42 64381 70744 50469957
Body temperature increased 16.07 10.51 10 64413 31331 50509370
Cardiomyopathy 16.06 10.51 50 64373 15536 50525165
Duodenal ulcer 16.03 10.51 30 64393 6745 50533956
Left ventricular end-diastolic pressure increased 16.02 10.51 8 64415 321 50540380
Haematoma 15.94 10.51 79 64344 30431 50510270
Device dislocation 15.73 10.51 4 64419 21542 50519159
Injection site swelling 15.69 10.51 18 64405 41755 50498946
Blood calcium increased 15.61 10.51 32 64391 7687 50533014
Generalised tonic-clonic seizure 15.54 10.51 7 64416 26303 50514398
Hyperhidrosis 15.43 10.51 178 64245 89248 50451453
Erythema 15.42 10.51 116 64307 146298 50394403
Catheterisation cardiac 15.12 10.51 22 64401 4018 50536683
Bacteriuria 15.06 10.51 10 64413 691 50540010
Coronary ostial stenosis 15.02 10.51 5 64418 68 50540633
Rectal haemorrhage 14.90 10.51 92 64331 38466 50502235
Chest discomfort 14.88 10.51 182 64241 92540 50448161
Neuropathy peripheral 14.80 10.51 68 64355 96689 50444012
Therapeutic product effect incomplete 14.79 10.51 63 64360 91452 50449249
Troponin T increased 14.50 10.51 11 64412 939 50539762
Coagulopathy 14.46 10.51 53 64370 17891 50522810
Gastric haemorrhage 14.45 10.51 26 64397 5670 50535031
Blood pressure decreased 14.40 10.51 121 64302 55788 50484913
Drug eruption 14.39 10.51 6 64417 23600 50517101
Non-cardiac chest pain 14.34 10.51 26 64397 5706 50534995
Lung opacity 14.32 10.51 15 64408 1958 50538743
Ventricular hypertrophy 14.26 10.51 19 64404 3196 50537505
Cardiac failure chronic 14.21 10.51 20 64403 3543 50537158
Peripheral ischaemia 14.17 10.51 22 64401 4254 50536447
Therapeutic response decreased 14.10 10.51 24 64399 47207 50493494
Sleep apnoea syndrome 14.07 10.51 64 64359 23804 50516897
Device issue 14.03 10.51 4 64419 19968 50520733
Headache 13.96 10.51 516 63907 506019 50034682
Haemoptysis 13.92 10.51 67 64356 25506 50515195
Cytomegalovirus infection 13.78 10.51 3 64420 17959 50522742
Acne 13.63 10.51 4 64419 19591 50521110
Flushing 13.56 10.51 42 64381 66973 50473728
Psoriasis 13.44 10.51 44 64379 68956 50471745
Hypokalaemia 13.38 10.51 171 64252 87821 50452880
Coronary artery thrombosis 13.37 10.51 11 64412 1056 50539645
Discoloured vomit 13.30 10.51 9 64414 642 50540059
Dizziness 13.26 10.51 553 63870 345816 50194885
Nodal rhythm 13.22 10.51 13 64410 1574 50539127
Arteriosclerosis 13.19 10.51 33 64390 9044 50531657
Femur fracture 13.16 10.51 17 64406 37447 50503254
Ascites 12.88 10.51 16 64407 35845 50504856
Ischaemia 12.72 10.51 21 64402 4276 50536425
Nephrogenic systemic fibrosis 12.63 10.51 21 64402 4301 50536400
Hypertensive heart disease 12.59 10.51 15 64408 2255 50538446
Respiration abnormal 12.58 10.51 23 64400 5079 50535622
Rheumatic fever 12.57 10.51 3 64420 16864 50523837
Multiple injuries 12.56 10.51 13 64410 1673 50539028
Atrioventricular block second degree 12.52 10.51 19 64404 3602 50537099
Bronchiectasis 12.52 10.51 35 64388 10248 50530453
Cardiogenic shock 12.50 10.51 46 64377 15553 50525148
Cardioactive drug level increased 12.50 10.51 14 64409 1970 50538731
Finger amputation 12.49 10.51 8 64415 520 50540181
Palmar-plantar erythrodysaesthesia syndrome 12.43 10.51 5 64418 20093 50520608
Obstructive airways disorder 12.42 10.51 46 64377 15606 50525095
Periorbital haematoma 12.40 10.51 9 64414 718 50539983
Arteriogram coronary abnormal 12.40 10.51 3 64420 11 50540690
Hydrothorax 12.35 10.51 9 64414 722 50539979
Colitis ischaemic 12.26 10.51 33 64390 9450 50531251
Mitral valve calcification 12.23 10.51 10 64413 951 50539750
Lethargy 12.22 10.51 106 64317 49326 50491375
Essential hypertension 12.20 10.51 21 64402 4423 50536278
No adverse event 12.04 10.51 15 64408 33563 50507138
Urogenital disorder 12.04 10.51 4 64419 54 50540647
Abdominal wall haematoma 12.01 10.51 16 64407 2692 50538009
Rhabdomyolysis 12.00 10.51 88 64335 38939 50501762
COVID-19 11.93 10.51 26 64397 46636 50494065
Vascular graft 11.93 10.51 9 64414 762 50539939
Acquired epidermolysis bullosa 11.91 10.51 4 64419 56 50540645
Inappropriate schedule of product administration 11.89 10.51 49 64374 71782 50468919
Mental status changes 11.86 10.51 83 64340 36189 50504512
Stent placement 11.83 10.51 18 64405 3420 50537281
Creatinine renal clearance increased 11.83 10.51 8 64415 570 50540131
Drug-induced liver injury 11.80 10.51 11 64412 28084 50512617
Gastric ulcer 11.73 10.51 56 64367 21249 50519452
Pancytopenia 11.73 10.51 61 64362 83969 50456732
Lupus myocarditis 11.60 10.51 4 64419 61 50540640
Foot deformity 11.52 10.51 5 64418 19205 50521496
Arterial intramural haematoma 11.49 10.51 3 64420 16 50540685
Platelet count decreased 11.47 10.51 78 64345 100648 50440053
Tricuspid valve incompetence 11.39 10.51 39 64384 12731 50527970
Throat irritation 11.39 10.51 13 64410 30226 50510475
Depressive symptom 11.36 10.51 17 64406 3183 50537518
Anaemia macrocytic 11.16 10.51 15 64408 2544 50538157
Stent malfunction 11.14 10.51 4 64419 69 50540632
Electrocardiogram T wave abnormal 11.06 10.51 14 64409 2239 50538462
Head injury 11.03 10.51 60 64363 23960 50516741
Ventricular fibrillation 11.00 10.51 34 64389 10525 50530176
Left ventricular failure 10.91 10.51 21 64402 4820 50535881
Blood urea increased 10.89 10.51 59 64364 23526 50517175
Reflux gastritis 10.76 10.51 9 64414 884 50539817
Tuberculosis of central nervous system 10.71 10.51 6 64417 305 50540396
Hypertension 10.69 10.51 348 64075 210855 50329846
Leg amputation 10.67 10.51 13 64410 2000 50538701
Confusional state 10.65 10.51 311 64112 185617 50355084
Acute myeloid leukaemia 10.63 10.51 3 64420 15071 50525630
