glyceryl trinitrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| NO2 - derivatives | 1952 | 55-63-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 5 | mg | O |
| 2.50 | mg | oral aerosol |
| 2.50 | mg | SL |
| 5 | mg | TD |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 28, 1981 | FDA | FOUGERA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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 |
| Hyperkeratosis | 29.77 | 10.97 | 36 | 74305 | 5982 | 63408699 |
| Lip swelling | 29.77 | 10.97 | 92 | 74249 | 30971 | 63383710 |
| 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 |
| Injection site swelling | 16.28 | 10.97 | 19 | 74322 | 47553 | 63367128 |
| Neuropathy peripheral | 16.28 | 10.97 | 73 | 74268 | 113594 | 63301087 |
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Soluble guanylate cyclase | Enzyme | ACTIVATOR | CHEMBL | CHEMBL | |||||
| Atrial natriuretic peptide receptor 1 | Enzyme | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |