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
Drug ineffective 514.41 9.93 507 98132 818826 49687659
Febrile neutropenia 367.13 9.93 672 97967 96995 50409490
Vomiting 365.08 9.93 1816 96823 458942 50047543
Joint swelling 255.89 9.93 80 98559 245206 50261279
Rheumatoid arthritis 252.70 9.93 45 98594 202505 50303980
Drug intolerance 248.05 9.93 61 98578 219043 50287442
Contraindicated product administered 217.21 9.93 20 98619 148938 50357547
Arthropathy 188.59 9.93 39 98600 157867 50348618
Therapeutic product effect decreased 186.25 9.93 23 98616 136027 50370458
Synovitis 185.02 9.93 15 98624 123850 50382635
Hand deformity 175.94 9.93 4 98635 100195 50406290
Hypokalaemia 171.73 9.93 466 98173 87526 50418959
Nausea 169.64 9.93 2106 96533 703292 49803193
Neutropenic sepsis 159.65 9.93 166 98473 13981 50492504
Swelling 155.48 9.93 100 98539 200772 50305713
Systemic lupus erythematosus 153.59 9.93 42 98597 140580 50365905
Arthralgia 150.74 9.93 402 98237 438300 50068185
Glossodynia 149.99 9.93 23 98616 115546 50390939
Abdominal discomfort 131.24 9.93 155 98484 231486 50274999
Dehydration 130.00 9.93 615 98024 151834 50354651
Dystonia 129.33 9.93 137 98502 11789 50494696
Weight increased 124.39 9.93 126 98513 201765 50304720
Pyrexia 114.74 9.93 1188 97451 379015 50127470
Sinusitis 113.80 9.93 99 98540 170459 50336026
Neutropenia 113.35 9.93 579 98060 147386 50359099
Abdominal pain 107.45 9.93 808 97831 235420 50271065
General physical health deterioration 105.38 9.93 552 98087 141882 50364603
Mucosal inflammation 104.02 9.93 237 98402 39905 50466580
Extrapyramidal disorder 103.19 9.93 121 98518 11649 50494836
Pain 99.50 9.93 691 97948 578212 49928273
Hyponatraemia 99.44 9.93 411 98228 95728 50410757
Injection site pain 99.32 9.93 46 98593 110978 50395507
Pericarditis 99.08 9.93 17 98622 78672 50427813
Hypomagnesaemia 98.01 9.93 168 98471 22988 50483497
Thrombocytopenia 96.64 9.93 498 98141 127175 50379310
Wound 95.94 9.93 43 98596 105751 50400734
Product use issue 95.84 9.93 90 98549 149385 50357100
Product dose omission issue 95.78 9.93 131 98508 183707 50322778
Decreased appetite 94.59 9.93 693 97946 200230 50306255
Nasopharyngitis 93.14 9.93 145 98494 192782 50313703
Impaired gastric emptying 92.50 9.93 99 98540 8619 50497866
Tardive dyskinesia 92.34 9.93 91 98548 7188 50499297
Torsade de pointes 91.25 9.93 114 98525 11721 50494764
Constipation 87.10 9.93 640 97999 185068 50321417
Peripheral swelling 86.48 9.93 169 98470 205767 50300718
Completed suicide 85.02 9.93 79 98560 131810 50374675
Treatment failure 84.61 9.93 86 98553 137551 50368934
Toxic epidermal necrolysis 83.25 9.93 148 98491 20844 50485641
Atelectasis 81.90 9.93 136 98503 18134 50488351
Discomfort 81.02 9.93 56 98583 108324 50398161
Serotonin syndrome 76.73 9.93 157 98482 24556 50481929
Phaeochromocytoma crisis 76.30 9.93 25 98614 202 50506283
Anaemia 74.14 9.93 785 97854 251671 50254814
Diarrhoea 73.33 9.93 1578 97061 586898 49919587
Pulmonary embolism 72.33 9.93 390 98249 101314 50405171
Musculoskeletal stiffness 70.53 9.93 88 98551 128393 50378092
Malignant neoplasm progression 70.23 9.93 291 98348 67833 50438652
Duodenal ulcer perforation 69.55 9.93 5 98634 45606 50460879
Therapeutic product effect incomplete 68.78 9.93 47 98592 91468 50415017
Hepatic enzyme increased 63.68 9.93 106 98533 137274 50369211
Cholecystitis chronic 61.91 9.93 85 98554 9584 50496901
Psoriatic arthropathy 61.82 9.93 9 98630 47023 50459462
Acute kidney injury 61.80 9.93 698 97941 227360 50279125
Neutrophil count decreased 60.97 9.93 213 98426 45813 50460672
Electrocardiogram QT prolonged 59.37 9.93 229 98410 51657 50454828
Neovascularisation 59.11 9.93 32 98607 981 50505504
Parkinsonism 58.50 9.93 79 98560 8768 50497717
Helicobacter infection 55.83 9.93 14 98625 49688 50456797
Hypersensitivity 55.10 9.93 224 98415 214937 50291548
Computerised tomogram thorax abnormal 54.88 9.93 34 98605 1349 50505136
Alopecia 53.84 9.93 270 98369 244777 50261708
Psoriasis 53.79 9.93 34 98605 68966 50437519
Gastritis 52.99 9.93 163 98476 32820 50473665
Arthritis 51.23 9.93 56 98583 86665 50419820
Infusion related reaction 50.33 9.93 166 98473 169391 50337094
Sepsis 49.65 9.93 435 98204 132490 50373995
Impaired healing 49.62 9.93 38 98601 69748 50436737
Phaeochromocytoma 48.94 9.93 22 98617 446 50506039
Hypoxia 46.26 9.93 210 98429 50913 50455572
Ileus 45.83 9.93 88 98551 13141 50493344
Restlessness 45.77 9.93 130 98509 25043 50481442
Cytokine release syndrome 45.20 9.93 69 98570 8565 50497920
Renal ischaemia 44.37 9.93 22 98617 560 50505925
Injection site bruising 44.01 9.93 9 98630 36759 50469726
Stevens-Johnson syndrome 43.18 9.93 116 98523 21636 50484849
Knee arthroplasty 42.45 9.93 9 98630 35837 50470648
Hip arthroplasty 41.96 9.93 5 98634 30424 50476061
Neuropathy peripheral 41.66 9.93 327 98312 96430 50410055
Device expulsion 41.62 9.93 4 98635 28818 50477667
Duodenal stenosis 41.56 9.93 20 98619 476 50506009
Cardiac arrest 40.70 9.93 291 98348 83360 50423125
Irritable bowel syndrome 40.57 9.93 25 98614 51416 50455069
Folliculitis 40.44 9.93 13 98626 39212 50467273
Leukopenia 40.16 9.93 247 98392 67281 50439204
Electrolyte imbalance 39.71 9.93 97 98542 17072 50489413
Encephalopathy 39.56 9.93 150 98489 33561 50472924
Injection site erythema 39.38 9.93 53 98586 74883 50431602
Septic shock 39.10 9.93 217 98422 56958 50449527
Tachycardia 39.08 9.93 330 98309 99433 50407052
Colitis 38.45 9.93 163 98476 38366 50468119
Pleural effusion 38.27 9.93 281 98358 81173 50425312
Contusion 38.19 9.93 103 98536 112080 50394405
PCO2 increased 37.68 9.93 25 98614 1118 50505367
PO2 increased 37.24 9.93 22 98617 800 50505685
Cholecystitis 37.15 9.93 83 98556 13788 50492697
Diabetes insipidus 36.58 9.93 33 98606 2331 50504154
Subileus 35.94 9.93 35 98604 2724 50503761
Left ventricular dysfunction 35.31 9.93 69 98570 10437 50496048
Blood pressure increased 35.06 9.93 137 98502 132995 50373490
Wrong technique in product usage process 34.87 9.93 34 98605 55476 50451009
Rash 34.76 9.93 622 98017 436849 50069636
Injection site reaction 34.61 9.93 28 98611 50004 50456481
Blood bicarbonate decreased 34.44 9.93 34 98605 2691 50503794
Malnutrition 34.30 9.93 78 98561 13111 50493374
Aplastic anaemia 34.06 9.93 57 98582 7646 50498839
Cholestasis 34.02 9.93 118 98521 25283 50481202
Dysphagia 33.92 9.93 263 98376 77255 50429230
Dyskinesia 33.54 9.93 125 98514 27736 50478749
Injection site swelling 33.36 9.93 20 98619 41753 50464732
Abortion spontaneous 33.36 9.93 20 98619 41752 50464733
Adverse drug reaction 33.35 9.93 35 98604 55187 50451298
Rash maculo-papular 33.31 9.93 121 98518 26520 50479965
Mouth ulceration 33.13 9.93 125 98514 27899 50478586
Aplasia 33.09 9.93 39 98600 3774 50502711
C-reactive protein abnormal 32.89 9.93 7 98632 27802 50478683
Injection site pruritus 32.77 9.93 19 98620 40392 50466093
Condition aggravated 32.74 9.93 396 98243 296662 50209823
Akathisia 32.60 9.93 58 98581 8171 50498314
Hepatocellular injury 32.57 9.93 118 98521 25829 50480656
Oculogyric crisis 32.53 9.93 25 98614 1412 50505073
Excessive eye blinking 31.93 9.93 21 98618 925 50505560
Disease progression 31.37 9.93 305 98334 95561 50410924
Small intestinal obstruction 31.20 9.93 85 98554 15983 50490502
Mixed liver injury 31.12 9.93 36 98603 3415 50503070
Osteoarthritis 30.79 9.93 54 98585 68552 50437933
Therapeutic response decreased 30.76 9.93 28 98611 47203 50459282
Peripheral circulatory failure 30.71 9.93 17 98622 545 50505940
Haematemesis 30.60 9.93 121 98518 27604 50478881
Hypotension 30.27 9.93 635 98004 234834 50271651
Gastroenteritis 30.18 9.93 107 98532 23174 50483311
Hyperprolactinaemia 30.17 9.93 35 98604 3330 50503155
Peritonitis 30.15 9.93 82 98557 15404 50491081
Red blood cell sedimentation rate increased 29.89 9.93 10 98629 29406 50477079
Pancytopenia 29.31 9.93 271 98368 83759 50422726
Ascites 29.28 9.93 143 98496 35718 50470767
Ejection fraction decreased 29.25 9.93 91 98548 18429 50488056
Accidental exposure to product 28.97 9.93 5 98634 23052 50483433
Antinuclear antibody negative 28.62 9.93 12 98627 204 50506281
Respiratory syncytial virus infection 28.46 9.93 42 98597 5060 50501425
Influenza 28.42 9.93 85 98554 89453 50417032
Mobility decreased 27.51 9.93 73 98566 79875 50426610
Adverse event 27.26 9.93 27 98612 43736 50462749
Pain in extremity 27.01 9.93 372 98267 272493 50233992
Emotional distress 26.87 9.93 119 98520 28544 50477941
Blood magnesium decreased 26.83 9.93 64 98575 11096 50495389
Coombs positive haemolytic anaemia 26.39 9.93 13 98626 326 50506159
Paradoxical drug reaction 26.32 9.93 34 98605 3613 50502872
Blood pressure fluctuation 26.11 9.93 19 98620 35804 50470681
Urticaria 26.05 9.93 147 98492 129414 50377071
Infusion site streaking 25.84 9.93 14 98625 430 50506055
Abdominal pain upper 25.73 9.93 445 98194 158864 50347621
Skin candida 25.58 9.93 21 98618 1305 50505180
Polydipsia 25.54 9.93 31 98608 3093 50503392
Alveolitis 25.52 9.93 28 98611 2506 50503979
Computerised tomogram thorax 25.30 9.93 10 98629 145 50506340
Respiratory dyskinesia 25.29 9.93 7 98632 29 50506456
Onychalgia 25.27 9.93 17 98622 778 50505707
Blood cholesterol increased 25.20 9.93 43 98596 55172 50451313
Gamma-glutamyltransferase increased 24.82 9.93 119 98520 29504 50476981
Heart rate decreased 24.53 9.93 21 98618 36476 50470009
Blood pH decreased 24.51 9.93 27 98612 2428 50504057
Herpes simplex reactivation 24.45 9.93 13 98626 384 50506101
Erysipelas 24.18 9.93 45 98594 6563 50499922
Therapy non-responder 23.96 9.93 39 98600 50983 50455502
Secondary adrenocortical insufficiency 23.95 9.93 19 98620 1124 50505361
Hyponatraemic seizure 23.88 9.93 13 98626 403 50506082
Immune effector cell-associated neurotoxicity syndrome 23.85 9.93 19 98620 1131 50505354
Hypocalcaemia 23.39 9.93 109 98530 26707 50479778
Gastritis haemorrhagic 23.37 9.93 20 98619 1317 50505168
Cataract 23.31 9.93 35 98604 47265 50459220
Oesophagitis 23.25 9.93 68 98571 13315 50493170
Gelastic seizure 22.76 9.93 5 98634 5 50506480
Neuroleptic malignant syndrome 22.74 9.93 60 98579 11070 50495415
Ventricular fibrillation 22.68 9.93 58 98581 10501 50495984
Fall 22.38 9.93 490 98149 334442 50172043
Respiratory failure 22.38 9.93 274 98365 90907 50415578
Pancreatitis 22.34 9.93 151 98488 42463 50464022
Pneumonitis 22.21 9.93 115 98524 29395 50477090
Multiple organ dysfunction syndrome 22.14 9.93 171 98468 50166 50456319
Febrile bone marrow aplasia 21.88 9.93 42 98597 6269 50500216
Dyspnoea 21.81 9.93 1289 97350 546319 49960166
No adverse event 21.75 9.93 20 98619 33558 50472927
Brain oedema 21.63 9.93 63 98576 12307 50494178
Thymus disorder 21.58 9.93 10 98629 218 50506267
Hypergastrinaemia 21.46 9.93 8 98631 98 50506387
Carcinoid tumour of the stomach 21.36 9.93 9 98630 155 50506330
Enterochromaffin cell hyperplasia 21.32 9.93 7 98632 57 50506428
Aquagenic pruritus 21.28 9.93 6 98633 27 50506458
Urinary retention 21.07 9.93 104 98535 26086 50480399
Maternal exposure during pregnancy 20.77 9.93 205 98434 159573 50346912
Drug interaction 20.57 9.93 522 98117 199099 50307386
Deep vein thrombosis 20.54 9.93 226 98413 73078 50433407
Loss of personal independence in daily activities 20.47 9.93 69 98570 69981 50436504
Delusional disorder, persecutory type 20.46 9.93 9 98630 173 50506312
Pituitary tumour benign 20.27 9.93 21 98618 1760 50504725
Malignant polyp 20.27 9.93 9 98630 177 50506308
Cholelithiasis 20.17 9.93 135 98504 37838 50468647
Nail infection 20.14 9.93 22 98617 1959 50504526
Urosepsis 19.98 9.93 71 98568 15394 50491091
Intestinal perforation 19.91 9.93 55 98584 10424 50496061
Foetal death 19.76 9.93 47 98592 8133 50498352
Obstruction gastric 19.72 9.93 15 98624 834 50505651
Duodenal perforation 19.59 9.93 14 98625 707 50505778
Fatigue 19.57 9.93 1155 97484 706446 49800039
Ill-defined disorder 19.49 9.93 49 98590 54605 50451880
Radiation pneumonitis 19.42 9.93 18 98621 1317 50505168
Oxygen saturation abnormal 19.21 9.93 25 98614 2677 50503808
Herpes zoster 19.17 9.93 72 98567 70714 50435771
Intentional product use issue 19.08 9.93 81 98558 76837 50429648
Acute interstitial pneumonitis 19.04 9.93 13 98626 610 50505875
Aortic rupture 18.98 9.93 7 98632 83 50506402
Torticollis 18.92 9.93 20 98619 1716 50504769
Injection site haemorrhage 18.83 9.93 9 98630 21337 50485148
Hypophagia 18.79 9.93 105 98534 27623 50478862
Anxiety disorder 18.73 9.93 29 98610 3644 50502841
Plantar erythema 18.71 9.93 9 98630 214 50506271
Clonus 18.60 9.93 31 98608 4144 50502341
Agitation 18.52 9.93 172 98467 53212 50453273
Electrocardiogram T wave inversion 18.41 9.93 27 98612 3234 50503251
Vitamin B12 decreased 18.40 9.93 25 98614 2790 50503695
Catheter site bruise 18.20 9.93 10 98629 316 50506169
Acute abdomen 18.09 9.93 18 98621 1438 50505047
Lethargy 18.03 9.93 161 98478 49271 50457214
Hypochloraemia 18.00 9.93 19 98620 1628 50504857
Seizure 17.86 9.93 326 98313 117548 50388937
Blood pressure systolic increased 17.69 9.93 26 98613 35423 50471062
Pneumonia 17.65 9.93 904 97735 377497 50128988
Asthma 17.61 9.93 102 98537 89235 50417250
Thirst 17.44 9.93 53 98586 10597 50495888
Long QT syndrome 17.38 9.93 25 98614 2942 50503543
Pancreatitis acute 17.37 9.93 92 98547 23720 50482765
Hypoglycaemic seizure 17.37 9.93 11 98628 454 50506031
Blood alkaline phosphatase increased 17.35 9.93 129 98510 37397 50469088
Inappropriate schedule of product administration 16.99 9.93 77 98562 71754 50434731
Joint injury 16.62 9.93 11 98628 21778 50484707
Bronchitis 16.47 9.93 127 98512 104032 50402453
Nervous system disorder 16.47 9.93 69 98570 16154 50490331
Disturbance in social behaviour 16.40 9.93 24 98615 2870 50503615
Premature baby 16.34 9.93 75 98564 18262 50488223
Dyspepsia 16.21 9.93 218 98421 73879 50432606
Staring 16.10 9.93 17 98622 1457 50505028
Gallbladder injury 16.08 9.93 16 98623 1278 50505207
Intentional overdose 16.01 9.93 65 98574 62439 50444046
Confusional state 15.98 9.93 475 98164 185453 50321032
Hospitalisation 15.97 9.93 73 98566 67864 50438621
Headache 15.96 9.93 816 97823 505719 50000766
Sinus disorder 15.95 9.93 8 98631 18450 50488035
Haemangioma of skin 15.91 9.93 9 98630 301 50506184
Gastrointestinal stoma complication 15.76 9.93 17 98622 1493 50504992
Gait disturbance 15.73 9.93 202 98437 149803 50356682
Biliary dyskinesia 15.70 9.93 22 98617 2528 50503957
Neuroendocrine tumour 15.54 9.93 11 98628 547 50505938
Multiple drug therapy 15.48 9.93 19 98620 1918 50504567
Cancer pain 15.45 9.93 22 98617 2565 50503920
Drug resistance 15.29 9.93 9 98630 18980 50487505
Pruritus 15.09 9.93 429 98210 283139 50223346
Hepatic failure 14.94 9.93 111 98528 32172 50474313