Weight increased 10.58 10.51 187 64236 201704 50338997
Hypoosmolar state 10.57 10.51 5 64418 178 50540523

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 934.05 10.99 1147 60449 109149 29403782
Coronary artery disease 436.21 10.99 498 61098 43692 29469239
Acute myocardial infarction 392.90 10.99 494 61102 47944 29464987
Chest pain 360.32 10.99 749 60847 111224 29401707
Cardiac failure congestive 349.38 10.99 595 61001 75986 29436945
Angina pectoris 337.79 10.99 350 61246 27500 29485431
Injury 221.27 10.99 234 61362 18812 29494119
Fear 217.70 10.99 171 61425 9333 29503598
Angina unstable 214.03 10.99 179 61417 10686 29502245
Anhedonia 190.11 10.99 141 61455 7059 29505872
Coronary arterial stent insertion 184.93 10.99 110 61486 3787 29509144
Renal injury 160.64 10.99 148 61448 10054 29502877
Emotional distress 154.81 10.99 167 61429 13728 29499203
Drug abuse 128.46 10.99 10 61586 79873 29433058
Off label use 116.39 10.99 287 61309 300513 29212418
Product solubility abnormal 106.60 10.99 39 61557 420 29512511
Hypotension 103.16 10.99 725 60871 193629 29319302
Myocardial ischaemia 97.07 10.99 142 61454 15886 29497045
Bradycardia 96.97 10.99 329 61267 65300 29447631
Stress 95.15 10.99 165 61431 21325 29491606
Unevaluable event 92.52 10.99 197 61399 29654 29483277
Syncope 89.48 10.99 371 61225 81000 29431931
Ischaemic cardiomyopathy 85.29 10.99 80 61516 5558 29507373
Cardiac disorder 81.84 10.99 215 61381 37048 29475883
Toxicity to various agents 78.28 10.99 152 61444 173509 29339422
Dizziness 78.01 10.99 667 60929 189017 29323914
Coronary artery bypass 69.95 10.99 66 61530 4619 29508312
Anxiety 69.93 10.99 357 61239 85008 29427923
Chronic obstructive pulmonary disease 69.20 10.99 215 61381 40740 29472191
Pyrexia 67.59 10.99 339 61257 287283 29225648
Neutropenia 63.11 10.99 111 61485 131600 29381331
Coronary artery occlusion 59.05 10.99 88 61508 10006 29502925
Product use in unapproved indication 58.22 10.99 57 61539 86818 29426113
Cerebrovascular accident 57.05 10.99 313 61283 76598 29436333
Acute coronary syndrome 56.34 10.99 96 61500 12229 29500702
Febrile neutropenia 55.21 10.99 93 61503 112147 29400784
Ventricular extrasystoles 54.53 10.99 87 61509 10495 29502436
Atrial fibrillation 54.07 10.99 391 61205 105255 29407676
Foetal exposure during pregnancy 52.34 10.99 5 61591 33862 29479069
Ventricular tachycardia 51.34 10.99 132 61464 22442 29490489
Presyncope 49.62 10.99 106 61490 15983 29496948
Dyspnoea 48.73 10.99 952 60644 325780 29187151
Malignant neoplasm progression 46.61 10.99 51 61545 73808 29439123
Middle insomnia 45.83 10.99 58 61538 5650 29507281
Renal failure 44.99 10.99 410 61186 118189 29394742
Coronary artery stenosis 44.89 10.99 71 61525 8502 29504429
Completed suicide 44.16 10.99 75 61521 90171 29422760
Drug ineffective 41.61 10.99 521 61075 362649 29150282
Ventricular fibrillation 40.67 10.99 97 61499 15736 29497195
Troponin increased 39.97 10.99 70 61526 9113 29503818
Pain 39.48 10.99 537 61059 170895 29342036
Chest discomfort 38.79 10.99 194 61402 45789 29467142
C-reactive protein increased 38.71 10.99 22 61574 44241 29468690
Therapeutic product effect incomplete 38.18 10.99 17 61579 39288 29473643
Cerebral artery thrombosis 37.98 10.99 22 61574 720 29512211
Brain scan abnormal 35.21 10.99 22 61574 828 29512103
Arteriosclerosis coronary artery 35.19 10.99 72 61524 10533 29502398
Gastrointestinal haemorrhage 34.87 10.99 284 61312 79249 29433682
Leukopenia 32.79 10.99 40 61556 55163 29457768
Cardiac failure 32.56 10.99 279 61317 79008 29433923
Drug reaction with eosinophilia and systemic symptoms 32.50 10.99 9 61587 27983 29484948
Soft tissue mass 30.29 10.99 18 61578 618 29512313
International normalised ratio increased 28.57 10.99 174 61422 44198 29468733
Hepatic function abnormal 28.37 10.99 24 61572 39235 29473696
Cytomegalovirus infection 27.84 10.99 7 61589 23208 29489723
Prinzmetal angina 27.68 10.99 19 61577 840 29512091
Neutrophil count decreased 27.57 10.99 30 61566 43537 29469394
Multimorbidity 27.20 10.99 16 61580 539 29512392
Hyperlipidaemia 26.96 10.99 72 61524 12518 29500413
Acute kidney injury 26.14 10.99 730 60866 264537 29248394
Mucosal inflammation 25.81 10.99 17 61579 31578 29481353
Post procedural complication 24.92 10.99 62 61534 10327 29502604
Renal impairment 24.88 10.99 269 61327 81064 29431867
Cardiomegaly 24.82 10.99 74 61522 13702 29499229
Product dose omission issue 24.64 10.99 110 61486 96273 29416658
Electrocardiogram ST segment elevation 24.62 10.99 38 61558 4454 29508477
Base excess decreased 24.52 10.99 11 61585 207 29512724
Rash 24.48 10.99 265 61331 189554 29323377
Diarrhoea 24.47 10.99 518 61078 332180 29180751
Coronary artery thrombosis 23.92 10.99 25 61571 1980 29510951
Orthostatic hypotension 23.91 10.99 102 61494 22527 29490404
Treatment failure 23.85 10.99 25 61571 36914 29476017
Neuroleptic malignant syndrome 23.39 10.99 3 61593 16145 29496786
Oesophageal perforation 22.69 10.99 16 61580 739 29512192
White blood cell count decreased 22.00 10.99 94 61502 83268 29429663
Infusion related reaction 21.89 10.99 36 61560 43850 29469081
Cardiac arrest 21.69 10.99 273 61323 85318 29427613
Peripheral vascular disorder 21.43 10.99 36 61560 4531 29508400
Vascular stent occlusion 21.05 10.99 9 61587 150 29512781
Ventricular dysfunction 20.87 10.99 30 61566 3301 29509630
Bone marrow failure 20.81 10.99 16 61580 27433 29485498
Infection 20.59 10.99 86 61510 76665 29436266
Post procedural haemorrhage 20.44 10.99 47 61549 7444 29505487
Reperfusion arrhythmia 20.35 10.99 7 61589 62 29512869
Disease progression 20.03 10.99 95 61501 81821 29431110
