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

Stem definitionDrug idCAS RN
sulpiride derivatives 1782 364-62-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metoclopramide
  • metoclopramide hydrochloride
  • metochlopramide
  • methochlopramide
  • metoclopramide hydrochloride hydrate
  • metoclopramide monohydrochloride
  • metoclopramide HCl
  • AHR-3070-C
  • metaclopramide
A dopamine D2 antagonist that is used as an antiemetic.
  • Molecular weight: 299.80
  • Formula: C14H22ClN3O2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 67.59
  • ALOGS: -2.99
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P
30 mg R

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 33.36 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.20 mg/mL Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 20 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 76 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.60 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 7, 1979 FDA BAXTER HLTHCARE CORP

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
Rheumatoid arthritis 534.01 9.97 48 104290 382556 55805173
Drug ineffective 515.60 9.97 570 103768 918419 55269310
Vomiting 482.48 9.97 2010 102328 496218 55691511
Febrile neutropenia 413.83 9.97 719 103619 104826 56082903
Nausea 378.00 9.97 2560 101778 761618 55426111
Joint swelling 305.81 9.97 80 104258 289720 55898009
Drug intolerance 273.90 9.97 76 104262 264742 55922987
Contraindicated product administered 263.21 9.97 22 104316 186264 56001465
Arthropathy 244.87 9.97 39 104299 200236 55987493
Synovitis 239.48 9.97 15 104323 161290 56026439
Therapeutic product effect decreased 231.36 9.97 23 104315 169429 56018300
Hand deformity 229.04 9.97 4 104334 134488 56053241
Systemic lupus erythematosus 205.13 9.97 42 104296 180036 56007693
Glossodynia 202.21 9.97 23 104315 152435 56035294
Hypokalaemia 194.06 9.97 494 103844 93943 56093786
Swelling 179.97 9.97 111 104227 239660 55948069
Arthralgia 175.71 9.97 422 103916 501247 55686482
Neutropenic sepsis 165.77 9.97 171 104167 15014 56172715
Abdominal discomfort 164.34 9.97 163 104175 277111 55910618
Dystonia 161.78 9.97 154 104184 12267 56175462
Dehydration 144.25 9.97 630 103708 158195 56029534
Pericarditis 142.99 9.97 17 104321 108906 56078823
Wound 134.03 9.97 45 104293 138759 56048970
Weight increased 133.82 9.97 137 104201 229566 55958163
Pyrexia 129.71 9.97 1264 103074 417509 55770220
Abdominal pain 129.58 9.97 872 103466 257933 55929796
Sinusitis 129.13 9.97 106 104232 197475 55990254
Neutropenia 124.78 9.97 602 103736 157565 56030164
Mucosal inflammation 124.53 9.97 257 104081 42553 56145176
Serotonin syndrome 121.76 9.97 194 104144 26296 56161433
Hyponatraemia 120.70 9.97 440 103898 101699 56086030
Product use issue 118.87 9.97 102 104236 185939 56001790
Hypomagnesaemia 117.46 9.97 185 104153 24830 56162899
Discomfort 117.33 9.97 58 104280 141703 56046026
Tardive dyskinesia 117.01 9.97 106 104232 7925 56179804
Pain 116.38 9.97 737 103601 662447 55525282
Impaired gastric emptying 115.26 9.97 112 104226 9151 56178578
Treatment failure 114.35 9.97 89 104249 170303 56017426
Constipation 109.90 9.97 695 103643 201248 55986481
Thrombocytopenia 107.79 9.97 519 103819 135705 56052024
Nasopharyngitis 107.21 9.97 152 104186 220807 55966922
Extrapyramidal disorder 106.71 9.97 123 104215 12233 56175496
Duodenal ulcer perforation 105.58 9.97 5 104333 68337 56119392
Torsade de pointes 104.36 9.97 122 104216 12318 56175411
Peripheral swelling 102.86 9.97 173 104165 234553 55953176
Decreased appetite 102.17 9.97 726 103612 218505 55969224
Injection site pain 96.78 9.97 48 104290 117070 56070659
General physical health deterioration 96.78 9.97 592 103746 169418 56018311
Product dose omission issue 96.23 9.97 144 104194 204609 55983120
Psoriatic arthropathy 96.01 9.97 12 104326 73996 56113733
Hepatic enzyme increased 95.54 9.97 106 104232 171278 56016451
Musculoskeletal stiffness 93.14 9.97 91 104247 155916 56031813
Diarrhoea 92.53 9.97 1678 102660 636829 55550900
Atelectasis 92.32 9.97 144 104194 19164 56168565
Helicobacter infection 87.83 9.97 15 104323 73253 56114476
Anaemia 85.84 9.97 814 103524 266697 55921032
Toxic epidermal necrolysis 84.70 9.97 149 104189 21893 56165836
Malignant neoplasm progression 84.37 9.97 314 104024 73273 56114456
Pulmonary embolism 83.17 9.97 406 103932 106718 56081011
Electrocardiogram QT prolonged 78.34 9.97 251 104087 54337 56133392
Psoriasis 78.08 9.97 37 104301 92655 56095074
Phaeochromocytoma crisis 76.90 9.97 25 104313 208 56187521
Alopecia 76.35 9.97 283 104055 293175 55894554
Acute kidney injury 75.42 9.97 729 103609 240034 55947695
Completed suicide 73.23 9.97 84 104254 133749 56053980
Parkinsonism 69.28 9.97 87 104251 9459 56178270
Impaired healing 68.18 9.97 38 104300 86803 56100926
Computerised tomogram thorax abnormal 67.40 9.97 39 104299 1436 56186293
Cholecystitis chronic 64.71 9.97 85 104253 9663 56178066
Hypersensitivity 64.26 9.97 251 104087 256157 55931572
Sepsis 62.69 9.97 459 103879 139381 56048348
Gastritis 62.55 9.97 173 104165 34529 56153200
Neovascularisation 62.39 9.97 33 104305 1016 56186713
Folliculitis 60.15 9.97 14 104324 54965 56132764
Neutrophil count decreased 59.11 9.97 215 104123 49607 56138122
Therapeutic product effect incomplete 58.60 9.97 66 104272 105965 56081764
Irritable bowel syndrome 58.15 9.97 27 104311 68431 56119298
Arthritis 57.57 9.97 60 104278 99792 56087937
Ileus 57.48 9.97 97 104241 13785 56173944
Cytokine release syndrome 56.07 9.97 84 104254 10791 56176938
Cardiac arrest 55.82 9.97 311 104027 86003 56101726
Subileus 55.41 9.97 45 104293 2899 56184830
Hip arthroplasty 53.30 9.97 5 104333 38618 56149111
Knee arthroplasty 53.17 9.97 9 104329 44250 56143479
Hypoxia 52.86 9.97 219 104119 53678 56134051
Infusion related reaction 52.66 9.97 204 104134 208727 55979002
Aplastic anaemia 51.91 9.97 73 104265 8855 56178874
Phaeochromocytoma 51.84 9.97 23 104315 476 56187253
Restlessness 50.37 9.97 135 104203 26451 56161278
Oculogyric crisis 48.50 9.97 32 104306 1492 56186237
Colitis 47.56 9.97 178 104160 41633 56146096
Electrolyte imbalance 47.50 9.97 104 104234 17929 56169800
Stevens-Johnson syndrome 46.95 9.97 119 104219 22544 56165185
Leukopenia 46.80 9.97 257 104081 70683 56117046
Peripheral circulatory failure 46.73 9.97 26 104312 887 56186842
Pancytopenia 46.73 9.97 303 104035 88412 56099317
Contusion 46.37 9.97 106 104232 128324 56059405
Neuropathy peripheral 46.25 9.97 338 104000 102555 56085174
Septic shock 45.36 9.97 228 104110 60607 56127122
C-reactive protein abnormal 45.31 9.97 7 104331 36802 56150927
Renal ischaemia 45.10 9.97 22 104316 569 56187160
Injection site bruising 43.78 9.97 9 104329 38512 56149217
Left ventricular dysfunction 42.49 9.97 75 104263 11048 56176681
Condition aggravated 42.23 9.97 422 103916 344476 55843253
Tachycardia 42.11 9.97 338 104000 105538 56082191
Duodenal stenosis 42.10 9.97 20 104318 487 56187242
Encephalopathy 41.53 9.97 152 104186 35173 56152556
Pleural effusion 41.44 9.97 286 104052 85194 56102535
Blood cholesterol increased 40.29 9.97 45 104293 72534 56115195
Rash 40.04 9.97 658 103680 492389 55695340
Cholecystitis 40.02 9.97 85 104253 14350 56173379
Adverse drug reaction 40.00 9.97 37 104301 65095 56122634
Device expulsion 39.33 9.97 5 104333 30444 56157285
Ejection fraction decreased 38.85 9.97 102 104236 19739 56167990
Red blood cell sedimentation rate increased 38.75 9.97 10 104328 36613 56151116
Computerised tomogram thorax 38.59 9.97 15 104323 219 56187510
PCO2 increased 38.33 9.97 25 104313 1143 56186586
Dyskinesia 38.31 9.97 130 104208 28978 56158751
Adverse event 38.29 9.97 28 104310 55348 56132381
PO2 increased 38.14 9.97 22 104316 805 56186924
Osteoarthritis 37.16 9.97 57 104281 80239 56107490
Diabetes insipidus 37.15 9.97 33 104305 2404 56185325
Rash maculo-papular 37.08 9.97 128 104210 28779 56158950
Ventricular fibrillation 36.96 9.97 70 104268 10882 56176847
Injection site erythema 36.79 9.97 54 104284 77394 56110335
Aplasia 36.57 9.97 41 104297 3955 56183774
Dysphagia 36.13 9.97 268 104070 81679 56106050
Mouth ulceration 36.08 9.97 129 104209 29511 56158218
Malnutrition 36.00 9.97 80 104258 13928 56173801
Excessive eye blinking 35.77 9.97 23 104315 1026 56186703
Blood bicarbonate decreased 35.66 9.97 34 104304 2712 56185017
Hepatocellular injury 35.41 9.97 119 104219 26395 56161334
Cholestasis 35.24 9.97 120 104218 26793 56160936
Disease progression 35.12 9.97 323 104015 104850 56082879
Therapeutic response decreased 34.79 9.97 28 104310 52730 56134999
Gastroenteritis 34.78 9.97 112 104226 24300 56163429
Injection site reaction 34.20 9.97 29 104309 53218 56134511
Ascites 34.06 9.97 149 104189 37395 56150334
Peritonitis 33.48 9.97 85 104253 16117 56171612
Wrong technique in product usage process 33.46 9.97 35 104303 58133 56129596
Haematemesis 33.18 9.97 123 104215 28635 56159094
Hypotension 33.15 9.97 650 103688 249858 55937871
Mobility decreased 33.12 9.97 85 104253 98906 56088823
Abortion spontaneous 33.12 9.97 20 104318 43733 56143996
Injection site swelling 32.87 9.97 20 104318 43558 56144171
Blood pressure increased 32.68 9.97 148 104190 145028 56042701
Akathisia 32.61 9.97 58 104280 8594 56179135
Small intestinal obstruction 32.44 9.97 86 104252 16739 56170990
Drug interaction 31.83 9.97 556 103782 209199 55978530
Emotional distress 31.62 9.97 124 104214 29639 56158090
Intentional product use issue 31.58 9.97 88 104250 99645 56088084
Therapy non-responder 30.92 9.97 41 104297 61314 56126415
Hyperprolactinaemia 30.86 9.97 36 104302 3625 56184104
Blood magnesium decreased 30.73 9.97 68 104270 11806 56175923
Injection site pruritus 30.59 9.97 20 104318 41911 56145818
Urticaria 30.51 9.97 151 104187 144525 56043204
Asthma 29.76 9.97 108 104230 112662 56075067
Gamma-glutamyltransferase increased 29.63 9.97 125 104213 30880 56156849
Ill-defined disorder 29.52 9.97 51 104287 68492 56119237
Polydipsia 29.28 9.97 33 104305 3202 56184527
Antinuclear antibody negative 29.21 9.97 12 104326 204 56187525
Hypocalcaemia 29.09 9.97 118 104220 28642 56159087
Mixed liver injury 28.71 9.97 36 104302 3908 56183821
Urinary retention 28.25 9.97 115 104223 27959 56159770
Erysipelas 28.02 9.97 49 104289 7164 56180565
Paradoxical drug reaction 28.02 9.97 35 104303 3785 56183944
Respiratory syncytial virus infection 27.89 9.97 42 104296 5419 56182310
Accidental exposure to product 27.51 9.97 6 104332 24641 56163088
Heart rate decreased 27.23 9.97 21 104317 40406 56147323
Alveolitis 27.20 9.97 29 104309 2644 56185085
Immune effector cell-associated neurotoxicity syndrome 26.98 9.97 23 104315 1585 56186144
Coombs positive haemolytic anaemia 26.83 9.97 13 104325 331 56187398
Influenza 26.63 9.97 89 104249 95172 56092557
Abdominal pain upper 26.45 9.97 471 103867 177842 56009887
Loss of personal independence in daily activities 26.36 9.97 71 104267 81298 56106431
Pancreatitis 26.24 9.97 158 104180 44922 56142807
Oesophagitis 26.24 9.97 71 104267 13986 56173743
Maternal exposure during pregnancy 26.14 9.97 225 104113 189328 55998401
Pain in extremity 26.09 9.97 391 103947 297040 55890689
Urosepsis 25.94 9.97 79 104259 16637 56171092
Blood pressure fluctuation 25.90 9.97 22 104316 40338 56147391
Infusion site streaking 25.64 9.97 14 104324 460 56187269
Respiratory dyskinesia 25.64 9.97 7 104331 29 56187700
Skin candida 25.56 9.97 21 104317 1375 56186354
Respiratory failure 25.48 9.97 279 104059 94783 56092946
Cholelithiasis 25.37 9.97 142 104196 39322 56148407
Dyspnoea 25.31 9.97 1341 102997 591236 55596493
Blood pH decreased 25.28 9.97 27 104311 2467 56185262
Onychalgia 25.03 9.97 17 104321 832 56186897
Secondary adrenocortical insufficiency 25.01 9.97 20 104318 1260 56186469
Nail infection 24.78 9.97 26 104312 2327 56185402
Multiple organ dysfunction syndrome 24.65 9.97 175 104163 52595 56135134
Neuroleptic malignant syndrome 24.54 9.97 61 104277 11417 56176312
Fibromyalgia 24.19 9.97 46 104292 59557 56128172
Cataract 24.08 9.97 36 104302 51211 56136518
Deep vein thrombosis 23.99 9.97 233 104105 76744 56110985
Hyponatraemic seizure 23.95 9.97 13 104325 422 56187307
Duodenal perforation 23.56 9.97 16 104322 783 56186946
Febrile bone marrow aplasia 23.42 9.97 43 104295 6529 56181200
Pituitary tumour benign 23.40 9.97 23 104315 1905 56185824
Gastritis haemorrhagic 23.21 9.97 20 104318 1399 56186330
Foetal death 23.16 9.97 50 104288 8537 56179192
Pancreatitis acute 23.01 9.97 100 104238 25024 56162705
Gelastic seizure 23.01 9.97 5 104333 5 56187724
Infection 22.81 9.97 249 104089 199957 55987772
Multiple drug therapy 22.78 9.97 27 104311 2765 56184964
Disturbance in social behaviour 22.52 9.97 28 104310 3013 56184716
Agitation 22.32 9.97 179 104159 55857 56131872
Herpes simplex reactivation 22.26 9.97 13 104325 487 56187242
Enterocolitis 22.26 9.97 44 104294 7060 56180669
Hypophagia 22.06 9.97 109 104229 28767 56158962
Pneumonitis 21.92 9.97 116 104222 31448 56156281
Dyspepsia 21.92 9.97 244 104094 83227 56104502
Brain oedema 21.80 9.97 64 104274 13207 56174522
Carcinoid tumour of the stomach 21.80 9.97 9 104329 155 56187574
Hypergastrinaemia 21.70 9.97 8 104330 100 56187629
Seizure 21.67 9.97 339 103999 124780 56062949
Enterochromaffin cell hyperplasia 21.66 9.97 7 104331 57 56187672
Aquagenic pruritus 21.58 9.97 6 104332 27 56187702
Pneumonia 21.07 9.97 939 103399 406159 55781570
Fatigue 20.91 9.97 1223 103115 787329 55400400
Lethargy 20.86 9.97 165 104173 51276 56136453
No adverse event 20.79 9.97 22 104316 36352 56151377
Delusional disorder, persecutory type 20.70 9.97 9 104329 177 56187552
Long QT syndrome 20.69 9.97 27 104311 3049 56184680
Malignant polyp 20.52 9.97 9 104329 181 56187548
Joint injury 20.45 9.97 11 104327 25643 56162086
Electrocardiogram T wave inversion 20.43 9.97 28 104310 3315 56184414
Radiation pneumonitis 20.42 9.97 19 104319 1470 56186259
Grip strength decreased 20.21 9.97 3 104335 16253 56171476
Intestinal perforation 20.10 9.97 55 104283 10904 56176825
Inappropriate schedule of product administration 19.98 9.97 83 104255 83304 56104425
Blood alkaline phosphatase increased 19.87 9.97 132 104206 38813 56148916
Obstruction gastric 19.75 9.97 15 104323 876 56186853
Thirst 19.69 9.97 55 104283 11035 56176694
Thymus disorder 19.61 9.97 10 104328 285 56187444
Clonus 19.36 9.97 31 104307 4218 56183511
Torticollis 19.31 9.97 20 104318 1763 56185966
Plantar erythema 19.14 9.97 9 104329 214 56187515
Eructation 19.12 9.97 43 104295 7545 56180184
Anxiety disorder 18.97 9.97 29 104309 3791 56183938
Fall 18.96 9.97 511 103827 356999 55830730
Acute interstitial pneumonitis 18.86 9.97 13 104325 652 56187077
Oxygen saturation abnormal 18.85 9.97 25 104313 2869 56184860
Acute abdomen 18.65 9.97 18 104320 1458 56186271
Hepatic failure 18.63 9.97 116 104222 33370 56154359
Nervous system disorder 18.46 9.97 71 104267 16818 56170911
Catheter site bruise 18.44 9.97 10 104328 324 56187405
Aortic rupture 18.34 9.97 7 104331 97 56187632
Hypochloraemia 18.18 9.97 19 104319 1693 56186036
Bone erosion 18.08 9.97 3 104335 14971 56172758
Blood pressure systolic increased 17.94 9.97 30 104308 40806 56146923
Sinus disorder 17.88 9.97 8 104330 20726 56167003
Hypoglycaemic seizure 17.70 9.97 11 104327 462 56187267
Vitamin B12 decreased 17.66 9.97 25 104313 3050 56184679
Haemorrhoids 17.43 9.97 79 104259 20127 56167602
Hypoalbuminaemia 17.30 9.97 51 104287 10548 56177181
Herpes zoster 17.28 9.97 77 104261 75812 56111917
Premature baby 17.25 9.97 76 104262 19129 56168600
COVID-19 17.19 9.97 76 104262 74982 56112747
Gait disturbance 17.09 9.97 207 104131 163114 56024615
Presyncope 17.07 9.97 93 104245 25489 56162240
Inflammation 17.02 9.97 68 104270 69003 56118726
Nasal congestion 16.92 9.97 51 104287 56319 56131410
Intestinal obstruction 16.90 9.97 99 104239 27872 56159857
Intentional overdose 16.82 9.97 67 104271 68050 56119679
Dysuria 16.81 9.97 106 104232 30623 56157106
Gallbladder injury 16.70 9.97 16 104322 1284 56186445
Staring 16.58 9.97 17 104321 1481 56186248
Joint stiffness 16.53 9.97 25 104313 35400 56152329
Hypoaesthesia 16.50 9.97 175 104163 141316 56046413
Cystitis noninfective 16.48 9.97 14 104324 960 56186769
Biliary dyskinesia 16.47 9.97 22 104316 2541 56185188
Sleep disorder 16.43 9.97 67 104271 67596 56120133
Prescribed underdose 16.20 9.97 9 104329 20608 56167121
Neuroglycopenia 16.20 9.97 10 104328 415 56187314
Hypophosphataemia 16.14 9.97 47 104291 9655 56178074
Diabetic gastroparesis 16.12 9.97 8 104330 215 56187514
Drug resistance 16.10 9.97 9 104329 20533 56167196
Renal failure 16.06 9.97 291 104047 110209 56077520
Haemangioma of skin 15.94 9.97 9 104329 316 56187413
Headache 15.87 9.97 861 103477 558183 55629546
Gastrointestinal stoma complication 15.87 9.97 17 104321 1558 56186171
Hiccups 15.85 9.97 19 104319 1969 56185760
Blood bilirubin increased 15.80 9.97 111 104227 33243 56154486
Sciatica 15.70 9.97 15 104323 25995 56161734
Ileus paralytic 15.65 9.97 28 104310 4167 56183562
Injection site haemorrhage 15.64 9.97 11 104327 22190 56165539
Gastric polyps 15.49 9.97 24 104314 3174 56184555
Cancer pain 15.30 9.97 23 104315 2963 56184766
Bronchitis 15.17 9.97 134 104204 112177 56075552
Blister 15.11 9.97 129 104209 108758 56078971
Generalised tonic-clonic seizure 15.02 9.97 95 104243 27471 56160258
Anuria 15.01 9.97 52 104286 11708 56176021
Granulocytopenia neonatal 14.76 9.97 4 104334 16 56187713
Blood creatinine increased 14.54 9.97 219 104119 79972 56107757
Aspiration 14.49 9.97 45 104293 9576 56178153
Bone density decreased 14.46 9.97 3 104335 12757 56174972
Pruritus 14.42 9.97 462 103876 316161 55871568
Aspartate aminotransferase increased 14.37 9.97 224 104114 82378 56105351
Palmar-plantar erythrodysaesthesia syndrome 14.34 9.97 77 104261 20988 56166741
Vascular encephalopathy 14.34 9.97 9 104329 385 56187344
Immunodeficiency 14.30 9.97 6 104332 16151 56171578
Hospitalisation 14.28 9.97 81 104257 74919 56112810
Bezoar 14.20 9.97 15 104323 1353 56186376
