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

Stem definitionDrug idCAS RN
124 315-30-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zyloprim
  • allopurinol
  • tautomeric mixture of 1H-pyrazolo[3,4-d]pyrimidin-4-ol and 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one
  • allopurinol sodium
A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.
  • Molecular weight: 136.11
  • Formula: C5H4N4O
  • CLOGP: 0.63
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 74.69
  • ALOGS: -0.79
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.80 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 12 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 97.71 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 53 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 11 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.97 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 19, 1966 FDA PROMETHEUS LABS

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
Drug reaction with eosinophilia and systemic symptoms 2181.74 9.98 1161 129293 32675 63325893
Acute kidney injury 958.02 9.98 1839 128615 261576 63096992
Drug ineffective 512.96 9.98 853 129601 1043912 62314656
Febrile neutropenia 470.42 9.98 860 129594 117589 63240979
Toxic epidermal necrolysis 445.88 9.98 389 130065 24945 63333623
Anaemia 409.70 9.98 1429 129025 292001 63066567
Stevens-Johnson syndrome 377.78 9.98 352 130102 24598 63333970
Renal failure 361.39 9.98 767 129687 116885 63241683
Pemphigus 360.54 9.98 3 130451 183723 63174845
Hyperkalaemia 356.81 9.98 496 129958 53707 63304861
Glossodynia 305.04 9.98 15 130439 178861 63179707
Cytokine release syndrome 295.50 9.98 241 130213 14073 63344495
Rash maculo-papular 283.93 9.98 339 130115 31557 63327011
Systemic lupus erythematosus 281.10 9.98 46 130408 208872 63149696
Maternal exposure during pregnancy 275.66 9.98 58 130396 220004 63138564
Thrombocytopenia 264.63 9.98 796 129658 150361 63208207
Tumour lysis syndrome 264.46 9.98 187 130267 8803 63349765
Renal impairment 255.16 9.98 562 129892 87793 63270775
Cardiac failure 250.66 9.98 561 129893 88581 63269987
Arthropathy 250.47 9.98 85 130369 234707 63123861
Alopecia 243.30 9.98 202 130252 337334 63021234
Melaena 243.20 9.98 306 130148 30059 63328509
Abdominal discomfort 231.30 9.98 192 130262 320693 63037875
Hand deformity 219.23 9.98 33 130421 159424 63199144
Pancytopenia 216.51 9.98 558 129896 96375 63262193
Gout 202.34 9.98 188 130266 13083 63345485
Pericarditis 198.52 9.98 20 130434 131559 63227009
Therapeutic product effect decreased 194.06 9.98 77 130377 193110 63165458
Atrial fibrillation 193.56 9.98 603 129851 116033 63242535
Discomfort 192.12 9.98 53 130401 167321 63191247
Pain 186.84 9.98 836 129618 739792 62618776
Sepsis 185.54 9.98 713 129741 152410 63206158
Joint swelling 177.29 9.98 249 130205 327417 63031151
Blood creatinine increased 172.28 9.98 482 129972 87362 63271206
Exposure during pregnancy 171.65 9.98 53 130401 155494 63203074
Contraindicated product administered 169.76 9.98 120 130334 217528 63141040
Plasma cell myeloma 168.73 9.98 281 130173 35624 63322944
Rheumatoid arthritis 167.14 9.98 165 130289 253654 63104914
Haemoglobin decreased 165.36 9.98 664 129790 144821 63213747
Synovitis 163.81 9.98 90 130364 186828 63171740
Rheumatoid factor positive 158.37 9.98 3 130451 84403 63274165
Duodenal ulcer perforation 156.41 9.98 5 130449 87204 63271364
Eosinophilia 152.31 9.98 210 130244 22546 63336022
Completed suicide 151.37 9.98 55 130399 145618 63212950
Drug interaction 148.85 9.98 891 129563 228240 63130328
Dehydration 147.68 9.98 726 129728 172628 63185940
Drug intolerance 147.44 9.98 255 130199 308406 63050162
Treatment failure 147.14 9.98 116 130338 198927 63159641
Product use issue 143.26 9.98 145 130309 220375 63138193
Helicobacter infection 140.21 9.98 14 130440 92771 63265797
General physical health deterioration 139.75 9.98 797 129657 200605 63157963
Chronic kidney disease 139.24 9.98 296 130158 45102 63313466
Wound 138.19 9.98 82 130372 163181 63195387
Product prescribing error 136.10 9.98 215 130239 26074 63332494
Hyponatraemia 133.79 9.98 519 129935 111381 63247187
Platelet count decreased 131.91 9.98 530 129924 115592 63242976
Infusion related reaction 130.31 9.98 189 130265 245332 63113236
Toxic skin eruption 129.81 9.98 146 130308 12739 63345829
Bradycardia 129.28 9.98 387 130067 72840 63285728
Hypotension 122.33 9.98 968 129486 271636 63086932
Swelling 120.40 9.98 240 130214 275138 63083430
Muscle injury 119.93 9.98 3 130451 65342 63293226
Labelled drug-drug interaction medication error 116.89 9.98 141 130313 13258 63345310
Oedema peripheral 114.85 9.98 724 129730 188787 63169781
Neutropenia 114.51 9.98 682 129772 174323 63184245
Lactic acidosis 114.38 9.98 247 130207 38040 63320528
Arthralgia 112.57 9.98 698 129756 569012 62789556
Hypersensitivity 112.41 9.98 274 130180 292411 63066157
Irritable bowel syndrome 111.08 9.98 18 130436 82394 63276174
Folliculitis 110.57 9.98 9 130445 70308 63288260
International normalised ratio increased 109.57 9.98 273 130181 46152 63312416
Pyrexia 109.18 9.98 1459 128995 469019 62889549
Hyperuricaemia 107.86 9.98 89 130365 5281 63353287
Blood urea increased 106.38 9.98 193 130261 26186 63332382
Gastrointestinal haemorrhage 104.86 9.98 386 130068 80790 63277778
Drug hypersensitivity 101.28 9.98 315 130139 310372 63048196
Hypoglycaemia 100.91 9.98 312 130142 59753 63298815
Headache 100.68 9.98 826 129628 632415 62726153
Sinusitis 98.64 9.98 198 130256 226455 63132113
Psoriatic arthropathy 97.72 9.98 33 130421 91487 63267081
Hepatic enzyme increased 97.58 9.98 166 130288 202162 63156406
Blood uric acid increased 93.56 9.98 82 130372 5285 63353283
Nasopharyngitis 92.97 9.98 244 130210 254013 63104555
Off label use 90.60 9.98 918 129536 673544 62685024
Syncope 90.36 9.98 478 129976 116907 63241661
Haematoma 89.91 9.98 212 130242 34608 63323960
Neutropenic sepsis 87.25 9.98 136 130318 16302 63342266
Ill-defined disorder 86.38 9.98 30 130424 81725 63276843
Gastrointestinal disorder 83.24 9.98 88 130366 131151 63227417
Intentional product use issue 81.97 9.98 85 130369 127807 63230761
Hypokalaemia 81.47 9.98 425 130029 103379 63255189
Acute myeloid leukaemia 78.94 9.98 133 130321 17014 63341554
Sleep disorder due to general medical condition, insomnia type 76.03 9.98 9 130445 52208 63306360
Pneumonia 73.13 9.98 1331 129123 455436 62903132
Injection site erythema 72.88 9.98 40 130414 83134 63275434
Diarrhoea 72.22 9.98 1951 128503 713415 62645153
Asthenia 69.00 9.98 1139 129315 382465 62976103
Intentional overdose 68.94 9.98 33 130421 74119 63284449
Product monitoring error 68.88 9.98 64 130390 4452 63354116
Multiple organ dysfunction syndrome 67.59 9.98 263 130191 56489 63302079
Hip arthroplasty 67.45 9.98 9 130445 47637 63310931
Dilatation intrahepatic duct acquired 66.23 9.98 31 130423 655 63357913
Impaired healing 65.87 9.98 68 130386 102474 63256094
Fatigue 64.90 9.98 1363 129091 886665 62471903
Injection site pain 64.87 9.98 104 130350 129696 63228872
Multiple sclerosis relapse 64.40 9.98 11 130443 48467 63310101
Diabetes mellitus inadequate control 63.97 9.98 113 130341 15013 63343555
Therapeutic product effect incomplete 62.68 9.98 100 130354 124956 63233612
Face oedema 62.20 9.98 132 130322 20080 63338488
Epistaxis 62.13 9.98 305 130149 72420 63286148
Blood lactate dehydrogenase increased 61.04 9.98 142 130312 22974 63335594
Multiple drug therapy 60.16 9.98 54 130400 3592 63354976
Dermatitis exfoliative generalised 60.10 9.98 55 130399 3752 63354816
Musculoskeletal stiffness 59.51 9.98 188 130266 184430 63174138
Sopor 59.46 9.98 137 130317 22027 63336541
Dermatitis exfoliative 58.68 9.98 64 130390 5395 63353173
Loss of personal independence in daily activities 58.65 9.98 68 130386 97222 63261346
Chronic lymphocytic leukaemia 58.17 9.98 46 130408 2568 63356000
Purpura 56.03 9.98 91 130363 11294 63347274
Injection site reaction 56.02 9.98 25 130429 58499 63300069
Metabolic acidosis 54.60 9.98 210 130244 44859 63313709
Splenomegaly 53.31 9.98 88 130366 11069 63347499
Anxiety 53.05 9.98 248 130206 217293 63141275
Sleep disorder 52.49 9.98 54 130400 81512 63277056
Pleural effusion 50.84 9.98 347 130107 92863 63265705
Knee arthroplasty 50.57 9.98 24 130430 54182 63304386
Abortion spontaneous 50.40 9.98 17 130437 47178 63311390
Adverse event 49.08 9.98 40 130414 67519 63291049
Injection site pruritus 48.62 9.98 16 130438 45100 63313468
Tumour flare 48.49 9.98 21 130433 367 63358201
Anuria 48.29 9.98 90 130364 12461 63346107
Respiratory failure 47.94 9.98 366 130088 101492 63257076
Conjunctivitis 47.70 9.98 121 130333 20675 63337893
Cardioactive drug level increased 47.43 9.98 38 130416 2162 63356406
Electrolyte imbalance 47.29 9.98 118 130336 19958 63338610
Dialysis 46.84 9.98 80 130374 10347 63348221
Suicidal ideation 46.55 9.98 36 130418 62385 63296183
Tubulointerstitial nephritis 45.86 9.98 116 130338 19787 63338781
Depression 45.57 9.98 228 130226 196264 63162304
Pregnancy 45.47 9.98 10 130444 36826 63321742
Dyspnoea 43.79 9.98 1716 128738 659597 62698971
Enanthema 43.46 9.98 20 130434 406 63358162
Anaemia macrocytic 43.38 9.98 44 130410 3410 63355158
Dermatitis bullous 43.23 9.98 69 130385 8439 63350129
Injection site swelling 42.96 9.98 22 130432 47550 63311018
Rash morbilliform 42.94 9.98 43 130411 3282 63355286
Weight increased 42.72 9.98 337 130117 260455 63098113
Septic shock 41.82 9.98 257 130197 66372 63292196
Mucosal inflammation 41.65 9.98 199 130255 46729 63311839
Blast crisis in myelogenous leukaemia 41.25 9.98 21 130433 536 63358032
Product dose omission issue 41.11 9.98 297 130157 234016 63124552
Petechiae 40.75 9.98 89 130365 13808 63344760
White blood cell count decreased 40.63 9.98 451 130003 138653 63219915
Leukopenia 40.53 9.98 285 130169 77005 63281563
Subdural haematoma 40.02 9.98 90 130364 14238 63344330
Allergic reaction to excipient 39.58 9.98 18 130436 355 63358213
Injury 39.18 9.98 56 130398 73191 63285377
Red blood cell sedimentation rate increased 38.74 9.98 21 130433 43961 63314607
Rhabdomyolysis 38.73 9.98 186 130268 43765 63314803
Blood potassium increased 38.38 9.98 103 130351 18206 63340362
Anti-neutrophil cytoplasmic antibody positive vasculitis 38.38 9.98 38 130416 2861 63355707
Acute motor-sensory axonal neuropathy 37.30 9.98 16 130438 273 63358295
Injection site bruising 36.93 9.98 20 130434 41890 63316678
Fibromyalgia 36.90 9.98 68 130386 80352 63278216
Shock haemorrhagic 36.88 9.98 70 130384 9825 63348743
Erythema multiforme 36.75 9.98 71 130383 10098 63348470
Osteoarthritis 36.73 9.98 89 130365 95254 63263314
Lower respiratory tract infection 36.41 9.98 144 130310 132163 63226405
Intentional self-injury 36.01 9.98 5 130449 25682 63332886
Live birth 35.90 9.98 5 130449 25625 63332943
Toxicity to various agents 35.35 9.98 331 130123 246919 63111649
Right ventricular failure 35.33 9.98 96 130358 17092 63341476
Allergy to chemicals 35.05 9.98 37 130417 3005 63355563
Glomerular filtration rate decreased 34.87 9.98 82 130372 13359 63345209
Inappropriate schedule of product administration 34.81 9.98 104 130350 103861 63254707
Lip erosion 34.76 9.98 23 130431 970 63357598
Rash erythematous 34.68 9.98 176 130278 42334 63316234
Blister 34.65 9.98 143 130311 129671 63228897
Agranulocytosis 34.54 9.98 122 130332 25012 63333556
Insomnia 34.38 9.98 280 130174 214972 63143596
Hyperglycaemia 33.92 9.98 173 130281 41694 63316874
Device dislocation 33.78 9.98 6 130448 25699 63332869
Muscle spasticity 33.68 9.98 3 130451 21791 63336777
Suicide attempt 33.15 9.98 46 130408 60872 63297696
Gravitational oedema 32.83 9.98 24 130430 1190 63357378
Drug abuse 32.67 9.98 62 130392 72456 63286112
Hyperbilirubinaemia 32.65 9.98 72 130382 11242 63347326
Sternal fracture 32.57 9.98 31 130423 2223 63356345
Differentiation syndrome 32.57 9.98 23 130431 1080 63357488
Azotaemia 32.56 9.98 43 130411 4428 63354140
Mucosal erosion 32.29 9.98 26 130428 1490 63357078
Blood cholesterol increased 32.25 9.98 93 130361 93939 63264629
Sinoatrial block 32.13 9.98 21 130433 867 63357701
Dementia 31.90 9.98 98 130356 18696 63339872
Arrhythmia 31.88 9.98 159 130295 37981 63320587
Foetal exposure during pregnancy 31.63 9.98 13 130441 31949 63326619
Therapeutic drug monitoring analysis incorrectly performed 31.53 9.98 15 130439 329 63358239
Dyspnoea exertional 31.40 9.98 222 130232 60080 63298488
Ear infection 31.18 9.98 20 130434 38193 63320375
HLA-B*5801 assay positive 31.14 9.98 6 130448 0 63358568
Disseminated intravascular coagulation 31.09 9.98 98 130356 18953 63339615
Pulmonary fibrosis 30.92 9.98 22 130432 39787 63318781
Platelet disorder 30.87 9.98 28 130426 1888 63356680
Hyperphosphataemia 30.75 9.98 30 130424 2218 63356350
Pulmonary arterial hypertension 30.52 9.98 109 130345 22468 63336100
Hepatocellular injury 30.27 9.98 124 130330 27257 63331311
Wrist deformity 30.22 9.98 29 130425 2101 63356467
Skin exfoliation 30.10 9.98 171 130283 42931 63315637
Thermohypoaesthesia 29.92 9.98 11 130443 122 63358446
Alanine aminotransferase increased 29.63 9.98 335 130119 103435 63255133
Condition aggravated 29.58 9.98 616 129838 401601 62956967
Haemodialysis 29.36 9.98 60 130394 8887 63349681
Hypervolaemia 29.33 9.98 126 130328 28287 63330281
Sight disability 29.14 9.98 11 130443 132 63358436
Leukocytosis 29.11 9.98 118 130336 25817 63332751
Lymphocytosis 28.98 9.98 32 130422 2735 63355833
Cardiac failure congestive 28.98 9.98 304 130150 92129 63266439
Immune effector cell-associated neurotoxicity syndrome 28.59 9.98 29 130425 2248 63356320
Blood creatine phosphokinase increased 28.43 9.98 131 130323 30299 63328269
Acute generalised exanthematous pustulosis 28.02 9.98 67 130387 11032 63347536
Chemical burn of oral cavity 28 9.98 9 130445 64 63358504
Grip strength decreased 27.61 9.98 6 130448 22281 63336287
Accidental exposure to product 27.36 9.98 11 130443 27394 63331174
Human herpesvirus 6 infection 27.24 9.98 32 130422 2925 63355643
Blood pressure fluctuation 27.23 9.98 33 130421 46284 63312284
Rash pruritic 27.09 9.98 213 130241 59586 63298982
Hypocalcaemia 27.07 9.98 133 130321 31580 63326988
Cardiac failure chronic 26.93 9.98 39 130415 4379 63354189
Mood swings 26.92 9.98 3 130451 18245 63340323
Hypovolaemic shock 26.87 9.98 47 130407 6194 63352374
Migraine 26.86 9.98 115 130339 103231 63255337
Drug eruption 26.42 9.98 123 130331 28571 63329997
Klebsiella infection 26.42 9.98 56 130398 8510 63350058
Libido increased 26.40 9.98 22 130432 1323 63357245
Pericardial effusion 26.33 9.98 127 130327 29931 63328637
Hypoaesthesia 25.99 9.98 221 130233 168172 63190396
Bone erosion 25.92 9.98 3 130451 17714 63340854