Intentional product misuse 19.66 10.99 26 61570 34635 29478296
Oxygen consumption decreased 19.56 10.99 9 61587 180 29512751
Arteriosclerosis 19.34 10.99 56 61540 10200 29502731
Ischaemic stroke 19.24 10.99 75 61521 15902 29497029
Stomatitis 18.92 10.99 30 61566 37083 29475848
Orthopnoea 18.86 10.99 34 61562 4526 29508405
Platelet count decreased 18.85 10.99 134 61462 104538 29408393
Alanine aminotransferase increased 18.71 10.99 80 61516 70864 29442067
Pulmonary oedema 18.39 10.99 152 61444 42583 29470348
Pneumocystis jirovecii pneumonia 18.38 10.99 6 61590 16773 29496158
International normalised ratio decreased 18.31 10.99 32 61564 4158 29508773
Rectal haemorrhage 18.29 10.99 129 61467 34420 29478511
Blood loss anaemia 18.10 10.99 44 61552 7222 29505709
Circulatory collapse 18.08 10.99 82 61514 18591 29494340
Vascular graft 17.90 10.99 18 61578 1362 29511569
Cardiac procedure complication 17.81 10.99 8 61588 151 29512780
Laryngeal haematoma 17.71 10.99 8 61588 153 29512778
Cytokine release syndrome 17.70 10.99 3 61593 13116 29499815
Areflexia 17.54 10.99 25 61571 2729 29510202
Arrhythmia 17.21 10.99 118 61478 31195 29481736
Acute pulmonary oedema 16.83 10.99 41 61555 6738 29506193
Carotid artery stenosis 16.83 10.99 32 61564 4437 29508494
Cardiac arrest neonatal 16.66 10.99 5 61591 27 29512904
Nerve degeneration 16.49 10.99 8 61588 181 29512750
Neurotoxicity 16.41 10.99 5 61591 14608 29498323
Labelled drug-drug interaction medication error 16.23 10.99 59 61537 12100 29500831
Full blood count abnormal 16.11 10.99 68 61528 14945 29497986
Sinus bradycardia 16.09 10.99 57 61539 11546 29501385
Normochromic normocytic anaemia 16.07 10.99 28 61568 3630 29509301
Supraventricular tachycardia 15.86 10.99 51 61545 9833 29503098
Non-cardiac chest pain 15.73 10.99 29 61567 3928 29509003
Coronary steal syndrome 15.53 10.99 3 61593 0 29512931
Chronic kidney disease 15.38 10.99 129 61467 36287 29476644
Decreased appetite 15.27 10.99 212 61384 145130 29367801
Stent placement 15.20 10.99 30 61566 4276 29508655
Gastrointestinal tract irritation 14.94 10.99 8 61588 224 29512707
COVID-19 14.93 10.99 33 61563 35981 29476950
Vascular graft occlusion 14.80 10.99 11 61585 552 29512379
Generalised tonic-clonic seizure 14.71 10.99 11 61585 19128 29493803
Intentional overdose 14.62 10.99 37 61559 38491 29474440
Ecchymosis 14.56 10.99 37 61559 6243 29506688
Cervicogenic headache 14.50 10.99 4 61592 15 29512916
Coagulation time prolonged 14.28 10.99 15 61581 1195 29511736
Multiple injuries 14.23 10.99 18 61578 1752 29511179
Atrial flutter 14.19 10.99 62 61534 13832 29499099
Psychotic disorder 14.03 10.99 13 61583 20341 29492590
Overdose 13.97 10.99 103 61493 79716 29433215
Fall 13.78 10.99 474 61122 176704 29336227
Intentional product use issue 13.77 10.99 44 61552 42454 29470477
Discharge 13.76 10.99 7 61589 176 29512755
Seizure 13.64 10.99 126 61470 92997 29419934
Cold sweat 13.63 10.99 45 61551 8797 29504134
Gastrooesophageal reflux disease 13.53 10.99 112 61484 31384 29481547
Ureteric haemorrhage 13.52 10.99 6 61590 110 29512821
Atrioventricular block complete 13.46 10.99 42 61554 7969 29504962
Palmar-plantar erythrodysaesthesia syndrome 13.39 10.99 7 61589 14752 29498179
Mitral valve incompetence 13.33 10.99 59 61537 13234 29499697
Faeces discoloured 13.20 10.99 59 61537 13292 29499639
Organ failure 12.96 10.99 18 61578 1918 29511013
Melaena 12.93 10.99 110 61486 31066 29481865
Porphyria acute 12.88 10.99 7 61589 202 29512729
Transaminases increased 12.85 10.99 17 61579 22645 29490286
Swollen tongue 12.73 10.99 55 61541 12211 29500720
Intentional self-injury 12.72 10.99 5 61591 12456 29500475
Coronary artery restenosis 12.65 10.99 13 61583 1009 29511922
Myocardial bridging 12.57 10.99 4 61592 27 29512904
Bronchopulmonary aspergillosis 12.53 10.99 5 61591 12339 29500592
Superinfection 12.50 10.99 18 61578 1983 29510948
Drug intolerance 12.48 10.99 55 61541 48324 29464607
Hemiplegia 12.43 10.99 36 61560 6558 29506373
Injection site pain 12.43 10.99 31 61565 32415 29480516
Tricuspid valve incompetence 12.30 10.99 42 61554 8352 29504579
Poor quality product administered 12.29 10.99 16 61580 1603 29511328
Rales 12.28 10.99 39 61557 7471 29505460
Haemoptysis 12.26 10.99 107 61489 30443 29482488
Morning glory syndrome 12.25 10.99 3 61593 6 29512925
Coronary ostial stenosis 12.24 10.99 5 61591 74 29512857
Sedation 12.14 10.99 11 61585 17394 29495537
Hiatus hernia 11.91 10.99 36 61560 6716 29506215
Interstitial lung disease 11.85 10.99 71 61525 57647 29455284
Neuropathy peripheral 11.79 10.99 93 61503 70934 29441997
Arteriospasm coronary 11.75 10.99 20 61576 2545 29510386
Death 11.70 10.99 588 61008 341496 29171435
Reversible airways obstruction 11.69 10.99 7 61589 244 29512687
Fungal infection 11.68 10.99 7 61589 13678 29499253
Hyperhidrosis 11.63 10.99 194 61402 64346 29448585
Neoplasm progression 11.57 10.99 13 61583 18599 29494332
Pancytopenia 11.55 10.99 114 61482 83054 29429877
General physical health deterioration 11.53 10.99 148 61448 102709 29410222
Myocardial necrosis marker increased 11.49 10.99 15 61581 1507 29511424
Osteonecrosis 11.42 10.99 7 61589 13512 29499419
Ventricular asystole 11.40 10.99 6 61590 162 29512769
Coronary bypass thrombosis 11.39 10.99 3 61593 9 29512922
Left ventricular enlargement 11.33 10.99 10 61586 642 29512289
Disseminated intravascular coagulation 11.31 10.99 15 61581 19965 29492966
Product monitoring error 11.30 10.99 20 61576 2625 29510306
Septic shock 11.29 10.99 80 61516 62480 29450451
Herpes zoster 11.29 10.99 29 61567 30023 29482908
