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

Stem definitionDrug idCAS RN
52 103-90-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • acetaminophen
  • acetaminofen
  • aminofen
  • panadol
  • paracetamol
  • neopap
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • Molecular weight: 151.17
  • Formula: C8H9NO2
  • CLOGP: 0.49
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -1.56
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
3 g O
3 g P
3 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 23.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 330.76 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 88 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.52 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 7, 1968 FDA POLYMEDICA

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
Toxicity to various agents 2425.99 11.09 8014 775349 204485 49617276
Completed suicide 1241.73 11.09 4672 778691 127217 49694544
Intentional overdose 1165.29 11.09 2819 780544 59685 49762076
Acute hepatic failure 1138.75 11.09 1308 782055 14369 49807392
Overdose 1035.71 11.09 3648 779715 96079 49725682
Analgesic drug level increased 874.69 11.09 460 782903 1271 49820490
Drug ineffective 778.61 11.09 8535 774828 810798 49010963
Hepatocellular injury 683.94 11.09 1346 782017 24601 49797160
Metabolic acidosis 443.59 11.09 1467 781896 37358 49784403
Poisoning deliberate 432.18 11.09 572 782791 7340 49814421
Suicide attempt 404.68 11.09 1731 781632 50001 49771760
Injection site pain 354.86 11.09 741 782622 110283 49711478
Product dose omission issue 340.67 11.09 1574 781789 182264 49639497
Device expulsion 305.02 11.09 42 783321 28780 49792981
Infusion related reaction 302.38 11.09 3979 779384 165578 49656183
Intentional product misuse 298.87 11.09 1474 781889 45260 49776501
Exposure to toxic agent 292.60 11.09 321 783042 3337 49818424
Cholestasis 291.20 11.09 961 782402 24440 49797321
Drug hypersensitivity 256.01 11.09 2566 780797 248444 49573317
Hepatic failure 242.29 11.09 1067 782296 31216 49790545
Off label use 236.84 11.09 5567 777796 468859 49352902
Hepatotoxicity 233.26 11.09 937 782426 26289 49795472
Alopecia 229.99 11.09 2554 780809 242493 49579268
Injection site erythema 227.90 11.09 514 782849 74422 49747339
Injection site reaction 189.16 11.09 301 783062 49731 49772030
Coma 172.45 11.09 1486 781877 55393 49766368
Coagulopathy 169.55 11.09 637 782726 17307 49804454
Blood pressure fluctuation 168.68 11.09 1040 782323 34783 49786978
Treatment failure 168.67 11.09 1342 782021 136295 49685466
Drug resistance 166.42 11.09 44 783319 18945 49802816
Anion gap 165.86 11.09 139 783224 998 49820763
Somnolence 160.48 11.09 3327 780036 151658 49670103
Therapeutic product effect incomplete 152.96 11.09 812 782551 90703 49731058
Sinusitis 152.74 11.09 3586 779777 166972 49654789
Cholecystitis chronic 151.86 11.09 409 782954 9260 49812501
Hepatitis 151.17 11.09 918 782445 30535 49791226
Wrong technique in product usage process 150.53 11.09 404 782959 55106 49766655
Hospitalisation 147.92 11.09 546 782817 67391 49754370
Lower respiratory tract infection 147.20 11.09 2179 781184 93022 49728739
Abdominal discomfort 147.07 11.09 2611 780752 229030 49592731
Confusional state 138.75 11.09 3815 779548 182113 49639648
International normalised ratio increased 135.87 11.09 1137 782226 42015 49779746
Systemic lupus erythematosus 134.38 11.09 1459 781904 139163 49682598
Injection site swelling 132.37 11.09 280 783083 41493 49780268
Injection site pruritus 132.17 11.09 266 783097 40145 49781616
Accidental overdose 129.80 11.09 623 782740 18910 49802851
Depressed level of consciousness 129.17 11.09 1301 782062 50652 49771109
Psoriasis 128.67 11.09 589 782774 68411 49753350
Folliculitis 127.50 11.09 1041 782322 38184 49783577
Maternal exposure during pregnancy 125.67 11.09 1729 781634 158049 49663712
Muscle injury 121.22 11.09 986 782377 36125 49785636
Pemphigus 120.80 11.09 1232 782131 118934 49702827
Body temperature increased 115.85 11.09 857 782506 30484 49791277
Hepatitis acute 114.39 11.09 326 783037 7635 49814126
Pyroglutamate increased 112.47 11.09 74 783289 346 49821415
Injection site bruising 111.10 11.09 253 783110 36515 49785246
Irritable bowel syndrome 109.63 11.09 1249 782114 50192 49771569
Hepatic cytolysis 108.92 11.09 324 783039 7779 49813982
Medication error 106.68 11.09 938 782425 35166 49786595
Hepatitis fulminant 106.00 11.09 179 783184 2889 49818872
Hepatic necrosis 105.60 11.09 244 783119 5004 49816757
Cardiac failure congestive 104.59 11.09 820 782543 83562 49738199
Hepatitis cholestatic 102.43 11.09 265 783098 5852 49815909
Liver injury 100.80 11.09 694 782669 24112 49797649
Red blood cell sedimentation rate abnormal 98.33 11.09 66 783297 16277 49805484
Therapy cessation 95.95 11.09 159 783204 25852 49795909
Psoriatic arthropathy 94.68 11.09 390 782973 46642 49775119
Respiratory depression 93.95 11.09 402 782961 11608 49810153
Vomiting 90.54 11.09 8293 775070 452465 49369296
Prothrombin time shortened 90.24 11.09 120 783243 1547 49820214
Condition aggravated 88.62 11.09 3728 779635 293330 49528431
Urine abnormality 88.23 11.09 254 783109 5984 49815777
Blister 88.11 11.09 1833 781530 83585 49738176
Drug abuse 87.90 11.09 1358 782005 58488 49763273
Transaminases increased 84.87 11.09 728 782635 27096 49794665
Accidental exposure to product 84.07 11.09 142 783221 22915 49798846
Urticaria 83.86 11.09 2612 780751 126949 49694812
Pyroglutamic acidosis 83.58 11.09 63 783300 380 49821381
Therapeutic response decreased 83.46 11.09 411 782952 46820 49774941
Abdominal pain 83.40 11.09 4463 778900 231765 49589996
Bradypnoea 81.62 11.09 160 783203 2914 49818847
Therapy interrupted 80.24 11.09 117 783246 20035 49801726
Contraindicated product administered 80.14 11.09 1726 781637 147232 49674529
Disease progression 79.46 11.09 1026 782337 94840 49726921
Acute generalised exanthematous pustulosis 77.66 11.09 309 783054 8629 49813132
Prothrombin time ratio decreased 75.92 11.09 58 783305 358 49821403
Miosis 74.34 11.09 241 783122 6069 49815692
Poisoning 73.10 11.09 383 782980 12046 49809715
Therapy non-responder 72.84 11.09 476 782887 50546 49771215
Alanine aminotransferase increased 72.44 11.09 1836 781527 86523 49735238
Toxic epidermal necrolysis 70.86 11.09 562 782801 20430 49801331
Glossodynia 70.29 11.09 1312 782051 114257 49707504
Blood pressure diastolic abnormal 69.91 11.09 309 783054 9052 49812709
Bone marrow failure 69.74 11.09 208 783155 27416 49794345
Diarrhoea 69.60 11.09 8013 775350 580463 49241298
Injection site warmth 68.49 11.09 68 783295 13798 49807963
No adverse event 68.48 11.09 277 783086 33301 49788460
Lymphocyte count decreased 68.39 11.09 665 782698 25642 49796119
Drug intolerance 68.19 11.09 2736 780627 216368 49605393
Urine leukocyte esterase positive 68.15 11.09 143 783220 2740 49819021
Mixed liver injury 67.85 11.09 159 783204 3292 49818469
Hepatic encephalopathy 67.42 11.09 312 783051 9324 49812437
Intentional self-injury 65.46 11.09 595 782768 22517 49799244
Ductus arteriosus premature closure 65.17 11.09 48 783315 278 49821483
Prothrombin time prolonged 64.70 11.09 290 783073 8548 49813213
Ill-defined disorder 63.10 11.09 1193 782170 53461 49768300
Surgery 62.34 11.09 248 783115 29957 49791804
Sleep disorder due to general medical condition, insomnia type 61.88 11.09 752 782611 30695 49791066
Myocardial infarction 61.76 11.09 987 782376 88040 49733721
Transplant rejection 60.28 11.09 37 783326 9572 49812189
Device issue 59.87 11.09 138 783225 19834 49801927
Unintentional medical device removal 59.73 11.09 7 783356 5428 49816333
Pruritus 59.71 11.09 5131 778232 278437 49543324
Haematotoxicity 59.16 11.09 24 783339 7871 49813890
Oxygen saturation decreased 58.85 11.09 1518 781845 71730 49750031
Heart rate increased 58.63 11.09 1589 781774 75661 49746100
White blood cells urine positive 57.73 11.09 179 783184 4399 49817362
Product use in unapproved indication 57.73 11.09 1358 782005 114461 49707300
Drug-induced liver injury 57.54 11.09 677 782686 27418 49794343
Device dislocation 57.50 11.09 158 783205 21388 49800373
Encephalopathy 57.42 11.09 785 782578 32926 49788835
Acute kidney injury 57.20 11.09 4183 779180 223875 49597886
Tachycardia 56.50 11.09 1980 781383 97783 49723978
Pyrexia 56.33 11.09 6715 776648 373488 49448273
Product storage error 54.78 11.09 65 783298 12159 49809602
Acute lung injury 54.53 11.09 86 783277 1307 49820454
Neoplasm progression 54.27 11.09 249 783114 28908 49792853
Throat irritation 53.91 11.09 710 782653 29529 49792232
Crystal urine present 53.60 11.09 88 783275 1386 49820375
Product prescribing error 53.52 11.09 157 783206 20804 49800957
Ear pain 53.35 11.09 671 782692 27612 49794149
Cytomegalovirus infection 53.13 11.09 125 783238 17837 49803924
Malignant neoplasm progression 52.85 11.09 739 782624 67385 49754376
Blood pressure systolic abnormal 52.81 11.09 248 783115 7458 49814303
Blood parathyroid hormone decreased 52.70 11.09 22 783341 7092 49814669
Device malfunction 52.52 11.09 96 783267 15025 49806736
Granuloma skin 51.90 11.09 13 783350 5805 49815956
Abortion spontaneous 51.71 11.09 406 782957 41366 49780395
Gallbladder injury 50.81 11.09 80 783283 1214 49820547
Heart rate decreased 50.12 11.09 819 782544 35678 49786083
Urinary sediment present 49.71 11.09 101 783262 1890 49819871
Respiratory arrest 48.76 11.09 693 782670 29316 49792445
Muscle spasticity 48.47 11.09 442 782921 16742 49805019
Acidosis 48.19 11.09 297 783066 9930 49811831
Diabetes mellitus 47.88 11.09 506 782857 48527 49773234
Interstitial lung disease 47.87 11.09 559 782804 52617 49769144
Rheumatoid nodule 47.76 11.09 77 783286 12658 49809103
Cholelithiasis 47.37 11.09 839 782524 37134 49784627
Device difficult to use 47.11 11.09 50 783313 9836 49811925
Injection site haemorrhage 46.81 11.09 171 783192 21175 49800586
Infusion site extravasation 46.71 11.09 223 783140 6753 49815008
Renal papillary necrosis 46.15 11.09 34 783329 197 49821564
Adverse drug reaction 45.75 11.09 591 782772 54631 49767130
Arthropathy 45.67 11.09 1988 781375 155918 49665843
Injury 45.35 11.09 1034 782329 47891 49773870
Infusion site pain 45.28 11.09 337 783026 12009 49809752
Orthostatic hypotension 45.21 11.09 674 782689 28807 49792954
Loss of personal independence in daily activities 45.17 11.09 787 782576 69263 49752498
Injection site rash 45.16 11.09 116 783247 16061 49805700
Post transplant lymphoproliferative disorder 44.78 11.09 6 783357 4198 49817563
Device use error 44.65 11.09 13 783350 5253 49816508
Oligohydramnios 44.62 11.09 192 783171 5558 49816203
Cardio-respiratory arrest 44.20 11.09 1120 782243 52772 49768989
Red blood cells urine positive 44.20 11.09 118 783245 2657 49819104
Hypotension 43.64 11.09 4222 779141 231247 49590514
C-reactive protein abnormal 43.56 11.09 252 783111 27557 49794204
Infusion site swelling 43.50 11.09 223 783140 6953 49814808
Palmar-plantar erythrodysaesthesia syndrome 43.41 11.09 162 783201 19936 49801825
Product use issue 42.99 11.09 1883 781480 147592 49674169
Bone erosion 42.58 11.09 72 783291 11615 49810146
Adverse event 42.17 11.09 453 782910 43310 49778451
Injection site mass 41.83 11.09 115 783248 15565 49806196
Hypertransaminasaemia 41.72 11.09 137 783226 3474 49818287
Brain oedema 41.66 11.09 331 783032 12039 49809722
Myelodysplastic syndrome 41.11 11.09 110 783253 15022 49806739
Metastases to liver 40.90 11.09 166 783197 19938 49801823
Cardiac failure 40.88 11.09 881 782482 75159 49746602
Chills 40.55 11.09 1858 781505 94829 49726932
Rash maculo-papular 40.44 11.09 608 782755 26033 49795728
Injection site urticaria 40.30 11.09 80 783283 12137 49809624
Stevens-Johnson syndrome 40.15 11.09 514 782849 21238 49800523
Myelosuppression 40.03 11.09 94 783269 13423 49808338
Pathogen resistance 39.93 11.09 19 783344 5670 49816091
Drug abuser 39.85 11.09 115 783248 2713 49819048
Liver transplant 39.51 11.09 96 783267 2036 49819725
Disease recurrence 38.87 11.09 169 783194 19912 49801849
Emotional distress 38.54 11.09 641 782722 28022 49793739
Panniculitis 38.33 11.09 45 783318 8458 49813303
Unevaluable event 38.16 11.09 493 782870 45573 49776188
Jaundice 38.13 11.09 598 782765 25831 49795930
Genital haemorrhage 37.64 11.09 28 783335 6546 49815215
Blood pressure increased 37.55 11.09 2466 780897 130666 49691095
Analgesic drug level above therapeutic 37.24 11.09 27 783336 152 49821609
Abdominal pain upper 37.22 11.09 2906 780457 156403 49665358
Abortion incomplete 37.05 11.09 3 783360 3123 49818638
Infusion site erythema 35.95 11.09 245 783118 8482 49813279
Exposure via ingestion 35.72 11.09 110 783253 2693 49819068
Blood iron abnormal 34.83 11.09 5 783358 3321 49818440
Blood pressure systolic increased 34.36 11.09 754 782609 34695 49787066
Blood urine present 34.14 11.09 326 783037 12507 49809254
Blood alkaline phosphatase increased 34.13 11.09 791 782572 36735 49785026
Red cell distribution width increased 33.91 11.09 238 783125 8321 49813440
Transplant dysfunction 33.88 11.09 15 783348 4669 49817092
Posterior reversible encephalopathy syndrome 33.79 11.09 118 783245 14810 49806951
