pantoprazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiulcer, benzimidazole derivatives | 2054 | 102625-70-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Pantoprazole sodium is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 40 | mg | O |
| 40 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.74 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 0.17 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.02 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1.90 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 2, 2000 | FDA | WYETH PHARMS INC |
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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 749.67 | 9.84 | 2620 | 398597 | 144322 | 52803527 |
| Chronic kidney disease | 566.57 | 9.84 | 1102 | 400115 | 42268 | 52905581 |
| Completed suicide | 466.30 | 9.84 | 228 | 400989 | 137973 | 52809876 |
| Toxicity to various agents | 409.90 | 9.84 | 636 | 400581 | 218962 | 52728887 |
| Drug ineffective | 401.10 | 9.84 | 4077 | 397140 | 813168 | 52134681 |
| Exposure during pregnancy | 325.63 | 9.84 | 276 | 400941 | 124584 | 52823265 |
| Haematochezia | 284.67 | 9.84 | 831 | 400386 | 41527 | 52906322 |
| Folliculitis | 271.25 | 9.84 | 680 | 400537 | 31029 | 52916820 |
| Muscle injury | 260.58 | 9.84 | 644 | 400573 | 29122 | 52918727 |
| Maternal exposure during pregnancy | 246.63 | 9.84 | 499 | 400718 | 155140 | 52792709 |
| Irritable bowel syndrome | 218.58 | 9.84 | 774 | 400443 | 42858 | 52904991 |
| Product prescribing error | 206.59 | 9.84 | 503 | 400714 | 22528 | 52925321 |
| Acute kidney injury | 204.52 | 9.84 | 2856 | 398361 | 251012 | 52696837 |
| Death | 197.61 | 9.84 | 1727 | 399490 | 355505 | 52592344 |
| Anaemia | 177.84 | 9.84 | 2996 | 398221 | 273722 | 52674127 |
| Rheumatoid arthritis | 171.46 | 9.84 | 1526 | 399691 | 313005 | 52634844 |
| End stage renal disease | 170.35 | 9.84 | 221 | 400996 | 5950 | 52941899 |
| Device expulsion | 168.70 | 9.84 | 15 | 401202 | 29798 | 52918051 |
| Treatment failure | 162.64 | 9.84 | 463 | 400754 | 127940 | 52819909 |
| Abdominal pain upper | 161.66 | 9.84 | 1937 | 399280 | 164354 | 52783495 |
| Off label use | 160.97 | 9.84 | 2541 | 398676 | 469671 | 52478178 |
| Sleep disorder due to general medical condition, insomnia type | 160.03 | 9.84 | 474 | 400743 | 23875 | 52923974 |
| Lower respiratory tract infection | 159.26 | 9.84 | 1201 | 400016 | 89780 | 52858069 |
| Abortion spontaneous | 155.56 | 9.84 | 78 | 401139 | 46557 | 52901292 |
| Impaired healing | 154.88 | 9.84 | 918 | 400299 | 63287 | 52884562 |
| Renal injury | 154.83 | 9.84 | 272 | 400945 | 9632 | 52938217 |
| Drug hypersensitivity | 147.52 | 9.84 | 1280 | 399937 | 263962 | 52683887 |
| Injection site erythema | 142.69 | 9.84 | 225 | 400992 | 77024 | 52870825 |
| Injection site pain | 139.12 | 9.84 | 415 | 400802 | 112976 | 52834873 |
| Hypomagnesaemia | 134.59 | 9.84 | 452 | 400765 | 24359 | 52923490 |
| Hyponatraemia | 133.13 | 9.84 | 1325 | 399892 | 107282 | 52840567 |
| Dyspnoea | 127.50 | 9.84 | 5504 | 395713 | 580728 | 52367121 |
| Peripheral swelling | 124.85 | 9.84 | 2211 | 399006 | 203897 | 52743952 |
| Injection site reaction | 122.74 | 9.84 | 122 | 401095 | 51044 | 52896805 |
| Ill-defined disorder | 122.50 | 9.84 | 712 | 400505 | 48732 | 52899117 |
| Gastrointestinal disorder | 122.15 | 9.84 | 1122 | 400095 | 88882 | 52858967 |
| Intentional overdose | 118.28 | 9.84 | 202 | 401015 | 67003 | 52880846 |
| Muscle spasticity | 117.93 | 9.84 | 348 | 400869 | 17490 | 52930359 |
| Drug intolerance | 112.26 | 9.84 | 996 | 400221 | 204497 | 52743352 |
| Alopecia | 110.46 | 9.84 | 1179 | 400038 | 233404 | 52714445 |
| Asthenia | 106.57 | 9.84 | 3358 | 397859 | 340232 | 52607617 |
| Stomatitis | 104.97 | 9.84 | 1165 | 400052 | 96993 | 52850856 |
| Tubulointerstitial nephritis | 104.40 | 9.84 | 317 | 400900 | 16187 | 52931662 |
| Labelled drug-drug interaction medication error | 104.17 | 9.84 | 244 | 400973 | 10655 | 52937194 |
| Blister | 101.48 | 9.84 | 971 | 400246 | 77782 | 52870067 |
| Orthostatic intolerance | 91.11 | 9.84 | 74 | 401143 | 1119 | 52946730 |
| Body temperature increased | 91.01 | 9.84 | 487 | 400730 | 32312 | 52915537 |
| Abdominal pain | 90.92 | 9.84 | 2544 | 398673 | 253359 | 52694490 |
| Wrong technique in product usage process | 90.35 | 9.84 | 198 | 401019 | 59834 | 52888015 |
| Ear pain | 89.54 | 9.84 | 451 | 400766 | 29222 | 52918627 |
| Product monitoring error | 89.30 | 9.84 | 110 | 401107 | 2807 | 52945042 |
| Hypokalaemia | 88.38 | 9.84 | 1112 | 400105 | 95405 | 52852444 |
| Melaena | 88.09 | 9.84 | 443 | 400774 | 28686 | 52919163 |
| Hepatic function abnormal | 87.34 | 9.84 | 89 | 401128 | 36810 | 52911039 |
| Haematemesis | 86.87 | 9.84 | 460 | 400757 | 30397 | 52917452 |
| Pemphigus | 84.18 | 9.84 | 449 | 400768 | 103582 | 52844267 |
| Night sweats | 83.82 | 9.84 | 499 | 400718 | 34448 | 52913401 |
| Systemic lupus erythematosus | 82.80 | 9.84 | 577 | 400640 | 124837 | 52823012 |
| Systemic infection | 82.58 | 9.84 | 91 | 401126 | 2054 | 52945795 |
| Injection site swelling | 80.77 | 9.84 | 122 | 401095 | 42506 | 52905343 |
| Drug abuse | 78.06 | 9.84 | 243 | 400974 | 65283 | 52882566 |
| No adverse event | 77.71 | 9.84 | 109 | 401108 | 39156 | 52908693 |
| Confusional state | 76.15 | 9.84 | 1956 | 399261 | 192265 | 52755584 |
| Product dose omission issue | 75.21 | 9.84 | 1002 | 400215 | 190618 | 52757231 |
| Injection site pruritus | 73.17 | 9.84 | 125 | 401092 | 41464 | 52906385 |
| Pruritus | 72.10 | 9.84 | 2796 | 398421 | 291036 | 52656813 |
| Hypocalcaemia | 71.71 | 9.84 | 421 | 400796 | 28916 | 52918933 |
| Gastrointestinal haemorrhage | 68.27 | 9.84 | 913 | 400304 | 79417 | 52868432 |
| Foetal exposure during pregnancy | 66.11 | 9.84 | 99 | 401118 | 34616 | 52913233 |
| Gastritis | 66.01 | 9.84 | 483 | 400734 | 35751 | 52912098 |
| Subacute cutaneous lupus erythematosus | 65.67 | 9.84 | 85 | 401132 | 2283 | 52945566 |
| Therapeutic product effect incomplete | 65.24 | 9.84 | 413 | 400804 | 91371 | 52856478 |
| Sinusitis | 65.00 | 9.84 | 1694 | 399523 | 166870 | 52780979 |
| Drug resistance | 64.18 | 9.84 | 35 | 401182 | 19927 | 52927922 |
| Respiratory arrest | 63.53 | 9.84 | 96 | 401121 | 33444 | 52914405 |
| Agranulocytosis | 63.43 | 9.84 | 349 | 400868 | 23400 | 52924449 |
| Cardio-respiratory arrest | 63.08 | 9.84 | 228 | 400989 | 58530 | 52889319 |
| Therapeutic response decreased | 57.66 | 9.84 | 175 | 401042 | 47394 | 52900455 |
| Accidental exposure to product | 57.29 | 9.84 | 56 | 401161 | 23618 | 52924231 |
| Respiratory disorder | 56.22 | 9.84 | 444 | 400773 | 33653 | 52914196 |
| Leukopenia | 55.98 | 9.84 | 819 | 400398 | 72644 | 52875205 |
| Premature delivery | 55.19 | 9.84 | 69 | 401148 | 26035 | 52921814 |
| Foetal death | 54.84 | 9.84 | 4 | 401213 | 9343 | 52938506 |
| Renal failure | 52.41 | 9.84 | 1213 | 400004 | 117239 | 52830610 |
| Seizure | 51.95 | 9.84 | 674 | 400543 | 128835 | 52819014 |
| Suicidal ideation | 51.85 | 9.84 | 256 | 400961 | 60255 | 52887594 |
| Blood loss anaemia | 51.67 | 9.84 | 165 | 401052 | 8658 | 52939191 |
| Hypoaesthesia | 51.22 | 9.84 | 698 | 400519 | 132297 | 52815552 |
| Gastroenteritis clostridial | 51.14 | 9.84 | 41 | 401176 | 608 | 52947241 |
| Faecaloma | 49.07 | 9.84 | 155 | 401062 | 8086 | 52939763 |
| Overdose | 47.64 | 9.84 | 549 | 400668 | 107187 | 52840662 |
| Anaphylactic reaction | 47.57 | 9.84 | 251 | 400966 | 58075 | 52889774 |
| Neuropathy peripheral | 47.13 | 9.84 | 522 | 400695 | 102665 | 52845184 |
| Abdominal discomfort | 46.46 | 9.84 | 1286 | 399931 | 219776 | 52728073 |
| Musculoskeletal stiffness | 46.24 | 9.84 | 651 | 400566 | 122717 | 52825132 |
| Injection site bruising | 45.26 | 9.84 | 139 | 401078 | 37507 | 52910342 |
| Product use in unapproved indication | 45.17 | 9.84 | 584 | 400633 | 111705 | 52836144 |
| Pneumonia viral | 44.41 | 9.84 | 136 | 401081 | 6976 | 52940873 |
| Caesarean section | 44.24 | 9.84 | 39 | 401178 | 17281 | 52930568 |
| Loss of personal independence in daily activities | 44.21 | 9.84 | 325 | 400892 | 69490 | 52878359 |
| Pallor | 43.78 | 9.84 | 332 | 400885 | 24850 | 52922999 |
| Product quality issue | 43.59 | 9.84 | 138 | 401079 | 36885 | 52910964 |
| Gastrooesophageal reflux disease | 43.47 | 9.84 | 868 | 400349 | 81795 | 52866054 |
| Depression | 42.93 | 9.84 | 1048 | 400169 | 182004 | 52765845 |
| Sedation complication | 42.23 | 9.84 | 3 | 401214 | 7163 | 52940686 |
| Rebound acid hypersecretion | 42.10 | 9.84 | 28 | 401189 | 305 | 52947544 |
| Feeling abnormal | 41.63 | 9.84 | 741 | 400476 | 134560 | 52813289 |
| Infection | 41.06 | 9.84 | 1634 | 399583 | 170571 | 52777278 |
| Breast cancer | 41.04 | 9.84 | 211 | 401006 | 49147 | 52898702 |
| Glossodynia | 40.93 | 9.84 | 520 | 400697 | 99771 | 52848078 |
| Intentional self-injury | 40.90 | 9.84 | 80 | 401137 | 25204 | 52922645 |
| Electrolyte imbalance | 40.48 | 9.84 | 262 | 400955 | 18622 | 52929227 |
| Product use issue | 40.29 | 9.84 | 773 | 400444 | 138811 | 52809038 |
| Hypertensive nephropathy | 39.91 | 9.84 | 31 | 401186 | 438 | 52947411 |
| Stillbirth | 39.61 | 9.84 | 3 | 401214 | 6794 | 52941055 |
| Knee arthroplasty | 39.61 | 9.84 | 125 | 401092 | 33444 | 52914405 |
| Malaise | 39.55 | 9.84 | 2243 | 398974 | 355374 | 52592475 |
| Intentional product misuse | 39.48 | 9.84 | 214 | 401003 | 49178 | 52898671 |
| Adverse drug reaction | 38.24 | 9.84 | 241 | 400976 | 53384 | 52894465 |
| Arthropathy | 38.22 | 9.84 | 792 | 400425 | 140661 | 52807188 |
| Hip arthroplasty | 37.85 | 9.84 | 97 | 401120 | 27765 | 52920084 |
| Coma | 37.51 | 9.84 | 291 | 400926 | 61492 | 52886357 |
| Pyrexia | 37.43 | 9.84 | 3519 | 397698 | 399674 | 52548175 |
| Irritability | 37.42 | 9.84 | 114 | 401103 | 30839 | 52917010 |
| Device issue | 37.27 | 9.84 | 66 | 401151 | 21592 | 52926257 |
| Psoriasis | 37.25 | 9.84 | 447 | 400770 | 86642 | 52861207 |
| Soft tissue disorder | 36.67 | 9.84 | 92 | 401125 | 4198 | 52943651 |
| Hand deformity | 36.49 | 9.84 | 435 | 400782 | 84414 | 52863435 |
| Vomiting | 36.42 | 9.84 | 4270 | 396947 | 492869 | 52454980 |
| Clostridium difficile colitis | 36.30 | 9.84 | 264 | 400953 | 19501 | 52928348 |
| Eosinophilia | 35.82 | 9.84 | 279 | 400938 | 21056 | 52926793 |
| Polyneuropathy | 35.70 | 9.84 | 195 | 401022 | 13038 | 52934811 |
| Haemoglobin decreased | 35.12 | 9.84 | 1313 | 399904 | 135994 | 52811855 |
| Device difficult to use | 35.03 | 9.84 | 17 | 401200 | 10342 | 52937507 |
| Dystonia | 34.88 | 9.84 | 28 | 401189 | 12993 | 52934856 |
| Live birth | 34.87 | 9.84 | 37 | 401180 | 15022 | 52932827 |
| Adverse event | 34.44 | 9.84 | 175 | 401042 | 40886 | 52906963 |
| Disease progression | 34.00 | 9.84 | 550 | 400667 | 101370 | 52846479 |
| Sedation | 33.97 | 9.84 | 112 | 401105 | 29563 | 52918286 |
| Genital haemorrhage | 33.91 | 9.84 | 6 | 401211 | 7038 | 52940811 |
| Drug dependence | 33.82 | 9.84 | 69 | 401148 | 21403 | 52926446 |
| Injection site warmth | 33.52 | 9.84 | 34 | 401183 | 14094 | 52933755 |
| Dehydration | 33.44 | 9.84 | 1568 | 399649 | 166842 | 52781007 |
| Haematoma | 33.15 | 9.84 | 395 | 400822 | 33449 | 52914400 |
| Angina pectoris | 33.03 | 9.84 | 346 | 400871 | 28379 | 52919470 |
| White blood cell count decreased | 33.02 | 9.84 | 699 | 400518 | 123776 | 52824073 |
| Therapeutic drug monitoring analysis not performed | 32.91 | 9.84 | 34 | 401183 | 711 | 52947138 |
| Product used for unknown indication | 32.84 | 9.84 | 33 | 401184 | 667 | 52947182 |
| Pre-eclampsia | 32.76 | 9.84 | 12 | 401205 | 8635 | 52939214 |
| Mycotic allergy | 32.75 | 9.84 | 37 | 401180 | 859 | 52946990 |
| Weight increased | 32.57 | 9.84 | 1865 | 399352 | 202702 | 52745147 |
| Gestational diabetes | 32.47 | 9.84 | 10 | 401207 | 8029 | 52939820 |
| Hypoparathyroidism secondary | 32.47 | 9.84 | 13 | 401204 | 41 | 52947808 |
| Restlessness | 31.67 | 9.84 | 337 | 400880 | 27750 | 52920099 |
| Atrial fibrillation | 31.58 | 9.84 | 1080 | 400137 | 110572 | 52837277 |
| Blood parathyroid hormone decreased | 31.26 | 9.84 | 5 | 401212 | 6313 | 52941536 |
| Therapy non-responder | 30.93 | 9.84 | 229 | 400988 | 48891 | 52898958 |
| Normal newborn | 30.72 | 9.84 | 8 | 401209 | 7171 | 52940678 |
| Neutropenic sepsis | 30.68 | 9.84 | 39 | 401178 | 14610 | 52933239 |
| Infusion related reaction | 30.53 | 9.84 | 916 | 400301 | 155041 | 52792808 |
| Fall | 30.11 | 9.84 | 3107 | 398110 | 355333 | 52592516 |
| Contusion | 30.05 | 9.84 | 1066 | 400151 | 109666 | 52838183 |
| Flushing | 29.95 | 9.84 | 363 | 400854 | 70237 | 52877612 |
| Painful respiration | 29.94 | 9.84 | 64 | 401153 | 2626 | 52945223 |
| Drug eruption | 29.92 | 9.84 | 93 | 401124 | 25001 | 52922848 |
| Anxiety | 29.58 | 9.84 | 1194 | 400023 | 195510 | 52752339 |
| Cardiac arrest | 29.44 | 9.84 | 511 | 400706 | 93156 | 52854693 |
| Eructation | 29.29 | 9.84 | 127 | 401090 | 7728 | 52940121 |
| Neutrophil count decreased | 28.99 | 9.84 | 233 | 400984 | 48865 | 52898984 |
| Duodenitis | 28.83 | 9.84 | 74 | 401143 | 3425 | 52944424 |
| Drug reaction with eosinophilia and systemic symptoms | 28.77 | 9.84 | 375 | 400842 | 32425 | 52915424 |
| Dyspepsia | 28.76 | 9.84 | 776 | 400441 | 76824 | 52871025 |
| Gamma-glutamyltransferase increased | 28.75 | 9.84 | 382 | 400835 | 33173 | 52914676 |
| Uterine perforation | 28.61 | 9.84 | 10 | 401207 | 7409 | 52940440 |
| Device dislocation | 28.46 | 9.84 | 87 | 401130 | 23510 | 52924339 |
| Premature baby | 28.41 | 9.84 | 67 | 401150 | 19734 | 52928115 |
| Abnormal behaviour | 28.28 | 9.84 | 78 | 401139 | 21788 | 52926061 |
| Cellulitis | 28.10 | 9.84 | 402 | 400815 | 75587 | 52872262 |
| Abdominal pain lower | 27.98 | 9.84 | 286 | 400931 | 23307 | 52924542 |
| Acute abdomen | 27.83 | 9.84 | 47 | 401170 | 1611 | 52946238 |
| Hiatus hernia | 27.82 | 9.84 | 247 | 400970 | 19373 | 52928476 |
| Platelet count decreased | 27.52 | 9.84 | 611 | 400606 | 107488 | 52840361 |
| Pregnancy | 27.52 | 9.84 | 132 | 401085 | 31309 | 52916540 |
| Product storage error | 27.45 | 9.84 | 35 | 401182 | 13095 | 52934754 |
| Injection site rash | 27.22 | 9.84 | 52 | 401165 | 16527 | 52931322 |
| Glomerulonephropathy | 26.92 | 9.84 | 14 | 401203 | 92 | 52947757 |
| Injection site haemorrhage | 26.81 | 9.84 | 81 | 401136 | 21970 | 52925879 |
| Rheumatoid factor positive | 26.45 | 9.84 | 191 | 401026 | 41007 | 52906842 |
| Body temperature decreased | 26.04 | 9.84 | 214 | 401003 | 16413 | 52931436 |
| Hypochromic anaemia | 25.88 | 9.84 | 49 | 401168 | 1840 | 52946009 |
| Suicide attempt | 25.86 | 9.84 | 296 | 400921 | 57872 | 52889977 |
| Nephrogenic anaemia | 25.83 | 9.84 | 50 | 401167 | 1909 | 52945940 |
| Device use error | 25.79 | 9.84 | 5 | 401212 | 5494 | 52942355 |
| Abortion induced | 25.74 | 9.84 | 26 | 401191 | 10800 | 52937049 |
| Food allergy | 25.56 | 9.84 | 126 | 401091 | 8092 | 52939757 |
| Cholestasis | 25.56 | 9.84 | 329 | 400888 | 28366 | 52919483 |
| Drug withdrawal syndrome | 25.50 | 9.84 | 116 | 401101 | 27906 | 52919943 |
| Clostridium test positive | 25.18 | 9.84 | 55 | 401162 | 2291 | 52945558 |
| Cholecystitis chronic | 25.09 | 9.84 | 150 | 401067 | 10368 | 52937481 |
| Joint stiffness | 24.87 | 9.84 | 130 | 401087 | 30153 | 52917696 |
| Pancytopenia | 24.82 | 9.84 | 876 | 400341 | 90052 | 52857797 |
| Vision blurred | 24.71 | 9.84 | 474 | 400743 | 85130 | 52862719 |
| Dysuria | 24.58 | 9.84 | 343 | 400874 | 30110 | 52917739 |
| Hepatitis acute | 24.46 | 9.84 | 132 | 401085 | 8784 | 52939065 |
| Blood pressure systolic increased | 24.40 | 9.84 | 386 | 400831 | 34791 | 52913058 |
| Brain contusion | 24.37 | 9.84 | 26 | 401191 | 565 | 52947284 |
| Premature rupture of membranes | 24.24 | 9.84 | 4 | 401213 | 4936 | 52942913 |
| Oesophagitis | 24.12 | 9.84 | 191 | 401026 | 14486 | 52933363 |
| Urosepsis | 24.01 | 9.84 | 210 | 401007 | 16400 | 52931449 |
| Diabetic nephropathy | 23.65 | 9.84 | 41 | 401176 | 1436 | 52946413 |
| Breath sounds abnormal | 23.60 | 9.84 | 126 | 401091 | 8351 | 52939498 |
| Pulmonary embolism | 23.45 | 9.84 | 1069 | 400148 | 113373 | 52834476 |
| Febrile infection | 23.34 | 9.84 | 38 | 401179 | 1263 | 52946586 |
| Colitis erosive | 23.31 | 9.84 | 12 | 401205 | 77 | 52947772 |
| Drug ineffective for unapproved indication | 23.17 | 9.84 | 79 | 401138 | 20641 | 52927208 |
| Somnolence | 23.14 | 9.84 | 1028 | 400189 | 166706 | 52781143 |
| Temperature regulation disorder | 23.13 | 9.84 | 77 | 401140 | 4130 | 52943719 |
| Injection site urticaria | 23 | 9.84 | 37 | 401180 | 12570 | 52935279 |
| Hyperkalaemia | 22.87 | 9.84 | 552 | 400665 | 53704 | 52894145 |
| Dysphoria | 22.81 | 9.84 | 6 | 401211 | 5343 | 52942506 |
| Underdose | 22.77 | 9.84 | 84 | 401133 | 21438 | 52926411 |
| Nephritis allergic | 22.43 | 9.84 | 15 | 401202 | 165 | 52947684 |
| Internal haemorrhage | 22.39 | 9.84 | 82 | 401135 | 4614 | 52943235 |
| Pancreatic steatosis | 22.35 | 9.84 | 34 | 401183 | 1065 | 52946784 |
| Coagulation test abnormal | 22.27 | 9.84 | 28 | 401189 | 730 | 52947119 |
| Device breakage | 22.27 | 9.84 | 28 | 401189 | 10539 | 52937310 |
| Disseminated intravascular coagulation | 22.18 | 9.84 | 75 | 401142 | 19644 | 52928205 |
| Panniculitis | 21.95 | 9.84 | 16 | 401201 | 7798 | 52940051 |
| Dyspnoea exertional | 21.82 | 9.84 | 555 | 400662 | 54445 | 52893404 |
| Hypertensive crisis | 21.81 | 9.84 | 185 | 401032 | 14321 | 52933528 |
| Colitis ulcerative | 21.60 | 9.84 | 248 | 400969 | 20813 | 52927036 |
| Synovial fluid analysis | 21.59 | 9.84 | 43 | 401174 | 1677 | 52946172 |
| Urinary tract infection enterococcal | 21.59 | 9.84 | 55 | 401162 | 2534 | 52945315 |
| Rapid eye movement sleep behaviour disorder | 21.55 | 9.84 | 15 | 401202 | 177 | 52947672 |
| Enthesopathy | 21.54 | 9.84 | 11 | 401206 | 6500 | 52941349 |
| Drug-induced liver injury | 21.51 | 9.84 | 324 | 400893 | 28909 | 52918940 |
| Hepatitis cholestatic | 21.48 | 9.84 | 108 | 401109 | 6991 | 52940858 |
| Syncope | 21.42 | 9.84 | 1039 | 400178 | 110954 | 52836895 |
| Peripheral arterial occlusive disease | 21.41 | 9.84 | 72 | 401145 | 3882 | 52943967 |
| Substance abuse | 21.26 | 9.84 | 4 | 401213 | 4490 | 52943359 |
| Myelosuppression | 21.26 | 9.84 | 40 | 401177 | 12788 | 52935061 |
| Haematotoxicity | 21.13 | 9.84 | 17 | 401200 | 7880 | 52939969 |
| Total lung capacity decreased | 20.91 | 9.84 | 38 | 401179 | 1382 | 52946467 |
| Pain in jaw | 20.91 | 9.84 | 200 | 401017 | 40469 | 52907380 |
| Urinary tract obstruction | 20.90 | 9.84 | 45 | 401172 | 1856 | 52945993 |
| Trimethylaminuria | 20.86 | 9.84 | 14 | 401203 | 155 | 52947694 |
| Treatment noncompliance | 20.80 | 9.84 | 154 | 401063 | 32881 | 52914968 |
| Thrombocytopenia | 20.77 | 9.84 | 1258 | 399959 | 137469 | 52810380 |
| Fracture | 20.69 | 9.84 | 217 | 401000 | 17802 | 52930047 |
| Hyperkinesia | 20.65 | 9.84 | 47 | 401170 | 2013 | 52945836 |
| Sopor | 20.61 | 9.84 | 246 | 400971 | 20838 | 52927011 |
| Subileus | 20.55 | 9.84 | 62 | 401155 | 3154 | 52944695 |
| Cardiac failure | 20.54 | 9.84 | 815 | 400402 | 85029 | 52862820 |
| Bursitis | 20.50 | 9.84 | 259 | 400958 | 22233 | 52925616 |
| Balance disorder | 20.32 | 9.84 | 408 | 400809 | 72799 | 52875050 |
| Somatic symptom disorder | 20.08 | 9.84 | 47 | 401170 | 2051 | 52945798 |
| Oesophageal dilatation | 20.07 | 9.84 | 19 | 401198 | 356 | 52947493 |
| Gastric haemorrhage | 20.03 | 9.84 | 96 | 401121 | 6095 | 52941754 |
| Headache | 20.00 | 9.84 | 3644 | 397573 | 533177 | 52414672 |
| Mydriasis | 19.96 | 9.84 | 34 | 401183 | 11292 | 52936557 |
| Sleep disorder | 19.94 | 9.84 | 582 | 400635 | 58288 | 52889561 |
| Poisoning | 19.76 | 9.84 | 47 | 401170 | 13803 | 52934046 |
| Haematocrit decreased | 19.61 | 9.84 | 392 | 400825 | 36939 | 52910910 |
| Neuropathy vitamin B12 deficiency | 19.49 | 9.84 | 5 | 401212 | 0 | 52947849 |
| Intermenstrual bleeding | 19.44 | 9.84 | 22 | 401195 | 8676 | 52939173 |
| Hepatitis B | 19.44 | 9.84 | 3 | 401214 | 3889 | 52943960 |
| Pharyngeal dystonia | 19.27 | 9.84 | 6 | 401211 | 6 | 52947843 |
| Shock | 19.19 | 9.84 | 99 | 401118 | 23040 | 52924809 |
| Rectal haemorrhage | 19.02 | 9.84 | 427 | 400790 | 41054 | 52906795 |
| Heavy menstrual bleeding | 18.92 | 9.84 | 67 | 401150 | 17309 | 52930540 |
| Cachexia | 18.88 | 9.84 | 83 | 401134 | 5081 | 52942768 |
| Diarrhoea | 18.83 | 9.84 | 5129 | 396088 | 620417 | 52327432 |
| Gastric ulcer | 18.77 | 9.84 | 263 | 400954 | 23106 | 52924743 |
| Prothrombin time shortened | 18.72 | 9.84 | 42 | 401175 | 1782 | 52946067 |
| Clostridium difficile infection | 18.57 | 9.84 | 304 | 400913 | 27589 | 52920260 |
| Spontaneous haemorrhage | 18.55 | 9.84 | 16 | 401201 | 264 | 52947585 |
| Cerebral ischaemia | 18.51 | 9.84 | 99 | 401118 | 6566 | 52941283 |
| Chronic gastritis | 18.41 | 9.84 | 51 | 401166 | 2471 | 52945378 |
| Prerenal failure | 18.33 | 9.84 | 39 | 401178 | 1595 | 52946254 |
| Therapeutic drug monitoring analysis incorrectly performed | 18.22 | 9.84 | 13 | 401204 | 160 | 52947689 |
| Spinal pain | 18.11 | 9.84 | 149 | 401068 | 11431 | 52936418 |
| Hepatic cyst | 18.04 | 9.84 | 80 | 401137 | 4916 | 52942933 |
| Medication error | 17.84 | 9.84 | 378 | 400839 | 35987 | 52911862 |
| Monoparesis | 17.83 | 9.84 | 38 | 401179 | 1556 | 52946293 |
| Complication associated with device | 17.83 | 9.84 | 62 | 401155 | 16103 | 52931746 |
| Wheelchair user | 17.78 | 9.84 | 7 | 401210 | 4819 | 52943030 |
| Low birth weight baby | 17.77 | 9.84 | 13 | 401204 | 6324 | 52941525 |
| Amenorrhoea | 17.47 | 9.84 | 27 | 401190 | 9322 | 52938527 |
| Gastritis erosive | 17.47 | 9.84 | 86 | 401131 | 5520 | 52942329 |
| Abdominal wall wound | 17.45 | 9.84 | 9 | 401208 | 58 | 52947791 |
| Vaginal haemorrhage | 17.44 | 9.84 | 124 | 401093 | 26717 | 52921132 |
| Hypotension | 17.43 | 9.84 | 2174 | 399043 | 251902 | 52695947 |
| Maternal drugs affecting foetus | 17.43 | 9.84 | 10 | 401207 | 5536 | 52942313 |
| Paresis | 17.42 | 9.84 | 47 | 401170 | 2242 | 52945607 |
| Musculoskeletal disorder | 17.42 | 9.84 | 70 | 401147 | 17429 | 52930420 |
| Tachyarrhythmia | 17.39 | 9.84 | 76 | 401141 | 4640 | 52943209 |
| Mixed liver injury | 17.36 | 9.84 | 67 | 401150 | 3866 | 52943983 |
| Tetany | 17.33 | 9.84 | 41 | 401176 | 1802 | 52946047 |
| Tenosynovitis stenosans | 17.18 | 9.84 | 47 | 401170 | 2261 | 52945588 |
| Reactive gastropathy | 17.13 | 9.84 | 19 | 401198 | 432 | 52947417 |
| Neuroleptic malignant syndrome | 17.04 | 9.84 | 41 | 401176 | 11992 | 52935857 |
| Pseudomembranous colitis | 17.01 | 9.84 | 59 | 401158 | 3232 | 52944617 |
| Hepatitis | 16.85 | 9.84 | 353 | 400864 | 33541 | 52914308 |
| Folate deficiency | 16.82 | 9.84 | 44 | 401173 | 2060 | 52945789 |
| Biliary dyskinesia | 16.55 | 9.84 | 52 | 401165 | 2705 | 52945144 |
| Pathogen resistance | 16.48 | 9.84 | 15 | 401202 | 6545 | 52941304 |
| Solar urticaria | 16.39 | 9.84 | 8 | 401209 | 45 | 52947804 |
| Haemarthrosis | 16.36 | 9.84 | 58 | 401159 | 3212 | 52944637 |
| Carcinoid tumour of the stomach | 16.34 | 9.84 | 12 | 401205 | 155 | 52947694 |
| Deafness | 16.29 | 9.84 | 70 | 401147 | 17106 | 52930743 |
| Fear of injection | 16.29 | 9.84 | 11 | 401206 | 5578 | 52942271 |
| Renal cyst | 16.12 | 9.84 | 125 | 401092 | 9420 | 52938429 |
| Nephropathy | 16.10 | 9.84 | 82 | 401135 | 5335 | 52942514 |
| Complication of device insertion | 16.04 | 9.84 | 13 | 401204 | 6004 | 52941845 |
| Sensory level abnormal | 16.02 | 9.84 | 12 | 401205 | 160 | 52947689 |
| Hepatic vein dilatation | 15.98 | 9.84 | 6 | 401211 | 15 | 52947834 |
| Joint injury | 15.92 | 9.84 | 99 | 401118 | 22001 | 52925848 |
| Agitation | 15.89 | 9.84 | 328 | 400889 | 58298 | 52889551 |
| Jaundice | 15.82 | 9.84 | 318 | 400899 | 29995 | 52917854 |
| Infective pulmonary exacerbation of cystic fibrosis | 15.81 | 9.84 | 38 | 401179 | 11118 | 52936731 |
| Hepatocellular injury | 15.79 | 9.84 | 315 | 400902 | 29671 | 52918178 |
| Serotonin syndrome | 15.73 | 9.84 | 125 | 401092 | 26281 | 52921568 |
| Renal impairment | 15.72 | 9.84 | 772 | 400445 | 82546 | 52865303 |
| Neutrophil function disorder | 15.71 | 9.84 | 6 | 401211 | 16 | 52947833 |
| Pseudarthrosis | 15.70 | 9.84 | 18 | 401199 | 425 | 52947424 |
| Strangury | 15.59 | 9.84 | 5 | 401212 | 6 | 52947843 |
| Flatulence | 15.59 | 9.84 | 328 | 400889 | 31189 | 52916660 |
| Arterial stenosis | 15.52 | 9.84 | 22 | 401195 | 646 | 52947203 |
| Helicobacter infection | 15.43 | 9.84 | 394 | 400823 | 38675 | 52909174 |
| Arterial occlusive disease | 15.41 | 9.84 | 77 | 401140 | 4972 | 52942877 |
| Injection site discolouration | 15.40 | 9.84 | 19 | 401198 | 7211 | 52940638 |
| Incorrect dosage administered | 15.35 | 9.84 | 39 | 401178 | 1794 | 52946055 |
| Pharyngitis | 15.29 | 9.84 | 82 | 401135 | 18898 | 52928951 |
| Iron deficiency anaemia | 15.29 | 9.84 | 210 | 401007 | 18370 | 52929479 |
| Occupational asthma | 15.25 | 9.84 | 11 | 401206 | 138 | 52947711 |
| Adenovirus infection | 15.23 | 9.84 | 3 | 401214 | 3259 | 52944590 |
| Nausea | 15.20 | 9.84 | 6104 | 395113 | 749987 | 52197862 |
| Patent ductus arteriosus | 15.12 | 9.84 | 6 | 401211 | 4112 | 52943737 |
| Bradycardia | 15.04 | 9.84 | 666 | 400551 | 70390 | 52877459 |
| Device malfunction | 14.99 | 9.84 | 65 | 401152 | 15843 | 52932006 |
| Deep vein thrombosis | 14.98 | 9.84 | 765 | 400452 | 82148 | 52865701 |
| Lipoedema | 14.95 | 9.84 | 13 | 401204 | 217 | 52947632 |
| Depressed level of consciousness | 14.91 | 9.84 | 304 | 400913 | 54124 | 52893725 |
| Nasopharyngitis | 14.86 | 9.84 | 1658 | 399559 | 190637 | 52757212 |
| Clostridium colitis | 14.78 | 9.84 | 40 | 401177 | 1912 | 52945937 |
| Pancreatitis | 14.76 | 9.84 | 453 | 400764 | 45689 | 52902160 |
| Atelectasis | 14.72 | 9.84 | 221 | 400996 | 19705 | 52928144 |
| Drug interaction | 14.69 | 9.84 | 1874 | 399343 | 217455 | 52730394 |
| Pneumonia aspiration | 14.68 | 9.84 | 176 | 401041 | 34125 | 52913724 |
| Poisoning deliberate | 14.59 | 9.84 | 27 | 401190 | 8686 | 52939163 |
| Gastrointestinal inflammation | 14.53 | 9.84 | 72 | 401145 | 4634 | 52943215 |
| Retroperitoneal haematoma | 14.44 | 9.84 | 51 | 401166 | 2819 | 52945030 |
| Post procedural pulmonary embolism | 14.29 | 9.84 | 14 | 401203 | 274 | 52947575 |
| Condition aggravated | 14.22 | 9.84 | 1988 | 399229 | 295146 | 52652703 |
| Pleural effusion | 14.15 | 9.84 | 808 | 400409 | 87771 | 52860078 |
| Nightmare | 14.13 | 9.84 | 77 | 401140 | 17674 | 52930175 |
| Salpingo-oophorectomy unilateral | 14.11 | 9.84 | 21 | 401196 | 645 | 52947204 |
| Toothache | 14.10 | 9.84 | 78 | 401139 | 17836 | 52930013 |
| Musculoskeletal pain | 14.03 | 9.84 | 696 | 400521 | 74504 | 52873345 |
| Device deployment issue | 14.02 | 9.84 | 5 | 401212 | 3659 | 52944190 |
| Liver injury | 14.02 | 9.84 | 239 | 400978 | 21864 | 52925985 |
| Dermatitis allergic | 14.01 | 9.84 | 160 | 401057 | 13408 | 52934441 |
| Rash | 14.00 | 9.84 | 3055 | 398162 | 443136 | 52504713 |
| Food aversion | 13.98 | 9.84 | 18 | 401199 | 481 | 52947368 |
| Complication of device removal | 13.93 | 9.84 | 7 | 401210 | 4175 | 52943674 |
| Hypochloraemia | 13.86 | 9.84 | 39 | 401178 | 1907 | 52945942 |
| Osteomyelitis | 13.85 | 9.84 | 116 | 401101 | 24119 | 52923730 |
| Mood swings | 13.84 | 9.84 | 76 | 401141 | 17410 | 52930439 |
| Swelling face | 13.73 | 9.84 | 326 | 400891 | 56842 | 52891007 |
| Pulmonary renal syndrome | 13.68 | 9.84 | 16 | 401201 | 386 | 52947463 |
| Metabolic surgery | 13.66 | 9.84 | 27 | 401190 | 1047 | 52946802 |
| Lactic acidosis | 13.64 | 9.84 | 372 | 400845 | 36881 | 52910968 |
| Joint swelling | 13.64 | 9.84 | 1988 | 399229 | 232650 | 52715199 |
| Intraocular pressure increased | 13.63 | 9.84 | 17 | 401200 | 6421 | 52941428 |
| Megacolon | 13.61 | 9.84 | 39 | 401178 | 1927 | 52945922 |
| Flank pain | 13.55 | 9.84 | 163 | 401054 | 13833 | 52934016 |
| Metastases to lung | 13.51 | 9.84 | 44 | 401173 | 11660 | 52936189 |
| Waist circumference increased | 13.48 | 9.84 | 23 | 401194 | 795 | 52947054 |
| Diverticulum intestinal | 13.46 | 9.84 | 90 | 401127 | 6467 | 52941382 |
| Hepatic enzyme abnormal | 13.46 | 9.84 | 74 | 401143 | 4960 | 52942889 |
| Transaminases increased | 13.44 | 9.84 | 309 | 400908 | 29823 | 52918026 |
| Anuria | 13.44 | 9.84 | 148 | 401069 | 12292 | 52935557 |
| Lethargy | 13.35 | 9.84 | 305 | 400912 | 53455 | 52894394 |
| Epstein-Barr virus infection | 13.32 | 9.84 | 22 | 401195 | 7396 | 52940453 |
| Surgery | 13.30 | 9.84 | 165 | 401052 | 31799 | 52916050 |
| Acute graft versus host disease | 13.26 | 9.84 | 8 | 401209 | 4309 | 52943540 |
| Hyperplastic cholecystopathy | 13.24 | 9.84 | 9 | 401208 | 102 | 52947747 |
| Cushingoid | 13.23 | 9.84 | 96 | 401121 | 7086 | 52940763 |
| Tuberculosis | 13.22 | 9.84 | 41 | 401176 | 11030 | 52936819 |
| Rapid correction of hyponatraemia | 13.13 | 9.84 | 10 | 401207 | 137 | 52947712 |
| Injection site mass | 13.09 | 9.84 | 70 | 401147 | 16144 | 52931705 |
| Hypergastrinaemia | 13.09 | 9.84 | 9 | 401208 | 104 | 52947745 |
| Sacroiliitis | 13.08 | 9.84 | 45 | 401172 | 2455 | 52945394 |
| Gastrointestinal toxicity | 13.06 | 9.84 | 10 | 401207 | 4752 | 52943097 |
| Bicytopenia | 12.95 | 9.84 | 40 | 401177 | 2061 | 52945788 |
| Carotid arteriosclerosis | 12.93 | 9.84 | 26 | 401191 | 1021 | 52946828 |
| Blood pressure diastolic abnormal | 12.87 | 9.84 | 111 | 401106 | 8634 | 52939215 |
| Abnormal dreams | 12.84 | 9.84 | 39 | 401178 | 10562 | 52937287 |
| Red blood cell sedimentation rate increased | 12.77 | 9.84 | 142 | 401075 | 27915 | 52919934 |
| Presyncope | 12.76 | 9.84 | 272 | 400945 | 25922 | 52921927 |
| Synovitis | 12.75 | 9.84 | 672 | 400545 | 107221 | 52840628 |
| Cerebellar ataxia | 12.75 | 9.84 | 24 | 401193 | 897 | 52946952 |
| Lung opacity | 12.72 | 9.84 | 38 | 401179 | 1923 | 52945926 |
| Therapeutic reaction time decreased | 12.70 | 9.84 | 30 | 401187 | 1317 | 52946532 |
| Gastric polyps | 12.62 | 9.84 | 45 | 401172 | 2499 | 52945350 |
| Vertigo | 12.62 | 9.84 | 529 | 400688 | 55552 | 52892297 |
| Lung diffusion test abnormal | 12.60 | 9.84 | 8 | 401209 | 80 | 52947769 |
| Dysphagia | 12.56 | 9.84 | 765 | 400452 | 83632 | 52864217 |
| Neurotoxicity | 12.54 | 9.84 | 66 | 401151 | 15283 | 52932566 |
| Productive cough | 12.51 | 9.84 | 534 | 400683 | 56195 | 52891654 |
| Application site pain | 12.51 | 9.84 | 8 | 401209 | 4175 | 52943674 |
| Hypomania | 12.46 | 9.84 | 11 | 401206 | 4871 | 52942978 |
| Pulmonary tuberculosis | 12.45 | 9.84 | 11 | 401206 | 4870 | 52942979 |
| Product administered to patient of inappropriate age | 12.45 | 9.84 | 3 | 401214 | 2833 | 52945016 |
| Oedema peripheral | 12.44 | 9.84 | 1467 | 399750 | 169320 | 52778529 |
| Multiple sclerosis relapse | 12.44 | 9.84 | 250 | 400967 | 44603 | 52903246 |
| Renal haemangioma | 12.40 | 9.84 | 6 | 401211 | 33 | 52947816 |
| Intestinal haemorrhage | 12.35 | 9.84 | 55 | 401162 | 3385 | 52944464 |
| Type I hypersensitivity | 12.34 | 9.84 | 46 | 401171 | 2611 | 52945238 |
| Vitamin B12 decreased | 12.31 | 9.84 | 51 | 401166 | 3041 | 52944808 |
| Therapy partial responder | 12.30 | 9.84 | 17 | 401200 | 6146 | 52941703 |
| Skin disorder | 12.30 | 9.84 | 124 | 401093 | 24834 | 52923015 |
| Respiratory depression | 12.26 | 9.84 | 52 | 401165 | 12754 | 52935095 |
| Feeling jittery | 12.26 | 9.84 | 142 | 401075 | 11941 | 52935908 |
| Basal cell carcinoma | 12.24 | 9.84 | 115 | 401102 | 23354 | 52924495 |
| Ear infection | 12.22 | 9.84 | 130 | 401087 | 25770 | 52922079 |
| Product complaint | 12.22 | 9.84 | 49 | 401168 | 12208 | 52935641 |
| Eosinophils urine present | 12.21 | 9.84 | 5 | 401212 | 17 | 52947832 |
| Aortic valve stenosis | 12.13 | 9.84 | 53 | 401164 | 3235 | 52944614 |
| Smear cervix abnormal | 12.12 | 9.84 | 3 | 401214 | 2783 | 52945066 |
| Spigelian hernia | 12.12 | 9.84 | 6 | 401211 | 35 | 52947814 |
| Thrombosis | 12.04 | 9.84 | 566 | 400651 | 60227 | 52887622 |
| Haemoptysis | 12.04 | 9.84 | 286 | 400931 | 27753 | 52920096 |
| Status epilepticus | 12.01 | 9.84 | 66 | 401151 | 15118 | 52932731 |
| Blood iron abnormal | 11.97 | 9.84 | 5 | 401212 | 3322 | 52944527 |
| Inappropriate antidiuretic hormone secretion | 11.90 | 9.84 | 168 | 401049 | 14783 | 52933066 |
| Acquired diaphragmatic eventration | 11.87 | 9.84 | 14 | 401203 | 341 | 52947508 |
| Oesophageal candidiasis | 11.85 | 9.84 | 76 | 401141 | 5384 | 52942465 |
| Bacterial test | 11.83 | 9.84 | 28 | 401189 | 1231 | 52946618 |
| Enterochromaffin cell hyperplasia | 11.83 | 9.84 | 7 | 401210 | 61 | 52947788 |
| Skin test positive | 11.82 | 9.84 | 21 | 401196 | 750 | 52947099 |
| Juvenile idiopathic arthritis | 11.78 | 9.84 | 10 | 401207 | 4514 | 52943335 |
| Laboratory test abnormal | 11.73 | 9.84 | 122 | 401095 | 24287 | 52923562 |
| Myocardial infarction | 11.71 | 9.84 | 619 | 400598 | 98735 | 52849114 |
| Disorientation | 11.70 | 9.84 | 383 | 400834 | 38976 | 52908873 |
| Automatism epileptic | 11.69 | 9.84 | 3 | 401214 | 0 | 52947849 |
| Speech rehabilitation | 11.69 | 9.84 | 3 | 401214 | 0 | 52947849 |
| Low density lipoprotein | 11.69 | 9.84 | 3 | 401214 | 0 | 52947849 |
| Demyelination | 11.62 | 9.84 | 18 | 401199 | 6209 | 52941640 |
| Neck pain | 11.61 | 9.84 | 353 | 400864 | 59663 | 52888186 |
| Tooth disorder | 11.56 | 9.84 | 128 | 401089 | 25184 | 52922665 |
| Neutropenia | 11.55 | 9.84 | 1035 | 400182 | 158150 | 52789699 |
| Cholangitis acute | 11.54 | 9.84 | 16 | 401201 | 460 | 52947389 |
| Breast discomfort | 11.54 | 9.84 | 16 | 401201 | 460 | 52947389 |
| Akathisia | 11.52 | 9.84 | 30 | 401187 | 8541 | 52939308 |
| Rash pruritic | 11.51 | 9.84 | 287 | 400930 | 49723 | 52898126 |
| Lymphoproliferative disorder | 11.47 | 9.84 | 4 | 401213 | 2968 | 52944881 |
| Squamous cell carcinoma of the oral cavity | 11.43 | 9.84 | 13 | 401204 | 304 | 52947545 |
| Wound treatment | 11.41 | 9.84 | 11 | 401206 | 211 | 52947638 |
| Cytomegalovirus infection | 11.41 | 9.84 | 93 | 401124 | 19446 | 52928403 |
| Hypertransaminasaemia | 11.39 | 9.84 | 60 | 401157 | 3956 | 52943893 |
| Coeliac disease | 11.39 | 9.84 | 108 | 401109 | 8627 | 52939222 |
| Myeloblast percentage decreased | 11.34 | 9.84 | 6 | 401211 | 41 | 52947808 |
| Wound infection fungal | 11.31 | 9.84 | 9 | 401208 | 132 | 52947717 |
| Rib deformity | 11.30 | 9.84 | 10 | 401207 | 171 | 52947678 |
| Abdominal distension | 11.28 | 9.84 | 720 | 400497 | 79070 | 52868779 |
| Enteritis | 11.21 | 9.84 | 95 | 401122 | 7351 | 52940498 |
| Nasal obstruction | 11.20 | 9.84 | 25 | 401192 | 1057 | 52946792 |
| Glomerulonephritis chronic | 11.16 | 9.84 | 10 | 401207 | 174 | 52947675 |
| Arterial haemorrhage | 11.13 | 9.84 | 34 | 401183 | 1742 | 52946107 |
| Natural killer cell count decreased | 11.11 | 9.84 | 6 | 401211 | 43 | 52947806 |
| Anal polyp | 11.11 | 9.84 | 6 | 401211 | 43 | 52947806 |
| Injection site induration | 11.11 | 9.84 | 31 | 401186 | 8627 | 52939222 |
| Epigastric discomfort | 11.08 | 9.84 | 82 | 401135 | 6091 | 52941758 |
| Vascular stent stenosis | 11.07 | 9.84 | 17 | 401200 | 537 | 52947312 |
| Duodenal polyp | 10.98 | 9.84 | 8 | 401209 | 102 | 52947747 |
| Pneumocystis jirovecii pneumonia | 10.97 | 9.84 | 75 | 401142 | 16303 | 52931546 |
| Iron deficiency | 10.92 | 9.84 | 83 | 401134 | 6217 | 52941632 |
| Gait deviation | 10.86 | 9.84 | 7 | 401210 | 72 | 52947777 |
| Blood creatinine increased | 10.80 | 9.84 | 741 | 400476 | 81921 | 52865928 |
| Spontaneous haematoma | 10.77 | 9.84 | 21 | 401196 | 806 | 52947043 |
| Hyperchlorhydria | 10.77 | 9.84 | 32 | 401185 | 1614 | 52946235 |
| Hypophysitis | 10.76 | 9.84 | 32 | 401185 | 1615 | 52946234 |
| Cytomegalovirus viraemia | 10.75 | 9.84 | 13 | 401204 | 4978 | 52942871 |
| Skin necrosis | 10.71 | 9.84 | 42 | 401175 | 10530 | 52937319 |
| Incorrect dose administered | 10.68 | 9.84 | 297 | 400920 | 50748 | 52897101 |
| Administration site discomfort | 10.66 | 9.84 | 8 | 401209 | 107 | 52947742 |
| Genital herpes simplex | 10.62 | 9.84 | 10 | 401207 | 186 | 52947663 |
| Norovirus infection | 10.55 | 9.84 | 7 | 401210 | 76 | 52947773 |
| Femoral hernia incarcerated | 10.50 | 9.84 | 22 | 401195 | 890 | 52946959 |
| Autoimmune nephritis | 10.48 | 9.84 | 13 | 401204 | 334 | 52947515 |
| White blood cell count abnormal | 10.47 | 9.84 | 15 | 401202 | 5343 | 52942506 |
| Adrenocortical insufficiency acute | 10.46 | 9.84 | 30 | 401187 | 1483 | 52946366 |
| Sexual dysfunction | 10.45 | 9.84 | 6 | 401211 | 3320 | 52944529 |
| Migraine | 10.44 | 9.84 | 496 | 400721 | 79921 | 52867928 |
| Metastases to bone | 10.39 | 9.84 | 94 | 401123 | 19234 | 52928615 |
| Tricuspid valve incompetence | 10.38 | 9.84 | 159 | 401058 | 14237 | 52933612 |
| Duodenal ulcer perforation | 10.36 | 9.84 | 342 | 400875 | 34841 | 52913008 |
| Injection site irritation | 10.34 | 9.84 | 11 | 401206 | 4461 | 52943388 |
| Ureteric stenosis | 10.31 | 9.84 | 18 | 401199 | 634 | 52947215 |
| Conjunctivitis | 10.30 | 9.84 | 183 | 401034 | 16874 | 52930975 |
| Incorrect product administration duration | 10.26 | 9.84 | 43 | 401174 | 10581 | 52937268 |
| C-reactive protein increased | 10.22 | 9.84 | 616 | 400601 | 67270 | 52880579 |
| Neurofibrosarcoma | 10.22 | 9.84 | 9 | 401208 | 153 | 52947696 |
| Faecal calprotectin increased | 10.21 | 9.84 | 37 | 401180 | 2071 | 52945778 |
| Anal haemorrhage | 10.19 | 9.84 | 32 | 401185 | 1664 | 52946185 |
| Premature labour | 10.19 | 9.84 | 53 | 401164 | 12309 | 52935540 |
| Grunting | 10.17 | 9.84 | 11 | 401206 | 243 | 52947606 |
| Microgenia | 10.14 | 9.84 | 4 | 401213 | 12 | 52947837 |
| Lung adenocarcinoma stage III | 10.14 | 9.84 | 4 | 401213 | 12 | 52947837 |
| Amnesia | 10.13 | 9.84 | 261 | 400956 | 45027 | 52902822 |
| Hepatic steatosis | 10.13 | 9.84 | 264 | 400953 | 25995 | 52921854 |
| Unevaluable event | 10.10 | 9.84 | 289 | 400928 | 49209 | 52898640 |
| White matter lesion | 10.09 | 9.84 | 31 | 401186 | 1593 | 52946256 |
| Cholecystitis | 10.09 | 9.84 | 166 | 401051 | 15080 | 52932769 |
| Maternal exposure before pregnancy | 10.08 | 9.84 | 17 | 401200 | 5669 | 52942180 |
| Psychomotor retardation | 10.08 | 9.84 | 54 | 401163 | 3584 | 52944265 |
| Tongue disorder | 10.06 | 9.84 | 34 | 401183 | 8907 | 52938942 |
| Rhabdomyolysis | 10.04 | 9.84 | 415 | 400802 | 43508 | 52904341 |
| Neurosensory hypoacusis | 10.02 | 9.84 | 12 | 401205 | 297 | 52947552 |
| Glomerular filtration rate decreased | 9.98 | 9.84 | 143 | 401074 | 12624 | 52935225 |
| Multiple sclerosis | 9.91 | 9.84 | 144 | 401073 | 27009 | 52920840 |
| Iliac artery occlusion | 9.89 | 9.84 | 9 | 401208 | 160 | 52947689 |
| Dyskinesia | 9.89 | 9.84 | 174 | 401043 | 31659 | 52916190 |
| Erysipelas | 9.88 | 9.84 | 91 | 401126 | 7210 | 52940639 |
| Lipase increased | 9.87 | 9.84 | 111 | 401106 | 9267 | 52938582 |
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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 837.80 | 10.83 | 2389 | 253165 | 112870 | 32145102 |
| Toxicity to various agents | 408.52 | 10.83 | 479 | 255075 | 177562 | 32080410 |
| Drug ineffective | 405.42 | 10.83 | 1599 | 253955 | 381878 | 31876094 |
| Completed suicide | 360.51 | 10.83 | 138 | 255416 | 92379 | 32165593 |
| Chronic kidney disease | 298.81 | 10.83 | 838 | 254716 | 39137 | 32218835 |
| Hypomagnesaemia | 246.50 | 10.83 | 491 | 255063 | 18314 | 32239658 |
| Drug abuse | 216.75 | 10.83 | 187 | 255367 | 80056 | 32177916 |
| Product prescribing error | 204.40 | 10.83 | 468 | 255086 | 19249 | 32238723 |
| Haematochezia | 187.73 | 10.83 | 706 | 254848 | 38502 | 32219470 |
| Anaemia | 175.06 | 10.83 | 2595 | 252959 | 221029 | 32036943 |
| Death | 146.37 | 10.83 | 2123 | 253431 | 380394 | 31877578 |
| Systemic infection | 138.43 | 10.83 | 124 | 255430 | 2059 | 32255913 |
| Hypocalcaemia | 128.15 | 10.83 | 436 | 255118 | 22618 | 32235354 |
| End stage renal disease | 127.86 | 10.83 | 228 | 255326 | 7809 | 32250163 |
| Foetal exposure during pregnancy | 121.86 | 10.83 | 88 | 255466 | 41213 | 32216759 |
| Hepatic function abnormal | 114.47 | 10.83 | 110 | 255444 | 44730 | 32213242 |
| Product monitoring error | 84.88 | 10.83 | 103 | 255451 | 2471 | 32255501 |
| Acute kidney injury | 84.45 | 10.83 | 2955 | 252599 | 290513 | 31967459 |
| Renal injury | 83.50 | 10.83 | 246 | 255308 | 11809 | 32246163 |
| Cholestasis | 82.20 | 10.83 | 425 | 255129 | 26608 | 32231364 |
| Electrolyte imbalance | 80.38 | 10.83 | 248 | 255306 | 12214 | 32245758 |
| Intentional overdose | 75.32 | 10.83 | 132 | 255422 | 41469 | 32216503 |
| Dyspnoea | 73.22 | 10.83 | 3511 | 252043 | 358534 | 31899438 |
| Overdose | 72.46 | 10.83 | 395 | 255159 | 86682 | 32171290 |
| Melaena | 71.32 | 10.83 | 492 | 255062 | 34173 | 32223799 |
| Hypokalaemia | 70.81 | 10.83 | 703 | 254851 | 54391 | 32203581 |
| Syncope | 69.90 | 10.83 | 1045 | 254509 | 89079 | 32168893 |
| Off label use | 68.75 | 10.83 | 1858 | 253696 | 304462 | 31953510 |
| Intentional product misuse | 65.62 | 10.83 | 114 | 255440 | 35937 | 32222035 |
| Drug resistance | 65.08 | 10.83 | 51 | 255503 | 22914 | 32235058 |
| Haematemesis | 63.36 | 10.83 | 403 | 255151 | 27232 | 32230740 |
| Neuropathy peripheral | 62.51 | 10.83 | 352 | 255202 | 76630 | 32181342 |
| Blood loss anaemia | 61.49 | 10.83 | 169 | 255385 | 7793 | 32250179 |
| Abdominal pain lower | 61.06 | 10.83 | 189 | 255365 | 9324 | 32248648 |
| Treatment failure | 60.78 | 10.83 | 136 | 255418 | 39027 | 32218945 |
| Respiratory arrest | 60.67 | 10.83 | 83 | 255471 | 28825 | 32229147 |
| Abdominal pain upper | 59.90 | 10.83 | 800 | 254754 | 66538 | 32191434 |
| Abdominal pain | 59.63 | 10.83 | 1568 | 253986 | 147961 | 32110011 |
| Erysipelas | 58.08 | 10.83 | 123 | 255431 | 4793 | 32253179 |
| Cardiac arrest | 57.09 | 10.83 | 486 | 255068 | 96290 | 32161682 |
| Agranulocytosis | 56.09 | 10.83 | 346 | 255208 | 23131 | 32234841 |
| Gastrointestinal haemorrhage | 54.90 | 10.83 | 974 | 254580 | 85908 | 32172064 |
| Product dose omission issue | 53.21 | 10.83 | 532 | 255022 | 102043 | 32155929 |
| Irritability | 51.52 | 10.83 | 71 | 255483 | 24583 | 32233389 |
| Normocytic anaemia | 50.80 | 10.83 | 73 | 255481 | 2074 | 32255898 |
| Oedema peripheral | 50.06 | 10.83 | 1212 | 254342 | 112879 | 32145093 |
| Acute abdomen | 49.11 | 10.83 | 69 | 255485 | 1919 | 32256053 |
| Abnormal behaviour | 47.88 | 10.83 | 84 | 255470 | 26382 | 32231590 |
| Hepatitis cholestatic | 47.86 | 10.83 | 158 | 255396 | 8067 | 32249905 |
| Cardio-respiratory arrest | 46.54 | 10.83 | 254 | 255300 | 55735 | 32202237 |
| Febrile infection | 45.88 | 10.83 | 71 | 255483 | 2158 | 32255814 |
| Premature baby | 45.44 | 10.83 | 47 | 255507 | 18471 | 32239501 |
| Pallor | 44.28 | 10.83 | 320 | 255234 | 22561 | 32235411 |
| Type I hypersensitivity | 44.04 | 10.83 | 50 | 255504 | 1115 | 32256857 |
| Lower respiratory tract infection | 42.62 | 10.83 | 105 | 255449 | 29138 | 32228834 |
| Hypoparathyroidism secondary | 42.60 | 10.83 | 21 | 255533 | 115 | 32257857 |
| Labelled drug-drug interaction medication error | 41.87 | 10.83 | 201 | 255353 | 12212 | 32245760 |
| Drug withdrawal syndrome | 41.54 | 10.83 | 59 | 255495 | 20172 | 32237800 |
| Immune reconstitution inflammatory syndrome | 41.13 | 10.83 | 12 | 255542 | 9547 | 32248425 |
| Feeling abnormal | 40.96 | 10.83 | 292 | 255262 | 60131 | 32197841 |
| Gastrointestinal bacterial overgrowth | 40.40 | 10.83 | 18 | 255536 | 75 | 32257897 |
| Rectal haemorrhage | 39.89 | 10.83 | 460 | 255094 | 36963 | 32221009 |
| Infective exacerbation of chronic obstructive airways disease | 39.56 | 10.83 | 60 | 255494 | 1791 | 32256181 |
| Musculoskeletal pain | 39.51 | 10.83 | 404 | 255150 | 31493 | 32226479 |
| Insomnia | 39.49 | 10.83 | 553 | 255001 | 99795 | 32158177 |
| Gastrooesophageal reflux disease | 39.30 | 10.83 | 432 | 255122 | 34306 | 32223666 |
| Therapeutic drug monitoring analysis not performed | 38.65 | 10.83 | 32 | 255522 | 475 | 32257497 |
| Neutrophil count decreased | 38.00 | 10.83 | 216 | 255338 | 46923 | 32211049 |
| Subileus | 37.72 | 10.83 | 81 | 255473 | 3187 | 32254785 |
| Dyspnoea exertional | 37.63 | 10.83 | 470 | 255084 | 38491 | 32219481 |
| Leukopenia | 37.60 | 10.83 | 673 | 254881 | 59449 | 32198523 |
| Hypoparathyroidism | 37.45 | 10.83 | 31 | 255523 | 460 | 32257512 |
| Pathogen resistance | 37.30 | 10.83 | 14 | 255540 | 9496 | 32248476 |
| Platelet count decreased | 37.17 | 10.83 | 655 | 254899 | 113936 | 32144036 |
| Malaise | 37.16 | 10.83 | 1084 | 254470 | 176054 | 32081918 |
| Gastritis | 37.04 | 10.83 | 296 | 255258 | 21531 | 32236441 |
| C-reactive protein increased | 36.57 | 10.83 | 556 | 254998 | 47546 | 32210426 |
| Shock haemorrhagic | 36.36 | 10.83 | 173 | 255381 | 10472 | 32247500 |
| Therapeutic product effect incomplete | 36.34 | 10.83 | 184 | 255370 | 41157 | 32216815 |
| Atrial fibrillation | 35.62 | 10.83 | 1184 | 254370 | 115520 | 32142452 |
| Suicidal ideation | 35.50 | 10.83 | 166 | 255388 | 37917 | 32220055 |
| Drug hypersensitivity | 35.47 | 10.83 | 387 | 255167 | 73013 | 32184959 |
| Haematoma | 35.07 | 10.83 | 332 | 255222 | 25352 | 32232620 |
| Stomatitis | 34.82 | 10.83 | 180 | 255374 | 40049 | 32217923 |
| Asthenia | 34.31 | 10.83 | 2221 | 253333 | 233723 | 32024249 |
| Psychotic disorder | 34.06 | 10.83 | 82 | 255472 | 22938 | 32235034 |
| Mucosal haemorrhage | 34.05 | 10.83 | 52 | 255502 | 1562 | 32256410 |
| Cytomegalovirus infection | 32.91 | 10.83 | 97 | 255457 | 25367 | 32232605 |
| Visual acuity reduced | 32.74 | 10.83 | 49 | 255505 | 16396 | 32241576 |
| Agitation | 32.59 | 10.83 | 290 | 255264 | 56946 | 32201026 |
| Tachyarrhythmia | 32.29 | 10.83 | 78 | 255476 | 3321 | 32254651 |
| Hypertensive nephropathy | 31.35 | 10.83 | 28 | 255526 | 463 | 32257509 |
| Rash | 31.28 | 10.83 | 1336 | 254218 | 207997 | 32049975 |
| Product use in unapproved indication | 31.04 | 10.83 | 490 | 255064 | 86714 | 32171258 |
| Diastolic dysfunction | 30.98 | 10.83 | 101 | 255453 | 5123 | 32252849 |
| Seizure | 30.76 | 10.83 | 603 | 254951 | 103251 | 32154721 |
| Suicide attempt | 30.42 | 10.83 | 176 | 255378 | 38068 | 32219904 |
| Cardiac failure | 29.76 | 10.83 | 937 | 254617 | 90736 | 32167236 |
| Dyspnoea at rest | 29.71 | 10.83 | 75 | 255479 | 3284 | 32254688 |
| Serum ferritin decreased | 29.51 | 10.83 | 29 | 255525 | 544 | 32257428 |
| Exposure during pregnancy | 29.46 | 10.83 | 18 | 255536 | 9211 | 32248761 |
| Interstitial lung disease | 28.95 | 10.83 | 349 | 255205 | 64652 | 32193320 |
| Aggression | 28.35 | 10.83 | 187 | 255367 | 39202 | 32218770 |
| Hyperlipasaemia | 28.34 | 10.83 | 28 | 255526 | 529 | 32257443 |
| Sedation | 28.20 | 10.83 | 65 | 255489 | 18461 | 32239511 |
| Low birth weight baby | 27.93 | 10.83 | 10 | 255544 | 6984 | 32250988 |
| Liver disorder | 27.75 | 10.83 | 141 | 255413 | 31513 | 32226459 |
| Fracture | 27.69 | 10.83 | 115 | 255439 | 6564 | 32251408 |
| Wrong technique in product usage process | 27.53 | 10.83 | 162 | 255392 | 34897 | 32223075 |
| Injection site pain | 27.45 | 10.83 | 150 | 255404 | 32908 | 32225064 |
| Polyneuropathy | 27.43 | 10.83 | 188 | 255366 | 13027 | 32244945 |
| Synovitis | 27.39 | 10.83 | 27 | 255527 | 10851 | 32247121 |
| Troponin increased | 27.29 | 10.83 | 152 | 255402 | 9790 | 32248182 |
| Haematoma muscle | 27.27 | 10.83 | 37 | 255517 | 995 | 32256977 |
| Upper gastrointestinal haemorrhage | 26.24 | 10.83 | 295 | 255259 | 23554 | 32234418 |
| Drug ineffective for unapproved indication | 26.22 | 10.83 | 43 | 255511 | 13869 | 32244103 |
| Tetanus | 26.21 | 10.83 | 12 | 255542 | 54 | 32257918 |
| Angina pectoris | 26.15 | 10.83 | 369 | 255185 | 31057 | 32226915 |
| Vertigo | 25.66 | 10.83 | 298 | 255256 | 23985 | 32233987 |
| Acute graft versus host disease | 25.63 | 10.83 | 9 | 255545 | 6361 | 32251611 |
| Tricuspid valve incompetence | 25.50 | 10.83 | 142 | 255412 | 9145 | 32248827 |
| Cerebral infarction | 25.36 | 10.83 | 121 | 255433 | 27493 | 32230479 |
| Psoriasis | 25.25 | 10.83 | 236 | 255318 | 45887 | 32212085 |
| Intentional self-injury | 25.24 | 10.83 | 44 | 255510 | 13856 | 32244116 |
| Accidental overdose | 24.75 | 10.83 | 74 | 255480 | 19265 | 32238707 |
| Chronic graft versus host disease | 24.54 | 10.83 | 3 | 255551 | 4437 | 32253535 |
| Depression | 24.54 | 10.83 | 578 | 254976 | 96482 | 32161490 |
| Fear of disease | 24.52 | 10.83 | 19 | 255535 | 255 | 32257717 |
| Osteochondrosis | 24.43 | 10.83 | 32 | 255522 | 831 | 32257141 |
| Serotonin syndrome | 23.86 | 10.83 | 74 | 255480 | 19043 | 32238929 |
| Arrhythmia | 23.80 | 10.83 | 400 | 255154 | 34903 | 32223069 |
| Occupational dermatitis | 23.74 | 10.83 | 12 | 255542 | 70 | 32257902 |
| Lower gastrointestinal haemorrhage | 23.67 | 10.83 | 134 | 255420 | 8683 | 32249289 |
| Gastritis erosive | 23.61 | 10.83 | 102 | 255452 | 5925 | 32252047 |
| Nephrogenic anaemia | 23.60 | 10.83 | 54 | 255500 | 2219 | 32255753 |
| Dysplastic naevus | 23.35 | 10.83 | 22 | 255532 | 391 | 32257581 |
| Hyponatraemia | 23.24 | 10.83 | 758 | 254796 | 73755 | 32184217 |
| Rebound acid hypersecretion | 23.21 | 10.83 | 13 | 255541 | 96 | 32257876 |
| Vitamin B12 deficiency | 22.84 | 10.83 | 64 | 255490 | 2985 | 32254987 |
| Disease progression | 22.59 | 10.83 | 515 | 255039 | 86347 | 32171625 |
| Hydrocholecystis | 22.49 | 10.83 | 18 | 255536 | 254 | 32257718 |
| Colitis microscopic | 22.43 | 10.83 | 48 | 255506 | 1884 | 32256088 |
| Therapeutic response decreased | 22.41 | 10.83 | 116 | 255438 | 25804 | 32232168 |
| Urticaria | 22.21 | 10.83 | 332 | 255222 | 59282 | 32198690 |
| Bradyarrhythmia | 22.17 | 10.83 | 51 | 255503 | 2103 | 32255869 |
| Solar lentigo | 22.12 | 10.83 | 22 | 255532 | 419 | 32257553 |
| Abnormal dreams | 21.86 | 10.83 | 21 | 255533 | 8543 | 32249429 |
| Degenerative mitral valve disease | 21.83 | 10.83 | 17 | 255537 | 230 | 32257742 |
| Cardiac failure congestive | 21.81 | 10.83 | 504 | 255050 | 84348 | 32173624 |
| Hiatus hernia | 21.80 | 10.83 | 118 | 255436 | 7518 | 32250454 |
| Hypersensitivity | 21.75 | 10.83 | 321 | 255233 | 57437 | 32200535 |
| Thrombocytopenia | 21.69 | 10.83 | 1397 | 254157 | 146902 | 32111070 |
| Dizziness | 21.67 | 10.83 | 1921 | 253633 | 207697 | 32050275 |
| Cerebellar ischaemia | 21.65 | 10.83 | 13 | 255541 | 111 | 32257861 |
| Gamma-glutamyltransferase increased | 21.57 | 10.83 | 351 | 255203 | 30431 | 32227541 |
| Product use issue | 21.40 | 10.83 | 289 | 255265 | 52488 | 32205484 |
| Headache | 21.07 | 10.83 | 1295 | 254259 | 194902 | 32063070 |
| Rheumatoid arthritis | 21.05 | 10.83 | 236 | 255318 | 44308 | 32213664 |
| Peritoneal dialysis complication | 21.04 | 10.83 | 4 | 255550 | 4264 | 32253708 |
| Hepatocellular injury | 20.95 | 10.83 | 297 | 255257 | 25021 | 32232951 |
| Drug dependence | 20.93 | 10.83 | 104 | 255450 | 23380 | 32234592 |
| Anaphylactic reaction | 20.83 | 10.83 | 145 | 255409 | 30027 | 32227945 |
| Lactic acidosis | 20.81 | 10.83 | 375 | 255179 | 33161 | 32224811 |
| Accidental exposure to product | 20.76 | 10.83 | 35 | 255519 | 11167 | 32246805 |
| No adverse event | 20.76 | 10.83 | 84 | 255470 | 19969 | 32238003 |
| Tetany | 20.75 | 10.83 | 28 | 255526 | 749 | 32257223 |
| Post transplant lymphoproliferative disorder | 20.63 | 10.83 | 10 | 255544 | 5824 | 32252148 |
| Memory impairment | 20.53 | 10.83 | 211 | 255343 | 40268 | 32217704 |
| Injection site haemorrhage | 20.52 | 10.83 | 22 | 255532 | 8506 | 32249466 |
| Aortic valve stenosis | 20.50 | 10.83 | 50 | 255504 | 2142 | 32255830 |
| Anxiety | 20.47 | 10.83 | 586 | 254968 | 95419 | 32162553 |
| Injection site erythema | 20.34 | 10.83 | 54 | 255500 | 14614 | 32243358 |
| Microcytic anaemia | 20.25 | 10.83 | 50 | 255504 | 2159 | 32255813 |
| Nightmare | 20.20 | 10.83 | 46 | 255508 | 13120 | 32244852 |
| Nicotine dependence | 20.18 | 10.83 | 23 | 255531 | 515 | 32257457 |
| Body temperature decreased | 20.14 | 10.83 | 152 | 255402 | 10862 | 32247110 |
| Drug eruption | 20.02 | 10.83 | 80 | 255474 | 19086 | 32238886 |
| Multiple-drug resistance | 19.80 | 10.83 | 3 | 255551 | 3772 | 32254200 |
| Therapy partial responder | 19.77 | 10.83 | 7 | 255547 | 4923 | 32253049 |
| Drug reaction with eosinophilia and systemic symptoms | 19.72 | 10.83 | 362 | 255192 | 32123 | 32225849 |
| Mood swings | 19.72 | 10.83 | 21 | 255533 | 8144 | 32249828 |
| Withdrawal syndrome | 19.71 | 10.83 | 41 | 255513 | 12081 | 32245891 |
| Mitral valve incompetence | 19.69 | 10.83 | 191 | 255363 | 14680 | 32243292 |
| Adverse event | 19.69 | 10.83 | 65 | 255489 | 16407 | 32241565 |
| Photodermatosis | 19.68 | 10.83 | 22 | 255532 | 482 | 32257490 |
| Paresis | 19.63 | 10.83 | 47 | 255507 | 1990 | 32255982 |
| Chest injury | 19.49 | 10.83 | 40 | 255514 | 1524 | 32256448 |
| Foetal malformation | 19.23 | 10.83 | 13 | 255541 | 139 | 32257833 |
| Glomerular filtration rate decreased | 19.21 | 10.83 | 169 | 255385 | 12642 | 32245330 |
| Eosinophilia | 19.16 | 10.83 | 289 | 255265 | 24669 | 32233303 |
| Mean cell haemoglobin decreased | 19.06 | 10.83 | 37 | 255517 | 1353 | 32256619 |
| Serum ferritin abnormal | 18.97 | 10.83 | 16 | 255538 | 244 | 32257728 |
| Myocardial infarction | 18.96 | 10.83 | 801 | 254753 | 124875 | 32133097 |
| Iron deficiency anaemia | 18.95 | 10.83 | 136 | 255418 | 9565 | 32248407 |
| Peripheral arterial occlusive disease | 18.93 | 10.83 | 92 | 255462 | 5617 | 32252355 |
| Urogenital haemorrhage | 18.91 | 10.83 | 22 | 255532 | 504 | 32257468 |
| Disseminated intravascular coagulation | 18.78 | 10.83 | 106 | 255448 | 23070 | 32234902 |
| Poisoning | 18.78 | 10.83 | 37 | 255517 | 11121 | 32246851 |
| Anger | 18.74 | 10.83 | 41 | 255513 | 11863 | 32246109 |
| Gravitational oedema | 18.53 | 10.83 | 24 | 255530 | 616 | 32257356 |
| Autoimmune colitis | 18.40 | 10.83 | 30 | 255524 | 954 | 32257018 |
| Cachexia | 18.40 | 10.83 | 107 | 255447 | 7002 | 32250970 |
| Urinary hesitation | 18.39 | 10.83 | 50 | 255504 | 2291 | 32255681 |
| Hallucination | 18.27 | 10.83 | 297 | 255257 | 52322 | 32205650 |
| Helicobacter gastritis | 18.16 | 10.83 | 30 | 255524 | 965 | 32257007 |
| Gastrointestinal angiodysplasia | 18.15 | 10.83 | 24 | 255530 | 629 | 32257343 |
| Intestinal angioedema | 18.12 | 10.83 | 13 | 255541 | 154 | 32257818 |
| Flushing | 18.03 | 10.83 | 157 | 255397 | 30970 | 32227002 |
| Joint swelling | 17.96 | 10.83 | 292 | 255262 | 51443 | 32206529 |
| Gastrointestinal pain | 17.88 | 10.83 | 57 | 255497 | 2857 | 32255115 |
| Product storage error | 17.86 | 10.83 | 18 | 255536 | 7160 | 32250812 |
| Product quality issue | 17.82 | 10.83 | 84 | 255470 | 19149 | 32238823 |
| Lethargy | 17.73 | 10.83 | 223 | 255331 | 41005 | 32216967 |
| Fall | 17.73 | 10.83 | 1781 | 253773 | 194420 | 32063552 |
| Presyncope | 17.69 | 10.83 | 211 | 255343 | 17090 | 32240882 |
| Victim of child abuse | 17.62 | 10.83 | 26 | 255528 | 757 | 32257215 |
| Electrocardiogram QT prolonged | 17.62 | 10.83 | 422 | 255132 | 39219 | 32218753 |
| Altered state of consciousness | 17.61 | 10.83 | 101 | 255453 | 21896 | 32236076 |
| Bronchial wall thickening | 17.48 | 10.83 | 29 | 255525 | 936 | 32257036 |
| Drug screen false positive | 17.47 | 10.83 | 26 | 255528 | 763 | 32257209 |
| Miosis | 17.26 | 10.83 | 26 | 255528 | 8678 | 32249294 |
| Thrombotic microangiopathy | 17.23 | 10.83 | 30 | 255524 | 9452 | 32248520 |
| Right atrial hypertrophy | 17.21 | 10.83 | 17 | 255537 | 321 | 32257651 |
| Occult blood | 17.20 | 10.83 | 20 | 255534 | 458 | 32257514 |
| Neuroleptic malignant syndrome | 17.05 | 10.83 | 75 | 255479 | 17420 | 32240552 |
| Erectile dysfunction | 17.03 | 10.83 | 89 | 255465 | 19750 | 32238222 |
| Adjustment disorder | 17.02 | 10.83 | 29 | 255525 | 957 | 32257015 |
| Mean cell haemoglobin concentration | 16.97 | 10.83 | 8 | 255546 | 39 | 32257933 |
| Cold sweat | 16.94 | 10.83 | 135 | 255419 | 9811 | 32248161 |
| Hypertrophy | 16.90 | 10.83 | 19 | 255535 | 419 | 32257553 |
| Injection site swelling | 16.81 | 10.83 | 31 | 255523 | 9553 | 32248419 |
| Drug use disorder | 16.61 | 10.83 | 4 | 255550 | 3617 | 32254355 |
| Cytomegalovirus viraemia | 16.59 | 10.83 | 17 | 255537 | 6710 | 32251262 |
| Cardiac aneurysm | 16.58 | 10.83 | 28 | 255526 | 917 | 32257055 |
| Apparent death | 16.57 | 10.83 | 4 | 255550 | 3611 | 32254361 |
| Base excess decreased | 16.52 | 10.83 | 14 | 255540 | 215 | 32257757 |
| Perihepatic abscess | 16.50 | 10.83 | 10 | 255544 | 87 | 32257885 |
| Chronic kidney disease-mineral and bone disorder | 16.44 | 10.83 | 18 | 255536 | 385 | 32257587 |
| Tuberculosis | 16.43 | 10.83 | 27 | 255527 | 8702 | 32249270 |
| Dermatitis infected | 16.24 | 10.83 | 11 | 255543 | 118 | 32257854 |
| White blood cell count decreased | 16.22 | 10.83 | 570 | 254984 | 90628 | 32167344 |
| Mania | 16.15 | 10.83 | 32 | 255522 | 9600 | 32248372 |
| Jaundice | 15.91 | 10.83 | 366 | 255188 | 33792 | 32224180 |
| Peritonitis bacterial | 15.86 | 10.83 | 48 | 255506 | 12448 | 32245524 |
| Therapy non-responder | 15.83 | 10.83 | 172 | 255382 | 32482 | 32225490 |
| Osteonecrosis | 15.75 | 10.83 | 72 | 255482 | 16550 | 32241422 |
| Burns second degree | 15.62 | 10.83 | 17 | 255537 | 361 | 32257611 |
| Extrapyramidal disorder | 15.59 | 10.83 | 45 | 255509 | 11850 | 32246122 |
| N-terminal prohormone brain natriuretic peptide increased | 15.56 | 10.83 | 43 | 255511 | 1989 | 32255983 |
| Rash maculo-papular | 15.55 | 10.83 | 308 | 255246 | 27714 | 32230258 |
| Ventricular arrhythmia | 15.53 | 10.83 | 80 | 255474 | 4999 | 32252973 |
| Trisomy 18 | 15.50 | 10.83 | 14 | 255540 | 235 | 32257737 |
| Duodenogastric reflux | 15.42 | 10.83 | 4 | 255550 | 0 | 32257972 |
| Treatment noncompliance | 15.40 | 10.83 | 138 | 255416 | 27064 | 32230908 |
| Sexual dysfunction | 15.39 | 10.83 | 16 | 255538 | 6273 | 32251699 |
| Acute graft versus host disease in skin | 15.36 | 10.83 | 10 | 255544 | 4947 | 32253025 |
| Pericardial disease | 15.15 | 10.83 | 16 | 255538 | 328 | 32257644 |
| Small for dates baby | 15.08 | 10.83 | 4 | 255550 | 3389 | 32254583 |
| Benign gastrointestinal neoplasm | 15.08 | 10.83 | 11 | 255543 | 134 | 32257838 |
| Blood iron decreased | 15.02 | 10.83 | 75 | 255479 | 4629 | 32253343 |
| Bronchopulmonary aspergillosis | 15.02 | 10.83 | 56 | 255498 | 13631 | 32244341 |
| Injection site bruising | 14.90 | 10.83 | 24 | 255530 | 7796 | 32250176 |
| Hospitalisation | 14.89 | 10.83 | 283 | 255271 | 48688 | 32209284 |
| Peripheral venous disease | 14.88 | 10.83 | 49 | 255505 | 2498 | 32255474 |
| Subacute cutaneous lupus erythematosus | 14.86 | 10.83 | 24 | 255530 | 757 | 32257215 |
| Bronchial obstruction | 14.81 | 10.83 | 38 | 255516 | 1681 | 32256291 |
| Injection site phlebitis | 14.71 | 10.83 | 7 | 255547 | 35 | 32257937 |
| Blood pressure fluctuation | 14.63 | 10.83 | 231 | 255323 | 19904 | 32238068 |
| Device issue | 14.61 | 10.83 | 30 | 255524 | 8882 | 32249090 |
| Uveitis | 14.60 | 10.83 | 17 | 255537 | 6333 | 32251639 |
| Upper motor neurone lesion | 14.55 | 10.83 | 10 | 255544 | 110 | 32257862 |
| Procalcitonin abnormal | 14.55 | 10.83 | 10 | 255544 | 110 | 32257862 |
| Dependence on oxygen therapy | 14.45 | 10.83 | 12 | 255542 | 179 | 32257793 |
| Thrombophlebitis | 14.43 | 10.83 | 55 | 255499 | 3017 | 32254955 |
| Flatulence | 14.42 | 10.83 | 223 | 255331 | 19132 | 32238840 |
| Hyperreflexia | 14.42 | 10.83 | 3 | 255551 | 3001 | 32254971 |
| Pulpitis dental | 14.20 | 10.83 | 17 | 255537 | 402 | 32257570 |
| Renal cyst | 14.12 | 10.83 | 117 | 255437 | 8602 | 32249370 |
| Pulmonary valve disease | 14.02 | 10.83 | 14 | 255540 | 268 | 32257704 |
| Neoplasm malignant | 13.92 | 10.83 | 89 | 255465 | 18796 | 32239176 |
| Cardiotoxicity | 13.91 | 10.83 | 11 | 255543 | 4921 | 32253051 |
| Mastitis | 13.91 | 10.83 | 12 | 255542 | 189 | 32257783 |
| Diverticulum intestinal | 13.89 | 10.83 | 59 | 255495 | 3401 | 32254571 |
| Procalcitonin increased | 13.87 | 10.83 | 37 | 255517 | 1676 | 32256296 |
| Weight decreased | 13.86 | 10.83 | 1489 | 254065 | 163329 | 32094643 |
| Tendonitis | 13.82 | 10.83 | 30 | 255524 | 8705 | 32249267 |
| Pulmonary embolism | 13.69 | 10.83 | 796 | 254758 | 82863 | 32175109 |
| Therapeutic product effect decreased | 13.62 | 10.83 | 167 | 255387 | 30850 | 32227122 |
| Drug abuser | 13.58 | 10.83 | 8 | 255546 | 4176 | 32253796 |
| Urinary straining | 13.54 | 10.83 | 5 | 255549 | 11 | 32257961 |
| Respiratory tract haemorrhage | 13.53 | 10.83 | 27 | 255527 | 1008 | 32256964 |
| Device leakage | 13.51 | 10.83 | 10 | 255544 | 4626 | 32253346 |
| Thrombocytosis | 13.40 | 10.83 | 61 | 255493 | 3624 | 32254348 |
| Faeces pale | 13.38 | 10.83 | 34 | 255520 | 1495 | 32256477 |
| Graft versus host disease | 13.36 | 10.83 | 42 | 255512 | 10764 | 32247208 |
| Leptospirosis | 13.28 | 10.83 | 6 | 255548 | 26 | 32257946 |
| Puncture site haematoma | 13.19 | 10.83 | 11 | 255543 | 165 | 32257807 |
| Activated partial thromboplastin time shortened | 13.18 | 10.83 | 18 | 255536 | 487 | 32257485 |
| Alanine aminotransferase increased | 13.17 | 10.83 | 494 | 255060 | 77985 | 32179987 |
| Exercise tolerance decreased | 13.16 | 10.83 | 71 | 255483 | 4517 | 32253455 |
| Myelocyte count increased | 13.11 | 10.83 | 16 | 255538 | 386 | 32257586 |
| Polypectomy | 13.09 | 10.83 | 19 | 255535 | 545 | 32257427 |
| Arteriosclerotic gangrene | 13.07 | 10.83 | 8 | 255546 | 71 | 32257901 |
| Fluid intake reduced | 13.06 | 10.83 | 57 | 255497 | 3325 | 32254647 |
| Lichenoid keratosis | 13.03 | 10.83 | 45 | 255509 | 2351 | 32255621 |
| Cellulitis | 13.00 | 10.83 | 298 | 255256 | 49932 | 32208040 |
| Hypertransaminasaemia | 12.94 | 10.83 | 66 | 255488 | 4108 | 32253864 |
| Tobacco abuse | 12.92 | 10.83 | 16 | 255538 | 392 | 32257580 |
| Confabulation | 12.92 | 10.83 | 10 | 255544 | 134 | 32257838 |
| Taste disorder | 12.91 | 10.83 | 72 | 255482 | 4639 | 32253333 |
| Gastrooesophageal sphincter insufficiency | 12.89 | 10.83 | 8 | 255546 | 73 | 32257899 |
| Dyskinesia | 12.82 | 10.83 | 121 | 255433 | 23482 | 32234490 |
| Jejunostomy | 12.77 | 10.83 | 6 | 255548 | 29 | 32257943 |
| Underdose | 12.75 | 10.83 | 56 | 255498 | 13013 | 32244959 |
| Abnormal faeces | 12.74 | 10.83 | 53 | 255501 | 3027 | 32254945 |
| Benign prostatic hyperplasia | 12.73 | 10.83 | 151 | 255403 | 12213 | 32245759 |
| Haemophagocytic lymphohistiocytosis | 12.69 | 10.83 | 46 | 255508 | 11289 | 32246683 |
| Occupational exposure to air contaminants | 12.66 | 10.83 | 9 | 255545 | 105 | 32257867 |
| Hypovolaemic shock | 12.66 | 10.83 | 95 | 255459 | 6777 | 32251195 |
| Paranasal sinus discomfort | 12.57 | 10.83 | 22 | 255532 | 742 | 32257230 |
| COVID-19 pneumonia | 12.55 | 10.83 | 114 | 255440 | 8606 | 32249366 |
| Hyperkinesia | 12.54 | 10.83 | 43 | 255511 | 2239 | 32255733 |
| Rhythm idioventricular | 12.51 | 10.83 | 14 | 255540 | 307 | 32257665 |
| Alveolar lung disease | 12.49 | 10.83 | 16 | 255538 | 406 | 32257566 |
| Sinusitis | 12.47 | 10.83 | 207 | 255347 | 36353 | 32221619 |
| Jugular vein distension | 12.43 | 10.83 | 19 | 255535 | 571 | 32257401 |
| Nuchal rigidity | 12.39 | 10.83 | 17 | 255537 | 462 | 32257510 |
| Incorrect dose administered | 12.39 | 10.83 | 197 | 255357 | 34831 | 32223141 |
| Granulomatous dermatitis | 12.33 | 10.83 | 13 | 255541 | 266 | 32257706 |
| Saliva altered | 12.31 | 10.83 | 11 | 255543 | 182 | 32257790 |
| Lymph node calcification | 12.30 | 10.83 | 12 | 255542 | 223 | 32257749 |
| Pneumonia cytomegaloviral | 12.30 | 10.83 | 4 | 255550 | 2968 | 32255004 |
| Wound haemorrhage | 12.30 | 10.83 | 39 | 255515 | 1949 | 32256023 |
| Chondrocalcinosis pyrophosphate | 12.26 | 10.83 | 24 | 255530 | 883 | 32257089 |
| Xyphoid retraction | 12.26 | 10.83 | 11 | 255543 | 183 | 32257789 |
| Road traffic accident | 12.26 | 10.83 | 83 | 255471 | 17298 | 32240674 |
| Painful respiration | 12.20 | 10.83 | 30 | 255524 | 1292 | 32256680 |
| Mood altered | 12.18 | 10.83 | 33 | 255521 | 8871 | 32249101 |
| Syringe issue | 12.18 | 10.83 | 7 | 255547 | 3704 | 32254268 |
| Pancreatic duct stenosis | 12.16 | 10.83 | 11 | 255543 | 185 | 32257787 |
| Congenital hiatus hernia | 12.14 | 10.83 | 13 | 255541 | 271 | 32257701 |
| Erythropenia | 12.13 | 10.83 | 12 | 255542 | 227 | 32257745 |
| Hepatorenal syndrome | 12.13 | 10.83 | 47 | 255507 | 2598 | 32255374 |
| Prolonged expiration | 12.12 | 10.83 | 11 | 255543 | 186 | 32257786 |
| Phlebitis infective | 12.10 | 10.83 | 10 | 255544 | 148 | 32257824 |
| Mucormycosis | 12.10 | 10.83 | 16 | 255538 | 5638 | 32252334 |
| Hemiparesis | 12.09 | 10.83 | 181 | 255373 | 15426 | 32242546 |
| Status epilepticus | 11.99 | 10.83 | 51 | 255503 | 11955 | 32246017 |
| Disorganised speech | 11.99 | 10.83 | 21 | 255533 | 709 | 32257263 |
| Myalgia | 11.98 | 10.83 | 519 | 255035 | 80711 | 32177261 |
| Faecal calprotectin increased | 11.94 | 10.83 | 31 | 255523 | 1381 | 32256591 |
| Medication error | 11.94 | 10.83 | 246 | 255308 | 22289 | 32235683 |
| Device dependence | 11.87 | 10.83 | 6 | 255548 | 35 | 32257937 |
| Pulmonary tuberculosis | 11.86 | 10.83 | 13 | 255541 | 4976 | 32252996 |
| Pneumonia aspiration | 11.86 | 10.83 | 240 | 255314 | 40916 | 32217056 |
| Gastrointestinal motility disorder | 11.84 | 10.83 | 43 | 255511 | 2304 | 32255668 |
| Bronchial secretion retention | 11.82 | 10.83 | 26 | 255528 | 1040 | 32256932 |
| Haemorrhagic disorder | 11.82 | 10.83 | 19 | 255535 | 597 | 32257375 |
| Haematotoxicity | 11.81 | 10.83 | 22 | 255532 | 6754 | 32251218 |
| Blood triglycerides increased | 11.77 | 10.83 | 67 | 255487 | 14552 | 32243420 |
| Vision blurred | 11.76 | 10.83 | 261 | 255293 | 43925 | 32214047 |
| Eosinophilic pneumonia | 11.73 | 10.83 | 52 | 255502 | 3054 | 32254918 |
| Retinitis viral | 11.72 | 10.83 | 8 | 255546 | 87 | 32257885 |
| Urosepsis | 11.72 | 10.83 | 144 | 255410 | 11746 | 32246226 |
| Post procedural haemorrhage | 11.68 | 10.83 | 108 | 255446 | 8192 | 32249780 |
| Epileptic encephalopathy | 11.67 | 10.83 | 9 | 255545 | 120 | 32257852 |
| Drug intolerance | 11.64 | 10.83 | 303 | 255251 | 49932 | 32208040 |
| Cytomegalovirus infection reactivation | 11.63 | 10.83 | 6 | 255548 | 3373 | 32254599 |
| Substance abuse | 11.59 | 10.83 | 24 | 255530 | 7083 | 32250889 |
| Splenic thrombosis | 11.58 | 10.83 | 5 | 255549 | 19 | 32257953 |
| Spinal cord herniation | 11.56 | 10.83 | 3 | 255551 | 0 | 32257972 |
| Blood alcohol abnormal | 11.56 | 10.83 | 3 | 255551 | 0 | 32257972 |
| Bladder diverticulitis | 11.56 | 10.83 | 3 | 255551 | 0 | 32257972 |
| Hypertensive crisis | 11.55 | 10.83 | 113 | 255441 | 8704 | 32249268 |
| Epstein-Barr virus infection | 11.51 | 10.83 | 24 | 255530 | 7066 | 32250906 |
| Pulmonary vascular disorder | 11.50 | 10.83 | 19 | 255535 | 611 | 32257361 |
| Adenovirus infection | 11.47 | 10.83 | 12 | 255542 | 4692 | 32253280 |
| Leptotrichia infection | 11.42 | 10.83 | 8 | 255546 | 91 | 32257881 |
| Strongyloidiasis | 11.42 | 10.83 | 3 | 255551 | 2558 | 32255414 |
| Clostridium difficile infection | 11.40 | 10.83 | 200 | 255354 | 17596 | 32240376 |
| Scan abnormal | 11.38 | 10.83 | 5 | 255549 | 20 | 32257952 |
| Renal haemangioma | 11.38 | 10.83 | 5 | 255549 | 20 | 32257952 |
| Degenerative aortic valve disease | 11.38 | 10.83 | 5 | 255549 | 20 | 32257952 |
| Seroma | 11.37 | 10.83 | 19 | 255535 | 617 | 32257355 |