C-reactive protein abnormal 25.90 9.98 34 130420 46062 63312506
Hypercalcaemia 25.78 9.98 121 130333 28201 63330367
Cerebral haemorrhage 25.61 9.98 128 130326 30601 63327967
Paraesthesia 25.60 9.98 203 130251 156763 63201805
Asthma 25.20 9.98 156 130298 127405 63231163
Prescribed overdose 25.08 9.98 20 130434 34133 63324435
Pemphigoid 24.99 9.98 50 130404 7294 63351274
Shock 24.95 9.98 105 130349 23358 63335210
Breast cancer 24.88 9.98 38 130416 48345 63310223
Acute respiratory failure 24.86 9.98 138 130316 34347 63324221
Cholestasis 24.81 9.98 123 130331 29311 63329257
Seizure 24.78 9.98 165 130289 132469 63226099
Hepatitis 24.66 9.98 153 130301 39635 63318933
Oral mucosa erosion 24.58 9.98 20 130434 1163 63357405
Bone marrow failure 24.41 9.98 122 130332 29168 63329400
Soft tissue injury 24.40 9.98 23 130431 1629 63356939
Ecchymosis 23.85 9.98 63 130391 11031 63347537
Hyperpyrexia 23.52 9.98 33 130421 3599 63354969
Blood alkaline phosphatase increased 23.44 9.98 160 130294 42807 63315761
Injection site rash 23.43 9.98 5 130449 18804 63339764
Neovascularisation 23.04 9.98 19 130435 1126 63357442
Pulmonary oedema 22.98 9.98 192 130262 54681 63303887
Rectal haemorrhage 22.96 9.98 176 130278 48854 63309714
Vessel puncture site haemorrhage 22.92 9.98 9 130445 121 63358447
Neutrophil count decreased 22.90 9.98 196 130258 56210 63302358
Transfusion 22.78 9.98 76 130378 15141 63343427
Tonsillar haemorrhage 22.77 9.98 11 130443 250 63358318
Wrong technique in product usage process 22.61 9.98 60 130394 62280 63296288
Papillary muscle rupture 22.49 9.98 5 130449 5 63358563
Tachyarrhythmia 22.48 9.98 36 130418 4414 63354154
Injection site haemorrhage 22.32 9.98 11 130443 24303 63334265
Aplastic anaemia 22.28 9.98 56 130398 9513 63349055
Therapeutic drug monitoring analysis not performed 22.26 9.98 20 130434 1332 63357236
Haematochezia 22.24 9.98 187 130267 53357 63305211
Uraemic encephalopathy 22.15 9.98 11 130443 266 63358302
Coagulation test abnormal 22.09 9.98 16 130438 782 63357786
Prerenal failure 22.02 9.98 22 130432 1674 63356894
Administration site discomfort 21.98 9.98 8 130446 86 63358482
Necrotising ulcerative gingivostomatitis 21.94 9.98 6 130448 22 63358546
Gamma-glutamyltransferase increased 21.81 9.98 132 130322 33899 63324669
Disorientation 21.57 9.98 147 130307 39305 63319263
Cerebellar stroke 21.53 9.98 11 130443 283 63358285
Mucosal ulceration 21.48 9.98 17 130437 950 63357618
Peripheral circulatory failure 21.47 9.98 17 130437 951 63357617
Hepatotoxicity 21.45 9.98 140 130314 36901 63321667
Multimorbidity 21.38 9.98 14 130440 580 63357988
Hepatic function abnormal 21.28 9.98 140 130314 37002 63321566
Cardiomegaly 21.27 9.98 82 130372 17532 63341036
Renal disorder 21.20 9.98 128 130326 32846 63325722
Haematocrit decreased 21.17 9.98 146 130308 39194 63319374
Drug tolerance decreased 21.05 9.98 5 130449 17468 63341100
Blood pressure increased 21.03 9.98 222 130232 161840 63196728
Macular degeneration 20.95 9.98 12 130442 24364 63334204
Medication error 20.87 9.98 181 130273 52103 63306465
Foot deformity 20.85 9.98 16 130438 27837 63330731
Hyperthermia 20.71 9.98 53 130401 9103 63349465
Encephalitis 20.71 9.98 52 130402 8828 63349740
Pulmonary hypertension 20.71 9.98 139 130315 36984 63321584
Hypoglycaemic coma 20.69 9.98 26 130428 2549 63356019
Product quality issue 20.62 9.98 26 130428 35839 63322729
Type 2 diabetes mellitus 20.58 9.98 65 130389 63803 63294765
Adverse drug reaction 20.53 9.98 89 130365 79625 63278943
Tachypnoea 20.44 9.98 80 130374 17222 63341346
Overlap syndrome 20.44 9.98 16 130438 880 63357688
Erythema 20.42 9.98 489 129965 175262 63183306
Cardiac failure acute 20.39 9.98 54 130400 9469 63349099
Hostility 20.21 9.98 22 130432 1850 63356718
Blood bilirubin increased 20.08 9.98 138 130316 37002 63321566
Post-traumatic neck syndrome 20.04 9.98 23 130431 2051 63356517
Mandibular mass 20.00 9.98 9 130445 173 63358395
Urine output decreased 19.96 9.98 60 130394 11310 63347258
Peripheral arterial occlusive disease 19.89 9.98 33 130421 4168 63354400
Death 19.87 9.98 950 129504 373431 62985137
Stress 19.84 9.98 71 130383 67096 63291472
Heart rate increased 19.80 9.98 113 130341 94125 63264443
Disturbance in social behaviour 19.76 9.98 32 130422 3961 63354607
Procedural pain 19.44 9.98 10 130444 21559 63337009
Feeling abnormal 19.37 9.98 203 130251 148189 63210379
Product use in unapproved indication 19.13 9.98 256 130198 178824 63179744
Hypertransaminasaemia 19.00 9.98 42 130412 6567 63352001
Influenza 18.95 9.98 138 130316 108584 63249984
Throat irritation 18.95 9.98 30 130424 37617 63320951
Fracture blisters 18.93 9.98 7 130447 79 63358489
Ear pain 18.93 9.98 28 130426 36090 63322478
Myeloblast percentage decreased 18.87 9.98 6 130448 41 63358527
Lip oedema 18.81 9.98 31 130423 3893 63354675
Limb discomfort 18.74 9.98 20 130434 29696 63328872
Amaurosis 18.68 9.98 13 130441 596 63357972
Serum ferritin increased 18.59 9.98 40 130414 6142 63352426
Metastases to bone 18.56 9.98 10 130444 21009 63337559
Abdominal wall wound 18.47 9.98 7 130447 85 63358483
Atrioventricular block first degree 18.46 9.98 44 130410 7229 63351339
Gait disturbance 18.45 9.98 265 130189 182913 63175655
Mantle cell lymphoma 18.39 9.98 12 130442 494 63358074
Proteinuria 18.32 9.98 83 130371 19062 63339506
Diverticulum oesophageal 18.31 9.98 8 130446 143 63358425
Aplasia pure red cell 18.30 9.98 33 130421 4454 63354114
Upper gastrointestinal haemorrhage 18.24 9.98 82 130372 18770 63339798
Chronic myeloid leukaemia 17.98 9.98 23 130431 2295 63356273
Injection site mass 17.80 9.98 8 130446 18648 63339920
Hypersensitivity vasculitis 17.75 9.98 31 130423 4081 63354487
Autoimmune haemolytic anaemia 17.71 9.98 33 130421 4568 63354000
Road traffic accident 17.68 9.98 30 130424 36602 63321966
Atrial flutter 17.56 9.98 52 130402 9720 63348848
Renal infarct 17.39 9.98 18 130436 1429 63357139
Leukocyturia 17.37 9.98 18 130436 1431 63357137
Full blood count decreased 17.35 9.98 102 130352 25922 63332646
Abdominal pain upper 17.34 9.98 309 130145 206135 63152433
Hepatic failure 17.26 9.98 129 130325 35527 63323041
Paraesthesia oral 17.24 9.98 9 130445 19247 63339321
Burning sensation 17.09 9.98 56 130398 54351 63304217
Hypercreatininaemia 17.08 9.98 12 130442 559 63358009
Glomerular filtration rate abnormal 17.05 9.98 14 130440 825 63357743
Autoimmune disorder 16.97 9.98 7 130447 17170 63341398
Oliguria 16.91 9.98 49 130405 9052 63349516
Atrioventricular block complete 16.87 9.98 46 130408 8205 63350363
Nodal arrhythmia 16.81 9.98 16 130438 1147 63357421
Fixed eruption 16.80 9.98 16 130438 1148 63357420
Uveitic glaucoma 16.73 9.98 4 130450 7 63358561
Eye oedema 16.65 9.98 18 130436 1502 63357066
Transaminases increased 16.63 9.98 116 130338 31251 63327317
Musculoskeletal disorder 16.58 9.98 11 130443 20633 63337935
Neuroglycopenia 16.56 9.98 11 130443 467 63358101
Constipation 16.54 9.98 591 129863 224352 63134216
Diabetic hyperosmolar coma 16.53 9.98 10 130444 360 63358208
Respiratory tract congestion 16.47 9.98 8 130446 17824 63340744
B-cell unclassifiable lymphoma high grade 16.38 9.98 4 130450 8 63358560
Inappropriate antidiuretic hormone secretion 16.29 9.98 69 130385 15393 63343175
Anger 16.17 9.98 3 130451 12453 63346115
Aspartate aminotransferase increased 16.13 9.98 268 130186 90009 63268559
Presyncope 16.08 9.98 105 130349 27680 63330888
Staphylococcal scalded skin syndrome 16.08 9.98 7 130447 124 63358444
Nephrogenic anaemia 16.06 9.98 21 130433 2141 63356427
Lichenoid keratosis 15.94 9.98 19 130435 1764 63356804
Drug-induced liver injury 15.93 9.98 139 130315 40083 63318485
Transient acantholytic dermatosis 15.90 9.98 6 130448 72 63358496
Blood pressure inadequately controlled 15.88 9.98 33 130421 4945 63353623
Rash macular 15.86 9.98 92 130362 23272 63335296
Cholestatic liver injury 15.85 9.98 23 130431 2587 63355981
Multiple sclerosis 15.83 9.98 16 130438 24356 63334212
Glomerulonephritis 15.74 9.98 19 130435 1787 63356781
Haemoptysis 15.69 9.98 107 130347 28619 63329949
Acute myeloid leukaemia recurrent 15.68 9.98 18 130436 1605 63356963
No adverse event 15.67 9.98 39 130415 41366 63317202
Pseudomonal bacteraemia 15.64 9.98 18 130436 1610 63356958
Facet joint syndrome 15.59 9.98 3 130451 12135 63346433
Subdural haemorrhage 15.45 9.98 25 130429 3093 63355475
Neuroleptic malignant syndrome 15.44 9.98 3 130451 12053 63346515
Premature delivery 15.36 9.98 24 130430 30257 63328311
Tenosynovitis stenosans 15.36 9.98 26 130428 3338 63355230
Psoriasis 15.33 9.98 110 130344 86847 63271721
Liver injury 15.32 9.98 68 130386 60452 63298116
Duodenal stenosis 15.31 9.98 11 130443 531 63358037
Mobility decreased 15.30 9.98 167 130287 120992 63237576
Eosinopenia 15.16 9.98 5 130449 39 63358529
Therapeutic response shortened 15.14 9.98 3 130451 11885 63346683
Surgery 15.06 9.98 32 130422 35880 63322688
Haemorrhage intracranial 15.01 9.98 61 130393 13358 63345210
Fluid retention 14.97 9.98 188 130266 59498 63299070
Orthopnoea 14.96 9.98 37 130417 6224 63352344
Drug resistance 14.96 9.98 15 130439 22918 63335650
Blood sodium decreased 14.87 9.98 93 130361 24159 63334409
Cytopenia 14.83 9.98 55 130399 11546 63347022
Chronic myeloid leukaemia recurrent 14.82 9.98 8 130446 231 63358337
Performance enhancing product use 14.77 9.98 4 130450 14 63358554
Gastritis erosive 14.76 9.98 36 130418 6003 63352565
Haematemesis 14.70 9.98 110 130344 30302 63328266
Underdose 14.67 9.98 21 130433 27435 63331133
Influenza like illness 14.65 9.98 79 130375 66745 63291823
Gouty arthritis 14.62 9.98 11 130443 570 63357998
Streptococcal sepsis 14.61 9.98 19 130435 1927 63356641
Erosive oesophagitis 14.59 9.98 18 130436 1732 63356836
Myelofibrosis 14.55 9.98 16 130438 1361 63357207
Cardiorenal syndrome 14.52 9.98 13 130441 862 63357706
Mucocutaneous haemorrhage 14.51 9.98 6 130448 93 63358475
Hypertensive crisis 14.42 9.98 66 130388 15220 63343348
Dermatitis 14.39 9.98 71 130383 16887 63341681
International normalised ratio abnormal 14.38 9.98 25 130429 3279 63355289
Staphylococcal sepsis 14.37 9.98 43 130411 8085 63350483
Oedema 14.34 9.98 281 130173 97341 63261227
Spontaneous haemorrhage 14.32 9.98 11 130443 588 63357980
Emphysematous cystitis 14.29 9.98 7 130447 164 63358404
Neutropenic colitis 14.24 9.98 24 130430 3071 63355497
Dysuria 14.10 9.98 118 130336 33620 63324948
Paraneoplastic syndrome 13.94 9.98 11 130443 612 63357956
Device issue 13.92 9.98 17 130437 23764 63334804
Synovial disorder 13.87 9.98 19 130435 2026 63356542
Hypercholesterolaemia 13.86 9.98 14 130440 21320 63337248
Pupillary reflex impaired 13.86 9.98 19 130435 2028 63356540
Stenosis 13.84 9.98 16 130438 1438 63357130
Platelet dysfunction 13.74 9.98 6 130448 107 63358461
Complication associated with device 13.69 9.98 9 130445 16969 63341599
Haemoperitoneum 13.61 9.98 22 130432 2719 63355849
Blood uric acid abnormal 13.56 9.98 5 130449 56 63358512
Lip haemorrhage 13.47 9.98 10 130444 508 63358060
Psychotic disorder 13.41 9.98 20 130434 25692 63332876
Serotonin syndrome 13.38 9.98 24 130430 28658 63329910
Intentional product misuse 13.36 9.98 72 130382 60845 63297723
Lung infiltration 13.32 9.98 62 130392 14401 63344167
Urosepsis 13.27 9.98 74 130380 18450 63340118
Dental restoration failure 13.18 9.98 13 130441 974 63357594
Adult failure to thrive 13.16 9.98 6 130448 119 63358449
Venoocclusive liver disease 13.09 9.98 30 130424 4805 63353763
Dystonia 13.07 9.98 6 130448 13813 63344755
Foot fracture 13.07 9.98 18 130436 23896 63334672
Chronic myeloid leukaemia transformation 13.03 9.98 6 130448 122 63358446
Maternal condition affecting foetus 13.00 9.98 7 130447 201 63358367
Balance disorder 12.93 9.98 111 130343 84311 63274257
Diverticulum intestinal haemorrhagic 12.92 9.98 16 130438 1545 63357023
Therapy non-responder 12.91 9.98 97 130357 75804 63282764
Generalised tonic-clonic seizure 12.90 9.98 25 130429 28991 63329577
Poisoning 12.88 9.98 6 130448 13694 63344874
HLA marker study positive 12.84 9.98 7 130447 206 63358362
Prescribed underdose 12.83 9.98 26 130428 29663 63328905
Stomatitis 12.83 9.98 204 130250 138521 63220047
Pleuritic pain 12.83 9.98 41 130413 7988 63350580
Electrocardiogram QT shortened 12.81 9.98 6 130448 127 63358441
Capillary leak syndrome 12.80 9.98 19 130435 2181 63356387
Mental status changes 12.76 9.98 131 130323 39468 63319100
Pulmonary congestion 12.75 9.98 70 130384 17348 63341220
Lip dry 12.75 9.98 8 130446 15462 63343106
Ileus 12.74 9.98 62 130392 14663 63343905
Haematuria 12.73 9.98 103 130351 29054 63329514
Synovial fluid analysis 12.73 9.98 20 130434 2413 63356155
Blood phosphorus increased 12.66 9.98 23 130431 3122 63355446
Nasal mucosal erosion 12.62 9.98 5 130449 69 63358499
Nephropathy 12.62 9.98 35 130419 6306 63352262
Hypertensive heart disease 12.61 9.98 20 130434 2432 63356136
Ankylosing spondylitis 12.61 9.98 3 130451 10471 63348097
Scleritis 12.58 9.98 28 130426 4400 63354168
Gait inability 12.52 9.98 61 130393 52898 63305670
Tongue dry 12.52 9.98 13 130441 1036 63357532
Renal tubular necrosis 12.51 9.98 53 130401 11825 63346743
Trichiasis 12.49 9.98 5 130449 71 63358497
Sciatica 12.47 9.98 33 130421 34291 63324277
Infection 12.45 9.98 367 130087 228806 63129762
Exostosis 12.45 9.98 11 130443 17851 63340717
Device malfunction 12.44 9.98 11 130443 17846 63340722
Urticaria 12.43 9.98 253 130201 165549 63193019
Cholecystitis chronic 12.41 9.98 3 130451 10358 63348210
Injection site warmth 12.33 9.98 8 130446 15187 63343381
Venoocclusive disease 12.30 9.98 18 130436 2040 63356528
Acute febrile neutrophilic dermatosis 12.29 9.98 22 130432 2952 63355616
Night sweats 12.26 9.98 55 130399 48759 63309809
Blood electrolytes increased 12.26 9.98 4 130450 30 63358538
Infusion site pain 12.23 9.98 10 130444 16859 63341709
Lymphocytic infiltration 12.18 9.98 12 130442 898 63357670
Prurigo 12.16 9.98 12 130442 900 63357668
Micturition disorder 12.10 9.98 20 130434 2518 63356050
Encephalopathy 12.09 9.98 127 130327 38493 63320075
Gastric disorder 12.06 9.98 38 130416 37331 63321237
Sleep disorder due to a general medical condition 11.99 9.98 5 130449 12183 63346385
Chronic lymphocytic leukaemia recurrent 11.96 9.98 7 130447 237 63358331
Red blood cell count decreased 11.95 9.98 132 130322 40513 63318055
Hydrothorax 11.95 9.98 12 130442 919 63357649
Degenerative aortic valve disease 11.93 9.98 6 130448 149 63358419
Gouty tophus 11.93 9.98 7 130447 238 63358330
Bradyarrhythmia 11.93 9.98 18 130436 2097 63356471
Vision blurred 11.89 9.98 126 130328 91798 63266770
Eosinophilic pustular folliculitis 11.82 9.98 4 130450 34 63358534
Spigelian hernia 11.82 9.98 4 130450 34 63358534
Blood cholesterol decreased 11.81 9.98 12 130442 932 63357636
Bone marrow necrosis 11.78 9.98 5 130449 83 63358485