Rectal haemorrhage 14.16 9.97 128 104210 41339 56146390
Vagus nerve disorder 14.09 9.97 6 104332 112 56187617
Foot deformity 14.08 9.97 14 104324 23811 56163918
Joint effusion 14.07 9.97 5 104333 14893 56172836
Hyperkalaemia 13.95 9.97 150 104188 50715 56137014
Bradykinesia 13.94 9.97 29 104309 4825 56182904
Meconium ileus 13.80 9.97 3 104335 3 56187726
Alanine aminotransferase increased 13.73 9.97 247 104091 93415 56094314
Hydronephrosis 13.71 9.97 43 104295 9199 56178530
Platelet count decreased 13.69 9.97 275 104063 106108 56081621
Leukoencephalopathy 13.66 9.97 26 104312 4056 56183673
Type 2 diabetes mellitus 13.64 9.97 43 104295 46819 56140910
Leukocytosis 13.60 9.97 83 104255 23708 56164021
Cachexia 13.58 9.97 29 104309 4913 56182816
Naevus haemorrhage 13.58 9.97 6 104332 123 56187606
Gastrointestinal submucosal tumour 13.58 9.97 4 104334 23 56187706
Muscle contracture 13.56 9.97 14 104324 1230 56186499
Myoclonus 13.53 9.97 60 104278 15143 56172586
Throat irritation 13.46 9.97 25 104313 32658 56155071
Neuroendocrine tumour 13.42 9.97 11 104327 718 56187011
Bursitis 13.32 9.97 19 104319 27563 56160166
Dermatitis exfoliative 13.32 9.97 30 104308 5269 56182460
Paranoia 13.28 9.97 47 104291 10697 56177032
Product storage error 13.25 9.97 4 104334 13209 56174520
Wheezing 13.24 9.97 83 104255 74943 56112786
Hypoglycaemia 13.24 9.97 160 104178 55655 56132074
Granulomatous liver disease 13.22 9.97 11 104327 733 56186996
Economic problem 13.21 9.97 17 104321 1894 56185835
Multiple sclerosis relapse 13.21 9.97 41 104297 44862 56142867
Neoplasm progression 13.15 9.97 103 104235 31913 56155816
Tumour pain 13.13 9.97 14 104324 1277 56186452
Drug dependence 13.13 9.97 79 104259 22454 56165275
Blood pressure diastolic decreased 13.06 9.97 10 104328 19313 56168416
Methaemoglobinaemia 13.05 9.97 18 104320 2144 56185585
Patent ductus arteriosus 13.02 9.97 25 104313 3926 56183803
Flail chest 12.99 9.97 5 104333 71 56187658
Hyperglycaemia 12.99 9.97 118 104220 38163 56149566
Catatonia 12.96 9.97 25 104313 3939 56183790
Muscle twitching 12.90 9.97 62 104276 16180 56171549
Hyperthyroidism 12.89 9.97 54 104284 13298 56174431
Illness 12.84 9.97 28 104310 34483 56153246
Myalgia 12.81 9.97 170 104168 131855 56055874
Thoracic operation 12.79 9.97 6 104332 142 56187587
Premature delivery 12.78 9.97 90 104248 26970 56160759
Carpal tunnel syndrome 12.77 9.97 9 104329 18135 56169594
Abdominal tenderness 12.76 9.97 37 104301 7584 56180145
Joint range of motion decreased 12.73 9.97 17 104321 25348 56162381
Amylase increased 12.68 9.97 31 104307 5740 56181989
Drug tolerance increased 12.68 9.97 7 104331 235 56187494
Foot fracture 12.68 9.97 13 104325 21796 56165933
Muscle spasticity 12.66 9.97 11 104327 19949 56167780
Escherichia test positive 12.65 9.97 18 104320 2207 56185522
Visual impairment 12.63 9.97 83 104255 74119 56113610
Electrocardiogram change 12.62 9.97 10 104328 622 56187107
Feeling abnormal 12.61 9.97 173 104165 133429 56054300
Lower respiratory tract infection 12.58 9.97 144 104194 114650 56073079
Gaze palsy 12.57 9.97 14 104324 1341 56186388
Basal cell carcinoma 12.56 9.97 17 104321 25204 56162525
Lung perforation 12.50 9.97 5 104333 79 56187650
Drug clearance decreased 12.49 9.97 14 104324 1350 56186379
Chronic sinusitis 12.45 9.97 39 104299 8339 56179390
Pulmonary air leakage 12.44 9.97 4 104334 32 56187697
Hyperhidrosis 12.37 9.97 244 104094 93844 56093885
Stridor 12.30 9.97 22 104316 3273 56184456
Nephritis allergic 12.27 9.97 6 104332 156 56187573
Premature labour 12.21 9.97 49 104289 11833 56175896
Oesophageal ulcer 12.21 9.97 25 104313 4114 56183615
Non-cardiac chest pain 12.18 9.97 31 104307 5885 56181844
Circulatory collapse 12.16 9.97 73 104265 20730 56166999
Antiphospholipid syndrome 12.12 9.97 15 104323 1606 56186123
Lung infiltration 12.06 9.97 54 104284 13684 56174045
Inappropriate antidiuretic hormone secretion 12.02 9.97 54 104284 13702 56174027
Ear infection 11.97 9.97 25 104313 31270 56156459
Porphyria 11.90 9.97 6 104332 167 56187562
Peripheral sensory neuropathy 11.86 9.97 34 104304 6922 56180807
Anaphylactic reaction 11.84 9.97 164 104174 58831 56128898
Muscle rigidity 11.77 9.97 45 104293 10626 56177103
Gastrointestinal necrosis 11.74 9.97 19 104319 2607 56185122
Chronic fatigue syndrome 11.63 9.97 12 104326 1053 56186676
Musculoskeletal disorder 11.61 9.97 11 104327 19136 56168593
Product quality issue 11.60 9.97 26 104312 31710 56156019
Face oedema 11.59 9.97 66 104272 18386 56169343
Vascular pain 11.57 9.97 10 104328 702 56187027
Diabetes mellitus inadequate control 11.57 9.97 54 104284 13926 56173803
Blood cholesterol decreased 11.55 9.97 11 104327 876 56186853
Device dislocation 11.50 9.97 15 104323 22591 56165138
Lip erosion 11.48 9.97 11 104327 883 56186846
Restless arm syndrome 11.39 9.97 4 104334 43 56187686
Device malfunction 11.36 9.97 8 104330 16128 56171601
Pregnancy 11.33 9.97 28 104310 33005 56154724
Mucosal erosion 11.23 9.97 13 104325 1298 56186431
Reflux gastritis 11.22 9.97 12 104326 1098 56186631
Hyperpyrexia 11.17 9.97 21 104317 3247 56184482
Abdominal distension 11.12 9.97 204 104134 77422 56110307
Prolactin-producing pituitary tumour 11.12 9.97 5 104333 107 56187622
Urea urine increased 11.07 9.97 3 104335 12 56187717
Abdominal mass 11.07 9.97 19 104319 2736 56184993
Peptic ulcer 11.03 9.97 24 104314 4120 56183609
Transfusion 11.02 9.97 52 104286 13468 56174261
Leukostasis syndrome 11.00 9.97 4 104334 48 56187681
Parkinson's disease 10.97 9.97 13 104325 1331 56186398
Urinary tract infection 10.96 9.97 548 103790 239965 55947764
Memory impairment 10.94 9.97 105 104233 86452 56101277
Tracheal injury 10.93 9.97 4 104334 49 56187680
Myocardial reperfusion injury 10.93 9.97 4 104334 49 56187680
Confusional state 10.92 9.97 481 103857 207674 55980055
Joint dislocation 10.87 9.97 8 104330 15765 56171964
Pneumoperitoneum 10.84 9.97 13 104325 1348 56186381
Sinus tachycardia 10.81 9.97 75 104263 22369 56165360
Suicide attempt 10.72 9.97 63 104275 57773 56129956
Epilepsy congenital 10.70 9.97 3 104335 14 56187715
Non-small cell lung cancer 10.68 9.97 22 104316 3636 56184093
Rhinorrhoea 10.64 9.97 62 104276 56975 56130754
Opisthotonus 10.64 9.97 7 104331 325 56187404
Respiratory tract congestion 10.63 9.97 8 104330 15583 56172146
Sinus arrhythmia 10.61 9.97 13 104325 1378 56186351
Coeliac disease 10.60 9.97 3 104335 10336 56177393
Starvation 10.59 9.97 6 104332 212 56187517
Terminal ileitis 10.59 9.97 9 104329 618 56187111
Head titubation 10.56 9.97 10 104328 791 56186938
Peritoneal perforation 10.55 9.97 5 104333 121 56187608
Intercepted product administration error 10.55 9.97 5 104333 121 56187608
Cholecystitis acute 10.54 9.97 34 104304 7382 56180347
Dementia 10.54 9.97 61 104277 17097 56170632
Urinary tract infection enterococcal 10.49 9.97 18 104320 2591 56185138
Foetal malpresentation 10.48 9.97 5 104333 123 56187606
Labelled drug-drug interaction issue 10.45 9.97 10 104328 801 56186928
Adrenal insufficiency 10.43 9.97 57 104281 15640 56172089
Urinary tract obstruction 10.41 9.97 15 104323 1860 56185869
Vocal cord paresis 10.33 9.97 5 104333 127 56187602
Apallic syndrome 10.33 9.97 9 104329 639 56187090
Nephrocalcinosis 10.31 9.97 11 104327 1004 56186725
Subacute combined cord degeneration 10.29 9.97 6 104332 224 56187505
Syncope 10.27 9.97 268 104070 107931 56079798
Ultrasound abdomen abnormal 10.25 9.97 4 104334 59 56187670
Therapy cessation 10.24 9.97 22 104316 27242 56160487
Peripheral venous disease 10.20 9.97 3 104335 10076 56177653
Off label use 10.19 9.97 890 103448 555290 55632439
PCO2 decreased 10.19 9.97 12 104326 1221 56186508
Motion sickness 10.17 9.97 10 104328 829 56186900
Malignant pleural effusion 10.16 9.97 17 104321 2399 56185330
Catheter site related reaction 10.16 9.97 10 104328 830 56186899
Bundle branch block 10.14 9.97 10 104328 832 56186897
Metastases to central nervous system 10.13 9.97 47 104291 12089 56175640
Tooth disorder 10.12 9.97 20 104318 25533 56162196
Road traffic accident 10.11 9.97 23 104315 27904 56159825
Gastrointestinal mucosal exfoliation 10.09 9.97 5 104333 134 56187595
Supraventricular tachycardia 10.03 9.97 50 104288 13241 56174488

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
Febrile neutropenia 405.63 10.34 802 61908 121047 31513587
Vomiting 286.40 10.34 1032 61678 222941 31411693
Nausea 245.07 10.34 1228 61482 306719 31327915
Drug ineffective 217.88 10.34 279 62431 395294 31239340
General physical health deterioration 126.38 10.34 501 62209 112934 31521700
Dehydration 106.35 10.34 492 62218 118619 31516015
Decreased appetite 89.24 10.34 563 62147 152654 31481980
Pyrexia 89.22 10.34 955 61755 302885 31331749
Drug abuse 85.99 10.34 33 62677 87725 31546909
Product dose omission issue 78.05 10.34 57 62653 105529 31529105
Dystonia 73.77 10.34 96 62614 10129 31624505
Neutropenic sepsis 72.39 10.34 105 62605 12274 31622360
Constipation 72.38 10.34 456 62254 123535 31511099
Impaired gastric emptying 71.75 10.34 56 62654 3188 31631446
