glyceryl trinitrate ๐Ÿถ 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 ยตM/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 998.56 10.97 871 73470 99022 63315659
Orthostatic hypotension 760.91 10.97 493 73848 35667 63379014
Sedation complication 669.76 10.97 326 74015 13496 63401185
Creatinine renal clearance decreased 658.82 10.97 340 74001 15968 63398713
Blood calcium decreased 535.22 10.97 352 73989 26099 63388582
Sedation 527.23 10.97 405 73936 38404 63376277
Cognitive disorder 490.40 10.97 453 73888 55362 63359319
Coronary artery disease 457.62 10.97 346 73995 32031 63382650
Balance disorder 420.22 10.97 506 73835 83916 63330765
Cardiac failure congestive 403.97 10.97 519 73822 91914 63322767
Depressed level of consciousness 383.20 10.97 416 73925 61662 63353019
Angina pectoris 369.79 10.97 296 74045 29782 63384899
Acute myocardial infarction 365.16 10.97 302 74039 31822 63382859
Hypotension 341.95 10.97 888 73453 271716 63142965
Fall 294.91 10.97 1068 73273 391266 63023415
Chest pain 264.92 10.97 698 73643 215261 63199420
Constipation 224.76 10.97 675 73666 224268 63190413
Angina unstable 208.83 10.97 120 74221 6975 63407706
Contraindicated product administered 181.80 10.97 21 74320 217627 63197054
Systemic lupus erythematosus 169.97 10.97 22 74319 208896 63205785
Renal failure 168.90 10.97 404 73937 117248 63297433
Hand deformity 163.83 10.97 5 74336 159452 63255229
Glossodynia 160.58 10.97 13 74328 178863 63235818
Treatment failure 157.10 10.97 23 74318 199020 63215661
Mobility decreased 144.65 10.97 388 73953 120771 63293910
Drug intolerance 144.03 10.97 92 74249 308569 63106112
Coronary arterial stent insertion 140.82 10.97 68 74273 2761 63411920
Renal injury 140.25 10.97 104 74237 9335 63405346
Drug ineffective 137.27 10.97 695 73646 1044070 62370611
Alopecia 136.33 10.97 117 74224 337419 63077262
Arthropathy 135.01 10.97 53 74288 234739 63179942
Acute coronary syndrome 131.58 10.97 103 74238 10023 63404658
Maternal exposure during pregnancy 129.31 10.97 48 74293 220014 63194667
Off label use 127.81 10.97 387 73954 674075 62740606
Gastrointestinal haemorrhage 124.35 10.97 286 74055 80890 63333791
Hepatic enzyme increased 122.51 10.97 42 74299 202286 63212395
Synovitis 121.79 10.97 34 74307 186884 63227797
Fear 121.28 10.97 119 74222 15647 63399034
Joint swelling 120.07 10.97 124 74217 327542 63087139
Abdominal discomfort 106.05 10.97 132 74209 320753 63093928
Bradycardia 103.45 10.97 250 74091 72977 63341704
Rheumatoid arthritis 102.40 10.97 88 74253 253731 63160950
Hyperkalaemia 101.32 10.97 207 74134 53996 63360685
Discomfort 100.86 10.97 35 74306 167339 63247342
Labile blood pressure 98.21 10.97 46 74295 1743 63412938
Product use issue 97.08 10.97 70 74271 220450 63194231
Therapeutic product effect decreased 95.05 10.97 54 74287 193133 63221548
Swelling 94.45 10.97 110 74231 275268 63139413
Anhedonia 94.20 10.97 88 74253 10886 63403795
Transient ischaemic attack 94.00 10.97 163 74178 37590 63377091
Cerebrovascular accident 92.82 10.97 308 74033 107716 63306965
Coronary artery occlusion 88.87 10.97 75 74266 8116 63406565
Helicobacter infection 85.34 10.97 6 74335 92779 63321902
Myocardial ischaemia 84.23 10.97 89 74252 12770 63401911
Emotional distress 82.96 10.97 142 74199 32407 63382274
Duodenal ulcer perforation 82.10 10.97 5 74336 87204 63327477
Peripheral vascular disorder 81.92 10.97 63 74278 5972 63408709
Infusion related reaction 72.02 10.97 110 74231 245411 63169270
Toxicity to various agents 71.48 10.97 515 73826 246735 63167946
Infection 69.83 10.97 100 74241 229073 63185608
Hypersensitivity 69.03 10.97 150 74191 292535 63122146
Condition aggravated 68.19 10.97 242 74099 401975 63012706
Wound 67.77 10.97 55 74286 163208 63251473
Atrial fibrillation 66.63 10.97 292 74049 116344 63298337
Pericarditis 64.38 10.97 37 74304 131542 63283139
Injury 63.03 10.97 209 74132 73038 63341643
Febrile neutropenia 62.84 10.97 30 74311 118419 63296262
Neutropenia 62.03 10.97 68 74273 174937 63239744
Syncope 61.90 10.97 287 74054 117098 63297583
Arthralgia 61.46 10.97 403 73938 569307 62845374
Renal impairment 61.37 10.97 235 74106 88120 63326561
Cardiac disorder 60.84 10.97 163 74178 50653 63364028
Psoriatic arthropathy 60.79 10.97 16 74325 91504 63323177
Rash 57.86 10.97 402 73939 560469 62854212
Acute kidney injury 56.20 10.97 512 73829 262903 63151778
Cardiac failure 56.20 10.97 230 74111 88912 63325769
Oesophageal pain 55.48 10.97 41 74300 3660 63411021
Ischaemic cardiomyopathy 55.08 10.97 35 74306 2442 63412239
Unevaluable event 53.81 10.97 157 74184 51229 63363452
Hepatic ischaemia 52.32 10.97 22 74319 642 63414039
Cardiac arrest 52.32 10.97 231 74110 92314 63322367
Coronary artery bypass 51.50 10.97 33 74308 2336 63412345
Total lung capacity decreased 51.43 10.97 32 74309 2151 63412530
Chronic obstructive pulmonary disease 50.52 10.97 175 74166 62511 63352170
Hallucination 50.39 10.97 160 74181 54657 63360024
Heart sounds 49.75 10.97 24 74317 972 63413709
Nasopharyngitis 49.29 10.97 144 74197 254113 63160568
Rales 48.76 10.97 67 74274 12630 63402051
Sputum discoloured 47.96 10.97 76 74265 16271 63398410
Angioplasty 47.64 10.97 26 74315 1366 63413315
Prolonged expiration 47.57 10.97 24 74317 1072 63413609
Dyspnoea 47.43 10.97 1059 73282 660254 62754427
Exposure during pregnancy 45.28 10.97 70 74271 155477 63259204
Intentional product use issue 44.97 10.97 50 74291 127842 63286839
Sinusitis 44.92 10.97 127 74214 226526 63188155
Arteriospasm coronary 44.42 10.97 37 74304 3931 63410750
Ventricular tachycardia 44.27 10.97 82 74259 19897 63394784
Pulmonary oedema 43.19 10.97 152 74189 54721 63359960
Troponin increased 42.83 10.97 56 74285 10065 63404616
White blood cell count decreased 41.06 10.97 62 74279 139042 63275639
Multiple drug therapy 40.82 10.97 34 74307 3612 63411069
Abortion spontaneous 40.78 10.97 4 74337 47191 63367490
Bronchopulmonary aspergillosis allergic 40.73 10.97 28 74313 2230 63412451
Coronary artery stenosis 40.63 10.97 38 74303 4706 63409975
Blister 40.15 10.97 56 74285 129758 63284923
Hepatorenal syndrome 39.75 10.97 26 74315 1906 63412775
Rheumatic fever 39.03 10.97 3 74338 43108 63371573
Fatigue 39.00 10.97 770 73571 887258 62527423
Drug interaction 38.96 10.97 425 73916 228706 63185975
Haematemesis 38.89 10.97 100 74241 30312 63384369
Hyponatraemia 38.82 10.97 244 74097 111656 63303025
Hypoglycaemia 38.66 10.97 156 74185 59909 63354772
Left ventricle outflow tract obstruction 38.13 10.97 14 74327 282 63414399
Irritable bowel syndrome 37.77 10.97 25 74316 82387 63332294
Musculoskeletal stiffness 37.65 10.97 102 74239 184516 63230165
Liver injury 37.58 10.97 12 74329 60508 63354173
Hypovolaemia 37.54 10.97 54 74287 10619 63404062
Intentional overdose 37.49 10.97 20 74321 74132 63340549
Injection site pain 37.22 10.97 59 74282 129741 63284940
Prinzmetal angina 36.93 10.97 18 74323 746 63413935
Muscle relaxant therapy 36.78 10.97 12 74329 167 63414514
Arteriosclerosis coronary artery 36.48 10.97 47 74294 8326 63406355
Lung opacity 36.42 10.97 30 74311 3138 63411543
Impaired healing 36.15 10.97 40 74301 102502 63312179
International normalised ratio increased 36.02 10.97 128 74213 46297 63368384
Disease progression 35.96 10.97 55 74286 122703 63291978
Anxiety 35.38 10.97 400 73941 217141 63197540
Stress 35.22 10.97 164 74177 67003 63347678
