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

Stem definitionDrug idCAS RN
725 76-57-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • codeine phosphate anhydrous
  • codeine anhydrous
  • codeine monohydrate
  • codeine
  • (-)-Codeine
  • morphine monomethyl ether
  • methylmorphine
  • codeine phosphate
  • codeine sulfate
  • codeine phosphate hydrate
  • codeine polistirex
  • N-Methylmorphine
An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.
  • Molecular weight: 299.37
  • Formula: C18H21NO3
  • CLOGP: 0.98
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 41.93
  • ALOGS: -2.72
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 435 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 15 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.899 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.432 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 16.866 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 19.409 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 75.590 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 84 % High 1
herg hERG pIC50 4.496 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.275 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 5.998 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 75.760 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MET,NTRK2,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TGFBR1,ZAP70 43
kinase-selectivity-class EIF2AK3 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.141 High 1
mh-clint Mouse hepatocyte intrinsic clearance 41.020 High 1
mppb Mouse plasma protein binding (% unbound) 67.120 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 10.814 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 86.070 % High 1
rh-clint Rat hepatocyte intrinsic clearance 73.621 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 86.850 % High 1
rppb Rat plasma protein binding (% unbound) 65.060 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 941.890 uM High 1

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 1952 FDA ANI PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 3921.21 12.55 5225 216894 458384 89947944
Rheumatoid arthritis 639.05 12.55 2147 219972 360467 90045861
Blood parathyroid hormone decreased 480.14 12.55 325 221794 11891 90394437
Granuloma skin 441.04 12.55 293 221826 10387 90395941
Panniculitis 433.09 12.55 326 221793 14132 90392196
Rheumatoid nodule 394.58 12.55 355 221764 19811 90386517
Drug intolerance 393.53 12.55 2146 219973 445445 89960883
Product dose omission issue 367.49 12.55 128 221991 291559 90114769
Skin necrosis 352.89 12.55 309 221810 16632 90389696
Fall 342.75 12.55 406 221713 481404 89924924
Infusion related reaction 317.52 12.55 1924 220195 414856 89991472
Hepatic enzyme increased 311.68 12.55 1722 220397 359014 90047314
Rheumatoid factor positive 290.79 12.55 1004 221115 170646 90235682
Urinary tract infection 288.30 12.55 198 221921 305434 90100894
Hypersensitivity 280.59 12.55 1991 220128 452686 89953642
C-reactive protein abnormal 275.78 12.55 811 221308 126618 90279710
Deep vein thrombosis postoperative 264.08 12.55 555 221564 70254 90336074
Prescribed overdose 251.38 12.55 662 221457 96963 90309365
Autoimmune disorder 247.06 12.55 567 221552 76177 90330151
Food allergy 246.10 12.55 308 221811 25170 90381158
Contraindicated product administered 241.74 12.55 1475 220644 318664 90087664
Anaemia 235.33 12.55 312 221807 352490 90053838
Bursitis 234.28 12.55 783 221336 130871 90275457
Drug tolerance decreased 233.30 12.55 338 221781 31792 90374536
Hypercalcaemia 231.06 12.55 348 221771 33892 90372436
Basal cell carcinoma 227.66 12.55 341 221778 33048 90373280
Helicobacter infection 226.74 12.55 1128 220991 225722 90180606
Joint swelling 225.34 12.55 2048 220071 501252 89905076
Duodenal ulcer perforation 225.20 12.55 1106 221013 220182 90186146
Ulcer 220.18 12.55 333 221786 32549 90373779
Hypotension 216.76 12.55 288 221831 325109 90081219
Fibromyalgia 214.22 12.55 1037 221082 205232 90201096
Contrast media allergy 211.21 12.55 117 222002 2964 90403364
Synovitis 210.22 12.55 1456 220663 328296 90078032
COVID-19 204.24 12.55 79 222040 168764 90237564
Treatment failure 203.26 12.55 1358 220761 302570 90103758
Neutropenia 202.47 12.55 153 221966 224751 90181577
Injection site pain 202.42 12.55 86 222033 173613 90232715
Red blood cell sedimentation rate increased 200.44 12.55 548 221571 82047 90324281
Adjustment disorder with depressed mood 200.28 12.55 435 221684 56318 90350010
Blood cholesterol increased 198.48 12.55 1021 221098 206991 90199337
Drug eruption 196.37 12.55 329 221790 35078 90371250
Musculoskeletal stiffness 195.92 12.55 1321 220798 295211 90111117
Skin ulcer 195.50 12.55 400 221719 49675 90356653
Swollen joint count increased 192.19 12.55 655 221464 110551 90295777
Pancytopenia 189.65 12.55 33 222086 120230 90286098
Dehydration 187.25 12.55 123 221996 194324 90212004
Acute kidney injury 184.84 12.55 313 221806 320074 90086254
Sleep disorder due to general medical condition, insomnia type 183.48 12.55 712 221407 127982 90278346
Peripheral swelling 177.66 12.55 1667 220452 411439 89994889
Musculoskeletal pain 176.36 12.55 859 221260 170392 90235936
Muscle injury 172.63 12.55 873 221246 175781 90230547
Tenosynovitis 171.83 12.55 195 221924 14372 90391956
Anti-cyclic citrullinated peptide antibody positive 171.82 12.55 1079 221040 235354 90170974
Disease progression 170.90 12.55 85 222034 156530 90249798
Lower limb fracture 170.62 12.55 527 221592 84486 90321842
Temperature regulation disorder 166.63 12.55 192 221927 14387 90391941
Immunodeficiency 164.82 12.55 342 221777 42892 90363436
Joint range of motion decreased 160.75 12.55 709 221410 134934 90271394
Lower respiratory tract infection 157.99 12.55 1104 221015 249555 90156773
Injection site erythema 157.58 12.55 26 222093 98476 90307852
Dislocation of vertebra 156.93 12.55 392 221727 55576 90350752
Lip dry 156.70 12.55 574 221545 100381 90305947
Folliculitis 156.26 12.55 945 221174 203408 90202920
Mobility decreased 154.92 12.55 1099 221020 249635 90156693
Psoriatic arthropathy 154.82 12.55 1024 221095 227311 90179017
Inflammation 154.23 12.55 853 221266 177739 90228589
Liver injury 153.57 12.55 824 221295 169743 90236585
Rheumatic fever 151.90 12.55 760 221359 152361 90253967
Injury 149.87 12.55 911 221208 196438 90209890
Arthropathy 148.55 12.55 1460 220659 364782 90041546
Pulmonary fibrosis 148.54 12.55 589 221530 106914 90299414
Hypercholesterolaemia 145.26 12.55 560 221559 100332 90305996
Sciatica 143.75 12.55 560 221559 100822 90305506
Blister 142.87 12.55 1092 221027 253906 90152422
X-ray abnormal 142.20 12.55 332 221787 45092 90361236
Discomfort 141.73 12.55 1153 220966 273182 90133146
Therapeutic product effect decreased 140.39 12.55 1161 220958 276410 90129918
Road traffic accident 138.64 12.55 577 221542 107049 90299279
Sepsis 136.95 12.55 143 221976 179671 90226657
Hypertension 134.54 12.55 1712 220407 455820 89950508
Death 134.04 12.55 619 221500 455932 89950396
Neuropathy peripheral 132.72 12.55 86 222033 136884 90269444
Platelet count decreased 132.72 12.55 86 222033 136883 90269445
Foetal death 131.88 12.55 205 221914 20518 90385810
Substance abuse 131.87 12.55 108 222011 5298 90401030
Contusion 129.29 12.55 1055 221064 250161 90156167
Atrial fibrillation 127.96 12.55 85 222034 133526 90272802
Delirium 127.83 12.55 551 221568 103808 90302520
Peripheral venous disease 125.08 12.55 471 221648 83450 90322878
Liver disorder 124.59 12.55 608 221511 120661 90285667
Febrile neutropenia 123.92 12.55 123 221996 158226 90248102
Product use issue 123.09 12.55 1293 220826 328626 90077702
Renal failure 119.30 12.55 88 222031 130919 90275409
Irritable bowel syndrome 114.83 12.55 886 221233 206562 90199766
Hand deformity 114.57 12.55 1170 220949 295192 90111136
Haemoglobin decreased 114.35 12.55 137 221982 161819 90244509
Pericarditis 112.91 12.55 1084 221035 269067 90137261
Type 2 diabetes mellitus 112.47 12.55 868 221251 202376 90203952
Cerebrovascular accident 112.46 12.55 83 222036 123450 90282878
White blood cell count decreased 112.09 12.55 147 221972 166962 90239366
Cough 111.38 12.55 495 221624 368467 90037861
Toxicity to various agents 110.13 12.55 1134 220985 286712 90119616
Drug abuse 108.02 12.55 444 221675 81903 90324425
Asthma 107.85 12.55 985 221134 241175 90165153
Adverse event 106.16 12.55 568 221551 116850 90289478
Rash pruritic 106.05 12.55 441 221678 81773 90324555
Drug use disorder 105.81 12.55 116 222003 8227 90398101
Therapy interrupted 105.14 12.55 4 222115 50104 90356224
Pulmonary embolism 104.22 12.55 100 222019 130720 90275608
Respiratory failure 103.42 12.55 83 222036 118335 90287993
Lung disorder 103.24 12.55 675 221444 149208 90257120
Injection site swelling 99.81 12.55 14 222105 59825 90346503
Infection 99.68 12.55 1339 220780 360755 90045573
Enthesopathy 99.41 12.55 119 222000 9285 90397043
Red blood cell sedimentation rate 99.09 12.55 86 222033 4572 90401756
Swollen tongue 98.87 12.55 292 221827 45664 90360664
Obesity 96.48 12.55 512 221607 104995 90301333
C-reactive protein increased 96.12 12.55 767 221352 180622 90225706
Night sweats 95.54 12.55 591 221528 128175 90278153
Gastric pH decreased 94.91 12.55 47 222072 939 90405389
C-reactive protein 94.63 12.55 226 221893 31141 90375187
Grip strength 94.04 12.55 113 222006 8852 90397476
Hypokalaemia 93.52 12.55 110 222009 131006 90275322
Soft tissue disorder 92.87 12.55 80 222039 4210 90402118
Impaired healing 92.10 12.55 928 221191 233271 90173057
Pleural effusion 89.92 12.55 85 222034 111906 90294422
Facet joint syndrome 88.96 12.55 476 221643 97913 90308415
Tongue disorder 88.86 12.55 121 221998 10739 90395589
Dry skin 88.49 12.55 53 222066 88020 90318308
Chest discomfort 88.47 12.55 126 221993 138239 90268089
Deformity 88.30 12.55 128 221991 12042 90394286
Device expulsion 86.70 12.55 3 222116 40883 90365445
Nausea 85.15 12.55 2073 220046 1108243 89298085
Accidental exposure to product 83.69 12.55 5 222114 42361 90363967
Renal impairment 83.49 12.55 81 222038 105340 90300988
Influenza like illness 83.13 12.55 47 222072 80564 90325764
Ill-defined disorder 82.76 12.55 753 221366 184138 90222190
Injection site pruritus 82.21 12.55 16 222103 53818 90352510
Loss of employment 82.09 12.55 64 222055 2923 90403405
Glossodynia 82.07 12.55 1174 220945 320605 90085723
Derealisation 82.04 12.55 49 222070 1436 90404892
Intentional product misuse 81.35 12.55 434 221685 89170 90317158
Overdose 80.90 12.55 662 221457 157047 90249281
Urticaria 80.55 12.55 1143 220976 311591 90094737
Depersonalisation/derealisation disorder 80.29 12.55 50 222069 1582 90404746
Gait inability 79.61 12.55 623 221496 145833 90260495
Lupus vulgaris 77.45 12.55 265 221854 44794 90361534
Unevaluable event 76.35 12.55 20 222099 54828 90351500
White blood cell count abnormal 76.13 12.55 93 222026 7411 90398917
Amnesia 76.13 12.55 491 221628 108014 90298314
Loss of personal independence in daily activities 75.66 12.55 582 221537 135523 90270805
Chronic obstructive pulmonary disease 74.77 12.55 44 222075 73785 90332543
Wound 74.71 12.55 1099 221020 301881 90104447
Pneumonia 74.50 12.55 1108 221011 636951 89769377
Stomatitis 74.38 12.55 1013 221106 273685 90132643
Osteoarthritis 73.80 12.55 769 221350 194961 90211367
Blood potassium decreased 73.28 12.55 14 222105 47713 90358615
Full blood count abnormal 73.27 12.55 4 222115 36593 90369735
Rash 72.52 12.55 2504 219615 793596 89612732
Influenza 72.27 12.55 145 221974 139119 90267209
Porphyria acute 71.82 12.55 145 221974 17830 90388498
Hypoaesthesia 71.41 12.55 1124 220995 313086 90093242
Abdominal distension 70.36 12.55 133 221986 130468 90275860
Dry mouth 70.27 12.55 725 221394 183334 90222994
Hyperkalaemia 69.73 12.55 36 222083 64928 90341400
Chills 69.71 12.55 136 221983 131845 90274483
Retinitis 69.47 12.55 230 221889 38228 90368100
Sleep disorder 68.61 12.55 765 221354 197265 90209063
H1N1 influenza 68.50 12.55 49 222070 1961 90404367
Obliterative bronchiolitis 68.43 12.55 55 222064 2626 90403702
Wrong technique in product usage process 67.88 12.55 46 222073 71525 90334803
Malignant neoplasm progression 67.64 12.55 98 222021 106772 90299556
Multiple sclerosis relapse 67.44 12.55 22 222097 52283 90354045
Premature delivery 67.22 12.55 8 222111 38754 90367574
Hyperhidrosis 67.14 12.55 567 221552 135738 90270590
Injection site reaction 67.01 12.55 76 222043 92004 90314324
Mental status changes 66.73 12.55 14 222105 44665 90361663
Hypoxia 66.72 12.55 48 222071 72351 90333977
Oxygen saturation decreased 66.63 12.55 100 222019 107383 90298945
Haemorrhage 66.58 12.55 44 222075 69325 90337003
Hyperglycaemia 66.50 12.55 21 222098 50949 90355379
Bone erosion 66.49 12.55 282 221837 52739 90353589
Pulmonary hypertension 66.30 12.55 12 222107 42511 90363817
Breast cancer stage II 66.24 12.55 214 221905 35120 90371208
Drug ineffective 65.66 12.55 2752 219367 1381546 89024782
Macular degeneration 65.45 12.55 8 222111 37962 90368366