Serotonin syndrome 66.35 10.34 127 62583 18646 31615988
Aplastic anaemia 64.21 10.34 85 62625 9118 31625516
Neutropenia 57.44 10.34 474 62236 139890 31494744
Drug intolerance 55.39 10.34 17 62693 52016 31582618
Psoriasis 52.06 10.34 14 62696 46705 31587929
Malignant neoplasm progression 50.77 10.34 298 62412 78700 31555934
Rheumatoid arthritis 48.46 10.34 17 62693 47792 31586842
Thrombocytopenia 47.08 10.34 460 62250 142287 31492347
Therapeutic product effect incomplete 47.00 10.34 14 62696 43682 31590952
Completed suicide 46.56 10.34 68 62642 91446 31543188
Pneumonitis 43.86 10.34 147 62563 30505 31604129
Meconium abnormal 40.25 10.34 12 62698 67 31634567
Peripheral swelling 40.14 10.34 45 62665 67820 31566814
Therapeutic product effect decreased 38.13 10.34 8 62702 31614 31603020
Off label use 37.47 10.34 474 62236 346800 31287834
Death 37.12 10.34 497 62213 360072 31274562
Hypokalaemia 36.96 10.34 206 62504 53368 31581266
Alveolar lung disease 36.64 10.34 17 62693 366 31634268
Abdominal pain 35.55 10.34 443 62267 145509 31489125
Treatment failure 34.25 10.34 19 62691 40773 31593861
Mucosal inflammation 34.25 10.34 147 62563 34280 31600354
Arthralgia 33.97 10.34 169 62541 151255 31483379
Genital erythema 33.51 10.34 13 62697 176 31634458
Pulmonary interstitial emphysema syndrome 33.20 10.34 17 62693 457 31634177
Sepsis 32.76 10.34 451 62259 151478 31483156
Neuroleptic malignant syndrome 32.68 10.34 90 62620 16779 31617855
Oesophagitis 32.19 10.34 74 62636 12342 31622292
Foetal exposure during pregnancy 30.78 10.34 161 62549 40715 31593919
Hiccups 30.59 10.34 61 62649 9226 31625408
Hyponatraemia 30.55 10.34 250 62460 73549 31561085
Pneumonia 29.62 10.34 870 61840 334442 31300192
Hypophagia 29.16 10.34 103 62607 21939 31612695
Diarrhoea 29.16 10.34 907 61803 351502 31283132
Mesothelioma 29.06 10.34 15 62695 410 31634224
Blood pressure fluctuation 29.01 10.34 5 62705 22731 31611903
Toxic epidermal necrolysis 28.25 10.34 94 62616 19430 31615204
Weight increased 28.15 10.34 78 62632 82869 31551765
Laparotomy 27.97 10.34 13 62697 281 31634353
Premature baby 27.96 10.34 89 62621 17977 31616657
Anaemia 27.78 10.34 584 62126 212938 31421696
Necrotising enterocolitis neonatal 27.28 10.34 12 62698 227 31634407
Extrapyramidal disorder 27.08 10.34 67 62643 11711 31622923
Joint swelling 26.87 10.34 40 62670 53391 31581243
Toxicity to various agents 26.75 10.34 230 62480 181257 31453377
Ileus 26.53 10.34 78 62632 15091 31619543
Rash maculo-papular 26.49 10.34 111 62599 25608 31609026
Malnutrition 26.03 10.34 65 62645 11428 31623206
Condition aggravated 25.92 10.34 204 62506 163805 31470829
Long QT syndrome 25.09 10.34 27 62683 2329 31632305
Leukopenia 24.52 10.34 197 62513 57631 31577003
Drug resistance 24.35 10.34 8 62702 23445 31611189
Hepatic failure 24.07 10.34 128 62582 32574 31602060
Haematopoietic stem cell mobilisation 23.98 10.34 10 62700 165 31634469
Intentional product misuse 23.73 10.34 24 62686 37927 31596707
Pleural effusion 23.47 10.34 239 62471 74681 31559953
Hyperthermia malignant 23.38 10.34 24 62686 1960 31632674
Asthma 23.33 10.34 30 62680 42581 31592053
Intentional overdose 22.80 10.34 29 62681 41360 31593274
Gastrointestinal hypermotility 22.55 10.34 9 62701 132 31634502
Electrocardiogram QT prolonged 22.28 10.34 140 62570 37847 31596787
Psoriatic arthropathy 22.06 10.34 6 62704 19877 31614757
Intentional product use issue 21.96 10.34 40 62670 49307 31585327
Impetigo 21.83 10.34 17 62693 964 31633670
Vascular access site occlusion 21.66 10.34 7 62703 53 31634581
Congenital pneumonia 21.64 10.34 8 62702 94 31634540
Pseudomonal sepsis 21.50 10.34 29 62681 3167 31631467
Enteritis 21.45 10.34 45 62665 7054 31627580
Cytokine release syndrome 21.36 10.34 77 62633 16565 31618069
Toxic encephalopathy 21.20 10.34 36 62674 4814 31629820
Cardiac failure congestive 21.17 10.34 83 62627 79304 31555330
Conjunctival irritation 21.13 10.34 8 62702 101 31634533
Product use issue 21.07 10.34 51 62659 56708 31577926
Colitis 20.57 10.34 126 62584 33761 31600873
Dysphagia 20.52 10.34 189 62521 57487 31577147
Urticaria 20.33 10.34 53 62657 57464 31577170
Vocal cord inflammation 20.31 10.34 7 62703 66 31634568
Delirium 20.30 10.34 146 62564 41275 31593359
Heart sounds abnormal 19.87 10.34 15 62695 812 31633822
Post concussion syndrome 19.76 10.34 8 62702 122 31634512
Lymphoid tissue hypoplasia 19.52 10.34 9 62701 191 31634443
Thymus hypoplasia 19.52 10.34 9 62701 191 31634443
Talipes 19.39 10.34 21 62689 1825 31632809
Erectile dysfunction 19.21 10.34 7 62703 19228 31615406
Hepatocellular injury 19.17 10.34 89 62621 21455 31613179
Arthropathy 19.06 10.34 12 62698 24039 31610595
Feeling abnormal 19.04 10.34 54 62656 56948 31577686
Wheezing 19.02 10.34 26 62684 35960 31598674
Wrong technique in product usage process 18.75 10.34 23 62687 33320 31601314
Heart rate decreased 18.69 10.34 17 62693 28249 31606385
Electrocardiogram QT shortened 18.50 10.34 8 62702 145 31634489
Stress cardiomyopathy 18.17 10.34 20 62690 1770 31632864
Jaundice 18.00 10.34 112 62598 30175 31604459
Superior vena cava occlusion 17.83 10.34 7 62703 98 31634536
Tardive dyskinesia 17.69 10.34 36 62674 5523 31629111
Myocardial infarction 17.50 10.34 142 62568 113312 31521322
Non-small cell lung cancer 17.31 10.34 30 62680 4079 31630555
Laryngeal cancer metastatic 17.19 10.34 6 62704 59 31634575
Lower respiratory tract infection 17.14 10.34 105 62605 28132 31606502
Device dislocation 17.05 10.34 34 62676 5142 31629492
Failure to thrive 16.96 10.34 44 62666 7918 31626716
Hospitalisation 16.77 10.34 47 62663 49760 31584874
Pulmonary embolism 16.61 10.34 240 62470 81406 31553228
Cytokine storm 16.36 10.34 12 62698 622 31634012
Hyperbilirubinaemia 16.24 10.34 68 62642 15682 31618952
Septic shock 16.15 10.34 201 62509 65957 31568677
Chemotherapeutic drug level increased 16.04 10.34 8 62702 203 31634431
Ileus paralytic 16.01 10.34 34 62676 5374 31629260
Chills 15.90 10.34 220 62490 73930 31560704
Suicide attempt 15.86 10.34 31 62679 37217 31597417
Spleen congestion 15.82 10.34 9 62701 300 31634334
Blood alkaline phosphatase increased 15.71 10.34 106 62604 29347 31605287
Bacterial tracheitis 15.68 10.34 3 62707 0 31634634
Tumour lysis syndrome 15.53 10.34 66 62644 15319 31619315
Subileus 15.53 10.34 24 62686 2966 31631668
Disturbance in attention 15.45 10.34 13 62697 22437 31612197
Diffuse alveolar damage 15.44 10.34 20 62690 2099 31632535
Musculoskeletal stiffness 15.44 10.34 37 62673 41288 31593346
Gait disturbance 15.41 10.34 90 62620 77405 31557229
Eczema asteatotic 15.16 10.34 8 62702 229 31634405
Abdominal compartment syndrome 15.15 10.34 13 62697 846 31633788
Gastrointestinal motility disorder 15.14 10.34 21 62689 2355 31632279
Synovitis 15.03 10.34 3 62707 12280 31622354
Neutrophil count decreased 15.00 10.34 149 62561 46245 31588389
Tumour pain 14.89 10.34 14 62696 1027 31633607
Ascites 14.89 10.34 135 62575 40878 31593756
Fall 14.82 10.34 269 62441 185820 31448814
Acute abdomen 14.72 10.34 18 62692 1783 31632851
Injection site pain 14.60 10.34 29 62681 34605 31600029
Blood creatine phosphokinase increased 14.58 10.34 39 62671 41935 31592699
Loss of personal independence in daily activities 14.39 10.34 21 62689 28267 31606367
Stress 14.24 10.34 17 62693 24924 31609710
Seborrhoeic dermatitis 14.19 10.34 16 62694 1454 31633180
Hypoalbuminaemia 14.13 10.34 51 62659 10977 31623657
Dyschezia 14.07 10.34 15 62695 1280 31633354
Blood pressure increased 14.02 10.34 96 62614 79537 31555097
Platelet count decreased 13.98 10.34 301 62409 110134 31524500
Neutropenic infection 13.79 10.34 15 62695 1310 31633324
Symmetrical drug-related intertriginous and flexural exanthema 13.76 10.34 8 62702 278 31634356
Phaeochromocytoma crisis 13.66 10.34 5 62705 57 31634577
Bladder cancer 13.66 10.34 6 62704 14719 31619915
Renal vasculitis 13.57 10.34 7 62703 191 31634443
Product use in unapproved indication 13.57 10.34 128 62582 99043 31535591
Swelling 13.52 10.34 34 62676 37324 31597310
Diabetic gastroparesis 13.52 10.34 6 62704 116 31634518
Immune-mediated hepatitis 13.52 10.34 17 62693 1733 31632901
Dyskinesia 13.49 10.34 79 62631 20831 31613803
Performance status decreased 13.41 10.34 26 62684 3852 31630782
Cachexia 13.30 10.34 36 62674 6643 31627991
Maternal drugs affecting foetus 13.29 10.34 26 62684 3877 31630757
Headache 13.24 10.34 270 62440 183382 31451252
Pulmonary sepsis 13.14 10.34 18 62692 1994 31632640
Retching 13.07 10.34 34 62676 6127 31628507
Body temperature increased 13.00 10.34 62 62648 15111 31619523
Blood bilirubin increased 12.93 10.34 116 62594 35020 31599614
Therapy non-responder 12.85 10.34 30 62680 33781 31600853
Device related infection 12.82 10.34 65 62645 16234 31618400
Venous angioma of brain 12.65 10.34 4 62706 28 31634606
Klebsiella bacteraemia 12.45 10.34 14 62696 1268 31633366
Restlessness 12.42 10.34 84 62626 23277 31611357
Acute kidney injury 12.40 10.34 674 62036 279040 31355594
Blood aluminium increased 12.40 10.34 3 62707 6 31634628
