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

Stem definitionDrug idCAS RN
phenylazosalicylic acid derivatives antibacterial 1710 89-57-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • 5-ASA
  • mesalamine
  • 2-Hydroxy-5-aminobenzoic acid
  • 3-Carboxy-4-hydroxyaniline
  • 5-Amino-2-hydroxybenzoic acid
  • 5-Aminosalicylic acid
  • claversal
  • mesacol
  • mesalazine
  • mesalsal
  • mesasal
  • m-Aminosalicylic acid
  • mesalamine hydrochloride
  • mesalamine HCl
An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)
  • Molecular weight: 153.14
  • Formula: C7H7NO3
  • CLOGP: 1.06
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 83.55
  • ALOGS: -1.10
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.50 g O
1.50 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.84 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 7 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 447.77 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.33 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.39 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.61 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 3 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.634 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.785 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 5.023 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.038 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 22.340 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 42.120 % High 1
herg hERG pIC50 4.607 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.510 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.184 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 23.400 % High 1
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AURKB,AURKC,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHA2,EPHB4,ERBB2,FGFR1,FLT1,FLT3,FLT4,GRK2,GRK3,GSK3B,IGF1R,IKBKB,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K1,MAP3K10,MAP3K14,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK10,MAPK12,MAPK14,MAPK7,MAPK8,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MELK,MTOR,NTRK1,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIM1,PIM2,PLK1,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK10,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ULK2,ZAP70 90
kinase-selectivity-class ACVR2A,ACVR2B,AURKB,AXL,BMX,BRAF,CAMK2B,CAMK2D,CDK4,CDK9,DDR1,DYRK1B,DYRK3,EIF2AK3,EPHB4,ERBB2,FGFR1,GRK2,HIPK2,IKBKB,JAK2,MAP2K3,MAP2K6,MAP3K14,MAP3K2,MAPK1,MAPK12,MAPK7,MAPK8,MARK4,PIK3CB,PIM3,PRKDC,SIK2,STK10,STK33,SYK,TEK,TGFBR1,TTK,UHMK1,ULK1,ULK2 43
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.528 High 1
mh-clint Mouse hepatocyte intrinsic clearance 4.325 High 1
mppb Mouse plasma protein binding (% unbound) 52.130 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.274 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 24.150 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.164 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.200 % High 1
rppb Rat plasma protein binding (% unbound) 23.150 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 914.113 uM High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1987 FDA MEDA PHARMS

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
Colitis ulcerative 3594.54 10.84 1835 150251 58431 90417930
Haematochezia 1560.71 10.84 1141 150945 69772 90406589
Frequent bowel movements 1376.24 10.84 970 151116 55965 90420396
Rectal haemorrhage 656.76 10.84 751 151335 81993 90394368
Off label use 578.60 10.84 3481 148605 1098771 89377590
Lupus-like syndrome 514.06 10.84 515 151571 48331 90428030
Macular degeneration 501.71 10.84 454 151632 37516 90438845
Retinitis 452.39 10.84 431 151655 38027 90438334
Abdominal pain 391.10 10.84 1503 150583 394218 90082143
Faecal calprotectin increased 386.74 10.84 170 151916 3817 90472544
Condition aggravated 382.54 10.84 1989 150097 593556 89882805
Mucous stools 377.33 10.84 182 151904 5089 90471272
Joint dislocation 357.56 10.84 407 151679 44175 90432186
Exostosis 342.38 10.84 434 151652 52700 90423661
Bone erosion 336.79 10.84 430 151656 52591 90423770
Laryngitis 324.57 10.84 413 151673 50340 90426021
Hepatic cirrhosis 315.25 10.84 456 151630 62797 90413564
Diarrhoea haemorrhagic 312.91 10.84 205 151881 10458 90465903
Toxicity to various agents 311.33 10.84 54 152032 287792 90188569
Proctitis 298.45 10.84 229 151857 15030 90461331
Fall 294.30 10.84 227 151859 481583 89994778
Death 275.14 10.84 218 151868 456333 90020028
Foot deformity 268.51 10.84 410 151676 59241 90417120
Ear infection 259.92 10.84 440 151646 69335 90407026
Therapeutic reaction time decreased 254.89 10.84 124 151962 3534 90472827
Inappropriate schedule of product administration 244.31 10.84 676 151410 149257 90327104
Lupus vulgaris 243.96 10.84 338 151748 44721 90431640
Crohn's disease 241.15 10.84 131 151955 4720 90471641
Defaecation urgency 233.50 10.84 140 151946 6102 90470259
Colitis 221.74 10.84 411 151675 69531 90406830
Completed suicide 211.77 10.84 7 152079 145051 90331310
Red blood cell sedimentation rate increased 208.33 10.84 441 151645 82154 90394207
Female genital tract fistula 207.71 10.84 199 151887 17669 90458692
Drug level below therapeutic 201.05 10.84 124 151962 5690 90470671
Joint stiffness 199.51 10.84 419 151667 77623 90398738
Acute kidney injury 195.38 10.84 151 151935 320236 90156125
Porphyria acute 191.76 10.84 191 151895 17784 90458577
Vaginal flatulence 184.60 10.84 160 151926 12478 90463883
Weight decreased 182.52 10.84 1176 150910 378734 90097627
Osteoporosis 179.25 10.84 457 151629 96074 90380287
Pancreatitis 173.97 10.84 371 151715 69455 90406906
Dislocation of vertebra 171.30 10.84 324 151762 55644 90420717
Autoimmune disorder 165.61 10.84 385 151701 76359 90400002
Deep vein thrombosis postoperative 159.17 10.84 361 151725 70448 90405913
Loss of therapeutic response 158.04 10.84 71 152015 1681 90474680
Intentional product use issue 153.82 10.84 746 151340 216146 90260215
Febrile neutropenia 152.06 10.84 39 152047 158310 90318051
Clostridium difficile infection 151.74 10.84 241 151845 36004 90440357
Visual impairment 150.74 10.84 527 151559 131838 90344523
Drug interaction 150.63 10.84 145 151941 276308 90200053
Rectal tenesmus 150.48 10.84 61 152025 1111 90475250
Chronic sinusitis 149.47 10.84 192 151894 23610 90452751
Adjustment disorder with depressed mood 148.89 10.84 308 151778 56445 90419916
Neutropenia 148.89 10.84 97 151989 224807 90251554
Radiculopathy 148.43 10.84 169 151917 18336 90458025
Vaginal discharge 146.46 10.84 172 151914 19292 90457069
Anti-cyclic citrullinated peptide antibody 145.54 10.84 203 151883 27018 90449343
Hypotension 143.57 10.84 202 151884 325195 90151166
Pregnancy 143.56 10.84 320 151766 61727 90414634
Hypercholesterolaemia 132.92 10.84 422 151664 100470 90375891
Walking aid user 128.35 10.84 221 151865 35285 90441076
Malignant neoplasm progression 127.21 10.84 15 152071 106855 90369506
Overdose 126.57 10.84 53 152033 157656 90318705
Product residue present 124.69 10.84 82 152004 4209 90472152
Arthritis 122.57 10.84 581 151505 166734 90309627
Seronegative arthritis 120.69 10.84 151 151935 18083 90458278
White blood cell count decreased 117.66 10.84 67 152019 167042 90309319
Drug specific antibody present 117.24 10.84 87 151999 5427 90470934
Platelet count decreased 116.58 10.84 42 152044 136927 90339434
Drug level decreased 116.19 10.84 110 151976 9620 90466741
Dyspnoea 113.22 10.84 941 151145 880014 89596347
Intentional overdose 112.11 10.84 13 152073 93821 90382540
Paraesthesia oral 111.75 10.84 195 151891 31464 90444897
Grip strength 110.21 10.84 103 151983 8862 90467499
C-reactive protein increased 109.81 10.84 597 151489 180792 90295569
Neuropathy peripheral 108.36 10.84 47 152039 136923 90339438
X-ray abnormal 107.02 10.84 236 151850 45188 90431173
Atrial fibrillation 103.88 10.84 47 152039 133564 90342797
Inflammatory bowel disease 101.98 10.84 78 152008 5093 90471268
Lower limb fracture 101.57 10.84 344 151742 84669 90391692
Fistula 101.38 10.84 113 151973 11976 90464385
Intestinal stenosis 101.10 10.84 65 152021 3209 90473152
Wound infection 99.73 10.84 398 151688 106004 90370357
Hyponatraemia 93.34 10.84 54 152032 133484 90342877
Oral candidiasis 91.32 10.84 191 151895 35264 90441097
Procedural pain 90.98 10.84 184 151902 33176 90443185
Therapeutic product effect incomplete 90.35 10.84 596 151490 193300 90283061
Road traffic accident 90.21 10.84 389 151697 107237 90369124
Seizure 89.12 10.84 75 152011 152554 90323807
Blood creatinine increased 88.14 10.84 30 152056 101356 90375005
Disease progression 85.42 10.84 82 152004 156533 90319828
Cardiac failure congestive 84.43 10.84 30 152056 98664 90377697
Cardiac failure 84.37 10.84 39 152047 109457 90366904
Premature labour 84.14 10.84 108 151978 13268 90463093
Cardiac arrest 83.01 10.84 36 152050 104899 90371462
Poor venous access 81.95 10.84 130 151956 19397 90456964
Large intestinal stenosis 80.65 10.84 51 152035 2446 90473915
Gastrointestinal inflammation 80.53 10.84 76 152010 6620 90469741
Coma 79.83 10.84 13 152073 72619 90403742
Electrocardiogram QT prolonged 79.57 10.84 13 152073 72443 90403918
Erythema nodosum 78.65 10.84 70 152016 5654 90470707
Sciatica 78.59 10.84 358 151728 101024 90375337
Depressed level of consciousness 75.72 10.84 15 152071 72769 90403592
Ileal stenosis 73.58 10.84 48 152038 2430 90473931
Balance disorder 71.12 10.84 37 152049 97043 90379318
Prescribed underdose 69.79 10.84 280 151806 74739 90401622
Dyspepsia 69.35 10.84 569 151517 197591 90278770
Osteoarthritis 69.02 10.84 563 151523 195167 90281194
Somnolence 68.55 10.84 156 151930 208928 90267433
Feeling hot 68.50 10.84 286 151800 77722 90398639
Grip strength decreased 66.68 10.84 320 151766 92256 90384105
Cytomegalovirus colitis 66.61 10.84 51 152035 3335 90473026
Gastrooesophageal reflux disease 65.87 10.84 111 151975 166226 90310135
Anal abscess 65.25 10.84 63 152023 5645 90470716
Thrombocytopenia 65.02 10.84 160 151926 208565 90267796
Renal failure 64.26 10.84 75 152011 130932 90345429
Anal fistula 63.92 10.84 55 152031 4246 90472115
Overlap syndrome 63.42 10.84 75 152011 8473 90467888
Spondylitis 63.13 10.84 97 151989 14081 90462280
Abdominal pain lower 62.47 10.84 149 151937 30028 90446333
Drug abuse 62.41 10.84 30 152056 82317 90394044
Sedation 61.94 10.84 5 152081 48166 90428195
Flatulence 61.92 10.84 181 151905 41186 90435175
Segmental diverticular colitis 60.63 10.84 19 152067 155 90476206
Hypoxia 60.25 10.84 23 152063 72376 90403985
Hypoglycaemia 60.14 10.84 21 152065 69827 90406534
Respiratory failure 60.03 10.84 66 152020 118352 90358009
Urinary tract infection 58.85 10.84 288 151798 305344 90171017
Breast cancer stage III 58.73 10.84 289 151797 84158 90392203
Epistaxis 58.66 10.84 35 152051 85090 90391271
Contraindicated product administered 58.62 10.84 307 151779 319832 90156529
Infusion related reaction 58.31 10.84 1003 151083 415777 90060584
Drug ineffective 58.31 10.84 2858 149228 1381440 89094921
Cardio-respiratory arrest 57.88 10.84 17 152069 63123 90413238
Lactic acidosis 57.83 10.84 8 152078 50455 90425906
Amnesia 57.65 10.84 345 151741 108160 90368201
Cryopyrin associated periodic syndrome 57.63 10.84 25 152061 543 90475818
Swollen joint count increased 57.44 10.84 351 151735 110855 90365506
Rash 56.87 10.84 967 151119 795133 89681228
Hyperkalaemia 56.85 10.84 19 152067 64945 90411416
Delirium 56.85 10.84 334 151752 104025 90372336
Cough 56.82 10.84 374 151712 368588 90107773
Product dose omission issue 56.66 10.84 274 151812 291413 90184948
Neoplasm progression 56.15 10.84 5 152081 44481 90431880
Large intestinal ulcer 56.01 10.84 49 152037 3868 90472493
Oral allergy syndrome 55.73 10.84 16 152070 93 90476268
Tremor 55.47 10.84 108 151978 153065 90323296
Organising pneumonia 55.28 10.84 66 152020 7531 90468830
Intestinal obstruction 55.13 10.84 162 151924 36969 90439392
White blood cell count increased 54.77 10.84 241 151845 67000 90409361
Agitation 54.71 10.84 22 152064 67076 90409285
Pulmonary fibrosis 54.07 10.84 337 151749 107166 90369195
Therapeutic response shortened 54.03 10.84 119 151967 22760 90453601
Multiple sclerosis relapse 53.95 10.84 11 152075 52294 90424067
Drug level above therapeutic 53.42 10.84 57 152029 5752 90470609
Device expulsion 53.26 10.84 4 152082 40882 90435479
Blood glucose increased 52.94 10.84 49 152037 95197 90381164
Hypoaesthesia 52.91 10.84 780 151306 313430 90162931
Eosinophilic pneumonia 52.87 10.84 41 152045 2732 90473629
Chronic obstructive pulmonary disease 52.81 10.84 29 152057 73800 90402561
Neutrophil count decreased 52.79 10.84 27 152059 71505 90404856
Sepsis 52.05 10.84 143 151943 179671 90296690
Pedal pulse abnormal 52.02 10.84 18 152068 206 90476155
Hyperglycaemia 51.99 10.84 11 152075 50959 90425402
Rectal abscess 51.88 10.84 32 152054 1468 90474893
Intestinal fistula 51.28 10.84 28 152058 1019 90475342
Faeces soft 50.99 10.84 63 152023 7448 90468913
Steroid dependence 50.95 10.84 37 152049 2232 90474129
Oedema peripheral 50.62 10.84 658 151428 257257 90219104
Myocardial infarction 50.55 10.84 62 152024 105910 90370451
Alanine aminotransferase increased 49.64 10.84 76 152010 118262 90358099
Pain 49.47 10.84 1284 150802 995057 89481304
Blood pressure fluctuation 49.05 10.84 196 151890 52217 90424144
Pyoderma gangrenosum 48.66 10.84 48 152038 4416 90471945
Proctalgia 48.15 10.84 64 152022 8134 90468227
Anal fissure 48.04 10.84 52 152034 5333 90471028
Cerebrovascular accident 46.57 10.84 85 152001 123448 90352913
Exposure during pregnancy 46.26 10.84 607 151479 237803 90238558
Intestinal anastomosis 46.11 10.84 25 152061 897 90475464
Injection site reaction 45.92 10.84 52 152034 92028 90384333
Cognitive disorder 45.80 10.84 30 152056 69377 90406984
Accidental exposure to product 45.63 10.84 8 152078 42358 90434003
Drug-induced liver injury 45.34 10.84 283 151803 90035 90386326
Femur fracture 44.89 10.84 11 152075 46071 90430290
Suicidal ideation 44.71 10.84 35 152051 73820 90402541
Oxygen saturation decreased 44.15 10.84 70 152016 107413 90368948
Rheumatoid factor positive 43.94 10.84 461 151625 171189 90305172
Hyperhidrosis 43.61 10.84 103 151983 136202 90340159
Calcium ionised decreased 43.32 10.84 18 152068 350 90476011
Aspartate aminotransferase increased 43.28 10.84 66 152020 102871 90373490