Product solubility abnormal 35.11 10.97 18 74323 832 63413849
Knee arthroplasty 35.01 10.97 10 74331 54196 63360485
Blood calcium increased 33.90 10.97 48 74293 9302 63405379
Malignant neoplasm progression 33.64 10.97 28 74313 82093 63332588
Ill-defined disorder 33.34 10.97 28 74313 81727 63332954
Paraesthesia oral 33.01 10.97 71 74270 19185 63395496
Haemorrhage 32.74 10.97 150 74191 60872 63353809
Bursitis infective 32.44 10.97 20 74321 1323 63413358
Sinus arrest 32.42 10.97 23 74318 1926 63412755
Sinus node dysfunction 31.70 10.97 33 74308 4652 63410029
Product use in unapproved indication 31.45 10.97 106 74235 178974 63235707
Red blood cell sedimentation rate increased 30.54 10.97 7 74334 43975 63370706
Cardiomegaly 30.25 10.97 65 74276 17549 63397132
C-reactive protein increased 30.14 10.97 40 74301 94667 63320014
Suicide attempt 29.97 10.97 17 74324 60901 63353780
Mitral valve incompetence 29.93 10.97 69 74272 19525 63395156
Lip swelling 29.77 10.97 92 74249 30971 63383710
Hyperkeratosis 29.77 10.97 36 74305 5982 63408699
Pregnancy 29.63 10.97 4 74337 36832 63377849
Injection site reaction 29.27 10.97 16 74325 58508 63356173
Pyrexia 29.23 10.97 382 73959 470096 62944585
Tinnitus 29.17 10.97 100 74241 35528 63379153
Hip arthroplasty 28.61 10.97 10 74331 47636 63367045
Ventricular hyperkinesia 28.51 10.97 8 74333 64 63414617
Haemoptysis 28.39 10.97 86 74255 28640 63386041
Mucosal inflammation 27.93 10.97 10 74331 46918 63367763
Hyperhidrosis 27.92 10.97 219 74122 107617 63307064
Vascular pseudoaneurysm 27.62 10.97 19 74322 1515 63413166
Vaginal flatulence 27.48 10.97 26 74315 3267 63411414
Rectal haemorrhage 27.40 10.97 122 74219 48908 63365773
Cardiac murmur 26.50 10.97 55 74286 14497 63400184
Lower gastrointestinal haemorrhage 26.41 10.97 39 74302 7851 63406830
Chronic sinusitis 26.33 10.97 51 74290 12792 63401889
Left ventricular dysfunction 26.30 10.97 49 74292 11939 63402742
Injection site pruritus 26.20 10.97 10 74331 45106 63369575
Dyspnoea exertional 25.79 10.97 139 74202 60163 63354518
Percutaneous coronary intervention 25.64 10.97 10 74331 239 63414442
Injection site erythema 25.59 10.97 36 74305 83138 63331543
Blood loss anaemia 25.24 10.97 41 74300 8960 63405721
Chest discomfort 25.07 10.97 217 74124 109752 63304929
Oedema peripheral 24.97 10.97 335 74006 189176 63225505
Carotid artery occlusion 24.73 10.97 29 74312 4665 63410016
Post procedural haemorrhage 24.72 10.97 38 74303 7926 63406755
Hyperlipidaemia 24.66 10.97 64 74277 19507 63395174
Melaena 24.66 10.97 85 74256 30280 63384401
Fear of eating 24.40 10.97 11 74330 381 63414300
Cardiospasm 23.92 10.97 19 74322 1888 63412793
Chronic kidney disease 23.91 10.97 111 74230 45287 63369394
Coronary artery dissection 23.83 10.97 14 74327 848 63413833
Stomatitis 23.75 10.97 83 74258 138642 63276039
Neutrophil count decreased 23.39 10.97 19 74322 56387 63358294
Sleep apnoea syndrome 23.18 10.97 81 74260 29052 63385629
Sinus bradycardia 23.07 10.97 52 74289 14499 63400182
Palmoplantar keratoderma 23.06 10.97 19 74322 1988 63412693
Presyncope 22.75 10.97 78 74263 27707 63386974
Acute pulmonary oedema 22.66 10.97 37 74304 8121 63406560
Subarachnoid haemorrhage 22.60 10.97 51 74290 14232 63400449
Product dose omission issue 22.59 10.97 171 74170 234142 63180539
Ventricular extrasystoles 22.26 10.97 45 74296 11642 63403039
Lymphoedema 22.25 10.97 45 74296 11647 63403034
Arterial occlusive disease 22.22 10.97 31 74310 5927 63408754
Peripheral swelling 22.05 10.97 202 74139 265740 63148941
Diarrhoea 22.02 10.97 654 73687 714712 62699969
Malaise 21.99 10.97 640 73701 415314 62999367
Multiple organ dysfunction syndrome 21.74 10.97 127 74214 56625 63358056
Procedural pain 21.71 10.97 65 74276 21504 63393177
Silent myocardial infarction 21.62 10.97 10 74331 368 63414313
Coronary artery restenosis 21.47 10.97 10 74331 374 63414307
Obstructive airways disorder 21.43 10.97 63 74278 20636 63394045
Leukopenia 21.34 10.97 36 74305 77254 63337427
Proctitis 21.33 10.97 29 74312 5412 63409269
Depressive symptom 21.05 10.97 25 74316 4077 63410604
Drug abuse 20.74 10.97 33 74308 72485 63342196
Therapeutic response decreased 20.60 10.97 25 74316 61500 63353181
Cerebral mass effect 20.55 10.97 13 74328 900 63413781
Macular degeneration 20.46 10.97 69 74272 24307 63390374
Respiration abnormal 20.45 10.97 31 74310 6386 63408295
Atrioventricular block 20.32 10.97 34 74307 7613 63407068
Pituitary apoplexy 19.80 10.97 7 74334 126 63414555
Pruritus 19.75 10.97 301 74040 361152 63053529
Herpes zoster 19.61 10.97 42 74299 82420 63332261
Bundle branch block left 19.59 10.97 32 74309 7027 63407654
Autonomic dysreflexia 19.57 10.97 9 74332 327 63414354
Weight increased 19.55 10.97 203 74138 260589 63154092
Anaemia 19.40 10.97 465 73876 292965 63121716
Subdural haematoma 19.24 10.97 48 74293 14280 63400401
Haematoma 18.97 10.97 86 74255 34734 63379947
Dermatitis bullous 18.95 10.97 35 74306 8473 63406208
Coronary ostial stenosis 18.69 10.97 6 74335 79 63414602
Duodenal ulcer 18.66 10.97 33 74308 7723 63406958
Radiculopathy 18.65 10.97 35 74306 8576 63406105
Electrocardiogram ST segment elevation 18.63 10.97 23 74318 3904 63410777
Bronchiectasis 18.53 10.97 51 74290 16091 63398590
Pruritus genital 18.51 10.97 19 74322 2635 63412046
Laryngotracheal oedema 18.40 10.97 5 74336 35 63414646
Left ventricular end-diastolic pressure increased 18.38 10.97 9 74332 377 63414304
Sleep terror 18.36 10.97 19 74322 2661 63412020
Foot deformity 18.24 10.97 5 74336 27848 63386833
Laryngospasm 18.15 10.97 20 74321 3008 63411673
Myelosuppression 18.08 10.97 3 74338 23700 63390981
Coronary artery reocclusion 18.04 10.97 5 74336 38 63414643
Inappropriate schedule of product administration 17.93 10.97 62 74279 103903 63310778
Rhabdomyolysis 17.91 10.97 100 74241 43851 63370830
Psoriasis 17.74 10.97 48 74293 86909 63327772
Dizziness 17.66 10.97 642 73699 429283 62985398
Gastric ulcer 17.56 10.97 65 74276 23972 63390709
Catheterisation cardiac 17.24 10.97 24 74317 4579 63410102
Cardiomyopathy 16.77 10.97 52 74289 17532 63397149
Cardiac failure chronic 16.49 10.97 23 74318 4395 63410286
Tension headache 16.45 10.97 25 74316 5161 63409520
Aspiration 16.34 10.97 38 74303 10813 63403868
Neuropathy peripheral 16.28 10.97 73 74268 113594 63301087
Injection site swelling 16.28 10.97 19 74322 47553 63367128
Blood pressure decreased 16.25 10.97 131 74210 64891 63349790
Bone marrow failure 16.18 10.97 7 74334 29283 63385398
Live birth 16.05 10.97 5 74336 25625 63389056
COVID-19 15.98 10.97 73 74268 113030 63301651
Generalised tonic-clonic seizure 15.92 10.97 7 74334 29009 63385672
Subcapsular splenic haematoma 15.86 10.97 4 74337 20 63414661
Drug eruption 15.62 10.97 7 74334 28687 63385994
Brain stem stroke 15.62 10.97 8 74333 369 63414312
Non-cardiac chest pain 15.50 10.97 27 74314 6245 63408436
Feeling abnormal 15.49 10.97 252 74089 148140 63266541
Cytomegalovirus infection 15.23 10.97 3 74338 20949 63393732
Immunisation 15.21 10.97 12 74329 1181 63413500
Ventricular fibrillation 15.15 10.97 39 74302 11828 63402853
Angioedema 15.04 10.97 102 74239 47863 63366818
Nodal rhythm 15.00 10.97 14 74327 1729 63412952
Blood cholesterol increased 14.95 10.97 58 74283 93974 63320707
Blood creatinine increased 14.93 10.97 163 74178 87681 63327000
Appetite disorder 14.92 10.97 29 74312 7292 63407389
