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

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 1610 114798-26-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • losartan
  • allisartan
  • lortaan
  • losartan potassium
  • losartan monopotassium
  • losartan monopotassium salt
An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
  • Molecular weight: 422.92
  • Formula: C22H23ClN6O
  • CLOGP: 3.85
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 92.51
  • ALOGS: -4.97
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.05 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 12 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.95 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 35 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.37 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.80 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.752 Moderate 0.77
caco2-efflux Caco-2 efflux ratio (BA/AB) 23.227 Moderate 0.77
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 5.272 10^-6 cm/s Moderate 0.77
dh-clint Dog hepatocyte intrinsic clearance 4.688 uL/min/10^6 cells Moderate 0.77
dppb Dog plasma protein binding (% unbound) 4.150 % Moderate 0.77
fcs-ppb Fetal calf serum protein binding (% unbound) 4.330 % Moderate 0.77
herg hERG pIC50 4.430 pIC50 Moderate 0.77
hh-clint Human hepatocyte intrinsic clearance 5.794 uL/min/10^6 cells Moderate 0.77
hlm-clint Human liver microsomal intrinsic clearance 16.596 uL/min/mg protein Moderate 0.77
hppb Human plasma protein binding (% unbound) 2.010 % Moderate 0.77
kinase-safety-class ACVR2B,AXL,EIF2AK3,GRK2,MAPKAPK2,PDK1,PDK4,PRKDC 8
kinase-selectivity-class EIF2AK3,PDK1 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 5.070 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.458 Moderate 0.77
mh-clint Mouse hepatocyte intrinsic clearance 37.670 Moderate 0.77
mppb Mouse plasma protein binding (% unbound) 2.910 Moderate 0.77
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.483 Moderate 0.77
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 2.870 % Moderate 0.77
rat-kpuu-brain Rat brain Kpuu 0.013 % High 1
rh-clint Rat hepatocyte intrinsic clearance 15.382 uL/min/10^6 cells Moderate 0.77
rh-fuinc Rat hepatocyte fraction unbound in incubation 53.450 % Moderate 0.77
rppb Rat plasma protein binding (% unbound) 1.170 % Moderate 0.77
solubility-dd Solubility at pH 7.4 in DMSO 977.237 uM Moderate 0.77

Approvals:

DateAgencyCompanyOrphan
April 14, 1995 FDA MERCK SHARP DOHME

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
Pemphigus 695.68 9.55 4 199396 326860 90102187
Synovitis 597.99 9.55 31 199369 329721 90099326
Hand deformity 581.49 9.55 15 199385 296347 90132700
Systemic lupus erythematosus 564.74 9.55 67 199333 361829 90067218
Glossodynia 491.19 9.55 64 199336 321715 90107332
Maternal exposure during pregnancy 482.32 9.55 102 199298 359961 90069086
Duodenal ulcer perforation 469.20 9.55 3 199397 221285 90207762
Infusion related reaction 453.53 9.55 175 199225 416605 90012442
Wound 439.75 9.55 70 199330 302910 90126137
Folliculitis 409.87 9.55 8 199392 204345 90224702
Helicobacter infection 405.90 9.55 23 199377 226827 90202220
Cardiac failure congestive 368.07 9.55 726 198674 97968 90331079
Rheumatoid factor positive 351.39 9.55 5 199395 171645 90257402
Pericarditis 350.62 9.55 82 199318 270069 90158978
Arthropathy 336.49 9.55 194 199206 366048 90062999
Muscle injury 328.49 9.55 14 199386 176640 90252407
Acute kidney injury 325.67 9.55 1482 197918 318905 90110142
Treatment failure 305.82 9.55 143 199257 303785 90125262
Contraindicated product administered 299.17 9.55 166 199234 319973 90109074
Lower respiratory tract infection 298.88 9.55 90 199310 250569 90178478
Hepatic enzyme increased 292.24 9.55 220 199180 360516 90068531
Drug intolerance 281.06 9.55 343 199057 447248 89981799
Irritable bowel syndrome 271.05 9.55 62 199338 207386 90221661
C-reactive protein abnormal 259.56 9.55 4 199396 127425 90301622
Blood glucose increased 252.79 9.55 611 198789 94635 90334412
Sleep disorder due to general medical condition, insomnia type 243.30 9.55 9 199391 128685 90300362
Cough 240.16 9.55 1510 197890 367452 90061595
Liver injury 228.84 9.55 48 199352 170519 90258528
Impaired healing 228.21 9.55 115 199285 234084 90194963
Blood pressure increased 225.10 9.55 945 198455 196272 90232775
Exposure during pregnancy 225.02 9.55 122 199278 238288 90190759
Hyponatraemia 217.82 9.55 718 198682 132820 90296227
Myocardial infarction 212.11 9.55 612 198788 105360 90323687
Swelling 201.51 9.55 385 199015 418673 90010374
Facet joint syndrome 200.75 9.55 3 199397 98386 90330661
Type 2 diabetes mellitus 200.72 9.55 98 199302 203146 90225901
Fibromyalgia 199.88 9.55 102 199298 206167 90222880
General physical health deterioration 196.67 9.55 298 199102 354817 90074230
Discomfort 185.31 9.55 198 199202 274137 90154910
Hyperkalaemia 184.54 9.55 428 198972 64536 90364511
Diarrhoea 179.91 9.55 2981 196419 936209 89492838
Blister 177.92 9.55 179 199221 254819 90174228
Product dose omission issue 172.69 9.55 1166 198234 290521 90138526
Off label use 171.72 9.55 1576 197824 1100676 89328371
Injury 170.70 9.55 112 199288 197237 90231810
Ill-defined disorder 169.55 9.55 98 199302 184793 90244254
Joint swelling 166.99 9.55 559 198841 502741 89926306
Joint range of motion decreased 166.58 9.55 46 199354 135597 90293450
Dizziness 164.25 9.55 1999 197401 587285 89841762
Rheumatoid arthritis 164.11 9.55 345 199055 362269 90066778
Therapeutic product effect decreased 163.43 9.55 223 199177 277348 90151699
Feeling abnormal 161.81 9.55 763 198637 166472 90262575
C-reactive protein increased 155.45 9.55 104 199296 181285 90247762
Dry skin 153.95 9.55 485 198915 87588 90341459
Lip dry 151.69 9.55 21 199379 100934 90328113
Mobility decreased 150.07 9.55 199 199201 250535 90178512
Live birth 147.92 9.55 6 199394 79101 90349946
Psoriatic arthropathy 146.29 9.55 172 199228 228163 90200884
Myalgia 139.87 9.55 757 198643 174368 90254679
Cerebrovascular accident 133.95 9.55 583 198817 122950 90306097
Product substitution issue 132.12 9.55 180 199220 17828 90411219
Product use issue 131.45 9.55 336 199064 329583 90099464
Grip strength decreased 130.60 9.55 23 199377 92553 90336494
Hypersensitivity 129.83 9.55 537 198863 454140 89974907
Atrial fibrillation 128.78 9.55 609 198791 133002 90296045
Multi-organ disorder 127.23 9.55 72 199328 2128 90426919
Vision blurred 125.34 9.55 528 198872 109765 90319282
Wound infection 125.30 9.55 39 199361 106363 90322684
Drug ineffective 119.11 9.55 2240 197160 1382058 89046989
Dyspnoea 118.38 9.55 2650 196750 878305 89550742
Palpitations 118.07 9.55 604 198796 136124 90292923
Fall 117.82 9.55 1596 197804 480214 89948833
Autoimmune disorder 115.21 9.55 16 199384 76728 90352319
Urinary tract infection 114.26 9.55 1100 198300 304532 90124515
BRASH syndrome 112.75 9.55 63 199337 1816 90427231
Loss of employment 111.76 9.55 74 199326 2913 90426134
Infection 110.74 9.55 416 198984 361678 90067369
Gastrointestinal disorder 109.65 9.55 252 199148 256435 90172612
Dislocation of vertebra 109.03 9.55 3 199397 55965 90373082
Bursitis 104.29 9.55 82 199318 131572 90297475
Peripheral venous disease 103.89 9.55 28 199372 83893 90345154
Dermatitis atopic 102.75 9.55 185 199215 23287 90405760
Musculoskeletal stiffness 101.91 9.55 324 199076 296208 90132839
Adjustment disorder with depressed mood 100.69 9.55 6 199394 56747 90372300
Coronary artery disease 100.43 9.55 226 199174 33397 90395650
Transient ischaemic attack 99.89 9.55 263 199137 42913 90386134
Prescribed overdose 99.53 9.55 45 199355 97580 90331467
Hypercholesterolaemia 99.03 9.55 49 199351 100843 90328204
Blood cholesterol increased 96.48 9.55 195 199205 207817 90221230
Dehydration 96.31 9.55 745 198655 193702 90235345
Chronic kidney disease 95.72 9.55 285 199115 49906 90379141
Eye haemorrhage 95.56 9.55 115 199285 10065 90418982
Blood creatinine increased 95.41 9.55 459 198941 100927 90328120
Pregnancy 95.38 9.55 12 199388 62035 90367012
Stomatitis 95.20 9.55 299 199101 274399 90154648
COVID-19 94.50 9.55 666 198734 168177 90260870
Acute myocardial infarction 93.78 9.55 225 199175 34665 90394382
Blood pressure inadequately controlled 93.17 9.55 90 199310 6134 90422913
Night sweats 92.52 9.55 88 199312 128678 90300369
Eye irritation 92.27 9.55 220 199180 33758 90395289
Lactic acidosis 90.10 9.55 280 199120 50183 90378864
Pulmonary oedema 89.11 9.55 320 199080 61760 90367287
Hypotension 88.30 9.55 1099 198301 324298 90104749
Suspected suicide 88.04 9.55 107 199293 9461 90419586
Bone erosion 87.25 9.55 8 199392 53013 90376034
Drug interaction 86.20 9.55 959 198441 275494 90153553
Bradycardia 85.05 9.55 388 199012 83459 90345588
Inflammation 84.90 9.55 165 199235 178427 90250620
Blepharospasm 84.55 9.55 11 199389 55434 90373613
Pyrexia 83.76 9.55 990 198410 659495 89769552
Epilepsy 83.63 9.55 38 199362 82168 90346879
Renal failure 81.81 9.55 531 198869 130476 90298571
Febrile neutropenia 79.96 9.55 141 199259 158208 90270839
Alopecia 78.35 9.55 704 198696 494367 89934680
Lower limb fracture 77.99 9.55 45 199355 84968 90344079
Thyroid disorder 77.62 9.55 140 199260 17645 90411402
Eye pruritus 76.73 9.55 186 199214 28841 90400206
Back pain 75.91 9.55 1047 198353 316128 90112919
Tension headache 75.73 9.55 88 199312 7421 90421626
Skin discolouration 73.74 9.55 240 199160 44075 90384972
Angioedema 72.46 9.55 309 199091 64567 90364480
Pruritus genital 72.19 9.55 68 199332 4490 90424557
Pulmonary fibrosis 72.06 9.55 78 199322 107425 90321622
Anti-neutrophil cytoplasmic antibody positive vasculitis 71.88 9.55 64 199336 3929 90425118
Hypertensive crisis 70.10 9.55 134 199266 17650 90411397
Red blood cell sedimentation rate increased 69.87 9.55 48 199352 82547 90346500
Intentional product use issue 69.67 9.55 244 199156 216648 90212399
Drug abuse 68.15 9.55 49 199351 82298 90346749
Therapeutic product effect incomplete 67.18 9.55 211 199189 193685 90235362
Prescribed underdose 66.99 9.55 41 199359 74978 90354069
Hip arthroplasty 66.20 9.55 43 199357 76165 90352882
Anosmia 65.62 9.55 94 199306 9754 90419293
Cardiospasm 65.57 9.55 57 199343 3389 90425658
Eye pain 65.38 9.55 230 199170 43938 90385109
Inappropriate antidiuretic hormone secretion 64.96 9.55 137 199263 19368 90409679
Obesity 64.86 9.55 82 199318 105425 90323622
Palmoplantar keratoderma 64.71 9.55 57 199343 3450 90425597
Neuropathy peripheral 64.61 9.55 519 198881 136451 90292596
Abdominal discomfort 64.54 9.55 705 198695 476623 89952424
Sleep terror 63.92 9.55 63 199337 4401 90424646
Hepatic steatosis 62.29 9.55 201 199199 36744 90392303
Cardiac disorder 62.06 9.55 269 199131 56603 90372444
Renal impairment 62.01 9.55 421 198979 105000 90324047
Wheezing 61.90 9.55 291 199109 237789 90191258
Carotid artery occlusion 61.76 9.55 73 199327 6269 90422778
Onychomadesis 61.55 9.55 13 199387 45985 90383062
Muscle spasms 61.26 9.55 834 198566 251049 90177998
Syncope 61.12 9.55 500 198900 132163 90296884
Oligohydramnios 60.59 9.55 77 199323 7124 90421923
Pruritus 60.08 9.55 1588 197812 539937 89889110
Hypoglycaemia 59.18 9.55 307 199093 69541 90359506
Pain of skin 58.32 9.55 117 199283 15965 90413082
Malaise 57.07 9.55 1690 197710 584296 89844751
Condition aggravated 56.79 9.55 945 198455 594600 89834447
Gastrointestinal haemorrhage 55.23 9.55 364 199036 89884 90339163
Intestinal angioedema 55.19 9.55 30 199370 818 90428229
Chest pain 54.80 9.55 998 198402 318647 90110400
Atrial tachycardia 53.51 9.55 66 199334 5924 90423123
Lung disorder 53.41 9.55 161 199239 149722 90279325
Coeliac disease 53.15 9.55 16 199384 44594 90384453
Cardiac failure 52.78 9.55 417 198983 109079 90319968
Blood pressure abnormal 50.98 9.55 125 199275 19520 90409527
Body height decreased 50.80 9.55 93 199307 11856 90417191
Hypomagnesaemia 50.68 9.55 183 199217 35405 90393642
Malignant mediastinal neoplasm 50.55 9.55 34 199366 1374 90427673
Abortion spontaneous 50.46 9.55 28 199372 54028 90375019
Product taste abnormal 49.47 9.55 42 199358 2418 90426629
Therapy cessation 49.28 9.55 184 199216 36177 90392870
International normalised ratio increased 48.75 9.55 220 199180 47096 90381951
Full blood count decreased 47.79 9.55 159 199241 29530 90399517
Lupus-like syndrome 47.51 9.55 24 199376 48822 90380225
Lip swelling 47.12 9.55 189 199211 38421 90390626
Myelosuppression 46.87 9.55 30 199370 53561 90375486
Musculoskeletal pain 46.48 9.55 206 199194 171045 90258002
Nausea 46.41 9.55 2931 196469 1107385 89321662
Balance disorder 46.39 9.55 369 199031 96711 90332336
Asthenia 46.29 9.55 1518 197882 532233 89896814
Sciatica 45.33 9.55 97 199303 101285 90327762
Glomerular filtration rate decreased 45.29 9.55 109 199291 16823 90412224
Nasopharyngitis 44.55 9.55 629 198771 406475 90022572
Subarachnoid haemorrhage 44.44 9.55 112 199288 17792 90411255
Blindness 44.30 9.55 144 199256 26424 90402623
Headache 44.18 9.55 2320 197080 860426 89568621