Blood bilirubin increased 14.74 9.93 110 98529 31928 50474557
Product storage error 14.61 9.93 3 98636 12221 50494264
Infection 14.61 9.93 243 98396 172711 50333774
Granulocytopenia neonatal 14.56 9.93 4 98635 16 50506469
Nasal congestion 14.50 9.93 51 98588 51069 50455416
Grip strength decreased 14.44 9.93 3 98636 12118 50494367
Joint stiffness 14.39 9.93 23 98616 30285 50476200
Vagus nerve disorder 14.26 9.93 6 98633 103 50506382
Multiple sclerosis relapse 14.20 9.93 40 98599 42924 50463561
Haemorrhoids 14.16 9.93 74 98565 18979 50487506
Aspiration 14.15 9.93 45 98594 9219 50497266
Intestinal obstruction 14.13 9.93 94 98545 26289 50480196
Enterocolitis 14.03 9.93 36 98603 6531 50499954
Vascular encephalopathy 14.00 9.93 9 98630 381 50506104
Anuria 13.99 9.93 51 98588 11193 50495292
Feeling abnormal 13.90 9.93 167 98472 125325 50381160
Drug clearance decreased 13.90 9.93 14 98625 1135 50505350
Cystitis noninfective 13.87 9.93 12 98627 802 50505683
Bezoar 13.76 9.93 15 98624 1333 50505152
Bone erosion 13.70 9.93 3 98636 11684 50494801
Leukoencephalopathy 13.66 9.93 26 98613 3857 50502628
Meconium ileus 13.65 9.93 3 98636 3 50506482
Renal failure 13.49 9.93 287 98352 106346 50400139
Immunodeficiency 13.47 9.93 6 98633 14822 50491663
Presyncope 13.44 9.93 87 98552 24111 50482374
Throat irritation 13.38 9.93 24 98615 30215 50476270
Gastrointestinal submucosal tumour 13.38 9.93 4 98635 23 50506462
Pulmonary air leakage 13.38 9.93 4 98635 23 50506462
Hypoalbuminaemia 13.37 9.93 46 98593 9814 50496671
Non-small cell lung cancer 13.34 9.93 22 98617 2915 50503570
Muscle contracture 13.32 9.93 14 98625 1193 50505292
Hyperthyroidism 13.32 9.93 53 98586 12122 50494363
Diabetic gastroparesis 13.22 9.93 7 98632 205 50506280
Eructation 13.16 9.93 37 98602 7084 50499401
Catatonia 13.12 9.93 25 98614 3711 50502774
Hypoaesthesia 13.10 9.93 172 98467 127085 50379400
Generalised tonic-clonic seizure 13.06 9.93 92 98547 26218 50480267
Dermatitis exfoliative 12.92 9.93 30 98609 5112 50501373
Reflux gastritis 12.91 9.93 12 98627 881 50505604
Palmar-plantar erythrodysaesthesia syndrome 12.89 9.93 75 98564 20023 50486462
Myalgia 12.81 9.93 168 98471 124151 50382334
Granulomatous liver disease 12.75 9.93 11 98628 732 50505753
Economic problem 12.74 9.93 17 98622 1865 50504620
Patent ductus arteriosus 12.73 9.93 25 98614 3795 50502690
Bone density decreased 12.67 9.93 3 98636 11072 50495413
Device dislocation 12.62 9.93 14 98625 21532 50484953
Off label use 12.60 9.93 777 97862 473649 50032836
Intentional self-injury 12.49 9.93 16 98623 23096 50483389
Drug tolerance increased 12.46 9.93 7 98632 231 50506254
Visual impairment 12.38 9.93 80 98559 68195 50438290
Product quality issue 12.35 9.93 26 98613 30832 50475653
Antiphospholipid syndrome 12.32 9.93 15 98624 1502 50504983
Joint effusion 12.26 9.93 5 98634 13016 50493469
Carpal tunnel syndrome 12.26 9.93 9 98630 16884 50489601
Hiccups 12.22 9.93 16 98623 1723 50504762
Gaze palsy 12.18 9.93 14 98625 1319 50505166
Oesophageal ulcer 12.17 9.93 25 98614 3920 50502565
Stridor 12.12 9.93 22 98617 3147 50503338
Porphyria acute 12.03 9.93 9 98630 488 50505997
Fibromyalgia 12.01 9.93 46 98593 44932 50461553
Cachexia 12.00 9.93 27 98612 4506 50501979
Nephritis allergic 11.98 9.93 6 98633 156 50506329
Foot fracture 11.83 9.93 13 98626 20078 50486407
Leukocytosis 11.83 9.93 80 98559 22499 50483986
Non-cardiac chest pain 11.81 9.93 31 98608 5701 50500784
Anaphylactic reaction 11.81 9.93 159 98480 53896 50452589
Basal cell carcinoma 11.78 9.93 17 98622 23339 50483146
Lip erosion 11.77 9.93 11 98628 813 50505672
Intercepted product administration error 11.77 9.93 5 98634 88 50506397
Porphyria 11.71 9.93 6 98633 164 50506321
Abdominal tenderness 11.71 9.93 36 98603 7244 50499241
Parkinson's disease 11.68 9.93 13 98626 1182 50505303
Methaemoglobinaemia 11.66 9.93 17 98622 2025 50504460
Drug dependence 11.57 9.93 72 98567 19687 50486798
Vascular pain 11.50 9.93 10 98629 673 50505812
Hyperpyrexia 11.45 9.93 21 98618 3028 50503457
Chronic fatigue syndrome 11.42 9.93 12 98627 1023 50505462
Tumour pain 11.38 9.93 13 98626 1217 50505268
Prolactin-producing pituitary tumour 11.37 9.93 5 98634 96 50506389
Lung infiltration 11.36 9.93 54 98585 13339 50493146
Sciatica 11.35 9.93 15 98624 21367 50485118
Premature delivery 11.31 9.93 82 98557 23581 50482904
Myoclonus 11.31 9.93 57 98582 14413 50492072
Head titubation 11.25 9.93 10 98629 693 50505792
Restless arm syndrome 11.20 9.93 4 98635 43 50506442
Therapy cessation 11.20 9.93 21 98618 25990 50480495
Gastrointestinal necrosis 11.19 9.93 19 98620 2579 50503906
Respiratory tract congestion 11.06 9.93 7 98632 14192 50492293
Naevus haemorrhage 11.05 9.93 5 98634 103 50506382
Device malfunction 11.04 9.93 8 98631 15113 50491372
Sleep disorder 10.97 9.93 66 98573 57217 50449268
Tracheal injury 10.96 9.93 4 98635 46 50506439
Pregnancy 10.95 9.93 26 98613 29551 50476934
Prescribed underdose 10.93 9.93 9 98630 15940 50490545
Tooth disorder 10.93 9.93 19 98620 24209 50482276
Urea urine increased 10.92 9.93 3 98636 12 50506473
Pancreatitis haemorrhagic 10.90 9.93 7 98632 296 50506189
Mucosal erosion 10.90 9.93 13 98626 1274 50505211
Leukostasis syndrome 10.88 9.93 4 98635 47 50506438
Blood pressure diastolic decreased 10.86 9.93 10 98629 16771 50489714
Muscle twitching 10.83 9.93 59 98580 15372 50491113
Foetal malpresentation 10.83 9.93 5 98634 108 50506377
Amylase increased 10.82 9.93 29 98610 5401 50501084
Urinary tract infection enterococcal 10.75 9.93 18 98621 2416 50504069
Foot deformity 10.69 9.93 13 98626 19197 50487288
Inflammation 10.67 9.93 66 98573 56846 50449639
Urinary tract obstruction 10.64 9.93 15 98624 1733 50504752
Circulatory collapse 10.56 9.93 71 98568 19929 50486556
Epilepsy congenital 10.55 9.93 3 98636 14 50506471
Platelet count decreased 10.54 9.93 264 98375 100462 50406023
Musculoskeletal disorder 10.47 9.93 11 98628 17338 50489147
COVID-19 10.46 9.93 51 98588 46611 50459874
Terminal ileitis 10.39 9.93 9 98630 602 50505883
Gastrointestinal mucosal exfoliation 10.39 9.93 5 98634 119 50506366
Opisthotonus 10.37 9.93 7 98632 322 50506163
Hypophosphataemia 10.33 9.93 38 98601 8376 50498109
Peritoneal perforation 10.31 9.93 5 98634 121 50506364
Electrocardiogram change 10.31 9.93 9 98630 609 50505876
Sinus arrhythmia 10.25 9.93 13 98626 1356 50505129
Proctalgia 10.25 9.93 27 98612 4976 50501509
Muscle spasticity 10.25 9.93 11 98628 17173 50489312
Systemic infection 10.24 9.93 17 98622 2266 50504219
Nephrocalcinosis 10.22 9.93 11 98628 963 50505522
Sinus tachycardia 10.21 9.93 74 98565 21280 50485205
Aspartate aminotransferase increased 10.21 9.93 211 98428 77787 50428698
Thoracic operation 10.20 9.93 5 98634 124 50506361
Metastatic malignant melanoma 10.17 9.93 12 98627 1162 50505323
Flail chest 10.12 9.93 4 98635 58 50506427
Motion sickness 10.10 9.93 10 98629 794 50505691
Febrile infection 10.09 9.93 12 98627 1172 50505313
Ultrasound abdomen abnormal 10.06 9.93 4 98635 59 50506426
Subacute combined cord degeneration 10.04 9.93 6 98633 223 50506262
Bundle branch block 10.02 9.93 10 98629 802 50505683
Abdominal mass 9.99 9.93 18 98621 2561 50503924
Dysuria 9.97 9.93 92 98547 28412 50478073

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 359.70 10.22 733 58576 111507 29403711
Vomiting 247.20 10.22 958 58351 211302 29303916
