perindopril 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
angiotensin-converting enzyme inhibitors 2108 82834-16-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • perindopril
  • perindopril erbumine
  • perindopril arginine
An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.
  • Molecular weight: 368.47
  • Formula: C19H32N2O5
  • CLOGP: 1.21
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 95.94
  • ALOGS: -2.48
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.60 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma) 0.31 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.496 Moderate 0.78
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.439 Moderate 0.78
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 4.677 10^-6 cm/s Moderate 0.78
dh-clint Dog hepatocyte intrinsic clearance 6.397 uL/min/10^6 cells Moderate 0.78
dppb Dog plasma protein binding (% unbound) 43.020 % Moderate 0.78
fcs-ppb Fetal calf serum protein binding (% unbound) 34.990 % Moderate 0.78
herg hERG pIC50 4.149 pIC50 Moderate 0.78
hh-clint Human hepatocyte intrinsic clearance 4.426 uL/min/10^6 cells Moderate 0.78
hlm-clint Human liver microsomal intrinsic clearance 4.457 uL/min/mg protein Moderate 0.78
hppb Human plasma protein binding (% unbound) 45.350 % Moderate 0.78
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAP3K7,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,SYK,TEK,TGFBR1 29
kinase-selectivity-class AXL,BRAF,GRK2,MAP2K6,TGFBR1 5
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.855 Moderate 0.78
mh-clint Mouse hepatocyte intrinsic clearance 46.452 Moderate 0.78
mppb Mouse plasma protein binding (% unbound) 52.300 Moderate 0.78
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.959 Moderate 0.78
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 39.290 % Moderate 0.78
rh-clint Rat hepatocyte intrinsic clearance 29.512 uL/min/10^6 cells Moderate 0.78
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.620 % Moderate 0.78
rppb Rat plasma protein binding (% unbound) 39.890 % Moderate 0.78
solubility-dd Solubility at pH 7.4 in DMSO 1016.249 uM Moderate 0.78

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1993 FDA SYMPLMED PHARMS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 496.58 10.69 863 65719 319524 90242341
Sensitisation 375.32 10.69 134 66448 4041 90557824
Hyponatraemia 359.22 10.69 466 66116 133072 90428793
Polycystic ovaries 346.23 10.69 137 66445 5517 90556348
Ejection fraction 306.46 10.69 106 66476 2905 90558960
Hypothyroidism 281.99 10.69 265 66317 52862 90509003
Sleep apnoea syndrome 236.28 10.69 192 66390 31555 90530310
Systemic lupus erythematosus 220.33 10.69 11 66571 361885 90199980
Lactic acidosis 219.87 10.69 226 66356 50237 90511628
Rhinitis allergic 207.73 10.69 138 66444 16647 90545218
Carpal tunnel syndrome 206.68 10.69 158 66424 23770 90538095
Hyperkalaemia 202.14 10.69 244 66338 64720 90497145
Pemphigus 201.98 10.69 9 66573 326855 90235010
Blood test abnormal 197.98 10.69 146 66436 20806 90541059
Hand deformity 183.63 10.69 8 66574 296354 90265511
Glossodynia 183.20 10.69 14 66568 321765 90240100
Ejection fraction abnormal 168.91 10.69 65 66517 2426 90559439
Renal disorder 167.53 10.69 171 66411 37688 90524177
Blood pressure fluctuation 156.78 10.69 193 66389 52220 90509645
Pericarditis 155.92 10.69 11 66571 270140 90291725
Blood pressure systolic increased 155.76 10.69 203 66379 58142 90503723
Maternal exposure during pregnancy 153.18 10.69 38 66544 360025 90201840
Synovitis 147.86 10.69 31 66551 329721 90232144
Drug interaction 140.87 10.69 485 66097 275968 90285897
Cardiac disorder 139.71 10.69 190 66392 56682 90505183
Blood pressure increased 139.53 10.69 388 66194 196829 90365036
Nephrectomy 135.43 10.69 52 66530 1929 90559936
Loss of employment 134.14 10.69 58 66524 2929 90558936
Alopecia 132.55 10.69 102 66480 494969 90066896
Folliculitis 128.28 10.69 5 66577 204348 90357517
Cardiac failure 124.53 10.69 259 66323 109237 90452628
Treatment failure 118.25 10.69 38 66544 303890 90257975
Hypotension 115.28 10.69 509 66073 324888 90236977
Helicobacter infection 111.02 10.69 17 66565 226833 90335032
Injury 108.38 10.69 10 66572 197339 90364526
Arthropathy 107.84 10.69 68 66514 366174 90195691
Irritable bowel syndrome 107.55 10.69 13 66569 207435 90354430
Inappropriate antidiuretic hormone secretion 106.73 10.69 99 66483 19406 90542459
Metabolic acidosis 106.15 10.69 165 66417 55511 90506354
Wound 105.89 10.69 45 66537 302935 90258930
Bradycardia 105.66 10.69 207 66375 83640 90478225
Cough 105.18 10.69 542 66040 368420 90193445
Burning sensation 104.56 10.69 176 66406 63276 90498589
Pemphigoid 104.00 10.69 71 66511 8955 90552910
Discomfort 100.35 10.69 38 66544 274297 90287568
Impaired healing 97.09 10.69 26 66556 234173 90327692
Hyperlactacidaemia 95.90 10.69 51 66531 4085 90557780
Atrial fibrillation 94.57 10.69 263 66319 133348 90428517
Hypertension 92.64 10.69 614 65968 456918 90104947
Conjoined twins 92.11 10.69 28 66554 502 90561363
Angioedema 91.42 10.69 168 66414 64708 90497157
Muscle injury 89.32 10.69 12 66570 176642 90385223
Infection 83.15 10.69 86 66496 362008 90199857
Psoriatic arthropathy 81.23 10.69 33 66549 228302 90333563
Exposure during pregnancy 80.77 10.69 37 66545 238373 90323492
Sleep disorder due to a general medical condition 77.60 10.69 127 66455 44611 90517254
Fall 77.56 10.69 612 65970 481198 90080667
Mixed liver injury 76.27 10.69 55 66527 7568 90554297
Blister 75.50 10.69 47 66535 254951 90306914
Blood pressure systolic abnormal 72.03 10.69 80 66502 19398 90542467
Oesophageal spasm 71.11 10.69 39 66543 3322 90558543
Completed suicide 70.66 10.69 11 66571 145047 90416818
Joint range of motion decreased 69.07 10.69 9 66573 135634 90426231
Tinnitus 68.95 10.69 118 66464 42984 90518881
Ill-defined disorder 66.94 10.69 26 66556 184865 90377000
Type 2 diabetes mellitus 65.11 10.69 34 66548 203210 90358655
Swelling 62.63 10.69 134 66448 418924 90142941
Cerebral haematoma 62.28 10.69 39 66543 4250 90557615
Blood pressure diastolic decreased 61.93 10.69 87 66495 26739 90535126
Oesophageal pain 61.58 10.69 39 66543 4335 90557530
C-reactive protein abnormal 61.30 10.69 10 66572 127419 90434446
Lip dry 58.53 10.69 4 66578 100951 90460914
Tongue oedema 58.37 10.69 41 66541 5413 90556452
Lipase increased 58.11 10.69 55 66527 11056 90550809
Sleep disorder 57.92 10.69 37 66545 197993 90363872
Product tampering 57.78 10.69 19 66563 444 90561421
Mobility decreased 57.02 10.69 60 66522 250674 90311191
Rhabdomyolysis 56.79 10.69 120 66462 51136 90510729
Grip strength decreased 55.68 10.69 3 66579 92573 90469292
Product dose omission issue 52.70 10.69 83 66499 291604 90270261
Adulterated product 52.53 10.69 17 66565 377 90561488
Congenital bladder anomaly 52.27 10.69 15 66567 218 90561647
Labile hypertension 51.90 10.69 18 66564 497 90561368
Urachal abnormality 51.77 10.69 15 66567 226 90561639
Heart rate decreased 51.07 10.69 118 66464 53387 90508478
Persistent cloaca 50.99 10.69 15 66567 239 90561626
Hypersensitivity 50.78 10.69 168 66414 454509 90107356
Aphthous ulcer 50.62 10.69 63 66519 17224 90544641
Intestinal malrotation 50.46 10.69 17 66565 429 90561436
Lower limb fracture 50.38 10.69 3 66579 85010 90476855
Peripheral venous disease 49.61 10.69 3 66579 83918 90477947
Diabetes mellitus 49.16 10.69 131 66451 64744 90497121
Loss of personal independence in daily activities 48.92 10.69 214 66368 135891 90425974
Electrocardiogram QT prolonged 48.67 10.69 140 66442 72316 90489549
Orthostatic hypotension 47.59 10.69 99 66483 41728 90520137
Hepatic steatosis 47.48 10.69 92 66490 36853 90525012
Nephropathy 46.94 10.69 45 66537 9190 90552675
Death 46.76 10.69 175 66407 456376 90105489
Therapy non-responder 46.62 10.69 21 66561 136683 90425182
Live birth 46.25 10.69 3 66579 79104 90482761
Pain 45.76 10.69 490 66092 995851 89566014
Hepatic enzyme increased 45.48 10.69 126 66456 360610 90201255
Hepatic cytolysis 44.73 10.69 81 66501 30835 90531030
Claustrophobia 44.45 10.69 21 66561 1306 90560559
Renal impairment 44.36 10.69 174 66408 105247 90456618
Diabetes mellitus inadequate control 43.73 10.69 61 66521 18623 90543242
Stress 43.29 10.69 145 66437 81250 90480615
Stomatitis 42.56 10.69 86 66496 274612 90287253
Hypercholesterolaemia 42.17 10.69 11 66571 100881 90460984
Hypophagia 41.99 10.69 86 66496 35851 90526014
Product use in unapproved indication 41.97 10.69 118 66464 336118 90225747
Neurological symptom 41.87 10.69 37 66545 6810 90555055
Obesity 41.33 10.69 13 66569 105494 90456371
Hypokalaemia 41.07 10.69 198 66384 130918 90430947
Blood pressure diastolic abnormal 40.82 10.69 61 66521 19820 90542045
Deep vein thrombosis postoperative 40.48 10.69 3 66579 70806 90491059
Cholestasis 40.23 10.69 85 66497 36214 90525651
Dyspepsia 40.11 10.69 52 66530 198108 90363757
Shock 39.87 10.69 74 66508 28704 90533161
Shock haemorrhagic 39.72 10.69 47 66535 12198 90549667
Somatic symptom disorder 39.48 10.69 27 66555 3414 90558451
Rhinalgia 39.36 10.69 24 66558 2494 90559371
Melaena 39.16 10.69 82 66500 34715 90527150
Myocardial infarction 39.13 10.69 168 66414 105804 90456061
Epistaxis 38.69 10.69 144 66438 84981 90476884
Prescribed overdose 38.29 10.69 12 66570 97613 90464252
Abdominal discomfort 37.98 10.69 201 66381 477127 90084738
Infusion related reaction 37.50 10.69 168 66414 416612 90145253
Pulse abnormal 37.33 10.69 25 66557 3054 90558811
Hypoaesthesia 37.23 10.69 113 66469 314097 90247768
Dermatitis artefacta 37.16 10.69 9 66573 64 90561801
Nephropathy toxic 36.76 10.69 46 66536 12642 90549223
Liver injury 36.37 10.69 43 66539 170524 90391341
Renal failure 36.22 10.69 191 66391 130816 90431049
Vulvovaginal burning sensation 36.19 10.69 23 66559 2572 90559293
Upper respiratory tract infection 36.13 10.69 25 66557 128293 90433572
Autoimmune nephritis 35.88 10.69 13 66569 409 90561456
Asthma 35.83 10.69 302 66280 241858 90320007
Respiratory tract oedema 35.66 10.69 15 66567 707 90561158
Mental disorder 35.03 10.69 75 66507 32243 90529622
Product packaging confusion 34.96 10.69 11 66571 222 90561643
Hypersensitivity vasculitis 34.89 10.69 27 66555 4132 90557733
Peripheral artery stenosis 34.41 10.69 14 66568 606 90561259
Pulmonary fibrosis 34.39 10.69 18 66564 107485 90454380
Blood pressure decreased 34.29 10.69 127 66455 74768 90487097
Diabetic ketoacidosis 34.11 10.69 63 66519 24344 90537521
Drug reaction with eosinophilia and systemic symptoms 34.09 10.69 88 66494 42670 90519195
Labelled drug-drug interaction issue 33.97 10.69 21 66561 2237 90559628
Haematoma 33.89 10.69 83 66499 38965 90522900
Troponin increased 33.56 10.69 45 66537 13236 90548629
Renal tubular necrosis 33.29 10.69 47 66535 14508 90547357