Blood creatine phosphokinase MB increased 11.27 10.99 16 61580 1741 29511190
Mean cell haemoglobin decreased 11.20 10.99 14 61582 1347 29511584
Sepsis 11.07 10.99 220 61376 142462 29370469
Rhabdomyolysis 11.03 10.99 183 61413 60625 29452306
Ureteral disorder 11.01 10.99 6 61590 174 29512757

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 1761.10 10.28 1746 105598 164075 64227313
Coronary artery disease 801.54 10.28 721 106623 59712 64331676
Acute myocardial infarction 713.85 10.28 721 106623 68997 64322391
Cardiac failure congestive 687.53 10.28 961 106383 129619 64261769
Angina pectoris 566.54 10.28 522 106822 44559 64346829
Chest pain 459.51 10.28 1130 106214 234850 64156538
Orthostatic hypotension 457.54 10.28 472 106872 46266 64345122
Sedation complication 420.17 10.28 244 107100 10110 64381278
Creatinine renal clearance decreased 393.31 10.28 264 107080 14157 64377231
Angina unstable 367.27 10.28 260 107084 15207 64376181
Coronary arterial stent insertion 321.80 10.28 167 107177 5525 64385863
Hypotension 312.05 10.28 1357 105987 379617 64011771
Fear 293.82 10.28 254 107090 19917 64371471
Blood calcium decreased 279.23 10.28 274 107070 25280 64366108
Renal injury 276.26 10.28 219 107125 15210 64376178
Injury 256.18 10.28 386 106958 55606 64335782
Anhedonia 250.68 10.28 197 107147 13509 64377879
Sedation 238.69 10.28 319 107025 41143 64350245
Cognitive disorder 227.17 10.28 362 106982 54725 64336663
Balance disorder 211.92 10.28 446 106898 83480 64307908
Off label use 207.19 10.28 468 106876 632338 63759050
Emotional distress 200.92 10.28 273 107071 35765 64355623
Renal failure 177.39 10.28 684 106660 181004 64210384
Myocardial ischaemia 175.62 10.28 205 107139 23046 64368342
Fall 167.77 10.28 1227 106117 415599 63975789
Unevaluable event 159.70 10.28 295 107049 50194 64341194
Bradycardia 157.94 10.28 494 106850 117725 64273663
Drug abuse 157.42 10.28 18 107326 132356 64259032
Acute coronary syndrome 150.44 10.28 173 107171 19137 64372251
Depressed level of consciousness 145.52 10.28 378 106966 81058 64310330
Ischaemic cardiomyopathy 141.97 10.28 106 107238 6732 64384656
Cerebrovascular accident 139.19 10.28 524 106820 137059 64254329
Gastrointestinal haemorrhage 130.60 10.28 500 106844 131812 64259576
Syncope 128.15 10.28 561 106783 157074 64234314
Coronary artery occlusion 124.64 10.28 134 107210 13757 64377631
Drug ineffective 121.68 10.28 860 106484 839387 63552001
Coronary artery bypass 113.76 10.28 87 107257 5728 64385660
Pyrexia 107.20 10.28 522 106822 558122 63833266
Chronic obstructive pulmonary disease 106.24 10.28 309 107035 70739 64320649
Infusion related reaction 104.43 10.28 73 107271 164394 64226994
Atrial fibrillation 102.50 10.28 558 106786 170531 64220857
Neutropenia 101.44 10.28 151 107193 239473 64151915
Cardiac disorder 99.59 10.28 259 107085 55557 64335831
Stress 98.04 10.28 271 107073 60263 64331125
Treatment failure 97.82 10.28 36 107308 116780 64274608
Febrile neutropenia 95.26 10.28 103 107241 187554 64203834
Mobility decreased 95.25 10.28 337 107007 85503 64305885
Alopecia 90.89 10.28 85 107259 165605 64225783
Hyperkalaemia 87.59 10.28 367 106977 100762 64290626
Renal impairment 84.68 10.28 446 106898 134571 64256817
Hand deformity 84.32 10.28 5 107339 62766 64328622
Troponin increased 80.32 10.28 113 107231 15286 64376102
Labile blood pressure 79.07 10.28 47 107297 2033 64389355
Anxiety 78.65 10.28 592 106752 202057 64189331
Coronary artery stenosis 78.06 10.28 95 107249 11153 64380235
Cardiac failure 77.41 10.28 429 106915 131944 64259444
Drug intolerance 77.09 10.28 121 107223 187871 64203517
Product use in unapproved indication 76.97 10.28 109 107235 176509 64214879
Hepatic enzyme increased 75.67 10.28 63 107281 129880 64261508
Acute kidney injury 74.54 10.28 1104 106240 448136 63943252
Completed suicide 73.90 10.28 165 107179 224249 64167139
Systemic lupus erythematosus 73.81 10.28 19 107325 77593 64313795
Rheumatoid arthritis 72.98 10.28 100 107244 164194 64227194
Maternal exposure during pregnancy 70.05 10.28 36 107308 95848 64295540
Infection 69.35 10.28 126 107218 184754 64206634
Dizziness 67.42 10.28 1047 106297 429116 63962272
Contraindicated product administered 64.37 10.28 51 107293 107778 64283610
Synovitis 64.18 10.28 43 107301 99047 64292341
Joint swelling 62.55 10.28 169 107175 215213 64176175
Arteriosclerosis coronary artery 62.54 10.28 101 107243 15428 64375960
Malignant neoplasm progression 60.60 10.28 59 107285 112812 64278576
Injection site pain 60.09 10.28 58 107286 111350 64280038
Dyspnoea 60.04 10.28 1592 105752 717082 63674306
Peripheral vascular disorder 58.15 10.28 66 107278 7195 64384193
Constipation 57.94 10.28 610 106734 228727 64162661
Glossodynia 57.51 10.28 18 107326 64678 64326710
Product solubility abnormal 57.35 10.28 28 107316 811 64390577
Presyncope 56.71 10.28 157 107187 34932 64356456
Therapeutic product effect decreased 55.58 10.28 66 107278 115285 64276103
Arthralgia 55.55 10.28 470 106874 441790 63949598
Arthropathy 55.37 10.28 72 107272 120895 64270493
Abdominal discomfort 55.27 10.28 140 107204 182182 64209206
Ventricular tachycardia 55.07 10.28 153 107191 34112 64357276
Nasopharyngitis 51.71 10.28 161 107183 195912 64195476
Ventricular fibrillation 50.25 10.28 118 107226 23742 64367646
Cardiomegaly 49.74 10.28 117 107227 23567 64367821
Rash 49.54 10.28 506 106838 458043 63933345
White blood cell count decreased 48.76 10.28 120 107224 157717 64233671
Product use issue 48.73 10.28 113 107231 151602 64239786
Diarrhoea 48.61 10.28 879 106465 721825 63669563
Transient ischaemic attack 48.59 10.28 173 107171 44009 64347379