Drug ineffective 227.29 10.22 237 59072 362933 29152285
Nausea 136.27 10.22 1018 58291 288237 29226981
General physical health deterioration 114.95 10.22 459 58850 102398 29412820
Dehydration 91.28 10.22 463 58846 114285 29400933
Drug abuse 81.78 10.22 29 59280 79854 29435364
Pyrexia 81.28 10.22 907 58402 286715 29228503
Decreased appetite 79.46 10.22 531 58778 144811 29370407
Product dose omission issue 71.88 10.22 53 59256 96330 29418888
Serotonin syndrome 70.16 10.22 126 59183 17386 29497832
Dystonia 65.48 10.22 89 59220 9660 29505558
Impaired gastric emptying 60.90 10.22 50 59259 3020 29512198
Constipation 60.49 10.22 414 58895 113746 29401472
Neutropenic sepsis 58.42 10.22 93 59216 11634 29503584
Neutropenia 57.99 10.22 457 58852 131254 29383964
Drug intolerance 52.24 10.22 16 59293 48363 29466855
Completed suicide 49.53 10.22 65 59244 90181 29425037
Malignant neoplasm progression 49.15 10.22 284 59025 73575 29441643
Thrombocytopenia 43.42 10.22 437 58872 134386 29380832
Therapeutic product effect incomplete 40.66 10.22 14 59295 39291 29475927
Meconium abnormal 37.92 10.22 11 59298 54 29515164
Pneumonitis 37.77 10.22 133 59176 27911 29487307
Alveolar lung disease 37.03 10.22 17 59292 352 29514866
Peripheral swelling 36.96 10.22 44 59265 63695 29451523
Aplastic anaemia 36.64 10.22 59 59250 7451 29507767
Death 36.42 10.22 476 58833 341608 29173610
Hypokalaemia 35.33 10.22 196 59113 50007 29465211
Sepsis 35.24 10.22 439 58870 142243 29372975
Therapeutic product effect decreased 35.09 10.22 8 59301 29443 29485775
Genital erythema 34.09 10.22 13 59296 165 29515053
Off label use 33.31 10.22 415 58894 300385 29214833
Pulmonary interstitial emphysema syndrome 33.25 10.22 17 59292 449 29514769
Oesophagitis 32.41 10.22 73 59236 11850 29503368
Neuroleptic malignant syndrome 32.38 10.22 88 59221 16060 29499158
Treatment failure 32.08 10.22 17 59292 36922 29478296
Abdominal pain 31.53 10.22 412 58897 134945 29380273
Hypophagia 30.74 10.22 102 59207 20770 29494448
Toxicity to various agents 30.20 10.22 214 59095 173447 29341771
Arthralgia 30.02 10.22 161 59148 139456 29375762
Hyponatraemia 29.88 10.22 235 59074 67398 29447820
Diarrhoea 29.54 10.22 874 58435 331824 29183394
Mesothelioma 29.28 10.22 15 59294 398 29514820
Psoriasis 29.24 10.22 14 59295 32213 29483005
Joint swelling 29.05 10.22 34 59275 49596 29465622
Weight increased 27.95 10.22 71 59238 76596 29438622
Foetal exposure during pregnancy 27.80 10.22 138 59171 33729 29481489
Rheumatoid arthritis 27.62 10.22 15 59294 32137 29483081
Malnutrition 27.55 10.22 65 59244 10876 29504342
Toxic epidermal necrolysis 26.99 10.22 89 59220 18064 29497154
Premature baby 26.85 10.22 86 59223 17194 29498024
Pneumonia 26.77 10.22 835 58474 319337 29195881
Ileus 25.47 10.22 75 59234 14327 29500891
Laparotomy 25.31 10.22 12 59297 268 29514950
Necrotising enterocolitis neonatal 25.26 10.22 11 59298 200 29515018
Blood pressure fluctuation 24.52 10.22 5 59304 19889 29495329
Hepatic failure 24.18 10.22 126 59183 31386 29483832
Condition aggravated 24.11 10.22 183 59126 146112 29369106
Mucosal inflammation 24.01 10.22 126 59183 31469 29483749
Haematopoietic stem cell mobilisation 23.96 10.22 10 59299 163 29515055
Intentional product use issue 23.93 10.22 30 59279 42468 29472750
Pleural effusion 23.55 10.22 234 59075 71674 29443544
Leukopenia 23.39 10.22 190 59119 55013 29460205
Hyperthermia malignant 23.38 10.22 23 59286 1761 29513457
Colitis 23.32 10.22 124 59185 31124 29484094
Gastrointestinal hypermotility 23.20 10.22 9 59300 120 29515098
Extrapyramidal disorder 22.70 10.22 60 59249 10771 29504447
Impetigo 22.52 10.22 17 59292 908 29514310
Enteritis 22.41 10.22 45 59264 6746 29508472
Long QT syndrome 22.25 10.22 25 59284 2233 29512985
Intentional product misuse 22.22 10.22 22 59287 34639 29480579
Delirium 22.09 10.22 145 59164 39252 29475966
Anaemia 22.08 10.22 543 58766 200408 29314810
Intentional overdose 21.90 10.22 27 59282 38501 29476717
Drug resistance 21.72 10.22 8 59301 21532 29493686
Hiccups 21.65 10.22 52 59257 8801 29506417
Congenital pneumonia 21.54 10.22 8 59301 94 29515124
Cytokine release syndrome 21.03 10.22 66 59243 13053 29502165
Conjunctival irritation 21.02 10.22 8 59301 101 29515117
Toxic encephalopathy 20.83 10.22 35 59274 4577 29510641
Electrocardiogram QT prolonged 20.26 10.22 133 59176 36004 29479214
Cardiac failure congestive 20.17 10.22 82 59227 76499 29438719
Feeling abnormal 20.16 10.22 50 59259 54395 29460823
Post concussion syndrome 20.08 10.22 8 59301 115 29515103
Pseudomonal sepsis 19.97 10.22 27 59282 2915 29512303
Non-small cell lung cancer 19.69 10.22 27 59282 2954 29512264
Talipes 19.67 10.22 21 59288 1771 29513447
Erectile dysfunction 19.35 10.22 6 59303 18003 29497215
Product use issue 19.24 10.22 47 59262 51397 29463821
Rash maculo-papular 19.24 10.22 98 59211 24191 29491027
Hepatocellular injury 19.19 10.22 89 59220 21154 29494064
Jaundice 19.04 10.22 112 59197 29184 29486034
Lower respiratory tract infection 18.99 10.22 104 59205 26398 29488820
Urticaria 18.87 10.22 52 59257 54608 29460610
Tardive dyskinesia 18.76 10.22 36 59273 5222 29509996
Electrocardiogram QT shortened 18.60 10.22 8 59301 141 29515077
Vascular access site occlusion 18.53 10.22 6 59303 45 29515173
Suicide attempt 18.26 10.22 25 59284 34085 29481133
Ascites 17.71 10.22 130 59179 36489 29478729
Myocardial infarction 17.67 10.22 139 59170 110157 29405061
Vocal cord inflammation 17.48 10.22 6 59303 55 29515163
Dysphagia 17.14 10.22 177 59132 54749 29460469
Laryngeal cancer metastatic 17.11 10.22 6 59303 59 29515159
Heart rate decreased 16.92 10.22 15 59294 24897 29490321
Hyperbilirubinaemia 16.91 10.22 67 59242 14867 29500351
Wrong technique in product usage process 16.85 10.22 23 59286 31405 29483813
Blood alkaline phosphatase increased 16.81 10.22 106 59203 28300 29486918
Pulmonary embolism 16.57 10.22 230 59079 76304 29438914
Failure to thrive 16.54 10.22 43 59266 7641 29507577
Cytokine storm 16.50 10.22 12 59297 605 29514613
Renal vasculitis 16.35 10.22 7 59302 122 29515096
Tumour pain 16.27 10.22 14 59295 902 29514316
Wheezing 16.20 10.22 26 59283 33214 29482004
Chemotherapeutic drug level increased 15.98 10.22 8 59301 202 29515016
Arthropathy 15.86 10.22 12 59297 21542 29493676
Diffuse alveolar damage 15.81 10.22 20 59289 2023 29513195
Spleen congestion 15.70 10.22 9 59300 300 29514918
Bacterial tracheitis 15.64 10.22 3 59306 0 29515218
Ileus paralytic 15.35 10.22 33 59276 5190 29510028
Symmetrical drug-related intertriginous and flexural exanthema 15.32 10.22 8 59301 221 29514997
Abdominal compartment syndrome 15.26 10.22 13 59296 826 29514392
Acute abdomen 14.96 10.22 18 59291 1729 29513489
Hospitalisation 14.95 10.22 45 59264 45943 29469275
Hypoalbuminaemia 14.85 10.22 50 59259 10255 29504963
Subileus 14.74 10.22 23 59286 2827 29512391
Lymphoid tissue hypoplasia 14.61 10.22 7 59302 160 29515058
Thymus hypoplasia 14.61 10.22 7 59302 160 29515058
Chills 14.52 10.22 212 59097 71088 29444130
Gait disturbance 14.44 10.22 87 59222 73262 29441956
Disturbance in attention 14.43 10.22 13 59296 21411 29493807
Neutrophil count decreased 14.36 10.22 142 59167 43425 29471793
Septic shock 14.35 10.22 190 59119 62370 29452848
Musculoskeletal stiffness 14.18 10.22 34 59275 37424 29477794
Seborrhoeic dermatitis 14.17 10.22 16 59293 1437 29513781
