domperidone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antipsychotics, risperidone derivatives 945 57808-66-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • domperidone betadex
  • domperidone betacyclodextrin
  • domperidone
  • motilium
  • peridon
  • domperidone maleate
A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.
  • Molecular weight: 425.92
  • Formula: C22H24ClN5O2
  • CLOGP: 3.87
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 67.92
  • ALOGS: -3.66
  • ROTB: 5

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P
0.12 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.34 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 15 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.08 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.50 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Jan. 1, 1982 YEAR INTRODUCED

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
Blepharospasm 670.88 12.90 563 116415 54882 90456587
Epilepsy 604.85 12.90 633 116345 81573 90429896
Taste disorder 558.09 12.90 531 116447 61015 90450454
Breast cancer stage III 472.94 12.90 564 116414 83883 90427586
Nail disorder 432.88 12.90 454 116524 58613 90452856
Onychomadesis 430.59 12.90 404 116574 45594 90465875
Gastrooesophageal reflux disease 384.14 12.90 734 116244 165603 90345866
Back injury 344.54 12.90 360 116618 46262 90465207
Facet joint syndrome 335.05 12.90 516 116462 97873 90413596
Product quality issue 307.32 12.90 442 116536 78883 90432586
Peripheral venous disease 306.85 12.90 455 116523 83466 90428003
Live birth 282.21 12.90 424 116554 78683 90432786
Wound infection 272.41 12.90 491 116487 105911 90405558
Bursitis 261.84 12.90 546 116432 131108 90380361
Lip dry 261.17 12.90 468 116510 100487 90410982
Onychomycosis 253.85 12.90 276 116702 37100 90474369
Obesity 250.11 12.90 471 116507 105036 90406433
Sensory loss 244.62 12.90 196 116782 17879 90493590
Hypercholesterolaemia 241.14 12.90 452 116526 100440 90411029
Arterial occlusive disease 228.53 12.90 162 116816 12284 90499185
Liver function test increased 226.71 12.90 399 116579 84456 90427013
Gangrene 225.87 12.90 163 116815 12713 90498756
Finger deformity 221.79 12.90 242 116736 32655 90478814
Product label confusion 220.15 12.90 204 116774 22646 90488823
Carotid artery thrombosis 216.39 12.90 139 116839 8953 90502516
Neurologic neglect syndrome 214.89 12.90 137 116841 8710 90502759
Inflammation 204.11 12.90 599 116379 177993 90333476
Joint range of motion decreased 200.22 12.90 500 116478 135143 90376326
Adverse reaction 199.31 12.90 218 116760 29494 90481975
Adjustment disorder 196.96 12.90 134 116844 9508 90501961
Infusion site reaction 195.18 12.90 176 116802 18863 90492606
C-reactive protein increased 185.37 12.90 585 116393 180804 90330665
Drug ineffective 184.71 12.90 1043 115935 1383255 89128214
Personality disorder 183.60 12.90 142 116836 12302 90499167
Lung disorder 183.14 12.90 515 116463 149368 90362101
Type 2 diabetes mellitus 181.35 12.90 626 116352 202618 90308851
Night sweats 181.02 12.90 466 116512 128300 90383169
Product dose omission issue 169.88 12.90 82 116896 291605 90219864
Coeliac disease 166.06 12.90 244 116734 44366 90467103
Completed suicide 164.26 12.90 5 116973 145053 90366416
Paraesthesia 162.56 12.90 697 116281 249629 90261840
Pruritus 160.84 12.90 283 116695 541242 89970227
Hemiplegia 159.02 12.90 146 116832 16014 90495455
Dry mouth 149.69 12.90 550 116428 183509 90327960
Motor dysfunction 141.14 12.90 148 116830 19082 90492387
Sinus congestion 138.56 12.90 174 116804 27250 90484219
Affect lability 136.13 12.90 141 116837 17922 90493547
Hypoaesthesia 132.38 12.90 774 116204 313436 90198033
Infection 128.89 12.90 167 116811 361927 90149542
Musculoskeletal pain 127.06 12.90 497 116481 170754 90340715
Premature labour 126.11 12.90 118 116860 13258 90498211
Migraine 124.98 12.90 532 116446 189860 90321609
Coordination abnormal 123.35 12.90 145 116833 21211 90490258
Skin haemorrhage 123.22 12.90 145 116833 21235 90490234
Muscular weakness 123.17 12.90 561 116417 206105 90305364
Memory impairment 121.73 12.90 541 116437 196703 90314766
Neck pain 121.39 12.90 373 116605 113590 90397879
Intentional product use issue 119.91 12.90 576 116402 216316 90295153
Abdominal pain upper 117.93 12.90 784 116194 331890 90179579
Osteoarthritis 117.15 12.90 532 116446 195198 90316271
Psoriatic arthropathy 116.71 12.90 593 116385 227742 90283727
Confusional state 114.72 12.90 872 116106 385333 90126136
Lower respiratory tract infection 113.78 12.90 630 116348 250029 90261440
Gastric pH decreased 113.18 12.90 44 116934 942 90510527
Grip strength decreased 112.92 12.90 318 116660 92258 90419211
Bronchopulmonary aspergillosis allergic 111.03 12.90 66 116912 3700 90507769
Fibromyalgia 110.57 12.90 543 116435 205726 90305743
Rheumatoid arthritis 109.52 12.90 822 116156 361792 90149677
Respiratory tract congestion 109.42 12.90 155 116823 27255 90484214
Derealisation 108.51 12.90 48 116930 1437 90510032
Depersonalisation/derealisation disorder 107.31 12.90 49 116929 1583 90509886
Duodenal ulcer perforation 107.06 12.90 566 116412 220722 90290747
Helicobacter infection 106.87 12.90 576 116402 226274 90285195
Pulmonary malformation 105.54 12.90 33 116945 357 90511112
Folliculitis 105.31 12.90 532 116446 203821 90307648
Wheezing 103.81 12.90 592 116386 237488 90273981
Hepatitis 102.46 12.90 259 116719 70480 90440989
Drug-induced liver injury 101.24 12.90 301 116677 90017 90421452
Aphasia 101.22 12.90 191 116787 42621 90468848
Gait inability 99.80 12.90 414 116564 146042 90365427
Sinus disorder 98.53 12.90 167 116811 34280 90477189
Sleep disorder 98.18 12.90 510 116468 197520 90313949
Toxicity to various agents 97.10 12.90 138 116840 287708 90223761
Muscle injury 94.63 12.90 465 116513 176189 90335280
Erythema 94.28 12.90 94 116884 229152 90282317
Injection site pain 93.45 12.90 54 116924 173645 90337824
Blood cholesterol increased 93.15 12.90 521 116457 207491 90303978
Liver injury 92.81 12.90 451 116527 170116 90341353
Total lung capacity decreased 92.74 12.90 59 116919 3736 90507733
Abdominal distension 91.99 12.90 373 116605 130228 90381241
Angina pectoris 90.47 12.90 173 116805 38987 90472482
Sneezing 89.69 12.90 148 116830 29721 90481748
Overlap syndrome 89.54 12.90 80 116898 8468 90503001
Feeling abnormal 84.41 12.90 56 116922 167179 90344290
Lung opacity 84.33 12.90 67 116911 6035 90505434
Eating disorder 84.16 12.90 139 116839 27934 90483535
Muscle spasticity 84.02 12.90 158 116820 35164 90476305
General physical health deterioration 81.03 12.90 756 116222 354359 90157110
H1N1 influenza 80.34 12.90 43 116935 1967 90509502
Hemiparesis 79.03 12.90 145 116833 31674 90479795
Cogwheel rigidity 78.53 12.90 43 116935 2059 90509410
Cardiac failure congestive 78.25 12.90 16 116962 98678 90412791
Rheumatic fever 76.32 12.90 395 116583 152726 90358743
Injection site erythema 75.99 12.90 17 116961 98485 90412984
Renal failure 75.95 12.90 37 116941 130970 90380499
Aspiration 75.21 12.90 97 116881 15596 90495873
Depression 74.71 12.90 652 116326 299949 90211520
Muscle spasms 73.72 12.90 567 116411 251316 90260153
Anti-cyclic citrullinated peptide antibody positive 73.58 12.90 540 116438 235893 90275576
Pericarditis 71.37 12.90 594 116384 269557 90241912
Irritable bowel syndrome 71.08 12.90 485 116493 206963 90304506
Hypersensitivity 69.51 12.90 326 116652 454351 90057118
Death 65.93 12.90 334 116644 456217 90055252
Hypotension 64.63 12.90 210 116768 325187 90186282
Respiratory tract malformation 64.60 12.90 19 116959 164 90511305
Blister 64.34 12.90 555 116423 254443 90257026
Hepatic enzyme 64.03 12.90 54 116924 5290 90506179
Sleep disorder due to general medical condition, insomnia type 63.72 12.90 44 116934 128650 90382819
On and off phenomenon 63.30 12.90 40 116938 2503 90508966
Injection site reaction 63.25 12.90 261 116717 91819 90419650
Acute kidney injury 62.78 12.90 208 116770 320179 90191290
Feeling of despair 61.83 12.90 43 116935 3161 90508308
COVID-19 59.87 12.90 78 116900 168765 90342704
Wrong technique in product usage process 58 12.90 11 116967 71560 90439909
Abortion spontaneous 57.35 12.90 3 116975 54053 90457416
Myalgia 57.02 12.90 86 116892 175039 90336430
Sepsis 56.92 12.90 90 116888 179724 90331745
Back pain 56.09 12.90 215 116763 316960 90194509
Drug abuse 54.61 12.90 19 116959 82328 90429141
Sputum discoloured 54.57 12.90 96 116882 20295 90491174
Myelosuppression 53.79 12.90 4 116974 53587 90457882
Hyperprolactinaemia 53.28 12.90 49 116929 5384 90506085
Drooling 52.55 12.90 45 116933 4501 90506968
Atrial fibrillation 51.31 12.90 58 116920 133553 90377916
Lung cyst 50.31 12.90 20 116958 455 90511014