Blood pressure diastolic increased 33.72 11.09 214 783149 7229 49814532
Disturbance in social behaviour 33.69 11.09 3 783360 2891 49818870
Creatinine renal clearance decreased 33.20 11.09 305 783058 11576 49810185
Injection site induration 33.19 11.09 49 783314 8348 49813413
Musculoskeletal disorder 32.98 11.09 147 783216 17202 49804559
Hypocoagulable state 32.86 11.09 55 783308 881 49820880
Skin necrosis 32.64 11.09 75 783288 10792 49810969
Impaired healing 32.57 11.09 1356 782007 68430 49753331
Drug level increased 32.53 11.09 448 782915 18820 49802941
Multiple-drug resistance 32.43 11.09 6 783357 3308 49818453
Cerebrovascular accident 32.33 11.09 1169 782194 93511 49728250
Metastases to bone 32.13 11.09 156 783207 17839 49803922
Aspartate aminotransferase increased 32.08 11.09 1496 781867 76502 49745259
Ear pruritus 32.07 11.09 99 783264 2427 49819334
Wrong patient received product 31.99 11.09 77 783286 1623 49820138
Breast cancer 31.94 11.09 469 782894 42421 49779340
Haemoglobin urine present 31.89 11.09 50 783313 756 49821005
Mydriasis 31.85 11.09 277 783086 10350 49811411
Second primary malignancy 31.81 11.09 36 783327 6878 49814883
Hepatitis toxic 31.78 11.09 106 783257 2710 49819051
Brain death 31.63 11.09 105 783258 2678 49819083
Gamma-glutamyltransferase increased 31.61 11.09 639 782724 28984 49792777
Blood pressure diastolic decreased 31.59 11.09 398 782965 16383 49805378
Liver function test abnormal 31.38 11.09 904 782459 43435 49778326
Renal impairment 31.37 11.09 911 782452 74750 49747011
Hypertensive crisis 31.12 11.09 102 783261 13052 49808709
Dyspnoea exertional 31.01 11.09 582 782781 50651 49771110
Full blood count abnormal 30.99 11.09 223 783140 23165 49798596
Meningitis aseptic 30.96 11.09 137 783226 4015 49817746
Hypothermia 30.86 11.09 303 783060 11713 49810048
Sedation complication 30.86 11.09 237 783126 8529 49813232
Femur fracture 30.64 11.09 402 782961 37062 49784699
Biliary dyskinesia 30.59 11.09 98 783265 2452 49819309
Cerebral haematoma 30.34 11.09 114 783249 3097 49818664
Unresponsive to stimuli 30.29 11.09 653 782710 29956 49791805
Respiratory rate increased 30.18 11.09 289 783074 11096 49810665
Urine ketone body present 30.15 11.09 92 783271 2241 49819520
Lupus-like syndrome 29.74 11.09 64 783299 9427 49812334
Temperature regulation disorder 29.67 11.09 137 783226 4090 49817671
Gastrointestinal disorder 29.64 11.09 1766 781597 92690 49729071
Visceral congestion 29.62 11.09 30 783333 282 49821479
Congenital pulmonary hypertension 29.50 11.09 16 783347 48 49821713
Gallbladder disorder 29.39 11.09 392 782971 16350 49805411
Metastases to lung 29.26 11.09 81 783282 10939 49810822
Substance abuse 29.20 11.09 134 783229 3990 49817771
Knee arthroplasty 29.18 11.09 385 782978 35461 49786300
Neuropathy peripheral 29.03 11.09 1213 782150 95544 49726217
Haemophagocytic lymphohistiocytosis 28.93 11.09 56 783307 8577 49813184
Lymphocyte percentage decreased 28.62 11.09 101 783262 2659 49819102
Anion gap abnormal 28.56 11.09 31 783332 318 49821443
Feeling abnormal 28.29 11.09 1621 781742 123871 49697890
Nasopharyngitis 28.29 11.09 3406 779957 189521 49632240
Night sweats 28.19 11.09 700 782663 32874 49788887
Acute graft versus host disease 28.12 11.09 13 783350 3945 49817816
Toxic skin eruption 28.07 11.09 282 783081 10969 49810792
Complication associated with device 27.96 11.09 124 783239 14531 49807230
Product quality issue 27.53 11.09 325 783038 30533 49791228
Respiratory disorder 27.32 11.09 654 782709 30533 49791228
Blood bilirubin increased 27.21 11.09 669 782694 31369 49790392
Underdose 27.04 11.09 193 783170 20085 49801676
Product administration error 27.02 11.09 442 782921 19257 49802504
Coagulation factor V level decreased 26.95 11.09 28 783335 272 49821489
Musculoskeletal stiffness 26.94 11.09 1671 781692 126810 49694951
White blood cell count decreased 26.81 11.09 1505 781858 115217 49706544
Chest discomfort 26.76 11.09 1721 781642 91001 49730760
Red blood cell sedimentation rate 26.71 11.09 11 783352 3575 49818186
Infusion site pruritus 26.46 11.09 126 783237 3811 49817950
Cell death 26.46 11.09 85 783278 2130 49819631
Osteonecrosis 26.42 11.09 222 783141 22295 49799466
Chronic graft versus host disease 26.38 11.09 6 783357 2861 49818900
Complication of device removal 26.17 11.09 16 783347 4148 49817613
Cardiotoxicity 25.87 11.09 43 783320 6984 49814777
Jaundice cholestatic 25.72 11.09 151 783212 4960 49816801
Urine analysis abnormal 25.55 11.09 134 783229 4216 49817545
Flushing 25.38 11.09 1275 782088 65740 49756021
Drug ineffective for unapproved indication 25.34 11.09 209 783154 21072 49800689
Mucosal inflammation 25.23 11.09 453 782910 39689 49782072
Blood glucose increased 25.18 11.09 877 782486 70447 49751314
Anion gap increased 25.16 11.09 65 783298 1434 49820327
Platelet count decreased 25.14 11.09 1288 782075 99438 49722323
Culture urine positive 25.08 11.09 113 783250 3338 49818423
Product substitution issue 25.01 11.09 122 783241 13935 49807826
Hyperthermia 24.87 11.09 204 783159 7492 49814269
Memory impairment 24.85 11.09 990 782373 78370 49743391
Hyponatraemia 24.84 11.09 1768 781595 94371 49727390
Device breakage 24.74 11.09 71 783292 9476 49812285
Fear of injection 24.72 11.09 35 783328 6068 49815693
Prothrombin level increased 24.66 11.09 24 783339 214 49821547
Medication overuse headache 24.58 11.09 39 783324 596 49821165
Osteonecrosis of jaw 24.45 11.09 355 783008 32171 49789590
Coagulation factor VII level decreased 24.36 11.09 15 783348 61 49821700
Electric shock 24.31 11.09 51 783312 977 49820784
Blood calcium decreased 24.24 11.09 453 782910 20253 49801508
Complication of device insertion 24.12 11.09 35 783328 6006 49815755
Foot deformity 24.10 11.09 186 783177 19024 49802737
Neutropenia 24.07 11.09 1967 781396 145998 49675763
Brain stem glioma 24.06 11.09 19 783344 124 49821637
Bradycardia 24.04 11.09 1224 782139 63202 49758559
Neurotoxicity 23.94 11.09 132 783231 14608 49807153
Fixed eruption 23.91 11.09 45 783318 794 49820967
Diabetic ketoacidosis 23.88 11.09 170 783193 17702 49804059
Body temperature fluctuation 23.83 11.09 76 783287 1897 49819864
Cytokine release syndrome 23.80 11.09 221 783142 8413 49813348
Type I hypersensitivity 23.64 11.09 86 783277 2299 49819462
Basal cell carcinoma 23.63 11.09 239 783124 23117 49798644
Varicella zoster virus infection 23.32 11.09 5 783358 2484 49819277
Glycosylated haemoglobin increased 23.23 11.09 85 783278 10521 49811240
Gait disturbance 23.21 11.09 2002 781361 148003 49673758
Premature delivery 23.18 11.09 244 783119 23419 49798342
Anti-neutrophil cytoplasmic antibody positive vasculitis 23.16 11.09 4 783359 2318 49819443
Product monitoring error 23.12 11.09 7 783356 2757 49819004
Pulmonary arterial hypertension 23.09 11.09 202 783161 20117 49801644
Thrombotic microangiopathy 23.06 11.09 65 783298 8726 49813035
Hyperleukocytosis 22.99 11.09 32 783331 432 49821329
Drug dose omission by device 22.28 11.09 7 783356 2692 49819069
Back pain 22.16 11.09 3801 779562 216229 49605532
Osteoporosis 22.12 11.09 527 782836 44352 49777409
Infusion site bruising 22.12 11.09 82 783281 2213 49819548
Upper gastrointestinal haemorrhage 22.07 11.09 360 783003 15675 49806086
Pneumonia 22.01 11.09 5359 778004 373042 49448719
Neutrophil percentage increased 21.89 11.09 92 783271 2635 49819126
Injection site discolouration 21.88 11.09 47 783316 6927 49814834
Cholestatic liver injury 21.86 11.09 75 783288 1946 49819815
Anaemia 21.86 11.09 3503 779860 248953 49572808
Eosinophilia 21.82 11.09 408 782955 18244 49803517
Duodenal ulcer perforation 21.68 11.09 888 782475 44723 49777038
Asphyxia 21.55 11.09 151 783212 5276 49816485
Stomatitis 21.45 11.09 1835 781528 99509 49722252
Deep vein thrombosis 21.41 11.09 1362 782001 71942 49749819
Blood lactic acid increased 21.37 11.09 154 783209 5431 49816330
Forced expiratory volume decreased 21.19 11.09 22 783341 4372 49817389
Poor venous access 21.10 11.09 249 783114 10091 49811670
Coma scale abnormal 20.89 11.09 136 783227 4635 49817126
Caesarean section 20.78 11.09 149 783214 15490 49806271
Agranulocytosis 20.56 11.09 455 782908 20966 49800795
Administration site pain 20.51 11.09 37 783326 631 49821130
Respiratory acidosis 20.13 11.09 161 783202 5867 49815894
Pain 20.04 11.09 8372 774991 570531 49251230
Rash erythematous 20.03 11.09 693 782670 34159 49787602
Foot operation 20.03 11.09 34 783329 5476 49816285
Hypoprothrombinaemia 19.92 11.09 23 783340 254 49821507
Biliary sepsis 19.91 11.09 42 783321 808 49820953
Renal failure neonatal 19.82 11.09 19 783344 166 49821595
Specific gravity urine decreased 19.77 11.09 37 783326 650 49821111
Helicobacter infection 19.73 11.09 950 782413 48752 49773009
Subacute cutaneous lupus erythematosus 19.66 11.09 5 783358 2210 49819551
Ovarian hyperstimulation syndrome 19.65 11.09 13 783350 3231 49818530
Incorrect dose administered by device 19.64 11.09 15 783348 3460 49818301
Lymphoproliferative disorder 19.60 11.09 10 783353 2867 49818894
Drug screen positive 19.44 11.09 104 783259 3298 49818463
Arthritis 19.39 11.09 1121 782242 85600 49736161
Joint stiffness 19.37 11.09 341 783022 29967 49791794
Fracture 19.28 11.09 167 783196 16666 49805095
Cognitive disorder 19.16 11.09 851 782512 43272 49778489
Ductus arteriosus stenosis foetal 19.15 11.09 18 783345 153 49821608
Nasal necrosis 19.15 11.09 14 783349 80 49821681
Haemorrhage 18.88 11.09 657 782706 52784 49768977
Sexual dysfunction 18.87 11.09 14 783349 3278 49818483
Graft versus host disease in skin 18.78 11.09 8 783355 2548 49819213
Inadequate analgesia 18.77 11.09 84 783279 2474 49819287
Pulmonary embolism 18.71 11.09 1823 781540 99881 49721880
Seizure 18.71 11.09 1570 781793 116304 49705457
Oedema 18.56 11.09 892 782471 69289 49752472
Abortion induced 18.48 11.09 78 783285 9266 49812495
Unintended pregnancy 18.46 11.09 30 783333 4916 49816845
Cholesterosis 18.44 11.09 28 783335 411 49821350
Hallucination 18.36 11.09 891 782472 45766 49775995
Enthesopathy 18.27 11.09 54 783309 7139 49814622
Intentional product use issue 18.25 11.09 1405 781958 75513 49746248
Delirium 18.25 11.09 744 782619 37448 49784313
Bacterial test 18.23 11.09 49 783314 1108 49820653
Injury associated with device 18.20 11.09 13 783350 3104 49818657
Cardiomyopathy 18.13 11.09 154 783209 15432 49806329
Congenital tricuspid valve incompetence 18.13 11.09 14 783349 88 49821673
Right ventricular failure 18.06 11.09 158 783205 15735 49806026
Product adhesion issue 17.98 11.09 25 783338 4367 49817394
Posturing 17.88 11.09 29 783334 452 49821309
Hand deformity 17.85 11.09 1322 782041 98877 49722884
Lip oedema 17.83 11.09 97 783266 3096 49818665
Vitamin K deficiency 17.80 11.09 27 783336 396 49821365
Neutropenic sepsis 17.79 11.09 313 783050 13834 49807927
Pulmonary hypertension 17.71 11.09 388 782975 33029 49788732
Impaired work ability 17.62 11.09 131 783232 13509 49808252
Truncus coeliacus thrombosis 17.54 11.09 7 783356 7 49821754
Labelled drug-drug interaction medication error 17.47 11.09 93 783270 10384 49811377
Device deployment issue 17.43 11.09 17 783346 3479 49818282
Hip arthroplasty 17.39 11.09 349 783014 30080 49791681
Infectious thyroiditis 17.25 11.09 8 783355 15 49821746
Laboratory test abnormal 17.20 11.09 254 783109 22954 49798807
Administration site swelling 17.16 11.09 45 783318 1002 49820759
Decreased appetite 17.15 11.09 2790 780573 198133 49623628
Acute graft versus host disease in skin 17.09 11.09 13 783350 3005 49818756
Breast cancer female 17.08 11.09 52 783311 6810 49814951
Systemic infection 17.01 11.09 7 783356 2276 49819485
Pneumocystis jirovecii pneumonia 17.01 11.09 145 783218 14518 49807243
Gallbladder cholesterolosis 16.95 11.09 36 783327 696 49821065
Shoulder arthroplasty 16.93 11.09 17 783346 3431 49818330
Fatigue 16.90 11.09 10355 773008 697246 49124515
Drug reaction with eosinophilia and systemic symptoms 16.79 11.09 567 782796 27857 49793904
Dyspnoea at rest 16.77 11.09 19 783344 3628 49818133
Epstein-Barr virus infection 16.73 11.09 54 783309 6943 49814818
Coagulation factor V level increased 16.72 11.09 6 783357 3 49821758
Glutathione decreased 16.72 11.09 6 783357 3 49821758
Bursitis 16.41 11.09 454 782909 21681 49800080
Human herpesvirus 6 infection 16.39 11.09 10 783353 2596 49819165
JC virus infection 16.30 11.09 4 783359 1811 49819950
Metastases to lymph nodes 16.25 11.09 55 783308 6969 49814792
Hepatitis B reactivation 16.21 11.09 6 783357 2081 49819680
Acute myeloid leukaemia 16.20 11.09 152 783211 14922 49806839
Hyperglycaemia 16.19 11.09 434 782929 35971 49785790
Akathisia 16.08 11.09 69 783294 8160 49813601
Specific gravity urine increased 16.06 11.09 18 783345 192 49821569
Abnormal clotting factor 15.93 11.09 14 783349 108 49821653
Drug eruption 15.93 11.09 263 783100 23343 49798418
Pregnancy with contraceptive device 15.93 11.09 24 783339 4055 49817706
Vulvar erosion 15.91 11.09 16 783347 149 49821612
Tenosynovitis 15.88 11.09 97 783266 10468 49811293
Graft versus host disease 15.87 11.09 46 783317 6120 49815641
Pregnancy 15.80 11.09 343 783020 29234 49792527
Ecchymosis 15.79 11.09 233 783130 9936 49811825
Macular oedema 15.77 11.09 20 783343 3634 49818127