Product use in unapproved indication 14.14 10.22 109 59200 86766 29428452
Klebsiella bacteraemia 14.00 10.22 14 59295 1093 29514125
Blood bilirubin increased 14.00 10.22 116 59193 33777 29481441
Pulmonary sepsis 13.96 10.22 18 59291 1856 29513362
Psoriatic arthropathy 13.92 10.22 6 59303 14685 29500533
Dyskinesia 13.89 10.22 78 59231 19983 29495235
Fall 13.88 10.22 261 59048 176917 29338301
Neutropenic infection 13.79 10.22 15 59294 1292 29513926
Blood creatine phosphokinase increased 13.78 10.22 39 59270 40605 29474613
Pericardial effusion 13.73 10.22 81 59228 21127 29494091
Diabetic gastroparesis 13.64 10.22 6 59303 112 29515106
Phaeochromocytoma crisis 13.60 10.22 5 59304 57 29515161
Asthma 13.40 10.22 30 59279 33819 29481399
Loss of personal independence in daily activities 13.26 10.22 19 59290 25421 29489797
Headache 13.11 10.22 258 59051 173749 29341469
Maternal drugs affecting foetus 13.09 10.22 26 59283 3867 29511351
Device related infection 13.03 10.22 64 59245 15572 29499646
Intestinal ischaemia 12.95 10.22 36 59273 6656 29508562
Dyschezia 12.94 10.22 14 59295 1199 29514019
Synovitis 12.89 10.22 3 59306 10887 29504331
Scan abnormal 12.72 10.22 4 59305 27 29515191
Underdose 12.67 10.22 4 59305 11865 29503353
Performance status decreased 12.66 10.22 25 59284 3702 29511516
Injection site pain 12.64 10.22 29 59280 32417 29482801
Swelling 12.60 10.22 33 59276 35250 29479968
Tumour lysis syndrome 12.42 10.22 58 59251 13826 29501392
Contraindicated product administered 12.40 10.22 11 59298 18255 29496963
Ventricular septal defect 12.39 10.22 24 59285 3505 29511713
Blood aluminium increased 12.36 10.22 3 59306 6 29515212
Aphthous ulcer 12.30 10.22 26 59283 4042 29511176
Cholangitis 12.15 10.22 38 59271 7499 29507719
Cachexia 12.13 10.22 34 59275 6315 29508903
Restlessness 12.10 10.22 81 59228 22064 29493154
Immune-mediated hepatitis 11.90 10.22 15 59294 1512 29513706
Type III immune complex mediated reaction 11.85 10.22 7 59302 247 29514971
Blood pressure increased 11.82 10.22 93 59216 73710 29441508
Hygroma colli 11.82 10.22 4 59305 35 29515183
Platelet count decreased 11.81 10.22 284 59025 104388 29410830
Therapy non-responder 11.75 10.22 28 59281 30883 29484335
Acute kidney injury 11.54 10.22 646 58663 264621 29250597
Product quality issue 11.50 10.22 9 59300 15886 29499332
Herpes zoster reactivation 11.46 10.22 7 59302 263 29514955
Retching 11.43 10.22 32 59277 5941 29509277
Stress 11.25 10.22 16 59293 21474 29493744
Body temperature increased 11.20 10.22 58 59251 14407 29500811
COVID-19 11.17 10.22 36 59273 35978 29479240
Stress cardiomyopathy 11.17 10.22 15 59294 1609 29513609
Spinal cord injury thoracic 11.14 10.22 5 59304 98 29515120
Sopor 11.12 10.22 4 59305 10930 29504288
Renal dysplasia 11.07 10.22 6 59303 179 29515039
Drug clearance decreased 11.07 10.22 14 59295 1416 29513802
Hepatitis fulminant 11 10.22 23 59286 3548 29511670
Gastrointestinal malformation 10.92 10.22 4 59305 45 29515173
Colorectal cancer metastatic 10.84 10.22 9 59300 552 29514666
Oesophageal hypomotility 10.84 10.22 3 59306 12 29515206
Congenital nasal septum deviation 10.84 10.22 3 59306 12 29515206
Lenticulostriatal vasculopathy 10.84 10.22 3 59306 12 29515206
Rheumatoid nodule 10.80 10.22 17 59292 2105 29513113
Hypoaesthesia 10.74 10.22 63 59246 53404 29461814
Therapy cessation 10.70 10.22 8 59301 14454 29500764
Eastern Cooperative Oncology Group performance status worsened 10.68 10.22 10 59299 720 29514498
Skeletal dysplasia 10.61 10.22 5 59304 110 29515108
Cholestasis 10.61 10.22 82 59227 23380 29491838
Buttock injury 10.55 10.22 4 59305 50 29515168
Calcium ionised increased 10.47 10.22 3 59306 14 29515204
Bacteraemia 10.34 10.22 62 59247 16261 29498957
Restrictive cardiomyopathy 10.30 10.22 9 59300 592 29514626
Generalised oedema 10.25 10.22 47 59262 11118 29504100

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 641.40 9.72 1290 133468 186367 64177607
Vomiting 522.20 9.72 2403 132355 548714 63815260
Drug ineffective 489.84 9.72 625 134133 839622 63524352
Nausea 267.30 9.72 2656 132102 783144 63580830
Drug intolerance 238.10 9.72 51 134707 187941 64176033
Joint swelling 209.27 9.72 94 134664 215288 64148686
Rheumatoid arthritis 203.14 9.72 47 134711 164247 64199727
General physical health deterioration 201.77 9.72 904 133854 203521 64160453
Neutropenic sepsis 193.53 9.72 241 134517 23031 64340943
Pyrexia 188.63 9.72 1887 132871 556757 63807217
Hypokalaemia 171.84 9.72 603 134155 121300 64242674
Dehydration 171.02 9.72 899 133859 215864 64148110
Synovitis 166.87 9.72 10 134748 99080 64264894
Decreased appetite 165.17 9.72 1079 133679 280210 64083764
Therapeutic product effect decreased 164.15 9.72 23 134735 115328 64248646
Completed suicide 161.27 9.72 139 134619 224275 64139699
Dystonia 161.11 9.72 198 134560 18667 64345307
Arthralgia 149.65 9.72 452 134306 441808 63922166
Neutropenia 146.64 9.72 929 133829 238695 64125279
Constipation 145.25 9.72 897 133861 228440 64135534
Arthropathy 141.03 9.72 39 134719 120928 64243046
Contraindicated product administered 134.95 9.72 30 134728 107799 64256175
Weight increased 130.54 9.72 152 134606 213196 64150778
Serotonin syndrome 127.81 9.72 265 134493 39017 64324957
Product dose omission issue 125.45 9.72 133 134625 194614 64169360
Thrombocytopenia 119.01 9.72 838 133920 222963 64141011
Hand deformity 113.25 9.72 4 134754 62767 64301207
Diarrhoea 111.09 9.72 2121 132637 720583 63643391
Swelling 109.37 9.72 104 134654 160114 64203860
Malignant neoplasm progression 107.36 9.72 494 134264 112377 64251597
Mucosal inflammation 103.63 9.72 327 134431 62257 64301717
Abdominal pain 103.48 9.72 1052 133706 311323 64052651
Impaired gastric emptying 101.59 9.72 108 134650 8696 64355278
Hyponatraemia 100.70 9.72 591 134167 147748 64216226
Injection site pain 97.10 9.72 56 134702 111352 64252622
Toxic epidermal necrolysis 92.10 9.72 225 134533 36941 64327033
Therapeutic product effect incomplete 90.21 9.72 52 134706 103430 64260544
Sinusitis 89.18 9.72 104 134654 145824 64218150
Systemic lupus erythematosus 86.82 9.72 27 134731 77585 64286389
Peripheral swelling 86.49 9.72 193 134565 208960 64155014
Phaeochromocytoma crisis 86.00 9.72 30 134728 277 64363697
Torsade de pointes 81.36 9.72 137 134621 17226 64346748
Pulmonary embolism 80.65 9.72 553 134205 145803 64218171
Nasopharyngitis 79.38 9.72 183 134575 195890 64168084
Hypomagnesaemia 74.91 9.72 209 134549 37167 64326807
Anaemia 73.27 9.72 1154 133604 377526 63986448
Psoriasis 73.24 9.72 29 134729 71674 64292300
Product use issue 70.35 9.72 131 134627 151584 64212390
Extrapyramidal disorder 69.66 9.72 137 134621 19415 64344559
Musculoskeletal stiffness 68.82 9.72 94 134664 123112 64240862
Aplastic anaemia 68.12 9.72 112 134646 13808 64350166
Sepsis 67.43 9.72 757 134001 229584 64134390
Treatment failure 66.39 9.72 88 134670 116728 64247246
Glossodynia 64.73 9.72 27 134731 64669 64299305
Atelectasis 64.32 9.72 162 134596 27104 64336870
Abdominal discomfort 63.91 9.72 183 134575 182139 64181835
Blood pressure fluctuation 63.74 9.72 15 134743 51856 64312118
Neutrophil count decreased 59.26 9.72 318 134440 76878 64287096
Leukopenia 58.42 9.72 387 134371 100855 64263119
Ileus 57.93 9.72 140 134618 22826 64341148
Wound 57.81 9.72 45 134713 76432 64287542
Fall 57.50 9.72 575 134183 416251 63947723