Cataract 50.03 12.90 205 116773 71887 90439582
Feeling of body temperature change 49.76 12.90 48 116930 5601 90505868
Therapy interrupted 49.56 12.90 4 116974 50104 90461365
Blood calcium increased 49.33 12.90 69 116909 11989 90499480
Chronic obstructive pulmonary disease 49.02 12.90 17 116961 73812 90437657
Myocardial infarction 48.89 12.90 39 116939 105933 90405536
Chills 48.85 12.90 59 116919 131922 90379547
Pemphigus 47.55 12.90 637 116341 326227 90185242
Muscle disorder 47.21 12.90 46 116932 5433 90506036
Bronchitis 47.03 12.90 78 116900 152849 90358620
Respiratory failure 47.02 12.90 50 116928 118368 90393101
Rash 46.99 12.90 734 116244 795366 89716103
Injection site swelling 46.81 12.90 10 116968 59829 90451640
Haemoglobin decreased 46.72 12.90 86 116892 161870 90349599
C-reactive protein abnormal 46.68 12.90 303 116675 127126 90384343
Chest pain 46.58 12.90 233 116745 319412 90192057
Therapeutic product ineffective 45.66 12.90 32 116946 2382 90509087
Maternal exposure during pregnancy 45.30 12.90 684 116294 359379 90152090
Dyspnoea 45.26 12.90 833 116145 880122 89631347
Bradycardia 45.18 12.90 26 116952 83821 90427648
Hypoaesthesia oral 45.10 12.90 76 116902 15524 90495945
Hypocholesterolaemia 44.43 12.90 48 116930 6401 90505068
Rales 44.29 12.90 76 116902 15751 90495718
Dysarthria 43.55 12.90 162 116816 54320 90457149
Cestode infection 43.22 12.90 16 116962 298 90511171
Deep vein thrombosis 43.17 12.90 33 116945 91587 90419882
Cardiac arrest 43.14 12.90 43 116935 104892 90406577
Cystitis 42.62 12.90 185 116793 66533 90444936
Wound 42.23 12.90 586 116392 302394 90209075
Rheumatoid factor positive 42.07 12.90 100 116878 171550 90339919
Thrombocytopenia 41.90 12.90 134 116844 208591 90302878
Impaired healing 41.63 12.90 474 116504 233725 90277744
Vascular encephalopathy 41.03 12.90 20 116958 750 90510719
Fatigue 40.98 12.90 1156 115822 1152867 89358602
Stoma site erythema 40.96 12.90 25 116953 1471 90509998
Mental status changes 40.46 12.90 5 116973 44674 90466795
Injection site bruising 40.39 12.90 9 116969 52298 90459171
Stomatitis 39.79 12.90 535 116443 274163 90237306
Pituitary tumour benign 39.71 12.90 28 116950 2104 90509365
Hallucinations, mixed 39.12 12.90 43 116935 5846 90505623
Stoma site discharge 39.10 12.90 27 116951 1962 90509507
Congenital anomaly 38.16 12.90 44 116934 6303 90505166
Vomiting 38.12 12.90 1307 115671 786986 89724483
Blood glucose increased 38.06 12.90 40 116938 95206 90416263
Dissociation 37.79 12.90 45 116933 6670 90504799
Menstrual disorder 37.66 12.90 43 116935 6095 90505374
Multiple organ dysfunction syndrome 37.09 12.90 21 116957 68315 90443154
Underdose 37.00 12.90 153 116825 53864 90457605
Intentional overdose 36.83 12.90 40 116938 93794 90417675
White blood cell count decreased 36.62 12.90 103 116875 167006 90344463
Injection site pruritus 36.43 12.90 12 116966 53822 90457647
Normal newborn 36.42 12.90 88 116890 23274 90488195
Cardio-respiratory arrest 36.33 12.90 18 116960 63122 90448347
Asthenia 36.13 12.90 923 116055 532828 89978641
Plasma cell myeloma 35.93 12.90 5 116973 40823 90470646
Rhinalgia 35.55 12.90 28 116950 2490 90508979
Therapeutic response decreased 35.50 12.90 38 116940 89691 90421778
Inappropriate schedule of product administration 35.44 12.90 89 116889 149844 90361625
Hepatotoxicity 35.17 12.90 8 116970 45834 90465635
Gastrointestinal disorder 35.17 12.90 495 116483 256192 90255277
Nasopharyngitis 34.98 12.90 728 116250 406376 90105093
Synovitis 34.95 12.90 609 116369 329143 90182326
Pleuritic pain 34.36 12.90 54 116924 10407 90501062
Staphylococcal infection 34.21 12.90 10 116968 48429 90463040
Skin ulcer 34.17 12.90 11 116967 50064 90461405
Obstructive airways disorder 33.64 12.90 91 116887 25778 90485691
Flushing 33.34 12.90 39 116939 88452 90423017
Glossodynia 33.29 12.90 592 116386 321187 90190282
Herpes zoster 33.26 12.90 44 116934 94600 90416869
Enzyme inhibition 33.23 12.90 8 116970 28 90511441
Multiple sclerosis relapse 33.11 12.90 13 116965 52292 90459177
Therapy cessation 33.09 12.90 4 116974 36357 90475112
Cardiac disorder 33.05 12.90 16 116962 56856 90454613
Magnesium deficiency 32.97 12.90 17 116961 720 90510749
Parosmia 32.79 12.90 43 116935 7026 90504443
Ocular hyperaemia 32.60 12.90 3 116975 33795 90477674
Burning sensation 32.34 12.90 21 116957 63431 90448038
Aspartate aminotransferase increased 32.11 12.90 52 116926 102885 90408584
Hand deformity 32.00 12.90 549 116429 295813 90215656
Fluid retention 31.94 12.90 40 116938 88051 90423418
Haematochezia 31.59 12.90 27 116951 70886 90440583
Muscle rigidity 31.56 12.90 62 116916 14247 90497222
International normalised ratio increased 31.23 12.90 11 116967 47305 90464164
Road traffic accident 31.17 12.90 57 116921 107569 90403900
Lung diffusion test decreased 31.05 12.90 17 116961 814 90510655
Product use in unapproved indication 30.77 12.90 607 116371 335629 90175840
Bone marrow failure 30.71 12.90 3 116975 32218 90479251
Urinary tract infection 30.55 12.90 250 116728 305382 90206087
Dyspepsia 30.37 12.90 390 116588 197770 90313699
Anaemia 29.86 12.90 301 116677 352501 90158968
Nightmare 29.85 12.90 78 116900 21647 90489822
Syncope 29.63 12.90 81 116897 132582 90378887
Incorrect dose administered 29.50 12.90 35 116943 78895 90432574
Neutropenic sepsis 29.02 12.90 69 116909 18061 90493408
Thrombosis 29.00 12.90 31 116947 73220 90438249
Foot deformity 28.72 12.90 21 116957 59630 90451839
Suicide attempt 28.65 12.90 33 116945 75366 90436103
Renal impairment 28.64 12.90 58 116920 105363 90406106
Angioedema 28.53 12.90 25 116953 64851 90446618
Subileus 28.46 12.90 29 116949 3615 90507854
Anaphylactic reaction 28.46 12.90 43 116935 87481 90423988
Poor sucking reflex 28.13 12.90 13 116965 432 90511037
Folate deficiency 28.08 12.90 27 116951 3138 90508331
Forced vital capacity decreased 28.01 12.90 18 116960 1160 90510309
Knee arthroplasty 27.89 12.90 40 116938 83142 90428327
Chronic kidney disease 27.85 12.90 15 116963 50176 90461293
Exposure during pregnancy 27.70 12.90 447 116531 237963 90273506
Coronary artery disease 27.60 12.90 5 116973 33618 90477851
Discomfort 27.59 12.90 224 116754 274111 90237358
Hyperkalaemia 27.42 12.90 26 116952 64938 90446531
Alanine aminotransferase increased 27.38 12.90 71 116907 118267 90393202
Diabetes mellitus 27.34 12.90 26 116952 64849 90446620
Eye swelling 27.32 12.90 3 116975 29383 90482086
Surgery 27.05 12.90 12 116966 44875 90466594
Exposure via breast milk 26.93 12.90 23 116955 2292 90509177
Transient ischaemic attack 26.89 12.90 11 116967 43165 90468304
Basal ganglion degeneration 26.80 12.90 12 116966 370 90511099
Femur fracture 26.72 12.90 13 116965 46069 90465400
Dehydration 26.48 12.90 145 116833 194302 90317167
Neutropenia 26.28 12.90 176 116802 224728 90286741
Incorrect product administration duration 26.17 12.90 69 116909 19253 90492216
Ear infection 26.02 12.90 31 116947 69744 90441725
Premenstrual syndrome 26 12.90 15 116963 795 90510674
Eye irritation 25.93 12.90 6 116972 33972 90477497
Lip pruritus 25.66 12.90 18 116960 1342 90510127
Mayer-Rokitansky-Kuster-Hauser syndrome 25.63 12.90 6 116972 18 90511451
Dyskinesia 25.43 12.90 104 116874 36430 90475039
Freezing phenomenon 25.26 12.90 20 116958 1792 90509677
Acute respiratory failure 25.05 12.90 12 116966 42906 90468563
Cellulitis 25.03 12.90 50 116928 91287 90420182
Drug dependence 24.87 12.90 4 116974 29323 90482146
Inguinal hernia 24.72 12.90 21 116957 2077 90509392
Ulcer 24.71 12.90 6 116972 32876 90478593
Vulvovaginal burning sensation 24.67 12.90 23 116955 2572 90508897
Joint injury 24.47 12.90 6 116972 32658 90478811
Disease recurrence 24.43 12.90 9 116969 37644 90473825
Systemic lupus erythematosus 24.21 12.90 625 116353 361271 90150198
Weight decreased 24.15 12.90 345 116633 379565 90131904
Aggression 24.11 12.90 3 116975 26665 90484804
Productive cough 23.97 12.90 39 116939 77024 90434445
Cannabinoid hyperemesis syndrome 23.95 12.90 7 116971 59 90511410
Influenza like illness 23.84 12.90 182 116796 80429 90431040
Blood calcium decreased 23.70 12.90 5 116973 30177 90481292
Cognitive disorder 23.64 12.90 33 116945 69374 90442095
Dysphagia 23.55 12.90 235 116743 112043 90399426
Uterine enlargement 23.49 12.90 17 116961 1331 90510138
Emotional distress 23.39 12.90 9 116969 36653 90474816
Basal cell carcinoma 23.38 12.90 7 116971 33382 90478087
Skin exfoliation 23.36 12.90 159 116819 67754 90443715
Hip arthroplasty 23.30 12.90 39 116939 76169 90435300
Mental disorder 23.29 12.90 93 116885 32225 90479244
Mood swings 23.19 12.90 69 116909 20633 90490836
Multiple sclerosis 23.16 12.90 4 116974 27836 90483633
Ill-defined disorder 23.12 12.90 351 116627 184540 90326929