Metabolic acidosis 42.62 10.84 20 152066 55656 90420705
Helicobacter infection 42.53 10.84 574 151512 226276 90250085
Disability 41.91 10.84 157 151929 40588 90435773
Syncope 41.85 10.84 101 151985 132562 90343799
Unresponsive to stimuli 41.50 10.84 7 152079 38114 90438247
Joint range of motion decreased 41.42 10.84 378 151708 135265 90341096
Facet joint syndrome 41.37 10.84 295 151791 98094 90378267
Hip arthroplasty 40.28 10.84 242 151844 75966 90400395
Maternal exposure timing unspecified 40.21 10.84 105 151981 22378 90453983
Endometriosis 40.17 10.84 51 152035 6197 90470164
Spinal fusion surgery 39.94 10.84 73 152013 12210 90464151
Therapy interrupted 39.93 10.84 17 152069 50091 90426270
Loss of consciousness 39.49 10.84 113 151973 140125 90336236
Suicide attempt 39.35 10.84 41 152045 75358 90401003
Full blood count abnormal 39.22 10.84 7 152079 36590 90439771
Rheumatic fever 39.08 10.84 411 151675 152710 90323651
Tubulointerstitial nephritis 39.00 10.84 112 151974 25231 90451130
Fibromyalgia 38.69 10.84 522 151564 205747 90270614
Cardiac disorder 38.33 10.84 24 152062 56848 90419513
Stoma closure 38.30 10.84 14 152072 190 90476171
Hypervolaemia 37.99 10.84 5 152081 32752 90443609
Anorectal discomfort 37.57 10.84 35 152051 2999 90473362
Hepatitis 37.45 10.84 38 152048 70701 90405660
Stress 37.15 10.84 249 151837 81146 90395215
Bradycardia 36.97 10.84 52 152034 83795 90392566
Liver injury 36.80 10.84 443 151643 170124 90306237
Anal incontinence 36.73 10.84 83 152003 16147 90460214
Dysarthria 36.70 10.84 23 152063 54459 90421902
Gastric disorder 36.63 10.84 6 152080 33378 90442983
Product use issue 36.48 10.84 766 151320 329153 90147208
Myocarditis 36.28 10.84 75 152011 13731 90462630
Device dislocation 36.05 10.84 5 152081 31477 90444884
Abnormal faeces 35.97 10.84 50 152036 6632 90469729
Disturbance in attention 35.94 10.84 17 152069 47092 90429269
Finger deformity 35.90 10.84 6 152080 32891 90443470
Dyspnoea exertional 35.85 10.84 41 152045 72247 90404114
Maternal exposure during breast feeding 35.68 10.84 48 152038 6172 90470189
Back pain 35.65 10.84 350 151736 316825 90159536
Swollen joint count 35.47 10.84 57 152029 8596 90467765
Colectomy total 35.46 10.84 13 152073 178 90476183
Diabetes mellitus 35.32 10.84 34 152052 64841 90411520
Intentional product misuse 35.27 10.84 60 152026 89544 90386817
Renal impairment 35.07 10.84 78 152008 105343 90371018
Colon dysplasia 34.78 10.84 12 152074 136 90476225
Sleep disorder due to a general medical condition 34.67 10.84 158 151928 44580 90431781
Pulmonary hypertension 34.57 10.84 14 152072 42509 90433852
Small intestinal stenosis 34.46 10.84 19 152067 705 90475656
Mental status changes 34.28 10.84 16 152070 44663 90431698
Drug withdrawal syndrome 34.25 10.84 4 152082 28719 90447642
Coeliac disease 34.18 10.84 16 152070 44594 90431767
Social problem 34.03 10.84 23 152063 1236 90475125
Type 2 diabetes mellitus 33.96 10.84 504 151582 202740 90273621
Hypercalcaemia 33.69 10.84 8 152078 34232 90442129
Encephalopathy 33.57 10.84 18 152068 46426 90429935
Prescribed overdose 33.41 10.84 279 151807 97346 90379015
Full blood count decreased 33.33 10.84 5 152081 29684 90446677
Gastrointestinal stenosis 33.33 10.84 14 152072 280 90476081
Vision blurred 33.20 10.84 86 152000 110207 90366154
Mucosal inflammation 32.79 10.84 29 152057 57596 90418765
Multiple organ dysfunction syndrome 32.57 10.84 40 152046 68296 90408065
Intestinal ulcer 32.39 10.84 25 152061 1654 90474707
Lipase increased 32.36 10.84 63 152023 11048 90465313
Plasma cell myeloma 32.29 10.84 14 152072 40814 90435547
Blood cholesterol increased 32.14 10.84 509 151577 207503 90268858
Eye pain 32.10 10.84 17 152069 44151 90432210
Plasmablastic lymphoma 31.91 10.84 13 152073 240 90476121
Fatigue 31.88 10.84 1598 150488 1152425 89323936
Osteonecrosis of jaw 31.58 10.84 13 152073 39090 90437271
Rhabdomyolysis 31.39 10.84 24 152062 51232 90425129
Psychotic disorder 31.32 10.84 7 152079 31223 90445138
Iron deficiency 31.09 10.84 57 152029 9555 90466806
Nail disorder 30.96 10.84 32 152054 59035 90417326
Anal stenosis 30.62 10.84 16 152070 532 90475829
Abscess 30.55 10.84 85 152001 18806 90457555
Respiratory arrest 30.47 10.84 9 152077 33302 90443059
Anorectal disorder 30.24 10.84 26 152060 2005 90474356
Swelling 30.15 10.84 508 151578 418550 90057811
Pulmonary oedema 29.94 10.84 36 152050 62044 90414317
Enterovesical fistula 29.90 10.84 17 152069 670 90475691
Muscle twitching 29.80 10.84 3 152083 24199 90452162
Urinary retention 29.76 10.84 13 152073 37731 90438630
Bacillus infection 29.51 10.84 19 152067 940 90475421
Acute febrile neutrophilic dermatosis 29.49 10.84 33 152053 3512 90472849
Anal cancer 29.31 10.84 16 152070 582 90475779
Drug specific antibody 29.23 10.84 28 152058 2484 90473877
Acute respiratory failure 29.07 10.84 18 152068 42900 90433461
Impaired healing 28.95 10.84 553 151533 233646 90242715
Hepatic cytolysis 28.93 10.84 8 152078 30908 90445453
Cytokine release syndrome 28.61 10.84 6 152080 27967 90448394
Infusion site thrombosis 28.50 10.84 11 152075 175 90476186
Weight fluctuation 28.21 10.84 85 152001 19664 90456697
Dyskinesia 28.15 10.84 13 152073 36521 90439840
Skin exfoliation 28.11 10.84 44 152042 67869 90408492
Pulmonary arterial hypertension 28.08 10.84 5 152081 26182 90450179
Liver disorder 27.94 10.84 319 151767 120950 90355411
Eye irritation 27.93 10.84 11 152075 33967 90442394
Hepatitis infectious mononucleosis 27.89 10.84 10 152076 128 90476233
Malaise 27.71 10.84 1225 150861 584761 89891600
Ileocaecal resection 27.70 10.84 15 152071 537 90475824
Aphasia 27.58 10.84 19 152067 42793 90433568
Dry eye 27.51 10.84 34 152052 57897 90418464
Anxiety 27.35 10.84 697 151389 309075 90167286
Sleep disorder due to general medical condition, insomnia type 27.21 10.84 333 151753 128361 90348000
Haematoma 26.98 10.84 16 152070 39032 90437329
Idiosyncratic drug reaction 26.87 10.84 18 152068 953 90475408
Pus in stool 26.84 10.84 8 152078 54 90476307
Pleural effusion 26.81 10.84 97 151989 111894 90364467
Hypokalaemia 26.71 10.84 121 151965 130995 90345366
Aggression 26.70 10.84 6 152080 26662 90449699
Incorrect dose administered 26.70 10.84 225 151861 78705 90397656
International normalised ratio increased 26.70 10.84 24 152062 47292 90429069
Pneumonia aspiration 26.60 10.84 18 152068 40922 90435439
Herpes simplex hepatitis 26.57 10.84 15 152071 583 90475778
Catarrh 26.56 10.84 22 152064 1612 90474749
Adverse drug reaction 26.44 10.84 306 151780 116395 90359966
Rectal spasm 26.32 10.84 10 152076 152 90476209
Altered state of consciousness 26.26 10.84 10 152076 31522 90444839
Injection site pain 26.24 10.84 177 151909 173522 90302839
Ileectomy 26.22 10.84 12 152074 297 90476064
Weight increased 26.19 10.84 901 151185 417026 90059335
Hepatocellular injury 26.17 10.84 8 152078 28950 90447411
Feeding intolerance 26.16 10.84 18 152068 996 90475365
Blood calcium decreased 26.11 10.84 9 152077 30173 90446188
Toxic epidermal necrolysis 25.97 10.84 11 152075 32517 90443844
Metastases to liver 25.96 10.84 8 152078 28799 90447562
Iron deficiency anaemia 25.87 10.84 93 151993 23569 90452792
Arthritis enteropathic 25.86 10.84 13 152073 398 90475963
Coronary artery disease 25.85 10.84 12 152074 33611 90442750
Hypocalcaemia 25.74 10.84 20 152066 42348 90434013
Angina pectoris 25.74 10.84 17 152069 39143 90437218
Proctitis ulcerative 25.50 10.84 12 152074 317 90476044
Bowel movement irregularity 25.47 10.84 42 152044 6472 90469889
Pneumonia 25.37 10.84 847 151239 637212 89839149
Taste disorder 25.35 10.84 40 152046 61506 90414855
Onychomadesis 25.16 10.84 24 152062 45974 90430387
Urticaria chronic 24.97 10.84 16 152070 785 90475576
Terminal ileitis 24.97 10.84 19 152067 1231 90475130
Myelosuppression 24.88 10.84 32 152054 53559 90422802
Palmar-plantar erythrodysaesthesia syndrome 24.86 10.84 8 152078 28015 90448346
Laboratory test abnormal 24.78 10.84 137 151949 41717 90434644
Blood urea increased 24.74 10.84 10 152076 30403 90445958
Speech disorder 24.69 10.84 24 152062 45561 90430800
Generalised tonic-clonic seizure 24.54 10.84 14 152072 34889 90441472
Acute myocardial infarction 24.53 10.84 14 152072 34876 90441485
Injury 24.39 10.84 466 151620 196883 90279478
Hypothyroidism 24.38 10.84 32 152054 53095 90423266
Dysstasia 24.36 10.84 6 152080 25046 90451315
Adenocarcinoma of appendix 24.32 10.84 6 152080 17 90476344
Fear of disease 24.25 10.84 20 152066 1456 90474905
Ejection fraction decreased 24.18 10.84 7 152079 26246 90450115
Night sweats 24.18 10.84 326 151760 128440 90347921
Respiratory distress 24.15 10.84 18 152068 38928 90437433
Influenza 24.10 10.84 136 151950 139128 90337233
Colectomy 24.08 10.84 29 152057 3338 90473023
Bone pain 23.94 10.84 42 152044 61941 90414420
Neck pain 23.92 10.84 104 151982 113859 90362502
Abortion spontaneous 23.85 10.84 164 151922 53892 90422469
Infrequent bowel movements 23.81 10.84 20 152066 1494 90474867
Bacterial vulvovaginitis 23.72 10.84 16 152070 857 90475504
Impaired quality of life 23.65 10.84 89 151997 23055 90453306
Onychomycosis 23.54 10.84 17 152069 37359 90439002
Feeling abnormal 23.50 10.84 174 151912 167061 90309300
Knee arthroplasty 23.48 10.84 228 151858 82954 90393407
Hallucination 23.44 10.84 47 152039 65912 90410449
Upper gastrointestinal haemorrhage 23.35 10.84 5 152081 22971 90453390
Lymphocyte count decreased 23.33 10.84 15 152071 35035 90441326
Intentional self-injury 23.29 10.84 10 152076 29324 90447037
Disorientation 23.00 10.84 24 152062 44090 90432271
Cytomegalovirus infection 22.93 10.84 97 151989 26505 90449856
Burns second degree 22.91 10.84 22 152064 1958 90474403
Decreased appetite 22.89 10.84 809 151277 375731 90100630
Colitis erosive 22.85 10.84 10 152076 222 90476139
Septic shock 22.82 10.84 69 152017 84091 90392270
Irritability 22.75 10.84 16 152070 35646 90440715
Haemoptysis 22.53 10.84 14 152072 33306 90443055
Back injury 22.52 10.84 27 152059 46595 90429766
Circulatory collapse 22.29 10.84 7 152079 24897 90451464
Red blood cell count decreased 22.22 10.84 27 152059 46324 90430037
Skin ulcer 22.13 10.84 31 152055 50044 90426317
Lacrimation increased 21.85 10.84 9 152077 27053 90449308
Rash erythematous 21.79 10.84 48 152038 65056 90411305
Rectal stenosis 21.68 10.84 10 152076 252 90476109
Restlessness 21.53 10.84 17 152069 35703 90440658
Abscess intestinal 21.51 10.84 21 152065 1907 90474454
Dysphagia 21.47 10.84 106 151980 112172 90364189
Folliculitis 21.45 10.84 471 151615 203882 90272479
Metastases to bone 21.39 10.84 8 152078 25497 90450864
Cytomegalovirus enterocolitis 21.34 10.84 15 152071 859 90475502
Autoimmune pancreatitis 21.33 10.84 11 152075 356 90476005
Diabetes mellitus inadequate control 21.32 10.84 3 152083 18681 90457680
Ileostomy 21.28 10.84 21 152065 1933 90474428
Urinary incontinence 21.26 10.84 19 152067 37547 90438814
Neurotoxicity 21.15 10.84 5 152081 21462 90454899
Muscle injury 21.10 10.84 415 151671 176239 90300122
Pyrexia 20.98 10.84 1330 150756 659155 89817206
Diarrhoea 20.88 10.84 1838 150248 937352 89539009
Transient ischaemic attack 20.86 10.84 25 152061 43151 90433210
Peripheral venous disease 20.81 10.84 224 151862 83697 90392664
Irritable bowel syndrome 20.79 10.84 475 151611 206973 90269388
Blood creatine phosphokinase increased 20.75 10.84 16 152070 34007 90442354
Appendicitis 20.62 10.84 50 152036 10181 90466180
Haematuria 20.59 10.84 17 152069 34920 90441441
Rash maculo-papular 20.53 10.84 23 152063 40910 90435451
Skin warm 20.48 10.84 42 152044 7645 90468716
Haemorrhoids 20.46 10.84 94 151992 26608 90449753
Disseminated cytomegaloviral infection 20.36 10.84 10 152076 291 90476070
Palpitations 20.31 10.84 140 151946 136588 90339773
Glutamate dehydrogenase level abnormal 20.05 10.84 5 152081 15 90476346
Large intestine erosion 20.03 10.84 8 152078 140 90476221
Skin discolouration 20.02 10.84 27 152059 44288 90432073
Sinus disorder 20.01 10.84 17 152069 34430 90441931
Injection site erythema 20 10.84 91 151995 98411 90377950
Diabetic ketoacidosis 19.90 10.84 8 152078 24399 90451962
Therapy cessation 19.86 10.84 19 152067 36342 90440019
Bone disorder 19.81 10.84 7 152079 23113 90453248
Cardiac myxoma 19.81 10.84 10 152076 309 90476052
Aphthous ulcer 19.80 10.84 69 152017 17218 90459143
Acute haemorrhagic ulcerative colitis 19.71 10.84 7 152079 87 90476274
Subcutaneous abscess 19.66 10.84 38 152048 6628 90469733
Red blood cell sedimentation rate abnormal 19.62 10.84 8 152078 24196 90452165
Product administered to patient of inappropriate age 19.55 10.84 31 152055 4622 90471739
Product label confusion 19.44 10.84 7 152079 22843 90453518
Sleep apnoea syndrome 19.27 10.84 15 152071 31732 90444629
Papilloma viral infection 19.12 10.84 19 152067 1763 90474598
Therapy non-responder 19.06 10.84 329 151757 136375 90339986
Tachypnoea 19.05 10.84 6 152080 21303 90455058
Intestinal resection 18.99 10.84 24 152062 2903 90473458
C-reactive protein abnormal 18.99 10.84 310 151776 127119 90349242
Product quality issue 18.79 10.84 69 152017 79256 90397105
Obstructive airways disorder 18.73 10.84 10 152076 25859 90450502
Leukopenia 18.73 10.84 96 151990 100614 90375747
Dry skin 18.71 10.84 80 152006 87993 90388368
Skin necrosis 18.69 10.84 3 152083 16938 90459423
Sopor 18.63 10.84 9 152077 24635 90451726
Bladder trabeculation 18.63 10.84 6 152080 54 90476307
Blood glucose decreased 18.58 10.84 8 152078 23421 90452940
Gastrointestinal haemorrhage 18.55 10.84 83 152003 90165 90386196
Musculoskeletal stiffness 18.48 10.84 639 151447 295893 90180468
Transverse sinus thrombosis 18.44 10.84 12 152074 605 90475756
Cardiogenic shock 18.40 10.84 9 152077 24459 90451902
Discomfort 18.32 10.84 596 151490 273739 90202622
Lip dry 18.30 10.84 254 151832 100701 90375660
Blood pressure systolic abnormal 18.30 10.84 5 152081 19473 90456888
Pulmonary congestion 18.24 10.84 5 152081 19428 90456933
Affect lability 18.21 10.84 4 152082 18059 90458302
Lupus hepatitis 18.21 10.84 5 152081 24 90476337
Lung disorder 18.20 10.84 353 151733 149530 90326831
Tachycardia 18.03 10.84 368 151718 157305 90319056
Intestinal mucosal hypertrophy 17.92 10.84 9 152077 275 90476086
Serum ferritin decreased 17.86 10.84 22 152064 2592 90473769
Dysuria 17.80 10.84 24 152062 39377 90436984
Listeriosis 17.63 10.84 18 152068 1725 90474636
Target skin lesion 17.60 10.84 7 152079 121 90476240
Cataract 17.55 10.84 62 152024 72030 90404331