Heart rate irregular 15.77 11.09 402 782961 18958 49802803
Device leakage 15.76 11.09 43 783320 5835 49815926
Neoplasm malignant 15.74 11.09 265 783098 23450 49798311
Graft versus host disease in gastrointestinal tract 15.72 11.09 12 783351 2769 49818992
Splenic vein thrombosis 15.70 11.09 22 783341 299 49821462
Bacterial test positive 15.70 11.09 126 783237 4597 49817164
Osmolar gap 15.66 11.09 13 783350 92 49821669
Peptic ulcer haemorrhage 15.63 11.09 43 783320 986 49820775
Agitation 15.61 11.09 992 782371 52392 49769369
Biliary colic 15.58 11.09 95 783268 3164 49818597
Bladder dilatation 15.46 11.09 36 783327 742 49821019
Amenorrhoea 15.46 11.09 73 783290 8411 49813350
Galactorrhoea 15.43 11.09 21 783342 3702 49818059
Blood pH decreased 15.38 11.09 77 783286 2378 49819383
Diffuse large B-cell lymphoma recurrent 15.37 11.09 3 783360 1592 49820169
Food allergy 15.32 11.09 193 783170 7944 49813817
Leukocyturia 15.27 11.09 43 783320 1000 49820761
Dilatation intrahepatic duct acquired 15.26 11.09 32 783331 613 49821148
Sensitisation 15.19 11.09 3 783360 1579 49820182
Treatment noncompliance 15.15 11.09 353 783010 29797 49791964
Angioedema 15.14 11.09 721 782642 36955 49784806
Acute haemorrhagic oedema of infancy 15.14 11.09 7 783356 13 49821748
Infusion site nodule 15.09 11.09 45 783318 1082 49820679
Coma hepatic 15.08 11.09 31 783332 585 49821176
Blood creatinine decreased 15.07 11.09 130 783233 4846 49816915
Self-medication 15.04 11.09 73 783290 2226 49819535
Prothrombin level decreased 15.03 11.09 28 783335 490 49821271
Therapy partial responder 14.98 11.09 52 783311 6539 49815222
Virologic failure 14.95 11.09 3 783360 1561 49820200
Hypothyroidism 14.87 11.09 408 782955 33717 49788044
Tardive dyskinesia 14.87 11.09 60 783303 7219 49814542
Septic shock 14.86 11.09 728 782635 56447 49765314
Endophthalmitis 14.75 11.09 14 783349 2902 49818859
Joint dislocation 14.74 11.09 121 783242 12212 49809549
Infusion site discomfort 14.66 11.09 38 783325 840 49820921
Disability 14.52 11.09 127 783236 12648 49809113
Syncope 14.43 11.09 1385 781978 101617 49720144
Coronary artery disease 14.39 11.09 350 783013 29376 49792385
Joint destruction 14.38 11.09 24 783339 3892 49817869
Visual acuity reduced 14.38 11.09 222 783141 19917 49801844
Cardiac disorder 14.36 11.09 532 782831 42447 49779314
Hepatic enzyme increased 14.34 11.09 2378 780985 135002 49686759
Pancreatic fibrosis 14.34 11.09 12 783351 86 49821675
Sedation 14.33 11.09 595 782768 30015 49791746
Dizziness 14.32 11.09 4976 778387 341393 49480368
Oedema peripheral 14.30 11.09 2186 781177 155775 49665986
Device use issue 14.23 11.09 6 783357 1923 49819838
Myopathy 14.21 11.09 83 783280 9056 49812705
Blood copper decreased 14.14 11.09 6 783357 8 49821753
Hepatectomy 14.02 11.09 11 783352 71 49821690
Toxic shock syndrome streptococcal 14.02 11.09 12 783351 89 49821672
Periorbital cellulitis 13.95 11.09 29 783334 552 49821209
Anaphylactic reaction 13.94 11.09 994 782369 53061 49768700
Hyperprolactinaemia 13.93 11.09 19 783344 3346 49818415
Obstructive airways disorder 13.90 11.09 165 783198 15487 49806274
Sensitivity to weather change 13.87 11.09 47 783316 5954 49815807
Open globe injury 13.86 11.09 9 783354 41 49821720
Serotonin syndrome 13.85 11.09 490 782873 24223 49797538
Leukopenia 13.84 11.09 880 782483 66648 49755113
Infusion site rash 13.82 11.09 49 783314 1293 49820468
Gallbladder adenocarcinoma 13.82 11.09 12 783351 91 49821670
Spleen congestion 13.79 11.09 13 783350 111 49821650
Incorrect drug administration rate 13.77 11.09 78 783285 2528 49819233
Autonomic dysreflexia 13.75 11.09 21 783342 310 49821451
Mediastinal abscess 13.74 11.09 6 783357 9 49821752
Cytomegalovirus viraemia 13.74 11.09 33 783330 4676 49817085
Gestational diabetes 13.74 11.09 64 783299 7401 49814360
Haematoma muscle 13.73 11.09 33 783330 695 49821066
Retinitis 13.71 11.09 6 783357 1881 49819880
Blood phosphorus decreased 13.65 11.09 103 783260 3686 49818075
Hypercalcaemia 13.60 11.09 267 783096 23085 49798676
Transverse sinus thrombosis 13.58 11.09 27 783336 497 49821264
Gallbladder hypofunction 13.55 11.09 27 783336 498 49821263
Aspergillus infection 13.45 11.09 57 783306 6764 49814997
Creatinine urine decreased 13.38 11.09 15 783348 160 49821601
Nitrite urine present 13.36 11.09 38 783325 889 49820872
Brain compression 13.32 11.09 21 783342 319 49821442
Neck deformity 13.29 11.09 7 783356 1971 49819790
Cardiac steatosis 13.28 11.09 8 783355 31 49821730
Hypoglycaemic coma 13.27 11.09 10 783353 2323 49819438
Red blood cell sedimentation rate increased 13.26 11.09 350 783013 29066 49792695
Kidney transplant rejection 13.24 11.09 26 783337 3961 49817800
Suspected suicide 13.23 11.09 134 783229 5223 49816538
Cholecystitis acute 13.15 11.09 168 783195 6938 49814823
Bone density decreased 13.08 11.09 109 783254 10966 49810795
Respiratory failure 13.06 11.09 1224 782139 89957 49731804
Intervertebral discitis 13.06 11.09 78 783285 2578 49819183
Intestinal pseudo-obstruction 12.97 11.09 33 783330 721 49821040
Hepatitis B 12.96 11.09 21 783342 3445 49818316
Lethargy 12.92 11.09 910 782453 48522 49773239
Coronary arterial stent insertion 12.91 11.09 13 783350 2621 49819140
Exposure during pregnancy 12.91 11.09 1658 781705 119357 49702404
Cytomegalovirus infection reactivation 12.88 11.09 13 783350 2618 49819143
Adverse reaction 12.81 11.09 79 783284 8507 49813254
Product tampering 12.75 11.09 16 783347 194 49821567
Analgesic drug level therapeutic 12.74 11.09 4 783359 0 49821761
Neurone-specific enolase increased 12.74 11.09 4 783359 0 49821761
Fibrin D dimer decreased 12.74 11.09 4 783359 0 49821761
Generalised bullous fixed drug eruption 12.74 11.09 4 783359 0 49821761
Therapy change 12.72 11.09 40 783323 5185 49816576
Stent placement 12.69 11.09 21 783342 3417 49818344
Neonatal respiratory acidosis 12.65 11.09 14 783349 147 49821614
Dependence 12.60 11.09 60 783303 1815 49819946
Eosinophil percentage increased 12.59 11.09 38 783325 920 49820841
Cerebral infarction 12.58 11.09 247 783116 21357 49800404
Toxicologic test abnormal 12.57 11.09 29 783334 594 49821167
Eye irritation 12.56 11.09 188 783175 16952 49804809
Accidental exposure to product by child 12.50 11.09 40 783323 1000 49820761
Hyperbilirubinaemia 12.49 11.09 213 783150 9357 49812404
Migraine with aura 12.48 11.09 69 783294 2216 49819545
Product preparation error 12.48 11.09 31 783332 4341 49817420
Chronic kidney disease 12.47 11.09 496 782867 39275 49782486
Thrombosis 12.43 11.09 722 782641 55111 49766650
Hyperlipidaemia 12.42 11.09 193 783170 17297 49804464
Sputum culture positive 12.38 11.09 49 783314 1365 49820396
Fluid retention 12.37 11.09 649 782714 50000 49771761
Libido disorder 12.37 11.09 9 783354 51 49821710
Haemolysis 12.33 11.09 145 783218 5871 49815890
Myocardial fibrosis 12.31 11.09 31 783332 673 49821088
Bone disorder 12.30 11.09 210 783153 18542 49803219
General physical health deterioration 12.24 11.09 1977 781386 140457 49681304
Diffuse axonal injury 12.24 11.09 10 783353 69 49821692
Vascular purpura 12.23 11.09 44 783319 1170 49820591
Serum sickness 12.22 11.09 74 783289 2458 49819303
Immune reconstitution inflammatory syndrome 12.22 11.09 44 783319 5472 49816289
Pleural fibrosis 12.20 11.09 92 783271 3292 49818469
Cholangitis acute 12.14 11.09 23 783340 408 49821353
Depression 12.13 11.09 2316 781047 163107 49658654
Administration site erythema 12.03 11.09 26 783337 509 49821252
Breast cancer stage I 12.02 11.09 8 783355 1982 49819779
Dysphoria 12.01 11.09 36 783327 4738 49817023
Tonsillar inflammation 11.93 11.09 11 783352 91 49821670
Needle issue 11.89 11.09 65 783298 7210 49814551
Sinus tachycardia 11.87 11.09 423 782940 20931 49800830
Acute lymphocytic leukaemia recurrent 11.85 11.09 8 783355 1967 49819794
Dose calculation error 11.75 11.09 11 783352 93 49821668
Impaired quality of life 11.70 11.09 51 783312 6005 49815756
Red blood cell spherocytes present 11.64 11.09 7 783356 27 49821734
Cystitis haemorrhagic 11.57 11.09 25 783338 3677 49818084
Cholelithiasis obstructive 11.55 11.09 6 783357 16 49821745
Ascites 11.52 11.09 446 782917 35415 49786346
Palatal oedema 11.44 11.09 23 783340 427 49821334
Anaphylactoid reaction 11.39 11.09 91 783272 3315 49818446
Intentional dose omission 11.37 11.09 40 783323 5010 49816751
Polycystic ovaries 11.35 11.09 13 783350 2471 49819290
Lupus vasculitis 11.33 11.09 24 783339 463 49821298
Lung neoplasm malignant 11.29 11.09 170 783193 15314 49806447
Blood glucose decreased 11.29 11.09 206 783157 18005 49803756
Congenital central hypoventilation syndrome 11.27 11.09 7 783356 29 49821732
Tuberculin test positive 11.27 11.09 20 783343 3166 49818595
Hernial eventration 11.27 11.09 5 783358 8 49821753
Acute myocardial infarction 11.26 11.09 356 783007 28917 49792844
Coagulation factor X level decreased 11.25 11.09 9 783354 60 49821701
BK virus infection 11.20 11.09 17 783346 2864 49818897
Melaena 11.20 11.09 516 782847 26348 49795413
Renal disorder 11.19 11.09 332 783031 27173 49794588
Metastases to central nervous system 11.18 11.09 116 783247 11166 49810595
Mesenteric artery thrombosis 11.16 11.09 13 783350 145 49821616
Pulmonary alveolar haemorrhage 11.15 11.09 29 783334 3998 49817763
Accidental death 11.14 11.09 55 783308 1689 49820072
Weight decreased 11.13 11.09 3153 780210 218092 49603669
Full blood count decreased 11.12 11.09 262 783101 22084 49799677
Blood thyroid stimulating hormone decreased 11.11 11.09 106 783257 4066 49817695

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
Toxicity to various agents 962.24 11.73 4684 385795 168977 29015071
Drug ineffective 608.64 11.73 2602 387877 360568 28823480
Acute hepatic failure 525.03 11.73 716 389763 11236 29172812
Overdose 519.12 11.73 2259 388220 77560 29106488
Intentional overdose 495.94 11.73 1369 389110 37159 29146889
Infusion related reaction 484.58 11.73 1476 389003 42410 29141638
Completed suicide 413.04 11.73 2311 388168 87935 29096113
Hepatocellular injury 384.49 11.73 860 389619 20383 29163665
Analgesic drug level increased 343.01 11.73 164 390315 428 29183620
Product dose omission issue 180.38 11.73 659 389820 95724 29088324
Poisoning deliberate 171.33 11.73 287 390192 5444 29178604
Drug resistance 164.06 11.73 41 390438 21499 29162549
Intentional product misuse 161.86 11.73 893 389586 33768 29150280
Exposure to toxic agent 149.05 11.73 177 390302 2398 29181650
Liver injury 146.71 11.73 434 390045 12256 29171792
Accidental overdose 143.76 11.73 535 389944 17058 29166990
Treatment failure 142.94 11.73 166 390313 36773 29147275
Cholestasis 129.98 11.73 634 389845 22828 29161220
Blood pressure fluctuation 129.78 11.73 564 389915 19330 29164718
Toxic epidermal necrolysis 124.87 11.73 523 389956 17630 29166418
Chills 124.20 11.73 1464 389015 69836 29114212
Myocardial infarction 119.72 11.73 908 389571 109388 29074660
Suicide attempt 115.40 11.73 809 389670 33301 29150747
Hepatitis 110.43 11.73 555 389924 20228 29163820
Urticaria 104.95 11.73 1144 389335 53516 29130532
Hepatitis acute 101.98 11.73 248 390231 6214 29177834
Therapeutic product effect incomplete 97.09 11.73 236 390243 39069 29144979
Cardiac failure congestive 96.64 11.73 603 389876 75978 29108070
Vomiting 94.72 11.73 3559 386920 208701 28975347
Metabolic acidosis 90.58 11.73 826 389653 36836 29147212
Hepatic cytolysis 86.70 11.73 275 390204 8072 29175976
Off label use 85.75 11.73 3179 387300 297621 28886427
Hospitalisation 84.27 11.73 317 390162 45671 29138377
Coagulopathy 79.36 11.73 455 390024 17452 29166596
Drug interaction 77.96 11.73 1997 388482 195388 28988660
Somnolence 76.15 11.73 1699 388780 92256 29091792
Injection site pain 74.60 11.73 202 390277 32244 29151804
Hepatotoxicity 73.38 11.73 445 390034 17422 29166626
Cardiac failure 71.07 11.73 686 389793 78601 29105447
Hepatic necrosis 69.28 11.73 148 390331 3394 29180654
Product use in unapproved indication 68.36 11.73 775 389704 86100 29097948
Wrong technique in product usage process 67.59 11.73 202 390277 31226 29152822
Diarrhoea 67.00 11.73 3652 386827 329046 28855002
Anaphylactic reaction 66.43 11.73 605 389874 26968 29157080
Death 66.14 11.73 3770 386709 338314 28845734
Coma 65.12 11.73 802 389677 38648 29145400
Prothrombin time shortened 64.81 11.73 86 390393 1312 29182736
Hepatitis cholestatic 63.46 11.73 218 390261 6675 29177373
Fixed eruption 62.07 11.73 78 390401 1124 29182924
Contraindicated product administered 60.54 11.73 92 390387 18174 29165874
Transaminases increased 60.17 11.73 508 389971 22154 29161894
Anion gap 58.95 11.73 60 390419 676 29183372
Heart rate decreased 57.68 11.73 542 389937 24370 29159678
Oxygen saturation decreased 57.58 11.73 873 389606 44064 29139984
Mixed liver injury 56.42 11.73 99 390380 1952 29182096
Haematotoxicity 54.53 11.73 11 390468 6688 29177360
Abdominal pain 54.24 11.73 2244 388235 133113 29050935
Immune reconstitution inflammatory syndrome 53.62 11.73 18 390461 7784 29176264
Diabetes mellitus 52.11 11.73 310 390169 39521 29144527
Ductus arteriosus premature closure 51.30 11.73 34 390445 195 29183853
Pyroglutamic acidosis 49.75 11.73 36 390443 243 29183805
Blood pressure diastolic abnormal 49.22 11.73 106 390373 2445 29181603