Limbic encephalitis 23.06 12.90 10 116968 285 90511184
Disease progression 22.88 12.90 114 116864 156501 90354968
Stoma site hypergranulation 22.83 12.90 11 116967 402 90511067
Blood test abnormal 22.68 12.90 69 116909 20883 90490586
Abdominal tenderness 22.53 12.90 42 116936 9282 90502187
Premature delivery 22.38 12.90 11 116967 38751 90472718
Lip swelling 22.22 12.90 11 116967 38599 90472870
Hyperchlorhydria 22.00 12.90 19 116959 1922 90509547
Sedation 21.87 12.90 18 116960 48153 90463316
Hepatic failure 21.86 12.90 12 116966 39716 90471753
Bronchiectasis 21.84 12.90 71 116907 22259 90489210
Blindness 21.70 12.90 4 116974 26564 90484905
Loss of consciousness 21.70 12.90 100 116878 140138 90371331
Anaesthesia 21.62 12.90 11 116967 453 90511016
Metabolic acidosis 21.55 12.90 24 116954 55652 90455817
Encephalopathy 21.53 12.90 17 116961 46427 90465042
Cardiogenic shock 21.52 12.90 3 116975 24465 90487004
Osteonecrosis 21.33 12.90 4 116974 26237 90485232
Vulvovaginal pruritus 21.23 12.90 26 116952 3967 90507502
Nausea 21.04 12.90 1196 115782 1109120 89402349
Paralysis 20.94 12.90 46 116932 11432 90500037
Drug intolerance 20.78 12.90 739 116239 446852 90064617
Haemorrhage 20.75 12.90 36 116942 69333 90442136
Mydriasis 20.73 12.90 54 116924 14958 90496511
Restless legs syndrome 20.69 12.90 70 116908 22400 90489069
Gait disturbance 20.50 12.90 226 116752 260270 90251199
Metastases to bone 20.49 12.90 4 116974 25501 90485968
Serotonin syndrome 20.45 12.90 100 116878 37787 90473682
Somnolence 20.44 12.90 172 116806 208912 90302557
Mobility decreased 20.41 12.90 445 116533 250289 90261180
Nephrolithiasis 20.30 12.90 20 116958 49065 90462404
Gastrointestinal haemorrhage 20.23 12.90 55 116923 90193 90421276
Pneumococcal infection 20.11 12.90 15 116963 1230 90510239
Procedural pain 19.98 12.90 9 116969 33351 90478118
Tissue infiltration 19.96 12.90 13 116965 857 90510612
Platelet count decreased 19.84 12.90 100 116878 136869 90374600
Osteopenia 19.82 12.90 3 116975 22999 90488470
Unevaluable event 19.78 12.90 25 116953 54823 90456646
Dystonia 19.74 12.90 57 116921 16762 90494707
Injection site haemorrhage 19.71 12.90 6 116972 28312 90483157
Foot fracture 19.71 12.90 5 116973 26601 90484868
Gastroenteritis bacterial 19.62 12.90 10 116968 413 90511056
Skin lesion 19.54 12.90 12 116966 37353 90474116
Neuroleptic malignant syndrome 19.52 12.90 53 116925 15043 90496426
Irritability 19.29 12.90 11 116967 35651 90475818
Leukopenia 19.27 12.90 66 116912 100644 90410825
Malignant neoplasm progression 19.15 12.90 72 116906 106798 90404671
Drug level increased 19.12 12.90 6 116972 27756 90483713
Injection site rash 18.99 12.90 4 116974 24169 90487300
Contusion 18.96 12.90 220 116758 250996 90260473
Injury 18.96 12.90 359 116619 196990 90314479
Kidney infection 18.95 12.90 5 116973 25911 90485558
Lichen sclerosus 18.91 12.90 15 116963 1348 90510121
Thyroid stimulating immunoglobulin increased 18.73 12.90 7 116971 134 90511335
Eye pruritus 18.73 12.90 7 116971 29020 90482449
Therapy partial responder 18.71 12.90 3 116975 22040 90489429
Rhinorrhoea 18.60 12.90 185 116793 88131 90423338
Gastrointestinal sounds abnormal 18.59 12.90 26 116952 4517 90506952
Acute myocardial infarction 18.53 12.90 11 116967 34879 90476590
Biliary sepsis 18.48 12.90 13 116965 973 90510496
Polymenorrhoea 18.39 12.90 15 116963 1402 90510067
Musculoskeletal disorder 18.39 12.90 3 116975 21766 90489703
Acute respiratory distress syndrome 18.37 12.90 7 116971 28679 90482790
Glomerulonephritis chronic 18.35 12.90 7 116971 142 90511327
Hyperhidrosis 18.35 12.90 102 116876 136203 90375266
Septic shock 18.34 12.90 52 116926 84108 90427361
Lactic acidosis 18.20 12.90 23 116955 50440 90461029
Eczema 18.15 12.90 25 116953 52845 90458624
Galactorrhoea 18.03 12.90 26 116952 4646 90506823
Diverticulitis 18.02 12.90 19 116959 45168 90466301
Nasal congestion 17.83 12.90 52 116926 83362 90428107
Emotional disorder 17.77 12.90 51 116927 14946 90496523
Nervousness 17.72 12.90 11 116967 34045 90477424
Oedema 17.72 12.90 169 116809 200126 90311343
Seasonal allergy 17.65 12.90 4 116974 22979 90488490
Body temperature fluctuation 17.58 12.90 18 116960 2257 90509212
Neoplasm malignant 17.55 12.90 11 116967 33869 90477600
Full blood count abnormal 17.47 12.90 13 116965 36584 90474885
Respiratory tract infection 17.36 12.90 31 116947 59047 90452422
Secondary adrenocortical insufficiency 17.29 12.90 18 116960 2300 90509169
Nail dystrophy 17.21 12.90 14 116964 1304 90510165
Deafness 17.13 12.90 4 116974 22510 90488959
Eye disorder 17.02 12.90 7 116971 27383 90484086
Transfusion-associated dyspnoea 17.02 12.90 5 116973 43 90511426
Vaginal cellulitis 16.93 12.90 6 116972 98 90511371
Craniocervical syndrome 16.61 12.90 6 116972 104 90511365
Genital pain 16.60 12.90 11 116967 747 90510722
Liver function test abnormal 16.51 12.90 25 116953 50820 90460649
Colitis ulcerative 16.50 12.90 33 116945 60233 90451236
Dry eye 16.49 12.90 31 116947 57900 90453569
Stoma site inflammation 16.39 12.90 11 116967 763 90510706
Lower respiratory tract infection viral 16.35 12.90 12 116966 960 90510509
Akathisia 16.30 12.90 41 116937 11118 90500351
Injection site extravasation 16.29 12.90 36 116942 8983 90502486
Treatment noncompliance 16.25 12.90 26 116952 51701 90459768
Incontinence 16.22 12.90 46 116932 13389 90498080
Cytomegalovirus infection 16.21 12.90 7 116971 26595 90484874
Pulmonary oedema 16.15 12.90 35 116943 62045 90449424
Seizure 16.09 12.90 123 116855 152506 90358963
Renal fusion anomaly 16.00 12.90 4 116974 17 90511452
Dysgeusia 15.97 12.90 27 116951 52533 90458936
Adrenal suppression 15.95 12.90 12 116966 997 90510472
Impaired quality of life 15.94 12.90 5 116973 23139 90488330
Blood pressure decreased 15.79 12.90 47 116931 74848 90436621
Complication associated with device 15.73 12.90 3 116975 19446 90492023
Coma 15.73 12.90 45 116933 72587 90438882
Chest discomfort 15.53 12.90 258 116720 138107 90373362
Paraesthesia oral 15.43 12.90 11 116967 31648 90479821
Anaphylactic shock 15.39 12.90 11 116967 31606 90479863
Spinal osteoarthritis 15.39 12.90 3 116975 19145 90492324
Dry skin 15.35 12.90 60 116918 88013 90423456
Asthma 15.34 12.90 220 116758 241940 90269529
Genital ulceration 15.30 12.90 12 116966 1061 90510408
Hypercalcaemia 15.29 12.90 13 116965 34227 90477242
Immunodeficiency 15.29 12.90 20 116958 43214 90468255
Cardiac failure 15.26 12.90 81 116897 109415 90402054
Haematocrit decreased 15.16 12.90 19 116959 41813 90469656
Cardiomegaly 15.14 12.90 3 116975 18922 90492547
Skin disorder 15.13 12.90 15 116963 36691 90474778
Pulmonary embolism 14.96 12.90 103 116875 130717 90380752
Dermatitis 14.95 12.90 5 116973 22215 90489254
Nail bed tenderness 14.87 12.90 8 116970 370 90511099
Musculoskeletal stiffness 14.85 12.90 494 116484 296038 90215431
Menstruation delayed 14.84 12.90 16 116962 2129 90509340
Mania 14.81 12.90 46 116932 14078 90497391
Product storage error 14.62 12.90 4 116974 20237 90491232
Vertigo 14.58 12.90 44 116934 69767 90441702
Hypoacusis 14.49 12.90 9 116969 27841 90483628
Stoma site infection 14.49 12.90 11 116967 927 90510542
Blood bilirubin increased 14.48 12.90 21 116957 43449 90468020
Stoma site pain 14.33 12.90 13 116965 1404 90510065
Breast cancer 14.24 12.90 30 116948 53731 90457738
Infusion related reaction 14.23 12.90 666 116312 416114 90095355
Schizophrenia 14.21 12.90 47 116931 14867 90496602
Eosinophil count decreased 14.07 12.90 19 116959 3193 90508276
Hyperlipidaemia 14.01 12.90 6 116972 22910 90488559
Hypervolaemia 13.95 12.90 13 116965 32744 90478725
Red blood cell count decreased 13.91 12.90 24 116954 46327 90465142
Respiratory distress 13.79 12.90 18 116960 38928 90472541
Acne 13.77 12.90 10 116968 28497 90482972
Gastritis fungal 13.71 12.90 6 116972 175 90511294
Myelodysplastic syndrome 13.55 12.90 5 116973 20898 90490571
Duodenal stenosis 13.45 12.90 9 116969 621 90510848
Tubulointerstitial nephritis 13.45 12.90 8 116970 25335 90486134
Glaucoma 13.40 12.90 5 116973 20750 90490719
Blood potassium increased 13.39 12.90 5 116973 20744 90490725
Nodule 13.37 12.90 9 116969 26677 90484792
Stoma site extravasation 13.35 12.90 7 116971 307 90511162
Oral cavity fistula 13.27 12.90 9 116969 635 90510834
Congenital central nervous system anomaly 13.18 12.90 8 116970 466 90511003
Osteomyelitis 13.15 12.90 10 116968 27836 90483633
Oropharyngeal pain 13.02 12.90 91 116887 115096 90396373
Ankle fracture 13.00 12.90 5 116973 20365 90491104
Therapeutic product effect incomplete 12.98 12.90 335 116643 193561 90317908
Visual acuity reduced 12.98 12.90 7 116971 23403 90488066
Hypochromic anaemia 12.97 12.90 15 116963 2156 90509313
Skin necrosis 12.91 12.90 3 116975 16938 90494531