Mitral valve incompetence 43.99 9.55 129 199271 22395 90406652
Dysgeusia 43.82 9.55 230 199170 52330 90376717
Urticaria 43.79 9.55 458 198942 312276 90116771
Back injury 43.73 9.55 24 199376 46598 90382449
Drug tolerance decreased 43.15 9.55 9 199391 32121 90396926
Immunisation 42.91 9.55 37 199363 2176 90426871
Blood potassium decreased 42.68 9.55 213 199187 47514 90381533
Delirium 42.50 9.55 105 199295 104254 90324793
Malnutrition 41.86 9.55 112 199288 18446 90410601
Sinusitis 41.57 9.55 519 198881 342569 90086478
Pericardial effusion 41.56 9.55 176 199224 36657 90392390
Diabetes mellitus 41.12 9.55 264 199136 64611 90364436
Tremor 40.48 9.55 515 198885 152658 90276389
Product odour abnormal 40.46 9.55 31 199369 1540 90427507
Tinnitus 40.43 9.55 195 199205 42907 90386140
Onychomycosis 40.05 9.55 16 199384 37360 90391687
Osteoarthritis 40.03 9.55 259 199141 195471 90233576
Frequent bowel movements 39.62 9.55 40 199360 56895 90372152
Glycosylated haemoglobin increased 39.31 9.55 98 199302 15464 90413583
Weight increased 39.18 9.55 665 198735 417262 90011785
Drug hypersensitivity 38.96 9.55 752 198648 462857 89966190
Red blood cell sedimentation rate abnormal 38.90 9.55 4 199396 24200 90404847
Ventricular tachycardia 38.60 9.55 131 199269 24577 90404470
Flatulence 37.98 9.55 186 199214 41181 90387866
Fatigue 37.88 9.55 2987 196413 1151036 89278011
Dysphonia 37.73 9.55 253 199147 62831 90366216
Oedema 37.51 9.55 272 199128 200023 90229024
Exostosis 37.36 9.55 37 199363 53097 90375950
Anuria 37.10 9.55 93 199307 14725 90414322
Nervousness 37.09 9.55 161 199239 33895 90395152
Colitis ulcerative 36.87 9.55 47 199353 60219 90368828
Haemoglobin decreased 36.43 9.55 529 198871 161427 90267620
Blood glucose decreased 36.40 9.55 124 199276 23305 90405742
Dry eye 36.26 9.55 235 199165 57696 90371351
Blood sodium decreased 35.99 9.55 138 199262 27475 90401572
Road traffic accident 35.95 9.55 119 199281 107507 90321540
Hyperglycaemia 35.81 9.55 213 199187 50757 90378290
Liver function test increased 35.64 9.55 84 199316 84771 90344276
Sleep disorder 35.62 9.55 272 199128 197758 90231289
Contusion 35.53 9.55 367 199033 250849 90178198
Therapy interrupted 34.95 9.55 209 199191 49899 90379148
Normal newborn 34.76 9.55 5 199395 23357 90405690
Gait inability 34.62 9.55 185 199215 146271 90282776
Renal disorder 34.59 9.55 170 199230 37689 90391358
Foetal death 34.44 9.55 3 199397 20720 90408327
Influenza 34.19 9.55 462 198938 138802 90290245
Disability 34.03 9.55 24 199376 40721 90388326
Thrombosis 33.68 9.55 276 199124 72975 90356072
Knee arthroplasty 33.63 9.55 84 199316 83098 90345949
Eructation 33.45 9.55 74 199326 10808 90418239
Muscle spasticity 33.40 9.55 18 199382 35304 90393743
Hallucination 33.33 9.55 254 199146 65705 90363342
Blood pressure decreased 33.26 9.55 280 199120 74615 90354432
Hypokalaemia 33.03 9.55 437 198963 130679 90298368
Nasal congestion 32.98 9.55 304 199096 83110 90345937
Diplopia 32.24 9.55 137 199263 28577 90400470
Glomerulonephritis rapidly progressive 32.23 9.55 25 199375 1265 90427782
Oral pain 32.21 9.55 150 199250 32533 90396514
Haemorrhagic stroke 32.08 9.55 54 199346 6442 90422605
Sprue-like enteropathy 31.81 9.55 22 199378 931 90428116
Eye swelling 31.30 9.55 138 199262 29248 90399799
Chronic obstructive pulmonary disease 31.20 9.55 273 199127 73556 90355491
Facial pain 31.20 9.55 81 199319 13101 90415946
Foot deformity 31.12 9.55 52 199348 59599 90369448
Lacrimation increased 31.07 9.55 130 199270 26932 90402115
Finger deformity 30.76 9.55 17 199383 32880 90396167
Rheumatoid nodule 30.75 9.55 4 199396 20162 90408885
Rhinorrhoea 30.57 9.55 313 199087 88003 90341044
Gastritis 30.31 9.55 176 199224 41577 90387470
Blood urea increased 30.28 9.55 140 199260 30273 90398774
Hyperhidrosis 30.17 9.55 444 198956 135861 90293186
Laryngitis 29.60 9.55 41 199359 50712 90378335
Arrhythmia 29.16 9.55 176 199224 42156 90386891
Therapy non-responder 28.92 9.55 179 199221 136525 90292522
Hypoaesthesia 28.77 9.55 502 198898 313708 90115339
Hepatic cirrhosis 28.70 9.55 60 199340 63193 90365854
Drug tolerance 28.70 9.55 3 199397 17913 90411134
Gout 28.67 9.55 92 199308 16767 90412280
Leukopenia 28.63 9.55 119 199281 100591 90328456
Ageusia 28.50 9.55 89 199311 15987 90413060
Bundle branch block left 28.16 9.55 57 199343 7828 90421219
Completed suicide 28.09 9.55 462 198938 144596 90284451
Swelling face 28.00 9.55 288 199112 81064 90347983
Diverticulum intestinal 27.91 9.55 62 199338 9080 90419967
Haemorrhage intracranial 27.87 9.55 85 199315 15077 90413970
Oedema peripheral 27.85 9.55 754 198646 257161 90171886
Hyperlipidaemia 27.82 9.55 112 199288 22804 90406243
Vasculitis 27.62 9.55 111 199289 22582 90406465
Depressed mood 27.42 9.55 197 199203 50025 90379022
Epistaxis 27.26 9.55 297 199103 84828 90344219
Pseudoporphyria 27.17 9.55 13 199387 269 90428778
Pain 27.15 9.55 1858 197542 994483 89434564
Food allergy 27.15 9.55 11 199389 25467 90403580
Pancreatitis acute 27.09 9.55 141 199259 31974 90397073
Device expulsion 27.02 9.55 30 199370 40856 90388191
Walking aid user 27.00 9.55 23 199377 35483 90393564
Pulmonary hypertension 26.92 9.55 173 199227 42350 90386697
Death 26.88 9.55 1245 198155 455306 89973741
Heart rate increased 26.67 9.55 372 199028 112530 90316517
Inappropriate schedule of product administration 26.67 9.55 471 198929 149462 90279585
Skin exfoliation 26.59 9.55 247 199153 67666 90361381
Mouth swelling 26.55 9.55 46 199354 5616 90423431
Infusion site reaction 26.27 9.55 5 199395 19034 90410013
Illness 26.25 9.55 286 199114 81683 90347364
Rash papular 25.93 9.55 101 199299 20254 90408793
Diabetes mellitus inadequate control 25.69 9.55 95 199305 18589 90410458
Osteoporosis 25.65 9.55 117 199283 96414 90332633
Ocular hyperaemia 25.54 9.55 144 199256 33654 90395393
Hiatus hernia 25.44 9.55 117 199283 25244 90403803
Injection site reaction 25.44 9.55 110 199290 91970 90337077
Diabetic foot 25.20 9.55 24 199376 1607 90427440
Nail disorder 25.18 9.55 58 199342 59009 90370038
Hypovolaemia 25.05 9.55 72 199328 12359 90416688
Haemarthrosis 24.98 9.55 37 199363 3957 90425090
Migraine 24.96 9.55 283 199117 190109 90238938
Joint stiffness 24.90 9.55 88 199312 77954 90351093
Diverticulitis 24.53 9.55 177 199223 45010 90384037
Rebound tachycardia 24.50 9.55 6 199394 11 90429036
Product residue present 24.36 9.55 38 199362 4253 90424794
Cardiovascular disorder 24.20 9.55 75 199325 13417 90415630
Constipation 24.13 9.55 797 198603 279598 90149449
Dopamine transporter scintigraphy abnormal 24.11 9.55 9 199391 97 90428950
Hypertensive emergency 24.08 9.55 27 199373 2190 90426857
Bone pain 24.05 9.55 225 199175 61758 90367289
Hypoacusis 23.99 9.55 123 199277 27727 90401320
Atrioventricular block 23.85 9.55 57 199343 8758 90420289
Colitis microscopic 23.82 9.55 66 199334 11093 90417954
Muscle twitching 23.79 9.55 111 199289 24091 90404956
CD30 expression 23.76 9.55 8 199392 62 90428985
Ischaemic cardiomyopathy 23.68 9.55 29 199371 2584 90426463
Pancytopenia 23.64 9.55 161 199239 120102 90308945
Angina unstable 23.59 9.55 50 199350 7093 90421954
Cutaneous T-cell dyscrasia 23.53 9.55 8 199392 64 90428983
Blood immunoglobulin E increased 23.49 9.55 38 199362 4387 90424660
Osmotic demyelination syndrome 23.28 9.55 19 199381 1035 90428012
Visual impairment 23.25 9.55 415 198985 131950 90297097
Platelet count decreased 23.20 9.55 427 198973 136542 90292505
Plasma cell myeloma 22.78 9.55 161 199239 40667 90388380
Psoriasis 22.77 9.55 454 198946 147300 90281747
Choking 22.62 9.55 68 199332 11965 90417082
Weight decreased 22.56 9.55 1037 198363 378873 90050174
Disturbance in attention 22.47 9.55 179 199221 46930 90382117
Product dose omission in error 22.38 9.55 97 199303 20406 90408641
Head injury 22.34 9.55 131 199269 31057 90397990
Primary hyperaldosteronism 22.33 9.55 8 199392 76 90428971
Hypoparathyroidism 22.02 9.55 18 199382 983 90428064
Temperature regulation disorder 21.97 9.55 3 199397 14576 90414471
Diabetic ketoacidosis 21.87 9.55 109 199291 24298 90404749
Haematoma 21.80 9.55 154 199246 38894 90390153
Adverse event 21.71 9.55 160 199240 117258 90311789
Adverse reaction 21.69 9.55 20 199380 29692 90399355
Skin fissures 21.62 9.55 97 199303 20712 90408335
Malignant neoplasm progression 21.54 9.55 142 199258 106728 90322319
Gait disturbance 21.53 9.55 737 198663 259759 90169288
Incorrect route of product administration 21.35 9.55 50 199350 50576 90378471
Diabetic retinopathy 21.34 9.55 28 199372 2674 90426373
Ischaemic stroke 21.31 9.55 101 199299 22065 90406982
Gastric disorder 21.24 9.55 136 199264 33248 90395799
Blood glucose abnormal 21.12 9.55 57 199343 9435 90419612
Arteriosclerosis 21.04 9.55 62 199338 10791 90418256
Product dispensing error 20.89 9.55 67 199333 12206 90416841
Noninfectious peritonitis 20.69 9.55 9 199391 148 90428899
Surgery 20.56 9.55 169 199231 44718 90384329
Skin swelling 20.36 9.55 45 199355 6569 90422478
Chromaturia 20.35 9.55 90 199310 19097 90409950
Blindness transient 20.13 9.55 36 199364 4507 90424540
Pain in extremity 20.12 9.55 1197 198203 449332 89979715
Sodium retention 20.10 9.55 9 199391 159 90428888
Blood magnesium decreased 20.10 9.55 78 199322 15615 90413432
Fear 19.99 9.55 81 199319 16541 90412506
Intentional self-injury 19.97 9.55 21 199379 29313 90399734
Chronic sinusitis 19.90 9.55 14 199386 23788 90405259
Sialoadenitis 19.42 9.55 24 199376 2158 90426889
Injection site pain 19.37 9.55 510 198890 173189 90255858
Rhabdomyolysis 19.36 9.55 185 199215 51071 90377976
Foetal exposure during pregnancy 19.30 9.55 41 199359 42934 90386113
Overdose 19.29 9.55 238 199162 157471 90271576
Femoral hernia incarcerated 19.25 9.55 20 199380 1488 90427559
Venous occlusion 19.16 9.55 16 199384 900 90428147
Dysstasia 19.10 9.55 107 199293 24945 90404102
Blood pressure diastolic abnormal 18.99 9.55 10 199390 19871 90409176
Speech disorder 18.97 9.55 168 199232 45417 90383630
Bromhidrosis 18.96 9.55 5 199395 14 90429033
Faeces discoloured 18.95 9.55 95 199305 21225 90407822
Pollakiuria 18.92 9.55 131 199269 32874 90396173
Urine albumin/creatinine ratio increased 18.91 9.55 13 199387 545 90428502
Neurodermatitis 18.79 9.55 28 199372 3010 90426037
Dizziness postural 18.79 9.55 53 199347 9000 90420047
Blindness unilateral 18.79 9.55 48 199352 7688 90421359
Adrenal insufficiency 18.65 9.55 23 199377 29898 90399149
Asthmatic crisis 18.62 9.55 22 199378 1888 90427159
Swollen tongue 18.42 9.55 168 199232 45788 90383259
Essential hypertension 18.36 9.55 42 199358 6273 90422774
Nodular rash 18.27 9.55 9 199391 199 90428848
Premature baby 18.16 9.55 17 199383 25060 90403987
Tricuspid valve incompetence 18.14 9.55 79 199321 16652 90412395
Proteinuria 18.11 9.55 100 199300 23191 90405856
Urinary incontinence 18.05 9.55 143 199257 37423 90391624
Cerebral haemorrhage 18.04 9.55 134 199266 34388 90394659
Cardiomegaly 18.02 9.55 86 199314 18839 90410208
Lymphatic fistula 17.97 9.55 19 199381 1442 90427605
Aortic arteriosclerosis 17.96 9.55 47 199353 7637 90421410
Overweight 17.84 9.55 40 199360 5894 90423153
Pancreatic steatosis 17.84 9.55 20 199380 1622 90427425
Acute respiratory failure 17.77 9.55 158 199242 42760 90386287
Chest discomfort 17.73 9.55 414 198986 137951 90291096
Haemophagocytic lymphohistiocytosis 17.61 9.55 6 199394 15453 90413594
Sinus bradycardia 17.59 9.55 79 199321 16873 90412174
Abdominal pain upper 17.42 9.55 897 198503 331777 90097270
Lethargy 17.40 9.55 214 199186 62925 90366122
Pseudolymphoma 17.30 9.55 13 199387 627 90428420
Proctitis 17.24 9.55 6 199394 15253 90413794
Anaemia 17.22 9.55 945 198455 351857 90077190
Myeloma cast nephropathy 17.20 9.55 8 199392 155 90428892
Dry mouth 17.17 9.55 293 199107 183766 90245281
Therapeutic response unexpected 17.05 9.55 94 199306 21786 90407261
Female genital tract fistula 17.05 9.55 9 199391 17859 90411188
Stent placement 16.97 9.55 32 199368 4171 90424876
Thymus disorder 16.95 9.55 10 199390 320 90428727
Cataract 16.80 9.55 237 199163 71855 90357192
Loss of personal independence in daily activities 16.79 9.55 205 199195 135900 90293147
Renin decreased 16.67 9.55 7 199393 105 90428942
Papillary muscle rupture 16.54 9.55 5 199395 26 90429021
Left ventricular dysfunction 16.47 9.55 70 199330 14599 90414448
Eosinophilia myalgia syndrome 16.46 9.55 4 199396 7 90429040
Scleroderma renal crisis 16.43 9.55 11 199389 441 90428606
Polyuria 16.36 9.55 54 199346 9986 90419061
Incorrect dose administered 16.26 9.55 254 199146 78676 90350371
Norepinephrine increased 16.21 9.55 6 199394 63 90428984
Burning sensation 16.18 9.55 212 199188 63240 90365807
Neutropenia 16.16 9.55 374 199026 224530 90204517
Product packaging issue 16.16 9.55 19 199381 1622 90427425
Angina pectoris 16.13 9.55 144 199256 39016 90390031
Upper gastrointestinal haemorrhage 16.13 9.55 96 199304 22880 90406167
Haemorrhagic fever 16.11 9.55 4 199396 8 90429039
Hepatic cytolysis 16.08 9.55 27 199373 30889 90398158
Wound infection pseudomonas 16.03 9.55 21 199379 2002 90427045
