paracetamol 🐶 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 µM/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
Feb. 24, 2023 PMDA AYUMI PHARMACEUTICAL CORPORATION

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 2741.57 11.19 9119 955176 238131 62286596
Intentional overdose 1466.76 11.19 3383 960912 70769 62453958
Completed suicide 1320.18 11.19 5033 959262 140640 62384087
Acute hepatic failure 1187.64 11.19 1429 962866 16898 62507829
Overdose 1043.09 11.19 3977 960318 111101 62413626
Analgesic drug level increased 960.81 11.19 541 963754 1831 62522896
Drug ineffective 850.06 11.19 11000 953295 1033765 61490962
Hepatocellular injury 706.07 11.19 1392 962903 25989 62498738
Poisoning deliberate 565.01 11.19 772 963523 10446 62514281
Suicide attempt 563.71 11.19 2120 962175 58798 62465929
Exposure to toxic agent 557.29 11.19 547 963748 5040 62519687
Metabolic acidosis 458.82 11.19 1618 962677 43451 62481276
Injection site pain 360.86 11.19 907 963388 128893 62395834
Device expulsion 360.10 11.19 51 964244 34871 62489856
Product dose omission issue 320.31 11.19 2162 962133 232151 62292576
Cholestasis 309.34 11.19 1068 963227 28366 62496361
Infusion related reaction 306.40 11.19 5336 958959 240185 62284542
Intentional product misuse 305.74 11.19 1773 962522 59144 62465583
Blood pressure fluctuation 254.24 11.19 1381 962914 44936 62479791
Hepatic failure 242.88 11.19 1130 963165 34526 62490201
Drug hypersensitivity 232.55 11.19 3320 960975 307367 62217360
Injection site erythema 228.92 11.19 584 963711 82590 62442137
Hepatotoxicity 227.16 11.19 1139 963156 35902 62488825
Coma 217.91 11.19 1699 962596 62665 62462062
Hepatic cytolysis 211.41 11.19 613 963682 14794 62509933
Alopecia 209.44 11.19 3736 960559 333800 62190927
Somnolence 196.69 11.19 3809 960486 174876 62349851
Off label use 192.61 11.19 8332 955963 666130 61858597
Injection site reaction 192.11 11.19 373 963922 58151 62466576
Anion gap 184.43 11.19 156 964139 1161 62523566
Drug resistance 179.35 11.19 62 964233 22871 62501856
Sinusitis 177.13 11.19 4602 959693 222051 62302676
Coagulopathy 172.87 11.19 694 963601 19850 62504877
Therapeutic product effect incomplete 165.21 11.19 1165 963130 123891 62400836
Wrong technique in product usage process 162.97 11.19 449 963846 61891 62462836
Depressed level of consciousness 157.13 11.19 1537 962758 60541 62464186
Hospitalisation 148.97 11.19 724 963571 84357 62440370
Abdominal discomfort 148.43 11.19 3724 960571 317161 62207566
Treatment failure 145.93 11.19 2135 962160 196908 62327819
Lower respiratory tract infection 144.71 11.19 2818 961477 129489 62395238
International normalised ratio increased 142.77 11.19 1199 963096 45226 62479501
Cholecystitis chronic 141.93 11.19 412 963883 9949 62514778
Psoriasis 138.70 11.19 764 963531 86193 62438534
Confusional state 138.39 11.19 4630 959665 231750 62292977
Accidental overdose 137.48 11.19 709 963586 22600 62502127
Hepatitis 136.15 11.19 1053 963242 38735 62485992
Hepatitis acute 132.07 11.19 370 963925 8750 62515977
Systemic lupus erythematosus 131.76 11.19 2305 961990 206613 62318114
Body temperature increased 129.89 11.19 989 963306 36203 62488524
Injection site swelling 128.59 11.19 337 963958 47235 62477492
Injection site pruritus 126.27 11.19 314 963981 44802 62479925
Maternal exposure during pregnancy 121.48 11.19 2484 961811 217578 62307149
Pyroglutamate increased 117.73 11.19 77 964218 364 62524363
Prothrombin time shortened 117.04 11.19 148 964147 1847 62522880
Cardiac failure congestive 115.83 11.19 874 963421 91559 62433168
Medication error 114.51 11.19 1257 963038 51027 62473700
Hepatitis fulminant 114.40 11.19 196 964099 3268 62521459
Psoriatic arthropathy 114.39 11.19 866 963429 90654 62434073
Injection site bruising 113.96 11.19 296 963999 41614 62483113
Hepatitis cholestatic 113.66 11.19 293 964002 6585 62518142
Pemphigus 113.30 11.19 2035 962260 181691 62343036
Disease progression 113.29 11.19 1254 963041 121504 62403223
Muscle injury 112.55 11.19 1501 962794 63844 62460883
Folliculitis 108.10 11.19 1583 962712 68734 62455993
Pyroglutamic acidosis 107.46 11.19 84 964211 551 62524176
Therapeutic response decreased 106.85 11.19 525 963770 61000 62463727
Blood pressure diastolic abnormal 103.57 11.19 467 963828 14075 62510652
Respiratory depression 103.41 11.19 448 963847 13267 62511460
Irritable bowel syndrome 103.23 11.19 1793 962502 80619 62444108
Red blood cell sedimentation rate abnormal 101.99 11.19 90 964205 19692 62505035
Therapy cessation 101.80 11.19 192 964103 30265 62494462
Prothrombin time ratio decreased 101.66 11.19 76 964219 462 62524265
Vomiting 100.58 11.19 9834 954461 549783 61974944
Hepatic necrosis 99.96 11.19 248 964047 5439 62519288
Therapy interrupted 98.76 11.19 216 964079 32239 62492488
Oxygen saturation decreased 95.88 11.19 1884 962411 86701 62438026
Urine abnormality 95.08 11.19 278 964017 6741 62517986
Throat irritation 94.22 11.19 930 963365 36717 62488010
Condition aggravated 93.28 11.19 5076 959219 397141 62127586
Drug abuse 90.92 11.19 1578 962717 70940 62453787
Blood pressure systolic abnormal 88.78 11.19 421 963874 12965 62511762
Transaminases increased 88.55 11.19 795 963500 30572 62494155
Therapy non-responder 88.45 11.19 732 963563 75169 62449558
Miosis 88.14 11.19 279 964016 7074 62517653
Accidental exposure to product 87.91 11.19 177 964118 27228 62497499
Contraindicated product administered 86.50 11.19 2580 961715 215068 62309659
Acute generalised exanthematous pustulosis 86.34 11.19 366 963929 10733 62513994
Heart rate increased 85.08 11.19 1952 962343 92286 62432441
Blister 84.57 11.19 2576 961719 127238 62397489
Myelosuppression 84.08 11.19 144 964151 23559 62501168
Urine leukocyte esterase positive 82.81 11.19 174 964121 3405 62521322
Mixed liver injury 81.66 11.19 205 964090 4530 62520197
Diarrhoea 81.35 11.19 9570 954725 705796 61818931
Abdominal pain 81.32 11.19 5333 958962 288123 62236604
Blood pressure increased 77.38 11.19 3103 961192 158959 62365768
Heart rate decreased 76.17 11.19 1041 963254 44519 62480208
Malignant neoplasm progression 76.09 11.19 838 963457 81283 62443444
Hepatic encephalopathy 75.68 11.19 356 963939 10926 62513801
Blood parathyroid hormone decreased 75.65 11.19 27 964268 9764 62514963
Poisoning 74.83 11.19 408 963887 13292 62511435
Granuloma skin 74.82 11.19 18 964277 8419 62516308
Glossodynia 74.42 11.19 2107 962188 176769 62347958
Device dislocation 73.42 11.19 177 964118 25528 62499199
Urticaria 73.10 11.19 3148 961147 162654 62362073
Bone marrow failure 72.12 11.19 217 964078 29073 62495654
Alanine aminotransferase increased 71.87 11.19 2075 962220 101695 62423032
Blood pressure systolic increased 71.65 11.19 1064 963231 46333 62478394
Breast cancer stage I 71.16 11.19 10 964285 6879 62517848
Infusion site pain 70.19 11.19 468 963827 16401 62508326
Ill-defined disorder 69.98 11.19 1681 962614 80074 62444653
Surgery 69.78 11.19 294 964001 35618 62489109
Product use in unapproved indication 69.61 11.19 2129 962166 176951 62347776
Intentional self-injury 69.44 11.19 645 963650 25042 62499685
Bradypnoea 69.05 11.19 161 964134 3389 62521338
Lymphocyte count decreased 68.82 11.19 733 963562 29524 62495203
Toxic epidermal necrolysis 67.92 11.19 635 963660 24699 62500028
Device difficult to use 67.44 11.19 57 964238 12739 62511988
Transplant rejection 67.37 11.19 40 964255 10740 62513987
Neoplasm progression 66.08 11.19 306 963989 36122 62488605
Product storage error 65.79 11.19 78 964217 14878 62509849
Pyrexia 65.76 11.19 8133 956162 462345 62062382
Device malfunction 65.65 11.19 106 964189 17751 62506976
Hypocoagulable state 65.26 11.19 86 964209 1121 62523606
Infusion site extravasation 64.90 11.19 322 963973 10104 62514623
Ductus arteriosus premature closure 64.69 11.19 48 964247 288 62524439
Sleep disorder due to general medical condition, insomnia type 63.92 11.19 1132 963163 51085 62473642
Rheumatoid nodule 63.85 11.19 101 964194 17054 62507673
No adverse event 63.18 11.19 369 963926 41036 62483691
Prothrombin time prolonged 62.85 11.19 300 963995 9264 62515463
Myocardial infarction 62.30 11.19 1104 963191 98789 62425938
Injection site warmth 61.90 11.19 84 964211 15111 62509616
Drug intolerance 61.35 11.19 3952 960343 304709 62220018
Panniculitis 60.89 11.19 50 964245 11335 62513392
Unintentional medical device removal 60.59 11.19 10 964285 6105 62518622
Infusion site swelling 60.29 11.19 301 963994 9469 62515258
Haematotoxicity 59.71 11.19 34 964261 9342 62515385
Tachycardia 59.58 11.19 2276 962019 115880 62408847
Breast cancer female 59.34 11.19 71 964224 13488 62511239
Acute kidney injury 58.88 11.19 4705 959590 258710 62266017
Encephalopathy 58.78 11.19 868 963427 37752 62486975
White blood cells urine positive 58.46 11.19 192 964103 4966 62519761
Device issue 57.96 11.19 177 964118 23604 62501123
Nasopharyngitis 57.90 11.19 4548 959747 249709 62275018
Product prescribing error 56.98 11.19 206 964089 26083 62498644
Cardiac failure 56.93 11.19 981 963314 88161 62436566
Hypotension 56.91 11.19 4844 959451 267760 62256967
Cytomegalovirus infection 56.18 11.19 149 964146 20803 62503924
Blood pressure diastolic decreased 55.88 11.19 559 963736 22147 62502580
Post transplant lymphoproliferative disorder 55.15 11.19 6 964289 5025 62519702
Acute lung injury 54.68 11.19 91 964204 1480 62523247
Arthropathy 53.96 11.19 2965 961330 231827 62292900
Crystal urine present 53.85 11.19 93 964202 1561 62523166
Pruritus 53.16 11.19 6269 958026 355184 62169543
Cardio-respiratory arrest 52.26 11.19 1236 963059 58723 62466004
Abortion spontaneous 51.91 11.19 462 963833 46733 62477994
Urinary sediment present 50.85 11.19 107 964188 2096 62522631
Ear pain 50.82 11.19 801 963494 35317 62489410
Orthostatic hypotension 50.52 11.19 801 963494 35359 62489368
Diabetes mellitus 50.32 11.19 573 963722 55237 62469490
Palmar-plantar erythrodysaesthesia syndrome 50.11 11.19 180 964115 22835 62501892
Injection site haemorrhage 49.78 11.19 195 964100 24119 62500608
Drug-induced liver injury 49.60 11.19 873 963422 39349 62485378
Skin necrosis 49.25 11.19 85 964210 13865 62510862
Disturbance in social behaviour 48.63 11.19 3 964292 3990 62520737
Ear pruritus 48.03 11.19 151 964144 3814 62520913
Multiple-drug resistance 47.92 11.19 10 964285 5160 62519567
Product use issue 47.89 11.19 2800 961495 217720 62307007
Systemic infection 47.58 11.19 7 964288 4653 62520074
Acidosis 47.56 11.19 313 963982 10920 62513807
Infusion site erythema 47.38 11.19 322 963973 11357 62513370
Pathogen resistance 47.17 11.19 19 964276 6379 62518348
Respiratory arrest 47.08 11.19 727 963568 31918 62492809
Muscle spasticity 46.81 11.19 522 963773 21272 62503455
Unevaluable event 46.55 11.19 527 963768 50859 62473868
Gallbladder injury 46.31 11.19 80 964215 1343 62523384
Drug level increased 45.88 11.19 538 963757 22198 62502529
Renal papillary necrosis 45.61 11.19 36 964259 240 62524487
Full blood count abnormal 45.60 11.19 288 964007 31429 62493298
Interstitial lung disease 45.32 11.19 664 963631 61244 62463483
Genital haemorrhage 44.71 11.19 28 964267 7304 62517423
Injection site rash 44.43 11.19 142 964153 18667 62506060
Metastases to liver 44.41 11.19 196 964099 23443 62501284
Loss of personal independence in daily activities 44.35 11.19 1131 963164 96159 62428568
Device use error 44.32 11.19 16 964279 5745 62518982
Renal impairment 44.15 11.19 1013 963282 87342 62437385
Fixed eruption 44.01 11.19 70 964225 1094 62523633
Posterior reversible encephalopathy syndrome 43.79 11.19 127 964168 17218 62507509
Blood pressure diastolic increased 43.65 11.19 281 964014 9729 62514998
Chills 43.51 11.19 2123 962172 111255 62413472
Red blood cells urine positive 43.49 11.19 125 964170 3001 62521726
Cholelithiasis 42.83 11.19 920 963375 43005 62481722
Infusion site pruritus 42.37 11.19 193 964102 5842 62518885
Rash maculo-papular 42.12 11.19 700 963595 31196 62493531
Creatinine renal clearance decreased 41.84 11.19 405 963890 15903 62508824
Red blood cell sedimentation rate 41.80 11.19 11 964284 4843 62519884
Drug ineffective for unapproved indication 41.75 11.19 324 963971 33739 62490988
Blood iron abnormal 41.54 11.19 5 964290 3871 62520856
Brain oedema 41.21 11.19 362 963933 13833 62510894
Underdose 41.19 11.19 246 964049 27210 62497517
Hypertransaminasaemia 41.05 11.19 204 964091 6405 62518322
Poor venous access 40.85 11.19 373 963922 14412 62510315
Injection site mass 40.55 11.19 146 964149 18510 62506217
Rheumatoid arthritis 40.50 11.19 4426 959869 249393 62275334
Injection site urticaria 40.12 11.19 97 964198 13976 62510751
Myelodysplastic syndrome 39.91 11.19 126 964169 16628 62508099
Oligohydramnios 39.90 11.19 197 964098 6169 62518558
Gamma-glutamyltransferase increased 38.93 11.19 730 963565 33301 62491426
Drug abuser 38.85 11.19 115 964180 2808 62521919
Premature delivery 38.55 11.19 285 964010 29996 62494731
Metastases to bone 38.45 11.19 176 964119 20843 62503884
Sedation complication 38.33 11.19 349 963946 13473 62511254
Anion gap abnormal 38.30 11.19 39 964256 377 62524350
Bone erosion 38.28 11.19 139 964156 17578 62507149
Drug dose omission by device 37.50 11.19 13 964282 4788 62519939
Product monitoring error 37.46 11.19 11 964284 4505 62520222
Stevens-Johnson syndrome 37.28 11.19 559 963736 24391 62500336
Sensitisation 37.21 11.19 4 964291 3382 62521345
Analgesic drug level above therapeutic 37.17 11.19 27 964268 156 62524571
Lupus-like syndrome 37.16 11.19 114 964181 15181 62509546
Metastases to lung 37.04 11.19 87 964208 12663 62512064
Respiratory rate increased 36.54 11.19 342 963953 13306 62511421
Abortion incomplete 36.27 11.19 3 964292 3128 62521599
Liver transplant 36.22 11.19 96 964199 2195 62522532
Jaundice 36.10 11.19 635 963660 28616 62496111
Anaemia 35.95 11.19 3904 960391 289526 62235201
Impaired healing 35.84 11.19 1903 962392 100639 62424088
Injection site induration 35.60 11.19 53 964242 9173 62515554
Second primary malignancy 35.50 11.19 41 964254 7912 62516815
Emotional distress 35.45 11.19 693 963602 31856 62492871
Basal cell carcinoma 35.37 11.19 264 964031 27727 62497000
Transplant dysfunction 35.06 11.19 15 964280 4857 62519870
Cardiotoxicity 35.03 11.19 46 964249 8392 62516335
Hepatitis toxic 35.01 11.19 119 964176 3134 62521593