Sinus disorder 65.31 12.55 5 222114 34442 90371886
Deep vein thrombosis 65.19 12.55 77 222042 91543 90314785
Haematocrit decreased 64.80 12.55 12 222107 41820 90364508
Musculoskeletal disorder 64.75 12.55 156 221963 21613 90384715
Therapy cessation 64.32 12.55 7 222112 36354 90369974
Septic shock 63.97 12.55 67 222052 84093 90322235
Fatigue 63.71 12.55 2253 219866 1151770 89254558
Bradycardia 63.45 12.55 67 222052 83780 90322548
Gastrointestinal disorder 63.23 12.55 931 221188 255756 90150572
Haematochezia 62.80 12.55 49 222070 70864 90335464
Drug interaction 62.77 12.55 408 221711 276045 90130283
Asphyxia 62.50 12.55 82 222037 7021 90399307
Subcutaneous drug absorption impaired 62.34 12.55 116 222003 13429 90392899
Cogwheel rigidity 62.06 12.55 47 222072 2055 90404273
Blood calcium decreased 61.37 12.55 3 222116 30179 90376149
Hip arthroplasty 61.12 12.55 357 221762 75851 90330477
Blood glucose increased 60.62 12.55 87 222032 95159 90311169
Maternal exposure timing unspecified 60.43 12.55 155 221964 22328 90384000
Grip strength decreased 60.15 12.55 411 221708 92165 90314163
Pemphigus 60.05 12.55 1130 220989 325734 90080594
Suicide attempt 59.62 12.55 58 222061 75341 90330987
Transient ischaemic attack 59.61 12.55 16 222103 43160 90363168
Feeling abnormal 59.53 12.55 210 221909 167025 90239303
Agranulocytosis 58.82 12.55 8 222111 34994 90371334
Skin exfoliation 58.79 12.55 48 222071 67865 90338463
Fungal infection 58.54 12.55 16 222103 42645 90363683
Myalgia 58.34 12.55 226 221893 174899 90231429
Staphylococcal infection 57.99 12.55 23 222096 48416 90357912
Inappropriate schedule of product administration 57.67 12.55 182 221937 149751 90256577
Bone marrow failure 57.52 12.55 6 222113 32215 90374113
Dysphagia 57.32 12.55 118 222001 112160 90294168
Onychomycosis 57.30 12.55 11 222108 37365 90368963
Walking aid user 56.85 12.55 204 221915 35302 90371026
Wound infection 56.37 12.55 450 221669 105952 90300376
Thrombosis 56.03 12.55 58 222061 73193 90333135
Surgery 55.93 12.55 20 222099 44867 90361461
Wheezing 55.71 12.55 856 221263 237224 90169104
Lactic acidosis 55.61 12.55 27 222092 50436 90355892
Foetal exposure during pregnancy 55.54 12.55 18 222101 42957 90363371
Acute respiratory failure 55.43 12.55 18 222101 42900 90363428
Chronic kidney disease 55.09 12.55 27 222092 50164 90356164
Breast cancer stage III 54.32 12.55 374 221745 84073 90322255
Cognitive disorder 54.18 12.55 54 222065 69353 90336975
Pericardial effusion 54.07 12.55 12 222107 36821 90369507
Device issue 54.04 12.55 5 222114 29532 90376796
Disease recurrence 53.82 12.55 13 222106 37640 90368688
Hypoglycaemia 53.77 12.55 55 222064 69793 90336535
Tendonitis 53.02 12.55 143 221976 21229 90385099
Cytomegalovirus infection 52.97 12.55 3 222116 26599 90379729
Myelosuppression 52.78 12.55 33 222086 53558 90352770
Drug dependence 52.62 12.55 175 221944 29152 90377176
Palpitations 52.56 12.55 166 221953 136562 90269766
Gastrointestinal haemorrhage 52.12 12.55 88 222031 90160 90316168
Upper respiratory tract infection 52.11 12.55 512 221607 127806 90278522
Myocardial infarction 51.90 12.55 114 222005 105858 90300470
General physical health deterioration 51.27 12.55 1185 220934 353930 90052398
Swelling face 50.39 12.55 357 221762 80995 90325333
Dyspnoea exertional 50.10 12.55 62 222057 72226 90334102
Abortion spontaneous 49.60 12.55 36 222083 54020 90352308
Feeling of despair 48.57 12.55 49 222070 3155 90403173
Sopor 48.40 12.55 3 222116 24641 90381687
Arthritis 48.14 12.55 624 221495 166691 90239637
Oedema 47.95 12.55 723 221396 199572 90206756
Neutrophil count decreased 47.87 12.55 63 222056 71469 90334859
Rash erythematous 47.75 12.55 298 221821 64806 90341522
Seizure 47.67 12.55 202 221917 152427 90253901
Abdominal pain upper 47.36 12.55 1108 221011 331566 90074762
Blood pressure increased 47.36 12.55 286 221833 196931 90209397
Epistaxis 47.34 12.55 85 222034 85040 90321288
Dyspnoea 47.33 12.55 1725 220394 879230 89527098
Full blood count decreased 47.11 12.55 8 222111 29681 90376647
Multiple organ dysfunction syndrome 46.95 12.55 59 222060 68277 90338051
Hospitalisation 46.16 12.55 160 221959 127940 90278388
Exostosis 45.95 12.55 254 221865 52880 90353448
Anti-cyclic citrullinated peptide antibody 45.82 12.55 159 221960 27062 90379266
Psoriasis 45.47 12.55 558 221561 147196 90259132
Toxicologic test abnormal 45.31 12.55 26 222093 706 90405622
Injection site bruising 45.24 12.55 37 222082 52270 90354058
Prescribed underdose 45.19 12.55 327 221792 74692 90331636
Flushing 45.17 12.55 93 222026 88398 90317930
Eosinophilia 44.60 12.55 8 222111 28525 90377803
Haematuria 44.51 12.55 15 222104 34922 90371406
Blood pressure fluctuation 44.19 12.55 38 222081 52375 90353953
Overlap syndrome 44.19 12.55 77 222042 8471 90397857
Oropharyngeal pain 44.16 12.55 140 221979 115047 90291281
Hypervolaemia 43.63 12.55 13 222106 32744 90373584
Mitral valve incompetence 43.47 12.55 3 222116 22521 90383807
Feeling of body temperature change 43.31 12.55 61 222058 5588 90400740
Gastrooesophageal reflux disease 43.28 12.55 235 221884 166102 90240226
Rhinorrhoea 43.25 12.55 95 222024 88221 90318107
Confusional state 43.24 12.55 1246 220873 384959 90021369
Throat irritation 42.67 12.55 34 222085 48661 90357667
Abdominal discomfort 42.48 12.55 1498 220621 475830 89930498
Cardiac failure congestive 42.17 12.55 114 222005 98580 90307748
Pustular psoriasis 41.92 12.55 120 221999 18436 90387892
Presyncope 41.68 12.55 13 222106 31792 90374536
Diabetes mellitus 41.53 12.55 59 222060 64816 90341512
Lymphopenia 41.52 12.55 4 222115 22877 90383451
Nasal congestion 41.45 12.55 89 222030 83325 90323003
No adverse event 41.40 12.55 64 222055 67918 90338410
Asthenia 41.39 12.55 994 221125 532757 89873571
Lymphocyte count decreased 41.37 12.55 17 222102 35033 90371295
Respiratory distress 41.18 12.55 22 222097 38924 90367404
Bone pain 41.06 12.55 55 222064 61928 90344400
Bronchitis 40.93 12.55 214 221905 152713 90253615
Transaminases increased 40.83 12.55 20 222099 37172 90369156
Head injury 40.42 12.55 13 222106 31175 90375153
Visual acuity reduced 40.18 12.55 5 222114 23405 90382923
Emotional distress 39.82 12.55 20 222099 36642 90369686
Ascites 39.78 12.55 35 222084 47705 90358623
Swollen joint count 39.69 12.55 74 222045 8579 90397749
Blood pressure decreased 39.69 12.55 77 222042 74818 90331510
Toxic epidermal necrolysis 39.67 12.55 15 222104 32513 90373815
Poisoning deliberate 39.59 12.55 109 222010 16377 90389951
Cellulitis 39.40 12.55 105 222014 91232 90315096
General symptom 39.29 12.55 101 222018 14567 90391761
Plasma cell myeloma 39.04 12.55 26 222093 40802 90365526
Blood urea increased 38.84 12.55 13 222106 30400 90375928
Cerebral haemorrhage 38.76 12.55 18 222101 34504 90371824
Encephalopathy 38.76 12.55 34 222085 46410 90359918
Visceral congestion 38.76 12.55 19 222100 371 90405957
Libido increased 38.72 12.55 33 222086 1711 90404617
Systemic lupus erythematosus 38.71 12.55 1161 220958 360735 90045593
Lupus-like syndrome 38.63 12.55 228 221891 48618 90357710
Urinary incontinence 38.59 12.55 22 222097 37544 90368784
Electrolyte imbalance 38.57 12.55 6 222113 23739 90382589
Drug reaction with eosinophilia and systemic symptoms 38.55 12.55 29 222090 42729 90363599
Haematoma 38.52 12.55 24 222095 39024 90367304
Renal papillary necrosis 38.02 12.55 17 222102 267 90406061
Alanine aminotransferase abnormal 37.81 12.55 56 222063 5370 90400958
Intervertebral disc protrusion 37.69 12.55 10 222109 27186 90379142
Pregnancy 37.68 12.55 271 221848 61776 90344552
Rash vesicular 37.60 12.55 114 222005 18083 90388245
Proteinuria 37.57 12.55 6 222113 23285 90383043
Fluid retention 37.49 12.55 355 221764 87736 90318592
Adverse reaction 37.43 12.55 13 222106 29699 90376629
Breast cancer 37.37 12.55 46 222073 53715 90352613
Miosis 37.29 12.55 76 222043 9408 90396920
Hot flush 37.20 12.55 55 222064 59433 90346895
Therapy partial responder 37.13 12.55 5 222114 22038 90384290
Incorrect dose administered 36.95 12.55 87 222032 78843 90327485
Hyponatraemia 36.79 12.55 185 221934 133353 90272975
Wrist surgery 36.79 12.55 25 222094 920 90405408
Knee arthroplasty 36.79 12.55 338 221781 82844 90323484
Hypocalcaemia 36.60 12.55 30 222089 42338 90363990
Procedural pain 36.53 12.55 18 222101 33342 90372986
Generalised tonic-clonic seizure 36.49 12.55 20 222099 34883 90371445
Acute myeloid leukaemia 36.44 12.55 4 222115 20636 90385692
Adverse drug reaction 36.02 12.55 441 221678 116260 90290068
Hepatic cirrhosis 35.98 12.55 272 221847 62981 90343347
Laryngitis 35.79 12.55 230 221889 50523 90355805
Skin haemorrhage 35.66 12.55 5 222114 21375 90384953
Coronary artery disease 35.54 12.55 19 222100 33604 90372724
Cardiomyopathy 35.46 12.55 4 222115 20202 90386126
Skin laceration 35.28 12.55 10 222109 26025 90380303
Cardiac arrest 35.21 12.55 135 221984 104800 90301528
Pain in extremity 35.19 12.55 838 221281 449691 89956637
Pancreatic fibrosis 35.18 12.55 12 222107 86 90406242
Back disorder 35.03 12.55 140 221979 25491 90380837
Therapy non-responder 34.88 12.55 499 221620 136205 90270123
Patient uncooperative 34.86 12.55 16 222103 268 90406060
Device malfunction 34.77 12.55 5 222114 20972 90385356
Burning sensation 34.71 12.55 64 222055 63388 90342940
Osteonecrosis of jaw 34.64 12.55 27 222092 39076 90367252
Cerebral infarction 34.62 12.55 11 222108 26585 90379743
Hip fracture 34.51 12.55 19 222100 33058 90373270
Decreased appetite 34.29 12.55 1185 220934 375355 90030973
Skin lesion 34.13 12.55 25 222094 37340 90368988
Dysuria 33.91 12.55 28 222091 39373 90366955
Back pain 33.80 12.55 560 221559 316615 90089713
Respiratory tract infection 33.75 12.55 58 222061 59020 90347308
Product dose omission in error 33.72 12.55 5 222114 20498 90385830
Acute myocardial infarction 33.65 12.55 22 222097 34868 90371460
Neurotoxicity 33.59 12.55 6 222113 21461 90384867
Soft tissue injury 33.57 12.55 33 222086 2059 90404269
Femur fracture 33.56 12.55 38 222081 46044 90360284
Drooling 33.25 12.55 48 222071 4498 90401830
Muscle disorder 33.20 12.55 53 222066 5426 90400902
Obstructive airways disorder 33.14 12.55 11 222108 25858 90380470
Off label use 32.95 12.55 2293 219826 1099959 89306369
Eye pruritus 32.80 12.55 15 222104 29012 90377316
Product administration error 32.54 12.55 12 222107 26411 90379917
Chronic sinusitis 32.52 12.55 9 222110 23793 90382535
Status epilepticus 32.47 12.55 4 222115 18870 90387458
Blood creatinine increased 32.39 12.55 133 221986 101253 90305075
Shock 32.32 12.55 15 222104 28763 90377565
Orthostatic hypotension 32.12 12.55 33 222086 41794 90364534
Tubulointerstitial nephritis 32.08 12.55 11 222108 25332 90380996
Infusion site pain 32.03 12.55 5 222114 19733 90386595
Swelling 31.95 12.55 1293 220826 417765 89988563
Injection site warmth 31.95 12.55 3 222116 17512 90388816
Red blood cell count decreased 31.86 12.55 40 222079 46311 90360017
Dermatitis atopic 31.84 12.55 9 222110 23463 90382865
Pneumonia aspiration 31.78 12.55 32 222087 40908 90365420
Heavy menstrual bleeding 31.56 12.55 6 222113 20524 90385804
Tachypnoea 31.16 12.55 7 222112 21302 90385026
Eczema 31.04 12.55 51 222068 52819 90353509
Ataxia 30.61 12.55 4 222115 18038 90388290
Therapeutic response unexpected 30.41 12.55 8 222111 21872 90384456
Post-traumatic neck syndrome 30.24 12.55 34 222085 2480 90403848
Tricuspid valve incompetence 30.16 12.55 3 222116 16728 90389600
Pneumocystis jirovecii pneumonia 29.86 12.55 8 222111 21608 90384720
Injection site rash 29.73 12.55 11 222108 24162 90382166
Drug tolerance 29.59 12.55 104 222015 17812 90388516
Rheumatoid lung 29.54 12.55 43 222076 4060 90402268
Incorrect route of product administration 29.53 12.55 219 221900 50407 90355921
Hostility 29.51 12.55 32 222087 2241 90404087
Posterior reversible encephalopathy syndrome 29.51 12.55 9 222110 22330 90383998
Bronchiectasis 29.49 12.55 9 222110 22321 90384007
Hemiparesis 29.44 12.55 21 222098 31798 90374530
Cardiac failure 29.42 12.55 153 221966 109343 90296985
Hallucinations, mixed 29.09 12.55 52 222067 5837 90400491
Mouth ulceration 29.07 12.55 33 222086 39941 90366387
Fracture 28.97 12.55 9 222110 22067 90384261
Respiratory depression 28.89 12.55 94 222025 15481 90390847
Hiatus hernia 28.82 12.55 13 222106 25348 90380980
Motor dysfunction 28.77 12.55 6 222113 19224 90387104
Cholelithiasis 28.68 12.55 53 222066 52453 90353875
Blood lactate dehydrogenase increased 28.38 12.55 14 222105 25918 90380410
Post procedural complication 28.37 12.55 6 222113 19036 90387292
Blood bilirubin increased 28.36 12.55 39 222080 43431 90362897
Nervousness 28.34 12.55 25 222094 34031 90372297
Colitis 28.24 12.55 83 222036 69859 90336469
Subarachnoid haemorrhage 28.02 12.55 5 222114 17899 90388429
Allergy to chemicals 27.99 12.55 40 222079 3714 90402614
Therapeutic product ineffective 27.93 12.55 32 222087 2382 90403946
Mental disorder 27.77 12.55 23 222096 32295 90374033
Bacteraemia 27.68 12.55 10 222109 22290 90384038
Insomnia 27.54 12.55 1038 221081 332436 90073892