Arteriosclerosis 14.88 10.97 35 74306 10031 63404650
Systolic anterior motion of mitral valve 14.85 10.97 4 74337 27 63414654
No adverse event 14.75 10.97 16 74325 41389 63373292
Peripheral ischaemia 14.75 10.97 23 74318 4855 63409826
Vaginal discharge 14.72 10.97 33 74308 9165 63405516
Stent malfunction 14.68 10.97 5 74336 80 63414601
Troponin T increased 14.68 10.97 12 74329 1242 63413439
Coagulopathy 14.55 10.97 55 74286 20489 63394192
Ventricular hypertrophy 14.52 10.97 19 74322 3417 63411264
Nephrogenic systemic fibrosis 14.51 10.97 22 74319 4534 63410147
Gastrointestinal disorder 14.50 10.97 92 74249 131147 63283534
Device dislocation 14.43 10.97 6 74335 25699 63388982
Device issue 14.26 10.97 5 74336 23776 63390905
Atrial tachycardia 14.25 10.97 21 74320 4219 63410462
Swollen tongue 14.06 10.97 79 74262 34721 63379960
Atrioventricular block second degree 14.05 10.97 20 74321 3894 63410787
Gastric haemorrhage 13.85 10.97 26 74315 6372 63408309
Acne 13.80 10.97 5 74336 23288 63391393
Body temperature increased 13.67 10.97 14 74327 37178 63377503
Prescribed overdose 13.55 10.97 12 74329 34141 63380540
Hepatotoxicity 13.55 10.97 14 74327 37027 63377654
Coronary artery thrombosis 13.54 10.97 11 74330 1128 63413553
Lethargy 13.54 10.97 112 74229 55895 63358786
Palmar-plantar erythrodysaesthesia syndrome 13.53 10.97 5 74336 23010 63391671
Hypertensive crisis 13.48 10.97 44 74297 15242 63399439
Colitis ischaemic 13.47 10.97 35 74306 10673 63404008
Arthritis 13.46 10.97 80 74261 115841 63298840
Torsade de pointes 13.22 10.97 40 74301 13311 63401370
Stent placement 13.21 10.97 19 74322 3736 63410945
Palpitations 13.09 10.97 195 74146 112575 63302106
Neoplasm progression 13.06 10.97 14 74327 36414 63378267
General physical health deterioration 13.03 10.97 162 74179 201240 63213441
Bundle branch block right 12.99 10.97 22 74319 4976 63409705
Femur fracture 12.91 10.97 18 74323 41738 63372943
Essential hypertension 12.87 10.97 22 74319 5011 63409670
Drug-induced liver injury 12.78 10.97 17 74324 40205 63374476
Multiple injuries 12.77 10.97 13 74328 1785 63412896
Electrocardiogram T wave abnormal 12.70 10.97 15 74326 2432 63412249
Cardiogenic shock 12.69 10.97 48 74293 17884 63396797
Finger amputation 12.68 10.97 8 74333 551 63414130
Hypertensive heart disease 12.67 10.97 15 74326 2437 63412244
Arteriogram coronary abnormal 12.65 10.97 3 74338 11 63414670
Mitral valve calcification 12.64 10.97 10 74331 988 63413693
Therapy non-responder 12.59 10.97 46 74295 75855 63338826
Sleep disorder 12.53 10.97 51 74290 81515 63333166
Platelet count decreased 12.52 10.97 82 74259 116040 63298641
Ischaemia 12.39 10.97 21 74320 4751 63409930
Periorbital haematoma 12.36 10.97 9 74332 785 63413896
Mental status changes 12.29 10.97 84 74257 39515 63375166
Cardioactive drug level increased 12.28 10.97 14 74327 2186 63412495
Colitis microscopic 12.24 10.97 31 74310 9308 63405373
Acquired epidermolysis bullosa 12.24 10.97 4 74337 56 63414625
Bacteriuria 12.17 10.97 10 74331 1043 63413638
Ascites 12.16 10.97 18 74323 40710 63373971
Urogenital disorder 12.05 10.97 4 74337 59 63414622
Female genital tract fistula 11.97 10.97 27 74314 7532 63407149
Vascular graft 11.92 10.97 9 74332 830 63413851
Amnesia 11.79 10.97 108 74233 55477 63359204
Lupus myocarditis 11.75 10.97 4 74337 64 63414617
Creatinine renal clearance increased 11.71 10.97 8 74333 631 63414050
Impaired work ability 11.70 10.97 3 74338 17472 63397209
Abdominal wall haematoma 11.55 10.97 16 74325 3039 63411642
Discoloured vomit 11.41 10.97 9 74332 885 63413796
Blood glucose increased 11.41 10.97 149 74192 83607 63331074
Autoimmune disorder 11.41 10.97 3 74338 17174 63397507
Acute myeloid leukaemia 11.38 10.97 3 74338 17144 63397537
Electrocardiogram change 11.32 10.97 8 74333 666 63414015
Arterial intramural haematoma 11.30 10.97 3 74338 19 63414662
Stridor 11.25 10.97 17 74324 3493 63411188
Pancytopenia 11.20 10.97 67 74274 96866 63317815
Choking 11.13 10.97 31 74310 9848 63404833
Hydrothorax 11.09 10.97 9 74332 922 63413759
Circulatory collapse 11.08 10.97 53 74288 21885 63392796
Tricuspid valve incompetence 11.07 10.97 40 74301 14581 63400100

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 939.81 11.07 1164 66683 119921 34769163
Coronary artery disease 452.25 11.07 512 67335 47793 34841291
Acute myocardial infarction 411.50 11.07 514 67333 53205 34835879
Angina pectoris 381.24 11.07 382 67465 30981 34858103
Cardiac failure congestive 375.41 11.07 619 67228 82651 34806433
Chest pain 371.63 11.07 783 67064 125979 34763105
Angina unstable 222.42 11.07 183 67664 11470 34877614
Injury 220.66 11.07 235 67612 20452 34868632
Fear 213.63 11.07 171 67676 10305 34878779
Anhedonia 192.42 11.07 141 67706 7444 34881640
Coronary arterial stent insertion 188.84 11.07 111 67736 4018 34885066
Renal injury 159.72 11.07 149 67698 11046 34878038
Emotional distress 153.73 11.07 167 67680 14859 34874225
Off label use 151.50 11.07 373 67474 419151 34469933
Drug abuse 144.55 11.07 13 67834 99083 34790001
Hypotension 125.64 11.07 797 67050 220852 34668232
Myocardial ischaemia 116.54 11.07 156 67691 17252 34871832
Product solubility abnormal 104.61 11.07 39 67808 480 34888604
Bradycardia 100.92 11.07 349 67498 75069 34814015
Syncope 99.63 11.07 396 67451 91055 34798029
Unevaluable event 90.19 11.07 197 67650 32393 34856691
Ischaemic cardiomyopathy 83.45 11.07 81 67766 6308 34882776
Dizziness 79.52 11.07 708 67139 217813 34671271
Cardiac disorder 79.37 11.07 223 67624 42903 34846181
Chronic obstructive pulmonary disease 75.81 11.07 238 67609 48680 34840404
Toxicity to various agents 72.89 11.07 177 67670 200185 34688899
Stress 72.40 11.07 173 67674 30174 34858910
Coronary artery bypass 71.37 11.07 66 67781 4836 34884248
Neutropenia 71.03 11.07 122 67725 156656 34732428
Febrile neutropenia 67.15 11.07 101 67746 136748 34752336
Cerebrovascular accident 65.03 11.07 331 67516 84480 34804604
Anxiety 64.05 11.07 370 67477 99058 34790026
Coronary artery occlusion 62.56 11.07 91 67756 10871 34878213
Acute coronary syndrome 59.93 11.07 100 67747 13445 34875639
Troponin increased 58.50 11.07 90 67757 11299 34877785
Product use in unapproved indication 56.40 11.07 88 67759 117411 34771673
Soft tissue mass 56.30 11.07 31 67816 988 34888096
Presyncope 55.92 11.07 118 67729 18941 34870143
Dyspnoea 54.74 11.07 1030 66817 375752 34513332
Multimorbidity 52.99 11.07 29 67818 913 34888171
Foetal exposure during pregnancy 52.91 11.07 6 67841 38095 34850989
Ventricular extrasystoles 52.26 11.07 88 67759 11920 34877164
Pyrexia 51.99 11.07 406 67441 332607 34556477
Malignant neoplasm progression 51.40 11.07 57 67790 87989 34801095
Atrial fibrillation 49.91 11.07 407 67440 121986 34767098
Drug ineffective 49.80 11.07 608 67239 456143 34432941
Reversible airways obstruction 48.11 11.07 22 67825 467 34888617
Ventricular tachycardia 47.48 11.07 136 67711 26443 34862641
Coronary artery stenosis 46.62 11.07 74 67773 9542 34879542
Oesophageal perforation 46.49 11.07 29 67818 1170 34887914
Renal failure 45.83 11.07 420 67427 130137 34758947
Middle insomnia 45.58 11.07 61 67786 6741 34882343
C-reactive protein increased 44.17 11.07 25 67822 54073 34835011
Cardiac failure 43.06 11.07 314 67533 90934 34798150
Renal impairment 42.76 11.07 322 67525 94191 34794893
Cardiomegaly 40.08 11.07 91 67756 15347 34873737