Ocular discomfort 15.97 9.55 40 199360 6330 90422717
Affect lability 15.95 9.55 10 199390 18053 90410994
Body temperature increased 15.94 9.55 48 199352 44662 90384385
Cardiac pacemaker insertion 15.91 9.55 32 199368 4375 90424672
Panniculitis 15.80 9.55 6 199394 14452 90414595
Spinal epidural haematoma 15.80 9.55 17 199383 1317 90427730
Electrocardiogram PR prolongation 15.77 9.55 14 199386 856 90428191
Hypophagia 15.77 9.55 134 199266 35803 90393244
Product physical issue 15.75 9.55 37 199363 5623 90423424
Vertigo 15.67 9.55 228 199172 69583 90359464
Liver disorder 15.60 9.55 181 199219 121088 90307959
Nephrolithiasis 15.59 9.55 171 199229 48914 90380133
Blood pressure systolic abnormal 15.58 9.55 12 199388 19466 90409581
Myopathy 15.56 9.55 65 199335 13453 90415594
Pancreatic carcinoma 15.43 9.55 47 199353 8330 90420717
Blood potassium increased 15.41 9.55 88 199312 20661 90408386
Pustular psoriasis 15.40 9.55 11 199389 18545 90410502
White blood cell count decreased 15.40 9.55 479 198921 166630 90262417
Tubulointerstitial nephritis 15.37 9.55 102 199298 25241 90403806
Hypervolaemia 15.36 9.55 124 199276 32633 90396414
Dengue fever 15.34 9.55 14 199386 888 90428159
Vitamin B6 deficiency 15.28 9.55 8 199392 202 90428845
Hypophosphataemia 15.25 9.55 69 199331 14785 90414262
Dyspepsia 15.25 9.55 326 199074 197834 90231213
Exposure via skin contact 15.20 9.55 55 199345 10650 90418397
Impaired quality of life 15.17 9.55 95 199305 23049 90405998
Patella fracture 15.11 9.55 23 199377 2520 90426527
Eyelid pain 15.00 9.55 13 199387 770 90428277
Instillation site pain 14.97 9.55 14 199386 916 90428131
Retinopathy hypertensive 14.93 9.55 9 199391 300 90428747
Sedation 14.91 9.55 55 199345 48116 90380931
Oral mucosal blistering 14.83 9.55 41 199359 6883 90422164
Iron deficiency anaemia 14.81 9.55 96 199304 23566 90405481
Left ventricular hypertrophy 14.80 9.55 38 199362 6106 90422941
Cardiac valve disease 14.79 9.55 32 199368 4603 90424444
End stage renal disease 14.78 9.55 47 199353 8524 90420523
Vascular stenosis 14.74 9.55 11 199389 525 90428522
Unevaluable event 14.73 9.55 185 199215 54663 90374384
Near death experience 14.69 9.55 13 199387 792 90428255
Milk-alkali syndrome 14.68 9.55 16 199384 1257 90427790
Cardiorenal syndrome 14.65 9.55 15 199385 1097 90427950
Suffocation feeling 14.64 9.55 18 199382 1610 90427437
Carbohydrate antigen 125 increased 14.62 9.55 26 199374 3240 90425807
Oropharyngeal pain 14.56 9.55 344 199056 114843 90314204
Seroma 14.53 9.55 25 199375 3035 90426012
Hypertrophic cardiomyopathy 14.46 9.55 21 199379 2207 90426840
Foreign body sensation in eyes 14.43 9.55 26 199374 3274 90425773
Hepatotoxicity 14.42 9.55 52 199348 45790 90383257
Renal phospholipidosis 14.40 9.55 8 199392 228 90428819
Crystal urine 14.39 9.55 5 199395 43 90429004
Orthostatic hypotension 14.35 9.55 148 199252 41679 90387368
Mental status changes 14.35 9.55 156 199244 44523 90384524
Blood loss anaemia 14.32 9.55 52 199348 10088 90418959
Arrhythmia supraventricular 14.31 9.55 15 199385 1127 90427920
Otolithiasis 14.29 9.55 4 199396 15 90429032
Premature delivery 14.26 9.55 41 199359 38721 90390326
Wrong technique in product usage process 14.24 9.55 229 199171 71342 90357705
Extradural haematoma 14.16 9.55 20 199380 2048 90426999
Electrolyte imbalance 14.05 9.55 95 199305 23650 90405397
Calciphylaxis 14.00 9.55 26 199374 3350 90425697
Blood phosphorus increased 14.00 9.55 30 199370 4288 90424759
Eye discharge 13.98 9.55 45 199355 8213 90420834
Urine protein/creatinine ratio increased 13.97 9.55 14 199386 998 90428049
Personality disorder 13.88 9.55 5 199395 12439 90416608
Arterial haemorrhage 13.85 9.55 22 199378 2501 90426546
Renal pain 13.80 9.55 43 199357 7716 90421331
Cerebral infarction 13.76 9.55 103 199297 26493 90402554
Acidosis 13.71 9.55 60 199340 12676 90416371
Spider naevus 13.54 9.55 7 199393 172 90428875
Blood parathyroid hormone decreased 13.47 9.55 5 199395 12211 90416836
Goitre 13.45 9.55 39 199361 6728 90422319
Bone marrow failure 13.44 9.55 32 199368 32189 90396858
Oral candidiasis 13.41 9.55 37 199363 35418 90393629
Maternal exposure before pregnancy 13.40 9.55 4 199396 11209 90417838
Myocardial ischaemia 13.32 9.55 63 199337 13751 90415296
Head discomfort 13.29 9.55 71 199329 16262 90412785
Hypochloraemia 13.22 9.55 22 199378 2600 90426447
Drug ineffective for unapproved indication 13.20 9.55 89 199311 66555 90362492
Atrioventricular block first degree 13.18 9.55 45 199355 8466 90420581
Hospice care 13.06 9.55 49 199351 9655 90419392
Aortic stenosis 13.06 9.55 37 199363 6299 90422748
Coronary artery occlusion 13.05 9.55 45 199355 8509 90420538
Chikungunya virus infection 13.04 9.55 7 199393 186 90428861
Gangrene 13.02 9.55 6 199394 12870 90416177
Hyponatraemic seizure 13.00 9.55 10 199390 500 90428547
Jaw disorder 12.99 9.55 34 199366 5525 90423522
Ear infection 12.93 9.55 95 199305 69680 90359367
Radiation overdose 12.90 9.55 4 199396 23 90429024
Drug resistance 12.90 9.55 30 199370 30419 90398628
Carotid artery stenosis 12.85 9.55 33 199367 5301 90423746
Blood glucose fluctuation 12.83 9.55 32 199368 5051 90423996
Taste disorder 12.80 9.55 81 199319 61465 90367582
Hip fracture 12.79 9.55 120 199280 32957 90396090
Suspiciousness 12.79 9.55 9 199391 392 90428655
Blood triglycerides increased 12.72 9.55 62 199338 13699 90415348
Dystonia 12.66 9.55 11 199389 16808 90412239
Thrombocytosis 12.64 9.55 39 199361 6962 90422085
Scratch 12.60 9.55 49 199351 9817 90419230
Cardiac flutter 12.56 9.55 30 199370 4608 90424439
Blood pressure diastolic decreased 12.55 9.55 25 199375 26801 90402246
Blood aldosterone increased 12.52 9.55 7 199393 202 90428845
Tongue haematoma 12.50 9.55 6 199394 125 90428922
Sluggishness 12.48 9.55 35 199365 5924 90423123
Coma 12.47 9.55 101 199299 72531 90356516
Haemodialysis 12.47 9.55 45 199355 8702 90420345
Hypersensitivity vasculitis 12.47 9.55 28 199372 4131 90424916
Peripheral coldness 12.42 9.55 62 199338 13830 90415217
Product solubility abnormal 12.41 9.55 13 199387 976 90428071
Generalised oedema 12.36 9.55 78 199322 18975 90410072
Refusal of treatment by patient 12.31 9.55 34 199366 5704 90423343
Skin discomfort 12.31 9.55 18 199382 1903 90427144
Cytokine release syndrome 12.30 9.55 27 199373 27946 90401101
Red blood cell count decreased 12.30 9.55 156 199244 46195 90382852
Orthopnoea 12.27 9.55 38 199362 6797 90422250
Pulmonary toxicity 12.25 9.55 5 199395 11526 90417521
Product availability issue 12.22 9.55 40 199360 7364 90421683
Foreign body in reproductive tract 12.22 9.55 14 199386 1163 90427884
Tongue necrosis 12.16 9.55 5 199395 71 90428976
Therapeutic nerve ablation 12.08 9.55 3 199397 6 90429041
Diabetic metabolic decompensation 12.05 9.55 18 199382 1939 90427108
Poor quality product administered 12.03 9.55 27 199373 3981 90425066
Muscle tightness 12.03 9.55 60 199340 13379 90415668
Bronchopulmonary aspergillosis 12.02 9.55 5 199395 11393 90417654
Eyelids pruritus 12.01 9.55 18 199382 1946 90427101
Heart rate irregular 12.00 9.55 93 199307 24175 90404872
Haemorrhage 12.00 9.55 217 199183 69152 90359895
Product prescribing error 11.98 9.55 110 199290 30035 90399012
Renal artery stenosis 11.97 9.55 19 199381 2158 90426889
Disease progression 11.94 9.55 258 199142 156357 90272690
Cardiac failure acute 11.94 9.55 55 199345 11874 90417173
Malignant hypertension 11.93 9.55 14 199386 1193 90427854
Carotid bruit 11.93 9.55 11 199389 707 90428340
Faecaloma 11.89 9.55 50 199350 10381 90418666
Diabetic vascular disorder 11.88 9.55 4 199396 31 90429016
Joint dislocation 11.86 9.55 54 199346 44528 90384519
Chills 11.82 9.55 377 199023 131604 90297443
Leukaemoid reaction 11.81 9.55 7 199393 226 90428821
Pulmonary renal syndrome 11.79 9.55 10 199390 575 90428472
Acute pulmonary oedema 11.77 9.55 47 199353 9533 90419514
Product packaging quantity issue 11.73 9.55 16 199384 1586 90427461
Acute myeloid leukaemia 11.71 9.55 17 199383 20623 90408424
Respiratory disorder 11.66 9.55 89 199311 64727 90364320
Cellulitis 11.61 9.55 273 199127 91064 90337983
Glomerulonephritis 11.49 9.55 20 199380 2450 90426597
Periorbital oedema 11.47 9.55 37 199363 6762 90422285
Hypertensive encephalopathy 11.46 9.55 11 199389 744 90428303
Cardio-respiratory arrest 11.45 9.55 199 199201 62941 90366106
Ascites 11.44 9.55 60 199340 47680 90381367
Linear IgA disease 11.36 9.55 19 199381 2255 90426792
Onychoclasis 11.35 9.55 39 199361 7360 90421687
Product administration interrupted 11.34 9.55 56 199344 12436 90416611
Macular degeneration 11.34 9.55 44 199356 37926 90391121
Carotid artery disease 11.31 9.55 16 199384 1641 90427406
Cold sweat 11.31 9.55 61 199339 14020 90415027
Blood uric acid abnormal 11.30 9.55 6 199394 156 90428891
Accelerated hypertension 11.27 9.55 9 199391 475 90428572
Groin pain 11.27 9.55 55 199345 12158 90416889
Bronchitis 11.23 9.55 427 198973 152500 90276547
Haematuria 11.23 9.55 122 199278 34815 90394232
Eczema 11.22 9.55 171 199229 52699 90376348
Generalised anxiety disorder 11.20 9.55 21 199379 2726 90426321
Petechiae 11.20 9.55 66 199334 15675 90413372
Product supply issue 11.13 9.55 22 199378 2970 90426077
Anaphylactic reaction 11.11 9.55 131 199269 87393 90341654
Coronary artery stenosis 11.10 9.55 31 199369 5235 90423812
Drug monitoring procedure not performed 11.07 9.55 11 199389 776 90428271
Abdominal pain 11.04 9.55 736 198664 394985 90034062
Amenorrhoea 11.04 9.55 6 199394 11716 90417331
Knee operation 11.03 9.55 37 199363 6899 90422148
Aortic valve stenosis 11.02 9.55 27 199373 4213 90424834
Medication error 11.02 9.55 126 199274 84526 90344521
Premature labour 11.01 9.55 8 199392 13368 90415679
Photopsia 11.01 9.55 30 199370 4994 90424053
Hiccups 10.95 9.55 22 199378 3004 90426043
Full blood count abnormal 10.95 9.55 126 199274 36471 90392576
Nail bed tenderness 10.94 9.55 8 199392 370 90428677
Nail infection 10.91 9.55 20 199380 2552 90426495
Coronary artery bypass 10.91 9.55 19 199381 2330 90426717
Lentigo 10.91 9.55 10 199390 638 90428409
Vitreous floaters 10.90 9.55 39 199361 7510 90421537
Haemorrhoids 10.90 9.55 98 199302 26604 90402443
Feeling cold 10.80 9.55 100 199300 27365 90401682
Seasonal allergy 10.78 9.55 87 199313 22896 90406151
Recalled product administered 10.75 9.55 11 199389 804 90428243
Mouth haemorrhage 10.68 9.55 42 199358 8459 90420588
Bladder catheterisation 10.66 9.55 8 199392 385 90428662
Presyncope 10.66 9.55 112 199288 31693 90397354
Internal haemorrhage 10.63 9.55 34 199366 6186 90422861
Atrial septal defect 10.61 9.55 41 199359 8193 90420854
Inferior vena cava dilatation 10.61 9.55 5 199395 100 90428947
Mitral valve stenosis 10.60 9.55 14 199386 1345 90427702
Tachyarrhythmia 10.59 9.55 31 199369 5375 90423672
Hypocalcaemia 10.57 9.55 141 199259 42227 90386820
Pseudopapilloedema 10.56 9.55 3 199397 12 90429035
Intraocular pressure increased 10.55 9.55 37 199363 7056 90421991
Obstructive airways disorder 10.55 9.55 26 199374 25843 90403204
Gastric haemorrhage 10.52 9.55 37 199363 7066 90421981
Breast cancer stage I 10.51 9.55 4 199396 9620 90419427
Blood sodium abnormal 10.48 9.55 11 199389 828 90428219
Skin cancer 10.48 9.55 58 199342 13461 90415586
Blood cholesterol abnormal 10.45 9.55 21 199379 2869 90426178
Lower gastrointestinal haemorrhage 10.43 9.55 43 199357 8849 90420198
Hepatic cyst 10.41 9.55 35 199365 6533 90422514
Loss of consciousness 10.40 9.55 392 199008 139846 90289201
Urine output decreased 10.40 9.55 55 199345 12548 90416499
Muscle disorder 10.34 9.55 31 199369 5448 90423599
Ulcer haemorrhage 10.31 9.55 27 199373 26294 90402753
Overlap syndrome 10.30 9.55 3 199397 8545 90420502
Genital infection 10.29 9.55 6 199394 188 90428859
Arterial disorder 10.23 9.55 14 199386 1392 90427655
Hair growth abnormal 10.19 9.55 24 199376 3652 90425395
Heart valve calcification 10.19 9.55 3 199397 14 90429033
Renal hypertrophy 10.19 9.55 4 199396 50 90428997
Hyporesponsive to stimuli 10.14 9.55 15 199385 1602 90427445
Musculoskeletal discomfort 10.14 9.55 80 199320 20911 90408136
Dermatofibrosarcoma protuberans 10.11 9.55 4 199396 51 90428996
Drug dependence 10.09 9.55 32 199368 29295 90399752
Renal injury 10.08 9.55 47 199353 10196 90418851
Pharyngeal swelling 10.06 9.55 46 199354 9898 90419149
Non-infectious endophthalmitis 10.06 9.55 7 199393 299 90428748
Nightmare 10.06 9.55 82 199318 21643 90407404
Application site mass 10.04 9.55 4 199396 52 90428995
Skin tightness 10.03 9.55 27 199373 4461 90424586
Transplant rejection 10.03 9.55 8 199392 12750 90416297
Bladder neoplasm surgery 10.02 9.55 3 199397 15 90429032
Hepatitis toxic 9.98 9.55 24 199376 3701 90425346
Neonatal anuria 9.98 9.55 4 199396 53 90428994
Ultrasound kidney abnormal 9.98 9.55 4 199396 53 90428994
Renin increased 9.93 9.55 6 199394 201 90428846
Hair colour changes 9.89 9.55 23 199377 3471 90425576
Eye injury 9.87 9.55 6 199394 11014 90418033
Rash macular 9.85 9.55 106 199294 30174 90398873
Thyroid mass 9.82 9.55 30 199370 5325 90423722
Poor peripheral circulation 9.80 9.55 25 199375 4000 90425047