Electrocardiogram QT prolonged 56.78 9.72 321 134437 79127 64284847
Neovascularisation 54.50 9.72 32 134726 1071 64362903
Psoriatic arthropathy 54.22 9.72 12 134746 43269 64320705
Colitis 53.69 9.72 254 134504 58420 64305554
Pericarditis 53.64 9.72 32 134726 62484 64301490
Oesophagitis 52.58 9.72 130 134628 21500 64342474
Pneumonitis 52.04 9.72 226 134532 50139 64313835
Hepatic enzyme increased 51.99 9.72 122 134636 129821 64234153
Phaeochromocytoma 51.52 9.72 25 134733 564 64363410
Neuroleptic malignant syndrome 51.30 9.72 141 134617 24855 64339119
Arthritis 50.90 9.72 60 134698 83754 64280220
Injection site bruising 50.00 9.72 8 134750 36365 64327609
Cholecystitis chronic 49.93 9.72 78 134680 9209 64354765
Injection site erythema 49.41 9.72 45 134713 70755 64293219
Pneumonia 49.31 9.72 1523 133235 558053 63805921
Condition aggravated 49.19 9.72 519 134239 371907 63992067
Parkinsonism 49.15 9.72 99 134659 14274 64349700
Computerised tomogram thorax abnormal 48.39 9.72 37 134721 1932 64362042
Hepatocellular injury 48.29 9.72 205 134553 45030 64318944
Blood pressure increased 47.65 9.72 192 134566 172360 64191614
Drug abuse 47.01 9.72 132 134626 132242 64231732
Duodenal ulcer perforation 46.74 9.72 8 134750 34617 64329357
Rash maculo-papular 45.55 9.72 207 134551 46819 64317155
Pleural effusion 45.08 9.72 433 134325 126126 64237848
Pain 44.19 9.72 853 133905 552658 63811316
Tardive dyskinesia 43.77 9.72 73 134685 9105 64354869
Injection site swelling 43.44 9.72 16 134742 41337 64322637
Heart rate decreased 43.43 9.72 31 134727 55036 64308938
Malnutrition 43.41 9.72 112 134646 19013 64344961
Sleep disorder due to general medical condition, insomnia type 43.18 9.72 3 134755 26267 64337707
Acute kidney injury 43.13 9.72 1236 133522 448004 63915970
Restlessness 43.01 9.72 181 134577 39604 64324370
Wrong technique in product usage process 42.21 9.72 44 134714 64930 64299044
Subileus 42.10 9.72 52 134706 4925 64359049
Discomfort 41.92 9.72 65 134693 80813 64283161
Helicobacter infection 41.74 9.72 14 134744 38348 64325626
Contusion 41.69 9.72 112 134646 113853 64250121
Toxicity to various agents 41.21 9.72 524 134234 362989 64000985
Injection site pruritus 40.82 9.72 14 134744 37812 64326162
Pain in extremity 40.55 9.72 421 134337 302664 64061310
Therapeutic response decreased 40.35 9.72 30 134728 52158 64311816
Hypophagia 39.65 9.72 176 134582 39411 64324563
Intentional product use issue 39.38 9.72 88 134670 95276 64268698
Impaired healing 39.23 9.72 41 134717 60432 64303542
Injection site reaction 38.49 9.72 25 134733 46639 64317335
Cytokine release syndrome 38.36 9.72 113 134645 20716 64343258
Neuropathy peripheral 37.94 9.72 394 134364 117131 64246843
Cholestasis 37.29 9.72 189 134569 44683 64319291
Osteoarthritis 36.70 9.72 47 134711 63289 64300685
Septic shock 36.69 9.72 359 134399 105078 64258896
Red blood cell sedimentation rate increased 36.51 9.72 10 134748 31225 64332749
Intentional overdose 36.32 9.72 84 134674 89860 64274114
Long QT syndrome 36.13 9.72 49 134709 5090 64358884
Asthma 36.04 9.72 92 134666 95133 64268841
Hiccups 35.21 9.72 63 134695 8313 64355661
Mixed liver injury 35.15 9.72 50 134708 5431 64358543
Gastritis 35.06 9.72 179 134579 42439 64321535
Urticaria 34.61 9.72 174 134584 147143 64216831
Drug resistance 34.55 9.72 15 134743 35087 64328887
Genital erythema 33.99 9.72 14 134744 211 64363763
Dysphagia 33.96 9.72 357 134401 106455 64257519
Hepatic failure 33.31 9.72 214 134544 55180 64308794
Knee arthroplasty 32.79 9.72 8 134750 26991 64336983
Aplasia 32.76 9.72 55 134703 6898 64357076
Pulmonary interstitial emphysema syndrome 32.70 9.72 17 134741 446 64363528
Oculogyric crisis 32.64 9.72 33 134725 2505 64361469
Haematemesis 32.33 9.72 188 134570 46811 64317163
Off label use 31.61 9.72 1045 133713 631761 63732213
Loss of personal independence in daily activities 31.46 9.72 65 134693 72389 64291585
Gastroenteritis 31.21 9.72 134 134624 29577 64334397
Febrile bone marrow aplasia 30.98 9.72 71 134687 11184 64352790
Small intestinal obstruction 30.94 9.72 114 134644 23459 64340515
Device expulsion 30.56 9.72 4 134754 21132 64342842
Alveolar lung disease 30.33 9.72 17 134741 520 64363454
Renal ischaemia 30.30 9.72 22 134736 1061 64362913
Ascites 29.91 9.72 227 134531 61774 64302200
Suicide attempt 29.74 9.72 65 134693 70942 64293032
C-reactive protein abnormal 29.25 9.72 12 134746 29035 64334939
Duodenal stenosis 28.93 9.72 18 134740 670 64363304
Headache 28.92 9.72 864 133894 528603 63835371
Peripheral circulatory failure 28.86 9.72 18 134740 673 64363301
Akathisia 28.85 9.72 70 134688 11440 64352534
Gait disturbance 28.73 9.72 226 134532 171929 64192045
Electrolyte imbalance 28.19 9.72 116 134642 25127 64338847
PO2 increased 28.11 9.72 24 134734 1468 64362506
Dyskinesia 28.03 9.72 159 134599 39229 64324745
Peritonitis 27.95 9.72 115 134643 24908 64339066
PCO2 increased 27.76 9.72 25 134733 1642 64362332
Stevens-Johnson syndrome 27.58 9.72 143 134615 34106 64329868
Hypoxia 27.26 9.72 293 134465 87856 64276118
Blood magnesium decreased 27.11 9.72 77 134681 13828 64350146
Therapy non-responder 27.05 9.72 61 134697 65838 64298136
Feeling abnormal 26.91 9.72 166 134592 133436 64230538
Abdominal pain upper 26.76 9.72 514 134244 174516 64189458
Foetal death 26.74 9.72 46 134712 5884 64358090
Cholecystitis 26.65 9.72 96 134662 19540 64344434
Hypersensitivity 26.61 9.72 272 134486 196180 64167794
Abortion spontaneous 25.95 9.72 10 134748 25133 64338841
Cataract 25.80 9.72 42 134716 51220 64312754
Disease progression 25.52 9.72 427 134331 141253 64222721
Pancytopenia 25.48 9.72 431 134327 142878 64221096
Blood alkaline phosphatase increased 25.46 9.72 203 134555 56076 64307898
Intestinal perforation 25.32 9.72 80 134678 15233 64348741
Stress 24.87 9.72 56 134702 60478 64303496
Infusion site streaking 24.84 9.72 14 134744 433 64363541
Non-small cell lung cancer 24.81 9.72 40 134718 4850 64359124
Accidental exposure to product 24.80 9.72 12 134746 26352 64337622
Gamma-glutamyltransferase increased 24.76 9.72 180 134578 48330 64315644
Acute abdomen 24.69 9.72 30 134728 2794 64361180
Irritable bowel syndrome 24.62 9.72 25 134733 37344 64326630
Computerised tomogram thorax 24.56 9.72 10 134748 146 64363828
Blood cholesterol increased 24.29 9.72 42 134716 50024 64313950
Adverse drug reaction 24.07 9.72 36 134722 45428 64318546
Secondary adrenocortical insufficiency 23.98 9.72 27 134731 2318 64361656
Wheezing 23.95 9.72 87 134671 80492 64283482
Joint injury 23.89 9.72 9 134749 22938 64341036
Intentional product misuse 23.56 9.72 75 134683 72220 64291754
Blood pressure systolic increased 23.53 9.72 42 134716 49411 64314563
Cancer pain 23.23 9.72 36 134722 4221 64359753
Drug clearance decreased 23.19 9.72 28 134730 2591 64361383
Myocardial infarction 23.11 9.72 228 134530 165593 64198381
Hyperprolactinaemia 23.06 9.72 35 134723 4030 64359944
Blood bilirubin increased 23.05 9.72 202 134556 57351 64306623
Platelet count decreased 22.80 9.72 484 134274 167227 64196747
Injection site rash 22.71 9.72 3 134755 15739 64348235
Carcinoid tumour of the stomach 22.46 9.72 10 134748 184 64363790
Tachycardia 22.43 9.72 438 134320 149141 64214833
Gelastic seizure 22.41 9.72 5 134753 5 64363969
Folliculitis 22.34 9.72 18 134740 30059 64333915
Encephalopathy 22.31 9.72 204 134554 58615 64305359