Chest discomfort 39.81 11.07 210 67637 54320 34834764
Gastrointestinal haemorrhage 39.78 11.07 301 67546 88176 34800908
Cerebral artery thrombosis 38.40 11.07 22 67825 758 34888326
Completed suicide 37.82 11.07 84 67763 98084 34791000
Ventricular fibrillation 37.70 11.07 114 67733 22840 34866244
Therapeutic product effect incomplete 37.61 11.07 26 67821 50515 34838569
Arteriosclerosis coronary artery 37.44 11.07 78 67769 12407 34876677
Leukopenia 36.34 11.07 41 67806 62815 34826269
Brain scan abnormal 35.94 11.07 22 67825 858 34888226
Drug reaction with eosinophilia and systemic symptoms 35.52 11.07 10 67837 33002 34856082
Disease progression 35.03 11.07 101 67746 107976 34781108
Ventricular dysfunction 34.13 11.07 40 67807 3865 34885219
Pain 33.65 11.07 571 67276 204104 34684980
International normalised ratio increased 32.34 11.07 179 67668 47148 34841936
Superinfection 31.15 11.07 31 67816 2488 34886596
Treatment failure 30.97 11.07 27 67820 46670 34842414
Acute kidney injury 30.25 11.07 790 67057 304198 34584886
Hepatic function abnormal 30.21 11.07 25 67822 44338 34844746
Cytomegalovirus infection 29.88 11.07 7 67840 26128 34862956
Neutrophil count decreased 28.82 11.07 34 67813 51070 34838014
Hypoglycaemia 28.67 11.07 193 67654 54447 34834637
Mucosal inflammation 28.56 11.07 20 67827 38602 34850482
Cytokine release syndrome 28.49 11.07 5 67842 22872 34866212
Prinzmetal angina 28.26 11.07 20 67827 999 34888085
Hyperlipidaemia 27.57 11.07 76 67771 14453 34874631
Pulmonary oedema 27.45 11.07 172 67675 47357 34841727
Labelled drug-drug interaction medication error 26.25 11.07 76 67771 14863 34874221
Post procedural complication 26.16 11.07 64 67783 11324 34877760
Rales 25.37 11.07 58 67789 9825 34879259
Infusion related reaction 25.18 11.07 40 67807 53017 34836067
Base excess decreased 25.07 11.07 11 67836 211 34888873
Electrocardiogram ST segment elevation 24.97 11.07 40 67807 5198 34883886
Cardiac arrest 24.53 11.07 290 67557 95869 34793215
Diarrhoea 24.35 11.07 574 67273 389338 34499746
Rash 24.34 11.07 296 67551 222456 34666628
White blood cell count decreased 24.27 11.07 99 67748 95346 34793738
Intentional product use issue 24.01 11.07 50 67797 59766 34829318
Infection 23.94 11.07 93 67754 90822 34798262
Coronary artery thrombosis 23.85 11.07 25 67822 2134 34886950
Haemoptysis 23.64 11.07 132 67715 34874 34854210
Peripheral vascular disorder 23.38 11.07 38 67809 4998 34884086
COVID-19 23.31 11.07 75 67772 77475 34811609
Transplant failure 22.50 11.07 31 67816 3522 34885562
Rhabdomyolysis 22.24 11.07 216 67631 67947 34821137
Neuroleptic malignant syndrome 22.16 11.07 4 67843 17930 34871154
Inflammatory marker increased 22.08 11.07 37 67810 4991 34884093
Ureteric injury 22.02 11.07 7 67840 51 34889033
Product dose omission issue 22.00 11.07 139 67708 119572 34769512
Orthostatic hypotension 21.86 11.07 104 67743 25815 34863269
Stomatitis 21.19 11.07 31 67816 42483 34846601
Arteriosclerosis 21.13 11.07 61 67786 11907 34877177
Intentional product misuse 21.07 11.07 35 67812 45576 34843508
Cardiac procedure complication 20.74 11.07 9 67838 168 34888916
Ischaemic stroke 20.61 11.07 80 67767 18170 34870914
Post procedural haemorrhage 20.57 11.07 48 67799 8241 34880843
Reperfusion arrhythmia 20.54 11.07 7 67840 65 34889019
Bone marrow failure 20.52 11.07 16 67831 29237 34859847
Platelet count decreased 20.49 11.07 142 67705 119575 34769509
Neurotoxicity 20.24 11.07 5 67842 18005 34871079
Vascular stent occlusion 20.08 11.07 9 67838 182 34888902
Fall 19.90 11.07 525 67322 202360 34686724
Alanine aminotransferase increased 19.82 11.07 85 67762 80730 34808354
Pneumocystis jirovecii pneumonia 19.37 11.07 7 67840 19703 34869381
Nerve degeneration 19.34 11.07 9 67838 199 34888885
Vascular graft 19.32 11.07 19 67828 1503 34887581
Orthopnoea 19.09 11.07 35 67812 5068 34884016
Blood loss anaemia 18.77 11.07 46 67801 8148 34880936
Acute pulmonary oedema 18.74 11.07 43 67804 7300 34881784
Device dislocation 18.69 11.07 39 67808 6210 34882874
Rectal haemorrhage 18.67 11.07 138 67709 40111 34848973
Tendon disorder 18.08 11.07 25 67822 2850 34886234
International normalised ratio decreased 17.95 11.07 32 67815 4535 34884549
Arteriospasm coronary 17.75 11.07 27 67820 3355 34885729
Laryngeal haematoma 17.53 11.07 8 67839 169 34888915
Oxygen consumption decreased 17.40 11.07 9 67838 252 34888832
Bronchial irritation 17.16 11.07 5 67842 26 34889058
Areflexia 17.06 11.07 25 67822 3006 34886078
Gastrooesophageal reflux disease 17.01 11.07 129 67718 37795 34851289
Cardiac arrest neonatal 17.00 11.07 5 67842 27 34889057
Cold sweat 16.77 11.07 50 67797 9937 34879147
Sinus bradycardia 16.45 11.07 59 67788 12904 34876180
Melaena 16.24 11.07 121 67726 35259 34853825
Chronic kidney disease 16.20 11.07 136 67711 41074 34848010
Neoplasm progression 16.02 11.07 13 67834 23287 34865797
Circulatory collapse 16.02 11.07 82 67765 20956 34868128
Carotid artery stenosis 15.81 11.07 32 67815 4987 34884097
Overdose 15.58 11.07 108 67739 90951 34798133
Stent placement 15.55 11.07 32 67815 5046 34884038
Non-cardiac chest pain 15.48 11.07 29 67818 4268 34884816
Vascular graft occlusion 15.17 11.07 11 67836 571 34888513
Productive cough 14.98 11.07 125 67722 37688 34851396
Cervicogenic headache 14.78 11.07 4 67843 15 34889069
Bronchopulmonary aspergillosis 14.76 11.07 5 67842 14654 34874430
Device malfunction 14.59 11.07 49 67798 10372 34878712
Arrhythmia 14.52 11.07 119 67728 35689 34853395
Injection site pain 14.50 11.07 34 67813 38971 34850113
Supraventricular tachycardia 14.45 11.07 51 67796 11066 34878018
Ecchymosis 14.33 11.07 37 67810 6766 34882318
Lung consolidation 14.32 11.07 34 67813 5902 34883182
Normochromic normocytic anaemia 14.30 11.07 28 67819 4259 34884825
Multiple injuries 14.26 11.07 18 67829 1877 34887207
Atrial flutter 14.25 11.07 64 67783 15510 34873574
Coagulation time prolonged 14.24 11.07 15 67832 1287 34887797
Neuropathy peripheral 14.12 11.07 99 67748 83164 34805920
Seizure 13.98 11.07 133 67714 104724 34784360
Ureteric haemorrhage 13.92 11.07 6 67841 110 34888974
Drug resistance 13.82 11.07 18 67829 25909 34863175
Hemiplegia 13.75 11.07 37 67810 6935 34882149
Full blood count abnormal 13.69 11.07 72 67775 18596 34870488
Coronary steal syndrome 13.67 11.07 3 67844 3 34889081
Drug interaction 13.65 11.07 552 67295 225394 34663690
Hepatotoxicity 13.55 11.07 13 67834 21472 34867612
Palmar-plantar erythrodysaesthesia syndrome 13.36 11.07 8 67839 16787 34872297
Intentional self-injury 13.35 11.07 5 67842 13766 34875318
Coronary artery restenosis 13.30 11.07 13 67834 1021 34888063
Therapy interrupted 13.23 11.07 5 67842 13692 34875392
Generalised tonic-clonic seizure 13.14 11.07 13 67834 21161 34867923
Gastrointestinal tract irritation 13.11 11.07 8 67839 310 34888774
Loss of consciousness 12.95 11.07 229 67618 82438 34806646
Alopecia 12.89 11.07 17 67830 24338 34864746
Organ failure 12.87 11.07 18 67829 2073 34887011
Prostate cancer 12.87 11.07 37 67810 39612 34849472
Hypercalcaemia 12.83 11.07 7 67840 15461 34873623
Immunosuppressant drug level increased 12.83 11.07 33 67814 6022 34883062
Myocardial bridging 12.72 11.07 4 67843 28 34889056
Mitral valve incompetence 12.63 11.07 60 67787 14883 34874201
Hiatus hernia 12.58 11.07 38 67809 7607 34881477
Myocardial necrosis marker increased 12.55 11.07 16 67831 1685 34887399