Schizophrenia 9.79 9.55 11 199389 14903 90414144
Cardiac failure chronic 9.77 9.55 31 199369 5615 90423432
Normochromic normocytic anaemia 9.75 9.55 29 199371 5073 90423974
Device dislocation 9.71 9.55 36 199364 31446 90397601
Vascular parkinsonism 9.70 9.55 5 199395 122 90428925
Haematotoxicity 9.68 9.55 8 199392 12527 90416520
Asphyxia 9.67 9.55 36 199364 7067 90421980
Oral pustule 9.65 9.55 4 199396 58 90428989
Sinus node dysfunction 9.63 9.55 30 199370 5382 90423665
Hordeolum 9.58 9.55 28 199372 4850 90424197
Therapy change 9.57 9.55 40 199360 8282 90420765
Graft versus host disease 9.56 9.55 3 199397 8141 90420906
Duodenogastric reflux 9.56 9.55 5 199395 126 90428921

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
Angioedema 258.22 10.52 456 125486 42021 42453372
Febrile neutropenia 197.14 10.52 156 125786 185547 42309846
Drug abuse 185.99 10.52 41 125901 104730 42390663
Off label use 160.01 10.52 1169 124773 637166 41858227
Dizziness 150.92 10.52 1254 124688 248000 42247393
Cardiospasm 130.00 10.52 77 125865 1830 42493563
Myocardial infarction 122.57 10.52 704 125238 123305 42372088
Neutropenia 121.14 10.52 255 125687 199176 42296217
Palmoplantar keratoderma 113.28 10.52 75 125867 2179 42493214
Tension headache 106.27 10.52 85 125857 3329 42492064
Pruritus genital 104.86 10.52 76 125866 2563 42492830
Sleep terror 102.23 10.52 78 125864 2848 42492545
Anosmia 99.35 10.52 98 125844 5078 42490315
Carotid artery occlusion 96.92 10.52 88 125854 4106 42491287
Cardiac failure congestive 93.22 10.52 499 125443 85103 42410290
Hyperkalaemia 92.42 10.52 476 125466 79982 42415411
Atrial tachycardia 90.09 10.52 84 125858 4056 42491337
Foetal exposure during pregnancy 89.18 10.52 16 125926 47295 42448098
Eye pruritus 88.82 10.52 137 125805 11275 42484118
Fatigue 87.10 10.52 1786 124156 433855 42061538
Immunisation 86.29 10.52 51 125891 1207 42494186
Pruritus 85.01 10.52 892 125050 187879 42307514
Blood glucose increased 84.63 10.52 436 125506 73263 42422130
Toxicity to various agents 84.48 10.52 369 125573 228767 42266626
Facial pain 84.27 10.52 82 125860 4178 42491215
Peripheral swelling 80.50 10.52 499 125443 89771 42405622
General physical health deterioration 77.03 10.52 212 125730 151034 42344359
Drug ineffective 75.16 10.52 1362 124580 628835 41866558
Leukopenia 71.68 10.52 69 125873 74677 42420716
Visual impairment 68.78 10.52 281 125661 42832 42452561
Feeling abnormal 68.75 10.52 396 125546 69390 42426003
Thrombocytopenia 67.94 10.52 310 125632 189969 42305424
Acute myocardial infarction 66.00 10.52 343 125599 57822 42437571
Lip swelling 64.51 10.52 161 125781 18892 42476501
Psoriasis 63.23 10.52 298 125644 48306 42447087
Multiple organ dysfunction syndrome 62.31 10.52 120 125822 96915 42398478
Dermatitis atopic 61.39 10.52 122 125820 12282 42483111
Transient ischaemic attack 59.54 10.52 227 125715 33512 42461881
Dry skin 57.59 10.52 289 125653 48049 42447344
Treatment failure 56.42 10.52 61 125881 62563 42432830
Condition aggravated 55.45 10.52 498 125444 260256 42235137
Pain of skin 54.65 10.52 91 125851 7989 42487404
Blood pressure increased 54.28 10.52 499 125443 101429 42393964
Product dose omission issue 54.04 10.52 695 125247 153670 42341723
Blindness 53.75 10.52 145 125797 17833 42477560
Angina unstable 53.56 10.52 110 125832 11338 42484055
Palpitations 52.49 10.52 292 125650 50505 42444888
Disease progression 51.87 10.52 233 125709 143423 42351970
Hepatic cytolysis 50.76 10.52 9 125933 26835 42468558
Suspected suicide 50.47 10.52 76 125866 6123 42489270
Cytokine release syndrome 50.26 10.52 35 125907 44492 42450901
Pyrexia 49.84 10.52 842 125100 393200 42102193
Suicide attempt 49.75 10.52 38 125904 46062 42449331
Coma 49.54 10.52 51 125891 53503 42441890
Myalgia 49.46 10.52 467 125475 95613 42399780
Rash papular 48.92 10.52 108 125834 11703 42483690
Serotonin syndrome 48.14 10.52 9 125933 25836 42469557
Amnesia 47.47 10.52 188 125754 28249 42467144
Sprue-like enteropathy 46.40 10.52 27 125915 620 42494773
Pericarditis 45.93 10.52 114 125828 13330 42482063
Septic shock 45.52 10.52 130 125812 91542 42403851
Ventricular tachycardia 45.30 10.52 193 125749 29967 42465426
Cytomegalovirus infection 44.22 10.52 20 125922 32286 42463107
Pancytopenia 43.69 10.52 189 125753 117554 42377839
Mucosal inflammation 43.47 10.52 49 125893 49325 42446068
Overdose 43.45 10.52 162 125780 105102 42390291
Abdominal discomfort 43.43 10.52 375 125567 74880 42420513
Atrial fibrillation 42.89 10.52 614 125328 138979 42356414
Muscle twitching 42.49 10.52 102 125840 11678 42483715
Completed suicide 42.01 10.52 453 125489 96012 42399381
Dyspnoea 41.75 10.52 1650 124292 440971 42054422
Myelosuppression 41.59 10.52 35 125907 40426 42454967
Product substitution issue 40.98 10.52 98 125844 11192 42484201
Muscular weakness 40.58 10.52 401 125541 83097 42412296
Back pain 40.19 10.52 615 125327 141161 42354232
Tinnitus 39.53 10.52 180 125762 28758 42466635
Cerebrovascular accident 38.99 10.52 449 125493 96711 42398682
Malignant neoplasm progression 38.41 10.52 177 125765 108223 42387170
Therapeutic product effect incomplete 36.40 10.52 99 125843 70840 42424553
BRASH syndrome 35.86 10.52 35 125907 1790 42493603
Sedation 35.68 10.52 23 125919 30452 42464941
Hypertensive crisis 35.34 10.52 87 125855 10119 42485274
Neuroleptic malignant syndrome 34.98 10.52 10 125932 21462 42473931
Memory impairment 34.81 10.52 261 125681 49961 42445432
Haemophagocytic lymphohistiocytosis 34.69 10.52 6 125936 18216 42477177
Diarrhoea 34.57 10.52 1678 124264 459171 42036222
Chest pain 34.23 10.52 591 125351 138939 42356454
Ascites 33.90 10.52 73 125869 56605 42438788
Hypertensive emergency 33.53 10.52 29 125913 1268 42494125
C-reactive protein increased 33.14 10.52 88 125854 63472 42431921
Epilepsy 33.11 10.52 18 125924 26153 42469240
Syncope 32.85 10.52 443 125499 98963 42396430
Drug dependence 32.66 10.52 23 125919 29071 42466322
Cough 32.09 10.52 720 125222 177383 42318010
Intentional overdose 31.84 10.52 65 125877 51391 42444002
Rash 31.80 10.52 1056 124886 275898 42219495
Obstructive airways disorder 31.36 10.52 17 125925 24742 42470651
Drug dispensed to wrong patient 30.42 10.52 19 125923 498 42494895
Plasmapheresis 30.42 10.52 18 125924 427 42494966
Coronary artery disease 29.59 10.52 265 125677 53455 42441938
Cardiac disorder 29.36 10.52 246 125696 48686 42446707
Cholestasis 28.54 10.52 33 125909 32846 42462547
Acute kidney injury 28.44 10.52 1342 124600 365995 42129398
Muscle spasms 28.24 10.52 383 125559 85661 42409732
Graft versus host disease 27.57 10.52 3 125939 12922 42482471
Subarachnoid haemorrhage 26.88 10.52 99 125843 14373 42481020
Diplopia 26.73 10.52 125 125817 20191 42475202
Premature baby 26.39 10.52 18 125924 23135 42472258
Status epilepticus 25.85 10.52 7 125935 15571 42479822
Intestinal angioedema 25.78 10.52 13 125929 222 42495171
Respiratory depression 25.33 10.52 12 125930 18856 42476537
Product use in unapproved indication 24.94 10.52 389 125553 184067 42311326
Eosinophilia 23.53 10.52 38 125904 32861 42462532
Bronchiectasis 23.37 10.52 12 125930 18007 42477386
Hallucination 23.17 10.52 266 125676 57241 42438152
Bone marrow failure 22.95 10.52 39 125903 33054 42462339
Psychotic disorder 22.57 10.52 32 125910 29176 42466217
Skin fissures 22.18 10.52 71 125871 9605 42485788
Arthralgia 21.87 10.52 776 125166 204462 42290931
Delirium 21.55 10.52 81 125861 52438 42442955
Dysphonia 21.52 10.52 151 125791 28299 42467094
Abdominal pain upper 21.37 10.52 353 125589 82256 42413137
Paraesthesia 21.31 10.52 320 125622 73139 42422254
Schizophrenia 21.15 10.52 3 125939 10547 42484846
Abdominal wall haematoma 21.12 10.52 30 125912 2292 42493101
Drug ineffective for unapproved indication 21.09 10.52 68 125874 46095 42449298
Rash maculo-papular 21.04 10.52 50 125892 37453 42457940
Blood creatinine increased 20.84 10.52 448 125494 109555 42385838
Diabetic neuropathy 20.76 10.52 43 125899 4459 42490934
Drug resistance 20.57 10.52 44 125898 34204 42461189
Infusion related reaction 20.52 10.52 101 125841 60705 42434688
Agranulocytosis 20.39 10.52 37 125905 30575 42464818
Blood pressure inadequately controlled 20.34 10.52 33 125909 2835 42492558
Chronic kidney disease 20.15 10.52 221 125721 47020 42448373
Pneumonia aspiration 20.05 10.52 78 125864 50000 42445393
Activated partial thromboplastin time prolonged 20.02 10.52 11 125931 15892 42479501
Skin exfoliation 19.90 10.52 199 125743 41354 42454039
Sepsis 19.90 10.52 443 125499 198891 42296502
Insomnia 19.41 10.52 472 125470 117781 42377612
Skin discolouration 18.92 10.52 116 125826 20774 42474619
Ageusia 18.78 10.52 76 125866 11529 42483864
Cytomegalovirus infection reactivation 18.59 10.52 5 125937 11173 42484220
Balance disorder 18.57 10.52 219 125723 47426 42447967
Cardiac flutter 18.52 10.52 27 125915 2113 42493280
Glomerular filtration rate decreased 18.24 10.52 96 125846 16255 42479138
COVID-19 18.20 10.52 460 125482 115488 42379905
Headache 18.16 10.52 873 125069 238496 42256897
Toxic epidermal necrolysis 18.12 10.52 32 125910 26718 42468675
Haematotoxicity 18.11 10.52 5 125937 10980 42484413
Lactic acidosis 18.07 10.52 209 125733 45052 42450341
Febrile bone marrow aplasia 18.02 10.52 4 125938 10177 42485216
Alanine aminotransferase increased 17.80 10.52 171 125771 88235 42407158
Injection site oedema 17.70 10.52 12 125930 363 42495030
Neoplasm progression 17.63 10.52 37 125905 28963 42466430
Wrong drug 17.58 10.52 9 125933 159 42495234
Alopecia 17.46 10.52 147 125795 29129 42466264
Pharyngeal swelling 17.45 10.52 34 125908 3373 42492020
Posterior reversible encephalopathy syndrome 17.45 10.52 8 125934 12813 42482580
Bacterial infection 17.43 10.52 35 125907 27844 42467549
Blood pressure abnormal 17.41 10.52 67 125875 9931 42485462
Miosis 17.37 10.52 9 125933 13437 42481956
Product quality issue 17.28 10.52 101 125841 17781 42477612
Heart rate increased 17.03 10.52 236 125706 53019 42442374
Paraplegia 17.01 10.52 33 125909 3264 42492129
Akathisia 16.78 10.52 5 125937 10446 42484947
High frequency ablation 16.71 10.52 9 125933 177 42495216
Eye irritation 16.66 10.52 72 125870 11246 42484147
Hepatic function abnormal 16.63 10.52 87 125855 51480 42443913
Peri-implantitis 16.62 10.52 8 125934 123 42495270
Yellow skin 16.58 10.52 27 125915 2327 42493066
Vasculitis 16.57 10.52 102 125840 18292 42477101
Carcinogenicity 16.54 10.52 7 125935 78 42495315
Cognitive disorder 16.53 10.52 164 125778 34008 42461385
Iron deficiency 16.52 10.52 6 125936 11055 42484338
Appendicitis 16.51 10.52 22 125920 20591 42474802
BK virus infection 16.49 10.52 3 125939 8781 42486612
Respiratory failure 16.38 10.52 273 125669 127859 42367534
Tendonitis 16.18 10.52 65 125877 9829 42485564
Progressive multifocal leukoencephalopathy 16.01 10.52 7 125935 11529 42483864
Antineutrophil cytoplasmic antibody increased 15.96 10.52 5 125937 21 42495372
Osteoarthritis 15.88 10.52 125 125817 24280 42471113
Dystonia 15.88 10.52 9 125933 12781 42482612
Full blood count abnormal 15.85 10.52 41 125901 29835 42465558
Pathogen resistance 15.81 10.52 7 125935 11443 42483950
Dengue fever 15.73 10.52 12 125930 438 42494955
Pain 15.72 10.52 879 125063 243969 42251424
Klebsiella infection 15.53 10.52 7 125935 11325 42484068
Lymphopenia 15.33 10.52 25 125917 21538 42473855
Pityriasis rubra pilaris 15.06 10.52 10 125932 292 42495101
Neutrophil count increased 15.00 10.52 22 125920 19782 42475611
Epstein-Barr virus infection 14.98 10.52 5 125937 9713 42485680
Hyperphosphataemia 14.97 10.52 10 125932 12994 42482399
Blood glucose decreased 14.85 10.52 82 125860 14137 42481256
Burning feet syndrome 14.81 10.52 7 125935 103 42495290
Drug use disorder 14.77 10.52 6 125936 10327 42485066
Milk-alkali syndrome 14.72 10.52 14 125928 693 42494700
Gastroenteritis eosinophilic 14.72 10.52 9 125933 227 42495166
Seizure 14.72 10.52 259 125683 120302 42375091
Tumour lysis syndrome 14.69 10.52 27 125915 22204 42473189
Tenosynovitis stenosans 14.64 10.52 5 125937 29 42495364
Fungal balanitis 14.62 10.52 4 125938 9 42495384
Therapy interrupted 14.50 10.52 114 125828 22136 42473257
Oropharyngeal surgery 14.48 10.52 3 125939 0 42495393
Therapy partial responder 14.44 10.52 23 125919 19998 42475395
Blood potassium increased 14.38 10.52 99 125843 18437 42476956
Seborrhoeic keratosis 14.34 10.52 21 125921 1650 42493743
Vitamin B1 deficiency 14.29 10.52 11 125931 407 42494986
Anaemia 14.22 10.52 680 125262 279598 42215795
Accidental overdose 14.18 10.52 40 125902 28290 42467103
Generalised tonic-clonic seizure 14.14 10.52 36 125906 26343 42469050
Somnolence 13.95 10.52 314 125628 140791 42354602
Blood phosphorus increased 13.93 10.52 10 125932 12515 42482878
Hypogammaglobulinaemia 13.88 10.52 9 125933 11882 42483511
Clostridium difficile colitis 13.88 10.52 26 125916 21226 42474167
Blister 13.82 10.52 133 125809 27357 42468036
Erectile dysfunction 13.77 10.52 123 125819 24790 42470603
Diabetic foot 13.76 10.52 29 125913 3044 42492349