Hypothermia 34.71 11.19 337 963958 13244 62511483
C-reactive protein abnormal 34.58 11.19 492 963803 45604 62479123
Exposure via ingestion 34.52 11.19 110 964185 2799 62521928
Blood alkaline phosphatase increased 33.94 11.19 874 963421 42093 62482634
Product substitution issue 33.58 11.19 127 964168 15869 62508858
Blood urine present 33.31 11.19 363 963932 14706 62510021
Thrombotic microangiopathy 33.20 11.19 69 964226 10492 62514235
Foot deformity 33.18 11.19 267 964028 27586 62497141
Adverse event 33.07 11.19 777 963518 66782 62457945
Abdominal pain upper 32.93 11.19 3600 960695 202844 62321883
Lymphocyte percentage decreased 32.84 11.19 110 964185 2875 62521852
White blood cell count decreased 32.79 11.19 1752 962543 137352 62387375
Injury 32.76 11.19 1393 962902 71854 62452873
Mydriasis 32.71 11.19 301 963994 11655 62513072
Neuropathy peripheral 32.65 11.19 1402 962893 112265 62412462
Coagulation factor V level decreased 32.50 11.19 32 964263 296 62524431
Bronchial secretion retention 32.13 11.19 104 964191 2669 62522058
Aspartate aminotransferase increased 31.87 11.19 1677 962618 88600 62436127
Haemoglobin urine present 31.82 11.19 50 964245 773 62523954
Complication of device insertion 31.64 11.19 41 964254 7523 62517204
Blood calcium decreased 31.51 11.19 571 963724 25880 62498847
Musculoskeletal disorder 31.48 11.19 184 964111 20460 62504267
Wrong patient received product 31.43 11.19 89 964206 2118 62522609
Unresponsive to stimuli 31.30 11.19 703 963592 33113 62491614
Hypothyroidism 31.29 11.19 457 963838 42175 62482552
Product quality issue 31.25 11.19 371 963924 35494 62489233
Dyspnoea exertional 30.79 11.19 689 963606 59613 62465114
Osteonecrosis 30.69 11.19 232 964063 24298 62500429
Complication associated with device 30.56 11.19 143 964152 16835 62507892
Jaundice cholestatic 30.35 11.19 203 964092 7121 62517606
Blood glucose increased 30.28 11.19 1005 963290 82751 62441976
Gastrointestinal disorder 30.23 11.19 2350 961945 128889 62395838
Toxic skin eruption 30.17 11.19 314 963981 12571 62512156
Anosognosia 30.00 11.19 6 964289 3190 62521537
Congenital pulmonary hypertension 29.79 11.19 16 964279 48 62524679
Blood bilirubin increased 29.78 11.19 757 963538 36383 62488344
Chest discomfort 29.76 11.19 1995 962300 107974 62416753
Labelled drug-drug interaction medication error 29.70 11.19 104 964191 13295 62511432
Platelet count decreased 29.38 11.19 1452 962843 114670 62410057
Meningitis aseptic 29.34 11.19 148 964147 4675 62520052
Brain death 29.33 11.19 116 964179 3294 62521433
Electric shock 29.18 11.19 63 964232 1257 62523470
Temperature regulation disorder 29.15 11.19 176 964119 5956 62518771
Urine ketone body present 29.11 11.19 94 964201 2409 62522318
Pulmonary arterial hypertension 28.97 11.19 212 964083 22365 62502362
Infusion site bruising 28.75 11.19 125 964170 3707 62521020
Neutropenia 28.64 11.19 2278 962017 172727 62352000
Device breakage 28.06 11.19 86 964209 11456 62513271
Coagulation factor VII level decreased 28.02 11.19 18 964277 82 62524645
Adverse drug reaction 28.00 11.19 960 963335 78754 62445973
Visceral congestion 27.95 11.19 30 964265 310 62524417
Ovarian hyperstimulation syndrome 27.88 11.19 13 964282 4001 62520726
Urine analysis abnormal 27.81 11.19 150 964145 4866 62519861
Biliary dyskinesia 27.78 11.19 98 964197 2631 62522096
Mucormycosis 27.78 11.19 5 964290 2866 62521861
Type I hypersensitivity 27.70 11.19 103 964192 2839 62521888
Cytokine release syndrome 27.69 11.19 336 963959 13978 62510749
Therapy partial responder 27.67 11.19 77 964218 10581 62514146
Cerebral haematoma 27.53 11.19 120 964175 3563 62521164
Femur fracture 27.47 11.19 457 963838 41299 62483428
Bradycardia 27.42 11.19 1368 962927 71859 62452868
Haemophagocytic lymphohistiocytosis 27.42 11.19 77 964218 10550 62514177
Medication overuse headache 27.37 11.19 47 964248 785 62523942
Red cell distribution width increased 27.32 11.19 262 964033 10262 62514465
Memory impairment 27.29 11.19 1299 962996 102959 62421768
Liver function test abnormal 27.18 11.19 940 963355 47241 62477486
Eosinophilia 27.02 11.19 491 963804 22265 62502462
Cell death 26.99 11.19 94 964201 2507 62522220
Complication of device removal 26.98 11.19 23 964272 5119 62519608
Anion gap increased 26.90 11.19 76 964219 1806 62522921
Hyperthermia 26.84 11.19 234 964061 8922 62515805
Chronic graft versus host disease 26.77 11.19 7 964288 3095 62521632
Weight fluctuation 26.76 11.19 247 964048 9572 62515155
Breast cancer stage II 26.69 11.19 58 964237 8678 62516049
Back pain 26.64 11.19 4482 959813 259663 62265064
Colorectal cancer 26.59 11.19 11 964284 3634 62521093
Respiratory disorder 26.36 11.19 779 963516 38303 62486424
Sexual dysfunction 26.10 11.19 17 964278 4342 62520385
Diabetic ketoacidosis 26.09 11.19 193 964102 20312 62504415
Breast cancer 26.09 11.19 548 963747 47835 62476892
Neutrophil percentage increased 26.03 11.19 101 964194 2842 62521885
Polycystic ovaries 26.01 11.19 18 964277 4453 62520274
Cerebrovascular accident 25.93 11.19 1358 962937 106666 62418061
Fear of injection 25.89 11.19 43 964252 7121 62517606
Knee arthroplasty 25.82 11.19 626 963669 53580 62471147
Gallbladder disorder 25.80 11.19 416 963879 18426 62506301
Heart rate irregular 25.66 11.19 481 963814 21940 62502787
Neurotoxicity 25.61 11.19 152 964143 16838 62507889
Osteonecrosis of jaw 25.60 11.19 377 963918 34746 62489981
Substance abuse 25.48 11.19 142 964153 4665 62520062
Duodenal ulcer perforation 25.38 11.19 1592 962703 85617 62439110
Hepatitis B reactivation 25.37 11.19 8 964287 3129 62521598
Disease recurrence 25.18 11.19 288 964007 27742 62496985
Incorrect drug administration rate 25.11 11.19 123 964172 3839 62520888
Hypertensive crisis 25.08 11.19 133 964162 15153 62509574
Body temperature fluctuation 24.96 11.19 84 964211 2201 62522526
Drug use disorder 24.95 11.19 145 964150 4839 62519888
Flushing 24.95 11.19 1387 962908 73700 62451027
Subacute cutaneous lupus erythematosus 24.73 11.19 5 964290 2638 62522089
Intentional product use issue 24.55 11.19 2259 962036 125633 62399094
Prothrombin level increased 24.53 11.19 25 964270 242 62524485
Unintended pregnancy 24.33 11.19 35 964260 6144 62518583
Drug eruption 24.17 11.19 299 963996 28395 62496332
Mucosal inflammation 24.01 11.19 536 963759 46392 62478335
Helicobacter infection 24.00 11.19 1677 962618 91108 62433619
Hypercalcaemia 23.90 11.19 295 964000 28027 62496700
Culture urine positive 23.75 11.19 115 964180 3572 62521155
Stomatitis 23.64 11.19 2430 961865 136295 62388432
Brain stem glioma 23.38 11.19 21 964274 171 62524556
Anaphylactic reaction 23.35 11.19 1228 963067 64872 62459855
Varicella zoster virus infection 23.34 11.19 6 964289 2683 62522044
Musculoskeletal stiffness 23.29 11.19 2451 961844 182167 62342560
Feeling abnormal 23.14 11.19 1939 962356 146453 62378274
Product administration error 23.10 11.19 473 963822 21924 62502803
Joint destruction 23.09 11.19 37 964258 6215 62518512
Sputum culture positive 23.09 11.19 79 964216 2088 62522639
Arthritis 23.01 11.19 1484 962811 114437 62410290
Acute graft versus host disease 23 11.19 20 964275 4408 62520319
Hyperglycaemia 22.93 11.19 473 963822 41394 62483333
Forced expiratory volume decreased 22.84 11.19 25 964270 4943 62519784
Lymphoproliferative disorder 22.67 11.19 10 964285 3180 62521547
Cholestatic liver injury 22.62 11.19 89 964206 2521 62522206
Diffuse large B-cell lymphoma recurrent 22.53 11.19 4 964291 2316 62522411
Graft versus host disease in skin 22.46 11.19 8 964287 2897 62521830
Oedema 22.35 11.19 1233 963062 96389 62428338
Foot operation 22.10 11.19 48 964247 7183 62517544
Pulmonary hypertension 21.97 11.19 414 963881 36709 62488018
Neoplasm malignant 21.95 11.19 320 963975 29541 62495186
Prothrombin level decreased 21.91 11.19 36 964259 579 62524148
Exposure during pregnancy 21.84 11.19 2049 962246 153498 62371229
Enthesopathy 21.80 11.19 63 964232 8551 62516176
Blood immunoglobulin E increased 21.73 11.19 16 964279 3833 62520894
Rheumatoid lung 21.72 11.19 16 964279 3832 62520895
Abortion induced 21.70 11.19 81 964214 10161 62514566
Specific gravity urine decreased 21.67 11.19 41 964254 741 62523986
Injection site discolouration 21.66 11.19 55 964240 7793 62516934
Cognitive disorder 21.58 11.19 1046 963249 54769 62469958
Pain 21.47 11.19 10565 953730 730063 61794664
Schizoaffective disorder 21.46 11.19 109 964186 3453 62521274
Neutropenic sepsis 21.43 11.19 360 963935 16078 62508649
Acute graft versus host disease in skin 21.30 11.19 13 964282 3439 62521288
Joint stiffness 21.20 11.19 479 963816 41390 62483337
Metastases to lymph nodes 21.13 11.19 59 964236 8099 62516628
Infusion site haemorrhage 21.10 11.19 141 964154 4945 62519782
Hypoprothrombinaemia 21.03 11.19 24 964271 267 62524460
Septic shock 21.01 11.19 813 963482 65816 62458911
Tardive dyskinesia 20.92 11.19 63 964232 8439 62516288
Coma scale abnormal 20.86 11.19 142 964153 5011 62519716
Night sweats 20.86 11.19 924 963371 47890 62476837
Right ventricular failure 20.82 11.19 164 964131 17024 62507703
Dizziness 20.74 11.19 6018 958277 423907 62100820
Osteoporosis 20.72 11.19 688 963607 56650 62468077
Product preparation error 20.71 11.19 38 964257 6054 62518673
Joint dislocation 20.69 11.19 184 964111 18616 62506111
Angioedema 20.51 11.19 908 963387 47057 62477670
Product adhesion issue 20.34 11.19 25 964270 4694 62520033
Drug reaction with eosinophilia and systemic symptoms 20.32 11.19 665 963630 33171 62491556
Superinfection 20.30 11.19 86 964209 2521 62522206
Akathisia 20.26 11.19 71 964224 9075 62515652
Device leakage 20.16 11.19 49 964246 7047 62517680
Decreased appetite 20.10 11.19 3429 960866 247623 62277104
Biliary sepsis 20.09 11.19 44 964251 887 62523840
Human herpesvirus 6 infection 19.89 11.19 10 964285 2947 62521780
Aspergillus infection 19.89 11.19 60 964235 8033 62516694
Device deployment issue 19.82 11.19 18 964277 3884 62520843
Infusion site rash 19.78 11.19 71 964224 1923 62522804
Renal failure neonatal 19.78 11.19 19 964276 170 62524557
Hepatic enzyme increased 19.71 11.19 3427 960868 198901 62325826
Seizure 19.65 11.19 1740 962555 130894 62393833
Weight increased 19.54 11.19 4360 959935 256432 62268295
Cytomegalovirus viraemia 19.42 11.19 35 964260 5614 62519113
Bacterial test 19.39 11.19 50 964245 1124 62523603
Respiratory acidosis 19.36 11.19 171 964124 6544 62518183
Leukopenia 19.24 11.19 968 963327 76322 62448405
Infectious thyroiditis 19.21 11.19 9 964286 18 62524709
Glutathione decreased 19.10 11.19 10 964285 28 62524699
Drug screen positive 19.10 11.19 107 964188 3522 62521205
Hyperleukocytosis 19.06 11.19 36 964259 650 62524077
Respiratory failure 19.03 11.19 1311 962984 100547 62424180
JC virus infection 18.94 11.19 4 964291 2047 62522680
Endophthalmitis 18.93 11.19 16 964279 3576 62521151
Graft versus host disease in gastrointestinal tract 18.92 11.19 13 964282 3228 62521499
Anticholinergic syndrome 18.88 11.19 79 964216 2303 62522424
Epstein-Barr virus infection 18.85 11.19 61 964234 7989 62516738
Vitamin K deficiency 18.80 11.19 28 964267 412 62524315
Incorrect dose administered by device 18.78 11.19 23 964272 4325 62520402
Hyperbilirubinaemia 18.69 11.19 258 964037 11056 62513671
Glycosylated haemoglobin increased 18.64 11.19 111 964184 12287 62512440
Virologic failure 18.55 11.19 3 964292 1859 62522868
Vital capacity decreased 18.41 11.19 63 964232 1665 62523062
Infusion site discomfort 18.38 11.19 56 964239 1390 62523337
Congenital tricuspid valve incompetence 18.37 11.19 14 964281 88 62524639
Hyponatraemia 18.33 11.19 1955 962340 109945 62414782
Chronic kidney disease 18.28 11.19 537 963758 44861 62479866
Lip oedema 18.26 11.19 112 964183 3812 62520915
Ductus arteriosus stenosis foetal 18.24 11.19 18 964277 167 62524560
Cholesterosis 18.09 11.19 28 964267 427 62524300
Pregnancy with contraceptive device 18.08 11.19 27 964268 4667 62520060
Administration site pain 18.02 11.19 40 964255 814 62523913
Administration site swelling 17.93 11.19 52 964243 1255 62523472
Galactorrhoea 17.93 11.19 22 964273 4133 62520594
Cytopenia 17.90 11.19 103 964192 11498 62513229
Nasal necrosis 17.89 11.19 14 964281 92 62524635
Visual acuity reduced 17.80 11.19 229 964066 21597 62503130
Self-medication 17.67 11.19 86 964209 2677 62522050
Haemorrhage 17.65 11.19 752 963543 60270 62464457
Acute myeloid leukaemia 17.50 11.19 171 964124 16976 62507751
Graft versus host disease 17.45 11.19 49 964246 6714 62518013
Full blood count decreased 17.39 11.19 284 964011 25740 62498987
Pneumonia 17.38 11.19 6454 957841 450313 62074414
Posturing 17.37 11.19 29 964266 473 62524254
Specific gravity urine increased 17.36 11.19 19 964276 201 62524526
Injury associated with device 17.36 11.19 18 964277 3648 62521079
Cholecystitis acute 17.36 11.19 197 964098 8063 62516664
Laboratory test abnormal 17.22 11.19 296 963999 26616 62498111
Blood copper decreased 17.20 11.19 7 964288 8 62524719
Hand deformity 17.12 11.19 2140 962155 157317 62367410
Creatinine urine decreased 17.07 11.19 18 964277 182 62524545
Product tampering 17.01 11.19 26 964269 392 62524335
Myopathy 16.93 11.19 100 964195 11091 62513636
Hip arthroplasty 16.91 11.19 573 963722 47073 62477654
Periorbital cellulitis 16.89 11.19 35 964260 678 62524049
Upper gastrointestinal haemorrhage 16.85 11.19 390 963905 18462 62506265
Sensitivity to weather change 16.84 11.19 55 964240 7182 62517545
Hepatic cirrhosis 16.83 11.19 269 964026 24465 62500262
Coagulation factor V level increased 16.83 11.19 6 964289 3 62524724
Coronary artery disease 16.79 11.19 369 963926 32008 62492719
Pneumocystis jirovecii pneumonia 16.71 11.19 170 964125 16744 62507983
Renal disorder 16.48 11.19 378 963917 32596 62492131
Cardiomyopathy 16.45 11.19 179 964116 17405 62507322
Suspected suicide 16.31 11.19 162 964133 6406 62518321
Gait disturbance 16.29 11.19 2487 961808 180691 62344036
Polyomavirus-associated nephropathy 16.28 11.19 4 964291 1844 62522883
Cardiac disorder 16.25 11.19 619 963676 50197 62474530
Gastrooesophageal reflux disease 16.24 11.19 1241 963054 94398 62430329
Macular oedema 16.23 11.19 21 964274 3856 62520871
Nitrite urine present 16.18 11.19 44 964251 1022 62523705
Device use issue 16.10 11.19 10 964285 2620 62522107
Ascites 16.09 11.19 483 963812 40245 62484482
Oedema peripheral 16.07 11.19 2580 961715 186931 62337796
Abnormal clotting factor 16.07 11.19 14 964281 109 62524618
Hallucination 16.00 11.19 1001 963294 53816 62470911
Truncus coeliacus thrombosis 15.97 11.19 7 964288 11 62524716
Delirium 15.90 11.19 929 963366 49612 62475115
Blood creatinine decreased 15.88 11.19 141 964154 5404 62519323
Syncope 15.81 11.19 1551 962744 115834 62408893
Blood lactic acid increased 15.80 11.19 171 964124 6915 62517812
Coagulation factor X level decreased 15.80 11.19 12 964283 75 62524652
General physical health deterioration 15.78 11.19 2754 961541 198648 62326079
Dependence 15.78 11.19 68 964227 2009 62522718
Bacterial test positive 15.75 11.19 136 964159 5171 62519556
Caesarean section 15.69 11.19 174 964121 16858 62507869
Diffuse axonal injury 15.66 11.19 13 964282 94 62524633
Cerebral infarction 15.55 11.19 262 964033 23631 62501096
Fluid retention 15.54 11.19 744 963551 58942 62465785
Splenic vein thrombosis 15.50 11.19 22 964273 309 62524418
Lethargy 15.49 11.19 1018 963277 54989 62469738
Blood pH decreased 15.47 11.19 79 964216 2508 62522219
Fracture 15.41 11.19 207 964088 19377 62505350
Body temperature decreased 15.37 11.19 411 963884 19908 62504819
Bladder cancer 15.37 11.19 39 964256 5527 62519200
Hyperlipidaemia 15.35 11.19 207 964088 19364 62505363
Food allergy 15.34 11.19 251 964044 11150 62513577
Blood phosphorus decreased 15.31 11.19 118 964177 4335 62520392
Acute haemorrhagic oedema of infancy 15.27 11.19 7 964288 13 62524714
Fatigue 15.24 11.19 12856 951439 875172 61649555
Peptic ulcer haemorrhage 15.14 11.19 43 964252 1025 62523702
Impaired work ability 15.13 11.19 181 964114 17294 62507433
Asphyxia 15.13 11.19 152 964143 6029 62518698
Kidney transplant rejection 15.10 11.19 26 964269 4245 62520482
Gallbladder cholesterolosis 15.07 11.19 36 964259 770 62523957
Cytomegalovirus infection reactivation 15.07 11.19 23 964272 3940 62520787
Rash pruritic 15.06 11.19 748 963547 59051 62465676
Immune reconstitution inflammatory syndrome 15.03 11.19 45 964250 6039 62518688
Liver injury 14.98 11.19 1090 963205 59430 62465297
Inadequate analgesia 14.98 11.19 86 964209 2857 62521870
Sedation 14.94 11.19 727 963568 38082 62486645
Intervertebral discitis 14.93 11.19 92 964203 3136 62521591
Body tinea 14.91 11.19 5 964290 1880 62522847
Pancytopenia 14.75 11.19 1269 963026 95664 62429063
Osmolar gap 14.74 11.19 13 964282 103 62524624
Leukocyturia 14.72 11.19 52 964243 1397 62523330
Post cholecystectomy syndrome 14.71 11.19 25 964270 414 62524313
Foetal exposure during pregnancy 14.71 11.19 371 963924 31591 62493136
Allodynia 14.70 11.19 36 964259 783 62523944
Bladder dilatation 14.67 11.19 37 964258 820 62523907
Agranulocytosis 14.59 11.19 492 963803 24642 62500085
Anticipatory anxiety 14.57 11.19 47 964248 1204 62523523
Depression 14.55 11.19 2695 961600 193797 62330930
Pancreatic fibrosis 14.53 11.19 12 964283 86 62524641
Skin ulcer 14.51 11.19 521 963774 42524 62482203
Loss of employment 14.49 11.19 8 964287 2236 62522491
Hyperprolactinaemia 14.48 11.19 23 964272 3877 62520850
Rash erythematous 14.46 11.19 787 963508 41723 62483004
Gallbladder adenocarcinoma 14.46 11.19 13 964282 106 62524621
Haematochezia 14.43 11.19 665 963630 52879 62471848
Dilatation intrahepatic duct acquired 14.33 11.19 32 964263 654 62524073
Therapy change 14.30 11.19 46 964249 6035 62518692
Biliary colic 14.24 11.19 99 964196 3518 62521209
Acute myocardial infarction 14.22 11.19 375 963920 31749 62492978
Hepatectomy 14.21 11.19 11 964284 71 62524656
Eosinophil percentage increased 14.17 11.19 41 964254 988 62523739
Disability 14.05 11.19 195 964100 18152 62506575
Stoma site cellulitis 14.01 11.19 9 964286 41 62524686
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.99 11.19 14 964281 2885 62521842
Vasoplegia syndrome 13.98 11.19 57 964238 1642 62523085
Gene mutation 13.91 11.19 4 964291 1661 62523066
Spleen congestion 13.91 11.19 13 964282 112 62524615
Migraine with aura 13.90 11.19 80 964215 2660 62522067
Open globe injury 13.85 11.19 9 964286 42 62524685
Renal cancer 13.84 11.19 41 964254 5521 62519206
Vulvar erosion 13.82 11.19 16 964279 181 62524546
Autonomic dysreflexia 13.81 11.19 21 964274 315 62524412
Cholangitis acute 13.80 11.19 27 964268 501 62524226
Red blood cell sedimentation rate increased 13.79 11.19 537 963758 43445 62481282
Reversible airways obstruction 13.76 11.19 60 964235 1782 62522945
Bacterial disease carrier 13.72 11.19 48 964247 1283 62523444
Deep vein thrombosis 13.71 11.19 1464 962831 82336 62442391
Treatment noncompliance 13.69 11.19 447 963848 36878 62487849
Victim of chemical submission 13.65 11.19 27 964268 505 62524222
Shoulder arthroplasty 13.57 11.19 25 964270 3977 62520750
Lupus vasculitis 13.56 11.19 28 964267 541 62524186
Sleep disorder due to a general medical condition 13.54 11.19 119 964176 12069 62512658
Tenosynovitis 13.49 11.19 139 964156 13656 62511071
BK virus infection 13.49 11.19 18 964277 3261 62521466
Pulmonary embolism 13.47 11.19 1995 962300 114689 62410038
Obstructive airways disorder 13.46 11.19 227 964068 20472 62504255
Impaired quality of life 13.42 11.19 139 964156 13644 62511083
Dyspnoea at rest 13.38 11.19 26 964269 4053 62520674
Ventricular tachycardia 13.36 11.19 218 964077 19761 62504966
Cyanosis neonatal 13.32 11.19 23 964272 386 62524341
Coronary arterial stent insertion 13.27 11.19 14 964281 2815 62521912
Granuloma 13.25 11.19 44 964251 5717 62519010
Amenorrhoea 13.25 11.19 92 964203 9822 62514905
Gestational diabetes 13.25 11.19 74 964221 8322 62516405
Injection site haematoma 13.23 11.19 56 964239 6776 62517951
Obesity 13.16 11.19 350 963945 29602 62495125
Accidental exposure to product by child 13.16 11.19 44 964251 1149 62523578
Breast cancer recurrent 13.12 11.19 29 964266 4312 62520415
Oropharyngeal pain 13.08 11.19 1633 962662 92854 62431873
Sinus tachycardia 13.07 11.19 471 963824 23797 62500930
Coma hepatic 13.01 11.19 31 964264 662 62524065
Eye irritation 13.00 11.19 245 964050 21726 62503001
Arthrodesis 12.98 11.19 14 964281 2787 62521940
Renal tubular necrosis 12.97 11.19 253 964042 11625 62513102
Infusion site mass 12.96 11.19 64 964231 2004 62522723
Throat tightness 12.92 11.19 481 963814 24406 62500321
Secretion discharge 12.90 11.19 121 964174 12110 62512617
Metastases to central nervous system 12.83 11.19 132 964163 12973 62511754
Nocardiosis 12.82 11.19 7 964288 1969 62522758
Analgesic drug level therapeutic 12.81 11.19 4 964291 0 62524727
Fibrin D dimer decreased 12.81 11.19 4 964291 0 62524727
Blood thyroid stimulating hormone decreased 12.78 11.19 116 964179 4474 62520253
Pneumonia streptococcal 12.78 11.19 58 964237 1753 62522974
Agitation 12.77 11.19 1064 963231 58693 62466034
Transverse sinus thrombosis 12.76 11.19 27 964268 531 62524196
Pancreatic carcinoma 12.72 11.19 66 964229 7562 62517165
Eosinophil count increased 12.70 11.19 235 964060 10693 62514034
Ecchymosis 12.69 11.19 238 964057 10856 62513871
Polyneuropathy 12.68 11.19 151 964144 14438 62510289
Administration site bruise 12.64 11.19 23 964272 403 62524324
Dermatitis atopic 12.63 11.19 91 964204 9633 62515094
Haematoma muscle 12.60 11.19 42 964253 1095 62523632
Atelectasis 12.58 11.19 421 963874 21062 62503665
Exostosis 12.58 11.19 193 964102 17669 62507058
Lung neoplasm malignant 12.55 11.19 216 964079 19417 62505310
Libido disorder 12.52 11.19 9 964286 51 62524676
Dose calculation error 12.52 11.19 14 964281 152 62524575
Thrombosis 12.50 11.19 831 963464 63924 62460803
Pleural fibrosis 12.50 11.19 93 964202 3379 62521348
Retinitis 12.49 11.19 50 964245 6146 62518581
Physical disability 12.45 11.19 14 964281 2734 62521993
Hypomania 12.42 11.19 149 964146 6181 62518546
Neutrophil count increased 12.42 11.19 334 963961 16193 62508534
Dry skin 12.38 11.19 722 963573 56165 62468562
Vaccination site swelling 12.36 11.19 8 964287 37 62524690
Cardiac steatosis 12.36 11.19 8 964287 37 62524690
Coagulation factor decreased 12.30 11.19 11 964284 89 62524638
Stent placement 12.26 11.19 24 964271 3731 62520996
Gingival hypertrophy 12.26 11.19 5 964290 1666 62523061
Intestinal pseudo-obstruction 12.24 11.19 36 964259 876 62523851
Infusion site nodule 12.23 11.19 50 964245 1442 62523285
Aspartate aminotransferase 12.22 11.19 23 964272 414 62524313
Toxicologic test abnormal 12.21 11.19 31 964264 690 62524037
Metabolic disorder 12.17 11.19 54 964241 6449 62518278
Thyroid cancer 12.14 11.19 44 964251 5567 62519160
Gallbladder hypofunction 12.11 11.19 27 964268 551 62524176
Cystitis haemorrhagic 12.09 11.19 28 964267 4095 62520632
Dysphoria 12.07 11.19 37 964258 4929 62519798
Balance disorder 12.07 11.19 1462 962833 82960 62441767
Asthma 12.01 11.19 1726 962569 125835 62398892
Headache 11.91 11.19 10098 954197 623143 61901584
Hepatitis B 11.90 11.19 25 964270 3787 62520940
Congestive hepatopathy 11.87 11.19 81 964214 2861 62521866
Toxic shock syndrome streptococcal 11.86 11.19 12 964283 115 62524612
Myocardial fibrosis 11.85 11.19 32 964263 740 62523987
Tonsillar inflammation 11.84 11.19 11 964284 94 62524633
Hypocalcaemia 11.82 11.19 379 963916 31334 62493393
Face oedema 11.82 11.19 396 963899 19816 62504911
Infusion site irritation 11.81 11.19 36 964259 894 62523833
Blood prolactin increased 11.78 11.19 22 964273 3481 62521246
Mediastinal abscess 11.76 11.19 7 964288 27 62524700
Oral pruritus 11.69 11.19 67 964228 2224 62522503
Serum sickness 11.69 11.19 79 964216 2781 62521946
Catheter management 11.68 11.19 17 964278 2970 62521757
Acute myeloid leukaemia recurrent 11.67 11.19 5 964290 1618 62523109
Death 11.66 11.19 5327 958968 369054 62155673
Bone density decreased 11.66 11.19 154 964141 14458 62510269
Adverse reaction 11.61 11.19 99 964196 10104 62514623
Red blood cell spherocytes present 11.58 11.19 7 964288 28 62524699
Breast cancer stage IV 11.55 11.19 8 964287 1978 62522749
Muscle spasms 11.53 11.19 2142 962153 154008 62370719
Pregnancy 11.49 11.19 450 963845 36386 62488341
Bursitis 11.49 11.19 680 963615 36361 62488366
Haemolysis 11.45 11.19 155 964140 6613 62518114
Foetal heart rate abnormal 11.43 11.19 28 964267 609 62524118
Lip infection 11.40 11.19 12 964283 121 62524606
Congenital central hypoventilation syndrome 11.39 11.19 7 964288 29 62524698
SJS-TEN overlap 11.39 11.19 21 964274 372 62524355
Hernial eventration 11.36 11.19 5 964290 8 62524719
Normal newborn 11.35 11.19 77 964218 8264 62516463
Multiple allergies 11.26 11.19 282 964013 13520 62511207
Intentional dose omission 11.26 11.19 74 964221 8001 62516726
Visual impairment 11.20 11.19 1117 963178 83329 62441398

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 1113.55 11.72 5286 441593 195076 34314976
Drug ineffective 717.51 11.72 3208 443671 453543 34056509
Intentional overdose 603.40 11.72 1561 445318 42113 34467939
Overdose 579.30 11.72 2503 444376 88556 34421496
Infusion related reaction 565.62 11.72 1726 445153 51331 34458721
Acute hepatic failure 550.30 11.72 784 446095 13290 34496762
Completed suicide 453.00 11.72 2461 444418 95707 34414345
Hepatocellular injury 395.24 11.72 876 446003 21335 34488717
Analgesic drug level increased 392.11 11.72 200 446679 656 34509396
Exposure to toxic agent 299.57 11.72 298 446581 3377 34506675
Poisoning deliberate 210.82 11.72 368 446511 7476 34502576
Blood pressure fluctuation 207.86 11.72 753 446126 24496 34485556
Drug resistance 198.69 11.72 44 446835 25883 34484169
Product dose omission issue 182.24 11.72 848 446031 118863 34391189
Intentional product misuse 177.17 11.72 1093 445786 44518 34465534
Treatment failure 171.95 11.72 206 446673 46491 34463561
Suicide attempt 167.73 11.72 962 445917 38154 34471898
Cholestasis 156.16 11.72 721 446158 26227 34483825
Accidental overdose 152.71 11.72 585 446294 19555 34490497
Liver injury 138.31 11.72 462 446417 14416 34495636
Chills 137.04 11.72 1612 445267 79431 34430621
Hepatic cytolysis 131.10 11.72 446 446433 14050 34496002
Therapeutic product effect incomplete 127.17 11.72 286 446593 50255 34459797
Myocardial infarction 118.03 11.72 985 445894 120100 34389952
Toxic epidermal necrolysis 116.56 11.72 567 446312 21079 34488973
Heart rate decreased 113.52 11.72 745 446134 31000 34479052
Vomiting 111.36 11.72 4038 442841 243583 34266469
Hepatitis 111.18 11.72 601 446278 23303 34486749
Metabolic acidosis 107.60 11.72 939 445940 42741 34467311
Hepatitis acute 106.22 11.72 273 446606 7328 34502724
Cardiac failure congestive 103.73 11.72 631 446248 82639 34427413
Urticaria 101.57 11.72 1232 445647 61145 34448907
Coagulopathy 97.83 11.72 506 446373 19283 34490769
Myelosuppression 93.41 11.72 66 446813 19199 34490853
Cardiac failure 86.76 11.72 747 446132 90501 34419551
Blood pressure diastolic abnormal 84.52 11.72 189 446690 4629 34505423
Hepatotoxicity 80.97 11.72 511 446368 20974 34489078
Somnolence 80.84 11.72 1925 444954 109191 34400861
Oxygen saturation decreased 79.94 11.72 1045 445834 52773 34457279
Injection site pain 79.60 11.72 245 446634 38760 34471292
Hospitalisation 79.06 11.72 416 446463 56486 34453566
Blood pressure increased 78.99 11.72 1573 445306 86529 34423523
Drug interaction 78.65 11.72 2243 444636 223703 34286349
Disease progression 77.90 11.72 945 445934 107132 34402920
Pyroglutamic acidosis 77.64 11.72 55 446824 371 34509681
Cytokine release syndrome 77.05 11.72 529 446350 22348 34487704
Wrong technique in product usage process 75.62 11.72 223 446656 35763 34474289
Mixed liver injury 71.06 11.72 130 446749 2743 34507309
Therapy non-responder 70.25 11.72 260 446619 38886 34471166
Hepatic necrosis 70.14 11.72 152 446727 3642 34506410
Anion gap 70.10 11.72 70 446809 797 34509255
Coma 68.69 11.72 889 445990 44789 34465263
Anaphylactic reaction 67.77 11.72 671 446208 31630 34478422
Therapy partial responder 66.62 11.72 20 446859 9596 34500456
Off label use 66.09 11.72 4548 442331 414976 34095076
Product use in unapproved indication 66.00 11.72 1080 445799 116419 34393633
Drug ineffective for unapproved indication 65.70 11.72 127 446752 23588 34486464
Prothrombin time shortened 65.40 11.72 87 446792 1377 34508675
Fixed eruption 65.40 11.72 94 446785 1606 34508446
Diarrhoea 64.58 11.72 4208 442671 385704 34124348
Death 64.21 11.72 4306 442573 393743 34116309
Bladder cancer 64.06 11.72 68 446811 16210 34493842
