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

Stem definitionDrug idCAS RN
916 58-73-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • benadryl
  • diphenhydramine salicylate
  • diphenhydramine laurylsulfate
  • diphenhydramine
  • benzhydramine
  • probedryl
  • diphenhydramine hydrochloride
  • diphenhydramine citrate
  • diphenhydramine HCl
A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
  • Molecular weight: 255.36
  • Formula: C17H21NO
  • CLOGP: 3.45
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -3.53
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O
0.30 g O
0.20 g R
0.30 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.26 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.19 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 4, 1946 FDA MCNEIL CONS

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
Completed suicide 3101.34 10.30 5074 500168 126815 49973067
Toxicity to various agents 2563.21 10.30 6178 499064 206321 49893561
Infusion related reaction 1174.18 10.30 4042 501200 165515 49934367
Sinusitis 506.79 10.30 3173 502069 167385 49932497
Overdose 454.37 10.30 2087 503155 97640 50002242
Drug abuse 441.76 10.30 1459 503783 58387 50041495
Urticaria 426.50 10.30 2476 502766 127085 49972797
Exposure to toxic agent 426.41 10.30 327 504915 3331 50096551
Intentional product misuse 373.59 10.30 1171 504071 45563 50054319
Blood pressure fluctuation 371.93 10.30 986 504256 34837 50065045
Acute hepatic failure 357.60 10.30 596 504646 15081 50084801
Pruritus 337.17 10.30 4316 500926 279252 49820630
Flushing 318.96 10.30 1421 503821 65594 50034288
Respiratory arrest 300.45 10.30 815 504427 29194 50070688
Muscle injury 295.77 10.30 929 504313 36182 50063700
Folliculitis 291.82 10.30 959 504283 38266 50061616
Product dose omission issue 276.72 10.30 926 504316 182912 49916970
Cardio-respiratory arrest 261.15 10.30 1149 504093 52743 50047139
Irritable bowel syndrome 244.91 10.30 1091 504151 50350 50049532
Drug ineffective 234.71 10.30 6314 498928 813019 49286863
Injection site pain 229.65 10.30 477 504765 110547 49989335
Lower respiratory tract infection 227.90 10.30 1680 503562 93521 50006361
Metabolic acidosis 209.99 10.30 856 504386 37969 50061913
Throat irritation 199.23 10.30 710 504532 29529 50070353
Impaired healing 197.41 10.30 1283 503959 68503 50031379
Device expulsion 196.94 10.30 27 505215 28795 50071087
Diarrhoea 196.84 10.30 4429 500813 584047 49515835
Ill-defined disorder 186.47 10.30 1055 504187 53599 50046283
Anion gap 183.84 10.30 124 505118 1013 50098869
Sleep disorder due to general medical condition, insomnia type 181.02 10.30 707 504535 30740 50069142
Intentional overdose 179.15 10.30 1153 504089 61351 50038531
Exposure via ingestion 171.97 10.30 174 505068 2629 50097253
Blister 170.14 10.30 1445 503797 83973 50015909
Hypersensitivity 169.85 10.30 3055 502187 212106 49887776
Body temperature increased 168.69 10.30 690 504552 30651 50069231
Cardiac failure 164.66 10.30 318 504924 75722 50024160
Blood pressure increased 164.02 10.30 2041 503201 131091 49968791
Anaemia 163.80 10.30 1670 503572 250786 49849096
Nasopharyngitis 162.52 10.30 2768 502474 190159 49909723
Oxygen saturation decreased 155.98 10.30 1258 503984 71990 50027892
Drug interaction 154.88 10.30 1262 503980 198359 49901523
Acute kidney injury 154.44 10.30 1493 503749 226565 49873317
Sopor 150.07 10.30 13 505229 19866 50080016
Intentional product use issue 148.87 10.30 1293 503949 75625 50024257
Poisoning 145.45 10.30 358 504884 12071 50087811
Blood pressure diastolic abnormal 144.55 10.30 301 504941 9060 50090822
Heart rate increased 138.94 10.30 1278 503964 75972 50023910
Urine abnormality 138.05 10.30 234 505008 6004 50093878
Neutropenia 135.62 10.30 892 504350 147073 49952809
Cardiac failure congestive 135.23 10.30 413 504829 83969 50015913
Hereditary angioedema 135.09 10.30 215 505027 5227 50094655
Wrong technique in product usage process 133.86 10.30 217 505025 55293 50044589
Blood pressure systolic increased 133.50 10.30 703 504539 34746 50065136
Infusion site pain 132.37 10.30 344 504898 12002 50087880
Hepatotoxicity 131.48 10.30 580 504662 26646 50073236
Psoriasis 128.33 10.30 314 504928 68686 50031196
Infusion site swelling 120.61 10.30 239 505003 6937 50092945
Heart rate decreased 120.20 10.30 698 504544 35799 50064083
Helicobacter infection 115.40 10.30 871 504371 48831 50051051
Therapeutic product effect incomplete 114.85 10.30 496 504746 91019 50008863
Blood pressure systolic abnormal 113.43 10.30 243 504999 7463 50092419
Duodenal ulcer perforation 113.14 10.30 812 504430 44799 50055083
Osteonecrosis of jaw 111.80 10.30 96 505146 32430 50067452
Medication error 110.90 10.30 678 504564 35426 50064456
Injection site erythema 110.87 10.30 380 504862 74556 50025326
Rheumatoid arthritis 108.10 10.30 2717 502525 199833 49900049
Malignant neoplasm progression 107.32 10.30 336 504906 67788 50032094
Hospitalisation 106.38 10.30 336 504906 67601 50032281
Throat tightness 104.40 10.30 449 504793 20398 50079484
Drug resistance 104.30 10.30 30 505212 18959 50080923
Urine leukocyte esterase positive 103.98 10.30 136 505106 2747 50097135
Renal impairment 103.13 10.30 397 504845 75264 50024618
Stomatitis 102.63 10.30 1500 503742 99844 50000038
Infusion site erythema 101.73 10.30 251 504991 8476 50091406
Therapy cessation 100.61 10.30 68 505174 25943 50073939
Gastrointestinal disorder 99.20 10.30 1407 503835 93049 50006833
Injection site bruising 98.10 10.30 134 505108 36634 50063248
Pancytopenia 93.89 10.30 475 504767 83555 50016327
Weight increased 93.06 10.30 2657 502585 199234 49900648
Myocardial infarction 91.83 10.30 517 504725 88510 50011372
Peripheral swelling 90.75 10.30 2695 502547 203241 49896641
Hyperkalaemia 88.50 10.30 220 505022 47869 50052013
Suspected suicide 88.33 10.30 177 505065 5180 50094702
Analgesic drug level increased 87.62 10.30 97 505145 1634 50098248
Food allergy 87.51 10.30 227 505015 7910 50091972
Chest discomfort 87.13 10.30 1355 503887 91367 50008515
Infusion site extravasation 87.06 10.30 206 505036 6770 50093112
Rash 86.30 10.30 5260 499982 432211 49667671
Anti-cyclic citrullinated peptide antibody positive 83.79 10.30 1075 504167 69512 50030370
Cardiac arrest 83.06 10.30 1234 504008 82417 50017465
Lymphocyte count decreased 82.68 10.30 497 504745 25810 50074072
Pericarditis 81.76 10.30 1170 504072 77519 50022363
Abortion spontaneous 80.92 10.30 186 505056 41586 50058296
Hepatic enzyme increased 80.85 10.30 1868 503374 135512 49964370
Crystal urine present 80.54 10.30 86 505156 1388 50098494
White blood cells urine positive 80.00 10.30 155 505087 4423 50095459
Ear pain 79.94 10.30 520 504722 27763 50072119
Interstitial lung disease 79.77 10.30 268 504974 52908 50046974
Blood pressure diastolic decreased 79.14 10.30 355 504887 16426 50083456
Joint swelling 79.00 10.30 3095 502147 242191 49857691
Synovitis 77.52 10.30 1699 503543 122166 49977716
Infusion site pruritus 75.88 10.30 139 505103 3798 50096084
Coagulopathy 74.66 10.30 366 504876 17578 50082304
Hyponatraemia 74.36 10.30 608 504634 95531 50004351
Pharyngitis 73.53 10.30 358 504884 17145 50082737
Urinary sediment present 73.49 10.30 95 505147 1896 50097986
Depressed level of consciousness 73.42 10.30 818 504424 51135 50048747
Thrombocytopenia 73.31 10.30 868 504374 126805 49973077
Sedation complication 72.18 10.30 222 505020 8544 50091338
Hepatic cytolysis 71.23 10.30 210 505032 7893 50091989
Fall 70.77 10.30 2682 502560 332250 49767632
Ear infection 70.68 10.30 473 504769 25497 50074385
Erythema 70.52 10.30 1938 503304 144476 49955406
Cerebrovascular accident 70.41 10.30 605 504637 94075 50005807
Acute lung injury 70.40 10.30 78 505164 1315 50098567
Deafness transitory 69.93 10.30 88 505154 1708 50098174
Pneumonia 69.34 10.30 3080 502162 375321 49724561
Temperature regulation disorder 67.71 10.30 138 505104 4089 50095793
Product substitution issue 67.22 10.30 28 505214 14029 50085853
Posterior reversible encephalopathy syndrome 66.30 10.30 33 505209 14895 50084987
Therapeutic product effect decreased 65.28 10.30 1800 503442 134250 49965632
Chills 64.28 10.30 1338 503904 95349 50004533
Product prescribing error 63.74 10.30 69 505173 20892 50078990
Tachycardia 63.55 10.30 1372 503870 98391 50001491
Red blood cells urine positive 62.61 10.30 105 505137 2670 50097212
Poor venous access 61.56 10.30 235 505007 10105 50089777
Alopecia 61.51 10.30 1920 503322 243127 49856755
Hepatic necrosis 61.23 10.30 151 505091 5097 50094785
Renal failure 61.19 10.30 725 504517 105908 49993974
Anticholinergic syndrome 60.63 10.30 82 505160 1713 50098169
Neoplasm progression 60.46 10.30 125 505117 29032 50070850
Disease progression 59.65 10.30 640 504602 95226 50004656
Foetal exposure during pregnancy 59.56 10.30 114 505128 27245 50072637
Bone marrow failure 59.36 10.30 116 505126 27508 50072374
Cholecystitis chronic 58.60 10.30 221 505021 9448 50090434
Injury 58.43 10.30 746 504496 48179 50051703
Oedema peripheral 58.22 10.30 1169 504073 156792 49943090
Respiratory rate increased 56.84 10.30 245 504997 11140 50088742
Lactic acidosis 56.50 10.30 159 505083 33196 50066686
Neuropathy peripheral 56.23 10.30 656 504586 96101 50003781
Diabetes mellitus 56.00 10.30 275 504967 48758 50051124
Product storage error 55.85 10.30 26 505216 12198 50087684
Feeling hot 55.73 10.30 618 504624 38584 50061298
Osteoarthritis 54.83 10.30 430 504812 68176 50031706
Discomfort 54.28 10.30 1442 503800 106938 49992944
Muscle spasticity 54.22 10.30 325 504917 16859 50083023
Maternal exposure during pregnancy 53.75 10.30 1200 504042 158578 49941304
Creatinine renal clearance decreased 53.54 10.30 248 504994 11633 50088249
No adverse event 53.30 10.30 165 505077 33413 50066469
Hepatic failure 52.52 10.30 523 504719 31760 50068122
Ear pruritus 52.29 10.30 92 505150 2434 50097448
Breast cancer 52.24 10.30 235 505007 42655 50057227
Red cell distribution width increased 52.17 10.30 196 505046 8363 50091519
Heart rate irregular 51.72 10.30 351 504891 19009 50080873
Epilepsy 51.34 10.30 85 505157 21482 50078400
Therapy interrupted 50.26 10.30 77 505165 20075 50079807
Injection site reaction 50.25 10.30 293 504949 49739 50050143
Respiratory depression 49.98 10.30 245 504997 11765 50088117
Product quality issue 48.72 10.30 152 505090 30706 50069176
Sepsis 48.29 10.30 986 504256 131939 49967943
Septic shock 48.22 10.30 353 504889 56822 50043060
Blood urine present 47.96 10.30 254 504988 12579 50087303
Pyroglutamate increased 47.76 10.30 37 505205 383 50099499
