candesartan cilexetil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 475 145040-37-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • candesartan cilexetil
  • TCV-116
  • TCV 116
a nonpeptide angiotensin II receptor antagonist
  • Molecular weight: 610.67
  • Formula: C33H34N6O6
  • CLOGP: 7.08
  • LIPINSKI: 3
  • HAC: 12
  • HDO: 1
  • TPSA: 143.34
  • ALOGS: -5.48
  • ROTB: 13

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
8 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.61 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0.42 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
June 4, 1998 FDA ASTRAZENECA
March 12, 1999 PMDA Takeda Pharmaceutical Company Limited

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 489.30 10.20 1076 82854 262339 63142753
Hyponatraemia 361.50 10.20 580 83350 111320 63293772
Pemphigus 201.30 10.20 10 83920 183716 63221376
General physical health deterioration 199.99 10.20 653 83277 200749 63204343
Drug ineffective 192.14 10.20 724 83206 1044041 62361051
Synovitis 184.91 10.20 17 83913 186901 63218191
Hyperkalaemia 177.65 10.20 283 83647 53920 63351172
Glossodynia 167.35 10.20 20 83910 178856 63226236
Arthropathy 160.60 10.20 55 83875 234737 63170355
Hand deformity 151.22 10.20 17 83913 159440 63245652
Completed suicide 150.28 10.20 11 83919 145662 63259430
Swelling 150.12 10.20 89 83841 275289 63129803
Product dose omission issue 140.52 10.20 67 83863 234246 63170846
Maternal exposure during pregnancy 139.71 10.20 58 83872 220004 63185088
Product monitoring error 138.84 10.20 82 83848 4434 63400658
Sputum discoloured 135.86 10.20 136 83794 16211 63388881
Angina pectoris 133.20 10.20 181 83749 29897 63375195
Product prescribing error 131.58 10.20 168 83762 26121 63378971
Systemic infection 131.30 10.20 80 83850 4580 63400512
Haematochezia 125.22 10.20 241 83689 53303 63351789
Renal impairment 120.57 10.20 321 83609 88034 63317058
Lactic acidosis 118.75 10.20 195 83735 38092 63367000
Bradycardia 116.53 10.20 282 83648 72945 63332147
Cardiospasm 114.01 10.20 54 83876 1853 63403239
Subarachnoid haemorrhage 111.71 10.20 115 83815 14168 63390924
Palmoplantar keratoderma 111.38 10.20 54 83876 1953 63403139
Anti-cyclic citrullinated peptide antibody positive 111.15 10.20 12 83918 116200 63288892
Oligohydramnios 110.86 10.20 81 83849 6285 63398807
Pruritus genital 108.23 10.20 58 83872 2596 63402496
Alopecia 104.14 10.20 179 83751 337357 63067735
Drug hypersensitivity 103.12 10.20 157 83773 310530 63094562
Systemic lupus erythematosus 102.36 10.20 76 83854 208842 63196250
Arterial occlusive disease 101.93 10.20 75 83855 5883 63399209
Death 101.13 10.20 215 83715 374166 63030926
Hypotension 99.67 10.20 659 83271 271945 63133147
Sleep terror 99.39 10.20 55 83875 2625 63402467
Joint swelling 98.15 10.20 177 83753 327489 63077603
Contraindicated product administered 98.11 10.20 86 83844 217562 63187530
Blood pressure increased 96.32 10.20 447 83483 161615 63243477
Wound 95.84 10.20 48 83882 163215 63241877
Syncope 95.03 10.20 356 83574 117029 63288063
Product use issue 94.81 10.20 91 83839 220429 63184663
Cough 94.24 10.20 686 83244 292057 63113035
Carotid artery occlusion 91.57 10.20 64 83866 4630 63400462
Tinnitus 91.56 10.20 167 83763 35461 63369631
Palpitations 91.28 10.20 342 83588 112428 63292664
Rheumatoid factor positive 91.12 10.20 5 83925 84401 63320691
Atrial tachycardia 90.24 10.20 61 83869 4179 63400913
Skin haemorrhage 89.49 10.20 87 83843 10007 63395085
Infusion related reaction 88.45 10.20 117 83813 245404 63159688
Hypersensitivity 86.83 10.20 159 83771 292526 63112566
Discomfort 85.77 10.20 58 83872 167316 63237776
Hepatic enzyme increased 85.23 10.20 85 83845 202243 63202849
Blepharospasm 83.96 10.20 67 83863 5929 63399163
Anaemia 82.91 10.20 667 83263 292763 63112329
Drug interaction 82.55 10.20 552 83378 228579 63176513
Cardiac failure 82.07 10.20 282 83648 88860 63316232
Fall 80.92 10.20 833 83097 391501 63013591
Duodenal ulcer perforation 80.91 10.20 10 83920 87199 63317893
Neovascularisation 79.61 10.20 36 83894 1109 63403983
Neurologic neglect syndrome 77.40 10.20 47 83883 2674 63402418
Anuria 77.12 10.20 89 83841 12462 63392630
Tension headache 77.03 10.20 60 83870 5126 63399966
Treatment failure 75.68 10.20 91 83839 198952 63206140
Angioedema 75.52 10.20 184 83746 47781 63357311
Infection 73.90 10.20 118 83812 229055 63176037
Carotid artery thrombosis 73.72 10.20 46 83884 2748 63402344
Injection site pain 73.45 10.20 40 83890 129760 63275332
Helicobacter infection 72.13 10.20 17 83913 92768 63312324
Immunisation 71.99 10.20 34 83896 1159 63403933
Sinusitis 71.87 10.20 118 83812 226535 63178557
Inappropriate antidiuretic hormone secretion 71.43 10.20 95 83835 15367 63389725
Blood creatinine increased 70.73 10.20 266 83664 87578 63317514
Gastrointestinal disorder 70.61 10.20 43 83887 131196 63273896
Anosmia 70.15 10.20 64 83866 6796 63398296
Dizziness 68.88 10.20 869 83061 429056 62976036
Hemiplegia 67.43 10.20 72 83858 9251 63395841
Muscle injury 67.18 10.20 5 83925 65340 63339752
Gangrene 66.31 10.20 59 83871 6064 63399028
Disturbance in attention 66.08 10.20 152 83778 38037 63367055
Rubber sensitivity 65.63 10.20 40 83890 2291 63402801
Dyspnoea 65.29 10.20 1231 82699 660082 62745010
Hypertensive crisis 64.68 10.20 90 83840 15196 63389896
Lung opacity 63.68 10.20 44 83886 3124 63401968
Therapeutic drug monitoring analysis not performed 62.11 10.20 32 83898 1320 63403772
Labelled drug-drug interaction medication error 61.40 10.20 82 83848 13317 63391775
Atrial fibrillation 60.84 10.20 310 83620 116326 63288766
Rash 60.42 10.20 464 83466 560407 62844685
Vasculitis 59.52 10.20 95 83835 18114 63386978
Abdominal discomfort 58.69 10.20 222 83708 320663 63084429
Folliculitis 58.52 10.20 11 83919 70306 63334786
Mobility decreased 58.12 10.20 45 83885 121114 63283978
Therapeutic product effect decreased 58.09 10.20 104 83826 193083 63212009
Pain of skin 56.09 10.20 73 83857 11561 63393531
Pain 54.74 10.20 672 83258 739956 62665136
Epilepsy 53.92 10.20 114 83816 26951 63378141
Therapy non-responder 53.20 10.20 17 83913 75884 63329208
Vertigo 52.97 10.20 187 83743 59700 63345392
Taste disorder 52.74 10.20 77 83853 13585 63391507
Adjustment disorder 52.11 10.20 39 83891 3139 63401953
Diplopia 52.06 10.20 104 83826 23624 63381468
Circulatory collapse 51.58 10.20 99 83831 21839 63383253
Dehydration 51.03 10.20 398 83532 172956 63232136
Hip arthroplasty 50.88 10.20 3 83927 47643 63357449
Total lung capacity decreased 50.30 10.20 33 83897 2150 63402942
Exposure during pregnancy 50.20 10.20 80 83850 155467 63249625
Forced expiratory volume decreased 50.12 10.20 46 83884 4922 63400170
Hypoglycaemia 50.10 10.20 184 83746 59881 63345211
Hemiparesis 49.83 10.20 101 83829 23181 63381911
Injection site erythema 49.47 10.20 24 83906 83150 63321942
Labile hypertension 49.41 10.20 20 83910 466 63404626
Transient ischaemic attack 48.30 10.20 134 83796 37619 63367473
Fibromyalgia 48.14 10.20 23 83907 80397 63324695
Drug intolerance 48.12 10.20 227 83703 308434 63096658
Blister 47.59 10.20 61 83869 129753 63275339
Muscular weakness 46.57 10.20 299 83631 122054 63283038
Productive cough 46.46 10.20 186 83744 63022 63342070
C-reactive protein abnormal 46.06 10.20 4 83926 46092 63359000
Eye pruritus 46.06 10.20 86 83844 18585 63386507
Facial pain 45.91 10.20 63 83867 10498 63394594
Personality disorder 45.82 10.20 47 83883 5764 63399328
Rheumatic fever 45.18 10.20 3 83927 43108 63361984
Aphasia 45.08 10.20 120 83810 32880 63372212
Lip swelling 44.52 10.20 115 83815 30948 63374144
Irritable bowel syndrome 44.32 10.20 27 83903 82385 63322707
Pericarditis 44.05 10.20 66 83864 131513 63273579
Orthostatic hypotension 43.96 10.20 126 83804 36034 63369058
Arthralgia 43.51 10.20 513 83417 569197 62835895
Ventricular tachycardia 43.15 10.20 87 83843 19892 63385200
Cholestatic liver injury 42.73 10.20 32 83898 2578 63402514
Electrocardiogram abnormal 41.79 10.20 56 83874 9123 63395969
Occupational asthma 40.75 10.20 13 83917 147 63404945
Basilar artery occlusion 40.37 10.20 12 83918 105 63404987
Bronchopulmonary aspergillosis allergic 39.93 10.20 29 83901 2229 63402863
Paradoxical drug reaction 39.10 10.20 37 83893 4115 63400977
Oedema peripheral 38.77 10.20 402 83528 189109 63215983
Chronic spontaneous urticaria 38.19 10.20 22 83908 1135 63403957
Hospitalisation 37.83 10.20 34 83896 85047 63320045
Hypomagnesaemia 37.75 10.20 103 83827 28634 63376458
Obstructive airways disorder 37.60 10.20 84 83846 20615 63384477
Tubulointerstitial nephritis 37.54 10.20 82 83848 19821 63385271
Paresis 36.99 10.20 29 83901 2501 63402591
Androgenetic alopecia 36.90 10.20 12 83918 145 63404947
Therapeutic product effect incomplete 36.08 10.20 69 83861 124987 63280105
Disorientation 35.58 10.20 124 83806 39328 63365764
Gamma-glutamyltransferase increased 35.17 10.20 112 83818 33919 63371173
Peripheral swelling 35.05 10.20 207 83723 265735 63139357
Cystostomy 34.88 10.20 10 83920 76 63405016
Cerebral infarction 34.80 10.20 89 83841 23804 63381288
Ill-defined disorder 34.79 10.20 34 83896 81721 63323371
Arrhythmia 34.50 10.20 120 83810 38020 63367072
Adverse event 33.80 10.20 24 83906 67535 63337557
Cystitis 33.59 10.20 153 83777 54838 63350254
Psoriatic arthropathy 33.54 10.20 43 83887 91477 63313615
Injection site reaction 33.14 10.20 18 83912 58506 63346586
Transaminases increased 33.12 10.20 104 83826 31263 63373829
Abdominal pain upper 32.82 10.20 417 83513 206027 63199065
Oesophageal dilatation 32.36 10.20 14 83916 387 63404705
Catarrh 32.29 10.20 22 83908 1527 63403565
Affect lability 32.17 10.20 55 83875 11096 63393996
Impaired healing 31.89 10.20 54 83876 102488 63302604
Haematoma 31.88 10.20 110 83820 34710 63370382
Gastrointestinal tract adenoma 31.27 10.20 13 83917 325 63404767
Musculoskeletal stiffness 31.01 10.20 132 83798 184486 63220606
Motor dysfunction 30.94 10.20 53 83877 10708 63394384
Tachycardia 30.82 10.20 264 83666 117892 63287200
Thalamus haemorrhage 30.34 10.20 16 83914 693 63404399
Knee arthroplasty 30.22 10.20 17 83913 54189 63350903
Vertigo positional 29.95 10.20 27 83903 2822 63402270
Vitamin B1 decreased 29.65 10.20 11 83919 201 63404891
Burns second degree 29.63 10.20 23 83907 1955 63403137
Malaise 29.54 10.20 739 83191 415215 62989877
Mental status changes 29.33 10.20 8 83922 39591 63365501
Blood pressure measurement 29.28 10.20 12 83918 289 63404803