International normalised ratio increased 47.88 10.28 259 107085 78908 64312480
Pulmonary oedema 46.65 10.28 256 107088 78418 64312970
Cardiac arrest 46.30 10.28 425 106919 153639 64237749
Discomfort 46.11 10.28 40 107304 80838 64310550
C-reactive protein increased 46.05 10.28 54 107290 94855 64296533
Product dose omission issue 45.83 10.28 168 107176 194579 64196809
Prinzmetal angina 44.57 10.28 29 107315 1474 64389914
Arteriospasm coronary 44.32 10.28 50 107294 5415 64385973
Neutrophil count decreased 44.22 10.28 38 107306 77158 64314230
Helicobacter infection 43.67 10.28 6 107338 38356 64353032
Mucosal inflammation 43.51 10.28 25 107319 62559 64328829
Pericarditis 43.43 10.28 25 107319 62491 64328897
Injection site erythema 42.86 10.28 33 107311 70767 64320621
Post procedural haemorrhage 42.30 10.28 75 107269 12356 64379032
Sinusitis 41.97 10.28 115 107229 145813 64245575
Leukopenia 41.63 10.28 65 107279 101177 64290211
Hepatic ischaemia 41.23 10.28 24 107320 998 64390390
Condition aggravated 41.00 10.28 409 106935 372017 64019371
Intentional overdose 40.68 10.28 54 107290 89890 64301498
Hyperlipidaemia 40.34 10.28 106 107238 22870 64368518
Therapeutic product effect incomplete 40.16 10.28 69 107275 103413 64287975
Swelling 39.16 10.28 136 107208 160082 64231306
Hypersensitivity 39.02 10.28 181 107163 196271 64195117
Exposure during pregnancy 38.98 10.28 43 107301 77632 64313756
Haemorrhage 38.53 10.28 245 107099 79106 64312282
Brain scan abnormal 38.27 10.28 24 107320 1144 64390244
Bone marrow failure 38.11 10.28 16 107328 47936 64343452
Duodenal ulcer perforation 38.07 10.28 6 107338 34619 64356769
Melaena 37.83 10.28 183 107161 53365 64338023
Blood loss anaemia 37.58 10.28 76 107268 13816 64377572
Cytomegalovirus infection 37.55 10.28 8 107336 37191 64354197
Intentional product use issue 37.55 10.28 63 107281 95301 64296087
Coronary artery thrombosis 37.52 10.28 34 107310 2835 64388553
Hypoglycaemia 37.33 10.28 267 107077 89625 64301763
Ventricular extrasystoles 36.16 10.28 86 107258 17443 64373945
Rectal haemorrhage 35.87 10.28 200 107144 61617 64329771
Disease progression 35.48 10.28 119 107225 141561 64249827
Sinus node dysfunction 35.45 10.28 50 107294 6778 64384610
Injection site reaction 34.85 10.28 17 107327 46647 64344741
Injection site pruritus 34.57 10.28 10 107334 37816 64353572
Stomatitis 34.10 10.28 83 107261 109522 64281866
Middle insomnia 33.12 10.28 69 107275 12808 64378580
Muscle relaxant therapy 32.85 10.28 12 107332 164 64391224
Cerebral artery thrombosis 32.80 10.28 21 107323 1038 64390350
Angioplasty 32.50 10.28 25 107319 1660 64389728
Acute pulmonary oedema 32.21 10.28 68 107276 12741 64378647
Cardiac murmur 32.16 10.28 64 107280 11499 64379889
Erythema 31.71 10.28 182 107162 186888 64204500
Chest discomfort 31.26 10.28 313 107031 115793 64275595
Haemoptysis 30.70 10.28 162 107182 48886 64342502
Mitral valve incompetence 30.69 10.28 103 107241 25435 64365953
Drug reaction with eosinophilia and systemic symptoms 30.67 10.28 27 107317 54190 64337198
Sinus bradycardia 29.91 10.28 95 107249 22798 64368590
Intentional self-injury 29.83 10.28 6 107338 29038 64362350
Drug interaction 29.75 10.28 801 106543 361282 64030106
Arteriosclerosis 29.68 10.28 75 107269 15802 64375586
Neurotoxicity 29.56 10.28 5 107339 27399 64363989
Neuropathy peripheral 29.23 10.28 99 107245 117426 64273962
Coronary artery restenosis 28.86 10.28 21 107323 1281 64390107
Fear of eating 28.82 10.28 14 107330 401 64390987
Rales 28.53 10.28 72 107272 15157 64376231
Vascular graft 28.26 10.28 24 107320 1835 64389553
Soft tissue mass 28.09 10.28 18 107326 891 64390497
Herpes zoster 27.89 10.28 56 107288 79131 64312257
Generalised tonic-clonic seizure 27.59 10.28 16 107328 39841 64351547
Vascular stent occlusion 27.50 10.28 11 107333 195 64391193
Prolonged expiration 27.19 10.28 17 107327 806 64390582
Pain 27.01 10.28 1152 106192 552359 63839029
Chronic kidney disease 26.99 10.28 177 107167 57742 64333646
Hyponatraemia 26.65 10.28 370 106974 147969 64243419
Heart sounds 26.57 10.28 15 107329 588 64390800
Non-cardiac chest pain 26.53 10.28 50 107294 8630 64382758
Multiple injuries 26.44 10.28 30 107314 3269 64388119
Psoriatic arthropathy 26.42 10.28 20 107324 43261 64348127
Platelet count decreased 26.40 10.28 167 107177 167544 64223844
Pruritus 26.26 10.28 364 106980 312036 64079352
Carotid artery stenosis 25.85 10.28 47 107297 7894 64383494
Oesophageal pain 25.02 10.28 29 107315 3234 64388154
Impaired healing 24.69 10.28 39 107305 60434 64330954
Post procedural complication 24.67 10.28 85 107259 21268 64370120
Rhabdomyolysis 24.55 10.28 247 107097 91479 64299909
Lymphadenopathy 24.36 10.28 25 107319 46661 64344727
Muscle injury 24.14 10.28 7 107337 26430 64364958
Multimorbidity 23.99 10.28 17 107327 995 64390393
Pancytopenia 23.97 10.28 140 107204 143169 64248219
COVID-19 23.86 10.28 45 107299 65095 64326293
Fatigue 23.77 10.28 1012 106332 747718 63643670
Electrocardiogram ST segment elevation 23.68 10.28 43 107301 7216 64384172
Ischaemia 23.60 10.28 43 107301 7235 64384153
Arrhythmia 23.59 10.28 160 107184 52784 64338604
Coronary ostial stenosis 23.52 10.28 9 107335 141 64391247
Coagulation time prolonged 23.41 10.28 23 107321 2123 64389265
Haematemesis 23.36 10.28 146 107198 46853 64344535
Suicide attempt 22.70 10.28 53 107291 70954 64320434
Vascular pseudoaneurysm 22.68 10.28 27 107317 3097 64388291
Cardiac procedure complication 22.68 10.28 11 107333 314 64391074
Neoplasm progression 22.46 10.28 21 107323 40943 64350445
Pneumocystis jirovecii pneumonia 22.32 10.28 9 107335 27625 64363763