Lymphocyte percentage decreased 47.68 10.30 93 505149 2667 50097215
Device malfunction 46.84 10.30 49 505193 15072 50084810
Infusion site bruising 46.75 10.30 83 505159 2212 50097670
Blood calcium decreased 46.44 10.30 360 504882 20346 50079536
Atrial fibrillation 46.38 10.30 725 504517 101020 49998862
Swelling 46.37 10.30 2451 502791 198421 49901461
Dyspnoea exertional 46.30 10.30 310 504932 50923 50048959
Syncope 45.93 10.30 737 504505 102265 49997617
Blood pressure diastolic increased 45.83 10.30 171 505071 7272 50092610
Urine ketone body present 45.76 10.30 83 505159 2250 50097632
Leukopenia 45.63 10.30 442 504800 67086 50032796
Accidental overdose 45.15 10.30 342 504900 19191 50080691
Pulmonary hypertension 45.10 10.30 176 505066 33241 50066641
Myelodysplastic syndrome 44.70 10.30 51 505191 15081 50084801
Treatment failure 44.51 10.30 1040 504202 136597 49963285
Product use in unapproved indication 44.21 10.30 852 504390 114967 49984915
Infusion site nodule 43.53 10.30 55 505187 1072 50098810
Accidental death 43.42 10.30 69 505173 1675 50098207
Bone erosion 43.29 10.30 32 505210 11655 50088227
Pulmonary arterial hypertension 43.07 10.30 86 505156 20233 50079649
Body temperature decreased 43.06 10.30 296 504946 16099 50083783
Postmortem blood drug level increased 42.98 10.30 40 505202 542 50099340
Diabetic ketoacidosis 42.95 10.30 70 505172 17802 50082080
Respiratory failure 42.82 10.30 646 504596 90535 50009347
Injection site pruritus 42.56 10.30 233 505009 40178 50059704
Device dislocation 42.49 10.30 95 505147 21451 50078431
Neutrophil percentage increased 42.47 10.30 88 505154 2639 50097243
Cytomegalovirus infection 41.64 10.30 72 505170 17890 50081992
Pneumocystis jirovecii pneumonia 41.63 10.30 51 505191 14612 50085270
Mucosal inflammation 41.43 10.30 233 505009 39909 50059973
Anaphylactic reaction 41.29 10.30 764 504478 53291 50046591
Pneumonia viral 41.24 10.30 156 505086 6678 50093204
Cerebral haemorrhage 40.80 10.30 136 505106 26916 50072966
Gait disturbance 40.65 10.30 1163 504079 148842 49951040
Haematotoxicity 40.63 10.30 14 505228 7881 50092001
Hypertensive crisis 40.33 10.30 43 505199 13111 50086771
Administration site swelling 40.29 10.30 51 505191 996 50098886
Infection 40.24 10.30 2112 503130 170842 49929040
Rash erythematous 40.17 10.30 528 504714 34324 50065558
Pyroglutamic acidosis 39.77 10.30 34 505208 409 50099473
Immunodeficiency 39.71 10.30 269 504973 14559 50085323
Hepatocellular injury 39.44 10.30 130 505112 25817 50074065
Cognitive disorder 39.23 10.30 639 504603 43484 50056398
Psoriatic arthropathy 38.88 10.30 292 504950 46740 50053142
Death 38.85 10.30 3762 501480 321617 49778265
Anion gap abnormal 38.07 10.30 30 505212 319 50099563
Polyneuropathy 37.93 10.30 39 505203 12092 50087790
Electric shock 37.86 10.30 49 505193 979 50098903
Intentional self-injury 37.81 10.30 112 505130 23000 50076882
Surgery 37.69 10.30 164 505078 30041 50069841
Pyrexia 37.27 10.30 4338 500904 375865 49724017
Visual acuity reduced 37.15 10.30 92 505150 20047 50079835
Hypocalcaemia 36.98 10.30 140 505102 26676 50073206
Osteonecrosis 36.20 10.30 110 505132 22407 50077475
Hypokalaemia 36.16 10.30 639 504603 87353 50012529
Injection site haemorrhage 35.97 10.30 102 505140 21244 50078638
Body temperature fluctuation 35.95 10.30 68 505174 1905 50097977
Fracture 35.89 10.30 71 505171 16762 50083120
Full blood count abnormal 35.67 10.30 117 505125 23271 50076611
Injection site swelling 35.18 10.30 258 504984 41515 50058367
Pathogen resistance 35.15 10.30 7 505235 5682 50094200
Gastrointestinal haemorrhage 34.93 10.30 518 504724 72803 50027079
Febrile bone marrow aplasia 34.61 10.30 10 505232 6301 50093581
Myelosuppression 34.33 10.30 51 505191 13466 50086416
Second primary malignancy 34.33 10.30 13 505229 6901 50092981
Right ventricular failure 33.92 10.30 67 505175 15826 50084056
Culture urine positive 33.80 10.30 93 505149 3358 50096524
Premature delivery 33.64 10.30 122 505120 23541 50076341
Memory impairment 33.35 10.30 574 504668 78786 50021096
Administration site pain 33.07 10.30 37 505205 631 50099251
Gastrooesophageal reflux disease 32.70 10.30 551 504691 75877 50024005
Transient ischaemic attack 32.68 10.30 188 505054 32022 50067860
Brain death 32.39 10.30 80 505162 2703 50097179
Coronary artery disease 32.08 10.30 170 505072 29556 50070326
Night sweats 32.03 10.30 492 504750 33082 50066800
Inappropriate antidiuretic hormone secretion 32.03 10.30 51 505191 13092 50086790
Injection site warmth 31.76 10.30 56 505186 13810 50086072
Headache 31.71 10.30 5631 499611 500904 49598978
Incorrect drug administration rate 31.49 10.30 76 505166 2530 50097352
Multiple organ dysfunction syndrome 31.31 10.30 336 504906 50001 50049881
Malaise 31.29 10.30 2904 502338 332628 49767254
Heart rate abnormal 30.93 10.30 99 505143 3893 50095989
Infusion site mass 30.84 10.30 48 505194 1144 50098738
Haemoglobin urine present 30.60 10.30 39 505203 767 50099115
Specific gravity urine decreased 30.55 10.30 36 505206 651 50099231
Suicidal ideation 30.45 10.30 380 504862 55005 50044877
Dehydration 30.09 10.30 1230 504012 151219 49948663
Mydriasis 29.79 10.30 195 505047 10432 50089450
Disease recurrence 29.57 10.30 102 505140 19979 50079903
Alanine aminotransferase increased 29.57 10.30 1120 504122 87239 50012643