Morning glory syndrome 12.46 11.07 3 67844 6 34889078
Dizziness postural 12.45 11.07 33 67814 6131 34882953
Septic shock 12.38 11.07 85 67762 71749 34817335
Paranoia 12.36 11.07 4 67843 12064 34877020
Product use issue 12.34 11.07 72 67775 63144 34825940
Inappropriate schedule of product administration 12.13 11.07 71 67776 62225 34826859
Vascular stent thrombosis 12.10 11.07 21 67826 2914 34886170
Blood pressure decreased 12.10 11.07 153 67694 51362 34837722
Faeces discoloured 12.04 11.07 59 67788 14819 34874265
Coronary ostial stenosis 12 11.07 5 67842 84 34889000
Herpes zoster 11.99 11.07 31 67816 34368 34854716
Osteonecrosis 11.98 11.07 7 67840 14883 34874201
Extrapyramidal disorder 11.96 11.07 5 67842 12875 34876209
Intentional overdose 11.93 11.07 44 67803 43630 34845454
Viral infection 11.91 11.07 10 67837 17613 34871471
Coma 11.84 11.07 47 67800 45631 34843453
Tubulointerstitial nephritis 11.83 11.07 14 67833 21010 34868074
Haemorrhage 11.82 11.07 152 67695 51218 34837866
Myalgia 11.79 11.07 229 67618 83881 34805203
Disseminated intravascular coagulation 11.78 11.07 15 67832 21801 34867283
Ventricular asystole 11.77 11.07 6 67841 163 34888921
Colitis 11.70 11.07 36 67811 37714 34851370
Cardiac resynchronisation therapy 11.66 11.07 4 67843 38 34889046
Confusional state 11.61 11.07 364 67483 143796 34745288
Coronary bypass thrombosis 11.60 11.07 3 67844 9 34889075
Extrasystoles 11.60 11.07 24 67823 3799 34885285
Acute myeloid leukaemia 11.59 11.07 11 67836 18259 34870825
Essential hypertension 11.52 11.07 21 67826 3027 34886057
Wheezing 11.50 11.07 127 67720 41275 34847809
Atrioventricular block complete 11.48 11.07 42 67805 9277 34879807
Ankle fracture 11.48 11.07 25 67822 4100 34884984
Haematoma 11.43 11.07 87 67760 25518 34863566
Interstitial lung disease 11.37 11.07 77 67770 65205 34823879
Gastritis 11.31 11.07 77 67770 21796 34867288
Left ventricular enlargement 11.30 11.07 10 67837 692 34888392
Blood creatine phosphokinase MB increased 11.26 11.07 16 67831 1870 34887214
Decreased appetite 11.17 11.07 242 67605 166150 34722934
Myeloperoxidase deficiency 11.13 11.07 4 67843 44 34889040
Poor quality product administered 11.13 11.07 16 67831 1891 34887193
Ureteral disorder 11.11 11.07 6 67841 184 34888900

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 1843.75 10.37 1807 120115 182322 79440144
Coronary artery disease 854.17 10.37 746 121176 64728 79557738
Acute myocardial infarction 748.59 10.37 745 121177 76291 79546175
Cardiac failure congestive 744.79 10.37 1000 120922 141402 79481064
Angina pectoris 637.82 10.37 571 121351 51161 79571305
Orthostatic hypotension 605.24 10.37 575 121347 55589 79566877
Sedation complication 586.29 10.37 340 121582 15329 79607137
Creatinine renal clearance decreased 570.59 10.37 358 121564 18644 79603822
Chest pain 470.39 10.37 1209 120713 281095 79341371
Blood calcium decreased 425.70 10.37 368 121554 31451 79591015
Hypotension 422.39 10.37 1554 120368 438763 79183703
Angina unstable 383.30 10.37 265 121657 16262 79606204
Sedation 361.41 10.37 421 121501 51474 79570992
Cognitive disorder 357.41 10.37 486 121436 69440 79553026
Coronary arterial stent insertion 331.51 10.37 169 121753 5875 79616591
Balance disorder 318.72 10.37 555 121367 98302 79524164
Fear 293.50 10.37 254 121668 21732 79600734
Renal injury 276.87 10.37 220 121702 16707 79605759
Anhedonia 250.91 10.37 197 121725 14701 79607765
Fall 245.59 10.37 1425 120497 486204 79136262
Off label use 244.34 10.37 653 121269 906562 78715904
Depressed level of consciousness 232.54 10.37 479 121443 96173 79526293
Myocardial ischaemia 204.89 10.37 223 121699 25296 79597170
Injury 198.22 10.37 394 121528 77102 79545364
Emotional distress 196.92 10.37 273 121649 39696 79582770
Renal failure 185.09 10.37 701 121221 200267 79422199
Bradycardia 173.44 10.37 528 121394 135029 79487437
Acute coronary syndrome 161.56 10.37 180 121742 20953 79601513
Unevaluable event 159.79 10.37 297 121625 55288 79567178
Treatment failure 147.77 10.37 39 121883 170447 79452019
Cerebrovascular accident 147.34 10.37 547 121375 154745 79467721
Ischaemic cardiomyopathy 143.24 10.37 108 121814 7587 79614879
Gastrointestinal haemorrhage 140.70 10.37 521 121401 147198 79475268
Syncope 140.38 10.37 595 121327 178854 79443612
Hand deformity 136.69 10.37 5 121917 103914 79518552
Drug abuse 134.00 10.37 41 121881 162650 79459816
Coronary artery occlusion 128.49 10.37 137 121785 15178 79607288
Mobility decreased 124.90 10.37 441 121481 121734 79500732
Alopecia 123.90 10.37 103 121819 231252 79391214
Systemic lupus erythematosus 120.82 10.37 20 121902 121129 79501337
Constipation 120.57 10.37 793 121129 282257 79340209
Drug ineffective 118.90 10.37 1070 120852 1079843 78542623
Coronary artery bypass 117.11 10.37 87 121835 5975 79616491
Drug intolerance 116.86 10.37 139 121783 263980 79358486
Neutropenia 115.38 10.37 163 121759 287547 79334919
Renal impairment 114.84 10.37 512 121410 157271 79465195
Chronic obstructive pulmonary disease 114.19 10.37 338 121584 85081 79537385
Hepatic enzyme increased 112.54 10.37 70 121852 182540 79439926
Febrile neutropenia 110.50 10.37 114 121808 230885 79391581
Contraindicated product administered 107.77 10.37 53 121869 157485 79464981
Synovitis 104.19 10.37 50 121872 150684 79471782
Atrial fibrillation 101.63 10.37 582 121340 197304 79425162
Troponin increased 101.61 10.37 136 121786 19119 79603347
Glossodynia 100.97 10.37 18 121904 103319 79519147
Arthropathy 99.66 10.37 75 121847 177036 79445430
Cardiac disorder 99.37 10.37 272 121650 65485 79556981
Maternal exposure during pregnancy 97.93 10.37 43 121879 136495 79485971
Joint swelling 97.50 10.37 183 121739 288463 79334003
Rheumatoid arthritis 97.33 10.37 105 121817 208365 79414101
Hyperkalaemia 97.04 10.37 389 121533 114009 79508457
Infection 94.86 10.37 139 121783 241573 79380893
Cardiac failure 92.74 10.37 475 121447 154367 79468099
Infusion related reaction 89.76 10.37 133 121789 230104 79392362
Acute kidney injury 88.97 10.37 1197 120725 518207 79104259
Therapeutic product effect decreased 88.88 10.37 72 121850 163791 79458675
Coronary artery stenosis 86.39 10.37 101 121821 12383 79610083
Stress 86.23 10.37 293 121629 79319 79543147
Labile blood pressure 84.55 10.37 49 121873 2204 79620262
Helicobacter infection 83.35 10.37 6 121916 69698 79552768
Dyspnoea 81.88 10.37 1797 120125 855228 78767238
Duodenal ulcer perforation 78.31 10.37 6 121916 66205 79556261
Anxiety 77.11 10.37 646 121276 247866 79374600
Product use issue 75.35 10.37 128 121794 209694 79412772
Arthralgia 74.54 10.37 540 121382 571263 79051203
Product use in unapproved indication 74.17 10.37 171 121751 250188 79372278
Discomfort 72.20 10.37 52 121870 125565 79496901
Dizziness 70.10 10.37 1162 120760 525279 79097187
Intentional product use issue 69.45 10.37 78 121844 152034 79470432
Peripheral vascular disorder 69.43 10.37 73 121849 7957 79614509
Pyrexia 69.12 10.37 684 121238 678025 78944441
Ventricular tachycardia 68.95 10.37 179 121743 41756 79580710
Abdominal discomfort 67.44 10.37 180 121742 250547 79371919
Arteriosclerosis coronary artery 66.66 10.37 107 121815 17709 79604757
Rales 66.62 10.37 114 121808 19887 79602579
Hypersensitivity 66.28 10.37 194 121728 262045 79360421
Malignant neoplasm progression 66.27 10.37 66 121856 135924 79486542