Pulmonary arterial hypertension 27.38 12.55 15 222104 26172 90380156
Haemophagocytic lymphohistiocytosis 27.28 12.55 3 222116 15456 90390872
Vitamin D deficiency 27.27 12.55 5 222114 17551 90388777
Vaginal haemorrhage 27.19 12.55 22 222097 31249 90375079
Exposure during pregnancy 27.15 12.55 771 221348 237639 90168689
Neoplasm progression 26.97 12.55 42 222077 44444 90361884
Supraventricular tachycardia 26.83 12.55 4 222115 16332 90389996
Premature baby 26.76 12.55 14 222105 25063 90381265
Lung neoplasm malignant 26.72 12.55 13 222106 24260 90382068
Rash macular 26.71 12.55 21 222098 30259 90376069
Foot deformity 26.69 12.55 243 221876 59408 90346920
Necrosis ischaemic 26.65 12.55 21 222098 974 90405354
Device related infection 26.63 12.55 15 222104 25771 90380557
Palmar-plantar erythrodysaesthesia syndrome 26.58 12.55 18 222101 28005 90378323
Disability 26.52 12.55 181 221938 40564 90365764
Heart rate increased 26.43 12.55 165 221954 112737 90293591
Skin fissures 26.39 12.55 9 222110 20800 90385528
Blood pressure diastolic abnormal 26.28 12.55 8 222111 19873 90386455
Gastrointestinal stoma output abnormal 26.22 12.55 15 222104 405 90405923
Product substitution issue 26.17 12.55 6 222113 18002 90388326
Oral candidiasis 26.08 12.55 29 222090 35426 90370902
Osteonecrosis 26.06 12.55 16 222103 26225 90380103
Breath sounds abnormal 26.01 12.55 90 222029 15296 90391032
Coordination abnormal 25.79 12.55 10 222109 21346 90384982
Ischaemic stroke 25.76 12.55 11 222108 22155 90384173
Electrocardiogram QT prolonged 25.76 12.55 91 222028 72365 90333963
Hypertensive crisis 25.69 12.55 6 222113 17778 90388550
Stoma site dermatitis 25.67 12.55 13 222106 273 90406055
Cardiogenic shock 25.61 12.55 14 222105 24454 90381874
Alanine aminotransferase increased 25.58 12.55 420 221699 117918 90288410
Herpes zoster 25.56 12.55 349 221770 94295 90312033
Clostridium difficile colitis 25.54 12.55 17 222102 26689 90379639
Haemorrhoids 25.53 12.55 17 222102 26685 90379643
Thrombotic microangiopathy 25.52 12.55 4 222115 15739 90390589
Myositis 25.50 12.55 122 221997 24006 90382322
Bradypnoea 25.44 12.55 43 222076 4615 90401713
Caesarean section 25.43 12.55 7 222112 18570 90387758
Pharyngitis 25.33 12.55 11 222108 21936 90384392
Product prescribing error 25.24 12.55 22 222097 30123 90376205
Cytokine release syndrome 25.18 12.55 19 222100 27954 90378374
Sedation 25.11 12.55 50 222069 48121 90358207
Ileus 25.09 12.55 5 222114 16541 90389787
Diarrhoea 24.94 12.55 1973 220146 937217 89469111
Right ventricular failure 24.90 12.55 8 222111 19197 90387131
Sternal fracture 24.89 12.55 33 222086 2854 90403474
Gastroenteritis 24.87 12.55 21 222098 29208 90377120
Arthralgia 24.74 12.55 2222 219897 776300 89630028
Tremor 24.63 12.55 248 221871 152925 90253403
Upper limb fracture 24.62 12.55 11 222108 21567 90384761
Lung infiltration 24.51 12.55 4 222115 15278 90391050
Tooth disorder 24.48 12.55 24 222095 31066 90375262
Hallucination, visual 24.48 12.55 13 222106 23079 90383249
Spinal compression fracture 24.28 12.55 4 222115 15174 90391154
Hemiplegia 24.26 12.55 5 222114 16155 90390173
Anaphylactic shock 24.21 12.55 25 222094 31592 90374736
Foot fracture 24.04 12.55 18 222101 26588 90379740
Stress 24.03 12.55 110 222009 81285 90325043
Spinal fracture 23.92 12.55 12 222107 22004 90384324
Pneumonia viral 23.89 12.55 61 222058 8762 90397566
Hyperbilirubinaemia 23.86 12.55 3 222116 13933 90392395
Rash papular 23.82 12.55 10 222109 20345 90385983
Paralysis 23.80 12.55 72 222047 11406 90394922
Hypothyroidism 23.73 12.55 60 222059 53067 90353261
Vasculitis 23.73 12.55 13 222106 22680 90383648
Blood pressure systolic abnormal 23.73 12.55 9 222110 19469 90386859
Renal disorder 23.67 12.55 35 222084 37824 90368504
Complication associated with device 23.67 12.55 9 222110 19440 90386888
Pseudomonas infection 23.60 12.55 4 222115 14861 90391467
Rhinitis allergic 23.59 12.55 6 222113 16779 90389549
Blood triglycerides increased 23.47 12.55 3 222116 13758 90392570
Polyneuropathy 23.45 12.55 9 222110 19332 90386996
Obstructive defaecation 23.44 12.55 12 222107 258 90406070
Productive cough 23.44 12.55 103 222016 76960 90329368
Gastroenteritis viral 23.25 12.55 24 222095 30331 90375997
Metastases to eye 23.25 12.55 11 222108 198 90406130
International normalised ratio increased 23.08 12.55 51 222068 47265 90359063
Nephrolithiasis 23.06 12.55 54 222065 49031 90357297
Melaena 22.92 12.55 31 222088 34766 90371562
Blood immunoglobulin M increased 22.69 12.55 22 222097 1350 90404978
Cardio-respiratory arrest 22.65 12.55 79 222040 63061 90343267
Constipation 22.57 12.55 519 221600 279876 90126452
Acne 22.45 12.55 22 222097 28485 90377843
Blood iron decreased 22.38 12.55 8 222111 17951 90388377
Bacterial infection 22.32 12.55 15 222104 23429 90382899
Muscle tension dysphonia 22.28 12.55 12 222107 287 90406041
Coeliac disease 22.18 12.55 186 221933 44424 90361904
Fear of injection 22.16 12.55 58 222061 8457 90397871
Mucosal inflammation 22.11 12.55 70 222049 57555 90348773
Breast cancer metastatic 22.07 12.55 5 222114 15127 90391201
Gastritis 22.06 12.55 43 222076 41710 90364618
Pulmonary oedema 22.05 12.55 78 222041 62002 90344326
Eosinophil count increased 21.96 12.55 3 222116 13078 90393250
Malnutrition 21.91 12.55 9 222110 18549 90387779
Carpal tunnel syndrome 21.87 12.55 16 222103 23912 90382416
Radiculopathy 21.80 12.55 9 222110 18496 90387832
Impaired quality of life 21.78 12.55 15 222104 23129 90383199
Candida infection 21.77 12.55 31 222088 34026 90372302
Eating disorder 21.72 12.55 22 222097 28051 90378277
Sinobronchitis 21.42 12.55 16 222103 685 90405643
Multiple sclerosis 21.34 12.55 22 222097 27818 90378510
Cyst 21.29 12.55 7 222112 16554 90389774
Drug resistance 21.22 12.55 26 222093 30423 90375905
Injection site mass 21.21 12.55 14 222105 22076 90384252
Cardiac murmur 21.19 12.55 9 222110 18185 90388143
Feeling jittery 21.04 12.55 84 222035 15287 90391041
Dysarthria 21.03 12.55 66 222053 54416 90351912
Infusion site erythema 21.00 12.55 4 222115 13666 90392662
Dissociation 20.92 12.55 49 222070 6666 90399662
Blood pressure abnormal 20.91 12.55 11 222108 19634 90386694
Labelled drug-drug interaction medication error 20.91 12.55 5 222114 14577 90391751
Malignant melanoma 20.84 12.55 3 222116 12573 90393755
Product complaint 20.64 12.55 4 222115 13496 90392832
Onychomadesis 20.51 12.55 52 222067 45946 90360382
Menstrual disorder 20.46 12.55 46 222073 6092 90400236
Interstitial lung disease 20.39 12.55 107 222012 76298 90330030
Angioedema 20.38 12.55 246 221873 64630 90341698
Weight fluctuation 20.25 12.55 99 222020 19650 90386678
Gout 20.19 12.55 8 222111 16851 90389477
Iron deficiency anaemia 20.14 12.55 17 222102 23645 90382683
Duodenal ulcer repair 20.07 12.55 7 222112 54 90406274
Sphincter of Oddi dysfunction 20.02 12.55 13 222106 443 90405885
Crying 19.96 12.55 20 222099 25625 90380703
Poisoning 19.90 12.55 82 222037 15135 90391193
Hepatocellular injury 19.89 12.55 25 222094 28933 90377395
Device difficult to use 19.89 12.55 9 222110 17516 90388812
Diverticulum 19.81 12.55 3 222116 12110 90394218
Gastric disorder 19.80 12.55 145 221974 33239 90373089
Device breakage 19.78 12.55 5 222114 14039 90392289
Subdural haematoma 19.76 12.55 8 222111 16637 90389691
Blood glucose decreased 19.73 12.55 17 222102 23412 90382916
Vision blurred 19.68 12.55 174 221945 110119 90296209
Metastases to liver 19.65 12.55 25 222094 28782 90377546
Syncope 19.62 12.55 219 221900 132444 90273884
Hypophosphataemia 19.59 12.55 6 222113 14848 90391480
Peritonitis 19.59 12.55 12 222107 19693 90386635
Synovial fluid analysis 19.52 12.55 29 222090 2789 90403539
Cardiac failure acute 19.41 12.55 3 222116 11926 90394402
Pain in jaw 19.33 12.55 57 222062 47928 90358400
Angina pectoris 19.27 12.55 42 222077 39118 90367210
Parosmia 19.27 12.55 49 222070 7020 90399308
Leukopenia 19.27 12.55 156 221963 100554 90305774
Sleep apnoea syndrome 19.22 12.55 30 222089 31717 90374611
Chronic spontaneous urticaria 19.19 12.55 23 222096 1797 90404531
Leukocytosis 19.04 12.55 29 222090 30961 90375367
Blood creatine phosphokinase increased 18.89 12.55 34 222085 33989 90372339
Hyperlipidaemia 18.85 12.55 17 222102 22899 90383429
Therapeutic response shortened 18.79 12.55 17 222102 22862 90383466
Nasopharyngitis 18.78 12.55 1197 220922 405907 90000421
Sedation complication 18.77 12.55 9 222110 16935 90389393
Balance disorder 18.75 12.55 150 221969 96930 90309398
Product label confusion 18.74 12.55 17 222102 22833 90383495
Neutropenic sepsis 18.67 12.55 91 222028 18039 90388289
Cholestasis 18.65 12.55 38 222081 36261 90370067
Diaphragmatic rupture 18.61 12.55 10 222109 238 90406090
Tooth extraction 18.49 12.55 3 222116 11510 90394818
Haemorrhage intracranial 18.48 12.55 7 222112 15155 90391173
Postmortem blood drug level abnormal 18.46 12.55 10 222109 242 90406086
Gastrointestinal stoma complication 18.37 12.55 26 222093 2393 90403935
Treatment noncompliance 18.36 12.55 65 222054 51662 90354666
Anaphylactic reaction 18.31 12.55 309 221810 87215 90319113
Skin neoplasm excision 18.30 12.55 22 222097 1724 90404604
Carbuncle 18.27 12.55 20 222099 1416 90404912
Decreased immune responsiveness 18.26 12.55 55 222064 8693 90397635
Kidney infection 18.20 12.55 22 222097 25894 90380434
Blindness 18.18 12.55 23 222096 26545 90379783
Abscess 18.10 12.55 12 222107 18879 90387449
Skin burning sensation 18.07 12.55 13 222106 19598 90386730
Alopecia 18.06 12.55 1428 220691 493643 89912685
Alveolar rhabdomyosarcoma 17.93 12.55 5 222114 16 90406312
Weight decreased 17.89 12.55 755 221364 379155 90027173
Heart rate decreased 17.84 12.55 69 222050 53436 90352892
Myocarditis 17.46 12.55 6 222113 13800 90392528
Splenomegaly 17.45 12.55 5 222114 12919 90393409
Mydriasis 17.41 12.55 78 222041 14934 90391394
Myocardial fibrosis 17.33 12.55 16 222103 923 90405405
Cardiac disorder 17.30 12.55 76 222043 56796 90349532
Hepatic steatosis 17.29 12.55 152 221967 36793 90369535
Insurance issue 17.28 12.55 3 222116 10955 90395373
Renal tubular necrosis 17.28 12.55 7 222112 14548 90391780
Excessive eye blinking 17.27 12.55 19 222100 1353 90404975
Arrhythmia 17.26 12.55 50 222069 42282 90364046
Pelvic pain 17.25 12.55 8 222111 15349 90390979
Neoplasm skin 17.16 12.55 29 222090 3113 90403215
Skin irritation 17.05 12.55 6 222113 13597 90392731
Hyperthyroidism 17.05 12.55 12 222107 18298 90388030
Drug level increased 17.03 12.55 26 222093 27736 90378592
Pelvic fracture 16.99 12.55 8 222111 15211 90391117
Injection site haemorrhage 16.92 12.55 27 222092 28291 90378037
Aspartate aminotransferase increased 16.89 12.55 350 221769 102587 90303741
Skin cancer 16.88 12.55 6 222113 13513 90392815
COVID-19 pneumonia 16.81 12.55 12 222107 18165 90388163
Throat tightness 16.79 12.55 29 222090 29455 90376873
Secretion discharge 16.77 12.55 9 222110 15887 90390441
Stoma site pain 16.76 12.55 19 222100 1398 90404930
Suicidal ideation 16.74 12.55 109 222010 73746 90332582
Postoperative wound infection 16.70 12.55 6 222113 13420 90392908
Blood immunoglobulin A decreased 16.59 12.55 21 222098 1735 90404593
Metastases to bone 16.52 12.55 23 222096 25482 90380846
Intervertebral disc degeneration 16.51 12.55 11 222108 17263 90389065
Allergic sinusitis 16.47 12.55 23 222096 2090 90404238
Concomitant disease aggravated 16.41 12.55 4 222115 11514 90394814
Ear infection 16.34 12.55 251 221868 69524 90336804
Nightmare 16.28 12.55 100 222019 21625 90384703
Condition aggravated 16.25 12.55 1682 220437 593863 89812465
Intentional dose omission 16.11 12.55 12 222107 17771 90388557
Incubator therapy 16.02 12.55 6 222113 58 90406270
Spinal osteoarthritis 16.00 12.55 14 222105 19134 90387194
Lymphadenopathy 15.93 12.55 58 222061 45717 90360611
Tenosynovitis stenosans 15.92 12.55 32 222087 3921 90402407
Infusion site extravasation 15.92 12.55 3 222116 10325 90396003
Electrocardiogram abnormal 15.85 12.55 3 222116 10295 90396033
Bone disorder 15.84 12.55 20 222099 23100 90383228
Ligament sprain 15.80 12.55 8 222111 14591 90391737
Product preparation error 15.77 12.55 3 222116 10258 90396070
Infrequent bowel movements 15.74 12.55 19 222100 1495 90404833
Pain of skin 15.70 12.55 10 222109 16072 90390256
Derailment 15.67 12.55 6 222113 62 90406266
Spinal operation 15.63 12.55 3 222116 10193 90396135
Cardiomegaly 15.62 12.55 14 222105 18911 90387417
Lipase increased 15.56 12.55 4 222115 11107 90395221
Soft tissue swelling 15.50 12.55 18 222101 1360 90404968
Mycotic allergy 15.48 12.55 16 222103 1060 90405268
Torsade de pointes 15.44 12.55 9 222110 15173 90391155
Disseminated intravascular coagulation 15.42 12.55 18 222101 21520 90384808
Viral infection 15.41 12.55 51 222068 41363 90364965
Frequent bowel movements 15.39 12.55 210 221909 56725 90349603
Live birth 15.37 12.55 276 221843 78831 90327497
Escherichia infection 15.36 12.55 10 222109 15885 90390443
Vertigo 15.33 12.55 104 222015 69707 90336621
Chest pain 15.31 12.55 943 221176 318702 90087626
Hiccups 15.31 12.55 27 222092 2999 90403329