Swollen tongue 22.25 10.28 116 107228 34838 64356550
Neuroleptic malignant syndrome 22.13 10.28 7 107337 24989 64366399
Dyspnoea exertional 21.93 10.28 203 107141 73527 64317861
Percutaneous coronary intervention 21.88 10.28 11 107333 340 64391048
Injection site swelling 21.74 10.28 22 107322 41331 64350057
Tricuspid valve incompetence 21.71 10.28 70 107274 16933 64374455
Bronchopulmonary aspergillosis 21.69 10.28 3 107341 19082 64372306
Coronary steal syndrome 21.60 10.28 4 107340 0 64391388
Bundle branch block left 21.54 10.28 50 107294 9984 64381404
Circulatory collapse 21.51 10.28 112 107232 33620 64357768
Labelled drug-drug interaction medication error 21.42 10.28 83 107261 21979 64369409
Hepatic function abnormal 21.37 10.28 47 107297 64266 64327122
Base excess decreased 21.36 10.28 11 107333 358 64391030
Haematoma 21.34 10.28 141 107203 46109 64345279
Oesophageal perforation 21.30 10.28 16 107328 1025 64390363
Acne 21.28 10.28 6 107338 23075 64368313
Sinus arrest 21.28 10.28 26 107318 3064 64388324
Flushing 21.12 10.28 64 107280 78584 64312804
Ischaemic stroke 21.06 10.28 100 107244 28935 64362453
Coronary artery dissection 20.91 10.28 15 107329 895 64390493
Haematuria 20.85 10.28 172 107172 60299 64331089
Palmar-plantar erythrodysaesthesia syndrome 20.77 10.28 11 107333 28808 64362580
Obstructive airways disorder 20.73 10.28 85 107259 23100 64368288
Progressive multifocal leukoencephalopathy 20.41 10.28 3 107341 18229 64373159
Inappropriate schedule of product administration 20.15 10.28 82 107262 92204 64299184
Confusional state 20.10 10.28 573 106771 260571 64130817
Supraventricular tachycardia 19.91 10.28 73 107271 18834 64372554
Essential hypertension 19.85 10.28 33 107311 5161 64386227
Coronary artery reocclusion 19.68 10.28 8 107336 148 64391240
Faeces discoloured 19.68 10.28 90 107254 25639 64365749
Weight increased 19.59 10.28 244 107100 213104 64178284
Atrioventricular block second degree 19.51 10.28 37 107307 6417 64384971
Hyperhidrosis 19.45 10.28 304 107040 124616 64266772
Areflexia 19.39 10.28 32 107312 4975 64386413
Lower gastrointestinal haemorrhage 19.28 10.28 59 107285 13880 64377508
Laryngeal haematoma 19.25 10.28 8 107336 157 64391231
Drug resistance 19.24 10.28 18 107326 35084 64356304
Atrioventricular block complete 18.99 10.28 60 107284 14358 64377030
Cardiomyopathy 18.88 10.28 88 107256 25268 64366120
Hip arthroplasty 18.87 10.28 6 107338 21345 64370043
Septic shock 18.71 10.28 101 107243 105336 64286052
Cold sweat 18.58 10.28 65 107279 16390 64374998
Irritable bowel syndrome 18.40 10.28 21 107323 37348 64354040
Sleep apnoea syndrome 18.30 10.28 98 107246 29734 64361654
Multiple sclerosis relapse 18.29 10.28 25 107319 41110 64350278
Musculoskeletal stiffness 18.21 10.28 125 107219 123081 64268307
Ventricular dysfunction 18.19 10.28 32 107312 5238 64386150
Stent placement 18.17 10.28 33 107311 5538 64385850
Cytokine release syndrome 18.15 10.28 6 107338 20823 64370565
Vascular stent thrombosis 18.01 10.28 25 107319 3339 64388049
Oxygen consumption decreased 18.00 10.28 10 107334 380 64391008
International normalised ratio decreased 18.00 10.28 39 107305 7439 64383949
Blood creatine phosphokinase MB increased 17.96 10.28 22 107322 2599 64388789
Peripheral swelling 17.81 10.28 243 107101 208910 64182478
Atrioventricular block 17.70 10.28 52 107292 11963 64379425
Acute myeloid leukaemia 17.66 10.28 12 107332 27451 64363937
Head injury 17.57 10.28 104 107240 32738 64358650
Silent myocardial infarction 17.53 10.28 12 107332 664 64390724
Autonomic dysreflexia 17.46 10.28 10 107334 403 64390985
Therapeutic response decreased 17.45 10.28 38 107306 52150 64339238
Normochromic normocytic anaemia 17.38 10.28 36 107308 6654 64384734
Drug-induced liver injury 17.37 10.28 33 107311 47610 64343778
Hepatorenal syndrome 17.37 10.28 26 107318 3720 64387668
Arterial stenosis 17.31 10.28 16 107328 1369 64390019
Red blood cell sedimentation rate increased 17.14 10.28 16 107328 31219 64360169
Knee arthroplasty 17.10 10.28 12 107332 26987 64364401
Hepatotoxicity 17.06 10.28 25 107319 39937 64351451
Left ventricular failure 17.04 10.28 41 107303 8376 64383012
Inflammation 16.92 10.28 54 107290 65246 64326142
Hot flush 16.88 10.28 32 107312 46203 64345185
Ventricular hypertrophy 16.86 10.28 35 107309 6481 64384907
Heparin-induced thrombocytopenia 16.85 10.28 41 107303 8438 64382950
Wheezing 16.56 10.28 206 107138 80373 64311015
Subdural haematoma 16.43 10.28 91 107253 27963 64363425
Psychotic disorder 16.42 10.28 20 107324 34558 64356830
Headache 16.26 10.28 718 106626 528749 63862639
Arterial occlusive disease 16.15 10.28 36 107308 6997 64384391
Product complaint 15.98 10.28 50 107294 11904 64379484
Weight decreased 15.96 10.28 358 106986 285381 64106007
Breast cancer 15.91 10.28 15 107329 29133 64362255
Orthopnoea 15.89 10.28 42 107302 9092 64382296
Left ventricular dysfunction 15.83 10.28 63 107281 16891 64374497
Nausea 15.79 10.28 1111 106233 784689 63606699
Oedema peripheral 15.76 10.28 460 106884 209857 64181531
Ventricular asystole 15.74 10.28 8 107336 253 64391135
Body temperature increased 15.59 10.28 23 107321 36643 64354745
Gastrooesophageal reflux disease 15.58 10.28 209 107135 82934 64308454
Laryngotracheal oedema 15.56 10.28 5 107339 45 64391343
Pituitary apoplexy 15.47 10.28 7 107337 170 64391218
Haemophagocytic lymphohistiocytosis 15.47 10.28 5 107339 17604 64373784
Nerve degeneration 15.46 10.28 8 107336 263 64391125
Vascular graft occlusion 15.34 10.28 11 107333 656 64390732
Device related infection 15.31 10.28 17 107327 30609 64360779