Adverse drug reaction 13.69 10.52 170 125772 37264 42458129
Food allergy 13.68 10.52 24 125918 2197 42493196
Atheroembolism 13.65 10.52 10 125932 343 42495050
Idiopathic pulmonary fibrosis 13.63 10.52 37 125905 4567 42490826
Asthenia 13.63 10.52 984 124958 279809 42215584
Aplastic anaemia 13.62 10.52 10 125932 12374 42483019
Chikungunya virus infection 13.60 10.52 5 125937 37 42495356
Poisoning 13.59 10.52 14 125928 14685 42480708
Respiratory symptom 13.53 10.52 8 125934 11098 42484295
Aggression 13.42 10.52 76 125866 44087 42451306
Arterial occlusive disease 13.39 10.52 36 125906 4417 42490976
Hypophosphataemia 13.35 10.52 26 125916 20919 42474474
Product odour abnormal 13.31 10.52 15 125927 907 42494486
Acute respiratory distress syndrome 13.30 10.52 45 125897 30063 42465330
Shoshin beriberi 13.29 10.52 6 125936 79 42495314
Hypoxia 13.21 10.52 137 125805 69649 42425744
Aspartate aminotransferase increased 13.21 10.52 155 125787 77008 42418385
Synovitis 13.11 10.52 16 125926 15551 42479842
Neutrophil count decreased 13.05 10.52 122 125820 63293 42432100
Loss of consciousness 12.93 10.52 361 125581 91993 42403400
Rash pruritic 12.89 10.52 154 125788 33449 42461944
Abdominal pain 12.89 10.52 447 125495 190024 42305369
Oral mucosal blistering 12.86 10.52 25 125917 2476 42492917
Cachexia 12.79 10.52 4 125938 8100 42487293
Somnambulism 12.78 10.52 30 125912 3385 42492008
Hyperthermia 12.77 10.52 11 125931 12563 42482830
Myocardial rupture 12.77 10.52 8 125934 211 42495182
Gamma-glutamyltransferase increased 12.76 10.52 51 125891 32446 42462947
Diffuse large B-cell lymphoma 12.71 10.52 6 125936 9448 42485945
Cardiac valve disease 12.69 10.52 30 125912 3401 42491992
Renal pain 12.65 10.52 31 125911 3596 42491797
Vision blurred 12.62 10.52 226 125716 53473 42441920
Vascular injury 12.51 10.52 9 125933 300 42495093
Bronchopulmonary aspergillosis 12.48 10.52 24 125918 19405 42475988
Product use issue 12.44 10.52 156 125786 76595 42418798
B-cell small lymphocytic lymphoma stage IV 12.41 10.52 3 125939 3 42495390
Application site haematoma 12.30 10.52 5 125937 50 42495343
C-reactive protein abnormal 12.26 10.52 6 125936 9255 42486138
Transient aphasia 12.24 10.52 12 125930 617 42494776
Contusion 12.21 10.52 183 125759 41802 42453591
Granulocytopenia 12.18 10.52 3 125939 7111 42488282
Fluid retention 12.17 10.52 145 125797 31474 42463919
Exposure during pregnancy 12.16 10.52 5 125937 8543 42486850
Fungal infection 12.12 10.52 25 125917 19697 42475696
Eye pain 12.08 10.52 89 125853 16941 42478452
Hypertension 12.07 10.52 607 125335 166597 42328796
Infection 12.06 10.52 246 125696 111822 42383571
Blood growth hormone increased 12.00 10.52 12 125930 632 42494761
Stress 11.92 10.52 79 125863 44133 42451260
Eye infection 11.88 10.52 34 125908 4327 42491066
Urinary bladder polyp 11.87 10.52 7 125935 165 42495228
Carotid bruit 11.87 10.52 7 125935 165 42495228
Blood cholesterol abnormal 11.70 10.52 21 125921 1958 42493435
Pulmonary alveolar haemorrhage 11.68 10.52 16 125926 14800 42480593
Haemorrhagic stroke 11.60 10.52 48 125894 7354 42488039
Tendon rupture 11.58 10.52 51 125891 8032 42487361
Pneumocystis jirovecii pneumonia 11.56 10.52 37 125905 25144 42470249
Brain oedema 11.54 10.52 19 125923 16308 42479085
Loss of personal independence in daily activities 11.51 10.52 93 125849 49723 42445670
Anaemia Heinz body 11.46 10.52 4 125938 25 42495368
Genital swelling 11.40 10.52 8 125934 256 42495137
Haematochezia 11.35 10.52 114 125828 58322 42437071
Lung disorder 11.29 10.52 89 125853 47834 42447559
Malaise 11.25 10.52 749 125193 211407 42283986
Nephrogenic systemic fibrosis 11.24 10.52 29 125913 3472 42491921
Coeliac disease 11.23 10.52 14 125928 942 42494451
Granulomatous liver disease 11.12 10.52 12 125930 691 42494702
Heat stroke 11.11 10.52 15 125927 1093 42494300
Neurological symptom 11.08 10.52 8 125934 9983 42485410
Diabetic vascular disorder 11.07 10.52 5 125937 66 42495327
Disseminated intravascular coagulation 10.99 10.52 37 125905 24757 42470636
Follicle centre lymphoma, follicular grade I, II, III 10.89 10.52 3 125939 7 42495386
Migraine 10.89 10.52 119 125823 25295 42470098
Eosinophilic granulomatosis with polyangiitis 10.84 10.52 6 125936 8632 42486761
Orthostatic hypotension 10.82 10.52 138 125804 30432 42464961
Hepatic failure 10.82 10.52 67 125875 38033 42457360
Extrapyramidal disorder 10.78 10.52 20 125922 16392 42479001
Renal disorder 10.76 10.52 132 125810 28848 42466545
Drug level below therapeutic 10.75 10.52 3 125939 6542 42488851
Acrochordon 10.74 10.52 10 125932 482 42494911
Renal cortical necrosis 10.74 10.52 7 125935 198 42495195
Eczema nummular 10.74 10.52 7 125935 198 42495195
Toxic skin eruption 10.65 10.52 15 125927 13715 42481678
Prostatic specific antigen increased 10.64 10.52 86 125856 16839 42478554
Shock 10.63 10.52 47 125895 29074 42466319
Angina pectoris 10.61 10.52 146 125796 32750 42462643
Encephalitis 10.60 10.52 7 125935 9151 42486242
Vital functions abnormal 10.59 10.52 9 125933 384 42495009
Encephalopathy 10.57 10.52 75 125867 41258 42454135
Pneumonia fungal 10.57 10.52 7 125935 9139 42486254
Enterococcal infection 10.54 10.52 12 125930 12027 42483366

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
Synovitis 511.40 9.72 38 265038 274054 110050169
Hand deformity 459.53 9.72 14 265062 218492 110105731
Maternal exposure during pregnancy 441.44 9.72 48 265028 254835 110069388
Cardiac failure congestive 438.66 9.72 1057 264019 149943 110174280
Pemphigus 436.43 9.72 18 265058 214552 110109671
Systemic lupus erythematosus 401.94 9.72 64 265012 254274 110069949
Duodenal ulcer perforation 371.43 9.72 12 265064 177688 110146535
Infusion related reaction 363.13 9.72 233 264843 380929 109943294
Myocardial infarction 359.44 9.72 1145 263931 190938 110133285
Folliculitis 358.96 9.72 9 265067 167644 110156579
Helicobacter infection 336.96 9.72 26 265050 181851 110142372
Acute kidney injury 332.04 9.72 2630 262446 632800 109691423
Angioedema 309.35 9.72 711 264365 97789 110226434
Glossodynia 308.62 9.72 76 265000 221928 110102295
Blood glucose increased 307.90 9.72 853 264223 131643 110192580
Wound 291.45 9.72 99 264977 234338 110089885
Rheumatoid factor positive 289.99 9.72 5 265071 131635 110192588
Treatment failure 277.17 9.72 160 264916 277074 110047149
C-reactive protein abnormal 273.77 9.72 8 265068 129687 110194536
Muscle injury 264.03 9.72 19 265057 140788 110183435
Off label use 255.71 9.72 2335 262741 1497850 108826373
Hyperkalaemia 252.58 9.72 808 264268 134988 110189235
Lower respiratory tract infection 247.75 9.72 137 264939 242969 110081254
Irritable bowel syndrome 246.96 9.72 47 265029 164168 110160055
Hepatic enzyme increased 234.24 9.72 254 264822 320638 110003585
Arthropathy 232.44 9.72 208 264868 287314 110036909
Drug intolerance 231.62 9.72 386 264690 406126 109918097
General physical health deterioration 224.13 9.72 424 264652 424871 109899352
Sleep disorder due to general medical condition, insomnia type 214.30 9.72 9 265067 105634 110218589
Dizziness 210.99 9.72 2578 262498 695615 109628608
Drug abuse 210.15 9.72 81 264995 177330 110146893
Febrile neutropenia 208.50 9.72 272 264804 316495 110007728
Facet joint syndrome 208 9.72 5 265071 96823 110227400
Fibromyalgia 202.49 9.72 78 264998 170831 110153392
Drug ineffective 193.84 9.72 2529 262547 1518011 108806212
Exposure during pregnancy 189.28 9.72 82 264994 167342 110156881
Cardiospasm 187.93 9.72 128 264948 4839 110319384
Feeling abnormal 180.15 9.72 884 264192 179827 110144396
Palmoplantar keratoderma 173.98 9.72 126 264950 5261 110318962
Tension headache 173.06 9.72 160 264916 9458 110314765
Lip dry 172.81 9.72 19 265057 100064 110224159
Contraindicated product administered 171.90 9.72 205 264871 248062 110076161
Blood pressure increased 171.77 9.72 1134 263942 257239 110066984
Impaired healing 170.41 9.72 133 264943 196584 110127639
Pruritus genital 169.55 9.72 134 264942 6388 110317835
Atrial fibrillation 169.43 9.72 1035 264041 228607 110095616
Sleep terror 167.97 9.72 134 264942 6476 110317747
Liver injury 167.93 9.72 75 265001 150338 110173885
Cerebrovascular accident 167.48 9.72 868 264208 180416 110143807
C-reactive protein increased 166.29 9.72 166 264910 217753 110106470
Product dose omission issue 164.37 9.72 1326 263750 320456 110003767
Acute myocardial infarction 158.94 9.72 502 264574 83275 110240948
Anosmia 158.90 9.72 172 264904 12300 110311923
Myalgia 158.85 9.72 994 264082 221387 110102836
Ill-defined disorder 157.45 9.72 90 264986 156763 110167460
Carotid artery occlusion 156.59 9.72 151 264925 9414 110314809
Cough 154.92 9.72 1740 263336 459901 109864322
Dry skin 150.43 9.72 583 264493 107070 110217153
Diarrhoea 149.24 9.72 3677 261399 1135828 109188395
Joint range of motion decreased 148.69 9.72 53 265023 121779 110202444
Live birth 147.68 9.72 4 265072 69480 110254743
Hyponatraemia 147.51 9.72 960 264116 216693 110107530
Atrial tachycardia 146.70 9.72 143 264933 9035 110315188
Pericarditis 146.35 9.72 186 264890 218928 110105295
BRASH syndrome 145.77 9.72 98 264978 3625 110320598
Transient ischaemic attack 145.68 9.72 409 264667 63573 110260650
Suspected suicide 144.03 9.72 180 264896 15019 110309204
Type 2 diabetes mellitus 143.43 9.72 128 264948 177104 110147119
Dyspnoea 142.61 9.72 3564 261512 1103308 109220915
Palpitations 134.57 9.72 744 264332 158468 110165755
Psoriatic arthropathy 134.57 9.72 164 264912 196597 110127626
Rheumatoid arthritis 125.70 9.72 338 264738 299275 110024948
Coronary artery disease 124.64 9.72 417 264659 71273 110252950
Immunisation 122.75 9.72 83 264993 3100 110321123
Swelling 122.41 9.72 431 264645 350610 109973613
Myelosuppression 120.42 9.72 38 265038 94302 110229921
Peripheral venous disease 120.40 9.72 27 265049 84090 110240133
Dermatitis atopic 118.86 9.72 217 264859 25324 110298899
Grip strength decreased 118.30 9.72 24 265052 80150 110244073
Mobility decreased 116.96 9.72 246 264830 237176 110087047
Bursitis 114.84 9.72 86 264990 129832 110194391
Lip swelling 113.50 9.72 322 264754 50345 110273878
Eye pruritus 113.42 9.72 246 264830 32529 110291694
Lactic acidosis 112.49 9.72 481 264595 92330 110231893
Injury 111.72 9.72 157 264919 177108 110147115
Autoimmune disorder 111.62 9.72 13 265063 65470 110258753
Therapeutic product effect decreased 110.68 9.72 265 264811 244051 110080172
Blood creatinine increased 108.63 9.72 781 264295 182108 110142115
Pain of skin 108.58 9.72 182 264894 19847 110304376
Inflammation 107.62 9.72 186 264890 193052 110131171
Blister 106.71 9.72 242 264834 227134 110097089
Joint swelling 105.80 9.72 625 264451 442220 109882003
Dehydration 105.01 9.72 1078 263998 278433 110045790
COVID-19 104.22 9.72 970 264106 244090 110080133
Product substitution issue 102.38 9.72 192 264884 22869 110301354
Musculoskeletal stiffness 101.98 9.72 337 264739 279485 110044738
Loss of employment 100.73 9.72 75 265001 3269 110320954
Therapeutic product effect incomplete 99.60 9.72 245 264831 223560 110100663
Facial pain 99.11 9.72 151 264925 15188 110309035
Infection 98.75 9.72 489 264587 361711 109962512
Multi-organ disorder 97.78 9.72 74 265002 3307 110320916
Epilepsy 97.03 9.72 60 265016 100149 110224074
Stomatitis 96.74 9.72 328 264748 269914 110054309
Syncope 96.57 9.72 822 264254 201714 110122509
Chest pain 95.88 9.72 1348 263728 375027 109949196
Blepharospasm 95.74 9.72 10 265066 54841 110269382
Ventricular tachycardia 95.15 9.72 300 264776 49709 110274514
Product use issue 94.34 9.72 405 264671 311290 110012933
Discomfort 94.01 9.72 237 264839 214470 110109753
Back pain 93.00 9.72 1325 263751 369671 109954552
Night sweats 92.31 9.72 111 264965 133872 110190351
Fatigue 91.48 9.72 3670 261406 1212288 109111935
Hypotension 91.44 9.72 1763 263313 522086 109802137
Dislocation of vertebra 91.16 9.72 3 265073 43718 110280505
Pregnancy 89.94 9.72 9 265067 51058 110273165
Wound infection 88.99 9.72 61 265015 96404 110227819
Pyrexia 88.20 9.72 1569 263507 896696 109427527
Condition aggravated 88.09 9.72 1236 263840 733600 109590623
Fall 87.40 9.72 1976 263100 601506 109722717
Blindness 87.29 9.72 237 264839 36122 110288101
Chronic kidney disease 85.32 9.72 386 264690 75905 110248318
Adjustment disorder with depressed mood 84.97 9.72 5 265071 43878 110280345
Bone erosion 84.81 9.72 7 265069 46364 110277859
Cardiac disorder 84.60 9.72 385 264691 75895 110248328
Hypersensitivity 83.35 9.72 596 264480 403402 109920821
Lung disorder 82.56 9.72 194 264882 179853 110144370
Completed suicide 81.80 9.72 915 264161 241466 110082757
Urinary tract infection 80.04 9.72 1161 263915 325121 109999102
Intestinal angioedema 79.79 9.72 43 265033 1054 110323169
Vision blurred 78.35 9.72 554 264522 128468 110195755
Hypertensive crisis 77.65 9.72 177 264899 24195 110300028
Eye haemorrhage 77.62 9.72 117 264959 11657 110312566
Sprue-like enteropathy 77.05 9.72 49 265027 1647 110322576
Tinnitus 75.87 9.72 317 264759 60223 110264000
Subarachnoid haemorrhage 75.75 9.72 198 264878 29504 110294719