Dysarthria 29.26 10.20 123 83807 42588 63362504
Neuropathy peripheral 29.19 10.20 67 83863 113600 63291492
Rheumatoid arthritis 29.14 10.20 206 83724 253613 63151479
Acute myocardial infarction 28.99 10.20 101 83829 32023 63373069
Respiratory tract congestion 28.69 10.20 69 83861 17763 63387329
Muscle twitching 28.38 10.20 73 83857 19595 63385497
Injury 28.33 10.20 33 83897 73214 63331878
Sensitivity to weather change 28.24 10.20 41 83889 7196 63397896
Renal failure 28.17 10.20 258 83672 117394 63287698
No adverse event 27.75 10.20 10 83920 41395 63363697
Sensory loss 27.59 10.20 49 83881 10189 63394903
Steroid dependence 27.49 10.20 21 83909 1743 63403349
Drug ineffective for unapproved indication 27.27 10.20 103 83827 33960 63371132
Toxicity to various agents 27.26 10.20 203 83727 247047 63158045
Disease progression 27.18 10.20 78 83852 122680 63282412
Non-cardiogenic pulmonary oedema 27.10 10.20 15 83915 716 63404376
Heart rate 26.91 10.20 8 83922 70 63405022
Sneezing 26.68 10.20 68 83862 18150 63386942
Vomiting 26.64 10.20 946 82984 558671 62846421
Rhabdomyolysis 26.63 10.20 122 83808 43829 63361263
Diffuse alopecia 26.51 10.20 16 83914 900 63404192
Pemphigoid 26.35 10.20 40 83890 7304 63397788
Coordination abnormal 26.27 10.20 57 83873 13716 63391376
Upper gastrointestinal haemorrhage 26.20 10.20 69 83861 18783 63386309
Myocardial oedema 26.03 10.20 10 83920 202 63404890
Multiple sclerosis relapse 25.90 10.20 16 83914 48462 63356630
Confusional state 25.62 10.20 447 83483 235933 63169159
Bronchiectasis 25.48 10.20 62 83868 16080 63389012
Extrapyramidal disorder 25.36 10.20 55 83875 13229 63391863
Potentiating drug interaction 25.28 10.20 30 83900 4326 63400766
Chromaturia 25.11 10.20 63 83867 16654 63388438
Blood lactic acid decreased 25.08 10.20 9 83921 149 63404943
Vestibular migraine 25.03 10.20 10 83920 225 63404867
Injection site swelling 25.00 10.20 16 83914 47556 63357536
Sinus congestion 24.85 10.20 66 83864 18057 63387035
Gastrooesophageal reflux disease 24.58 10.20 213 83717 95426 63309666
Ear infection 24.33 10.20 10 83920 38203 63366889
Orbital swelling 24.33 10.20 7 83923 54 63405038
Blood hyposmosis 24.16 10.20 6 83924 24 63405068
Intentional self-injury 23.68 10.20 3 83927 25684 63379408
Barotrauma 23.55 10.20 9 83921 179 63404913
Brain stem stroke 23.54 10.20 11 83919 366 63404726
Sinonasal obstruction 23.40 10.20 10 83920 268 63404824
Dyspnoea exertional 23.32 10.20 148 83782 60154 63344938
Blood uric acid increased 23.30 10.20 32 83898 5335 63399757
Flatulence 23.04 10.20 99 83831 34603 63370489
Ultrasound uterus abnormal 22.99 10.20 7 83923 67 63405025
Cerebrovascular accident 22.95 10.20 231 83699 107793 63297299
Painful respiration 22.90 10.20 23 83907 2751 63402341
Pulmonary hypoplasia 22.90 10.20 10 83920 283 63404809
Liver injury 22.62 10.20 28 83902 60492 63344600
Therapeutic response decreased 22.44 10.20 29 83901 61496 63343596
Lichen planus 22.33 10.20 21 83909 2317 63402775
Condition aggravated 22.22 10.20 386 83544 401831 63003261
Purpura senile 22.11 10.20 12 83918 551 63404541
Intraventricular haemorrhage 22.11 10.20 20 83910 2100 63402992
White blood cell count decreased 21.82 10.20 102 83828 139002 63266090
Gastroenteritis 21.78 10.20 81 83849 26509 63378583
Hypoventilation 21.63 10.20 29 83901 4725 63400367
Gastrointestinal haemorrhage 21.49 10.20 182 83748 80994 63324098
Rales 21.37 10.20 50 83880 12647 63392445
Accidental exposure to product 21.33 10.20 5 83925 27400 63377692
Respiratory tract inflammation 21.32 10.20 12 83918 592 63404500
Peripheral arterial occlusive disease 21.25 10.20 27 83903 4174 63400918
Blindness 21.14 10.20 70 83860 21629 63383463
Female sterilisation 21.12 10.20 12 83918 603 63404489
Hypokalaemia 21.11 10.20 220 83710 103584 63301508
Haematoma muscle 21.01 10.20 15 83915 1122 63403970
Iron deficiency anaemia 20.89 10.20 66 83864 19903 63385189
Cerebrovascular arteriovenous malformation 20.85 10.20 7 83923 94 63404998
Injection site bruising 20.81 10.20 15 83915 41895 63363197
Blood cholesterol increased 20.63 10.20 60 83870 93972 63311120
Osteochondrosis 20.60 10.20 16 83914 1361 63403731
Eosinophilic fasciitis 20.58 10.20 8 83922 167 63404925
Weight increased 20.54 10.20 233 83697 260559 63144533
Hyperglycaemic hyperosmolar nonketotic syndrome 20.50 10.20 14 83916 975 63404117
Cerebellar syndrome 19.92 10.20 24 83906 3515 63401577
Haemoptysis 19.89 10.20 83 83847 28643 63376449
Metastases to fallopian tube 19.84 10.20 6 83924 56 63405036
Internal haemorrhage 19.77 10.20 29 83901 5136 63399956
Full blood count decreased 19.76 10.20 5 83925 26019 63379073
Nightmare 19.68 10.20 63 83867 19131 63385961
Mental status changes postoperative 19.54 10.20 8 83922 192 63404900
Glomerular filtration rate decreased 19.51 10.20 50 83880 13391 63391701
International normalised ratio increased 19.24 10.20 116 83814 46309 63358783
Occult blood 19.21 10.20 15 83915 1286 63403806
Pneumobilia 19.12 10.20 7 83923 123 63404969
Periorbital inflammation 19.04 10.20 6 83924 65 63405027
Lip infection 18.97 10.20 7 83923 126 63404966
Lichenoid keratosis 18.95 10.20 17 83913 1766 63403326
Melaena 18.92 10.20 85 83845 30280 63374812
Spontaneous haemorrhage 18.74 10.20 11 83919 588 63404504
Contusion 18.59 10.20 119 83811 149925 63255167
Hypopnoea 18.53 10.20 24 83906 3782 63401310
Cardiac output increased 18.46 10.20 8 83922 222 63404870
Hypocalcaemia 18.45 10.20 87 83843 31626 63373466
Ballismus 18.38 10.20 7 83923 138 63404954
Endometrial cancer 18.37 10.20 22 83908 3203 63401889
Therapy interrupted 18.35 10.20 10 83920 32445 63372647
Intravascular haemolysis 18.15 10.20 9 83921 342 63404750
Renal tubular disorder 18.15 10.20 20 83910 2662 63402430
Haematemesis 18.11 10.20 84 83846 30328 63374764
Electrolyte imbalance 18.01 10.20 63 83867 20013 63385079
Confusion postoperative 17.95 10.20 8 83922 238 63404854
Off label use 17.87 10.20 720 83210 673742 62731350
Sedation 17.87 10.20 15 83915 38794 63366298
Psoas abscess 17.77 10.20 10 83920 493 63404599
Stomatitis 17.71 10.20 109 83821 138616 63266476
Agranulocytosis 17.70 10.20 73 83857 25061 63380031
Sinus arrest 17.65 10.20 17 83913 1932 63403160
Flail chest 17.64 10.20 6 83924 84 63405008
Body temperature increased 17.59 10.20 14 83916 37178 63367914
Therapeutic response changed 17.53 10.20 13 83917 1032 63404060
Hyperuricaemia 17.53 10.20 28 83902 5342 63399750
Glossitis 17.51 10.20 21 83909 3061 63402031
Sinus rhythm 17.47 10.20 12 83918 844 63404248
Abortion spontaneous 17.47 10.20 22 83908 47173 63357919
Lower respiratory tract infection 17.40 10.20 103 83827 132204 63272888
Febrile neutropenia 17.33 10.20 89 83841 118360 63286732
Acute coronary syndrome 17.18 10.20 40 83890 10086 63395006
Myelosuppression 17.16 10.20 5 83925 23698 63381394
Gastroenteritis viral 17.16 10.20 5 83925 23695 63381397
Aortic dissection 17.15 10.20 17 83913 2001 63403091
Lung perforation 17.14 10.20 6 83924 92 63405000
Blood calcium increased 17.04 10.20 38 83892 9312 63395780
Cerebral haemorrhage 16.94 10.20 83 83847 30646 63374446
Diverticulum intestinal haemorrhagic 16.82 10.20 15 83915 1546 63403546
Histamine intolerance 16.80 10.20 5 83925 44 63405048
Injection site pruritus 16.73 10.20 21 83909 45095 63359997
Tarsal tunnel syndrome 16.55 10.20 10 83920 564 63404528
Supraventricular extrasystoles 16.47 10.20 25 83905 4564 63400528
Diabetic ketoacidosis 16.41 10.20 62 83868 20443 63384649
Dermatosis 16.41 10.20 8 83922 293 63404799
Myocardial infarction 16.37 10.20 203 83727 99690 63305402
Product quality issue 16.34 10.20 14 83916 35851 63369241
Blood pressure inadequately controlled 16.31 10.20 26 83904 4952 63400140
Sinus disorder 16.27 10.20 70 83860 24483 63380609
Multiple sclerosis 16.14 10.20 6 83924 24366 63380726
Gastrointestinal dysplasia 16.14 10.20 5 83925 51 63405041
Sputum retention 16.11 10.20 10 83920 592 63404500
Pregnancy 16.04 10.20 15 83915 36821 63368271
Putamen haemorrhage 16.03 10.20 7 83923 198 63404894
Prescribed overdose 15.97 10.20 13 83917 34140 63370952
Renal impairment neonatal 15.97 10.20 5 83925 53 63405039
Neutropenia 15.96 10.20 151 83779 174854 63230238
Asthenia 15.94 10.20 639 83291 382965 63022127
Dyspnoea at rest 15.76 10.20 23 83907 4056 63401036
Vasoplegia syndrome 15.73 10.20 15 83915 1684 63403408
Grip strength decreased 15.60 10.20 5 83925 22282 63382810
Joint range of motion decreased 15.60 10.20 12 83918 32416 63372676
Suicide attempt 15.56 10.20 36 83894 60882 63344210
Drug therapeutic incompatibility 15.56 10.20 5 83925 58 63405034
Injection site rash 15.52 10.20 3 83927 18806 63386286
Seizure 15.52 10.20 107 83823 132527 63272565
Staphylococcal infection 15.51 10.20 19 83911 41237 63363855
Ventricular extrasystoles 15.46 10.20 42 83888 11645 63393447
Cerebral ischaemia 15.37 10.20 30 83900 6698 63398394
Skin texture abnormal 15.35 10.20 9 83921 480 63404612
Wrong strength 15.33 10.20 5 83925 61 63405031
Treatment noncompliance 15.33 10.20 16 83914 37309 63367783
Nausea 15.28 10.20 1319 82611 853152 62551940
Altered state of consciousness 15.26 10.20 70 83860 25160 63379932
Accidental overdose 15.09 10.20 66 83864 23243 63381849
Therapy cessation 15.00 10.20 11 83919 30446 63374646
Oropharyngeal pain 14.98 10.20 69 83861 94418 63310674
Fibromuscular dysplasia 14.92 10.20 7 83923 235 63404857
Depression 14.90 10.20 177 83753 196315 63208777
Hepatic function abnormal 14.88 10.20 92 83838 37050 63368042
Blood pressure abnormal 14.78 10.20 49 83881 15149 63389943
Incorrect route of product administration 14.75 10.20 9 83921 27443 63377649
Drug dependence 14.65 10.20 7 83923 24476 63380616
Drug resistance 14.60 10.20 6 83924 22927 63382165
Gait inability 14.60 10.20 30 83900 52929 63352163
Tryptase increased 14.59 10.20 8 83922 375 63404717
Cornea verticillata 14.50 10.20 6 83924 148 63404944
Lymphangiectasia 14.45 10.20 5 83925 74 63405018
Device dislocation 14.41 10.20 8 83922 25697 63379395
Chest wall mass 14.33 10.20 5 83925 76 63405016
Laboratory test abnormal 14.21 10.20 9 83921 26903 63378189
Cor pulmonale acute 14.17 10.20 8 83922 397 63404695
Lupus endocarditis 14.17 10.20 7 83923 264 63404828
Coronavirus test positive 14.16 10.20 10 83920 735 63404357
Surgery 14.08 10.20 16 83914 35896 63369196
Myalgia 14.08 10.20 272 83658 146257 63258835
Spider naevus 14.04 10.20 6 83924 161 63404931
Urogenital haemorrhage 14.02 10.20 7 83923 270 63404822