Extensor plantar response 11.77 9.98 14 130440 1297 63357271
Ileal ulcer 11.75 9.98 9 130445 479 63358089
Overdose 11.75 9.98 166 130288 114912 63243656
Metastases to liver 11.74 9.98 19 130435 23620 63334948
Granulomatous dermatitis 11.72 9.98 6 130448 155 63358413
Diabetic ketoacidosis 11.64 9.98 15 130439 20490 63338078
End stage renal disease 11.45 9.98 35 130419 6658 63351910
Therapeutic response unexpected 11.42 9.98 13 130441 18746 63339822
Cutaneous vasculitis 11.40 9.98 30 130424 5239 63353329
Bundle branch block right 11.38 9.98 29 130425 4969 63353599
Gastric polyps 11.37 9.98 23 130431 3382 63355186
Liver function test abnormal 11.34 9.98 150 130304 48031 63310537
Acid base balance abnormal 11.32 9.98 7 130447 262 63358306
Neutropenic infection 11.30 9.98 14 130440 1353 63357215
Cardiac murmur functional 11.25 9.98 4 130450 40 63358528
Joint stiffness 11.24 9.98 46 130408 41823 63316745
Genital infection 11.15 9.98 6 130448 172 63358396
Insulin-requiring type 2 diabetes mellitus 11.12 9.98 5 130449 96 63358472
Bronchopulmonary aspergillosis 11.09 9.98 41 130413 8594 63349974
Oral contusion 11.07 9.98 5 130449 97 63358471
Product used for unknown indication 11.07 9.98 9 130445 523 63358045
Carpal tunnel syndrome 11.04 9.98 16 130438 20801 63337767
Crepitations 11.02 9.98 39 130415 8001 63350567
Hypocoagulable state 11.02 9.98 13 130441 1194 63357374
Localised oedema 11.01 9.98 30 130424 5348 63353220
Strangury 10.97 9.98 3 130451 11 63358557
Device breakage 10.93 9.98 5 130449 11537 63347031
Hepatic necrosis 10.93 9.98 31 130423 5656 63352912
Chorea 10.88 9.98 15 130439 1609 63356959
Abnormal dreams 10.86 9.98 4 130450 10512 63348056
Dropped head syndrome 10.81 9.98 6 130448 183 63358385
Hyperviscosity syndrome 10.81 9.98 6 130448 183 63358385
Halo vision 10.80 9.98 8 130446 405 63358163
Memory impairment 10.78 9.98 150 130304 104108 63254460
Drug withdrawal syndrome 10.77 9.98 25 130429 27169 63331399
Thrombosis 10.76 9.98 190 130264 64565 63294003
Chest discomfort 10.75 9.98 160 130294 109809 63248759
Head banging 10.75 9.98 8 130446 408 63358160
Parakeratosis 10.73 9.98 7 130447 288 63358280
Conjunctival discolouration 10.71 9.98 5 130449 105 63358463
Leukostasis syndrome 10.60 9.98 4 130450 48 63358520
Corneal thinning 10.58 9.98 5 130449 108 63358460
Calciphylaxis 10.56 9.98 21 130433 3051 63355517
Escherichia infection 10.54 9.98 53 130401 12701 63345867
Spontaneous haematoma 10.54 9.98 11 130443 882 63357686
Haemolytic anaemia 10.52 9.98 45 130409 10080 63348488
Sudden death 10.52 9.98 46 130408 10403 63348165
Diffuse large B-cell lymphoma 10.47 9.98 34 130420 6678 63351890
Hospice care 10.47 9.98 38 130416 7894 63350674
Cardiopulmonary failure 10.44 9.98 23 130431 3589 63354979
Lung consolidation 10.43 9.98 25 130429 4123 63354445
Wrong drug 10.41 9.98 6 130448 197 63358371
Acne 10.41 9.98 20 130434 23273 63335295
Hypozincaemia 10.39 9.98 3 130451 14 63358554
Vaginal discharge 10.38 9.98 3 130451 9195 63349373
Conjunctival hyperaemia 10.35 9.98 18 130436 2361 63356207
Bone marrow transplant 10.33 9.98 10 130444 732 63357836
Prothrombin time prolonged 10.32 9.98 43 130411 9521 63349047
Affect lability 10.30 9.98 5 130449 11146 63347422
Renal function test abnormal 10.26 9.98 23 130431 3630 63354938
Mouth haemorrhage 10.26 9.98 34 130420 6749 63351819
Acidosis 10.23 9.98 48 130406 11185 63347383
Herbal interaction 10.22 9.98 5 130449 117 63358451
Gingival bleeding 10.18 9.98 52 130402 12535 63346033
White blood cell count increased 10.14 9.98 148 130306 48413 63310155
Rhinorrhoea 10.14 9.98 86 130368 65491 63293077
Blood loss anaemia 10.14 9.98 41 130413 8960 63349608
Retroperitoneal haematoma 10.11 9.98 20 130434 2893 63355675
Heavy menstrual bleeding 10.09 9.98 13 130441 17760 63340808
Frequent bowel movements 10.09 9.98 20 130434 23002 63335566
Deficiency anaemia 10.06 9.98 3 130451 16 63358552
Gastroenteritis viral 10.04 9.98 21 130433 23679 63334889
Urate nephropathy 10.03 9.98 5 130449 122 63358446
Rebound acid hypersecretion 10.02 9.98 7 130447 323 63358245
Pulmonary haemorrhage 9.99 9.98 35 130419 7146 63351422
Pelvic venous thrombosis 9.99 9.98 15 130439 1740 63356828
Periorbital oedema 9.98 9.98 30 130424 5654 63352914

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
Drug reaction with eosinophilia and systemic symptoms 1249.75 10.77 1280 220356 31732 34703563
Drug ineffective 642.64 10.77 1203 220433 455548 34279747
Acute kidney injury 450.53 10.77 3388 218248 301600 34433695
Drug abuse 405.38 10.77 70 221566 99026 34636269
Toxicity to various agents 355.91 10.77 449 221187 199913 34535382
Gout 314.78 10.77 491 221145 18762 34716533
Off label use 267.01 10.77 1566 220070 417958 34317337
Tumour lysis syndrome 242.05 10.77 408 221228 16651 34718644
Hyperkalaemia 215.71 10.77 942 220694 68447 34666848
Stevens-Johnson syndrome 206.07 10.77 400 221236 18239 34717056
Completed suicide 195.76 10.77 200 221436 97968 34637327
Anaemia 190.99 10.77 2289 219347 231046 34504249
Renal failure 188.69 10.77 1445 220191 129112 34606183
General physical health deterioration 179.98 10.77 1410 220226 126859 34608436
Cardiac failure 179.57 10.77 1090 220546 90158 34645137
Foetal exposure during pregnancy 164.59 10.77 23 221613 38078 34697217
Cytokine release syndrome 156.07 10.77 405 221231 22472 34712823
Product use in unapproved indication 154.13 10.77 321 221315 117178 34618117
Febrile neutropenia 141.97 10.77 1408 220228 135441 34599854
Toxic epidermal necrolysis 128.41 10.77 364 221272 21282 34714013
Eosinophilia 124.67 10.77 408 221228 25814 34709481
Product monitoring error 117.50 10.77 142 221494 4239 34731056
Hyperuricaemia 112.26 10.77 191 221445 7852 34727443
Renal impairment 112.21 10.77 1001 220635 93512 34641783
Intentional overdose 109.37 10.77 71 221565 43603 34691692
Treatment failure 108.90 10.77 82 221554 46615 34688680
Drug dependence 101.40 10.77 16 221620 24201 34711094
Blood creatinine increased 101.24 10.77 983 220653 93993 34641302
Oedema peripheral 100.19 10.77 1181 220455 118631 34616664
Atrial fibrillation 96.47 10.77 1193 220443 121200 34614095
Chronic lymphocytic leukaemia 92.66 10.77 124 221512 4108 34731187
Overdose 88.54 10.77 289 221347 90770 34644525
Toxic skin eruption 85.42 10.77 209 221427 11176 34724119
Suicide attempt 84.58 10.77 74 221562 39042 34696253
Chronic kidney disease 83.97 10.77 497 221139 40713 34694582
Product dose omission issue 83.78 10.77 432 221204 119279 34616016
Dermatitis exfoliative generalised 78.70 10.77 107 221529 3600 34731695
Suicidal ideation 78.51 10.77 84 221552 40304 34694991
Seizure 77.02 10.77 372 221264 104485 34630810
Thrombocytopenia 74.90 10.77 1399 220237 154848 34580447
Premature baby 73.66 10.77 17 221619 19616 34715679
Headache 72.69 10.77 868 220768 199767 34535528
Pyrexia 70.75 10.77 2678 218958 330335 34404960
Dermatitis exfoliative 69.16 10.77 139 221497 6500 34728795
Sepsis 67.38 10.77 1454 220182 165107 34570188
Drug withdrawal syndrome 67.19 10.77 21 221615 19813 34715482
Injection site pain 65.38 10.77 91 221545 38914 34696381
Inappropriate schedule of product administration 65.30 10.77 191 221445 62105 34673190
Right atrial hypertrophy 64.69 10.77 48 221588 757 34734538
Intentional product use issue 62.98 10.77 183 221453 59633 34675662
Intentional product misuse 61.96 10.77 122 221514 45489 34689806
Rash maculo-papular 61.12 10.77 348 221288 28103 34707192
Drug resistance 61.12 10.77 45 221591 25882 34709413
Appendicolith 58.37 10.77 152 221484 8449 34726846
Drug intolerance 57.92 10.77 189 221447 59381 34675914
Drug ineffective for unapproved indication 57.42 10.77 40 221596 23675 34711620
Hypotension 57.36 10.77 1824 219812 219825 34515470
Blood lactate dehydrogenase increased 56.69 10.77 292 221344 22698 34712597
Aortic valve stenosis 55.84 10.77 77 221559 2626 34732669
Face oedema 55.45 10.77 180 221456 11336 34723959
Product use issue 55.15 10.77 210 221426 63006 34672289
Serotonin syndrome 54.71 10.77 29 221607 19904 34715391
Infective exacerbation of chronic obstructive airways disease 54.61 10.77 63 221573 1788 34733507
Melaena 54.59 10.77 398 221238 34982 34700313
Pain 52.94 10.77 946 220690 203729 34531566
Sedation 52.78 10.77 34 221602 20972 34714323
Ventricular enlargement 52.03 10.77 39 221597 625 34734670
Inferior vena cava dilatation 51.61 10.77 41 221595 719 34734576
Splenomegaly 51.38 10.77 211 221425 14906 34720389
Synovitis 51.16 10.77 13 221623 14053 34721242
Anxiety 50.41 10.77 396 221240 99032 34636263
Aggression 49.72 10.77 108 221528 38856 34696439
Respiratory depression 48.62 10.77 21 221615 16224 34719071
Syncope 47.33 10.77 829 220807 90622 34644673
Depression 47.25 10.77 391 221245 96707 34638588
Insomnia 46.76 10.77 427 221209 103480 34631815
Gouty arthritis 46.37 10.77 45 221591 1041 34734254
Therapeutic product effect incomplete 45.98 10.77 165 221471 50376 34684919
Purpura 45.07 10.77 156 221480 10155 34725140
Bronchial secretion retention 44.85 10.77 52 221584 1484 34733811
Musculoskeletal stiffness 44.76 10.77 149 221487 46531 34688764
Pulmonary function test abnormal 44.65 10.77 68 221568 2542 34732753
Neuroleptic malignant syndrome 43.75 10.77 30 221606 17904 34717391
Plasma cell myeloma 43.22 10.77 432 221204 41605 34693690
Febrile infection 42.72 10.77 61 221575 2150 34733145
Haematoma 42.39 10.77 293 221343 25312 34709983
Product prescribing error 41.96 10.77 269 221367 22658 34712637
Blood urea increased 41.49 10.77 332 221304 30032 34705263
Tumour flare 41.12 10.77 38 221598 825 34734470
IgM nephropathy 40.36 10.77 19 221617 119 34735176
Blood pressure fluctuation 40.25 10.77 61 221575 25188 34710107
Death 40.23 10.77 2089 219547 395960 34339335
Hyponatraemia 40.10 10.77 742 220894 81949 34653346
Rheumatoid arthritis 38.79 10.77 119 221517 38119 34697176
Right ventricular hypertrophy 38.36 10.77 48 221588 1486 34733809
Nasopharyngitis 38.14 10.77 273 221363 69695 34665600
Blood uric acid increased 38.13 10.77 141 221495 9483 34725812
Psychotic disorder 38.10 10.77 60 221576 24392 34710903
Bronchial wall thickening 37.76 10.77 45 221591 1323 34733972
Labelled drug-drug interaction medication error 37.70 10.77 191 221445 14748 34720547
Acute myeloid leukaemia 37.62 10.77 221 221415 18049 34717246
Degenerative mitral valve disease 37.54 10.77 23 221613 259 34735036
Cardio-respiratory arrest 37.21 10.77 202 221434 55071 34680224
Irritability 37.14 10.77 62 221574 24628 34710667
Rales 36.84 10.77 142 221494 9741 34725554
Device interaction 36.56 10.77 30 221606 552 34734743
Immune reconstitution inflammatory syndrome 36.19 10.77 6 221630 8753 34726542
Epistaxis 36.07 10.77 544 221092 57707 34677588
Cardiac failure chronic 36.01 10.77 121 221515 7758 34727537
Blood phosphorus increased 35.67 10.77 119 221517 7602 34727693
Respiratory arrest 35.55 10.77 78 221558 27965 34707330
Neutropenic sepsis 35.44 10.77 177 221459 13590 34721705
Platelet count decreased 35.43 10.77 1002 220634 118715 34616580
Glomerular filtration rate abnormal 35.43 10.77 35 221601 828 34734467
Dyspnoea 35.35 10.77 2809 218827 373973 34361322
Arthralgia 35.25 10.77 815 220821 169226 34566069
No adverse event 35.02 10.77 57 221579 22870 34712425
Appendicitis 34.39 10.77 185 221451 14622 34720673
Exercise tolerance decreased 34.39 10.77 91 221545 5107 34730188
Therapeutic drug monitoring analysis incorrectly performed 34.36 10.77 23 221613 305 34734990
Diastolic dysfunction 34.30 10.77 102 221534 6125 34729170
Haemoglobin decreased 33.59 10.77 1003 220633 119769 34615526
Normocytic anaemia 33.15 10.77 56 221580 2288 34733007
Abnormal behaviour 32.87 10.77 68 221568 24901 34710394
Intentional self-injury 32.33 10.77 24 221612 13747 34721548
Gouty tophus 32.24 10.77 17 221619 140 34735155
Substance abuse 32.10 10.77 5 221631 7636 34727659
Poisoning 31.81 10.77 19 221617 12207 34723088
Cardiogenic shock 31.57 10.77 282 221354 26336 34708959
Electrolyte imbalance 31.42 10.77 177 221459 14235 34721060
Pelvic mass 31.01 10.77 19 221617 214 34735081
Therapeutic product effect decreased 30.56 10.77 115 221521 34628 34700667
Full blood count abnormal 30.53 10.77 213 221423 18455 34716840
Rhabdomyolysis 30.09 10.77 603 221033 67560 34667735
Hyperphosphataemia 29.68 10.77 78 221558 4359 34730936
Bradycardia 29.67 10.77 656 220980 74762 34660533
Obstruction 29.61 10.77 58 221578 2661 34732634
Erythema multiforme 29.61 10.77 121 221515 8528 34726767
Generalised tonic-clonic seizure 29.30 10.77 56 221580 21118 34714177
Accidental exposure to product 29.17 10.77 23 221613 12779 34722516
Ascites 28.86 10.77 435 221201 46136 34689159
Drug hypersensitivity 28.85 10.77 349 221287 80180 34655115
Dermatitis allergic 28.70 10.77 102 221534 6728 34728567
Blood electrolytes abnormal 28.65 10.77 33 221603 935 34734360
Dyspnoea exertional 27.89 10.77 407 221229 42872 34692423
Haematuria 27.75 10.77 459 221177 49607 34685688
Hypercreatininaemia 27.71 10.77 24 221612 477 34734818
Coma 26.99 10.77 174 221462 45504 34689791
Thrombotic microangiopathy 26.99 10.77 17 221619 10613 34724682
Withdrawal syndrome 26.39 10.77 24 221612 12431 34722864
International normalised ratio increased 26.27 10.77 434 221202 46893 34688402
Blood potassium increased 26.27 10.77 187 221449 16308 34718987
Hepatic vein dilatation 26.08 10.77 17 221619 215 34735080
Multimorbidity 26.03 10.77 31 221605 911 34734384
Dehydration 25.98 10.77 1039 220597 128930 34606365
Condition aggravated 25.84 10.77 977 220659 191219 34544076
Post transplant lymphoproliferative disorder 25.82 10.77 5 221631 6523 34728772
Pathogen resistance 25.72 10.77 14 221622 9468 34725827
Soft tissue mass 25.66 10.77 32 221604 987 34734308
Systemic infection 25.58 10.77 82 221554 5130 34730165
Dyskinesia 25.50 10.77 66 221570 22347 34712948
Agitation 25.32 10.77 237 221399 57162 34678133
Therapy non-responder 25.29 10.77 145 221491 39001 34696294
Lymphoid tissue hypoplasia 25.12 10.77 21 221615 397 34734898
Thymus hypoplasia 25.12 10.77 21 221615 397 34734898
Therapy partial responder 24.94 10.77 15 221621 9601 34725694
Atrial septal defect 24.73 10.77 8 221628 7384 34727911
Vascular purpura 24.52 10.77 42 221594 1736 34733559
Blood lactic acid 24.21 10.77 19 221617 327 34734968
Hypocalcaemia 24.19 10.77 248 221388 24041 34711254
Hallucination, auditory 24.04 10.77 24 221612 11893 34723402
Renal function test abnormal 24.04 10.77 51 221585 2479 34732816
Differentiation syndrome 23.95 10.77 37 221599 1401 34733894
Pancytopenia 23.73 10.77 780 220856 94377 34640918
Pleural effusion 23.68 10.77 681 220955 80865 34654430
Paranoia 23.56 10.77 25 221611 12043 34723252
Atrial enlargement 23.50 10.77 25 221611 647 34734648