Pruritus 75.26 9.72 1875 263201 579685 109744538
Anti-neutrophil cytoplasmic antibody positive vasculitis 74.84 9.72 78 264998 5339 110318884
Gastrointestinal disorder 74.66 9.72 312 264764 241640 110082583
Drug interaction 74.65 9.72 1645 263431 498538 109825685
Rash papular 74.37 9.72 188 264888 27451 110296772
Eye irritation 73.37 9.72 211 264865 33241 110290982
Neutropenia 73.27 9.72 561 264515 374059 109950164
Onychomadesis 73.20 9.72 11 265065 45652 110278571
Obesity 72.81 9.72 99 264977 113252 110210971
Muscle twitching 70.74 9.72 194 264882 29741 110294482
Hypercholesterolaemia 70.64 9.72 68 265008 90769 110233454
Blood cholesterol increased 69.77 9.72 219 264857 184566 110139657
Leukopenia 68.47 9.72 160 264916 148631 110175592
Thyroid disorder 67.65 9.72 135 264941 16834 110307389
Glomerular filtration rate decreased 66.79 9.72 186 264890 28770 110295453
Prescribed overdose 65.31 9.72 68 265008 87513 110236710
Angina unstable 64.64 9.72 130 264946 16302 110307921
Diplopia 63.57 9.72 233 264843 41661 110282562
Visual impairment 62.69 9.72 543 264533 133885 110190338
Blood pressure inadequately controlled 62.33 9.72 84 264992 7549 110316674
Renal impairment 61.12 9.72 706 264370 187739 110136484
Intentional product use issue 60.67 9.72 347 264729 247559 110076664
Hypoglycaemia 60.57 9.72 481 264595 115623 110208600
Red blood cell sedimentation rate increased 60.44 9.72 59 265017 78243 110245980
Lower limb fracture 59.06 9.72 56 265020 75292 110248931
Nasopharyngitis 57.82 9.72 635 264441 393726 109930497
Frequent bowel movements 57.21 9.72 52 265024 71338 110252885
Sinusitis 57.19 9.72 446 264630 296242 110027981
Drug hypersensitivity 55.66 9.72 760 264316 453330 109870893
Skin discolouration 55.47 9.72 249 264827 48797 110275426
Hepatic cytolysis 54.64 9.72 32 265044 55021 110269202
Musculoskeletal pain 54.62 9.72 239 264837 182784 110141439
Pulmonary oedema 54.15 9.72 420 264656 100239 110223984
Renal failure 53.87 9.72 802 264274 225772 110098451
Body height decreased 53.33 9.72 93 264983 10470 110313753
Vasculitis 53.16 9.72 198 264878 35675 110288548
Wheezing 52.85 9.72 376 264700 254854 110069369
Bradycardia 52.40 9.72 587 264489 154930 110169293
Back injury 52.31 9.72 24 265052 47375 110276848
Pulmonary fibrosis 51.69 9.72 104 264972 101938 110222285
Sciatica 51.37 9.72 89 264987 92310 110231913
Product use in unapproved indication 49.84 9.72 763 264313 446614 109877609
Coma 49.36 9.72 133 264943 117736 110206487
Gastrointestinal haemorrhage 49.24 9.72 610 264466 164908 110159315
Pancytopenia 48.32 9.72 299 264777 209314 110114909
Hypertensive emergency 47.65 9.72 49 265027 3302 110320921
Coeliac disease 47.46 9.72 22 265054 43165 110281058
Hallucination 46.39 9.72 408 264668 101024 110223199
Balance disorder 46.35 9.72 455 264621 116105 110208118
Malignant mediastinal neoplasm 46.26 9.72 33 265043 1345 110322878
Onychomycosis 44.93 9.72 18 265058 38513 110285710
Delirium 44.88 9.72 169 264907 134856 110189367
Cytokine release syndrome 44.55 9.72 62 265014 70244 110253979
Therapy cessation 44.34 9.72 219 264857 44638 110279585
Prescribed underdose 43.82 9.72 55 265021 65119 110259104
Hepatic steatosis 43.80 9.72 232 264844 48599 110275624
Dysphonia 42.62 9.72 320 264756 75609 110248614
Eye pain 42.22 9.72 234 264842 49865 110274358
Weight increased 42 9.72 730 264346 418914 109905309
Death 41.86 9.72 2062 263014 696807 109627416
Drug resistance 41.77 9.72 44 265032 56330 110267893
Haemophagocytic lymphohistiocytosis 41.56 9.72 12 265064 31547 110292676
Blood glucose decreased 41.42 9.72 160 264916 29328 110294895
Headache 41.18 9.72 2544 262532 879833 109444390
Overdose 40.71 9.72 361 264715 233433 110090790
Haemorrhagic stroke 40.49 9.72 97 264979 13692 110310531
Ageusia 40.30 9.72 121 264955 19524 110304699
Drug tolerance decreased 39.08 9.72 9 265067 27531 110296692
Colitis ulcerative 39.05 9.72 79 264997 77284 110246939
Sedation 38.84 9.72 67 265009 69616 110254607
Muscle spasms 38.36 9.72 905 264171 277252 110046971
Bundle branch block left 38.21 9.72 91 264985 12797 110311426
Normal newborn 38.19 9.72 4 265072 21892 110302331
Mucosal inflammation 37.66 9.72 112 264964 96029 110228194
Product taste abnormal 37.53 9.72 38 265038 2514 110321709
Rheumatoid nodule 37.29 9.72 3 265073 20293 110303930
Aspergillus infection 37.10 9.72 8 265068 25608 110298615
Red blood cell sedimentation rate abnormal 36.86 9.72 7 265069 24502 110299721
Malaise 36.71 9.72 1965 263111 669854 109654369
Cytomegalovirus infection 36.55 9.72 46 265030 54398 110269825
Glycosylated haemoglobin increased 36.37 9.72 132 264944 23487 110300736
Blood urea increased 36.33 9.72 241 264835 54716 110269507
Hyperhidrosis 36.30 9.72 641 264435 186657 110137566
Thrombocytopenia 36.17 9.72 603 264473 348282 109975941
Diabetic neuropathy 35.83 9.72 62 265014 6937 110317286
Haemorrhage intracranial 35.76 9.72 151 264925 28818 110295405
Malignant neoplasm progression 35.72 9.72 258 264818 174309 110149914
Drug ineffective for unapproved indication 35.30 9.72 127 264949 102711 110221512
Drug dispensed to wrong patient 34.93 9.72 22 265054 727 110323496
Asthenia 34.85 9.72 2001 263075 686998 109637225
Inappropriate antidiuretic hormone secretion 34.70 9.72 167 264909 33684 110290539
Finger deformity 34.63 9.72 18 265058 33074 110291149
Osteoporosis 34.52 9.72 101 264975 87051 110237172
Gait inability 34.38 9.72 189 264887 136187 110188036
Muscle spasticity 34.08 9.72 22 265054 35893 110288330
Blood pressure diastolic abnormal 33.66 9.72 10 265066 25805 110298418
Oral pain 33.65 9.72 178 264898 37266 110286957
Sleep disorder 33.59 9.72 309 264767 198335 110125888
Blood pressure decreased 33.29 9.72 422 264654 114669 110209554
Therapy interrupted 33.25 9.72 219 264857 49603 110274620
Osteoarthritis 33.12 9.72 279 264797 182344 110141879
Disturbance in attention 32.96 9.72 258 264818 61737 110262486
Flatulence 32.86 9.72 226 264850 51923 110272300
Hip arthroplasty 32.66 9.72 52 265024 55761 110268462
Cardiac failure 32.49 9.72 631 264445 186995 110137228
Rhabdomyolysis 32.13 9.72 435 264641 119966 110204257
Full blood count decreased 31.93 9.72 157 264919 31942 110292281
Blood pressure abnormal 31.76 9.72 122 264954 22302 110301921
Renal disorder 31.52 9.72 215 264861 49264 110274959
Heart rate increased 31.43 9.72 502 264574 143332 110180891
Abortion spontaneous 31.19 9.72 22 265054 34260 110289963
Mouth swelling 31.13 9.72 60 265016 7294 110316929
Ascites 30.95 9.72 116 264960 92692 110231531
Blood potassium decreased 30.90 9.72 229 264847 53885 110270338
Septic shock 30.71 9.72 236 264840 157292 110166931
Exostosis 30.67 9.72 39 265037 45917 110278306
Diabetic foot 30.34 9.72 43 265033 4052 110320171
Premature delivery 30.12 9.72 18 265058 30614 110293609
Loss of personal independence in daily activities 30.08 9.72 223 264853 149797 110174426
Atrioventricular block 30.06 9.72 99 264977 16778 110307445
Skin exfoliation 30.04 9.72 332 264744 87319 110236904
Obstructive airways disorder 29.94 9.72 40 265036 46109 110278114
Drug dependence 29.84 9.72 46 265030 49974 110274249
Hypomagnesaemia 29.80 9.72 247 264829 60123 110264100
Product odour abnormal 29.78 9.72 27 265049 1556 110322667
Diverticulum intestinal 29.76 9.72 78 264998 11641 110312582
Loss of consciousness 29.65 9.72 647 264429 195659 110128564
Neuroleptic malignant syndrome 29.51 9.72 23 265053 34036 110290187
Nail disorder 29.38 9.72 59 265017 57876 110266347
Diabetic ketoacidosis 29.37 9.72 187 264889 41871 110282352
Urticaria 29.27 9.72 563 264513 318294 110005929
Pericardial effusion 28.72 9.72 235 264841 56982 110267241
Respiratory depression 28.51 9.72 21 265055 31980 110292243
Toxicity to various agents 28.45 9.72 906 264170 479649 109844574
Mitral valve incompetence 28.30 9.72 156 264920 33173 110291050
Dysgeusia 28.21 9.72 274 264802 69711 110254512
Cytomegalovirus infection reactivation 28.08 9.72 5 265071 18328 110305895
Chromaturia 28.07 9.72 142 264934 29218 110295005
Milk-alkali syndrome 27.93 9.72 29 265047 1976 110322247
Cardiac valve disease 27.93 9.72 53 265023 6368 110317855
Hypoaesthesia 27.88 9.72 558 264518 313665 110010558
Diabetes mellitus inadequate control 27.76 9.72 143 264933 29632 110294591
Blood pressure diastolic decreased 27.74 9.72 27 265049 35858 110288365
Bone marrow failure 27.58 9.72 61 265015 57787 110266436
Road traffic accident 27.53 9.72 148 264928 107250 110216973
Graft versus host disease 26.98 9.72 6 265070 18800 110305423
Haematuria 26.91 9.72 311 264765 82694 110241529
Oral mucosal blistering 26.82 9.72 59 265017 7875 110316348
Nausea 26.71 9.72 3366 261710 1232324 109091899
Disease progression 26.53 9.72 418 264658 243616 110080607
Erectile dysfunction 26.32 9.72 101 264975 18455 110305768
Febrile bone marrow aplasia 26.24 9.72 5 265071 17460 110306763
Suicide attempt 26.22 9.72 143 264933 103251 110220972
Oedema peripheral 26.16 9.72 999 264077 327661 109996562
Proteinuria 26.15 9.72 175 264901 39843 110284380
Psoriasis 26.02 9.72 476 264600 139517 110184706
Haematotoxicity 26.01 9.72 9 265067 21073 110303150
Pancreatitis acute 25.80 9.72 239 264837 60035 110264188
Renal pain 25.60 9.72 66 265010 9751 110314472
Dengue fever 25.51 9.72 23 265053 1316 110322907
Status epilepticus 25.29 9.72 23 265053 31548 110292675
Blood potassium increased 25.20 9.72 151 264925 33098 110291125
Poisoning deliberate 25.16 9.72 16 265060 26315 110297908
Rebound tachycardia 24.89 9.72 7 265069 24 110324199
Lupus-like syndrome 24.83 9.72 37 265039 40755 110283468
Infusion site reaction 24.66 9.72 6 265070 17676 110306547
Hyperglycaemia 24.61 9.72 312 264764 84778 110239445
Liver disorder 24.59 9.72 220 264856 142023 110182200
Gout 24.56 9.72 161 264915 36405 110287818
Post transplant lymphoproliferative disorder 24.48 9.72 4 265072 15609 110308614
Nasal congestion 24.17 9.72 350 264726 97932 110226291
Foot deformity 24.05 9.72 50 265026 48430 110275793
Essential hypertension 23.91 9.72 56 265020 7791 110316432
Blood pressure systolic abnormal 23.88 9.72 15 265061 24835 110299388
Glomerulonephritis rapidly progressive 23.87 9.72 28 265048 2187 110322036
Plasmapheresis 23.75 9.72 18 265058 806 110323417
Eructation 23.75 9.72 81 264995 13976 110310247
Blood magnesium decreased 23.73 9.72 103 264973 19893 110304330
Immune reconstitution inflammatory syndrome 23.64 9.72 5 265071 16221 110308002
Hyperlipidaemia 23.57 9.72 157 264919 35691 110288532
Drug use disorder 23.57 9.72 7 265069 18067 110306156
Anuria 23.46 9.72 118 264958 24223 110300000
Hypokalaemia 23.45 9.72 588 264488 181860 110142363
Agranulocytosis 23.44 9.72 73 265003 61687 110262536
Nervousness 23.40 9.72 160 264916 36691 110287532
Adverse reaction 23.18 9.72 22 265054 29572 110294651
Cardiomegaly 23.18 9.72 134 264942 28996 110295227
Arrhythmia 23.14 9.72 262 264814 69313 110254910
Chronic obstructive pulmonary disease 23.11 9.72 379 264697 108779 110215444
Cutaneous T-cell dyscrasia 23.08 9.72 8 265068 62 110324161
Pneumonia aspiration 23.07 9.72 108 264968 81125 110243098
Dystonia 22.90 9.72 17 265059 25788 110298435
Orthostatic hypotension 22.73 9.72 251 264825 65998 110258225
Injection site reaction 22.69 9.72 123 264953 88947 110235276
Schizophrenia 22.65 9.72 12 265064 21814 110302409
Therapeutic response unexpected 22.57 9.72 115 264961 23728 110300495
Depressed mood 22.54 9.72 234 264842 60575 110263648
Chikungunya virus infection 22.52 9.72 11 265065 218 110324005
Eye swelling 22.50 9.72 146 264930 32902 110291321
Skin fissures 22.48 9.72 117 264959 24341 110299882
Abdominal pain 22.39 9.72 1003 264073 511986 109812237
Therapy non-responder 22.35 9.72 255 264821 157052 110167171
Ischaemic cardiomyopathy 22.08 9.72 55 265021 7956 110316267
Pharyngeal swelling 21.81 9.72 71 265005 11961 110312262
Epistaxis 21.74 9.72 436 264640 129936 110194287
International normalised ratio increased 21.73 9.72 310 264766 86462 110237761
CD30 expression 21.57 9.72 8 265068 77 110324146
Hypovolaemia 21.55 9.72 106 264970 21568 110302655
Diabetic retinopathy 21.51 9.72 34 265042 3530 110320693
Rash maculo-papular 21.48 9.72 98 264978 74124 110250099
Progressive multifocal leukoencephalopathy 21.43 9.72 17 265059 24939 110299284
Nephrolithiasis 21.42 9.72 248 264828 65964 110258259
Alopecia 21.26 9.72 689 264387 364064 109960159
Dizziness postural 21.12 9.72 80 264996 14529 110309694
Ischaemic stroke 20.99 9.72 170 264906 41093 110283130
Hyponatraemic seizure 20.99 9.72 16 265060 723 110323500
Urine albumin/creatinine ratio increased 20.97 9.72 19 265057 1094 110323129
Haemarthrosis 20.93 9.72 51 265025 7278 110316945
Acute myeloid leukaemia 20.91 9.72 37 265039 38073 110286150
Disability 20.85 9.72 25 265051 30198 110294025
Abdominal pain upper 20.83 9.72 1030 264046 348081 109976142
Faeces discoloured 20.73 9.72 146 264930 33802 110290421
Myopathy 20.64 9.72 116 264960 24844 110299379
Drug tolerance 20.60 9.72 7 265069 16578 110307645
Female genital tract fistula 20.47 9.72 7 265069 16512 110307711