Gestational diabetes 29.57 10.30 19 505223 7446 50092436
Soft tissue disorder 29.52 10.30 101 505141 4113 50095769
Decreased appetite 29.42 10.30 1673 503569 199250 49900632
Urine analysis abnormal 29.38 10.30 103 505139 4247 50095635
Respiratory disorder 29.36 10.30 456 504786 30731 50069151
Emotional distress 29.28 10.30 425 504817 28238 50071644
Palmar-plantar erythrodysaesthesia syndrome 28.98 10.30 103 505139 19995 50079887
Metastases to bone 28.86 10.30 88 505154 17907 50081975
Agranulocytosis 28.79 10.30 113 505129 21308 50078574
Chronic kidney disease 28.72 10.30 256 504986 39515 50060367
Ischaemic stroke 28.53 10.30 74 505168 15874 50084008
Gastrointestinal pain 28.45 10.30 157 505085 7899 50091983
Unresponsive to stimuli 28.23 10.30 446 504796 30163 50069719
Labelled drug-drug interaction medication error 28.13 10.30 38 505204 10439 50089443
Infusion site discomfort 27.98 10.30 39 505203 839 50099043
Exposure during pregnancy 27.97 10.30 958 504284 120057 49979825
Bacterial test positive 27.83 10.30 107 505135 4616 50095266
Thrombotic microangiopathy 27.78 10.30 28 505214 8763 50091119
Hyperglycaemia 27.78 10.30 231 505011 36174 50063708
Transplant rejection 27.72 10.30 33 505209 9576 50090306
Injection site rash 27.48 10.30 77 505165 16100 50083782
Hypotension 27.41 10.30 2718 502524 232751 49867131
Unintentional medical device removal 27.35 10.30 10 505232 5425 50094457
Injection site mass 27.11 10.30 74 505168 15606 50084276
General physical health deterioration 27.09 10.30 1154 504088 141280 49958602
Meningitis aseptic 26.92 10.30 97 505145 4055 50095827
Lung neoplasm malignant 26.83 10.30 73 505169 15411 50084471
Infusion site rash 26.65 10.30 48 505194 1294 50098588
Toxicologic test abnormal 26.64 10.30 32 505210 591 50099291
Serum sickness 26.58 10.30 70 505172 2462 50097420
Bacterial test 26.40 10.30 44 505198 1113 50098769
Device difficult to use 26.40 10.30 36 505206 9850 50090032
Cardiac failure acute 26.39 10.30 26 505216 8224 50091658
Post transplant lymphoproliferative disorder 26.34 10.30 5 505237 4199 50095683
Opiates positive 26.16 10.30 24 505218 319 50099563
Arthralgia 26.15 10.30 4865 500377 433837 49666045
Hepatic cirrhosis 26.07 10.30 89 505153 17488 50082394
Treatment noncompliance 25.97 10.30 185 505057 29965 50069917
Accidental exposure to product 25.93 10.30 130 505112 22927 50076955
Blood pH decreased 25.90 10.30 68 505174 2387 50097495
Haematocrit decreased 25.55 10.30 491 504751 34485 50065397
Electrolyte imbalance 25.42 10.30 87 505155 17082 50082800
Anion gap increased 25.28 10.30 50 505192 1449 50098433
Therapeutic response decreased 25.24 10.30 326 504916 46905 50052977
Infusion site urticaria 25.23 10.30 40 505202 969 50098913
Metastases to liver 25.18 10.30 109 505133 19995 50079887
Upper respiratory tract infection 25.17 10.30 848 504394 65050 50034832
Electrocardiogram QRS complex prolonged 25.16 10.30 113 505129 5231 50094651
Complication associated with device 24.71 10.30 70 505172 14585 50085297
Transplant dysfunction 24.64 10.30 8 505234 4676 50095206
Full blood count decreased 24.55 10.30 127 505115 22219 50077663
Haemophagocytic lymphohistiocytosis 24.53 10.30 30 505212 8603 50091279
Incorrect dose administered by device 24.35 10.30 3 505239 3472 50096410
Sedation 24.20 10.30 435 504807 30175 50069707
Spinal stenosis 24.14 10.30 63 505179 13487 50086395
Substance abuse 23.95 10.30 93 505149 4031 50095851
Administration site erythema 23.73 10.30 28 505214 507 50099375
Neurotoxicity 23.70 10.30 72 505170 14668 50085214
Renal disorder 23.58 10.30 169 505073 27336 50072546
Pharyngeal paraesthesia 23.58 10.30 48 505194 1421 50098461
Depression 23.56 10.30 1381 503861 164042 49935840
Arthropathy 23.50 10.30 1856 503386 156050 49943832
Bursitis 23.32 10.30 330 504912 21805 50078077
Atypical femur fracture 23.17 10.30 10 505232 4906 50094976
Iron deficiency anaemia 23.14 10.30 88 505154 16746 50083136
Analgesic drug level above therapeutic 23.08 10.30 17 505225 162 50099720
Brain oedema 22.90 10.30 206 505036 12164 50087718
Muscle spasms 22.89 10.30 1022 504220 124531 49975351
Therapeutic response shortened 22.83 10.30 139 505103 7250 50092632
Drug reaction with eosinophilia and systemic symptoms 22.77 10.30 178 505064 28246 50071636
Sexual dysfunction 22.69 10.30 3 505239 3289 50096593
Haemorrhage 22.62 10.30 386 504856 53055 50046827
Acute myeloid leukaemia 22.58 10.30 76 505166 14998 50084884
Pain 22.58 10.30 6295 498947 572608 49527274
Lung disorder 22.56 10.30 313 504929 44486 50055396
Joint stiffness 22.37 10.30 194 505048 30114 50069768
Tongue disorder 22.23 10.30 163 505079 9053 50090829
Contusion 22.19 10.30 1350 503892 110833 49989049
Vitamin K deficiency 21.92 10.30 24 505218 399 50099483
Hand deformity 21.77 10.30 1216 504026 98983 50000899
Hypomania 21.77 10.30 96 505146 4409 50095473
Condition aggravated 21.74 10.30 2615 502627 294443 49805439
Drug screen positive 21.65 10.30 79 505163 3323 50096559
Epistaxis 21.57 10.30 480 504762 63474 50036408
Device use error 21.41 10.30 13 505229 5253 50094629
Abortion induced 21.17 10.30 38 505204 9306 50090576
Unevaluable event 21.06 10.30 328 504914 45738 50054144
Infusion site haemorrhage 21.05 10.30 72 505170 2932 50096950
Hip fracture 20.96 10.30 162 505080 25769 50074113