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
Pulmonary vasculitis 358.51 14.38 131 21694 6135 42593375
Respiratory symptom 333.97 14.38 146 21679 10960 42588550
Neuritis 311.73 14.38 118 21707 6102 42593408
Total lung capacity abnormal 262.00 14.38 95 21730 4348 42595162
Neurological symptom 260.88 14.38 119 21706 9872 42589638
Eosinophilic granulomatosis with polyangiitis 257.87 14.38 113 21712 8525 42590985
Pulmonary alveolar haemorrhage 241.60 14.38 128 21697 14688 42584822
Spirometry abnormal 220.04 14.38 87 21738 5059 42594451
Vasculitis 207.92 14.38 125 21700 18269 42581241
Pulmonary fibrosis 197.48 14.38 139 21686 26542 42572968
Mite allergy 193.91 14.38 79 21746 4967 42594543
Mycotic allergy 192.85 14.38 78 21747 4813 42594697
Obstructive airways disorder 192.62 14.38 133 21692 24626 42574884
Conjunctivitis allergic 191.71 14.38 82 21743 5829 42593681
Forced expiratory volume decreased 190.15 14.38 88 21737 7542 42591968
Dust allergy 189.70 14.38 79 21746 5253 42594257
Sleep disorder due to a general medical condition 177.82 14.38 111 21714 17342 42582168
Full blood count abnormal 174.59 14.38 135 21690 29741 42569769
Antineutrophil cytoplasmic antibody positive 169.99 14.38 69 21756 4296 42595214
Lung disorder 164.94 14.38 160 21665 47763 42551747
Asthma 156.92 14.38 176 21649 62138 42537372
Normochromic normocytic anaemia 155.67 14.38 81 21744 8950 42590560
Hypothyroidism 155.63 14.38 130 21695 31954 42567556
Wheezing 131.57 14.38 151 21674 54630 42544880
Nodule 130.91 14.38 81 21744 12453 42587057
Cerebral hypoperfusion 128.91 14.38 39 21786 1004 42598506
Haemoptysis 122.39 14.38 134 21691 46033 42553477
Arteriosclerosis coronary artery 112.58 14.38 86 21739 18591 42580919
Arteriosclerosis 108.80 14.38 83 21742 17906 42581604
Loss of personal independence in daily activities 100.99 14.38 126 21699 49690 42549820
Therapeutic product effect incomplete 99.34 14.38 150 21675 70789 42528721
Capillaritis 96.39 14.38 38 21787 2190 42597320
On and off phenomenon 89.53 14.38 41 21784 3426 42596084
Drug ineffective 81.02 14.38 124 21701 630073 41969437
Thrombosis 76.89 14.38 131 21694 68380 42531130
Regurgitation 63.18 14.38 27 21798 1913 42597597
Sleep disorder 62.10 14.38 98 21727 47997 42551513
Pulmonary embolism 57.05 14.38 162 21663 119450 42480060
Anxiety 56.96 14.38 161 21664 118399 42481111
Aspiration 54.61 14.38 56 21769 17830 42581680
Binocular eye movement disorder 49.15 14.38 14 21811 290 42599220
Productive cough 46.86 14.38 90 21735 51477 42548033
Congenital hiatus hernia 40.68 14.38 30 21795 6144 42593366
Hypoxia 39.77 14.38 101 21724 69685 42529825
Eructation 39.20 14.38 28 21797 5458 42594052
Cerebellar stroke 38.96 14.38 14 21811 623 42598887
Lower respiratory tract infection 37.53 14.38 72 21753 41134 42558376
Oropharyngeal discomfort 36.32 14.38 24 21801 4125 42595385
Micturition urgency 35.86 14.38 37 21788 11861 42587649
Pleuritic pain 34.95 14.38 29 21796 7048 42592462
Vitamin B12 deficiency 34.89 14.38 25 21800 4897 42594613
Toxicity to various agents 34.43 14.38 40 21785 229096 42370414
Bronchopulmonary aspergillosis allergic 34.09 14.38 24 21801 4574 42594936
Intentional medical device removal by patient 32.10 14.38 11 21814 425 42599085
Anticoagulant therapy 32.07 14.38 23 21802 4512 42594998
Speech disorder 31.73 14.38 55 21770 29066 42570444
Antacid therapy 31.26 14.38 23 21802 4694 42594816
Completed suicide 30.79 14.38 6 21819 96459 42503051
Stoma site discharge 30.58 14.38 15 21810 1461 42598049
Hyperkinesia 28.29 14.38 16 21809 2082 42597428
Oesophageal haemorrhage 28.20 14.38 14 21811 1400 42598110
Hyporesponsive to stimuli 27.01 14.38 14 21811 1532 42597978
Feeling cold 26.56 14.38 33 21792 12940 42586570
Stoma site erythema 26.25 14.38 12 21813 998 42598512
Saliva altered 26.18 14.38 8 21817 213 42599297
Drug therapy 25.16 14.38 23 21802 6357 42593153
Pain in extremity 25.06 14.38 147 21678 150457 42449053
Neuralgia 24.82 14.38 46 21779 25601 42573909
Analgesic therapy 24.72 14.38 23 21802 6501 42593009
Oesophagitis 23.85 14.38 34 21791 15213 42584297
Blood test abnormal 23.54 14.38 31 21794 12875 42586635
Device dislocation 22.96 14.38 24 21801 7807 42591703
Radiation inflammation 22.76 14.38 11 21814 1037 42598473
Disease progression 22.74 14.38 24 21801 143632 42455878
Sleep disorder therapy 21.79 14.38 22 21803 6872 42592638
Freezing phenomenon 21.75 14.38 13 21812 1876 42597634
Renal failure 21.66 14.38 25 21800 143701 42455809
Pruritus 21.44 14.38 40 21785 188731 42410779
Genital ulceration 21.33 14.38 10 21815 881 42598629
Genital pain 21.13 14.38 10 21815 900 42598610
Condition aggravated 21.09 14.38 215 21610 260539 42338971
Akinesia 20.92 14.38 14 21811 2458 42597052
Sputum increased 20.01 14.38 15 21810 3148 42596362
Activated partial thromboplastin time prolonged 19.95 14.38 32 21793 15871 42583639
Blood calcium increased 19.75 14.38 23 21802 8431 42591079
Stoma site inflammation 19.28 14.38 8 21817 526 42598984
Stoma site pain 19.19 14.38 9 21816 794 42598716
Hypercholesterolaemia 19.14 14.38 28 21797 12821 42586689
Asthma-chronic obstructive pulmonary disease overlap syndrome 18.66 14.38 11 21814 1548 42597962
Impulse-control disorder 18.55 14.38 11 21814 1564 42597946
Pulmonary pain 18.53 14.38 11 21814 1567 42597943
Bradykinesia 18.39 14.38 18 21807 5418 42594092
Gene mutation identification test positive 17.75 14.38 6 21819 222 42599288
Dyspepsia 17.75 14.38 54 21771 41298 42558212
Impaired gastric emptying 17.73 14.38 16 21809 4350 42595160
Incorrect product dosage form administered 17.40 14.38 6 21819 236 42599274
Embedded device 17.25 14.38 7 21818 435 42599075
Dyskinesia 16.86 14.38 39 21786 25351 42574159
Pneumonia haemophilus 16.79 14.38 9 21816 1055 42598455
Respiratory failure 16.53 14.38 25 21800 128107 42471403
Splenic embolism 16.16 14.38 6 21819 293 42599217
Cataract 16.09 14.38 43 21782 30561 42568949
Drug abuse 16.02 14.38 18 21807 104753 42494757
Dyskinesia oesophageal 16 14.38 4 21821 49 42599461
Vomiting 15.56 14.38 221 21604 289502 42310008
Rash 15.54 14.38 81 21744 276873 42322637
Abdominal distension 15.30 14.38 75 21750 71660 42527850
Off label use 15.20 14.38 233 21592 638102 41961408
Colectomy total 15.11 14.38 6 21819 352 42599158
Stoma site infection 14.86 14.38 8 21817 945 42598565
Hyperphosphataemia 14.74 14.38 25 21800 12979 42586531
Breath sounds abnormal 14.71 14.38 24 21801 12069 42587441
Liver disorder 14.50 14.38 49 21776 39595 42559915
Blood glucose increased 14.48 14.38 10 21815 73689 42525821

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
Blepharospasm 641.64 12.77 534 134721 54317 110399727
Breast cancer stage III 529.55 12.77 565 134690 78552 110375492
Taste disorder 519.27 12.77 512 134743 64875 110389169
Epilepsy 505.33 12.77 618 134637 99591 110354453
Nail disorder 464.40 12.77 456 134799 57479 110396565
Onychomadesis 449.75 12.77 403 134852 45260 110408784
Gastrooesophageal reflux disease 400.47 12.77 758 134497 179218 110274826
Facet joint syndrome 363.95 12.77 517 134738 96311 110357733
Back injury 357.56 12.77 361 134894 47038 110407006
Hypercholesterolaemia 334.02 12.77 480 134775 90357 110363687
Wound infection 331.92 12.77 494 134761 95971 110358073
Product quality issue 330.06 12.77 439 134816 76860 110377184
Live birth 315.88 12.77 407 134848 69077 110384967
Peripheral venous disease 304.18 12.77 441 134814 83676 110370368
Lung disorder 289.81 12.77 664 134591 179383 110274661
Bursitis 288.66 12.77 547 134708 129371 110324673
Onychomycosis 269.86 12.77 282 134973 38249 110415795
Lip dry 266.53 12.77 456 134799 99627 110354417
Obesity 262.71 12.77 486 134769 112865 110341179
Type 2 diabetes mellitus 259.56 12.77 630 134625 176602 110277442
Completed suicide 249.51 12.77 11 135244 242370 110211674
Pulmonary vasculitis 245.74 12.77 132 135123 6428 110447616
Finger deformity 238.59 12.77 246 135009 32846 110421198
Joint range of motion decreased 235.62 12.77 484 134771 121348 110332696
Sensory loss 232.54 12.77 200 135055 21257 110432787
Liver function test increased 231.25 12.77 400 134855 88148 110365896
Product label confusion 230.92 12.77 204 135051 22473 110431571
Carotid artery thrombosis 223.26 12.77 142 135113 9496 110444548
Neurologic neglect syndrome 222.90 12.77 140 135115 9158 110444886
Gangrene 216.15 12.77 171 135084 16170 110437874
Adverse reaction 215.17 12.77 221 135034 29373 110424671
Arterial occlusive disease 215.06 12.77 166 135089 15142 110438902
Wheezing 211.56 12.77 740 134515 254490 110199554
Helicobacter infection 205.53 12.77 587 134668 181290 110272754
Inflammation 200.52 12.77 605 134650 192633 110261411
Rheumatoid arthritis 200.46 12.77 811 134444 298802 110155242
Adjustment disorder 196.78 12.77 137 135118 10658 110443386
Neuritis 196.69 12.77 119 135136 7280 110446764
Lower respiratory tract infection 196.44 12.77 699 134556 242407 110211637
Duodenal ulcer perforation 195.46 12.77 568 134687 177132 110276912
Toxicity to various agents 195.36 12.77 180 135075 480375 109973669
Personality disorder 193.11 12.77 145 135110 12692 110441352
Drug ineffective 191.76 12.77 1086 134169 1519454 108934590
Coeliac disease 186.96 12.77 247 135008 42940 110411104
Night sweats 186.29 12.77 467 134788 133516 110320528
Infusion site reaction 185.92 12.77 162 135093 17520 110436524
Sleep disorder 184.06 12.77 598 134657 198046 110255998
Pemphigus 183.77 12.77 629 134626 213941 110240103
Psoriatic arthropathy 182.91 12.77 593 134662 196168 110257876
Fibromyalgia 182.90 12.77 541 134714 170368 110283676
Total lung capacity abnormal 182.34 12.77 96 135159 4487 110449557
Respiratory symptom 181.98 12.77 149 135106 14796 110439248
C-reactive protein increased 175.54 12.77 626 134629 217293 110236751
Folliculitis 174.01 12.77 525 134730 167128 110286916
Acute kidney injury 168.70 12.77 326 134929 635104 109818940
Osteoarthritis 168.48 12.77 549 134706 182074 110271970
Muscle injury 168.42 12.77 464 134791 140343 110313701
Anti-cyclic citrullinated peptide antibody positive 155.38 12.77 533 134722 181451 110272593
Grip strength decreased 152.02 12.77 316 134939 79858 110374186
Affect lability 147.99 12.77 146 135109 18491 110435553
Obstructive airways disorder 146.87 12.77 228 135027 45921 110408123
Neck pain 146.50 12.77 405 134850 122725 110331319
Pericarditis 146.38 12.77 593 134662 218521 110235523
Eosinophilic granulomatosis with polyangiitis 146.02 12.77 114 135141 10572 110443472
Spirometry abnormal 145.07 12.77 88 135167 5409 110448635
Hypotension 144.94 12.77 262 134993 523587 109930457
Glossodynia 141.35 12.77 592 134663 221412 110232632
Abdominal pain upper 140.70 12.77 817 134438 348294 110105750
Blood cholesterol increased 140.47 12.77 521 134734 184264 110269780
Irritable bowel syndrome 140.21 12.77 481 134774 163734 110290310
Dry mouth 139.87 12.77 549 134706 199399 110254645
Gait inability 137.69 12.77 423 134832 135953 110318091
Sinus congestion 136.17 12.77 177 135078 30282 110423762
Liver injury 135.86 12.77 449 134806 149964 110304080
Paraesthesia 135.70 12.77 683 134572 275838 110178206
Pruritus 135.45 12.77 321 134934 581239 109872805
Musculoskeletal pain 134.94 12.77 511 134744 182512 110271532
Migraine 133.86 12.77 488 134767 171164 110282880
Hemiplegia 133.80 12.77 152 135103 22630 110431414
Rheumatic fever 132.04 12.77 389 134866 122190 110331854
Maternal exposure during pregnancy 131.78 12.77 639 134616 254244 110199800
Hypoaesthesia 131.61 12.77 743 134512 313480 110140564
Motor dysfunction 128.59 12.77 154 135101 24252 110429792
Renal failure 127.02 12.77 59 135196 226515 110227529
Bronchopulmonary aspergillosis allergic 124.13 12.77 94 135161 8332 110445712
Mite allergy 123.33 12.77 81 135174 5722 110448322
Wound 122.81 12.77 590 134665 233847 110220197
Systemic lupus erythematosus 122.52 12.77 625 134630 253713 110200331
Memory impairment 119.80 12.77 518 134737 196426 110257618
Neurological symptom 119.73 12.77 120 135135 15488 110438556
Dust allergy 118.46 12.77 80 135175 5921 110448123
Skin haemorrhage 118.43 12.77 149 135106 24678 110429366
Sinus disorder 117.40 12.77 171 135084 32557 110421487
Mycotic allergy 116.64 12.77 79 135176 5875 110448169
Coordination abnormal 116.53 12.77 149 135106 25079 110428965
Product dose omission issue 116.52 12.77 133 135122 321649 110132395
Drug abuse 116.44 12.77 36 135219 177375 110276669
Conjunctivitis allergic 114.86 12.77 83 135172 6848 110447196
Pulmonary alveolar haemorrhage 114.22 12.77 132 135123 20018 110434026
Hand deformity 113.79 12.77 549 134706 217957 110236087
Gastric pH decreased 110.07 12.77 43 135212 987 110453057
Forced expiratory volume decreased 109.82 12.77 106 135149 13070 110440974
Blister 108.98 12.77 558 134697 226818 110227226
Respiratory tract congestion 108.91 12.77 160 135095 30697 110423347
Intentional product use issue 107.63 12.77 592 134663 247314 110206730
Antineutrophil cytoplasmic antibody positive 105.81 12.77 70 135185 5006 110449038
Aspiration 104.43 12.77 156 135099 30377 110423667
Muscular weakness 104.31 12.77 588 134667 247880 110206164
Confusional state 102.67 12.77 948 134307 467732 109986312
Respiratory failure 99.43 12.77 71 135184 215261 110238783
Cardiac failure congestive 98.44 12.77 31 135224 150969 110303075
Infection 97.57 12.77 184 135071 362016 110092028
Depersonalisation/derealisation disorder 96.30 12.77 49 135206 2132 110451912
Derealisation 93.88 12.77 48 135207 2110 110451934
Death 93.73 12.77 488 134767 698381 109755663
Pulmonary fibrosis 92.47 12.77 305 134950 101737 110352307
Sneezing 92.12 12.77 151 135104 31833 110422211
Muscle spasticity 92.10 12.77 161 135094 35754 110418290
Impaired healing 91.64 12.77 479 134776 196238 110257806
Eating disorder 90.66 12.77 147 135108 30711 110423333
General physical health deterioration 89.49 12.77 853 134402 424442 110029602
Overlap syndrome 89.25 12.77 80 135175 8979 110445065
Myocardial infarction 89.12 12.77 63 135192 192020 110262024
Erythema 88.63 12.77 137 135118 291310 110162734
Hepatitis 87.79 12.77 276 134979 89778 110364266
Synovitis 87.70 12.77 605 134650 273487 110180557
On and off phenomenon 87.38 12.77 59 135196 4365 110449679
Drug-induced liver injury 85.80 12.77 332 134923 119735 110334309
Abdominal distension 83.37 12.77 429 134826 174674 110279370
Depression 83.12 12.77 668 134587 316667 110137377
Cardiac arrest 81.87 12.77 72 135183 196681 110257363
Premature labour 80.64 12.77 76 135179 9096 110444948
Injection site reaction 80.50 12.77 266 134989 88804 110365240
Gastrointestinal disorder 79.14 12.77 537 134718 241415 110212629
Total lung capacity decreased 78.48 12.77 67 135188 7047 110446997
Aphasia 78.17 12.77 202 135053 58795 110395249
Injection site pain 76.60 12.77 63 135192 177859 110276185
Myelosuppression 76.26 12.77 12 135243 94328 110359716
Mental status changes 73.51 12.77 5 135250 76117 110377927
Bradycardia 73.47 12.77 50 135205 155467 110298577
Pulmonary malformation 72.82 12.77 22 135233 223 110453821
Muscle spasms 72.00 12.77 584 134671 277573 110176471
Thrombocytopenia 71.60 12.77 205 135050 348680 110105364
Hepatic enzyme 70.37 12.77 55 135200 5108 110448936
Deep vein thrombosis 70.16 12.77 42 135213 139845 110314199
Atrial fibrillation 69.75 12.77 108 135147 229534 110224510
H1N1 influenza 68.74 12.77 44 135211 2974 110451070
Normochromic normocytic anaemia 68.14 12.77 82 135173 12975 110441069
Cataract 67.95 12.77 233 135022 79252 110374792
Injection site erythema 67.64 12.77 16 135239 94160 110359884
Haemoglobin decreased 67.26 12.77 126 135129 248601 110205443
Blood calcium increased 67.24 12.77 96 135159 17944 110436100
Contraindicated product administered 66.84 12.77 526 134729 247741 110206303
Angioedema 64.59 12.77 20 135235 98480 110355564
Stomatitis 64.41 12.77 557 134698 269685 110184359
Exposure during pregnancy 64.24 12.77 387 134868 167037 110287007
Vasculitis 64.05 12.77 138 135117 35735 110418309
Haemoptysis 63.50 12.77 212 135043 71142 110382902
Angina pectoris 62.63 12.77 193 135062 62102 110391942
Capillaritis 61.69 12.77 38 135217 2401 110451643
Nasopharyngitis 61.05 12.77 744 134511 393617 110060427
Lung opacity 60.52 12.77 73 135182 11579 110442465
Wrong technique in product usage process 60.48 12.77 16 135239 87332 110366712
Pleuritic pain 60.32 12.77 86 135169 16054 110437990
Disease progression 59.70 12.77 131 135124 243903 110210141
COVID-19 59.58 12.77 132 135123 244928 110209116
Therapeutic product effect incomplete 59.04 12.77 472 134783 223333 110230711
Dyspepsia 58.98 12.77 418 134837 190547 110263497
Cogwheel rigidity 58.37 12.77 43 135212 3655 110450389
C-reactive protein abnormal 57.77 12.77 312 134943 129383 110324661
Feeling of despair 57.34 12.77 43 135212 3755 110450289
Hemiparesis 56.80 12.77 149 135106 43754 110410290
Myalgia 56.37 12.77 117 135138 222264 110231780
Sepsis 56.29 12.77 208 135047 327138 110126906
Neutropenia 56.28 12.77 251 135004 374369 110079675
Ill-defined disorder 56.05 12.77 356 134899 156497 110297547
Blood glucose increased 55.70 12.77 48 135207 132448 110321596
Chills 55.64 12.77 92 135163 190488 110263556
Gastrointestinal haemorrhage 55.04 12.77 73 135182 165445 110288599
Aspartate aminotransferase increased 52.71 12.77 71 135184 159865 110294179
Hyperkalaemia 52.59 12.77 53 135202 135743 110318301
Feeling abnormal 52.04 12.77 88 135167 180623 110273421
Sleep disorder due to a general medical condition 51.96 12.77 161 135094 51951 110402093
Acute respiratory failure 51.70 12.77 14 135241 75246 110378798
Swelling 51.62 12.77 656 134599 350385 110103659
Sputum discoloured 51.61 12.77 109 135146 27836 110426208
Vomiting 51.06 12.77 1466 133789 909209 109544835
Cystitis 50.81 12.77 187 135068 65849 110388195
Hypothyroidism 50.79 12.77 200 135055 72699 110381345
Arthropathy 50.53 12.77 556 134699 286966 110167078
Stoma site discharge 49.84 12.77 35 135220 2760 110451284
International normalised ratio increased 49.53 12.77 22 135233 86750 110367294
Menstrual disorder 48.62 12.77 43 135212 4741 110449303
Stoma site erythema 48.55 12.77 31 135224 2086 110451958
Drug intolerance 48.54 12.77 732 134523 405780 110048264
Feeling of body temperature change 48.24 12.77 48 135207 6140 110447904
Chest pain 48.03 12.77 267 134988 376108 110077936
Intentional overdose 47.66 12.77 55 135200 132446 110321598
Haematochezia 47.17 12.77 43 135212 115481 110338563
Alanine aminotransferase increased 47.16 12.77 96 135159 183677 110270367
Hepatotoxicity 47.08 12.77 10 135245 63390 110390654
Cardiogenic shock 47.01 12.77 7 135248 57331 110396713
Inappropriate schedule of product administration 46.82 12.77 113 135142 203524 110250520
Hypocholesterolaemia 46.75 12.77 48 135207 6373 110447671
Cardiac failure 46.47 12.77 100 135155 187526 110266518
Therapy interrupted 46.05 12.77 4 135251 49818 110404226
Alopecia 45.97 12.77 663 134592 364090 110089954
Back pain 45.82 12.77 266 134989 370730 110083314
Hyperprolactinaemia 45.80 12.77 48 135207 6527 110447517
Encephalopathy 45.57 12.77 21 135234 81034 110373010
Acute myocardial infarction 45.12 12.77 23 135232 83754 110370290
Therapeutic product ineffective 45.02 12.77 32 135223 2572 110451472
Weight decreased 44.72 12.77 362 134893 467695 109986349
Normal newborn 44.68 12.77 89 135166 21807 110432237
Rhabdomyolysis 44.37 12.77 49 135206 120352 110333692
Disease recurrence 44.30 12.77 10 135245 60774 110393270
Multiple organ dysfunction syndrome 43.57 12.77 74 135181 151636 110302408
Injection site swelling 43.39 12.77 11 135244 61779 110392265
Blood test abnormal 43.34 12.77 103 135152 28451 110425593
Lung cyst 43.11 12.77 18 135237 493 110453551
Sedation 42.48 12.77 16 135239 69667 110384377
Hypoaesthesia oral 42.02 12.77 75 135180 16927 110437117
Muscle disorder 41.72 12.77 46 135209 6626 110447418
Respiratory tract malformation 41.50 12.77 12 135243 103 110453941
White blood cell count decreased 41.25 12.77 143 135112 229247 110224797
Bone marrow failure 41.20 12.77 10 135245 57838 110396206
Mobility decreased 41.19 12.77 458 134797 236964 110217080
Plasma cell myeloma 40.87 12.77 13 135242 62923 110391121
Infusion related reaction 40.82 12.77 674 134581 380488 110073556
Underdose 40.80 12.77 170 135085 63384 110390660
Anaemia 40.77 12.77 450 134805 546636 109907408
Vascular encephalopathy 40.77 12.77 20 135235 804 110453240
Cestode infection 40.64 12.77 15 135240 293 110453751
Dehydration 40.34 12.77 190 135065 279321 110174723
Syncope 40.08 12.77 121 135134 202415 110251629
Cardio-respiratory arrest 39.63 12.77 50 135205 115786 110338258
Musculoskeletal stiffness 39.47 12.77 519 134736 279303 110174741
Poor sucking reflex 39.42 12.77 12 135243 125 110453919
Flushing 39.29 12.77 42 135213 104694 110349350
Septic shock 38.98 12.77 84 135171 157444 110296600
Sleep disorder due to general medical condition, insomnia type 38.92 12.77 43 135212 105600 110348444
Staphylococcal infection 37.97 12.77 19 135236 69925 110384119
Therapy cessation 37.89 12.77 5 135250 44852 110409192
Renal impairment 37.70 12.77 112 135143 188333 110265711
Haemorrhage 37.61 12.77 45 135210 106647 110347397
Leukocytosis 37 12.77 10 135245 53818 110400226
Acute respiratory distress syndrome 36.35 12.77 10 135245 53188 110400856
Metabolic acidosis 36.31 12.77 41 135214 99703 110354341
Leukopenia 36.27 12.77 80 135175 148711 110305333
Rales 36.22 12.77 88 135167 24651 110429393
Bronchitis 35.42 12.77 88 135167 156944 110297100
Arteriosclerosis coronary artery 35.35 12.77 88 135167 25030 110429014
Full blood count abnormal 35.25 12.77 149 135106 55903 110398141
Pancytopenia 34.84 12.77 135 135120 209478 110244566
Cellulitis 34.79 12.77 63 135192 125953 110328091
Drooling 34.29 12.77 43 135212 7096 110446948
Fluid retention 34.07 12.77 39 135216 94268 110359776
Pituitary tumour benign 33.85 12.77 28 135227 2819 110451225
Exposure via breast milk 33.85 12.77 19 135236 1009 110453035
Genital pain 33.36 12.77 21 135234 1379 110452665
Arteriosclerosis 33.01 12.77 85 135170 24682 110429362
Magnesium deficiency 32.82 12.77 17 135238 768 110453276
Injection site pruritus 32.56 12.77 11 135244 51247 110402797
Treatment noncompliance 32.47 12.77 25 135230 72965 110381079
Cytomegalovirus infection 32.36 12.77 13 135242 54431 110399613
Aggression 32.27 12.77 16 135239 59194 110394850
Injury 32.14 12.77 345 134910 176920 110277124
Lip swelling 31.96 12.77 11 135244 50656 110403388
Herpes zoster 31.92 12.77 52 135203 108327 110345717
Anaphylactic reaction 31.68 12.77 57 135198 114243 110339801
Therapy partial responder 31.62 12.77 4 135251 37057 110416987
Chronic kidney disease 31.62 12.77 28 135227 76263 110377781
Neutropenic sepsis 31.59 12.77 96 135159 30650 110423394
Seizure 31.53 12.77 151 135104 221034 110233010
Drug dependence 31.31 12.77 11 135244 50009 110404035
Hepatic failure 31.27 12.77 23 135232 68716 110385328
Suicide attempt 31.02 12.77 49 135206 103345 110350699
Premenstrual syndrome 30.86 12.77 15 135240 591 110453453
Skin exfoliation 30.72 12.77 198 135057 87453 110366591
Skin ulcer 30.67 12.77 20 135235 63625 110390419
Eczema 30.61 12.77 26 135229 72267 110381777
Cardiac disorder 30.42 12.77 29 135226 76251 110377793
Vulvovaginal burning sensation 30.30 12.77 23 135232 2046 110451998
Lactic acidosis 29.77 12.77 42 135213 92769 110361275
Dyspnoea 29.58 12.77 1082 134173 1105790 109348254
Uterine enlargement 29.20 12.77 17 135238 968 110453076
Genital ulceration 29.02 12.77 22 135233 1953 110452091
Cytokine release syndrome 28.90 12.77 26 135229 70280 110383764
Therapeutic response decreased 28.70 12.77 46 135209 96453 110357591
Asthenia 28.42 12.77 1070 134185 687929 109766115
Pulmonary oedema 28.08 12.77 50 135205 100609 110353435
Emotional distress 27.84 12.77 10 135245 44837 110409207
Surgery 27.76 12.77 8 135247 41275 110412769
Hallucinations, mixed 27.72 12.77 43 135212 8650 110445394
Eye swelling 27.17 12.77 4 135251 33044 110421000
Lip pruritus 27.00 12.77 18 135237 1304 110452740
Incorrect product administration duration 26.96 12.77 70 135185 20428 110433616
Eosinophilia 26.86 12.77 19 135236 57917 110396127
Drug interaction 26.86 12.77 440 134815 499743 109954301
Incorrect dose administered 26.70 12.77 54 135201 103587 110350457
Anaphylactic shock 26.52 12.77 15 135240 51531 110402513
Dissociation 26.38 12.77 45 135210 9797 110444247
Chronic obstructive pulmonary disease 26.35 12.77 59 135196 109099 110344945
Acute myeloid leukaemia 26.34 12.77 7 135248 38103 110415941
Rash 26.28 12.77 784 134471 820180 109633864
Vulvovaginal pruritus 26.27 12.77 26 135229 3305 110450739
Rhinalgia 26.16 12.77 28 135227 3901 110450143
Platelet count decreased 25.95 12.77 170 135085 230273 110223771
Basal ganglion degeneration 25.90 12.77 12 135243 424 110453620
Mental disorder 25.87 12.77 105 135150 38686 110415358
Ocular hyperaemia 25.71 12.77 8 135247 39278 110414766
Hepatic cytolysis 25.59 12.77 18 135237 55035 110399009
Blood pressure decreased 25.56 12.77 65 135190 115026 110339018
Hyperhidrosis 25.46 12.77 130 135125 187168 110266876
Withdrawal syndrome 25.34 12.77 4 135251 31376 110422668
Multiple sclerosis relapse 25.30 12.77 15 135240 50225 110403819
Red blood cell count decreased 25.21 12.77 26 135229 65897 110388147
Skin lesion 25.19 12.77 16 135239 51615 110402429
Dysphagia 25.13 12.77 293 134962 153307 110300737
Folate deficiency 25.03 12.77 29 135226 4409 110449635
Basal cell carcinoma 25.03 12.77 12 135243 45258 110408786
Colitis ulcerative 24.82 12.77 35 135220 77328 110376716
Device expulsion 24.80 12.77 4 135251 30887 110423157
Dysarthria 24.72 12.77 182 135073 83939 110370105
Influenza like illness 24.69 12.77 189 135066 88223 110365821
Eye pruritus 24.68 12.77 5 135250 32770 110421274
Hypervolaemia 24.58 12.77 15 135240 49445 110404599
Dyskinesia 24.43 12.77 126 135129 51320 110402724
Drug level increased 24.38 12.77 14 135241 47705 110406339
Ischaemic stroke 24.29 12.77 10 135245 41253 110412791
Haematocrit decreased 24.26 12.77 27 135228 66090 110387954
Unevaluable event 24.23 12.77 22 135233 59205 110394839
Mood swings 24.17 12.77 72 135183 22740 110431304
Loss of consciousness 24.08 12.77 141 135114 196165 110257879
Prostate cancer 24.04 12.77 8 135247 37633 110416411
Blood calcium decreased 24.00 12.77 7 135248 35838 110418206
Osteonecrosis 23.70 12.77 6 135249 33735 110420309
Freezing phenomenon 23.67 12.77 22 135233 2587 110451457
Road traffic accident 23.58 12.77 61 135194 107337 110346707
Burning sensation 23.54 12.77 30 135225 69182 110384862
Regurgitation 23.49 12.77 25 135230 3460 110450584
Eye irritation 23.40 12.77 6 135249 33446 110420598
Lower respiratory tract infection viral 23.29 12.77 17 135238 1424 110452620
Lung diffusion test decreased 23.26 12.77 18 135237 1647 110452397
Malignant neoplasm progression 23.26 12.77 122 135133 174445 110279599
Cognitive disorder 23.05 12.77 45 135210 87466 110366578
Foetal exposure timing unspecified 22.99 12.77 7 135248 73 110453971
Hypersensitivity 22.47 12.77 353 134902 403645 110050399
Coronary artery disease 22.44 12.77 33 135222 71657 110382387
Renal tubular necrosis 22.23 12.77 5 135250 30470 110423574
Enzyme inhibition 22.23 12.77 8 135247 145 110453899
Therapeutic product effect decreased 22.20 12.77 421 134834 243895 110210149
Toxic epidermal necrolysis 22.12 12.77 22 135233 56705 110397339
Cannabinoid hyperemesis syndrome 22.10 12.77 7 135248 84 110453960
Poisoning deliberate 22.09 12.77 3 135252 26328 110427716
Polymenorrhoea 21.98 12.77 15 135240 1129 110452915
Hypoglycaemia 21.81 12.77 71 135184 116033 110338011
Impaired quality of life 21.75 12.77 5 135250 30012 110424032
Lichen sclerosus 21.70 12.77 15 135240 1153 110452891
Blood creatine phosphokinase increased 21.57 12.77 35 135220 73042 110381002
Nodule 21.50 12.77 88 135167 32543 110421501
Dystonia 21.49 12.77 75 135180 25730 110428314
Status epilepticus 21.45 12.77 6 135249 31565 110422479
Haemophagocytic lymphohistiocytosis 21.43 12.77 6 135249 31553 110422491
Bronchiectasis 21.41 12.77 95 135160 36398 110417646
Femur fracture 21.39 12.77 14 135241 44455 110409589
Multiple sclerosis 21.39 12.77 3 135252 25695 110428349
Subdural haematoma 21.19 12.77 9 135246 36445 110417599
Rheumatoid factor positive 21.09 12.77 86 135169 131554 110322490
Muscle rigidity 21.02 12.77 71 135184 23960 110430084
Restless legs syndrome 20.88 12.77 72 135183 24554 110429490
Hepatic enzyme increased 20.87 12.77 527 134728 320365 110133679
Thrombotic microangiopathy 20.83 12.77 5 135250 29144 110424900
Subileus 20.75 12.77 32 135223 6405 110447639
Generalised tonic-clonic seizure 20.42 12.77 22 135233 54658 110399386
Procedural pain 20.32 12.77 9 135246 35556 110418488
Coma 20.17 12.77 75 135180 117794 110336250
Dry skin 20.10 12.77 66 135189 107587 110346457
Respiratory depression 20.09 12.77 7 135248 31994 110422050
Abdominal discomfort 20.07 12.77 627 134628 393231 110060813
Abdominal tenderness 20.07 12.77 46 135209 12411 110441633
Nasal congestion 19.95 12.77 58 135197 98224 110355820
Cardiomyopathy 19.93 12.77 8 135247 33517 110420527
Diverticulitis 19.48 12.77 22 135233 53500 110400544
Anaesthesia 19.45 12.77 11 135244 593 110453451
Respiratory distress 19.40 12.77 34 135221 68840 110385204
Lymphadenopathy 19.39 12.77 30 135225 63805 110390239
Rhinorrhoea 19.15 12.77 201 135054 102465 110351579
Myelodysplastic syndrome 19.15 12.77 11 135244 37473 110416571
Hyperchlorhydria 19.12 12.77 18 135237 2151 110451893
Kidney infection 19.08 12.77 4 135251 25595 110428449
Respiratory arrest 19.08 12.77 26 135229 58273 110395771
Poisoning 18.92 12.77 6 135249 29099 110424945
Agranulocytosis 18.78 12.77 29 135226 61731 110392313
Petechiae 18.76 12.77 3 135252 23314 110430730
Nail dystrophy 18.76 12.77 14 135241 1214 110452830
Skin disorder 18.70 12.77 15 135240 42898 110411146
Congenital hiatus hernia 18.63 12.77 30 135225 6229 110447815
Forced vital capacity decreased 18.63 12.77 17 135238 1953 110452091
Transposition of the great vessels 18.58 12.77 6 135249 77 110453967
Stoma site inflammation 18.55 12.77 13 135242 1022 110453022
Tissue infiltration 18.46 12.77 13 135242 1030 110453014
Transfusion-associated dyspnoea 18.37 12.77 6 135249 80 110453964
Oedema peripheral 18.33 12.77 287 134968 328373 110125671
Oropharyngeal pain 18.32 12.77 94 135161 135182 110318862
Gastroenteritis bacterial 18.32 12.77 10 135245 503 110453541
Oral cavity fistula 18.13 12.77 11 135244 676 110453368
Blood potassium increased 18.10 12.77 9 135246 33240 110420804
Cardiac murmur 18.05 12.77 4 135251 24624 110429420
Product use issue 17.99 12.77 504 134751 311191 110142853
Menstruation delayed 17.98 12.77 16 135239 1778 110452266
Stoma site infection 17.98 12.77 16 135239 1779 110452265
Bronchopulmonary aspergillosis 17.96 12.77 7 135248 29856 110424188
Injection site haemorrhage 17.89 12.77 9 135246 33019 110421025
Respiratory tract infection 17.87 12.77 38 135217 71579 110382465
Subarachnoid haemorrhage 17.80 12.77 7 135248 29695 110424349
Anxiety 17.75 12.77 550 134705 344528 110109516
Product prescribing error 17.72 12.77 22 135233 51309 110402735
Injection site bruising 17.66 12.77 22 135233 51241 110402803
Dermatitis 17.63 12.77 6 135249 27831 110426213
Haematuria 17.58 12.77 48 135207 82957 110371087
Melaena 17.56 12.77 36 135219 68721 110385323
Thyroid stimulating immunoglobulin increased 17.47 12.77 7 135248 172 110453872
Medication error 17.41 12.77 68 135187 105298 110348746
Pneumocystis jirovecii pneumonia 17.33 12.77 16 135239 42719 110411325
Vaginal cellulitis 17.25 12.77 6 135249 98 110453946
Cardiomegaly 17.24 12.77 7 135248 29123 110424921
Hypercalcaemia 17.17 12.77 19 135236 46638 110407406
Urticaria 17.15 12.77 511 134744 318346 110135698
Foot fracture 17.08 12.77 5 135250 25541 110428503
Atelectasis 17.07 12.77 12 135243 36700 110417344
Bacteraemia 17.04 12.77 16 135239 42374 110411670
Product storage error 17.03 12.77 3 135252 21725 110432319
Tubulointerstitial nephritis 16.98 12.77 25 135230 54259 110399785
Craniocervical syndrome 16.92 12.77 6 135249 104 110453940
Stoma site hypergranulation 16.79 12.77 10 135245 594 110453450
Injection site rash 16.77 12.77 4 135251 23415 110430629
Stoma site pain 16.75 12.77 16 135239 1947 110452097
Ear infection 16.75 12.77 32 135223 62700 110391344
Dysuria 16.72 12.77 30 135225 60201 110393843
Hyperkinesia 16.62 12.77 20 135235 3164 110450880
Blood urea increased 16.53 12.77 26 135229 54931 110399113
Parosmia 16.31 12.77 44 135211 13136 110440908
Paralysis 16.30 12.77 49 135206 15551 110438493
Product administration error 16.23 12.77 13 135242 37204 110416840
Dry eye 16.21 12.77 27 135228 55766 110398278
Urinary tract infection 16.21 12.77 291 134964 325991 110128053
Off label use 16.19 12.77 1598 133657 1498587 108955457
Emotional disorder 16.18 12.77 50 135205 16110 110437934
Irritability 15.97 12.77 21 135234 47788 110406256
Hypertensive crisis 15.88 12.77 5 135250 24367 110429677
Amaurosis fugax 15.85 12.77 17 135238 2373 110451671
Pneumococcal infection 15.85 12.77 15 135240 1804 110452240
Nephrolithiasis 15.80 12.77 36 135219 66176 110387868
Cerebral haemorrhage 15.77 12.77 35 135220 64933 110389111
Therapy non-responder 15.77 12.77 120 135135 157187 110296857
Osteomyelitis 15.69 12.77 13 135242 36587 110417457
Intentional medical device removal by patient 15.68 12.77 9 135246 499 110453545
Visual acuity reduced 15.65 12.77 10 135245 32163 110421881
Premature delivery 15.63 12.77 9 135246 30623 110423421
Haemorrhage intracranial 15.53 12.77 8 135247 28961 110425083
Neoplasm progression 15.52 12.77 35 135220 64560 110389484
Shock 15.51 12.77 26 135229 53562 110400482
Foot deformity 15.49 12.77 22 135233 48458 110405586
Extrapyramidal disorder 15.43 12.77 8 135247 28859 110425185
Blood triglycerides increased 15.43 12.77 5 135250 23921 110430123
Shock haemorrhagic 15.40 12.77 7 135248 27240 110426804
Therapeutic response unexpected 15.35 12.77 5 135250 23838 110430206
Transfusion 15.27 12.77 6 135249 25466 110428578
Dysphonia 15.27 12.77 45 135210 75884 110378160
Nail bed tenderness 15.15 12.77 8 135247 376 110453668
Sedation complication 15.01 12.77 3 135252 19852 110434192
Stress 14.96 12.77 72 135183 105276 110348768
Emphysema 14.91 12.77 3 135252 19753 110434291
Pulmonary hypertension 14.89 12.77 28 135227 55192 110398852
Deafness 14.89 12.77 7 135248 26702 110427342
Clostridium difficile colitis 14.86 12.77 19 135236 43759 110410285
Skin necrosis 14.78 12.77 4 135251 21508 110432536
Tachycardia 14.72 12.77 192 135063 226453 110227591
Injection site extravasation 14.70 12.77 36 135219 10133 110443911
Duodenal stenosis 14.61 12.77 11 135244 966 110453078
Blood bilirubin increased 14.58 12.77 46 135209 75926 110378118
Posterior reversible encephalopathy syndrome 14.55 12.77 12 135243 33849 110420195
Liver function test abnormal 14.50 12.77 40 135215 68910 110385134
Paraesthesia oral 14.39 12.77 12 135243 33659 110420385
Akinesia 14.39 12.77 20 135235 3647 110450397
Breast cancer stage II 14.38 12.77 69 135186 27306 110426738
Blood alkaline phosphatase increased 14.30 12.77 42 135213 70893 110383151
Skin fissures 14.28 12.77 6 135249 24452 110429592
Face oedema 14.21 12.77 12 135243 33457 110420587
Pancreatitis acute 14.20 12.77 33 135222 60241 110393803
Gastrointestinal sounds abnormal 14.17 12.77 26 135229 5992 110448052
Gait disturbance 14.17 12.77 247 135008 277961 110176083
Glomerulonephritis chronic 14.16 12.77 7 135248 286 110453758
Arrhythmia 14.16 12.77 41 135214 69534 110384510
Impaired gastric emptying 14.16 12.77 42 135213 13233 110440811
Limbic encephalitis 14.13 12.77 10 135245 798 110453246
Lymphopenia 14.09 12.77 17 135238 40153 110413891
Radiation inflammation 13.93 12.77 11 135244 1037 110453007
Galactorrhoea 13.88 12.77 21 135234 4134 110449910
Neoplasm malignant 13.81 12.77 15 135240 37128 110416916
Vertigo 13.76 12.77 57 135198 86813 110367231
Schizophrenia 13.71 12.77 58 135197 21768 110432276
Dyspnoea exertional 13.70 12.77 73 135182 103987 110350057
Neurotoxicity 13.64 12.77 19 135236 42188 110411856
Erectile dysfunction 13.63 12.77 3 135252 18553 110435491
Somnolence 13.62 12.77 269 134986 297180 110156864
Peripheral coldness 13.61 12.77 3 135252 18537 110435507
Incontinence 13.55 12.77 48 135207 16587 110437457
Cold sweat 13.53 12.77 5 135250 22026 110432018
Impulse-control disorder 13.50 12.77 15 135240 2179 110451865
Feeling cold 13.46 12.77 13 135242 33974 110420070
Glycosylated haemoglobin increased 13.46 12.77 6 135249 23613 110430431
Oesophageal haemorrhage 13.45 12.77 14 135241 1889 110452155
Spinal osteoarthritis 13.41 12.77 4 135251 20179 110433865
Hypochromic anaemia 13.38 12.77 18 135237 3183 110450861
Left ventricular dysfunction 13.34 12.77 6 135249 23487 110430557
Blood glucose decreased 13.24 12.77 10 135245 29478 110424566
Oedema 13.22 12.77 179 135076 209797 110244247
Gastrointestinal pain 13.10 12.77 38 135217 11822 110442222
Blood uric acid increased 13.03 12.77 5 135250 21524 110432520
Seasonal allergy 12.94 12.77 4 135251 19718 110434326
Metastases to lung 12.92 12.77 6 135249 23057 110430987
Pemphigoid 12.92 12.77 4 135251 19703 110434341
Product use in unapproved indication 12.92 12.77 670 134585 446707 110007337
Mitral valve incompetence 12.91 12.77 13 135242 33316 110420728
Transplant rejection 12.85 12.77 7 135248 24560 110429484
Dialysis 12.83 12.77 4 135251 19615 110434429
Tuberculosis 12.80 12.77 3 135252 17771 110436273
Orthostatic hypotension 12.80 12.77 40 135215 66209 110387835
Pyrexia 12.78 12.77 936 134319 897329 109556715