Pancytopenia 17.44 10.84 124 151962 120139 90356222
Coordination abnormal 17.41 10.84 7 152079 21349 90455012
Pericarditis 17.30 10.84 584 151502 269567 90206794
Enterocutaneous fistula 17.30 10.84 17 152069 1557 90474804
Pain in jaw 17.22 10.84 34 152052 47951 90428410
Small intestinal obstruction 17.21 10.84 76 152010 21158 90455203
Peripheral swelling 17.19 10.84 545 151541 412561 90063800
Mediastinal effusion 17.16 10.84 6 152080 71 90476290
Blood pressure diastolic abnormal 17.07 10.84 6 152080 19875 90456486
Inflammation 16.99 10.84 406 151680 178186 90298175
Hemiparesis 16.94 10.84 17 152069 31802 90444559
Haematemesis 16.86 10.84 19 152067 33707 90442654
Cervix carcinoma stage 0 16.67 10.84 11 152075 568 90475793
Stenosis 16.66 10.84 19 152067 2065 90474296
Nephritis bacterial 16.62 10.84 5 152081 35 90476326
Psoriasis 16.61 10.84 344 151742 147410 90328951
Blood potassium increased 16.59 10.84 7 152079 20742 90455619
Drug eruption 16.58 10.84 21 152065 35386 90440975
Vein rupture 16.53 10.84 17 152069 1644 90474717
Cholestasis 16.51 10.84 22 152064 36277 90440084
Seasonal allergy 16.47 10.84 9 152077 22974 90453387
Productive cough 16.37 10.84 70 152016 76993 90399368
Sensory loss 16.32 10.84 5 152081 18070 90458291
Blood bilirubin increased 16.30 10.84 30 152056 43440 90432921
Mycobacterium tuberculosis complex test positive 16.29 10.84 21 152065 2591 90473770
Ataxia 16.27 10.84 5 152081 18037 90458324
Anastomotic ulcer 16.18 10.84 11 152075 597 90475764
Rectal ulcer 16.13 10.84 16 152070 1482 90474879
Poisoning 16.11 10.84 3 152083 15214 90461147
Immunodeficiency 16.07 10.84 30 152056 43204 90433157
Haemorrhage intracranial 16.03 10.84 3 152083 15159 90461202
Blood iron decreased 15.88 10.84 66 152020 17893 90458468
Chest discomfort 15.81 10.84 152 151934 138213 90338148
Drug tolerance decreased 15.70 10.84 100 151986 32030 90444331
Adverse reaction 15.68 10.84 16 152070 29696 90446665
Cholangitis sclerosing 15.68 10.84 19 152067 2202 90474159
Schizophrenia 15.67 10.84 3 152083 14911 90461450
Cerebral infarction 15.60 10.84 13 152073 26583 90449778
Drug reaction with eosinophilia and systemic symptoms 15.60 10.84 30 152056 42728 90433633
Unevaluable event 15.58 10.84 44 152042 54804 90421557
Limb injury 15.48 10.84 18 152068 31490 90444871
Caesarean section 15.44 10.84 67 152019 18510 90457851
Ischaemic stroke 15.43 10.84 9 152077 22157 90454204
Heart rate irregular 15.43 10.84 81 152005 24187 90452174
Herpes simplex colitis 15.40 10.84 6 152080 98 90476263
Clostridium colitis 15.26 10.84 18 152068 2027 90474334
Central obesity 15.25 10.84 15 152071 1375 90474986
Joint effusion 15.21 10.84 7 152079 19703 90456658
Joint swelling 15.18 10.84 690 151396 502610 89973751
Hip fracture 15.10 10.84 20 152066 33057 90443304
Large intestine polyp 14.95 10.84 42 152044 9344 90467017
Emotional distress 14.94 10.84 24 152062 36638 90439723
Respiratory tract infection 14.92 10.84 50 152036 59028 90417333
Vaginal abscess 14.88 10.84 10 152076 532 90475829
Oral administration complication 14.87 10.84 6 152080 108 90476253
Progressive multifocal leukoencephalopathy 14.74 10.84 4 152082 15651 90460710
Pyoderma 14.73 10.84 10 152076 541 90475820
Fluid retention 14.72 10.84 87 151999 88004 90388357
Cerebral venous sinus thrombosis 14.65 10.84 19 152067 2357 90474004
Blepharospasm 14.65 10.84 46 152040 55399 90420962
Hypothermia 14.63 10.84 4 152082 15571 90460790
Ventricular tachycardia 14.59 10.84 12 152074 24696 90451665
Motor dysfunction 14.58 10.84 7 152079 19223 90457138
Dystonia 14.57 10.84 5 152081 16814 90459547
Anaphylactic shock 14.55 10.84 19 152067 31598 90444763
Mitral valve incompetence 14.50 10.84 10 152076 22514 90453847
Uveitis 14.50 10.84 59 152027 15844 90460517
Deafness 14.49 10.84 10 152076 22504 90453857
Middle insomnia 14.48 10.84 5 152081 16746 90459615
Hepatic failure 14.38 10.84 28 152058 39700 90436661
Blindness 14.37 10.84 14 152072 26554 90449807
Nausea 14.37 10.84 1638 150448 1108678 89367683
Subdural haematoma 14.33 10.84 5 152081 16640 90459721
Gastroenteritis radiation 14.32 10.84 10 152076 567 90475794
Listeria sepsis 14.29 10.84 11 152075 725 90475636
Injection site papule 14.24 10.84 12 152074 900 90475461
Stevens-Johnson syndrome 14.20 10.84 17 152069 29359 90447002
Delusion 14.09 10.84 3 152083 13837 90462524
Gastrointestinal scarring 14.08 10.84 9 152077 440 90475921
Tooth disorder 13.98 10.84 19 152067 31071 90445290
Renal cell carcinoma stage IV 13.97 10.84 4 152082 23 90476338
Lymphoedema 13.96 10.84 3 152083 13750 90462611
Fracture 13.95 10.84 10 152076 22066 90454295
Spinal fracture 13.88 10.84 10 152076 22006 90454355
Mobility decreased 13.83 10.84 533 151553 250201 90226160
Mydriasis 13.83 10.84 4 152082 15008 90461353
Transfusion 13.82 10.84 6 152080 17482 90458879
Neonatal gastrointestinal haemorrhage 13.82 10.84 4 152082 24 90476337
Eye pruritus 13.82 10.84 17 152069 29010 90447351
Infectious mononucleosis 13.80 10.84 17 152069 2004 90474357
Depressed mood 13.74 10.84 41 152045 50181 90426180
Body temperature fluctuation 13.73 10.84 18 152068 2257 90474104
Vomiting 13.68 10.84 1138 150948 787155 89689206
Eosinophilic pneumonia chronic 13.64 10.84 7 152079 224 90476137
Lethargy 13.63 10.84 57 152029 63082 90413279
Type IV hypersensitivity reaction 13.62 10.84 24 152062 3902 90472459
Gastrointestinal oedema 13.60 10.84 15 152071 1571 90474790
Hypoacusis 13.59 10.84 16 152070 27834 90448527
Gastrointestinal sounds abnormal 13.52 10.84 26 152060 4517 90471844
Neuralgia 13.43 10.84 20 152066 31480 90444881
Enteritis 13.42 10.84 43 152043 10278 90466083
Hallucination, auditory 13.41 10.84 5 152081 15970 90460391
Complication associated with device 13.39 10.84 8 152078 19441 90456920
Nodule 13.38 10.84 15 152071 26671 90449690
Blister 13.35 10.84 539 151547 254459 90221902
Epilepsy 13.31 10.84 82 152004 82124 90394237
Withdrawal syndrome 13.22 10.84 11 152075 22513 90453848
Nervousness 13.22 10.84 23 152063 34033 90442328
Arthropathy 13.18 10.84 492 151594 365750 90110611
Vulval abscess 13.16 10.84 12 152074 1000 90475361
Sinus congestion 13.12 10.84 16 152070 27408 90448953
Skin haemorrhage 13.11 10.84 10 152076 21370 90454991
Abdominal distension 13.06 10.84 299 151787 130302 90346059
Mediastinal abscess 13.06 10.84 4 152082 30 90476331
Posterior reversible encephalopathy syndrome 13.00 10.84 11 152075 22328 90454033
Product prescribing error 12.99 10.84 19 152067 30126 90446235
Coagulopathy 12.92 10.84 12 152074 23277 90453084
Eosinophilic pleural effusion 12.91 10.84 6 152080 154 90476207
Small intestine carcinoma 12.89 10.84 9 152077 510 90475851
Pouchitis 12.89 10.84 10 152076 667 90475694
Anal skin tags 12.85 10.84 10 152076 670 90475691
Tricuspid valve incompetence 12.82 10.84 6 152080 16725 90459636
Cerebral haemorrhage 12.79 10.84 24 152062 34498 90441863
Cystitis 12.74 10.84 63 152023 66655 90409706
Serum sickness 12.74 10.84 22 152064 3520 90472841
Eczema infected 12.73 10.84 6 152080 159 90476202
Abdominal abscess 12.70 10.84 28 152058 5359 90471002
Blood alkaline phosphatase increased 12.62 10.84 40 152046 48039 90428322
Renal disorder 12.60 10.84 28 152058 37831 90438530
Jaundice 12.59 10.84 22 152064 32495 90443866
Malignant splenic neoplasm 12.58 10.84 3 152083 7 90476354
Actinomycotic skin infection 12.58 10.84 3 152083 7 90476354
Osteomyelitis 12.54 10.84 17 152069 27829 90448532
General physical health deterioration 12.54 10.84 722 151364 354393 90121968
Myelodysplastic syndrome 12.53 10.84 10 152076 20893 90455468
Rectal discharge 12.51 10.84 11 152075 874 90475487
Central nervous system necrosis 12.50 10.84 6 152080 166 90476195
Ileus 12.49 10.84 58 152028 16488 90459873
Alopecia universalis 12.43 10.84 6 152080 168 90476193
Device difficult to use 12.36 10.84 7 152079 17518 90458843
Multiple allergies 12.29 10.84 5 152081 15141 90461220
Tooth fracture 12.29 10.84 3 152083 12597 90463764
Colostomy 12.25 10.84 13 152073 1304 90475057
Haematotoxicity 12.19 10.84 3 152083 12532 90463829
Hospitalisation 12.12 10.84 147 151939 127953 90348408
Food allergy 12.05 10.84 15 152071 25463 90450898
Product administration error 12.04 10.84 16 152070 26407 90449954
Intestinal dilatation 12.01 10.84 17 152069 2293 90474068
Acute generalised exanthematous pustulosis 12.00 10.84 4 152082 13699 90462662
Heart rate decreased 11.98 10.84 140 151946 53365 90422996
Pain of skin 11.97 10.84 6 152080 16076 90460285
Infusion site erythema 11.96 10.84 4 152082 13666 90462695
Foetal malformation 11.93 10.84 7 152079 293 90476068
Cervical dysplasia 11.90 10.84 23 152063 4011 90472350
Duodenal ulcer perforation 11.87 10.84 469 151617 220819 90255542
Movement disorder 11.82 10.84 19 152067 29000 90447361
Dysphonia 11.80 10.84 60 152026 63024 90413337
Contusion 11.80 10.84 525 151561 250691 90225670
Self-injurious ideation 11.66 10.84 20 152066 3183 90473178
Rales 11.64 10.84 6 152080 15821 90460540
Amniotic cavity infection 11.62 10.84 13 152073 1383 90474978
Glomerular filtration rate decreased 11.61 10.84 7 152079 16925 90459436
Shock 11.57 10.84 19 152067 28759 90447602
Haematocrit decreased 11.55 10.84 34 152052 41798 90434563
Gastrointestinal wall thickening 11.52 10.84 16 152070 2121 90474240
Abdominal tenderness 11.37 10.84 38 152048 9286 90467075
Status epilepticus 11.35 10.84 9 152077 18865 90457496
Campylobacter infection 11.33 10.84 12 152074 1200 90475161
Respiratory disorder 11.31 10.84 162 151924 64654 90411707
Chest pain 11.30 10.84 650 151436 318995 90157366
Drug specific antibody absent 11.30 10.84 5 152081 114 90476247
Colonic fistula 11.24 10.84 7 152079 327 90476034
Invasive papillary breast carcinoma 11.18 10.84 3 152083 13 90476348
Hepatic function abnormal 11.14 10.84 40 152046 46248 90430113
Eye disorder 11.09 10.84 18 152068 27372 90448989
Breath sounds abnormal 11.07 10.84 6 152080 15380 90460981
Feeling jittery 11.05 10.84 6 152080 15365 90460996
Haemolytic anaemia 11.00 10.84 3 152083 11694 90464667
Anal squamous cell carcinoma 10.95 10.84 9 152077 652 90475709
Mania 10.92 10.84 5 152081 14119 90462242
Disseminated intravascular coagulation 10.91 10.84 12 152074 21526 90454835
Cytopenia 10.90 10.84 8 152078 17441 90458920
Abortion 10.90 10.84 18 152068 2777 90473584
Spinal stenosis 10.87 10.84 8 152078 17416 90458945

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
Colitis ulcerative 3427.02 12.07 1376 69775 24799 42525385
Haematochezia 1472.97 12.07 1018 70133 57418 42492766
Frequent bowel movements 1424.27 12.07 701 70450 20706 42529478
Off label use 998.19 12.07 2806 68345 635529 41914655
Condition aggravated 600.99 12.07 1334 69817 259420 42290764
Colitis 479.97 12.07 484 70667 46088 42504096
Inappropriate schedule of product administration 466.95 12.07 681 70470 95221 42454963
Intentional product use issue 458.80 12.07 582 70569 71251 42478933
Defaecation urgency 354.31 12.07 156 70995 3538 42546646
Rectal haemorrhage 350.46 12.07 423 70728 49183 42501001
Death 329.18 12.07 190 70961 470995 42079189
Faecal calprotectin increased 301.08 12.07 132 71019 2962 42547222
Drug ineffective 293.73 12.07 1922 69229 628275 41921909
Bronchiectasis 288.81 12.07 240 70911 17779 42532405
Abdominal pain 283.29 12.07 827 70324 189644 42360540
Mucous stools 265.57 12.07 114 71037 2426 42547758
Clostridium difficile infection 256.48 12.07 248 70903 22411 42527773
Blood pressure fluctuation 247.05 12.07 263 70888 26645 42523539
Therapeutic reaction time decreased 246.41 12.07 102 71049 1976 42548208
Weight decreased 245.82 12.07 834 70317 207114 42343070
Congenital hiatus hernia 220.13 12.07 134 71017 6040 42544144
Drug level decreased 218.79 12.07 160 70991 9817 42540367
Toxicity to various agents 215.85 12.07 58 71093 229078 42321106
Diarrhoea haemorrhagic 202.41 12.07 138 71013 7569 42542615
Loss of therapeutic response 196.97 12.07 76 71075 1215 42548969
Crohn's disease 196.03 12.07 97 71054 2887 42547297
Drug level below therapeutic 195.56 12.07 127 71024 6418 42543766
Anal abscess 186.10 12.07 132 71019 7718 42542466
Steroid dependence 185.21 12.07 124 71027 6598 42543586
Myocarditis 184.34 12.07 191 70960 18747 42531437
Product use issue 181.75 12.07 398 70753 76353 42473831
Impaired quality of life 181.16 12.07 166 70985 14011 42536173
Drug specific antibody present 179.95 12.07 101 71050 3905 42546279
Acute kidney injury 168.80 12.07 220 70931 367117 42183067
Tubulointerstitial nephritis 163.41 12.07 231 70920 31317 42518867
Hypotension 158.87 12.07 119 71032 257512 42292672
Febrile neutropenia 158.63 12.07 56 71095 185647 42364537
Cytomegalovirus colitis 153.83 12.07 91 71060 3890 42546294
Breath sounds abnormal 132.39 12.07 130 71021 11963 42538221
Inflammatory bowel disease 129.42 12.07 78 71073 3451 42546733
Malignant melanoma in situ 127.66 12.07 71 71080 2696 42547488
Fall 126.60 12.07 123 71028 234397 42315787
Platelet count decreased 124.97 12.07 38 71113 138543 42411641
Gastrointestinal inflammation 124.81 12.07 84 71067 4508 42545676
Large intestinal stenosis 123.59 12.07 62 71089 1901 42548283
Neutropenia 121.73 12.07 93 71058 199338 42350846
Faeces soft 119.68 12.07 84 71067 4828 42545356
Impaired work ability 115.95 12.07 121 71030 11970 42538214
Fistula 115.70 12.07 100 71051 7812 42542372
Anal fistula 114.88 12.07 90 71061 6123 42544061
Stress 113.48 12.07 237 70914 43975 42506209
Completed suicide 112.99 12.07 14 71137 96451 42453733
Systemic lupus erythematosus 112.97 12.07 106 71045 9218 42540966
Product residue present 112.55 12.07 66 71085 2775 42547409
Loss of personal independence in daily activities 111.85 12.07 253 70898 49563 42500621
Malignant neoplasm progression 110.69 12.07 23 71128 108377 42441807
Burns second degree 105.63 12.07 85 71066 6011 42544173
Catarrh 104.86 12.07 84 71067 5902 42544282
Night sweats 103.06 12.07 146 71005 19823 42530361
Disease progression 102.60 12.07 56 71095 143600 42406584
Cholangitis sclerosing 102.21 12.07 54 71097 1848 42548336
Drug interaction 102.10 12.07 181 70970 266818 42283366
Micturition urgency 101.65 12.07 112 71039 11786 42538398
Drug abuse 101.43 12.07 25 71126 104746 42445438
Heart rate decreased 99.85 12.07 201 70950 36331 42513853
Blood pressure increased 99.03 12.07 384 70767 101544 42448640
Pericarditis 97.05 12.07 116 71035 13328 42536856
Weight increased 93.10 12.07 392 70759 107591 42442593
Proctitis 92.77 12.07 59 71092 2874 42547310
Diarrhoea 92.26 12.07 1173 69978 459676 42090508
Joint injury 92.06 12.07 118 71033 14558 42535626
Hypopnoea 90.53 12.07 87 71064 7795 42542389
Parosmia 90.44 12.07 86 71065 7605 42542579
Therapeutic response shortened 88.22 12.07 111 71040 13443 42536741
Hypercholesterolaemia 88.08 12.07 108 71043 12741 42537443
Benign prostatic hyperplasia 87.35 12.07 139 71012 20913 42529271
Renal failure 86.40 12.07 68 71083 143658 42406526
Therapeutic product effect decreased 85.84 12.07 197 70954 38953 42511231
Hepatosplenic T-cell lymphoma 85.16 12.07 32 71119 474 42549710
Cardiac arrest 85.02 12.07 38 71113 109282 42440902
Gingival pain 83.23 12.07 86 71065 8408 42541776
Anal fissure 82.29 12.07 69 71082 5170 42545014
Thrombocytopenia 82.09 12.07 119 71032 190160 42360024
Rhinitis 81.01 12.07 100 71051 11877 42538307
Treatment failure 80.68 12.07 259 70892 62365 42487819
Hyperkalaemia 80.23 12.07 18 71133 80440 42469744
Cardiac failure congestive 79.84 12.07 22 71129 85580 42464604
Rectal tenesmus 77.44 12.07 38 71113 1110 42549074
Infusion related reaction 74.30 12.07 247 70904 60559 42489625
Small intestinal stenosis 73.67 12.07 34 71117 863 42549321
Myocardial infarction 71.63 12.07 61 71090 123948 42426236
Therapeutic product effect incomplete 67.02 12.07 265 70886 70674 42479510
Ileal stenosis 64.88 12.07 40 71111 1844 42548340
Pulmonary tuberculosis 63.71 12.07 61 71090 5440 42544744
Disseminated tuberculosis 63.52 12.07 46 71105 2778 42547406
Mucosal inflammation 63.45 12.07 5 71146 49369 42500815
Poor venous access 63.22 12.07 69 71082 7183 42543001
Cardiac murmur 62.39 12.07 91 71060 12684 42537500
Coma 62.14 12.07 8 71143 53546 42496638
Drug level above therapeutic 61.88 12.07 62 71089 5844 42544340
Intentional overdose 61.39 12.07 7 71144 51449 42498735
Intestinal stenosis 59.28 12.07 44 71107 2760 42547424
Proctalgia 59.26 12.07 66 71085 7027 42543157
Cardiac failure 58.78 12.07 55 71096 106801 42443383
Eosinophilic pneumonia 58.26 12.07 55 71096 4819 42545365
Drug specific antibody 58.04 12.07 23 71128 396 42549788
Cardio-respiratory arrest 56.71 12.07 14 71137 58622 42491562
Pyrexia 55.74 12.07 945 70206 393097 42157087
Abdominal abscess 54.35 12.07 54 71097 5039 42545145
Pouchitis 54.01 12.07 28 71123 921 42549263
Flatulence 53.40 12.07 125 71026 25027 42525157
Transient ischaemic attack 53.32 12.07 150 71001 33589 42516595
Arthritis 53.28 12.07 173 70978 41892 42508292
Dyspnoea 52.75 12.07 479 70672 442142 42108042
Colectomy 52.53 12.07 38 71113 2291 42547893
COVID-19 52.25 12.07 352 70799 115596 42434588
Pneumonia 51.99 12.07 453 70698 421696 42128488
Lactic acidosis 51.94 12.07 7 71144 45254 42504930
Seizure 51.36 12.07 76 71075 120485 42429699
Hypoglycaemia 51.11 12.07 18 71133 59836 42490348
Acne 51.06 12.07 86 71065 13558 42536626
Neutrophil count decreased 50.94 12.07 21 71130 63394 42486790
Intestinal fistula 50.92 12.07 29 71122 1153 42549031
Incorrect dose administered 50.92 12.07 199 70952 52775 42497409
Neuropathy peripheral 50.82 12.07 57 71094 101796 42448388
Philadelphia positive chronic myeloid leukaemia 50.46 12.07 16 71135 137 42550047
Rhabdomyolysis 49.32 12.07 35 71116 77984 42472200
Overdose 49.23 12.07 62 71089 105202 42444982
Cytokine release syndrome 48.53 12.07 8 71143 44519 42505665
Cytomegalovirus infection 48.49 12.07 141 71010 32165 42518019
Full blood count abnormal 48.36 12.07 134 71017 29742 42520442
Hallucination 47.91 12.07 18 71133 57489 42492695
Intestinal obstruction 46.14 12.07 124 71027 27034 42523150
Alcohol poisoning 46.09 12.07 60 71091 7514 42542670
Aggression 45.83 12.07 9 71142 44154 42506030
International normalised ratio increased 43.75 12.07 13 71138 48155 42502029
Atrial fibrillation 43.65 12.07 106 71045 139487 42410697
Mental status changes 42.83 12.07 9 71142 42106 42508078
Delirium 42.82 12.07 17 71134 52502 42497682
Respiratory failure 42.71 12.07 94 71057 128038 42422146
Abnormal faeces 42.45 12.07 42 71109 3899 42546285
Heart rate irregular 42.28 12.07 87 71064 15963 42534221
Cytomegalovirus enteritis 41.97 12.07 21 71130 640 42549544
Large intestinal ulcer 41.94 12.07 34 71117 2429 42547755
Depressed level of consciousness 41.70 12.07 14 71137 47956 42502228
Migraine 41.15 12.07 114 71037 25300 42524884
Pulmonary oedema 40.64 12.07 19 71132 53253 42496931
Drug intolerance 40.40 12.07 251 70900 80173 42470011
Swollen tongue 40.24 12.07 101 71050 21130 42529054
Intestinal perforation 39.98 12.07 68 71083 10806 42539378
Abdominal distension 39.95 12.07 230 70921 71505 42478679
Agitation 39.16 12.07 30 71121 64284 42485900
Gait disturbance 38.67 12.07 65 71086 97935 42452249
Anorectal discomfort 38.13 12.07 31 71120 2224 42547960
Pancreatitis acute 38.04 12.07 133 71018 33431 42516753
Encephalopathy 37.83 12.07 11 71140 41322 42508862
Plasma cell myeloma 37.82 12.07 16 71135 47562 42502622
Gastrointestinal disorder 37.57 12.07 166 70985 46487 42503697
Blood creatine phosphokinase increased 37.25 12.07 17 71134 48321 42501863
Periumbilical abscess 36.87 12.07 11 71140 75 42550109
Rectal abscess 36.45 12.07 27 71124 1688 42548496
Small intestinal obstruction 36.44 12.07 85 71066 16976 42533208
Confusional state 36.40 12.07 150 71001 167447 42382737
Ulcer 36.32 12.07 83 71068 16358 42533826
Epistaxis 36.03 12.07 35 71116 66791 42483393
Hypoxia 35.97 12.07 38 71113 69748 42480436
White blood cell count decreased 35.96 12.07 82 71069 110314 42439870
Pseudopolyp 35.88 12.07 15 71136 298 42549886
Vitamin D deficiency 35.84 12.07 55 71096 8018 42542166
Pancreatitis 35.63 12.07 155 70996 43113 42507071
Chronic gastrointestinal bleeding 34.73 12.07 15 71136 324 42549860
Erythema nodosum 34.66 12.07 27 71124 1821 42548363
Cytomegalovirus enterocolitis 34.50 12.07 24 71127 1359 42548825
Anal stenosis 34.48 12.07 15 71136 330 42549854
Suicide attempt 34.31 12.07 17 71134 46083 42504101
Muscular weakness 34.23 12.07 54 71097 83444 42466740
Abdominal discomfort 34.19 12.07 229 70922 75026 42475158
C-reactive protein decreased 34.19 12.07 29 71122 2207 42547977
Tuberculous pleurisy 33.97 12.07 16 71135 426 42549758
Abdominal pain lower 33.58 12.07 67 71084 12025 42538159
Blood urea increased 33.36 12.07 7 71144 32786 42517398
Pyoderma gangrenosum 33.17 12.07 27 71124 1940 42548244
Congenital monorchidism 32.94 12.07 7 71144 7 42550177
Angioedema 32.63 12.07 15 71136 42462 42507722
Hyperglycaemia 32.52 12.07 18 71133 45841 42504343
Gastrointestinal anastomotic leak 32.17 12.07 17 71134 582 42549602
Enterovesical fistula 32.01 12.07 20 71131 944 42549240
Orchitis 32.00 12.07 28 71123 2223 42547961
Alanine aminotransferase increased 31.87 12.07 62 71089 88344 42461840
Job dissatisfaction 31.49 12.07 12 71139 185 42549999
Gastrointestinal tract irritation 31.41 12.07 14 71137 327 42549857
Oedema peripheral 31.31 12.07 119 71032 135957 42414227
Respiratory arrest 31.21 12.07 5 71146 28419 42521765
Haemorrhoids 31.01 12.07 80 71071 17017 42533167
Therapy non-responder 30.96 12.07 173 70978 53186 42496998
Pneumonia aspiration 30.94 12.07 23 71128 50055 42500129
Epiploic appendagitis 30.60 12.07 9 71142 58 42550126
Weight fluctuation 29.95 12.07 43 71108 5908 42544276
Acute myocardial infarction 29.61 12.07 32 71119 58133 42492051
Arthralgia 29.54 12.07 494 70657 204744 42345440
Insomnia 29.47 12.07 100 71051 118153 42432031
Campylobacter infection 29.46 12.07 22 71129 1393 42548791
Dyschezia 29.06 12.07 24 71127 1760 42548424
Drug effect less than expected 29.02 12.07 34 71117 3823 42546361
Abscess intestinal 28.81 12.07 24 71127 1782 42548402
Stomatitis 28.74 12.07 25 71126 50304 42499880
Pulmonary hypertension 28.63 12.07 3 71148 23566 42526618
Pleuritic pain 28.35 12.07 46 71105 7031 42543153
Proctitis ulcerative 28.21 12.07 11 71140 181 42550003
Sedation 28.09 12.07 8 71143 30467 42519717
Tinnitus 28.03 12.07 109 71042 28829 42521355
Hypokalaemia 27.89 12.07 48 71103 71673 42478511
Fluid retention 27.88 12.07 9 71142 31610 42518574
Angiolymphoid hyperplasia with eosinophilia 27.80 12.07 10 71141 130 42550054
Pancreatic toxicity 27.69 12.07 8 71143 48 42550136
Renal impairment 27.61 12.07 93 71058 110135 42440049
Proctocolectomy 27.52 12.07 11 71140 194 42549990
Bradycardia 27.43 12.07 64 71087 85420 42464764
Gastrointestinal mucosa hyperaemia 27.36 12.07 13 71138 353 42549831
Bronchopulmonary aspergillosis allergic 27.32 12.07 36 71115 4562 42545622
Dysphagia 27.08 12.07 50 71101 72669 42477515
Ileostomy 26.96 12.07 19 71132 1099 42549085
Hypothyroidism 26.79 12.07 10 71141 32074 42518110
Body temperature fluctuation 26.50 12.07 22 71129 1625 42548559
Rectal stenosis 26.38 12.07 11 71140 217 42549967
Eosinophilic colitis 26.02 12.07 12 71139 304 42549880
Listeria sepsis 25.93 12.07 11 71140 227 42549957
Unresponsive to stimuli 25.87 12.07 10 71141 31393 42518791
Ventricular tachycardia 25.87 12.07 9 71142 30151 42520033
Sepsis 25.74 12.07 211 70940 199123 42351061
Gastroenteritis clostridial 25.72 12.07 13 71138 405 42549779
Secondary adrenocortical insufficiency 25.69 12.07 24 71127 2075 42548109
Aspartate aminotransferase increased 25.38 12.07 57 71094 77106 42473078
Blood bilirubin increased 25.35 12.07 20 71131 42232 42507952
Anastomotic infection 25.16 12.07 9 71142 115 42550069
Campylobacter gastroenteritis 25.15 12.07 18 71133 1067 42549117
Ileal ulcer 25.01 12.07 17 71134 927 42549257
Muscle abscess 25.01 12.07 17 71134 927 42549257
Histoplasmosis 24.94 12.07 22 71129 1765 42548419
Serum ferritin decreased 24.61 12.07 17 71134 952 42549232
Asthenia 24.50 12.07 326 70825 280467 42269717
Perirectal abscess 24.41 12.07 22 71129 1816 42548368
Eczema 24.27 12.07 117 71034 33969 42516215
Latent tuberculosis 24.25 12.07 21 71130 1644 42548540
Lupus-like syndrome 24.06 12.07 28 71123 3126 42547058
Drug reaction with eosinophilia and systemic symptoms 23.90 12.07 21 71130 42054 42508130
Septic shock 23.88 12.07 76 71075 91596 42458588
Large intestine erosion 23.85 12.07 6 71145 19 42550165
Vertigo 23.81 12.07 117 71034 34230 42515954
Acute respiratory failure 23.81 12.07 18 71133 38840 42511344
Narcotic bowel syndrome 23.79 12.07 9 71142 136 42550048
Dizziness 23.75 12.07 284 70867 248970 42301214
Organising pneumonia 23.69 12.07 44 71107 7488 42542696
COVID-19 pneumonia 23.29 12.07 4 71147 21609 42528575
Sleep apnoea syndrome 23.28 12.07 4 71147 21604 42528580
Myelosuppression 23.22 12.07 20 71131 40441 42509743
Anticoagulant therapy 23.16 12.07 33 71118 4502 42545682
Dyskinesia 22.79 12.07 7 71144 25383 42524801
Enterocutaneous fistula 22.74 12.07 18 71133 1243 42548941
Anorectal disorder 22.71 12.07 18 71133 1245 42548939
Faecal calprotectin abnormal 22.52 12.07 11 71140 318 42549866
Abnormal behaviour 22.50 12.07 8 71143 26443 42523741
Nightmare 22.45 12.07 92 71059 24920 42525264
Short-bowel syndrome 22.39 12.07 11 71140 322 42549862
Loss of consciousness 22.39 12.07 79 71072 92275 42457909
C-reactive protein increased 22.35 12.07 182 70969 63378 42486806
Antacid therapy 22.16 12.07 33 71118 4684 42545500
Gastrointestinal stenosis 22.14 12.07 9 71142 166 42550018
Gastrointestinal bacterial infection 22.10 12.07 14 71137 677 42549507
Tumour lysis syndrome 22.10 12.07 5 71146 22226 42527958
Faeces hard 21.85 12.07 20 71131 1684 42548500
Iron deficiency anaemia 21.61 12.07 59 71092 12980 42537204
Palpitations 21.54 12.07 152 70999 50645 42499539
Accidental exposure to product 21.49 12.07 4 71147 20389 42529795
Subdural haematoma 21.46 12.07 6 71145 23132 42527052
Hypervolaemia 21.44 12.07 6 71145 23119 42527065
Speech disorder 21.28 12.07 11 71140 29110 42521074
Hyponatraemia 21.27 12.07 92 71059 101370 42448814
Arteriosclerosis coronary artery 21.16 12.07 3 71148 18674 42531510
Memory impairment 21.04 12.07 32 71119 50190 42499994
Skin exfoliation 20.99 12.07 23 71128 41530 42508654
Aphasia 20.98 12.07 7 71144 24076 42526108
Growth retardation 20.95 12.07 23 71128 2409 42547775
Medication error 20.92 12.07 110 71041 33044 42517140
Blood glucose increased 20.70 12.07 59 71092 73640 42476544
Plasmablastic lymphoma 20.65 12.07 13 71138 622 42549562
Enteritis infectious 20.64 12.07 19 71132 1612 42548572
Psoriatic arthropathy 20.48 12.07 8 71143 24959 42525225
Syncope 20.31 12.07 91 71060 99315 42450869
Orthostatic hypotension 20.27 12.07 13 71138 30557 42519627
Abscess 20.25 12.07 61 71090 14187 42535997
Hypercalcaemia 20.23 12.07 3 71148 18055 42532129
Urinary tract infection 20.22 12.07 91 71060 99193 42450991
Infection parasitic 20.06 12.07 11 71140 406 42549778
Blood creatinine increased 19.99 12.07 105 71046 109898 42440286
Chronic kidney disease 19.88 12.07 30 71121 47211 42502973
Amoebiasis 19.39 12.07 7 71144 92 42550092
Anal spasm 19.32 12.07 8 71143 155 42550029
Oedema 19.14 12.07 36 71115 51965 42498219
Dysarthria 19.06 12.07 23 71128 39784 42510400
Enteritis 18.99 12.07 50 71101 10766 42539418
Clostridium difficile colitis 18.94 12.07 78 71073 21174 42529010
Cytomegalovirus gastrointestinal infection 18.85 12.07 10 71141 345 42549839
Cardiac disorder 18.79 12.07 33 71118 48899 42501285
Bowel movement irregularity 18.68 12.07 26 71125 3470 42546714
Gastrooesophageal reflux disease 18.67 12.07 134 71017 44889 42505295
Psychotic disorder 18.58 12.07 13 71138 29195 42520989
Multiple organ dysfunction syndrome 18.55 12.07 91 71060 96944 42453240
Large intestine polyp 18.53 12.07 45 71106 9220 42540964
Intestinal resection 18.49 12.07 19 71132 1845 42548339
Balance disorder 18.42 12.07 32 71119 47613 42502571
Anastomotic ulcer 18.39 12.07 11 71140 480 42549704
Cognitive disorder 18.29 12.07 18 71133 34154 42516030
Adenocarcinoma of colon 18.20 12.07 27 71124 3820 42546364
Irritable bowel syndrome 18.18 12.07 30 71121 4651 42545533
Cerebral haemorrhage 18.15 12.07 23 71128 38943 42511241
Decreased appetite 18.02 12.07 221 70930 192916 42357268
Aphthous ulcer 17.97 12.07 34 71117 5867 42544317
Inappropriate antidiuretic hormone secretion 17.96 12.07 3 71148 16538 42533646
Henoch-Schonlein purpura 17.95 12.07 20 71131 2130 42548054
Drain site complication 17.93 12.07 4 71147 6 42550178
Haemoptysis 17.85 12.07 31 71120 46136 42504048
Product administered to patient of inappropriate age 17.80 12.07 30 71121 4731 42545453
Intestinal anastomosis complication 17.78 12.07 8 71143 191 42549993
Ascites 17.72 12.07 43 71108 56635 42493549
Urinary incontinence 17.68 12.07 7 71144 21661 42528523
Brain oedema 17.64 12.07 3 71148 16324 42533860
Flushing 17.61 12.07 114 71037 36914 42513270
Anxiety 17.42 12.07 121 71030 118439 42431745
Restlessness 17.35 12.07 14 71137 29235 42520949
Suicidal ideation 17.15 12.07 34 71117 48127 42502057
Haematoma 17.14 12.07 13 71138 28010 42522174
Intestinal diaphragm disease 17.14 12.07 9 71142 304 42549880
Abdominal pain upper 17.11 12.07 212 70939 82397 42467787
Listeriosis 17.01 12.07 16 71135 1395 42548789
Hepatic cytolysis 17.01 12.07 12 71139 26832 42523352
Atrial flutter 16.91 12.07 4 71147 17247 42532937
Disturbance in attention 16.85 12.07 15 71136 29851 42520333
Drug hypersensitivity 16.85 12.07 246 70905 99143 42451041
Haemorrhage intracranial 16.82 12.07 4 71147 17188 42532996
Gastrointestinal pain 16.75 12.07 28 71123 4387 42545797
Cardiac perforation 16.68 12.07 6 71145 78 42550106
Rash maculo-papular 16.59 12.07 23 71128 37480 42512704
Rectal cancer 16.57 12.07 20 71131 2320 42547864
Overgrowth bacterial 16.57 12.07 7 71144 143 42550041
Pseudopolyposis 16.54 12.07 6 71145 80 42550104
Disorientation 16.41 12.07 22 71129 36367 42513817
Procedural intestinal perforation 16.41 12.07 5 71146 37 42550147
Anal cancer 16.34 12.07 10 71141 455 42549729
Haemophagocytic lymphohistiocytosis 16.33 12.07 67 71084 18155 42532029
Hepatic function abnormal 16.22 12.07 39 71112 51528 42498656
Obstructive airways disorder 16.21 12.07 83 71068 24676 42525508
Dry mouth 16.14 12.07 26 71125 39853 42510331
Anal incontinence 16.10 12.07 43 71108 9338 42540846
Pneumonia streptococcal 16.04 12.07 17 71134 1711 42548473
Irritability 16.02 12.07 14 71137 28114 42522070
Sudden death 16.02 12.07 4 71147 16625 42533559
Drug withdrawal syndrome 15.95 12.07 8 71143 21541 42528643
Infection reactivation 15.94 12.07 19 71132 2175 42548009
Sacroiliitis 15.80 12.07 18 71133 1964 42548220
Chronic obstructive pulmonary disease 15.77 12.07 168 70983 62946 42487238
Extrapyramidal disorder 15.71 12.07 4 71147 16408 42533776
Cardiogenic shock 15.62 12.07 22 71129 35618 42514566
Sleep disorder therapy 15.44 12.07 35 71116 6859 42543325
Body temperature decreased 15.38 12.07 56 71095 14357 42535827
Sleep disorder due to a general medical condition 15.33 12.07 5 71146 17448 42532736
Hepatic failure 15.27 12.07 25 71126 38075 42512109
Nausea 15.25 12.07 526 70625 396273 42153911
Accidental overdose 15.22 12.07 90 71061 28240 42521944
Altered state of consciousness 15.00 12.07 16 71135 29243 42520941
Subcutaneous abscess 14.94 12.07 27 71124 4501 42545683
Subarachnoid haemorrhage 14.90 12.07 3 71148 14469 42535715
Deep vein thrombosis 14.88 12.07 195 70956 76762 42473422
Urinary retention 14.86 12.07 30 71121 42184 42508000
Pleural effusion 14.85 12.07 98 71053 97068 42453116
Gastrointestinal infection 14.84 12.07 34 71117 6709 42543475
Calcinosis 14.83 12.07 12 71139 855 42549329
Hypersensitivity myocarditis 14.82 12.07 5 71146 53 42550131
Omphalitis 14.80 12.07 4 71147 18 42550166
Rectal dysplasia 14.80 12.07 4 71147 18 42550166
Rectal lesion 14.74 12.07 5 71146 54 42550130
Palmar-plantar erythrodysaesthesia syndrome 14.71 12.07 8 71143 20574 42529610
Constipation 14.65 12.07 187 70964 162104 42388080
Anorectal stenosis 14.62 12.07 4 71147 19 42550165
B-cell lymphoma 14.59 12.07 28 71123 4885 42545299
Rectal prolapse 14.51 12.07 10 71141 558 42549626
Acute haemorrhagic ulcerative colitis 14.45 12.07 4 71147 20 42550164
Arteriosclerosis 14.37 12.07 6 71145 17983 42532201
Spondyloarthropathy 14.28 12.07 12 71139 902 42549282
Subileus 14.26 12.07 23 71128 3498 42546686
Rectal discharge 14.07 12.07 8 71143 317 42549867
Colon dysplasia 13.82 12.07 7 71144 219 42549965
Epilepsy 13.76 12.07 14 71137 26157 42524027
T-cell lymphoma 13.76 12.07 13 71138 1140 42549044
Cytopenia 13.72 12.07 6 71145 17491 42532693
Large intestine perforation 13.71 12.07 41 71110 9495 42540689
Blood lactate dehydrogenase increased 13.66 12.07 14 71137 26067 42524117
Respiratory distress 13.66 12.07 31 71120 41789 42508395
Injection site pain 13.63 12.07 50 71101 57748 42492436
Neoplasm progression 13.63 12.07 17 71134 28983 42521201
Anaemia 13.61 12.07 360 70791 279918 42270266
Intestinal haemorrhage 13.60 12.07 24 71127 3927 42546257
Rectal ulcer 13.52 12.07 13 71138 1165 42549019
Fluctuance 13.44 12.07 4 71147 27 42550157
Thrombotic microangiopathy 13.40 12.07 4 71147 14778 42535406
Analgesic therapy 13.38 12.07 32 71119 6492 42543692
General physical health deterioration 13.38 12.07 175 70976 151071 42399113
Gastrooesophageal sphincter insufficiency 13.37 12.07 5 71146 73 42550111
Gamma-glutamyltransferase increased 13.33 12.07 21 71130 32476 42517708
Adenocarcinoma 13.32 12.07 17 71134 2087 42548097
Full blood count decreased 13.28 12.07 9 71142 20551 42529633
Large intestine infection 13.21 12.07 17 71134 2104 42548080
Dysgeusia 13.17 12.07 100 71051 34089 42516095
Proctectomy 13.12 12.07 6 71145 149 42550035
Dysphonia 13.04 12.07 17 71134 28433 42521751
Amnesia 13.02 12.07 17 71134 28420 42521764
Small intestinal perforation 13.00 12.07 20 71131 2921 42547263
Meningitis listeria 13.00 12.07 10 71141 662 42549522
Upper gastrointestinal haemorrhage 12.98 12.07 19 71132 30280 42519904
Pelvic abscess 12.89 12.07 12 71139 1033 42549151
Angina pectoris 12.80 12.07 22 71129 32874 42517310
Ischaemic stroke 12.74 12.07 11 71140 22222 42527962
Blood pressure diastolic increased 12.69 12.07 31 71120 6374 42543810
Epstein-Barr virus associated lymphoma 12.68 12.07 12 71139 1054 42549130
Graft versus host disease 12.66 12.07 3 71148 12922 42537262
Glycosylated haemoglobin increased 12.66 12.07 3 71148 12921 42537263
Clostridial infection 12.65 12.07 23 71128 3851 42546333
Dry skin 12.63 12.07 40 71111 48298 42501886
Anti-platelet antibody 12.59 12.07 3 71148 7 42550177
Faeces discoloured 12.54 12.07 59 71092 16955 42533229
Blood pressure diastolic decreased 12.53 12.07 42 71109 10333 42539851
Abdominal adhesions 12.52 12.07 15 71136 1727 42548457
Dystonia 12.47 12.07 3 71148 12787 42537397
Calcium deficiency 12.46 12.07 7 71144 271 42549913
Unemployment 12.44 12.07 4 71147 36 42550148
Laboratory test abnormal 12.42 12.07 12 71139 22966 42527218
Haematuria 12.36 12.07 52 71099 57747 42492437
Nasopharyngitis 12.36 12.07 203 70948 83793 42466391
Dental caries 12.35 12.07 26 71125 4846 42545338
Hepatic encephalopathy 12.33 12.07 6 71145 16436 42533748
Visual acuity reduced 12.28 12.07 7 71144 17543 42532641
Toxic epidermal necrolysis 12.24 12.07 16 71135 26734 42523450
Autoimmune pancreatitis 12.20 12.07 8 71143 411 42549773
Anastomotic stenosis 12.16 12.07 8 71143 413 42549771
Spondylitis 12.09 12.07 14 71137 1554 42548630

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
Colitis ulcerative 5612.83 10.84 2707 186504 74656 110325432
Haematochezia 2568.93 10.84 1884 187327 113640 110286448
Frequent bowel movements 2224.68 10.84 1434 187777 69956 110330132
Off label use 1670.78 10.84 5974 183237 1494211 108905877
Condition aggravated 962.15 10.84 3098 186113 731738 109668350
Rectal haemorrhage 808.86 10.84 1011 188200 118822 110281266
Inappropriate schedule of product administration 742.84 10.84 1285 187926 202352 110197736
Faecal calprotectin increased 667.50 10.84 293 188918 6426 110393662
Intentional product use issue 623.21 10.84 1336 187875 246570 110153518
Abdominal pain 544.95 10.84 2020 187191 510969 109889119
Mucous stools 527.02 10.84 250 188961 6597 110393491
Toxicity to various agents 500.41 10.84 106 189105 480449 109919639
Colitis 499.72 10.84 738 188473 101585 110298503
Defaecation urgency 494.55 10.84 259 188952 8488 110391600
Death 466.62 10.84 312 188899 698557 109701531
Therapeutic reaction time decreased 422.45 10.84 198 189013 5081 110395007
Diarrhoea haemorrhagic 409.07 10.84 282 188929 15357 110384731
Drug level below therapeutic 406.96 10.84 252 188959 11421 110388667
Weight decreased 385.68 10.84 1704 187507 466353 109933735
Lupus-like syndrome 378.99 10.84 406 188805 40386 110359702
Fall 369.39 10.84 295 188916 603187 109796901
Acute kidney injury 367.66 10.84 328 188883 635102 109764986
Clostridium difficile infection 356.57 10.84 443 188768 51686 110348402
Completed suicide 350.33 10.84 15 189196 242366 110157722
Drug level decreased 331.42 10.84 266 188945 18282 110381806
Proctitis 317.97 10.84 250 188961 16677 110383411
Retinitis 313.15 10.84 329 188882 31998 110368090
Febrile neutropenia 305.67 10.84 82 189129 316685 110083403
Hypotension 289.19 10.84 282 188929 523567 109876521
Loss of therapeutic response 287.29 10.84 121 189090 2389 110397699
Drug specific antibody present 286.24 10.84 179 189032 8255 110391833
Neutropenia 255.38 10.84 163 189048 374457 110025631
Blood pressure fluctuation 254.12 10.84 458 188753 74366 110325722
Drug interaction 242.13 10.84 300 188911 499883 109900205
Exostosis 241.05 10.84 343 188868 45613 110354475
Bone erosion 237.22 10.84 342 188869 46029 110354059
Platelet count decreased 231.24 10.84 55 189156 230388 110169700
Drug ineffective 230.76 10.84 3762 185449 1516778 108883310
Congenital hiatus hernia 217.87 10.84 135 189076 6124 110393964
Laryngitis 209.97 10.84 308 188903 42103 110357985
Joint dislocation 207.72 10.84 274 188937 33916 110366172
Anal abscess 206 10.84 166 189045 11472 110388616
Porphyria acute 197.90 10.84 200 189011 18580 110381508
Steroid dependence 194.35 10.84 141 189070 8328 110391760
Rectal tenesmus 193.94 10.84 89 189122 2173 110397915
Malignant neoplasm progression 188.82 10.84 35 189176 174532 110225556
Therapeutic product effect incomplete 187.84 10.84 820 188391 222985 110177103
Myocarditis 187.45 10.84 244 188967 29811 110370277
Ear infection 186.82 10.84 363 188848 62369 110337719
Cytomegalovirus colitis 186.25 10.84 128 189083 6933 110393155
Foot deformity 185.75 10.84 313 188898 48167 110351921
Therapeutic response shortened 176.51 10.84 235 188976 29348 110370740
Fistula 176.17 10.84 171 189040 15128 110384960
Tubulointerstitial nephritis 175.10 10.84 325 188886 53959 110346129
Inflammatory bowel disease 174.16 10.84 124 189087 7110 110392978
Intentional overdose 173.84 10.84 14 189197 132487 110267601
Macular degeneration 172.61 10.84 199 189012 21460 110378628
Female genital tract fistula 170.57 10.84 174 189037 16345 110383743
Cardiac arrest 168.25 10.84 63 189148 196690 110203398
Product use issue 167.64 10.84 1008 188203 310687 110089401
Hepatic cirrhosis 166.77 10.84 362 188849 67264 110332824
Dyspnoea 161.74 10.84 1170 188041 1105702 109294386
Drug abuse 161.74 10.84 51 189160 177360 110222728
Bronchiectasis 157.97 10.84 249 188962 36244 110363844
Large intestinal stenosis 153.46 10.84 90 189121 3690 110396398
Lupus vulgaris 153.37 10.84 236 188975 33647 110366441
Vaginal flatulence 151.73 10.84 142 189069 12002 110388086
Anal fistula 148.15 10.84 120 189091 8353 110391735
Disease progression 148.14 10.84 120 189091 243914 110156174
Cardiac failure congestive 147.64 10.84 38 189173 150962 110249126
Arthritis 147.48 10.84 623 188588 166963 110233125
Poor venous access 143.55 10.84 193 189018 24329 110375759
Gastrointestinal inflammation 140.54 10.84 122 189089 9347 110390741
Chronic sinusitis 140.14 10.84 193 189018 24891 110375197
Faeces soft 139.91 10.84 131 189080 11079 110389009
Hyperkalaemia 139.01 10.84 31 189180 135765 110264323
X-ray abnormal 138.00 10.84 240 188971 37877 110362211
Coma 137.87 10.84 19 189192 117850 110282238
Stress 136.70 10.84 444 188767 104904 110295184
White blood cell count decreased 136.51 10.84 115 189096 229275 110170813
Cardiac failure 134.24 10.84 77 189134 187549 110212539
Red blood cell sedimentation rate increased 133.94 10.84 364 188847 77938 110322150
Renal failure 130.69 10.84 117 189094 226457 110173631
Impaired quality of life 128.80 10.84 204 189007 29813 110370275
Thrombocytopenia 128.79 10.84 251 188960 348634 110051454
Anal fissure 128.21 10.84 118 189093 9763 110390325
Dislocation of vertebra 126.53 10.84 250 188961 43471 110356617
Atrial fibrillation 126.09 10.84 124 189087 229518 110170570
Cardio-respiratory arrest 125.73 10.84 23 189188 115813 110284275
Drug level above therapeutic 125.02 10.84 125 189086 11463 110388625
Product residue present 124.64 10.84 80 189131 3861 110396227
Depressed level of consciousness 122.50 10.84 22 189189 112256 110287832
Catarrh 122.20 10.84 101 189110 7234 110392854
Autoimmune disorder 120.71 10.84 313 188898 65170 110334918
Vaginal discharge 118.93 10.84 150 189061 17758 110382330
Burns second degree 117.54 10.84 101 189110 7632 110392456
Neuropathy peripheral 116.69 10.84 82 189129 179195 110220893
Deep vein thrombosis postoperative 116.15 10.84 290 188921 59001 110341087
Paraesthesia oral 115.43 10.84 207 189004 33464 110366624
Pregnancy 115.38 10.84 264 188947 50803 110349285
Hypercholesterolaemia 113.51 10.84 378 188833 90459 110309629
Malignant melanoma in situ 112.27 10.84 72 189139 3470 110396618
Radiculopathy 111.38 10.84 151 189060 19185 110380903
Osteoporosis 110.98 10.84 365 188846 86787 110313301
Grip strength 110.60 10.84 105 189106 9036 110391052
Procedural pain 108.57 10.84 208 189003 35357 110364731
Lactic acidosis 108.46 10.84 15 189196 92796 110307292
Seizure 107.57 10.84 132 189079 221053 110179035
Pancreatitis 106.20 10.84 377 188834 93156 110306932
Adjustment disorder with depressed mood 106.01 10.84 233 188978 43650 110356438
Eosinophilic pneumonia 105.02 10.84 92 189119 7135 110392953
Overdose 102.07 10.84 151 189060 233643 110166445
Hypoxia 101.79 10.84 47 189164 129468 110270620
Heart rate decreased 101.30 10.84 342 188869 82414 110317674
Respiratory failure 100.06 10.84 133 189078 215199 110184889
Flatulence 99.98 10.84 253 188958 51896 110348192
Hyponatraemia 99.55 10.84 136 189075 217517 110182571
Hypoglycaemia 99.53 10.84 37 189174 116067 110284021
Benign prostatic hyperplasia 98.42 10.84 138 189073 18096 110381992
Neutrophil count decreased 98.02 10.84 42 189169 120899 110279189
Joint stiffness 96.97 10.84 294 188917 66949 110333139
Crohn's disease 94.72 10.84 53 189158 1985 110398103
Myocardial infarction 94.06 10.84 114 189097 191969 110208119
Weight increased 92.42 10.84 1111 188100 418533 109981555
Hypopnoea 89.74 10.84 104 189107 11276 110388812
Erythema nodosum 89.35 10.84 81 189130 6572 110393516
Parosmia 88.48 10.84 111 189100 13069 110387019
Cytokine release syndrome 87.99 10.84 9 189202 70297 110329791
Serotonin syndrome 87.68 10.84 3 189208 59150 110340938
Intestinal stenosis 87.17 10.84 69 189142 4646 110395442