Cerebral infarction 20.91 10.30 128 505114 21476 50078406
Platelet count decreased 20.88 10.30 808 504434 99918 49999964
Blood glucose increased 20.85 10.30 547 504695 70777 50029105
Multiple-drug resistance 20.64 10.30 4 505238 3310 50096572
Hypoglycaemia 20.48 10.30 394 504848 53187 50046695
Acute graft versus host disease 20.40 10.30 7 505235 3951 50095931
Subdural haematoma 20.28 10.30 64 505178 12883 50086999
Suicide attempt 20.09 10.30 667 504575 51065 50048817
Device issue 20.03 10.30 117 505125 19855 50080027
Serum sickness-like reaction 19.82 10.30 24 505218 447 50099435
Macular oedema 19.65 10.30 6 505236 3648 50096234
Altered state of consciousness 19.58 10.30 133 505109 21777 50078105
Coeliac disease 19.48 10.30 151 505091 8534 50091348
Endophthalmitis 19.30 10.30 3 505239 2913 50096969
Acute myocardial infarction 19.18 10.30 193 505049 29080 50070802
Lumbar vertebral fracture 19.18 10.30 11 505231 4586 50095296
Myalgia 19.13 10.30 1030 504212 123289 49976593
White blood cell count decreased 19.11 10.30 961 504281 115761 49984121
Urticaria thermal 19.00 10.30 15 505227 160 50099722
Jaundice cholestatic 18.99 10.30 101 505141 5010 50094872
Blood creatinine decreased 18.94 10.30 99 505143 4877 50095005
Metastases to central nervous system 18.94 10.30 54 505188 11228 50088654
Bronchopulmonary aspergillosis 18.94 10.30 29 505213 7563 50092319
Orthostatic hypotension 18.93 10.30 406 504836 29075 50070807
Chronic obstructive pulmonary disease 18.90 10.30 398 504844 53037 50046845
Hypothyroidism 18.80 10.30 234 505008 33891 50065991
Confusional state 18.64 10.30 2125 503117 183803 49916079
Ascites 18.62 10.30 249 504993 35612 50064270
Shoulder arthroplasty 18.62 10.30 76 505166 3372 50096510
Specific gravity urine increased 18.61 10.30 16 505226 194 50099688
Spinal fracture 18.56 10.30 86 505156 15487 50084395
Galactorrhoea 18.48 10.30 7 505235 3716 50096166
Cardiotoxicity 18.35 10.30 26 505216 7001 50092881
Metastases to lymph nodes 18.33 10.30 26 505216 6998 50092884
Ageusia 18.32 10.30 57 505185 11526 50088356
Oral pruritus 18.24 10.30 47 505195 1631 50098251
Cytokine release syndrome 18.20 10.30 148 505094 8486 50091396
Drug ineffective for unapproved indication 18.12 10.30 131 505111 21150 50078732
Immune reconstitution inflammatory syndrome 18.09 10.30 17 505225 5499 50094383
Hyperlipidaemia 17.79 10.30 102 505140 17388 50082494
Infusion site streaking 17.68 10.30 22 505220 422 50099460
Arrhythmia 17.58 10.30 229 505013 32903 50066979
Low turnover osteopathy 17.48 10.30 9 505233 3985 50095897
Infusion site irritation 17.35 10.30 26 505216 599 50099283
Pancreatic carcinoma 17.23 10.30 22 505220 6192 50093690
Kidney infection 17.23 10.30 273 504969 18473 50081409
Seizure 17.14 10.30 982 504260 116892 49982990
Left ventricular dysfunction 17.12 10.30 51 505191 10455 50089427
Oedema 17.05 10.30 552 504690 69629 50030253
Intermenstrual bleeding 17.02 10.30 26 505216 6788 50093094
Aphasia 17.00 10.30 192 505050 28302 50071580
Adrenergic syndrome 16.97 10.30 8 505234 29 50099853
Nitrite urine present 16.95 10.30 32 505210 895 50098987
Coma 16.93 10.30 712 504530 56167 50043715
Pneumonia aspiration 16.93 10.30 213 505029 30791 50069091
Vertigo 16.92 10.30 391 504851 51441 50048441
Aspartate aminotransferase increased 16.83 10.30 946 504296 77052 50022830
Diffuse large B-cell lymphoma 16.82 10.30 19 505223 5643 50094239
Pain in jaw 16.77 10.30 276 504966 38152 50061730
Ejection fraction decreased 16.76 10.30 112 505130 18408 50081474
Chronic graft versus host disease 16.75 10.30 4 505238 2863 50097019
Hemiplegia 16.73 10.30 30 505212 7351 50092531
Anxiety 16.62 10.30 2021 503221 175585 49924297
Injection site induration 16.57 10.30 37 505205 8360 50091522
Administration site bruise 16.54 10.30 17 505225 262 50099620
Femoral neck fracture 16.49 10.30 31 505211 7459 50092423
Product residue present 16.48 10.30 8 505234 3664 50096218
Infusion site warmth 16.46 10.30 41 505201 1393 50098489
Large intestine polyp 16.44 10.30 30 505212 7302 50092580
Administration site reaction 16.25 10.30 15 505227 201 50099681
Pericardial effusion 16.24 10.30 170 505072 25419 50074463
Urinary casts 16.19 10.30 26 505216 637 50099245
Complication of device insertion 16.13 10.30 22 505220 6019 50093863
Graft versus host disease in skin 16.10 10.30 3 505239 2553 50097329
Dizziness 15.99 10.30 3132 502110 343237 49756645
Wound 15.98 10.30 1245 503997 104549 49995333
Vein rupture 15.92 10.30 30 505212 838 50099044
Graft versus host disease 15.92 10.30 23 505219 6143 50093739
Multiple drug therapy 15.90 10.30 49 505193 1888 50097994
Pleural effusion 15.89 10.30 658 504584 80796 50019086
Impaired work ability 15.86 10.30 76 505166 13564 50086318
Angina pectoris 15.81 10.30 176 505066 26012 50073870
Prothrombin time prolonged 15.76 10.30 146 505096 8692 50091190
Liver transplant 15.73 10.30 52 505190 2080 50097802
Lung adenocarcinoma 15.73 10.30 11 505231 4123 50095759
Plasma cell myeloma 15.71 10.30 219 505023 31103 50068779
Concomitant disease aggravated 15.69 10.30 36 505206 8055 50091827
Vaginal haemorrhage 15.62 10.30 163 505079 24388 50075494
Cardiac disorder 15.53 10.30 319 504923 42660 50057222
Rhabdomyolysis 15.52 10.30 285 504957 38742 50061140