Hepatic failure 48.75 11.73 633 389846 30879 29153169
Cytomegalovirus infection 48.64 11.73 151 390328 23064 29160984
Therapy non-responder 47.42 11.73 228 390251 30683 29153365
Myelosuppression 46.16 11.73 56 390423 12171 29171877
Hepatitis fulminant 46.00 11.73 127 390352 3444 29180604
Pathogen resistance 45.78 11.73 25 390454 8091 29175957
Renal impairment 45.56 11.73 777 389702 80556 29103492
Loss of personal independence in daily activities 45.53 11.73 177 390302 25263 29158785
Stevens-Johnson syndrome 43.89 11.73 370 390109 16127 29167921
Methaemoglobinaemia 43.75 11.73 104 390375 2567 29181481
International normalised ratio increased 42.99 11.73 824 389655 43548 29140500
Cerebral infarction 42.69 11.73 174 390305 24501 29159547
Cytokine release syndrome 42.51 11.73 308 390171 12811 29171237
Progressive multifocal leukoencephalopathy 40.90 11.73 33 390446 8686 29175362
Confusional state 40.39 11.73 2070 388409 125807 29058241
Glycosylated haemoglobin increased 40.21 11.73 39 390440 9387 29174661
Multiple-drug resistance 39.97 11.73 3 390476 3897 29180151
Graft versus host disease 39.74 11.73 41 390438 9587 29174461
Disease progression 39.22 11.73 804 389675 81112 29102936
Liver function test abnormal 39.07 11.73 567 389912 28351 29155697
Inadequate analgesia 38.87 11.73 99 390380 2555 29181493
Respiratory depression 38.51 11.73 308 390171 13215 29170833
Cell death 38.37 11.73 84 390395 1960 29182088
Pyroglutamate increased 37.96 11.73 30 390449 235 29183813
Blood glucose increased 37.55 11.73 550 389929 58434 29125614
Drug-induced liver injury 36.49 11.73 442 390037 21213 29162835
Blood pressure increased 36.33 11.73 1252 389227 72551 29111497
Drug abuser 36.08 11.73 122 390357 3705 29180343
Prothrombin time ratio decreased 35.78 11.73 33 390446 326 29183722
Therapeutic product effect decreased 35.53 11.73 235 390244 29216 29154832
Post transplant lymphoproliferative disorder 35.50 11.73 14 390465 5479 29178569
Jaundice 34.80 11.73 562 389917 28734 29155314
C-reactive protein abnormal 34.23 11.73 22 390457 6514 29177534
Blood pressure systolic abnormal 34.16 11.73 83 390396 2078 29181970
Venoocclusive liver disease 33.94 11.73 25 390454 6892 29177156
Acute generalised exanthematous pustulosis 33.92 11.73 155 390324 5428 29178620
Psoriasis 33.18 11.73 269 390210 31958 29152090
Drug ineffective for unapproved indication 33.04 11.73 88 390391 14126 29169922
Apparent death 32.47 11.73 4 390475 3500 29180548
Depressed level of consciousness 32.43 11.73 676 389803 36266 29147782
Therapy partial responder 32.39 11.73 14 390465 5185 29178863
Alanine aminotransferase increased 31.85 11.73 1191 389288 69753 29114295
Unresponsive to stimuli 31.73 11.73 487 389992 24639 29159409
Fluid retention 31.54 11.73 182 390297 23378 29160670
Cerebrovascular accident 31.38 11.73 774 389705 76137 29107911
Medication error 30.70 11.73 421 390058 20790 29163258
BK virus infection 30.42 11.73 12 390467 4695 29179353
Throat tightness 30.00 11.73 178 390301 6913 29177135
Sinusitis 29.97 11.73 628 389851 33722 29150326
Tachycardia 29.77 11.73 1204 389275 71206 29112842
Body temperature increased 29.72 11.73 307 390172 14158 29169890
Renal papillary necrosis 29.23 11.73 21 390458 140 29183908
Treatment noncompliance 28.88 11.73 194 390285 24033 29160015
Chronic graft versus host disease 28.21 11.73 9 390470 4020 29180028
Infusion site extravasation 28.01 11.73 98 390381 3029 29181019
Respiratory arrest 27.91 11.73 488 389991 25345 29158703
Hepatorenal failure 26.69 11.73 34 390445 497 29183551
Substance abuse 26.58 11.73 167 390312 6620 29177428
Bone marrow failure 26.51 11.73 233 390246 27216 29156832
Coronary artery disease 26.43 11.73 417 390062 43773 29140275
Nasal necrosis 26.16 11.73 13 390466 38 29184010
Dysmorphism 26.10 11.73 4 390475 2967 29181081
Prescription form tampering 26.04 11.73 31 390448 421 29183627
Factor VIII inhibition 26.02 11.73 26 390453 286 29183762
Pyrexia 25.98 11.73 4248 386231 283374 28900674
Bladder cancer 25.64 11.73 60 390419 10067 29173981
Acute graft versus host disease in skin 25.40 11.73 15 390464 4649 29179399
Flushing 25.28 11.73 530 389949 28462 29155586
Hypotension 25.24 11.73 2933 387546 191421 28992627
Cardiac disorder 24.93 11.73 344 390135 36919 29147129
Psoriatic arthropathy 24.54 11.73 105 390374 14586 29169462
Neuropathy peripheral 24.49 11.73 732 389747 70295 29113753
Injection site swelling 24.48 11.73 55 390424 9362 29174686
Miosis 24.23 11.73 185 390294 7824 29176224
Labelled drug-drug interaction medication error 24.14 11.73 81 390398 12078 29171970
Mydriasis 24 11.73 150 390329 5935 29178113
Acute graft versus host disease 23.81 11.73 25 390454 5799 29178249
Therapeutic response decreased 23.76 11.73 210 390269 24501 29159547
Blood alkaline phosphatase increased 23.70 11.73 516 389963 27890 29156158
Nocardiosis 23.33 11.73 7 390472 3253 29180795
Cardio-respiratory arrest 23.31 11.73 852 389627 49749 29134299
Aspartate aminotransferase increased 23.15 11.73 987 389492 58738 29125310
Constipation 22.90 11.73 1777 388702 112383 29071665
Platelet count decreased 22.82 11.73 1139 389340 103533 29080515
Viral mutation identified 22.67 11.73 3 390476 2485 29181563
Infusion site pruritus 22.55 11.73 31 390448 490 29183558
Dizziness 22.40 11.73 2178 388301 187506 28996542
Full blood count abnormal 22.29 11.73 112 390367 14901 29169147
Aspergillus infection 22.04 11.73 69 390410 10512 29173536
Bronchopulmonary aspergillosis 22.01 11.73 86 390393 12258 29171790
Coagulation factor VII level decreased 22.00 11.73 16 390463 109 29183939
COVID-19 treatment 21.95 11.73 22 390457 243 29183805
Prothrombin time prolonged 21.88 11.73 195 390284 8637 29175411
Livedo reticularis 21.87 11.73 69 390410 2019 29182029
Vascular stent thrombosis 21.85 11.73 4 390475 2606 29181442
Back pain 21.83 11.73 1600 388879 100684 29083364
Mucocutaneous disorder 21.77 11.73 16 390463 111 29183937
Mucosal inflammation 21.74 11.73 290 390189 31305 29152743
Visual acuity reduced 21.51 11.73 112 390367 14764 29169284
Blood pressure diastolic increased 21.41 11.73 101 390378 3585 29180463
Therapy cessation 21.41 11.73 108 390371 14354 29169694
Product prescribing error 21.40 11.73 144 390335 17832 29166216
Intracranial pressure increased 21.36 11.73 97 390382 3388 29180660
Anaemia 21.33 11.73 2325 388154 198626 28985422
Heart rate increased 21.32 11.73 669 389810 38269 29145779
Agranulocytosis 21.18 11.73 382 390097 19958 29164090
Unintentional medical device removal 21.15 11.73 3 390476 2358 29181690
Angina pectoris 20.89 11.73 251 390228 27599 29156449
Infusion site swelling 20.71 11.73 63 390416 1807 29182241
Interstitial lung disease 20.61 11.73 592 389887 57126 29126922
Drug intolerance 20.51 11.73 484 389995 47895 29136153
Body temperature decreased 20.35 11.73 223 390256 10441 29173607
Condition aggravated 20.30 11.73 1659 388820 144636 29039412
Acidosis 19.95 11.73 206 390273 9499 29174549
Use of accessory respiratory muscles 19.94 11.73 24 390455 330 29183718
Graft versus host disease in gastrointestinal tract 19.94 11.73 9 390470 3249 29180799
Injection site bruising 19.93 11.73 44 390435 7536 29176512
Infusion site pain 19.90 11.73 84 390395 2841 29181207
Acute myocardial infarction 19.87 11.73 487 389992 47951 29136097
Kidney transplant rejection 19.82 11.73 39 390440 6966 29177082
Lip oedema 19.68 11.73 69 390410 2135 29181913
Hyperlipasaemia 19.63 11.73 28 390451 459 29183589
Rash maculo-papular 19.56 11.73 439 390040 23850 29160198
Psychotic disorder 19.55 11.73 173 390306 20181 29163867
Renal cortical necrosis 19.49 11.73 17 390462 155 29183893
Injection site haemorrhage 19.43 11.73 52 390427 8334 29175714
Therapy interrupted 19.43 11.73 52 390427 8334 29175714
No adverse event 19.34 11.73 143 390336 17335 29166713
Accidental exposure to product by child 19.30 11.73 50 390429 1304 29182744
Transplant rejection 19.24 11.73 60 390419 9152 29174896
Coronary arterial stent insertion 19.23 11.73 14 390465 3883 29180165
Hyperhidrosis 19.18 11.73 1039 389440 63501 29120547
Intraocular pressure increased 19.09 11.73 21 390458 4768 29179280
Hypertransaminasaemia 18.94 11.73 96 390383 3510 29180538
Peripheral swelling 18.85 11.73 670 389809 63069 29120979
Oral pruritus 18.68 11.73 20 390459 240 29183808
Sphincter of Oddi dysfunction 18.64 11.73 15 390464 121 29183927
Atrial fibrillation 18.38 11.73 1175 389304 104471 29079577
Anaphylactic shock 18.21 11.73 262 390217 13074 29170974
Bezoar 18.11 11.73 36 390443 783 29183265
Syringe issue 18.10 11.73 14 390465 3764 29180284
Underdose 17.93 11.73 88 390391 11781 29172267
Diffuse large B-cell lymphoma recurrent 17.83 11.73 6 390473 2591 29181457
Blood pressure systolic increased 17.76 11.73 317 390162 16528 29167520
Low birth weight baby 17.67 11.73 38 390441 6570 29177478
Brain death 17.65 11.73 70 390409 2300 29181748
Device leakage 17.60 11.73 20 390459 4475 29179573
Drug reaction with eosinophilia and systemic symptoms 17.51 11.73 489 389990 27503 29156545
Viral load increased 17.46 11.73 3 390476 2046 29182002
Pneumonia 17.45 11.73 3851 386628 316321 28867727
Cardiac failure chronic 17.45 11.73 37 390442 6430 29177618
Eyelid ptosis 17.30 11.73 26 390453 5160 29178888
Prothrombin time abnormal 17.24 11.73 28 390451 517 29183531
Rhinalgia 17.04 11.73 23 390456 357 29183691
Glucose-6-phosphate dehydrogenase deficiency 16.91 11.73 14 390465 118 29183930
Oedematous pancreatitis 16.91 11.73 25 390454 424 29183624
General physical health deterioration 16.87 11.73 1150 389329 101707 29082341
Lower respiratory tract infection 16.87 11.73 464 390015 26038 29158010
Prostatic specific antigen increased 16.84 11.73 97 390382 12467 29171581
Disease recurrence 16.76 11.73 132 390347 15782 29168266
Band neutrophil percentage decreased 16.55 11.73 7 390472 12 29184036
Enthesopathy 16.54 11.73 15 390464 3728 29180320
Environmental exposure 16.53 11.73 19 390460 248 29183800
Feeling hot 16.52 11.73 292 390187 15196 29168852
Failure to suspend medication 16.48 11.73 23 390456 369 29183679
Poisoning 16.41 11.73 203 390276 9790 29174258
Posterior reversible encephalopathy syndrome 16.35 11.73 62 390417 8914 29175134
Erythema 16.35 11.73 1184 389295 74422 29109626
Injection site reaction 16.31 11.73 84 390395 11104 29172944
Hepatitis toxic 16.26 11.73 59 390420 1857 29182191
Palmar-plantar erythrodysaesthesia syndrome 16.21 11.73 121 390358 14638 29169410
Infection 16.17 11.73 838 389641 75913 29108135
Periportal oedema 16.15 11.73 10 390469 50 29183998
Dependent personality disorder 16.13 11.73 12 390467 85 29183963
Paradoxical drug reaction 16.12 11.73 8 390471 2733 29181315
Coronary artery bypass 16.10 11.73 23 390456 4662 29179386
Accidental exposure to product 16.09 11.73 80 390399 10673 29173375
Hepatitis B 16.08 11.73 30 390449 5467 29178581
Angular cheilitis 16.04 11.73 15 390464 151 29183897
Myopathy 15.97 11.73 78 390401 10455 29173593
Blood pH decreased 15.89 11.73 63 390416 2070 29181978
Gamma-glutamyltransferase increased 15.88 11.73 464 390015 26273 29157775
Cryopyrin associated periodic syndrome 15.83 11.73 11 390468 69 29183979
Beta haemolytic streptococcal infection 15.80 11.73 25 390454 451 29183597
Feeling abnormal 15.71 11.73 574 389905 53871 29130177
Nipple inflammation 15.70 11.73 10 390469 53 29183995
Cytomegalovirus chorioretinitis 15.51 11.73 12 390467 3226 29180822
Parkinsonism 15.48 11.73 47 390432 7231 29176817
Neutropenic sepsis 15.46 11.73 229 390250 11498 29172550
Kidney fibrosis 15.39 11.73 4 390475 2043 29182005
Lymph node calcification 15.36 11.73 14 390465 136 29183912
Haematemesis 15.35 11.73 430 390049 24196 29159852
Hepatocellular carcinoma 15.30 11.73 45 390434 6993 29177055
Dyspnoea at rest 15.28 11.73 12 390467 3202 29180846
Neutrophil percentage increased 15.25 11.73 55 390424 1726 29182322
Gastric ulcer perforation 15.22 11.73 35 390444 845 29183203
Rhabdomyolysis 15.19 11.73 652 389827 60156 29123892
Cerebral atrophy congenital 15.00 11.73 10 390469 58 29183990
Nipple disorder 14.94 11.73 15 390464 166 29183882
Immunosuppressant drug level increased 14.84 11.73 25 390454 4740 29179308
Cytomegalovirus viraemia 14.78 11.73 39 390440 6281 29177767
Neuroleptic malignant syndrome 14.75 11.73 139 390340 16009 29168039
Aptyalism 14.70 11.73 19 390460 282 29183766
Throat irritation 14.66 11.73 179 390300 8606 29175442
Incision site complication 14.65 11.73 19 390460 283 29183765
Sleep disorder due to a general medical condition 14.64 11.73 12 390467 3134 29180914
Antipsychotic drug level below therapeutic 14.57 11.73 4 390475 1970 29182078
Prostate cancer 14.56 11.73 243 390236 25284 29158764
Lymphocyte count abnormal 14.40 11.73 28 390451 599 29183449
Hepatic encephalopathy 14.35 11.73 247 390232 12788 29171260
Cryptococcosis 14.32 11.73 4 390475 1948 29182100
Tenosynovitis 14.19 11.73 17 390462 3716 29180332
Duodenal ulcer perforation 14.19 11.73 48 390431 1458 29182590
Patent ductus arteriosus 14.16 11.73 80 390399 3051 29180997
Erythema multiforme 14.10 11.73 160 390319 7557 29176491
Pneumonia cytomegaloviral 14.08 11.73 9 390470 2673 29181375
Cardiomyopathy 14.06 11.73 126 390353 14661 29169387