Blood pressure systolic abnormal 63.87 11.72 150 446729 3798 34506254
Haematotoxicity 62.58 11.72 14 446865 8180 34501872
Abdominal pain 61.59 11.72 2618 444261 161000 34349052
Renal impairment 61.23 11.72 845 446034 93668 34416384
Hepatitis fulminant 60.11 11.72 152 446727 4038 34506014
Hepatitis cholestatic 57.92 11.72 228 446651 7719 34502333
Immune reconstitution inflammatory syndrome 57.53 11.72 20 446859 8739 34501313
Prostate cancer 54.99 11.72 290 446589 39359 34470693
Multiple-drug resistance 54.66 11.72 3 446876 5236 34504816
Hepatic failure 54.44 11.72 678 446201 33853 34476199
Pathogen resistance 53.68 11.72 27 446852 9455 34500597
Transaminases increased 52.34 11.72 549 446330 26274 34483778
Blood pressure systolic increased 52.20 11.72 485 446394 22467 34487585
Ductus arteriosus premature closure 50.60 11.72 35 446844 226 34509826
Loss of personal independence in daily activities 49.25 11.72 237 446642 32942 34477110
C-reactive protein abnormal 49.01 11.72 25 446854 8685 34501367
Contraindicated product administered 48.93 11.72 128 446751 21353 34488699
Cytomegalovirus infection 48.60 11.72 171 446708 25964 34484088
Diabetes mellitus 48.51 11.72 375 446504 46498 34463554
Infusion site extravasation 47.80 11.72 143 446736 4201 34505851
Oesophageal carcinoma 47.63 11.72 30 446849 9274 34500778
Sinusitis 46.88 11.72 767 446112 40635 34469417
Confusional state 46.68 11.72 2272 444607 141888 34368164
Medication error 46.52 11.72 516 446363 25049 34485003
Methaemoglobinaemia 46.35 11.72 125 446754 3456 34506596
Body temperature decreased 44.84 11.72 303 446576 12731 34497321
Cerebral infarction 44.40 11.72 190 446689 27265 34482787
Body temperature increased 44.13 11.72 376 446503 16992 34493060
Progressive multifocal leukoencephalopathy 44.07 11.72 36 446843 9728 34500324
Blood pressure diastolic increased 44.03 11.72 153 446726 4872 34505180
Inadequate analgesia 43.81 11.72 109 446770 2866 34507186
International normalised ratio increased 43.73 11.72 849 446030 46478 34463574
Acute generalised exanthematous pustulosis 43.54 11.72 187 446692 6589 34503463
Stevens-Johnson syndrome 43.47 11.72 396 446483 18243 34491809
Therapeutic product effect decreased 42.85 11.72 264 446615 34479 34475573
Post transplant lymphoproliferative disorder 42.71 11.72 15 446864 6513 34503539
Liver function test abnormal 42.27 11.72 594 446285 30480 34479572
Prothrombin time ratio decreased 42.23 11.72 37 446842 352 34509700
Cell death 41.95 11.72 93 446786 2264 34507788
Graft versus host disease 41.76 11.72 44 446835 10525 34499527
Alanine aminotransferase increased 40.71 11.72 1336 445543 79479 34430573
Intercepted product preparation error 40.57 11.72 3 446876 4075 34505977
Pyroglutamate increased 40.20 11.72 32 446847 263 34509789
Blood glucose increased 39.86 11.72 606 446273 66112 34443940
Drug abuser 39.64 11.72 126 446753 3828 34506224
BK virus infection 39.63 11.72 12 446867 5726 34504326
Respiratory depression 38.83 11.72 347 446532 15898 34494154
Glycosylated haemoglobin increased 38.81 11.72 53 446826 11307 34498745
Drug-induced liver injury 38.36 11.72 549 446330 28283 34481769
Labelled drug-drug interaction medication error 38.00 11.72 84 446795 14855 34495197
Depressed level of consciousness 37.06 11.72 761 446118 42080 34467972
Throat tightness 36.75 11.72 207 446672 8151 34501901
Venoocclusive liver disease 36.42 11.72 29 446850 7937 34502115
Psoriasis 36.29 11.72 319 446560 38493 34471559
Full blood count abnormal 36.16 11.72 120 446759 18548 34491504
Jaundice 35.85 11.72 590 446289 31292 34478760
Pyrexia 35.78 11.72 4818 442061 328195 34181857
Psoriatic arthropathy 33.90 11.72 134 446745 19664 34490388
Virologic failure 33.40 11.72 3 446876 3477 34506575
Coronary artery disease 33.03 11.72 427 446452 47878 34462174
Apparent death 32.77 11.72 4 446875 3640 34506412
Infusion site swelling 32.56 11.72 88 446791 2436 34507616
Therapeutic response decreased 32.48 11.72 230 446649 29083 34480969
Sleep disorder due to a general medical condition 32.48 11.72 13 446866 5208 34504844
Treatment noncompliance 32.37 11.72 218 446661 27882 34482170
Bezoar 32.03 11.72 55 446824 1102 34508950
Infusion site pain 31.80 11.72 115 446764 3736 34506316
Flushing 31.80 11.72 587 446292 31833 34478219
Hypotension 31.37 11.72 3264 443615 218385 34291667
Device leakage 31.25 11.72 23 446856 6552 34503500
Back pain 30.97 11.72 1877 445002 119912 34390140
Syringe issue 30.78 11.72 17 446862 5647 34504405
Chronic graft versus host disease 30.47 11.72 9 446870 4364 34505688
Drug intolerance 30.05 11.72 558 446321 59012 34451040
Mydriasis 29.71 11.72 176 446703 7061 34502991
Nocardiosis 29.68 11.72 7 446872 3944 34506108
Tachycardia 29.53 11.72 1346 445533 83426 34426626
Renal cortical necrosis 29.51 11.72 24 446855 204 34509848
Cerebrovascular accident 29.39 11.72 842 446037 83969 34426083
Unresponsive to stimuli 28.75 11.72 504 446375 27065 34482987
Renal papillary necrosis 28.59 11.72 21 446858 151 34509901
Obstructive airways disorder 28.39 11.72 102 446777 15392 34494660
Product prescribing error 28.38 11.72 174 446705 22753 34487299
Infusion site pruritus 28.06 11.72 43 446836 780 34509272
Aspergillus infection 27.92 11.72 73 446806 12181 34497871
Hepatorenal failure 27.41 11.72 35 446844 531 34509521
Miosis 27.23 11.72 212 446667 9323 34500729
Viral mutation identified 27.17 11.72 3 446876 2951 34507101
Dysmorphism 27.10 11.72 4 446875 3152 34506900
Bone marrow failure 27.10 11.72 241 446638 29012 34481040
Rash maculo-papular 26.82 11.72 512 446367 27939 34482113
Heart rate increased 26.74 11.72 779 446100 45564 34464488
Nasal necrosis 26.56 11.72 13 446866 38 34510014
Pharyngeal paraesthesia 26.53 11.72 38 446841 647 34509405
Agranulocytosis 26.48 11.72 440 446439 23381 34486671
Aspartate aminotransferase increased 26.45 11.72 1089 445790 66694 34443358
Cardiac disorder 26.34 11.72 390 446489 42736 34467316
Acute graft versus host disease in skin 26.31 11.72 17 446862 5184 34504868
Anaemia 26.14 11.72 2598 444281 230737 34279315
Prescription form tampering 26.09 11.72 31 446848 435 34509617
Injection site swelling 26.01 11.72 69 446810 11458 34498594
Substance abuse 25.91 11.72 177 446702 7464 34502588
Bronchopulmonary aspergillosis 25.88 11.72 98 446781 14561 34495491
Cardio-respiratory arrest 25.86 11.72 906 445973 54367 34455685
Factor VIII inhibition 25.77 11.72 26 446853 300 34509752
Hand deformity 25.35 11.72 8 446871 3717 34506335
Pemphigus 25.34 11.72 61 446818 1570 34508482
Constipation 25.22 11.72 2056 444823 134926 34375126
Therapy interrupted 25.21 11.72 90 446789 13607 34496445
Respiratory arrest 25.20 11.72 501 446378 27542 34482510
Dizziness 25.18 11.72 2428 444451 216093 34293959
Febrile neutropenia 24.88 11.72 2052 444827 134797 34375255
Atrial fibrillation 24.78 11.72 1295 445584 121098 34388954
Throat irritation 24.74 11.72 225 446654 10360 34499692
Acidosis 24.24 11.72 230 446649 10715 34499337
Neuropathy peripheral 24.17 11.72 846 446033 82417 34427635
Therapy cessation 24.17 11.72 123 446756 16850 34493202
Blood alkaline phosphatase increased 24.14 11.72 545 446334 30630 34479422
Mucocutaneous disorder 23.96 11.72 17 446862 115 34509937
Acute myocardial infarction 23.85 11.72 514 446365 53205 34456847
Livedo reticularis 23.77 11.72 73 446806 2176 34507876
Poisoning 23.74 11.72 250 446629 11976 34498076
Renal cancer 23.60 11.72 39 446840 7696 34502356
Acute graft versus host disease 23.60 11.72 29 446850 6474 34503578
Visual acuity reduced 23.01 11.72 117 446762 16032 34494020
Fluid retention 22.97 11.72 226 446653 26661 34483391
Cardiac failure chronic 22.88 11.72 41 446838 7838 34502214
Oral pruritus 22.68 11.72 24 446855 294 34509758
Mucosal inflammation 22.65 11.72 352 446527 38270 34471782
Peripheral swelling 22.61 11.72 776 446103 75765 34434287
Systemic infection 22.56 11.72 20 446859 5192 34504860
General physical health deterioration 22.53 11.72 1376 445503 126893 34383159
Prothrombin time prolonged 22.52 11.72 201 446678 9205 34500847
Coagulation factor VII level decreased 22.46 11.72 16 446863 109 34509943
Vascular stent thrombosis 22.44 11.72 5 446874 2930 34507122
Hypothermia 22.40 11.72 223 446656 10525 34499527
Erythema 22.32 11.72 1367 445512 87413 34422639
Unintentional medical device removal 22.30 11.72 4 446875 2732 34507320
Immunosuppressant drug level increased 21.97 11.72 27 446852 6028 34504024
COVID-19 treatment 21.66 11.72 22 446857 256 34509796
Graft versus host disease in gastrointestinal tract 21.59 11.72 10 446869 3673 34506379
Transplant rejection 21.58 11.72 64 446815 10247 34499805
Condition aggravated 21.36 11.72 2141 444738 190055 34319997
Platelet count decreased 21.24 11.72 1283 445596 118434 34391618
Prostatic specific antigen increased 21.12 11.72 106 446773 14574 34495478
Lymphocyte count abnormal 21.02 11.72 47 446832 1151 34508901
Injection site bruising 20.99 11.72 50 446829 8613 34501439
Kidney transplant rejection 20.89 11.72 40 446839 7457 34502595
No adverse event 20.75 11.72 190 446689 22737 34487315
Lip oedema 20.71 11.72 77 446802 2536 34507516
Rebound effect 20.62 11.72 8 446871 3266 34506786
Body temperature fluctuation 20.39 11.72 57 446822 1610 34508442
Injection site haemorrhage 20.18 11.72 61 446818 9707 34500345
Antipsychotic drug level below therapeutic 20.17 11.72 4 446875 2543 34507509
Diffuse large B-cell lymphoma recurrent 20.14 11.72 8 446871 3220 34506832
Synovitis 19.99 11.72 102 446777 13964 34496088
Poor venous access 19.98 11.72 124 446755 5059 34504993
Ejection fraction decreased 19.92 11.72 153 446726 19001 34491051
Agitation 19.90 11.72 911 445968 56488 34453564
Anaphylactic shock 19.81 11.72 300 446579 15641 34494411
Use of accessory respiratory muscles 19.80 11.72 26 446853 406 34509646
Drug reaction with eosinophilia and systemic symptoms 19.62 11.72 557 446322 32455 34477597
Blood pressure diastolic decreased 19.60 11.72 190 446689 8904 34501148
Underdose 19.54 11.72 100 446779 13680 34496372
Intraocular pressure increased 19.54 11.72 24 446855 5359 34504693
Thrombotic microangiopathy 19.46 11.72 70 446809 10560 34499492
Hyperlipasaemia 19.45 11.72 28 446851 479 34509573
Intracranial pressure increased 19.45 11.72 101 446778 3854 34506198
Angina pectoris 19.37 11.72 283 446596 31080 34478972
Prostate cancer stage IV 19.29 11.72 4 446875 2464 34507588
Rhinalgia 19.25 11.72 42 446837 1011 34509041
Bone erosion 19.14 11.72 14 446865 4001 34506051
Sphincter of Oddi dysfunction 19.06 11.72 15 446864 121 34509931
Cryptococcosis 18.74 11.72 4 446875 2415 34507637
Periportal oedema 18.73 11.72 11 446868 51 34510001
Infusion site bruising 18.69 11.72 34 446845 714 34509338
Psychotic disorder 18.67 11.72 211 446668 24241 34485811
Disease recurrence 18.63 11.72 180 446699 21310 34488742
Maternal exposure before pregnancy 18.57 11.72 35 446844 756 34509296
Dose calculation error 18.56 11.72 11 446868 52 34510000
Endophthalmitis 18.39 11.72 11 446868 3497 34506555
Interstitial lung disease 18.33 11.72 666 446213 64616 34445436
Paradoxical drug reaction 18.29 11.72 10 446869 3341 34506711
Gamma-glutamyltransferase increased 18.15 11.72 496 446383 28735 34481317
Infusion site erythema 18.03 11.72 67 446812 2206 34507846
Failure to suspend medication 18.01 11.72 25 446854 413 34509639
Viral load increased 17.98 11.72 5 446874 2522 34507530
Cystitis haemorrhagic 17.92 11.72 28 446851 5651 34504401
Cytomegalovirus chorioretinitis 17.79 11.72 12 446867 3577 34506475
Injection site reaction 17.69 11.72 96 446783 12937 34497115
Respiratory rate increased 17.68 11.72 199 446680 9695 34500357
Cytopenia 17.67 11.72 93 446786 12630 34497422
Accidental exposure to product by child 17.60 11.72 50 446829 1426 34508626
Dyspnoea exertional 17.54 11.72 420 446459 42859 34467193
Device issue 17.49 11.72 65 446814 9712 34500340
Hepatitis B 17.49 11.72 31 446848 5952 34504100
Hyperhidrosis 17.47 11.72 1157 445722 74535 34435517
Neutropenic sepsis 17.46 11.72 260 446619 13507 34496545
Myopathy 17.45 11.72 82 446797 11472 34498580
Haematemesis 17.43 11.72 471 446408 27240 34482812
Generalised bullous fixed drug eruption 17.41 11.72 12 446867 77 34509975
Low birth weight baby 17.32 11.72 48 446831 7857 34502195
Product storage error 17.30 11.72 50 446829 8072 34501980
Therapeutic product effect variable 17.21 11.72 5 446874 2451 34507601
Akathisia 17.21 11.72 50 446829 8059 34501993
Glucose-6-phosphate dehydrogenase deficiency 17.12 11.72 14 446865 120 34509932
Graft versus host disease in skin 17.07 11.72 15 446864 3910 34506142
Psychomotor retardation 17.05 11.72 13 446866 3637 34506415
Thrombosis 16.96 11.72 503 446376 49955 34460097
Infusion site rash 16.92 11.72 27 446852 508 34509544
Heart rate irregular 16.85 11.72 290 446589 15517 34494535
Band neutrophil percentage decreased 16.77 11.72 7 446872 12 34510040
Hypertransaminasaemia 16.77 11.72 126 446753 5480 34504572
Hepatic cirrhosis 16.76 11.72 141 446738 17173 34492879
Eyelid ptosis 16.74 11.72 30 446849 5736 34504316
Parkinsonism 16.68 11.72 51 446828 8087 34501965
Posterior reversible encephalopathy syndrome 16.64 11.72 68 446811 9886 34500166
Coronary artery bypass 16.61 11.72 23 446856 4879 34505173
Ear infection 16.60 11.72 202 446677 10029 34500023
Hypoxia 16.49 11.72 862 446017 54233 34455819
Dependent personality disorder 16.48 11.72 12 446867 85 34509967
JC virus infection 16.41 11.72 4 446875 2204 34507848
Cytomegalovirus viraemia 16.37 11.72 45 446834 7385 34502667
Prothrombin time abnormal 16.22 11.72 32 446847 716 34509336
Dyspnoea at rest 16.20 11.72 15 446864 3813 34506239
Hepatitis toxic 16.17 11.72 65 446814 2222 34507830
Visual impairment 16.05 11.72 342 446537 35460 34474592
Infection 16.00 11.72 975 445904 89940 34420112
Nipple inflammation 16.00 11.72 10 446869 53 34509999
Tenosynovitis 15.94 11.72 21 446858 4549 34505503
Chondrocalcinosis 15.92 11.72 23 446856 395 34509657
Incorrect drug administration rate 15.89 11.72 53 446826 1652 34508400
Feeling abnormal 15.81 11.72 654 446225 62581 34447471
Disinhibition 15.71 11.72 11 446868 3215 34506837
Cryopyrin associated periodic syndrome 15.67 11.72 11 446868 73 34509979
Environmental exposure 15.65 11.72 19 446860 273 34509779
Oedematous pancreatitis 15.60 11.72 25 446854 472 34509580
Angular cheilitis 15.49 11.72 15 446864 164 34509888