Ventricular tachycardia 15.29 12.55 23 222096 24685 90381643
Hepatitis 15.23 12.55 106 222013 70633 90335695
Toxic skin eruption 15.14 12.55 10 222109 15764 90390564
Tooth fracture 15.05 12.55 6 222113 12594 90393734
Gingival bleeding 14.92 12.55 9 222110 14894 90391434
Chromaturia 14.89 12.55 15 222104 19172 90387156
Stevens-Johnson syndrome 14.88 12.55 31 222088 29345 90376983
Atrial flutter 14.82 12.55 4 222115 10754 90395574
Intentional self-injury 14.82 12.55 31 222088 29303 90377025
Pneumonia streptococcal 14.78 12.55 22 222097 2119 90404209
Administration site bruise 14.75 12.55 11 222108 470 90405858
Pulmonary thrombosis 14.74 12.55 3 222116 9779 90396549
Sneezing 14.73 12.55 32 222087 29837 90376491
Priapism 14.70 12.55 7 222112 128 90406200
Clostridium difficile infection 14.64 12.55 43 222076 36202 90370126
Large intestine perforation 14.59 12.55 3 222116 9709 90396619
Optic neuritis 14.52 12.55 3 222116 9675 90396653
Blood test abnormal 14.48 12.55 18 222101 20934 90385394
Anhedonia 14.40 12.55 5 222114 11426 90394902
Ageusia 14.37 12.55 11 222108 16065 90390263
Escherichia urinary tract infection 14.32 12.55 8 222111 13807 90392521
Intestinal obstruction 14.32 12.55 45 222074 37086 90369242
Respiratory syncytial virus infection 14.25 12.55 4 222115 10476 90395852
Spinal stenosis 14.25 12.55 13 222106 17411 90388917
Muscle spasticity 14.20 12.55 42 222077 35280 90371048
Bedridden 14.16 12.55 6 222113 12142 90394186
Affect lability 14.16 12.55 14 222105 18049 90388279
Breast pain 14.12 12.55 4 222115 10414 90395914
Cold urticaria 14.12 12.55 9 222110 297 90406031
Neutrophil count increased 14.11 12.55 16 222103 19374 90386954
Scleritis 14.09 12.55 36 222083 5172 90401156
Fear 14.07 12.55 12 222107 16610 90389718
Dysmetropsia 14.04 12.55 6 222113 84 90406244
Granuloma 13.97 12.55 40 222079 6145 90400183
Diplopia 13.96 12.55 31 222088 28683 90377645
Acute respiratory distress syndrome 13.92 12.55 31 222088 28655 90377673
Stoma site inflammation 13.92 12.55 13 222106 761 90405567
Urosepsis 13.90 12.55 19 222100 21213 90385115
Transfusion-associated dyspnoea 13.87 12.55 5 222114 43 90406285
Acarodermatitis 13.77 12.55 17 222102 1369 90404959
Myopathy 13.76 12.55 8 222111 13510 90392818
Acidosis 13.75 12.55 7 222112 12729 90393599
Gastroenteritis bacterial 13.70 12.55 10 222109 413 90405915
Blood magnesium decreased 13.69 12.55 11 222108 15682 90390646
Breast cancer female 13.54 12.55 10 222109 14876 90391452
Abdominal pain lower 13.54 12.55 34 222085 30143 90376185
Gait disturbance 13.51 12.55 774 221345 259722 90146606
Squamous cell carcinoma 13.47 12.55 4 222115 10097 90396231
Glycosylated haemoglobin increased 13.47 12.55 11 222108 15551 90390777
Serotonin syndrome 13.39 12.55 147 221972 37740 90368588
Jaundice cholestatic 13.35 12.55 4 222115 10039 90396289
Amenorrhoea 13.33 12.55 6 222113 11716 90394612
Tendon operation 13.32 12.55 9 222110 328 90406000
Vaginal cellulitis 13.21 12.55 6 222113 98 90406230
Sensory disturbance 13.21 12.55 11 222108 15402 90390926
Cataract 13.19 12.55 113 222006 71979 90334349
Pemphigoid 13.13 12.55 3 222116 9023 90397305
Skin disorder 13.11 12.55 46 222073 36660 90369668
Tendinous contracture 13.09 12.55 7 222112 165 90406163
Bladder disorder 13.08 12.55 5 222114 10767 90395561
Rheumatic disorder 13.03 12.55 27 222092 3381 90402947
Medication error 12.97 12.55 285 221834 84367 90321961
Hernia 12.96 12.55 69 222050 14162 90392166
Incorrect product administration duration 12.94 12.55 17 222102 19305 90387023
Postmortem blood drug level increased 12.84 12.55 12 222107 703 90405625
Hypoalbuminaemia 12.83 12.55 12 222107 15885 90390443
Unresponsive to stimuli 12.81 12.55 49 222070 38072 90368256
Hypoacusis 12.79 12.55 31 222088 27819 90378509
Diverticulitis 12.79 12.55 62 222057 45125 90361203
Pollakiuria 12.73 12.55 40 222079 32965 90373363
Colitis ulcerative 12.69 12.55 213 221906 60053 90346275
Gallbladder disorder 12.68 12.55 18 222101 19785 90386543
Vomiting 12.66 12.55 1716 220403 786577 89619751
Foetal monitoring abnormal 12.66 12.55 8 222111 260 90406068
Post procedural haemorrhage 12.65 12.55 3 222116 8795 90397533
Illness 12.64 12.55 134 221985 81835 90324493
Paranoia 12.64 12.55 8 222111 12900 90393428
Intestinal strangulation 12.63 12.55 6 222113 109 90406219

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 2268.21 13.22 1286 34604 103485 42481960
Toxicity to various agents 1913.51 13.22 1557 34333 227579 42357866
Substance abuse 593.14 13.22 238 35652 8667 42576778
Drug hypersensitivity 421.61 13.22 467 35423 98922 42486523
Nightmare 306.07 13.22 215 35675 24797 42560648
Drug dependence 303.45 13.22 227 35663 28867 42556578
Poisoning 275.06 13.22 165 35725 14534 42570911
Sedation 270.31 13.22 216 35674 30259 42555186
Intentional product misuse 243.58 13.22 280 35610 61620 42523825
Asphyxia 236.56 13.22 123 35767 8203 42577242
Overdose 227.21 13.22 355 35535 104909 42480536
Nephrolithiasis 174.96 13.22 184 35706 36646 42548799
Drug use disorder 160.37 13.22 103 35787 10230 42575215
Depressed level of consciousness 157.48 13.22 198 35692 47772 42537673
Hyperhidrosis 144.45 13.22 267 35623 90245 42495200
Miosis 120.63 13.22 96 35794 13350 42572095
Bradykinesia 120.12 13.22 68 35822 5368 42580077
Dysarthria 105.49 13.22 148 35742 39659 42545786
Respiratory depression 101.79 13.22 101 35789 18767 42566678
Drug interaction 98.55 13.22 465 35425 266534 42318911
Aggression 89.66 13.22 145 35745 44018 42541427
Pulmonary oedema 78.51 13.22 152 35738 53120 42532325
Completed suicide 77.72 13.22 217 35673 96248 42489197
Intentional overdose 66.48 13.22 139 35751 51317 42534128
Product used for unknown indication 66.01 13.22 28 35862 1173 42584272
Chemical poisoning 61.68 13.22 15 35875 93 42585352
Poisoning deliberate 59.81 13.22 57 35833 10077 42575368
Self-medication 56.79 13.22 35 35855 3231 42582214
Product dose omission issue 51.88 13.22 33 35857 154332 42431113
Pulmonary congestion 51.68 13.22 65 35825 15665 42569780
Thrombocytopenia 49.87 13.22 52 35838 190227 42395218
Psychotic behaviour 48.34 13.22 21 35869 933 42584512
Vestibular disorder 47.20 13.22 22 35868 1155 42584290
Coma 46.61 13.22 124 35766 53430 42532015
Needle fatigue 46.56 13.22 22 35868 1191 42584254
Fatigue 46.52 13.22 199 35691 435442 42150003
Adulterated product 45.93 13.22 19 35871 747 42584698
Substance use disorder 45.46 13.22 37 35853 5308 42580137
Relapsing-remitting multiple sclerosis 45.09 13.22 23 35867 1472 42583973
Gait spastic 43.43 13.22 22 35868 1387 42584058
Bradypnoea 42.93 13.22 33 35857 4360 42581085
Red blood cell sedimentation rate 42.73 13.22 20 35870 1060 42584385
Hypertonic bladder 42.64 13.22 26 35864 2355 42583090
Patient uncooperative 41.44 13.22 17 35873 654 42584791
Granuloma skin 41.12 13.22 20 35870 1155 42584290
Chronic gastrointestinal bleeding 40.79 13.22 14 35876 325 42585120
Bradyphrenia 39.73 13.22 34 35856 5228 42580217
Logorrhoea 38.72 13.22 26 35864 2781 42582664
Disease progression 36.79 13.22 40 35850 143616 42441829
Asthenia 36.63 13.22 118 35772 280675 42304770
Sepsis 35.90 13.22 71 35819 199263 42386182
Ventricular dysfunction 35.85 13.22 30 35860 4473 42580972
Blood parathyroid hormone decreased 34.81 13.22 20 35870 1623 42583822
Tooth injury 34.15 13.22 18 35872 1233 42584212
Blood ethanol 33.87 13.22 9 35881 83 42585362
Nausea 33.65 13.22 494 35396 396305 42189140
Monoparesis 32.85 13.22 24 35866 2936 42582509
Lethargy 32.46 13.22 100 35790 46790 42538655
Opiates positive 30.89 13.22 13 35877 534 42584911
Impaired driving ability 30.64 13.22 23 35867 2932 42582513
Somnolence 30.27 13.22 213 35677 140892 42444553
Accidental death 29.78 13.22 23 35867 3060 42582385
Panniculitis 29.60 13.22 20 35870 2161 42583284
Hospitalisation 29.19 13.22 13 35877 74317 42511128
Gas poisoning 29.01 13.22 8 35882 86 42585359
Tendon discomfort 28.23 13.22 11 35879 369 42585076
Leukopenia 27.93 13.22 14 35876 74732 42510713
Lower respiratory tract infection 27.71 13.22 87 35803 41119 42544326
Alcohol interaction 27.60 13.22 19 35871 2116 42583329
Oesophagitis chemical 27.57 13.22 7 35883 53 42585392
Stoma complication 27.25 13.22 12 35878 551 42584894
Rheumatoid arthritis 27.08 13.22 88 35802 42352 42543093
Intestinal diaphragm disease 26.63 13.22 10 35880 303 42585142
Prescription form tampering 26.29 13.22 12 35878 600 42584845
Perineal pain 26.19 13.22 14 35876 987 42584458
Rheumatoid nodule 26.04 13.22 21 35869 2974 42582471
Perineal infection 25.57 13.22 12 35878 640 42584805
Poor feeding infant 25.53 13.22 13 35877 829 42584616
Optic nerve operation 25.49 13.22 11 35879 481 42584964
Alice in wonderland syndrome 24.92 13.22 5 35885 10 42585435
Nervous system neoplasm 24.91 13.22 8 35882 150 42585295
Respiratory arrest 24.91 13.22 66 35824 28358 42557087
Abnormal behaviour 24.80 13.22 63 35827 26388 42559057
Infected dermal cyst 24.27 13.22 13 35877 920 42584525
Myocardial necrosis 23.89 13.22 9 35881 275 42585170
Pancytopenia 23.81 13.22 39 35851 117704 42467741
Coma scale abnormal 23.81 13.22 24 35866 4541 42580904
Mood swings 23.63 13.22 33 35857 8793 42576652
Substance use 23.63 13.22 16 35874 1735 42583710
Drug diversion 23.58 13.22 13 35877 974 42584471
Pyrexia 23.27 13.22 216 35674 393826 42191619
Condition aggravated 23.16 13.22 127 35763 260627 42324818
Scrotal infection 22.64 13.22 12 35878 831 42584614
Analgesic drug level above therapeutic 22.55 13.22 9 35881 322 42585123
Spinal cord infection 22.34 13.22 9 35881 330 42585115
Diarrhoea 22.20 13.22 265 35625 460584 42124861
Drug screen positive 22.06 13.22 22 35868 4109 42581336
COVID-19 21.99 13.22 40 35850 115908 42469537
Drug ineffective for unapproved indication 21.68 13.22 6 35884 46157 42539288
Tenosynovitis 21.46 13.22 23 35867 4672 42580773
Overgrowth bacterial 21.23 13.22 7 35883 143 42585302
Thrombosis 21.20 13.22 16 35874 68495 42516950
Enthesopathy 20.93 13.22 23 35867 4805 42580640
Anal haemorrhage 20.55 13.22 18 35872 2855 42582590
Agitated depression 20.49 13.22 8 35882 270 42585175
Blood alcohol increased 20.36 13.22 10 35880 590 42584855
Postmortem blood drug level 20.33 13.22 7 35883 164 42585281
Tendon pain 20.31 13.22 19 35871 3281 42582164
Accidental poisoning 20.30 13.22 13 35877 1283 42584162
Accidental overdose 20.15 13.22 61 35829 28269 42557176
Cardio-respiratory arrest 19.98 13.22 100 35790 58536 42526909
Pneumonia aspiration 19.68 13.22 89 35801 49989 42535456
Analgesic drug level increased 19.59 13.22 12 35878 1096 42584349
Dehydration 19.56 13.22 58 35832 141709 42443736
Tendonitis 19.40 13.22 32 35858 9862 42575583
Prescription drug used without a prescription 19.32 13.22 17 35873 2713 42582732
Amphetamines positive 19.06 13.22 7 35883 199 42585246
Bronchial haemorrhage 18.85 13.22 10 35880 694 42584751
Idiopathic pulmonary fibrosis 18.36 13.22 21 35869 4583 42580862
Anaemia 18.13 13.22 150 35740 280128 42305317
Screaming 17.67 13.22 14 35876 1933 42583512
Lactic acidosis 17.64 13.22 8 35882 45253 42540192
Chronic kidney disease 17.42 13.22 9 35881 47232 42538213
Tongue disorder 17.29 13.22 22 35868 5361 42580084
Morganella infection 17.16 13.22 9 35881 610 42584835
Coordination abnormal 17.10 13.22 27 35863 8023 42577422
Calcium deficiency 17.02 13.22 7 35883 271 42585174
Febrile neutropenia 16.72 13.22 90 35800 185613 42399832
Mydriasis 16.71 13.22 28 35862 8742 42576703
Arteriovenous fistula 16.68 13.22 11 35879 1141 42584304
Dry skin 16.68 13.22 10 35880 48328 42537117
Duodenal ulcer perforation 16.61 13.22 13 35877 1763 42583682
Anal fissure 16.18 13.22 21 35869 5218 42580227
Serotonin syndrome 15.95 13.22 53 35837 25792 42559653
Atrial fibrillation 15.93 13.22 62 35828 139531 42445914
Clumsiness 15.84 13.22 13 35877 1887 42583558
Pancreatitis acute 15.78 13.22 63 35827 33501 42551944
Drug ineffective 15.63 13.22 408 35482 629789 41955656
Unresponsive to stimuli 15.62 13.22 60 35830 31343 42554102
Mobility decreased 15.59 13.22 65 35825 35241 42550204
Alanine aminotransferase abnormal 15.56 13.22 20 35870 4924 42580521
Patient dissatisfaction with treatment 15.55 13.22 5 35885 94 42585351
Pneumonitis 15.54 13.22 73 35817 41645 42543800
Contusion 15.30 13.22 73 35817 41912 42543533
Gastrointestinal mucosa hyperaemia 15.17 13.22 7 35883 359 42585086
Drug resistance 15.09 13.22 5 35885 34243 42551202
Injection site pain 14.89 13.22 16 35874 57782 42527663
Dyspnoea 14.86 13.22 273 35617 442348 42143097
Compartment syndrome 14.83 13.22 16 35874 3273 42582172
Presyncope 14.80 13.22 47 35843 22340 42563105
Paratracheal lymphadenopathy 14.78 13.22 5 35885 111 42585334
Seizure 14.77 13.22 52 35838 120509 42464936
Intracranial aneurysm 14.53 13.22 12 35878 1756 42583689
Product use in unapproved indication 14.53 13.22 227 35663 184229 42401216
Wrong technique in product usage process 14.46 13.22 9 35881 42626 42542819
Death 14.24 13.22 507 35383 470678 42114767
Phlebosclerosis 14.11 13.22 5 35885 128 42585317
Umbilical hernia 14.04 13.22 20 35870 5427 42580018