COVID-19 12.37 10.34 61 62649 54760 31579874
Pericardial effusion 12.14 10.34 81 62629 22342 31612292
Intestinal ischaemia 12.10 10.34 36 62674 7009 31627625
Cholangitis 12.04 10.34 39 62671 7947 31626687
Ventricular septal defect 11.93 10.34 24 62686 3653 31630981
Underdose 11.91 10.34 5 62705 12602 31622032
Sopor 11.89 10.34 4 62706 11548 31623086
Hygroma colli 11.87 10.34 4 62706 35 31634599
Systemic infection 11.77 10.34 23 62687 3426 31631208
Aortitis 11.73 10.34 8 62702 369 31634265
Prostate cancer 11.56 10.34 37 62673 37564 31597070
Product quality issue 11.50 10.34 9 62701 16102 31618532
Disseminated aspergillosis 11.46 10.34 9 62701 517 31634117
Disease recurrence 11.44 10.34 12 62698 18649 31615985
Scan abnormal 11.40 10.34 4 62706 40 31634594
Herpes zoster reactivation 11.33 10.34 7 62703 272 31634362
Tumour perforation 11.22 10.34 7 62703 277 31634357
Kounis syndrome 11.21 10.34 17 62693 2067 31632567
Spinal cord injury thoracic 11.21 10.34 5 62705 98 31634536
Restrictive cardiomyopathy 11.02 10.34 10 62700 701 31633933
Clostridium difficile colitis 11.02 10.34 56 62654 14000 31620634
Gastrointestinal malformation 10.98 10.34 4 62706 45 31634589
Eastern Cooperative Oncology Group performance status worsened 10.96 10.34 11 62699 875 31633759
Cholestasis 10.94 10.34 86 62624 24989 31609645
Type III immune complex mediated reaction 10.93 10.34 7 62703 290 31634344
Psychotic disorder 10.90 10.34 17 62693 22276 31612358
Obstruction gastric 10.89 10.34 11 62699 881 31633753
Oesophageal hypomotility 10.88 10.34 3 62707 12 31634622
Congenital nasal septum deviation 10.88 10.34 3 62707 12 31634622
Lenticulostriatal vasculopathy 10.88 10.34 3 62707 12 31634622
Aphthous ulcer 10.87 10.34 26 62684 4448 31630186
Gastritis 10.80 10.34 73 62637 20219 31614415
Nasopharyngitis 10.76 10.34 77 62633 63168 31571466
Angina pectoris 10.71 10.34 27 62683 29614 31605020
Skeletal dysplasia 10.68 10.34 5 62705 110 31634524
Road traffic accident 10.65 10.34 10 62700 16371 31618263
Hypoaesthesia 10.64 10.34 66 62644 55956 31578678
Buttock injury 10.60 10.34 4 62706 50 31634584
Aggression 10.58 10.34 38 62672 37253 31597381
Gastroenteritis 10.51 10.34 53 62657 13209 31621425
Calcium ionised increased 10.51 10.34 3 62707 14 31634620
Neutropenic colitis 10.49 10.34 19 62691 2673 31631961
Hepatitis fulminant 10.46 10.34 23 62687 3723 31630911
Cardiac disorder 10.44 10.34 41 62669 39173 31595461
Diabetes mellitus 10.40 10.34 46 62664 42510 31592124
Hypothermia 10.37 10.34 3 62707 9541 31625093
Bacteraemia 10.34 10.34 65 62645 17569 31617065

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
Febrile neutropenia 727.79 9.91 1401 141819 202917 70582307
Vomiting 663.79 9.91 2655 140565 590456 70194768
Nausea 560.84 9.91 3273 139947 848815 69936409
Drug ineffective 477.92 9.91 727 142493 939025 69846199
Rheumatoid arthritis 416.90 9.91 50 143170 291755 70493469
Drug intolerance 262.72 9.91 66 143154 225621 70559603
Joint swelling 248.70 9.91 100 143120 253111 70532113
Synovitis 218.54 9.91 10 143210 129218 70656006
Neutropenic sepsis 213.31 9.91 257 142963 24573 70760651
Pyrexia 210.65 9.91 2007 141213 604945 70180279
Therapeutic product effect decreased 207.84 9.91 23 143197 142995 70642229
General physical health deterioration 205.40 9.91 982 142238 235049 70550175
Dystonia 199.53 9.91 222 142998 19484 70765740
Dehydration 196.86 9.91 941 142279 225201 70560023
Hypokalaemia 189.95 9.91 640 142580 130548 70654676
Arthropathy 184.29 9.91 39 143181 150018 70635206
Constipation 179.73 9.91 993 142227 251445 70533779
Decreased appetite 179.17 9.91 1140 142080 303640 70481584
Arthralgia 178.84 9.91 478 142742 502912 70282312
Serotonin syndrome 165.94 9.91 302 142918 41812 70743412
Contraindicated product administered 157.28 9.91 39 143181 134573 70650651
Hand deformity 155.62 9.91 4 143216 86478 70698746
Neutropenia 153.62 9.91 966 142254 256190 70529034
Completed suicide 144.72 9.91 147 143073 226988 70558236
Weight increased 143.15 9.91 167 143053 242164 70543060
Product dose omission issue 134.87 9.91 144 143076 217324 70567900
Mucosal inflammation 133.79 9.91 369 142851 67481 70717743
Thrombocytopenia 131.62 9.91 880 142340 238230 70546994
Swelling 129.49 9.91 114 143106 188425 70596799
Diarrhoea 125.52 9.91 2248 140972 781093 70004131
Abdominal pain 124.58 9.91 1144 142076 340983 70444241
Systemic lupus erythematosus 124.04 9.91 27 143193 101875 70683349
Impaired gastric emptying 121.44 9.91 121 143099 9345 70775879
Malignant neoplasm progression 120.99 9.91 527 142693 121212 70664012
Hyponatraemia 116.67 9.91 634 142586 159453 70625771
Aplastic anaemia 113.56 9.91 154 143066 16562 70768662
Psoriasis 110.26 9.91 31 143189 98402 70686822
Peripheral swelling 107.35 9.91 196 143024 236367 70548857
Sinusitis 104.92 9.91 112 143108 169083 70616141
Injection site pain 97.85 9.91 58 143162 117561 70667663
Glossodynia 97.31 9.91 27 143193 86460 70698764
Nasopharyngitis 94.79 9.91 191 143029 222015 70563209
Toxic epidermal necrolysis 94.27 9.91 231 142989 39326 70745898
Torsade de pointes 92.70 9.91 146 143074 17970 70767254
Treatment failure 92.09 9.91 93 143127 144049 70641175
Anaemia 89.58 9.91 1224 141996 402199 70383025
Musculoskeletal stiffness 89.18 9.91 100 143120 147660 70637564
Pulmonary embolism 88.93 9.91 579 142641 155288 70629936
Phaeochromocytoma crisis 86.16 9.91 30 143190 286 70784938
Pericarditis 85.47 9.91 32 143188 84673 70700551
Therapeutic product effect incomplete 85.32 9.91 70 143150 119812 70665412
Abdominal discomfort 85.31 9.91 192 143028 214466 70570758
Hypomagnesaemia 84.65 9.91 226 142994 40538 70744686
Product use issue 83.48 9.91 147 143073 179790 70605434
Psoriatic arthropathy 83.35 9.91 15 143205 64756 70720468
Extrapyramidal disorder 78.20 9.91 146 143074 20604 70764620
Wound 77.56 9.91 52 143168 98680 70686544
Hepatic enzyme increased 76.74 9.91 124 143096 156866 70628358
Sepsis 76.28 9.91 792 142428 243753 70541471
Electrocardiogram QT prolonged 74.31 9.91 350 142870 83167 70702057
Duodenal ulcer perforation 72.28 9.91 9 143211 51103 70734121
Atelectasis 69.93 9.91 170 143050 28792 70756432
Ileus 69.24 9.91 152 143068 24085 70761139
Discomfort 67.36 9.91 68 143152 105368 70679856
Helicobacter infection 67.21 9.91 15 143205 55641 70729583
Blood pressure fluctuation 67.17 9.91 18 143202 58994 70726230
Muscle injury 64.98 9.91 3 143217 38491 70746733
Leukopenia 64.55 9.91 402 142818 106158 70679066
Subileus 60.12 9.91 63 143157 5164 70780060
Sleep disorder due to general medical condition, insomnia type 59.63 9.91 3 143217 35729 70749495
Arthritis 59.45 9.91 66 143154 97914 70687310
Colitis 59.40 9.91 271 142949 63543 70721681
Condition aggravated 59.15 9.91 565 142655 427070 70358154
Computerised tomogram thorax abnormal 58.59 9.91 42 143178 2056 70783168
Neutrophil count decreased 58.19 9.91 327 142893 83229 70701995
Asthma 57.54 9.91 97 143123 120696 70664528
Neovascularisation 57.04 9.91 33 143187 1112 70784112
Pneumonitis 57.01 9.91 240 142980 54357 70730867
Parkinsonism 56.71 9.91 107 143113 15218 70770006
Pneumonia 56.14 9.91 1588 141632 594644 70190580
Impaired healing 55.99 9.91 41 143179 74333 70710891
Oesophagitis 55.80 9.91 134 143086 22518 70762706
Rash maculo-papular 55.78 9.91 226 142994 50319 70734905
Pain 55.71 9.91 914 142306 627902 70157322
Fall 55.54 9.91 601 142619 443495 70341729
Phaeochromocytoma 53.92 9.91 26 143194 599 70784625
Neuroleptic malignant syndrome 53.80 9.91 144 143076 25863 70759361
Tardive dyskinesia 53.56 9.91 82 143138 9847 70775377
Acute kidney injury 53 9.91 1293 141927 473331 70311893
Cholecystitis chronic 51.38 9.91 78 143142 9298 70775926
Hepatocellular injury 50.79 9.91 206 143014 45885 70739339
Injection site bruising 50.72 9.91 8 143212 38024 70747200
Intentional product use issue 49.73 9.91 105 143115 120037 70665187
Contusion 49.64 9.91 116 143104 127920 70657304
Hiccups 49.17 9.91 75 143145 8977 70776247
Drug abuse 49.01 9.91 144 143076 147112 70638112
Injection site erythema 48.94 9.91 45 143175 72879 70712345
Blood pressure increased 48.89 9.91 205 143015 188312 70596912
Heart rate decreased 48.24 9.91 33 143187 61982 70723242
Pleural effusion 47.57 9.91 443 142777 132421 70652803
Red blood cell sedimentation rate increased 47.50 9.91 10 143210 38632 70746592
Therapeutic response decreased 46.96 9.91 30 143190 58423 70726801
Cytokine release syndrome 46.38 9.91 138 143082 26329 70758895
Restlessness 46.19 9.91 188 143032 41940 70743284
Oculogyric crisis 45.20 9.91 40 143180 2658 70782566
Injection site swelling 44.04 9.91 16 143204 43141 70742083
Knee arthroplasty 44.01 9.91 8 143212 34293 70750931
Osteoarthritis 43.83 9.91 51 143169 74096 70711128
Peripheral circulatory failure 43.51 9.91 27 143193 1036 70784188
Gastritis 43.47 9.91 192 143028 44399 70740825
C-reactive protein abnormal 43.47 9.91 12 143208 38567 70746657
Septic shock 43.09 9.91 380 142840 111878 70673346
Wrong technique in product usage process 43.09 9.91 45 143175 68653 70716571