Colorectal cancer 15.48 11.72 23 446856 4738 34505314
Macrophages increased 15.42 11.72 15 446864 165 34509887
Coronary arterial stent insertion 15.42 11.72 18 446861 4111 34505941
Self-medication 15.41 11.72 72 446807 2631 34507421
Accidental exposure to product 15.41 11.72 98 446781 12704 34497348
Lymphoproliferative disorder 15.40 11.72 8 446871 2751 34507301
Patent ductus arteriosus 15.37 11.72 84 446795 3270 34506782
Neutrophil percentage increased 15.36 11.72 55 446824 1778 34508274
Memory impairment 15.27 11.72 429 446450 42889 34467163
Red blood cell sedimentation rate abnormal 15.26 11.72 14 446865 3575 34506477
Hypertriglyceridaemia 15.22 11.72 56 446823 8392 34501660
Aptyalism 15.22 11.72 22 446857 378 34509674
Intentional self-injury 15.17 11.72 254 446625 13517 34496535
Asthma 15.15 11.72 422 446457 42234 34467818
Lymph node calcification 15.13 11.72 14 446865 144 34509908
Product quality issue 15.06 11.72 142 446737 16893 34493159
Erythema multiforme 15.02 11.72 173 446706 8476 34501576
Brain death 14.96 11.72 71 446808 2612 34507440
Electrocardiogram abnormal 14.95 11.72 64 446815 9183 34500869
Drug dose omission by device 14.90 11.72 5 446874 2234 34507818
Asthenia 14.86 11.72 2836 444043 242415 34267637
Hepatic cancer 14.81 11.72 55 446824 8220 34501832
Face oedema 14.81 11.72 218 446661 11298 34498754
Hepatocellular carcinoma 14.73 11.72 48 446831 7461 34502591
Blood pH decreased 14.68 11.72 64 446815 2270 34507782
Mucormycosis 14.63 11.72 34 446845 5908 34504144
Encephalopathy 14.59 11.72 571 446308 34748 34475304
Duodenal ulcer perforation 14.57 11.72 50 446829 1582 34508470
Gastric ulcer perforation 14.55 11.72 38 446841 1030 34509022
Haemarthrosis 14.52 11.72 81 446798 3178 34506874
Beta haemolytic streptococcal infection 14.48 11.72 25 446854 503 34509549
Incision site complication 14.46 11.72 19 446860 297 34509755
Neuroleptic malignant syndrome 14.39 11.72 153 446726 17781 34492271
Oedema peripheral 14.37 11.72 1327 445552 118485 34391567
Anion gap abnormal 14.35 11.72 15 446864 181 34509871
Metastases to liver 14.27 11.72 109 446770 13554 34496498
Angioedema 14.24 11.72 599 446280 36775 34473277
Ductus arteriosus stenosis foetal 14.22 11.72 15 446864 183 34509869
Cerebral atrophy congenital 14.05 11.72 10 446869 68 34509984
Sleep terror 14.05 11.72 6 446873 2312 34507740
Acute haemorrhagic oedema of infancy 13.97 11.72 8 446871 35 34510017
Intentional product use issue 13.92 11.72 915 445964 58901 34451151
Gynaecomastia 13.81 11.72 75 446804 10105 34499947
Transplant failure 13.80 11.72 15 446864 3538 34506514
Ear injury 13.80 11.72 8 446871 36 34510016
Specific gravity urine increased 13.73 11.72 13 446866 138 34509914
Haemolytic anaemia 13.72 11.72 199 446680 10280 34499772
Ventricular tachycardia 13.70 11.72 248 446631 26331 34483721
Prostate cancer stage II 13.67 11.72 6 446873 2275 34507777
Testicular infarction 13.66 11.72 9 446870 53 34509999
Obsessive-compulsive disorder 13.57 11.72 32 446847 5532 34504520
Nipple disorder 13.49 11.72 15 446864 195 34509857
Coagulation factor V level decreased 13.49 11.72 16 446863 224 34509828
Injection site pruritus 13.45 11.72 45 446834 6938 34503114
Lower respiratory tract infection 13.43 11.72 513 446366 31124 34478928
Mitochondrial toxicity 13.41 11.72 9 446870 2690 34507362
Kussmaul respiration 13.39 11.72 11 446868 95 34509957
Complications of transplanted kidney 13.37 11.72 24 446855 4585 34505467
Electrocardiogram QT prolonged 13.32 11.72 410 446469 40542 34469510
Colour blindness acquired 13.28 11.72 10 446869 75 34509977
Carotid artery occlusion 13.21 11.72 17 446862 3720 34506332
Palmar-plantar erythrodysaesthesia syndrome 13.19 11.72 144 446735 16651 34493401
Insomnia 13.16 11.72 1146 445733 102761 34407291
Hyperthermia 13.12 11.72 199 446680 10378 34499674
Blood lactic acid 13.12 11.72 19 446860 327 34509725
Ureteric obstruction 13.11 11.72 40 446839 1188 34508864
Full blood count decreased 13.07 11.72 158 446721 17930 34492122
Psychiatric decompensation 13.04 11.72 11 446868 2926 34507126
Hepatitis C 13.02 11.72 73 446806 9757 34500295
Crystal urine present 13.01 11.72 23 446856 472 34509580
Fragile X syndrome 13.00 11.72 8 446871 41 34510011
Feeling hot 12.98 11.72 332 446547 19040 34491012
Pleural thickening 12.96 11.72 20 446859 365 34509687
Blood creatine phosphokinase increased 12.96 11.72 456 446423 44401 34465651
Laboratory test abnormal 12.94 11.72 183 446696 20208 34489844
Skin toxicity 12.92 11.72 26 446853 4758 34505294
Hyperbilirubinaemia 12.90 11.72 294 446585 16549 34493503
Pneumonia cytomegaloviral 12.89 11.72 12 446867 3042 34507010
Cytomegalovirus infection reactivation 12.83 11.72 29 446850 5089 34504963
Cerebral haemorrhage 12.83 11.72 344 446535 34593 34475459
Pulmonary alveolar haemorrhage 12.76 11.72 51 446828 7461 34502591
Acute kidney injury 12.75 11.72 4217 442662 300771 34209281
Blood ethanol increased 12.74 11.72 23 446856 480 34509572
Brain natriuretic peptide increased 12.67 11.72 34 446845 5625 34504427
Incorrect dose administered by device 12.63 11.72 4 446875 1854 34508198
Drug screen positive 12.58 11.72 90 446789 3853 34506199
Oesophageal obstruction 12.58 11.72 23 446856 485 34509567
Acute myeloid leukaemia recurrent 12.55 11.72 6 446873 2164 34507888
Paranoid personality disorder 12.51 11.72 7 446872 29 34510023
Dermo-hypodermitis 12.49 11.72 22 446857 450 34509602
Cardiomyopathy 12.46 11.72 146 446733 16662 34493390
Leukaemia 12.45 11.72 25 446854 4578 34505474
Chronic obstructive pulmonary disease 12.42 11.72 505 446374 48413 34461639
Oropharyngeal blistering 12.42 11.72 14 446865 185 34509867
Obesity 12.41 11.72 105 446774 12773 34497279
Skin degenerative disorder 12.39 11.72 6 446873 17 34510035
Negative pressure pulmonary oedema 12.23 11.72 15 446864 218 34509834
Specific gravity urine decreased 12.21 11.72 10 446869 86 34509966
Chronic gastrointestinal bleeding 12.17 11.72 18 446861 316 34509736
Aplasia pure red cell 12.16 11.72 39 446840 6093 34503959
Hepatic encephalopathy 12.09 11.72 259 446620 14426 34495626
Consciousness fluctuating 12.06 11.72 38 446841 1149 34508903
Head discomfort 12.02 11.72 92 446787 4024 34506028
Ataxia 12.02 11.72 116 446763 13737 34496315
Neurotoxicity 12.01 11.72 160 446719 17850 34492202
Allergic cough 11.99 11.72 7 446872 32 34510020
Syncope 11.97 11.72 1006 445873 90445 34419607
Myelodysplastic syndrome 11.97 11.72 173 446706 19035 34491017
Blindness 11.96 11.72 128 446751 14858 34495194
Injection site mass 11.89 11.72 44 446835 6582 34503470
Enterocolitis infectious 11.85 11.72 48 446831 1647 34508405
Fatigue 11.84 11.72 4409 442470 366244 34143808
Retinal haemorrhage 11.84 11.72 30 446849 5059 34504993
Injection site erythema 11.82 11.72 138 446741 15761 34494291
Pyloric stenosis 11.81 11.72 31 446848 843 34509209
Bicytopenia 11.81 11.72 61 446818 2323 34507729
Jaundice cholestatic 11.76 11.72 103 446776 4691 34505361

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 3526.35 11.21 13875 1159126 407665 78163722
Intentional overdose 2042.78 11.21 4693 1168308 101267 78470120
Completed suicide 1900.29 11.21 7902 1165099 237865 78333522
Acute hepatic failure 1654.46 11.21 2127 1170874 27986 78543401
Overdose 1408.19 11.21 5904 1167097 178302 78393085
Analgesic drug level increased 1317.71 11.21 728 1172273 2450 78568937
Hepatocellular injury 1043.12 11.21 2220 1170781 45373 78526014
Drug ineffective 984.01 11.21 10674 1162327 1070239 77501148
Exposure to toxic agent 830.53 11.21 839 1172162 8319 78563068
Poisoning deliberate 713.80 11.21 1114 1171887 17714 78553673
Suicide attempt 694.03 11.21 2735 1170266 80197 78491190
Infusion related reaction 663.29 11.21 5713 1167288 224524 78346863
Intentional product misuse 526.63 11.21 2778 1170223 92387 78479000
Metabolic acidosis 455.83 11.21 2408 1170593 80121 78491266
Blood pressure fluctuation 442.49 11.21 2060 1170941 65085 78506302
Cholestasis 410.69 11.21 1687 1171314 50422 78520965
Product dose omission issue 388.61 11.21 2096 1170905 245441 78325946
Injection site pain 370.60 11.21 852 1172149 128986 78442401
Drug resistance 355.30 11.21 91 1172910 42122 78529265
Hepatotoxicity 311.92 11.21 1539 1171462 49813 78521574
Hepatic cytolysis 292.95 11.21 973 1172028 26178 78545209
Coma 269.04 11.21 2458 1170543 98191 78473196
Coagulopathy 258.37 11.21 1133 1171868 34873 78536514
Accidental overdose 258.27 11.21 1211 1171790 38370 78533017
Somnolence 255.59 11.21 4936 1168065 234045 78337342
Device expulsion 239.40 11.21 45 1172956 25816 78545571
Hepatic failure 238.03 11.21 1630 1171371 59582 78511805
Anion gap 233.75 11.21 219 1172782 1962 78569425
Hepatitis 231.78 11.21 1509 1171492 54218 78517169
Cardiac failure congestive 228.76 11.21 1196 1171805 141206 78430181
Injection site erythema 220.78 11.21 516 1172485 77681 78493706
Hepatitis acute 209.54 11.21 602 1172399 14940 78556447
Therapeutic product effect incomplete 209.28 11.21 1223 1171778 140422 78430965
Wrong technique in product usage process 208.15 11.21 488 1172513 73387 78498000
Vomiting 204.89 11.21 11855 1161146 653973 77917414
Off label use 204.59 11.21 11089 1161912 896126 77675261
Hepatic necrosis 203.38 11.21 428 1172573 8672 78562715
Disease progression 184.51 11.21 1776 1171225 182586 78388801
Heart rate decreased 180.71 11.21 1703 1171298 68613 78502774
Myocardial infarction 180.38 11.21 1783 1171218 182346 78389041
Myelosuppression 179.90 11.21 196 1172805 40100 78531287
Prothrombin time shortened 178.80 11.21 229 1172772 2999 78568388
Pyroglutamic acidosis 176.67 11.21 138 1172863 938 78570449
Liver injury 171.25 11.21 1421 1171580 55193 78516194
Blood pressure diastolic abnormal 170.11 11.21 645 1172356 18557 78552830
Depressed level of consciousness 169.15 11.21 2169 1170832 94483 78476904
Product use in unapproved indication 164.72 11.21 2639 1170362 247720 78323667
Blood pressure increased 162.68 11.21 4166 1168835 207194 78364193
Medication error 157.66 11.21 1624 1171377 67018 78504369
Injection site reaction 156.66 11.21 359 1172642 54426 78516961
Treatment failure 156.66 11.21 1676 1171325 168810 78402577
Oxygen saturation decreased 155.14 11.21 2715 1170286 126332 78445055
Toxic epidermal necrolysis 152.97 11.21 1152 1171849 43429 78527958
Cardiac failure 151.39 11.21 1500 1171501 153342 78418045
Hepatitis fulminant 150.19 11.21 331 1172670 6931 78564456
Hepatitis cholestatic 149.06 11.21 496 1172505 13356 78558031
Hospitalisation 145.47 11.21 802 1172199 93434 78477953
International normalised ratio increased 142.69 11.21 1888 1171113 82833 78488554
Pyroglutamate increased 142.33 11.21 102 1172899 597 78570790
Blood pressure systolic abnormal 141.93 11.21 566 1172435 16681 78554706
Cholecystitis chronic 140.68 11.21 391 1172610 9515 78561872
Injection site swelling 137.91 11.21 305 1172696 46827 78524560
Urticaria 137.14 11.21 3632 1169369 181569 78389818
Drug hypersensitivity 136.65 11.21 3349 1169652 295567 78275820
Mixed liver injury 136.41 11.21 327 1172674 7251 78564136
Prothrombin time ratio decreased 133.50 11.21 110 1172891 815 78570572
Therapy non-responder 132.60 11.21 804 1172197 91501 78479886
Confusional state 128.17 11.21 5812 1167189 312185 78259202
Transaminases increased 127.41 11.21 1242 1171759 50501 78520886
Body temperature increased 126.45 11.21 1100 1171901 43320 78528067
Cytomegalovirus infection 123.92 11.21 277 1172724 42367 78529020
Throat irritation 121.83 11.21 1024 1171977 39922 78531465
Injection site pruritus 120.96 11.21 277 1172724 42006 78529381
Abdominal pain 119.01 11.21 6934 1166067 382635 78188752
Blood pressure systolic increased 118.77 11.21 1507 1171494 65479 78505908
Diarrhoea 117.70 11.21 11254 1161747 869235 77702152
Drug interaction 117.23 11.21 4953 1168048 410230 78161157
Renal impairment 116.88 11.21 1625 1171376 156158 78415229
Respiratory depression 115.98 11.21 750 1172251 26880 78544507
Psoriasis 115.65 11.21 806 1172195 88781 78482606
Heart rate increased 114.82 11.21 2451 1170550 118273 78453114
Haematotoxicity 113.51 11.21 43 1172958 15476 78555911
Acute generalised exanthematous pustulosis 108.98 11.21 523 1172478 16731 78554656
Drug ineffective for unapproved indication 108.79 11.21 387 1172614 50851 78520536
Urine abnormality 107.57 11.21 315 1172686 7904 78563483
Injection site bruising 106.79 11.21 282 1172719 40720 78530667
Pathogen resistance 106.14 11.21 39 1172962 14303 78557084
Condition aggravated 105.92 11.21 6161 1166840 494963 78076424
Red blood cell sedimentation rate abnormal 105.11 11.21 92 1172909 20871 78550516
Bone marrow failure 104.56 11.21 392 1172609 50715 78520672
Chills 104.50 11.21 3092 1169909 157142 78414245
Intentional self-injury 101.95 11.21 821 1172180 31598 78539789
Post transplant lymphoproliferative disorder 101.83 11.21 22 1172979 11442 78559945
Fixed eruption 97.29 11.21 164 1172837 2790 78568597
Therapy cessation 95.81 11.21 261 1172740 37301 78534086
Therapy interrupted 94.86 11.21 199 1172802 31142 78540245
Therapeutic response decreased 94.61 11.21 585 1172416 66268 78505119
Product prescribing error 93.46 11.21 341 1172660 44472 78526915
Alanine aminotransferase increased 92.80 11.21 3087 1169914 159483 78411904
Bladder cancer 92.80 11.21 90 1172911 19436 78551951
Multiple-drug resistance 91.44 11.21 11 1172990 8797 78562590
Product monitoring error 87.98 11.21 13 1172988 8893 78562494
Miosis 87.33 11.21 461 1172540 15328 78556059
Urine leukocyte esterase positive 85.21 11.21 187 1172814 3904 78567483
Loss of personal independence in daily activities 84.96 11.21 1032 1171969 101548 78469839
Prostate cancer 82.01 11.21 235 1172766 33033 78538354
Anaemia 80.85 11.21 5547 1167454 439468 78131919
Cardio-respiratory arrest 80.84 11.21 2130 1170871 106380 78465007
Drug-induced liver injury 80.12 11.21 1393 1171608 64724 78506663
Tachycardia 79.54 11.21 3285 1169716 174483 78396904
Therapy partial responder 79.46 11.21 83 1172918 17314 78554073
Blood pressure diastolic increased 79.34 11.21 423 1172578 14119 78557268
Diabetes mellitus 79.27 11.21 753 1172248 77637 78493750
Oesophageal carcinoma 78.94 11.21 32 1172969 11052 78560335
Transplant rejection 78.79 11.21 102 1172899 19335 78552052
Hepatic encephalopathy 78.73 11.21 617 1172384 23549 78547838
Labelled drug-drug interaction medication error 78.39 11.21 182 1172819 27468 78543919
Blood pressure diastolic decreased 77.70 11.21 732 1172269 29484 78541903
Lower respiratory tract infection 76.90 11.21 2466 1170535 126754 78444633
Poisoning 76.77 11.21 635 1172366 24637 78546750
Granuloma skin 76.77 11.21 20 1172981 9154 78562233
Cytokine release syndrome 76.25 11.21 838 1172163 35160 78536227
Prothrombin time prolonged 76.08 11.21 467 1172534 16432 78554955
Blood parathyroid hormone decreased 75.72 11.21 30 1172971 10506 78560881
Rheumatoid arthritis 75.57 11.21 3771 1169230 204699 78366688
Systemic infection 74.78 11.21 25 1172976 9727 78561660
Unintentional medical device removal 74.49 11.21 12 1172989 7700 78563687
Immune reconstitution inflammatory syndrome 74.04 11.21 57 1172944 13784 78557603
Interstitial lung disease 72.61 11.21 1191 1171810 111409 78459978
Hypotension 72.23 11.21 7465 1165536 432852 78138535
Anaphylactic reaction 69.83 11.21 1669 1171332 82074 78489313
Graft versus host disease 69.41 11.21 71 1172930 14955 78556432
Full blood count abnormal 68.91 11.21 333 1172668 40141 78531246
Liver function test abnormal 68.55 11.21 1331 1171670 63144 78508243
Device issue 67.18 11.21 191 1172810 26917 78544470
Neoplasm progression 67.17 11.21 464 1172537 51218 78520169
Product storage error 66.97 11.21 84 1172917 16142 78555245
Acidosis 66.85 11.21 509 1172492 19253 78552134
Device use error 66.49 11.21 12 1172989 7089 78564298
Crystal urine present 65.99 11.21 116 1172885 2044 78569343
Breast cancer stage I 65.68 11.21 10 1172991 6690 78564697
Stevens-Johnson syndrome 65.58 11.21 872 1172129 38294 78533093
Sinusitis 65.48 11.21 3510 1169491 191991 78379396
Acute graft versus host disease 65.19 11.21 34 1172967 10133 78561254
Rheumatoid nodule 65.19 11.21 97 1172904 17341 78554046
Posterior reversible encephalopathy syndrome 64.52 11.21 186 1172815 26095 78545292
Drug abuser 64.42 11.21 215 1172786 5798 78565589
Cerebral infarction 63.94 11.21 401 1172600 45275 78526112
Renal papillary necrosis 63.88 11.21 52 1172949 378 78571009
Aspergillus infection 62.88 11.21 116 1172885 19045 78552342
Drug intolerance 62.76 11.21 3209 1169792 260910 78310477
White blood cells urine positive 62.25 11.21 214 1172787 5861 78565526
Infusion site extravasation 62.12 11.21 304 1172697 9804 78561583
Device difficult to use 60.98 11.21 64 1172937 13321 78558066
Lymphocyte count decreased 60.82 11.21 1006 1171995 46283 78525104
General physical health deterioration 60.36 11.21 3371 1169630 271867 78299520
Panniculitis 59.98 11.21 56 1172945 12315 78559072
Accidental exposure to product 59.76 11.21 247 1172754 31075 78540312
Injection site haemorrhage 59.49 11.21 210 1172791 27660 78543727
Mydriasis 59.44 11.21 454 1172547 17189 78554198
Respiratory arrest 59.15 11.21 1182 1171819 56368 78515019
Jaundice 57.63 11.21 1104 1171897 52245 78519142
BK virus infection 57.11 11.21 29 1172972 8775 78562612
Flushing 56.89 11.21 1701 1171300 86567 78484820
Injection site warmth 56.69 11.21 81 1172920 14726 78556661
Cell death 56.69 11.21 175 1172826 4524 78566863
Acute graft versus host disease in skin 56.38 11.21 21 1172980 7637 78563750
Chronic graft versus host disease 56.33 11.21 15 1172986 6766 78564621
Thrombotic microangiopathy 56.18 11.21 134 1172867 20035 78551352
Surgery 56.12 11.21 269 1172732 32497 78538890
Rash maculo-papular 55.39 11.21 1145 1171856 54933 78516454
C-reactive protein abnormal 54.90 11.21 451 1172550 47916 78523471
Hypocoagulable state 54.73 11.21 107 1172894 2052 78569335
Underdose 54.56 11.21 276 1172725 32875 78538512
Urinary sediment present 54.08 11.21 117 1172884 2418 78568969
Platelet count decreased 54.04 11.21 2326 1170675 192338 78379049
Acute myocardial infarction 53.99 11.21 802 1172199 76234 78495153
Psoriatic arthropathy 53.30 11.21 816 1172185 77183 78494204
Injection site mass 53.18 11.21 138 1172863 20046 78551341
Mucosal inflammation 52.92 11.21 787 1172214 74793 78496594
Transplant dysfunction 52.83 11.21 20 1172981 7201 78564186
Infusion site pain 52.45 11.21 373 1172628 13803 78557584
Colorectal cancer 52.43 11.21 31 1172970 8616 78562771
Myelodysplastic syndrome 52.34 11.21 248 1172753 30053 78541334
Renal cancer 51.82 11.21 62 1172939 12164 78559223
Bone erosion 51.79 11.21 116 1172885 17731 78553656
Device malfunction 51.78 11.21 153 1172848 21295 78550092
Bradypnoea 51.73 11.21 201 1172800 5851 78565536
Palmar-plantar erythrodysaesthesia syndrome 51.66 11.21 281 1172720 32853 78538534
Ear pruritus 51.28 11.21 155 1172846 3960 78567427
Blood glucose increased 51.14 11.21 1293 1171708 113682 78457705
Acute lung injury 50.75 11.21 129 1172872 2971 78568416
Nocardiosis 50.24 11.21 11 1172990 5668 78565719
Encephalopathy 49.90 11.21 1322 1171679 66075 78505312
Blood alkaline phosphatase increased 49.83 11.21 1258 1171743 62406 78508981
Muscle injury 49.78 11.21 997 1172004 47564 78523823
Pneumonia 49.69 11.21 8750 1164251 651496 77919891
Bronchopulmonary aspergillosis 49.61 11.21 165 1172836 22129 78549258
Respiratory rate increased 49.56 11.21 511 1172490 21089 78550298
Device leakage 49.35 11.21 52 1172949 10804 78560583
Anion gap abnormal 48.85 11.21 54 1172947 599 78570788
Septic shock 48.13 11.21 1406 1171595 121395 78449992
Aspartate aminotransferase increased 47.98 11.21 2497 1170504 136144 78435243
Breast cancer female 47.65 11.21 59 1172942 11402 78559985
Coagulation factor VII level decreased 47.58 11.21 34 1172967 198 78571189
Poor venous access 47.33 11.21 441 1172560 17708 78553679
Blood calcium decreased 47.05 11.21 693 1172308 31126 78540261
Metastases to liver 47.02 11.21 235 1172766 28079 78543308
Gamma-glutamyltransferase increased 46.56 11.21 1093 1171908 53587 78517800
Cytomegalovirus viraemia 46.31 11.21 73 1172928 12748 78558639
Drug dose omission by device 46.24 11.21 17 1172984 6233 78565154
Heart rate irregular 46.09 11.21 706 1172295 31973 78539414
Gallbladder injury 45.93 11.21 72 1172929 1149 78570238
Unresponsive to stimuli 45.64 11.21 1109 1171892 54679 78516708
Neuropathy peripheral 45.59 11.21 1659 1171342 139646 78431741
Strongyloidiasis 45.49 11.21 3 1172998 3895 78567492
Second primary malignancy 45.23 11.21 89 1172912 14261 78557126
Coronary artery disease 45.07 11.21 684 1172317 64790 78506597
Immunosuppressant drug level increased 44.79 11.21 40 1172961 8987 78562400
Emotional distress 44.50 11.21 831 1172170 39138 78532249
Dyspnoea exertional 44.07 11.21 960 1172041 86113 78485274
Lymphoproliferative disorder 43.75 11.21 14 1172987 5601 78565786
Hepatitis toxic 43.23 11.21 170 1172831 4977 78566410
Mucormycosis 42.66 11.21 37 1172964 8432 78562955
Cerebrovascular accident 42.59 11.21 1858 1171143 153434 78417953
Hypothermia 42.57 11.21 517 1172484 22229 78549158
Glycosylated haemoglobin increased 42.55 11.21 143 1172858 19117 78552270
Hypertransaminasaemia 42.53 11.21 311 1172690 11613 78559774
Body temperature fluctuation 42.47 11.21 138 1172863 3669 78567718
Irritable bowel syndrome 42.45 11.21 1208 1171793 61033 78510354
Lymphocyte percentage decreased 42.31 11.21 165 1172836 4811 78566576
Skin necrosis 42.25 11.21 131 1172870 17956 78553431
Neurotoxicity 42.23 11.21 292 1172709 32226 78539161
Haematochezia 42.17 11.21 974 1172027 86671 78484716
Substance abuse 41.92 11.21 282 1172719 10244 78561143
Back pain 41.87 11.21 5099 1167902 299081 78272306
Drug abuse 41.87 11.21 2854 1170147 159837 78411550
Virologic failure 41.67 11.21 6 1172995 4185 78567202
Metastases to lung 41.41 11.21 133 1172868 18030 78553357
Cytopenia 41.26 11.21 157 1172844 20226 78551161
Blister 41.17 11.21 2151 1170850 117325 78454062
Body temperature decreased 41.03 11.21 683 1172318 31462 78539925
Intercepted product preparation error 40.79 11.21 3 1172998 3557 78567830
Venoocclusive liver disease 40.67 11.21 69 1172932 11702 78559685
Myopathy 40.59 11.21 160 1172841 20403 78550984
Injection site induration 40.35 11.21 51 1172950 9768 78561619
Neutrophil percentage increased 40.29 11.21 156 1172845 4533 78566854
Kidney transplant rejection 40.28 11.21 55 1172946 10191 78561196
Vascular stent thrombosis 40.12 11.21 4 1172997 3706 78567681
Disease recurrence 39.92 11.21 435 1172566 43674 78527713
Pruritus 39.89 11.21 6497 1166504 388151 78183236
Malignant neoplasm progression 39.82 11.21 1615 1171386 134375 78437012
Red blood cell sedimentation rate 39.74 11.21 16 1172985 5549 78565838
Respiratory failure 39.58 11.21 2216 1170785 178695 78392692
Folliculitis 39.49 11.21 1081 1171920 54299 78517088
Oedema peripheral 39.45 11.21 3184 1169817 249104 78322283
Lipodystrophy acquired 39.03 11.21 8 1172993 4317 78567070
Ventricular tachycardia 38.99 11.21 411 1172590 41524 78529863
Infusion site swelling 38.92 11.21 222 1172779 7604 78563783
Nasopharyngitis 38.71 11.21 4284 1168717 249597 78321790
Basal cell carcinoma 38.22 11.21 358 1172643 37017 78534370
Infusion site pruritus 37.87 11.21 140 1172861 3978 78567409
Device dislocation 37.39 11.21 226 1172775 25744 78545643
Treatment noncompliance 37.37 11.21 542 1172459 51726 78519661
Graft versus host disease in gastrointestinal tract 36.86 11.21 24 1172977 6332 78565055
Neutropenia 36.84 11.21 3687 1169314 284023 78287364
Intentional product use issue 36.81 11.21 2655 1170346 149457 78421930
Pyrexia 36.80 11.21 10849 1162152 667860 77903527
Atrial fibrillation 36.62 11.21 2462 1170539 195424 78375963
Graft versus host disease in skin 36.50 11.21 22 1172979 6051 78565336
Hepatic enzyme increased 36.44 11.21 3140 1169861 179470 78391917
Coronary arterial stent insertion 36.18 11.21 22 1172979 6022 78565365
Jaundice cholestatic 36.15 11.21 287 1172714 10997 78560390
Sedation complication 36.10 11.21 371 1172630 15298 78556089
Disturbance in social behaviour 35.97 11.21 14 1172987 4956 78566431
Abdominal pain upper 35.97 11.21 3790 1169211 220029 78351358
Cardiac disorder 35.92 11.21 716 1172285 65041 78506346
Injection site urticaria 35.90 11.21 85 1172916 12741 78558646
Epstein-Barr virus infection 35.41 11.21 102 1172899 14314 78557073
JC virus infection 35.40 11.21 7 1172994 3874 78567513
Coagulation factor V level decreased 35.32 11.21 45 1172956 586 78570801
Pulmonary hypertension 35.28 11.21 496 1172505 47584 78523803
Osteonecrosis 35.26 11.21 290 1172711 30805 78540582
Infusion site erythema 34.47 11.21 248 1172753 9212 78562175
Cystitis haemorrhagic 34.31 11.21 51 1172950 9121 78562266
Inadequate analgesia 34.22 11.21 147 1172854 4482 78566905
Duodenal ulcer perforation 34.18 11.21 1243 1171758 64968 78506419
Obstructive airways disorder 34.05 11.21 297 1172704 31162 78540225
Diabetic ketoacidosis 33.97 11.21 329 1172672 33793 78537594
Abortion incomplete 33.94 11.21 3 1172998 3061 78568326
Creatinine renal clearance decreased 33.88 11.21 428 1172573 18574 78552813
Endophthalmitis 33.72 11.21 27 1172974 6401 78564986
Diffuse large B-cell lymphoma recurrent 33.66 11.21 10 1172991 4197 78567190
Brain death 33.65 11.21 169 1172832 5508 78565879
Dyspnoea 33.60 11.21 11702 1161299 845323 77726064
Oedema 33.55 11.21 1427 1171574 118153 78453234
Decreased appetite 33.54 11.21 4468 1168533 337950 78233437
Ascites 33.53 11.21 850 1172151 74712 78496675
Injection site rash 33.38 11.21 143 1172858 17811 78553576
Drug tolerance decreased 33.23 11.21 90 1172911 12888 78558499
Cytomegalovirus infection reactivation 33.05 11.21 48 1172953 8668 78562719
Nasal necrosis 32.98 11.21 23 1172978 128 78571259
Pulmonary arterial hypertension 32.88 11.21 263 1172738 28103 78543284
Exposure via ingestion 32.79 11.21 157 1172844 5017 78566370
Cardiotoxicity 32.77 11.21 83 1172918 12156 78559231
Orthostatic hypotension 32.66 11.21 1069 1171932 55095 78516292
Lip oedema 32.62 11.21 181 1172820 6135 78565252
Unevaluable event 32.58 11.21 598 1172403 54987 78516400
Accidental exposure to product by child 32.58 11.21 106 1172895 2820 78568567
Urine analysis abnormal 32.45 11.21 185 1172816 6335 78565052
Coronary artery bypass 32.38 11.21 25 1172976 6037 78565350
Agitation 32.31 11.21 1785 1171216 97930 78473457
Weight fluctuation 32.13 11.21 287 1172714 11388 78559999
Product substitution issue 32.01 11.21 171 1172830 20085 78551302
Biliary dyskinesia 31.84 11.21 96 1172905 2449 78568938
Electric shock 31.66 11.21 66 1172935 1328 78570059
Enthesopathy 31.64 11.21 78 1172923 11530 78559857
Prothrombin level increased 31.39 11.21 36 1172965 417 78570970
Syncope 31.32 11.21 2244 1170757 177205 78394182
Sleep disorder due to general medical condition, insomnia type 31.28 11.21 851 1172150 42705 78528682
Sexual dysfunction 31.20 11.21 41 1172960 7722 78563665
Thrombosis 31.19 11.21 970 1172031 83130 78488257
Hepatic cancer 30.91 11.21 68 1172933 10461 78560926
Blood urine present 30.77 11.21 462 1172539 20835 78550552
Chronic kidney disease 30.76 11.21 739 1172262 65415 78505972
Specific gravity urine decreased 30.60 11.21 50 1172951 828 78570559
Memory impairment 30.59 11.21 1337 1171664 110397 78460990
Specific gravity urine increased 30.56 11.21 36 1172965 430 78570957
Anion gap increased 30.54 11.21 122 1172879 3598 78567789
Bezoar 30.49 11.21 98 1172903 2590 78568797
No adverse event 30.47 11.21 375 1172626 36817 78534570
Visual acuity reduced 30.25 11.21 282 1172719 29187 78542200
Human herpesvirus 6 infection 30.17 11.21 21 1172980 5349 78566038
Ear pain 30.16 11.21 664 1172337 32205 78539182
Urine ketone body present 30.14 11.21 118 1172883 3447 78567940
Incorrect dose administered by device 30.09 11.21 18 1172983 4971 78566416
Cholelithiasis 30.01 11.21 1000 1172001 51664 78519723
Fluid retention 29.99 11.21 789 1172212 69020 78502367
Dizziness 29.93 11.21 7075 1165926 519366 78052021
Neuroleptic malignant syndrome 29.91 11.21 260 1172741 27299 78544088
Prostatic specific antigen increased 29.73 11.21 68 1172933 10318 78561069
Red blood cells urine positive 29.60 11.21 148 1172853 4815 78566572
Acute myeloid leukaemia 29.41 11.21 301 1172700 30584 78540803
Subacute cutaneous lupus erythematosus 29.35 11.21 8 1172993 3553 78567834
Hepatic cirrhosis 29.34 11.21 350 1172651 34556 78536831
Temperature regulation disorder 29.08 11.21 166 1172835 5687 78565700
Meningitis aseptic 29.04 11.21 188 1172813 6740 78564647
Chest discomfort 29.01 11.21 2383 1170618 135661 78435726
Pulmonary alveolar haemorrhage 28.93 11.21 80 1172921 11377 78560010
Dyspnoea at rest 28.90 11.21 39 1172962 7263 78564124
Gastric cancer 28.85 11.21 67 1172934 10112 78561275
Syringe issue 28.82 11.21 30 1172971 6268 78565119
Forced expiratory volume decreased 28.69 11.21 44 1172957 7770 78563617
Breast cancer stage II 28.61 11.21 47 1172954 8073 78563314
Osteonecrosis of jaw 28.59 11.21 455 1172546 42771 78528616
Agranulocytosis 28.53 11.21 866 1172135 44164 78527223
Brain stem glioma 28.49 11.21 24 1172977 184 78571203
Genital haemorrhage 28.39 11.21 30 1172971 6225 78565162
Complications of transplanted kidney 28.37 11.21 31 1172970 6335 78565052
Hyperthermia 28.32 11.21 397 1172604 17640 78553747
Throat tightness 28.28 11.21 572 1172429 27335 78544052
Anosognosia 28.25 11.21 10 1172991 3754 78567633
Metastases to lymph nodes 28.23 11.21 70 1172931 10327 78561060
Drug screen positive 28.21 11.21 169 1172832 5894 78565493
Sensitisation 28.13 11.21 7 1172994 3304 78568083
Red cell distribution width increased 27.90 11.21 345 1172656 14897 78556490
Methaemoglobinaemia 27.87 11.21 158 1172843 5399 78565988
Cardiomyopathy 27.57 11.21 280 1172721 28494 78542893
Rash erythematous 27.54 11.21 1075 1171926 56694 78514693
Haemoglobin urine present 27.53 11.21 50 1172951 905 78570482
Ill-defined disorder 27.34 11.21 1208 1171793 64667 78506720
Hypothyroidism 27.27 11.21 575 1172426 51817 78519570
Drug eruption 27.24 11.21 468 1172533 43467 78527920
Right ventricular failure 27.17 11.21 218 1172783 23279 78548108
Acute myeloid leukaemia recurrent 27.14 11.21 8 1172993 3375 78568012
Self-medication 27.13 11.21 148 1172853 4984 78566403
Haemorrhage 27.12 11.21 1080 1171921 90038 78481349
Livedo reticularis 27.10 11.21 126 1172875 3977 78567410
Hepatitis B reactivation 26.94 11.21 30 1172971 6078 78565309
Acute kidney injury 26.82 11.21 8287 1164714 511117 78060270
Brain oedema 26.67 11.21 521 1172480 24742 78546645
Fear of injection 26.58 11.21 43 1172958 7431 78563956
Gait disturbance 26.57 11.21 2659 1170342 204847 78366540
Liver transplant 26.45 11.21 132 1172869 4291 78567096
Injury 26.45 11.21 1394 1171607 76102 78495285
Status epilepticus 26.40 11.21 238 1172763 24803 78546584
Intracranial pressure increased 26.30 11.21 211 1172790 8111 78563276
Foot deformity 26.18 11.21 227 1172774 23847 78547540
Pancytopenia 26.01 11.21 2091 1170910 163654 78407733
Drug reaction with eosinophilia and systemic symptoms 25.77 11.21 1174 1171827 63070 78508317
Blood bilirubin increased 25.63 11.21 1206 1171795 65026 78506361
Renal cortical necrosis 25.61 11.21 29 1172972 331 78571056
Neoplasm malignant 25.58 11.21 322 1172679 31488 78539899
Neutropenic sepsis 25.56 11.21 549 1172452 26515 78544872
Polyomavirus-associated nephropathy 25.53 11.21 27 1172974 5600 78565787
Leukopenia 25.50 11.21 1427 1171574 115086 78456301
Mycobacterial infection 25.46 11.21 11 1172990 3657 78567730
Pharyngeal paraesthesia 25.44 11.21 93 1172908 2628 78568759
Medication overuse headache 25.34 11.21 47 1172954 865 78570522
Tenosynovitis 25.31 11.21 130 1172871 15424 78555963
Coma scale abnormal 25.27 11.21 216 1172785 8462 78562925
Helicobacter infection 25.25 11.21 1261 1171740 68443 78502944
Alopecia 25.20 11.21 2998 1170003 228357 78343030
Infusion site bruising 25.20 11.21 98 1172903 2854 78568533
Cardiac failure acute 25.06 11.21 169 1172832 18760 78552627
Constipation 24.98 11.21 4627 1168374 278423 78292964
Acute haemorrhagic oedema of infancy 24.94 11.21 14 1172987 49 78571338
Oral pruritus 24.88 11.21 86 1172915 2362 78569025
Product administration error 24.83 11.21 629 1172372 31217 78540170
Progressive multifocal leukoencephalopathy 24.81 11.21 189 1172812 20411 78550976
Type I hypersensitivity 24.73 11.21 129 1172872 4269 78567118
Contraindicated product administered 24.49 11.21 1989 1171012 155549 78415838
White blood cell count decreased 24.49 11.21 2410 1170591 185878 78385509
Analgesic drug level above therapeutic 24.47 11.21 33 1172968 456 78570931
Bacterial test 24.46 11.21 55 1172946 1168 78570219
Sphincter of Oddi dysfunction 24.43 11.21 31 1172970 402 78570985
Akathisia 24.41 11.21 106 1172895 13153 78558234
Cardiac failure chronic 24.37 11.21 83 1172918 11052 78560335
Ovarian hyperstimulation syndrome 24.33 11.21 11 1172990 3560 78567827
Hepatitis B 24.30 11.21 54 1172947 8278 78563109
Varicella zoster virus infection 24.12 11.21 18 1172983 4423 78566964
Metastases to bone 24.11 11.21 236 1172765 24191 78547196
Pleurothotonus 24.11 11.21 4 1172997 2512 78568875
Muscle spasticity 24.08 11.21 447 1172554 21028 78550359
Chondrocalcinosis 23.99 11.21 50 1172951 1006 78570381
COVID-19 treatment 23.95 11.21 32 1172969 438 78570949
Blood immunoglobulin E increased 23.70 11.21 31 1172970 5851 78565536
Polycystic ovaries 23.70 11.21 13 1172988 3766 78567621
Feeling abnormal 23.68 11.21 2017 1170984 157182 78414205
Laboratory test abnormal 23.66 11.21 281 1172720 27767 78543620
Pneumocystis jirovecii pneumonia 23.62 11.21 336 1172665 32172 78539215
Pulmonary fibrosis 23.59 11.21 482 1172519 43630 78527757
Culture urine positive 23.51 11.21 128 1172873 4307 78567080
Cryptococcosis 23.43 11.21 11 1172990 3482 78567905
Sleep disorder due to a general medical condition 23.42 11.21 119 1172882 14158 78557229
Abdominal discomfort 23.41 11.21 3281 1169720 247446 78323941
Suspected suicide 23.23 11.21 248 1172753 10328 78561059
Cytomegalovirus chorioretinitis 23.10 11.21 28 1172973 5462 78565925
Pancreatic carcinoma 22.94 11.21 112 1172889 13465 78557922
Lung neoplasm malignant 22.85 11.21 280 1172721 27512 78543875
Maternal exposure during pregnancy 22.75 11.21 1714 1171287 134824 78436563
Angioedema 22.68 11.21 1351 1171650 74684 78496703
Gallbladder disorder 22.54 11.21 405 1172596 18935 78552452
Product quality issue 22.53 11.21 357 1172644 33583 78537804
Therapeutic response shortened 22.48 11.21 343 1172658 15520 78555867
Adverse event 22.45 11.21 694 1172307 59520 78511867
Acute graft versus host disease in intestine 22.44 11.21 16 1172985 4025 78567362
Hyperbilirubinaemia 22.40 11.21 495 1172506 24023 78547364
Hyperglycaemia 22.40 11.21 827 1172174 69508 78501879
Blood pH decreased 22.36 11.21 132 1172869 4579 78566808
Glutathione decreased 22.26 11.21 13 1172988 50 78571337
Rheumatoid lung 22.05 11.21 18 1172983 4227 78567160
Hepatocellular carcinoma 22.03 11.21 64 1172937 8957 78562430
Infusion site discomfort 21.97 11.21 57 1172944 1330 78570057
Cholestatic liver injury 21.90 11.21 136 1172865 4805 78566582
Incorrect drug administration rate 21.89 11.21 117 1172884 3909 78567478
Lupus-like syndrome 21.89 11.21 117 1172884 13740 78557647
Dose calculation error 21.86 11.21 22 1172979 217 78571170
Generalised bullous fixed drug eruption 21.71 11.21 20 1172981 175 78571212
Wrong patient received product 21.67 11.21 129 1172872 4489 78566898
Impaired work ability 21.66 11.21 185 1172816 19496 78551891
Angina pectoris 21.61 11.21 587 1172414 51145 78520242
Lethargy 21.60 11.21 1430 1171571 79862 78491525
Asthma 21.55 11.21 1702 1171299 133393 78437994
Full blood count decreased 21.37 11.21 272 1172729 26547 78544840
Accidental poisoning 21.20 11.21 63 1172938 1594 78569793
Macular oedema 20.90 11.21 30 1172971 5444 78565943
Obesity 20.86 11.21 377 1172624 34748 78536639
Systemic candida 20.78 11.21 42 1172959 6664 78564723
Prescribed underdose 20.76 11.21 307 1172694 29207 78542180
Secondary immunodeficiency 20.46 11.21 11 1172990 3223 78568164
Acquired gene mutation 20.43 11.21 4 1172997 2229 78569158
Visual impairment 20.42 11.21 1127 1171874 91004 78480383
Body height below normal 20.27 11.21 3 1172998 2050 78569337
Transplant failure 20.25 11.21 23 1172978 4618 78566769
Fracture 20.13 11.21 214 1172787 21587 78549800
Infection reactivation 20.05 11.21 7 1172994 2650 78568737
Hypertensive crisis 19.95 11.21 202 1172799 20568 78550819
Renal disorder 19.94 11.21 469 1172532 41636 78529751
Bacterial test positive 19.93 11.21 182 1172819 7267 78564120
Mucocutaneous disorder 19.92 11.21 17 1172984 133 78571254
Monocyte percentage increased 19.86 11.21 73 1172928 2068 78569319
Premature delivery 19.84 11.21 235 1172766 23232 78548155
Sopor 19.70 11.21 354 1172647 32656 78538731
Intervertebral discitis 19.62 11.21 130 1172871 4698 78566689
Leukocyturia 19.58 11.21 69 1172932 1914 78569473
Serum sickness 19.57 11.21 106 1172895 3560 78567827
Hepatorenal failure 19.53 11.21 52 1172949 1233 78570154
Galactorrhoea 19.52 11.21 15 1172986 3631 78567756
Nitrite urine present 19.47 11.21 50 1172951 1159 78570228
Electrolyte imbalance 19.45 11.21 328 1172673 30553 78540834
Injection site discolouration 19.35 11.21 53 1172948 7561 78563826
Hyperlipasaemia 19.31 11.21 51 1172950 1203 78570184
Eyelid ptosis 19.30 11.21 90 1172911 10954 78560433
Sedation 19.25 11.21 941 1172060 50954 78520433
Oropharyngeal pain 19.17 11.21 1863 1171138 107490 78463897
Eosinophilia 18.92 11.21 832 1172169 44513 78526874
Torsade de pointes 18.89 11.21 187 1172814 19125 78552262
Viral load increased 18.69 11.21 10 1172991 2938 78568449
Complication of device insertion 18.65 11.21 41 1172960 6309 78565078
Face oedema 18.61 11.21 544 1172457 27592 78543795
Osmolar gap 18.40 11.21 18 1172983 171 78571216
Prostate cancer stage II 18.35 11.21 5 1172996 2221 78569166
Nipple disorder 18.31 11.21 19 1172982 195 78571192
Skin toxicity 18.18 11.21 62 1172939 8252 78563135
Gestational diabetes 18.18 11.21 41 1172960 6252 78565135
Retinal haemorrhage 18.16 11.21 61 1172940 8156 78563231
Hepatitis C 18.11 11.21 102 1172899 11823 78559564
Tardive dyskinesia 17.98 11.21 87 1172914 10484 78560903
Aplasia pure red cell 17.93 11.21 57 1172944 7753 78563634
Ductus arteriosus stenosis foetal 17.89 11.21 13 1172988 78 78571309
Vital capacity decreased 17.77 11.21 63 1172938 1753 78569634
Congestive cardiomyopathy 17.76 11.21 101 1172900 11679 78559708
Hypertriglyceridaemia 17.75 11.21 112 1172889 12628 78558759
Abortion spontaneous 17.75 11.21 316 1172685 29191 78542196
Candida infection 17.73 11.21 427 1172574 37787 78533600
Dry skin 17.72 11.21 818 1172183 67177 78504210
Concomitant disease aggravated 17.71 11.21 117 1172884 13050 78558337
Therapy change 17.70 11.21 53 1172948 7346 78564041
Metabolic disorder 17.69 11.21 72 1172929 9098 78562289
Mycobacterium chelonae infection 17.64 11.21 7 1172994 2449 78568938
Skin cancer 17.64 11.21 139 1172862 14901 78556486
Red blood cell sedimentation rate increased 17.50 11.21 528 1172473 45414 78525973
Granuloma 17.39 11.21 63 1172938 8234 78563153
Gastrointestinal toxicity 17.38 11.21 61 1172940 8048 78563339
Coagulation factor X level decreased 17.28 11.21 14 1172987 101 78571286
Post-traumatic stress disorder 17.23 11.21 127 1172874 4754 78566633
Kussmaul respiration 17.22 11.21 26 1172975 401 78570986
Gene mutation 17.20 11.21 9 1172992 2677 78568710
Feeling hot 17.19 11.21 1058 1171943 58676 78512711
Product tampering 17.17 11.21 26 1172975 402 78570985
Delirium 17.15 11.21 1457 1171544 83170 78488217
Hypercalcaemia 17.13 11.21 432 1172569 37998 78533389
C-reactive protein increased 17.12 11.21 1649 1171352 127378 78444009
Infusion site mass 17.10 11.21 57 1172944 1536 78569851
Faeces discoloured 17.09 11.21 555 1172446 28572 78542815
Disability 17.07 11.21 165 1172836 16955 78554432
Erythema 17.02 11.21 3624 1169377 219666 78351721
Systemic mycosis 16.97 11.21 9 1172992 2657 78568730
Blood creatinine decreased 16.96 11.21 183 1172818 7642 78563745
Stent placement 16.86 11.21 45 1172956 6475 78564912
Neonatal respiratory acidosis 16.83 11.21 11 1172990 54 78571333
Vascular purpura 16.82 11.21 90 1172911 3008 78568379
Cholesterosis 16.76 11.21 24 1172977 352 78571035
Carotid artery occlusion 16.74 11.21 57 1172944 7590 78563797
Sputum culture positive 16.71 11.21 104 1172897 3677 78567710
Granulocytopenia 16.71 11.21 99 1172902 11332 78560055
Needle issue 16.65 11.21 118 1172883 12950 78558437
Osteoporosis 16.62 11.21 639 1172362 53473 78517914
Acute graft versus host disease in liver 16.61 11.21 4 1172997 1931 78569456
Infusion site rash 16.61 11.21 59 1172942 1643 78569744
Seizure 16.59 11.21 2480 1170521 186354 78385033
Anticipatory anxiety 16.58 11.21 47 1172954 1157 78570230
Respiratory acidosis 16.58 11.21 244 1172757 10956 78560431
Food allergy 16.50 11.21 237 1172764 10587 78560800
Parkinsonism 16.46 11.21 160 1172841 16424 78554963
Pleural thickening 16.44 11.21 87 1172914 2895 78568492
Histoplasmosis disseminated 16.42 11.21 7 1172994 2346 78569041
Apparent death 16.37 11.21 11 1172990 2854 78568533
Gallbladder cholesterolosis 16.36 11.21 32 1172969 614 78570773
Red blood cell spherocytes present 16.35 11.21 9 1172992 30 78571357
Diffuse axonal injury 16.26 11.21 14 1172987 111 78571276
Bilirubin urine present 16.22 11.21 23 1172978 334 78571053
Rhabdomyolysis 16.19 11.21 1301 1171700 101830 78469557
Glucose-6-phosphate dehydrogenase deficiency 16.17 11.21 23 1172978 335 78571052
SJS-TEN overlap 16.16 11.21 35 1172966 724 78570663
Toxic skin eruption 16.13 11.21 436 1172565 21857 78549530
Peritonitis bacterial 16.12 11.21 79 1172922 9488 78561899
Prothrombin time abnormal 16.05 11.21 44 1172957 1062 78570325
Haematuria 16.01 11.21 838 1172163 67998 78503389
Psychotic symptom 15.89 11.21 10 1172991 2687 78568700
Skin ulcer 15.86 11.21 643 1172358 53507 78517880
Drug effective for unapproved indication 15.83 11.21 41 1172960 5960 78565427
Band neutrophil percentage decreased 15.83 11.21 7 1172994 12 78571375
Injury associated with device 15.71 11.21 17 1172984 3489 78567898
Factor VIII inhibition 15.69 11.21 22 1172979 316 78571071
Euglycaemic diabetic ketoacidosis 15.68 11.21 50 1172951 6794 78564593
Tongue disorder 15.54 11.21 131 1172870 13844 78557543
Lactic acidosis 15.53 11.21 861 1172140 69498 78501889
Sleep terror 15.52 11.21 26 1172975 4432 78566955
Intraocular pressure increased 15.51 11.21 76 1172925 9129 78562258
Gallbladder adenocarcinoma 15.51 11.21 14 1172987 119 78571268
Pneumonia cytomegaloviral 15.50 11.21 31 1172970 4938 78566449
Pancreatic fibrosis 15.50 11.21 13 1172988 99 78571288
Gingival hypertrophy 15.50 11.21 14 1172987 3128 78568259
Device use issue 15.49 11.21 11 1172990 2773 78568614
Truncus coeliacus thrombosis 15.48 11.21 7 1172994 13 78571374
Long QT syndrome 15.47 11.21 41 1172960 5914 78565473
Bronchospasm 15.46 11.21 477 1172524 24382 78547005
Sudden infant death syndrome 15.44 11.21 20 1172981 265 78571122
Failure of child resistant product closure 15.40 11.21 11 1172990 64 78571323
Tuberculosis 15.35 11.21 146 1172855 15052 78556335
Retinitis 15.32 11.21 38 1172963 5605 78565782
Haematemesis 15.28 11.21 927 1172074 51337 78520050
Dermo-hypodermitis 15.27 11.21 35 1172966 753 78570634
Joint destruction 15.24 11.21 41 1172960 5884 78565503
Asthenia 15.20 11.21 7055 1165946 504634 78066753
Failure to suspend medication 15.19 11.21 26 1172975 448 78570939
Bronchial secretion retention 15.19 11.21 108 1172893 3996 78567391
Complication of device removal 15.16 11.21 21 1172980 3868 78567519
Nipple inflammation 15.16 11.21 10 1172991 50 78571337
Pneumonia streptococcal 15.08 11.21 80 1172921 2665 78568722
Device deployment issue 15.04 11.21 15 1172986 3197 78568190
Cognitive disorder 14.99 11.21 1209 1171792 68717 78502670
Migraine with aura 14.97 11.21 79 1172922 2626 78568761
Osteolysis 14.96 11.21 27 1172974 4471 78566916
Transient ischaemic attack 14.95 11.21 628 1172373 52067 78519320
Hyperlipidaemia 14.89 11.21 282 1172719 25811 78545576
Vitamin K deficiency 14.85 11.21 33 1172968 695 78570692
Nephrogenic systemic fibrosis 14.83 11.21 44 1172957 6116 78565271
Cardiospasm 14.79 11.21 16 1172985 3285 78568102
Physical disability 14.77 11.21 16 1172985 3282 78568105
Osteomyelitis 14.77 11.21 369 1172632 32496 78538891
Hyperprolactinaemia 14.74 11.21 29 1172972 4647 78566740
Multiple organ dysfunction syndrome 14.68 11.21 1546 1171455 118700 78452687
Anti-neutrophil cytoplasmic antibody positive vasculitis 14.67 11.21 20 1172981 3709 78567678
Mania 14.62 11.21 185 1172816 18075 78553312
Viral haemorrhagic cystitis 14.60 11.21 6 1172995 2055 78569332
Post cholecystectomy syndrome 14.59 11.21 23 1172978 369 78571018
Toxoplasmosis 14.56 11.21 11 1172990 2686 78568701
Fungal rhinitis 14.52 11.21 11 1172990 71 78571316
Allergy test negative 14.42 11.21 21 1172980 313 78571074
Renal failure neonatal 14.40 11.21 11 1172990 72 78571315
Osmolar gap abnormal 14.35 11.21 12 1172989 91 78571296
Enterococcal infection 14.35 11.21 154 1172847 15506 78555881
Vulvar erosion 14.30 11.21 16 1172985 180 78571207
White coat hypertension 14.30 11.21 36 1172965 824 78570563
Beta haemolytic streptococcal infection 14.30 11.21 65 1172936 2032 78569355
Cryopyrin associated periodic syndrome 14.28 11.21 23 1172978 376 78571011
Vascular graft 14.24 11.21 6 1172995 2025 78569362
Drug use disorder 14.23 11.21 192 1172809 8459 78562928
Fibrin D dimer increased 14.21 11.21 192 1172809 8462 78562925
Hyponatraemia 14.20 11.21 2893 1170108 174955 78396432
Cardiac operation 14.20 11.21 33 1172968 4979 78566408
Delusion 14.17 11.21 213 1172788 20210 78551177
Bundle branch block left 14.16 11.21 105 1172896 11408 78559979
Cyanosis neonatal 14.16 11.21 10 1172991 57 78571330
Environmental exposure 14.15 11.21 23 1172978 379 78571008
Consciousness fluctuating 14.15 11.21 62 1172939 1907 78569480
Biliary sepsis 14.06 11.21 54 1172947 1563 78569824
Psychotic disorder 14.05 11.21 483 1172518 40919 78530468
Chronic graft versus host disease in skin 14.02 11.21 3 1172998 1571 78569816
Toxicologic test abnormal 14.02 11.21 48 1172953 1312 78570075
Pulmonary tuberculosis 13.80 11.21 64 1172937 7801 78563586
Stoma site cellulitis 13.80 11.21 9 1172992 44 78571343
Haemolysis 13.79 11.21 265 1172736 12547 78558840
Hypoglycaemic coma 13.76 11.21 31 1172970 4729 78566658
Gastric ulcer perforation 13.69 11.21 65 1172936 2070 78569317
Periportal oedema 13.66 11.21 12 1172989 98 78571289
Oedematous pancreatitis 13.63 11.21 43 1172958 1125 78570262
Histoplasmosis 13.62 11.21 9 1172992 2356 78569031
Hyperleukocytosis 13.62 11.21 75 1172926 2535 78568852
Abortion induced 13.60 11.21 56 1172945 7053 78564334
Erythema multiforme 13.58 11.21 348 1172653 17303 78554084
Hypocalcaemia 13.53 11.21 598 1172403 49326 78522061
Bursitis 13.51 11.21 651 1172350 35193 78536194
Creatinine urine decreased 13.49 11.21 18 1172983 246 78571141
Urine bilirubin decreased 13.46 11.21 14 1172987 144 78571243
Tendonitis 13.46 11.21 258 1172743 23572 78547815
Eosinophil percentage increased 13.45 11.21 51 1172950 1467 78569920
Dilatation intrahepatic duct acquired 13.45 11.21 32 1172969 706 78570681
Metastases to central nervous system 13.45 11.21 165 1172836 16210 78555177
Dependent personality disorder 13.41 11.21 13 1172988 122 78571265
Left ventricular dysfunction 13.41 11.21 202 1172799 19159 78552228
Transverse sinus thrombosis 13.40 11.21 30 1172971 635 78570752
Hypoprothrombinaemia 13.34 11.21 32 1172969 710 78570677
Intestinal haemorrhage 13.33 11.21 49 1172952 6377 78565010
Thymus disorder 13.30 11.21 19 1172982 278 78571109
Mycobacterium avium complex infection 13.26 11.21 30 1172971 4570 78566817
Dystonia 13.24 11.21 228 1172773 21171 78550216
Strawberry tongue 13.24 11.21 7 1172994 21 78571366
Catatonia 13.24 11.21 75 1172926 8681 78562706
Sensitivity to weather change 13.24 11.21 67 1172934 7980 78563407
Type IIa hyperlipidaemia 13.23 11.21 18 1172983 251 78571136
Latent tuberculosis 13.18 11.21 18 1172983 3335 78568052
Cytomegalovirus colitis 13.15 11.21 31 1172970 4654 78566733
Pneumatosis intestinalis 13.13 11.21 49 1172952 6348 78565039
Musculoskeletal disorder 13.12 11.21 229 1172772 21219 78550168
Catheter management 13.09 11.21 21 1172980 3642 78567745
Hallucination 13.06 11.21 1447 1171554 84298 78487089
Leukoencephalopathy 13.06 11.21 66 1172935 7863 78563524
Exercise tolerance decreased 13.03 11.21 79 1172922 8992 78562395
Hyperkalaemia 13.01 11.21 1478 1171523 112920 78458467
Knee arthroplasty 13.00 11.21 512 1172489 42736 78528651
Dyslipidaemia 12.96 11.21 109 1172892 11524 78559863
Hepatitis non-A non-B 12.94 11.21 4 1172997 0 78571387
Analgesic drug level therapeutic 12.94 11.21 4 1172997 0 78571387
Murphy's sign positive 12.94 11.21 4 1172997 0 78571387
Blindness 12.93 11.21 318 1172683 28065 78543322
Dependence 12.91 11.21 70 1172931 2352 78569035
Epilepsy 12.88 11.21 481 1172520 40379 78531008
Electrocardiogram abnormal 12.87 11.21 171 1172830 16566 78554821
Lupus vasculitis 12.83 11.21 27 1172974 547 78570840
Anisocytosis 12.82 11.21 39 1172962 1000 78570387
Pleural fibrosis 12.81 11.21 105 1172896 4062 78567325
Erythema annulare 12.81 11.21 15 1172986 178 78571209
Anaphylactic shock 12.79 11.21 650 1172351 35346 78536041
Hemiparesis 12.77 11.21 388 1172613 33345 78538042
Stress cardiomyopathy 12.72 11.21 104 1172897 11062 78560325
Acute lymphocytic leukaemia recurrent 12.68 11.21 32 1172969 4692 78566695
Rash macular 12.67 11.21 533 1172468 28366 78543021
Sulphaemoglobinaemia 12.65 11.21 9 1172992 52 78571335
Palatal oedema 12.62 11.21 48 1172953 1383 78570004
Sinus tachycardia 12.61 11.21 664 1172337 36244 78535143
Cells in urine 12.58 11.21 16 1172985 208 78571179
Impaired quality of life 12.57 11.21 143 1172858 14243 78557144
Plasma cell myeloma recurrent 12.57 11.21 35 1172966 4966 78566421
Aspartate aminotransferase 12.54 11.21 27 1172974 556 78570831
Splenic vein thrombosis 12.53 11.21 33 1172968 777 78570610
Hypertonia 12.52 11.21 162 1172839 7070 78564317
Testicular infarction 12.52 11.21 9 1172992 53 78571334
Starvation ketoacidosis 12.41 11.21 13 1172988 135 78571252
Blood copper decreased 12.39 11.21 6 1172995 14 78571373
Anxiety 12.39 11.21 3960 1169041 244552 78326835
Autonomic dysreflexia 12.34 11.21 23 1172978 425 78570962
Vaccination site swelling 12.28 11.21 8 1172993 39 78571348
Procalcitonin increased 12.25 11.21 81 1172920 2925 78568462
Therapeutic product effect decreased 12.22 11.21 2172 1170829 161691 78409696
Arthritis 12.20 11.21 1491 1171510 113389 78457998
pH urine increased 12.19 11.21 23 1172978 429 78570958
Body tinea 12.19 11.21 6 1172995 1848 78569539
Diffuse large B-cell lymphoma 12.15 11.21 117 1172884 12032 78559355
Eosinophilic granulomatosis with polyangiitis 12.15 11.21 22 1172979 3638 78567749
Bradycardia neonatal 12.15 11.21 10 1172991 74 78571313
Cerebral haemorrhage 12.14 11.21 709 1172292 56964 78514423
Asphyxia 12.13 11.21 241 1172760 11479 78559908
Blood triglycerides increased 12.13 11.21 227 1172774 20813 78550574
Ductus arteriosus premature closure 12.13 11.21 8 1172993 40 78571347
Paresis 12.12 11.21 28 1172973 4233 78567154
Pharyngeal disorder 12.04 11.21 65 1172936 2180 78569207
Hypermagnesaemia 12.04 11.21 43 1172958 1201 78570186
Use of accessory respiratory muscles 12.03 11.21 25 1172976 502 78570885
Subarachnoid haemorrhage 12.01 11.21 271 1172730 24194 78547193
Death 11.97 11.21 7892 1165109 558622 78012765
Breast cancer stage IV 11.97 11.21 7 1172994 1957 78569430
Coronary artery occlusion 11.95 11.21 156 1172845 15159 78556228
Muscular weakness 11.93 11.21 2131 1170870 158598 78412789
Allodynia 11.93 11.21 52 1172949 1596 78569791
Prescription form tampering 11.91 11.21 21 1172980 371 78571016
Adenovirus infection 11.90 11.21 74 1172927 8373 78563014
Hypomagnesaemia 11.89 11.21 566 1172435 46345 78525042
Respiratory alkalosis 11.87 11.21 106 1172895 4205 78567182
Nephropathy toxic 11.86 11.21 220 1172781 20199 78551188
Embolic stroke 11.85 11.21 67 1172934 7759 78563628
Aminoaciduria 11.83 11.21 21 1172980 373 78571014
Glucose tolerance impaired 11.82 11.21 70 1172931 8014 78563373
Urobilinogen urine increased 11.79 11.21 29 1172972 654 78570733
Glutathione synthetase deficiency 11.78 11.21 7 1172994 28 78571359
Paranoid personality disorder 11.78 11.21 7 1172994 28 78571359
Jaundice neonatal 11.77 11.21 13 1172988 144 78571243
Leukaemia 11.76 11.21 46 1172955 5879 78565508
Open globe injury 11.74 11.21 10 1172991 78 78571309
Headache 11.70 11.21 10093 1162908 643679 77927708
Blood magnesium increased 11.69 11.21 90 1172911 3416 78567971
End stage renal disease 11.67 11.21 119 1172882 12101 78559286
Stem cell transplant 11.65 11.21 23 1172978 3681 78567706
Hypervolaemia 11.64 11.21 511 1172490 42179 78529208
Internal haemorrhage 11.62 11.21 79 1172922 8754 78562633
Scoliosis 11.60 11.21 164 1172837 7300 78564087
Congenital central hypoventilation syndrome 11.60 11.21 7 1172994 29 78571358
Herpes zoster 11.60 11.21 1195 1171806 91888 78479499
Ischaemic cardiomyopathy 11.59 11.21 66 1172935 7629 78563758
Vasoconstriction 11.56 11.21 30 1172971 700 78570687
Sarcopenia 11.53 11.21 23 1172978 448 78570939
Immunisation 11.49 11.21 9 1172992 2158 78569229
Disseminated tuberculosis 11.49 11.21 28 1172973 4155 78567232
Metastasis 11.48 11.21 57 1172944 6823 78564564
Acute respiratory failure 11.47 11.21 738 1172263 58803 78512584
Device breakage 11.46 11.21 101 1172900 10574 78560813
Hyperammonaemia 11.45 11.21 106 1172895 10987 78560400
Periorbital cellulitis 11.45 11.21 35 1172966 900 78570487
Polydipsia 11.44 11.21 54 1172947 6551 78564836
Rebound effect 11.42 11.21 61 1172940 7165 78564222
Capillary nail refill test abnormal 11.41 11.21 8 1172993 45 78571342
Noninfective encephalitis 11.40 11.21 27 1172974 594 78570793
Gallbladder hypofunction 11.39 11.21 25 1172976 522 78570865
High density lipoprotein decreased 11.39 11.21 33 1172968 4622 78566765
Choluria 11.38 11.21 21 1172980 385 78571002
Calciphylaxis 11.36 11.21 24 1172977 3746 78567641
Hyperprolinaemia 11.35 11.21 6 1172995 18 78571369
Depression 11.35 11.21 2924 1170077 213866 78357521
Thyroid cancer 11.34 11.21 43 1172958 5545 78565842
Blood glucose abnormal 11.33 11.21 100 1172901 10466 78560921
Mean cell haemoglobin concentration decreased 11.31 11.21 110 1172891 4469 78566918
Actinic keratosis 11.31 11.21 48 1172953 5994 78565393
Dermatitis atopic 11.30 11.21 94 1172907 9962 78561425
Complication associated with device 11.29 11.21 185 1172816 17311 78554076
Hyperhidrosis 11.27 11.21 2456 1170545 149036 78422351
Infection masked 11.21 11.21 12 1172989 128 78571259

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 30.99 13.82 17 894 90 88791
Analgesic drug level increased 25.23 13.82 7 904 0 88881
Overdose 16.94 13.82 9 902 44 88837
Incorrect dosage administered 15.15 13.82 6 905 12 88869

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 | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 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;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 10532036 Sept. 22, 2025 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 ZEVRA THERAP N208653 Jan. 4, 2019 DISCN 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 ZEVRA THERAP N208653 Feb. 23, 2018 DISCN 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 ZEVRA THERAP N208653 Jan. 4, 2019 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 11197830 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 11534407 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

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
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL March 1, 2026 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
Transient receptor potential cation channel subfamily V member 4 Ion channel INHIBITOR IC50 6.52 IUPHAR
Myoglobin Unclassified IC50 5.64 CHEMBL
Transient receptor potential cation channel subfamily V member 4 Ion channel INHIBITOR IC50 6.52 IUPHAR
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
1983 PUBCHEM_CID
387517004 SNOMEDCT_US
90332006 SNOMEDCT_US
D000082 MESH_DESCRIPTOR_UI
626 INN_ID
4017513 VANDF
4119 MMSL
4973 MMSL
4992 MMSL
5005 MMSL
52845 MMSL
97317 MMSL
d00049 MMSL
362O9ITL9D UNII
001605 NDDF

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 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 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 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 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
Robitussin Honey Severe Cough, Flu Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8771 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Direct Sore Throat Pain HUMAN OTC DRUG LABEL 1 0031-9301 TABLET, COATED 500 mg ORAL OTC monograph not final 15 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 0054-0650 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
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 0067-2000 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 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