Post concussion syndrome 22.22 9.72 14 134744 533 64363441
Mobility decreased 22.15 9.72 98 134660 85742 64278232
Hypoaesthesia 22.11 9.72 185 134573 138923 64225051
Enterocolitis 21.94 9.72 65 134693 11953 64352021
Respiratory dyskinesia 21.76 9.72 7 134751 49 64363925
Infusion related reaction 21.74 9.72 229 134529 164238 64199736
Inappropriate schedule of product administration 21.67 9.72 109 134649 92177 64271797
Diabetes insipidus 21.62 9.72 36 134722 4485 64359489
Cardiac failure congestive 21.51 9.72 172 134586 130408 64233566
Haematopoietic stem cell mobilisation 21.43 9.72 10 134748 206 64363768
Pancreatitis 21.24 9.72 204 134554 59403 64304571
Porphyria acute 21.00 9.72 15 134743 705 64363269
Thymus disorder 20.88 9.72 10 134748 219 64363755
Deep vein thrombosis 20.81 9.72 322 134436 104860 64259114
Hyponatraemic seizure 20.80 9.72 13 134745 488 64363486
Confusional state 20.63 9.72 702 134056 260442 64103532
Jaundice 20.34 9.72 172 134586 48340 64315634
COVID-19 20.25 9.72 69 134689 65071 64298903
Influenza 20.11 9.72 135 134623 106396 64257578
Injection site haemorrhage 20.03 9.72 13 134745 24265 64339709
Blood bicarbonate decreased 19.89 9.72 36 134722 4793 64359181
Ileus paralytic 19.84 9.72 50 134708 8365 64355609
Onychalgia 19.64 9.72 15 134743 782 64363192
Intentional self-injury 19.63 9.72 19 134739 29025 64334949
Ill-defined disorder 19.56 9.72 39 134719 44013 64319961
Hypoalbuminaemia 19.56 9.72 81 134677 17593 64346381
Herpes zoster 19.48 9.72 92 134666 79095 64284879
Sopor 19.36 9.72 20 134738 29641 64334333
Mouth ulceration 19.29 9.72 125 134633 32319 64331655
Excessive eye blinking 19.24 9.72 18 134740 1242 64362732
Throat irritation 19.24 9.72 24 134734 32687 64331287
Respiratory tract congestion 19.23 9.72 5 134753 16160 64347814
Tumour lysis syndrome 19.14 9.72 86 134672 19354 64344620
Hypocalcaemia 19.10 9.72 151 134607 41602 64322372
Klebsiella bacteraemia 19.08 9.72 24 134734 2316 64361658
Conjunctival irritation 18.99 9.72 8 134750 128 64363846
Toxic encephalopathy 18.80 9.72 54 134704 9761 64354213
Aortic rupture 18.75 9.72 9 134749 198 64363776
Heart rate increased 18.64 9.72 125 134633 98550 64265424
Lymphoid tissue hypoplasia 18.54 9.72 12 134746 479 64363495
Enterochromaffin cell hyperplasia 18.36 9.72 7 134751 85 64363889
Blood pressure diastolic decreased 18.32 9.72 12 134746 22289 64341685
Urosepsis 18.31 9.72 93 134665 22001 64341973
Skin candida 18.09 9.72 20 134738 1683 64362291
Respiratory syncytial virus infection 18.00 9.72 44 134714 7224 64356750
Therapy cessation 17.92 9.72 25 134733 32464 64331510
Immune-mediated hepatitis 17.91 9.72 24 134734 2465 64361509
Intestinal ischaemia 17.89 9.72 59 134699 11490 64352484
Multiple sclerosis relapse 17.77 9.72 37 134721 41098 64322876
Hepatitis fulminant 17.74 9.72 40 134718 6234 64357740
Tumour pain 17.66 9.72 21 134737 1912 64362062
Thymus hypoplasia 17.64 9.72 12 134746 521 64363453
Hospitalisation 17.56 9.72 89 134669 75118 64288856
Adverse event 17.50 9.72 35 134723 39454 64324520
Neutropenic colitis 17.42 9.72 33 134725 4548 64359426
Cardiac arrest 17.33 9.72 433 134325 153631 64210343
Cystitis noninfective 17.27 9.72 16 134742 1090 64362884
Malignant polyp 17.27 9.72 8 134750 162 64363812
Alveolitis 17.12 9.72 29 134729 3663 64360311
Diabetic gastroparesis 16.94 9.72 9 134749 247 64363727
Hypergastrinaemia 16.84 9.72 8 134750 172 64363802
Vascular access site occlusion 16.78 9.72 6 134752 60 64363914
Left ventricular dysfunction 16.69 9.72 75 134683 16879 64347095
Fluid retention 16.64 9.72 66 134692 59540 64304434
Road traffic accident 16.61 9.72 24 134734 30721 64333253
Hypochloraemia 16.58 9.72 21 134737 2040 64361934
Cholangitis 16.57 9.72 55 134703 10747 64353227
Polydipsia 16.33 9.72 37 134721 5784 64358190
Pituitary tumour benign 16.33 9.72 22 134736 2271 64361703
Emotional distress 16.30 9.72 130 134628 35908 64328066
Device issue 16.27 9.72 14 134744 22634 64341340
Product storage error 16.07 9.72 4 134754 13314 64350660
Acute interstitial pneumonitis 16.07 9.72 15 134743 1032 64362942
Failure to thrive 15.98 9.72 53 134705 10351 64353623
Gaze palsy 15.97 9.72 23 134735 2527 64361447
Hypophosphataemia 15.93 9.72 67 134691 14653 64349321
Irritability 15.92 9.72 33 134725 36713 64327261
Pseudomonal sepsis 15.78 9.72 34 134724 5138 64358836
Pruritus 15.74 9.72 515 134243 311885 64052089
Pancreatic carcinoma metastatic 15.71 9.72 27 134731 3451 64360523
Torticollis 15.67 9.72 21 134737 2156 64361818
Immune effector cell-associated neurotoxicity syndrome 15.66 9.72 23 134735 2572 64361402
Sudden death 15.56 9.72 83 134675 20013 64343961
Fibromyalgia 15.55 9.72 32 134726 35699 64328275
Acanthosis 15.52 9.72 10 134748 396 64363578
Enteritis 15.51 9.72 58 134700 12019 64351955
Nasal congestion 15.45 9.72 68 134690 59590 64304384
Obstruction gastric 15.39 9.72 17 134741 1429 64362545
Product quality issue 15.39 9.72 24 134734 29775 64334199
Incorrect dose administered 15.29 9.72 70 134688 60695 64303279
Illness 15.24 9.72 14 134744 21924 64342050
Disseminated aspergillosis 15.22 9.72 12 134746 656 64363318
Colorectal cancer metastatic 15.21 9.72 14 134744 946 64363028
Oxygen saturation abnormal 15.19 9.72 27 134731 3544 64360430
Eructation 15.18 9.72 48 134710 9143 64354831
Burning sensation 15.17 9.72 53 134705 49611 64314363
Opisthotonus 15.17 9.72 12 134746 659 64363315
Cachexia 15.10 9.72 48 134710 9169 64354805
Embolism 15.09 9.72 58 134700 12177 64351797
Memory impairment 14.98 9.72 111 134647 85571 64278403
Non-cardiac chest pain 14.95 9.72 46 134712 8634 64355340
Urinary retention 14.95 9.72 163 134595 49038 64314936
Vitamin B12 decreased 14.87 9.72 23 134735 2692 64361282
Therapy interrupted 14.87 9.72 12 134746 20024 64343950
Spleen congestion 14.75 9.72 10 134748 432 64363542
Tooth disorder 14.74 9.72 15 134743 22387 64341587
Electrocardiogram T wave inversion 14.74 9.72 32 134726 4862 64359112
Metastatic malignant melanoma 14.59 9.72 22 134736 2519 64361455
Mesothelioma 14.52 9.72 9 134749 333 64363641
Tumour perforation 14.49 9.72 9 134749 334 64363640
Bacteraemia 14.39 9.72 101 134657 26810 64337164
Biliary dyskinesia 14.28 9.72 21 134737 2351 64361623
Clonus 14.26 9.72 36 134722 6031 64357943
Immunodeficiency 14.19 9.72 8 134750 16116 64347858
Balance disorder 14.07 9.72 110 134648 83816 64280158
Pulmonary sepsis 14.06 9.72 24 134734 3051 64360923
Laryngeal cancer metastatic 13.98 9.72 5 134753 50 64363924
Bronchitis 13.73 9.72 153 134605 108590 64255384
Dyspepsia 13.71 9.72 240 134518 80072 64283902
Hyperthermia malignant 13.71 9.72 21 134737 2438 64361536
Myalgia 13.67 9.72 241 134517 158376 64205598
Palmar-plantar erythrodysaesthesia syndrome 13.61 9.72 105 134653 28714 64335260
Adrenal insufficiency 13.59 9.72 87 134671 22400 64341574
Rash 13.55 9.72 802 133956 457747 63906227
Extravasation blood 13.45 9.72 9 134749 380 64363594
Tenosynovitis 13.44 9.72 4 134754 11829 64352145
Blood pressure diastolic increased 13.43 9.72 3 134755 10749 64353225
Hyperbilirubinaemia 13.41 9.72 83 134675 21122 64342852
Insomnia 13.34 9.72 313 134445 197523 64166451
Chills 13.20 9.72 378 134380 136886 64227088
Tracheal injury 13.17 9.72 5 134753 60 64363914
Gallbladder injury 13.10 9.72 14 134744 1134 64362840
Foetal malpresentation 13.09 9.72 5 134753 61 64363913