Epistaxis 85.67 10.84 59 189152 130313 110269775
Large intestinal ulcer 85.05 10.84 74 189137 5687 110394401
Night sweats 84.93 10.84 453 188758 133530 110266558
C-reactive protein increased 84.88 10.84 651 188560 217268 110182820
Sedation 84.47 10.84 10 189201 69673 110330415
Sepsis 84.09 10.84 283 188928 327063 110073025
Diarrhoea 84.07 10.84 2546 186665 1136959 109263129
Ileal stenosis 83.24 10.84 58 189153 3212 110396876
Incorrect dose administered 82.54 10.84 374 188837 103267 110296821
Rhabdomyolysis 81.11 10.84 53 189158 120348 110279740
Blood creatinine increased 77.04 10.84 121 189090 182768 110217320
Orthostatic hypotension 76.72 10.84 11 189200 66238 110333850
Infusion related reaction 76.55 10.84 992 188219 380170 110019918
Rectal abscess 76.17 10.84 51 189160 2645 110397443
Alanine aminotransferase increased 76.08 10.84 123 189088 183650 110216438
Pneumonia 75.67 10.84 1051 188160 875663 109524425
Abdominal pain lower 74.75 10.84 184 189027 37099 110362989
Agitation 73.17 10.84 52 189159 112999 110287089
Hyperglycaemia 73.13 10.84 27 189184 85063 110315025
Proctalgia 72.75 10.84 101 189110 13121 110386967
Anti-cyclic citrullinated peptide antibody 72.65 10.84 126 189085 19838 110380250
Pulmonary oedema 72.42 10.84 41 189170 100618 110299470
Cholangitis sclerosing 71.83 10.84 55 189156 3527 110396561
Micturition urgency 71.70 10.84 123 189088 19197 110380891
Impaired work ability 71.59 10.84 147 189064 26272 110373816
Mucosal inflammation 69.40 10.84 39 189172 96102 110303986
Respiratory arrest 69.12 10.84 9 189202 58290 110341798
Encephalopathy 67.53 10.84 27 189184 81028 110319060
Mental status changes 67.39 10.84 23 189188 76099 110323989
Bradycardia 67.32 10.84 101 189110 155416 110244672
Abnormal faeces 67.19 10.84 81 189130 9155 110390933
Intestinal fistula 67.05 10.84 40 189171 1693 110398395
Weight fluctuation 66.96 10.84 129 189082 22016 110378072
Urinary tract infection 66.65 10.84 309 188902 325973 110074115
Gingival pain 66.21 10.84 106 189105 15630 110384458
International normalised ratio increased 65.87 10.84 33 189178 86739 110313349
Renal impairment 65.72 10.84 140 189071 188305 110211783
Rhinitis 65.33 10.84 129 189082 22416 110377672
Balance disorder 65.04 10.84 62 189149 116498 110283590
Hypokalaemia 64.08 10.84 135 189076 182313 110217775
Electrocardiogram QT prolonged 63.12 10.84 56 189155 108904 110291184
Organising pneumonia 62.77 10.84 98 189113 14145 110385943
Pyoderma gangrenosum 62.66 10.84 61 189150 5415 110394673
Aspartate aminotransferase increased 62.56 10.84 111 189100 159825 110240263
Feeling hot 62.55 10.84 315 188896 90791 110309297
Unresponsive to stimuli 62.44 10.84 16 189195 63774 110336314
Overlap syndrome 61.94 10.84 77 189134 8982 110391106
Aggression 61.63 10.84 13 189198 59197 110340891
Breath sounds abnormal 61.49 10.84 135 189076 25269 110374819
Syncope 61.44 10.84 162 189049 202374 110197714
Suicide attempt 61.28 10.84 52 189159 103342 110296746
Hepatosplenic T-cell lymphoma 60.31 10.84 31 189180 976 110399112
Segmental diverticular colitis 60.27 10.84 19 189192 155 110399933
Drug specific antibody 60.20 10.84 45 189166 2783 110397305
Lower limb fracture 60.06 10.84 272 188939 75076 110325012
Neoplasm progression 59.87 10.84 18 189193 64577 110335511
Therapy non-responder 59.61 10.84 467 188744 156840 110243248
Pouchitis 58.66 10.84 34 189177 1363 110398725
Blood creatine phosphokinase increased 58.22 10.84 26 189185 73051 110327037
Colectomy 58.20 10.84 53 189158 4325 110395763
Heart rate irregular 57.27 10.84 158 189053 34116 110365972
Anorectal discomfort 56.92 10.84 51 189160 4075 110396013
Multiple sclerosis relapse 56.66 10.84 9 189202 50231 110349857
Acute respiratory failure 56.56 10.84 29 189182 75231 110324857
Accidental exposure to product 56.31 10.84 9 189202 49999 110350089
Oxygen saturation decreased 56.10 10.84 115 189096 156867 110243221
Hypervolaemia 55.47 10.84 9 189202 49451 110350637
Cryopyrin associated periodic syndrome 54.87 10.84 25 189186 600 110399488
Exposure during pregnancy 54.85 10.84 481 188730 166943 110233145
Enterovesical fistula 54.82 10.84 33 189178 1420 110398668
Pneumonia aspiration 54.38 10.84 36 189175 81197 110318891
Cognitive disorder 54.37 10.84 42 189169 87469 110312619
Visual impairment 54.24 10.84 405 188806 134023 110266065
Treatment failure 54.15 10.84 718 188493 276516 110123572
Intestinal obstruction 54.07 10.84 207 189004 53020 110347068
Acute myocardial infarction 53.60 10.84 39 189172 83738 110316350
Haemorrhoids 53.35 10.84 158 189053 35514 110364574
Loss of consciousness 52.96 10.84 166 189045 196140 110203948
Myelosuppression 52.85 10.84 50 189161 94290 110305798
Oral allergy syndrome 52.73 10.84 15 189196 82 110400006
Small intestinal stenosis 52.61 10.84 31 189180 1282 110398806
Cytomegalovirus enterocolitis 52.39 10.84 38 189173 2243 110397845
Malaise 52.32 10.84 1512 187699 670307 109729781
Pulmonary hypertension 51.89 10.84 15 189196 55205 110344883
Multiple organ dysfunction syndrome 51.82 10.84 114 189097 151596 110248492
Blood glucose increased 51.77 10.84 92 189119 132404 110267684
Walking aid user 51.60 10.84 125 189086 24950 110375138
Blood urea increased 51.51 10.84 15 189196 54942 110345146
Adverse drug reaction 51.41 10.84 333 188878 105226 110294862
COVID-19 50.93 10.84 642 188569 244418 110155670
Cytomegalovirus infection 50.68 10.84 206 189005 54238 110345850
Somnolence 50.48 10.84 300 188911 297149 110102939
Dysarthria 50.23 10.84 42 189169 84079 110316009
Pedal pulse abnormal 49.88 10.84 18 189193 230 110399858
Colon dysplasia 49.03 10.84 20 189191 363 110399725
Pyrexia 48.97 10.84 1939 187272 896326 109503762
Injection site reaction 48.97 10.84 48 189163 89022 110311066
Hallucination 48.80 10.84 61 189150 101371 110298717
Plasmablastic lymphoma 48.70 10.84 25 189186 785 110399303
Aphasia 48.58 10.84 20 189191 58977 110341111
Rash maculo-papular 48.21 10.84 34 189177 74188 110325900
Suicidal ideation 47.85 10.84 54 189157 93883 110306205
Plasma cell myeloma 47.67 10.84 24 189187 62912 110337176
Bowel movement irregularity 47.47 10.84 62 189149 7598 110392490
Endometriosis 47.21 10.84 47 189164 4287 110395801
Osteonecrosis of jaw 47.08 10.84 12 189199 48005 110352083
Hypercalcaemia 47.04 10.84 11 189200 46646 110353442
Blood pressure increased 46.71 10.84 660 188551 257713 110142375
Hepatic cytolysis 46.42 10.84 18 189193 55035 110345053
Diabetic ketoacidosis 46.40 10.84 8 189203 42050 110358038
Hyperhidrosis 45.99 10.84 165 189046 187133 110212955
Pericarditis 45.95 10.84 575 188636 218539 110181549
Femur fracture 45.80 10.84 10 189201 44459 110355629
Maternal exposure timing unspecified 45.67 10.84 107 189104 20906 110379182
Disseminated tuberculosis 45.65 10.84 50 189161 5096 110394992
Cardiac disorder 45.65 10.84 38 189173 76242 110323846
Oral candidiasis 45.41 10.84 174 189037 44586 110355502
Myoclonus 44.66 10.84 3 189208 32995 110367093
Facet joint syndrome 44.45 10.84 301 188910 96527 110303561
Large intestine erosion 43.80 10.84 14 189197 120 110399968
Vomiting 43.76 10.84 1205 188006 909470 109490618
Sleep disorder due to general medical condition, insomnia type 43.02 10.84 319 188892 105324 110294764
Iron deficiency anaemia 42.72 10.84 135 189076 31424 110368664
Abdominal abscess 42.13 10.84 63 189148 8756 110391332
Philadelphia positive chronic myeloid leukaemia 42.05 10.84 15 189196 185 110399903
Septic shock 41.93 10.84 134 189077 157394 110242694
Dyspepsia 41.70 10.84 505 188706 190460 110209628
Hypothyroidism 41.58 10.84 38 189173 72861 110327227
Gastrointestinal stenosis 41.37 10.84 18 189193 386 110399702
Device expulsion 41.25 10.84 3 189208 30888 110369200
Ventricular tachycardia 41.10 10.84 17 189194 49992 110350096
Alcohol poisoning 41.06 10.84 63 189148 8957 110391131
Therapy interrupted 40.85 10.84 17 189194 49805 110350283
Disturbance in attention 40.79 10.84 28 189183 61967 110338121
Inappropriate antidiuretic hormone secretion 40.68 10.84 5 189206 33846 110366242
Pulmonary tuberculosis 40.44 10.84 63 189148 9076 110391012
Drug withdrawal syndrome 40.34 10.84 8 189203 38046 110362042
Disorientation 40.12 10.84 37 189174 70634 110329454
Abscess intestinal 40.06 10.84 38 189173 3266 110396822
Drug reaction with eosinophilia and systemic symptoms 39.88 10.84 49 189162 82046 110318042
Anorectal disorder 39.84 10.84 35 189176 2724 110397364
Discomfort 39.83 10.84 551 188660 214156 110185932
Haemoptysis 39.75 10.84 38 189173 71316 110328772
Altered state of consciousness 39.31 10.84 25 189186 57601 110342487
Loss of personal independence in daily activities 39.23 10.84 411 188800 149609 110250479
White blood cell count increased 39.19 10.84 292 188919 96550 110303538
Serum ferritin decreased 39.12 10.84 36 189175 2978 110397110
Aphthous ulcer 38.91 10.84 101 189110 21035 110379053
Hepatocellular injury 38.83 10.84 19 189192 50623 110349465
Acne 38.80 10.84 136 189075 33384 110366704
Pseudopolyp 38.61 10.84 20 189191 640 110399448
Dysphagia 38.59 10.84 134 189077 153466 110246622
Road traffic accident 38.58 10.84 315 188896 107083 110293005
Abscess 38.57 10.84 119 189092 27350 110372738
Terminal ileitis 38.56 10.84 28 189183 1656 110398432
Rheumatoid factor positive 38.45 10.84 369 188842 131271 110268817
Injection site pain 38.41 10.84 165 189046 177757 110222331
Dyskinesia 38.40 10.84 20 189191 51426 110348662
Poisoning 38.38 10.84 3 189208 29102 110370986
Swollen joint count increased 38.36 10.84 260 188951 83401 110316687
Blood bilirubin increased 38.34 10.84 44 189167 75928 110324160
Toxic epidermal necrolysis 38.16 10.84 25 189186 56702 110343386
Extrapyramidal disorder 37.99 10.84 3 189208 28864 110371224
Angioedema 37.94 10.84 69 189142 98431 110301657
Product administered to patient of inappropriate age 37.81 10.84 57 189154 7979 110392109
Psychotic disorder 37.72 10.84 20 189191 50917 110349171
Haematoma 37.70 10.84 27 189184 58449 110341639
Speech disorder 37.68 10.84 30 189181 61539 110338549
Pancreatitis acute 37.64 10.84 203 189008 60071 110340017
Device dislocation 37.33 10.84 5 189206 31699 110368389
Gastrointestinal haemorrhage 37.28 10.84 151 189060 165367 110234721
Muscle twitching 37.02 10.84 4 189207 29931 110370157
Wound infection 36.87 10.84 287 188924 96178 110303910
Anal stenosis 36.83 10.84 19 189192 603 110399485
Rectal stenosis 36.78 10.84 17 189194 422 110399666
Cardiac murmur 36.75 10.84 109 189102 24519 110375569
Cardiogenic shock 36.28 10.84 27 189184 57311 110342777
Restlessness 36.24 10.84 26 189185 56233 110343855
Sleep apnoea syndrome 36.19 10.84 12 189199 40435 110359653
Urinary incontinence 36.10 10.84 19 189192 48568 110351520
Skin exfoliation 35.95 10.84 59 189152 87592 110312496
Tumour lysis syndrome 35.93 10.84 5 189206 30796 110369292
Tremor 35.89 10.84 201 189010 202031 110198057
Pleural effusion 35.85 10.84 169 189042 177540 110222548
Body temperature fluctuation 35.82 10.84 38 189173 3735 110396353
Proctocolectomy 35.71 10.84 14 189197 228 110399860
Urinary retention 35.56 10.84 40 189171 69643 110330445
Acute febrile neutrophilic dermatosis 35.44 10.84 43 189168 4893 110395195
Gastric disorder 35.39 10.84 7 189204 33350 110366738
Gastrointestinal disorder 35.27 10.84 596 188615 241356 110158732
Taste disorder 35.07 10.84 36 189175 65351 110334737
Finger deformity 34.99 10.84 7 189204 33085 110367003
Drug effect less than expected 34.56 10.84 52 189159 7268 110392820
Liver disorder 34.55 10.84 384 188827 141859 110258229
Swollen joint count 34.55 10.84 57 189154 8617 110391471
Listeria sepsis 34.41 10.84 20 189191 806 110399282
Generalised tonic-clonic seizure 34.27 10.84 26 189185 54654 110345434
Pulmonary arterial hypertension 34.21 10.84 7 189204 32561 110367527
Hepatitis 33.87 10.84 64 189147 89990 110310098
Ileostomy 33.86 10.84 30 189181 2362 110397726
Upper gastrointestinal haemorrhage 33.80 10.84 22 189189 50074 110350014
Palmar-plantar erythrodysaesthesia syndrome 33.63 10.84 14 189197 41011 110359077
Intestinal ulcer 33.48 10.84 30 189181 2397 110397691
Thrombotic microangiopathy 33.38 10.84 5 189206 29144 110370944
Right ventricular failure 33.33 10.84 3 189208 25951 110374137
Rash 33.31 10.84 1111 188100 819853 109580235
Large intestine polyp 32.87 10.84 77 189134 15040 110385048
Subcutaneous abscess 32.86 10.84 58 189153 9259 110390829
Calcium ionised decreased 32.82 10.84 18 189193 648 110399440
Sciatica 32.64 10.84 270 188941 92129 110307959
Metabolic acidosis 32.40 10.84 77 189134 99667 110300421
Proctitis ulcerative 32.40 10.84 16 189195 462 110399626
Ischaemic stroke 32.37 10.84 15 189196 41248 110358840
Subdural haematoma 32.29 10.84 11 189200 36443 110363645
Irritability 32.25 10.84 21 189190 47788 110352300
Abortion spontaneous 32.13 10.84 130 189081 34152 110365936
Skin ulcer 31.97 10.84 37 189174 63608 110336480
Coeliac disease 31.92 10.84 17 189194 43170 110356918
Chronic gastrointestinal bleeding 31.84 10.84 16 189195 480 110399608
Arthralgia 31.72 10.84 1634 187577 777998 109622090
Migraine 31.62 10.84 440 188771 171212 110228876
Colectomy total 31.60 10.84 16 189195 488 110399600
Angina pectoris 31.52 10.84 36 189175 62259 110337829
Abdominal distension 31.51 10.84 447 188764 174656 110225432
Maternal exposure during pregnancy 31.23 10.84 611 188600 254272 110145816
Breast cancer stage III 31.13 10.84 237 188974 78880 110321208
Anuria 30.76 10.84 3 189208 24338 110375750
C-reactive protein decreased 30.68 10.84 31 189180 2878 110397210
Neuroleptic malignant syndrome 30.65 10.84 10 189201 34049 110366039
Faecal calprotectin abnormal 30.57 10.84 14 189197 340 110399748
Shock 30.48 10.84 28 189183 53560 110346528
Ejection fraction decreased 30.35 10.84 16 189195 40864 110359224
Haematuria 30.34 10.84 60 189151 82945 110317143
Helicobacter infection 30.25 10.84 458 188753 181419 110218669
Cough 29.93 10.84 583 188628 461058 109939030
Nail disorder 29.84 10.84 33 189178 57902 110342186
Listeriosis 29.70 10.84 30 189181 2784 110397304
Full blood count decreased 29.65 10.84 9 189202 32090 110367998
Blood glucose decreased 29.63 10.84 7 189204 29481 110370607
Respiratory distress 29.53 10.84 45 189166 68829 110331259
Cytomegalovirus enteritis 29.52 10.84 20 189191 1058 110399030
Intestinal anastomosis 29.51 10.84 19 189192 922 110399166
Anaphylactic shock 29.24 10.84 27 189184 51519 110348569
Dysuria 29.20 10.84 36 189175 60195 110339893