Monocyte percentage increased 15.52 10.30 33 505209 1008 50098874
Mucormycosis 15.46 10.30 3 505239 2480 50097402
Body height decreased 15.43 10.30 42 505200 8866 50091016
Invasive ductal breast carcinoma 15.37 10.30 22 505220 5899 50093983
Epstein-Barr virus infection 15.36 10.30 29 505213 6968 50092914
Organising pneumonia 15.32 10.30 15 505227 4759 50095123
Blood iron abnormal 15.31 10.30 7 505235 3319 50096563
Disturbance in attention 15.31 10.30 219 505023 30967 50068915
Ventricular fibrillation 15.30 10.30 54 505188 10505 50089377
Cardiomyopathy 15.26 10.30 92 505150 15494 50084388
Extrapyramidal disorder 15.24 10.30 63 505179 11707 50088175
Mean cell haemoglobin concentration increased 15.23 10.30 21 505221 447 50099435
Compartment syndrome 15.22 10.30 49 505193 1933 50097949
Mitral valve incompetence 15.14 10.30 107 505135 17364 50082518
Forced expiratory volume decreased 15.06 10.30 13 505229 4381 50095501
Product adhesion issue 15.05 10.30 13 505229 4379 50095503
Eosinophil percentage increased 15.02 10.30 31 505211 927 50098955
Drug specific antibody present 14.95 10.30 70 505172 3298 50096584
Cystic fibrosis pancreatic 14.94 10.30 9 505233 59 50099823
Intentional dose omission 14.94 10.30 17 505225 5033 50094849
Metastases to lung 14.89 10.30 58 505184 10962 50088920
Gallbladder injury 14.85 10.30 37 505205 1257 50098625
Congestive cardiomyopathy 14.83 10.30 20 505222 5498 50094384
Liver disorder 14.75 10.30 272 504970 36950 50062932
Infective pulmonary exacerbation of cystic fibrosis 14.69 10.30 36 505206 7873 50092009
Mean cell haemoglobin concentration decreased 14.64 10.30 62 505180 2797 50097085
Low density lipoprotein increased 14.64 10.30 21 505221 5625 50094257
Personality change 14.63 10.30 21 505221 5624 50094258
Dysgeusia 14.61 10.30 287 504955 38629 50061253
Hypertransaminasaemia 14.56 10.30 9 505233 3602 50096280
Human herpesvirus 6 infection 14.53 10.30 4 505238 2602 50097280
Therapeutic response unexpected 14.53 10.30 96 505146 15819 50084063
Pupil fixed 14.39 10.30 41 505201 1511 50098371
Injection site discolouration 14.37 10.30 30 505212 6944 50092938
Ductus arteriosus premature closure 14.36 10.30 17 505225 309 50099573
Migraine 14.34 10.30 903 504339 74377 50025505
Glycosylated haemoglobin increased 14.22 10.30 56 505186 10550 50089332
Dysphoria 14.20 10.30 16 505226 4758 50095124
Drug withdrawal syndrome 14.19 10.30 171 505071 24910 50074972
Hallucination, auditory 14.16 10.30 57 505185 10671 50089211
Device leakage 14.14 10.30 23 505219 5855 50094027
Bone pain 14.12 10.30 361 504881 46868 50053014
Ketoacidosis 14.00 10.30 11 505231 3884 50095998
Haematuria 13.97 10.30 176 505066 25437 50074445
Intervertebral discitis 13.91 10.30 58 505184 2598 50097284
Dermatitis bullous 13.84 10.30 32 505210 7141 50092741
Mobility decreased 13.80 10.30 951 504291 78997 50020885
Malignant melanoma 13.79 10.30 53 505189 10055 50089827
Breast cancer female 13.74 10.30 30 505212 6832 50093050
Asthenia 13.74 10.30 2895 502347 316147 49783735
Haemolysis 13.71 10.30 105 505137 5911 50093971
Device deployment issue 13.71 10.30 9 505233 3487 50096395
Rheumatoid factor positive 13.70 10.30 619 504623 49240 50050642
Pulmonary alveolar haemorrhage 13.70 10.30 12 505230 4015 50095867
Sinus tachycardia 13.68 10.30 294 504948 21060 50078822
Osmolar gap 13.60 10.30 10 505232 95 50099787
Renal papillary necrosis 13.55 10.30 14 505228 217 50099665
Transfusion-related acute lung injury 13.52 10.30 10 505232 96 50099786
Obstructive airways disorder 13.50 10.30 96 505146 15556 50084326
Oropharyngeal discomfort 13.50 10.30 75 505167 3783 50096099
Anuria 13.45 10.30 62 505180 11182 50088700
Anoxia 13.45 10.30 14 505228 219 50099663
Swollen joint count increased 13.44 10.30 216 505026 14657 50085225
Blindness 13.44 10.30 109 505133 17160 50082722
Administration site extravasation 13.32 10.30 25 505217 696 50099186
Accidental exposure to product by child 13.29 10.30 31 505211 1009 50098873
Myelocyte count increased 13.27 10.30 17 505225 336 50099546
Spinal pain 13.27 10.30 59 505183 10744 50089138
Liver injury 13.26 10.30 333 504909 24473 50075409
Blood thyroid stimulating hormone decreased 13.22 10.30 79 505163 4093 50095789
Visual impairment 13.21 10.30 552 504690 67723 50032159
Rhinitis allergic 13.19 10.30 33 505209 7167 50092715
Thinking abnormal 13.16 10.30 50 505192 9517 50090365
Pre-eclampsia 13.14 10.30 39 505203 8005 50091877
Systemic lupus erythematosus rash 13.13 10.30 43 505199 1712 50098170
Corneal reflex decreased 13.09 10.30 11 505231 129 50099753
Bradyphrenia 13.07 10.30 26 505216 6126 50093756
Myopathy 13.07 10.30 47 505195 9092 50090790
Pulmonary tuberculosis 13.06 10.30 14 505228 4259 50095623
Pulmonary infarction 13.06 10.30 53 505189 2345 50097537
Pregnancy 13.05 10.30 212 505030 29365 50070517
Peripheral sensory neuropathy 13.04 10.30 29 505213 6562 50093320
Administration site pruritus 13.00 10.30 15 505227 265 50099617
Vitamin D deficiency 12.98 10.30 64 505178 11338 50088544
Cytomegalovirus infection reactivation 12.97 10.30 5 505237 2626 50097256
Exostosis 12.93 10.30 66 505176 11587 50088295
Toxic skin eruption 12.90 10.30 63 505179 11188 50088694
Vascular rupture 12.90 10.30 36 505206 1311 50098571
Cardiovascular disorder 12.90 10.30 57 505185 10397 50089485