Malnutrition 42.54 9.91 113 143107 20204 70765020
Long QT syndrome 42.29 9.91 53 143167 5274 70779950
Pain in extremity 42.19 9.91 441 142779 327641 70457583
Hypophagia 41.29 9.91 180 143040 41390 70743834
Urticaria 41.23 9.91 179 143041 162870 70622354
Loss of personal independence in daily activities 40.60 9.91 68 143152 84842 70700382
Irritable bowel syndrome 39.63 9.91 27 143193 50823 70734401
Pancytopenia 39.58 9.91 473 142747 150634 70634590
Injection site reaction 39.49 9.91 26 143194 49826 70735398
Injection site pruritus 39.23 9.91 15 143205 39195 70746029
Blood cholesterol increased 38.66 9.91 44 143176 64560 70720664
Cholestasis 38.54 9.91 195 143025 47677 70737547
Intentional overdose 38.30 9.91 89 143131 98346 70686878
Folliculitis 38.30 9.91 19 143201 42551 70742673
Dysphagia 38.29 9.91 372 142848 112462 70672762
Neuropathy peripheral 38.11 9.91 408 142812 126488 70658736
Haematemesis 38.05 9.91 197 143023 48600 70736624
Toxicity to various agents 37.67 9.91 544 142676 381628 70403596
Drug resistance 37.57 9.91 15 143205 38175 70747049
Computerised tomogram thorax 37.28 9.91 15 143205 220 70785004
Hepatic failure 37.17 9.91 221 142999 57404 70727820
Aplasia 36.49 9.91 58 143162 7193 70778031
Gastroenteritis 36.39 9.91 142 143078 31071 70754153
Hypoxia 34.29 9.91 313 142907 93031 70692193
Therapy non-responder 33.72 9.91 65 143155 76850 70708374
Genital erythema 33.63 9.91 14 143206 225 70784999
Pulmonary interstitial emphysema syndrome 33.00 9.91 17 143203 453 70784771
Wheezing 32.87 9.91 90 143130 94080 70691144
Hypersensitivity 32.84 9.91 301 142919 229511 70555713
Electrolyte imbalance 31.97 9.91 123 143097 26738 70758486
Stevens-Johnson syndrome 31.57 9.91 150 143070 35757 70749467
Mixed liver injury 31.47 9.91 50 143170 6199 70779025
Adverse drug reaction 31.19 9.91 37 143183 53307 70731917
Small intestinal obstruction 31.08 9.91 115 143105 24540 70760684
Ascites 30.93 9.91 238 142982 67309 70717915
Suicide attempt 30.84 9.91 72 143148 79438 70705786
Dyskinesia 30.77 9.91 164 143056 40910 70744314
Gait disturbance 30.72 9.91 233 142987 184873 70600351
Febrile bone marrow aplasia 30.69 9.91 72 143148 11919 70773305
Renal ischaemia 30.62 9.91 22 143198 1081 70784143
Alveolar lung disease 30.32 9.91 17 143203 539 70784685
Headache 30.23 9.91 917 142303 579488 70205736
Foetal death 30.16 9.91 49 143171 6190 70779034
Peritonitis 29.68 9.91 118 143102 26041 70759183
Off label use 29.55 9.91 1214 142006 741846 70043378
Blood magnesium decreased 29.52 9.91 81 143139 14760 70770464
Fibromyalgia 29.31 9.91 32 143188 47842 70737382
Gamma-glutamyltransferase increased 29.30 9.91 189 143031 50496 70734728
Joint injury 29.20 9.91 9 143211 26923 70758301
Device expulsion 28.95 9.91 5 143215 22241 70762983
Duodenal stenosis 28.91 9.91 18 143202 695 70784529
Platelet count decreased 28.83 9.91 513 142707 177709 70607515
Enterocolitis 28.71 9.91 74 143146 12992 70772232
PO2 increased 28.61 9.91 24 143196 1483 70783741
Stress 28.45 9.91 59 143161 67907 70717317
Akathisia 28.45 9.91 71 143149 12222 70773002
Cholecystitis 28.17 9.91 99 143121 20602 70764622
Mobility decreased 27.95 9.91 110 143110 102889 70682335
PCO2 increased 27.91 9.91 25 143195 1688 70783536
Ill-defined disorder 27.91 9.91 42 143178 54699 70730525
Cardiac arrest 27.62 9.91 465 142755 159369 70625855
COVID-19 27.40 9.91 115 143105 105642 70679582
Blood pressure systolic increased 27.24 9.91 46 143174 57213 70728011
Cataract 27.13 9.91 44 143176 55601 70729623
Abdominal pain upper 27.10 9.91 545 142675 193057 70592167
Hypoaesthesia 26.72 9.91 191 143029 153548 70631676
Abortion spontaneous 26.71 9.91 10 143210 26469 70758755
Blood alkaline phosphatase increased 26.68 9.91 206 143014 58315 70726909
Feeling abnormal 26.62 9.91 173 143047 142146 70643078
Inappropriate schedule of product administration 26.62 9.91 119 143101 107436 70677788
Ileus paralytic 26.23 9.91 56 143164 8705 70776519
Disease progression 26.06 9.91 453 142767 156219 70629005
Adverse event 25.17 9.91 38 143182 49423 70735801
Tachycardia 25.15 9.91 455 142765 158091 70627133
Acute abdomen 24.92 9.91 30 143190 2864 70782360
Intestinal perforation 24.72 9.91 80 143140 15964 70769260
Accidental exposure to product 24.52 9.91 13 143207 28038 70757186
Infusion site streaking 24.44 9.91 14 143206 463 70784761
Lymphoid tissue hypoplasia 24.05 9.91 15 143205 581 70784643
Hypocalcaemia 23.96 9.91 164 143056 44695 70740529
Encephalopathy 23.79 9.91 209 143011 61452 70723772
Secondary adrenocortical insufficiency 23.72 9.91 28 143192 2619 70782605
Pancreatitis 23.45 9.91 211 143009 62457 70722767
Cancer pain 23.18 9.91 38 143182 4836 70780388
Infusion related reaction 23.18 9.91 271 142949 197263 70587961
Hyperprolactinaemia 23.18 9.91 36 143184 4377 70780847
Tumour lysis syndrome 23.16 9.91 95 143125 21265 70763959
Neutropenic colitis 23.16 9.91 39 143181 5075 70780149
Hypoalbuminaemia 23.11 9.91 88 143132 19034 70766190
Blood bilirubin increased 23.09 9.91 203 143017 59698 70725526
Thymus hypoplasia 23.09 9.91 15 143205 624 70784600
Injection site rash 22.93 9.91 3 143217 16407 70768817
Carcinoid tumour of the stomach 22.79 9.91 10 143210 184 70785040
Gelastic seizure 22.58 9.91 5 143215 5 70785219
Deep vein thrombosis 22.57 9.91 332 142888 110710 70674514
Urosepsis 22.50 9.91 102 143118 23847 70761377
Blood pressure diastolic decreased 22.45 9.91 12 143208 25768 70759456
Post concussion syndrome 22.45 9.91 14 143206 542 70784682
Respiratory dyskinesia 21.99 9.91 7 143213 49 70785175
Immune-mediated hepatitis 21.93 9.91 28 143192 2838 70782386
Alopecia 21.89 9.91 276 142944 198214 70587010
Non-small cell lung cancer 21.87 9.91 43 143177 6304 70778920
Haematopoietic stem cell mobilisation 21.67 9.91 10 143210 208 70785016
Diabetes insipidus 21.65 9.91 36 143184 4635 70780589
Intentional product misuse 21.59 9.91 85 143135 79510 70705714
Excessive eye blinking 21.39 9.91 20 143200 1427 70783797
Cardiac failure congestive 21.31 9.91 173 143047 135284 70649940
Left ventricular dysfunction 21.18 9.91 82 143138 17875 70767349
Myocardial infarction 21.11 9.91 233 142987 171412 70613812
Drug clearance decreased 20.83 9.91 28 143192 2985 70782239
Hyponatraemic seizure 20.72 9.91 13 143207 509 70784715
Jaundice 20.46 9.91 172 143048 49936 70735288
Hypophosphataemia 20.45 9.91 76 143144 16250 70768974
Mouth ulceration 20.42 9.91 129 143091 34220 70751004
Blood bicarbonate decreased 20.18 9.91 36 143184 4905 70780319
Palmar-plantar erythrodysaesthesia syndrome 20.14 9.91 117 143103 30130 70755094
Eructation 20.14 9.91 54 143166 9706 70775518
Throat irritation 20.10 9.91 25 143195 35279 70749945
Diabetic gastroparesis 19.92 9.91 10 143210 252 70784972
Illness 19.74 9.91 21 143199 31770 70753454
Disseminated aspergillosis 19.63 9.91 15 143205 810 70784414
Herpes zoster 19.51 9.91 97 143123 85138 70700086
Onychalgia 19.46 9.91 15 143205 821 70784403
Cystitis noninfective 19.39 9.91 18 143202 1273 70783951
Influenza 19.39 9.91 142 143078 113558 70671666
Injection site haemorrhage 19.30 9.91 14 143206 25513 70759711
Systemic infection 19.30 9.91 42 143178 6615 70778609
Vascular access site occlusion 19.29 9.91 7 143213 76 70785148
Emotional distress 19.29 9.91 135 143085 37053 70748171
Road traffic accident 19.29 9.91 25 143195 34657 70750567
Conjunctival irritation 19.25 9.91 8 143212 128 70785096
Urinary retention 19.22 9.91 176 143044 52344 70732880
Nasal congestion 19.21 9.91 68 143152 65604 70719620
Sopor 19.03 9.91 21 143199 31246 70753978
Respiratory tract congestion 18.96 9.91 6 143214 17647 70767577
Toxic encephalopathy 18.94 9.91 55 143165 10351 70774873
Thymus disorder 18.83 9.91 10 143210 284 70784940
Polydipsia 18.77 9.91 39 143181 5949 70779275
Dyspepsia 18.77 9.91 268 142952 88809 70696415
Pituitary tumour benign 18.63 9.91 24 143196 2455 70782769
Enterochromaffin cell hyperplasia 18.59 9.91 7 143213 85 70785139
Alveolitis 18.52 9.91 30 143190 3781 70781443
Hepatitis fulminant 18.49 9.91 41 143179 6540 70778684
Tumour pain 18.48 9.91 22 143198 2076 70783148
Pseudomonal sepsis 18.46 9.91 37 143183 5500 70779724
Bursitis 18.44 9.91 16 143204 26657 70758567
Heart rate increased 18.37 9.91 132 143088 106016 70679208
Multiple sclerosis relapse 18.29 9.91 37 143183 42980 70742244
Aortic rupture 18.29 9.91 9 143211 217 70785007
Cholangitis 18.17 9.91 58 143162 11491 70773733
Multiple drug therapy 18.12 9.91 27 143193 3165 70782059
Skin candida 17.88 9.91 20 143200 1765 70783459
Cachexia 17.71 9.91 52 143168 9848 70775376
Rash 17.60 9.91 847 142373 509715 70275509
Opisthotonus 17.56 9.91 13 143207 669 70784555
Intestinal ischaemia 17.56 9.91 59 143161 12005 70773219
Respiratory syncytial virus infection 17.49 9.91 44 143176 7611 70777613
Intentional self-injury 17.41 9.91 23 143197 31627 70753597
Malignant polyp 17.36 9.91 8 143212 166 70785058
Klebsiella bacteraemia 17.34 9.91 24 143196 2630 70782594
Memory impairment 17.12 9.91 113 143107 92528 70692696
Device issue 17.12 9.91 14 143206 24011 70761213