Hyperhidrosis 33.18 10.69 192 66390 136113 90425752
Pancreatitis acute 33.06 10.69 73 66509 32042 90529823
Road traffic accident 33.01 10.69 19 66563 107607 90454258
Palpitations 32.90 10.69 192 66390 136536 90425329
Bursitis 32.83 10.69 29 66553 131625 90430240
Hallucination, gustatory 32.10 10.69 8 66574 65 90561800
Pregnancy 31.86 10.69 4 66578 62043 90499822
Prescribed underdose 31.69 10.69 8 66574 75011 90486854
Vulvovaginal pruritus 31.50 10.69 25 66557 3968 90557897
Lip injury 31.25 10.69 16 66566 1185 90560680
Euglycaemic diabetic ketoacidosis 31.11 10.69 30 66552 6171 90555694
Pyrexia 30.98 10.69 323 66259 660162 89901703
Wound infection 30.93 10.69 20 66562 106382 90455483
General physical health deterioration 30.82 10.69 145 66437 354970 90206895
Gait inability 30.08 10.69 38 66544 146418 90415447
Blepharospasm 29.92 10.69 3 66579 55442 90506423
Nail disorder 29.87 10.69 4 66578 59063 90502802
Cardiac failure chronic 29.62 10.69 28 66554 5618 90556247
Troponin T increased 29.37 10.69 17 66565 1606 90560259
Hypoglycaemia 29.14 10.69 115 66467 69733 90492132
Hepatocellular injury 28.89 10.69 65 66517 28893 90532972
Full blood count abnormal 28.84 10.69 75 66507 36522 90525343
Degenerative aortic valve disease 28.54 10.69 9 66573 183 90561682
International normalised ratio increased 28.52 10.69 88 66494 47228 90514637
Spinal flattening 28.40 10.69 10 66572 289 90561576
Head banging 28.32 10.69 11 66571 421 90561444
Pressure of speech 28.32 10.69 13 66569 757 90561108
Alopecia scarring 28.01 10.69 9 66573 195 90561670
Neglect of personal appearance 27.58 10.69 8 66574 121 90561744
Cardiac amyloidosis 27.53 10.69 14 66568 1022 90560843
Blood pressure diastolic increased 27.07 10.69 40 66542 12866 90548999
Oxygen saturation decreased 26.55 10.69 152 66430 107331 90454534
Swollen tongue 26.35 10.69 84 66498 45872 90515993
Myelosuppression 26.23 10.69 4 66578 53587 90508278
Exercise tolerance decreased 26.19 10.69 30 66552 7521 90554344
Hypomagnesaemia 26.09 10.69 71 66511 35517 90526348
Blood cholesterol increased 25.94 10.69 73 66509 207939 90353926
Injection site reaction 25.84 10.69 18 66564 92062 90469803
Neuropathy peripheral 25.65 10.69 38 66544 136932 90424933
Brain injury 25.59 10.69 30 66552 7708 90554157
Swelling face 25.57 10.69 123 66459 81229 90480636
Injection site erythema 25.41 10.69 21 66561 98481 90463384
Malaise 25.39 10.69 586 65996 585400 89976465
Sinusitis 25.34 10.69 148 66434 342940 90218925
Rash 25.34 10.69 422 66160 795678 89766187
Knee arthroplasty 25.06 10.69 15 66567 83167 90478698
Allergic reaction to excipient 24.96 10.69 12 66570 776 90561089
Night sweats 24.83 10.69 35 66547 128731 90433134
Oral herpes 24.69 10.69 67 66515 33457 90528408
Calcification metastatic 24.65 10.69 8 66574 179 90561686
Screaming 24.41 10.69 21 66561 3729 90558136
Body temperature decreased 24.36 10.69 54 66528 23762 90538103
Depressed level of consciousness 24.30 10.69 112 66470 72672 90489193
Disease progression 24.27 10.69 49 66533 156566 90405299
Catheter site injury 24.15 10.69 9 66573 307 90561558
Convulsive threshold lowered 24.09 10.69 10 66572 456 90561409
Vascular access site haemorrhage 24.05 10.69 8 66574 194 90561671
Paranasal sinus discomfort 23.81 10.69 26 66556 6184 90555681
Livedo reticularis 23.81 10.69 20 66562 3439 90558426
Lymphoedema 23.79 10.69 39 66543 13714 90548151
Blood iron decreased 23.41 10.69 45 66537 17914 90543951
Benign abdominal neoplasm 23.27 10.69 8 66574 215 90561650
Rebound psychosis 23.27 10.69 8 66574 215 90561650
Drug ineffective 23.22 10.69 809 65773 1383489 89178376
Vasoplegia syndrome 23.02 10.69 18 66564 2796 90559069
Anuria 22.95 10.69 40 66542 14778 90547087
Product quality issue 22.93 10.69 15 66567 79310 90482555
Allergic sinusitis 22.88 10.69 16 66566 2097 90559768
Mental status changes 22.65 10.69 3 66579 44676 90517189
Hypovolaemic shock 22.63 10.69 27 66555 7067 90554798
Gravitational oedema 22.58 10.69 13 66569 1216 90560649
Cystitis 22.52 10.69 103 66479 66615 90495250
Hypertensive crisis 22.50 10.69 44 66538 17740 90544125
Ischaemic stroke 22.38 10.69 50 66532 22116 90539749
Underdose 22.36 10.69 6 66576 54011 90507854
No adverse event 22.31 10.69 11 66571 67971 90493894
Laryngitis 22.25 10.69 5 66577 50748 90511117
Polydipsia 22.23 10.69 21 66561 4210 90557655
Bone density decreased 22.05 10.69 43 66539 17302 90544563
Seasonal affective disorder 21.96 10.69 9 66573 397 90561468
Troponin abnormal 21.89 10.69 6 66576 73 90561792
Blood thyroid stimulating hormone increased 21.59 10.69 30 66552 9125 90552740
Mixed anxiety and depressive disorder 21.40 10.69 9 66573 424 90561441
Lupus-like syndrome 21.04 10.69 5 66577 48841 90513024
Joint abscess 20.99 10.69 9 66573 445 90561420
Hormone receptor positive HER2 negative breast cancer 20.85 10.69 8 66574 296 90561569
Lip swelling 20.71 10.69 69 66513 38541 90523324
Dehydration 20.58 10.69 226 66356 194221 90367644
Acute coronary syndrome 20.54 10.69 32 66550 10781 90551084
Intra-abdominal haematoma 20.38 10.69 15 66567 2129 90559736
Venous oxygen saturation increased 20.35 10.69 5 66577 38 90561827
Impaired insulin secretion 20.24 10.69 5 66577 39 90561826
Acute myocardial infarction 20.21 10.69 64 66518 34826 90527039
Urinary straining 20.13 10.69 5 66577 40 90561825
Poor dental condition 19.99 10.69 9 66573 501 90561364
Therapy interrupted 19.94 10.69 6 66576 50102 90511763
Arthropod bite 19.59 10.69 28 66554 8739 90553126
Uveitic glaucoma 19.59 10.69 4 66578 11 90561854
Coloboma 19.51 10.69 6 66576 112 90561753
Hypocalvaria 19.32 10.69 5 66577 48 90561817
Oropharyngeal discomfort 19.22 10.69 26 66556 7709 90554156
Hypoosmolar state 19.15 10.69 7 66575 226 90561639
Capillary disorder 18.98 10.69 6 66576 123 90561742
Gingival abscess 18.98 10.69 11 66571 1042 90560823
Abortion spontaneous 18.90 10.69 8 66574 54048 90507817
Hallucination, visual 18.90 10.69 48 66534 23044 90538821
Morganella infection 18.74 10.69 10 66572 806 90561059
Expanded disability status scale score increased 18.66 10.69 10 66572 813 90561052
Humerus fracture 18.64 10.69 29 66553 9756 90552109
Kidney malformation 18.54 10.69 6 66576 133 90561732
Adverse drug reaction 18.52 10.69 36 66546 116665 90445200
Supraventricular extrasystoles 18.42 10.69 21 66561 5236 90556629
Agranulocytosis 18.29 10.69 62 66520 34940 90526925
Therapeutic product effect decreased 18.29 10.69 124 66458 277447 90284418
Gastrointestinal disorder 18.27 10.69 112 66470 256575 90305290
Bone contusion 18.12 10.69 11 66571 1134 90560731
Eosinophilia 18.07 10.69 54 66528 28479 90533386
Abdominal pain 17.81 10.69 398 66184 395323 90166542
Sleep disorder due to general medical condition, insomnia type 17.69 10.69 43 66539 128651 90433214
Blood creatine phosphokinase increased 17.54 10.69 60 66522 33963 90527902
Gastrointestinal haemorrhage 17.52 10.69 120 66462 90128 90471737
Onychomadesis 17.43 10.69 6 66576 45992 90515873
Hallucination 17.43 10.69 95 66487 65864 90496001
Infusion site mobility decreased 17.40 10.69 5 66577 73 90561792
Synovial disorder 17.39 10.69 16 66566 3102 90558763
Left ventricular failure 17.38 10.69 23 66559 6677 90555188
Infective myositis 17.34 10.69 5 66577 74 90561791
Coma scale abnormal 17.27 10.69 21 66561 5605 90556260
Hypovolaemia 17.26 10.69 32 66550 12399 90549466
Dry mouth 17.25 10.69 73 66509 183986 90377879
Normochromic normocytic anaemia 17.24 10.69 20 66562 5082 90556783
Hepatitis cholestatic 17.19 10.69 26 66556 8535 90553330
Skin laceration 17.18 10.69 50 66532 25985 90535880
Therapy cessation 17.16 10.69 3 66579 36358 90525507
Labelled drug-drug interaction medication error 17.15 10.69 35 66547 14547 90547318
Benign ovarian tumour 16.97 10.69 8 66574 495 90561370
Pharyngeal swelling 16.93 10.69 28 66554 9916 90551949
Injection site pain 16.83 10.69 68 66514 173631 90388234
Therapeutic product effect incomplete 16.83 10.69 217 66365 193679 90368186
Morbid thoughts 16.65 10.69 9 66573 745 90561120
Ear infection 16.64 10.69 16 66566 69759 90492106
Body mass index decreased 16.57 10.69 8 66574 522 90561343
Page kidney 16.57 10.69 4 66578 28 90561837
Joint swelling 16.57 10.69 265 66317 503035 90058830
Oesophageal irritation 16.56 10.69 7 66575 334 90561531
Paranoia 16.41 10.69 32 66550 12876 90548989
Toxic skin eruption 16.40 10.69 36 66546 15738 90546127
Haemorrhagic stroke 16.40 10.69 22 66560 6474 90555391
Multiple sclerosis relapse 16.37 10.69 9 66573 52296 90509569
Sinus rhythm 16.20 10.69 11 66571 1375 90560490
Therapy partial responder 16.18 10.69 44 66538 21999 90539866
Albuminuria 16.18 10.69 7 66575 354 90561511
Nail injury 16.17 10.69 9 66573 789 90561076
Protrusion tongue 16.10 10.69 7 66575 358 90561507
Hallucination, auditory 16.09 10.69 36 66546 15939 90545926
Pneumonia 16.03 10.69 352 66230 637707 89924158
Fungal infection 16.02 10.69 68 66514 42593 90519272
Vision blurred 16.00 10.69 137 66445 110156 90451709
Hyperreflexia 15.97 10.69 22 66560 6635 90555230
Stomatitis haemorrhagic 15.94 10.69 5 66577 100 90561765
Phantom limb syndrome 15.93 10.69 6 66576 211 90561654
Urine albumin/creatinine ratio decreased 15.89 10.69 5 66577 101 90561764
Injection site pruritus 15.81 10.69 10 66572 53824 90508041
Breath odour 15.74 10.69 11 66571 1440 90560425
Allergic cough 15.73 10.69 10 66572 1118 90560747
Histoplasmosis 15.70 10.69 13 66569 2191 90559674
Contraindicated product administered 15.61 10.69 155 66427 319984 90241881
Wrong patient 15.57 10.69 9 66573 848 90561017
Product use issue 15.57 10.69 161 66421 329758 90232107
Spontaneous haematoma 15.49 10.69 10 66572 1148 90560717
Insulin resistance 15.49 10.69 10 66572 1148 90560717
Febrile neutropenia 15.34 10.69 62 66520 158287 90403578
Pruritus 15.30 10.69 293 66289 541232 90020633
Influenza 15.25 10.69 163 66419 139101 90422764
Stent placement 15.09 10.69 17 66565 4186 90557679
Coma 14.95 10.69 98 66484 72534 90489331
Blood uric acid increased 14.91 10.69 23 66559 7681 90554184
Diabetic metabolic decompensation 14.90 10.69 12 66570 1945 90559920
Injection site extravasation 14.83 10.69 25 66557 8994 90552871
Hypouricaemia 14.79 10.69 6 66576 258 90561607
Hepatitis A antibody abnormal 14.77 10.69 5 66577 128 90561737
Consciousness fluctuating 14.75 10.69 9 66573 937 90560928
Renal vasculitis 14.73 10.69 7 66575 441 90561424
Fibromyalgia 14.73 10.69 223 66359 206046 90355819
Visual impairment 14.68 10.69 49 66533 132316 90429549
Enterococcal sepsis 14.68 10.69 11 66571 1605 90560260
Sciatica 14.63 10.69 33 66549 101349 90460516
Tubulointerstitial nephritis and uveitis syndrome 14.61 10.69 6 66576 266 90561599
Cardiomyopathy 14.50 10.69 40 66542 20166 90541699