Walking disability 13.98 10.20 13 83917 1414 63403678
Visual acuity reduced transiently 13.97 10.20 6 83924 163 63404929
Vestibular disorder 13.95 10.20 13 83917 1418 63403674
Thoracic operation 13.87 10.20 6 83924 166 63404926
Rash papular 13.85 10.20 49 83881 15653 63389439
Prothrombin time shortened 13.71 10.20 15 83915 1980 63403112
Thrombosis 13.71 10.20 42 83888 64713 63340379
Microangiopathy 13.63 10.20 12 83918 1216 63403876
Laryngeal papilloma 13.60 10.20 3 83927 6 63405086
Ultrasound kidney abnormal 13.56 10.20 4 83926 34 63405058
Wrong technique in product usage process 13.51 10.20 40 83890 62300 63342792
Unevaluable event 13.42 10.20 30 83900 51356 63353736
Complication associated with device 13.41 10.20 3 83927 16975 63388117
Binocular eye movement disorder 13.36 10.20 4 83926 36 63405056
Atrioventricular block complete 13.35 10.20 32 83898 8219 63396873
Ischaemic stroke 13.31 10.20 53 83877 17904 63387188
Stress urinary incontinence 13.31 10.20 16 83914 2339 63402753
Fluid intake reduced 13.30 10.20 20 83910 3621 63401471
Retroperitoneal fibrosis 13.30 10.20 7 83923 302 63404790
Electrocardiogram ST-T segment abnormal 13.26 10.20 7 83923 304 63404788
Clostridium difficile infection 13.25 10.20 12 83918 29910 63375182
Blood creatine phosphokinase increased 13.23 10.20 77 83853 30353 63374739
Renal aplasia 13.07 10.20 7 83923 313 63404779
Disability 13.05 10.20 4 83926 18343 63386749
Flushing 13.02 10.20 53 83877 75034 63330058
Laryngeal dysplasia 13.00 10.20 3 83927 8 63405084
Psychotic symptom 12.99 10.20 13 83917 1548 63403544
Cardiac murmur functional 12.98 10.20 4 83926 40 63405052
Haemorrhagic cyst 12.94 10.20 6 83924 196 63404896
Idiopathic orbital inflammation 12.94 10.20 6 83924 196 63404896
Joint injury 12.93 10.20 12 83918 29560 63375532
Exposure to allergen 12.87 10.20 7 83923 323 63404769
Serum serotonin increased 12.86 10.20 6 83924 199 63404893
Transient global amnesia 12.81 10.20 9 83921 656 63404436
Microcytic anaemia 12.76 10.20 19 83911 3410 63401682
Iron deficiency 12.75 10.20 29 83901 7201 63397891
Decreased ventricular preload 12.74 10.20 3 83927 9 63405083
Cardiorenal syndrome 12.73 10.20 10 83920 865 63404227
Kidney enlargement 12.72 10.20 9 83921 664 63404428
Pneumoconiosis 12.70 10.20 5 83925 108 63404984
Tenderness 12.70 10.20 7 83923 22571 63382521
Therapeutic drug monitoring analysis incorrectly performed 12.59 10.20 7 83923 337 63404755
Neisseria infection 12.58 10.20 5 83925 111 63404981
Acute respiratory distress syndrome 12.57 10.20 63 83867 23471 63381621
Nocturia 12.56 10.20 31 83899 8110 63396982
Breast discomfort 12.54 10.20 8 83922 497 63404595
Shock haemorrhagic 12.53 10.20 35 83895 9860 63395232
Illness 12.52 10.20 29 83901 49030 63356062
Pain in extremity 12.51 10.20 338 83592 331148 63073944
Spur cell anaemia 12.48 10.20 4 83926 46 63405046
Eating disorder 12.43 10.20 54 83876 18962 63386130
Type 2 diabetes mellitus 12.43 10.20 43 83887 63825 63341267
Premature delivery 12.41 10.20 13 83917 30268 63374824
Metastases to bladder 12.40 10.20 6 83924 216 63404876
Liver function test increased 12.36 10.20 80 83850 32731 63372361
Rhinitis 12.29 10.20 38 83892 11328 63393764
Gastritis 12.29 10.20 88 83842 37215 63367877
Nasal congestion 12.25 10.20 45 83885 65615 63339477
Anaemia folate deficiency 12.20 10.20 6 83924 224 63404868
Aortic arteriosclerosis 12.19 10.20 26 83904 6183 63398909
Spinal osteoarthritis 12.18 10.20 48 83882 16138 63388954
Stasis dermatitis 12.09 10.20 9 83921 718 63404374
Rectal haemorrhage 11.97 10.20 108 83822 48922 63356170
Vital capacity decreased 11.89 10.20 13 83917 1715 63403377
Drug metabolising enzyme decreased 11.89 10.20 3 83927 13 63405079
Abdominal pain lower 11.84 10.20 66 83864 25612 63379480
Pharyngeal enanthema 11.83 10.20 4 83926 55 63405037
Neonatal hypotension 11.70 10.20 5 83925 134 63404958
Hyperhidrosis 11.69 10.20 204 83726 107632 63297460
Chemotherapeutic drug level increased 11.63 10.20 5 83925 136 63404956
Disease recurrence 11.53 10.20 12 83918 28018 63377074
Irritability 11.50 10.20 15 83915 31679 63373413
Aspiration 11.47 10.20 36 83894 10815 63394277
Angiodysplasia 11.47 10.20 7 83923 402 63404690
Coronary artery occlusion 11.40 10.20 30 83900 8161 63396931
Joint space narrowing 11.38 10.20 8 83922 584 63404508
Endometrial cancer stage I 11.35 10.20 6 83924 261 63404831
Eczema nummular 11.33 10.20 6 83924 262 63404830
Adrenal adenoma 11.23 10.20 10 83920 1028 63404064
Cholestasis 11.23 10.20 72 83858 29362 63375730
Device issue 11.18 10.20 9 83921 23772 63381320
Organising pneumonia 11.12 10.20 24 83906 5752 63399340
Product storage error 11.12 10.20 3 83927 14953 63390139
Language disorder 11.11 10.20 14 83916 2146 63402946
Radiation pneumonitis 11.05 10.20 12 83918 1571 63403521
Coronary artery disease 11.03 10.20 77 83853 32300 63372792
Breast cancer 11.02 10.20 105 83825 48278 63356814
Leiomyoma 10.98 10.20 7 83923 434 63404658
Chronic gastritis 10.95 10.20 16 83914 2825 63402267
Fungal infection 10.93 10.20 20 83910 36854 63368238
Atypical fracture 10.86 10.20 8 83922 628 63404464
Eosinophilia 10.83 10.20 59 83871 22697 63382395
Night sweats 10.81 10.20 31 83899 48783 63356309
Skull fracture 10.78 10.20 10 83920 1085 63404007
Lipoedema 10.73 10.20 6 83924 292 63404800
Uterine dilation and evacuation 10.68 10.20 3 83927 21 63405071
Interstitial lung disease 10.66 10.20 127 83803 61781 63343311
Pulmonary atypical adenomatous hyperplasia 10.64 10.20 4 83926 76 63405016
Hallucination 10.59 10.20 115 83815 54702 63350390
Delayed fontanelle closure 10.56 10.20 3 83927 22 63405070
Gastric disorder 10.54 10.20 85 83845 37284 63367808
Live birth 10.51 10.20 11 83919 25619 63379473
Lordosis 10.46 10.20 6 83924 307 63404785
Cerebral haematoma 10.41 10.20 18 83912 3665 63401427
Hallucinations, mixed 10.39 10.20 21 83909 4808 63400284
Prerenal failure 10.37 10.20 12 83918 1684 63403408
Drug abuse 10.32 10.20 55 83875 72463 63332629
Hypochloraemia 10.30 10.20 13 83917 1996 63403096
Atelectasis 10.27 10.20 8 83922 21475 63383617
Base excess decreased 10.22 10.20 4 83926 85 63405007
Incarcerated incisional hernia 10.22 10.20 3 83927 25 63405067

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
General physical health deterioration 229.43 10.82 625 62312 127644 34766350
Death 212.64 10.82 243 62694 397806 34496188
Product monitoring error 174.77 10.82 105 62832 4276 34889718
Hyperkalaemia 157.14 10.82 370 62567 69019 34824975
Acute kidney injury 155.71 10.82 1009 61928 303979 34590015
Completed suicide 141.17 10.82 9 62928 98159 34795835
Cardiospasm 140.94 10.82 65 62872 1523 34892471
Toxicity to various agents 135.57 10.82 98 62839 200264 34693730
Palmoplantar keratoderma 128.15 10.82 65 62872 1888 34892106
Tension headache 121.58 10.82 73 62864 2969 34891025
Drug ineffective 120.77 10.82 421 62516 456330 34437664
Pruritus genital 120.74 10.82 65 62872 2139 34891855
Haematochezia 118.47 10.82 260 62677 46274 34847720
Product dose omission issue 115.36 10.82 36 62901 119675 34774319
Sleep terror 112.21 10.82 63 62874 2255 34891739
Facial pain 103.63 10.82 71 62866 3633 34890361
Carotid artery occlusion 100.71 10.82 70 62867 3667 34890327
Drug abuse 96.90 10.82 29 62908 99067 34794927
Immunisation 95.32 10.82 44 62893 1033 34892961
Atrial tachycardia 92.94 10.82 66 62871 3579 34890415
Pain of skin 91.77 10.82 81 62856 6028 34887966
Anosmia 91.54 10.82 68 62869 3956 34890038
Product prescribing error 91.46 10.82 155 62782 22772 34871222
Bradycardia 88.66 10.82 318 62619 75100 34818894
Vasculitis 82.87 10.82 102 62835 11194 34882800
Dizziness 78.60 10.82 666 62271 217855 34676139
Neutropenia 68.84 10.82 110 62827 156668 34737326
Disease progression 67.75 10.82 57 62880 108020 34785974
Angina pectoris 66.35 10.82 163 62774 31200 34862794
Tinnitus 66.12 10.82 125 62812 19993 34874001
Renal artery stenosis 62.45 10.82 43 62894 2218 34891776
Blood cholesterol 62.32 10.82 21 62916 204 34893790
Pericarditis 57.80 10.82 87 62850 11558 34882436
Labelled drug-drug interaction medication error 56.95 10.82 99 62838 14840 34879154
Off label use 56.05 10.82 485 62452 419039 34474955
Muscle twitching 55.54 10.82 80 62857 10218 34883776
Migraine 55.47 10.82 107 62830 17371 34876623
Nipple swelling 54.65 10.82 21 62916 306 34893688
Sepsis 54.21 10.82 139 62798 166422 34727572
Renal cyst haemorrhage 53.12 10.82 25 62912 614 34893380
Subarachnoid haemorrhage 51.15 10.82 86 62851 12549 34881445
Disturbance in attention 50.86 10.82 131 62806 25814 34868180
Palpitations 50.75 10.82 173 62764 39813 34854181
Eye pruritus 50.75 10.82 65 62872 7424 34886570
Drug hypersensitivity 49.81 10.82 43 62894 80486 34813508
Rectal prolapse 49.56 10.82 22 62915 470 34893524
Pulmonary hypoplasia 49.35 10.82 22 62915 475 34893519
Presyncope 49.04 10.82 107 62830 18952 34875042
Neuropathy peripheral 48.48 10.82 47 62890 83216 34810778
Cardiac failure 46.30 10.82 302 62635 90946 34803048
Lip swelling 45.69 10.82 94 62843 15986 34878008
Dyspnoea 45.21 10.82 939 61998 375843 34518151
Intraductal papillary mucinous neoplasm 44.69 10.82 21 62916 514 34893480
Urogenital haemorrhage 43.71 10.82 23 62914 722 34893272
Pneumonia 43.29 10.82 431 62506 362196 34531798
Actinic keratosis 43.17 10.82 47 62890 4520 34889474
Systemic infection 43.05 10.82 50 62887 5162 34888832
Diplopia 42.70 10.82 94 62843 16749 34877245
Febrile neutropenia 42.39 10.82 117 62820 136732 34757262
Hospitalisation 42.23 10.82 25 62912 56877 34837117
Gastrointestinal angiodysplasia 41.97 10.82 21 62916 592 34893402
Oedema peripheral 41.29 10.82 362 62575 119450 34774544
Transient ischaemic attack 40.94 10.82 126 62811 27487 34866507
Seizure 40.19 10.82 80 62857 104777 34789217
Vena cava injury 40.12 10.82 17 62920 323 34893671
Renal impairment 39.27 10.82 298 62639 94215 34799779
Agitation 38.82 10.82 28 62909 57371 34836623
Abdominal wall haemorrhage 37.17 10.82 18 62919 472 34893522
SARS-CoV-2 antibody test positive 36.52 10.82 17 62920 407 34893587
Large intestine polyp 36.29 10.82 57 62880 7857 34886137
Hypertensive crisis 36.00 10.82 60 62877 8691 34885303
Myalgia 35.39 10.82 266 62671 83844 34810150
Product use in unapproved indication 35.24 10.82 102 62835 117397 34776597
Blindness 35.05 10.82 81 62856 14905 34879089
Aortic valve incompetence 35.00 10.82 48 62889 5856 34888138
Aortic dilatation 34.87 10.82 25 62912 1376 34892618
Adrenal insufficiency 34.04 10.82 77 62860 13970 34880024