C-reactive protein abnormal 23.42 10.77 13 221623 8697 34726598
Nicotine dependence 23.42 10.77 24 221612 594 34734701
Erysipelas 23.40 10.77 76 221560 4787 34730508
Haematochezia 23.40 10.77 420 221216 46114 34689181
Electrolyte depletion 23.40 10.77 15 221621 184 34735111
Blood urea abnormal 23.00 10.77 27 221609 781 34734514
Cardiac failure congestive 22.98 10.77 691 220945 82579 34652716
Drug interaction 22.85 10.77 1695 219941 224251 34511044
Pulmonary vascular disorder 22.83 10.77 25 221611 669 34734626
Acute graft versus host disease in skin 22.79 10.77 3 221633 5198 34730097
Ventricular fibrillation 22.68 10.77 234 221402 22720 34712575
Feeling abnormal 22.67 10.77 274 221362 62961 34672334
Colitis ulcerative 22.59 10.77 44 221592 16476 34718819
Low birth weight baby 22.44 10.77 11 221625 7894 34727401
Accidental overdose 22.39 10.77 60 221576 20080 34715215
Ejection fraction decreased 22.24 10.77 202 221434 18952 34716343
Lacunar stroke 22.21 10.77 15 221621 202 34735093
Restlessness 21.99 10.77 85 221551 25397 34709898
Oligoasthenozoospermia 21.93 10.77 7 221629 11 34735284
Somnolence 21.77 10.77 537 221099 110579 34624716
Gastrointestinal haemorrhage 21.74 10.77 724 220912 87753 34647542
Eczema 21.70 10.77 195 221441 18241 34717054
Oesophageal perforation 21.60 10.77 32 221604 1167 34734128
Azotaemia 21.58 10.77 75 221561 4892 34730403
Gravitational oedema 21.52 10.77 24 221612 656 34734639
Therapeutic drug monitoring analysis not performed 21.51 10.77 22 221614 543 34734752
Hypertrophy 21.39 10.77 20 221616 441 34734854
Diabetic ketoacidosis 21.37 10.77 52 221584 17980 34717315
Depressed mood 21.13 10.77 58 221578 19259 34716036
Narrow anterior chamber angle 21.05 10.77 12 221624 117 34735178
Orthostatic hypotension 20.95 10.77 254 221382 25665 34709630
Serum ferritin abnormal 20.73 10.77 15 221621 227 34735068
Pneumonia aspiration 20.70 10.77 168 221468 41735 34693560
Abnormal loss of weight 20.67 10.77 65 221571 4025 34731270
Anger 20.64 10.77 27 221609 11857 34723438
Hospitalisation 20.61 10.77 246 221390 56656 34678639
Malignant neoplasm progression 20.53 10.77 414 221222 87632 34647663
Psoriatic arthropathy 20.52 10.77 61 221575 19737 34715558
Chest X-ray abnormal 20.51 10.77 68 221568 4330 34730965
Glomerular filtration rate decreased 20.10 10.77 146 221490 12815 34722480
Eye injury 20.09 10.77 26 221610 833 34734462
Benign prostatic hyperplasia 20.07 10.77 159 221477 14336 34720959
Epidermolysis 20.07 10.77 16 221620 282 34735013
Intestinal haemorrhage 19.96 10.77 58 221578 3438 34731857
Asthenia 19.85 10.77 1809 219827 243442 34491853
Aptyalism 19.81 10.77 18 221618 382 34734913
Mantle cell lymphoma 19.70 10.77 33 221603 1339 34733956
Base excess decreased 19.57 10.77 14 221622 208 34735087
Transplant rejection 19.42 10.77 22 221614 10289 34725006
Arrhythmia 19.37 10.77 327 221309 35481 34699814
Frequent bowel movements 19.33 10.77 32 221604 12755 34722540
Heart rate increased 19.31 10.77 194 221442 46149 34689146
COVID-19 pneumonia 19.23 10.77 178 221458 16789 34718506
Coating in mouth 19.10 10.77 10 221626 81 34735214
Sinusitis 19.10 10.77 169 221467 41233 34694062
Chronic myeloid leukaemia 19.05 10.77 43 221593 2181 34733114
Maternal exposure during pregnancy 18.97 10.77 4 221632 4914 34730381
Unresponsive to stimuli 18.96 10.77 100 221536 27469 34707826
Lymphocytopenia neonatal 18.96 10.77 6 221630 9 34735286
Mucormycosis 18.90 10.77 7 221629 5935 34729360
Device leakage 18.89 10.77 9 221627 6566 34728729
Oedema 18.66 10.77 400 221236 45341 34689954
Obsessive-compulsive disorder 18.65 10.77 6 221630 5558 34729737
Productive cough 18.55 10.77 340 221296 37473 34697822
Electrocardiogram abnormal 18.49 10.77 111 221525 9136 34726159
Rash 18.47 10.77 1646 219990 221106 34514189
Activated partial thromboplastin time shortened 18.42 10.77 19 221617 474 34734821
Dialysis 18.40 10.77 128 221508 11080 34724215
Graft versus host disease 18.37 10.77 24 221612 10545 34724750
Myelofibrosis 18.32 10.77 35 221601 1576 34733719
Blood uric acid abnormal 18.31 10.77 10 221626 89 34735206
Hyperhidrosis 18.22 10.77 354 221282 75338 34659957
Prostate cancer 18.22 10.77 162 221474 39487 34695808
Hypertonic bladder 18.20 10.77 38 221598 1826 34733469
Prostate cancer recurrent 18.20 10.77 27 221609 986 34734309
Liver palpable 18.06 10.77 15 221621 281 34735014
Needle fatigue 18.05 10.77 25 221611 856 34734439
Tooth deposit 18.03 10.77 10 221626 92 34735203
Blood pressure increased 18.02 10.77 423 221213 87679 34647616
Oroantral fistula 17.96 10.77 13 221623 197 34735098
Mental disorder 17.91 10.77 44 221592 15165 34720130
Tremor 17.89 10.77 393 221243 82194 34653101
Cardiac aneurysm 17.84 10.77 26 221610 934 34734361
Device malfunction 17.77 10.77 24 221612 10397 34724898
Subacute hepatic failure 17.76 10.77 10 221626 95 34735200
Lymphadenopathy 17.68 10.77 266 221370 28197 34707098
Sexual dysfunction 17.55 10.77 9 221627 6294 34729001
Myocardial infarction 17.50 10.77 610 221026 120475 34614820
Wrong technique in product usage process 17.45 10.77 145 221491 35841 34699454
Multiple organ dysfunction syndrome 17.42 10.77 621 221015 75945 34659350
Acne 17.38 10.77 27 221609 11039 34724256
Dependence on oxygen therapy 17.36 10.77 13 221623 208 34735087
Disseminated aspergillosis 17.30 10.77 23 221613 757 34734538
Migraine 17.29 10.77 55 221581 17423 34717872
Asphyxia 17.26 10.77 11 221625 6824 34728471
Device issue 17.20 10.77 22 221614 9755 34725540
Metabolic acidosis 17.18 10.77 380 221256 43300 34691995
Acute graft versus host disease 17.07 10.77 10 221626 6493 34728802
Subcutaneous haematoma 17.05 10.77 26 221610 973 34734322
Adenovirus infection 17.04 10.77 6 221630 5251 34730044
Nephrogenic anaemia 17.02 10.77 41 221595 2170 34733125
Influenza like illness 16.97 10.77 104 221532 27530 34707765
Glomerular filtration rate 16.91 10.77 10 221626 105 34735190
Peripheral arterial occlusive disease 16.91 10.77 78 221558 5796 34729499
Crying 16.88 10.77 8 221628 5854 34729441
Amnesia 16.83 10.77 99 221537 26464 34708831
Poisoning deliberate 16.76 10.77 15 221621 7829 34727466
Injection site reaction 16.73 10.77 36 221600 12997 34722298
Hypocoagulable state 16.69 10.77 25 221611 921 34734374
Product quality issue 16.58 10.77 54 221582 16981 34718314
Skin exfoliation 16.51 10.77 255 221381 27177 34708118
Abnormal clotting factor 16.49 10.77 9 221627 80 34735215
Malignant spinal cord compression 16.42 10.77 11 221625 146 34735149
Drug therapeutic incompatibility 16.37 10.77 10 221626 112 34735183
Renal atrophy 16.35 10.77 28 221608 1157 34734138
Neck pain 16.31 10.77 94 221542 25255 34710040
Periarthritis calcarea 16.30 10.77 9 221627 82 34735213
Post-traumatic amnestic disorder 16.26 10.77 8 221628 56 34735239
Bronchospasm 16.09 10.77 27 221609 10704 34724591
Dyspepsia 16.05 10.77 152 221484 36580 34698715
Articular calcification 16.03 10.77 9 221627 85 34735210
Cardiovascular insufficiency 16.02 10.77 34 221602 1653 34733642
Therapeutic response shortened 16.01 10.77 14 221622 7390 34727905
Haemodialysis 15.99 10.77 118 221518 10408 34724887
Body temperature decreased 15.91 10.77 37 221599 12997 34722298
Catatonia 15.84 10.77 6 221630 5019 34730276
Gastritis erosive 15.79 10.77 77 221559 5855 34729440
Hypoglycaemia 15.77 10.77 456 221180 54184 34681111
Mantle cell lymphoma refractory 15.77 10.77 9 221627 88 34735207
Injection site erythema 15.75 10.77 50 221586 15849 34719446
Pneumothorax 15.64 10.77 65 221571 19027 34716268
Small for dates baby 15.55 10.77 3 221633 3924 34731371
Injection site swelling 15.50 10.77 31 221605 11496 34723799
Atrial flutter 15.50 10.77 159 221477 15415 34719880
Gastrointestinal adenocarcinoma 15.47 10.77 8 221628 63 34735232
Multiple sclerosis relapse 15.46 10.77 38 221598 13095 34722200
Decreased gait velocity 15.34 10.77 11 221625 164 34735131
Jugular vein distension 15.33 10.77 20 221616 646 34734649
Multiple-drug resistance 15.32 10.77 7 221629 5232 34730063
Activated partial thromboplastin time prolonged 15.28 10.77 101 221535 8594 34726701
Dizziness 15.06 10.77 1594 220042 216927 34518368
Pruritus allergic 15.03 10.77 13 221623 258 34735037
Mucosal necrosis 14.96 10.77 8 221628 68 34735227
Platelet distribution width increased 14.85 10.77 10 221626 134 34735161
Oxygen saturation decreased 14.75 10.77 246 221390 53572 34681723
Brain oedema 14.75 10.77 42 221594 13779 34721516
Vision blurred 14.68 10.77 204 221432 45759 34689536
Lens dislocation 14.57 10.77 9 221627 103 34735192
Left ventricular enlargement 14.50 10.77 20 221616 682 34734613
Cardioactive drug level increased 14.49 10.77 33 221603 1684 34733611
Lip erosion 14.48 10.77 19 221617 617 34734678
Heart rate decreased 14.46 10.77 130 221506 31615 34703680
Nervousness 14.43 10.77 37 221599 12569 34722726
Human herpesvirus 6 infection 14.35 10.77 37 221599 2044 34733251
Ichthyosis acquired 14.29 10.77 5 221631 12 34735283
Uveitis 14.27 10.77 16 221620 7519 34727776
Therapeutic response decreased 14.26 10.77 118 221518 29195 34706100
Fear 14.24 10.77 28 221608 10448 34724847
Neonatal respiratory distress syndrome 14.16 10.77 4 221632 4030 34731265
Exposure to toxic agent 14.15 10.77 3 221633 3672 34731623
Carcinoma in situ of skin 14.12 10.77 8 221628 77 34735218
Mydriasis 14.12 10.77 15 221621 7222 34728073
Paroxysmal arrhythmia 14.05 10.77 4 221632 3 34735292
Anticoagulation drug level above therapeutic 13.95 10.77 37 221599 2079 34733216
Impaired work ability 13.93 10.77 14 221622 6916 34728379
Hypomagnesaemia 13.88 10.77 205 221431 21646 34713649
Type V hyperlipidaemia 13.83 10.77 21 221615 783 34734512
Aplasia pure red cell 13.82 10.77 76 221560 6056 34729239
Flushing 13.81 10.77 135 221501 32285 34703010
Myelosuppression 13.75 10.77 69 221567 19196 34716099
Hepatitis C 13.60 10.77 26 221610 9804 34725491
Diverticulum intestinal 13.56 10.77 56 221580 3965 34731330
Poor venous access 13.56 10.77 8 221628 5175 34730120
Product storage error 13.55 10.77 19 221617 8103 34727192
Fistula 13.54 10.77 14 221622 6826 34728469
Skin swelling 13.53 10.77 28 221608 1337 34733958
Portal vein flow decreased 13.50 10.77 5 221631 15 34735280
Tricuspid valve incompetence 13.48 10.77 107 221529 9653 34725642
Intervertebral disc degeneration 13.45 10.77 78 221558 6339 34728956
Relapsing-remitting multiple sclerosis 13.43 10.77 24 221612 1026 34734269
Adrenal insufficiency 13.35 10.77 45 221591 14002 34721293
Hypersensitivity vasculitis 13.33 10.77 49 221587 3286 34732009
Genital erosion 13.27 10.77 12 221624 253 34735042
Vomiting 13.27 10.77 1371 220265 246250 34489045
Cytopenia 13.19 10.77 131 221505 12592 34722703
Pulmonary hypertension 13.17 10.77 196 221440 20728 34714567
Speech disorder 13.14 10.77 102 221534 25584 34709711
Weight increased 13.13 10.77 470 221166 92563 34642732
Syringe issue 13.13 10.77 10 221626 5654 34729641
Skin oedema 13.09 10.77 18 221618 612 34734683
Leukostasis syndrome 13.09 10.77 6 221630 35 34735260
Nightmare 13.07 10.77 47 221589 14344 34720951
Acquired epidermolysis bullosa 13.04 10.77 5 221631 17 34735278
Bladder cancer 12.97 10.77 56 221580 16222 34719073
Light chain disease 12.97 10.77 9 221627 127 34735168
Unevaluable event 12.93 10.77 138 221498 32452 34702843
Microcytic anaemia 12.92 10.77 39 221597 2361 34732934
Sarcopenia 12.91 10.77 15 221621 429 34734866
Rash morbilliform 12.88 10.77 46 221590 3041 34732254
Organic brain syndrome 12.85 10.77 12 221624 264 34735031
Cardiac autonomic neuropathy 12.85 10.77 7 221629 62 34735233
Schizophrenia 12.81 10.77 22 221614 8644 34726651
Lichenoid keratosis 12.80 10.77 40 221596 2468 34732827
Alopecia 12.80 10.77 96 221540 24259 34711036
Increased appetite 12.78 10.77 17 221619 7412 34727883
Immature granulocyte count increased 12.74 10.77 9 221627 131 34735164
Anaphylactic reaction 12.73 10.77 137 221499 32164 34703131
Lip oedema 12.72 10.77 41 221595 2572 34732723
Nephrocalcinosis 12.70 10.77 18 221618 630 34734665
Gait spastic 12.70 10.77 24 221612 1072 34734223
White blood cell count decreased 12.68 10.77 733 220903 94712 34640583
Strangury 12.68 10.77 9 221627 132 34735163
Joint swelling 12.68 10.77 286 221350 59604 34675691
Dyspnoea at rest 12.67 10.77 53 221583 3775 34731520
Eczema nummular 12.62 10.77 9 221627 133 34735162
Alanine aminotransferase abnormal 12.60 10.77 7 221629 4681 34730614
Impaired quality of life 12.58 10.77 11 221625 5807 34729488
Eyelid oedema 12.57 10.77 65 221571 5059 34730236
Hypoaesthesia 12.56 10.77 295 221341 61149 34674146
Drooling 12.54 10.77 3 221633 3379 34731916
Cardiac failure acute 12.54 10.77 112 221524 10458 34724837
Memory impairment 12.54 10.77 196 221440 43122 34692173
Monoparesis 12.52 10.77 38 221598 2308 34732987
Underdose 12.52 10.77 45 221591 13735 34721560
Helicobacter test positive 12.50 10.77 21 221615 854 34734441
Respiratory fatigue 12.49 10.77 8 221628 98 34735197
Illness 12.41 10.77 44 221592 13485 34721810
Thrombin time prolonged 12.37 10.77 10 221626 180 34735115
Hallucination 12.34 10.77 241 221395 51257 34684038
Pulmonary sarcoidosis 12.34 10.77 17 221619 579 34734716
Mitral valve incompetence 12.32 10.77 147 221489 14796 34720499
Surgical vascular shunt 12.20 10.77 3 221633 0 34735295
HLA-B*5801 assay positive 12.20 10.77 3 221633 0 34735295
Oesophageal mucosal blister 12.20 10.77 3 221633 0 34735295
Presyncope 12.18 10.77 179 221457 18880 34716415
Hypervolaemia 12.17 10.77 184 221452 19525 34715770
Vasculitis necrotising 12.15 10.77 20 221616 800 34734495
Tubulointerstitial nephritis 12.11 10.77 194 221442 20830 34714465
Apparent death 12.09 10.77 4 221632 3640 34731655
Tenosynovitis 12.03 10.77 7 221629 4563 34730732
Implant site inflammation 12.02 10.77 8 221628 105 34735190
Treatment noncompliance 11.97 10.77 117 221519 27983 34707312
Drug screen positive 11.95 10.77 5 221631 3938 34731357
Skin reaction 11.91 10.77 65 221571 5165 34730130
Jaundice cholestatic 11.89 10.77 61 221575 4733 34730562
Microphthalmos 11.88 10.77 10 221626 191 34735104
Transfusion reaction 11.87 10.77 21 221615 891 34734404
Graft versus host disease in skin 11.86 10.77 5 221631 3920 34731375
Systolic dysfunction 11.86 10.77 41 221595 2667 34732628
Superinfection 11.79 10.77 39 221597 2480 34732815
Rash macular 11.79 10.77 129 221507 12713 34722582
Needle issue 11.78 10.77 13 221623 6152 34729143
Extrapyramidal disorder 11.74 10.77 42 221594 12838 34722457
Mood swings 11.73 10.77 20 221616 7881 34727414
Ankylosing spondylitis 11.64 10.77 11 221625 5593 34729702
Cardiac amyloidosis 11.63 10.77 25 221611 1226 34734069
Malignant transformation 11.60 10.77 20 221616 831 34734464
Arrhythmia supraventricular 11.58 10.77 26 221610 1314 34733981
Drug level decreased 11.52 10.77 20 221616 7826 34727469
Adrenal cyst 11.51 10.77 9 221627 154 34735141