Cutaneous B-cell lymphoma 14.49 10.69 4 66578 50 90561815
Mean cell haemoglobin concentration decreased 14.37 10.69 17 66565 4411 90557454
Myalgia 14.37 10.69 194 66388 174931 90386934
Human papilloma virus test positive 14.34 10.69 8 66574 704 90561161
Lung disorder 14.32 10.69 59 66523 149824 90412041
Cardioactive drug level below therapeutic 14.26 10.69 3 66579 10 90561855
Epilepsy 14.26 10.69 24 66558 82182 90479683
Tubulointerstitial nephritis 14.23 10.69 46 66536 25297 90536568
Teratogenicity 14.22 10.69 6 66576 285 90561580
Bacterial pyelonephritis 14.22 10.69 7 66575 477 90561388
Coccydynia 14.20 10.69 12 66570 2079 90559786
Anti-thyroid antibody positive 14.08 10.69 7 66575 487 90561378
Device dislocation 14.01 10.69 3 66579 31479 90530386
Vascular access site pain 13.92 10.69 7 66575 499 90561366
Fatigue 13.88 10.69 700 65882 1153323 89408542
Micrognathia 13.84 10.69 6 66576 305 90561560
Product contamination chemical 13.83 10.69 3 66579 12 90561853
Disability assessment scale score decreased 13.83 10.69 3 66579 12 90561853
Myocarditis 13.78 10.69 31 66551 13775 90548090
Acquired haemophilia 13.74 10.69 9 66573 1060 90560805
Accidental exposure to product 13.69 10.69 7 66575 42359 90519506
Liver function test increased 13.61 10.69 26 66556 84829 90477036
Hallucination, olfactory 13.60 10.69 6 66576 318 90561547
Gastrooesophageal reflux disease 13.53 10.69 184 66398 166153 90395712
Chronic spontaneous urticaria 13.52 10.69 11 66571 1809 90560056
Vasculitis 13.48 10.69 42 66540 22651 90539214
Vitamin B12 decreased 13.43 10.69 18 66564 5292 90556573
Tachycardia paroxysmal 13.43 10.69 6 66576 328 90561537
Meralgia paraesthetica 13.41 10.69 7 66575 540 90561325
Affective disorder 13.34 10.69 22 66560 7771 90554094
Eyelid injury 13.32 10.69 5 66577 174 90561691
Rheumatoid arthritis 13.27 10.69 187 66395 362427 90199438
Procedural pain 13.26 10.69 4 66578 33356 90528509
Ventricular tachycardia 13.12 10.69 44 66538 24664 90537201
Electrocardiogram Q wave abnormal 13.06 10.69 5 66577 184 90561681
Pericarditis constrictive 13.04 10.69 7 66575 571 90561294
Drug hypersensitivity 13.04 10.69 251 66331 463358 90098507
Acid base balance abnormal 13.00 10.69 6 66576 354 90561511
Cardiac failure congestive 12.98 10.69 120 66462 98574 90463291
Cerebral haemorrhage 12.94 10.69 55 66527 34467 90527398
Oedema 12.93 10.69 90 66492 200205 90361660
Torsade de pointes 12.88 10.69 32 66550 15150 90546715
Iliac artery stenosis 12.84 10.69 4 66578 78 90561787
Walking aid user 12.83 10.69 5 66577 35501 90526364
Nasal discomfort 12.81 10.69 18 66564 5530 90556335
Heart rate increased 12.76 10.69 133 66449 112769 90449096
Vasoconstriction 12.73 10.69 8 66574 877 90560988
Necrotising panniculitis 12.69 10.69 3 66579 19 90561846
Macular degeneration 12.68 10.69 6 66576 37964 90523901
Mean cell volume increased 12.67 10.69 17 66565 5004 90556861
Resorption bone increased 12.66 10.69 9 66573 1210 90560655
Intentional self-injury 12.64 10.69 3 66579 29331 90532534
Polycythaemia 12.64 10.69 9 66573 1214 90560651
Renin increased 12.62 10.69 5 66577 202 90561663
Arrhythmia 12.58 10.69 63 66519 42269 90519596
Epileptic encephalopathy 12.55 10.69 6 66576 383 90561482
Drug abuse 12.55 10.69 26 66556 82321 90479544
Hyperglycaemia 12.53 10.69 72 66510 50898 90510967
Vipoma 12.43 10.69 4 66578 87 90561778
Ejection fraction decreased 12.42 10.69 45 66537 26208 90535657
Increased appetite 12.40 10.69 27 66555 11738 90550127
Nail discomfort 12.39 10.69 4 66578 88 90561777
Cardioactive drug level decreased 12.39 10.69 4 66578 88 90561777
Microtia 12.38 10.69 6 66576 395 90561470
Onychomycosis 12.34 10.69 6 66576 37370 90524495
Schizoaffective disorder 12.34 10.69 17 66565 5130 90556735
Agitation 12.30 10.69 88 66494 67010 90494855
Contusion 12.09 10.69 122 66460 251094 90310771
Infected lymphocele 12.04 10.69 5 66577 228 90561637
Transplant dysfunction 12.00 10.69 17 66565 5265 90556600
Palatal oedema 11.99 10.69 7 66575 672 90561193
Defect conduction intraventricular 11.98 10.69 5 66577 231 90561634
Hypocalcaemia 11.86 10.69 62 66520 42306 90519559
Angular cheilitis 11.83 10.69 8 66574 993 90560872
Postoperative hypertension 11.76 10.69 3 66579 27 90561838
Bacterial rhinitis 11.76 10.69 3 66579 27 90561838
Sacroiliitis 11.75 10.69 15 66567 4204 90557661
Anal fissure 11.74 10.69 17 66565 5368 90556497
Respiration abnormal 11.69 10.69 21 66561 7942 90553923
Complicated appendicitis 11.69 10.69 4 66578 106 90561759
Inflammation 11.65 10.69 80 66502 178512 90383353
Renin decreased 11.62 10.69 4 66578 108 90561757
Renal tubular disorder 11.56 10.69 13 66569 3194 90558671
Musculoskeletal chest pain 11.48 10.69 41 66541 23709 90538156
Pachymeningitis 11.46 10.69 5 66577 258 90561607
Needle issue 11.44 10.69 29 66553 13905 90547960
Thirst 11.44 10.69 32 66550 16263 90545602
Faeces discoloured 11.35 10.69 38 66544 21282 90540583
Dyspnoea paroxysmal nocturnal 11.28 10.69 8 66574 1072 90560793
Nasal dryness 11.27 10.69 17 66565 5566 90556299
Lichen planus 11.25 10.69 12 66570 2779 90559086
Vulvovaginal inflammation 11.16 10.69 8 66574 1090 90560775
Left-to-right cardiac shunt 11.13 10.69 5 66577 277 90561588
Incision site swelling 11.09 10.69 5 66577 279 90561586
Surgery 11.05 10.69 10 66572 44877 90516988
Bifascicular block 11.01 10.69 4 66578 127 90561738
Dry skin 10.90 10.69 31 66551 88042 90473823
Monocyte count increased 10.90 10.69 22 66560 9075 90552790
Incision site erythema 10.89 10.69 6 66576 516 90561349
Anticoagulation drug level abnormal 10.86 10.69 4 66578 132 90561733
Eye oedema 10.86 10.69 10 66572 1942 90559923
Paraneoplastic pleural effusion 10.83 10.69 3 66579 38 90561827
Immune-mediated myositis 10.82 10.69 11 66571 2410 90559455
Skin oedema 10.81 10.69 8 66574 1146 90560719
Ultrasound antenatal screen abnormal 10.80 10.69 4 66578 134 90561731
Mucosal hyperaemia 10.76 10.69 3 66579 39 90561826
Acute generalised exanthematous pustulosis 10.71 10.69 28 66554 13675 90548190

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 231.60 11.04 1099 60776 366238 42193222
Lactic acidosis 176.20 11.04 269 61606 44992 42514468
Death 156.17 11.04 279 61596 470906 42088554
Hyperkalaemia 113.63 11.04 314 61561 80144 42479316
Ejection fraction decreased 109.01 11.04 147 61728 21940 42537520
Product dose omission issue 99.34 11.04 50 61825 154315 42405145
Blood pressure increased 95.34 11.04 345 61530 101583 42457877
Drug interaction 91.66 11.04 682 61193 266317 42293143
Bradycardia 90.05 11.04 301 61574 85183 42474277
Drug abuse 87.70 11.04 22 61853 104749 42454711
Red blood cell sedimentation rate abnormal 83.50 11.04 58 61817 3778 42555682
Bone erosion 83.02 11.04 61 61814 4342 42555118
Atrial enlargement 81.58 11.04 33 61842 696 42558764
Eosinophilia 81.30 11.04 160 61715 32739 42526721
Euglycaemic diabetic ketoacidosis 79.75 11.04 66 61809 5594 42553866
Completed suicide 79.31 11.04 21 61854 96444 42463016
Blood pressure systolic increased 76.47 11.04 142 61733 27826 42531634
Venous pressure jugular increased 76.38 11.04 32 61843 740 42558720
Left ventricular dysfunction 75.01 11.04 88 61787 11413 42548047
Drug ineffective 71.92 11.04 579 61296 629618 41929842
Drug tolerance decreased 71.76 11.04 44 61831 2316 42557144
Asthma-chronic obstructive pulmonary disease overlap syndrome 71.46 11.04 38 61837 1521 42557939
Atrial fibrillation 70.24 11.04 393 61482 139200 42420260
Ischaemic stroke 66.01 11.04 117 61758 22116 42537344
Rheumatoid factor negative 64.95 11.04 31 61844 983 42558477
Cardiomyopathy 63.47 11.04 106 61769 19104 42540356
Left atrial enlargement 61.33 11.04 30 61845 1005 42558455
Melaena 59.46 11.04 156 61719 38590 42520870
Angioedema 57.19 11.04 163 61712 42314 42517146
Hyponatraemia 56.66 11.04 294 61581 101168 42458292
White blood cell count decreased 55.72 11.04 47 61828 110349 42449111
Cardiac failure 54.49 11.04 302 61573 106554 42452906
Skin injury 53.00 11.04 38 61837 2603 42556857
Dyspnoea exertional 52.25 11.04 176 61699 49972 42509488
Cardiac failure chronic 52.16 11.04 67 61808 9534 42549926
Middle insomnia 49.53 11.04 59 61816 7774 42551686
Thrombosis 49.06 11.04 19 61856 68492 42490968
Disease progression 48.29 11.04 84 61791 143572 42415888
Pneumonia 47.90 11.04 388 61487 421761 42137699
Coma scale abnormal 47.84 11.04 45 61830 4520 42554940
Joint ankylosis 45.29 11.04 29 61846 1648 42557812
Ventricular enlargement 44.11 11.04 21 61854 662 42558798
Heart rate decreased 43.29 11.04 134 61741 36398 42523062
Left ventricular enlargement 43.06 11.04 22 61853 810 42558650
Obesity 43.03 11.04 82 61793 16377 42543083
Inappropriate antidiuretic hormone secretion 42.75 11.04 82 61793 16459 42543001
Hepatic vein dilatation 42.35 11.04 15 61860 216 42559244
Bone cyst 40.79 11.04 27 61848 1624 42557836
Rash 40.55 11.04 236 61639 276718 42282742
Depression 40.33 11.04 62 61813 111301 42448159
Hypokalaemia 40.14 11.04 208 61667 71513 42487947
Contraindicated product administered 40.05 11.04 103 61772 25169 42534291
Febrile neutropenia 40.00 11.04 137 61738 185566 42373894
Diastolic dysfunction 39.94 11.04 50 61825 6933 42552527
Encephalitis toxic 39.69 11.04 15 61860 262 42559198
Liver palpable 38.62 11.04 15 61860 283 42559177
Dyspnoea at rest 37.27 11.04 38 61837 4211 42555249
Anti-cyclic citrullinated peptide antibody positive 37.20 11.04 27 61848 1885 42557575
Asthma 36.46 11.04 183 61692 62131 42497329
Rales 36.45 11.04 62 61813 11338 42548122
Transferrin saturation decreased 36.09 11.04 17 61858 523 42558937
Hypotension 34.44 11.04 545 61330 257086 42302374
Obstructive airways disorder 34.28 11.04 96 61779 24663 42534797
Body temperature decreased 34.27 11.04 69 61806 14344 42545116
Congestive cardiomyopathy 33.94 11.04 52 61823 8712 42550748
Hepatic fibrosis 32.97 11.04 38 61837 4834 42554626
Cardiac dysfunction 32.76 11.04 32 61843 3367 42556093
Exercise tolerance decreased 32.43 11.04 42 61833 6024 42553436
Mental status changes 31.29 11.04 11 61864 42104 42517356
Product use in unapproved indication 30.96 11.04 150 61725 184306 42375154
Ventricular hyperkinesia 30.92 11.04 12 61863 226 42559234
Sinusitis 30.86 11.04 15 61860 47277 42512183
Aptyalism 30.81 11.04 14 61861 396 42559064
Hypomagnesaemia 30.57 11.04 101 61774 28387 42531073
Chest discomfort 30.55 11.04 177 61698 63439 42496021
Pyrexia 30.28 11.04 397 61478 393645 42165815
Haemorrhagic stroke 30.20 11.04 45 61830 7357 42552103
Oedema peripheral 30.11 11.04 316 61559 135760 42423700
Coronary artery stenosis 30.01 11.04 54 61821 10325 42549135
Tricuspid valve incompetence 29.84 11.04 56 61819 11057 42548403
Decreased gait velocity 29.77 11.04 11 61864 180 42559280
Hepatitis B core antibody positive 29.58 11.04 13 61862 339 42559121
Blood iron decreased 29.57 11.04 41 61834 6277 42553183
Retroperitoneal fibrosis 29.50 11.04 14 61861 438 42559022
Metabolic acidosis 29.43 11.04 151 61724 51707 42507753
Blood pressure diastolic increased 29.14 11.04 41 61834 6364 42553096
Right atrial enlargement 28.70 11.04 12 61863 276 42559184
Stenosis 28.56 11.04 24 61851 2077 42557383
Bronchial hyperreactivity 28.24 11.04 23 61852 1906 42557554
Diabetes mellitus 28.09 11.04 166 61709 59921 42499539
Mitral valve incompetence 28.00 11.04 69 61806 16420 42543040
Foetal exposure during pregnancy 27.97 11.04 17 61858 47294 42512166
Breath sounds abnormal 27.70 11.04 57 61818 12036 42547424
Bone marrow failure 27.57 11.04 7 61868 33086 42526374
Hypochromasia 27.10 11.04 12 61863 319 42559141
Ventricular hypokinesia 26.88 11.04 41 61834 6843 42552617
Inferior vena cava dilatation 26.77 11.04 16 61859 804 42558656
Drug ineffective for unapproved indication 26.72 11.04 17 61858 46146 42513314
Left ventricular hypertrophy 26.33 11.04 48 61827 9271 42550189
Cytokine release syndrome 26.32 11.04 16 61859 44511 42514949
Hypovolaemic shock 26.26 11.04 46 61829 8613 42550847
Rheumatoid arthritis 25.79 11.04 126 61749 42314 42517146
Toxicity to various agents 25.71 11.04 211 61664 228925 42330535
Onychoclasis 25.62 11.04 25 61850 2627 42556833
Gait spastic 25.40 11.04 19 61856 1390 42558070
Glomerular filtration rate decreased 25.24 11.04 66 61809 16285 42543175
Parathyroid hormone-related protein abnormal 25.18 11.04 6 61869 17 42559443
Platelet count decreased 24.84 11.04 110 61765 138471 42420989
Mean platelet volume increased 24.83 11.04 14 61861 630 42558830
Stomatitis 24.68 11.04 22 61853 50307 42509153
Myelosuppression 24.68 11.04 14 61861 40447 42519013
Cerebral haemorrhage 24.63 11.04 117 61758 38849 42520611
No adverse event 24.53 11.04 13 61862 39008 42520452
Osteolysis 24.36 11.04 28 61847 3552 42555908
Plasma cell myeloma 24.30 11.04 20 61855 47558 42511902
Therapy non-responder 24.21 11.04 25 61850 53334 42506126
Dyspnoea 24.02 11.04 825 61050 441796 42117664
Vasoplegia syndrome 23.75 11.04 24 61851 2631 42556829
Cardiac failure congestive 23.67 11.04 56 61819 85546 42473914
Pulmonary function test abnormal 23.46 11.04 24 61851 2670 42556790
Haemorrhagic transformation stroke 23.41 11.04 20 61855 1771 42557689
Arthropathy 23.37 11.04 95 61780 29502 42529958
Atheroembolism 23.24 11.04 11 61864 342 42559118
Hypokinesia 23.17 11.04 47 61828 9824 42549636
Cytomegalovirus infection 23.05 11.04 9 61866 32297 42527163
Mitral valve thickening 22.85 11.04 12 61863 468 42558992
Off label use 22.85 11.04 730 61145 637605 41921855
Ventricular dyskinesia 22.82 11.04 10 61865 259 42559201
Dermatomyositis 22.82 11.04 19 61856 1624 42557836
Cough 22.72 11.04 374 61501 177729 42381731
Neuropathy peripheral 22.68 11.04 74 61801 101779 42457681
Wheezing 22.26 11.04 146 61729 54635 42504825
Orthopnoea 22.20 11.04 33 61842 5384 42554076
Unevaluable event 22.18 11.04 11 61864 34277 42525183
Multiple organ dysfunction syndrome 21.96 11.04 70 61805 96965 42462495
Acute coronary syndrome 21.93 11.04 59 61816 14806 42544654
Lip oedema 21.83 11.04 25 61850 3159 42556301
N-terminal prohormone brain natriuretic peptide increased 21.82 11.04 26 61849 3427 42556033
Metabolic syndrome 21.65 11.04 20 61855 1963 42557497
Hypocalcaemia 21.60 11.04 94 61781 30079 42529381
Electrocardiogram QT prolonged 21.48 11.04 131 61744 47814 42511646
Dissociation 21.41 11.04 27 61848 3771 42555689
Neutrophil count decreased 21.36 11.04 37 61838 63378 42496082
Cerebral haematoma 21.32 11.04 33 61842 5577 42553883
Cardiac murmur 21.21 11.04 53 61822 12722 42546738
Joint swelling 21.14 11.04 170 61705 67852 42491608
Psychotic disorder due to a general medical condition 21.00 11.04 7 61868 83 42559377
Intentional product misuse 20.96 11.04 36 61839 61864 42497596
Orthostatic hypotension 20.95 11.04 94 61781 30476 42528984
Ventricular tachycardia 20.86 11.04 93 61782 30067 42529393
Seizure 20.82 11.04 97 61778 120464 42438996
Weight increased 20.78 11.04 244 61631 107739 42451721
Portal vein flow decreased 20.77 11.04 5 61870 15 42559445
Tachyarrhythmia 20.67 11.04 27 61848 3905 42555555
Pancreatitis acute 20.64 11.04 100 61775 33464 42525996
Crepitations 20.49 11.04 25 61850 3376 42556084
Bundle branch block left 20.41 11.04 35 61840 6441 42553019
Abdominal mass 20.31 11.04 21 61854 2365 42557095
Respiratory arrest 20.15 11.04 8 61867 28416 42531044
Heart rate irregular 20.06 11.04 60 61815 15990 42543470
Sputum discoloured 20.04 11.04 45 61830 10087 42549373
Hand deformity 20.00 11.04 26 61849 3742 42555718
Hypocalvaria 19.89 11.04 6 61869 50 42559410
Pain 19.76 11.04 244 61631 244604 42314856
Carboxyhaemoglobin increased 19.58 11.04 6 61869 53 42559407
Sepsis 19.52 11.04 190 61685 199144 42360316
Paratracheal lymphadenopathy 19.26 11.04 7 61868 109 42559351
Lower respiratory tract congestion 19.16 11.04 17 61858 1583 42557877
Myocardial ischaemia 19.08 11.04 63 61812 17699 42541761
Ischaemic cardiomyopathy 18.94 11.04 34 61841 6488 42552972
Scan gallium abnormal 18.93 11.04 5 61870 24 42559436
Chondropathy 18.82 11.04 15 61860 1205 42558255
Decreased ventricular preload 18.60 11.04 5 61870 26 42559434
Sarcopenia 18.47 11.04 13 61862 865 42558595
Hypertrophic cardiomyopathy 18.42 11.04 16 61859 1449 42558011
Syncope 18.41 11.04 223 61652 99183 42460277
Anuria 18.27 11.04 47 61828 11485 42547975
Hypoparathyroidism 18.26 11.04 12 61863 713 42558747
Anion gap abnormal 18.21 11.04 10 61865 427 42559033
Injection site erosion 18.03 11.04 7 61868 132 42559328
Glycosylated haemoglobin decreased 18 11.04 10 61865 437 42559023
Crystalluria 17.89 11.04 12 61863 738 42558722
Blood pressure fluctuation 17.88 11.04 82 61793 26826 42532634
Productive cough 17.75 11.04 132 61743 51435 42508025
Diabetic foot 17.57 11.04 22 61853 3051 42556409
Varicose vein 17.53 11.04 16 61859 1546 42557914
Ligament calcification 17.39 11.04 8 61867 233 42559227
Necrotising oesophagitis 17.29 11.04 13 61862 958 42558502
Renal phospholipidosis 17.24 11.04 7 61868 149 42559311
Hypoosmolar state 17.24 11.04 7 61868 149 42559311
Intensive care 16.98 11.04 14 61861 1180 42558280
Incorrect route of product administration 16.97 11.04 7 61868 24298 42535162
Perfume sensitivity 16.82 11.04 7 61868 159 42559301
Poisoning deliberate 16.78 11.04 42 61833 10092 42549368
Muscle haemorrhage 16.72 11.04 25 61850 4100 42555360
Osmolar gap abnormal 16.65 11.04 5 61870 41 42559419
Laryngeal haematoma 16.62 11.04 7 61868 164 42559296
Sinoatrial block 16.51 11.04 10 61865 515 42558945
Dermatitis exfoliative generalised 16.45 11.04 30 61845 5794 42553666
Vascular purpura 16.42 11.04 18 61857 2168 42557292
Tongue oedema 16.28 11.04 22 61853 3288 42556172
Mumps 16.25 11.04 6 61869 98 42559362
Acute myeloid leukaemia 16.21 11.04 6 61869 22250 42537210
Blood pressure diastolic decreased 16.14 11.04 42 61833 10333 42549127
Atrioventricular block 16.08 11.04 40 61835 9575 42549885
Shock haemorrhagic 16.03 11.04 56 61819 16186 42543274
Type 2 diabetes mellitus 15.96 11.04 61 61814 18410 42541050
Ill-defined disorder 15.92 11.04 56 61819 16240 42543220
Rhabdomyolysis 15.77 11.04 178 61697 77841 42481619
Episcleral venous pressure increased 15.73 11.04 4 61871 16 42559444
Drug resistance 15.59 11.04 16 61859 34232 42525228
Acute pulmonary oedema 15.54 11.04 37 61838 8614 42550846
Renal failure 15.53 11.04 294 61581 143432 42416028
Electrocardiogram T wave inversion 15.45 11.04 18 61857 2316 42557144
Photosensitivity reaction 15.42 11.04 47 61828 12655 42546805
Expiratory reserve volume decreased 15.36 11.04 6 61869 115 42559345
Muscular weakness 15.32 11.04 187 61688 83311 42476149
Pancytopenia 15.29 11.04 104 61771 117639 42441821
Anticoagulation drug level increased 15.25 11.04 10 61865 592 42558868
Smoke sensitivity 15.18 11.04 7 61868 205 42559255
Hepatic enzyme increased 15.16 11.04 27 61848 45757 42513703
Drug dependence 15.14 11.04 12 61863 29082 42530378
Blood chromogranin A increased 15.05 11.04 8 61867 320 42559140
Fall 14.98 11.04 446 61429 234074 42325386
C-reactive protein abnormal 14.93 11.04 38 61837 9223 42550237
Coagulation factor VII level decreased 14.90 11.04 6 61869 125 42559335
Procedural hypertension 14.87 11.04 5 61870 61 42559399
Muscle injury 14.75 11.04 15 61860 1657 42557803
Acute myocardial infarction 14.75 11.04 139 61736 58026 42501434
Dry skin 14.69 11.04 30 61845 48308 42511152
Blood lactic acid decreased 14.65 11.04 5 61870 64 42559396
Alanine aminotransferase abnormal 14.65 11.04 26 61849 4918 42554542
Postoperative respiratory failure 14.60 11.04 6 61869 132 42559328
Peripheral artery haematoma 14.58 11.04 5 61870 65 42559395
Dyslipidaemia 14.52 11.04 38 61837 9380 42550080
Product quality issue 14.48 11.04 4 61871 17878 42541582
Nausea 14.32 11.04 453 61422 396346 42163114
Diabetes mellitus inadequate control 14.28 11.04 52 61823 15338 42544122
Volume blood decreased 14.27 11.04 7 61868 236 42559224
Wrong technique in product usage process 14.24 11.04 25 61850 42610 42516850
Potentiating drug interaction 14.24 11.04 30 61845 6438 42553022
Cholestasis 14.20 11.04 89 61786 32790 42526670
Vital capacity decreased 14.11 11.04 9 61866 508 42558952
Liver function test increased 14.08 11.04 62 61813 19936 42539524
Injection site injury 13.99 11.04 8 61867 370 42559090
Laboratory test abnormal 13.94 11.04 8 61867 22970 42536490
Unresponsive to stimuli 13.92 11.04 15 61860 31388 42528072
Dropped head syndrome 13.92 11.04 7 61868 249 42559211
Heart rate increased 13.87 11.04 128 61747 53127 42506333
Biopsy bone marrow 13.75 11.04 5 61870 78 42559382
Neuroleptic malignant syndrome 13.72 11.04 7 61868 21465 42537995
Neck injury 13.72 11.04 13 61862 1318 42558142
Drug level above therapeutic 13.71 11.04 28 61847 5878 42553582
Coronary artery occlusion 13.64 11.04 41 61834 10956 42548504
Choking 13.62 11.04 29 61846 6269 42553191
Transitional cell carcinoma 13.58 11.04 18 61857 2640 42556820
High density lipoprotein decreased 13.54 11.04 22 61853 3875 42555585
Rash maculo-papular 13.48 11.04 97 61778 37406 42522054
Ascites 13.45 11.04 40 61835 56638 42502822
Faeces pale 13.37 11.04 14 61861 1600 42557860
Colitis ulcerative 13.33 11.04 74 61801 26101 42533359
Cutaneous symptom 13.33 11.04 8 61867 405 42559055
Left ventricular failure 13.31 11.04 28 61847 6003 42553457
Hospitalisation 13.31 11.04 59 61816 74271 42485189
Abnormal loss of weight 13.22 11.04 25 61850 4962 42554498
Balance disorder 13.16 11.04 116 61759 47529 42511931
Accidental overdose 13.16 11.04 13 61862 28317 42531143
Arteriovenous fistula site haematoma 13.09 11.04 4 61871 35 42559425
Right ventricular dysfunction 13.09 11.04 13 61862 1396 42558064