Nipple pain 33.64 10.82 21 62916 916 34893078
Vascular anastomotic haemorrhage 32.71 10.82 14 62923 273 34893721
Respiratory tract haemorrhage 32.39 10.82 23 62914 1247 34892747
Hyperparathyroidism secondary 32.35 10.82 25 62912 1543 34892451
Diverticulum intestinal 32.25 10.82 38 62899 3983 34890011
Vascular compression 32.15 10.82 15 62922 361 34893633
Ventricular tachycardia 31.98 10.82 113 62824 26466 34867528
Hyperuricaemia 31.57 10.82 54 62883 7989 34886005
White blood cell count decreased 31.52 10.82 79 62858 95366 34798628
Renal artery thrombosis 31.46 10.82 14 62923 301 34893693
Respiratory symptom 31.42 10.82 26 62911 1771 34892223
Lymphocyte count abnormal 31.25 10.82 22 62915 1176 34892818
Anencephaly 30.87 10.82 11 62926 128 34893866
Carotid arteriosclerosis 30.66 10.82 26 62911 1832 34892162
Glycosylated haemoglobin increased 30.63 10.82 65 62872 11295 34882699
Rash papular 30.28 10.82 61 62876 10217 34883777
Abdominal pain lower 30.27 10.82 62 62875 10509 34883485
Perineal cyst 30.12 10.82 13 62924 259 34893735
Treatment failure 30.02 10.82 24 62913 46673 34847321
Sinusitis 29.59 10.82 19 62918 41383 34852611
Multiple drug therapy 29.25 10.82 15 62922 446 34893548
Blood creatinine increased 29.17 10.82 280 62657 94696 34799298
Interstitial lung disease 27.76 10.82 207 62730 65075 34828919
Patient dissatisfaction with treatment 27.62 10.82 9 62928 78 34893916
Sedation 27.23 10.82 3 62934 21003 34872991
Vertigo 26.90 10.82 104 62833 25432 34868562
Blood pressure inadequately controlled 26.41 10.82 28 62909 2612 34891382
Drug resistance 26.41 10.82 7 62930 25920 34868074
Pemphigoid 26.21 10.82 52 62885 8614 34885380
Respiratory arrest 25.98 10.82 9 62928 28034 34865960
Cerebral infarction 25.87 10.82 108 62829 27347 34866647
Hypoxia 25.74 10.82 37 62900 55058 34838936
No adverse event 25.73 10.82 5 62932 22922 34871072
Drug dependence 25.71 10.82 6 62931 24211 34869783
Electrolyte imbalance 25.43 10.82 70 62867 14342 34879652
Angioedema 24.27 10.82 132 62805 37242 34856752
Therapy non-responder 24.07 10.82 21 62916 39125 34854869
Mental status changes 23.94 10.82 20 62917 38063 34855931
Visual impairment 23.62 10.82 127 62810 35675 34858319
Therapeutic product effect decreased 23.42 10.82 17 62920 34726 34859268
Post concussion syndrome 23.37 10.82 9 62928 132 34893862
Jaundice 23.04 10.82 116 62821 31766 34862228
Hypotension 22.85 10.82 541 62396 221108 34672886
Atrioventricular block 22.74 10.82 47 62890 8016 34885978
Syncope 22.60 10.82 258 62679 91193 34802801
Coronary artery stenosis 22.51 10.82 52 62885 9564 34884430
Peripheral arterial occlusive disease 22.48 10.82 39 62898 5835 34888159
Full blood count decreased 22.42 10.82 3 62934 18085 34875909
Arrhythmia 22.26 10.82 125 62812 35683 34858311
Cardiac arrest 21.77 10.82 94 62843 96065 34797929
Abdominal pain upper 21.57 10.82 210 62727 71280 34822714
Congenital renal disorder 21.37 10.82 8 62929 108 34893886
Rash 21.29 10.82 278 62659 222474 34671520
Renal artery stent placement 21.13 10.82 5 62932 10 34893984
Renal artery angioplasty 21.13 10.82 5 62932 10 34893984
Lung hernia 21.05 10.82 7 62930 65 34893929
Papillary renal cell carcinoma 20.80 10.82 10 62927 258 34893736
Pallor 20.79 10.82 96 62841 25384 34868610
Blood 25-hydroxycholecalciferol decreased 20.76 10.82 10 62927 259 34893735
Pulmonary vasculitis 20.44 10.82 13 62924 586 34893408
Hyperthyroidism 20.34 10.82 53 62884 10513 34883481
Product use issue 20.34 10.82 53 62884 63163 34830831
Lactic acidosis 20.06 10.82 119 62818 34653 34859341
Neurotoxicity 20.06 10.82 4 62933 18006 34875988
Blood growth hormone increased 20.02 10.82 11 62926 377 34893617
Myelosuppression 20.01 10.82 5 62932 19260 34874734
Joint contracture 19.98 10.82 21 62916 1940 34892054
Plasma cell myeloma 19.86 10.82 28 62909 42009 34851985
Acute cutaneous lupus erythematosus 19.83 10.82 7 62930 79 34893915
Thrombocytopenia 19.70 10.82 183 62754 156064 34737930
Delayed graft function 19.51 10.82 22 62915 2199 34891795
Gastrointestinal ischaemia 19.51 10.82 9 62928 211 34893783
Sinus rhythm 19.51 10.82 11 62926 397 34893597
Aortic arteriosclerosis 19.36 10.82 32 62905 4604 34889390
Micturition disorder 19.30 10.82 22 62915 2226 34891768
Musculoskeletal stiffness 19.29 10.82 34 62903 46646 34847348
Nervous system neoplasm 18.98 10.82 8 62929 150 34893844
Anaemia 18.97 10.82 552 62385 232783 34661211
Hemiataxia 18.94 10.82 6 62931 47 34893947
Intermittent claudication 18.93 10.82 22 62915 2272 34891722
Costovertebral angle tenderness 18.74 10.82 7 62930 94 34893900
Hepatic steatosis 18.70 10.82 74 62863 18288 34875706
Bronchiectasis 18.70 10.82 49 62888 9752 34884242
Cytomegalovirus infection 18.67 10.82 12 62925 26123 34867871
Respiratory distress 18.66 10.82 22 62915 35643 34858351
Haematuria 18.65 10.82 154 62783 49912 34844082
Cytokine release syndrome 18.51 10.82 9 62928 22868 34871126
Respiratory failure 18.47 10.82 117 62820 108455 34785539
Tonsillar ulcer 18.41 10.82 8 62929 162 34893832
Total cholesterol/HDL ratio increased 18.24 10.82 8 62929 166 34893828
IIIrd nerve paresis 18.03 10.82 7 62930 105 34893889
Unresponsive to stimuli 17.93 10.82 14 62923 27555 34866439
Melaena 17.86 10.82 117 62820 35263 34858731
Endoscopy upper gastrointestinal tract abnormal 17.83 10.82 6 62931 58 34893936
Polyp 17.80 10.82 28 62909 3864 34890130
Eczema 17.74 10.82 73 62864 18363 34875631
Basal ganglia haemorrhage 17.46 10.82 14 62923 912 34893082
Oral lichen planus 17.44 10.82 8 62929 185 34893809
Neuritis 17.35 10.82 14 62923 920 34893074
Hypopnoea 17.32 10.82 21 62916 2268 34891726
Respiratory depression 17.30 10.82 4 62933 16241 34877753
Hypochromic anaemia 17.29 10.82 14 62923 925 34893069
Atrial fibrillation 17.27 10.82 313 62624 122080 34771914
Muscular weakness 17.26 10.82 204 62733 72693 34821301
Swelling of eyelid 17.22 10.82 15 62922 1096 34892898
Acute right ventricular failure 17.13 10.82 7 62930 121 34893873
Obstructive airways disorder 17.05 10.82 64 62873 15430 34878564
Vasculitic rash 17.03 10.82 14 62923 945 34893049
Coronavirus infection 17.01 10.82 29 62908 4278 34889716
pH body fluid increased 16.75 10.82 6 62931 71 34893923
Paresis cranial nerve 16.75 10.82 6 62931 71 34893923
Basal cell carcinoma 16.73 10.82 75 62862 19583 34874411
Macular ischaemia 16.67 10.82 6 62931 72 34893922
Injection site pain 16.49 10.82 28 62909 38977 34855017
Food aversion 16.38 10.82 10 62927 419 34893575
Hepatosplenomegaly 16.37 10.82 28 62909 4141 34889853
Gamma-glutamyltransferase increased 16.20 10.82 99 62838 29132 34864862
Mean cell volume increased 16.19 10.82 24 62913 3145 34890849
Vertebral artery stenosis 16.15 10.82 7 62930 141 34893853
Dry skin 16.12 10.82 104 62833 31183 34862811
Anxiety disorder due to a general medical condition 16.02 10.82 4 62933 11 34893983
Device lead damage 15.97 10.82 3 62934 0 34893994
Mesenteric artery thrombosis 15.96 10.82 10 62927 439 34893555
Candida infection 15.88 10.82 6 62931 17709 34876285
Intervertebral disc space narrowing 15.87 10.82 14 62923 1041 34892953
Type 2 diabetes mellitus 15.84 10.82 64 62873 15968 34878026
Xanthopsia 15.84 10.82 7 62930 148 34893846
Lymphocyte count 15.83 10.82 6 62931 84 34893910
Congenital muscle absence 15.80 10.82 5 62932 39 34893955
Congenital vas deferens absence 15.80 10.82 5 62932 39 34893955
Eosinophilic pneumonia 15.75 10.82 25 62912 3476 34890518
Hypervolaemia 15.57 10.82 8 62929 19701 34874293
Metabolic acidosis 15.55 10.82 133 62804 43547 34850447
Urinary hesitation 15.45 10.82 22 62915 2780 34891214
Supine hypertension 15.35 10.82 9 62928 350 34893644
Cardiovascular insufficiency 15.32 10.82 17 62920 1670 34892324
Eczema eyelids 15.18 10.82 5 62932 45 34893949
Urinary tract infection 15.14 10.82 89 62848 83992 34810002
Unevaluable event 15.11 10.82 22 62915 32568 34861426
Shock hypoglycaemic 15.10 10.82 6 62931 96 34893898
Troponin increased 15.08 10.82 50 62887 11339 34882655
Alopecia 14.47 10.82 84 62853 24271 34869723
Malaise 14.37 10.82 437 62500 185388 34708606
Multiple organ dysfunction syndrome 14.35 10.82 80 62857 76486 34817508
Mucosal inflammation 14.33 10.82 30 62907 38592 34855402
Atrioventricular block second degree 14.30 10.82 25 62912 3763 34890231
Pleurothotonus 14.27 10.82 14 62923 1191 34892803
Bacteraemia 14.15 10.82 9 62928 19708 34874286
Mucosal haemorrhage 14.11 10.82 16 62921 1609 34892385
Muscle rupture 14.10 10.82 19 62918 2279 34891715
Blood immunoglobulin E increased 14.05 10.82 20 62917 2526 34891468
Choroidal detachment 14.01 10.82 9 62928 413 34893581
Treatment noncompliance 14.00 10.82 18 62919 28082 34865912
Renal cyst 13.95 10.82 42 62895 9051 34884943
Platelet count decreased 13.91 10.82 143 62794 119574 34774420
Fracture 13.85 10.82 35 62902 6814 34887180
Hepatic ischaemia 13.80 10.82 9 62928 424 34893570
Hepatocellular carcinoma 13.78 10.82 37 62900 7472 34886522
Diabetic nephropathy 13.68 10.82 18 62919 2110 34891884
Blood creatine phosphokinase increased 13.63 10.82 132 62805 44725 34849269
Anti-erythropoietin antibody negative 13.59 10.82 7 62930 210 34893784
Overdose 13.57 10.82 102 62835 90957 34803037
Haemorrhoids 13.47 10.82 57 62880 14518 34879476
Memory impairment 13.43 10.82 128 62809 43190 34850804
Heart rate increased 13.42 10.82 135 62802 46208 34847786
Desmoplastic melanoma 13.41 10.82 4 62933 25 34893969
Blood glucose increased 13.36 10.82 181 62756 66537 34827457
Product quality issue 13.33 10.82 7 62930 17028 34876966
Peritoneal adhesions 13.31 10.82 6 62931 133 34893861
Appendicitis 13.29 10.82 5 62932 14802 34879192
Spinal osteoarthritis 13.24 10.82 37 62900 7646 34886348
Restless legs syndrome 13.21 10.82 39 62898 8315 34885679
Coronary artery bypass 13.16 10.82 28 62909 4874 34889120
Cerebral haematoma 13.13 10.82 27 62910 4588 34889406
Hypertension 13.12 10.82 330 62607 136113 34757881
Pterygium 13.03 10.82 6 62931 140 34893854
Idiopathic pulmonary fibrosis 12.92 10.82 23 62914 3511 34890483
Pseudarthrosis 12.82 10.82 5 62932 76 34893918
Neutrophil count decreased 12.79 10.82 48 62889 51056 34842938
Ventricular extrasystoles 12.72 10.82 49 62888 11959 34882035
Basilar artery thrombosis 12.69 10.82 7 62930 242 34893752
Renovascular hypertension 12.67 10.82 4 62933 31 34893963
Vascular stent stenosis 12.67 10.82 13 62924 1168 34892826
Cardiac valve sclerosis 12.64 10.82 5 62932 79 34893915
Dysuria 12.63 10.82 88 62849 27064 34866930