Haemolytic anaemia 14.06 11.73 188 390291 9231 29174817
Hypothermia 14.04 11.73 185 390294 9054 29174994
Lymphoproliferative disorder 13.94 11.73 8 390471 2519 29181529
Oesophageal obstruction 13.82 11.73 22 390457 399 29183649
Asthenia 13.75 11.73 2568 387911 212682 28971366
Acute haemorrhagic oedema of infancy 13.73 11.73 8 390471 35 29184013
JC virus infection 13.71 11.73 4 390475 1893 29182155
Cystitis haemorrhagic 13.66 11.73 27 390452 4815 29179233
Ureteric obstruction 13.65 11.73 40 390439 1123 29182925
Angioedema 13.64 11.73 533 389946 31382 29152666
Bacterial parotitis 13.61 11.73 6 390473 12 29184036
Product storage error 13.61 11.73 42 390437 6428 29177620
Product quality issue 13.61 11.73 139 390340 15756 29168292
Dermo-hypodermitis 13.58 11.73 17 390462 244 29183804
Pemphigus 13.55 11.73 40 390439 1128 29182920
Salivary gland calculus 13.53 11.73 9 390470 52 29183996
Joint swelling 13.49 11.73 527 389952 49103 29134945
Vascular purpura 13.47 11.73 45 390434 1358 29182690
Chondrocalcinosis 13.40 11.73 18 390461 278 29183770
Fragile X syndrome 13.40 11.73 8 390471 37 29184011
Hypertriglyceridaemia 13.38 11.73 52 390427 7423 29176625
Pneumococcal infection 13.37 11.73 20 390459 343 29183705
Device issue 13.37 11.73 55 390424 7725 29176323
Subcorneal pustular dermatosis 13.36 11.73 4 390475 0 29184048
Coma scale abnormal 13.36 11.73 85 390394 3384 29180664
Agitation 13.33 11.73 816 389663 50488 29133560
Thrombotic microangiopathy 13.33 11.73 64 390415 8617 29175431
Graft versus host disease in skin 13.27 11.73 15 390464 3364 29180684
Self-medication 13.23 11.73 60 390419 2094 29181954
Colour blindness acquired 13.21 11.73 10 390469 73 29183975
Ejection fraction decreased 13.16 11.73 141 390338 15837 29168211
Oropharyngeal blistering 13.14 11.73 14 390465 167 29183881
Oesophageal carcinoma 13.14 11.73 25 390454 4522 29179526
Coagulation factor V level decreased 13.13 11.73 16 390463 223 29183825
Metastases to liver 13.12 11.73 97 390382 11759 29172289
Fatigue 13.11 11.73 3858 386621 312963 28871085
Weight increased 13.10 11.73 854 389625 75813 29108235
Hemiparesis 13.10 11.73 125 390354 14361 29169687
Endophthalmitis 13.08 11.73 11 390468 2837 29181211
Synovitis 13.08 11.73 87 390392 10803 29173245
Thrombosis 13.06 11.73 451 390028 42594 29141454
Injection site pruritus 13.00 11.73 37 390442 5812 29178236
Drug abuse 12.95 11.73 1224 389255 78659 29105389
Adverse drug reaction 12.94 11.73 231 390248 23789 29160259
Dose calculation error 12.92 11.73 8 390471 40 29184008
Hepatic cirrhosis 12.91 11.73 125 390354 14319 29169729
Gait disturbance 12.88 11.73 815 389664 72534 29111514
Mast cell activation syndrome 12.82 11.73 14 390465 172 29183876
Blood triglycerides increased 12.81 11.73 108 390371 12726 29171322
Aplasia pure red cell 12.76 11.73 34 390445 5457 29178591
Drug screen positive 12.76 11.73 90 390389 3711 29180337
Pleural thickening 12.71 11.73 18 390461 293 29183755
Allergic cough 12.68 11.73 7 390472 27 29184021
Blood lactic acid 12.65 11.73 19 390460 327 29183721
Pneumothorax traumatic 12.64 11.73 9 390470 59 29183989
Blood ethanol increased 12.61 11.73 23 390456 468 29183580
Face oedema 12.48 11.73 198 390281 10085 29173963
Jaundice cholestatic 12.44 11.73 97 390382 4129 29179919
Macrocephaly 12.40 11.73 21 390458 402 29183646
Negative pressure pulmonary oedema 12.37 11.73 15 390464 208 29183840
Myelodysplastic syndrome 12.36 11.73 163 390316 17631 29166417
Electrocardiogram QT prolonged 12.31 11.73 373 390106 35764 29148284
Ear injury 12.30 11.73 7 390472 29 29184019
Paranoid personality disorder 12.30 11.73 7 390472 29 29184019
Surgery 12.27 11.73 98 390381 11681 29172367
Respiratory rate increased 12.26 11.73 172 390307 8536 29175512
Skin degenerative disorder 12.21 11.73 6 390473 17 29184031
Lip swelling 12.20 11.73 231 390248 12179 29171869
Crystal urine present 12.18 11.73 21 390458 408 29183640
Anion gap increased 12.04 11.73 47 390432 1533 29182515
Hyperthermia 11.99 11.73 183 390296 9247 29174801
Mucormycosis 11.94 11.73 32 390447 5126 29178922
Specific gravity urine decreased 11.92 11.73 10 390469 86 29183962
Infusion site rash 11.92 11.73 19 390460 345 29183703
Psychomotor retardation 11.91 11.73 13 390466 2963 29181085
Urine sodium decreased 11.83 11.73 13 390466 161 29183887
Rhinitis allergic 11.81 11.73 68 390411 2612 29181436
Specific gravity urine increased 11.80 11.73 12 390467 135 29183913
Therapeutic product effect variable 11.78 11.73 5 390474 1872 29182176
Obstructive airways disorder 11.78 11.73 91 390388 10925 29173123
Macrophages increased 11.77 11.73 13 390466 162 29183886
Leukopenia 11.76 11.73 602 389877 54601 29129447
Body temperature fluctuation 11.76 11.73 44 390435 1406 29182642

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
Toxicity to various agents 3113.64 11.46 12233 957316 351280 63177903
Completed suicide 1798.09 11.46 7404 962145 217010 63312173
Intentional overdose 1660.79 11.46 3969 965580 85975 63443208
Acute hepatic failure 1580.87 11.46 1957 967592 24155 63505028
Overdose 1350.57 11.46 5357 964192 154209 63374974
Analgesic drug level increased 1186.11 11.46 611 968938 1659 63527524
Hepatocellular injury 1015.34 11.46 2158 967391 43077 63486106
Drug ineffective 917 11.46 8158 961391 832089 62697094
Infusion related reaction 627.52 11.46 4429 965120 160038 63369145
Poisoning deliberate 551.27 11.46 835 968714 12623 63516560
Intentional product misuse 517.89 11.46 2308 967241 69987 63459196
Suicide attempt 481.87 11.46 2231 967318 68776 63460407
Metabolic acidosis 433.46 11.46 2163 967386 68795 63460388
Exposure to toxic agent 422.49 11.46 492 969057 5667 63523516
Product dose omission issue 404.40 11.46 1532 968017 193215 63335968
Cholestasis 373.70 11.46 1500 968049 43372 63485811
Injection site pain 368.95 11.46 695 968854 110713 63418470
Drug resistance 314.35 11.46 71 969478 35031 63494152
Liver injury 295.03 11.46 1056 968493 28876 63500307
Hepatotoxicity 290.03 11.46 1281 968268 38681 63490502
Blood pressure fluctuation 289.50 11.46 1542 968007 50329 63478854
Off label use 267.22 11.46 7358 962191 625448 62903735
Accidental overdose 256.77 11.46 1093 968456 32464 63496719
Hepatitis 245.53 11.46 1342 968207 44240 63484943
Coagulopathy 234.50 11.46 1027 968522 30893 63498290
Hepatic failure 234.35 11.46 1531 968018 53863 63475320
Coma 227.00 11.46 2162 967387 85453 63443730
Injection site erythema 222.83 11.46 455 969094 70345 63458838
Somnolence 220.11 11.46 4291 965258 199354 63329829
Hepatic necrosis 209.74 11.46 421 969128 8052 63521131
Cardiac failure congestive 207.61 11.46 1133 968416 129447 63399736
Anion gap 205.29 11.46 192 969357 1675 63527508
Device expulsion 199.06 11.46 38 969511 21098 63508085
Wrong technique in product usage process 190.01 11.46 435 969114 64539 63464644
Hepatitis acute 188.39 11.46 534 969015 12855 63516328
Therapeutic product effect incomplete 185.53 11.46 861 968688 102621 63426562
Vomiting 183.76 11.46 10081 959468 541036 62988147
Myocardial infarction 177.11 11.46 1615 967934 164206 63364977
Product use in unapproved indication 170.98 11.46 1762 967787 174856 63354327
Toxic epidermal necrolysis 167.55 11.46 1044 968505 36122 63493061
Hepatic cytolysis 163.42 11.46 524 969025 13525 63515658
Treatment failure 160.18 11.46 1062 968487 115754 63413429
Drug hypersensitivity 159.89 11.46 2562 966987 235253 63293930
Prothrombin time shortened 157.28 11.46 204 969345 2645 63526538
Injection site reaction 157.17 11.46 288 969261 46376 63482807
Urticaria 149.68 11.46 3076 966473 144241 63384942
Hepatitis cholestatic 148.40 11.46 461 969088 11694 63517489
Cholecystitis chronic 147.23 11.46 387 969162 8900 63520283
Injection site swelling 144.89 11.46 249 969300 41104 63488079
Depressed level of consciousness 142.45 11.46 1860 967689 79576 63449607
Hospitalisation 140.63 11.46 616 968933 74591 63454592
International normalised ratio increased 138.82 11.46 1809 967740 77358 63451825
Pyroglutamate increased 135.69 11.46 97 969452 551 63528632
Transaminases increased 133.15 11.46 1135 968414 43459 63485724
Medication error 132.37 11.46 1239 968310 48727 63480456
Hepatitis fulminant 132.34 11.46 292 969257 5982 63523201
Pyroglutamic acidosis 126.84 11.46 98 969451 638 63528545
Injection site pruritus 125.13 11.46 236 969313 37590 63491593
Abdominal pain 122.01 11.46 5803 963746 306572 63222611
Confusional state 120.90 11.46 4937 964612 256207 63272976
Cytomegalovirus infection 118.79 11.46 237 969312 36962 63492221
Cardiac failure 117.49 11.46 1347 968202 131026 63398157
Disease progression 117.22 11.46 1464 968085 140216 63388967
Psoriasis 114.54 11.46 621 968928 71082 63458101
Diarrhoea 113.60 11.46 9339 960210 713365 62815818
Respiratory depression 111.02 11.46 667 968882 22776 63506407
Mixed liver injury 109.90 11.46 250 969299 5231 63523952
Heart rate decreased 108.88 11.46 1287 968262 53780 63475403
Haematotoxicity 107.89 11.46 30 969519 12866 63516317
Blood pressure diastolic abnormal 107.82 11.46 409 969140 11508 63517675
Therapy non-responder 106.78 11.46 568 968981 65331 63463852
Injection site bruising 105.13 11.46 245 969304 36128 63493055
Body temperature increased 104.13 11.46 923 968626 35743 63493440
Prothrombin time ratio decreased 101.79 11.46 88 969461 685 63528498
Oxygen saturation decreased 100.77 11.46 2213 967336 104963 63424220
Bone marrow failure 100.18 11.46 376 969173 47576 63481607
Urine abnormality 99.10 11.46 289 969260 7073 63522110
Condition aggravated 97.34 11.46 4590 964959 367836 63161347
Acute generalised exanthematous pustulosis 97.00 11.46 444 969105 13614 63515569
Chills 96.78 11.46 2726 966823 134538 63394645
Drug interaction 95.13 11.46 4460 965089 357623 63171560
Intentional self-injury 93.53 11.46 752 968797 28292 63500891
Drug-induced liver injury 91.34 11.46 1107 968442 46536 63482647
Pathogen resistance 91.31 11.46 37 969512 12506 63516677
Red blood cell sedimentation rate abnormal 88.66 11.46 69 969480 16237 63512946
Myelosuppression 87.65 11.46 139 969410 23691 63505492
Alanine aminotransferase increased 87.13 11.46 2721 966828 136310 63392873
Therapy cessation 86.74 11.46 228 969321 32261 63496922
Renal impairment 84.28 11.46 1474 968075 133543 63395640
Loss of personal independence in daily activities 83.81 11.46 691 968858 71763 63457420
Product prescribing error 82.83 11.46 263 969286 35006 63494177
Heart rate increased 82.70 11.46 2005 967544 96670 63432513
Post transplant lymphoproliferative disorder 82.12 11.46 21 969528 9523 63519660
Blood pressure increased 80.65 11.46 3266 966283 169286 63359897
Blood pressure systolic abnormal 80.08 11.46 329 969220 9613 63519570
Hepatic encephalopathy 78.82 11.46 565 968984 20501 63508682
Tachycardia 78.39 11.46 2867 966682 146712 63382471
Diabetes mellitus 77.33 11.46 633 968916 65841 63463342
Prothrombin time prolonged 77.19 11.46 452 969097 15289 63513894
Miosis 77.17 11.46 399 969150 12867 63516316
Lower respiratory tract infection 76.16 11.46 1912 967637 92702 63436481
Interstitial lung disease 74.17 11.46 1028 968521 96704 63432479
Drug intolerance 73.79 11.46 2206 967343 185786 63343397
Transplant rejection 73.46 11.46 92 969457 17309 63511874
Fixed eruption 73.34 11.46 123 969426 2036 63527147
C-reactive protein abnormal 72.94 11.46 210 969339 28837 63500346
Acute graft versus host disease 72.59 11.46 23 969526 9061 63520122
Multiple-drug resistance 72.29 11.46 7 969542 6495 63522688
Cardio-respiratory arrest 72.13 11.46 1964 967585 96429 63432754
Liver function test abnormal 71.80 11.46 1274 968275 58127 63471056
Therapy interrupted 70.77 11.46 120 969429 19916 63509267
Poisoning 70.73 11.46 567 968982 21312 63507871
Unintentional medical device removal 70.45 11.46 9 969540 6725 63522458
Stevens-Johnson syndrome 69.26 11.46 804 968745 33445 63495738
Urine leukocyte esterase positive 69.10 11.46 156 969393 3247 63525936
Therapeutic response decreased 68.25 11.46 481 969068 51707 63477476
Throat irritation 67.99 11.46 772 968777 31939 63497244
Renal papillary necrosis 66.10 11.46 50 969499 314 63528869
Injection site warmth 65.86 11.46 63 969486 13399 63515784
Drug ineffective for unapproved indication 65.76 11.46 243 969306 30890 63498293
Graft versus host disease 64.86 11.46 67 969482 13746 63515437
Device use error 64.53 11.46 10 969539 6461 63522722
Crystal urine present 64.33 11.46 109 969440 1820 63527363
Device issue 64.30 11.46 154 969395 22494 63506689
Bradypnoea 64.22 11.46 197 969352 4962 63524221
Respiratory arrest 63.90 11.46 1136 968413 51849 63477334
Immune reconstitution inflammatory syndrome 63.80 11.46 56 969493 12414 63516769
Acidosis 62.99 11.46 471 969078 17324 63511859
Drug abuser 62.51 11.46 211 969338 5597 63523586
White blood cells urine positive 62.48 11.46 201 969348 5197 63523986
Accidental exposure to product 60.93 11.46 198 969351 26166 63503017
Pneumonia 60.77 11.46 7425 962124 552151 62977032
Psoriatic arthropathy 59.53 11.46 393 969156 42888 63486295
Jaundice 58.82 11.46 1041 968508 47471 63481712
Hypotension 57.95 11.46 6558 962991 374416 63154767
Surgery 57.78 11.46 223 969326 27990 63501193
Cerebral infarction 56.80 11.46 372 969177 40672 63488511