Seizure 15.27 10.28 191 107153 166701 64224687
Oral herpes 15.18 10.28 9 107335 22143 64369245
Mouth ulceration 15.16 10.28 19 107325 32425 64358963
Full blood count abnormal 15.14 10.28 93 107251 29664 64361724
Alanine aminotransferase increased 15.13 10.28 153 107191 138878 64252510
Hyperkeratosis 15.12 10.28 34 107310 6647 64384741
Urea renal clearance decreased 15.00 10.28 4 107340 17 64391371
Myocardial bridging 15.00 10.28 4 107340 17 64391371
Atrial flutter 14.98 10.28 68 107276 19312 64372076
Psoriasis 14.86 10.28 65 107279 71638 64319750
Wound 14.85 10.28 71 107273 76406 64314982
Hypovolaemia 14.82 10.28 58 107286 15428 64375960
Abdominal rigidity 14.78 10.28 20 107324 2607 64388781
Blood pressure decreased 14.67 10.28 213 107131 85986 64305402
Hallucination 14.49 10.28 185 107159 72603 64318785
Overdose 14.45 10.28 183 107161 159383 64232005
Multiple organ dysfunction syndrome 14.37 10.28 243 107101 101170 64290218
Anaemia 14.36 10.28 769 106575 377911 64013477
Normochromic anaemia 14.27 10.28 9 107335 433 64390955
Oropharyngeal pain 14.23 10.28 88 107256 88779 64302609
Coronary no-reflow phenomenon 14.15 10.28 4 107340 22 64391366
Drug eruption 14.10 10.28 24 107320 36112 64355276
Peripheral ischaemia 14.04 10.28 38 107306 8340 64383048
Bacteriuria 13.99 10.28 12 107332 930 64390458
Ecchymosis 13.82 10.28 53 107291 13969 64377419
Thrombocytopenia 13.78 10.28 276 107068 223525 64167863
Cervicogenic headache 13.72 10.28 4 107340 25 64391363
Transaminases increased 13.68 10.28 34 107310 44560 64346828
Intentional product misuse 13.53 10.28 68 107276 72227 64319161
Finger amputation 13.49 10.28 10 107334 628 64390760
Blood creatine phosphokinase increased 13.48 10.28 153 107191 58405 64332983
Lip swelling 13.37 10.28 95 107249 31812 64359576
Hypertension 13.37 10.28 543 106801 258718 64132670
Extrapyramidal disorder 13.32 10.28 8 107336 19544 64371844
Myelosuppression 13.32 10.28 12 107332 23818 64367570
Osteonecrosis of jaw 13.32 10.28 29 107315 39796 64351592
Dilatation atrial 13.30 10.28 22 107322 3428 64387960
Ill-defined disorder 13.20 10.28 34 107310 44018 64347370
Upper gastrointestinal haemorrhage 13.13 10.28 102 107242 35118 64356270
No adverse event 13.06 10.28 17 107327 28544 64362844
Osteoporosis 12.98 10.28 32 107312 42048 64349340
Morning glory syndrome 12.91 10.28 3 107341 6 64391382
Left ventricular enlargement 12.87 10.28 10 107334 674 64390714
Cerebral mass effect 12.81 10.28 15 107329 1691 64389697
Atrioventricular block first degree 12.64 10.28 43 107301 10691 64380697
Sputum discoloured 12.59 10.28 61 107283 17795 64373593
Injection site bruising 12.57 10.28 26 107318 36347 64355041
Gastrointestinal tract irritation 12.55 10.28 9 107335 537 64390851
Hiatus hernia 12.54 10.28 66 107278 19891 64371497
Blister 12.54 10.28 81 107263 80886 64310502
Product impurity 12.53 10.28 5 107339 88 64391300
Arthritis 12.40 10.28 85 107259 83729 64307659
General physical health deterioration 12.32 10.28 253 107091 204172 64187216
Left ventricular end-diastolic pressure increased 12.28 10.28 9 107335 555 64390833
Fear of death 12.25 10.28 13 107331 1314 64390074
Sepsis 12.18 10.28 291 107053 230050 64161338
Brain natriuretic peptide increased 12.18 10.28 34 107310 7599 64383789
Reperfusion arrhythmia 12.16 10.28 7 107337 285 64391103
Candida infection 12.14 10.28 21 107323 31398 64359990
Metastases to central nervous system 12.13 10.28 4 107340 13908 64377480
Coronary bypass thrombosis 12.06 10.28 3 107341 9 64391379
Immune reconstitution inflammatory syndrome 11.95 10.28 3 107341 12467 64378921
Poor venous access 11.88 10.28 3 107341 12414 64378974
Accidental exposure to product 11.74 10.28 16 107328 26348 64365040
Appendicitis 11.66 10.28 4 107340 13565 64377823
Viral infection 11.53 10.28 27 107317 36113 64355275
Superinfection 11.40 10.28 22 107322 3864 64387524
Therapy interrupted 11.31 10.28 10 107334 20026 64371362
Organ failure 11.19 10.28 21 107323 3612 64387776
Application site rash 11.18 10.28 15 107329 1939 64389449
Infarction 11.11 10.28 22 107322 3938 64387450
Myocardial necrosis marker increased 11.11 10.28 18 107326 2757 64388631
Total lung capacity decreased 11.07 10.28 14 107330 1708 64389680
Diabetic neuropathy 11.04 10.28 27 107317 5574 64385814
Coagulation time abnormal 10.97 10.28 6 107338 221 64391167
Productive cough 10.96 10.28 177 107167 73026 64318362
Urticaria 10.86 10.28 176 107168 147141 64244247
Blood chloride decreased 10.83 10.28 32 107312 7384 64384004
Colitis microscopic 10.79 10.28 32 107312 7400 64383988
Throat irritation 10.79 10.28 24 107320 32687 64358701
Blood calcium increased 10.75 10.28 35 107309 8507 64382881
Laryngospasm 10.72 10.28 20 107324 3425 64387963
Coronary angioplasty 10.68 10.28 7 107337 360 64391028
Therapy non-responder 10.68 10.28 65 107279 65834 64325554
Respiratory depression 10.67 10.28 14 107330 23429 64367959
Depression 10.65 10.28 389 106955 182902 64208486
Cardioactive drug level increased 10.64 10.28 20 107324 3445 64387943
Mania 10.63 10.28 7 107337 16279 64375109
Oesophageal carcinoma 10.58 10.28 24 107320 4719 64386669
Serotonin syndrome 10.52 10.28 32 107312 39250 64352138
Aplastic anaemia 10.50 10.28 5 107339 13915 64377473
Femur fracture 10.49 10.28 26 107318 34109 64357279
Interstitial lung disease 10.44 10.28 108 107236 97624 64293764
Product monitoring error 10.44 10.28 26 107318 5428 64385960
Troponin T increased 10.44 10.28 16 107328 2337 64389051
QRS axis abnormal 10.42 10.28 14 107330 1813 64389575
Intraventricular haemorrhage 10.39 10.28 22 107322 4131 64387257
Hyperbilirubinaemia 10.35 10.28 12 107332 21193 64370195