Gastrointestinal stoma output increased 13.91 13.22 7 35883 435 42585010
Substance dependence 13.87 13.22 8 35882 654 42584791
Restlessness 13.83 13.22 55 35835 29194 42556251
Pouchitis 13.59 13.22 9 35881 940 42584505
Road traffic accident 13.47 13.22 41 35849 19052 42566393
Blood pressure diastolic decreased 13.35 13.22 28 35862 10347 42575098
Defaecation urgency 13.32 13.22 16 35874 3678 42581767
Muscle spasticity 13.29 13.22 22 35868 6800 42578645
Incorrect dose administered 13.27 13.22 15 35875 52959 42532486

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 3229.39 12.32 4263 219098 449827 109916111
Drug abuse 1312.31 12.32 1702 221659 175709 110190229
Toxicity to various agents 917.75 12.32 2579 220782 477976 109887962
Rheumatoid arthritis 565.98 12.32 1603 221758 298010 110067928
Substance abuse 524.09 12.32 322 223039 12141 110353797
Blood parathyroid hormone decreased 502.08 12.32 319 223042 12770 110353168
Drug intolerance 480.39 12.32 1855 221506 404657 109961281
Granuloma skin 465.52 12.32 288 223073 10995 110354943
Panniculitis 453.81 12.32 320 223041 15262 110350676
Rheumatoid nodule 435.37 12.32 347 223014 19949 110345989
Rheumatoid factor positive 392.92 12.32 840 222521 130800 110235138
Contraindicated product administered 355.81 12.32 1207 222154 247060 110118878
C-reactive protein abnormal 342.43 12.32 788 222573 128907 110237031
Deep vein thrombosis postoperative 340.41 12.32 504 222857 58787 110307151
Skin necrosis 331.02 12.32 304 223057 21208 110344730
Autoimmune disorder 327.26 12.32 522 222839 64961 110300977
Bursitis 325.14 12.32 773 222588 129145 110236793
Infusion related reaction 316.56 12.32 1565 221796 379597 109986341
Product dose omission issue 311.31 12.32 130 223231 321652 110044286
Hypersensitivity 304.99 12.32 1615 221746 402383 109963555
Anaemia 303.74 12.32 396 222965 546690 109819248
Drug tolerance decreased 299.20 12.32 322 223039 27218 110338720
Hepatic enzyme increased 291.32 12.32 1352 222009 319540 110046398
Acute kidney injury 282.41 12.32 534 222827 634896 109731042
Swollen joint count increased 270.76 12.32 552 222809 83109 110282829
Red blood cell sedimentation rate increased 265.78 12.32 527 222834 77775 110288163
Neutropenia 258.18 12.32 226 223135 374394 109991544
Duodenal ulcer perforation 254.51 12.32 864 222497 176836 110189102
Lower limb fracture 253.20 12.32 505 222856 74843 110291095
Treatment failure 252.25 12.32 1169 222192 276065 110089873
Prescribed overdose 247.72 12.32 547 222814 87034 110278904
Synovitis 245.14 12.32 1150 222211 272942 110092996
Helicobacter infection 242.86 12.32 864 222497 181013 110184925
Fibromyalgia 238.65 12.32 824 222537 170085 110195853
Pancytopenia 236.85 12.32 65 223296 209548 110156390
Joint swelling 233.13 12.32 1612 221749 441233 109924705
Therapeutic product effect decreased 224.28 12.32 1033 222328 243283 110122655
Lip dry 222.31 12.32 569 222792 99514 110266424
COVID-19 221.36 12.32 109 223252 244951 110120987
Arthropathy 221.32 12.32 1156 222205 286366 110079572
Adjustment disorder with depressed mood 220.87 12.32 351 223010 43532 110322406
Sciatica 220.64 12.32 540 222821 91859 110274079
Psoriatic arthropathy 219.89 12.32 883 222478 195878 110170060
Drug dependence 216.71 12.32 374 222987 49646 110316292
Fall 215.83 12.32 571 222790 602911 109763027
Road traffic accident 215.59 12.32 588 222773 106810 110259128
Disease progression 215.25 12.32 112 223249 243922 110122016
Ulcer 213.07 12.32 342 223019 42774 110323164
Joint range of motion decreased 211.50 12.32 633 222728 121199 110244739
Anti-cyclic citrullinated peptide antibody positive 210.04 12.32 825 222536 181159 110184779
Febrile neutropenia 210.00 12.32 198 223163 316569 110049369
Inflammation 208.64 12.32 858 222503 192380 110173558
Urinary tract infection 208.15 12.32 211 223150 326071 110039867
Musculoskeletal stiffness 207.80 12.32 1114 222247 278708 110087230
Asphyxia 207.34 12.32 195 223166 14020 110351918
Muscle injury 207.22 12.32 691 222670 140116 110225822
Liver injury 206.34 12.32 721 222640 149692 110216246
Discomfort 205.39 12.32 919 222442 213788 110152150
Dehydration 204.44 12.32 159 223202 279352 110086586
Sepsis 200.62 12.32 219 223142 327127 110038811
Basal cell carcinoma 196.79 12.32 339 223022 44931 110321007
Hypercalcaemia 195.80 12.32 344 223017 46313 110319625
Musculoskeletal pain 194.72 12.32 809 222552 182214 110183724
Drug use disorder 194.00 12.32 210 223151 17864 110348074
Hypotension 192.35 12.32 489 222872 523360 109842578
Nightmare 191.68 12.32 308 223053 38555 110327383
Rheumatic fever 190.65 12.32 613 222748 121966 110243972
Hand deformity 188.90 12.32 908 222453 217598 110148340
Glossodynia 187.23 12.32 916 222445 221088 110144850
Blood cholesterol increased 186.66 12.32 804 222557 183981 110181957
Skin ulcer 183.92 12.32 401 222960 63244 110302694
Peripheral swelling 182.91 12.32 1419 221942 402615 109963323
Peripheral venous disease 182.44 12.32 474 222887 83643 110282295
Lower respiratory tract infection 179.21 12.32 966 222395 242140 110123798
Tenosynovitis 177.95 12.32 191 223170 16092 110349846
Folliculitis 176.72 12.32 739 222622 166914 110199024
Mobility decreased 176.09 12.32 945 222416 236477 110129461
Contrast media allergy 174.10 12.32 100 223261 3323 110362615
Poisoning 169.32 12.32 249 223112 28856 110337082
Dislocation of vertebra 167.71 12.32 310 223051 43411 110322527
Pemphigus 161.80 12.32 858 222503 213712 110152226
Contusion 159.12 12.32 908 222453 232453 110133485
Irritable bowel syndrome 157.84 12.32 704 222657 163511 110202427
Food allergy 157.60 12.32 198 223163 19750 110346188
Pulmonary fibrosis 157.49 12.32 509 222852 101533 110264405
Atrial fibrillation 152.79 12.32 143 223218 229499 110136439
Temperature regulation disorder 151.83 12.32 157 223204 12669 110353269
Drug eruption 150.42 12.32 334 223027 53325 110312613
Blister 149.99 12.32 877 222484 226499 110139439
Sleep disorder due to general medical condition, insomnia type 147.10 12.32 509 222852 105134 110260804
Injection site pain 146.30 12.32 89 223272 177833 110188105
Night sweats 146.22 12.32 597 222764 133386 110232552
Lupus vulgaris 145.01 12.32 252 223109 33631 110332307
Foetal death 142.56 12.32 169 223192 15876 110350062
Obesity 142.36 12.32 528 222833 112823 110253115
Injury 139.95 12.32 718 222643 176547 110189391
Liver disorder 139.10 12.32 613 222748 141630 110224308
Osteoarthritis 138.85 12.32 732 222629 181891 110184047
Pulmonary embolism 138.67 12.32 137 223224 214337 110151601
Renal failure 138.30 12.32 152 223209 226422 110139516
Facet joint syndrome 136.09 12.32 468 222893 96360 110269578
Overdose 133.59 12.32 869 222492 232925 110133013
X-ray abnormal 133.50 12.32 260 223101 37857 110328081
Platelet count decreased 132.67 12.32 162 223199 230281 110135657
Type 2 diabetes mellitus 132.42 12.32 707 222654 176525 110189413
Cerebrovascular accident 131.40 12.32 104 223257 181180 110184758
Product use issue 129.67 12.32 1074 222287 310621 110055317
Intentional product misuse 129.38 12.32 572 222789 132332 110233606
Renal impairment 129.33 12.32 114 223247 188331 110177607
Adverse event 129.32 12.32 498 222863 108311 110257627
Pericarditis 127.37 12.32 818 222543 218296 110147642
Impaired healing 121.56 12.32 746 222615 195971 110169967
Lung disorder 121.02 12.32 698 222663 179349 110186589
Red blood cell sedimentation rate 120.13 12.32 93 223268 5121 110360817
Haemoglobin decreased 118.37 12.32 200 223161 248527 110117411
Rash pruritic 115.85 12.32 448 222913 97621 110268317
Wound 115.33 12.32 840 222521 233597 110132341
Grip strength 113.84 12.32 115 223246 9026 110356912
C-reactive protein 113.74 12.32 213 223148 30118 110335820
Retinitis 112.59 12.32 220 223141 32107 110333831
Multiple organ dysfunction syndrome 112.53 12.32 85 223276 151625 110214313
Systemic lupus erythematosus 109.86 12.32 884 222477 253454 110112484
Septic shock 109.67 12.32 94 223267 157434 110208504
Hip arthroplasty 108.42 12.32 302 223059 55511 110310427
White blood cell count decreased 107.73 12.32 186 223175 229204 110136734
Injection site erythema 106.72 12.32 29 223332 94147 110271791
Breast cancer stage III 106.50 12.32 377 222984 78740 110287198
Enthesopathy 105.24 12.32 128 223233 12350 110353588
Hyperhidrosis 105.03 12.32 693 222668 186605 110179333
Neuropathy peripheral 104.27 12.32 125 223236 179152 110186786
Hypercholesterolaemia 101.67 12.32 408 222953 90429 110275509
Gastric pH decreased 101.61 12.32 47 223314 983 110364955
Respiratory depression 99.79 12.32 208 223153 31793 110334145
Dry mouth 97.51 12.32 715 222646 199233 110166705
Miosis 97.35 12.32 166 223195 21817 110344121
Lactic acidosis 97.19 12.32 33 223328 92778 110273160
C-reactive protein increased 96.05 12.32 761 222600 217158 110148780
Haematochezia 94.66 12.32 58 223303 115466 110250472
Porphyria acute 94.19 12.32 150 223211 18630 110347308
Asthma 93.87 12.32 843 222518 249448 110116490
Urticaria 93.37 12.32 1020 222341 317837 110048101
Hypokalaemia 93.12 12.32 140 223221 182308 110183630
Myelosuppression 92.95 12.32 37 223324 94303 110271635
Bone erosion 92.13 12.32 253 223108 46118 110319820
Prescribed underdose 91.56 12.32 315 223046 64859 110301079
Tongue disorder 91.49 12.32 128 223233 14170 110351768
Swollen tongue 91.22 12.32 299 223062 60063 110305875
Pleural effusion 91.05 12.32 136 223225 177573 110188365
Alopecia 89.59 12.32 1128 222233 363625 110002313
Amnesia 89.55 12.32 436 222925 104972 110260966
Maternal exposure timing unspecified 89.54 12.32 156 223205 20857 110345081
Cytomegalovirus infection 89.53 12.32 5 223356 54439 110311499
Immunodeficiency 89.53 12.32 224 223137 38614 110327324
Mental status changes 89.01 12.32 22 223339 76100 110289838
Hypertension 88.66 12.32 1485 221876 508599 109857339
Abdominal discomfort 87.56 12.32 1196 222165 392662 109973276
Loss of employment 86.68 12.32 64 223297 3280 110362658
Respiratory failure 86.06 12.32 192 223169 215140 110150798
Chronic kidney disease 85.50 12.32 24 223337 76267 110289671
Pregnancy 85.45 12.32 262 223099 50805 110315133
Myocardial infarction 83.73 12.32 163 223198 191920 110174018
Gastrointestinal haemorrhage 83.52 12.32 128 223233 165390 110200548
Hyperkalaemia 82.95 12.32 91 223270 135705 110230233
Dry skin 82.84 12.32 58 223303 107595 110258343
Pneumonia 82.22 12.32 1261 222100 875453 109490485
Anti-cyclic citrullinated peptide antibody 80.92 12.32 145 223216 19819 110346119
Delirium 80.84 12.32 508 222853 134517 110231421
Off label use 80.74 12.32 2362 220999 1497823 108868115
Loss of personal independence in daily activities 80.44 12.32 549 222812 149471 110216467
Cough 80.22 12.32 574 222787 461067 109904871
Injection site swelling 80.20 12.32 14 223347 61776 110304162
Dyspnoea 78.62 12.32 1672 221689 1105200 109260738
Thrombosis 77.90 12.32 63 223298 108599 110257339
Acute respiratory failure 76.67 12.32 28 223333 75232 110290706
Full blood count abnormal 76.59 12.32 11 223350 56041 110309897
Swelling face 76.37 12.32 379 222982 91942 110273996
Depersonalisation/derealisation disorder 75.87 12.32 50 223311 2131 110363807
Deep vein thrombosis 75.67 12.32 103 223258 139784 110226154
Arthritis 75.35 12.32 588 222773 166998 110198940
Accidental exposure to product 75.34 12.32 7 223354 50001 110315937
Therapy interrupted 74.99 12.32 7 223354 49815 110316123
Maternal exposure during pregnancy 74.42 12.32 815 222546 254068 110111870
Derealisation 73.93 12.32 49 223312 2109 110363829
Haemorrhage 73.84 12.32 64 223297 106628 110259310
Infection 73.72 12.32 1083 222278 361117 110004821
Bone marrow failure 73.16 12.32 14 223347 57834 110308104
Gait inability 73.07 12.32 499 222862 135877 110230061
Lupus-like syndrome 72.70 12.32 214 223147 40578 110325360
Hypoaesthesia 71.78 12.32 959 222402 313264 110052674
Blood creatinine increased 71.51 12.32 165 223196 182724 110183214
Wound infection 70.78 12.32 383 222978 96082 110269856
Exostosis 70.66 12.32 229 223132 45727 110320211
Abdominal pain upper 69.53 12.32 1040 222321 348071 110017867
Poisoning deliberate 69.44 12.32 160 223201 26171 110339767
Hypoxia 69.42 12.32 96 223265 129419 110236519
Walking aid user 69.05 12.32 155 223206 24920 110341018
Acute myocardial infarction 68.72 12.32 42 223319 83735 110282203
Wrong technique in product usage process 68.62 12.32 46 223315 87302 110278636
Transient ischaemic attack 68.30 12.32 22 223339 63960 110301978
Knee arthroplasty 68.15 12.32 286 223075 64662 110301276
Dysphagia 68.11 12.32 129 223232 153471 110212467
Death 67.93 12.32 998 222363 697871 109668067
Grip strength decreased 66.93 12.32 330 223031 79844 110286094
Laryngitis 66.72 12.32 213 223148 42198 110323740
Tendonitis 66.06 12.32 156 223205 25927 110340011
Chills 65.94 12.32 183 223178 190397 110175541
Rash 65.89 12.32 2145 221216 818819 109547119
Unevaluable event 65.69 12.32 19 223342 59208 110306730
Thrombocytopenia 64.94 12.32 425 222936 348460 110017478
Disease recurrence 64.71 12.32 21 223340 60763 110305175
Agranulocytosis 64.59 12.32 22 223339 61738 110304200