Blood potassium increased 12.61 10.82 61 62876 16434 34877560
Oligohydramnios 12.59 10.82 8 62929 360 34893634
Periorbital discomfort 12.56 10.82 4 62933 32 34893962
Cardio-respiratory arrest 12.52 10.82 54 62883 55219 34838775
Swollen joint count decreased 12.44 10.82 6 62931 156 34893838
Tender joint count decreased 12.44 10.82 6 62931 156 34893838
Drug intolerance 12.42 10.82 60 62877 59510 34834484
Cranial sutures widening 12.42 10.82 5 62932 83 34893911
Bone marrow failure 12.37 10.82 21 62916 29232 34864762
Amnesia 12.30 10.82 86 62851 26477 34867517
Albumin urine present 12.28 10.82 8 62929 376 34893618
Mixed liver injury 12.22 10.82 20 62917 2853 34891141
Retinal artery occlusion 12.21 10.82 16 62921 1869 34892125
Irritability 12.11 10.82 16 62921 24674 34869320
Hypozincaemia 12.08 10.82 3 62934 8 34893986
Bone hypertrophy 12.06 10.82 6 62931 167 34893827
Prothrombin time shortened 12.02 10.82 14 62923 1450 34892544
Hypertensive heart disease 11.96 10.82 18 62919 2390 34891604
Septic shock 11.91 10.82 78 62859 71756 34822238
Incarcerated inguinal hernia 11.90 10.82 6 62931 172 34893822
Psychotic disorder 11.84 10.82 16 62921 24436 34869558
Pancreatitis acute 11.82 10.82 89 62848 28052 34865942
Chronic coronary syndrome 11.80 10.82 6 62931 175 34893819
Neuroleptic malignant syndrome 11.80 10.82 9 62928 17925 34876069
Brain stem infarction 11.78 10.82 13 62924 1269 34892725
Faeces soft 11.77 10.82 22 62915 3486 34890508
Fractured skull depressed 11.77 10.82 4 62933 40 34893954
Orthostatic hypertension 11.76 10.82 7 62930 280 34893714
Adverse event 11.76 10.82 10 62927 18867 34875127
Pancytopenia 11.75 10.82 112 62825 95045 34798949
Aortic valve disease mixed 11.71 10.82 5 62932 97 34893897
Muscle spasms 11.66 10.82 83 62854 74918 34819076
Duodenal ulcer 11.64 10.82 43 62894 10289 34883705
Renal ischaemia 11.58 10.82 9 62928 560 34893434
Loss of control of legs 11.57 10.82 10 62927 723 34893271
Renin increased 11.57 10.82 5 62932 100 34893894
Acute on chronic liver failure 11.57 10.82 5 62932 100 34893894
Influenza like illness 11.53 10.82 20 62917 27614 34866380
Apnoeic attack 11.53 10.82 8 62929 418 34893576
Cranial nerve disorder 11.43 10.82 9 62928 571 34893423
Foetal heart rate abnormal 11.41 10.82 6 62931 188 34893806
Neurologic neglect syndrome 11.33 10.82 6 62931 191 34893803
Pulmonary fibrosis 11.29 10.82 64 62873 18332 34875662
Cerebellar haemorrhage 11.22 10.82 14 62923 1557 34892437
Mechanical urticaria 11.21 10.82 5 62932 108 34893886
Road traffic accident 11.17 10.82 9 62928 17441 34876553
Cerebrospinal fluid retention 11.16 10.82 3 62934 12 34893982
Lip ulceration 11.16 10.82 10 62927 759 34893235
Atrioventricular block first degree 11.16 10.82 30 62907 6062 34887932
Tremor 11.16 10.82 95 62842 82492 34811502
Hypothyroidism 11.09 10.82 70 62867 20832 34873162
Cognitive disorder 11.08 10.82 89 62848 28604 34865390
Cerebral ventricular rupture 11.02 10.82 6 62931 202 34893792
Infusion site thrombosis 10.97 10.82 5 62932 114 34893880
Atypical fibroxanthoma 10.94 10.82 6 62931 205 34893789

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 541.46 9.76 1970 128448 517434 79096536
General physical health deterioration 421.07 9.76 1192 129226 274046 79339924
Completed suicide 319.51 9.76 21 130397 245746 79368224
Product monitoring error 304.99 9.76 187 130231 8719 79605251
Hyperkalaemia 296.35 9.76 608 129810 113790 79500180
Cardiospasm 239.15 9.76 114 130304 3187 79610783
Haematochezia 229.51 9.76 468 129950 87177 79526793
Death 227.43 9.76 360 130058 566154 79047816
Palmoplantar keratoderma 226.33 9.76 114 130304 3602 79610368
Product prescribing error 223.70 9.76 319 130099 44494 79569476
Pruritus genital 214.39 9.76 117 130301 4369 79609601
Sleep terror 204.04 9.76 113 130305 4345 79609625
Drug ineffective 202.65 9.76 996 129422 1079917 78534053
Hyponatraemia 193.21 9.76 685 129733 177163 79436807
Tension headache 181.94 9.76 125 130293 7086 79606884
Product dose omission issue 181.40 9.76 89 130329 247448 79366522
Carotid artery occlusion 177.62 9.76 126 130292 7521 79606449
Synovitis 176.48 9.76 20 130398 150714 79463256
Atrial tachycardia 176.09 9.76 122 130296 7011 79606959
Bradycardia 175.50 9.76 554 129864 135003 79478967
Angina pectoris 161.99 9.76 298 130120 51434 79562536
Toxicity to various agents 159.58 9.76 278 130140 421262 79192708
Anosmia 159.09 9.76 125 130293 8719 79605251
Systemic infection 156.66 9.76 129 130289 9623 79604347
Immunisation 154.43 9.76 74 130344 2093 79611877
Subarachnoid haemorrhage 150.79 9.76 193 130225 24272 79589698
Pain of skin 144.00 9.76 147 130271 14466 79599504
Dizziness 143.22 9.76 1401 129017 525040 79088930
Drug hypersensitivity 138.63 9.76 171 130247 298745 79315225
Tinnitus 137.07 9.76 254 130164 44079 79569891
Vasculitis 133.14 9.76 184 130234 24918 79589052
Palpitations 126.73 9.76 475 129943 126135 79487835
Facial pain 124.91 9.76 126 130292 12224 79601746
Arthropathy 121.86 9.76 69 130349 177042 79436928
Hand deformity 121.10 9.76 14 130404 103905 79510065
Renal impairment 120.08 9.76 544 129874 157239 79456731
Pemphigus 119.65 9.76 12 130406 99570 79514400
Disturbance in attention 113.04 9.76 254 130164 50547 79563423
Labelled drug-drug interaction medication error 111.19 9.76 178 130240 27472 79586498
Maternal exposure during pregnancy 107.95 9.76 44 130374 136494 79477476
Lactic acidosis 105.57 9.76 303 130115 70056 79543914
Dyspnoea 100.73 9.76 1962 128456 855063 78758907
Anti-cyclic citrullinated peptide antibody positive 97.38 9.76 11 130407 83132 79530838
Glossodynia 96.31 9.76 25 130393 103312 79510658
Eye pruritus 96.18 9.76 142 130276 20428 79593542
Drug abuse 94.98 9.76 76 130342 162615 79451355
Cardiac failure 92.93 9.76 499 129919 154343 79459627
Cough 92.73 9.76 962 129456 365827 79248143
Hypotension 90.13 9.76 1108 129310 439209 79174761
Transient ischaemic attack 90.04 9.76 238 130180 52457 79561513
Syncope 89.82 9.76 551 129867 178898 79435072
Diplopia 89.08 9.76 180 130238 33286 79580684
Sputum discoloured 87.46 9.76 140 130278 21603 79592367
Product use issue 86.18 9.76 131 130287 209691 79404279
Hypersensitivity 86.05 9.76 188 130230 262051 79351919
Rheumatoid factor positive 84.44 9.76 3 130415 59836 79554134
Therapeutic product effect decreased 84.37 9.76 86 130332 163777 79450193
Anaemia 83.93 9.76 1103 129315 443912 79170058
Angioedema 80.87 9.76 291 130127 75744 79538226
Lip swelling 80.56 9.76 195 130223 40716 79573254
Sinusitis 80.34 9.76 122 130296 195379 79418591
Infusion related reaction 79.79 9.76 160 130258 230077 79383893
Treatment failure 79.53 9.76 97 130321 170389 79443581
Muscle twitching 79.21 9.76 144 130274 24620 79589350
Swelling 79.10 9.76 146 130272 216565 79397405
Duodenal ulcer perforation 76.94 9.76 9 130409 66202 79547768
Neutropenia 76.85 9.76 229 130189 287481 79326489
Blood pressure increased 76.79 9.76 600 129818 210760 79403210
Neurologic neglect syndrome 74.78 9.76 51 130367 2856 79611114
Joint swelling 74.77 9.76 233 130185 288413 79325557
Skin haemorrhage 73.01 9.76 94 130324 11887 79602083
Injection site pain 72.88 9.76 63 130355 129775 79484195
Hepatic enzyme increased 72.14 9.76 117 130301 182493 79431477
Disease progression 72.01 9.76 119 130299 184243 79429727
Contraindicated product administered 71.01 9.76 92 130326 157446 79456524
Oligohydramnios 69.65 9.76 52 130366 3360 79610610
Neovascularisation 69.45 9.76 36 130382 1209 79612761
Rubber sensitivity 68.38 9.76 40 130378 1709 79612261
Oedema peripheral 68.16 9.76 671 129747 251617 79362353
Arterial occlusive disease 67.34 9.76 76 130342 8380 79605590
Ventricular tachycardia 67.21 9.76 185 130233 41750 79572220
Vertigo 66.46 9.76 256 130162 68826 79545144
Muscular weakness 66.14 9.76 470 129948 160259 79453711
Blood creatinine increased 64.15 9.76 454 129964 154603 79459367
Therapy non-responder 63.41 9.76 36 130382 92269 79521701
Off label use 63.29 9.76 1074 129344 906141 78707829
Fall 63.14 9.76 1134 129284 486495 79127475
Hypertensive crisis 62.94 9.76 118 130300 20652 79593318
Febrile neutropenia 62.29 9.76 183 130235 230816 79383154
Renal artery stenosis 62.16 9.76 49 130369 3433 79610537
Blindness 61.00 9.76 140 130278 28243 79585727
Atrial fibrillation 59.76 9.76 539 129879 197347 79416623
Urogenital haemorrhage 59.58 9.76 30 130388 947 79613023
Carotid artery thrombosis 58.94 9.76 45 130373 3008 79610962
Muscle injury 57.94 9.76 6 130412 48555 79565415
Nipple swelling 56.99 9.76 21 130397 300 79613670
Renal cyst haemorrhage 56.63 9.76 26 130392 666 79613304
Infection 55.83 9.76 205 130213 241507 79372463
Hemiplegia 55.76 9.76 93 130325 14846 79599124
Drug intolerance 55.28 9.76 233 130185 263886 79350084
Neuropathy peripheral 53.52 9.76 93 130325 141212 79472758
Sleep disorder due to general medical condition, insomnia type 52.97 9.76 5 130413 43551 79570419
Gangrene 52.55 9.76 69 130349 8895 79605075
Dehydration 51.73 9.76 627 129791 247560 79366410
Exposure during pregnancy 51.00 9.76 54 130364 101078 79512892
Rash 50.88 9.76 654 129764 577704 79036266
Gastrointestinal disorder 50.44 9.76 76 130342 122129 79491841
Injection site erythema 50.22 9.76 33 130385 78164 79535806
Discomfort 50.05 9.76 80 130338 125537 79488433
Therapeutic drug monitoring analysis not performed 49.88 9.76 34 130384 1902 79612068
Helicobacter infection 49.60 9.76 26 130392 69678 79544292
Arrhythmia 49.39 9.76 215 130203 61057 79552913
Systemic lupus erythematosus 49.37 9.76 76 130342 121073 79492897
Pemphigoid 48.90 9.76 89 130329 15226 79598744
Presyncope 48.75 9.76 163 130255 40891 79573079
Drug interaction 48.67 9.76 951 129467 414232 79199738
Hospitalisation 47.88 9.76 50 130368 94186 79519784
Mental status changes 47.61 9.76 25 130393 66934 79547036
Intraductal papillary mucinous neoplasm 47.19 9.76 24 130394 774 79613196
Hip arthroplasty 46.58 9.76 3 130415 35753 79578217
Hemiparesis 46.51 9.76 141 130277 33592 79580378
Musculoskeletal stiffness 46.18 9.76 140 130278 174868 79439102
Bronchopulmonary aspergillosis allergic 46.07 9.76 39 130379 3022 79610948
Myalgia 45.45 9.76 484 129934 185157 79428813
Sepsis 44.67 9.76 258 130160 269170 79344800
White blood cell count decreased 44.59 9.76 158 130260 188130 79425840
Blister 44.01 9.76 80 130338 119396 79494574
Cerebral infarction 43.71 9.76 169 130249 45507 79568463
Fibromyalgia 42.90 9.76 26 130392 64314 79549656
Electrolyte imbalance 42.50 9.76 129 130289 30752 79583218
Seizure 42.39 9.76 162 130256 188672 79425298
Hyperuricaemia 42.11 9.76 72 130346 11727 79602243
Abdominal pain upper 41.76 9.76 554 129864 223265 79390705
Drug resistance 41.71 9.76 9 130409 42204 79571766
Mobility decreased 41.36 9.76 86 130332 122089 79491881
Hypoglycaemia 41.14 9.76 296 130122 101298 79512672
Vena cava injury 41.13 9.76 17 130401 335 79613635
C-reactive protein abnormal 40.88 9.76 14 130404 48353 79565617
Migraine 40.84 9.76 264 130154 87229 79526741
Sedation 40.56 9.76 17 130401 51878 79562092
Carotid arteriosclerosis 40.31 9.76 34 130384 2622 79611348
Bronchiectasis 40.17 9.76 103 130315 22283 79591687
Obstructive airways disorder 40.14 9.76 128 130290 31331 79582639
Wound 39.99 9.76 81 130337 116098 79497872
Sinus rhythm 39.96 9.76 22 130396 836 79613134
Labile hypertension 39.89 9.76 19 130399 530 79613440
Drug dependence 39.67 9.76 9 130409 40760 79573210
Rash papular 39.49 9.76 101 130317 21815 79592155
Folliculitis 38.90 9.76 21 130397 55359 79558611
Blood cholesterol 38.77 9.76 20 130398 665 79613305
Peripheral arterial occlusive disease 38.59 9.76 57 130361 8201 79605769
Orthostatic hypotension 38.54 9.76 188 130230 55976 79557994
Malaise 38.18 9.76 1060 129358 488809 79125161
Injection site reaction 38.15 9.76 21 130397 54764 79559206
Irritable bowel syndrome 37.67 9.76 28 130390 62213 79551757
Flatulence 37.60 9.76 154 130264 42570 79571400
Electrocardiogram abnormal 37.57 9.76 84 130334 16653 79597317
SARS-CoV-2 antibody test positive 37.52 9.76 17 130401 422 79613548
Myelosuppression 37.06 9.76 10 130408 40286 79573684
Gamma-glutamyltransferase increased 36.79 9.76 182 130236 54498 79559472
Blepharospasm 35.80 9.76 46 130372 5805 79608165
Nipple pain 35.74 9.76 21 130397 905 79613065
Abdominal wall haemorrhage 35.68 9.76 19 130399 675 79613295
Respiratory tract haemorrhage 35.48 9.76 27 130391 1796 79612174
Gastrointestinal angiodysplasia 35.46 9.76 22 130396 1047 79612923
Adjustment disorder 35.40 9.76 38 130380 3962 79610008
Blood pressure inadequately controlled 35.37 9.76 47 130371 6130 79607840
Cholestatic liver injury 35.31 9.76 42 130376 4899 79609071
Adverse event 35.28 9.76 28 130390 60186 79553784
Tachycardia 35.25 9.76 445 129973 177323 79436647
Tubulointerstitial nephritis 34.59 9.76 139 130279 38096 79575874
Personality disorder 34.02 9.76 46 130372 6100 79607870
Vascular anastomotic haemorrhage 34.01 9.76 14 130404 273 79613697
Alopecia 33.96 9.76 230 130188 231125 79382845
Total lung capacity decreased 33.79 9.76 32 130386 2873 79611097
Androgenetic alopecia 33.60 9.76 12 130406 156 79613814
Vascular compression 33.18 9.76 17 130401 557 79613413
Actinic keratosis 33.11 9.76 45 130373 5997 79607973
No adverse event 32.78 9.76 10 130408 37182 79576788
Therapeutic product effect incomplete 32.77 9.76 120 130298 141525 79472445
Injection site bruising 32.74 9.76 13 130405 40989 79572981
Chronic spontaneous urticaria 32.74 9.76 22 130396 1202 79612768
Aortic arteriosclerosis 32.60 9.76 55 130363 8863 79605107
Circulatory collapse 32.54 9.76 135 130283 37533 79576437
Knee arthroplasty 32.48 9.76 15 130403 43233 79570737
Abdominal pain lower 32.40 9.76 120 130298 31662 79582308
Accidental exposure to product 32.37 9.76 6 130412 31316 79582654
Multiple sclerosis relapse 32.17 9.76 18 130400 46515 79567455
Injury 32.16 9.76 48 130370 77448 79536522
Perineal cyst 31.46 9.76 13 130405 256 79613714
Basilar artery occlusion 31.16 9.76 12 130406 195 79613775
Forced expiratory volume decreased 30.99 9.76 50 130368 7764 79606206
Inappropriate antidiuretic hormone secretion 30.82 9.76 104 130314 26209 79587761
Psoriatic arthropathy 30.76 9.76 50 130368 77949 79536021
Pain 30.36 9.76 898 129520 702904 78911066
Aphasia 30.34 9.76 154 130264 46578 79567392
Paresis 30.09 9.76 36 130382 4225 79609745
Neurotoxicity 30.04 9.76 8 130410 32510 79581460
Melaena 29.82 9.76 186 130232 60704 79553266
Anuria 29.25 9.76 88 130330 20875 79593095
Catarrh 29.25 9.76 26 130392 2152 79611818
Burns second degree 28.77 9.76 28 130390 2600 79611370
Hypomagnesaemia 28.67 9.76 152 130266 46759 79567211
Rhabdomyolysis 28.64 9.76 276 130142 102855 79511115
Therapeutic response decreased 28.14 9.76 41 130377 66812 79547158
Cystostomy 27.97 9.76 9 130409 83 79613887
Ventricular extrasystoles 27.76 9.76 83 130335 19621 79594349
Interstitial lung disease 27.74 9.76 294 130124 112306 79501664
Jaundice 27.41 9.76 165 130253 53184 79560786
Rheumatoid arthritis 27.34 9.76 214 130204 208256 79405714
Ultrasound uterus abnormal 27.33 9.76 7 130411 25 79613945
Upper gastrointestinal haemorrhage 27.32 9.76 137 130281 41243 79572727
Aortic dilatation 27.10 9.76 23 130395 1789 79612181
Affect lability 26.97 9.76 58 130360 11201 79602769
Urinary hesitation 26.83 9.76 34 130384 4232 79609738
Atrioventricular block 26.65 9.76 66 130352 13975 79599995
Renal artery thrombosis 26.61 9.76 14 130404 485 79613485
Spinal osteoarthritis 26.45 9.76 74 130344 16853 79597117
Dry skin 26.32 9.76 196 130222 67799 79546171
Impaired healing 26.18 9.76 66 130352 87589 79526381
Cytomegalovirus infection 26.05 9.76 19 130399 42625 79571345
Full blood count decreased 25.93 9.76 6 130412 26813 79587157
Endoscopy upper gastrointestinal tract abnormal 25.87 9.76 8 130410 64 79613906
Ear infection 25.77 9.76 12 130406 34420 79579550
Large intestine polyp 25.47 9.76 61 130357 12647 79601323
Renal failure 25.44 9.76 466 129952 200502 79413468
Thalamus haemorrhage 25.39 9.76 22 130396 1760 79612210
Haematoma 25.28 9.76 159 130259 52036 79561934
Hypopnoea 25.21 9.76 37 130381 5292 79608678
Injection site swelling 25.09 9.76 24 130394 47108 79566862
Steroid dependence 25.08 9.76 26 130392 2604 79611366
Cytokine release syndrome 24.77 9.76 14 130404 35984 79577986
Amnesia 24.54 9.76 182 130236 62875 79551095
Ill-defined disorder 24.35 9.76 44 130374 65831 79548139
Prothrombin time shortened 24.00 9.76 28 130390 3200 79610770
Haematuria 23.64 9.76 193 130225 68643 79545327
Weight increased 23.46 9.76 316 130102 277070 79336900
Respiratory depression 23.34 9.76 8 130410 27622 79586348
Cardiac arrest 23.34 9.76 175 130243 171921 79442049
Acute myocardial infarction 23.31 9.76 210 130208 76826 79537144
Lung opacity 23.16 9.76 35 130383 5139 79608831
Memory impairment 23.12 9.76 282 130136 111452 79502518
Treatment noncompliance 23.05 9.76 31 130387 52237 79561733
Dyspnoea at rest 22.77 9.76 42 130376 7260 79606710
Eczema 22.75 9.76 129 130289 40689 79573281
Platelet count decreased 22.74 9.76 206 130212 194458 79419512
Orbital swelling 22.63 9.76 7 130411 56 79613914
Respiratory arrest 22.59 9.76 37 130381 57513 79556457
Diffuse alopecia 22.52 9.76 16 130402 957 79613013
Sensory loss 22.51 9.76 59 130359 12932 79601038
Visual impairment 22.43 9.76 240 130178 91891 79522079
Hypochromic anaemia 22.38 9.76 25 130393 2726 79611244
Heart rate 22.26 9.76 8 130410 106 79613864
Product quality issue 22.23 9.76 14 130404 33926 79580044
Blood pressure measurement 22.16 9.76 12 130406 441 79613529
Chromaturia 22.02 9.76 92 130326 25654 79588316
Lung hernia 22.01 9.76 7 130411 62 79613908
Patient dissatisfaction with treatment 21.79 9.76 9 130409 177 79613793
Vertigo positional 21.67 9.76 27 130391 3303 79610667
Rectal prolapse 21.62 9.76 22 130396 2156 79611814
Joint range of motion decreased 21.43 9.76 14 130404 33268 79580702
Vasoplegia syndrome 21.37 9.76 28 130390 3602 79610368
Premature delivery 21.25 9.76 6 130412 23461 79590509
Aortic dissection 21.24 9.76 30 130388 4145 79609825
Small intestinal obstruction 21.20 9.76 9 130409 27263 79586707
Barotrauma 21.16 9.76 9 130409 191 79613779
Pulmonary vasculitis 21.13 9.76 14 130404 747 79613223
Grip strength decreased 20.93 9.76 5 130413 21864 79592106
Acute cutaneous lupus erythematosus 20.91 9.76 11 130407 381 79613589
Respiratory failure 20.89 9.76 192 130226 180719 79433251
Glycosylated haemoglobin increased 20.71 9.76 74 130344 19186 79594784
Disease recurrence 20.65 9.76 25 130393 44084 79569886
Product use in unapproved indication 20.53 9.76 287 130131 250072 79363898
Aortic valve incompetence 20.47 9.76 47 130371 9483 79604487
Therapy interrupted 20.43 9.76 13 130405 31328 79582642
Intraventricular haemorrhage 20.39 9.76 32 130386 4855 79609115
Retinal artery occlusion 20.32 9.76 26 130392 3268 79610702
Cerebral haematoma 20.28 9.76 42 130376 7900 79606070
Lower respiratory tract infection 20.20 9.76 126 130292 129094 79484876
Poisoning 20.20 9.76 8 130410 25264 79588706
Clostridium difficile infection 20.19 9.76 24 130394 42661 79571309
Road traffic accident 20.18 9.76 25 130393 43639 79570331
Hypocalcaemia 19.94 9.76 145 130273 49779 79564191
Sensitivity to weather change 19.90 9.76 42 130376 8005 79605965
Hyperhidrosis 19.77 9.76 353 130065 151139 79462831
Vitamin B1 decreased 19.73 9.76 12 130406 551 79613419
Productive cough 19.63 9.76 226 130192 88105 79525865
Cardio-respiratory arrest 19.56 9.76 101 130317 108409 79505561
Blood glucose increased 19.55 9.76 280 130138 114695 79499275
Device issue 19.45 9.76 10 130408 27098 79586872
Blood creatine phosphokinase increased 19.40 9.76 179 130239 65911 79548059
Stomatitis 19.07 9.76 151 130267 146606 79467364
Haemophagocytic lymphohistiocytosis 19.01 9.76 6 130412 21831 79592139
Flushing 18.98 9.76 77 130341 88191 79525779
Lichenoid keratosis 18.95 9.76 28 130390 4029 79609941
Taste disorder 18.94 9.76 63 130355 15760 79598210
Disorientation 18.92 9.76 171 130247 62605 79551365
Unevaluable event 18.91 9.76 39 130379 55546 79558424
Hepatocellular carcinoma 18.84 9.76 44 130374 8977 79604993
Psychotic disorder 18.83 9.76 24 130394 41378 79572592
Therapy partial responder 18.71 9.76 3 130415 17394 79596576
Renal artery angioplasty 18.69 9.76 5 130413 22 79613948
Basal ganglia haemorrhage 18.66 9.76 18 130400 1653 79612317
Metastases to fallopian tube 18.58 9.76 6 130412 56 79613914
Irritability 18.55 9.76 24 130394 41120 79572850
Polyp 18.55 9.76 41 130377 8066 79605904
Glomerular filtration rate decreased 18.55 9.76 80 130338 22622 79591348
Device malfunction 18.49 9.76 6 130412 21442 79592528
Total cholesterol/HDL ratio increased 18.48 9.76 9 130409 264 79613706
Paradoxical drug reaction 18.35 9.76 38 130380 7147 79606823
Blood hyposmosis 18.34 9.76 5 130413 24 79613946
Depression 18.31 9.76 247 130171 216543 79397427
Epilepsy 18.27 9.76 122 130296 40738 79573232
Haematemesis 18.19 9.76 147 130271 52117 79561853
Blood 25-hydroxycholecalciferol decreased 18.19 9.76 10 130408 379 79613591
Fungal infection 18.17 9.76 25 130393 41723 79572247
Blood lactic acid decreased 18.08 9.76 9 130409 277 79613693
Hyperparathyroidism secondary 18.01 9.76 22 130396 2638 79611332
Diverticulum intestinal 18.00 9.76 42 130376 8563 79605407
Therapy cessation 17.90 9.76 21 130397 37541 79576429
Purpura senile 17.82 9.76 11 130407 519 79613451
Neutrophil count decreased 17.77 9.76 86 130332 93873 79520097
Cerebrovascular arteriovenous malformation 17.73 9.76 7 130411 122 79613848
Skull fracture 17.71 9.76 18 130400 1762 79612208
Pregnancy 17.69 9.76 11 130407 26840 79587130
Dysuria 17.57 9.76 143 130275 50808 79563162
Rales 17.52 9.76 72 130346 19929 79594041
Blood cholesterol increased 17.40 9.76 74 130344 83646 79530324
Supine hypertension 17.38 9.76 10 130408 414 79613556
Coordination abnormal 17.34 9.76 65 130353 17247 79596723
Respiratory tract inflammation 17.21 9.76 13 130405 855 79613115
Hyperthyroidism 17.19 9.76 77 130341 22132 79591838
Contusion 17.13 9.76 158 130260 148618 79465352
Motor dysfunction 17.05 9.76 58 130360 14675 79599295
Coronary artery stenosis 17.03 9.76 52 130366 12432 79601538
Encephalopathy 17.00 9.76 55 130363 67342 79546628
Product storage error 17.00 9.76 3 130415 16223 79597747
Pneumonia 16.93 9.76 895 129523 659351 78954619
Multiple organ dysfunction syndrome 16.91 9.76 121 130297 120125 79493845
Rhinitis 16.88 9.76 58 130360 14749 79599221
Duodenal ulcer 16.85 9.76 62 130356 16307 79597663
Sinonasal obstruction 16.82 9.76 9 130409 323 79613647
Musculoskeletal disorder 16.80 9.76 7 130411 21441 79592529
Diarrhoea 16.78 9.76 1664 128754 878825 78735145
Injection site pruritus 16.77 9.76 27 130391 42256 79571714
Complication associated with device 16.75 9.76 4 130414 17492 79596478
Hypertension 16.72 9.76 681 129737 330311 79283659
Heart rate increased 16.72 9.76 284 130134 120440 79493530
Sneezing 16.57 9.76 70 130348 19613 79594357
Staphylococcal infection 16.56 9.76 45 130373 58250 79555720
Pneumobilia 16.54 9.76 8 130410 231 79613739
Adrenal insufficiency 16.52 9.76 91 130327 28396 79585574
Metabolic acidosis 16.52 9.76 207 130211 82322 79531648
Candida infection 16.51 9.76 23 130395 38191 79575779
Non-cardiogenic pulmonary oedema 16.47 9.76 16 130402 1483 79612487
Pallor 16.46 9.76 139 130279 49923 79564047
Urticaria 16.38 9.76 209 130209 184992 79428978
Micturition disorder 16.29 9.76 26 130392 4002 79609968
Intervertebral disc space narrowing 16.27 9.76 17 130401 1718 79612252
Sedation complication 16.19 9.76 3 130415 15666 79598304
Neuritis 16.09 9.76 17 130401 1741 79612229
Paresis cranial nerve 16.06 9.76 5 130413 41 79613929
Pancreatitis acute 15.92 9.76 137 130281 49467 79564503
Gastrointestinal ischaemia 15.91 9.76 10 130408 487 79613483
Mesenteric artery thrombosis 15.89 9.76 11 130407 631 79613339
Hepatotoxicity 15.86 9.76 38 130380 51314 79562656
Periorbital inflammation 15.78 9.76 6 130412 94 79613876
Cardiac failure chronic 15.78 9.76 47 130371 11088 79602882
Hemiataxia 15.75 9.76 5 130413 44 79613926
Anxiety disorder due to a general medical condition 15.68 9.76 4 130414 14 79613956
Atrioventricular block second degree 15.64 9.76 36 130382 7276 79606694
Urinary tract infection 15.63 9.76 336 130082 274176 79339794
Cognitive disorder 15.57 9.76 179 130239 69747 79544223
Polyuria 15.56 9.76 57 130361 14957 79599013
Oral lichen planus 15.56 9.76 12 130406 814 79613156
Flail chest 15.49 9.76 6 130412 99 79613871
Joint injury 15.49 9.76 17 130401 31318 79582652
Cardiac output increased 15.45 9.76 8 130410 268 79613702
Oropharyngeal pain 15.40 9.76 110 130308 109243 79504727
Psoas abscess 15.39 9.76 13 130405 1004 79612966
Neoplasm progression 15.37 9.76 39 130379 51643 79562327
Respiratory tract congestion 15.30 9.76 69 130349 19885 79594085
Mental status changes postoperative 15.29 9.76 7 130411 178 79613792
Tarsal tunnel syndrome 15.22 9.76 10 130408 526 79613444
Dyspnoea exertional 15.18 9.76 213 130205 86860 79527110
Hypozincaemia 15.18 9.76 5 130413 50 79613920
Tender joint count decreased 15.15 9.76 7 130411 182 79613788
Wrong strength 15.15 9.76 7 130411 182 79613788
Haematoma muscle 15.13 9.76 20 130398 2595 79611375
Nasal congestion 15.10 9.76 69 130349 76483 79537487
Swollen joint count decreased 15.08 9.76 7 130411 184 79613786
Lung perforation 15.07 9.76 6 130412 107 79613863
Suicide attempt 15.05 9.76 77 130341 82855 79531115
Cerebrovascular accident 14.99 9.76 346 130072 154946 79459024
Vertebral artery stenosis 14.98 9.76 7 130411 187 79613783
Wrong technique in product usage process 14.92 9.76 66 130352 73809 79540161
Hepatic function abnormal 14.90 9.76 184 130234 72923 79541047
Cerebral haemorrhage 14.86 9.76 152 130266 57521 79556449
IIIrd nerve paresis 14.84 9.76 7 130411 191 79613779
Prostatomegaly 14.80 9.76 23 130395 3460 79610510
Brain stem stroke 14.77 9.76 11 130407 708 79613262
Sleep disorder 14.74 9.76 81 130337 85596 79528374
Lip infection 14.74 9.76 7 130411 194 79613776
Vasculitic rash 14.68 9.76 18 130400 2166 79611804
Breast cancer 14.59 9.76 100 130318 33681 79580289
Sputum retention 14.54 9.76 13 130405 1084 79612886
Supraventricular extrasystoles 14.50 9.76 34 130384 6953 79607017
Hypervolaemia 14.48 9.76 30 130388 42660 79571310
Unresponsive to stimuli 14.44 9.76 45 130373 55743 79558227
Liver injury 14.42 9.76 46 130372 56568 79557402
Body temperature increased 14.42 9.76 32 130386 44388 79569582
Parosmia 14.42 9.76 34 130384 6980 79606990
Renovascular hypertension 14.29 9.76 5 130413 61 79613909
Respiratory symptom 14.24 9.76 27 130391 4764 79609206
Red blood cell sedimentation rate increased 14.18 9.76 34 130384 45908 79568062
Device lead damage 14.18 9.76 3 130415 3 79613967
Incorrect route of product administration 14.14 9.76 22 130396 34907 79579063
Cerebral ventricular rupture 14.09 9.76 9 130409 451 79613519
Confusion postoperative 14.08 9.76 7 130411 215 79613755
Idiopathic pulmonary fibrosis 14.05 9.76 25 130393 4203 79609767
Coronavirus infection 13.98 9.76 35 130383 7462 79606508
Arteriosclerosis 13.96 9.76 63 130355 18164 79595806
Drug withdrawal syndrome 13.93 9.76 22 130396 34696 79579274
Surgery 13.88 9.76 20 130398 32746 79581224
Skin texture abnormal 13.88 9.76 9 130409 463 79613507
Tenderness 13.84 9.76 11 130407 23631 79590339
Transient global amnesia 13.82 9.76 12 130406 963 79613007
Confusional state 13.78 9.76 644 129774 317353 79296617
Prerenal failure 13.77 9.76 23 130395 3675 79610295
Plasma cell myeloma 13.76 9.76 43 130375 53216 79560754
Renal artery stent placement 13.66 9.76 5 130413 70 79613900
Transaminases increased 13.64 9.76 137 130281 51606 79562364
Hypokalaemia 13.62 9.76 320 130098 143720 79470250
Immune reconstitution inflammatory syndrome 13.58 9.76 3 130415 13838 79600132
Gait inability 13.56 9.76 50 130368 58867 79555103
Spontaneous haemorrhage 13.53 9.76 11 130407 806 79613164
Intermittent claudication 13.48 9.76 22 130396 3449 79610521
Overdose 13.43 9.76 216 130202 183990 79429980
Fibromuscular dysplasia 13.34 9.76 7 130411 241 79613729
Costovertebral angle tenderness 13.32 9.76 7 130411 242 79613728
Delayed graft function 13.31 9.76 22 130396 3485 79610485
Decreased appetite 13.28 9.76 686 129732 341732 79272238
Gastrooesophageal reflux disease 13.27 9.76 242 130176 104004 79509966
Acute coronary syndrome 13.27 9.76 69 130349 21064 79592906
Sinus congestion 13.22 9.76 66 130352 19830 79594140
Pulmonary fibrosis 13.21 9.76 120 130298 43992 79569978
Internal haemorrhage 13.20 9.76 38 130380 8795 79605175
pH body fluid increased 13.17 9.76 5 130413 78 79613892
Orthostatic intolerance 13.17 9.76 16 130402 1908 79612062
Coronary artery bypass 13.13 9.76 30 130388 6032 79607938
Spider naevus 13.13 9.76 6 130412 152 79613818
Shock hypoglycaemic 13.11 9.76 7 130411 250 79613720
Urinary retention 13.08 9.76 146 130272 56484 79557486
Diabetes mellitus inadequate control 13.07 9.76 76 130342 24188 79589782
Dyschezia 13.07 9.76 20 130398 2968 79611002
Vestibular migraine 13.06 9.76 6 130412 154 79613816
Blood calcium increased 12.98 9.76 42 130376 10358 79603612
Gerstmann's syndrome 12.97 9.76 3 130415 6 79613964
Device dislocation 12.94 9.76 14 130404 25956 79588014
Desmoplastic melanoma 12.93 9.76 4 130414 32 79613938
Device difficult to use 12.93 9.76 3 130415 13382 79600588
Iron deficiency anaemia 12.93 9.76 79 130339 25593 79588377
Occult blood 12.90 9.76 15 130403 1708 79612262
Fracture 12.88 9.76 70 130348 21731 79592239
Injection site haemorrhage 12.83 9.76 16 130402 27854 79586116
Gastroenteritis viral 12.81 9.76 13 130405 24818 79589152
Joint stiffness 12.78 9.76 30 130388 40800 79573170
Mucosal inflammation 12.71 9.76 72 130346 75508 79538462
Cornea verticillata 12.68 9.76 6 130412 165 79613805
Brain stem infarction 12.67 9.76 16 130402 1985 79611985
Papillary renal cell carcinoma 12.67 9.76 7 130411 268 79613702
Lichen planus 12.66 9.76 19 130399 2772 79611198
Nightmare 12.66 9.76 79 130339 25782 79588188
Periorbital discomfort 12.62 9.76 4 130414 35 79613935
Atrioventricular block first degree 12.59 9.76 47 130371 12444 79601526
Nocturia 12.58 9.76 50 130368 13631 79600339
Tendon rupture 12.54 9.76 46 130372 12080 79601890
Abortion spontaneous 12.51 9.76 18 130400 29489 79584481
Gastroenteritis 12.49 9.76 97 130321 33985 79579985
Respiratory distress 12.47 9.76 51 130367 58288 79555682
Faeces discoloured 12.45 9.76 86 130332 29041 79584929
Eosinophilic fasciitis 12.43 9.76 7 130411 278 79613692
Atelectasis 12.42 9.76 21 130397 32236 79581734
Illness 12.41 9.76 37 130381 46474 79567496
Blood growth hormone increased 12.38 9.76 10 130408 726 79613244
Drug tolerance decreased 12.36 9.76 3 130415 12975 79600995
Acute abdomen 12.34 9.76 20 130398 3117 79610853
Haematotoxicity 12.26 9.76 5 130413 15514 79598456
Cardiac murmur functional 12.23 9.76 4 130414 39 79613931
Histamine intolerance 12.23 9.76 4 130414 39 79613931
Upper respiratory tract infection 12.22 9.76 93 130325 91075 79522895
Kussmaul respiration 12.21 9.76 8 130410 419 79613551
Proteinuria 12.18 9.76 93 130325 32409 79581561
Feeling jittery 12.16 9.76 3 130415 12838 79601132
Multiple drug therapy 12.14 9.76 23 130395 4055 79609915
Fractured skull depressed 12.14 9.76 4 130414 40 79613930
Injection site urticaria 12.14 9.76 3 130415 12823 79601147
Tonsillar ulcer 12.14 9.76 8 130410 423 79613547
Pain in jaw 12.11 9.76 37 130381 46114 79567856
Cataract 12.08 9.76 155 130263 61965 79552005
Cerebral ischaemia 12.03 9.76 43 130375 11152 79602818
Dysarthria 12.02 9.76 166 130252 67456 79546514
Cerebellar haemorrhage 12.01 9.76 19 130399 2901 79611069
Ischaemic stroke 11.98 9.76 94 130324 33037 79580933
Ballismus 11.97 9.76 7 130411 299 79613671
Post concussion syndrome 11.95 9.76 9 130409 589 79613381
Macular ischaemia 11.94 9.76 5 130413 102 79613868
Bradyarrhythmia 11.88 9.76 23 130395 4123 79609847
Dermatosis 11.87 9.76 9 130409 595 79613375
Endometrial cancer stage I 11.81 9.76 6 130412 193 79613777
Cystitis 11.75 9.76 135 130283 52597 79561373
Cardiovascular insufficiency 11.72 9.76 19 130399 2962 79611008
Hypoventilation 11.70 9.76 32 130386 7192 79606778
Oesophagitis ulcerative 11.67 9.76 12 130406 1191 79612779
Exercise tolerance decreased 11.65 9.76 37 130381 9034 79604936
Lymphangiectasia 11.63 9.76 5 130413 109 79613861
Graft versus host disease 11.61 9.76 5 130413 15021 79598949
Atypical fibroxanthoma 11.59 9.76 6 130412 201 79613769
Tetany 11.57 9.76 18 130400 2710 79611260
Sciatica 11.57 9.76 23 130395 33199 79580771
Arthralgia 11.48 9.76 793 129625 571010 79042960
Cystitis escherichia 11.47 9.76 9 130409 626 79613344
Choroidal detachment 11.46 9.76 9 130409 627 79613343
Anti-erythropoietin antibody negative 11.46 9.76 7 130411 324 79613646
Paranoia 11.43 9.76 9 130409 19423 79594547
Agitation 11.43 9.76 106 130312 99609 79514361
Supraventricular tachyarrhythmia 11.39 9.76 5 130413 115 79613855
Crystal arthropathy 11.37 9.76 6 130412 209 79613761
Hepatitis acute 11.37 9.76 53 130365 15489 79598481
Hyperlactacidaemia 11.37 9.76 27 130391 5568 79608402
Potentiating drug interaction 11.35 9.76 36 130382 8783 79605187
Fluid intake reduced 11.35 9.76 29 130389 6259 79607711
Exposure to allergen 11.27 9.76 7 130411 334 79613636
Eating disorder 11.26 9.76 65 130353 20632 79593338
Drug metabolising enzyme decreased 11.25 9.76 3 130415 13 79613957
Leiomyoma 11.25 9.76 7 130411 335 79613635
Thrombocytopenia 11.25 9.76 339 130079 264920 79349050
Pulmonary haemorrhage 11.21 9.76 5 130413 14712 79599258
Lipoedema 11.19 9.76 6 130412 216 79613754
Bacteraemia 11.19 9.76 23 130395 32801 79581169
Pancreatic disorder 11.15 9.76 20 130398 3382 79610588
Necrotising myositis 11.14 9.76 12 130406 1256 79612714
Renal function test abnormal 11.12 9.76 25 130393 4973 79608997
Gliosis 11.09 9.76 8 130410 490 79613480
Gastritis erosive 11.09 9.76 41 130377 10806 79603164
Thoracic operation 11.07 9.76 6 130412 221 79613749
Neck pain 11.04 9.76 75 130343 75342 79538628
Xanthopsia 11.01 9.76 7 130411 348 79613622
Chronic gastritis 10.97 9.76 22 130396 4046 79609924
Hepatosplenomegaly 10.97 9.76 28 130390 6041 79607929
Atrioventricular block complete 10.97 9.76 55 130363 16555 79597415
Vascular stent stenosis 10.94 9.76 13 130405 1514 79612456
Akathisia 10.92 9.76 4 130414 13255 79600715
Hyperglycaemic hyperosmolar nonketotic syndrome 10.91 9.76 16 130402 2287 79611683
Enterococcal infection 10.91 9.76 6 130412 15654 79598316
Eczema nummular 10.90 9.76 7 130411 354 79613616
Acute right ventricular failure 10.90 9.76 7 130411 354 79613616
Duodenal ulcer haemorrhage 10.88 9.76 31 130387 7132 79606838
Mucosal haemorrhage 10.88 9.76 17 130401 2569 79611401
Dry eye 10.88 9.76 28 130390 36903 79577067
Deep vein thrombosis 10.86 9.76 136 130282 120783 79493187
Troponin increased 10.83 9.76 61 130357 19194 79594776
Albumin urine present 10.81 9.76 9 130409 682 79613288
Swelling of eyelid 10.74 9.76 21 130397 3790 79610180
Pharyngeal enanthema 10.74 9.76 4 130414 59 79613911
Septic shock 10.70 9.76 139 130279 122662 79491308
Ophthalmoplegia 10.70 9.76 18 130400 2894 79611076
Iron deficiency 10.67 9.76 40 130378 10614 79603356
Lupus endocarditis 10.66 9.76 6 130412 238 79613732
Renin increased 10.66 9.76 6 130412 238 79613732
Mouth ulceration 10.64 9.76 30 130388 38364 79575606
Live birth 10.63 9.76 9 130409 18735 79595235
Bronchitis 10.61 9.76 150 130268 130494 79483476
Sinus disorder 10.61 9.76 68 130350 22396 79591574
Conjunctivitis 10.60 9.76 16 130402 25699 79588271
Atrial natriuretic peptide increased 10.59 9.76 3 130415 17 79613953
Hypovolaemia 10.59 9.76 57 130361 17634 79596336
Alveolitis 10.55 9.76 22 130396 4158 79609812
Diabetic nephropathy 10.54 9.76 18 130400 2929 79611041
Blood immunoglobulin E increased 10.49 9.76 27 130391 5855 79608115
Swollen tongue 10.41 9.76 111 130307 42459 79571511
Microangiopathy 10.39 9.76 14 130404 1851 79612119
Wheezing 10.37 9.76 257 130161 116407 79497563
Cold sweat 10.36 9.76 59 130359 18640 79595330
Coronary artery occlusion 10.31 9.76 51 130367 15264 79598706
Dyskinesia 10.30 9.76 38 130380 44735 79569235
Idiopathic orbital inflammation 10.29 9.76 6 130412 255 79613715
Thrombosis 10.25 9.76 88 130330 84012 79529958
Stasis dermatitis 10.22 9.76 12 130406 1381 79612589
Prescribed overdose 10.20 9.76 30 130388 37853 79576117
Oxygen saturation increased 10.17 9.76 8 130410 559 79613411
Altered state of consciousness 10.13 9.76 113 130305 43709 79570261
Laboratory test abnormal 10.13 9.76 19 130399 28029 79585941
Vomiting 10.11 9.76 1240 129178 664588 78949382
Asthma 10.11 9.76 291 130127 134804 79479166
Coeliac disease 10.10 9.76 3 130415 11348 79602622
Uterine dilation and evacuation 10.05 9.76 3 130415 21 79613949
Diverticulum intestinal haemorrhagic 10.00 9.76 21 130397 3990 79609980
Disability 9.98 9.76 8 130410 17112 79596858
Visual acuity reduced transiently 9.98 9.76 6 130412 270 79613700
Intentional overdose 9.96 9.76 118 130300 105842 79508128
SAPHO syndrome 9.92 9.76 7 130411 414 79613556
Breast discomfort 9.88 9.76 7 130411 417 79613553
Hallucination 9.87 9.76 196 130222 85549 79528421
Basal cell carcinoma 9.87 9.76 99 130319 37276 79576694
Muscle rupture 9.86 9.76 20 130398 3707 79610263
Pleurothotonus 9.84 9.76 16 130402 2500 79611470
Crying 9.83 9.76 14 130404 23029 79590941
Lichen sclerosus 9.79 9.76 10 130408 984 79612986
Congenital anomaly in offspring 9.76 9.76 4 130414 77 79613893

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX19 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 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
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Oliguria contraindication 83128009
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Surgical procedure contraindication 387713003
Azotemia contraindication 445009001




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 4.25 acidic
pKa2 3.2 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST IC50 9.16 CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.52 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.76 CHEMBL
Beta-3 adrenergic receptor GPCR Ki 5.49 CHEMBL
Adenosine receptor A3 GPCR Ki 6.16 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 5.30 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.52 CHEMBL
Epidermal growth factor receptor Kinase IC50 5.48 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor EC50 5.38 CHEMBL
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.23 CHEMBL
Thromboxane-A synthase Enzyme IC50 5.51 CHEMBL
DNA polymerase kappa Enzyme IC50 5.25 CHEMBL
DNA polymerase iota Enzyme IC50 5.21 CHEMBL
DNA polymerase eta Enzyme IC50 4.95 CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.05 CHEMBL
NEDD8-activating enzyme E1 regulatory subunit Enzyme IC50 4.78 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 6.96 CHEMBL
Cruzipain Enzyme IC50 4.38 CHEMBL
Type-1 angiotensin II receptor GPCR Ki 9.19 CHEMBL

External reference:

IDSource
4021148 VUID
N0000179517 NUI
D00522 KEGG_DRUG
135481 RXNORM
C0527379 UMLSCUI
CHEBI:3348 CHEBI
CHEBI:149509 CHEBI
CHEMBL1014 ChEMBL_ID
DB00796 DRUGBANK_ID
C077793 MESH_SUPPLEMENTAL_RECORD_UI
C081643 MESH_SUPPLEMENTAL_RECORD_UI
8352 IUPHAR_LIGAND_ID
R85M2X0D68 UNII
2540 PUBCHEM_CID
DB13919 DRUGBANK_ID
188909 MMSL
7490 MMSL
d04322 MMSL
108587008 SNOMEDCT_US
372512008 SNOMEDCT_US
386878000 SNOMEDCT_US
C0717550 UMLSCUI
CHEMBL1016 ChEMBL_ID
4021148 VANDF
4021151 VANDF
7239 INN_ID
139481-59-7 SECONDARY_CAS_RN
2541 PUBCHEM_CID
587 IUPHAR_LIGAND_ID
S8Q36MD2XX UNII
007275 NDDF
007276 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3001 TABLET 16 mg ORAL ANDA 21 sections
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3002 TABLET 32 mg ORAL ANDA 21 sections
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3003 TABLET 32 mg ORAL ANDA 21 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3224 TABLET 4 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3225 TABLET 8 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3231 TABLET 16 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3232 TABLET 32 mg ORAL ANDA 27 sections
Candesartan HUMAN PRESCRIPTION DRUG LABEL 1 0904-7034 TABLET 32 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-114 TABLET 4 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-114 TABLET 4 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-114 TABLET 4 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-115 TABLET 8 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-115 TABLET 8 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-115 TABLET 8 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-116 TABLET 16 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-116 TABLET 16 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-116 TABLET 16 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-117 TABLET 32 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-117 TABLET 32 mg ORAL ANDA 28 sections
Candesartan Human Prescription Drug Label 1 33342-117 TABLET 32 mg ORAL ANDA 28 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-131 TABLET 16 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-131 TABLET 16 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-132 TABLET 32 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-132 TABLET 32 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-133 TABLET 32 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-133 TABLET 32 mg ORAL ANDA 19 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-459 TABLET 16 mg ORAL ANDA 22 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-460 TABLET 32 mg ORAL ANDA 22 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-461 TABLET 32 mg ORAL ANDA 22 sections
CANDESARTAN CILEXETIL Human Prescription Drug Label 1 46708-060 TABLET 32 mg ORAL ANDA 27 sections