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01DA02 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
VASODILATORS USED IN CARDIAC DISEASES
Organic nitrates
ATC C01DA52 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
VASODILATORS USED IN CARDIAC DISEASES
Organic nitrates
ATC C05AE01 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Muscle relaxants
FDA CS M0014874 Nitrates
FDA PE N0000009909 Vasodilation
FDA EPC N0000175415 Nitrate Vasodilator
MeSH PA D002317 Cardiovascular Agents
MeSH PA D053834 Explosive Agents
MeSH PA D014665 Vasodilator Agents
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50566 nitric oxide generators
CHEBI has role CHEBI:51371 muscle relaxants
CHEBI has role CHEBI:63490 explosive compounds
CHEBI has role CHEBI:66993 tocolytic drugs

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

DiseaseRelationSNOMED_IDDOID
Angina pectoris indication 194828000
Left ventricular cardiac dysfunction indication 429589006
Perioperative hypertension indication 434711000124103
Angina Pectoris Prevention indication
Myocardial infarction off-label use 22298006 DOID:5844
Anal fissure off-label use 30037006
Decompensated cardiac failure off-label use 195111005
Extravasation injury off-label use 371100002
Acute coronary syndrome off-label use 394659003
Hypertensive urgency off-label use 443482000
Hypovolemia contraindication 28560003
Cardiac tamponade contraindication 35304003 DOID:115
Methemoglobinemia contraindication 38959009 DOID:10783
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Injury of head contraindication 82271004
Constrictive pericarditis contraindication 85598007 DOID:11481
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Restrictive cardiomyopathy contraindication 415295002 DOID:397




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.4MG/SPRAY NITROLINGUAL PUMPSPRAY POHL BOSKAMP N018705 Jan. 10, 1997 RX SPRAY, METERED SUBLINGUAL 7872049 March 12, 2029 METHOD OF TREATING ANGINA PECTORIS

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
4017525 VUID
N0000145909 NUI
D00515 KEGG_DRUG
4017525 VANDF
CHEBI:28787 CHEBI
TNG PDB_CHEM_ID
CHEMBL730 ChEMBL_ID
7053 IUPHAR_LIGAND_ID
DB00727 DRUGBANK_ID
G59M7S0WS3 UNII
4510 PUBCHEM_CID
4917 RXNORM
2324 MMSL
5183 MMSL
d00321 MMSL
000683 NDDF
387404004 SNOMEDCT_US
71759000 SNOMEDCT_US
D005996 MESH_DESCRIPTOR_UI
C0017887 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 0071-0417 TABLET 0.30 mg SUBLINGUAL NDA 26 sections
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 0071-0418 TABLET 0.40 mg SUBLINGUAL NDA 26 sections
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 0071-0419 TABLET 0.60 mg SUBLINGUAL NDA 26 sections
Cyclease Menopause HUMAN OTC DRUG LABEL 5 0220-9082 TABLET 4 [hp_C] ORAL unapproved homeopathic 10 sections
NITRO-BID HUMAN PRESCRIPTION DRUG LABEL 1 0281-0326 OINTMENT 20 mg TOPICAL ANDA 21 sections
Nitroglycerin In Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0338-1047 INJECTION 10 mg INTRAVENOUS NDA 20 sections
Nitroglycerin In Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0338-1049 INJECTION 20 mg INTRAVENOUS NDA 20 sections
Nitroglycerin In Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0338-1051 INJECTION 40 mg INTRAVENOUS NDA 20 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0378-9102 PATCH 0.10 mg TRANSDERMAL ANDA 21 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0378-9104 PATCH 0.20 mg TRANSDERMAL ANDA 21 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0378-9112 PATCH 0.40 mg TRANSDERMAL ANDA 21 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0378-9116 PATCH 0.60 mg TRANSDERMAL ANDA 21 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9928 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 11 sections
NITROSTAT HUMAN PRESCRIPTION DRUG LABEL 1 0404-9929 TABLET 0.40 mg SUBLINGUAL NDA 16 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 0517-4810 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 21 sections
Nitro-Time HUMAN PRESCRIPTION DRUG LABEL 1 0904-0643 CAPSULE 2.50 mg ORAL Unapproved drug other 22 sections
Nitro-Time HUMAN PRESCRIPTION DRUG LABEL 1 0904-0644 CAPSULE 6.50 mg ORAL Unapproved drug other 22 sections
Nitro-Time HUMAN PRESCRIPTION DRUG LABEL 1 0904-0647 CAPSULE 9 mg ORAL Unapproved drug other 22 sections
Nitroglycerin Transdermal System HUMAN PRESCRIPTION DRUG LABEL 1 0904-5495 PATCH 0.20 mg TRANSDERMAL ANDA 18 sections
Nitroglycerin Transdermal System HUMAN PRESCRIPTION DRUG LABEL 1 0904-5496 PATCH 0.40 mg TRANSDERMAL ANDA 18 sections
Nitroglycerin Transdermal System HUMAN PRESCRIPTION DRUG LABEL 1 0904-5497 PATCH 0.60 mg TRANSDERMAL ANDA 18 sections
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 21695-450 TABLET 0.40 mg SUBLINGUAL NDA 23 sections
Nitroglycerin Slocaps HUMAN PRESCRIPTION DRUG LABEL 1 21695-635 CAPSULE 2.50 mg ORAL Unapproved drug other 19 sections
Nitroglycerin Slocaps HUMAN PRESCRIPTION DRUG LABEL 1 21695-636 CAPSULE 6.50 mg ORAL Unapproved drug other 19 sections
Nitroglycerin HUMAN PRESCRIPTION DRUG LABEL 1 21695-810 TABLET 0.40 mg ORAL Unapproved drug other 23 sections
NITROGLYCERIN LINGUAL HUMAN PRESCRIPTION DRUG LABEL 1 28595-120 SPRAY 400 ug ORAL NDA 26 sections
NITROLINGUAL HUMAN PRESCRIPTION DRUG LABEL 1 28595-550 SPRAY 400 ug ORAL NDA 26 sections
GONITRO HUMAN PRESCRIPTION DRUG LABEL 1 28595-705 POWDER 400 ug SUBLINGUAL NDA 26 sections
Minitran HUMAN PRESCRIPTION DRUG LABEL 1 29336-301 PATCH 2.50 mg TRANSDERMAL ANDA 21 sections
Minitran HUMAN PRESCRIPTION DRUG LABEL 1 29336-302 PATCH 5 mg TRANSDERMAL ANDA 21 sections