Product storage error 56.65 11.46 70 969479 13248 63515935
Urinary sediment present 55.29 11.46 111 969438 2123 63527060
Anaphylactic reaction 54.48 11.46 1385 968164 67279 63461904
Cell death 54.43 11.46 159 969390 3895 63525288
Drug abuse 54.32 11.46 2472 967077 129902 63399281
Posterior reversible encephalopathy syndrome 53.96 11.46 171 969378 22775 63506408
Lymphocyte count decreased 53.94 11.46 886 968663 39813 63489370
Mydriasis 53.47 11.46 404 969145 14908 63514275
Myelodysplastic syndrome 53.31 11.46 223 969326 27356 63501827
Mucosal inflammation 53.12 11.46 643 968906 61941 63467242
Product monitoring error 53.10 11.46 9 969540 5445 63523738
Granuloma skin 52.97 11.46 13 969536 6061 63523122
Injection site haemorrhage 52.93 11.46 187 969362 24091 63505092
Anaemia 52.79 11.46 4937 964612 373743 63155440
Injection site mass 52.63 11.46 113 969436 17157 63512026
Neoplasm progression 51.89 11.46 381 969168 40583 63488600
Flushing 51.85 11.46 1549 968000 77099 63452084
Chronic graft versus host disease 51.76 11.46 15 969534 6261 63522922
Blood parathyroid hormone decreased 51.58 11.46 23 969526 7343 63521840
Blood pressure diastolic increased 50.96 11.46 306 969243 10446 63518737
Palmar-plantar erythrodysaesthesia syndrome 50.90 11.46 241 969308 28578 63500605
Acute lung injury 50.85 11.46 121 969428 2610 63526573
Blood pressure systolic increased 50.63 11.46 1034 968515 48419 63480764
Blood alkaline phosphatase increased 50.34 11.46 1154 968395 55125 63474058
Disease recurrence 50.25 11.46 273 969276 31237 63497946
Rheumatoid nodule 50.22 11.46 70 969479 12581 63516602
Transplant dysfunction 50.13 11.46 19 969530 6689 63522494
Labelled drug-drug interaction medication error 49.40 11.46 168 969381 21894 63507289
Cerebrovascular accident 49.00 11.46 1635 967914 135948 63393235
Platelet count decreased 48.82 11.46 2042 967507 165669 63363514
Acute graft versus host disease in skin 48.65 11.46 21 969528 6834 63522349
Cytokine release syndrome 48.57 11.46 503 969046 20326 63508857
Aspergillus infection 48.40 11.46 109 969440 16270 63512913
Bone erosion 48.22 11.46 62 969487 11533 63517650
Gallbladder injury 48.11 11.46 72 969477 1076 63528107
Hypertransaminasaemia 48.05 11.46 225 969324 6966 63522217
Aspartate aminotransferase increased 47.85 11.46 2231 967318 117557 63411626
Rash maculo-papular 47.73 11.46 982 968567 46044 63483139
Glycosylated haemoglobin increased 47.02 11.46 107 969442 15912 63513271
Emotional distress 46.82 11.46 782 968767 35256 63493927
Substance abuse 46.33 11.46 268 969281 9024 63520159
Neuropathy peripheral 45.62 11.46 1381 968168 116144 63413039
Unresponsive to stimuli 45.59 11.46 1035 968514 49358 63479825
BK virus infection 44.75 11.46 28 969521 7384 63521799
Blood glucose increased 44.61 11.46 1127 968422 96946 63432237
Encephalopathy 44.21 11.46 1178 968371 57641 63471542
Acute myocardial infarction 44.16 11.46 759 968790 68959 63460224
Septic shock 43.93 11.46 1227 968322 104210 63424973
Full blood count abnormal 43.59 11.46 265 969284 29492 63499691
Device malfunction 43.17 11.46 129 969420 17504 63511679
Coagulation factor VII level decreased 43.11 11.46 31 969518 178 63529005
Blood pressure diastolic decreased 43.10 11.46 519 969030 21782 63507401
Muscle injury 42.98 11.46 596 968953 25841 63503342
Pruritus 42.48 11.46 5340 964209 307060 63222123
Therapy partial responder 42.41 11.46 55 969494 10193 63518990
Metastases to liver 42.40 11.46 200 969349 23741 63505442
Device difficult to use 42.20 11.46 51 969498 9747 63519436
Treatment noncompliance 40.31 11.46 438 969111 43044 63486139
Sinusitis 40.16 11.46 2626 966923 143302 63385881
Gamma-glutamyltransferase increased 40.12 11.46 984 968565 47526 63481657
General physical health deterioration 40.06 11.46 2591 966958 201834 63327349
Nocardiosis 40.05 11.46 11 969538 4756 63524427
Infusion site extravasation 40.02 11.46 206 969343 6631 63522552
Second primary malignancy 39.90 11.46 78 969471 12259 63516924
Hepatitis toxic 39.79 11.46 151 969398 4249 63524934
Bronchopulmonary aspergillosis 39.63 11.46 150 969399 18935 63510248
Blister 39.53 11.46 1540 968009 79427 63449756
Coronary arterial stent insertion 39.51 11.46 18 969531 5674 63523509
Rheumatoid arthritis 39.38 11.46 2923 966626 161371 63367812
Folliculitis 39.20 11.46 653 968896 29424 63499759
Lymphocyte percentage decreased 39.16 11.46 156 969393 4493 63524690
Alopecia 39.11 11.46 2063 967486 163627 63365556
Vascular stent thrombosis 39.10 11.46 3 969546 3361 63525822
Injection site induration 39.00 11.46 46 969503 8886 63520297
Lymphoproliferative disorder 38.90 11.46 14 969535 5089 63524094
Mucormycosis 38.74 11.46 32 969517 7309 63521874
Thrombotic microangiopathy 38.54 11.46 125 969424 16530 63512653
Red cell distribution width increased 38.17 11.46 316 969233 11993 63517190
Coronary artery disease 37.93 11.46 659 968890 59774 63469409
Underdose 37.85 11.46 230 969319 25599 63503584
Respiratory rate increased 37.81 11.46 432 969117 17899 63511284
Blood calcium decreased 37.54 11.46 566 968983 24988 63504195
Irritable bowel syndrome 37.48 11.46 779 968770 36590 63492593
Abdominal pain upper 37.35 11.46 3086 966463 171944 63357239
Cytomegalovirus viraemia 37.20 11.46 66 969483 10762 63518421
Neurotoxicity 37.10 11.46 250 969299 27154 63502029
Brain death 36.92 11.46 158 969391 4703 63524480
Device dislocation 36.88 11.46 178 969371 21000 63508183
Kidney transplant rejection 36.40 11.46 54 969495 9457 63519726
Panniculitis 36.39 11.46 48 969501 8831 63520352
Lipodystrophy acquired 36.35 11.46 8 969541 4019 63525164
Dyspnoea exertional 36.07 11.46 838 968711 72892 63456291
Contraindicated product administered 35.94 11.46 1292 968257 106537 63422646
Neutrophil percentage increased 35.73 11.46 147 969402 4298 63524885
Inadequate analgesia 35.55 11.46 136 969413 3842 63525341
Exposure via ingestion 35.45 11.46 157 969392 4745 63524438
Ear pruritus 35.40 11.46 104 969445 2556 63526627
Virologic failure 35.38 11.46 5 969544 3461 63525722
Strongyloidiasis 35.23 11.46 3 969546 3087 63526096
No adverse event 35.05 11.46 268 969281 28293 63500890
Oedema peripheral 34.93 11.46 2704 966845 207613 63321570
Gait disturbance 34.93 11.46 2175 967374 169980 63359203
Cardiac disorder 34.92 11.46 609 968940 55207 63473976
Abortion incomplete 34.82 11.46 3 969546 3058 63526125
Myopathy 34.77 11.46 142 969407 17538 63511645
Biliary dyskinesia 34.74 11.46 96 969453 2276 63526907
Enthesopathy 34.71 11.46 57 969492 9581 63519602
Nasal necrosis 34.41 11.46 23 969526 115 63529068
Metastases to lung 34.33 11.46 116 969433 15148 63514035
Injury 33.77 11.46 1091 968458 54901 63474282
Coronary artery bypass 33.71 11.46 23 969526 5792 63523391
Device leakage 33.55 11.46 45 969504 8221 63520962
Anion gap abnormal 33.52 11.46 41 969508 499 63528684
Rash erythematous 33.45 11.46 963 968586 47670 63481513
Injection site urticaria 33.37 11.46 74 969475 11107 63518076
Jaundice cholestatic 33.29 11.46 234 969315 8436 63520747
Injection site rash 33.16 11.46 123 969426 15619 63513564
Body temperature fluctuation 33.04 11.46 117 969432 3181 63526002
Graft versus host disease in gastrointestinal tract 32.79 11.46 22 969527 5590 63523593
Venoocclusive liver disease 32.67 11.46 63 969486 9952 63519231
Hypothermia 32.42 11.46 448 969101 19408 63509775
Immunosuppressant drug level increased 32.11 11.46 37 969512 7222 63521961
Meningitis aseptic 31.72 11.46 170 969379 5560 63523623
Dyspnoea at rest 31.69 11.46 29 969520 6300 63522883
Prothrombin level increased 31.67 11.46 35 969514 379 63528804
Incorrect dose administered by device 31.64 11.46 11 969538 4086 63525097
Cholelithiasis 31.55 11.46 902 968647 44604 63484579
Lip oedema 31.53 11.46 158 969391 5031 63524152
Osteonecrosis 31.39 11.46 272 969277 27957 63501226
Temperature regulation disorder 31.31 11.46 136 969413 4075 63525108
Dyspnoea 31.27 11.46 9996 959553 708678 62820505
Blood urine present 31.26 11.46 417 969132 17923 63511260
Neutropenia 30.96 11.46 3141 966408 236483 63292700
Brain oedema 30.91 11.46 485 969064 21590 63507593
Pulmonary hypertension 30.87 11.46 459 969090 42680 63486503
Urine analysis abnormal 30.67 11.46 169 969380 5587 63523596
Red blood cells urine positive 30.57 11.46 141 969408 4337 63524846
Haemoglobin urine present 30.43 11.46 50 969499 813 63528370
Agranulocytosis 30.28 11.46 771 968778 37458 63491725
Coagulation factor V level decreased 30.16 11.46 41 969508 558 63528625
Cardiomyopathy 30.15 11.46 240 969309 25116 63504067
Epstein-Barr virus infection 30.11 11.46 92 969457 12396 63516787
Decreased appetite 29.97 11.46 3736 965813 277553 63251630
Graft versus host disease in skin 29.87 11.46 22 969527 5325 63523858
Oedema 29.86 11.46 1105 968444 90830 63438353
Back pain 29.70 11.46 4242 965307 245929 63283254
Heart rate irregular 29.67 11.46 578 968971 26835 63502348
Anion gap increased 29.65 11.46 107 969442 2937 63526246
Product administration error 29.63 11.46 582 968967 27061 63502122
JC virus infection 29.61 11.46 7 969542 3348 63525835
Sedation complication 29.58 11.46 261 969288 10093 63519090
Fluid retention 29.56 11.46 676 968873 58930 63470253
Liver transplant 29.55 11.46 131 969418 3961 63525222
Urine ketone body present 29.50 11.46 113 969436 3194 63525989
Maternal exposure during pregnancy 29.48 11.46 1160 968389 94724 63434459
Feeling abnormal 29.39 11.46 1675 967874 131927 63397256
Tenosynovitis 29.38 11.46 86 969463 11747 63517436
Duodenal ulcer perforation 29.12 11.46 704 968845 33921 63495262
Drug screen positive 29.06 11.46 166 969383 5563 63523620
Respiratory failure 29.04 11.46 2058 967491 159125 63370058
Electric shock 29.03 11.46 57 969492 1072 63528111
Hepatic enzyme increased 28.99 11.46 2299 967250 127644 63401539
Agitation 28.57 11.46 1613 967936 86754 63442429
Bladder cancer 28.54 11.46 78 969471 10896 63518287
Haematochezia 28.51 11.46 769 968780 65604 63463579
Specific gravity urine decreased 28.47 11.46 46 969503 737 63528446
Thrombosis 28.42 11.46 826 968723 69816 63459367
Methaemoglobinaemia 28.29 11.46 135 969414 4213 63524970
Ear pain 28.23 11.46 533 969016 24603 63504580
Coma scale abnormal 28.22 11.46 207 969342 7567 63521616
Pyrexia 28.20 11.46 9092 960457 549552 62979631
Hypocoagulable state 28.14 11.46 76 969473 1777 63527406
Specific gravity urine increased 27.91 11.46 34 969515 412 63528771
Atrial fibrillation 27.88 11.46 2203 967346 168886 63360297
Unevaluable event 27.83 11.46 563 968986 49926 63479257
Cystitis haemorrhagic 27.78 11.46 48 969501 7908 63521275
Haemorrhage 27.77 11.46 945 968604 78406 63450777
Infusion site pain 27.62 11.46 258 969291 10139 63519044
Chest discomfort 27.52 11.46 2064 967485 114042 63415141
Acute kidney injury 27.48 11.46 7369 962180 441871 63087312
Accidental exposure to product by child 27.38 11.46 91 969458 2394 63526789
Brain stem glioma 27.38 11.46 21 969528 135 63529048
Ascites 27.25 11.46 716 968833 61285 63467898
Sleep disorder due to general medical condition, insomnia type 27.12 11.46 550 968999 25720 63503463
Intracranial pressure increased 27.05 11.46 189 969360 6800 63522383
Analgesic drug level above therapeutic 27.02 11.46 33 969516 401 63528782
Skin necrosis 27.00 11.46 117 969432 14212 63514971
Cytomegalovirus infection reactivation 26.94 11.46 28 969521 5728 63523455
Diffuse large B-cell lymphoma recurrent 26.92 11.46 7 969542 3139 63526044
Hyperthermia 26.68 11.46 354 969195 15196 63513987
Memory impairment 26.47 11.46 1036 968513 84646 63444537
Livedo reticularis 26.43 11.46 118 969431 3579 63525604
Neuroleptic malignant syndrome 26.41 11.46 244 969305 24752 63504431
Osteonecrosis of jaw 26.38 11.46 430 969119 39395 63489788
Endophthalmitis 26.37 11.46 25 969524 5340 63523843
Diabetic ketoacidosis 26.33 11.46 304 969245 29541 63499642
Creatinine renal clearance decreased 25.88 11.46 331 969218 14090 63515093
Feeling hot 25.81 11.46 883 968666 44780 63484403
Syncope 25.80 11.46 2029 967520 155606 63373577
Pulmonary arterial hypertension 25.78 11.46 250 969299 25117 63504066
Metastases to lymph nodes 25.77 11.46 58 969491 8659 63520524
Blood bilirubin increased 25.63 11.46 1084 968465 56469 63472714
Muscle spasticity 25.58 11.46 372 969177 16297 63512886
Pulmonary alveolar haemorrhage 25.49 11.46 69 969480 9669 63519514
Drug dose omission by device 25.49 11.46 10 969539 3447 63525736
Sphincter of Oddi dysfunction 25.42 11.46 31 969518 376 63528807
Basal cell carcinoma 25.35 11.46 319 969230 30519 63498664
Impaired work ability 25.30 11.46 130 969419 15089 63514094
Cytopenia 25.25 11.46 133 969416 15338 63513845
Orthostatic hypotension 25.23 11.46 899 968650 45839 63483344
Angina pectoris 25.05 11.46 502 969047 44579 63484604
Hepatitis B 25.02 11.46 49 969500 7696 63521487
Culture urine positive 24.95 11.46 126 969423 4025 63525158
Hypertensive crisis 24.94 11.46 166 969383 18082 63511101
Human herpesvirus 6 infection 24.92 11.46 20 969529 4634 63524549
Visual acuity reduced 24.91 11.46 274 969275 26867 63502316
COVID-19 treatment 24.66 11.46 32 969517 415 63528768
Acute haemorrhagic oedema of infancy 24.66 11.46 14 969535 49 63529134
Obstructive airways disorder 24.63 11.46 226 969323 22959 63506224