Hallucination, auditory 29.16 10.84 5 189206 26392 110373696
Tuberculous pleurisy 29.16 10.84 17 189194 689 110399399
Hypothermia 29.02 10.84 5 189206 26297 110373791
Acute haemorrhagic ulcerative colitis 28.98 10.84 10 189201 111 110399977
Systemic lupus erythematosus 28.94 10.84 603 188608 253735 110146353
Rheumatic fever 28.90 10.84 329 188882 122250 110277838
Haemorrhage intracranial 28.87 10.84 7 189204 28962 110371126
Anal incontinence 28.86 10.84 93 189118 21871 110378217
Pulmonary fibrosis 28.80 10.84 284 188927 101758 110298330
Enterocutaneous fistula 28.71 10.84 27 189184 2296 110397792
Epiploic appendagitis 28.64 10.84 11 189200 169 110399919
Hepatic failure 28.44 10.84 46 189165 68693 110331395
Blood calcium decreased 28.17 10.84 13 189198 35832 110364256
Joint injury 27.95 10.84 139 189072 39855 110360233
Eosinophilic colitis 27.94 10.84 16 189195 627 110399461
Neurotoxicity 27.85 10.84 19 189192 42188 110357900
Nephritis bacterial 27.64 10.84 8 189203 47 110400041
Vision blurred 27.63 10.84 120 189091 128902 110271186
Angiolymphoid hyperplasia with eosinophilia 27.49 10.84 10 189201 131 110399957
Dysstasia 27.46 10.84 11 189200 32975 110367113
Cerebral haemorrhage 27.33 10.84 43 189168 64925 110335163
Intentional self-injury 27.27 10.84 15 189196 37414 110362674
Skin warm 27.21 10.84 53 189158 9117 110390971
Spondylitis 27.15 10.84 60 189151 11278 110388810
Dyschezia 27.06 10.84 33 189178 3774 110396314
Anastomotic ulcer 27.03 10.84 19 189192 1067 110399021
Miosis 27.03 10.84 3 189208 21980 110378108
Gastrointestinal mucosa hyperaemia 27.02 10.84 15 189196 553 110399535
Progressive multifocal leukoencephalopathy 26.98 10.84 5 189206 24951 110375137
Glomerular filtration rate decreased 26.96 10.84 8 189203 28948 110371140
Anal cancer 26.83 10.84 17 189194 802 110399286
Hypocalcaemia 26.80 10.84 44 189167 65322 110334766
Campylobacter infection 26.29 10.84 26 189185 2353 110397735
Hepatitis infectious mononucleosis 26.22 10.84 11 189200 215 110399873
Dystonia 26.18 10.84 6 189205 25799 110374289
Sudden death 26.13 10.84 5 189206 24390 110375698
Stevens-Johnson syndrome 26.10 10.84 25 189186 46876 110353212
Premature labour 26.00 10.84 52 189159 9120 110390968
Atrial flutter 25.93 10.84 5 189206 24257 110375831
Hepatic function abnormal 25.88 10.84 73 189138 89222 110310866
Intentional product misuse 25.86 10.84 128 189083 132776 110267312
Urticaria chronic 25.31 10.84 16 189195 752 110399336
Pus in stool 25.19 10.84 8 189203 67 110400021
Confusional state 25.14 10.84 610 188601 468070 109932018
Drug eruption 25.05 10.84 33 189178 53626 110346462
Cholestasis 25.02 10.84 45 189166 64473 110335615
Herpes simplex hepatitis 24.91 10.84 16 189195 773 110399315
Fear of disease 24.90 10.84 20 189191 1375 110398713
Blood pressure systolic abnormal 24.77 10.84 6 189205 24844 110375244
Pancytopenia 24.76 10.84 234 188977 209379 110190709
Gastrointestinal bacterial infection 24.62 10.84 20 189191 1398 110398690
Schizophrenia 24.41 10.84 4 189207 21822 110378266
Spondyloarthropathy 24.37 10.84 21 189190 1593 110398495
Transplant rejection 24.36 10.84 6 189205 24561 110375527
Maternal exposure during breast feeding 24.26 10.84 33 189178 4205 110395883
Mycobacterium tuberculosis complex test positive 24.19 10.84 29 189182 3259 110396829
Epilepsy 24.12 10.84 89 189122 100120 110299968
Product quality issue 24.06 10.84 61 189150 77238 110322850
Blood iron decreased 24.03 10.84 80 189131 19134 110380954
Small intestinal obstruction 23.98 10.84 114 189097 32099 110367989
Lymphocyte count decreased 23.97 10.84 38 189173 57205 110342883
Ascites 23.96 10.84 80 189131 92728 110307360
Abdominal discomfort 23.96 10.84 861 188350 392997 110007091
Gastrointestinal tract irritation 23.91 10.84 16 189195 829 110399259
Transfusion 23.78 10.84 7 189204 25465 110374623
Ataxia 23.53 10.84 11 189200 30097 110369991
Onychomadesis 23.53 10.84 26 189185 45637 110354451
Anastomotic infection 23.51 10.84 9 189202 137 110399951
Feeding intolerance 23.35 10.84 18 189193 1166 110398922
C-reactive protein abnormal 23.30 10.84 331 188880 129364 110270724
Onychomycosis 23.29 10.84 19 189192 38512 110361576
Disseminated cytomegaloviral infection 23.02 10.84 14 189197 614 110399474
Nausea 22.95 10.84 1812 187399 1233878 109166210
Mydriasis 22.78 10.84 5 189206 22152 110377936
Infusion site thrombosis 22.75 10.84 11 189200 303 110399785
Gamma-glutamyltransferase increased 22.68 10.84 44 189167 61265 110338823
Amnesia 22.67 10.84 278 188933 105130 110294958
Transverse sinus thrombosis 22.66 10.84 15 189196 763 110399325
Periumbilical abscess 22.62 10.84 11 189200 307 110399781
Hepatic encephalopathy 22.59 10.84 10 189201 28246 110371842
Inflammation 22.58 10.84 460 188751 192778 110207310
Product prescribing error 22.53 10.84 33 189178 51298 110348790
Dry skin 22.52 10.84 101 189110 107552 110292536
Blood pressure diastolic abnormal 22.50 10.84 8 189203 25807 110374281
Amoebiasis 22.49 10.84 9 189202 155 110399933
Drug tolerance decreased 22.38 10.84 100 189111 27440 110372648
Bacterial vulvovaginitis 22.22 10.84 14 189197 654 110399434
Arthritis enteropathic 22.21 10.84 12 189199 419 110399669
Peripheral swelling 22.18 10.84 524 188687 403510 109996578
Graft versus host disease 22.06 10.84 3 189208 18803 110381285
Movement disorder 21.95 10.84 18 189193 36386 110363702
Tachypnoea 21.92 10.84 21 189190 39374 110360714
Blood potassium increased 21.90 10.84 15 189196 33234 110366854
Blindness 21.89 10.84 18 189193 36341 110363747
Brain oedema 21.89 10.84 13 189198 31085 110369003
Skin necrosis 21.83 10.84 5 189206 21507 110378581
Orchitis 21.79 10.84 21 189190 1841 110398247
Fibromyalgia 21.71 10.84 412 188799 170497 110229591
Product label confusion 21.60 10.84 6 189205 22671 110377417
Intestinal resection 21.60 10.84 30 189181 3899 110396189
Dry eye 21.56 10.84 39 189172 55754 110344334
Autoimmune pancreatitis 21.52 10.84 15 189196 831 110399257
Musculoskeletal stiffness 21.50 10.84 629 188582 279193 110120895
Peripheral venous disease 21.30 10.84 229 188982 83888 110316200
Intestinal mucosal hypertrophy 21.19 10.84 12 189199 460 110399628
Paranoia 21.16 10.84 6 189205 22368 110377720
Injection site erythema 21.15 10.84 86 189125 94090 110305998
Nodule 21.12 10.84 15 189196 32616 110367472
Growth retardation 21.04 10.84 24 189187 2558 110397530
Colitis erosive 20.66 10.84 10 189201 276 110399812
Fluid retention 20.63 10.84 87 189124 94220 110305868
Cytopenia 20.63 10.84 13 189198 30103 110369985
Bone pain 20.58 10.84 51 189160 65082 110335006
Aspergillus infection 20.58 10.84 9 189202 25607 110374481
Hypernatraemia 20.56 10.84 3 189208 17830 110382258
Motor dysfunction 20.54 10.84 8 189203 24398 110375690
Rectal discharge 20.53 10.84 16 189195 1053 110399035
Circulatory collapse 20.53 10.84 26 189185 42967 110357121
Product administration error 20.52 10.84 20 189191 37197 110362891
Underdose 20.50 10.84 182 189029 63372 110336716
Neck pain 20.44 10.84 125 189086 123005 110277083
Gastrointestinal wall thickening 20.42 10.84 28 189183 3595 110396493
Ileal ulcer 20.34 10.84 20 189191 1797 110398291
Perirectal abscess 20.33 10.84 22 189189 2212 110397876
Cerebrovascular accident 20.31 10.84 205 189006 181079 110219009
Cerebral infarction 20.24 10.84 36 189175 51802 110348286
Intestinal anastomosis complication 20.16 10.84 11 189200 392 110399696
Skin discolouration 20.12 10.84 33 189178 49013 110351075
Haemodynamic instability 20.11 10.84 7 189204 22881 110377207
Subarachnoid haemorrhage 20.10 10.84 13 189198 29689 110370399
Uveitis 20.09 10.84 82 189129 21628 110378460
Febrile bone marrow aplasia 19.99 10.84 3 189208 17462 110382626
Abdominal pain upper 19.97 10.84 758 188453 348353 110051735
Acute respiratory distress syndrome 19.83 10.84 38 189173 53160 110346928
Jaundice 19.82 10.84 45 189166 59191 110340897
Blood alkaline phosphatase increased 19.82 10.84 59 189152 70876 110329212
Tricuspid valve incompetence 19.81 10.84 8 189203 23865 110376223
Osteoarthritis 19.80 10.84 430 188781 182193 110217895
Rectal spasm 19.79 10.84 9 189202 215 110399873
Anticoagulant therapy 19.72 10.84 34 189177 5327 110394761
Grip strength decreased 19.72 10.84 217 188994 79957 110320131
Cardiac myxoma 19.60 10.84 9 189202 220 110399868
Withdrawal syndrome 19.57 10.84 15 189196 31365 110368723
Gastrooesophageal reflux disease 19.55 10.84 205 189006 179771 110220317
Therapy cessation 19.53 10.84 29 189182 44828 110355260
Emotional distress 19.52 10.84 29 189182 44818 110355270
Epstein-Barr virus test positive 19.51 10.84 17 189194 1309 110398779
Rectal ulcer 19.47 10.84 23 189188 2544 110397544
Akathisia 19.45 10.84 3 189208 17110 110382978
Lip dry 19.43 10.84 259 188952 99824 110300264
Pyoderma 19.35 10.84 12 189199 545 110399543
Idiosyncratic drug reaction 19.26 10.84 18 189193 1518 110398570
Antacid therapy 19.16 10.84 34 189177 5450 110394638
Small intestinal perforation 19.13 10.84 30 189181 4346 110395742
Back pain 19.04 10.84 486 188725 370510 110029578
Folliculitis 18.90 10.84 397 188814 167256 110232832
Liver injury 18.90 10.84 362 188849 150051 110250037
Iron deficiency 18.88 10.84 72 189139 18404 110381684
Cerebral venous sinus thrombosis 18.83 10.84 24 189187 2871 110397217
Vitamin D deficiency 18.72 10.84 72 189139 18480 110381608
Pancreatic toxicity 18.69 10.84 7 189204 100 110399988
Exposure to SARS-CoV-2 18.67 10.84 24 189187 2895 110397193
Disseminated intravascular coagulation 18.66 10.84 26 189185 41260 110358828
Sopor 18.62 10.84 21 189190 36525 110363563
Status epilepticus 18.55 10.84 16 189195 31555 110368533
Head injury 18.55 10.84 28 189183 42989 110357099
Coordination abnormal 18.54 10.84 10 189201 25218 110374870
Intestinal perforation 18.51 10.84 78 189133 20866 110379222
Bacillus infection 18.51 10.84 18 189193 1596 110398492
Leukopenia 18.48 10.84 164 189047 148627 110251461
Laboratory test abnormal 18.45 10.84 134 189077 43945 110356143
Blood cholesterol increased 18.44 10.84 430 188781 184355 110215733
Seronegative arthritis 18.42 10.84 57 189154 13120 110386968
Latent tuberculosis 18.42 10.84 28 189183 3949 110396139
Nasopharyngitis 18.40 10.84 838 188373 393523 110006565
Dysplasia 18.24 10.84 19 189192 1829 110398259
Anaemia 18.20 10.84 758 188453 546328 109853760
Bronchospasm 18.17 10.84 15 189196 30224 110369864
Anal spasm 18.16 10.84 8 189203 177 110399911
Apathy 18.11 10.84 3 189208 16236 110383852
Visual acuity reduced 18.08 10.84 17 189194 32156 110367932
Muscle abscess 18.01 10.84 17 189194 1452 110398636
Anaphylactic reaction 17.96 10.84 118 189093 114182 110285906
Narcotic bowel syndrome 17.91 10.84 9 189202 270 110399818
Dysphonia 17.90 10.84 68 189143 75861 110324227
Headache 17.90 10.84 1747 187464 880630 109519458
Atrioventricular block complete 17.89 10.84 6 189205 20076 110380012
Polyneuropathy 17.89 10.84 17 189194 31995 110368093
Gastrointestinal oedema 17.86 10.84 25 189186 3273 110396815
Dehydration 17.79 10.84 354 188857 279157 110120931
Subcutaneous drug absorption impaired 17.74 10.84 40 189171 7619 110392469
Herpes simplex colitis 17.63 10.84 7 189204 118 110399970
Respiratory tract infection 17.63 10.84 63 189148 71554 110328534
Myocardial ischaemia 17.62 10.84 12 189199 26672 110373416
Hemiparesis 17.59 10.84 30 189181 43873 110356215
Drug dependence 17.56 10.84 37 189174 49983 110350105
Chronic kidney disease 17.55 10.84 69 189142 76222 110323866
Enteritis infectious 17.51 10.84 27 189184 3855 110396233
Pleurisy 17.49 10.84 53 189158 12063 110388025
Enteritis 17.44 10.84 72 189139 19084 110381004
Henoch-Schonlein purpura 17.29 10.84 26 189185 3631 110396457
IgA nephropathy 17.10 10.84 24 189187 3149 110396939
Drug level increased 17.00 10.84 35 189176 47684 110352404
Arteriosclerosis coronary artery 16.99 10.84 11 189200 25107 110374981
Atrioventricular block 16.97 10.84 4 189207 16873 110383215
Red blood cell count decreased 16.90 10.84 57 189154 65866 110334222
Eye pain 16.81 10.84 38 189173 50061 110350027
Second primary malignancy 16.81 10.84 5 189206 18063 110382025
Anal skin tags 16.72 10.84 11 189200 554 110399534
Mediastinal effusion 16.68 10.84 6 189205 76 110400012
Pulmonary congestion 16.66 10.84 17 189194 30949 110369139
Pseudomembranous colitis 16.66 10.84 35 189176 6356 110393732
Incorrect route of product administration 16.50 10.84 175 189036 63886 110336202
Cytomegalovirus gastrointestinal infection 16.49 10.84 12 189199 712 110399376
Adenocarcinoma of colon 16.33 10.84 34 189177 6134 110393954
Muscular weakness 16.32 10.84 313 188898 248155 110151933
Gastrointestinal pain 16.30 10.84 51 189160 11809 110388279
Hyperthermia 16.28 10.84 8 189203 21264 110378824
Glutamate dehydrogenase level abnormal 16.22 10.84 4 189207 11 110400077
Adverse reaction 16.20 10.84 16 189195 29578 110370510
Lymphoedema 16.12 10.84 3 189208 14926 110385162
Foetal anaemia 16.12 10.84 3 189208 0 110400088
Supraventricular tachycardia 16.11 10.84 11 189200 24411 110375677
Renal tubular necrosis 16.09 10.84 17 189194 30458 110369630
Metastases to bone 16.01 10.84 18 189193 31354 110368734
Asthma 15.91 10.84 550 188661 249741 110150347
Hypertriglyceridaemia 15.91 10.84 4 189207 16150 110383938
Infective pulmonary exacerbation of cystic fibrosis 15.88 10.84 3 189208 14768 110385320
Affect lability 15.87 10.84 6 189205 18631 110381457
Back injury 15.87 10.84 36 189175 47363 110352725
Ventricular fibrillation 15.85 10.84 29 189182 41284 110358804
Blood pressure diastolic increased 15.82 10.84 69 189142 18738 110381350
Adenocarcinoma of appendix 15.81 10.84 6 189205 89 110399999
Joint effusion 15.79 10.84 8 189203 20897 110379191
Blepharospasm 15.78 10.84 45 189166 54806 110345282
Bladder trabeculation 15.75 10.84 6 189205 90 110399998
Drug resistance 15.67 10.84 47 189164 56327 110343761
Procedural intestinal perforation 15.65 10.84 8 189203 249 110399839
Posterior reversible encephalopathy syndrome 15.63 10.84 21 189190 33840 110366248
Pustular psoriasis 15.57 10.84 55 189156 13550 110386538
Sinus tachycardia 15.55 10.84 33 189178 44460 110355628
Gastrointestinal infection 15.50 10.84 56 189155 13949 110386139
Pain in jaw 15.46 10.84 41 189170 51136 110348952
Coagulopathy 15.45 10.84 29 189182 40882 110359206
Glossodynia 15.43 10.84 493 188718 221511 110178577
Metastases to central nervous system 15.42 10.84 10 189201 22807 110377281
Nervous system disorder 15.33 10.84 19 189192 31702 110368386
Skin haemorrhage 15.31 10.84 12 189199 24815 110375273
Delusion 15.27 10.84 11 189200 23744 110376344
Fracture 15.26 10.84 12 189199 24776 110375312
Middle insomnia 15.26 10.84 8 189203 20494 110379594
Cyanosis 15.25 10.84 17 189194 29724 110370364
COVID-19 pneumonia 15.23 10.84 25 189186 37118 110362970
Torsade de pointes 15.15 10.84 10 189201 22590 110377498
Medication error 15.14 10.84 259 188952 105107 110294981
Clostridium test positive 15.11 10.84 47 189164 10846 110389242
Caesarean section 15.08 10.84 55 189156 13762 110386326
Mitral valve incompetence 15.05 10.84 21 189190 33308 110366780
Asphyxia 15.04 10.84 3 189208 14212 110385876
Hip fracture 15.04 10.84 23 189188 35128 110364960
Sinus congestion 14.98 10.84 18 189193 30441 110369647
Anorectal stenosis 14.96 10.84 5 189206 50 110400038
Anhedonia 14.85 10.84 4 189207 15424 110384664
Product dose omission issue 14.82 10.84 428 188783 321354 110078734
Muscle injury 14.77 10.84 330 188881 140477 110259611
Labelled drug-drug interaction medication error 14.75 10.84 17 189194 29285 110370803
Large intestine perforation 14.75 10.84 62 189149 16567 110383521
Asthenia 14.73 10.84 998 188213 688001 109712087
Bone disorder 14.72 10.84 9 189202 21183 110378905
Complication associated with device 14.69 10.84 8 189203 20065 110380023
Arterial occlusive disease 14.68 10.84 4 189207 15304 110384784
Myelodysplastic syndrome 14.66 10.84 26 189185 37458 110362630
Unevaluable event 14.65 10.84 52 189159 59175 110340913
Hip arthroplasty 14.62 10.84 153 189058 55660 110344428
Gastrointestinal sounds abnormal 14.58 10.84 32 189179 5986 110394102
Cardiomegaly 14.56 10.84 17 189194 29113 110370975
Abortion 14.55 10.84 16 189195 1638 110398450
Device occlusion 14.50 10.84 4 189207 15181 110384907
Electrocardiogram abnormal 14.37 10.84 7 189204 18702 110381386
Dermatitis bullous 14.34 10.84 6 189205 17523 110382565
Wrong technique in product usage process 14.33 10.84 89 189122 87259 110312829
Infection parasitic 14.25 10.84 12 189199 882 110399206
Bronchopulmonary aspergillosis allergic 14.23 10.84 39 189172 8387 110391701
Gastroenteritis clostridial 14.23 10.84 13 189198 1065 110399023
Generalised oedema 14.21 10.84 19 189192 30685 110369403
Campylobacter gastroenteritis 14.17 10.84 17 189194 1912 110398176
Oesophagitis 14.09 10.84 17 189194 28698 110371390
Sleep disorder therapy 14.06 10.84 36 189175 7435 110392653
General symptom 14.01 10.84 40 189171 8806 110391282
Pseudopolyposis 13.99 10.84 6 189205 124 110399964
Histoplasmosis 13.97 10.84 21 189190 2932 110397156
Acute generalised exanthematous pustulosis 13.97 10.84 10 189201 21654 110378434
Lung disorder 13.89 10.84 405 188806 179642 110220446
Mental impairment 13.89 10.84 11 189200 22628 110377460
Glycosylated haemoglobin increased 13.84 10.84 12 189199 23607 110376481
Stress at work 13.76 10.84 14 189197 1311 110398777
Cervical dysplasia 13.70 10.84 20 189191 2720 110397368
Thyroiditis subacute 13.70 10.84 9 189202 452 110399636
Jaundice cholestatic 13.67 10.84 4 189207 14604 110385484
Infectious mononucleosis 13.66 10.84 18 189193 2224 110397864
Impaired gastric emptying 13.64 10.84 3 189208 13272 110386816
Acute hepatic failure 13.64 10.84 26 189185 36442 110363646
Stress cardiomyopathy 13.60 10.84 5 189206 15801 110384287
Left ventricular hypertrophy 13.60 10.84 3 189208 13241 110386847
Purpura 13.57 10.84 13 189198 24375 110375713
Nasal polyps 13.53 10.84 3 189208 13197 110386891
Lacrimation increased 13.48 10.84 20 189191 30930 110369158
Exposure via skin contact 13.45 10.84 3 189208 13144 110386944
Sinus disorder 13.45 10.84 22 189189 32706 110367382
Intestinal haemorrhage 13.43 10.84 35 189176 7306 110392782
Therapeutic product effect decreased 13.38 10.84 528 188683 243788 110156300
Drain site complication 13.35 10.84 4 189207 27 110400061
Antinuclear antibody increased 13.27 10.84 13 189198 1163 110398925
Small intestine adenocarcinoma 13.13 10.84 7 189204 238 110399850
Drug specific antibody absent 13.13 10.84 7 189204 238 110399850
Polyuria 13.08 10.84 7 189204 17731 110382357
Urine output decreased 13.04 10.84 9 189202 19867 110380221
Device difficult to use 13.04 10.84 8 189203 18797 110381291
Hiccups 13.04 10.84 3 189208 12866 110387222
Blood lactate dehydrogenase increased 13.03 10.84 36 189175 44298 110355790
Hypomagnesaemia 13.01 10.84 56 189155 60314 110339774
Pathogen resistance 13.00 10.84 7 189204 17665 110382423
Rectal dysplasia 12.98 10.84 4 189207 30 110400058
Social problem 12.93 10.84 16 189195 1858 110398230
Megacolon 12.92 10.84 25 189186 4280 110395808
Mania 12.89 10.84 10 189201 20786 110379302
Invasive papillary breast carcinoma 12.83 10.84 3 189208 6 110400082
Hypertrophic anal papilla 12.83 10.84 3 189208 6 110400082
Contraindicated product administered 12.79 10.84 325 188886 247942 110152146
Pleuropericarditis 12.78 10.84 10 189201 662 110399426
Pelvic abscess 12.78 10.84 19 189192 2627 110397461
Dialysis 12.72 10.84 9 189202 19610 110380478
Duodenal ulcer perforation 12.71 10.84 396 188815 177304 110222784
Ventricular extrasystoles 12.68 10.84 12 189199 22629 110377459
Salivary hypersecretion 12.67 10.84 7 189204 17414 110382674
Hand deformity 12.62 10.84 475 188736 218031 110182057
Cystitis 12.62 10.84 64 189147 65972 110334116
Swelling 12.61 10.84 482 188729 350559 110049529
Rash erythematous 12.60 10.84 85 189126 81747 110318341
Tuberculosis 12.58 10.84 62 189149 17712 110382376
Ecchymosis 12.56 10.84 7 189204 17331 110382757
Infrequent bowel movements 12.55 10.84 17 189194 2158 110397930
Gastroenteritis eosinophilic 12.52 10.84 8 189203 383 110399705
Cataract 12.52 10.84 82 189129 79403 110320685
Antibody test abnormal 12.51 10.84 12 189199 1046 110399042
Overgrowth bacterial 12.47 10.84 7 189204 264 110399824
Swollen tongue 12.46 10.84 158 189053 60204 110339884
Hospice care 12.46 10.84 3 189208 12470 110387618
Hypertensive crisis 12.42 10.84 14 189197 24358 110375730
Discouragement 12.41 10.84 17 189194 2181 110397907
Feeling abnormal 12.37 10.84 226 188985 180485 110219603
Alopecia 12.34 10.84 752 188459 364001 110036087
Bursitis 12.25 10.84 300 188911 129618 110270470
Pain 12.21 10.84 1439 187772 953516 109446572
Carbohydrate antigen 19-9 increased 12.18 10.84 9 189202 547 110399541
Histoplasmosis disseminated 12.14 10.84 23 189188 3876 110396212
Lethargy 12.13 10.84 102 189109 93474 110306614
Acute coronary syndrome 12.08 10.84 13 189198 23099 110376989
Mouth haemorrhage 12.07 10.84 4 189207 13484 110386604
Brain injury 12.05 10.84 4 189207 13472 110386616
Muscle rigidity 12.04 10.84 14 189197 24017 110376071
Chest discomfort 12.03 10.84 217 188994 173631 110226457
Omphalitis 12.03 10.84 6 189205 177 110399911
Pneumonitis 12.03 10.84 79 189132 76452 110323636
Irritable bowel syndrome 12.02 10.84 367 188844 163848 110236240
B-cell lymphoma 11.97 10.84 33 189178 7121 110392967
Target skin lesion 11.93 10.84 7 189204 287 110399801
Arrhythmia 11.88 10.84 70 189141 69505 110330583
Central obesity 11.88 10.84 16 189195 2020 110398068
Nightmare 11.87 10.84 110 189101 38753 110361335
Renal disorder 11.87 10.84 44 189167 49435 110350653
Needle issue 11.81 10.84 8 189203 17832 110382256
Transient ischaemic attack 11.77 10.84 164 189047 63818 110336270
T-cell lymphoma 11.76 10.84 14 189197 1562 110398526
Vein rupture 11.74 10.84 18 189193 2557 110397531
Eczema infected 11.73 10.84 6 189205 187 110399901
Eye pruritus 11.71 10.84 24 189187 32751 110367337
Impaired healing 11.69 10.84 429 188782 196288 110203800
Haemodialysis 11.66 10.84 8 189203 17711 110382377
Forced expiratory volume decreased 11.63 10.84 4 189207 13172 110386916
Anal haemorrhage 11.63 10.84 26 189185 4926 110395162
Infusion site extravasation 11.61 10.84 45 189166 11589 110388499
Analgesic therapy 11.60 10.84 33 189178 7251 110392837
Drug intolerance 11.58 10.84 826 188385 405686 109994402
Body temperature decreased 11.51 10.84 105 189106 36830 110363258
Injection site pruritus 11.39 10.84 47 189164 51211 110348877
Angina unstable 11.38 10.84 7 189204 16425 110383663
Tooth extraction 11.37 10.84 4 189207 12987 110387101
Urosepsis 11.36 10.84 22 189189 30653 110369435
Anti-platelet antibody 11.31 10.84 3 189208 12 110400076
Heavy menstrual bleeding 11.30 10.84 7 189204 16358 110383730
Hepatotoxicity 11.25 10.84 63 189148 63337 110336751
Secondary adrenocortical insufficiency 11.23 10.84 24 189187 4410 110395678
Gastroenteritis radiation 11.17 10.84 10 189201 798 110399290
Prothrombin time prolonged 11.09 10.84 8 189203 17253 110382835
Product complaint 11.08 10.84 5 189206 13967 110386121
Abnormal dreams 11.07 10.84 4 189207 12776 110387312
Disability 11.04 10.84 89 189122 30134 110369954
Hypoaesthesia 11.04 10.84 650 188561 313573 110086515
Large intestine infection 11.02 10.84 24 189187 4468 110395620
Gastrointestinal scarring 10.99 10.84 8 189203 475 110399613
Selective abortion 10.95 10.84 4 189207 53 110400035
Spinal osteoarthritis 10.95 10.84 11 189200 20172 110379916
Deafness 10.93 10.84 18 189193 26691 110373397
Vaginal abscess 10.84 10.84 8 189203 485 110399603

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EC02 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Aminosalicylic acid and similar agents
FDA CS M0000971 Aminosalicylic Acids
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
FDA EPC N0000175781 Aminosalicylate
MeSH PA D000700 Analgesics
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic

Related Drugs by ATC class:

A07EC Aminosalicylic acid and similar agents 3 drugs
balsalazideolsalazinesulfasalazine

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

DiseaseRelationSNOMED_IDDOID
Chronic ulcerative proctitis indication 52231000
Chronic ulcerative rectosigmoiditis indication 52506002
Ulcerative colitis indication 64766004 DOID:8577
Ulcerative colitis in remission indication 697969008
Crohn's disease off-label use 34000006
Interstitial nephritis contraindication 28689008 DOID:1063
Minimal change disease contraindication 44785005 DOID:10966
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Pyloric obstruction contraindication 244815007
Anemia contraindication 271737000 DOID:2355
Neutropenic disorder contraindication 303011007 DOID:1227




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.74 acidic
pKa2 13.47 acidic
pKa3 5.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
375MG APRISO SALIX N022301 Oct. 31, 2008 RX CAPSULE, EXTENDED RELEASE ORAL 8865688 May 1, 2030 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.12 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Arachidonate 5-lipoxygenase Enzyme INHIBITOR CHEMBL CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST UNKNOWN IUPHAR
Tumor necrosis factor Cytokine IC50 4.70 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.11 CHEMBL
Hydroxyacid oxidase 1 Enzyme IC50 5.11 CHEMBL

External reference:

IDSource
4019494 VUID
N0000147614 NUI
D00377 KEGG_DRUG
4019494 VANDF
C0127615 UMLSCUI
CHEBI:6775 CHEBI
OO3 PDB_CHEM_ID
CHEMBL704 ChEMBL_ID
DB00244 DRUGBANK_ID
2700 IUPHAR_LIGAND_ID
4075 PUBCHEM_CID
52582 RXNORM
37855 MMSL
37856 MMSL
5056 MMSL
d01031 MMSL
001600 NDDF
387501005 SNOMEDCT_US
86977007 SNOMEDCT_US
D019804 MESH_DESCRIPTOR_UI
5444 INN_ID
6291-36-7 SECONDARY_CAS_RN
4Q81I59GXC UNII
4Q81I59GXC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
sfRowasaSulfite-Free Formulation HUMAN PRESCRIPTION DRUG LABEL 1 0037-0022 SUSPENSION 4 g RECTAL NDA 28 sections
Rowasa HUMAN PRESCRIPTION DRUG LABEL 1 0037-0066 SUSPENSION 4 g RECTAL NDA 28 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5907 CAPSULE, DELAYED RELEASE 400 mg ORAL ANDA 26 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-9224 CAPSULE, EXTENDED RELEASE 375 mg ORAL NDA authorized generic 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1375 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 27 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0472-1915 SUPPOSITORY 1000 mg RECTAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0480-7750 TABLET, DELAYED RELEASE 800 mg ORAL ANDA 25 sections
MESALAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0527-3012 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 28 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0591-2245 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 24 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0781-2791 CAPSULE, EXTENDED RELEASE 250 mg ORAL ANDA 29 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0781-2793 CAPSULE, EXTENDED RELEASE 500 mg ORAL ANDA 29 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0832-6056 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 29 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6832 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 26 sections
Mesalamine Human Prescription Drug Label 1 16571-246 SUPPOSITORY 1000 mg RECTAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 16714-245 SUPPOSITORY 1000 mg RECTAL ANDA 23 sections
Mesalamine Human Prescription Drug Label 1 21922-045 SUSPENSION 4 g RECTAL ANDA 30 sections
Mesalamine Human Prescription Drug Label 1 21922-045 SUSPENSION 4 g RECTAL ANDA 30 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 31722-005 SUPPOSITORY 1000 mg RECTAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 31722-043 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 26 sections
MESALAMINE HUMAN PRESCRIPTION DRUG LABEL 1 31722-489 CAPSULE, EXTENDED RELEASE 375 mg ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-489 TABLET, DELAYED RELEASE 800 mg ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 45802-098 ENEMA 4 g RECTAL ANDA 27 sections
MESALAMINE Human Prescription Drug Label 1 46708-724 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 26 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50090-3497 TABLET, DELAYED RELEASE 800 mg ORAL NDA authorized generic 24 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50090-4168 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50268-577 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50742-371 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 27 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 51407-900 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 51407-976 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 29 sections
Asacol HUMAN PRESCRIPTION DRUG LABEL 1 53808-0205 TABLET, DELAYED RELEASE 400 mg ORAL NDA 24 sections