Cardiomegaly 64.97 10.37 132 121790 26220 79596246
Condition aggravated 64.91 10.37 474 121448 500650 79121816
C-reactive protein increased 63.58 10.37 62 121860 128965 79493501
Presyncope 63.20 10.37 171 121751 40883 79581583
Pericarditis 62.76 10.37 41 121881 104195 79518271
Nasopharyngitis 62.59 10.37 190 121732 253691 79368775
Pulmonary oedema 61.63 10.37 283 121639 87971 79534495
Injection site pain 59.90 10.37 66 121856 129772 79492694
Cardiac arrest 59.13 10.37 458 121464 171638 79450828
International normalised ratio increased 58.67 10.37 271 121651 84450 79538016
Transient ischaemic attack 57.99 10.37 195 121727 52500 79569966
Haemoptysis 57.93 10.37 203 121719 55796 79566670
White blood cell count decreased 57.05 10.37 127 121795 188161 79434305
Hypoglycaemia 56.90 10.37 306 121616 101288 79521178
Rash 55.89 10.37 590 121332 577768 79044698
Product solubility abnormal 55.70 10.37 28 121894 944 79621522
Drug interaction 55.41 10.37 917 121005 414266 79208200
Ventricular fibrillation 55.31 10.37 139 121783 31787 79590679
Disease progression 53.72 10.37 127 121795 184235 79438231
Soft tissue mass 53.68 10.37 30 121892 1258 79621208
Arteriospasm coronary 52.70 10.37 58 121864 6658 79615808
Psoriatic arthropathy 52.18 10.37 27 121895 77972 79544494
Diarrhoea 51.53 10.37 993 120929 879496 78742970
Completed suicide 51.03 10.37 198 121724 245569 79376897
Multimorbidity 50.58 10.37 30 121892 1409 79621057
Sinusitis 50.57 10.37 143 121779 195358 79427108
Exposure during pregnancy 49.36 10.37 49 121873 101083 79521383
Swelling 49.34 10.37 168 121754 216543 79405923
Rectal haemorrhage 48.42 10.37 238 121684 76062 79546404
Oesophageal pain 48.33 10.37 45 121877 4234 79618232
Prinzmetal angina 48.11 10.37 31 121891 1689 79620777
Mucosal inflammation 47.90 10.37 28 121894 75552 79546914
Leukopenia 47.66 10.37 65 121857 116448 79506018
Impaired healing 45.69 10.37 40 121882 87615 79534851
Rhabdomyolysis 45.68 10.37 292 121630 102839 79519627
Neutrophil count decreased 45.31 10.37 46 121876 93913 79528553
Chest discomfort 45.00 10.37 363 121559 137681 79484785
Hepatic ischaemia 43.84 10.37 25 121897 1090 79621376
Melaena 43.81 10.37 197 121725 60693 79561773
Total lung capacity decreased 43.78 10.37 36 121886 2869 79619597
Haemorrhage 43.50 10.37 263 121659 90855 79531611
Oesophageal perforation 43.17 10.37 28 121894 1543 79620923
Post procedural haemorrhage 42.73 10.37 76 121846 13668 79608798
Heart sounds 41.63 10.37 23 121899 943 79621523
Hyperlipidaemia 41.48 10.37 110 121812 25983 79596483
Angioplasty 41.15 10.37 29 121893 1834 79620632
Prolonged expiration 40.81 10.37 25 121897 1246 79621220
Intentional overdose 40.49 10.37 62 121860 105898 79516568
Cytomegalovirus infection 40.43 10.37 8 121914 42636 79579830
Injection site erythema 40.38 10.37 36 121886 78161 79544305
Stomatitis 39.70 10.37 105 121817 146652 79475814
COVID-19 39.55 10.37 117 121805 157557 79464909
Product dose omission issue 39.22 10.37 220 121702 247317 79375149
Brain scan abnormal 39.12 10.37 24 121898 1199 79621267
Blood loss anaemia 38.64 10.37 78 121844 15420 79607046
Ventricular extrasystoles 38.64 10.37 90 121832 19614 79602852
Muscle injury 38.61 10.37 13 121909 48548 79573918
Irritable bowel syndrome 38.12 10.37 24 121898 62217 79560249
Mitral valve incompetence 38.12 10.37 113 121809 28452 79594014
Bronchopulmonary aspergillosis allergic 38.11 10.37 34 121888 3027 79619439
Coronary artery thrombosis 37.68 10.37 34 121888 3072 79619394
Sinus node dysfunction 37.02 10.37 52 121870 7649 79614817
Bone marrow failure 36.78 10.37 16 121906 51091 79571375
Obstructive airways disorder 36.02 10.37 118 121804 31341 79591125
Pain 35.83 10.37 1364 120558 702438 78920028
Injection site reaction 35.13 10.37 20 121902 54765 79567701
Acute pulmonary oedema 34.74 10.37 71 121851 14159 79608307
Wound 34.66 10.37 79 121843 116100 79506366
Ventricular dysfunction 34.03 10.37 44 121878 5979 79616487
Drug reaction with eosinophilia and systemic symptoms 33.86 10.37 29 121893 64215 79558251
Sinus bradycardia 33.81 10.37 100 121822 25147 79597319
Muscle relaxant therapy 33.71 10.37 12 121910 166 79622300
Weight increased 33.65 10.37 267 121655 277119 79345347
Cerebral artery thrombosis 33.51 10.37 21 121901 1090 79621376
Hip arthroplasty 33.29 10.37 7 121915 35749 79586717
Neurotoxicity 33.24 10.37 5 121917 32513 79589953
Neuropathy peripheral 33.21 10.37 108 121814 141197 79481269
Herpes zoster 33.19 10.37 57 121865 93026 79529440
Injection site pruritus 32.45 10.37 12 121910 42271 79580195
Arteriosclerosis 32.24 10.37 80 121842 18147 79604319
Knee arthroplasty 31.99 10.37 13 121909 43235 79579231
Sputum discoloured 31.90 10.37 89 121833 21654 79600812
Blood calcium increased 31.68 10.37 57 121865 10343 79612123
Multiple drug therapy 31.62 10.37 35 121887 4043 79618423
Cytokine release syndrome 31.62 10.37 8 121914 35990 79586476
Intentional self-injury 30.90 10.37 6 121916 32413 79590053
Red blood cell sedimentation rate increased 30.58 10.37 16 121906 45926 79576540
Chronic kidney disease 30.34 10.37 189 121733 65965 79556501
Vascular graft 30.25 10.37 25 121897 2006 79620460
Labelled drug-drug interaction medication error 30.13 10.37 102 121820 27548 79594918
Inappropriate schedule of product administration 30.12 10.37 104 121818 133524 79488942
Coronary artery restenosis 30.08 10.37 21 121901 1308 79621158
Rheumatic fever 30.06 10.37 4 121918 28521 79593945
Left ventricle outflow tract obstruction 30.02 10.37 14 121908 399 79622067
Middle insomnia 29.99 10.37 72 121850 15997 79606469
Macular degeneration 29.54 10.37 58 121864 11238 79611228
Paraesthesia oral 29.26 10.37 83 121839 20388 79602078
Neoplasm progression 28.90 10.37 22 121900 51660 79570806
Hallucination 28.76 10.37 227 121695 85518 79536948
Fear of eating 28.21 10.37 14 121908 459 79622007
Carotid artery stenosis 27.96 10.37 49 121873 8709 79613757
Non-cardiac chest pain 27.49 10.37 51 121871 9473 79612993
Multiple injuries 27.11 10.37 30 121892 3465 79619001
Percutaneous coronary intervention 27.07 10.37 13 121909 396 79622070
Vaginal flatulence 27.02 10.37 26 121896 2549 79619917
Ill-defined disorder 26.68 10.37 37 121885 65838 79556628
Platelet count decreased 26.66 10.37 181 121741 194483 79427983
Therapeutic response decreased 26.63 10.37 38 121884 66815 79555651
Vascular stent occlusion 26.60 10.37 11 121911 233 79622233
Lung opacity 26.47 10.37 36 121886 5138 79617328
Haematoma 26.41 10.37 153 121769 52042 79570424
Coronary ostial stenosis 26.31 10.37 10 121912 168 79622298
Blister 26.25 10.37 94 121828 119382 79503084
Sleep apnoea syndrome 26.22 10.37 118 121804 36360 79586106
Post procedural complication 26.05 10.37 88 121834 23741 79598725
Electrocardiogram ST segment elevation 25.55 10.37 46 121876 8351 79614115
Generalised tonic-clonic seizure 25.45 10.37 18 121904 43892 79578574
Anaemia 25.41 10.37 874 121048 444141 79178325
Musculoskeletal stiffness 25.35 10.37 160 121762 174848 79447618
Dyspnoea exertional 25.20 10.37 223 121699 86850 79535616
Suicide attempt 25.05 10.37 56 121866 82876 79539590
Haematemesis 25.03 10.37 151 121771 52113 79570353
Superinfection 24.91 10.37 34 121888 4868 79617598
Reversible airways obstruction 24.80 10.37 23 121899 2153 79620313
Cardiac procedure complication 24.74 10.37 12 121910 374 79622092
Lymphadenopathy 24.62 10.37 27 121895 53220 79569246