Deformity 63.59 12.32 90 223271 10070 110355868
Therapy cessation 63.20 12.32 8 223353 44849 110321089
Gastrointestinal disorder 63.15 12.32 757 222604 241195 110124743
Chronic obstructive pulmonary disease 62.52 12.32 77 223284 109081 110256857
Patient uncooperative 62.48 12.32 33 223328 927 110365011
Foot deformity 61.82 12.32 227 223134 48253 110317685
Staphylococcal infection 61.78 12.32 32 223329 69912 110296026
Cardiac failure congestive 61.67 12.32 133 223228 150867 110215071
Leukopenia 61.65 12.32 130 223231 148661 110217277
Injection site pruritus 61.54 12.32 14 223347 51244 110314694
H1N1 influenza 61.32 12.32 50 223311 2968 110362970
Sopor 61.22 12.32 3 223358 36543 110329395
Epistaxis 60.92 12.32 106 223255 130266 110235672
Neurotoxicity 60.76 12.32 7 223354 42200 110323738
Ill-defined disorder 60.68 12.32 532 222829 156321 110209617
Blood glucose increased 59.87 12.32 110 223251 132386 110233552
Lymphopenia 59.52 12.32 6 223355 40164 110325774
Overlap syndrome 59.31 12.32 82 223279 8977 110356961
Tubulointerstitial nephritis 59.14 12.32 18 223343 54266 110311672
Seizure 58.97 12.32 238 223123 220947 110144991
Fungal infection 58.79 12.32 15 223346 50791 110315147
Oxygen saturation decreased 58.69 12.32 145 223216 156837 110209101
Stomatitis 58.12 12.32 816 222545 269426 110096512
Pulmonary hypertension 57.18 12.32 20 223341 55200 110310738
Drug tolerance 56.70 12.32 112 223249 16473 110349465
Chest discomfort 56.45 12.32 172 223189 173676 110192262
Bradycardia 56.31 12.32 146 223215 155371 110210567
Obliterative bronchiolitis 56.08 12.32 52 223309 3671 110362267
Dyspnoea exertional 55.90 12.32 77 223284 103983 110261955
Oedema 55.68 12.32 659 222702 209317 110156621
Wheezing 55.42 12.32 772 222589 254458 110111480
Obstructive airways disorder 54.62 12.32 13 223348 46136 110319802
Haematocrit decreased 54.43 12.32 33 223328 66084 110299854
Cytokine release syndrome 53.93 12.32 38 223323 70268 110295670
Sinus disorder 53.83 12.32 3 223358 32725 110333213
Bradypnoea 53.22 12.32 76 223285 8573 110357365
Malignant neoplasm progression 52.99 12.32 178 223183 174389 110191549
Inappropriate schedule of product administration 52.48 12.32 222 223139 203415 110162523
Abdominal distension 52.16 12.32 180 223181 174923 110191015
Adverse drug reaction 51.16 12.32 377 222984 105182 110260756
Blood pressure decreased 50.72 12.32 97 223264 114994 110250944
Neutrophil count decreased 50.66 12.32 105 223256 120836 110245102
Device expulsion 50.30 12.32 3 223358 30888 110335050
Blood urea increased 50.26 12.32 24 223337 54933 110311005
Feeling of despair 49.54 12.32 49 223312 3749 110362189
Cogwheel rigidity 48.77 12.32 48 223313 3650 110362288
Swollen joint count 48.71 12.32 73 223288 8601 110357337
Chemical poisoning 48.55 12.32 17 223344 165 110365773
Haematoma 48.40 12.32 29 223332 58447 110307491
Feeling of body temperature change 48.21 12.32 61 223300 6127 110359811
Arthralgia 48.11 12.32 1978 221383 777654 109588284
Diabetes mellitus 48.09 12.32 79 223282 99302 110266636
Drug resistance 48.02 12.32 27 223334 56347 110309591
Skin exfoliation 47.94 12.32 64 223297 87587 110278351
Hospitalisation 47.69 12.32 139 223222 142354 110223584
Alanine aminotransferase abnormal 47.42 12.32 75 223286 9259 110356679
Swelling 47.04 12.32 982 222379 350059 110015879
Soft tissue disorder 46.96 12.32 46 223315 3478 110362460
Influenza like illness 46.91 12.32 66 223295 88346 110277592
Shock 46.61 12.32 25 223336 53563 110312375
Acute myeloid leukaemia 46.57 12.32 10 223351 38100 110327838
Transaminases increased 46.38 12.32 36 223325 63354 110302584
Musculoskeletal disorder 46.36 12.32 125 223236 22539 110343399
Breast cancer stage II 46.31 12.32 141 223220 27234 110338704
Coronary artery disease 46.07 12.32 46 223315 71644 110294294
Haematuria 46.02 12.32 60 223301 82945 110282993
Hyperglycaemia 45.66 12.32 63 223298 85027 110280911
Encephalopathy 45.55 12.32 58 223303 80997 110284941
Hypoglycaemia 45.17 12.32 105 223256 115999 110249939
Exposure during pregnancy 45.07 12.32 527 222834 166897 110199041
Eosinophilia 44.85 12.32 31 223330 57905 110308033
Hypervolaemia 44.62 12.32 22 223339 49438 110316500
Tumour lysis syndrome 44.61 12.32 5 223356 30796 110335142
Rheumatoid lung 44.43 12.32 49 223312 4255 110361683
Therapy non-responder 44.06 12.32 499 222862 156808 110209130
Drug reaction with eosinophilia and systemic symptoms 43.84 12.32 61 223300 82034 110283904
Hyponatraemia 43.65 12.32 259 223102 217394 110148544
Sleep disorder 43.58 12.32 602 222759 198042 110167896
Haemophagocytic lymphohistiocytosis 43.57 12.32 6 223355 31553 110334385
Hepatic cirrhosis 43.35 12.32 259 223102 67367 110298571
Posterior reversible encephalopathy syndrome 43.23 12.32 8 223353 33853 110332085
Blood potassium decreased 43.18 12.32 28 223333 54086 110311852
Toxicologic test abnormal 43.14 12.32 29 223332 1278 110364660
Pyrexia 43.06 12.32 1435 221926 896830 109469108
Therapy partial responder 42.77 12.32 11 223350 37050 110328888
Ischaemic stroke 42.63 12.32 15 223346 41248 110324690
Visual acuity reduced 42.39 12.32 7 223354 32166 110333772
Device issue 42.33 12.32 9 223352 34526 110331412
Mitral valve incompetence 42.28 12.32 8 223353 33321 110332617
Injection site reaction 41.99 12.32 72 223289 88998 110276940
Pneumocystis jirovecii pneumonia 41.70 12.32 17 223344 42718 110323220
Onychomycosis 41.57 12.32 13 223348 38518 110327420
Influenza 41.35 12.32 188 223173 168913 110197025
Tachypnoea 41.25 12.32 14 223347 39381 110326557
Respiratory distress 41.13 12.32 47 223314 68827 110297111
Cerebral infarction 41.12 12.32 27 223334 51811 110314127
International normalised ratio increased 41.04 12.32 70 223291 86702 110279236
Product used for unknown indication 40.90 12.32 33 223328 1930 110364008
Live birth 40.69 12.32 260 223101 69224 110296714
Anaphylactic shock 40.68 12.32 27 223334 51519 110314419
Diabetes mellitus inadequate control 40.32 12.32 6 223355 29769 110336169
Renal disorder 40.31 12.32 25 223336 49454 110316484
Cerebral haemorrhage 40.26 12.32 43 223318 64925 110301013
Ascites 40.21 12.32 79 223282 92729 110273209
Cardiogenic shock 40.15 12.32 34 223327 57304 110308634
Full blood count decreased 40.10 12.32 8 223353 32091 110333847
Lymphocyte count decreased 40.02 12.32 34 223327 57209 110308729
Mood swings 40.00 12.32 119 223242 22693 110343245
Pericardial effusion 39.98 12.32 34 223327 57183 110308755
Melaena 39.90 12.32 48 223313 68709 110297229
Plasma cell myeloma 39.74 12.32 41 223320 62895 110303043
Confusional state 39.70 12.32 1233 222128 467447 109898491
Premature delivery 39.62 12.32 7 223354 30625 110335313
Psoriasis 39.17 12.32 444 222917 139549 110226389
Electrolyte imbalance 39.05 12.32 13 223348 37015 110328923
Product prescribing error 39.03 12.32 28 223333 51303 110314635
Progressive multifocal leukoencephalopathy 38.95 12.32 3 223358 24953 110340985
Depressed level of consciousness 38.94 12.32 372 222989 111906 110254032
Memory impairment 38.89 12.32 586 222775 196358 110169580
Blood calcium decreased 38.84 12.32 12 223349 35833 110330105
Asthenia 38.81 12.32 1077 222284 687922 109678016
Nephropathy toxic 38.47 12.32 5 223356 27473 110338465
Cardiac disorder 38.46 12.32 59 223302 76221 110289717
Prostate cancer 38.35 12.32 14 223347 37627 110328311
Bronchiectasis 38.16 12.32 13 223348 36480 110329458
Nasal congestion 38.14 12.32 89 223272 98193 110267745
Allergy to chemicals 38.10 12.32 40 223321 3285 110362653
Myelodysplastic syndrome 38.09 12.32 14 223347 37470 110328468
Visceral congestion 37.72 12.32 27 223334 1318 110364620
Hypocalcaemia 37.54 12.32 46 223315 65320 110300618
Cognitive disorder 37.48 12.32 75 223286 87436 110278502
Mucosal inflammation 37.36 12.32 87 223274 96054 110269884
Clostridium difficile colitis 37.24 12.32 21 223340 43757 110322181
Incorrect dose administered 36.98 12.32 98 223263 103543 110262395
Tricuspid valve incompetence 36.89 12.32 3 223358 23870 110342068
Post-traumatic neck syndrome 36.70 12.32 35 223326 2560 110363378
Acute respiratory distress syndrome 36.70 12.32 32 223329 53166 110312772
Soft tissue injury 36.65 12.32 33 223328 2243 110363695
Cellulitis 36.55 12.32 131 223230 125885 110240053
Fear of injection 36.47 12.32 65 223296 8846 110357092
Productive cough 36.45 12.32 114 223247 114191 110251747
Pancreatic fibrosis 36.42 12.32 12 223349 95 110365843
Oropharyngeal pain 36.39 12.32 145 223216 135131 110230807
Coeliac disease 36.21 12.32 178 223183 43009 110322929
Accidental poisoning 36.04 12.32 34 223327 2453 110363485
Rhinorrhoea 35.94 12.32 98 223263 102568 110263370
Muscle disorder 35.83 12.32 55 223306 6617 110359321
Colitis 35.57 12.32 98 223263 102225 110263713
Sedation 35.56 12.32 252 223109 69431 110296507
Menstrual disorder 35.44 12.32 46 223315 4738 110361200
Blood lactate dehydrogenase increased 35.29 12.32 23 223338 44311 110321627
Status epilepticus 35.25 12.32 10 223351 31561 110334377
Ear infection 35.06 12.32 232 223129 62500 110303438
Pseudomonas infection 34.67 12.32 7 223354 27846 110338092
Joint dislocation 34.66 12.32 149 223212 34041 110331897
Hemiparesis 34.65 12.32 23 223338 43880 110322058
Weight fluctuation 34.63 12.32 111 223250 22034 110343904
Nasopharyngitis 34.59 12.32 1042 222319 393319 109972619
Skin lesion 34.49 12.32 32 223329 51599 110314339
Eczema 34.48 12.32 58 223303 72235 110293703
Proteinuria 34.33 12.32 19 223342 39999 110325939
Polyneuropathy 34.18 12.32 11 223350 32001 110333937
Fatigue 34.14 12.32 2060 221301 1213898 109152040
Shock haemorrhagic 33.60 12.32 7 223354 27240 110338698
Disseminated intravascular coagulation 33.44 12.32 21 223340 41265 110324673
Surgery 33.43 12.32 21 223340 41262 110324676
Head injury 33.32 12.32 23 223338 42994 110322944
Labelled drug-drug interaction medication error 33.24 12.32 9 223352 29293 110336645
Cardiac failure 33.17 12.32 232 223129 187394 110178544
Upper respiratory tract infection 32.98 12.32 408 222953 130920 110235018
Dysuria 32.92 12.32 44 223317 60187 110305751
Hypophosphataemia 32.71 12.32 13 223348 33169 110332769
Syncope 32.67 12.32 257 223104 202279 110163659
Electrocardiogram QT prolonged 32.45 12.32 112 223249 108848 110257090
End stage renal disease 32.36 12.32 3 223358 21470 110344468
Ileus 32.04 12.32 11 223350 30718 110335220
Adulterated product 31.97 12.32 23 223338 1132 110364806
Osteonecrosis of jaw 31.79 12.32 30 223331 47987 110317951
Libido increased 31.72 12.32 32 223329 2507 110363431
Subdural haematoma 31.72 12.32 17 223344 36437 110329501
Injection site bruising 31.69 12.32 34 223327 51229 110314709
Cardiomyopathy 31.65 12.32 14 223347 33511 110332427
Gastrointestinal stoma output abnormal 31.42 12.32 16 223345 416 110365522
Bacterial infection 31.39 12.32 28 223333 46008 110319930
Product dose omission in error 31.24 12.32 5 223356 23507 110342431
Bradykinesia 31.19 12.32 68 223293 10720 110355218
Bacteraemia 31.10 12.32 24 223337 42366 110323572
Gastroenteritis 31.06 12.32 20 223341 38780 110327158
Therapeutic product ineffective 31.04 12.32 32 223329 2572 110363366
Drug ineffective 30.99 12.32 2648 220713 1517892 108848046
Aggression 30.72 12.32 215 223146 58995 110306943
Feeling abnormal 30.70 12.32 226 223135 180485 110185453
Neoplasm progression 30.65 12.32 52 223309 64543 110301395
Dermatitis atopic 30.61 12.32 7 223354 25534 110340404
Intervertebral disc protrusion 30.50 12.32 9 223352 27689 110338249
Throat irritation 30.42 12.32 38 223323 53514 110312424
No adverse event 30.17 12.32 65 223296 73774 110292164
Adverse reaction 30.16 12.32 11 223350 29583 110336355
Blood pressure increased 30.14 12.32 355 223006 258018 110107920
Hostility 30.12 12.32 32 223329 2664 110363274
Lymphoma 29.92 12.32 3 223358 20168 110345770
Feeling jittery 29.91 12.32 81 223280 14641 110351297
Sinobronchitis 29.77 12.32 16 223345 466 110365472
Cardiac arrest 29.75 12.32 254 223107 196499 110169439
Flushing 29.63 12.32 110 223251 104626 110261312
Skin haemorrhage 29.37 12.32 7 223354 24820 110341118
Blood bilirubin increased 29.31 12.32 69 223292 75903 110290035
Mydriasis 29.31 12.32 105 223256 22052 110343886
Eosinophil count increased 29.08 12.32 4 223357 21054 110344884
Skin laceration 28.99 12.32 16 223345 33737 110332201
Eye pruritus 28.93 12.32 15 223346 32760 110333178
Hepatocellular injury 28.70 12.32 36 223325 50606 110315332
Supraventricular tachycardia 28.66 12.32 7 223354 24415 110341523
Toxic skin eruption 28.43 12.32 10 223351 27505 110338433
Appendicitis 28.30 12.32 11 223350 28453 110337485
Hip fracture 28.30 12.32 18 223343 35133 110330805
Device related infection 28.21 12.32 23 223338 39496 110326442
Orthostatic hypotension 28.18 12.32 57 223304 66192 110299746
Product storage error 28.03 12.32 5 223356 21723 110344215
Renal papillary necrosis 28.00 12.32 15 223346 434 110365504
Needle fatigue 27.94 12.32 22 223339 1242 110364696
Sternal fracture 27.94 12.32 34 223327 3282 110362656
Macular degeneration 27.90 12.32 5 223356 21654 110344284
Blood triglycerides increased 27.80 12.32 7 223354 23919 110342019
Incorrect route of product administration 27.80 12.32 223 223138 63838 110302100
Hemiplegia 27.79 12.32 6 223355 22776 110343162
Wrist surgery 27.78 12.32 19 223342 862 110365076
Cytopenia 27.77 12.32 13 223348 30103 110335835
Bone pain 27.74 12.32 56 223305 65077 110300861
Blood uric acid increased 27.67 12.32 5 223356 21524 110344414
Stoma site dermatitis 27.51 12.32 13 223348 286 110365652
Fracture 27.40 12.32 8 223353 24780 110341158
COVID-19 pneumonia 27.29 12.32 21 223340 37122 110328816
Electrocardiogram abnormal 27.19 12.32 3 223358 18706 110347232
Ventricular fibrillation 27.13 12.32 26 223335 41287 110324651
Hot flush 27.09 12.32 58 223303 65978 110299960
Substance use disorder 27.09 12.32 51 223310 7239 110358699
Urinary incontinence 27.06 12.32 35 223326 48552 110317386
Post procedural complication 27.01 12.32 10 223351 26648 110339290
Aspergillus infection 27.00 12.32 9 223352 25607 110340331
Ventricular tachycardia 26.86 12.32 37 223324 49972 110315966
Skin fissures 26.84 12.32 8 223353 24450 110341488
Palmar-plantar erythrodysaesthesia syndrome 26.73 12.32 26 223335 40999 110324939
Pemphigoid 26.62 12.32 4 223357 19703 110346235
Burning sensation 26.59 12.32 63 223298 69149 110296789
Gastrointestinal stoma complication 26.54 12.32 33 223328 3256 110362682
Myalgia 26.54 12.32 304 223057 222077 110143861
Hallucinations, mixed 26.51 12.32 56 223305 8637 110357301
Cardiac failure acute 26.20 12.32 8 223353 24070 110341868
Multiple sclerosis relapse 26.16 12.32 38 223323 50202 110315736
Red blood cell count decreased 26.14 12.32 59 223302 65864 110300074
Obstructive defaecation 25.99 12.32 12 223349 250 110365688
Stress 25.82 12.32 117 223244 105231 110260707
Insomnia 25.75 12.32 930 222431 359660 110006278
Bladder cancer 25.47 12.32 5 223356 20287 110345651
Immunosuppression 25.43 12.32 3 223358 17756 110348182
Drooling 25.36 12.32 49 223312 7090 110358848
Lung infiltration 25.36 12.32 9 223352 24619 110341319
Pulmonary alveolar haemorrhage 25.22 12.32 5 223356 20145 110345793
Atrioventricular block complete 25.10 12.32 5 223356 20077 110345861
Lung neoplasm malignant 25.03 12.32 19 223342 33823 110332115
Thrombotic microangiopathy 24.77 12.32 14 223347 29135 110336803
Fluid retention 24.55 12.32 295 223066 94012 110271926
Device dislocation 24.49 12.32 17 223344 31687 110334251
Necrosis ischaemic 24.48 12.32 21 223340 1338 110364600
Pulmonary arterial hypertension 24.46 12.32 18 223343 32550 110333388
Bronchopulmonary aspergillosis 24.45 12.32 15 223346 29848 110336090
Chronic sinusitis 24.44 12.32 10 223351 25074 110340864
Joint stiffness 24.42 12.32 225 223136 67018 110298920
Opiates positive 24.40 12.32 18 223343 921 110365017
Rhabdomyolysis 24.28 12.32 143 223218 120258 110245680
Right ventricular failure 24.25 12.32 11 223350 25943 110339995
Subarachnoid haemorrhage 24.20 12.32 15 223346 29687 110336251
Gastric disorder 24.16 12.32 132 223229 33225 110332713
Gait spastic 24.04 12.32 22 223339 1527 110364411
Renal tubular necrosis 24 12.32 16 223345 30459 110335479
Palpitations 23.86 12.32 206 223155 159006 110206932
Cardiac murmur 23.70 12.32 10 223351 24618 110341320
Osteonecrosis 23.63 12.32 20 223341 33721 110332217
Psychotic behaviour 23.61 12.32 21 223340 1404 110364534
Enterococcal infection 23.59 12.32 6 223355 20360 110345578
Blood loss anaemia 23.57 12.32 4 223357 18021 110347917
Blood ethanol 23.56 12.32 9 223352 114 110365824
Synovial fluid analysis 23.42 12.32 28 223333 2653 110363285
Secretion discharge 23.38 12.32 6 223355 20238 110345700
Muscle spasms 23.31 12.32 731 222630 277426 110088512
Coagulopathy 23.27 12.32 29 223332 40882 110325056
Allergic sinusitis 23.27 12.32 23 223338 1758 110364180
Migraine 23.23 12.32 481 222880 171171 110194767
Treatment noncompliance 23.13 12.32 73 223288 72917 110293021
Haemorrhage intracranial 23.10 12.32 15 223346 28954 110336984
Vasculitis 23.07 12.32 23 223338 35850 110330088
Hypothyroidism 23.03 12.32 73 223288 72826 110293112
Blood immunoglobulin M increased 23.00 12.32 22 223339 1615 110364323
Hyperbilirubinaemia 22.97 12.32 17 223344 30654 110335284
Pathogen resistance 22.94 12.32 4 223357 17668 110348270
Hyperphosphataemia 22.89 12.32 3 223358 16378 110349560
Gout 22.88 12.32 24 223337 36542 110329396
Graft versus host disease 22.85 12.32 5 223356 18801 110347137
Blood phosphorus increased 22.81 12.32 3 223358 16337 110349601
Haemorrhoids 22.79 12.32 23 223338 35649 110330289
Decreased immune responsiveness 22.76 12.32 56 223305 9550 110356388
Product administration error 22.65 12.32 25 223336 37192 110328746
Procedural pain 22.64 12.32 23 223338 35542 110330396
Neutrophil count increased 22.53 12.32 22 223339 34630 110331308
Neoplasm skin 22.49 12.32 30 223331 3174 110362764
Generalised tonic-clonic seizure 22.45 12.32 48 223313 54632 110311306
Seronegative arthritis 22.41 12.32 68 223293 13109 110352829
Postmortem blood drug level increased 22.32 12.32 19 223342 1198 110364740
Premature labour 22.30 12.32 54 223307 9118 110356820
Lower gastrointestinal haemorrhage 22.29 12.32 5 223356 18481 110347457
Device malfunction 22.12 12.32 12 223349 25546 110340392
Squamous cell carcinoma of skin 22.10 12.32 4 223357 17199 110348739
Heart rate increased 22.05 12.32 185 223176 143649 110222289
Abortion spontaneous 22.02 12.32 22 223339 34260 110331678
Gas poisoning 21.87 12.32 8 223353 89 110365849
Muscle tension dysphonia 21.78 12.32 11 223350 281 110365657
Injection site rash 21.76 12.32 10 223351 23409 110342529
Herpes simplex 21.76 12.32 3 223358 15761 110350177
Hypertensive crisis 21.75 12.32 11 223350 24361 110341577
Sphincter of Oddi dysfunction 21.73 12.32 14 223347 574 110365364
Troponin increased 21.65 12.32 17 223344 29749 110336189
Respiratory disorder 21.62 12.32 230 223131 71152 110294786
Atrial flutter 21.57 12.32 11 223350 24251 110341687
Second primary malignancy 21.56 12.32 5 223356 18063 110347875
Blood pressure fluctuation 21.55 12.32 78 223283 74746 110291192
Cholestasis 21.53 12.32 63 223298 64455 110301483
Atrioventricular block 21.52 12.32 4 223357 16873 110349065
Diaphragmatic rupture 21.45 12.32 10 223351 213 110365725
Pharyngitis 21.40 12.32 12 223349 25086 110340852
Chronic gastrointestinal bleeding 21.32 12.32 13 223348 483 110365455
Suicide attempt 21.27 12.32 122 223239 103272 110262666
Tenosynovitis stenosans 21.21 12.32 31 223330 3572 110362366
Gastrointestinal stoma output increased 21.18 12.32 17 223344 987 110364951
Blood creatine phosphokinase increased 21.16 12.32 76 223285 73001 110292937
Carbuncle 21.16 12.32 20 223341 1447 110364491
Chronic spontaneous urticaria 21.11 12.32 23 223338 1970 110363968
Skin cancer 21.06 12.32 5 223356 17779 110348159
Respiratory tract infection 21.06 12.32 74 223287 71543 110294395
Therapeutic response unexpected 20.92 12.32 11 223350 23832 110342106
Administration site bruise 20.91 12.32 10 223351 226 110365712
Femur fracture 20.91 12.32 36 223325 44433 110321505
Peritonitis 20.86 12.32 21 223340 32586 110333352
Nephrolithiasis 20.83 12.32 215 223146 65997 110299941
Candida infection 20.68 12.32 41 223320 47968 110317970
Hepatic steatosis 20.66 12.32 169 223192 48662 110317276
Heavy menstrual bleeding 20.61 12.32 4 223357 16361 110349577
Malnutrition 20.58 12.32 15 223346 27264 110338674
Glycosylated haemoglobin increased 20.57 12.32 11 223350 23608 110342330
Dialysis 20.49 12.32 7 223354 19612 110346326
Infusion site pain 20.43 12.32 5 223356 17414 110348524
Oral candidiasis 20.36 12.32 37 223324 44723 110321215
Relapsing-remitting multiple sclerosis 20.29 12.32 23 223338 2059 110363879
Hypertriglyceridaemia 20.23 12.32 4 223357 16150 110349788
Cytomegalovirus infection reactivation 20.11 12.32 6 223355 18327 110347611
Serotonin syndrome 20.02 12.32 195 223166 58958 110306980
Infective pulmonary exacerbation of cystic fibrosis 19.94 12.32 3 223358 14768 110351170
Diffuse large B-cell lymphoma 19.78 12.32 4 223357 15894 110350044
Enteritis 19.73 12.32 7 223354 19149 110346789
Product substitution issue 19.71 12.32 11 223350 23050 110342888
Visual impairment 19.62 12.32 381 222980 134047 110231891
Blood potassium increased 19.51 12.32 23 223338 33226 110332712
Tremor 19.51 12.32 289 223072 201943 110163995
Oesophagitis chemical 19.37 12.32 7 223354 75 110365863
Drug interaction 19.24 12.32 820 222541 499363 109866575
Duodenal ulcer repair 19.21 12.32 7 223354 77 110365861
Sedation complication 19.21 12.32 8 223353 19847 110346091
Extrapyramidal disorder 19.15 12.32 18 223343 28849 110337089
Viral infection 19.14 12.32 50 223311 53089 110312849
Diverticulum 19.12 12.32 4 223357 15522 110350416
Large intestine perforation 19.07 12.32 5 223356 16624 110349314
Torsade de pointes 19.00 12.32 11 223350 22589 110343349
Bronchitis 18.99 12.32 214 223147 156818 110209120
Gastritis 18.98 12.32 51 223310 53648 110312290
Frequent bowel movements 18.88 12.32 224 223137 71166 110294772
Tooth injury 18.88 12.32 23 223338 2223 110363715
Cyst 18.84 12.32 5 223356 16491 110349447
Skin neoplasm excision 18.82 12.32 22 223339 2036 110363902
Hormone-dependent prostate cancer 18.76 12.32 9 223352 205 110365733
Emotional distress 18.72 12.32 39 223322 44808 110321130
Dysphonia 18.67 12.32 235 223126 75694 110290244
Pain in extremity 18.65 12.32 799 222562 486319 109879619
Iron deficiency 18.60 12.32 7 223354 18469 110347469
Accidental overdose 18.60 12.32 173 223188 51661 110314277
Diarrhoea 18.54 12.32 2017 221344 1137488 109228450
Skin irritation 18.53 12.32 5 223356 16314 110349624
Device occlusion 18.52 12.32 4 223357 15181 110350757
Myopathy 18.48 12.32 14 223347 24946 110340992
Spinal compression fracture 18.47 12.32 7 223354 18385 110347553
Impaired quality of life 18.45 12.32 20 223341 29997 110335941
Alveolar rhabdomyosarcoma 18.44 12.32 5 223356 18 110365920
Emotional disorder 18.40 12.32 73 223288 16087 110349851
Breast cancer 18.31 12.32 31 223330 38511 110327427
Disability 18.26 12.32 114 223247 30109 110335829
Paralysis 18.20 12.32 71 223290 15529 110350409
Rales 18.16 12.32 14 223347 24725 110341213
Granuloma 18.08 12.32 51 223310 9439 110356499
Injection site mass 17.97 12.32 14 223347 24599 110341339
Dissociation 17.89 12.32 52 223309 9790 110356148
Acne 17.80 12.32 25 223336 33495 110332443
Failure to thrive 17.78 12.32 3 223358 13571 110352367
Leukocytosis 17.65 12.32 53 223308 53775 110312163
Gingival bleeding 17.63 12.32 9 223352 19830 110346108
Coronary artery occlusion 17.60 12.32 5 223356 15767 110350171
Logorrhoea 17.58 12.32 34 223327 4923 110361015
Postoperative wound infection 17.57 12.32 5 223356 15748 110350190
Metastases to eye 17.53 12.32 10 223351 328 110365610
Blood albumin decreased 17.47 12.32 18 223343 27634 110338304
Hyperthyroidism 17.43 12.32 20 223341 29241 110336697
Diabetic ketoacidosis 17.20 12.32 37 223324 42021 110323917
Multiple-drug resistance 17.17 12.32 3 223358 13232 110352706
Foetal arrhythmia 17.16 12.32 6 223355 58 110365880
Cold urticaria 17.13 12.32 9 223352 250 110365688
Drug level decreased 17.11 12.32 8 223353 18540 110347398
Osteoporosis 17.07 12.32 259 223102 86893 110279045
Anhedonia 17.01 12.32 5 223356 15423 110350515
Mental disorder 16.82 12.32 33 223328 38758 110327180
Lymphadenopathy 16.80 12.32 69 223292 63766 110302172
Face oedema 16.76 12.32 26 223335 33443 110332495
Tooth extraction 16.73 12.32 3 223358 12988 110352950
Tendon discomfort 16.71 12.32 12 223349 589 110365349
Scleritis 16.63 12.32 35 223326 5385 110360553
Toxic epidermal necrolysis 16.42 12.32 59 223302 56668 110309270
Interstitial lung disease 16.41 12.32 191 223170 139143 110226795
Product complaint 16.41 12.32 4 223357 13968 110351970
Eating disorder 16.40 12.32 23 223338 30835 110335103
Optic nerve operation 16.40 12.32 11 223350 483 110365455
Iron deficiency anaemia 16.30 12.32 24 223337 31535 110334403
Jaundice 16.24 12.32 63 223298 59173 110306765
Paraesthesia 16.17 12.32 698 222663 275823 110090115
Pelvic pain 16.12 12.32 6 223355 15936 110350002
Myocardial fibrosis 16.07 12.32 20 223341 1975 110363963
Postmortem blood drug level abnormal 16.03 12.32 12 223349 628 110365310
Malignant melanoma 16.03 12.32 7 223354 16884 110349054
Device difficult to use 16.02 12.32 9 223352 18796 110347142
Vestibular disorder 16.01 12.32 23 223338 2609 110363329
Fear-related avoidance of activities 15.94 12.32 7 223354 129 110365809
Ageusia 15.90 12.32 10 223351 19635 110346303
Gastroenteritis viral 15.88 12.32 24 223337 31202 110334736
Ejection fraction decreased 15.87 12.32 37 223324 40843 110325095
Gallbladder cholesterolosis 15.85 12.32 12 223349 639 110365299
Haemodialysis 15.80 12.32 8 223353 17711 110348227
Cholelithiasis 15.80 12.32 70 223291 63352 110302586
Metastases to lung 15.75 12.32 14 223347 23049 110342889
Rheumatic disorder 15.74 12.32 27 223334 3564 110362374
Anxiety 15.74 12.32 850 222511 344228 110021710
Metastases to nervous system 15.72 12.32 9 223352 297 110365641
Headache 15.72 12.32 2023 221338 880354 109485584
Blood immunoglobulin A decreased 15.70 12.32 21 223340 2227 110363711
Diastolic dysfunction 15.69 12.32 3 223358 12401 110353537
Blood glucose decreased 15.65 12.32 22 223339 29466 110336472
Precancerous cells present 15.61 12.32 16 223345 1277 110364661
Derailment 15.56 12.32 6 223355 78 110365860
Squamous cell carcinoma 15.50 12.32 9 223352 18454 110347484
Radiculopathy 15.43 12.32 10 223351 19326 110346612
Respiratory syncytial virus infection 15.42 12.32 5 223356 14479 110351459
Constipation 15.37 12.32 579 222782 357207 110008731
Endocarditis 15.37 12.32 4 223357 13367 110352571
Weight decreased 15.26 12.32 781 222580 467276 109898662
Hiatus hernia 15.25 12.32 20 223341 27586 110338352
Hallucination, visual 15.25 12.32 36 223325 39569 110326369
Pain of skin 15.13 12.32 11 223350 20018 110345920
Hyperlipidaemia 15.11 12.32 31 223330 35817 110330121
Rash macular 15.03 12.32 35 223326 38651 110327287
Facial paralysis 15.03 12.32 16 223345 24198 110341740
Congestive cardiomyopathy 14.98 12.32 5 223356 14214 110351724
Glomerular filtration rate decreased 14.98 12.32 22 223339 28934 110337004
Accidental death 14.97 12.32 32 223329 4977 110360961
Toxic encephalopathy 14.93 12.32 6 223355 15208 110350730
Glaucoma 14.92 12.32 87 223274 22430 110343508
Hypertonic bladder 14.85 12.32 33 223328 5269 110360669
Hypomagnesaemia 14.82 12.32 67 223294 60303 110305635
Hallucination, auditory 14.71 12.32 19 223342 26378 110339560
Metastases to liver 14.58 12.32 31 223330 35355 110330583
Vertigo 14.58 12.32 109 223252 86761 110279177
Intestinal diaphragm disease 14.57 12.32 10 223351 456 110365482
Proctitis 14.57 12.32 8 223353 16919 110349019
Cardiotoxicity 14.50 12.32 8 223353 16873 110349065
Neutropenic sepsis 14.43 12.32 109 223252 30637 110335301
Herpes zoster 14.43 12.32 303 223058 108076 110257862
Haemodynamic instability 14.35 12.32 15 223346 22873 110343065
Vaginal cellulitis 14.32 12.32 6 223355 98 110365840
Splenomegaly 14.32 12.32 17 223344 24481 110341457
Urosepsis 14.27 12.32 25 223336 30650 110335288
Cutaneous vasculitis 14.27 12.32 4 223357 12725 110353213
Device breakage 14.23 12.32 5 223356 13764 110352174
Hepatitis cholestatic 14.14 12.32 9 223352 17557 110348381
Hepatic encephalopathy 14.10 12.32 22 223339 28234 110337704
Blindness 14.04 12.32 33 223328 36326 110329612
Skin burning sensation 14.03 12.32 14 223347 21811 110344127
Ventricular extrasystoles 14.01 12.32 15 223346 22626 110343312
Overgrowth bacterial 14.00 12.32 8 223353 263 110365675
Spinal fracture 14 12.32 15 223346 22618 110343320
Incubator therapy 13.97 12.32 5 223356 52 110365886
Dependence 13.96 12.32 22 223339 2707 110363231
Heparin-induced thrombocytopenia 13.95 12.32 3 223358 11421 110354517
Scrotal infection 13.94 12.32 12 223349 768 110365170
Complication associated with device 13.94 12.32 12 223349 20061 110345877
Excessive eye blinking 13.88 12.32 18 223343 1852 110364086
Therapeutic response shortened 13.86 12.32 24 223337 29559 110336379
Post procedural haemorrhage 13.84 12.32 7 223354 15505 110350433
Arrhythmia 13.83 12.32 83 223278 69492 110296446
Hyperuricaemia 13.83 12.32 6 223355 14525 110351413
Analgesic drug level above therapeutic 13.78 12.32 10 223351 499 110365439
Tooth disorder 13.77 12.32 24 223337 29485 110336453
Mouth haemorrhage 13.77 12.32 5 223356 13483 110352455
Nausea 13.73 12.32 2240 221121 1233450 109132488
Inflammatory marker increased 13.73 12.32 6 223355 14463 110351475
Haemoptysis 13.72 12.32 86 223275 71268 110294670
Alice in wonderland syndrome 13.72 12.32 5 223356 55 110365883
Hepatitis 13.72 12.32 116 223245 89938 110276000
Gastroenteritis bacterial 13.71 12.32 10 223351 503 110365435
Product dispensing error 13.67 12.32 8 223353 16337 110349601
Hepatic failure 13.66 12.32 82 223279 68657 110297281
Bedridden 13.66 12.32 5 223356 13420 110352518
Hydronephrosis 13.58 12.32 13 223348 20652 110345286
Blood test abnormal 13.53 12.32 23 223338 28531 110337407
Myoclonus 13.52 12.32 29 223332 32969 110332969
Encephalitis 13.40 12.32 11 223350 18828 110347110
Cystitis haemorrhagic 13.39 12.32 4 223357 12205 110353733
Rash papular 13.34 12.32 22 223339 27617 110338321
Cholesteatoma 13.34 12.32 7 223354 194 110365744
Rhinitis allergic 13.34 12.32 10 223351 17912 110348026
Metabolic encephalopathy 13.32 12.32 3 223358 11057 110354881
Foetal monitoring abnormal 13.31 12.32 7 223354 195 110365743
Colitis ulcerative 13.30 12.32 225 223136 77138 110288800
Perineal pain 13.27 12.32 16 223345 1529 110364409
Pelvic fracture 13.22 12.32 6 223355 14148 110351790
Hypernatraemia 13.21 12.32 10 223351 17823 110348115
Abnormal weight gain 13.19 12.32 25 223336 3566 110362372
Dysmetropsia 13.17 12.32 6 223355 121 110365817
Dermatitis exfoliative generalised 13.16 12.32 3 223358 10969 110354969
Lipase increased 13.16 12.32 11 223350 18661 110347277
Odynophagia 13.14 12.32 6 223355 14095 110351843
Aortic stenosis 13.06 12.32 5 223356 13054 110352884
Decreased appetite 12.99 12.32 1123 222238 474723 109891215
Blood pressure diastolic abnormal 12.98 12.32 20 223341 25795 110340143
Product label confusion 12.98 12.32 16 223345 22661 110343277
Gastrooesophageal reflux disease 12.94 12.32 271 223090 179705 110186233
Carpal tunnel syndrome 12.89 12.32 16 223345 22594 110343344
Perineal infection 12.85 12.32 12 223349 855 110365083
Cholecystitis acute 12.82 12.32 8 223353 15774 110350164
Postmortem blood drug level 12.77 12.32 8 223353 312 110365626
Intentional dose omission 12.77 12.32 13 223348 20067 110345871
Hypogammaglobulinaemia 12.76 12.32 13 223348 20063 110345875
Pulmonary thrombosis 12.76 12.32 6 223355 13857 110352081
Salpingo-oophorectomy bilateral 12.75 12.32 8 223353 313 110365625
Abdominal pain lower 12.74 12.32 36 223325 37247 110328691
Blood iron decreased 12.72 12.32 12 223349 19202 110346736
Clostridium difficile infection 12.71 12.32 58 223303 52071 110313867
Nephrotic syndrome 12.71 12.32 6 223355 13825 110352113
Photosensitivity reaction 12.70 12.32 20 223341 25569 110340369
Caesarean section 12.69 12.32 6 223355 13811 110352127
Blood pressure abnormal 12.64 12.32 16 223345 22408 110343530
Pharyngeal swelling 12.63 12.32 53 223308 11979 110353959
Fear 12.61 12.32 17 223344 23176 110342762
Paranoia 12.58 12.32 16 223345 22358 110343580
Diverticulum intestinal 12.56 12.32 4 223357 11715 110354223
Substance use 12.54 12.32 20 223341 2486 110363452
Insurance issue 12.54 12.32 3 223358 10609 110355329
Agitated depression 12.51 12.32 10 223351 577 110365361
Peritonitis bacterial 12.40 12.32 3 223358 10530 110355408
Hypovolaemic shock 12.40 12.32 7 223354 14576 110351362
Synovial disorder 12.39 12.32 22 223339 2985 110362953
Self-medication 12.37 12.32 34 223327 6198 110359740
Hepatomegaly 12.37 12.32 15 223346 21399 110344539
Monoclonal immunoglobulin present 12.34 12.32 20 223341 2520 110363418

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AA59 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA79 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ07 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ09 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC R05DA04 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000996 Antitussive Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018689 Sensory System Agents
MeSH PA D019141 Respiratory System Agents
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:60606 opioid receptor agonist
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:64946 anti-HIV agent

Related Drugs by ATC class:

N02AA Natural opium alkaloids 8 drugs
dihydrocodeinehydromorphonemorphinenaloxonenaltrexonenicomorphineoxycodoneoxymorphone
N02AJ Opioids in combination with non-opioid analgesics 9 drugs
acetylsalicylic acidcelecoxibdexketoprofendihydrocodeinehydrocodoneibuprofenoxycodoneparacetamoltramadol
R05DA Opium alkaloids and derivatives 10 drugs
acetyldihydrocodeinedextromethorphandimemorfanethylmorphinehydrocodonemorphinenormethadonenoscapinepholcodinethebacon

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

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Headache disorder indication 230461009
Sore throat symptom indication 267102003
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Muscle Spasm with Pain indication
Diarrhea off-label use 62315008
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Constipation contraindication 14760008 DOID:2089
Hyperbilirubinemia contraindication 14783006 DOID:2741
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Disorder of the central nervous system contraindication 23853001 DOID:331
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Sedation contraindication 72641008
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Acute intermittent porphyria contraindication 234422006 DOID:3890
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Poor metabolizer due to cytochrome p450 CYP2C19 variant contraindication 424500005
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Acute exacerbation of asthma contraindication 708038006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
8MG;54.3MG TUXARIN ER MAINPOINTE N206323 June 22, 2015 RX TABLET, EXTENDED RELEASE ORAL 9066942 Jan. 3, 2032 TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 6.14 CHEMBL CHEMBL
Kappa-type opioid receptor GPCR AGONIST Ki 4.59 CHEMBL
Delta-type opioid receptor GPCR AGONIST Ki 4.28 CHEMBL
Opioid receptor GPCR IC50 8 CHEMBL

External reference:

IDSource
4017509 VUID
N0000145894 NUI
D00195 KEGG_DRUG
52-28-8 SECONDARY_CAS_RN
41444-62-6 SECONDARY_CAS_RN
6854-40-6 SECONDARY_CAS_RN
1545976 RXNORM
C0009214 UMLSCUI
CHEBI:16714 CHEBI
CHEMBL485 ChEMBL_ID
CHEMBL6067642 ChEMBL_ID
CHEMBL369475 ChEMBL_ID
DB00318 DRUGBANK_ID
CHEMBL4297091 ChEMBL_ID
D003061 MESH_DESCRIPTOR_UI
5284371 PUBCHEM_CID
1673 IUPHAR_LIGAND_ID
Q830PW7520 UNII
32159 MMSL
4490 MMSL
4491 MMSL
4492 MMSL
4675 MMSL
4676 MMSL
d00012 MMSL
001550 NDDF
001551 NDDF
001552 NDDF
001553 NDDF
005189 NDDF
1014151000202108 SNOMEDCT_US
1268991009 SNOMEDCT_US
1365627003 SNOMEDCT_US
1476002 SNOMEDCT_US
261000 SNOMEDCT_US
387494007 SNOMEDCT_US
85990009 SNOMEDCT_US
CHEMBL1201463 ChEMBL_ID
6059-47-8 SECONDARY_CAS_RN
4017414 VANDF
4017415 VANDF
4017509 VANDF
4019491 VANDF
Q830PW7520 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0243 TABLET 15 mg ORAL NDA 32 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0244 TABLET 30 mg ORAL NDA 32 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0245 TABLET 60 mg ORAL NDA 32 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-0650 CAPSULE 30 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-3000 CAPSULE 30 mg ORAL ANDA 33 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-0504 SOLUTION 12 mg ORAL ANDA 23 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-0775 SOLUTION 10 mg ORAL OTC Monograph Drug 16 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-1008 SOLUTION 30 mg ORAL ANDA 23 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1550 SOLUTION 20 mg ORAL OTC Monograph Drug 16 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1775 SOLUTION 10 mg ORAL OTC Monograph Drug 16 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0483 TABLET 15 mg ORAL ANDA 24 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0484 TABLET 30 mg ORAL ANDA 24 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0485 TABLET 60 mg ORAL ANDA 24 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7026 TABLET 30 mg ORAL ANDA 31 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7027 TABLET 60 mg ORAL ANDA 31 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1698 TABLET 30 mg ORAL ANDA 32 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1699 TABLET 60 mg ORAL ANDA 32 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1727 TABLET 15 mg ORAL ANDA 32 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0591-2641 CAPSULE 30 mg ORAL ANDA 27 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0591-3220 CAPSULE 30 mg ORAL NDA authorized generic 32 sections
MAR-COF CGExpectorant HUMAN OTC DRUG LABEL 2 0682-0475 SYRUP 7.50 mg ORAL OTC Monograph Drug 15 sections
Promethazine Hydrochloride and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0713-0823 SOLUTION 10 mg ORAL ANDA 29 sections
Ascomp with Codeine HUMAN PRESCRIPTION DRUG LABEL 4 0722-6094 CAPSULE 30 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0722-6670 CAPSULE 30 mg ORAL ANDA 32 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0722-7028 CAPSULE 30 mg ORAL ANDA 32 sections
CODEINE AND CHLORPHENIRAMINE MALEATE ER HUMAN PRESCRIPTION DRUG LABEL 2 0722-7184 TABLET, EXTENDED RELEASE 54.30 mg ORAL NDA 32 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 10544-032 TABLET 30 mg ORAL ANDA 26 sections
Acetaminophen and Codeine HUMAN PRESCRIPTION DRUG LABEL 2 10544-100 TABLET 30 mg ORAL ANDA 28 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 12634-526 TABLET 30 mg ORAL ANDA 22 sections
promethazine hydrochloride and codeine phosphate HUMAN PRESCRIPTION DRUG LABEL 2 12634-907 SYRUP 10 mg ORAL ANDA 29 sections