Wrong patient received product 24.62 11.46 117 969432 3645 63525538
Gallbladder disorder 24.55 11.46 376 969173 16654 63512529
Prostatic specific antigen increased 24.52 11.46 60 969489 8700 63520483
Laboratory test abnormal 24.52 11.46 237 969312 23826 63505357
Acute myeloid leukaemia 24.52 11.46 279 969270 27184 63501999
Disturbance in social behaviour 24.43 11.46 14 969535 3873 63525310
Forced expiratory volume decreased 24.37 11.46 41 969508 6826 63522357
Self-medication 24.34 11.46 125 969424 4020 63525163
Adverse event 24.33 11.46 432 969117 39057 63490126
Malignant neoplasm progression 24.30 11.46 1418 968131 111453 63417730
Anti-neutrophil cytoplasmic antibody positive vasculitis 24.25 11.46 7 969542 2929 63526254
Chondrocalcinosis 24.02 11.46 41 969508 689 63528494
Cardiotoxicity 23.85 11.46 77 969472 10197 63518986
Hepatitis B reactivation 23.77 11.46 23 969526 4866 63524317
Subacute cutaneous lupus erythematosus 23.57 11.46 8 969541 3017 63526166
Sexual dysfunction 23.56 11.46 38 969511 6433 63522750
Genital haemorrhage 23.51 11.46 29 969520 5493 63523690
Right ventricular failure 23.38 11.46 208 969341 21263 63507920
Blood pH decreased 23.29 11.46 129 969420 4273 63524910
Leukopenia 23.23 11.46 1264 968285 99978 63429205
Bacterial test 23.04 11.46 54 969495 1153 63528030
Drug tolerance decreased 22.85 11.46 44 969505 6954 63522229
Hallucination 22.83 11.46 1325 968224 71463 63457720
Poor venous access 22.71 11.46 286 969263 12131 63517052
Abdominal discomfort 22.57 11.46 2397 967152 179925 63349258
Sopor 22.49 11.46 312 969237 29349 63499834
Red blood cell sedimentation rate 22.47 11.46 14 969535 3700 63525483
Progressive multifocal leukoencephalopathy 22.41 11.46 171 969378 18061 63511122
Hepatocellular carcinoma 22.40 11.46 59 969490 8344 63520839
Infusion site pruritus 22.40 11.46 88 969461 2518 63526665
Chronic kidney disease 22.36 11.46 681 968868 57238 63471945
Neoplasm malignant 22.36 11.46 250 969299 24438 63504745
Pneumocystis jirovecii pneumonia 22.29 11.46 287 969262 27347 63501836
Medication overuse headache 22.21 11.46 39 969510 671 63528512
Product substitution issue 22.20 11.46 167 969382 17694 63511489
Drug eruption 22.05 11.46 396 969153 35740 63493443
Neutropenic sepsis 22 11.46 481 969068 22791 63506392
Pleurothotonus 21.97 11.46 4 969545 2298 63526885
Drug reaction with eosinophilia and systemic symptoms 21.90 11.46 1011 968538 53206 63475977
Adverse drug reaction 21.88 11.46 518 969031 44946 63484237
Hyperhidrosis 21.83 11.46 2171 967378 122749 63406434
Vascular purpura 21.72 11.46 86 969463 2470 63526713
Eyelid ptosis 21.69 11.46 72 969477 9453 63519730
Throat tightness 21.68 11.46 478 969071 22682 63506501
Dizziness 21.65 11.46 5946 963603 424217 63104966
Polyomavirus-associated nephropathy 21.53 11.46 25 969524 4863 63524320
Accidental poisoning 21.47 11.46 59 969490 1394 63527789
Constipation 21.42 11.46 3838 965711 225499 63303684
Fear of injection 21.26 11.46 35 969514 5877 63523306
Prostate cancer 21.01 11.46 193 969356 19602 63509581
Metastases to bone 20.94 11.46 201 969348 20234 63508949
Body temperature decreased 20.86 11.46 524 969025 25404 63503779
Hepatorenal failure 20.83 11.46 51 969498 1121 63528062
Dose calculation error 20.73 11.46 18 969531 141 63529042
Complications of transplanted kidney 20.66 11.46 31 969518 5404 63523779
Acute myeloid leukaemia recurrent 20.61 11.46 8 969541 2776 63526407
Nipple disorder 20.56 11.46 19 969530 163 63529020
Varicella zoster virus infection 20.45 11.46 17 969532 3871 63525312
Fracture 20.28 11.46 182 969367 18573 63510610
Hyponatraemia 20.17 11.46 2536 967013 145803 63383380
Infusion site swelling 20.11 11.46 146 969403 5319 63523864
Monocyte percentage increased 20.08 11.46 71 969478 1929 63527254
Infusion site erythema 20.02 11.46 174 969375 6699 63522484
Acute graft versus host disease in intestine 19.97 11.46 15 969534 3594 63525589
Mycobacterial infection 19.89 11.46 10 969539 2978 63526205
Cardiac failure acute 19.76 11.46 154 969395 16190 63512993
Ill-defined disorder 19.68 11.46 830 968719 43222 63485961
Cytomegalovirus chorioretinitis 19.68 11.46 27 969522 4885 63524298
Cholestatic liver injury 19.59 11.46 108 969441 3571 63525612
Oedematous pancreatitis 19.49 11.46 42 969507 846 63528337
Angioedema 19.32 11.46 1125 968424 60696 63468487
Injection site discolouration 19.31 11.46 47 969502 6828 63522355
Serum sickness 19.31 11.46 97 969452 3092 63526091
Bacterial test positive 19.30 11.46 169 969380 6521 63522662
Ventricular tachycardia 19.21 11.46 381 969168 33884 63495299
Lethargy 19.18 11.46 1302 968247 71292 63457891
Needle issue 19.17 11.46 73 969476 9199 63519984
White blood cell count decreased 19.15 11.46 2078 967471 155759 63373424
Type I hypersensitivity 19.09 11.46 105 969444 3469 63525714
Gallbladder cholesterolosis 19.02 11.46 32 969517 531 63528652
Product quality issue 19.00 11.46 324 969225 29475 63499708
Status epilepticus 18.98 11.46 221 969328 21442 63507741
Cardiac failure chronic 18.81 11.46 71 969478 8970 63520213
Hyperprolactinaemia 18.77 11.46 20 969529 4045 63525138
Mucocutaneous disorder 18.76 11.46 16 969533 122 63529061
Pulmonary fibrosis 18.68 11.46 326 969223 29552 63499631
Cryptococcosis 18.68 11.46 9 969540 2746 63526437
Leukocyturia 18.47 11.46 58 969491 1480 63527703
Renal disorder 18.42 11.46 398 969151 34967 63494216
Gestational diabetes 18.38 11.46 35 969514 5555 63523628
Helicobacter infection 18.33 11.46 728 968821 37634 63491549
Suspected suicide 18.33 11.46 205 969344 8449 63520734
Lupus-like syndrome 18.31 11.46 69 969480 8722 63520461
Secondary immunodeficiency 18.31 11.46 9 969540 2715 63526468
Macular oedema 18.27 11.46 28 969521 4839 63524344
Oesophageal carcinoma 18.08 11.46 27 969522 4716 63524467
Food allergy 18.02 11.46 189 969360 7662 63521521
Haemolysis 18.00 11.46 249 969300 10790 63518393
Rhabdomyolysis 17.87 11.46 1163 968386 90563 63438620
Acquired gene mutation 17.81 11.46 4 969545 1982 63527201
Hyperglycaemia 17.79 11.46 742 968807 60226 63468957
Hyperbilirubinaemia 17.79 11.46 431 969118 20774 63508409
Syringe issue 17.74 11.46 23 969526 4263 63524920
Hepatic cirrhosis 17.73 11.46 283 969266 26015 63503168
Candida infection 17.72 11.46 349 969200 31070 63498113
Infusion site discomfort 17.71 11.46 37 969512 729 63528454
Body height below normal 17.70 11.46 3 969546 1815 63527368
Osteoporosis 17.69 11.46 489 969060 41591 63487592
Renal cortical necrosis 17.67 11.46 22 969527 273 63528910
Intentional product use issue 17.64 11.46 1664 967885 93700 63435483
Bursitis 17.52 11.46 435 969114 21050 63508133
Red blood cell sedimentation rate increased 17.30 11.46 348 969201 30887 63498296
Truncus coeliacus thrombosis 17.27 11.46 7 969542 8 63529175
Neonatal respiratory acidosis 17.25 11.46 11 969538 50 63529133
Pneumonia cytomegaloviral 17.23 11.46 24 969525 4315 63524868
Transplant failure 17.15 11.46 19 969530 3775 63525408
Abortion spontaneous 17.15 11.46 270 969279 24873 63504310
Beta haemolytic streptococcal infection 17.13 11.46 65 969484 1829 63527354
Seizure 17.09 11.46 2222 967327 164670 63364513
Prothrombin time abnormal 17.08 11.46 39 969510 818 63528365
Viral load increased 17.05 11.46 8 969541 2479 63526704
Long QT syndrome 17.05 11.46 32 969517 5107 63524076
Lip swelling 17.04 11.46 613 968936 31294 63497889
Galactorrhoea 17.03 11.46 14 969535 3205 63525978
Faeces discoloured 17.02 11.46 507 969042 25222 63503961
Systemic candida 16.97 11.46 34 969515 5295 63523888
Ductus arteriosus stenosis foetal 16.94 11.46 12 969537 67 63529116
Cognitive disorder 16.93 11.46 1001 968548 54086 63475097
Gastrointestinal toxicity 16.91 11.46 34 969515 5288 63523895
Cholesterosis 16.90 11.46 24 969525 341 63528842
Infection 16.87 11.46 2479 967070 182401 63346782
Ovarian hyperstimulation syndrome 16.83 11.46 11 969538 2834 63526349
Toxic skin eruption 16.80 11.46 394 969155 18890 63510293
Kussmaul respiration 16.78 11.46 25 969524 372 63528811
Delirium 16.72 11.46 1232 968317 67962 63461221
Sedation 16.71 11.46 773 968776 40689 63488494
Aplasia pure red cell 16.68 11.46 52 969497 6962 63522221
Systemic mycosis 16.67 11.46 7 969542 2316 63526867
Intervertebral discitis 16.55 11.46 107 969442 3750 63525433
Disability 16.50 11.46 111 969438 12061 63517122
Vulvar erosion 16.39 11.46 16 969533 148 63529035
Red blood cell spherocytes present 16.39 11.46 9 969540 29 63529154
Glutathione decreased 16.39 11.46 9 969540 29 63529154
Psychotic disorder 16.35 11.46 395 969154 34183 63495000
Nitrite urine present 16.31 11.46 44 969505 1028 63528155
Concomitant disease aggravated 16.28 11.46 104 969445 11438 63517745
Bezoar 16.27 11.46 71 969478 2132 63527051
Foot deformity 16.21 11.46 164 969385 16340 63512843
Retinal haemorrhage 16.11 11.46 57 969492 7341 63521842
Pleural thickening 16.10 11.46 82 969467 2628 63526555
Systemic infection 16.08 11.46 25 969524 4296 63524887
Akathisia 16.08 11.46 104 969445 11406 63517777
Mycobacterium chelonae infection 16.06 11.46 6 969543 2131 63527052
Dermo-hypodermitis 16.01 11.46 29 969520 512 63528671
Factor VIII inhibition 15.99 11.46 22 969527 303 63528880
Acute graft versus host disease in liver 15.96 11.46 3 969546 1684 63527499
Fatigue 15.92 11.46 10665 958884 738065 62791118
Erythema 15.91 11.46 3116 966433 183954 63345229
Pancytopenia 15.79 11.46 1899 967650 141410 63387773
Gastric ulcer perforation 15.78 11.46 61 969488 1732 63527451
Gingival hypertrophy 15.74 11.46 11 969538 2736 63526447
Stent placement 15.72 11.46 38 969511 5533 63523650
Use of accessory respiratory muscles 15.69 11.46 23 969526 337 63528846
Mean cell haemoglobin concentration decreased 15.68 11.46 102 969447 3582 63525601
Glucose-6-phosphate dehydrogenase deficiency 15.68 11.46 22 969527 309 63528874
Band neutrophil percentage decreased 15.68 11.46 7 969542 12 63529171
Sleep disorder due to a general medical condition 15.65 11.46 67 969482 8167 63521016
Full blood count decreased 15.57 11.46 242 969307 22340 63506843
Pancreatic fibrosis 15.56 11.46 13 969536 96 63529087
Respiratory acidosis 15.54 11.46 221 969328 9634 63519549
Hemiparesis 15.44 11.46 336 969213 29491 63499692
Retinitis 15.42 11.46 6 969543 2079 63527104
Blood creatinine decreased 15.38 11.46 168 969381 6882 63522301
Complication of device removal 15.30 11.46 16 969533 3264 63525919
Failure of child resistant product closure 15.19 11.46 11 969538 64 63529119
Peritonitis bacterial 15.17 11.46 77 969472 8966 63520217
Palatal oedema 15.17 11.46 46 969503 1151 63528032
Eosinophilia 15.16 11.46 709 968840 37367 63491816
Mania 15.11 11.46 164 969385 16122 63513061
Therapy change 15.09 11.46 48 969501 6386 63522797
Lung neoplasm malignant 15.07 11.46 229 969320 21219 63507964
Failure to suspend medication 15.01 11.46 24 969525 381 63528802
Apparent death 14.96 11.46 11 969538 2665 63526518
Asthenia 14.96 11.46 6002 963547 422042 63107141
Nipple inflammation 14.96 11.46 10 969539 50 63529133
Abnormal clotting factor 14.86 11.46 13 969536 103 63529080
Renal failure neonatal 14.80 11.46 11 969538 67 63529116
Vitamin K deficiency 14.77 11.46 32 969517 647 63528536
Gallbladder adenocarcinoma 14.76 11.46 13 969536 104 63529079
Infection reactivation 14.76 11.46 6 969543 2024 63527159
Post-traumatic stress disorder 14.71 11.46 111 969438 4094 63525089
Pulmonary mass 14.71 11.46 263 969286 23753 63505430
Upper gastrointestinal haemorrhage 14.71 11.46 659 968890 34561 63494622
Hypermagnesaemia 14.70 11.46 43 969506 1054 63528129
Orbital oedema 14.67 11.46 20 969529 273 63528910
Histoplasmosis 14.66 11.46 6 969543 2016 63527167
Hepatitis C 14.65 11.46 101 969448 10914 63518269
Ductus arteriosus premature closure 14.52 11.46 8 969541 26 63529157
Nephrogenic systemic fibrosis 14.50 11.46 43 969506 5849 63523334
Musculoskeletal disorder 14.43 11.46 186 969363 17720 63511463
Weight decreased 14.41 11.46 3949 965600 281790 63247393
Rash macular 14.41 11.46 462 969087 23223 63505960
Lactic acidosis 14.40 11.46 765 968784 60645 63468538
Skin cancer 14.39 11.46 113 969436 11861 63517322
Injury associated with device 14.37 11.46 13 969536 2840 63526343
Environmental exposure 14.36 11.46 22 969527 336 63528847
Leukoencephalopathy 14.31 11.46 55 969494 6912 63522271
Dilatation intrahepatic duct acquired 14.30 11.46 32 969517 662 63528521
Bilirubin urine present 14.26 11.46 21 969528 309 63528874
Infusion site bruising 14.21 11.46 53 969496 1479 63527704
Therapeutic response shortened 14.07 11.46 223 969326 9947 63519236
Parkinsonism 14.04 11.46 143 969406 14230 63514953
Device use issue 14.02 11.46 5 969544 1828 63527355
Gallbladder hypofunction 13.97 11.46 25 969524 437 63528746
Oral pruritus 13.96 11.46 59 969490 1746 63527437
Osmolar gap 13.90 11.46 14 969535 135 63529048
Hypoglycaemic coma 13.84 11.46 27 969522 4247 63524936
Gene mutation 13.81 11.46 7 969542 2075 63527108
Intraocular pressure increased 13.75 11.46 71 969478 8231 63520952
Pulmonary tuberculosis 13.74 11.46 59 969490 7185 63521998
Caesarean section 13.73 11.46 106 969443 11168 63518015
Renal cancer 13.66 11.46 55 969494 6820 63522363
Visual impairment 13.63 11.46 944 968605 73133 63456050
Toxicologic test abnormal 13.62 11.46 45 969504 1180 63528003