Mania 13.06 9.72 9 134749 16277 64347697
Musculoskeletal disorder 12.95 9.72 11 134747 17895 64346079
Mucosal erosion 12.93 9.72 18 134740 1916 64362058
No adverse event 12.93 9.72 25 134733 28536 64335438
Joint effusion 12.88 9.72 6 134752 13467 64350507
Angioedema 12.87 9.72 76 134682 61745 64302229
Escherichia test positive 12.85 9.72 22 134736 2803 64361171
Ocular hyperaemia 12.81 9.72 17 134741 22547 64341427
Immune reconstitution inflammatory syndrome 12.80 9.72 5 134753 12465 64351509
Faecaloma 12.73 9.72 47 134711 9681 64354293
Delusional disorder, persecutory type 12.71 9.72 9 134749 417 64363557
Neutropenic infection 12.71 9.72 18 134740 1947 64362027
Oesophageal ulcer 12.71 9.72 35 134723 6175 64357799
Neutrophilic dermatosis 12.71 9.72 10 134748 545 64363429
Radiation pneumonitis 12.69 9.72 24 134734 3304 64360670
Seizure 12.50 9.72 446 134312 166446 64197528
Vascular encephalopathy 12.44 9.72 10 134748 562 64363412
Death 12.42 9.72 855 133903 481850 63882124
Heart rate irregular 12.40 9.72 24 134734 27389 64336585
Bursitis 12.39 9.72 16 134742 21469 64342505
Flail chest 12.34 9.72 5 134753 72 64363902
COVID-19 treatment 12.32 9.72 9 134749 438 64363536
Seborrhoeic dermatitis 12.22 9.72 17 134741 1809 64362165
Multiple drug therapy 12.21 9.72 19 134739 2235 64361739
Myoclonus 12.13 9.72 92 134666 25026 64338948
Leukoencephalopathy 12.08 9.72 37 134721 6930 64357044
Nail infection 12.07 9.72 17 134741 1830 64362144
Paradoxical drug reaction 12.04 9.72 34 134724 6086 64357888
Aminoaciduria 12.04 9.72 7 134751 230 64363744
Overdose 12.04 9.72 248 134510 159318 64204656
Tooth fracture 11.94 9.72 3 134755 9924 64354050
Sleep apnoea syndrome 11.93 9.72 28 134730 29804 64334170
Glaucoma 11.88 9.72 10 134748 16338 64347636
Intestinal obstruction 11.86 9.72 122 134636 36164 64327810
Cytomegalovirus infection 11.83 9.72 39 134719 37160 64326814
Chemotherapeutic drug level increased 11.83 9.72 8 134750 344 64363630
Joint stiffness 11.79 9.72 29 134729 30375 64333599
Hypoglycaemic seizure 11.78 9.72 11 134747 757 64363217
Suicidal ideation 11.73 9.72 86 134672 66456 64297518
Generalised oedema 11.59 9.72 79 134679 20774 64343200
Prostate cancer metastatic 11.59 9.72 23 134735 3281 64360693
Acne 11.53 9.72 19 134739 23062 64340912
Urinary tract infection 11.52 9.72 593 134165 231003 64132971
Erectile dysfunction 11.50 9.72 6 134752 12621 64351353
Body temperature decreased 11.47 9.72 23 134735 25905 64338069
Pericardial effusion 11.45 9.72 129 134629 39125 64324849
Impaired work ability 11.44 9.72 9 134749 15210 64348764
Injection site warmth 11.39 9.72 7 134751 13455 64350519
Pathogen resistance 11.36 9.72 6 134752 12537 64351437
Blood pH decreased 11.28 9.72 27 134731 4375 64359599
Post transplant lymphoproliferative disorder 11.26 9.72 3 134755 9541 64354433
Delirium 11.18 9.72 205 134553 68989 64294985
Febrile infection 11.16 9.72 21 134737 2880 64361094
Muscle spasticity 11.15 9.72 11 134747 16658 64347316
Blood aluminium increased 11.14 9.72 3 134755 10 64363964
Abdominal tenderness 11.12 9.72 44 134714 9361 64354613
Carpal tunnel syndrome 11.11 9.72 10 134748 15818 64348156
Vascular pain 11.10 9.72 11 134747 815 64363159
Intercepted product administration error 11.06 9.72 6 134752 172 64363802
Blood sodium decreased 11.05 9.72 102 134656 29380 64334594
Poor quality sleep 11.04 9.72 14 134744 18937 64345037
Foot deformity 10.92 9.72 11 134747 16493 64347481
Cardiac disorder 10.90 9.72 70 134688 55746 64308228
Eye pain 10.88 9.72 32 134726 31593 64332381
Cholelithiasis 10.86 9.72 144 134614 45362 64318612
Restless arm syndrome 10.84 9.72 4 134754 44 64363930
Performance status decreased 10.75 9.72 30 134728 5334 64358640
Increased tendency to bruise 10.75 9.72 3 134755 9252 64354722
Naevus haemorrhage 10.72 9.72 5 134753 103 64363871
Stress cardiomyopathy 10.70 9.72 43 134715 9214 64354760
Catheter site bruise 10.65 9.72 7 134751 287 64363687
Abdominal compartment syndrome 10.63 9.72 14 134744 1414 64362560
Plantar erythema 10.63 9.72 7 134751 288 64363686
Abdominal sepsis 10.60 9.72 16 134742 1834 64362140
Muscle twitching 10.57 9.72 72 134686 18926 64345048
Hypoacusis 10.57 9.72 24 134734 25843 64338131
Sinus congestion 10.55 9.72 10 134748 15429 64348545
Systemic infection 10.53 9.72 26 134732 4295 64359679
Underdose 10.52 9.72 24 134734 25805 64338169
Transfusion 10.50 9.72 69 134689 17925 64346049
Eastern Cooperative Oncology Group performance status worsened 10.49 9.72 13 134745 1235 64362739
Retching 10.47 9.72 61 134697 15195 64348779
Respiratory failure 10.46 9.72 424 134334 160759 64203215
Sinus tachycardia 10.42 9.72 108 134650 32080 64331894
Alopecia 10.39 9.72 265 134493 165425 64198549
Sinus disorder 10.37 9.72 12 134746 16896 64347078
Numb chin syndrome 10.35 9.72 3 134755 14 64363960
Thrombosis 10.31 9.72 96 134662 70546 64293428
Limb injury 10.27 9.72 21 134737 23484 64340490
Porphyria 10.27 9.72 6 134752 199 64363775
Back disorder 10.27 9.72 4 134754 9986 64353988
Visual impairment 10.25 9.72 102 134656 73975 64289999
Pancreatitis haemorrhagic 10.19 9.72 9 134749 576 64363398
Faecalith 10.18 9.72 3 134755 15 64363959
Disturbance in social behaviour 10.13 9.72 24 134734 3863 64360111
Surgery 10.11 9.72 28 134730 28185 64335789
Progressive multifocal leukoencephalopathy 10.08 9.72 14 134744 18218 64345756
Mood swings 10.08 9.72 13 134745 17455 64346519
Grip strength decreased 10.06 9.72 6 134752 11718 64352256
Alanine aminotransferase increased 10.03 9.72 370 134388 138661 64225313
Morning sickness 10.02 9.72 8 134750 445 64363529
Transplant rejection 9.99 9.72 13 134745 17388 64346586
Foot fracture 9.98 9.72 14 134744 18143 64345831
Dyschezia 9.97 9.72 18 134740 2392 64361582
Immune-mediated enterocolitis 9.94 9.72 19 134739 2637 64361337
Spinal cord injury thoracic 9.91 9.72 5 134753 123 64363851
Circulatory collapse 9.90 9.72 111 134647 33621 64330353
Vocal cord inflammation 9.90 9.72 6 134752 213 64363761
Generalised tonic-clonic seizure 9.88 9.72 127 134631 39730 64324244
Device breakage 9.87 9.72 3 134755 8752 64355222
Electrocardiogram change 9.82 9.72 12 134746 1124 64362850
Injection site mass 9.81 9.72 13 134745 17257 64346717
Lung infiltration 9.80 9.72 76 134682 20813 64343161
Hyperpyrexia 9.79 9.72 28 134730 5049 64358925
Gastroenteritis clostridial 9.75 9.72 10 134748 772 64363202

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 (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 2A GPCR Ki 5.98 DRUG MATRIX
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
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
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 5.99 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 AGONIST Ki 6 IUPHAR
5-hydroxytryptamine receptor 4 GPCR Ki 6.26 CHEMBL

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 0121-1576 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 0409-3414 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 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
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 42291-595 TABLET 5 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 42291-596 TABLET 10 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 43353-274 TABLET 10 mg ORAL ANDA 22 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-808 TABLET 10 mg ORAL ANDA 22 sections