FDA Adverse Event Reporting System (Pediatric)

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
Generalised tonic-clonic seizure 54.89 26.52 10 7 139 113797

Pharmacologic Action:

SourceCodeDescription
ATC A03FA03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
PROPULSIVES
Propulsives
MeSH PA D000932 Antiemetics
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018492 Dopamine Antagonists
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:55323 antidiarrhoeal drug
CHEBI has role CHEBI:55324 gastrointestinal drug

Related Drugs by ATC class:

A03FA Propulsives 9 drugs

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

DiseaseRelationSNOMED_IDDOID
Nausea and vomiting indication 16932000
Acute gastric ulcer with perforation contraindication 19850005
Torsades de pointes contraindication 31722008
Acute nephropathy contraindication 58574008
Acute gastric ulcer with hemorrhage contraindication 89748001
Prolonged QT interval contraindication 111975006
Gastrointestinal obstruction contraindication 126765001
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Congenital long QT syndrome contraindication 442917000
Pituitary Prolactinoma contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Horses Prevention of fescue toxicosis in periparturient mares Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Equidone Gel Dechra, Ltd. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.45 acidic
pKa2 10.04 acidic
pKa3 7.79 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.40 IUPHAR IUPHAR
Alpha-2A adrenergic receptor GPCR Ki 5.99 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.79 WOMBAT-PK
Multidrug resistance protein 1 Transporter WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 5.79 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.59 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 7.96 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.78 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.16 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR Ki 6.65 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 6.01 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 8.46 CHEMBL
Histamine H1 receptor GPCR Ki 6.81 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5.52 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 6.83 DRUG MATRIX
Cytochrome P450 2D6 Enzyme Ki 5.10 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 6.94 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 6.28 WOMBAT-PK
Kappa-type opioid receptor GPCR Ki 5.55 DRUG MATRIX
Calmodulin Cytosolic other WOMBAT-PK
Retinoic acid receptor RXR-alpha Nuclear hormone receptor Kd 5.06 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.10 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.64 CHEMBL
Mu-type opioid receptor GPCR Ki 5.77 DRUG MATRIX
Multidrug and toxin extrusion protein 2 Transporter IC50 4.83 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.06 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 6.55 CHEMBL
D(2) dopamine receptor GPCR Ki 9.28 CHEMBL
D(3) dopamine receptor GPCR Ki 7.93 CHEMBL

External reference:

IDSource
4025225 VUID
N0000171760 NUI
D01745 KEGG_DRUG
4025225 VANDF
C0013015 UMLSCUI
CHEBI:31515 CHEBI
A1IVJ PDB_CHEM_ID
CHEMBL219916 ChEMBL_ID
D004294 MESH_DESCRIPTOR_UI
DB01184 DRUGBANK_ID
3151 PUBCHEM_CID
965 IUPHAR_LIGAND_ID
4110 INN_ID
83898-65-1 SECONDARY_CAS_RN
5587267Z69 UNII
203007 RXNORM
003454 NDDF
005091 NDDF
32955006 SNOMEDCT_US
384972001 SNOMEDCT_US
387181004 SNOMEDCT_US
5587267Z69 INXIGHT DRUGS

Pharmaceutical products:

None