Pruritus 24.55 10.37 440 121482 394208 79228258
Hyponatraemia 24.47 10.37 395 121527 177453 79445013
Cardiac murmur 24.44 10.37 66 121856 15758 79606708
Ischaemia 24.27 10.37 44 121878 8031 79614435
Hyperhidrosis 24.14 10.37 345 121577 151147 79471319
Myelosuppression 24.05 10.37 16 121906 40280 79582186
Vascular stent thrombosis 23.99 10.37 29 121893 3681 79618785
Fatigue 23.95 10.37 1170 120752 928557 78693909
Ischaemic stroke 23.68 10.37 107 121815 33024 79589442
Vascular pseudoaneurysm 23.63 10.37 28 121894 3482 79618984
Drug resistance 23.56 10.37 18 121904 42195 79580271
Essential hypertension 23.53 10.37 37 121885 6016 79616450
Coronary artery dissection 23.41 10.37 17 121905 1127 79621339
Injection site swelling 22.80 10.37 23 121899 47109 79575357
Hepatotoxicity 22.70 10.37 27 121895 51325 79571141
Hepatic function abnormal 22.38 10.37 49 121873 73058 79549408
Therapeutic product effect incomplete 22.36 10.37 126 121796 141519 79480947
Oedema peripheral 22.34 10.37 524 121398 251764 79370702
Erythema 22.22 10.37 226 121696 223064 79399402
Cold sweat 22.18 10.37 71 121851 18628 79603838
Atrioventricular block second degree 22.18 10.37 40 121882 7272 79615194
Coagulation time prolonged 22.14 10.37 23 121899 2472 79619994
Pneumocystis jirovecii pneumonia 22.12 10.37 11 121911 32497 79589969
Acne 22.11 10.37 7 121915 27183 79595283
Peripheral swelling 22.10 10.37 285 121637 269332 79353134
Gastrooesophageal reflux disease 21.96 10.37 250 121672 103996 79518470
Haematuria 21.87 10.37 180 121742 68656 79553810
Base excess decreased 21.77 10.37 11 121911 375 79622091
Bronchopulmonary aspergillosis 21.52 10.37 4 121918 22290 79600176
Circulatory collapse 21.45 10.37 114 121808 37554 79584912
Progressive multifocal leukoencephalopathy 21.45 10.37 3 121919 20597 79601869
Palmar-plantar erythrodysaesthesia syndrome 21.38 10.37 12 121910 33122 79589344
Subdural haematoma 21.34 10.37 100 121822 31334 79591132
Sinus arrest 21.31 10.37 27 121895 3595 79618871
Arrhythmia 20.98 10.37 163 121759 61109 79561357
Bundle branch block left 20.86 10.37 51 121871 11462 79611004
Neuroleptic malignant syndrome 20.85 10.37 8 121914 27551 79594915
Liver injury 20.80 10.37 34 121888 56580 79565886
Atrioventricular block complete 20.56 10.37 64 121858 16546 79605920
Inflammation 20.43 10.37 74 121848 93679 79528787
Arterial occlusive disease 20.42 10.37 42 121880 8414 79614052
Transplant failure 20.35 10.37 30 121892 4611 79617855
Gastrointestinal disorder 20.22 10.37 107 121815 122098 79500368
Tricuspid valve incompetence 19.98 10.37 71 121851 19641 79602825
Abdominal rigidity 19.75 10.37 24 121898 3064 79619402
Coronary artery reocclusion 19.72 10.37 8 121914 161 79622305
Coronary steal syndrome 19.71 10.37 4 121918 3 79622463
Drug-induced liver injury 19.68 10.37 45 121877 66072 79556394
Osteoporosis 19.41 10.37 33 121889 54079 79568387
Radiculopathy 19.19 10.37 42 121880 8782 79613684
Laryngeal haematoma 19.19 10.37 8 121914 173 79622293
Atrioventricular block 19.17 10.37 56 121866 13985 79608481
Cardiomyopathy 19.14 10.37 91 121831 28683 79593783
Oral herpes 19.12 10.37 9 121913 27445 79595021
Areflexia 19.03 10.37 32 121890 5502 79616964
Flushing 19.02 10.37 70 121852 88198 79534268
Multiple sclerosis relapse 18.98 10.37 26 121896 46507 79575959
Pancytopenia 18.96 10.37 162 121760 165583 79456883
Blood pressure decreased 18.94 10.37 234 121688 99232 79523234
Stent placement 18.93 10.37 35 121887 6485 79615981
Lower gastrointestinal haemorrhage 18.92 10.37 61 121861 16064 79606402
Acute myeloid leukaemia 18.79 10.37 12 121910 30873 79591593
Malaise 18.73 10.37 922 121000 488947 79133519
Faeces discoloured 18.57 10.37 91 121831 29036 79593430
Supraventricular tachycardia 18.56 10.37 73 121849 21197 79601269
Head injury 18.55 10.37 109 121813 37260 79585206
Alanine aminotransferase increased 18.55 10.37 159 121763 162411 79460055
Swollen tongue 18.51 10.37 120 121802 42450 79580016
Nerve degeneration 18.51 10.37 9 121913 282 79622184
Lymphoedema 18.40 10.37 51 121871 12362 79610104
Hot flush 18.31 10.37 35 121887 54842 79567624
Productive cough 18.23 10.37 211 121711 88120 79534346
International normalised ratio decreased 18.22 10.37 39 121883 8031 79614435
Blood creatine phosphokinase MB increased 18.22 10.37 22 121900 2789 79619677
Breast cancer 18.11 10.37 15 121907 33766 79588700
Arterial stenosis 17.98 10.37 16 121906 1420 79621046
Hepatorenal syndrome 17.96 10.37 27 121895 4222 79618244
Left ventricular failure 17.96 10.37 43 121879 9538 79612928
Septic shock 17.91 10.37 112 121810 122689 79499777
Chronic sinusitis 17.83 10.37 52 121870 12974 79609492
Heparin-induced thrombocytopenia 17.66 10.37 43 121879 9639 79612827
Lip swelling 17.59 10.37 115 121807 40796 79581670
Silent myocardial infarction 17.56 10.37 12 121910 722 79621744
Autonomic dysreflexia 17.50 10.37 10 121912 438 79622028
Drug eruption 17.47 10.37 25 121897 43910 79578556
Ventricular hypertrophy 17.39 10.37 35 121887 6903 79615563
Hypovolaemia 17.32 10.37 63 121859 17628 79604838
Oxygen consumption decreased 17.25 10.37 10 121912 450 79622016
Arthritis 17.16 10.37 104 121818 114776 79507690
Ureteric injury 17.11 10.37 7 121915 144 79622322
Haemophagocytic lymphohistiocytosis 17.09 10.37 6 121916 21831 79600635
Therapy partial responder 17.05 10.37 3 121919 17394 79605072
No adverse event 17.04 10.37 19 121903 37173 79585293
Thrombocytopenia 17.03 10.37 294 121628 264965 79357501
Multiple organ dysfunction syndrome 16.88 10.37 268 121654 119978 79502488
Proctitis 16.79 10.37 33 121889 6399 79616067
General physical health deterioration 16.74 10.37 308 121614 274930 79347536
Upper gastrointestinal haemorrhage 16.41 10.37 114 121808 41266 79581200
Wheezing 16.37 10.37 260 121662 116404 79506062
Atrial flutter 16.33 10.37 71 121851 21554 79600912
Therapy non-responder 16.31 10.37 79 121843 92226 79530240
Device related infection 16.29 10.37 17 121905 34277 79588189
Laryngotracheal oedema 15.98 10.37 5 121917 45 79622421
Normochromic normocytic anaemia 15.93 10.37 36 121886 7691 79614775
Hepatic cytolysis 15.91 10.37 11 121911 27140 79595326
Nausea 15.63 10.37 1256 120666 955940 78666526
Orthopnoea 15.54 10.37 42 121880 10031 79612435
Ventricular asystole 15.38 10.37 8 121914 290 79622176
Ventricular hyperkinesia 15.36 10.37 8 121914 291 79622175
Urea renal clearance decreased 15.33 10.37 4 121918 17 79622449
Vascular graft occlusion 15.31 10.37 11 121911 717 79621749
Product complaint 15.21 10.37 50 121872 13299 79609167
Bronchial irritation 15.17 10.37 5 121917 54 79622412
Peripheral ischaemia 15.16 10.37 40 121882 9417 79613049
Myocardial bridging 15.15 10.37 4 121918 18 79622448
Mouth ulceration 15.12 10.37 22 121900 38372 79584094
Psychotic disorder 15.08 10.37 25 121897 41377 79581089
Blood creatine phosphokinase increased 15.06 10.37 161 121761 65929 79556537
Therapeutic response shortened 14.99 10.37 3 121919 15860 79606606
Left ventricular dysfunction 14.95 10.37 64 121858 19297 79603169
Cardiac failure acute 14.95 10.37 63 121859 18866 79603600
Extrapyramidal disorder 14.95 10.37 8 121914 22671 79599795
Live birth 14.93 10.37 5 121917 18739 79603727
Oropharyngeal pain 14.80 10.37 102 121820 109251 79513215
Pituitary apoplexy 14.80 10.37 7 121915 206 79622260
Loss of personal independence in daily activities 14.73 10.37 94 121828 102486 79519980
Normochromic anaemia 14.66 10.37 9 121913 450 79622016
Hyperkeratosis 14.64 10.37 35 121887 7755 79614711
Coronary no-reflow phenomenon 14.49 10.37 4 121918 22 79622444
Therapy interrupted 14.37 10.37 16 121906 31325 79591141
Autoimmune disorder 14.01 10.37 4 121918 16608 79605858
Candida infection 13.99 10.37 23 121899 38191 79584275
Psoriasis 13.97 10.37 80 121842 89507 79532959
Ecchymosis 13.93 10.37 53 121869 15153 79607313
Aplastic anaemia 13.88 10.37 5 121917 17900 79604566
Metastases to central nervous system 13.70 10.37 4 121918 16371 79606095
Left ventricular end-diastolic pressure increased 13.65 10.37 10 121912 672 79621794
Seizure 13.54 10.37 205 121717 188629 79433837
Dilatation atrial 13.52 10.37 22 121900 3682 79618784
Finger amputation 13.50 10.37 10 121912 684 79621782
Depression 13.42 10.37 430 121492 216360 79406106
Body temperature increased 13.41 10.37 30 121892 44390 79578076
Duodenal ulcer 13.34 10.37 55 121867 16314 79606152
Gastric ulcer 13.20 10.37 93 121829 33812 79588654
Brain stem stroke 13.18 10.37 10 121912 709 79621757
Morning glory syndrome 13.17 10.37 3 121919 6 79622460
Left ventricular enlargement 12.85 10.37 10 121912 736 79621730
Lower limb fracture 12.83 10.37 10 121912 23205 79599261
Respiratory depression 12.79 10.37 14 121908 27616 79594850
Product impurity 12.74 10.37 5 121917 92 79622374
Cervicogenic headache 12.69 10.37 4 121918 37 79622429
Haemorrhagic transformation stroke 12.68 10.37 18 121904 2674 79619792
Confusional state 12.65 10.37 601 121321 317396 79305070
Grip strength decreased 12.63 10.37 9 121913 21860 79600606
Infarction 12.56 10.37 24 121898 4558 79617908
Reperfusion arrhythmia 12.54 10.37 7 121915 293 79622173
Cerebral mass effect 12.49 10.37 15 121907 1891 79620575
Vaginal discharge 12.41 10.37 32 121890 7431 79615035
Osteonecrosis of jaw 12.40 10.37 30 121892 43196 79579270
Coronary bypass thrombosis 12.31 10.37 3 121919 9 79622457
Immune reconstitution inflammatory syndrome 12.30 10.37 3 121919 13838 79608628
Cytopenia 12.29 10.37 8 121914 20375 79602091
Hiatus hernia 12.23 10.37 69 121853 23243 79599223
Hospitalisation 12.22 10.37 89 121833 94147 79528319
Blood creatinine increased 12.20 10.37 317 121605 154740 79467726
Cardioactive drug level increased 12.17 10.37 21 121901 3688 79618778
Asthma 12.07 10.37 281 121641 134814 79487652
Dizziness postural 12.05 10.37 42 121880 11507 79610959
Thrombotic microangiopathy 12.05 10.37 8 121914 20161 79602305
Epilepsy 12.01 10.37 28 121894 40832 79581634
Joint stiffness 11.98 10.37 28 121894 40802 79581664
Urticaria 11.97 10.37 205 121717 184996 79437470
Drug dependence 11.93 10.37 28 121894 40741 79581725
Carotid artery occlusion 11.91 10.37 32 121890 7615 79614851
Procedural pain 11.89 10.37 68 121854 23016 79599450
Atrioventricular block first degree 11.82 10.37 44 121878 12447 79610019
Hyperbilirubinaemia 11.82 10.37 12 121910 24506 79597960
Intentional product misuse 11.80 10.37 91 121831 95074 79527392
Bacteriuria 11.79 10.37 12 121910 1259 79621207
Peptic ulcer 11.74 10.37 28 121894 6195 79616271
Fear of death 11.73 10.37 13 121909 1503 79620963
Liver disorder 11.65 10.37 64 121858 72353 79550113
Angioedema 11.64 10.37 172 121750 75863 79546603
Epistaxis 11.57 10.37 237 121685 111278 79511188
Overdose 11.55 10.37 205 121717 184001 79438465
Abdominal wall haematoma 11.53 10.37 24 121898 4849 79617617
QRS axis abnormal 11.48 10.37 15 121907 2059 79620407
Intraventricular haemorrhage 11.48 10.37 24 121898 4863 79617603
Myocardial necrosis marker increased 11.47 10.37 19 121903 3227 79619239
Viral infection 11.46 10.37 31 121891 42985 79579481
Gastritis 11.44 10.37 118 121804 47875 79574591
Coagulation time abnormal 11.42 10.37 6 121916 222 79622244
Headache 11.40 10.37 853 121069 652919 78969547
Female genital tract fistula 11.40 10.37 27 121895 5948 79616518
Gastrointestinal tract irritation 11.40 10.37 9 121913 677 79621789
Immunosuppressant drug level increased 11.37 10.37 35 121887 8992 79613474
Weight decreased 11.37 10.37 436 121486 354762 79267704
Accidental exposure to product 11.33 10.37 19 121903 31303 79591163
Systolic anterior motion of mitral valve 11.26 10.37 4 121918 55 79622411
Hypertensive crisis 11.24 10.37 62 121860 20708 79601758
Mania 11.24 10.37 7 121915 18253 79604213
Febrile bone marrow aplasia 11.23 10.37 3 121919 13017 79609449
Tumour lysis syndrome 11.22 10.37 12 121910 23927 79598539
Application site rash 11.16 10.37 15 121907 2117 79620349
Poor venous access 11.11 10.37 7 121915 18142 79604324
Bursitis 10.99 10.37 24 121898 35820 79586646
Femur fracture 10.95 10.37 27 121895 38625 79583841
Device malfunction 10.93 10.37 63 121859 21385 79601081
Organ failure 10.90 10.37 21 121901 4012 79618454
Paraesthesia 10.81 10.37 197 121725 176126 79446340
Hypoaesthesia 10.80 10.37 201 121721 179151 79443315
Wound secretion 10.78 10.37 27 121895 6161 79616305
Electrocardiogram T wave abnormal 10.77 10.37 20 121902 3718 79618748
Ovarian cyst 10.76 10.37 3 121919 12652 79609814
Brain natriuretic peptide increased 10.75 10.37 34 121888 8866 79613600
Asthenia 10.74 10.37 915 121007 510774 79111692
Diabetic neuropathy 10.70 10.37 27 121895 6189 79616277
Basal cell carcinoma 10.67 10.37 26 121896 37349 79585117
Lung consolidation 10.64 10.37 34 121888 8913 79613553
Nodal rhythm 10.61 10.37 18 121904 3117 79619349
Illness 10.61 10.37 36 121886 46475 79575991
Sleep disorder 10.59 10.37 82 121840 85595 79536871
Blood chloride decreased 10.58 10.37 32 121890 8145 79614321
Respiration abnormal 10.57 10.37 31 121891 7757 79614709
Dilatation ventricular 10.50 10.37 21 121901 4123 79618343
Coronary angioplasty 10.47 10.37 7 121915 406 79622060
Carotid artery disease 10.46 10.37 15 121907 2249 79620217
Fungal infection 10.45 10.37 31 121891 41717 79580749
Urogenital disorder 10.43 10.37 4 121918 69 79622397
Stent malfunction 10.38 10.37 4 121918 70 79622396

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




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)

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
4917 RXNORM
2324 MMSL
5183 MMSL
d00321 MMSL
000683 NDDF
387404004 SNOMEDCT_US
71759000 SNOMEDCT_US
C0017887 UMLSCUI
D005996 MESH_DESCRIPTOR_UI
4510 PUBCHEM_CID
G59M7S0WS3 UNII

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 0071-0417 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 0071-0418 TABLET 0.40 mg SUBLINGUAL NDA 26 sections
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 0071-0419 TABLET 0.60 mg SUBLINGUAL NDA 26 sections
Nitrostat HUMAN PRESCRIPTION DRUG LABEL 1 0071-0419 TABLET 0.60 mg SUBLINGUAL NDA 26 sections
Minitran HUMAN PRESCRIPTION DRUG LABEL 1 0089-0171 PATCH 18 mg TRANSDERMAL Export only 1 sections
Minitran HUMAN PRESCRIPTION DRUG LABEL 1 0089-0172 PATCH 36 mg TRANSDERMAL Export only 1 sections
Minitran HUMAN PRESCRIPTION DRUG LABEL 1 0089-0173 PATCH 54 mg TRANSDERMAL Export only 1 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
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 0338-1047 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 0338-1049 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 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
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
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