Hepatic function abnormal 12.89 10.30 239 505003 32442 50067440
Creatinine urine decreased 12.87 10.30 12 505230 163 50099719
Pancreatitis acute 12.85 10.30 164 505078 23648 50076234
Normal newborn 12.79 10.30 30 505212 6661 50093221
Rheumatic fever 12.74 10.30 238 505004 16629 50083253
Haematoma 12.71 10.30 221 505021 30289 50069593
Blood creatine increased 12.69 10.30 88 505154 4799 50095083
Aplasia pure red cell 12.68 10.30 14 505228 4201 50095681
Pancreatitis 12.66 10.30 326 504916 42288 50057594
Thyroxine free increased 12.65 10.30 26 505216 775 50099107
Sexual abuse 12.62 10.30 11 505231 136 50099746
Loss of personal independence in daily activities 12.60 10.30 571 504671 69479 50030403
Vision blurred 12.58 10.30 649 504593 77998 50021884
Left ventricular failure 12.55 10.30 18 505224 4823 50095059
Long QT syndrome 12.53 10.30 7 505235 2960 50096922
Carpal tunnel syndrome 12.52 10.30 108 505134 16785 50083097
Small for dates baby 12.47 10.30 10 505232 3495 50096387
Taste disorder 12.45 10.30 42 505200 8282 50091600
Product monitoring error 12.44 10.30 6 505236 2758 50097124
Enthesopathy 12.42 10.30 118 505124 7075 50092807
Low birth weight baby 12.37 10.30 25 505217 5856 50094026
Red blood cells urine 12.37 10.30 20 505222 493 50099389
Withdrawal syndrome 12.36 10.30 114 505128 17476 50082406
Infusion site scar 12.35 10.30 16 505226 320 50099562
Hyperhidrosis 12.31 10.30 1045 504197 88381 50011501
Coagulation factor X level decreased 12.31 10.30 8 505234 61 50099821
Renal failure neonatal 12.30 10.30 12 505230 173 50099709
Platelet morphology abnormal 12.26 10.30 4 505238 3 50099879
Post procedural pulmonary embolism 12.23 10.30 14 505228 245 50099637
C-reactive protein abnormal 12.23 10.30 364 504878 27445 50072437
Blood loss anaemia 12.21 10.30 41 505201 8098 50091784
Focal dyscognitive seizures 12.19 10.30 6 505236 2726 50097156
Vasodilation procedure 12.10 10.30 6 505236 25 50099857
Angina unstable 12.08 10.30 31 505211 6675 50093207
Haemarthrosis 12.08 10.30 7 505235 2901 50096981
Red cell distribution width decreased 12.06 10.30 31 505211 1074 50098808
Melaena 12.04 10.30 192 505050 26672 50073210
Dermatitis allergic 11.98 10.30 76 505166 12644 50087238
Oropharyngeal pain 11.98 10.30 917 504325 76884 50022998
Drug level below therapeutic 11.97 10.30 71 505171 3669 50096213
Aspergillus infection 11.93 10.30 32 505210 6789 50093093
Coronary artery bypass 11.92 10.30 4 505238 2289 50097593
Cells in urine 11.88 10.30 12 505230 181 50099701
Circulatory collapse 11.84 10.30 135 505107 19865 50080017
Systemic infection 11.83 10.30 4 505238 2279 50097603
Band neutrophil count increased 11.80 10.30 16 505226 335 50099547
Muscle twitching 11.74 10.30 218 505024 15213 50084669
Cytomegalovirus viraemia 11.73 10.30 18 505224 4691 50095191
Spinal compression fracture 11.72 10.30 76 505166 12580 50087302
Skin cancer 11.72 10.30 51 505191 9343 50090539
Cardiac failure chronic 11.66 10.30 11 505231 3552 50096330
Coagulation factor VII level decreased 11.60 10.30 8 505234 68 50099814
Caesarean section 11.59 10.30 100 505142 15539 50084343
Underdose 11.57 10.30 138 505104 20140 50079742
Cellulitis 11.56 10.30 583 504659 70215 50029667
Lupus-like syndrome 11.56 10.30 52 505190 9439 50090443
COVID-19 immunisation 11.53 10.30 24 505218 722 50099160
Joint laxity 11.51 10.30 51 505191 2347 50097535
Hypervolaemia 11.51 10.30 182 505060 25317 50074565
Latent tuberculosis 11.50 10.30 4 505238 2239 50097643
Post-traumatic stress disorder 11.48 10.30 78 505164 4225 50095657
Peritonitis 11.48 10.30 99 505143 15387 50084495
Injection site extravasation 11.47 10.30 120 505122 7381 50092501
Prothrombin level increased 11.47 10.30 13 505229 225 50099657
Limb mass 11.44 10.30 55 505187 2620 50097262
Back pain 11.42 10.30 2424 502818 217606 49882276
Genital haemorrhage 11.38 10.30 31 505211 6543 50093339
Product physical issue 11.34 10.30 16 505226 4316 50095566
Somnolence 11.32 10.30 1738 503504 153247 49946635
Biliary dyskinesia 11.32 10.30 53 505189 2497 50097385
Unintended pregnancy 11.31 10.30 20 505222 4926 50094956
Mucosal dryness 11.30 10.30 51 505191 2366 50097516
Product dispensing error 11.26 10.30 48 505194 8843 50091039
Amenorrhoea 11.24 10.30 45 505197 8439 50091443
Breast cancer stage I 11.20 10.30 3 505239 1987 50097895
Infusion site oedema 11.16 10.30 20 505222 537 50099345
Sleep disorder due to a general medical condition 11.15 10.30 37 505205 7334 50092548
Procedural anxiety 11.11 10.30 22 505220 638 50099244
International normalised ratio increased 11.06 10.30 532 504710 42620 50057262
Nephropathy toxic 11.02 10.30 42 505200 7987 50091895
Tri-iodothyronine free increased 10.99 10.30 12 505230 199 50099683
Knee arthroplasty 10.98 10.30 273 504969 35573 50064309
Injury associated with device 10.96 10.30 9 505233 3108 50096774
Joint dislocation 10.95 10.30 75 505167 12258 50087624
Neutrophil count decreased 10.94 10.30 363 504879 45663 50054219
Sensation of foreign body 10.90 10.30 72 505170 3864 50096018
Acute respiratory failure 10.89 10.30 212 505030 28570 50071312
Mastocytosis 10.87 10.30 19 505223 500 50099382
Analgesic drug level below therapeutic 10.85 10.30 3 505239 0 50099882
Muckle-Wells syndrome 10.85 10.30 3 505239 0 50099882
Sucrose intolerance 10.85 10.30 3 505239 0 50099882