Cutaneous vasculitis 13.04 11.04 30 61845 6830 42552630
Duplicate therapy error 12.96 11.04 7 61868 289 42559171
Colon cancer 12.87 11.04 37 61838 9644 42549816
Traumatic intracranial haematoma 12.80 11.04 4 61871 38 42559422
Dysmetria 12.77 11.04 10 61865 783 42558677
Red cell distribution width increased 12.74 11.04 30 61845 6934 42552526
Skin laceration 12.62 11.04 47 61828 14011 42545449
Constipation 12.60 11.04 163 61712 162128 42397332
Blood pressure inadequately controlled 12.52 11.04 18 61857 2850 42556610
Measles 12.47 11.04 7 61868 312 42559148
Adverse drug reaction 12.46 11.04 22 61853 37412 42522048
Superior vena cava occlusion 12.42 11.04 5 61870 104 42559356
Wrong patient 12.38 11.04 9 61866 630 42558830
Respiratory depression 12.28 11.04 6 61869 18862 42540598
Blood cyanide increased 12.27 11.04 4 61871 44 42559416
Encephalopathy 12.27 11.04 26 61849 41307 42518153
Faeces soft 12.26 11.04 24 61851 4888 42554572
Living alone 12.11 11.04 4 61871 46 42559414
Hepatocellular injury 12.10 11.04 67 61808 23611 42535849
Acute respiratory failure 11.91 11.04 24 61851 38834 42520626
Left atrial dilatation 11.87 11.04 16 61859 2386 42557074
Lung diffusion test decreased 11.87 11.04 10 61865 869 42558591
Thyroxine decreased 11.82 11.04 6 61869 218 42559242
Ventricle rupture 11.81 11.04 4 61871 50 42559410
Therapy interrupted 11.81 11.04 9 61866 22241 42537219
Hepatic cytolysis 11.80 11.04 73 61802 26771 42532689
Hydrocholecystis 11.80 11.04 8 61867 501 42558959
Coagulopathy 11.71 11.04 9 61866 22153 42537307
Benign bone neoplasm 11.61 11.04 3 61872 13 42559447
Premature baby 11.49 11.04 10 61865 23143 42536317
Porokeratosis 11.46 11.04 5 61870 128 42559332
Bronchopulmonary aspergillosis 11.45 11.04 7 61868 19422 42540038
Ischaemic cerebral infarction 11.43 11.04 13 61862 1630 42557830
Hypoglycaemia 11.39 11.04 135 61740 59719 42499741
Ventricular extrasystoles 11.39 11.04 44 61831 13346 42546114
Cyclothymic disorder 11.36 11.04 5 61870 131 42559329
Fatigue 11.35 11.04 517 61358 435124 42124336
Myocarditis 11.34 11.04 56 61819 18882 42540578
Mixed liver injury 11.34 11.04 22 61853 4452 42555008
Carditis 11.33 11.04 6 61869 238 42559222
Electrocardiogram T wave amplitude decreased 11.30 11.04 7 61868 375 42559085
Oedema genital 11.30 11.04 8 61867 537 42558923
Peripheral swelling 11.28 11.04 189 61686 90081 42469379
Forced vital capacity decreased 11.28 11.04 10 61865 930 42558530
Needle issue 11.26 11.04 33 61842 8694 42550766
Tri-iodothyronine decreased 11.22 11.04 5 61870 135 42559325
Anxiety 11.18 11.04 114 61761 118446 42441014
Inflammation 11.17 11.04 20 61855 33827 42525633
Hepatic steatosis 11.17 11.04 61 61814 21387 42538073
Dementia 11.10 11.04 5 61870 16475 42542985
Arterial stenosis 11.10 11.04 11 61864 1178 42558282
Drug withdrawal syndrome 11.08 11.04 9 61866 21540 42537920
Respiratory distress 11.05 11.04 28 61847 41792 42517668

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 753.22 10.22 1939 118891 633491 109834978
Lactic acidosis 403.01 10.22 502 120328 92309 110376160
Hyponatraemia 337.76 10.22 739 120091 216914 110251555
Hyperkalaemia 293.75 10.22 530 120300 135266 110333203
Sensitisation 287.53 10.22 123 120707 4028 110464441
Polycystic ovaries 270.47 10.22 123 120707 4673 110463796
Ejection fraction 239.73 10.22 98 120732 2857 110465612
Drug interaction 236.60 10.22 1127 119703 499056 109969413
Systemic lupus erythematosus 222.34 10.22 14 120816 254324 110214145
Blood pressure increased 213.26 10.22 694 120136 257679 110210790
Bradycardia 203.56 10.22 494 120336 155023 110313446
Maternal exposure during pregnancy 200.92 10.22 22 120808 254861 110213608
Atrial fibrillation 193.26 10.22 621 120209 229021 110239448
Cardiac failure 191.41 10.22 543 120287 187083 110281386
Blood pressure systolic increased 189.80 10.22 332 120498 82659 110385810
Glossodynia 186.03 10.22 15 120815 221989 110246480
Pemphigus 175.68 10.22 16 120814 214554 110253915
Duodenal ulcer perforation 174.78 10.22 4 120826 177696 110290773
Sleep apnoea syndrome 169.46 10.22 215 120615 40232 110428237
Completed suicide 163.32 10.22 33 120797 242348 110226121
Hypothyroidism 163.29 10.22 289 120541 72610 110395859
Alopecia 153.84 10.22 105 120725 364648 110103821
Carpal tunnel syndrome 148.94 10.22 152 120678 22458 110446011
Synovitis 148.16 10.22 57 120773 274035 110194434
Hypotension 144.88 10.22 1024 119806 522825 109945644
Folliculitis 144.22 10.22 10 120820 167643 110300826
Angioedema 138.70 10.22 322 120508 98178 110370291
Hand deformity 138.65 10.22 34 120796 218472 110249997
Pericarditis 133.49 10.22 37 120793 219077 110249392
Helicobacter infection 132.93 10.22 20 120810 181857 110286612
Ejection fraction abnormal 132.30 10.22 68 120762 3392 110465077
Blood pressure fluctuation 132.09 10.22 268 120562 74556 110393913
Rhinitis allergic 131.94 10.22 128 120702 17794 110450675
Irritable bowel syndrome 129.83 10.22 14 120816 164201 110304268
Death 126.16 10.22 370 120460 698499 109769970
Inappropriate antidiuretic hormone secretion 124.83 10.22 169 120661 33682 110434787
Injury 121.79 10.22 23 120807 177242 110291227
Metabolic acidosis 121.14 10.22 308 120522 99436 110369033
Blood test abnormal 118.37 10.22 151 120679 28403 110440066
Anti-cyclic citrullinated peptide antibody positive 118.05 10.22 27 120803 181957 110286512
Ejection fraction decreased 114.23 10.22 179 120651 40701 110427768
Impaired healing 112.97 10.22 37 120793 196680 110271789
Cardiac disorder 112.51 10.22 254 120576 76026 110392443
Exposure during pregnancy 110.29 10.22 24 120806 167400 110301069
Melaena 109.38 10.22 236 120594 68521 110399948
Wound 109.22 10.22 60 120770 234377 110234092
Eosinophilia 108.85 10.22 213 120617 57723 110410746
Loss of employment 106.02 10.22 58 120772 3286 110465183
Euglycaemic diabetic ketoacidosis 104.89 10.22 93 120737 11530 110456939
Cough 102.19 10.22 857 119973 460784 110007685
Nephrectomy 98.39 10.22 51 120779 2589 110465880
Product dose omission issue 94.46 10.22 128 120702 321654 110146815
Lip dry 92.16 10.22 4 120826 100079 110368390
Ischaemic stroke 90.35 10.22 162 120668 41101 110427368
Cardiac failure chronic 89.43 10.22 92 120738 13719 110454750
Discomfort 87.58 10.22 64 120766 214643 110253826
Renal disorder 87.05 10.22 177 120653 49302 110419167
Hyperlactacidaemia 86.36 10.22 72 120758 8214 110460255
Drug abuse 86.18 10.22 43 120787 177368 110291101
Joint range of motion decreased 83.27 10.22 16 120814 121816 110346653
Heart rate decreased 82.85 10.22 238 120592 82518 110385951
Atrial enlargement 82.68 10.22 35 120795 1116 110467353
Diabetes mellitus 81.92 10.22 267 120563 99114 110369355
Fall 81.00 10.22 1011 119819 602471 109865998
Muscle injury 79.93 10.22 27 120803 140780 110327689
Stomatitis 77.79 10.22 109 120721 270133 110198336
Cardiomyopathy 77.77 10.22 135 120695 33390 110435079
Hepatic enzyme increased 76.88 10.22 146 120684 320746 110147723
Left ventricular dysfunction 75.77 10.22 110 120720 23383 110445086
Infection 74.13 10.22 180 120650 362020 110106449
Cerebral haematoma 73.18 10.22 70 120760 9562 110458907
Swelling 72.99 10.22 173 120657 350868 110117601
Peripheral venous disease 72.38 10.22 5 120825 84112 110384357
Product use in unapproved indication 72.09 10.22 249 120581 447128 110021341
Pain 71.52 10.22 683 120147 954272 109514197
Hypokalaemia 71.23 10.22 390 120440 182058 110286411
Mixed liver injury 70.27 10.22 76 120754 12003 110456466
Blister 70.25 10.22 87 120743 227289 110241180
Therapy non-responder 69.36 10.22 43 120787 157264 110311205
Rhabdomyolysis 68.54 10.22 287 120543 120114 110348355
Venous pressure jugular increased 67.90 10.22 32 120798 1320 110467149
Tongue oedema 66.55 10.22 62 120768 8194 110460275
Electrocardiogram QT prolonged 66.19 10.22 265 120565 108695 110359774
Rheumatoid factor negative 66.00 10.22 31 120799 1269 110467200
Grip strength decreased 65.54 10.22 6 120824 80168 110388301
Left atrial enlargement 63.25 10.22 33 120797 1698 110466771
Pemphigoid 63.16 10.22 92 120738 19615 110448854
Disease progression 62.96 10.22 106 120724 243928 110224541
Blood pressure diastolic decreased 62.68 10.22 128 120702 35757 110432712
Renal failure 61.93 10.22 442 120388 226132 110242337
Oesophageal spasm 60.71 10.22 42 120788 3624 110464845
Lower limb fracture 60.64 10.22 6 120824 75342 110393127
Blood pressure systolic abnormal 60.18 10.22 102 120728 24748 110443721
Orthostatic hypotension 60.10 10.22 184 120646 66065 110402404
Hypertension 59.82 10.22 834 119996 509250 109959219
Sleep disorder 58.28 10.22 79 120751 198565 110269904
Hypovolaemic shock 57.13 10.22 75 120755 14508 110453961
Hepatic steatosis 56.39 10.22 148 120682 48683 110419786
Coma scale abnormal 56.24 10.22 61 120769 9665 110458804
Middle insomnia 56.20 10.22 89 120741 20413 110448056
Diabetes mellitus inadequate control 55.35 10.22 109 120721 29666 110438803
Drug ineffective 55.30 10.22 1254 119576 1519286 108949183
Bursitis 55.25 10.22 37 120793 129881 110338588
Sinusitis 54.92 10.22 155 120675 296533 110171936
Treatment failure 54.20 10.22 141 120689 277093 110191376
Psoriatic arthropathy 54.02 10.22 82 120748 196679 110271790
Myocardial infarction 53.82 10.22 377 120453 191706 110276763
Pyrexia 53.42 10.22 677 120153 897588 109570881
Product tampering 53.39 10.22 20 120810 459 110468010
Pancreatitis acute 53.37 10.22 166 120664 60108 110408361
Deep vein thrombosis postoperative 52.58 10.22 3 120827 59288 110409181
Myelosuppression 51.98 10.22 19 120811 94321 110374148
Ventricular enlargement 51.95 10.22 22 120808 702 110467767
Asthma 51.79 10.22 458 120372 249833 110218636
Rash 51.74 10.22 611 120219 820353 109648116
Hypomagnesaemia 51.37 10.22 164 120666 60206 110408263
Arthropathy 51.18 10.22 153 120677 287369 110181100
Body temperature decreased 51.15 10.22 120 120710 36815 110431654
White blood cell count decreased 50.96 10.22 109 120721 229281 110239188
Shock haemorrhagic 50.96 10.22 100 120730 27147 110441322
Blood iron decreased 50.74 10.22 82 120748 19132 110449337
Autoimmune disorder 50.69 10.22 6 120824 65477 110402992
Exercise tolerance decreased 50.31 10.22 64 120766 12003 110456466
Burning sensation 50.04 10.22 178 120652 69034 110399435
Infusion related reaction 49.46 10.22 231 120599 380931 110087538
Dyspnoea at rest 49.40 10.22 53 120777 8293 110460176
Hypoaesthesia 48.51 10.22 178 120652 314045 110154424
Hypersensitivity 48.30 10.22 252 120578 403746 110064723
Oesophageal pain 48.23 10.22 42 120788 5083 110463386
Haemorrhagic stroke 48.06 10.22 67 120763 13722 110454747
Left ventricular enlargement 48.05 10.22 22 120808 849 110467620
Blepharospasm 47.96 10.22 3 120827 54848 110413621
Dry mouth 47.84 10.22 91 120739 199857 110268612