Primary hyperaldosteronism 20.44 9.72 11 265065 269 110323954
Renal artery stenosis 20.38 9.72 34 265042 3692 110320531
Product residue present 20.29 9.72 35 265041 3906 110320317
Coronary artery occlusion 20.08 9.72 83 264993 15689 110308534
Product physical issue 20.00 9.72 40 265036 4996 110319227
Diabetic vascular disorder 19.95 9.72 9 265067 148 110324075
Dry mouth 19.92 9.72 348 264728 199600 110124623
Diabetes mellitus 19.92 9.72 342 264734 99039 110225184
Device expulsion 19.81 9.72 27 265049 30864 110293359
Pulmonary hypertension 19.77 9.72 211 264865 55009 110269214
Cardiac flutter 19.67 9.72 43 265033 5714 110318509
Gastritis 19.60 9.72 206 264870 53493 110270730
Blood sodium decreased 19.57 9.72 158 264918 38161 110286062
Incorrect route of product administration 19.50 9.72 83 264993 63978 110260245
Myocardial ischaemia 19.47 9.72 120 264956 26564 110297659
Gait disturbance 19.44 9.72 834 264242 277374 110046849
Pathogen resistance 19.42 9.72 9 265067 17663 110306560
Surgery 19.36 9.72 167 264909 41116 110283107
Noninfectious peritonitis 19.35 9.72 11 265065 300 110323923
Seronegative arthritis 19.32 9.72 4 265072 13173 110311050
Pollakiuria 19.29 9.72 176 264900 44019 110280204
Pseudolymphoma 19.29 9.72 19 265057 1216 110323007
Laryngitis 19.19 9.72 46 265030 42365 110281858
Angiotensin converting enzyme inhibitor foetopathy 19.06 9.72 6 265070 33 110324190
Swollen tongue 19.04 9.72 225 264851 60137 110264086
Ocular hyperaemia 18.99 9.72 160 264916 39126 110285097
Cachexia 18.96 9.72 4 265072 13001 110311222
Sodium retention 18.90 9.72 10 265066 236 110323987
Blood glucose abnormal 18.89 9.72 71 265005 12845 110311378
Extravasation blood 18.89 9.72 13 265063 500 110323723
Malnutrition 18.87 9.72 121 264955 27158 110297065
Miosis 18.85 9.72 15 265061 21968 110302255
Skin swelling 18.73 9.72 52 265024 8028 110316195
Panniculitis 18.63 9.72 7 265069 15575 110308648
Paraplegia 18.62 9.72 44 265032 6156 110318067
Temperature regulation disorder 18.59 9.72 4 265072 12822 110311401
Burning feet syndrome 18.56 9.72 10 265066 245 110323978
Bromhidrosis 18.54 9.72 5 265071 14 110324209
Liver function test increased 18.53 9.72 130 264946 88418 110235805
Multiple organ dysfunction syndrome 18.52 9.72 254 264822 151456 110172767
Product dispensing error 18.49 9.72 83 264993 16262 110307961
Non-cardiac chest pain 18.32 9.72 60 265016 10138 110314085
Bronchopulmonary aspergillosis 18.26 9.72 27 265049 29836 110294387
Pustular psoriasis 18.24 9.72 5 265071 13600 110310623
Poisoning 18.10 9.72 26 265050 29079 110295144
Carotid artery stenosis 18.01 9.72 56 265020 9207 110315016
Hepatic cirrhosis 18.00 9.72 92 264984 67534 110256689
Pancreatic carcinoma 17.95 9.72 77 264999 14795 110309428
Mydriasis 17.92 9.72 16 265060 22141 110302082
Neurodermatitis 17.73 9.72 28 265048 2904 110321319
Dry eye 17.62 9.72 208 264868 55585 110268638
Weight decreased 17.61 9.72 1326 263750 466731 109857492
High frequency ablation 17.59 9.72 11 265065 359 110323864
Swelling face 17.53 9.72 315 264761 92006 110232217
Multiple-drug resistance 17.49 9.72 5 265071 13230 110310993
Photopsia 17.49 9.72 43 265033 6171 110318052
Psychotic disorder 17.42 9.72 63 265013 50874 110273349
Angina pectoris 17.41 9.72 227 264849 62068 110262155
Oligohydramnios 17.41 9.72 33 265043 3961 110320262
Enterococcal infection 17.33 9.72 14 265062 20352 110303871
Product dose omission in error 17.33 9.72 106 264970 23406 110300817
Head injury 17.13 9.72 168 264908 42849 110281374
Lacrimation increased 17.12 9.72 130 264946 30820 110293403
Oedema 17.11 9.72 378 264698 209598 110114625
Blood loss anaemia 17.11 9.72 87 264989 17938 110306285
Epstein-Barr virus infection 17.08 9.72 12 265064 18726 110305497
Tendon rupture 17.08 9.72 73 265003 14005 110310218
Chronic sinusitis 17.04 9.72 21 265055 25063 110299160
Hypophagia 16.97 9.72 197 264879 52429 110271794
Therapy partial responder 16.92 9.72 40 265036 37021 110287202
Oral candidiasis 16.92 9.72 53 265023 44707 110279516
Respiratory disorder 16.87 9.72 101 264975 71281 110252942
Urine output decreased 16.85 9.72 93 264983 19783 110304440
Extrasystoles 16.84 9.72 51 265025 8267 110315956
Haemoglobin decreased 16.79 9.72 743 264333 247984 110076239
Cognitive disorder 16.77 9.72 299 264777 87212 110237011
Carotid bruit 16.75 9.72 14 265062 723 110323500
Aortic arteriosclerosis 16.73 9.72 61 265015 10877 110313346
Joint destruction 16.73 9.72 3 265073 10940 110313283
Personality disorder 16.69 9.72 5 265071 12832 110311391
Atrioventricular block first degree 16.67 9.72 73 265003 14152 110310071
Cerebral haemorrhage 16.62 9.72 233 264843 64735 110259488
Intentional self-injury 16.61 9.72 41 265035 37388 110286835
Spider naevus 16.59 9.72 8 265068 154 110324069
Acute respiratory failure 16.56 9.72 263 264813 74997 110249226
Carcinogenicity 16.50 9.72 8 265068 156 110324067
Hypersensitivity vasculitis 16.43 9.72 45 265031 6892 110317331
Adjustment disorder 16.41 9.72 3 265073 10792 110313431
Lymphatic fistula 16.28 9.72 19 265057 1476 110322747
Transplant rejection 16.24 9.72 21 265055 24546 110299677
Memory impairment 16.23 9.72 601 264475 196343 110127880
Blindness unilateral 16.19 9.72 56 265020 9730 110314493
Tremor 16.15 9.72 615 264461 201617 110122606
Femoral hernia incarcerated 16.14 9.72 19 265057 1490 110322733
Fear 16.12 9.72 103 264973 23090 110301133
Eosinophilia myalgia syndrome 16.11 9.72 4 265072 7 110324216
Mucormycosis 16.06 9.72 3 265073 10625 110313598
Serotonin syndrome 16.01 9.72 80 264996 59073 110265150
Tricuspid valve incompetence 15.96 9.72 105 264971 23768 110300455
Cholestasis 15.93 9.72 90 264986 64428 110259795
Aortic dissection 15.91 9.72 36 265040 4897 110319326
Colitis microscopic 15.90 9.72 69 265007 13325 110310898
Exposure via skin contact 15.82 9.72 68 265008 13079 110311144
Accelerated hypertension 15.80 9.72 14 265062 783 110323440
Orthopnoea 15.64 9.72 60 265016 10961 110313262
Yellow skin 15.60 9.72 32 265044 4070 110320153
Contusion 15.52 9.72 433 264643 232928 110091295
Blood parathyroid hormone decreased 15.45 9.72 6 265070 13083 110311140
Focal segmental glomerulosclerosis 15.37 9.72 32 265044 4113 110320110
Linear IgA disease 15.25 9.72 33 265043 4356 110319867
Blood cholesterol abnormal 15.17 9.72 30 265046 3716 110320507
Gastric disorder 15.16 9.72 134 264942 33223 110291000
Calciphylaxis 15.14 9.72 32 265044 4155 110320068
Haemorrhagic fever 15.12 9.72 5 265071 33 110324190
Hyperammonaemia 15.08 9.72 7 265069 13725 110310498
Plasma cell myeloma 15.03 9.72 223 264853 62713 110261510
Walking aid user 15.01 9.72 23 265053 25052 110299171
Carbohydrate antigen 125 increased 14.96 9.72 24 265052 2523 110321700
Renin decreased 14.94 9.72 7 265069 126 110324097
Coronary artery stenosis 14.92 9.72 69 265007 13689 110310534
Papillary muscle rupture 14.88 9.72 4 265072 11 110324212
Atheroembolism 14.85 9.72 10 265066 371 110323852
Pancreatic steatosis 14.80 9.72 20 265056 1802 110322421
Knee arthroplasty 14.77 9.72 93 264983 64855 110259368
Eosinophilia 14.76 9.72 80 264996 57856 110266367
Hiatus hernia 14.74 9.72 115 264961 27491 110296732
Cataract 14.67 9.72 270 264806 79215 110245008
Ecchymosis 14.62 9.72 81 264995 17257 110306966
Gastroenteritis eosinophilic 14.61 9.72 10 265066 381 110323842
Duodenogastric reflux 14.56 9.72 8 265068 204 110324019
Hypogammaglobulinaemia 14.51 9.72 16 265060 20060 110304163
Shoshin beriberi 14.50 9.72 6 265070 79 110324144
Blindness transient 14.47 9.72 39 265037 5917 110318306
Peri-implantitis 14.45 9.72 8 265068 207 110324016
Patella fracture 14.44 9.72 23 265053 2403 110321820
Illness 14.43 9.72 277 264799 81894 110242329
Joint stiffness 14.43 9.72 98 264978 67145 110257078
Eye discharge 14.40 9.72 50 265026 8704 110315519
Microcytic anaemia 14.40 9.72 40 265036 6178 110318045
Blood immunoglobulin E increased 14.33 9.72 45 265031 7437 110316786
Hepatotoxicity 14.31 9.72 91 264985 63309 110260914
Low density lipoprotein increased 14.27 9.72 57 265019 10609 110313614
Cerebellar haemorrhage 14.23 9.72 27 265049 3244 110320979
Generalised tonic-clonic seizure 14.21 9.72 75 265001 54605 110269618
Ear infection 14.18 9.72 90 264986 62642 110261581
Sialoadenitis 14.10 9.72 24 265052 2649 110321574
Norepinephrine increased 14.04 9.72 6 265070 86 110324137
Forced expiratory volume decreased 14.04 9.72 7 265069 13169 110311054
Neuropathy peripheral 14.03 9.72 544 264532 178733 110145490
Venous occlusion 14.02 9.72 16 265060 1213 110323010
Cardiovascular disorder 13.96 9.72 98 264978 22662 110301561
BK virus infection 13.91 9.72 7 265069 13099 110311124
Diverticulitis 13.71 9.72 192 264884 53330 110270893
Body temperature increased 13.69 9.72 76 265000 54637 110269586
Constipation 13.68 9.72 1015 264061 356771 109967452
Taste disorder 13.68 9.72 96 264980 65291 110258932
Pseudomonas infection 13.58 9.72 29 265047 27824 110296399
Nodular rash 13.53 9.72 9 265067 327 110323896
Abdominal wall haematoma 13.51 9.72 37 265039 5668 110318555
Recalled product administered 13.47 9.72 16 265060 1266 110322957
Insomnia 13.46 9.72 1021 264055 359569 109964654
Adverse event 13.34 9.72 182 264894 108627 110215596
Amnesia 13.33 9.72 339 264737 105069 110219154
Sleep apnoea syndrome 13.31 9.72 152 264924 40295 110283928
Device adhesion issue 13.30 9.72 3 265073 9307 110314916
Poor venous access 13.28 9.72 24 265052 24498 110299725
Peripheral vascular disorder 13.26 9.72 48 265028 8528 110315695
Sinus bradycardia 13.17 9.72 118 264958 29365 110294858
Transient aphasia 13.16 9.72 12 265064 697 110323526
Haemodialysis 13.13 9.72 80 264996 17639 110306584
Carotid artery disease 13.13 9.72 21 265055 2202 110322021
Cardiac pacemaker insertion 13.10 9.72 39 265037 6262 110317961
Product solubility abnormal 13.04 9.72 15 265061 1147 110323076
B-cell small lymphocytic lymphoma stage IV 13.04 9.72 3 265073 3 110324220
Oropharyngeal surgery 13.04 9.72 3 265073 3 110324220
Injection site pain 13.02 9.72 536 264540 177386 110146837
No adverse event 13.00 9.72 249 264827 73590 110250633
Overlap syndrome 12.78 9.72 3 265073 9056 110315167
Pseudomonal sepsis 12.75 9.72 3 265073 9043 110315180
Drug level below therapeutic 12.74 9.72 6 265070 11667 110312556
Hypoparathyroidism 12.74 9.72 17 265059 1513 110322710
Acute coronary syndrome 12.74 9.72 97 264979 23015 110301208
Tumour lysis syndrome 12.71 9.72 35 265041 30766 110293457
Bradyarrhythmia 12.69 9.72 33 265043 4901 110319322
Suffocation feeling 12.69 9.72 20 265056 2071 110322152
Foreign body sensation in eyes 12.67 9.72 26 265050 3308 110320915
Wrong product administered 12.66 9.72 56 265020 10904 110313319
Instillation site pain 12.63 9.72 12 265064 734 110323489
Sinus node dysfunction 12.63 9.72 49 265027 8998 110315225
Tachyarrhythmia 12.58 9.72 46 265030 8215 110316008
Pityriasis rubra pilaris 12.58 9.72 8 265068 269 110323954
Cardiorenal syndrome 12.56 9.72 19 265057 1899 110322324
Hypertensive encephalopathy 12.54 9.72 15 265061 1196 110323027
Extrapyramidal disorder 12.52 9.72 32 265044 28835 110295388
Overweight 12.50 9.72 39 265037 6425 110317798
Cutaneous vasculitis 12.47 9.72 62 265014 12667 110311556
Muscle tightness 12.47 9.72 69 265007 14693 110309530
Polyuria 12.46 9.72 79 264997 17659 110306564
Heat stroke 12.43 9.72 19 265057 1916 110322307
Idiopathic pulmonary fibrosis 12.39 9.72 33 265043 4971 110319252
General symptom 12.34 9.72 3 265073 8843 110315380
Knee operation 12.34 9.72 41 265035 6981 110317242
Renal injury 12.33 9.72 82 264994 18631 110305592
Klebsiella infection 12.32 9.72 18 265058 19991 110304232
Lichen planus 12.26 9.72 26 265050 3384 110320839
Adrenal insufficiency 12.25 9.72 56 265020 42334 110281889
Affect lability 12.25 9.72 16 265060 18621 110305602
Diffuse large B-cell lymphoma 12.24 9.72 12 265064 15886 110308337
Cardio-respiratory arrest 12.23 9.72 364 264712 115472 110208751
Skin hypertrophy 12.21 9.72 33 265043 5014 110319209
Hypopnoea 12.19 9.72 6 265070 11374 110312849
Myocardial rupture 12.17 9.72 8 265068 285 110323938
Generalised anxiety disorder 12.16 9.72 23 265053 2756 110321467
Cardioactive drug level increased 12.15 9.72 28 265048 3854 110320369
Lethargy 12.14 9.72 302 264774 93274 110230949
Chest discomfort 12.10 9.72 521 264555 173327 110150896
Peripheral coldness 12.07 9.72 81 264995 18459 110305764
Intentional dose omission 12.05 9.72 86 264990 19994 110304229
Arteriosclerosis 12.04 9.72 101 264975 24666 110299557
Akathisia 11.97 9.72 14 265062 17099 110307124
Bone pain 11.93 9.72 221 264855 64912 110259311
Left ventricular hypertrophy 11.93 9.72 63 265013 13181 110311042
Ventricular extrasystoles 11.91 9.72 94 264982 22547 110301676
Sickle cell anaemia with crisis 11.90 9.72 4 265072 9541 110314682
Urethral haemorrhage 11.89 9.72 10 265066 521 110323702
Pseudoporphyria 11.89 9.72 12 265064 791 110323432
Wound infection pseudomonas 11.88 9.72 21 265055 2390 110321833
Ulcer 11.85 9.72 58 265018 43058 110281165
Parathyroid haemorrhage 11.83 9.72 3 265073 6 110324217