Obstruction gastric 17.07 9.91 18 143202 1486 70783738
Fluid retention 17.00 9.91 68 143152 63317 70721907
Pruritus 16.96 9.91 550 142670 345010 70440214
Insomnia 16.84 9.91 324 142896 217482 70567742
Tumour perforation 16.79 9.91 10 143210 356 70784868
Hypergastrinaemia 16.72 9.91 8 143212 181 70785043
Failure to thrive 16.69 9.91 54 143166 10775 70774449
Hospitalisation 16.67 9.91 98 143122 82470 70702754
Hypochloraemia 16.44 9.91 21 143199 2130 70783094
Tenosynovitis 16.41 9.91 4 143216 13972 70771252
Irritability 16.15 9.91 33 143187 38192 70747032
Nail infection 16.13 9.91 21 143199 2170 70783054
Therapy cessation 16.07 9.91 27 143193 33649 70751575
Transfusion 16.06 9.91 78 143142 18758 70766466
Electrocardiogram T wave inversion 16.04 9.91 33 143187 4998 70780226
Torticollis 16.00 9.91 21 143199 2188 70783036
Burning sensation 15.96 9.91 54 143166 52816 70732408
Confusional state 15.84 9.91 714 142506 283684 70501540
Incorrect dose administered 15.80 9.91 75 143145 66644 70718580
Non-cardiac chest pain 15.79 9.91 47 143173 8968 70776256
Acute interstitial pneumonitis 15.76 9.91 15 143205 1095 70784129
Pancreatic carcinoma metastatic 15.71 9.91 28 143192 3812 70781412
Sudden death 15.70 9.91 84 143136 20980 70764244
Grip strength decreased 15.69 9.91 6 143214 15679 70769545
Blood pressure diastolic increased 15.66 9.91 3 143217 12388 70772836
Immunodeficiency 15.54 9.91 8 143212 17547 70767677
Product storage error 15.51 9.91 5 143215 14536 70770688
Enteritis 15.47 9.91 59 143161 12772 70772452
Joint effusion 15.35 9.91 6 143214 15471 70769753
Gaze palsy 15.32 9.91 23 143197 2715 70782509
Neuroglycopenia 15.29 9.91 10 143210 421 70784803
Adrenal insufficiency 15.21 9.91 95 143125 25100 70760124
Escherichia test positive 15.20 9.91 24 143196 2959 70782265
Flail chest 15.10 9.91 6 143214 85 70785139
Embolism 15.07 9.91 59 143161 12929 70772295
Myoclonus 15.06 9.91 98 143122 26257 70758967
Product quality issue 15.05 9.91 24 143196 30537 70754687
Musculoskeletal disorder 15.04 9.91 11 143209 19960 70765264
Stress cardiomyopathy 15.04 9.91 49 143171 9813 70775411
Immune effector cell-associated neurotoxicity syndrome 15.00 9.91 28 143192 3950 70781274
Spleen congestion 14.99 9.91 10 143210 435 70784789
Foot deformity 14.76 9.91 12 143208 20643 70764581
Therapy interrupted 14.72 9.91 17 143203 24785 70760439
Balance disorder 14.68 9.91 114 143106 90014 70695210
Tooth disorder 14.65 9.91 16 143204 23922 70761302
Biliary dyskinesia 14.65 9.91 21 143199 2378 70782846
Muscle spasticity 14.63 9.91 11 143209 19678 70765546
Urinary tract infection 14.61 9.91 628 142592 248141 70537083
Disturbance in social behaviour 14.56 9.91 28 143192 4039 70781185
Mesothelioma 14.51 9.91 9 143211 345 70784879
Ocular hyperaemia 14.50 9.91 17 143203 24622 70760602
Chills 14.49 9.91 389 142831 144397 70640827
Alanine aminotransferase increased 14.41 9.91 395 142825 147085 70638139
Bacteraemia 14.39 9.91 105 143115 29204 70756020
Hyperthermia malignant 14.39 9.91 22 143198 2639 70782585
Oxygen saturation abnormal 14.37 9.91 27 143193 3827 70781397
Muscle rigidity 14.33 9.91 75 143145 18575 70766649
Joint stiffness 14.33 9.91 31 143189 35145 70750079
Acanthosis 14.31 9.91 10 143210 470 70784754
Clonus 14.29 9.91 36 143184 6232 70778992
Intestinal obstruction 14.15 9.91 130 143090 38695 70746529
Myalgia 14.15 9.91 246 142974 167646 70617578
Laryngeal cancer metastatic 14.15 9.91 5 143215 50 70785174
Bronchitis 14.07 9.91 160 143060 117083 70668141
Heart rate irregular 14.05 9.91 24 143196 29719 70755505
Sleep apnoea syndrome 14.03 9.91 28 143192 32685 70752539
Porphyria acute 13.97 9.91 15 143205 1264 70783960
Radiation pneumonitis 13.93 9.91 26 143194 3667 70781557
Vitamin B12 decreased 13.92 9.91 23 143197 2946 70782278
Mucosal erosion 13.82 9.91 19 143201 2070 70783154
Seizure 13.73 9.91 463 142757 177499 70607725
Extravasation blood 13.71 9.91 9 143211 381 70784843
Cholelithiasis 13.64 9.91 151 143069 47189 70738035
Hyperbilirubinaemia 13.57 9.91 85 143135 22483 70762741
Inflammation 13.53 9.91 98 143122 78567 70706657
Gallbladder injury 13.45 9.91 14 143206 1138 70784086
Pulmonary sepsis 13.38 9.91 24 143196 3283 70781941
No adverse event 13.38 9.91 28 143192 32125 70753099
Heart sounds abnormal 13.29 9.91 15 143205 1337 70783887
Superior vena cava occlusion 13.18 9.91 7 143213 199 70785025
Hypotension 13.16 9.91 967 142253 403414 70381810
Naevus haemorrhage 13.08 9.91 6 143214 123 70785101
Circulatory collapse 13.04 9.91 119 143101 35355 70749869
Blood sodium decreased 12.97 9.91 107 143113 30891 70754333
Immune reconstitution inflammatory syndrome 12.94 9.91 5 143215 12985 70772239
Neutropenic infection 12.88 9.91 18 143202 1991 70783233
Dyspnoea 12.87 9.91 1758 141462 768302 70016922
Tracheal injury 12.84 9.91 5 143215 67 70785157
Delusional disorder, persecutory type 12.80 9.91 9 143211 427 70784797
Gastric polyps 12.80 9.91 24 143196 3397 70781827
Neutrophilic dermatosis 12.79 9.91 10 143210 559 70784665
Muscle twitching 12.75 9.91 76 143144 19751 70765473
Performance status decreased 12.59 9.91 32 143188 5569 70779655
Vascular encephalopathy 12.57 9.91 10 143210 573 70784651
Faecaloma 12.55 9.91 48 143172 10403 70774821
Oesophageal ulcer 12.48 9.91 35 143185 6459 70778765
COVID-19 treatment 12.48 9.91 9 143211 445 70784779
Cytomegalovirus infection 12.42 9.91 40 143180 39718 70745506
Post transplant lymphoproliferative disorder 12.42 9.91 3 143217 10542 70774682
Aspartate aminotransferase increased 12.38 9.91 340 142880 126638 70658586
Bladder cancer 12.34 9.91 10 143210 17232 70767992
Vocal cord inflammation 12.34 9.91 7 143213 227 70784997
Venous angioma of brain 12.33 9.91 4 143216 30 70785194
Multiple sclerosis 12.32 9.91 20 143200 25265 70759959
Joint dislocation 12.31 9.91 7 143213 14524 70770700
Suicidal ideation 12.31 9.91 86 143134 69510 70715714
Impaired work ability 12.30 9.91 9 143211 16331 70768893
Lethargy 12.29 9.91 217 143003 75033 70710191
Joint range of motion decreased 12.29 9.91 21 143199 26005 70759219
Erectile dysfunction 12.28 9.91 6 143214 13556 70771668
Aminoaciduria 12.26 9.91 7 143213 230 70784994
Mania 12.25 9.91 10 143210 17164 70768060
Carpal tunnel syndrome 12.08 9.91 10 143210 17047 70768177
Seborrhoeic dermatitis 12.08 9.91 17 143203 1893 70783331
Chemotherapeutic drug level increased 12.06 9.91 8 143212 345 70784879
Poor quality sleep 12.02 9.91 14 143206 20335 70764889
Paradoxical drug reaction 12.01 9.91 35 143185 6601 70778623
Generalised oedema 11.97 9.91 80 143140 21628 70763596
Acne 11.95 9.91 20 143200 24969 70760255
Hypoglycaemic seizure 11.93 9.91 11 143209 771 70784453
Underdose 11.88 9.91 26 143194 29357 70755867
Pathogen resistance 11.83 9.91 6 143214 13273 70771951
Leukoencephalopathy 11.81 9.91 37 143183 7257 70777967
Abdominal tenderness 11.76 9.91 45 143175 9755 70775469
Cardiac disorder 11.74 9.91 71 143149 59344 70725880
Abdominal sepsis 11.64 9.91 17 143203 1958 70783266
Generalised tonic-clonic seizure 11.60 9.91 132 143088 41529 70743695
Metastatic malignant melanoma 11.59 9.91 22 143198 3142 70782082
Eye pain 11.59 9.91 33 143187 34069 70751155
Blood pH decreased 11.59 9.91 27 143193 4449 70780775
Gastric disorder 11.51 9.91 32 143188 33290 70751934
Visual impairment 11.49 9.91 105 143115 80145 70705079
Lung perforation 11.45 9.91 5 143215 91 70785133
Retching 11.43 9.91 63 143157 15916 70769308
Sinus congestion 11.33 9.91 11 143209 17362 70767862
Electrocardiogram change 11.32 9.91 13 143207 1180 70784044
Respiratory failure 11.29 9.91 432 142788 168303 70616921
Sinus disorder 11.24 9.91 13 143207 18946 70766278
Blood aluminium increased 11.24 9.91 3 143217 10 70785214
Injection site warmth 11.23 9.91 7 143213 13818 70771406
Overdose 11.21 9.91 259 142961 169486 70615738
Eastern Cooperative Oncology Group performance status worsened 11.20 9.91 15 143205 1593 70783631
Drug tolerance decreased 11.19 9.91 3 143217 9830 70775394
Glaucoma 11.18 9.91 12 143208 18080 70767144
Aortitis 11.14 9.91 14 143206 1397 70783827
Hypoacusis 11.14 9.91 24 143196 27245 70757979
Foot fracture 11.03 9.91 14 143206 19586 70765638
Vascular pain 11.02 9.91 11 143209 851 70784373
Foetal malpresentation 11.02 9.91 5 143215 100 70785124
Restless arm syndrome 10.98 9.91 4 143216 44 70785180
Hyperemesis gravidarum 10.98 9.91 8 143212 402 70784822
Dysuria 10.96 9.91 141 143079 45653 70739571
Lung infiltration 10.92 9.91 78 143142 21546 70763678
Increased tendency to bruise 10.92 9.91 3 143217 9672 70775552
Abdominal compartment syndrome 10.84 9.91 14 143206 1435 70783789
Peripheral venous disease 10.84 9.91 4 143216 10683 70774541
Apallic syndrome 10.80 9.91 11 143209 872 70784352
Type 2 diabetes mellitus 10.77 9.91 49 143171 44031 70741193
Tooth fracture 10.74 9.91 4 143216 10623 70774601
Prostate cancer 10.71 9.91 30 143190 31133 70754091
Thoracic operation 10.68 9.91 6 143214 191 70785033
Exostosis 10.67 9.91 8 143212 14337 70770887
Erysipelas 10.65 9.91 44 143176 9880 70775344