Blood lactic acid increased 13.62 11.46 226 969323 10175 63519008
Premature delivery 13.57 11.46 197 969352 18392 63510791
Complication of device insertion 13.51 11.46 35 969514 4977 63524206
Dependent personality disorder 13.50 11.46 13 969536 118 63529065
Haematuria 13.50 11.46 757 968792 59714 63469469
Choluria 13.46 11.46 21 969528 326 63528857
Tuberculosis 13.46 11.46 128 969421 12910 63516273
Erythema multiforme 13.43 11.46 320 969229 15381 63513802
Acute lymphocytic leukaemia recurrent 13.42 11.46 25 969524 4001 63525182
Hypothyroidism 13.42 11.46 485 969064 39972 63489211
Autonomic dysreflexia 13.33 11.46 23 969526 390 63528793
Haematemesis 13.32 11.46 848 968701 46151 63483032
Hepatic cancer 13.32 11.46 62 969487 7386 63521797
SJS-TEN overlap 13.25 11.46 25 969524 456 63528727
Transverse sinus thrombosis 13.24 11.46 29 969520 591 63528592
Bone disorder 13.17 11.46 175 969374 16584 63512599
Knee arthroplasty 13.16 11.46 307 969242 26692 63502491
Therapeutic product effect decreased 13.15 11.46 1525 968024 113826 63415357
Strawberry tongue 13.10 11.46 7 969542 21 63529162
Migraine with aura 13.08 11.46 69 969480 2243 63526940
Organising pneumonia 13.07 11.46 81 969468 8974 63520209
Vasoconstriction 12.99 11.46 29 969520 599 63528584
Diffuse axonal injury 12.99 11.46 11 969538 83 63529100
Multiple organ dysfunction syndrome 12.98 11.46 1330 968219 100083 63429100
Obesity 12.97 11.46 224 969325 20338 63508845
Euglycaemic diabetic ketoacidosis 12.94 11.46 40 969509 5370 63523813
Device deployment issue 12.94 11.46 14 969535 2812 63526371
Biliary sepsis 12.91 11.46 49 969500 1379 63527804
Pancreatic carcinoma 12.89 11.46 97 969452 10276 63518907
Catheter management 12.89 11.46 19 969530 3336 63525847
Cyanosis neonatal 12.88 11.46 9 969540 49 63529134
Blood magnesium increased 12.87 11.46 88 969461 3143 63526040
Bacterial parotitis 12.86 11.46 6 969543 12 63529171
Murphy's sign positive 12.85 11.46 4 969545 0 63529183
Hepatitis non-A non-B 12.85 11.46 4 969545 0 63529183
Neurone-specific enolase increased 12.85 11.46 4 969545 0 63529183
Analgesic drug level therapeutic 12.85 11.46 4 969545 0 63529183
Splenic vein thrombosis 12.84 11.46 31 969518 675 63528508
Histoplasmosis disseminated 12.84 11.46 7 969542 1991 63527192
Granulocytopenia 12.79 11.46 98 969451 10342 63518841
Pneumonia streptococcal 12.79 11.46 70 969479 2308 63526875
Tardive dyskinesia 12.79 11.46 83 969466 9095 63520088
Prescribed underdose 12.78 11.46 192 969357 17823 63511360
Vascular graft 12.71 11.46 6 969543 1853 63527330
Coagulation factor X level decreased 12.69 11.46 11 969538 86 63529097
Respiratory tract congestion 12.63 11.46 169 969380 15996 63513187
Pleural fibrosis 12.57 11.46 104 969445 3946 63525237
Product tampering 12.47 11.46 16 969533 205 63528978
Toxoplasmosis 12.47 11.46 11 969538 2433 63526750
Hypoprothrombinaemia 12.47 11.46 31 969518 688 63528495
Overflow diarrhoea 12.47 11.46 9 969540 52 63529131
Malabsorption 12.45 11.46 30 969519 4373 63524810
Bradycardia neonatal 12.38 11.46 10 969539 70 63529113
Skin toxicity 12.38 11.46 54 969495 6548 63522635
Torsade de pointes 12.33 11.46 185 969364 17178 63512005
Enterococcal infection 12.33 11.46 141 969408 13725 63515458
Urine bilirubin decreased 12.32 11.46 13 969536 133 63529050
Arthritis 12.32 11.46 1088 968461 82726 63446457
Prescription form tampering 12.30 11.46 21 969528 353 63528830
Left ventricular dysfunction 12.27 11.46 180 969369 16774 63512409
Stress cardiomyopathy 12.26 11.46 85 969464 9172 63520011
Urostomy complication 12.21 11.46 5 969544 6 63529177
Sarcopenia 12.17 11.46 21 969528 356 63528827
Eosinophil percentage increased 12.17 11.46 48 969501 1376 63527807
Catatonia 12.16 11.46 66 969483 7554 63521629
Tendonitis 12.14 11.46 223 969326 20059 63509124
Chronic graft versus host disease in skin 12.09 11.46 3 969546 1388 63527795
Herpes zoster 12.07 11.46 1025 968524 78162 63451021
Respiratory alkalosis 12.06 11.46 100 969449 3797 63525386
Hyperlipasaemia 12.05 11.46 38 969511 972 63528211
Thymus disorder 12.03 11.46 16 969533 213 63528970
Fibrin D dimer increased 12.02 11.46 155 969394 6610 63522573
Hypertriglyceridaemia 12 11.46 109 969440 11096 63518087
Open globe injury 11.96 11.46 10 969539 74 63529109
Type 2 diabetes mellitus 11.93 11.46 405 969144 33615 63495568
Cyanosis 11.92 11.46 426 969123 21729 63507454
Tongue disorder 11.88 11.46 120 969429 11960 63517223
Cerebral haemorrhage 11.88 11.46 637 968912 50453 63478730
Enanthema 11.87 11.46 31 969518 710 63528473
Polycystic ovaries 11.87 11.46 9 969540 2146 63527037
Skin ulcer 11.83 11.46 540 969009 43434 63485749
Congestive cardiomyopathy 11.80 11.46 99 969450 10245 63518938
Generalised bullous fixed drug eruption 11.79 11.46 5 969544 7 63529176
Visceral congestion 11.77 11.46 33 969516 789 63528394
Delusion 11.77 11.46 195 969354 17819 63511364
Osmolar gap abnormal 11.75 11.46 10 969539 76 63529107
Catheterisation cardiac 11.68 11.46 36 969513 4837 63524346
Cardiac steatosis 11.67 11.46 8 969541 42 63529141
Periportal oedema 11.67 11.46 11 969538 97 63529086
Nasopharyngitis 11.66 11.46 3213 966336 192860 63336323
Anxiety 11.65 11.46 3316 966233 199333 63329850
Paranoid personality disorder 11.64 11.46 7 969542 28 63529155
Exercise tolerance decreased 11.64 11.46 68 969481 7642 63521541
Pneumocystis jirovecii infection 11.61 11.46 11 969538 2350 63526833
Metabolic disorder 11.56 11.46 68 969481 7629 63521554
Lupus vulgaris 11.55 11.46 10 969539 78 63529105
Drug effective for unapproved indication 11.52 11.46 24 969525 3684 63525499
Congenital central hypoventilation syndrome 11.46 11.46 7 969542 29 63529154

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Accidental overdose 30.77 14.82 17 863 89 83709
Analgesic drug level increased 25.07 14.82 7 873 0 83798
Overdose 16.73 14.82 9 871 44 83754

Pharmacologic Action:

SourceCodeDescription
ATC N02AJ01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ13 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ17 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02BE01 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02BE51 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02BE71 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D058633 Antipyretics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50629 COX-2 inhibitor
CHEBI has role CHEBI:50630 COX-1 inhibitor
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:73263 cyclooxygenase-3 inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:85234 human blood serum metabolites
CHEBI has role CHEBI:173085 ferroptosis inducers
CHEBI has role CHEBI:176497 geroprotectors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Toothache indication 27355003
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Allergic rhinitis indication 61582004
Common cold indication 82272006 DOID:10459
Backache indication 161891005
Headache disorder indication 230461009
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Arthritic Pain indication
Pain Treatment Adjunct indication
Vascular headache off-label use 128187005
Fibromyalgia off-label use 203082005 DOID:631
Hepatic encephalopathy contraindication 13920009 DOID:13413
Cirrhosis of liver contraindication 19943007 DOID:5082
Hepatic failure contraindication 59927004
Disease of liver contraindication 235856003 DOID:409




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.69 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 7976870 June 1, 2027 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 10383834 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 10383834 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9610265 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN WITH ADJUNCTIVE OPIOID ANALGESICS
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9987238 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN OR MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8372432 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8668929 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8377453 Nov. 19, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;EQ 4.08MG BASE APADAZ KVK TECH INC N208653 Jan. 4, 2019 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
325MG;EQ 6.12MG BASE APADAZ KVK TECH INC N208653 Feb. 23, 2018 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
325MG;EQ 8.16MG BASE APADAZ KVK TECH INC N208653 Jan. 4, 2019 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9399012 Sept. 11, 2031 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN OR MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9399012 Sept. 11, 2031 MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8741885 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9468636 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG;125MG ADVIL DUAL ACTION WITH ACETAMINOPHEN GLAXOSMITHKLINE N211733 Feb. 28, 2020 OTC TABLET ORAL Feb. 28, 2023 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 4.31 WOMBAT-PK CHEMBL
Transient receptor potential cation channel subfamily V member 1 Ion channel OPENER WOMBAT-PK CHEMBL
Cannabinoid receptor 1 GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
Carbonic anhydrase 2 Enzyme Ki 5.21 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 5 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 4.94 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 4.15 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.39 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.04 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 5.15 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 4.97 CHEMBL
Arachidonate 5-lipoxygenase-activating protein Cytosolic other IC50 4.36 CHEMBL
Myoglobin Unclassified IC50 5.64 CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Arachidonate 15-lipoxygenase Enzyme IC50 4.55 DRUG MATRIX
Carbonic anhydrase 13 Enzyme Ki 4.52 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 5.03 CHEMBL

External reference:

IDSource
4017513 VUID
N0000145898 NUI
D00217 KEGG_DRUG
161 RXNORM
C0000970 UMLSCUI
CHEBI:46195 CHEBI
NNS PDB_CHEM_ID
CHEMBL112 ChEMBL_ID
DB00316 DRUGBANK_ID
5239 IUPHAR_LIGAND_ID
362O9ITL9D UNII
1983 PUBCHEM_CID
4119 MMSL
4973 MMSL
4992 MMSL
5005 MMSL
52845 MMSL
97317 MMSL
d00049 MMSL
001605 NDDF
4017513 VANDF
D000082 MESH_DESCRIPTOR_UI
626 INN_ID
387517004 SNOMEDCT_US
90332006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 320 mg ORAL Unapproved drug other 17 sections
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime HUMAN OTC DRUG LABEL 3 0031-8744 CAPSULE, LIQUID FILLED 325 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Maximum Strength Severe Cough Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8750 LIQUID 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 650 mg ORAL OTC monograph final 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8771 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 17 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-0650 CAPSULE 300 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-3000 CAPSULE 325 mg ORAL ANDA 33 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-3686 SOLUTION 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-4650 TABLET 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8648 SOLUTION 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8650 TABLET 325 mg ORAL ANDA 23 sections
TheraFlu Cold and Flu HUMAN OTC DRUG LABEL 3 0067-0924 POWDER 325 mg ORAL Export only 10 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2000 TABLET, FILM COATED 250 mg ORAL OTC monograph not final 13 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2001 TABLET, FILM COATED 250 mg ORAL OTC monograph not final 15 sections
ExcedrinExtra Strength Geltabs HUMAN OTC DRUG LABEL 3 0067-2021 TABLET, COATED 250 mg ORAL OTC monograph not final 14 sections
ExcedrinMigraine Geltabs HUMAN OTC DRUG LABEL 3 0067-2035 TABLET, COATED 250 mg ORAL NDA 14 sections
EXCEDRINMIGRAINE HUMAN OTC DRUG LABEL 3 0067-2039 TABLET, FILM COATED 250 mg ORAL NDA 15 sections
ExcedrinMigraine HUMAN OTC DRUG LABEL 3 0067-2040 TABLET, FILM COATED 250 mg ORAL NDA 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 250 mg ORAL OTC monograph not final 16 sections
TherafluPowerPods Daytime Severe Cold HUMAN OTC DRUG LABEL 3 0067-6094 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUPOWERPODS NIGHTTIME SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUMULTI-SYMPTOM SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6426 POWDER, FOR SOLUTION 500 mg ORAL OTC monograph final 17 sections
TherafluFlu and Sore Throat HUMAN OTC DRUG LABEL 3 0067-7916 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections
TherafluDaytime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-7917 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUNIGHTTIME SEVERE COLD AND COUGH HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections
THERAFLUSINUS AND PAIN HUMAN OTC DRUG LABEL 3 0067-7920 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections
THERAFLUSINUS AND PAIN HUMAN OTC DRUG LABEL 3 0067-7920 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections