perindopril ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % 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

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
Sensitisation 327.39 10.94 119 53629 3267 63432007
Polycystic ovaries 305.62 10.94 122 53626 4349 63430925
Ejection fraction 268.31 10.94 94 53654 2312 63432962
Hyponatraemia 258.86 10.94 391 53357 111509 63323765
Acute kidney injury 256.20 10.94 637 53111 262778 63172496
Hypothyroidism 206.87 10.94 216 53532 42416 63392858
Rhinitis allergic 196.62 10.94 123 53625 11604 63423670
Sleep apnoea syndrome 190.82 10.94 174 53574 28959 63406315
Blood test abnormal 178.12 10.94 129 53619 15500 63419774
Carpal tunnel syndrome 169.98 10.94 141 53607 20676 63414598
Sleep disorder due to a general medical condition 160.74 10.94 110 53638 12078 63423196
Systemic lupus erythematosus 132.83 10.94 12 53736 208906 63226368
Ejection fraction abnormal 126.49 10.94 50 53698 1735 63433539
Pemphigus 124.00 10.94 8 53740 183718 63251556
Glossodynia 117.21 10.94 9 53739 178867 63256407
Blood pressure fluctuation 115.81 10.94 168 53580 46149 63389125
Hypertension 115.33 10.94 505 53243 278798 63156476
Nephrectomy 113.05 10.94 44 53704 1464 63433810
Maternal exposure during pregnancy 109.34 10.94 26 53722 220036 63215238
Hand deformity 104.54 10.94 8 53740 159449 63275825
Cardiac disorder 104.03 10.94 168 53580 50648 63384626
Renal disorder 102.66 10.94 133 53615 32841 63402433
Loss of employment 99.34 10.94 45 53703 2199 63433075
Lactic acidosis 95.89 10.94 139 53609 38148 63397126
Hyperkalaemia 94.76 10.94 167 53581 54036 63381238
Treatment failure 92.25 10.94 27 53721 199016 63236258
Blood pressure systolic increased 92.03 10.94 153 53595 47244 63388030
Synovitis 91.05 10.94 23 53725 186895 63248379
Alopecia 89.83 10.94 92 53656 337444 63097830
Pericarditis 87.97 10.94 6 53742 131573 63303701
Fibromyalgia 87.03 10.94 203 53545 80217 63355057
Completed suicide 85.85 10.94 11 53737 145662 63289612
Asthma 84.74 10.94 269 53479 127292 63307982
Burning sensation 84.18 10.94 159 53589 54248 63381026
Blood pressure increased 80.99 10.94 311 53437 161751 63273523
Hyperlactacidaemia 80.43 10.94 42 53706 2807 63432467
Pemphigoid 80.01 10.94 59 53689 7285 63427989
Arthropathy 75.91 10.94 53 53695 234739 63200535
Inappropriate antidiuretic hormone secretion 72.57 10.94 77 53671 15385 63419889
Cough 71.52 10.94 458 53290 292285 63142989
Bradycardia 70.81 10.94 177 53571 73050 63362224
Oesophageal spasm 68.62 10.94 39 53709 3084 63432190
Tinnitus 63.85 10.94 111 53637 35517 63399757
Discomfort 63.70 10.94 31 53717 167343 63267931
Oesophageal pain 62.48 10.94 39 53709 3662 63431612
Loss of personal independence in daily activities 60.82 10.94 201 53547 97089 63338185
Conjoined twins 60.18 10.94 18 53730 262 63435012
Cardiac failure 60.10 10.94 189 53559 88953 63346321
Pain 58.81 10.94 377 53371 740251 62695023
Product dose omission issue 58.80 10.94 67 53681 234246 63201028
Death 57.27 10.94 147 53601 374234 63061040
Drug interaction 56.23 10.94 359 53389 228772 63206502
Exposure during pregnancy 55.94 10.94 31 53717 155516 63279758
Atrial fibrillation 55.13 10.94 220 53528 116416 63318858
Tongue oedema 54.87 10.94 39 53709 4547 63430727
Infection 53.82 10.94 69 53679 229104 63206170
Lipase increased 53.15 10.94 53 53695 9847 63425427
Blood pressure systolic abnormal 53.03 10.94 61 53687 13325 63421949
Metabolic acidosis 51.20 10.94 116 53632 44953 63390321
Hypotension 50.50 10.94 399 53349 272205 63163069
Labile hypertension 50.43 10.94 18 53730 468 63434806
Product tampering 49.18 10.94 17 53731 401 63434873
Angioedema 48.54 10.94 118 53630 47847 63387427
Irritable bowel syndrome 46.71 10.94 7 53741 82405 63352869
Congenital bladder anomaly 44.67 10.94 13 53735 171 63435103
Adulterated product 44.47 10.94 14 53734 244 63435030
Urachal abnormality 44.13 10.94 13 53735 179 63435095
Fall 43.34 10.94 515 53233 391819 63043455
Cerebral haematoma 43.33 10.94 31 53717 3652 63431622
Persistent cloaca 43.29 10.94 13 53735 192 63435082
Aphthous ulcer 43.03 10.94 56 53692 13882 63421392
Intestinal malrotation 42.96 10.94 15 53733 365 63434909
Wound 42.80 10.94 45 53703 163218 63272056
Folliculitis 42.17 10.94 5 53743 70312 63364962
Drug ineffective 39.31 10.94 636 53112 1044129 62391145
Rhinalgia 37.93 10.94 21 53727 1578 63433696
Autoimmune nephritis 37.72 10.94 14 53734 408 63434866
Respiratory tract oedema 37.69 10.94 15 53733 530 63434744
Injury 37.65 10.94 8 53740 73239 63362035
Claustrophobia 37.57 10.94 18 53730 1000 63434274
Hypersensitivity 37.39 10.94 125 53623 292560 63142714
Blood pressure diastolic decreased 37.16 10.94 68 53680 22638 63412636
Product packaging confusion 36.41 10.94 11 53737 166 63435108
Impaired healing 36.05 10.94 21 53727 102521 63332753
Helicobacter infection 35.57 10.94 17 53731 92768 63342506
Somatic symptom disorder 35.05 10.94 24 53724 2636 63432638
Blister 34.90 10.94 35 53713 129779 63305495
Swelling 34.23 10.94 119 53629 275259 63160015
Shock haemorrhagic 34.10 10.94 42 53706 9853 63425421
Hypersensitivity vasculitis 33.86 10.94 28 53720 4084 63431190
Shock 33.14 10.94 66 53682 23397 63411877
Disease progression 33.11 10.94 33 53715 122725 63312549
Hepatic enzyme increased 32.81 10.94 77 53671 202251 63233023
Pulse abnormal 32.74 10.94 22 53726 2342 63432932
Vulvovaginal burning sensation 32.55 10.94 21 53727 2088 63433186
Mixed liver injury 32.40 10.94 29 53719 4706 63430568
Injection site erythema 32.25 10.94 15 53733 83159 63352115
Allergic reaction to excipient 31.97 10.94 12 53736 361 63434913
Muscle injury 31.87 10.94 8 53740 65337 63369937
Hallucination, gustatory 30.97 10.94 8 53740 65 63435209
Diabetes mellitus inadequate control 30.93 10.94 50 53698 15076 63420198
Hypophagia 30.67 10.94 76 53672 31183 63404091
Stress 30.37 10.94 125 53623 67042 63368232
Diabetes mellitus 30.24 10.94 110 53638 55700 63379574
Neuropathy peripheral 30.15 10.94 31 53717 113636 63321638
Blood pressure diastolic abnormal 29.64 10.94 48 53700 14494 63420780
Peripheral artery stenosis 29.49 10.94 13 53735 595 63434679
Lip injury 29.46 10.94 15 53733 951 63434323
Gastrooesophageal reflux disease 29.33 10.94 159 53589 95480 63339794
Neurological symptom 29.29 10.94 30 53718 5753 63429521
Cardiac failure chronic 28.16 10.94 26 53722 4392 63430882
Abdominal discomfort 28.15 10.94 158 53590 320727 63114547
Hyperhidrosis 27.67 10.94 171 53577 107665 63327609
Neglect of personal appearance 27.65 10.94 8 53740 103 63435171
Therapy non-responder 27.46 10.94 15 53733 75886 63359388
Wheezing 27.36 10.94 156 53592 95439 63339835
Head banging 27.21 10.94 11 53737 405 63434869
Pyrexia 26.73 10.94 262 53486 470216 62965058
Vulvovaginal pruritus 26.53 10.94 22 53726 3221 63432053
Hypokalaemia 26.26 10.94 164 53584 103640 63331634
Malaise 25.90 10.94 495 53253 415459 63019815
Therapeutic product effect incomplete 25.89 10.94 188 53560 124868 63310406
Heart rate decreased 25.71 10.94 91 53657 45469 63389805
Livedo reticularis 25.29 10.94 19 53729 2413 63432861
Exercise tolerance decreased 25.13 10.94 27 53721 5470 63429804
Hormone receptor positive HER2 negative breast cancer 24.67 10.94 8 53740 154 63435120
Upper respiratory tract infection 24.58 10.94 20 53728 82027 63353247
Ill-defined disorder 24.41 10.94 20 53728 81735 63353539
Lymphoedema 24.38 10.94 39 53709 11653 63423621
Screaming 24.37 10.94 21 53727 3241 63432033
Pressure of speech 24.28 10.94 12 53736 714 63434560
Troponin increased 24.25 10.94 36 53712 10085 63425189
Palpitations 24.19 10.94 171 53577 112599 63322675
Drug reaction with eosinophilia and systemic symptoms 23.95 10.94 73 53675 33763 63401511
Calcification metastatic 23.54 10.94 8 53740 179 63435095
Psoriatic arthropathy 23.11 10.94 26 53722 91494 63343780
Injection site pain 23.01 10.94 47 53701 129753 63305521
Troponin abnormal 22.99 10.94 6 53742 51 63435223
Haematoma 22.69 10.94 73 53675 34747 63400527
Ischaemic stroke 22.40 10.94 48 53700 17909 63417365
Orthostatic hypotension 21.95 10.94 74 53674 36086 63399188
Seasonal affective disorder 21.80 10.94 9 53739 350 63434924
Electrocardiogram QT prolonged 21.77 10.94 104 53644 59426 63375848
Therapy partial responder 21.48 10.94 35 53713 10623 63424651
Pregnancy 21.17 10.94 3 53745 36833 63398441
Oral herpes 21.09 10.94 59 53689 26015 63409259
Anuria 21.06 10.94 38 53710 12513 63422761
Gravitational oedema 21.02 10.94 13 53735 1201 63434073
Degenerative aortic valve disease 20.97 10.94 7 53741 148 63435126
Paranasal sinus discomfort 20.90 10.94 22 53726 4354 63430920
Stomatitis haemorrhagic 20.82 10.94 5 53743 29 63435245
Catheter site injury 20.76 10.94 8 53740 259 63435015
Capillary disorder 20.75 10.94 6 53742 77 63435197
Hypovolaemic shock 20.72 10.94 26 53722 6215 63429059
International normalised ratio increased 20.67 10.94 86 53662 46339 63388935
Troponin T increased 20.63 10.94 13 53735 1241 63434033
Joint abscess 20.60 10.94 9 53739 403 63434871
Expanded disability status scale score increased 20.37 10.94 10 53738 586 63434688
Uveitic glaucoma 20.26 10.94 4 53744 7 63435267
Drug abuse 20.13 10.94 19 53729 72499 63362775
Coloboma 19.71 10.94 6 53742 93 63435181
Benign abdominal neoplasm 19.61 10.94 7 53741 182 63435092
Hypoosmolar state 19.50 10.94 7 53741 185 63435089
Cholestasis 19.45 10.94 62 53686 29372 63405902
Myocardial infarction 19.44 10.94 148 53600 99745 63335529
Urinary straining 19.42 10.94 5 53743 40 63435234
Hepatic steatosis 19.37 10.94 61 53687 28708 63406566
Bone density decreased 19.32 10.94 40 53708 14572 63420702
Hepatocellular injury 19.31 10.94 59 53689 27322 63407952
Vasoplegia syndrome 19.30 10.94 14 53734 1685 63433589
Rebound psychosis 19.29 10.94 7 53741 191 63435083
Rhabdomyolysis 19.24 10.94 81 53667 43870 63391404
Melaena 19.19 10.94 63 53685 30302 63404972
Blood pressure decreased 19.19 10.94 107 53641 64915 63370359
Injection site reaction 19.16 10.94 13 53735 58511 63376763
Abortion spontaneous 19.10 10.94 8 53740 47187 63388087
Fatigue 19.06 10.94 590 53158 887438 62547836
Hallucination, visual 19.01 10.94 47 53701 19251 63416023
Mean cell haemoglobin concentration decreased 18.77 10.94 19 53729 3593 63431681
Page kidney 18.77 10.94 4 53744 12 63435262
Pancreatitis acute 18.66 10.94 58 53690 27108 63408166
Convulsive threshold lowered 18.62 10.94 8 53740 344 63434930
Rash 18.52 10.94 349 53399 560522 62874752
Multiple sclerosis relapse 18.39 10.94 9 53739 48469 63386805
Swollen tongue 18.35 10.94 68 53680 34732 63400542
Bone contusion 18.12 10.94 11 53737 983 63434291
Kidney malformation 17.97 10.94 6 53742 127 63435147
Cystitis 17.93 10.94 93 53655 54898 63380376
Eosinophilia 17.93 10.94 51 53697 22705 63412569
Blood thyroid stimulating hormone increased 17.83 10.94 26 53722 7168 63428106
Renal impairment 17.81 10.94 132 53616 88223 63347051
Full blood count abnormal 17.59 10.94 63 53685 31654 63403620
White blood cell count decreased 17.33 10.94 60 53688 139044 63296230
Infective myositis 17.24 10.94 5 53743 65 63435209
Mean cell volume increased 17.22 10.94 18 53730 3533 63431741
Arthropod bite 17.17 10.94 27 53721 7951 63427323
Polydipsia 17.17 10.94 18 53730 3546 63431728
Pharyngeal swelling 17.13 10.94 24 53724 6380 63428894
Hypouricaemia 17.07 10.94 6 53742 149 63435125
Sinus rhythm 16.97 10.94 10 53738 846 63434428
Hypertensive crisis 16.97 10.94 39 53709 15247 63420027
Febrile neutropenia 16.94 10.94 48 53700 118401 63316873
Spontaneous haematoma 16.58 10.94 10 53738 883 63434391
Knee arthroplasty 16.50 10.94 13 53735 54193 63381081
Normochromic normocytic anaemia 16.50 10.94 20 53728 4616 63430658
Mixed anxiety and depressive disorder 16.43 10.94 7 53741 295 63434979
Therapy cessation 16.34 10.94 3 53745 30454 63404820
Product use in unapproved indication 16.33 10.94 87 53661 178993 63256281
Nephropathy toxic 16.29 10.94 29 53719 9450 63425824
Humerus fracture 16.26 10.94 28 53720 8888 63426386
Gastrointestinal disorder 16.09 10.94 57 53691 131182 63304092
Nephropathy 15.84 10.94 23 53725 6318 63428956
Sleep disorder 15.79 10.94 28 53720 81538 63353736
Labelled drug-drug interaction medication error 15.78 10.94 35 53713 13364 63421910
Agranulocytosis 15.75 10.94 52 53696 25082 63410192
Hepatic cytolysis 15.68 10.94 38 53710 15369 63419905
Allergic cough 15.68 10.94 9 53739 725 63434549
Schizoaffective disorder 15.42 10.94 17 53731 3545 63431729
C-reactive protein abnormal 15.42 10.94 10 53738 46086 63389188
Brain injury 15.39 10.94 24 53724 7019 63428255
Histoplasmosis 15.36 10.94 13 53735 1958 63433316
Urine albumin/creatinine ratio decreased 15.33 10.94 5 53743 98 63435176
Breath odour 15.27 10.94 11 53737 1309 63433965
Mobility decreased 15.27 10.94 52 53696 121107 63314167
Confusional state 15.26 10.94 283 53465 236097 63199177
Pericarditis constrictive 15.19 10.94 7 53741 356 63434918
Blood pressure diastolic increased 15.16 10.94 29 53719 9981 63425293
Vascular access site pain 15.10 10.94 5 53743 103 63435171
Infusion related reaction 15.08 10.94 134 53614 245387 63189887
Protrusion tongue 15.06 10.94 7 53741 363 63434911
Finger deformity 15.02 10.94 25 53723 7720 63427554
Euglycaemic diabetic ketoacidosis 14.99 10.94 17 53731 3657 63431617
Acute coronary syndrome 14.92 10.94 29 53719 10097 63425177
Epistaxis 14.85 10.94 109 53639 72616 63362658
Injection site pruritus 14.80 10.94 10 53738 45106 63390168
Respiratory failure 14.77 10.94 41 53707 101817 63333457
Left ventricular failure 14.75 10.94 21 53727 5666 63429608
Thrombosis 14.67 10.94 20 53728 64735 63370539
Benign ovarian tumour 14.64 10.94 7 53741 387 63434887
Enterococcal sepsis 14.57 10.94 11 53737 1407 63433867
Vasculitis 14.53 10.94 41 53707 18168 63417106
Tubulointerstitial nephritis and uveitis syndrome 14.40 10.94 6 53742 239 63435035
Diabetic ketoacidosis 14.29 10.94 44 53704 20461 63414813
Retinal occlusive vasculitis 14.24 10.94 4 53744 46 63435228
Renal vasculitis 14.22 10.94 7 53741 413 63434861
Hypomagnesaemia 14.20 10.94 55 53693 28682 63406592
Hemiplegia 14.10 10.94 27 53721 9296 63425978
Renal failure 14.08 10.94 157 53591 117495 63317779
Anti-thyroid antibody positive 14.06 10.94 7 53741 423 63434851
Hallucination, olfactory 13.94 10.94 6 53742 259 63435015
Acid base balance abnormal 13.86 10.94 6 53742 263 63435011
Cardioactive drug level below therapeutic 13.84 10.94 3 53745 10 63435264
No adverse event 13.82 10.94 9 53739 41396 63393878
Meralgia paraesthetica 13.74 10.94 7 53741 444 63434830
Body mass index decreased 13.70 10.94 7 53741 447 63434827
Psychotic symptom 13.63 10.94 11 53737 1550 63433724
Poor dental condition 13.47 10.94 7 53741 463 63434811
Swelling face 13.46 10.94 96 53652 63379 63371895
Cardiomyopathy 13.45 10.94 39 53709 17545 63417729
Hallucination, auditory 13.45 10.94 32 53716 12792 63422482
Therapeutic product effect decreased 13.43 10.94 102 53646 193085 63242189
Micrognathia 13.38 10.94 6 53742 286 63434988
Oxygen saturation decreased 13.37 10.94 124 53624 88461 63346813
Toxic skin eruption 13.35 10.94 32 53716 12853 63422421
Paranoia 13.19 10.94 30 53718 11649 63423625
Fungal infection 13.17 10.94 64 53684 36810 63398464
Tachycardia paroxysmal 13.08 10.94 6 53742 302 63434972
Stent placement 13.04 10.94 16 53732 3739 63431535
Monocyte count increased 12.97 10.94 23 53725 7470 63427804
Sinusitis 12.93 10.94 126 53622 226527 63208747
Acquired haemophilia 12.87 10.94 9 53739 1022 63434252
Device dislocation 12.82 10.94 3 53745 25702 63409572
Diabetic metabolic decompensation 12.76 10.94 11 53737 1699 63433575
Chest pain 12.72 10.94 255 53493 215704 63219570
Depressed level of consciousness 12.65 10.94 93 53655 61985 63373289
Unevaluable event 12.54 10.94 15 53733 51371 63383903
Electrocardiogram Q wave abnormal 12.53 10.94 5 53743 178 63435096
Dysphonia 12.52 10.94 76 53672 47538 63387736
Contraindicated product administered 12.41 10.94 121 53627 217527 63217747
Acute myocardial infarction 12.38 10.94 57 53691 32067 63403207
Mental disorder 12.32 10.94 49 53699 25870 63409404
Necrotising panniculitis 12.26 10.94 3 53745 19 63435255
Renin increased 12.24 10.94 5 53743 189 63435085
Intra-abdominal haematoma 12.24 10.94 11 53737 1794 63433480
Myocarditis 12.20 10.94 27 53721 10298 63424976
Human papilloma virus test positive 12.15 10.94 7 53741 568 63434706
Cardio-respiratory arrest 12.14 10.94 20 53728 59939 63375335
Dyspepsia 12.12 10.94 45 53703 102151 63333123
Wrong schedule 12.10 10.94 5 53743 195 63435079
Vulvovaginal inflammation 12.08 10.94 8 53740 831 63434443
Gingival abscess 11.95 10.94 8 53740 846 63434428
Consciousness fluctuating 11.84 10.94 8 53740 859 63434415
Insulin resistance 11.75 10.94 8 53740 870 63434404
Ear congestion 11.65 10.94 13 53735 2746 63432528
Urinary tract pain 11.62 10.94 5 53743 216 63435058
Injection site bruising 11.60 10.94 11 53737 41899 63393375
Microtia 11.57 10.94 6 53742 395 63434879
Nasal discomfort 11.50 10.94 17 53731 4743 63430531
Pancreatitis 11.47 10.94 76 53672 48979 63386295
Bacterial rhinitis 11.44 10.94 3 53745 26 63435248
Bendopnoea 11.44 10.94 3 53745 26 63435248
Infected lymphocele 11.42 10.94 5 53743 225 63435049
Incision site swelling 11.40 10.94 5 53743 226 63435048
Myelosuppression 11.37 10.94 3 53745 23700 63411574
Gastric disorder 11.36 10.94 62 53686 37307 63397967
Hyperreflexia 11.30 10.94 19 53729 5915 63429359
Nail injury 11.27 10.94 7 53741 652 63434622
Resorption bone increased 11.17 10.94 9 53739 1265 63434009
Increased appetite 11.17 10.94 25 53723 9605 63425669
Albuminuria 11.16 10.94 5 53743 238 63435036
Impaired insulin secretion 11.15 10.94 3 53745 29 63435245
Vision blurred 11.15 10.94 123 53625 91801 63343473
Renin decreased 11.03 10.94 4 53744 109 63435165
Serum ferritin decreased 10.96 10.94 11 53737 2059 63433215

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 173.46 11.72 873 48830 304115 34603113
Death 146.07 11.72 213 49490 397836 34509392
Ejection fraction decreased 106.86 11.72 134 49569 19020 34888208
Hyperkalaemia 96.77 11.72 266 49437 69123 34838105
Drug abuse 92.46 11.72 15 49688 99081 34808147
Atrial enlargement 81.33 11.72 32 49671 640 34906588
Completed suicide 80.87 11.72 20 49683 98148 34809080
Drug interaction 79.88 11.72 572 49131 225374 34681854
Venous pressure jugular increased 72.57 11.72 31 49672 770 34906458
Product dose omission issue 72.45 11.72 40 49663 119671 34787557
Left ventricular dysfunction 72.42 11.72 80 49623 9927 34897301
Blood pressure increased 72.35 11.72 282 49421 87820 34819408
Eosinophilia 69.74 11.72 130 49573 26092 34881136
Asthma-chronic obstructive pulmonary disease overlap syndrome 67.19 11.72 34 49669 1253 34905975
Lactic acidosis 66.02 11.72 150 49553 34622 34872606
Cardiomyopathy 64.25 11.72 98 49605 16710 34890518
Bradycardia 64.03 11.72 244 49459 75174 34832054
Left atrial enlargement 62.63 11.72 29 49674 876 34906352
Blood pressure systolic increased 60.05 11.72 113 49590 22839 34884389
Bone erosion 57.81 11.72 47 49656 3968 34903260
Atrial fibrillation 57.38 11.72 333 49370 122060 34785168
Red blood cell sedimentation rate abnormal 55.91 11.72 44 49659 3545 34903683
Skin injury 55.39 11.72 37 49666 2308 34904920
Dyspnoea exertional 54.52 11.72 160 49543 43119 34864109
Hyponatraemia 54.10 11.72 247 49456 82444 34824784
Coma scale abnormal 53.70 11.72 45 49658 3963 34903265
Ischaemic stroke 52.99 11.72 94 49609 18156 34889072
Obesity 51.94 11.72 77 49626 12801 34894427
Euglycaemic diabetic ketoacidosis 51.27 11.72 40 49663 3182 34904046
Asthma 49.31 11.72 153 49550 42503 34864725
Middle insomnia 48.56 11.72 54 49649 6748 34900480
Cardiac failure 47.89 11.72 256 49447 90992 34816236
Cardiac failure chronic 46.96 11.72 57 49646 7822 34899406
Melaena 46.68 11.72 133 49570 35247 34871981
Obstructive airways disorder 46.53 11.72 81 49622 15413 34891815
Breath sounds abnormal 46.35 11.72 53 49650 6828 34900400
Febrile neutropenia 46.34 11.72 77 49626 136772 34770456
Ventricular enlargement 45.09 11.72 21 49682 643 34906585
Joint ankylosis 45.02 11.72 28 49675 1544 34905684
Pneumonia 44.80 11.72 317 49386 362310 34544918
Rales 44.11 11.72 62 49641 9821 34897407
Drug tolerance decreased 43.99 11.72 30 49673 1937 34905291
Neuropathy peripheral 43.30 11.72 33 49670 83230 34823998
Hepatic vein dilatation 42.59 11.72 15 49688 217 34907011
White blood cell count decreased 42.23 11.72 44 49659 95401 34811827
Cardiac murmur 40.81 11.72 53 49650 7784 34899444
Diastolic dysfunction 40.33 11.72 47 49656 6180 34901048
Encephalitis toxic 39.43 11.72 15 49688 273 34906955
Dyspnoea at rest 39.37 11.72 37 49666 3791 34903437
Disease progression 39.25 11.72 58 49645 108019 34799209
Stenosis 39.09 11.72 25 49678 1448 34905780
Liver palpable 39.03 11.72 15 49688 281 34906947
Left ventricular enlargement 37.98 11.72 19 49684 683 34906545
Angioedema 37.72 11.72 128 49575 37246 34869982
Depression 37.35 11.72 50 49653 97048 34810180
Bone cyst 37.20 11.72 25 49678 1575 34905653
Cardiac dysfunction 37.15 11.72 29 49674 2309 34904919
Diabetes mellitus 36.79 11.72 148 49555 46725 34860503
Thrombosis 36.57 11.72 13 49690 50445 34856783
Dissociation 36.40 11.72 25 49678 1633 34905595
Congestive cardiomyopathy 36.35 11.72 49 49654 7461 34899767
Chest discomfort 34.98 11.72 162 49541 54368 34852860
Anti-cyclic citrullinated peptide antibody positive 34.01 11.72 25 49678 1818 34905410
Hepatic fibrosis 33.62 11.72 37 49666 4570 34902658
Tricuspid valve incompetence 33.27 11.72 54 49649 9706 34897522
Hypokalaemia 33.06 11.72 167 49536 58047 34849181
Ventricular hypokinesia 32.82 11.72 40 49663 5512 34901716
Wheezing 32.71 11.72 131 49572 41271 34865957
Dyspnoea 32.62 11.72 732 48971 376050 34531178
Ventricular hyperkinesia 32.29 11.72 12 49691 204 34907024
Transferrin saturation decreased 32.07 11.72 15 49688 464 34906764
Body temperature decreased 31.42 11.72 62 49641 12972 34894256
Aptyalism 31.42 11.72 14 49689 386 34906842
Retroperitoneal fibrosis 31.35 11.72 14 49689 388 34906840
Neutrophil count decreased 31.00 11.72 17 49686 51087 34856141
Decreased gait velocity 30.93 11.72 11 49692 164 34907064
Rheumatoid factor negative 30.89 11.72 18 49685 881 34906347
Toxicity to various agents 30.47 11.72 164 49539 200198 34707030
Hepatitis B core antibody positive 30.10 11.72 13 49690 332 34906896
Mitral valve incompetence 30.08 11.72 66 49637 14877 34892351
Right atrial enlargement 30.00 11.72 12 49691 251 34906977
Inappropriate antidiuretic hormone secretion 29.95 11.72 60 49643 12693 34894535
Platelet count decreased 29.90 11.72 80 49623 119637 34787591
Contraindicated product administered 29.55 11.72 82 49621 21399 34885829
Productive cough 29.36 11.72 119 49584 37694 34869534
Cough 29.13 11.72 334 49369 149806 34757422
Oedema peripheral 29.11 11.72 279 49424 119533 34787695
Left ventricular hypertrophy 29.10 11.72 46 49657 8084 34899144
Drug ineffective 29.10 11.72 466 49237 456285 34450943
Heart rate decreased 28.82 11.72 105 49598 31640 34875588
Bone marrow failure 28.24 11.72 4 49699 29249 34877979
Hypochromasia 27.69 11.72 12 49691 309 34906919
Mean platelet volume increased 27.66 11.72 14 49689 516 34906712
Hypokinesia 27.41 11.72 47 49656 8833 34898395
Dermatomyositis 27.35 11.72 19 49684 1264 34905964
Sarcopenia 26.96 11.72 13 49690 431 34906797
Exercise tolerance decreased 26.83 11.72 35 49668 5163 34902065
Respiratory arrest 26.69 11.72 4 49699 28039 34879189
Haemorrhagic transformation stroke 26.63 11.72 20 49683 1503 34905725
Rash 25.85 11.72 198 49505 222554 34684674
Foetal exposure during pregnancy 25.66 11.72 11 49692 38090 34869138
Inferior vena cava dilatation 25.54 11.72 15 49688 745 34906483
Mitral valve thickening 25.33 11.72 12 49691 382 34906846
Parathyroid hormone-related protein abnormal 25.31 11.72 6 49697 17 34907211
Vasoplegia syndrome 25.20 11.72 21 49682 1835 34905393
Sinusitis 24.78 11.72 14 49689 41388 34865840
Blood iron decreased 24.71 11.72 34 49669 5279 34901949
Metabolic syndrome 24.69 11.72 20 49683 1679 34905549
Glomerular filtration rate decreased 24.68 11.72 56 49647 12905 34894323
Cardiac failure congestive 24.49 11.72 51 49652 83219 34824009
Hypotension 24.21 11.72 446 49257 221203 34686025
Atheroembolism 24.17 11.72 11 49692 319 34906909
Ventricular dyskinesia 23.84 11.72 10 49693 237 34906991
N-terminal prohormone brain natriuretic peptide increased 23.72 11.72 24 49679 2691 34904537
Ventricular tachycardia 23.36 11.72 87 49616 26492 34880736
Hypomagnesaemia 23.07 11.72 76 49627 21775 34885453
Orthostatic hypotension 22.91 11.72 85 49618 25834 34881394
Bronchial hyperreactivity 22.51 11.72 19 49684 1690 34905538
Osteolysis 22.48 11.72 25 49678 3123 34904105
Dermatitis exfoliative generalised 22.38 11.72 27 49676 3680 34903548
Crepitations 22.17 11.72 25 49678 3171 34904057
Pyrexia 22.08 11.72 337 49366 332676 34574552
Blood pressure diastolic increased 21.65 11.72 31 49672 4994 34902234
Shock haemorrhagic 21.56 11.72 49 49654 11305 34895923
Plasma cell myeloma 21.41 11.72 17 49686 42020 34865208
Heart rate irregular 21.41 11.72 60 49643 15747 34891481
Tachyarrhythmia 21.33 11.72 26 49677 3582 34903646
Necrotising oesophagitis 21.23 11.72 12 49691 554 34906674
Rheumatoid arthritis 21.22 11.72 109 49594 38129 34869099
Lower respiratory tract congestion 21.20 11.72 16 49687 1211 34906017
Unevaluable event 21.02 11.72 10 49693 32580 34874648
Portal vein flow decreased 20.88 11.72 5 49698 15 34907213
Nausea 20.86 11.72 349 49354 339559 34567669
Sleep disorder due to a general medical condition 20.74 11.72 31 49672 5190 34902038
Atrioventricular block 20.22 11.72 39 49664 8024 34899204
Cytokine release syndrome 20.15 11.72 4 49699 22873 34884355
Varicose vein 19.72 11.72 16 49687 1347 34905881
Paratracheal lymphadenopathy 19.52 11.72 7 49696 107 34907121
Decreased ventricular preload 19.39 11.72 5 49698 22 34907206
Rhabdomyolysis 19.23 11.72 164 49539 67999 34839229
Scan gallium abnormal 19.21 11.72 5 49698 23 34907205
Hand deformity 19.10 11.72 25 49678 3700 34903528
Cerebral haemorrhage 18.97 11.72 99 49604 34838 34872390
Myocardial ischaemia 18.79 11.72 61 49642 17347 34889881
Hypovolaemic shock 18.67 11.72 35 49668 7050 34900178
Metabolic acidosis 18.61 11.72 116 49587 43564 34863664
Hypoosmolar state 18.52 11.72 7 49696 125 34907103
Orthopnoea 18.44 11.72 29 49674 5074 34902154
Diabetic foot 17.98 11.72 21 49682 2767 34904461
Lung disorder 17.94 11.72 97 49606 34599 34872629
Hypoparathyroidism 17.89 11.72 11 49692 594 34906634
Osmolar gap abnormal 17.82 11.72 5 49698 32 34907196
Dysmetria 17.78 11.72 11 49692 601 34906627
Hypocalcaemia 17.72 11.72 75 49628 24214 34883014
Muscle haemorrhage 17.60 11.72 24 49679 3694 34903534
Seizure 17.52 11.72 83 49620 104774 34802454
Mumps 17.41 11.72 6 49697 81 34907147
Pulmonary function test abnormal 17.40 11.72 20 49683 2590 34904638
Chronic obstructive pulmonary disease 17.28 11.72 124 49579 48794 34858434
Stomatitis 17.26 11.72 21 49682 42493 34864735
Pain 17.24 11.72 197 49506 204478 34702750
Acute coronary syndrome 16.97 11.72 50 49653 13495 34893733
Sinoatrial block 16.88 11.72 10 49693 505 34906723
Sepsis 16.62 11.72 154 49549 166407 34740821
Acute pulmonary oedema 16.59 11.72 34 49669 7309 34899919
Laryngeal haematoma 16.53 11.72 7 49696 170 34907058
Electrocardiogram T wave inversion 16.42 11.72 18 49685 2213 34905015
Duplicate therapy error 16.38 11.72 7 49696 174 34907054
Blood chromogranin A increased 16.38 11.72 8 49695 273 34906955
Hepatic enzyme increased 16.19 11.72 19 49684 39061 34868167
Gait spastic 16.14 11.72 13 49690 1083 34906145
Oropharyngeal discomfort 15.69 11.72 21 49682 3175 34904053
Left ventricular failure 15.58 11.72 27 49676 5117 34902111
Coronary artery stenosis 15.56 11.72 39 49664 9577 34897651
Pancreatitis acute 15.46 11.72 80 49623 28061 34879167
Cytomegalovirus infection 15.41 11.72 9 49694 26126 34881102
Lower respiratory tract infection 15.39 11.72 87 49616 31550 34875678
Right ventricular dysfunction 15.34 11.72 13 49690 1163 34906065
Coagulation factor VII level decreased 15.29 11.72 6 49697 119 34907109
Faeces pale 15.28 11.72 14 49689 1389 34905839
Therapy non-responder 15.20 11.72 20 49683 39126 34868102
Bundle branch block left 15.09 11.72 29 49674 5950 34901278
Episcleral venous pressure increased 15.09 11.72 4 49699 20 34907208
Ligament calcification 15.07 11.72 7 49696 213 34907015
Colon cancer 15.05 11.72 36 49667 8585 34898643
Cerebral haematoma 15.01 11.72 25 49678 4590 34902638
Procedural hypertension 14.97 11.72 5 49698 61 34907167
Crystalluria 14.88 11.72 9 49694 472 34906756
High density lipoprotein decreased 14.87 11.72 21 49682 3339 34903889
No adverse event 14.84 11.72 7 49696 22920 34884308
Blood lactic acid decreased 14.83 11.72 5 49698 63 34907165
Alanine aminotransferase abnormal 14.72 11.72 25 49678 4663 34902565
Fall 14.70 11.72 385 49318 202500 34704728
Neck injury 14.64 11.72 13 49690 1238 34905990
Anuria 14.64 11.72 40 49663 10345 34896883
Muscle injury 14.61 11.72 14 49689 1469 34905759
Biopsy bone marrow 14.55 11.72 5 49698 67 34907161
Acute myeloid leukaemia 14.50 11.72 4 49699 18266 34888962
Haemorrhagic stroke 14.45 11.72 30 49673 6509 34900719
Diabetes mellitus inadequate control 14.37 11.72 47 49656 13417 34893811
Peripheral artery haematoma 14.35 11.72 5 49698 70 34907158
Premature baby 14.32 11.72 5 49698 19628 34887600
Postoperative respiratory failure 14.27 11.72 6 49697 143 34907085
Vascular purpura 14.24 11.72 15 49688 1763 34905465
Unresponsive to stimuli 14.23 11.72 11 49692 27558 34879670
Hypoglycaemia 14.13 11.72 129 49574 54511 34852717
Lip oedema 14.12 11.72 18 49685 2595 34904633
Mastication disorder 13.93 11.72 13 49690 1320 34905908
Ischaemic cardiomyopathy 13.75 11.72 29 49674 6360 34900868
Multiple organ dysfunction syndrome 13.75 11.72 59 49644 76507 34830721
Cholestasis 13.70 11.72 75 49628 26873 34880355
Hepatocellular injury 13.51 11.72 65 49638 22146 34885082
Arteriovenous fistula site haematoma 13.49 11.72 4 49699 32 34907196
Intensive care 13.28 11.72 9 49694 575 34906653
Fatigue 13.22 11.72 414 49289 370239 34536989
Full blood count abnormal 13.12 11.72 57 49646 18611 34888617
Arthropathy 13.09 11.72 74 49629 26833 34880395
Product quality issue 13.02 11.72 4 49699 17031 34890197
Off label use 13.01 11.72 477 49226 419047 34488181
Sputum discoloured 12.97 11.72 32 49671 7780 34899448
Drug ineffective for unapproved indication 12.84 11.72 9 49694 23706 34883522
Acquired haemophilia 12.83 11.72 11 49692 999 34906229
Left atrial dilatation 12.81 11.72 15 49688 1981 34905247
C-reactive protein abnormal 12.73 11.72 34 49669 8676 34898552
Porokeratosis 12.71 11.72 5 49698 100 34907128
Blood uric acid increased 12.51 11.72 36 49667 9588 34897640
Injection site erosion 12.48 11.72 5 49698 105 34907123
Giant cell arteritis 12.46 11.72 10 49693 829 34906399
Adverse drug reaction 12.44 11.72 14 49689 29328 34877900
Coronary artery occlusion 12.36 11.72 39 49664 10923 34896305
Blood cyanide increased 12.35 11.72 4 49699 44 34907184
Musculoskeletal discomfort 12.30 11.72 32 49671 8036 34899192
Hypocalvaria 12.27 11.72 4 49699 45 34907183
Liver function test increased 12.24 11.72 47 49656 14518 34892710
Photosensitivity reaction 12.23 11.72 38 49665 10556 34896672
Tongue oedema 12.20 11.72 18 49685 2979 34904249
Needle issue 12.14 11.72 27 49676 6138 34901090
Drug dependence 12.07 11.72 10 49693 24207 34883021
Laboratory test abnormal 12.05 11.72 7 49696 20384 34886844
Ventricular extrasystoles 12.00 11.72 41 49662 11967 34895261
Joint swelling 11.93 11.72 134 49569 59756 34847472
Oedema genital 11.79 11.72 8 49695 512 34906716
Abnormal loss of weight 11.78 11.72 21 49682 4069 34903159
Linear IgA disease 11.76 11.72 13 49690 1613 34905615

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 424.78 10.32 1487 95135 517917 79129849
Sensitisation 255 10.32 109 96513 3202 79644564
Hyponatraemia 249.44 10.32 618 96004 177230 79470536
Polycystic ovaries 241.16 10.32 109 96513 3670 79644096
Ejection fraction 212.89 10.32 86 96536 2183 79645583
Completed suicide 194.77 10.32 32 96590 245735 79402031
Hyperkalaemia 172.55 10.32 409 96213 113989 79533777
Lactic acidosis 149.29 10.32 289 96333 70070 79577696
Death 148.24 10.32 289 96333 566225 79081541
Sleep disorder due to a general medical condition 137.59 10.32 124 96498 14153 79633613
Sleep apnoea syndrome 137.27 10.32 194 96428 36284 79611482
Rhinitis allergic 133.15 10.32 114 96508 12155 79635611
Blood pressure increased 130.03 10.32 554 96068 210806 79436960
Bradycardia 127.79 10.32 408 96214 135149 79512617
Blood test abnormal 127.51 10.32 131 96491 17579 79630187
Hypothyroidism 127.14 10.32 228 96394 52164 79595602
Atrial fibrillation 124.30 10.32 522 96100 197364 79450402
Drug interaction 122.75 10.32 892 95730 414291 79233475
Maternal exposure during pregnancy 122.07 10.32 12 96610 136526 79511240
Asthma 118.70 10.32 397 96225 134698 79513068
Blood pressure systolic increased 115.96 10.32 253 96369 66733 79581033
Carpal tunnel syndrome 115.20 10.32 130 96492 19398 79628368
Cardiac failure 112.08 10.32 427 96195 154415 79493351
Drug abuse 110.79 10.32 30 96592 162661 79485105
Ejection fraction abnormal 102.94 10.32 53 96569 2387 79645379
Systemic lupus erythematosus 99.98 10.32 14 96608 121135 79526631
Alopecia 95.29 10.32 84 96538 231271 79416495
Ejection fraction decreased 95.03 10.32 159 96463 34418 79613348
Glossodynia 92.58 10.32 9 96613 103328 79544438
Pemphigus 91.02 10.32 8 96614 99574 79548192
Blood pressure fluctuation 90.50 10.32 230 96392 66915 79580851
Product dose omission issue 89.20 10.32 101 96521 247436 79400330
Eosinophilia 88.63 10.32 180 96442 45165 79602601
Nephrectomy 83.67 10.32 44 96578 2071 79645695
Atrial enlargement 79.21 10.32 34 96588 1009 79646757
Angioedema 79.17 10.32 237 96385 75798 79571968
Cough 79.13 10.32 734 95888 366055 79281711
Inappropriate antidiuretic hormone secretion 79.08 10.32 126 96496 26187 79621579
Cardiac disorder 77.21 10.32 214 96408 65543 79582223
Hypertension 76.30 10.32 672 95950 330320 79317446
Loss of employment 75.38 10.32 44 96578 2543 79645223
Pain 73.65 10.32 525 96097 703277 78944489
Hyperlactacidaemia 73.30 10.32 58 96564 5537 79642229
Cardiac failure chronic 72.38 10.32 78 96544 11057 79636709
Synovitis 71.94 10.32 47 96575 150687 79497079
Diabetes mellitus 70.27 10.32 232 96390 78158 79569608
Ischaemic stroke 70.14 10.32 136 96486 32995 79614771
Cardiomyopathy 68.24 10.32 124 96498 28650 79619116
Disease progression 67.74 10.32 74 96548 184288 79463478
Melaena 66.45 10.32 193 96429 60697 79587069
Hypotension 66.40 10.32 820 95802 439497 79208269
Exposure during pregnancy 66.34 10.32 20 96602 101112 79546654
Left atrial enlargement 65.24 10.32 31 96591 1172 79646594
Mental status changes 65.12 10.32 4 96618 66955 79580811
Left ventricular dysfunction 62.76 10.32 96 96526 19265 79628501
Venous pressure jugular increased 62.06 10.32 31 96591 1309 79646457
Euglycaemic diabetic ketoacidosis 59.26 10.32 56 96566 6788 79640978
Oesophageal spasm 59.03 10.32 42 96580 3414 79644352
Pericarditis 57.69 10.32 27 96595 104209 79543557
Febrile neutropenia 57.55 10.32 121 96501 230878 79416888
Tongue oedema 57.40 10.32 56 96566 7061 79640705
Metabolic acidosis 55.93 10.32 223 96399 82306 79565460
White blood cell count decreased 55.46 10.32 89 96533 188199 79459567
Middle insomnia 55.39 10.32 82 96540 15987 79631779
Neuropathy peripheral 52.70 10.32 56 96566 141249 79506517
Fibromyalgia 51.17 10.32 183 96439 64157 79583609
Pemphigoid 51.14 10.32 77 96545 15238 79632528
Fall 51.07 10.32 852 95770 486777 79160989
Oesophageal pain 51.05 10.32 42 96580 4237 79643529
Hand deformity 50.12 10.32 32 96590 103887 79543879
Coma scale abnormal 49.87 10.32 57 96565 8621 79639145
Shock haemorrhagic 49.55 10.32 88 96534 19972 79627794
Ventricular enlargement 49.53 10.32 22 96600 710 79647056
Hepatic enzyme increased 49.50 10.32 91 96531 182519 79465247
Renal disorder 49.39 10.32 137 96485 41968 79605798
Pyrexia 49.10 10.32 556 96066 678153 78969613
Discomfort 48.87 10.32 48 96574 125569 79522197
Drug ineffective 47.84 10.32 974 95648 1079939 78567827
Hypokalaemia 47.43 10.32 318 96304 143722 79504044
Cerebral haematoma 47.06 10.32 53 96569 7889 79639877
Infection 46.76 10.32 144 96478 241568 79406198
Product tampering 46.37 10.32 18 96604 410 79647356
Injury 46.20 10.32 18 96604 77478 79570288
Asthma-chronic obstructive pulmonary disease overlap syndrome 45.69 10.32 35 96587 3186 79644580
Dyspnoea at rest 45.45 10.32 50 96572 7252 79640514
Irritable bowel syndrome 45.23 10.32 10 96612 62231 79585535
Exercise tolerance decreased 44.57 10.32 55 96567 9016 79638750
Heart rate decreased 44.47 10.32 186 96436 70130 79577636
Hepatic vein dilatation 43.96 10.32 15 96607 233 79647533
Rales 43.43 10.32 83 96539 19918 79627848
Hypovolaemic shock 42.83 10.32 63 96559 12213 79635553
Labile hypertension 42.03 10.32 18 96604 531 79647235
Vasoplegia syndrome 42.00 10.32 35 96587 3595 79644171
Blood pressure systolic abnormal 41.75 10.32 75 96547 17172 79630594
Burning sensation 40.99 10.32 160 96462 58472 79589294
Anti-cyclic citrullinated peptide antibody positive 40.93 10.32 25 96597 83118 79564648
Left ventricular enlargement 39.77 10.32 19 96603 727 79647039
Injection site erythema 39.21 10.32 23 96599 78174 79569592
Diabetes mellitus inadequate control 39 10.32 89 96533 24175 79623591
Helicobacter infection 38.65 10.32 18 96604 69686 79578080
Cardiac murmur 38.55 10.32 69 96553 15755 79632011
Swelling 38.52 10.32 134 96488 216577 79431189
Liver palpable 38.46 10.32 15 96607 346 79647420
Folliculitis 38.08 10.32 10 96612 55370 79592396
Rhabdomyolysis 37.82 10.32 234 96388 102897 79544869
Encephalitis toxic 37.80 10.32 14 96608 279 79647487
Adulterated product 37.76 10.32 14 96608 280 79647486
Therapy non-responder 37.39 10.32 34 96588 92271 79555495
Mixed liver injury 37.31 10.32 46 96576 7532 79640234
Tinnitus 36.89 10.32 128 96494 44205 79603561
Orthostatic hypotension 36.64 10.32 150 96472 56014 79591752
Thrombosis 36.48 10.32 29 96593 84071 79563695
Blood pressure diastolic decreased 36.11 10.32 99 96523 30117 79617649
Impaired healing 35.85 10.32 32 96590 87623 79560143
Wheezing 35.69 10.32 253 96369 116411 79531355
Hypoosmolar state 35.50 10.32 14 96608 333 79647433
Wound 35.07 10.32 54 96568 116125 79531641
Respiratory arrest 34.91 10.32 13 96609 57537 79590229
Dyspnoea exertional 34.76 10.32 202 96420 86871 79560895
Sarcopenia 34.61 10.32 15 96607 456 79647310
Pancreatitis acute 34.38 10.32 135 96487 49469 79598297
Ventricular tachycardia 33.96 10.32 120 96502 41815 79605951
Hypersensitivity 33.87 10.32 183 96439 262056 79385710
Joint ankylosis 33.83 10.32 25 96597 2155 79645611
Stenosis 33.66 10.32 26 96596 2396 79645370
Rash 33.57 10.32 496 96126 577862 79069904
Diastolic dysfunction 32.80 10.32 52 96570 10759 79637007
Mitral valve thickening 32.69 10.32 14 96608 413 79647353
Toxicity to various agents 32.55 10.32 340 96282 421200 79226566
Acute coronary syndrome 32.30 10.32 76 96546 21057 79626709
Decreased gait velocity 31.82 10.32 11 96611 178 79647588
Pneumonia 30.89 10.32 589 96033 659657 78988109
Vulvovaginal burning sensation 30.77 10.32 21 96601 1596 79646170
Breath sounds abnormal 30.69 10.32 63 96559 15921 79631845
Cardiac dysfunction 30.58 10.32 31 96591 4093 79643673
Body temperature decreased 30.48 10.32 97 96525 32048 79615718
Somatic symptom disorder 30.47 10.32 25 96597 2512 79645254
Ventricular hyperkinesia 30.37 10.32 12 96610 287 79647479
Hip arthroplasty 29.80 10.32 4 96618 35752 79612014
Full blood count abnormal 29.56 10.32 112 96510 40362 79607404
Congestive cardiomyopathy 29.51 10.32 52 96570 11728 79636038
Anuria 29.48 10.32 73 96549 20890 79626876
Treatment failure 29.24 10.32 107 96515 170379 79477387
Haemorrhagic transformation stroke 29.18 10.32 25 96597 2667 79645099
Rheumatoid factor negative 29.12 10.32 18 96604 1155 79646611
Obstructive airways disorder 28.98 10.32 94 96528 31365 79616401
Troponin T increased 28.94 10.32 28 96594 3494 79644272
Hypomagnesaemia 28.81 10.32 123 96499 46788 79600978
Product packaging confusion 28.52 10.32 11 96611 246 79647520
Allergic reaction to excipient 28.47 10.32 12 96610 340 79647426
Hallucination, gustatory 28.02 10.32 8 96614 66 79647700
Arthropathy 27.91 10.32 115 96507 176996 79470770
Skin injury 27.84 10.32 27 96595 3379 79644387
Mitral valve incompetence 27.82 10.32 87 96535 28478 79619288
Claustrophobia 27.81 10.32 18 96604 1252 79646514
Blister 27.75 10.32 65 96557 119411 79528355
Glomerular filtration rate decreased 27.75 10.32 75 96547 22627 79625139
Left ventricular failure 27.59 10.32 45 96577 9536 79638230
Blood pressure diastolic increased 27.55 10.32 57 96565 14485 79633281
Blood iron decreased 27.50 10.32 59 96563 15375 79632391
Hepatic steatosis 27.20 10.32 104 96518 37634 79610132
Sinusitis 27.17 10.32 133 96489 195368 79452398
Right atrial enlargement 27.14 10.32 12 96610 383 79647383
Neutrophil count decreased 27.10 10.32 45 96577 93914 79553852
Fatigue 27.07 10.32 890 95732 928837 78718929
Cholestasis 27.05 10.32 130 96492 51979 79595787
Nausea 27.00 10.32 920 95702 956276 78691490
Oropharyngeal discomfort 26.79 10.32 38 96584 7128 79640638
Electrocardiogram QT prolonged 26.48 10.32 194 96428 90192 79557574
Gastrointestinal disorder 26.42 10.32 69 96553 122136 79525630
Parathyroid hormone-related protein abnormal 26.26 10.32 6 96616 17 79647749
Left ventricular hypertrophy 26.24 10.32 48 96574 11143 79636623
Retroperitoneal fibrosis 26.23 10.32 14 96608 679 79647087
Hepatitis B core antibody positive 26.13 10.32 13 96609 544 79647222
Aphthous ulcer 26.10 10.32 61 96561 16828 79630938
Tricuspid valve incompetence 26.00 10.32 67 96555 19645 79628121
Inferior vena cava dilatation 25.87 10.32 15 96607 856 79646910
Respiratory tract oedema 25.82 10.32 15 96607 859 79646907
Blood thyroid stimulating hormone increased 25.82 10.32 44 96578 9664 79638102
Cerebral haemorrhage 25.81 10.32 138 96484 57535 79590231
Rhinalgia 25.69 10.32 22 96600 2345 79645421
Hepatocellular injury 25.63 10.32 120 96502 47473 79600293
Loss of personal independence in daily activities 25.53 10.32 212 96410 102368 79545398
Acquired haemophilia 25.44 10.32 20 96602 1891 79645875
Atheroembolism 25.42 10.32 11 96611 333 79647433
Autoimmune nephritis 25.39 10.32 14 96608 725 79647041
Blood pressure diastolic abnormal 25.06 10.32 65 96557 19137 79628629
Productive cough 24.97 10.32 188 96434 88143 79559623
Aptyalism 24.94 10.32 14 96608 751 79647015
Injection site reaction 24.90 10.32 18 96604 54767 79592999
Injection site pain 24.63 10.32 78 96544 129760 79518006
Transferrin saturation decreased 24.50 10.32 16 96606 1130 79646636
Drug hypersensitivity 24.33 10.32 238 96384 298678 79349088
Candida infection 24.26 10.32 8 96614 38206 79609560
Oedema peripheral 24.24 10.32 435 96187 251853 79395913
Bone cyst 24.00 10.32 25 96597 3408 79644358
Renal failure 23.93 10.32 359 96263 200609 79447157
Vulvovaginal pruritus 23.67 10.32 22 96600 2611 79645155
Pulmonary function test abnormal 23.44 10.32 27 96595 4117 79643649
Schizoaffective disorder 23.36 10.32 20 96602 2132 79645634
Seasonal affective disorder 23.16 10.32 10 96612 301 79647465
Atrioventricular block 23.12 10.32 52 96570 13989 79633777
Hypocalvaria 23.11 10.32 6 96616 33 79647733
Unevaluable event 23.08 10.32 20 96602 55565 79592201
Hormone receptor positive HER2 negative breast cancer 23.06 10.32 8 96614 131 79647635
Sepsis 23 10.32 212 96410 269216 79378550
Myelosuppression 22.98 10.32 10 96612 40286 79607480
Bone marrow failure 22.96 10.32 17 96605 51090 79596676
Haemorrhagic stroke 22.96 10.32 45 96577 11001 79636765
Calcification metastatic 22.94 10.32 8 96614 133 79647633
Heart rate irregular 22.69 10.32 89 96533 32590 79615176
Device issue 22.67 10.32 3 96619 27105 79620661
Hypoparathyroidism 22.67 10.32 15 96607 1083 79646683
Pulse abnormal 22.51 10.32 24 96598 3360 79644406
Hypoglycaemia 22.18 10.32 204 96418 101390 79546376
N-terminal prohormone brain natriuretic peptide increased 22.03 10.32 28 96594 4727 79643039
Lip injury 21.97 10.32 15 96607 1141 79646625
Troponin increased 21.94 10.32 62 96560 19193 79628573
Neglect of personal appearance 21.91 10.32 8 96614 153 79647613
Injection site pruritus 21.82 10.32 12 96610 42271 79605495
Product use in unapproved indication 21.80 10.32 196 96426 250163 79397603
Lymphoedema 21.60 10.32 47 96575 12366 79635400
Diabetic foot 21.11 10.32 24 96598 3608 79644158
Platelet count decreased 20.85 10.32 144 96478 194520 79453246
Myocardial infarction 20.80 10.32 326 96296 183803 79463963
Dissociation 20.76 10.32 25 96597 3996 79643770
Ventricular hypokinesia 20.76 10.32 39 96583 9240 79638526
Cytomegalovirus infection 20.74 10.32 13 96609 42631 79605135
Hypochromasia 20.71 10.32 12 96610 684 79647082
Myocardial ischaemia 20.64 10.32 73 96549 25446 79622320
Nephropathy 20.64 10.32 40 96582 9698 79638068
Ventricular dyskinesia 20.57 10.32 10 96612 398 79647368
Degenerative aortic valve disease 20.54 10.32 8 96614 184 79647582
Ventricular extrasystoles 20.10 10.32 61 96561 19643 79628123
Osteolysis 20.08 10.32 26 96596 4472 79643294
Hypocalcaemia 20.04 10.32 116 96506 49808 79597958
Mean platelet volume increased 20.03 10.32 14 96608 1106 79646660
Lip oedema 20.02 10.32 31 96591 6285 79641481
Hypertensive crisis 19.99 10.32 63 96559 20707 79627059
Acute respiratory failure 19.62 10.32 26 96596 59515 79588251
Injection site swelling 19.52 10.32 17 96605 47115 79600651
Injection site bruising 19.26 10.32 13 96609 40989 79606777
Metabolic syndrome 19.24 10.32 20 96602 2720 79645046
Scan gallium abnormal 19.18 10.32 5 96617 28 79647738
Myocarditis 19.18 10.32 64 96558 21669 79626097
Coronary artery occlusion 19.12 10.32 51 96571 15264 79632502
Needle issue 18.90 10.32 46 96576 13022 79634744
Uveitic glaucoma 18.83 10.32 4 96618 7 79647759
Stomatitis 18.61 10.32 103 96519 146654 79501112
Rash maculo-papular 18.56 10.32 124 96498 55954 79591812
Electrocardiogram ST segment elevation 18.42 10.32 35 96587 8362 79639404
Capillary disorder 18.30 10.32 7 96615 153 79647613
Blood uric acid increased 18.23 10.32 46 96576 13314 79634452
Coronary artery stenosis 18.11 10.32 44 96578 12440 79635326
Catheter site injury 18.07 10.32 8 96614 256 79647510
Wrong patient received product 18.02 10.32 25 96597 4593 79643173
Shock 18.01 10.32 102 96520 43446 79604320
Head banging 17.91 10.32 10 96612 531 79647235
Decreased ventricular preload 17.87 10.32 5 96617 38 79647728
Multiple sclerosis relapse 17.84 10.32 18 96604 46515 79601251
Tachyarrhythmia 17.79 10.32 31 96591 6931 79640835
Dyspnoea 17.74 10.32 1235 95387 855790 78791976
Sinoatrial block 17.69 10.32 14 96608 1337 79646429
Angiotensin converting enzyme inhibitor foetopathy 17.65 10.32 5 96617 40 79647726
Mucosal inflammation 17.64 10.32 41 96581 75539 79572227
Bronchial hyperreactivity 17.52 10.32 20 96602 3020 79644746
Cytokine release syndrome 17.47 10.32 11 96611 35987 79611779
Laryngeal haematoma 17.46 10.32 7 96615 174 79647592
Muscle haemorrhage 17.34 10.32 29 96593 6271 79641495
Abortion spontaneous 17.34 10.32 7 96615 29500 79618266
Paratracheal lymphadenopathy 17.28 10.32 7 96615 179 79647587
Seizure 17.25 10.32 146 96476 188688 79459078
Paranasal sinus discomfort 17.21 10.32 24 96598 4432 79643334
Fear 17.09 10.32 3 96619 21983 79625783
Product quality issue 16.99 10.32 10 96612 33930 79613836
Dyspnoea paroxysmal nocturnal 16.98 10.32 17 96605 2211 79645555
Chest pain 16.95 10.32 455 96167 281849 79365917
Duplicate therapy error 16.92 10.32 8 96614 299 79647467
Glomerular filtration rate increased 16.83 10.32 13 96609 1198 79646568
Infusion related reaction 16.82 10.32 188 96434 230049 79417717
Plasma cell myeloma 16.80 10.32 24 96598 53235 79594531
Urinary straining 16.75 10.32 5 96617 49 79647717
Hypoaesthesia 16.68 10.32 138 96484 179214 79468552
Pressure of speech 16.67 10.32 13 96609 1215 79646551
Electrocardiogram T wave inversion 16.52 10.32 26 96596 5346 79642420
Wrong technique in product usage process 16.51 10.32 41 96581 73834 79573932
Ear congestion 16.48 10.32 19 96603 2900 79644866
Acute myocardial infarction 16.47 10.32 154 96468 76882 79570884
Malaise 16.41 10.32 738 95884 489131 79158635
Lower limb fracture 16.33 10.32 4 96618 23211 79624555
Portal vein flow decreased 16.31 10.32 5 96617 54 79647712
Knee arthroplasty 16.27 10.32 17 96605 43231 79604535
Dermatomyositis 16.26 10.32 21 96601 3602 79644164
Toxic epidermal necrolysis 16.24 10.32 18 96604 44563 79603203
Confusional state 16.19 10.32 502 96120 317495 79330271
Sopor 16.14 10.32 10 96612 33000 79614766
Ligament calcification 16.11 10.32 7 96615 214 79647552
Faeces discoloured 16.09 10.32 74 96548 29053 79618713
Food aversion 16.07 10.32 12 96610 1051 79646715
Gingival abscess 16.06 10.32 11 96611 841 79646925
Cardiac failure acute 16.05 10.32 55 96567 18874 79628892
Blood pressure systolic decreased 16.03 10.32 39 96583 11037 79636729
Haematoma 15.84 10.32 113 96509 52082 79595684
Upper respiratory tract infection 15.77 10.32 57 96565 91111 79556655
Episcleral venous pressure increased 15.73 10.32 4 96618 20 79647746
Dermatitis exfoliative generalised 15.66 10.32 30 96592 7211 79640555
Necrotising oesophagitis 15.58 10.32 12 96610 1101 79646665
Hepatic fibrosis 15.55 10.32 30 96592 7250 79640516
Nocturia 15.53 10.32 44 96578 13637 79634129
Device dislocation 15.53 10.32 6 96616 25964 79621802
Renin increased 15.45 10.32 7 96615 237 79647529
Rebound psychosis 15.42 10.32 8 96614 366 79647400
Somnambulism 15.31 10.32 26 96596 5695 79642071
Joint abscess 15.22 10.32 9 96613 533 79647233
Muscle injury 15.20 10.32 22 96600 48539 79599227
Brain injury 15.04 10.32 39 96583 11478 79636288
Hepatic cytolysis 15.01 10.32 69 96553 27082 79620684
Neurological symptom 14.99 10.32 33 96589 8750 79639016
Prothrombin time shortened 14.94 10.32 19 96603 3209 79644557
Screaming 14.91 10.32 21 96601 3912 79643854
Diabetic ketoacidosis 14.83 10.32 81 96541 34041 79613725
Neoplasm progression 14.67 10.32 25 96597 51657 79596109
Lower respiratory tract congestion 14.65 10.32 21 96601 3976 79643790
Antipsychotic drug level increased 14.54 10.32 26 96596 5931 79641835
Acute pulmonary oedema 14.47 10.32 44 96578 14186 79633580
Road traffic accident 14.45 10.32 19 96603 43645 79604121
Hepatotoxicity 14.43 10.32 25 96597 51327 79596439
Benign abdominal neoplasm 14.39 10.32 7 96615 279 79647487
Procedural pain 14.36 10.32 5 96617 23079 79624687
Pharyngeal swelling 14.32 10.32 30 96592 7689 79640077
Serum ferritin decreased 14.30 10.32 16 96606 2364 79645402
Livedo reticularis 14.23 10.32 21 96601 4082 79643684
Enlarged uvula 14.20 10.32 8 96614 432 79647334
Intraventricular haemorrhage 14.13 10.32 23 96599 4864 79642902
Aspergillus infection 14.08 10.32 3 96619 19158 79628608
Swollen tongue 14.01 10.32 94 96528 42476 79605290
Depression 13.93 10.32 182 96440 216608 79431158
Arteriovenous fistula site haematoma 13.90 10.32 4 96618 34 79647732
Blood pressure inadequately controlled 13.86 10.32 26 96596 6151 79641615
Intensive care 13.76 10.32 11 96611 1066 79646700
Obesity 13.70 10.32 81 96541 35044 79612722
Labelled drug-drug interaction medication error 13.65 10.32 68 96554 27582 79620184
Hypophagia 13.64 10.32 98 96524 45269 79602497
Ventricle rupture 13.63 10.32 5 96617 97 79647669
Osmolar gap abnormal 13.58 10.32 5 96617 98 79647668
No adverse event 13.57 10.32 15 96607 37177 79610589
Therapeutic product effect decreased 13.52 10.32 130 96492 163733 79484033
Skin laceration 13.44 10.32 70 96552 28892 79618874
Hallucination, olfactory 13.43 10.32 8 96614 480 79647286
Therapy interrupted 13.35 10.32 11 96611 31330 79616436
Stomatitis haemorrhagic 13.35 10.32 5 96617 103 79647663
Dialysis 13.34 10.32 3 96619 18459 79629307
Accidental exposure to product 13.33 10.32 11 96611 31311 79616455
Insulin resistance 13.33 10.32 12 96610 1367 79646399
Staphylococcal infection 13.30 10.32 32 96590 58263 79589503
Ischaemic cardiomyopathy 13.23 10.32 29 96593 7666 79640100
Blood chromogranin A increased 13.22 10.32 8 96614 494 79647272
Chronic obstructive pulmonary disease 13.21 10.32 160 96462 85259 79562507
Consciousness fluctuating 13.16 10.32 14 96608 1955 79645811
Haemophagocytic lymphohistiocytosis 13.13 10.32 5 96617 21832 79625934
Allergic cough 13.07 10.32 9 96613 694 79647072
Blood cyanide increased 12.98 10.32 4 96618 44 79647722
Psychomotor skills impaired 12.97 10.32 23 96599 5214 79642552
Benign ovarian tumour 12.96 10.32 7 96615 348 79647418
Atelectasis 12.92 10.32 12 96610 32245 79615521
Postoperative respiratory failure 12.90 10.32 6 96616 216 79647550
Urine albumin/creatinine ratio decreased 12.88 10.32 5 96617 114 79647652
Flushing 12.87 10.32 59 96563 88209 79559557
Convulsive threshold lowered 12.80 10.32 10 96612 937 79646829
Back pain 12.78 10.32 276 96346 303904 79343862
Psychotic symptom 12.68 10.32 16 96606 2681 79645085
Abnormal loss of weight 12.67 10.32 30 96592 8346 79639420
Coagulation factor VII level decreased 12.65 10.32 6 96616 226 79647540
Polydipsia 12.64 10.32 26 96596 6579 79641187
Joint range of motion decreased 12.61 10.32 13 96609 33269 79614497
Cystitis 12.60 10.32 108 96514 52624 79595142
Skin wrinkling 12.51 10.32 11 96611 1215 79646551
Mydriasis 12.49 10.32 3 96619 17640 79630126
Bone contusion 12.44 10.32 11 96611 1224 79646542
Giant cell arteritis 12.43 10.32 16 96606 2735 79645031
Peripheral artery haematoma 12.41 10.32 5 96617 126 79647640
Infected lymphocele 12.36 10.32 6 96616 238 79647528
Blood pressure decreased 12.35 10.32 179 96443 99287 79548479
Angiocardiogram 12.34 10.32 6 96616 239 79647527
Vascular access site pain 12.26 10.32 5 96617 130 79647636
High density lipoprotein decreased 12.25 10.32 21 96601 4634 79643132
Tachycardia paroxysmal 12.16 10.32 7 96615 394 79647372
Gravitational oedema 12.16 10.32 13 96609 1826 79645940
Therapeutic product effect incomplete 12.13 10.32 240 96382 141405 79506361
Vitamin B12 deficiency 12.13 10.32 27 96595 7214 79640552
Jaundice 12.09 10.32 108 96514 53241 79594525
Orthopnoea 12.03 10.32 33 96589 10040 79637726
Injection site erosion 12.02 10.32 5 96617 137 79647629
Renal dysplasia 11.98 10.32 4 96618 58 79647708
Mixed anxiety and depressive disorder 11.97 10.32 7 96615 406 79647360
Renal tubular necrosis 11.95 10.32 61 96561 24978 79622788
Choking 11.91 10.32 37 96585 12064 79635702
Renal haematoma 11.88 10.32 9 96613 806 79646960
Oedema genital 11.84 10.32 8 96614 598 79647168
Dysprosody 11.79 10.32 3 96619 15 79647751
Spermatozoa progressive motility decreased 11.79 10.32 4 96618 61 79647705
Hypersensitivity vasculitis 11.75 10.32 26 96596 6917 79640849
Renal injury 11.74 10.32 3 96619 16924 79630842
Subileus 11.71 10.32 23 96599 5631 79642135
Hypouricaemia 11.68 10.32 7 96615 425 79647341
General physical health deterioration 11.49 10.32 250 96372 274988 79372778
Cardioactive drug level below therapeutic 11.48 10.32 3 96619 17 79647749
Diabetic metabolic decompensation 11.48 10.32 17 96605 3315 79644451
Left ventricular dilatation 11.48 10.32 10 96612 1091 79646675
Protrusion tongue 11.46 10.32 7 96615 440 79647326
Sedation 11.44 10.32 29 96593 51866 79595900
Stress 11.40 10.32 147 96475 79465 79568301
Arthropod bite 11.39 10.32 29 96593 8442 79639324
Pancreatic carcinoma metastatic 11.31 10.32 18 96604 3735 79644031
Tachypnoea 11.28 10.32 72 96550 31991 79615775
Hypersomnia 11.28 10.32 7 96615 23079 79624687
Page kidney 11.23 10.32 4 96618 71 79647695
Muscle spasticity 11.22 10.32 6 96616 21469 79626297
Device malfunction 11.19 10.32 6 96616 21442 79626324
Body mass index decreased 11.19 10.32 8 96614 655 79647111
Hepatic function abnormal 11.18 10.32 48 96574 73059 79574707
Crepitations 11.16 10.32 32 96590 9985 79637781
Bundle branch block left 11.15 10.32 35 96587 11478 79636288
Acute hepatic failure 11.15 10.32 12 96610 30101 79617665
International normalised ratio increased 11.13 10.32 154 96468 84567 79563199
Drug reaction with eosinophilia and systemic symptoms 11.13 10.32 123 96499 64121 79583645
Spontaneous haematoma 11.12 10.32 11 96611 1411 79646355
Bone erosion 11.12 10.32 47 96575 17800 79629966
Histoplasmosis 11.07 10.32 14 96608 2351 79645415
Escherichia infection 11.04 10.32 4 96618 18013 79629753
Infective myositis 11.04 10.32 5 96617 169 79647597
Conjunctivitis 10.98 10.32 9 96613 25706 79622060
Injection site rash 10.98 10.32 4 96618 17950 79629816
Red cell distribution width increased 10.98 10.32 42 96580 15200 79632566
Bladder stenosis 10.94 10.32 3 96619 21 79647745
Pulmonary arterial hypertension 10.84 10.32 11 96611 28355 79619411
Incorrect route of product administration 10.76 10.32 16 96606 34913 79612853
Left atrial dilatation 10.74 10.32 16 96606 3137 79644629
Anti-thyroid antibody positive 10.72 10.32 7 96615 494 79647272
Incorrect dosage administered 10.69 10.32 15 96607 2784 79644982
Faeces soft 10.68 10.32 28 96594 8295 79639471
Crystalluria 10.65 10.32 9 96613 942 79646824
Drug withdrawal syndrome 10.60 10.32 16 96606 34702 79613064
Hyperammonaemic encephalopathy 10.57 10.32 20 96602 4762 79643004
Tubulointerstitial nephritis and uveitis syndrome 10.57 10.32 6 96616 329 79647437
Adverse drug reaction 10.52 10.32 43 96579 66349 79581417
Blood bilirubin increased 10.43 10.32 43 96579 66189 79581577
Meralgia paraesthetica 10.41 10.32 7 96615 519 79647247
Blood calcium decreased 10.38 10.32 14 96608 31805 79615961
Hydrocholecystis 10.33 10.32 7 96615 526 79647240

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 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
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 ACE inhibitor
CHEBI has role CHEBI:35674 antihypertensive drugs

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX 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
DB00790 DRUGBANK_ID
CHEMBL1200343 ChEMBL_ID
D020913 MESH_DESCRIPTOR_UI
107807 PUBCHEM_CID
6367 IUPHAR_LIGAND_ID
C053500 MESH_SUPPLEMENTAL_RECORD_UI
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
5987 INN_ID
95153-31-4 SECONDARY_CAS_RN
72022 PUBCHEM_CID
6373 IUPHAR_LIGAND_ID
2UV6ZNQ92K UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0110 TABLET 2 mg ORAL ANDA 26 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0111 TABLET 4 mg ORAL ANDA 26 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0112 TABLET 8 mg ORAL ANDA 26 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0527-1919 TABLET 4 mg ORAL NDA 27 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0527-1920 TABLET 8 mg ORAL NDA 27 sections
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 65862-286 TABLET 2 mg ORAL ANDA 26 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 65862-287 TABLET 4 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 65862-288 TABLET 8 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