Therapeutic nerve ablation 11.83 9.72 3 265073 6 110324217
Radiation overdose 11.81 9.72 5 265071 70 110324153
Product administration interrupted 11.78 9.72 56 265020 11236 110312987
Granulocytopenia 11.78 9.72 8 265068 12707 110311516
Poor peripheral circulation 11.76 9.72 29 265047 4168 110320055
Proctitis 11.68 9.72 14 265062 16913 110307310
Arrhythmia supraventricular 11.66 9.72 21 265055 2425 110321798
Foreign body in reproductive tract 11.66 9.72 13 265063 961 110323262
Groin pain 11.65 9.72 70 265006 15358 110308865
Hair colour changes 11.64 9.72 31 265045 4670 110319553
Neutrophil count decreased 11.56 9.72 212 264864 120729 110203494
Vasculitic rash 11.56 9.72 20 265056 2237 110321986
Anaemia Heinz body 11.54 9.72 4 265072 31 110324192
Osmotic demyelination syndrome 11.52 9.72 19 265057 2044 110322179
Acute pulmonary oedema 11.51 9.72 75 265001 16921 110307302
Posterior reversible encephalopathy syndrome 11.50 9.72 42 265034 33819 110290404
Hypoacusis 11.47 9.72 132 264944 35059 110289164
Cardiac operation 11.43 9.72 36 265040 5959 110318264
Blood aldosterone increased 11.43 9.72 7 265069 220 110324003
Pseudoaldosteronism 11.39 9.72 8 265068 318 110323905
Burning sensation 11.38 9.72 231 264845 68981 110255242
Application site scab 11.34 9.72 7 265069 223 110324000
Radiculopathy 11.33 9.72 18 265058 19318 110304905
Application site haematoma 11.32 9.72 5 265071 78 110324145
Insulin-like growth factor increased 11.31 9.72 20 265056 2276 110321947
Eczema nummular 11.28 9.72 9 265067 435 110323788
Lung opacity 11.24 9.72 7 265069 11645 110312578
Head discomfort 11.19 9.72 81 264995 18919 110305304
Peripheral swelling 11.18 9.72 1119 263957 402915 109921308
Spinal epidural haematoma 11.17 9.72 17 265059 1708 110322515
Hepatic failure 11.15 9.72 108 264968 68631 110255592
Body temperature decreased 11.15 9.72 48 265028 36887 110287336
Genital infection 11.15 9.72 7 265069 230 110323993
Toe amputation 11.14 9.72 29 265047 4309 110319914
Acanthosis 11.09 9.72 10 265066 572 110323651
Systemic candida 11.08 9.72 5 265071 9969 110314254
Tongue blistering 11.03 9.72 18 265058 1919 110322304
Thymus disorder 11.03 9.72 10 265066 576 110323647
Blood triglycerides abnormal 10.99 9.72 10 265066 579 110323644
Hypertensive nephropathy 10.98 9.72 13 265063 1025 110323198
Skin tightness 10.98 9.72 34 265042 5579 110318644
Periorbital oedema 10.97 9.72 51 265025 10141 110314082
Speech disorder 10.97 9.72 208 264868 61361 110262862
Tubulointerstitial nephritis 10.94 9.72 187 264889 54097 110270126
Ocular discomfort 10.94 9.72 45 265031 8488 110315735
Aggression 10.94 9.72 90 264986 59120 110265103
Nocturia 10.92 9.72 74 265002 16916 110307307
Urine protein/creatinine ratio increased 10.90 9.72 16 265060 1557 110322666
Alcohol poisoning 10.87 9.72 4 265072 9016 110315207
Vitamin D deficiency 10.87 9.72 79 264997 18473 110305750
Mitral valve stenosis 10.80 9.72 15 265061 1387 110322836
Colon cancer 10.80 9.72 72 265004 16371 110307852
Atrial flutter 10.78 9.72 97 264979 24165 110300058
Sensory loss 10.75 9.72 22 265054 21435 110302788
Hepatic cyst 10.74 9.72 42 265034 7741 110316482
Blood growth hormone increased 10.69 9.72 13 265063 1055 110323168
Malacoplakia gastrointestinal 10.58 9.72 7 265069 252 110323971
Hypervolaemia 10.57 9.72 172 264904 49288 110274935
Seroma 10.54 9.72 24 265052 3277 110320946
Joint stabilisation 10.51 9.72 3 265073 11 110324212
Arterial disorder 10.51 9.72 19 265057 2200 110322023
Tongue haematoma 10.48 9.72 7 265069 256 110323967
Stasis dermatitis 10.47 9.72 17 265059 1805 110322418
Limb injury 10.46 9.72 137 264939 37499 110286724
Carotid artery thrombosis 10.45 9.72 5 265071 9633 110314590
Umbilical hernia repair 10.45 9.72 6 265070 167 110324056
Product supply issue 10.44 9.72 26 265050 3760 110320463
Bacterial infection 10.43 9.72 66 265010 45970 110278253
Infective pulmonary exacerbation of cystic fibrosis 10.42 9.72 12 265064 14759 110309464
Pneumonia fungal 10.40 9.72 12 265064 14742 110309481
Vascular stenosis 10.39 9.72 11 265065 767 110323456
Extremity necrosis 10.37 9.72 26 265050 3776 110320447
Coronary artery bypass 10.37 9.72 35 265041 6007 110318216
Hospice care 10.33 9.72 58 265018 12415 110311808
Electrocardiogram PR prolongation 10.33 9.72 17 265059 1826 110322397
Clostridium difficile colitis 10.31 9.72 62 265014 43716 110280507
Guillain-Barre syndrome 10.30 9.72 52 265024 10692 110313531
Thirst 10.28 9.72 88 264988 21619 110302604
Myeloma cast nephropathy 10.24 9.72 7 265069 266 110323957
Cerebral infarction 10.24 9.72 178 264898 51660 110272563
Nail bed tenderness 10.22 9.72 8 265068 376 110323847
Metastatic renal cell carcinoma 10.21 9.72 20 265056 2460 110321763
Dilatation atrial 10.15 9.72 26 265050 3826 110320397
Tumour excision 10.12 9.72 10 265066 642 110323581
Rotator cuff syndrome 10.12 9.72 72 265004 16722 110307501
Burns second degree 10.07 9.72 3 265073 7730 110316493
Near death experience 10.05 9.72 12 265064 955 110323268
Migraine 10.04 9.72 324 264752 171328 110152895
Muscle disorder 10.03 9.72 37 265039 6635 110317588
Vascular device infection 10.03 9.72 15 265061 16497 110307726
Hepatic function abnormal 10.02 9.72 152 264924 89143 110235080
Orbital oedema 10.00 9.72 9 265067 514 110323709
Diabetic metabolic decompensation 9.99 9.72 26 265050 3863 110320360
Blood urea abnormal 9.99 9.72 17 265059 1877 110322346
Psychomotor hyperactivity 9.98 9.72 21 265055 20256 110303967
Haematochezia 9.98 9.72 206 264870 115318 110208905
Haemorrhoids 9.97 9.72 130 264946 35542 110288681
Renal phospholipidosis 9.97 9.72 8 265068 390 110323833
Anticoagulation drug level above therapeutic 9.95 9.72 29 265047 4601 110319622
Dyspnoea exertional 9.93 9.72 323 264753 103737 110220486
Renal artery occlusion 9.93 9.72 6 265070 184 110324039
Hypocalvaria 9.93 9.72 4 265072 49 110324174
Foreign body in respiratory tract 9.91 9.72 8 265068 393 110323830
Chronic lymphocytic leukaemia stage 4 9.85 9.72 4 265072 50 110324173
Unevaluable event 9.84 9.72 198 264878 59029 110265194
Dry throat 9.78 9.72 46 265030 9192 110315031
Otolithiasis 9.77 9.72 3 265073 15 110324208
Skeletal injury 9.76 9.72 15 265061 1520 110322703
Petechiae 9.75 9.72 92 264984 23225 110300998
Sequestrectomy 9.74 9.72 11 265065 825 110323398
Extra dose administered 9.72 9.72 56 265020 12103 110312120

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:51451 endothelin receptor antagonist
CHEBI has role CHEBI:61016 angiotensin receptor antagonist
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76595 nephroprotective agent
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers

Related Drugs by ATC class:

C09CA Angiotensin II receptor blockers (ARBs), plain 9 drugs
azilsartan medoxomilcandesartan cilexetileprosartanfimasartanirbesartanolmesartan medoxomiltasosartantelmisartanvalsartan
C09DA Angiotensin II receptor blockers (ARBs) and diuretics 8 drugs
azilsartan medoxomilcandesartan cilexetileprosartanfimasartanirbesartanolmesartan medoxomiltelmisartanvalsartan
C09DB Angiotensin II receptor blockers (ARBs) and calcium channel blockers 8 drugs
amlodipinecandesartan cilexetilfimasartanirbesartanlercanidipineolmesartan medoxomiltelmisartanvalsartan

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Diabetic renal disease indication 127013003
Hypertensive urgency indication 443482000
Hypertension with Left Ventricular Hypertrophy indication
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
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
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
Azotemia contraindication 445009001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.5 acidic
pKa2 13.19 acidic
pKa3 3.89 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/ML ARBLI SCIENTURE N218772 March 13, 2025 RX SUSPENSION ORAL 12156869 Oct. 7, 2041 A METHOD OF USING LOSARTAN FOR THE REDUCTION OF THE RISK OF STROKE IN PATIENTS WITH HYPERTENSION AND LEFT VENTRICULAR HYPERTROPHY
10MG/ML ARBLI SCIENTURE N218772 March 13, 2025 RX SUSPENSION ORAL 12156869 Oct. 7, 2041 A METHOD OF USING LOSARTAN FOR THE TREATMENT OF DIABETIC NEPHROPATHY WITH AN ELEVATED SERUM CREATININE AND PROTEINURIA IN PATIENTS WITH TYPE 2 DIABETES AND A HISTORY OF HYPERTENSION
10MG/ML ARBLI SCIENTURE N218772 March 13, 2025 RX SUSPENSION ORAL 12156869 Oct. 7, 2041 A METHOD OF USING LOSARTAN FOR THE TREATMENT OF HYPERTENSION
10MG/ML ARBLI SCIENTURE N218772 March 13, 2025 RX SUSPENSION ORAL 12605365 Oct. 7, 2041 A METHOD OF USING LOSARTAN FOR THE TREATMENT OF DIABETIC NEPHROPATHY WITH AN ELEVATED SERUM CREATININE AND PROTEINURIA IN PATIENTS WITH TYPE 2 DIABETES AND A HISTORY OF HYPERTENSION
10MG/ML ARBLI SCIENTURE N218772 March 13, 2025 RX SUSPENSION ORAL 12605365 Oct. 7, 2041 A METHOD OF USING LOSARTAN FOR THE TREATMENT OF HYPERTENSION

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 9.48 CHEMBL CHEMBL
Multidrug resistance protein 1 Transporter Km 3.50 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 5.46 CHEMBL
Angiotensin-converting enzyme Enzyme IC50 7.72 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 4.46 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.54 DRUG MATRIX
Thromboxane A2 receptor GPCR IC50 4.70 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 5 CHEMBL
Phosphodiesterase 3 Enzyme IC50 4.89 CHEMBL
Phosphodiesterase 4 Enzyme IC50 4.59 CHEMBL
Angiotensin II receptor GPCR Kd 8.43 CHEMBL
Platelet glycoprotein VI Membrane receptor IC50 4.98 CHEMBL
Type-1B angiotensin II receptor GPCR Ki 8.44 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 5.13 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 7.02 CHEMBL
Type-1A angiotensin II receptor GPCR Ki 7.84 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 7.74 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR Ki 8.72 CHEMBL
Angiotensin II receptor GPCR IC50 8.34 CHEMBL
Type-1 angiotensin II receptor GPCR Kd 8.80 CHEMBL

External reference:

IDSource
4020913 VUID
N0000148401 NUI
D00357 KEGG_DRUG
124750-99-8 SECONDARY_CAS_RN
4020913 VANDF
4020920 VANDF
C0126174 UMLSCUI
CHEBI:6541 CHEBI
LSN PDB_CHEM_ID
CHEMBL191 ChEMBL_ID
CHEMBL995 ChEMBL_ID
D019808 MESH_DESCRIPTOR_UI
DB00678 DRUGBANK_ID
3961 PUBCHEM_CID
590 IUPHAR_LIGAND_ID
6913 INN_ID
JMS50MPO89 UNII
203160 RXNORM
172424 MMSL
4996 MMSL
d03821 MMSL
004991 NDDF
004992 NDDF
108582002 SNOMEDCT_US
373567002 SNOMEDCT_US
96309000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7367 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7368 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7369 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7958 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7959 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7960 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7047 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7048 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7049 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 11788-100 TABLET 25 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 11788-101 TABLET 50 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 11788-102 TABLET 100 mg ORAL ANDA 26 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-195 TABLET 25 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-196 TABLET 50 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-197 TABLET 100 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-952 TABLET 100 mg ORAL ANDA 12 sections
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 16590-954 TABLET, FILM COATED 100 mg ORAL ANDA 13 sections
Losartan Potassium and Hydrochlorothiazide Human Prescription Drug Label 2 16714-224 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Losartan Potassium and Hydrochlorothiazide Human Prescription Drug Label 2 16714-225 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Losartan Potassium and Hydrochlorothiazide Human Prescription Drug Label 2 16714-226 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Losortan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 21695-714 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Losortan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 21695-717 TABLET, FILM COATED 100 mg ORAL ANDA 13 sections
HYZAAR HUMAN PRESCRIPTION DRUG LABEL 2 21695-788 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HUMAN PRESCRIPTION DRUG LABEL 2 21695-831 TABLET, FILM COATED 100 mg ORAL ANDA 20 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 21695-966 TABLET 100 mg ORAL ANDA 20 sections
Losortan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 21695-989 TABLET, FILM COATED 25 mg ORAL ANDA 13 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 29300-144 TABLET 25 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 29300-145 TABLET 50 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 29300-146 TABLET 100 mg ORAL ANDA 26 sections
losartan potassium and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 29300-190 TABLET, FILM COATED 50 mg ORAL ANDA 19 sections