Cholestasis 47.57 10.22 167 120663 64351 110404118
Hypoglycaemia 47.20 10.22 251 120579 115853 110352616
Product quality issue 47.15 10.22 13 120817 77286 110391183
Acute coronary syndrome 47.13 10.22 88 120742 23024 110445445
Blood pressure diastolic increased 46.61 10.22 78 120752 18729 110449740
Sleep disorder due to a general medical condition 46.58 10.22 144 120686 51968 110416501
C-reactive protein abnormal 46.28 10.22 44 120786 129651 110338818
Vasoplegia syndrome 46.08 10.22 42 120788 5397 110463072
Dyspnoea exertional 45.80 10.22 230 120600 103830 110364639
Hepatic vein dilatation 45.72 10.22 15 120815 229 110468240
Hepatic cytolysis 45.44 10.22 148 120682 54905 110413564
Wound infection 44.45 10.22 25 120805 96440 110372029
Mental status changes 44.25 10.22 14 120816 76108 110392361
Pregnancy 44.04 10.22 3 120827 51064 110417405
Night sweats 43.80 10.22 49 120781 133934 110334535
Nephropathy 43.35 10.22 63 120767 13404 110455065
Mobility decreased 43.22 10.22 125 120705 237297 110231172
Nail disorder 43.18 10.22 6 120824 57929 110410540
Febrile neutropenia 42.86 10.22 189 120641 316578 110151891
Cerebral haemorrhage 42.69 10.22 162 120668 64806 110403663
Labile hypertension 42.31 10.22 18 120812 581 110467888
Pneumonia 42.17 10.22 689 120141 876025 109592444
Road traffic accident 41.26 10.22 34 120796 107364 110361105
Injection site reaction 41.16 10.22 23 120807 89047 110379422
Inflammation 41.13 10.22 94 120736 193144 110275325
Ventricular tachycardia 40.87 10.22 134 120696 49875 110418594
Rales 40.58 10.22 86 120744 24653 110443816
Liver palpable 40.38 10.22 15 120815 336 110468133
Shock 39.76 10.22 139 120691 53449 110415020
Acute myocardial infarction 39.60 10.22 189 120641 83588 110384881
Coronary artery stenosis 39.48 10.22 61 120769 13697 110454772
Diabetic ketoacidosis 39.26 10.22 118 120712 41940 110426529
Encephalitis toxic 38.98 10.22 14 120816 284 110468185
Type 2 diabetes mellitus 38.71 10.22 85 120745 177147 110291322
Blood pressure diastolic abnormal 38.10 10.22 86 120744 25729 110442740
Gastrointestinal disorder 38.03 10.22 136 120694 241816 110226653
Tinnitus 37.37 10.22 148 120682 60392 110408077
Asthma-chronic obstructive pulmonary disease overlap syndrome 37.05 10.22 40 120790 6304 110462165
Diastolic dysfunction 37.01 10.22 56 120774 12348 110456121
Anuria 36.94 10.22 82 120748 24259 110444210
Drug hypersensitivity 36.82 10.22 318 120512 453772 110014697
Renal impairment 36.01 10.22 339 120491 188106 110280363
Troponin T increased 35.99 10.22 33 120797 4273 110464196
Hypercholesterolaemia 35.84 10.22 28 120802 90809 110377660
Joint ankylosis 35.35 10.22 26 120804 2471 110465998
Renal tubular necrosis 34.81 10.22 92 120738 30383 110438086
Hepatocellular injury 34.71 10.22 128 120702 50514 110417955
Glomerular filtration rate decreased 34.70 10.22 89 120741 28867 110439602
Hypoosmolar state 34.34 10.22 14 120816 405 110468064
Hypocalcaemia 34.25 10.22 152 120678 65214 110403255
No adverse event 34.22 10.22 19 120811 73820 110394649
Somatic symptom disorder 34.07 10.22 28 120802 3131 110465338
Oedema peripheral 33.61 10.22 525 120305 328135 110140334
Injection site erythema 33.54 10.22 32 120798 94144 110374325
General physical health deterioration 33.52 10.22 300 120530 424995 110043474
Claustrophobia 33.21 10.22 21 120809 1558 110466911
Hip arthroplasty 32.91 10.22 10 120820 55803 110412666
Dermatitis artefacta 32.69 10.22 9 120821 72 110468397
Gait inability 32.67 10.22 62 120768 136314 110332155
Congestive cardiomyopathy 32.64 10.22 57 120773 14162 110454307
Vulvovaginal burning sensation 32.62 10.22 23 120807 2046 110466423
Mitral valve incompetence 31.57 10.22 94 120736 33235 110435234
Decreased gait velocity 31.45 10.22 11 120819 206 110468263
Onychomadesis 31.19 10.22 6 120824 45657 110422812
Adulterated product 31.10 10.22 18 120812 1137 110467332
Depression 31.00 10.22 211 120619 317124 110151345
Syncope 30.91 10.22 348 120482 202188 110266281
Bone cyst 30.87 10.22 28 120802 3575 110464894
Haemorrhagic transformation stroke 30.85 10.22 26 120804 3011 110465458
Cardiac dysfunction 30.80 10.22 36 120794 6187 110462282
Ventricular hyperkinesia 30.74 10.22 12 120818 309 110468160
Aphthous ulcer 30.73 10.22 70 120760 21066 110447403
Ill-defined disorder 30.47 10.22 80 120750 156773 110311696
Left ventricular hypertrophy 30.28 10.22 53 120777 13191 110455278
Pulmonary function test abnormal 30.03 10.22 32 120798 4968 110463501
Mental disorder 29.98 10.22 102 120728 38689 110429780
Heart rate irregular 29.97 10.22 94 120736 34180 110434289
Oropharyngeal discomfort 29.93 10.22 46 120784 10281 110458188
Blood cholesterol increased 29.62 10.22 103 120727 184682 110283787
Left ventricular failure 29.25 10.22 48 120782 11341 110457128
Sleep disorder due to general medical condition, insomnia type 29.01 10.22 44 120786 105599 110362870
Skin laceration 28.99 10.22 92 120738 33661 110434808
Hallucination, gustatory 28.84 10.22 8 120822 66 110468403
Transferrin saturation decreased 28.59 10.22 18 120812 1325 110467144
Inferior vena cava dilatation 28.54 10.22 16 120814 951 110467518
Product packaging confusion 28.51 10.22 12 120818 377 110468092
Skin injury 28.49 10.22 28 120802 3954 110464515
Lip oedema 28.10 10.22 38 120792 7562 110460907
Needle issue 28.09 10.22 61 120769 17779 110450690
Laryngitis 28.08 10.22 6 120824 42405 110426064
Blood thyroid stimulating hormone increased 27.83 10.22 49 120781 12252 110456217
Degenerative aortic valve disease 27.26 10.22 10 120820 216 110468253
Productive cough 27.26 10.22 216 120614 114089 110354380
Therapeutic product effect decreased 27.19 10.22 156 120674 244160 110224309
Myocardial ischaemia 26.95 10.22 77 120753 26607 110441862
Calcification metastatic 26.93 10.22 9 120821 146 110468323
Parathyroid hormone-related protein abnormal 26.88 10.22 6 120824 17 110468452
Vulvovaginal pruritus 26.82 10.22 25 120805 3306 110465163
Wrong patient 26.79 10.22 18 120812 1481 110466988
Cytomegalovirus infection 26.72 10.22 13 120817 54431 110414038
Stenosis 26.69 10.22 25 120805 3326 110465143
Hypocalvaria 26.62 10.22 7 120823 46 110468423
Lupus-like syndrome 26.54 10.22 6 120824 40786 110427683
Retroperitoneal fibrosis 26.38 10.22 14 120816 746 110467723
Respiratory tract oedema 26.32 10.22 16 120814 1107 110467362
Mitral valve thickening 26.23 10.22 14 120816 755 110467714
Tricuspid valve incompetence 26.19 10.22 71 120759 23802 110444667
Coronary artery occlusion 26.07 10.22 55 120775 15717 110452752
Candida infection 25.89 10.22 10 120820 47999 110420470
Pulse abnormal 25.71 10.22 27 120803 4122 110464347
Knee arthroplasty 25.65 10.22 20 120810 64928 110403541
Blood pressure decreased 25.56 10.22 214 120616 114877 110353592
Bronchial hyperreactivity 25.50 10.22 25 120805 3519 110464950
Obstructive airways disorder 25.47 10.22 109 120721 46040 110422429
Atheroembolism 25.43 10.22 11 120819 370 110468099
Liver injury 25.36 10.22 82 120748 150331 110318138
Hepatitis B core antibody positive 25.34 10.22 13 120817 646 110467823
Arrhythmia 25.32 10.22 146 120684 69429 110399040
Right atrial enlargement 25.26 10.22 12 120818 504 110467965
Bundle branch block left 24.95 10.22 48 120782 12840 110455629
Incorrect route of product administration 24.95 10.22 20 120810 64041 110404428
Haematoma 24.85 10.22 128 120702 58348 110410121
Neuropathy peripheral 24.82 10.22 106 120724 179171 110289298
Alopecia scarring 24.81 10.22 9 120821 188 110468281
Thrombosis 24.65 10.22 51 120779 108611 110359858
Potentiating drug interaction 24.58 10.22 45 120785 11598 110456871
Ventricular extrasystoles 24.50 10.22 67 120763 22574 110445895
Onychomycosis 24.42 10.22 6 120824 38525 110429944
Aptyalism 24.34 10.22 14 120816 874 110467595
Erectile dysfunction 24.30 10.22 59 120771 18497 110449972
Hypertensive crisis 24.29 10.22 70 120760 24302 110444167
Drug level increased 24.28 10.22 110 120720 47609 110420860
Respiratory arrest 24.25 10.22 17 120813 58282 110410187
Diabetic foot 24.23 10.22 26 120804 4069 110464400
Labelled drug-drug interaction issue 24.20 10.22 26 120804 4075 110464394
Full blood count abnormal 24.03 10.22 123 120707 55929 110412540
Injection site pruritus 24.03 10.22 13 120817 51245 110417224
Dyspnoea 23.85 10.22 1456 119374 1105416 109363053
Acquired haemophilia 23.64 10.22 21 120809 2610 110465859
Atrioventricular block 23.55 10.22 55 120775 16822 110451647
Prescribed underdose 23.38 10.22 22 120808 65152 110403317
Rash maculo-papular 23.37 10.22 150 120680 74072 110394397
Rhinalgia 23.34 10.22 25 120805 3904 110464565
Upper respiratory tract infection 23.27 10.22 70 120760 131258 110337211
Blood creatine phosphokinase increased 23.20 10.22 148 120682 72929 110395540
Myocarditis 23.20 10.22 79 120751 29976 110438493
Musculoskeletal pain 23.08 10.22 112 120718 182911 110285558
Autoimmune nephritis 22.91 10.22 13 120817 791 110467678
Cardiac murmur 22.89 10.22 69 120761 24559 110443910
Seasonal affective disorder 22.83 10.22 10 120820 347 110468122
Sarcopenia 22.71 10.22 15 120815 1199 110467270
Lip injury 22.66 10.22 16 120814 1426 110467043
Renin increased 22.59 10.22 10 120820 356 110468113
Osteolysis 22.56 10.22 29 120801 5494 110462975
Breath sounds abnormal 22.52 10.22 70 120760 25334 110443135
Oxygen saturation decreased 22.28 10.22 266 120564 156716 110311753
Ischaemic cardiomyopathy 22.27 10.22 35 120795 7976 110460493
Nocturia 22.23 10.22 54 120776 16936 110451533
Troponin increased 21.90 10.22 77 120753 29689 110438780
Fatigue 21.88 10.22 1096 119734 1214862 109253607
Hypoparathyroidism 21.81 10.22 16 120814 1514 110466955
Injection site pain 21.79 10.22 110 120720 177812 110290657
Gingival abscess 21.73 10.22 14 120816 1073 110467396
N-terminal prohormone brain natriuretic peptide increased 21.72 10.22 30 120800 6091 110462378
Procedural pain 21.65 10.22 6 120824 35559 110432910
Hypochromasia 21.61 10.22 12 120818 700 110467769
Intentional self-injury 21.54 10.22 7 120823 37422 110431047
Pulmonary fibrosis 21.41 10.22 50 120780 101992 110366477
Brain injury 21.13 10.22 46 120784 13430 110455039
Epilepsy 21.11 10.22 49 120781 100160 110368309
Neutrophil count decreased 21.04 10.22 65 120765 120876 110347593
Exostosis 21.04 10.22 12 120818 45944 110422525
Catheter site injury 21.03 10.22 9 120821 295 110468174
Ventricle rupture 20.98 10.22 7 120823 113 110468356
Prescribed overdose 20.81 10.22 40 120790 87541 110380928
Ventricular hypokinesia 20.78 10.22 41 120789 11173 110457296
Supraventricular extrasystoles 20.70 10.22 34 120796 8039 110460430
Swelling face 20.68 10.22 172 120658 92149 110376320
Dyspnoea paroxysmal nocturnal 20.57 10.22 19 120811 2483 110465986
Ventricular dyskinesia 20.43 10.22 10 120820 449 110468020
Adverse drug reaction 20.37 10.22 54 120776 105505 110362964
Allergic reaction to excipient 20.32 10.22 12 120818 787 110467682
Bone marrow failure 20.20 10.22 20 120810 57828 110410641
Dyspepsia 20.15 10.22 124 120706 190841 110277628
Therapy interrupted 20.11 10.22 15 120815 49807 110418662
Dehydration 19.93 10.22 422 120408 279089 110189380
Psychomotor skills impaired 19.84 10.22 31 120799 7027 110461442
Scan gallium abnormal 19.70 10.22 5 120825 28 110468441
Cytokine release syndrome 19.58 10.22 29 120801 70277 110398192
Ligament calcification 19.54 10.22 8 120822 234 110468235
Hypophagia 19.52 10.22 111 120719 52515 110415954
Gastrointestinal haemorrhage 19.49 10.22 271 120559 165247 110303222
Hormone receptor positive HER2 negative breast cancer 19.42 10.22 8 120822 238 110468231
Hepatic fibrosis 19.39 10.22 33 120797 8033 110460436
Heart rate increased 19.23 10.22 241 120589 143593 110324876
Pressure of speech 19.15 10.22 14 120816 1318 110467151
Muscle haemorrhage 19.08 10.22 30 120800 6839 110461630
Lymphoedema 19.06 10.22 47 120783 14882 110453587
Vascular access site haemorrhage 18.96 10.22 8 120822 253 110468216
Lip swelling 18.88 10.22 107 120723 50560 110417909
Electrocardiogram ST segment elevation 18.83 10.22 35 120795 9125 110459344
Abortion spontaneous 18.72 10.22 7 120823 34275 110434194
Schizoaffective disorder 18.71 10.22 20 120810 3116 110465353
Injection site swelling 18.70 10.22 24 120806 61766 110406703
Choking 18.69 10.22 47 120783 15063 110453406
Dry skin 18.63 10.22 58 120772 107595 110360874
Transitional cell carcinoma 18.51 10.22 20 120810 3155 110465314
Head banging 18.42 10.22 10 120820 558 110467911
Respiratory depression 18.39 10.22 6 120824 31995 110436474
Venous oxygen saturation increased 18.38 10.22 5 120825 38 110468431
Wrong patient received product 18.33 10.22 29 120801 6645 110461824
Rebound psychosis 18.29 10.22 9 120821 409 110468060
Uveitic glaucoma 18.28 10.22 4 120826 10 110468459
Malaise 18.23 10.22 903 119927 670916 109797553
Acute respiratory failure 18.21 10.22 34 120796 75226 110393243
Metabolic syndrome 18.14 10.22 20 120810 3227 110465242
Device dislocation 18.12 10.22 6 120824 31698 110436771
Product use issue 18.05 10.22 236 120594 311459 110157010
Polycythaemia 18.00 10.22 20 120810 3255 110465214
Sinoatrial block 17.96 10.22 14 120816 1451 110467018
Injection site erosion 17.94 10.22 7 120823 180 110468289
Capillary disorder 17.94 10.22 7 120823 180 110468289
Mucosal inflammation 17.94 10.22 50 120780 96091 110372378
Faeces discoloured 17.83 10.22 79 120751 33869 110434600
Paranasal sinus discomfort 17.82 10.22 28 120802 6377 110462092
Swollen tongue 17.79 10.22 120 120710 60242 110408227
Contusion 17.76 10.22 166 120664 233195 110235274
Allergic sinusitis 17.58 10.22 15 120815 1766 110466703
Tachyarrhythmia 17.53 10.22 32 120798 8229 110460240
Intensive care 17.53 10.22 17 120813 2362 110466107
International normalised ratio increased 17.52 10.22 158 120672 86614 110381855
Blood creatinine increased 17.50 10.22 289 120541 182600 110285869
Laryngeal haematoma 17.49 10.22 7 120823 193 110468276
Plasma cell myeloma 17.48 10.22 26 120804 62910 110405559
Nausea 17.46 10.22 1140 119690 1234550 109233919
Electrocardiogram T wave inversion 17.46 10.22 26 120804 5654 110462815
Amnesia 17.40 10.22 58 120772 105350 110363119
Benign abdominal neoplasm 17.39 10.22 8 120822 312 110468157
Convulsive threshold lowered 17.36 10.22 12 120818 1034 110467435
Device issue 17.33 10.22 8 120822 34527 110433942
Memory impairment 17.27 10.22 135 120695 196809 110271660
Taste disorder 17.22 10.22 28 120802 65359 110403110
Paratracheal lymphadenopathy 17.22 10.22 7 120823 201 110468268
Urticaria 17.18 10.22 245 120585 318612 110149857
Abdominal discomfort 17.11 10.22 315 120515 393543 110074926
Portal vein flow decreased 17.08 10.22 5 120825 51 110468418
Subdural haematoma 17.05 10.22 82 120748 36372 110432097
Urinary straining 16.99 10.22 5 120825 52 110468417
Blood uric acid increased 16.98 10.22 57 120773 21472 110446997
Episcleral venous pressure increased 16.86 10.22 4 120826 16 110468453
Mean platelet volume increased 16.85 10.22 14 120816 1590 110466879
Nephropathy toxic 16.81 10.22 67 120763 27411 110441058
Labelled drug-drug interaction medication error 16.78 10.22 70 120760 29232 110439237
Peripheral artery stenosis 16.73 10.22 13 120817 1341 110467128
Urine albumin/creatinine ratio increased 16.69 10.22 12 120818 1101 110467368
Intraventricular haemorrhage 16.63 10.22 25 120805 5482 110462987
Cardiac failure acute 16.61 10.22 61 120769 24017 110444452
Polydipsia 16.59 10.22 30 120800 7658 110460811
Coccydynia 16.58 10.22 17 120813 2524 110465945
Orthopnoea 16.58 10.22 37 120793 10984 110457485
Food aversion 16.46 10.22 14 120816 1641 110466828
Glomerular filtration rate increased 16.44 10.22 15 120815 1930 110466539
Drug reaction with eosinophilia and systemic symptoms 16.33 10.22 149 120681 81946 110386523
Carboxyhaemoglobin increased 16.27 10.22 5 120825 61 110468408
Decreased ventricular preload 16.27 10.22 5 120825 61 110468408
Lower respiratory tract congestion 16.26 10.22 23 120807 4773 110463696
Faeces soft 16.16 10.22 37 120793 11173 110457296
Abnormal loss of weight 16.07 10.22 35 120795 10222 110458247
Impaired insulin secretion 16.05 10.22 5 120825 64 110468405
Antipsychotic drug level increased 15.94 10.22 28 120802 6987 110461482
Infusion site mobility decreased 15.91 10.22 5 120825 66 110468403
Insulin resistance 15.90 10.22 14 120816 1720 110466749
Jaundice 15.84 10.22 115 120715 59121 110409348
Loss of personal independence in daily activities 15.83 10.22 241 120589 149779 110318690
Vascular purpura 15.72 10.22 20 120810 3751 110464718
Renal haematoma 15.67 10.22 11 120819 972 110467497
Anticoagulation drug level increased 15.65 10.22 11 120819 974 110467495
Blood pressure inadequately controlled 15.48 10.22 29 120801 7604 110460865
Tendonitis 15.48 10.22 63 120767 26020 110442449
Neglect of personal appearance 15.44 10.22 8 120822 406 110468063
Sputum discoloured 15.41 10.22 66 120764 27879 110440590
Vitamin B12 deficiency 15.40 10.22 34 120796 10021 110458448
Onychoclasis 15.31 10.22 28 120802 7209 110461260
Volume blood decreased 15.24 10.22 8 120822 417 110468052
Acute pulmonary oedema 15.22 10.22 47 120783 16949 110451520
Tachypnoea 15.21 10.22 84 120746 39311 110429158
Skin wrinkling 15.17 10.22 13 120817 1540 110466929
Underdose 15.12 10.22 29 120801 63525 110404944
Somnambulism 15.12 10.22 26 120804 6379 110462090
Duplicate therapy error 14.99 10.22 8 120822 431 110468038
Consciousness fluctuating 14.89 10.22 15 120815 2181 110466288
Anion gap abnormal 14.85 10.22 10 120820 826 110467643
Necrotising oesophagitis 14.83 10.22 13 120817 1587 110466882
Angiocardiogram 14.78 10.22 7 120823 292 110468177
Blood pressure systolic decreased 14.77 10.22 40 120790 13401 110455068
Dermatomyositis 14.75 10.22 21 120809 4385 110464084
Prothrombin time shortened 14.67 10.22 19 120811 3627 110464842
Psychotic disorder due to a general medical condition 14.63 10.22 7 120823 299 110468170
Ear infection 14.60 10.22 29 120801 62703 110405766
Crystalluria 14.59 10.22 12 120818 1343 110467126
Mixed anxiety and depressive disorder 14.55 10.22 9 120821 642 110467827
Benign ovarian tumour 14.55 10.22 8 120822 458 110468011
Dermatitis exfoliative generalised 14.49 10.22 35 120795 10937 110457532
Glycosylated haemoglobin decreased 14.46 10.22 10 120820 862 110467607
Injection site bruising 14.41 10.22 21 120809 51242 110417227
Red blood cell sedimentation rate abnormal 14.39 10.22 59 120771 24450 110444019
Epistaxis 14.37 10.22 211 120619 130161 110338308
Visual impairment 14.33 10.22 87 120743 134341 110334128
Enlarged uvula 14.23 10.22 8 120822 478 110467991
Angiotensin converting enzyme inhibitor foetopathy 14.21 10.22 4 120826 35 110468434
Osmolar gap abnormal 14.18 10.22 5 120825 96 110468373
Injection site rash 14.17 10.22 4 120826 23415 110445054
Pancreatic carcinoma metastatic 14.16 10.22 20 120810 4144 110464325
Poor dental condition 14.11 10.22 9 120821 678 110467791
Pruritus 14.02 10.22 507 120323 581053 109887416
Arteriovenous fistula site haematoma 14.01 10.22 4 120826 37 110468432
Blood pressure abnormal 13.98 10.22 55 120775 22369 110446100
Sedation 13.94 10.22 35 120795 69648 110398821
Joint abscess 13.94 10.22 9 120821 692 110467777
Livedo reticularis 13.86 10.22 23 120807 5483 110462986
Psychomotor retardation 13.85 10.22 28 120802 7764 110460705
Wrong technique in product usage process 13.78 10.22 49 120781 87299 110381170
Tubulointerstitial nephritis 13.73 10.22 104 120726 54180 110414289
Disability 13.68 10.22 8 120822 30215 110438254
Insomnia 13.67 10.22 295 120535 360295 110108174
Accidental exposure to product 13.56 10.22 21 120809 49987 110418482
Coagulation factor VII level decreased 13.52 10.22 6 120824 215 110468254
Dermatitis bullous 13.46 10.22 46 120784 17483 110450986
Postoperative respiratory failure 13.42 10.22 6 120824 219 110468250
Umbilical hernia 13.41 10.22 26 120804 6996 110461473
Traumatic intracranial haematoma 13.39 10.22 4 120826 44 110468425
Bronchopulmonary aspergillosis 13.39 10.22 8 120822 29855 110438614
Red cell distribution width increased 13.35 10.22 46 120784 17556 110450913
Neoplasm progression 13.27 10.22 32 120798 64563 110403906
Palpitations 13.22 10.22 246 120584 158966 110309503
Cystitis 13.21 10.22 120 120710 65916 110402553
Needle fatigue 13.21 10.22 11 120819 1253 110467216
High density lipoprotein decreased 13.18 10.22 23 120807 5710 110462759
Blood cyanide increased 13.15 10.22 4 120826 47 110468422
Product substitution issue 13.14 10.22 55 120775 23006 110445463
Myalgia 13.12 10.22 327 120503 222054 110246415
Screaming 13.12 10.22 21 120809 4860 110463609
Peripheral artery haematoma 13.10 10.22 5 120825 121 110468348
Hyperhidrosis 13.09 10.22 282 120548 187016 110281453
Ear congestion 13.06 10.22 18 120812 3647 110464822
Stress 13.02 10.22 174 120656 105174 110363295
Living alone 13.00 10.22 4 120826 49 110468420
Gravitational oedema 12.94 10.22 13 120817 1885 110466584
Sepsis 12.94 10.22 266 120564 327080 110141389
Allergic cough 12.93 10.22 10 120820 1025 110467444
Renal phospholipidosis 12.89 10.22 7 120823 391 110468078
Hepatitis A antibody abnormal 12.84 10.22 5 120825 128 110468341
Tachycardia paroxysmal 12.84 10.22 7 120823 394 110468075
Infected lymphocele 12.83 10.22 6 120824 243 110468226
Respiratory tract congestion 12.83 10.22 9 120821 30848 110437621
Sacroiliitis 12.81 10.22 21 120809 4957 110463512
Aspergillus infection 12.75 10.22 6 120824 25610 110442859
Hallucination, olfactory 12.74 10.22 8 120822 586 110467883