| Prothrombin time prolonged | 11.34 | 10.83 | 122 | 255432 | 9633 | 32248339 |
| Acute coronary syndrome | 11.31 | 10.83 | 163 | 255391 | 13778 | 32244194 |
| Muscular weakness | 11.30 | 10.83 | 428 | 255126 | 67501 | 32190471 |
| Ventricular enlargement | 11.28 | 10.83 | 16 | 255538 | 449 | 32257523 |
| Organic brain syndrome | 11.25 | 10.83 | 12 | 255542 | 249 | 32257723 |
| Oesophageal infection | 11.25 | 10.83 | 12 | 255542 | 249 | 32257723 |
| Atrial septal defect | 11.22 | 10.83 | 24 | 255530 | 7001 | 32250971 |
| Peripheral paralysis | 11.22 | 10.83 | 6 | 255548 | 40 | 32257932 |
| Blindness | 11.20 | 10.83 | 59 | 255495 | 13067 | 32244905 |
| Chronic actinic dermatitis | 11.19 | 10.83 | 5 | 255549 | 21 | 32257951 |
| Anaemia of malignant disease | 11.18 | 10.83 | 15 | 255539 | 399 | 32257573 |
| Pyelitis | 11.14 | 10.83 | 8 | 255546 | 95 | 32257877 |
| Pulmonary sepsis | 11.11 | 10.83 | 40 | 255514 | 2134 | 32255838 |
| Autoimmune encephalopathy | 11.10 | 10.83 | 6 | 255548 | 41 | 32257931 |
| Bladder tamponade | 11.07 | 10.83 | 17 | 255537 | 513 | 32257459 |
| Walking aid user | 11.06 | 10.83 | 32 | 255522 | 1520 | 32256452 |
| Arteriovenous fistula | 11.01 | 10.83 | 20 | 255534 | 695 | 32257277 |
| Blood pressure increased | 10.95 | 10.83 | 744 | 254810 | 78610 | 32179362 |
| Hallucination, auditory | 10.94 | 10.83 | 43 | 255511 | 10307 | 32247665 |
| Nocardiosis | 10.93 | 10.83 | 8 | 255546 | 3723 | 32254249 |
| Shock | 10.91 | 10.83 | 129 | 255425 | 23985 | 32233987 |
| Intestinal haemorrhage | 10.88 | 10.83 | 54 | 255500 | 3325 | 32254647 |
| Unevaluable event | 10.86 | 10.83 | 192 | 255362 | 33394 | 32224578 |
| Systolic dysfunction | 10.85 | 10.83 | 41 | 255513 | 2239 | 32255733 |
| Tumour pain | 10.85 | 10.83 | 25 | 255529 | 1032 | 32256940 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A02BC02 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Proton pump inhibitors |
| ATC | A02BD04 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori |
| ATC | A02BD11 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori |
| FDA MoA | N0000000147 | Proton Pump Inhibitors |
| FDA EPC | N0000175525 | Proton Pump Inhibitor |
| MeSH PA | D000897 | Anti-Ulcer Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D054328 | Proton Pump Inhibitors |
| CHEBI has role | CHEBI:35703 | Xenobiotic |
| CHEBI has role | CHEBI:49200 | proton pump inhibitors |
| CHEBI has role | CHEBI:49201 | anti-ulcer agents |
| CHEBI has role | CHEBI:78298 | environmental contaminants |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Peptic ulcer | indication | 13200003 | DOID:750 |
| Erosive esophagitis | indication | 40719004 | |
| Zollinger-Ellison syndrome | indication | 53132006 | DOID:0050782 |
| Multiple endocrine adenomas | indication | 60549007 | |
| Gastroesophageal reflux disease | indication | 235595009 | DOID:8534 |
| Maintenance of Healing Erosive Esophagitis | indication | ||
| Gastric Hypersecretory Conditions | indication | ||
| Upper gastrointestinal hemorrhage | off-label use | 37372002 | |
| Duodenal ulcer disease | off-label use | 51868009 | DOID:1724 |
| Gastric ulcer | off-label use | 397825006 | DOID:10808 |
| Pathological Gastric Hypersecretory Condition | off-label use | ||
| Duodenal Ulcer due to H. Pylori | off-label use | ||
| Prevention of NSAID-Induced Gastric Ulcer | off-label use | ||
| Osteoporosis | contraindication | 64859006 | DOID:11476 |
| Pernicious anemia | contraindication | 84027009 | DOID:13381 |
| Fracture of bone | contraindication | 125605004 | |
| Hypomagnesemia | contraindication | 190855004 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.42 | acidic |
| pKa2 | 3.58 | Basic |
| pKa3 | 2.32 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 40MG BASE | PROTONIX | WYETH PHARMS | N022020 | Nov. 14, 2007 | RX | FOR SUSPENSION, DELAYED RELEASE | ORAL | 7550153 | Sept. 30, 2024 | EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD |
| EQ 40MG BASE | PROTONIX | WYETH PHARMS | N022020 | Nov. 14, 2007 | RX | FOR SUSPENSION, DELAYED RELEASE | ORAL | 7553498 | Sept. 30, 2024 | EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD |
| EQ 40MG BASE | PROTONIX | WYETH PHARMS | N022020 | Nov. 14, 2007 | RX | FOR SUSPENSION, DELAYED RELEASE | ORAL | 7838027 | Sept. 30, 2024 | EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Potassium-transporting ATPase | Transporter | INHIBITOR | CHEMBL | CHEMBL | |||||
| Fatty acid synthase | Enzyme | Ki | 5.39 | CHEMBL | |||||
| Solute carrier family 22 member 2 | Transporter | IC50 | 5.82 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 5.55 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 2 | Transporter | IC50 | 4.36 | CHEMBL | |||||
| N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 | Enzyme | IC50 | 4.20 | CHEMBL | |||||
| Sodium/potassium-transporting ATPase subunit alpha-1 | Transporter | WOMBAT-PK | |||||||
| Indoleamine 2,3-dioxygenase 2 | Enzyme | IC50 | 4.90 | CHEMBL | |||||
| Potassium-transporting ATPase | Enzyme | IC50 | 6 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| 4021208 | VUID |
| N0000148654 | NUI |
| D02593 | KEGG_DRUG |
| 164579-32-2 | SECONDARY_CAS_RN |
| 4021208 | VANDF |
| 4021209 | VANDF |
| C0081876 | UMLSCUI |
| CHEBI:7915 | CHEBI |
| CHEMBL1502 | ChEMBL_ID |
| CHEMBL3989559 | ChEMBL_ID |
| CHEMBL1200408 | ChEMBL_ID |
| DB00213 | DRUGBANK_ID |
| D000077402 | MESH_DESCRIPTOR_UI |
| 4679 | PUBCHEM_CID |
| 7260 | IUPHAR_LIGAND_ID |
| 6548 | INN_ID |
| D8TST4O562 | UNII |
| 236632 | RXNORM |
| 130104 | MMSL |
| 8654 | MMSL |
| d04514 | MMSL |
| 006006 | NDDF |
| 006493 | NDDF |
| 009120 | NDDF |
| 116510001 | SNOMEDCT_US |
| 317317009 | SNOMEDCT_US |
| 395821003 | SNOMEDCT_US |
| 432408008 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Protonix Delayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-0841 | TABLET, DELAYED RELEASE | 40 mg | ORAL | NDA | 30 sections |
| Protonix Delayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-0843 | TABLET, DELAYED RELEASE | 20 mg | ORAL | NDA | 30 sections |
| Protonix Delayed-Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-0844 | GRANULE, DELAYED RELEASE | 40 mg | ORAL | NDA | 30 sections |
| Protonix I.V. | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-0923 | INJECTION, POWDER, FOR SOLUTION | 40 mg | INTRAVENOUS | NDA | 28 sections |
| Protonix I.V. | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-2001 | INJECTION, POWDER, FOR SOLUTION | 40 mg | INTRAVENOUS | NDA | 27 sections |
| Protonix I.V. | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0008-4001 | INJECTION, POWDER, FOR SOLUTION | 40 mg | INTRAVENOUS | NDA | 28 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9284 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | NDA | 26 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9300 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | NDA | 26 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6688 | TABLET, DELAYED RELEASE | 20 mg | ORAL | ANDA | 28 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6689 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 28 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8113 | TABLET, DELAYED RELEASE | 20 mg | ORAL | ANDA | 27 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8308 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 29 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3232 | INJECTION, POWDER, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 28 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6474 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6870 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-096 | TABLET, DELAYED RELEASE | 20 mg | ORAL | ANDA | 27 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-429 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |
| PANTOPRAZOLE SODIUMDELAYED RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-635 | TABLET, DELAYED RELEASE | 20 mg | ORAL | NDA | 30 sections |
| PROTONIXDELAYED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-939 | TABLET, DELAYED RELEASE | 20 mg | ORAL | NDA | 30 sections |
| Protonix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-108 | TABLET, DELAYED RELEASE | 40 mg | ORAL | NDA | 27 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-771 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 28 sections |
| PANTOPRAZOLE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-712 | TABLET, DELAYED RELEASE | 20 mg | ORAL | ANDA | 26 sections |
| PANTOPRAZOLE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-713 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 26 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-629 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 29 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33358-536 | TABLET, DELAYED RELEASE | 20 mg | ORAL | ANDA | 28 sections |
| Pantoprazole Sodium | Human Prescription Drug Label | 1 | 35573-428 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |
| PANTOPRAZOLE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-124 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |
| PANTOPRAZOLE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-765 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 26 sections |
| PANTOPRAZOLE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42708-104 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 29 sections |
| Pantoprazole Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-618 | TABLET, DELAYED RELEASE | 40 mg | ORAL | ANDA | 27 sections |