Oxygen consumption decreased 11.49 10.77 11 221625 250 34735045
Epididymitis 11.45 10.77 38 221598 2421 34732874
Acute cutaneous lupus erythematosus 11.41 10.77 7 221629 79 34735216
Pneumocystis jirovecii pneumonia 11.18 10.77 76 221560 19634 34715661
Serum ferritin increased 11.17 10.77 72 221564 6074 34729221
Tongue oedema 11.12 10.77 43 221593 2954 34732341
Bone marrow reticulin fibrosis 11.09 10.77 9 221627 163 34735132
Cardiomegaly 11.08 10.77 148 221488 15290 34720005
Erythema 11.07 10.77 678 220958 88102 34647193
Loss of personal independence in daily activities 11.05 10.77 146 221490 33033 34702262
Iron deficiency 11.02 10.77 65 221571 5316 34729979
Cytomegalovirus nephritis 11.01 10.77 8 221628 122 34735173
Urticaria 11.01 10.77 306 221330 62071 34673224
Injection site pruritus 11.00 10.77 17 221619 6966 34728329
Coronary artery stenosis 10.95 10.77 101 221535 9515 34725780
N-terminal prohormone brain natriuretic peptide increased 10.94 10.77 40 221596 2675 34732620
Urate nephropathy 10.94 10.77 5 221631 29 34735266
Oral mucosa erosion 10.91 10.77 21 221615 951 34734344
Age-related macular degeneration 10.85 10.77 12 221624 325 34734970
Adenocarcinoma of appendix 10.84 10.77 8 221628 125 34735170
Constipation 10.84 10.77 1009 220627 135973 34599322
Intestinal angioedema 10.82 10.77 10 221626 217 34735078

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
Drug reaction with eosinophilia and systemic symptoms 3370.18 9.68 2419 302079 61825 79378065
Acute kidney injury 1473.04 9.68 4838 299660 514566 78925324
Drug ineffective 990.56 9.68 1633 302865 1079280 78360610
Toxic epidermal necrolysis 613.51 9.68 803 303695 43778 79396112
Hyperkalaemia 585.63 9.68 1327 303171 113071 79326819
Anaemia 575.86 9.68 3273 301225 441742 78998148
Febrile neutropenia 553.03 9.68 2038 302460 228961 79210929
Renal failure 549.00 9.68 1852 302646 199116 79240774
Tumour lysis syndrome 502.04 9.68 535 303963 23404 79416486
Stevens-Johnson syndrome 493.79 9.68 676 303822 38490 79401400
Cytokine release syndrome 445.80 9.68 616 303882 35382 79404508
Gout 437.81 9.68 506 303992 24243 79415647
Cardiac failure 435.16 9.68 1441 303057 153401 79286489
General physical health deterioration 373.61 9.68 2052 302446 273186 79166704
Maternal exposure during pregnancy 364.05 9.68 46 304452 136492 79303398
Completed suicide 355.89 9.68 252 304246 245515 79194375
Renal impairment 349.08 9.68 1358 303140 156425 79283465
Alopecia 340.58 9.68 233 304265 231122 79208768
Pemphigus 334.09 9.68 10 304488 99572 79340318
Thrombocytopenia 318.93 9.68 1915 302583 263344 79176546
Pain 318.02 9.68 1495 303003 702307 78737583
Eosinophilia 312.92 9.68 595 303903 44750 79395140
Systemic lupus erythematosus 310.71 9.68 46 304452 121103 79318787
Atrial fibrillation 306.72 9.68 1531 302967 196355 79243535
Glossodynia 306.44 9.68 23 304475 103314 79336576
Synovitis 304.44 9.68 98 304400 150636 79289254
Joint swelling 303.70 9.68 394 304104 288252 79151638
Toxicity to various agents 302.09 9.68 732 303766 420808 79019082
Sepsis 298.11 9.68 1904 302594 267524 79172366
Drug abuse 296.21 9.68 125 304373 162566 79277324
Arthropathy 293.39 9.68 155 304343 176956 79262934
Hand deformity 284.46 9.68 32 304466 103887 79336003
Drug intolerance 280.43 9.68 358 304140 263761 79176129
Therapeutic product effect decreased 277.98 9.68 139 304359 163724 79276166
Off label use 274.90 9.68 2185 302313 905030 78534860
Rheumatoid arthritis 273.61 9.68 236 304262 208234 79231656
Exposure during pregnancy 272.20 9.68 33 304465 101099 79338791
Rash maculo-papular 271.87 9.68 637 303861 55441 79384449
Blood creatinine increased 269.42 9.68 1240 303258 153817 79286073
Headache 259.89 9.68 1451 303047 652321 78787569
Arthralgia 254.26 9.68 1221 303277 570582 78869308
Melaena 252.06 9.68 651 303847 60239 79379651
Treatment failure 249.10 9.68 173 304325 170313 79269577
Abdominal discomfort 221.29 9.68 386 304112 250341 79189549
Nasopharyngitis 218.54 9.68 397 304101 253484 79186406
Chronic kidney disease 214.38 9.68 647 303851 65507 79374383
Toxic skin eruption 213.31 9.68 338 304160 21955 79417935
Sinusitis 209.52 9.68 263 304235 195238 79244652
Discomfort 209.38 9.68 109 304389 125508 79314382
Oedema peripheral 206.36 9.68 1658 302840 250630 79189260
Drug interaction 205.23 9.68 2455 302043 412728 79027162
Drug hypersensitivity 203.13 9.68 533 303965 298383 79141507
Pyrexia 199.68 9.68 3668 300830 675041 78764849
Product monitoring error 195.53 9.68 204 304294 8702 79431188
Hyperuricaemia 194.97 9.68 233 304265 11566 79428324
Pericarditis 193.06 9.68 78 304420 104158 79335732
Product use issue 187.88 9.68 320 304178 209502 79230388
Pancytopenia 182.91 9.68 1171 303327 164574 79275316
Duodenal ulcer perforation 179.66 9.68 21 304477 66190 79373700
Hypotension 178.22 9.68 2510 301988 437807 79002083
Intentional overdose 173.56 9.68 94 304404 105866 79334024
Product prescribing error 171.12 9.68 465 304033 44348 79395542
Helicobacter infection 170.76 9.68 30 304468 69674 79370216
Musculoskeletal stiffness 167.87 9.68 255 304243 174753 79265137
Plasma cell myeloma 165.19 9.68 513 303985 52746 79387144
Irritable bowel syndrome 158.71 9.68 24 304474 62217 79377673
Labelled drug-drug interaction medication error 157.48 9.68 335 304163 27315 79412575
Bradycardia 156.55 9.68 969 303529 134588 79305302
Injection site pain 156.15 9.68 159 304339 129679 79310211
Contraindicated product administered 152.58 9.68 228 304270 157310 79282580
Hyponatraemia 152.02 9.68 1181 303317 176667 79263223
Syncope 151.38 9.68 1188 303310 178261 79261629
Dehydration 147.29 9.68 1522 302976 246665 79193225
Dermatitis exfoliative generalised 146.82 9.68 159 304339 7082 79432808
Haemoglobin decreased 141.36 9.68 1382 303116 220737 79219153
Platelet count decreased 139.83 9.68 1243 303255 193421 79246469
Blood urea increased 139.50 9.68 457 304041 48333 79391557
Intentional product use issue 138.89 9.68 229 304269 151883 79288007
Infusion related reaction 138.40 9.68 435 304063 229802 79210088
Product dose omission issue 136.27 9.68 486 304012 247051 79192839
Chronic lymphocytic leukaemia 135.70 9.68 127 304371 4739 79435151
Hepatic enzyme increased 134.62 9.68 312 304186 182298 79257592
Psoriatic arthropathy 133.98 9.68 65 304433 77934 79361956
Dermatitis exfoliative 132.07 9.68 184 304314 10645 79429245
Hypersensitivity 128.85 9.68 539 303959 261700 79178190
Blood lactate dehydrogenase increased 128.67 9.68 385 304113 38785 79401105
Rhabdomyolysis 125.25 9.68 747 303751 102384 79337506
International normalised ratio increased 124.44 9.68 646 303852 84075 79355815
Muscle injury 123.19 9.68 19 304479 48542 79391348
Injection site erythema 122.85 9.68 73 304425 78124 79361766
Sleep disorder due to general medical condition, insomnia type 122.81 9.68 12 304486 43544 79396346
Product use in unapproved indication 121.50 9.68 517 303981 249842 79190048
Hypoglycaemia 119.64 9.68 730 303768 100864 79339026
Swelling 119.58 9.68 425 304073 216286 79223604
Haematoma 119.18 9.68 454 304044 51741 79388149
Gastrointestinal haemorrhage 116.43 9.68 963 303535 146756 79293134
Appendicolith 112.92 9.68 151 304347 8400 79431490
Face oedema 112.50 9.68 297 304201 27839 79412051
Wound 111.65 9.68 169 304329 116010 79323880
Anxiety 109.35 9.68 532 303966 247980 79191910
Therapeutic product effect incomplete 108.46 9.68 237 304261 141408 79298482
Purpura 108.23 9.68 234 304264 19293 79420597
Neutropenia 106.30 9.68 1615 302883 286095 79153795
Multiple organ dysfunction syndrome 105.76 9.68 804 303694 119442 79320448
Epistaxis 102.82 9.68 754 303744 110761 79329129
Gastrointestinal disorder 99.87 9.68 197 304301 122008 79317882
C-reactive protein abnormal 98.40 9.68 31 304467 48336 79391554
Blood uric acid increased 98.00 9.68 180 304318 13180 79426710
Folliculitis 96.88 9.68 45 304453 55335 79384555
Suicide attempt 95.83 9.68 105 304393 82827 79357063
Inappropriate schedule of product administration 94.74 9.68 233 304265 133395 79306495
Suicidal ideation 94.63 9.68 91 304407 76249 79363641
Splenomegaly 94.35 9.68 230 304268 20524 79419366
Insomnia 92.82 9.68 552 303946 244618 79195272
Neutropenic sepsis 92.69 9.68 270 304228 26794 79413096
Lactic acidosis 91.50 9.68 519 303979 69840 79370050
Injection site pruritus 89.85 9.68 25 304473 42258 79397632
Blood pressure fluctuation 89.25 9.68 75 304423 67070 79372820
Abortion spontaneous 89.09 9.68 6 304492 29501 79410389
Acute myeloid leukaemia 88.02 9.68 289 304209 30596 79409294
Fibromyalgia 87.84 9.68 70 304428 64270 79375620
Hip arthroplasty 86.25 9.68 16 304482 35740 79404150
Weight increased 85.84 9.68 663 303835 276723 79163167
Pneumonia 85.40 9.68 3202 301296 657044 78782846
Injection site reaction 84.85 9.68 52 304446 54733 79385157
Right atrial hypertrophy 83.40 9.68 46 304452 725 79439165
Pleural effusion 82.87 9.68 884 303614 144378 79295512
Tumour flare 82.05 9.68 52 304446 1071 79438819
Device expulsion 81.94 9.68 4 304494 25857 79414033
Haematuria 81.90 9.68 496 304002 68340 79371550
Metabolic acidosis 81.28 9.68 567 303931 81962 79357928
Depression 80 9.68 492 304006 216298 79223592
Asthenia 79.50 9.68 2535 301963 509154 78930736
Impaired healing 78.11 9.68 134 304364 87521 79352369
Pregnancy 76.75 9.68 7 304491 26844 79413046
Multiple sclerosis relapse 76.59 9.68 41 304457 46492 79393398
Blood phosphorus increased 75.38 9.68 139 304359 10208 79429682
Loss of personal independence in daily activities 74.17 9.68 177 304321 102403 79337487
Injection site swelling 74.02 9.68 44 304454 47088 79392802
Fatigue 73.79 9.68 2855 301643 926872 78513018
Electrolyte imbalance 73.30 9.68 272 304226 30609 79409281
Migraine 71.52 9.68 141 304357 87352 79352538
Dyspnoea 70.95 9.68 3973 300525 853052 78586838
Injection site bruising 70.67 9.68 34 304464 40968 79398922
Red blood cell sedimentation rate increased 70.60 9.68 44 304454 45898 79393992
Ill-defined disorder 69.08 9.68 90 304408 65785 79374105
Hypoaesthesia 68.28 9.68 403 304095 178949 79260941
Paraesthesia 67.76 9.68 395 304103 175928 79263962
Infective exacerbation of chronic obstructive airways disease 66.98 9.68 67 304431 2717 79437173
Overdose 65.91 9.68 422 304076 183784 79256106
Haematochezia 65.64 9.68 565 303933 87080 79352810
Therapeutic drug monitoring analysis incorrectly performed 64.75 9.68 38 304460 678 79439212
Knee arthroplasty 64.30 9.68 43 304455 43205 79396685
Erythema multiforme 64.24 9.68 180 304318 17471 79422419
Ventricular enlargement 63.97 9.68 38 304460 694 79439196
Accidental exposure to product 63.85 9.68 20 304478 31302 79408588
Hyperphosphataemia 62.83 9.68 98 304400 6278 79433612
Inferior vena cava dilatation 62.81 9.68 40 304458 831 79439059
Serotonin syndrome 62.71 9.68 48 304450 44979 79394911
Cardiac failure chronic 62.35 9.68 134 304364 11001 79428889
Breast cancer 61.37 9.68 26 304472 33755 79406135
Cardiac failure congestive 61.16 9.68 821 303677 141581 79298309
Cardiogenic shock 59.74 9.68 317 304181 41597 79398293
Benign prostatic hyperplasia 59.66 9.68 135 304363 11477 79428413
Osteoarthritis 58.96 9.68 156 304342 87153 79352737
Feeling abnormal 58.87 9.68 361 304137 158838 79281052
Peripheral swelling 58.51 9.68 703 303795 268914 79170976
Tubulointerstitial nephritis 57.83 9.68 294 304204 37941 79401949
Differentiation syndrome 57.54 9.68 59 304439 2465 79437425
Dialysis 57.38 9.68 178 304320 18284 79421606
Blood potassium increased 56.73 9.68 242 304256 29033 79410857
Subdural haematoma 56.46 9.68 254 304244 31180 79408710
Intentional product misuse 56.29 9.68 181 304317 94984 79344906
Drug resistance 56.29 9.68 47 304451 42166 79397724
Condition aggravated 56.23 9.68 1470 303028 499654 78940236
Cardioactive drug level increased 56.02 9.68 70 304428 3639 79436251
Intentional self-injury 55.69 9.68 27 304471 32392 79407498
Leukopenia 54.76 9.68 683 303815 115830 79324060
Glomerular filtration rate decreased 54.75 9.68 201 304297 22501 79417389
Appendicitis 54.33 9.68 189 304309 20605 79419285
Right ventricular hypertrophy 54.07 9.68 47 304451 1590 79438300
Live birth 53.27 9.68 5 304493 18739 79421151
Pulmonary function test abnormal 52.92 9.68 72 304426 4072 79435818
Sleep disorder 52.76 9.68 160 304338 85517 79354373
Seizure 52.62 9.68 464 304034 188370 79251520
Gouty arthritis 52.45 9.68 44 304454 1417 79438473
Ascites 51.89 9.68 478 304020 75084 79364806
Haemodialysis 51.76 9.68 170 304328 17998 79421892
Skin exfoliation 51.02 9.68 373 304125 54727 79385163
Heart rate increased 49.89 9.68 264 304234 120460 79319430
Glomerular filtration rate abnormal 49.82 9.68 45 304453 1603 79438287
Blood pressure increased 49.79 9.68 541 303957 210819 79229071
IgM nephropathy 49.64 9.68 19 304479 119 79439771
Gravitational oedema 49.38 9.68 47 304451 1792 79438098
Illness 49.33 9.68 63 304435 46448 79393442
Azotaemia 49.13 9.68 102 304396 8174 79431716
Rash morbilliform 49.12 9.68 86 304412 6064 79433826
COVID-19 pneumonia 48.77 9.68 229 304269 28620 79411270
Dyspnoea exertional 48.75 9.68 528 303970 86545 79353345
Drug withdrawal syndrome 48.36 9.68 37 304461 34681 79405209
Aortic valve stenosis 47.54 9.68 78 304420 5216 79434674
Injury 47.52 9.68 145 304353 77351 79362539
Multimorbidity 46.90 9.68 41 304457 1398 79438492
Drug ineffective for unapproved indication 46.87 9.68 77 304421 51161 79388729
Adverse event 46.69 9.68 100 304398 60114 79379776
Degenerative mitral valve disease 46.07 9.68 23 304475 292 79439598
Sopor 45.91 9.68 248 304250 32762 79407128
Febrile infection 45.59 9.68 60 304438 3286 79436604
Ear infection 45.10 9.68 39 304459 34393 79405497
Exercise tolerance decreased 43.90 9.68 103 304395 8968 79430922
Dilatation intrahepatic duct acquired 43.77 9.68 30 304468 708 79439182
Respiratory arrest 43.45 9.68 97 304401 57453 79382437
Pain in extremity 42.54 9.68 1063 303435 363475 79076415
Ventricular fibrillation 42.49 9.68 237 304261 31689 79408201
Hypocalcaemia 42.30 9.68 331 304167 49593 79390297
Arthritis 42.20 9.68 261 304237 114619 79325271
Foot deformity 41.43 9.68 20 304478 24054 79415836
HLA-B*5801 assay positive 41.15 9.68 9 304489 0 79439890
Mobility decreased 41.12 9.68 285 304213 121890 79318000
Diastolic dysfunction 41.08 9.68 112 304386 10699 79429191
Hypokalaemia 40.86 9.68 775 303723 143265 79296625
Hypercreatininaemia 40.49 9.68 33 304465 1020 79438870
Nasal congestion 40.29 9.68 153 304345 76399 79363491
Rhinorrhoea 40.07 9.68 152 304346 75922 79363968
Back pain 39.65 9.68 872 303626 303308 79136582
Blood cholesterol increased 39.27 9.68 175 304323 83545 79356345
Gouty tophus 39.21 9.68 23 304475 410 79439480
Poisoning 39.11 9.68 24 304474 25248 79414642
Systemic infection 39.04 9.68 103 304395 9649 79430241
Asthma 38.94 9.68 329 304169 134766 79305124
Injection site haemorrhage 38.44 9.68 30 304468 27840 79412050
Hypervolaemia 38.38 9.68 287 304211 42403 79397487
Therapeutic drug monitoring analysis not performed 38.36 9.68 42 304456 1894 79437996
Grip strength decreased 37.89 9.68 18 304480 21851 79418039
Agranulocytosis 37.85 9.68 298 304200 44732 79395158
Influenza 37.64 9.68 315 304183 129291 79310599
Drug dependence 37.54 9.68 61 304437 40708 79399182
Myelofibrosis 37.47 9.68 47 304451 2453 79437437
Arrhythmia 37.34 9.68 378 304120 60894 79378996
Blast crisis in myelogenous leukaemia 37.07 9.68 29 304469 844 79439046
Device dislocation 37.05 9.68 27 304471 25943 79413947
Abdominal pain upper 37.03 9.68 616 303882 223203 79216687
Septic shock 37.01 9.68 667 303831 122134 79317756
Therapy non-responder 36.95 9.68 204 304294 92101 79347789
Atrial flutter 36.80 9.68 172 304326 21453 79418437
Urticaria 36.75 9.68 492 304006 184709 79255181
Lip erosion 36.54 9.68 37 304461 1523 79438367
Diarrhoea 36.01 9.68 3863 300635 876626 78563264
Immune effector cell-associated neurotoxicity syndrome 35.80 9.68 73 304425 5775 79434115
Anaemia macrocytic 35.62 9.68 71 304427 5526 79434364
Rales 35.46 9.68 161 304337 19840 79420050
Premature delivery 35.34 9.68 23 304475 23444 79416446
Neuroleptic malignant syndrome 35.15 9.68 32 304466 27527 79412363
Infective pulmonary exacerbation of cystic fibrosis 35.05 9.68 4 304494 12847 79427043
Obstruction 34.94 9.68 63 304435 4547 79435343
Hypersensitivity vasculitis 34.87 9.68 80 304418 6863 79433027
Blister 34.87 9.68 290 304208 119186 79320704
Sedation 34.82 9.68 93 304405 51802 79388088
Pemphigoid 34.77 9.68 133 304365 15182 79424708
Anuria 34.41 9.68 165 304333 20798 79419092
Conjunctivitis 34.29 9.68 191 304307 25524 79414366
Influenza like illness 34.17 9.68 149 304349 71558 79368332
Respiratory depression 34.16 9.68 33 304465 27597 79412293
Human herpesvirus 6 infection 34.03 9.68 68 304430 5302 79434588
Cardiomegaly 33.99 9.68 194 304304 26158 79413732
Generalised tonic-clonic seizure 33.98 9.68 73 304425 43837 79396053
Cytopenia 33.87 9.68 161 304337 20222 79419668
Wrong technique in product usage process 33.71 9.68 156 304342 73719 79366171
Road traffic accident 33.45 9.68 73 304425 43591 79396299
Neck pain 33.39 9.68 161 304337 75256 79364634
Disability 33.03 9.68 12 304486 17108 79422782
Lip dry 32.97 9.68 9 304489 15409 79424481
Memory impairment 32.70 9.68 271 304227 111463 79328427
Petechiae 32.42 9.68 160 304338 20405 79419485
Red blood cell sedimentation rate abnormal 32.31 9.68 20 304478 20943 79418947
Burning sensation 32.29 9.68 115 304383 58517 79381373
Therapy partial responder 32.23 9.68 13 304485 17384 79422506
Prostate cancer recurrent 32.22 9.68 26 304472 792 79439098
Electrocardiogram abnormal 32.15 9.68 138 304360 16599 79423291
White blood cell count decreased 32.11 9.68 944 303554 187344 79252546
Device interaction 32.03 9.68 25 304473 725 79439165
Hyperbilirubinaemia 31.96 9.68 181 304317 24337 79415553
Activated partial thromboplastin time prolonged 31.84 9.68 123 304375 14105 79425785
Gamma-glutamyltransferase increased 31.73 9.68 334 304164 54346 79385544
Acute motor-sensory axonal neuropathy 31.68 9.68 20 304478 409 79439481
Device issue 31.67 9.68 34 304464 27074 79412816
Crying 31.54 9.68 25 304473 23018 79416872
Frequent bowel movements 31.33 9.68 40 304458 29499 79410391
Lymphoid tissue hypoplasia 31.32 9.68 27 304471 903 79438987
Therapeutic response decreased 31.20 9.68 140 304358 66713 79373177
Injection site warmth 31.00 9.68 9 304489 14798 79425092
Soft tissue mass 30.99 9.68 31 304467 1257 79438633
Dermatitis bullous 30.95 9.68 122 304376 14123 79425767
Presyncope 30.91 9.68 265 304233 40789 79399101
Bronchial wall thickening 30.91 9.68 44 304454 2597 79437293
Shock haemorrhagic 30.86 9.68 155 304343 19905 79419985
Disseminated aspergillosis 30.83 9.68 29 304469 1089 79438801
Aplasia pure red cell 30.77 9.68 82 304416 7728 79432162
Mood swings 30.60 9.68 19 304479 19861 79420029
Atrial enlargement 30.59 9.68 28 304470 1015 79438875
Bone marrow failure 30.52 9.68 314 304184 50793 79389097
Gastritis erosive 30.46 9.68 101 304397 10746 79429144
Blood lactic acid 30.29 9.68 20 304478 443 79439447
Thymus hypoplasia 30.27 9.68 27 304471 946 79438944
Device difficult to use 30.20 9.68 7 304491 13378 79426512
Lichenoid keratosis 30.18 9.68 55 304443 4002 79435888
Epididymitis 30.07 9.68 37 304461 1893 79437997
Allergic reaction to excipient 30.05 9.68 18 304480 334 79439556
Gastric disorder 30.00 9.68 61 304437 37372 79402518
Normocytic anaemia 30.00 9.68 56 304442 4151 79435739
Withdrawal syndrome 29.93 9.68 35 304463 26819 79413071
Autoimmune disorder 29.83 9.68 13 304485 16599 79423291
Acne 29.70 9.68 36 304462 27154 79412736
Cardiac failure acute 29.64 9.68 147 304351 18782 79421108
Diabetes mellitus inadequate control 29.59 9.68 176 304322 24088 79415802
Rectal haemorrhage 29.55 9.68 432 304066 75868 79364022
Lymphadenopathy 29.39 9.68 322 304176 52925 79386965
Colitis ulcerative 29.25 9.68 55 304443 34687 79405203
Urinary retention 29.24 9.68 338 304160 56292 79383598
Lower respiratory tract infection 29.13 9.68 334 304164 128886 79311004
Hypovolaemic shock 29.02 9.68 108 304390 12168 79427722
Mantle cell lymphoma 29 9.68 31 304467 1360 79438530
Renal function test abnormal 28.97 9.68 61 304437 4937 79434953
Multiple drug therapy 28.73 9.68 54 304444 4024 79435866
Psychotic disorder 28.70 9.68 73 304425 41329 79398561
Renal atrophy 28.46 9.68 35 304463 1790 79438100
Eczema 28.42 9.68 259 304239 40559 79399331
Injection site urticaria 28.36 9.68 7 304491 12819 79427071
Tachyarrhythmia 28.35 9.68 74 304424 6888 79433002
Joint stiffness 28.29 9.68 72 304426 40758 79399132
Multiple sclerosis 28.26 9.68 26 304472 22256 79417634
Pulmonary vascular disorder 28.22 9.68 27 304471 1036 79438854
Flushing 28.19 9.68 209 304289 88059 79351831
Immune reconstitution inflammatory syndrome 27.92 9.68 9 304489 13832 79426058
Foot fracture 27.47 9.68 26 304472 21955 79417935
Vision blurred 27.41 9.68 265 304233 105633 79334257
Hepatic vein dilatation 27.39 9.68 15 304483 233 79439657
Facet joint syndrome 27.38 9.68 5 304493 11297 79428593
Device malfunction 27.24 9.68 25 304473 21423 79418467
Pulmonary hypertension 27.11 9.68 292 304206 47788 79392102
Peripheral arterial occlusive disease 26.95 9.68 81 304417 8177 79431713
Vascular purpura 26.95 9.68 45 304453 3053 79436837
Diverticulum intestinal haemorrhagic 26.88 9.68 52 304446 3959 79435931
Hypocoagulable state 26.80 9.68 37 304461 2122 79437768
Limb discomfort 26.79 9.68 53 304445 32797 79407093
Depressed mood 26.76 9.68 95 304403 48385 79391505
Blood urea abnormal 26.66 9.68 29 304469 1298 79438592
Lung consolidation 26.65 9.68 85 304413 8862 79431028
Cholestasis 26.45 9.68 310 304188 51799 79388091
Adverse drug reaction 26.42 9.68 147 304351 66245 79373645
Respiratory failure 26.37 9.68 890 303608 180021 79259869
Hepatitis 26.31 9.68 327 304171 55400 79384490
Poisoning deliberate 26.31 9.68 20 304478 18808 79421082
Throat irritation 26.27 9.68 75 304423 40871 79399019
Stomatitis 26.24 9.68 398 304100 146359 79293531
HLA marker study positive 26.12 9.68 12 304486 125 79439765
Musculoskeletal disorder 26.07 9.68 26 304472 21422 79418468
Nausea 26.03 9.68 3230 301268 953966 78485924
Gastroenteritis viral 25.95 9.68 34 304464 24797 79415093
Oesophageal perforation 25.92 9.68 31 304467 1540 79438350
Ecchymosis 25.92 9.68 121 304377 15085 79424805
Haemoptysis 25.76 9.68 327 304171 55672 79384218
Lip oedema 25.58 9.68 67 304431 6249 79433641
Coeliac disease 25.48 9.68 6 304492 11345 79428545
Oligoasthenozoospermia 25.43 9.68 7 304491 11 79439879
Enanthema 25.31 9.68 23 304475 826 79439064
Device breakage 25.27 9.68 5 304493 10670 79429220
Ear pain 25.14 9.68 55 304443 32814 79407076
Oral mucosa erosion 25.12 9.68 34 304464 1913 79437977
Cardiac aneurysm 25.12 9.68 30 304468 1488 79438402
Heavy menstrual bleeding 25.10 9.68 11 304487 14000 79425890
Leukocytosis 25.01 9.68 265 304233 43190 79396700
Product quality issue 24.97 9.68 58 304440 33882 79406008
Dysuria 24.93 9.68 301 304197 50650 79389240
Underdose 24.92 9.68 56 304442 33095 79406795
Bronchial secretion retention 24.85 9.68 51 304447 4053 79435837
Substance abuse 24.77 9.68 5 304493 10521 79429369
Therapeutic response shortened 24.64 9.68 15 304483 15848 79424042
Mucosal ulceration 24.61 9.68 33 304465 1840 79438050
Exposure to toxic agent 24.60 9.68 3 304495 9155 79430735
Amnesia 24.34 9.68 141 304357 62916 79376974
Hypertrophy 24.26 9.68 22 304476 788 79439102
Interstitial lung disease 24.22 9.68 582 303916 112018 79327872
Gait disturbance 24.19 9.68 605 303893 206901 79232989
Psoriasis 24.12 9.68 222 304276 89365 79350525
Needle fatigue 24.12 9.68 23 304475 879 79439011
Blood creatine phosphokinase increased 23.96 9.68 370 304128 65720 79374170
Post transplant lymphoproliferative disorder 23.95 9.68 7 304491 11457 79428433
Breast cancer female 23.94 9.68 7 304491 11454 79428436
Injection site rash 23.92 9.68 20 304478 17934 79421956
Prescribed overdose 23.85 9.68 70 304428 37813 79402077
Intestinal haemorrhage 23.85 9.68 66 304432 6360 79433530
Upper gastrointestinal haemorrhage 23.65 9.68 252 304246 41128 79398762
Prerenal failure 23.64 9.68 47 304451 3651 79436239
Base excess decreased 23.63 9.68 16 304482 370 79439520
Lymphocytosis 23.49 9.68 54 304444 4639 79435251
Cardio-respiratory arrest 23.48 9.68 283 304215 108227 79331663
Atrioventricular block complete 23.24 9.68 125 304373 16485 79423405
Constipation 23.22 9.68 1312 303186 281738 79158152
Blood pressure systolic increased 23.16 9.68 155 304343 66831 79373059
Lipase increased 23.09 9.68 124 304374 16342 79423548
Rash pustular 23.08 9.68 95 304403 11216 79428674
Hallucination, auditory 23.03 9.68 27 304471 20666 79419224
Mitral valve incompetence 22.89 9.68 187 304311 28378 79411512
Narrow anterior chamber angle 22.88 9.68 12 304486 170 79439720
Right ventricular failure 22.87 9.68 161 304337 23336 79416554
Injection site mass 22.82 9.68 26 304472 20158 79419732
Escherichia sepsis 22.81 9.68 78 304420 8430 79431460
Body temperature decreased 22.81 9.68 56 304442 32089 79407801
Serum ferritin increased 22.76 9.68 86 304412 9761 79430129
Chemical burn of oral cavity 22.67 9.68 9 304489 63 79439827
Pericardial effusion 22.56 9.68 273 304225 45964 79393926
Full blood count abnormal 22.45 9.68 245 304253 40229 79399661
Pulmonary oedema 22.39 9.68 467 304031 87787 79352103
Granuloma skin 22.35 9.68 4 304494 9170 79430720
Carpal tunnel syndrome 22.25 9.68 25 304473 19503 79420387
Liver palpable 22.19 9.68 15 304483 346 79439544
Strangury 22.10 9.68 12 304486 183 79439707
Urosepsis 22.08 9.68 175 304323 26320 79413570
Food allergy 21.90 9.68 7 304491 10817 79429073
Mydriasis 21.89 9.68 21 304477 17622 79422268
Skin oedema 21.86 9.68 30 304468 1711 79438179
Blood bilirubin increased 21.84 9.68 365 304133 65867 79374023
Disorientation 21.83 9.68 349 304149 62427 79377463
Dermatitis allergic 21.79 9.68 131 304367 17999 79421891
Erythema 21.75 9.68 1052 303446 222238 79217652
Vaginal haemorrhage 21.67 9.68 31 304467 21786 79418104
Acute generalised exanthematous pustulosis 21.59 9.68 126 304372 17128 79422762
Allergy to chemicals 21.58 9.68 37 304461 2565 79437325
Chronic myeloid leukaemia 21.56 9.68 45 304453 3619 79436271
Hyperhidrosis 21.56 9.68 428 304070 151064 79288826
Blood uric acid abnormal 21.54 9.68 12 304486 193 79439697
Prothrombin time prolonged 21.53 9.68 124 304374 16775 79423115
Diabetic ketoacidosis 21.52 9.68 63 304435 34059 79405831
Hepatocellular injury 21.50 9.68 277 304221 47316 79392574
Malignant spinal cord compression 21.47 9.68 11 304487 148 79439742
Glomerular filtration rate 21.41 9.68 11 304487 149 79439741
Erosive oesophagitis 21.35 9.68 39 304459 2843 79437047
Duodenitis 21.32 9.68 73 304425 7894 79431996
Bone erosion 21.28 9.68 22 304476 17825 79422065
Sciatica 21.20 9.68 61 304437 33161 79406729
Nicotine dependence 21.19 9.68 22 304476 933 79438957
Eosinophilic pustular folliculitis 21.13 9.68 10 304488 112 79439778
Thermohypoaesthesia 21.13 9.68 10 304488 112 79439778
Coronary artery stenosis 21.03 9.68 99 304399 12385 79427505
Breast cancer stage II 21 9.68 3 304495 8117 79431773
Epidermolysis 20.94 9.68 22 304476 946 79438944
Platelet disorder 20.90 9.68 39 304459 2890 79437000
Autoimmune haemolytic anaemia 20.89 9.68 75 304423 8305 79431585
Sarcopenia 20.77 9.68 16 304482 455 79439435
Drug tolerance 20.67 9.68 4 304494 8671 79431219
Mucosal erosion 20.61 9.68 34 304464 2284 79437606
Systolic dysfunction 20.48 9.68 45 304453 3750 79436140
No adverse event 20.44 9.68 73 304425 37119 79402771
Fistula 20.43 9.68 12 304486 12928 79426962
Organic brain syndrome 20.38 9.68 16 304482 468 79439422
Periarthritis calcarea 20.26 9.68 9 304489 86 79439804
Lower limb fracture 20.21 9.68 36 304462 23179 79416711
Aggression 20.18 9.68 113 304385 50845 79389045
Aplastic anaemia 20.02 9.68 127 304371 17778 79422112
Brain natriuretic peptide increased 19.97 9.68 77 304421 8823 79431067
Left ventricular enlargement 19.90 9.68 19 304479 727 79439163
Myocardial ischaemia 19.88 9.68 166 304332 25353 79414537
Exostosis 19.85 9.68 21 304477 16837 79423053
Ankylosing spondylitis 19.72 9.68 11 304487 12194 79427696
Decreased gait velocity 19.69 9.68 11 304487 178 79439712
Anticoagulation drug level above therapeutic 19.62 9.68 43 304455 3577 79436313
Sight disability 19.62 9.68 10 304488 133 79439757
Mental disorder 19.59 9.68 58 304440 31244 79408646
Surgery 19.59 9.68 62 304436 32704 79407186
Type V hyperlipidaemia 19.58 9.68 22 304476 1021 79438869
Stenosis 19.52 9.68 34 304464 2388 79437502
Platelet distribution width increased 19.49 9.68 10 304488 135 79439755
Anaphylactic reaction 19.44 9.68 215 304283 83528 79356362
Metastases to bone 19.41 9.68 40 304458 24387 79415503
Caesarean section 19.27 9.68 12 304486 12523 79427367
Sinus congestion 19.05 9.68 29 304469 19867 79420023
Procedural pain 19.03 9.68 37 304461 23047 79416843
Lupus-like syndrome 19.01 9.68 15 304483 13842 79426048
Lacunar stroke 18.93 9.68 14 304484 374 79439516
Oedema 18.89 9.68 594 303904 118986 79320904
Blood alkaline phosphatase increased 18.89 9.68 345 304153 63319 79376571
Neutrophil count decreased 18.82 9.68 481 304017 93478 79346412
Panniculitis 18.80 9.68 12 304486 12359 79427531
Hypercalcaemia 18.79 9.68 227 304271 38203 79401687
Vaginal discharge 18.74 9.68 3 304495 7460 79432430
Irritability 18.70 9.68 87 304411 41057 79398833
Uveitis 18.68 9.68 22 304476 16808 79423082
Activated partial thromboplastin time shortened 18.68 9.68 20 304478 879 79439011
Haemorrhage intracranial 18.64 9.68 167 304331 26026 79413864
Full blood count decreased 18.58 9.68 170 304328 26649 79413241
Angioedema 18.53 9.68 400 304098 75635 79364255
Joint range of motion decreased 18.51 9.68 65 304433 33217 79406673
Abnormal loss of weight 18.41 9.68 72 304426 8304 79431586
Head discomfort 18.30 9.68 17 304481 14485 79425405
Respiratory tract congestion 18.23 9.68 30 304468 19924 79419966
Overlap syndrome 18.21 9.68 21 304477 1003 79438887
Blood pressure diastolic decreased 18.19 9.68 57 304441 30159 79409731
Rheumatoid nodule 18.10 9.68 24 304474 17414 79422476
Tongue disorder 18.09 9.68 16 304482 13959 79425931
Cerebral haemorrhage 17.99 9.68 315 304183 57358 79382532
Middle insomnia 17.98 9.68 114 304384 15955 79423935
Mantle cell lymphoma refractory 17.98 9.68 9 304489 115 79439775
Hepatitis acute 17.85 9.68 111 304387 15431 79424459
Serum ferritin abnormal 17.85 9.68 14 304484 409 79439481
N-terminal prohormone brain natriuretic peptide increased 17.81 9.68 49 304449 4706 79435184
Acute respiratory failure 17.79 9.68 323 304175 59218 79380672
Electrolyte depletion 17.76 9.68 14 304484 412 79439478
Tinnitus 17.72 9.68 98 304400 44235 79395655
White blood cell count increased 17.67 9.68 391 304107 74242 79365648
Aptyalism 17.65 9.68 18 304480 747 79439143
Infection 17.58 9.68 749 303749 240963 79198927
Abortion induced 17.54 9.68 3 304495 7106 79432784
Chest X-ray abnormal 17.52 9.68 68 304430 7815 79432075
Erysipelas 17.52 9.68 85 304413 10765 79429125
Genital erosion 17.50 9.68 14 304484 421 79439469
Colon cancer 17.49 9.68 105 304393 14418 79425472
Microcytic anaemia 17.47 9.68 52 304446 5222 79434668
Blood creatine increased 17.43 9.68 77 304421 9378 79430512
Anger 17.43 9.68 24 304474 17138 79422752
Tricuspid valve incompetence 17.42 9.68 132 304366 19580 79420310
Papillary muscle rupture 17.40 9.68 5 304493 10 79439880
Prostatomegaly 17.35 9.68 40 304458 3443 79436447
Dyskinesia 17.34 9.68 100 304398 44673 79395217
Renal disorder 17.34 9.68 241 304257 41864 79398026
Coma 17.30 9.68 275 304223 100374 79339516
Ventricular tachycardia 17.26 9.68 240 304258 41695 79398195
Device leakage 17.24 9.68 10 304488 10846 79429044
Vasculitis necrotising 17.23 9.68 23 304475 1277 79438613
Post-traumatic amnestic disorder 17.17 9.68 7 304491 53 79439837
Hypomagnesaemia 17.15 9.68 263 304235 46648 79393242
Gait spastic 17.14 9.68 22 304476 1175 79438715
Conjunctival hyperaemia 17.05 9.68 46 304452 4367 79435523
Cardiovascular insufficiency 16.84 9.68 36 304462 2945 79436945
Hyperglycaemia 16.81 9.68 369 304129 69966 79369924
Staphylococcal sepsis 16.81 9.68 105 304393 14621 79425269
Drug use disorder 16.80 9.68 6 304492 8645 79431245
Blood loss anaemia 16.76 9.68 109 304389 15389 79424501
Dyspepsia 16.72 9.68 303 304195 108384 79331506
Diffuse large B-cell lymphoma 16.71 9.68 91 304407 12058 79427832
Viral infection 16.70 9.68 96 304402 42920 79396970
Blood electrolytes abnormal 16.70 9.68 28 304470 1906 79437984
Injection site extravasation 16.69 9.68 8 304490 9661 79430229
Spontaneous haemorrhage 16.67 9.68 18 304480 799 79439091
Sensitivity to weather change 16.65 9.68 5 304493 8042 79431848
Fear 16.64 9.68 37 304461 21949 79417941
Oliguria 16.61 9.68 113 304385 16196 79423694
Anti-neutrophil cytoplasmic antibody positive vasculitis 16.60 9.68 41 304457 3688 79436202
Sleep disorder due to a general medical condition 16.57 9.68 18 304480 14259 79425631
Heart rate decreased 16.53 9.68 180 304318 70136 79369754
Rash macular 16.52 9.68 176 304322 28723 79411167
Red blood cell count decreased 16.49 9.68 310 304188 57203 79382687
Hyperpyrexia 16.46 9.68 56 304442 6036 79433854
Nephrogenic anaemia 16.43 9.68 42 304456 3860 79436030
Anaphylactic shock 16.42 9.68 76 304422 35920 79403970
Muscle spasticity 16.37 9.68 36 304462 21439 79418451
Necrotising ulcerative gingivostomatitis 16.33 9.68 6 304492 33 79439857
Hypophosphataemia 16.30 9.68 131 304367 19782 79420108
Somnolence 16.26 9.68 746 303752 238235 79201655
Rash pruritic 16.25 9.68 373 304125 71256 79368634
Acute coronary syndrome 16.22 9.68 137 304361 20996 79418894
Wrist deformity 16.13 9.68 29 304469 2088 79437802
Cardiac autonomic neuropathy 16.13 9.68 7 304491 63 79439827
Arrhythmia supraventricular 16.03 9.68 29 304469 2098 79437792
Sternal fracture 15.99 9.68 32 304466 2498 79437392
Diabetic nephropathy 15.97 9.68 35 304463 2912 79436978
Acute pulmonary oedema 15.95 9.68 101 304397 14129 79425761
Angina pectoris 15.94 9.68 282 304216 51450 79388440
Disseminated intravascular coagulation 15.93 9.68 208 304290 35634 79404256
Cholecystitis chronic 15.91 9.68 9 304489 9897 79429993
Nocturia 15.90 9.68 98 304400 13583 79426307
Paraesthesia oral 15.87 9.68 34 304464 20437 79419453
Pulmonary arterial hypertension 15.86 9.68 172 304326 28194 79411696
Neurotoxicity 15.86 9.68 192 304306 32326 79407564
Lens dislocation 15.82 9.68 9 304489 151 79439739
Diverticulum intestinal 15.80 9.68 70 304428 8535 79431355
Ovarian cyst 15.78 9.68 15 304483 12640 79427250
Emotional disorder 15.77 9.68 19 304479 14368 79425522
Human herpes virus 6 serology positive 15.74 9.68 10 304488 207 79439683
Extravasation blood 15.70 9.68 13 304485 411 79439479
Affect lability 15.68 9.68 12 304486 11247 79428643
Multiple-drug resistance 15.65 9.68 7 304491 8801 79431089
Adrenal insufficiency 15.60 9.68 56 304442 28431 79411459
Testicular swelling 15.59 9.68 22 304476 1288 79438602
Drug eruption 15.56 9.68 245 304253 43690 79396200
Gingival bleeding 15.53 9.68 111 304387 16165 79423725
Mandibular mass 15.53 9.68 10 304488 212 79439678
Catatonia 15.49 9.68 7 304491 8749 79431141
Weight decreased 15.48 9.68 1157 303341 354041 79085849
Iron deficiency 15.47 9.68 81 304417 10573 79429317
Dyspnoea at rest 15.43 9.68 62 304436 7240 79432650
Dermatosis 15.39 9.68 15 304483 589 79439301
Muscle haemorrhage 15.38 9.68 56 304442 6244 79433646
Malaise 15.32 9.68 1637 302861 488232 78951658
Pelvic mass 15.30 9.68 21 304477 1198 79438692
Schizophrenia 15.27 9.68 22 304476 15418 79424472
Adrenal cyst 15.26 9.68 9 304489 162 79439728
Myelodysplastic syndrome 15.26 9.68 180 304318 30121 79409769
Myeloblast percentage decreased 15.24 9.68 6 304492 41 79439849
Hepatic failure 15.23 9.68 323 304175 60889 79379001
Blood sodium decreased 15.21 9.68 194 304304 33061 79406829
Ischaemic cardiomyopathy 15.21 9.68 64 304434 7631 79432259
Pseudomonal sepsis 15.17 9.68 55 304443 6119 79433771
Blood pressure inadequately controlled 15.15 9.68 55 304443 6122 79433768
Scrotal oedema 15.12 9.68 24 304474 1561 79438329
Blood blister 15.11 9.68 35 304463 3022 79436868
Oxygen saturation decreased 15.10 9.68 376 304122 128671 79311219
Subcutaneous haematoma 15.07 9.68 33 304465 2744 79437146
Sinoatrial block 15.07 9.68 22 304476 1329 79438561
Cardiac amyloidosis 15.05 9.68 26 304472 1814 79438076
Monoparesis 15.00 9.68 38 304460 3473 79436417
Endocarditis 15.00 9.68 80 304418 10517 79429373
Actinic keratosis 15.00 9.68 54 304444 5988 79433902
Neovascularisation 14.95 9.68 21 304477 1224 79438666
Oropharyngeal pain 14.95 9.68 311 304187 109042 79330848
Subacute hepatic failure 14.93 9.68 10 304488 227 79439663
Orthopnoea 14.91 9.68 77 304421 9996 79429894
Gastritis haemorrhagic 14.91 9.68 32 304466 2625 79437265
Leukocyturia 14.90 9.68 27 304471 1956 79437934
Urate nephropathy 14.75 9.68 9 304489 173 79439717
Fracture blisters 14.75 9.68 7 304491 79 79439811
Impaired quality of life 14.73 9.68 20 304478 14366 79425524
Hysterectomy 14.72 9.68 3 304495 6269 79433621
Unresponsive to stimuli 14.69 9.68 139 304359 55649 79384241
Mucosal necrosis 14.68 9.68 8 304490 123 79439767
Osteopenia 14.65 9.68 30 304468 18334 79421556
Drug dose omission by device 14.64 9.68 3 304495 6247 79433643
Subdural haemorrhage 14.63 9.68 53 304445 5895 79433995
Confusional state 14.61 9.68 1407 303091 316590 79123300
Disturbance in attention 14.50 9.68 124 304374 50677 79389213
Transplant rejection 14.48 9.68 33 304465 19404 79420486
Visual impairment 14.44 9.68 256 304242 91875 79348015
Thrombotic microangiopathy 14.41 9.68 35 304463 20134 79419756
Nervousness 14.40 9.68 72 304426 33343 79406547
Shock 14.36 9.68 240 304258 43308 79396582
Soft tissue injury 14.35 9.68 25 304473 1756 79438134
Alanine aminotransferase abnormal 14.32 9.68 8 304490 8859 79431031
Pelvic pain 14.32 9.68 18 304480 13363 79426527
Uveitic glaucoma 14.27 9.68 4 304494 7 79439883
Oroantral fistula 14.24 9.68 12 304486 389 79439501
Infusion site pain 14.22 9.68 20 304478 14156 79425734
Administration site discomfort 14.18 9.68 8 304490 132 79439758
Acute myocardial infarction 14.17 9.68 390 304108 76646 79363244
Fibrin D dimer increased 14.12 9.68 68 304430 8586 79431304
Muscle spasms 14.09 9.68 535 303963 174195 79265695
Localised oedema 14.09 9.68 64 304434 7888 79432002
Oedema mouth 14.07 9.68 34 304464 3017 79436873
Unevaluable event 14 9.68 140 304358 55445 79384445
Chronic myeloid leukaemia transformation 13.99 9.68 10 304488 253 79439637
Hypoglycaemic coma 13.97 9.68 45 304453 4715 79435175
Respiratory tract haemorrhage 13.93 9.68 25 304473 1798 79438092
Tongue oedema 13.92 9.68 59 304439 7058 79432832
Ejection fraction decreased 13.87 9.68 197 304301 34380 79405510
Orthostatic hypotension 13.85 9.68 296 304202 55868 79384022
Laryngitis 13.85 9.68 25 304473 16014 79423876
Amenorrhoea 13.84 9.68 6 304492 7686 79432204
Scrotal erythema 13.84 9.68 5 304493 26 79439864
Malignant transformation 13.83 9.68 20 304478 1198 79438692
Suspected suicide 13.82 9.68 12 304486 10564 79429326
Vessel puncture site haemorrhage 13.80 9.68 9 304489 195 79439695
Helicobacter test positive 13.79 9.68 21 304477 1317 79438573
Uraemic encephalopathy 13.78 9.68 15 304483 672 79439218
Jaundice 13.76 9.68 283 304215 53066 79386824
Thrombin time prolonged 13.75 9.68 11 304487 331 79439559
Granulomatous dermatitis 13.73 9.68 12 304486 409 79439481
Oesophageal mucosal blister 13.72 9.68 3 304495 0 79439890
Acute lymphocytic leukaemia 13.71 9.68 46 304452 4923 79434967
Trichiasis 13.68 9.68 7 304491 94 79439796
Antipsychotic drug level increased 13.67 9.68 3 304495 5954 79433936
Pathogen resistance 13.64 9.68 21 304477 14321 79425569
Cystitis 13.62 9.68 132 304366 52600 79387290
Complication associated with device 13.61 9.68 29 304469 17467 79422423
B-cell unclassifiable lymphoma high grade 13.61 9.68 4 304494 9 79439881
Injection site discolouration 13.61 9.68 6 304492 7608 79432282
Abdominal wall wound 13.55 9.68 7 304491 96 79439794
Pylorus dilatation 13.53 9.68 5 304493 28 79439862
Bone marrow reticulin fibrosis 13.52 9.68 11 304487 339 79439551
Coating in mouth 13.49 9.68 10 304488 268 79439622
Productive cough 13.49 9.68 437 304061 87894 79351996
Chronic sinusitis 13.45 9.68 18 304480 13008 79426882
Preternatural anus 13.42 9.68 7 304491 98 79439792
Tachypnoea 13.40 9.68 184 304314 31879 79408011
Cerebral haematoma 13.39 9.68 63 304435 7879 79432011
Product storage error 13.38 9.68 26 304472 16200 79423690
Kidney infection 13.31 9.68 41 304457 21810 79418080
Hyperamylasaemia 13.26 9.68 19 304479 1128 79438762
Wound infection 13.25 9.68 47 304451 23944 79415946
Cytomegalovirus nephritis 13.24 9.68 8 304490 151 79439739
Renal cyst 13.22 9.68 99 304399 14633 79425257
Haematocrit decreased 13.21 9.68 317 304181 60995 79378895
Articular calcification 13.18 9.68 9 304489 211 79439679
Rash erythematous 13.15 9.68 301 304197 57468 79382422
Urinary hesitation 13.14 9.68 41 304457 4225 79435665
Hepatic function abnormal 13.13 9.68 369 304129 72738 79367152
Relapsing-remitting multiple sclerosis 13.13 9.68 22 304476 1497 79438393
Haematemesis 13.07 9.68 276 304222 51988 79387902
Ichthyosis acquired 13.04 9.68 4 304494 11 79439879
Tooth deposit 12.99 9.68 10 304488 284 79439606
Squamous cell carcinoma of skin 12.99 9.68 95 304403 13938 79425952
Diverticulum oesophageal 12.96 9.68 8 304490 157 79439733
Acid base balance abnormal 12.94 9.68 11 304487 361 79439529
Blood pressure ambulatory increased 12.93 9.68 6 304492 64 79439826
Bradyarrhythmia 12.91 9.68 40 304458 4106 79435784
Hip fracture 12.85 9.68 67 304431 30694 79409196
Pneumonia fungal 12.84 9.68 80 304418 11130 79428760
Facial pain 12.81 9.68 17 304481 12333 79427557
Acute graft versus host disease 12.73 9.68 12 304486 10155 79429735
Dermatitis 12.73 9.68 131 304367 21190 79418700
Forced expiratory volume decreased 12.69 9.68 7 304491 7807 79432083
Systemic inflammatory response syndrome 12.62 9.68 81 304417 11384 79428506
Nail disorder 12.62 9.68 16 304482 11836 79428054
Rhinitis allergic 12.62 9.68 17 304481 12252 79427638
Subclavian artery occlusion 12.57 9.68 8 304490 166 79439724
Needle issue 12.56 9.68 19 304479 13049 79426841
Sexual dysfunction 12.54 9.68 7 304491 7756 79432134
Decreased appetite 12.50 9.68 1492 303006 340926 79098964
Gastric polyps 12.46 9.68 37 304461 3710 79436180
Feeling hot 12.46 9.68 157 304341 59577 79380313
Hepatic cirrhosis 12.45 9.68 80 304418 34826 79405064
Muscle necrosis 12.45 9.68 21 304477 1437 79438453
Sinus disorder 12.41 9.68 44 304454 22420 79417470
Genital ulceration 12.40 9.68 18 304480 1082 79438808
Parakeratosis 12.39 9.68 11 304487 383 79439507
Hypoxia 12.38 9.68 497 304001 102746 79337144
Sudden cardiac death 12.38 9.68 46 304452 5179 79434711
Parathyroid hyperplasia 12.36 9.68 8 304490 171 79439719
Multiple allergies 12.35 9.68 13 304485 10447 79429443
Coagulation test abnormal 12.33 9.68 20 304478 1325 79438565
Erectile dysfunction 12.30 9.68 97 304401 14567 79425323
Mastication disorder 12.26 9.68 30 304468 2683 79437207
Transfusion 12.24 9.68 130 304368 21200 79418690
Transaminases increased 12.22 9.68 271 304227 51472 79388418
Palpitations 12.22 9.68 379 304119 126231 79313659
International normalised ratio abnormal 12.21 9.68 49 304449 5719 79434171
Ischaemic stroke 12.21 9.68 186 304312 32945 79406945
Hypoaesthesia oral 12.21 9.68 22 304476 14102 79425788
Dementia 12.20 9.68 146 304352 24513 79415377
Breast cancer metastatic 12.20 9.68 9 304489 8593 79431297
Vomiting 12.14 9.68 2299 302199 663529 78776361
Hypertensive crisis 12.11 9.68 127 304371 20643 79419247
Faeces discoloured 12.11 9.68 167 304331 28960 79410930
Carcinoma in situ of skin 12.08 9.68 8 304490 178 79439712
Adult failure to thrive 12.08 9.68 8 304490 178 79439712
Device use error 12.07 9.68 6 304492 7095 79432795
Splenic infarction 12.02 9.68 36 304462 3628 79436262
Ventricular arrhythmia 12.01 9.68 66 304432 8774 79431116
Bladder tamponade 12.00 9.68 13 304485 579 79439311
Nephrocalcinosis 11.99 9.68 21 304477 1481 79438409
Anticoagulation drug level decreased 11.97 9.68 8 304490 181 79439709
Transplant failure 11.96 9.68 42 304456 4599 79435291
Oesophagobronchial fistula 11.96 9.68 9 304489 247 79439643
Streptococcal sepsis 11.94 9.68 31 304467 2876 79437014
Pharyngitis streptococcal 11.90 9.68 14 304484 10700 79429190
Hyperparathyroidism 11.85 9.68 33 304465 3191 79436699
Female genital tract fistula 11.85 9.68 4 304494 5971 79433919
Peripheral circulatory failure 11.83 9.68 18 304480 1128 79438762
Mucormycosis 11.83 9.68 9 304489 8460 79431430
Injection site induration 11.82 9.68 12 304486 9807 79430083
Abnormal clotting factor 11.81 9.68 8 304490 185 79439705
Bacterial infection 11.68 9.68 176 304322 31104 79408786
Joint dislocation 11.64 9.68 30 304468 16909 79422981
Genital infection 11.63 9.68 8 304490 190 79439700
Fixed eruption 11.62 9.68 31 304467 2923 79436967
Pulmonary haemorrhage 11.61 9.68 96 304402 14621 79425269
Paraneoplastic syndrome 11.57 9.68 17 304481 1033 79438857
Throat tightness 11.54 9.68 61 304437 27846 79412044
Gastritis 11.54 9.68 252 304246 47741 79392149
Temperature intolerance 11.53 9.68 12 304486 9693 79430197
Tachycardia induced cardiomyopathy 11.52 9.68 8 304490 193 79439697
Rheumatoid factor negative 11.52 9.68 18 304480 1155 79438735
Eye pain 11.51 9.68 90 304408 37488 79402402
Herpes zoster 11.49 9.68 269 304229 92814 79347076
Superinfection 11.48 9.68 43 304455 4859 79435031
Temperature regulation disorder 11.47 9.68 4 304494 5849 79434041
Papillary renal cell carcinoma 11.39 9.68 9 304489 266 79439624
Immunosuppressant drug level increased 11.34 9.68 66 304432 8961 79430929
Gastric ulcer haemorrhage 11.34 9.68 66 304432 8961 79430929
Cytogenetic analysis abnormal 11.32 9.68 18 304480 1172 79438718
Implant site inflammation 11.30 9.68 9 304489 269 79439621
Gallbladder disorder 11.28 9.68 37 304461 19303 79420587
Drug level above therapeutic 11.28 9.68 10 304488 8713 79431177
Retinitis viral 11.23 9.68 7 304491 140 79439750
Leukostasis syndrome 11.20 9.68 6 304492 89 79439801
Eyelid oedema 11.18 9.68 90 304408 13597 79426293
Scleral haemorrhage 11.18 9.68 7 304491 141 79439749
Pancreatitis acute 11.15 9.68 258 304240 49346 79390544
C-reactive protein increased 11.14 9.68 601 303897 128426 79311464
Brain oedema 11.14 9.68 54 304444 25209 79414681
Immunodeficiency 11.13 9.68 44 304454 21724 79418166
Circulatory collapse 11.13 9.68 204 304294 37464 79402426
Metastases to lymph nodes 11.11 9.68 14 304484 10383 79429507
Drug level decreased 11.10 9.68 24 304474 14378 79425512
Therapy interrupted 11.09 9.68 72 304426 31269 79408621
Coronary artery disease 11.08 9.68 328 304170 65146 79374744
Genital haemorrhage 11.07 9.68 5 304493 6250 79433640
Dry eye 11.06 9.68 89 304409 36842 79403048
Incorrect product administration duration 11.06 9.68 18 304480 12004 79427886
Hydrothorax 11.05 9.68 20 304478 1448 79438442
Hypogammaglobulinaemia 11.04 9.68 86 304412 12865 79427025
Chronic lymphocytic leukaemia recurrent 11.04 9.68 13 304485 635 79439255
Crystal arthropathy 11.04 9.68 8 304490 207 79439683
Inflammation 11.01 9.68 273 304225 93480 79346410
Hypercholesterolaemia 10.99 9.68 48 304450 23047 79416843
Tension headache 10.95 9.68 7 304491 7204 79432686
Hepatic calcification 10.94 9.68 10 304488 362 79439528
Oxygen consumption decreased 10.94 9.68 11 304487 449 79439441
Arteriospasm coronary 10.93 9.68 6 304492 6710 79433180
Coronary artery aneurysm 10.93 9.68 7 304491 147 79439743
Ear discomfort 10.90 9.68 10 304488 8573 79431317
Prothrombin time abnormal 10.90 9.68 17 304481 1089 79438801
Acute graft versus host disease in skin 10.87 9.68 8 304490 7650 79432240
Cerebellar stroke 10.86 9.68 12 304486 547 79439343
Reactive gastropathy 10.84 9.68 12 304486 548 79439342
Hypertonic bladder 10.81 9.68 38 304460 4163 79435727
Haemorrhoidal haemorrhage 10.80 9.68 53 304445 6742 79433148
Secretion discharge 10.79 9.68 26 304472 14996 79424894
Lactose intolerance 10.78 9.68 26 304472 2304 79437586
Duodenal ulcer haemorrhage 10.77 9.68 55 304443 7108 79432782
Potentiating drug interaction 10.77 9.68 64 304434 8755 79431135
Incorrect dose administered 10.75 9.68 217 304281 76413 79363477
Eosinopenia 10.72 9.68 5 304493 54 79439836
Portal vein flow decreased 10.72 9.68 5 304493 54 79439836
Enterococcal infection 10.71 9.68 99 304399 15561 79424329
Pulmonary sarcoidosis 10.67 9.68 19 304479 1358 79438532
Aspartate aminotransferase increased 10.66 9.68 639 303859 138002 79301888
Mesenteric panniculitis 10.64 9.68 10 304488 375 79439515
Analgesic therapy 10.63 9.68 16 304482 993 79438897
Alanine aminotransferase increased 10.63 9.68 739 303759 161831 79278059
Transient acantholytic dermatosis 10.60 9.68 7 304491 155 79439735
Orthostatic intolerance 10.60 9.68 23 304475 1901 79437989
Sleep inertia 10.60 9.68 4 304494 24 79439866
Human herpesvirus 6 infection reactivation 10.58 9.68 12 304486 563 79439327
Upper respiratory tract infection 10.56 9.68 266 304232 90902 79348988
Light chain disease 10.55 9.68 8 304490 222 79439668
Duodenal stenosis 10.55 9.68 14 304484 773 79439117
Adenovirus infection 10.54 9.68 10 304488 8437 79431453
Walking aid user 10.50 9.68 14 304484 10134 79429756
Drug screen positive 10.49 9.68 5 304493 6058 79433832
Neuroglycopenia 10.47 9.68 11 304487 473 79439417
Blood hyposmosis 10.46 9.68 4 304494 25 79439865
Pseudohyperkalaemia 10.44 9.68 3 304495 6 79439884
Brain stem ischaemia 10.44 9.68 9 304489 301 79439589
Amylase increased 10.44 9.68 76 304422 11133 79428757
Osteonecrosis of jaw 10.42 9.68 110 304388 43116 79396774
Transfusion reaction 10.42 9.68 22 304476 1784 79438106
Urine output decreased 10.41 9.68 110 304388 17912 79421978
Thyroid disorder 10.41 9.68 24 304474 14055 79425835
Cerebral infarction 10.40 9.68 238 304260 45438 79394452
Maternal condition affecting foetus 10.37 9.68 7 304491 161 79439729
Aplasia 10.37 9.68 58 304440 7762 79432128
Myelosuppression 10.35 9.68 101 304397 40195 79399695
Retroperitoneal fibrosis 10.34 9.68 13 304485 680 79439210
Dry skin 10.32 9.68 190 304308 67805 79372085
Macular degeneration 10.31 9.68 17 304481 11279 79428611
Upper-airway cough syndrome 10.30 9.68 18 304480 11675 79428215
Drug therapeutic incompatibility 10.30 9.68 7 304491 163 79439727
Myopathy 10.29 9.68 122 304376 20441 79419449
Tongue dry 10.27 9.68 17 304481 1145 79438745
Blood uric acid decreased 10.27 9.68 18 304480 1270 79438620
Oral herpes 10.27 9.68 62 304436 27392 79412498
Atrioventricular block 10.24 9.68 90 304408 13951 79425939
Acquired epidermolysis bullosa 10.23 9.68 6 304492 107 79439783
Interstitial granulomatous dermatitis 10.19 9.68 8 304490 234 79439656
Bladder dilatation 10.19 9.68 24 304474 2095 79437795
Granuloma 10.15 9.68 10 304488 8287 79431603
Prolymphocytic leukaemia 10.13 9.68 3 304495 7 79439883
Heat stroke 10.12 9.68 21 304477 1682 79438208
Diverticular perforation 10.12 9.68 47 304451 5846 79434044
Dyshidrotic eczema 10.11 9.68 12 304486 591 79439299
Night sweats 10.11 9.68 139 304359 51956 79387934
Drooling 10.10 9.68 5 304493 5929 79433961
Neutropenic infection 10.09 9.68 26 304472 2401 79437489
Obsessive-compulsive disorder 10.08 9.68 5 304493 5922 79433968
Endocarditis candida 10.08 9.68 6 304492 110 79439780
Blast cells present 10.08 9.68 15 304483 922 79438968
JC virus CSF test positive 10.08 9.68 7 304491 169 79439721
Respiratory distress 10.07 9.68 293 304205 58046 79381844
Lower gastrointestinal haemorrhage 10.07 9.68 100 304398 16025 79423865
Acinetobacter sepsis 10.05 9.68 5 304493 63 79439827
Mucosal haemorrhage 10.03 9.68 27 304471 2559 79437331
Restless legs syndrome 10.03 9.68 41 304457 20051 79419839
Renal tubular atrophy 10.01 9.68 22 304476 1834 79438056
Neoplasm progression 9.99 9.68 138 304360 51544 79388346
Libido increased 9.99 9.68 23 304475 1978 79437912
Amaurosis 9.96 9.68 17 304481 1174 79438716
Lacrimation increased 9.94 9.68 48 304450 22429 79417461
Lip haemorrhage 9.93 9.68 17 304481 1177 79438713
Sneezing 9.93 9.68 40 304458 19643 79420247
Pulmonary sepsis 9.92 9.68 34 304464 3678 79436212
Congestive cardiomyopathy 9.92 9.68 78 304420 11702 79428188
Bronchospasm 9.91 9.68 55 304443 24804 79415086
Immature granulocyte count increased 9.91 9.68 12 304486 604 79439286
Ventricular internal diameter abnormal 9.91 9.68 8 304490 244 79439646
Inguinal hernia 9.89 9.68 50 304448 6438 79433452
Hostility 9.87 9.68 25 304473 2285 79437605
Hereditary angioedema 9.86 9.68 4 304494 5331 79434559
Testicular cancer metastatic 9.85 9.68 5 304493 66 79439824
Accidental overdose 9.84 9.68 100 304398 39481 79400409
Infusion site erythema 9.84 9.68 13 304485 9447 79430443
Granulomatous liver disease 9.83 9.68 18 304480 1315 79438575
Xerosis 9.81 9.68 17 304481 1189 79438701
Anal haemorrhage 9.80 9.68 37 304461 4197 79435693
Gait inability 9.78 9.68 162 304336 58755 79381135
Haemorrhagic stroke 9.78 9.68 74 304424 10972 79428918
Salivary gland cancer stage IV 9.78 9.68 5 304493 67 79439823
Therapeutic response unexpected 9.77 9.68 41 304457 19905 79419985
X-ray abnormal 9.75 9.68 5 304493 5808 79434082
Sudden death 9.74 9.68 130 304368 22381 79417509

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M04AA01 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations inhibiting uric acid production
ATC M04AA51 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations inhibiting uric acid production
FDA MoA N0000000206 Xanthine Oxidase Inhibitors
MeSH PA D000963 Antimetabolites
MeSH PA D000975 Antioxidants
MeSH PA D018501 Antirheumatic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D016166 Free Radical Scavengers
MeSH PA D006074 Gout Suppressants
MeSH PA D009676 Noxae
FDA EPC N0000175698 Xanthine Oxidase Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35634 xanthine oxidase inhibitors
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:48578 free radical scavengers

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

DiseaseRelationSNOMED_IDDOID
Hyperuricemia indication 35885006 DOID:1920
Articular gout indication 48440001 DOID:13189
Gout indication 90560007 DOID:13189
Uric acid renal calculus indication 274401005
Calcium renal calculus indication 427649000
Uric Acid Nephropathy Gout indication
Chemotherapy-Induced Hyperuricemia indication
Recurrent Calcium Renal Calculi indication
Adjunctive treatment for bipolar disorder off-label use 13746004 DOID:3312
Deficiency of adenine phosphoribosyltransferase off-label use 124274002 DOID:0060350
Deficiency of ribose-phosphate pyrophosphokinase off-label use 124343001
Neonatal Phosphoribosylpyrophosphate Synthetase Superactivity off-label use
Dehydration contraindication 34095006
Chronic heart failure contraindication 48447003
Hypersensitivity angiitis contraindication 60555002
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 acidic
pKa2 9.43 acidic
pKa3 1.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 10183012 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8283369 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 10183012 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8283369 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8546437 April 29, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8546437 April 29, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8084483 Aug. 17, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8084483 Aug. 17, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8357713 Dec. 22, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8357713 Dec. 22, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9216179 Aug. 1, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9216179 Aug. 1, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9956205 Dec. 28, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9956205 Dec. 28, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Xanthine dehydrogenase/oxidase Enzyme INHIBITOR Ki 5.15 CHEMBL CHEMBL
Adenosine receptor A2a GPCR Kd 4.11 CHEMBL
Hypoxanthine-guanine phosphoribosyltransferase Enzyme WOMBAT-PK
Xanthine dehydrogenase/oxidase Enzyme Ki 6 CHEMBL
Xanthine dehydrogenase/oxidase Enzyme IC50 6.12 CHEMBL
Shiga toxin subunit A Ribosomal protein IC50 4.62 CHEMBL

External reference:

IDSource
4017895 VUID
N0000146247 NUI
D00224 KEGG_DRUG
17795-21-0 SECONDARY_CAS_RN
203600 RXNORM
C0002144 UMLSCUI
CHEBI:40279 CHEBI
CHEMBL1467 ChEMBL_ID
135401907 PUBCHEM_CID
DB00437 DRUGBANK_ID
D000493 MESH_DESCRIPTOR_UI
1731 INN_ID
6795 IUPHAR_LIGAND_ID
63CZ7GJN5I UNII
25246002 SNOMEDCT_US
387135004 SNOMEDCT_US
425496004 SNOMEDCT_US
CHEMBL1200477 ChEMBL_ID
4017895 VANDF
1590 MMSL
1816 MMSL
4150 MMSL
8255 MMSL
8256 MMSL
d00023 MMSL
001084 NDDF
005000 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Allopurinol sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9533 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 32 sections
Allopurinol sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9533 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 32 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0137 TABLET 100 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0137 TABLET 100 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0181 TABLET 300 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0181 TABLET 300 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5543 TABLET 100 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5543 TABLET 100 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5544 TABLET 300 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5544 TABLET 300 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2115 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2115 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2116 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2116 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-8321 TABLET 100 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-8385 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6571 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6571 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-7041 TABLET 100 mg ORAL ANDA 16 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-545 TABLET 100 mg ORAL ANDA 17 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-547 TABLET 300 mg ORAL ANDA 17 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-911 TABLET 300 mg ORAL ANDA 19 sections
Allopurinol Human Prescription Drug Label 1 16571-883 TABLET 100 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Allopurinol Human Prescription Drug Label 1 16571-883 TABLET 100 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Allopurinol Human Prescription Drug Label 1 16571-884 TABLET 200 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Allopurinol Human Prescription Drug Label 1 16571-884 TABLET 200 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Allopurinol Human Prescription Drug Label 1 16571-885 TABLET 300 mg ORAL NDA AUTHORIZED GENERIC 19 sections