Back disorder 10.64 9.91 4 143216 10560 70774664
Febrile infection 10.64 9.91 21 143199 3088 70782136
Sciatica 10.63 9.91 21 143199 24606 70760618
Myocardial reperfusion injury 10.59 9.91 4 143216 49 70785175
Pericardial effusion 10.59 9.91 130 143090 41646 70743578
Catheter site bruise 10.57 9.91 7 143213 301 70784923
Dyschezia 10.55 9.91 19 143201 2608 70782616
Progressive multifocal leukoencephalopathy 10.53 9.91 14 143206 19200 70766024
Pregnancy 10.50 9.91 20 143200 23761 70761463
Plantar erythema 10.47 9.91 7 143213 306 70784918
Basal cell carcinoma 10.46 9.91 34 143186 33664 70751560
Numb chin syndrome 10.45 9.91 3 143217 14 70785210
Kounis syndrome 10.44 9.91 22 143198 3389 70781835
Injection site mass 10.43 9.91 13 143207 18330 70766894
Mood swings 10.36 9.91 13 143207 18273 70766951
Disability 10.34 9.91 9 143211 14974 70770250
Prostate cancer metastatic 10.34 9.91 24 143196 3945 70781279
Disease recurrence 10.30 9.91 40 143180 37563 70747661
Faecalith 10.28 9.91 3 143217 15 70785209
Porphyria 10.27 9.91 6 143214 206 70785018
Limb injury 10.24 9.91 23 143197 25729 70759495
Peptic ulcer 10.21 9.91 30 143190 5683 70779541
Transplant rejection 10.21 9.91 13 143207 18158 70767066
Cyanosis 10.20 9.91 81 143139 23125 70762099
Sinus tachycardia 10.15 9.91 109 143111 33804 70751420
Multiple organ dysfunction syndrome 10.14 9.91 289 142931 108226 70676998
Spinal cord injury thoracic 10.07 9.91 5 143215 123 70785101
Eosinophilia 10.02 9.91 125 143095 40194 70745030
Blood urea increased 10.02 9.91 139 143081 45770 70739454
Haemorrhoids 10.01 9.91 87 143133 25501 70759723
Ventricular fibrillation 10.00 9.91 91 143129 27020 70758204
Tachypnoea 9.99 9.91 95 143125 28543 70756681
Full blood count abnormal 9.96 9.91 35 143185 33843 70751381
Immune-mediated enterocolitis 9.92 9.91 22 143198 3509 70781715
Intercepted product administration error 9.91 9.91 6 143214 220 70785004

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A03FA01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
PROPULSIVES
Propulsives
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA MoA N0000175799 Dopamine D2 Antagonists
FDA EPC N0000175800 Dopamine-2 Receptor Antagonist
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:48561 dopaminergic antagonists
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:55324 gastrointestinal drugs
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Diabetic gastroparesis indication 34140002
Intubation of gastrointestinal tract indication 235419001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Chemotherapy-induced nausea and vomiting indication 236084000
Prevention of Post-Operative Nausea and Vomiting indication
Gastrointestinal Radiography Adjunct indication
Suicidal thoughts contraindication 6471006
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Cirrhosis of liver contraindication 19943007 DOID:5082
Parkinsonism contraindication 32798002
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Body fluid retention contraindication 43498006
Mechanical ileus contraindication 46420000
Chronic heart failure contraindication 48447003
Gastrointestinal perforation contraindication 51875005
Gastrointestinal hemorrhage contraindication 74474003
Tardive dyskinesia contraindication 102449007
Deficiency of cytochrome-b>5< reductase contraindication 124184009
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003
Anastomosis of intestine contraindication 235407009
Pheochromocytoma contraindication 302835009
Porphyria contraindication 418470004
Acquired torsion dystonia contraindication 433493000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.17 acidic
pKa2 8.94 Basic
pKa3 1.08 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 15MG BASE/SPRAY GIMOTI EVOKE PHARMA INC N209388 June 19, 2020 RX SPRAY, METERED NASAL 11020361 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI EVOKE PHARMA INC N209388 June 19, 2020 RX SPRAY, METERED NASAL 8334281 May 16, 2030 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 15MG BASE/SPRAY GIMOTI EVOKE PHARMA INC N209388 June 19, 2020 RX SPRAY, METERED NASAL June 19, 2023 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 7.19 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 6.70 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 4 GPCR AGONIST EC50 6 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.40 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.90 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 7.66 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Aldehyde oxidase Enzyme IC50 4.51 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 6.10 DRUG MATRIX
Myeloperoxidase Enzyme IC50 6.46 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.02 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Kd 7.30 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.99 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.98 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 6.98 CHEMBL
D(2) dopamine receptor GPCR Ki 7.10 CHEMBL
D(2) dopamine receptor GPCR ANTAGONIST Ki 7.54 IUPHAR
5-hydroxytryptamine receptor 4 GPCR Ki 6.05 CHEMBL
D(3) dopamine receptor GPCR IC50 7.21 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 6.68 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR IC50 5.11 CHEMBL
Adrenergic receptor alpha-2 GPCR IC50 5.11 CHEMBL
Adrenergic receptor alpha-1 GPCR IC50 4.48 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR IC50 4.88 CHEMBL
Serotonin 3 receptor (5HT3) Ion channel Ki 6.70 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 6.26 CHEMBL
5-hydroxytryptamine receptor 4 GPCR AGONIST Ki 6 IUPHAR

External reference:

IDSource
4019835 VUID
N0000147923 NUI
D00726 KEGG_DRUG
54143-57-6 SECONDARY_CAS_RN
4017905 VANDF
4019835 VANDF
C0025853 UMLSCUI
CHEBI:107736 CHEBI
CHEMBL86 ChEMBL_ID
DB01233 DRUGBANK_ID
CHEMBL1200940 ChEMBL_ID
CHEMBL1256771 ChEMBL_ID
D008787 MESH_DESCRIPTOR_UI
4168 PUBCHEM_CID
241 IUPHAR_LIGAND_ID
1740 INN_ID
L4YEB44I46 UNII
267036 RXNORM
1062 MMSL
34842 MMSL
5099 MMSL
d00298 MMSL
001877 NDDF
004778 NDDF
31147000 SNOMEDCT_US
372776000 SNOMEDCT_US
56549003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0093-2203 TABLET 10 mg ORAL ANDA 26 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0093-2204 TABLET 5 mg ORAL ANDA 26 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0576 SOLUTION 5 mg ORAL ANDA 28 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0576 SOLUTION 5 mg ORAL ANDA 28 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-1576 SOLUTION 5 mg ORAL ANDA 28 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-1576 SOLUTION 5 mg ORAL ANDA 28 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0404-9910 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 13 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0404-9910 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 13 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0409-3414 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0409-5255 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 22 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0440-1771 TABLET 10 mg ORAL ANDA 22 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-7698 TABLET 5 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-7698 TABLET 5 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-8285 TABLET 10 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-8285 TABLET 10 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0703-4502 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 23 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0703-4502 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 23 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 12634-112 TABLET 10 mg ORAL ANDA 22 sections
METOCLOPRAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-150 TABLET 5 mg ORAL ANDA 25 sections
METOCLOPRAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-151 TABLET 10 mg ORAL ANDA 25 sections
REGLAN HUMAN PRESCRIPTION DRUG LABEL 1 16590-906 TABLET 10 mg ORAL NDA 24 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 17856-0576 SOLUTION 5 mg ORAL ANDA 24 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 21695-346 TABLET 10 mg ORAL ANDA 19 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 21695-485 TABLET 5 mg ORAL ANDA 19 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 23155-240 INJECTION 5 mg INTRAMUSCULAR ANDA 21 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 33261-166 TABLET 10 mg ORAL ANDA 22 sections
METOCLOPRAMIDE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 40032-580 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 25 sections
METOCLOPRAMIDE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 40032-581 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 25 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42254-196 TABLET 5 mg ORAL ANDA 22 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42254-266 TABLET 10 mg ORAL ANDA 22 sections