Giant cell arteritis 12.74 10.22 18 120812 3731 110464738
Nail injury 12.73 10.22 9 120821 804 110467665
Hallucination 12.73 10.22 168 120662 101264 110367205
Hydrocholecystis 12.71 10.22 8 120822 589 110467880
Face oedema 12.68 10.22 71 120759 33398 110435071
Crepitations 12.67 10.22 33 120797 10802 110457667
Disability assessment scale score decreased 12.65 10.22 3 120827 12 110468457
Spontaneous haematoma 12.58 10.22 13 120817 1948 110466521
Surgery 12.53 10.22 16 120814 41267 110427202
Body mass index decreased 12.50 10.22 9 120821 827 110467642
Subileus 12.49 10.22 24 120806 6413 110462056
Urine albumin/creatinine ratio decreased 12.49 10.22 5 120825 138 110468331
Thrombocytopenic purpura 12.48 10.22 16 120814 3023 110465446
Breathing-related sleep disorder 12.48 10.22 6 120824 259 110468210
Phimosis 12.48 10.22 9 120821 830 110467639
Pharyngeal swelling 12.42 10.22 35 120795 11997 110456472
Hyperleukocytosis 12.42 10.22 17 120813 3422 110465047
Hypersensitivity vasculitis 12.42 10.22 25 120805 6912 110461557
Incision site erythema 12.42 10.22 8 120822 613 110467856
Chronic spontaneous urticaria 12.41 10.22 13 120817 1980 110466489
Morganella infection 12.38 10.22 11 120819 1368 110467101
Dyslipidaemia 12.35 10.22 42 120788 15923 110452546
Psychotic symptom 12.31 10.22 18 120812 3849 110464620
Red blood cell sedimentation rate increased 12.30 10.22 44 120786 78258 110390211
Oesophagitis 12.30 10.22 63 120767 28652 110439817
Photosensitivity reaction 12.29 10.22 58 120772 25531 110442938
Bone contusion 12.27 10.22 11 120819 1383 110467086
Diabetic metabolic decompensation 12.24 10.22 18 120812 3871 110464598
Sudden death 12.23 10.22 56 120774 24339 110444130
Expiratory reserve volume decreased 12.19 10.22 5 120825 147 110468322
Progressive multifocal leukoencephalopathy 12.19 10.22 6 120824 24950 110443519
Oedema genital 12.17 10.22 8 120822 634 110467835
Ascites 12.16 10.22 56 120774 92752 110375717
Lung adenocarcinoma 12.16 10.22 30 120800 9501 110458968
Transaminases increased 12.08 10.22 114 120716 63276 110405193
Cutaneous symptom 12.05 10.22 9 120821 876 110467593
Neurological symptom 12.02 10.22 41 120789 15567 110452902
Hypertrophic cardiomyopathy 11.98 10.22 16 120814 3147 110465322
Left atrial dilatation 11.96 10.22 17 120813 3543 110464926
Renal dysplasia 11.96 10.22 4 120826 65 110468404
Oral candidiasis 11.95 10.22 19 120811 44741 110423728
Human papilloma virus test positive 11.94 10.22 8 120822 655 110467814
Muscle spasticity 11.88 10.22 13 120817 35902 110432567
Arthropod bite 11.87 10.22 30 120800 9641 110458828
Joint swelling 11.85 10.22 381 120449 442464 110026005
Adverse reaction 11.83 10.22 9 120821 29585 110438884
Vertigo 11.80 10.22 146 120684 86724 110381745
Cardioactive drug level below therapeutic 11.79 10.22 3 120827 17 110468452
Drug intolerance 11.79 10.22 346 120484 406166 110062303
Chronic obstructive pulmonary disease 11.77 10.22 176 120654 108982 110359487
Cardiac amyloidosis 11.75 10.22 15 120815 2822 110465647
Morbid thoughts 11.74 10.22 9 120821 910 110467559
Page kidney 11.74 10.22 4 120826 69 110468400
Toxic epidermal necrolysis 11.74 10.22 28 120802 56699 110411770
Oesophageal irritation 11.68 10.22 6 120824 299 110468170
Pancytopenia 11.66 10.22 160 120670 209453 110259016
Unevaluable event 11.65 10.22 30 120800 59197 110409272
Protrusion tongue 11.56 10.22 7 120823 481 110467988
Chondropathy 11.54 10.22 15 120815 2872 110465597
Coma scale 11.53 10.22 4 120826 73 110468396
Distributive shock 11.44 10.22 22 120808 5882 110462587
Cataract 11.41 10.22 135 120695 79350 110389119
Sciatica 11.38 10.22 57 120773 92342 110376127
Gait spastic 11.28 10.22 11 120819 1538 110466931
Drug level above therapeutic 11.28 10.22 33 120797 11555 110456914
Bladder cancer 11.25 10.22 48 120782 20244 110448225
Hallucination, visual 11.23 10.22 78 120752 39527 110428942
Dermatitis atopic 11.23 10.22 7 120823 25534 110442935
Blood chromogranin A increased 11.21 10.22 8 120822 725 110467744
Eyelid injury 11.17 10.22 5 120825 183 110468286
Dysprosody 11.12 10.22 3 120827 22 110468447
Bladder stenosis 11.12 10.22 3 120827 22 110468447
Synovial disorder 11.06 10.22 15 120815 2992 110465477
Serum ferritin decreased 11.04 10.22 15 120815 2999 110465470
Blood ketone body 11.02 10.22 5 120825 189 110468280
Product contamination chemical 11.01 10.22 3 120827 23 110468446
Albuminuria 10.98 10.22 9 120821 1002 110467467
Thrombin time prolonged 10.90 10.22 6 120824 344 110468125
Insulin-like growth factor increased 10.90 10.22 13 120817 2283 110466186
Arterial stenosis 10.87 10.22 11 120819 1608 110466861
Walking aid user 10.85 10.22 7 120823 25068 110443401
Immunodeficiency 10.83 10.22 16 120814 38822 110429647
Intra-abdominal haematoma 10.82 10.22 16 120814 3456 110465013
Physical assault 10.82 10.22 11 120819 1617 110466852
Dropped head syndrome 10.81 10.22 7 120823 541 110467928
Sinus rhythm 10.74 10.22 9 120821 1034 110467435
Platelet count decreased 10.73 10.22 182 120648 230261 110238208
Escherichia sepsis 10.72 10.22 30 120800 10242 110458227
Nail discomfort 10.71 10.22 4 120826 91 110468378
Urticaria pigmentosa 10.68 10.22 3 120827 26 110468443
Microcytic anaemia 10.65 10.22 22 120808 6196 110462273
Therapeutic reaction time decreased 10.64 10.22 20 120810 5259 110463210
Chest pain 10.62 10.22 508 120322 375867 110092602
Campylobacter infection 10.53 10.22 13 120817 2366 110466103
Tooth fracture 10.51 10.22 35 120795 13132 110455337
Vertebral end plate inflammation 10.50 10.22 5 120825 211 110468258
Overdose 10.50 10.22 332 120498 233462 110235007
Hypouricaemia 10.47 10.22 7 120823 571 110467898
Blood bilirubin increased 10.46 10.22 45 120785 75927 110392542
Anti-thyroid antibody positive 10.44 10.22 7 120823 574 110467895
Electrocardiogram T wave amplitude decreased 10.40 10.22 8 120822 813 110467656
Mean cell volume increased 10.39 10.22 26 120804 8304 110460165
Bacterial rhinitis 10.39 10.22 3 120827 29 110468440
Bacterial pyelonephritis 10.37 10.22 8 120822 817 110467652
Carditis 10.35 10.22 5 120825 218 110468251
Device related infection 10.34 10.22 17 120813 39502 110428967
Mucous stools 10.31 10.22 23 120807 6824 110461645
Injection site injury 10.29 10.22 9 120821 1095 110467374
Urinary retention 10.29 10.22 119 120711 69564 110398905
Vascular access site pain 10.29 10.22 7 120823 588 110467881
Carcinoid tumour 10.29 10.22 7 120823 588 110467881
Glycosylated haemoglobin increased 10.24 10.22 52 120778 23567 110444902
Postictal state 10.24 10.22 13 120817 2433 110466036
Multiple sclerosis relapse 10.23 10.22 25 120805 50215 110418254
Premature delivery 10.23 10.22 11 120819 30621 110437848
Hyperammonaemic encephalopathy 10.23 10.22 20 120810 5414 110463055
Infective myositis 10.23 10.22 5 120825 224 110468245

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09AA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, PLAIN
ACE inhibitors, plain
ATC C09BA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and diuretics
ATC C09BB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C10BX11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX12 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX15 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX21 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000181 Angiotensin-converting Enzyme Inhibitors
FDA EPC N0000175562 Angiotensin Converting Enzyme Inhibitor
MeSH PA D000806 Angiotensin-Converting Enzyme Inhibitors
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
CHEBI has role CHEBI:35457 EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:49103 drug metabolite

Related Drugs by ATC class:

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C09BA ACE inhibitors and diuretics 11 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Myocardial Infarction Prevention indication
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Hyperkalemia contraindication 14140009
Acute cerebrovascular insufficiency contraindication 29322000
Angioedema contraindication 41291007 DOID:1558
Low blood pressure contraindication 45007003
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Kidney disease contraindication 90708001 DOID:557
Disorder of connective tissue contraindication 105969002 DOID:65
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.23 acidic
pKa2 6.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 DISCN TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 DISCN TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 DISCN TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Angiotensin-converting enzyme Enzyme INHIBITOR IC50 8.82 CHEMBL CHEMBL

External reference:

IDSource
4021179 VUID
N0000148627 NUI
D00624 KEGG_DRUG
107133-36-8 SECONDARY_CAS_RN
4021179 VANDF
4021180 VANDF
4035259 VANDF
C0136123 UMLSCUI
CHEBI:8024 CHEBI
X94 PDB_CHEM_ID
CHEMBL1581 ChEMBL_ID
CHEMBL1200343 ChEMBL_ID
DB00790 DRUGBANK_ID
D020913 MESH_DESCRIPTOR_UI
107807 PUBCHEM_CID
6367 IUPHAR_LIGAND_ID
5754 INN_ID
612548-45-5 SECONDARY_CAS_RN
Y5GMK36KGY UNII
DB14213 DRUGBANK_ID
1546400 RXNORM
169198 MMSL
20915 MMSL
8245 MMSL
d04440 MMSL
004018 NDDF
004019 NDDF
011699 NDDF
129485000 SNOMEDCT_US
129486004 SNOMEDCT_US
372916001 SNOMEDCT_US
442509000 SNOMEDCT_US
C0070426 UMLSCUI
CHEMBL3544986 ChEMBL_ID
CHEMBL1201368 ChEMBL_ID
95153-31-4 SECONDARY_CAS_RN
72022 PUBCHEM_CID
6373 IUPHAR_LIGAND_ID
5987 INN_ID
C053500 MESH_SUPPLEMENTAL_RECORD_UI
2UV6ZNQ92K UNII
2UV6ZNQ92K INXIGHT DRUGS
Y5GMK36KGY INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 10135-599 TABLET 4 mg ORAL NDA 27 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 10135-600 TABLET 8 mg ORAL NDA 27 sections
Perindopril Erbumine Human Prescription Drug Label 1 65862-286 TABLET 2 mg ORAL ANDA 26 sections
Perindopril Erbumine Human Prescription Drug Label 1 65862-287 TABLET 4 mg ORAL ANDA 26 sections
Perindopril Erbumine Human Prescription Drug Label 1 65862-288 TABLET 8 mg ORAL ANDA 26 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-235 TABLET 2 mg ORAL ANDA 22 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-236 TABLET 4 mg ORAL ANDA 22 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-237 TABLET 8 mg ORAL ANDA 22 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 72931-010 TABLET 3.50 mg ORAL NDA 32 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 72931-011 TABLET 7 mg ORAL NDA 32 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 72931-012 TABLET 14 mg ORAL NDA 32 sections
Aceon HUMAN PRESCRIPTION DRUG LABEL 1 76234-000 TABLET 2 mg ORAL NDA 27 sections
Aceon HUMAN PRESCRIPTION DRUG LABEL 1 76234-001 TABLET 4 mg ORAL NDA 27 sections
Aceon HUMAN PRESCRIPTION DRUG LABEL 1 76234-002 TABLET 8 mg ORAL NDA 27 sections