Erysipelas 10.82 10.30 32 505210 6576 50093306
Sinus bradycardia 10.82 10.30 82 505160 13101 50086781
Infusion site discolouration 10.80 10.30 21 505221 601 50099281
Smear cervix abnormal 10.76 10.30 55 505187 2686 50097196
Transfusion 10.72 10.30 80 505162 12825 50087057
Status epilepticus 10.72 10.30 84 505158 13322 50086560
Cystitis 10.71 10.30 546 504696 44018 50055864
Immunosuppressant drug level increased 10.71 10.30 9 505233 3073 50096809
Meniscus injury 10.70 10.30 30 505212 6272 50093610
Skin toxicity 10.70 10.30 14 505228 3899 50095983
Akathisia 10.68 10.30 44 505198 8185 50091697
Muscular weakness 10.68 10.30 810 504432 94203 50005679
Hypothermia 10.67 10.30 174 505068 11842 50088040
Device related thrombosis 10.67 10.30 33 505209 1274 50098608
Cardiogenic shock 10.58 10.30 102 505140 15497 50084385
Gait inability 10.54 10.30 285 504957 36742 50063140
Band neutrophil percentage increased 10.53 10.30 12 505230 209 50099673
Spinal operation 10.48 10.30 30 505212 6230 50093652
White blood cells urine 10.48 10.30 15 505227 331 50099551
Anaphylactoid reaction 10.48 10.30 64 505178 3342 50096540
Pulmonary mass 10.40 10.30 128 505114 18577 50081305
Feeling cold 10.39 10.30 262 504980 19269 50080613
Pharyngitis streptococcal 10.38 10.30 134 505108 8674 50091208
Heavy menstrual bleeding 10.36 10.30 102 505140 15435 50084447
Gastric infection 10.36 10.30 58 505184 2934 50096948
Chondropathy 10.34 10.30 4 505238 2096 50097786
Temperature intolerance 10.33 10.30 118 505124 7421 50092461

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
Completed suicide 1813.04 10.20 2730 213873 87516 29270408
Toxicity to various agents 1726.23 10.20 3872 212731 169789 29188135
Infusion related reaction 1147.73 10.20 1508 215095 42378 29315546
Drug abuse 563.12 10.20 1566 215037 78317 29279607
Intentional product misuse 365.94 10.20 794 215809 33867 29324057
Blood pressure fluctuation 321.37 10.20 546 216057 19348 29338576
Urticaria 282.47 10.20 962 215641 53698 29304226
Overdose 272.74 10.20 1233 215370 78586 29279338
Exposure to toxic agent 244.99 10.20 180 216423 2395 29355529
Respiratory arrest 244.84 10.20 567 216036 25266 29332658
Drug ineffective 230.19 10.20 1638 214965 361532 28996392
Flushing 204.50 10.20 569 216034 28423 29329501
Chills 204.17 10.20 1047 215556 70253 29287671
Blood pressure increased 194.36 10.20 1059 215544 72744 29285180
Intentional overdose 169.06 10.20 643 215960 37885 29320039
Acute hepatic failure 164.62 10.20 306 216297 11646 29346278
Cardio-respiratory arrest 156.78 10.20 760 215843 49841 29308083
Heart rate decreased 149.86 10.20 462 216141 24450 29333474
Oxygen saturation decreased 139.25 10.20 675 215928 44262 29313662
Myocardial infarction 120.81 10.20 409 216194 109887 29248037
Exposure via ingestion 119.61 10.20 107 216496 1911 29356013
Heart rate increased 119.27 10.20 583 216020 38355 29319569
Accidental overdose 118.85 10.20 340 216263 17253 29340671
Respiratory depression 113.24 10.20 283 216320 13240 29344684
Drug interaction 108.25 10.20 925 215678 196460 29161464
Drug resistance 102.93 10.20 17 216586 21523 29336401
Cardiac failure 100.36 10.20 275 216328 79012 29278912
Sinusitis 98.61 10.20 505 216098 33845 29324079
Poisoning 96.47 10.20 221 216382 9772 29348152
Blood pressure diastolic abnormal 94.96 10.20 105 216498 2446 29355478
Anion gap 92.40 10.20 61 216542 675 29357249
Cardiac arrest 91.42 10.20 994 215609 84597 29273327
Cardiac failure congestive 89.35 10.20 276 216327 76305 29281619
Product dose omission issue 87.14 10.20 386 216217 95997 29261927
Unresponsive to stimuli 84.80 10.20 387 216216 24739 29333185
Blood pressure systolic increased 84.74 10.20 294 216309 16551 29341373
Pruritus 83.98 10.20 1261 215342 115588 29242336
Anaphylactic reaction 83.10 10.20 411 216192 27162 29330762
Anaemia 82.74 10.20 1008 215595 199943 29157981
Diarrhoea 75.69 10.20 1858 214745 330840 29027084
Suspected suicide 69.79 10.20 114 216489 3906 29354018
Throat tightness 69.75 10.20 158 216445 6933 29350991
Acute kidney injury 67.10 10.20 1457 215146 263810 29094114
Metabolic acidosis 65.21 10.20 486 216117 37176 29320748
General physical health deterioration 63.69 10.20 466 216137 102391 29255533
Blood pressure systolic abnormal 60.66 10.20 77 216526 2084 29355840
Throat irritation 59.54 10.20 170 216433 8615 29349309
Therapeutic product effect incomplete 59.50 10.20 124 216479 39181 29318743
Environmental exposure 59.40 10.20 32 216571 235 29357689
Heart rate irregular 59.22 10.20 221 216382 12896 29345028
Tachycardia 58.57 10.20 798 215805 71612 29286312
Foetal exposure during pregnancy 58.16 10.20 99 216504 33768 29324156
Renal impairment 58.11 10.20 353 216250 80980 29276944
Interstitial lung disease 56.56 10.20 224 216379 57494 29300430
Intentional product use issue 56.19 10.20 516 216087 41982 29315942
Infusion site swelling 53.07 10.20 67 216536 1803 29356121
Coagulopathy 51.19 10.20 263 216340 17644 29340280
Erythema 50.83 10.20 807 215796 74799 29283125
Blood pressure diastolic increased 50.28 10.20 94 216509 3592 29354332
Cerebral haemorrhage 48.53 10.20 98 216505 31328 29326596
Infusion site pain 48.16 10.20 81 216522 2844 29355080
Infusion site extravasation 48.08 10.20 84 216519 3043 29354881
Hepatic cytolysis 47.60 10.20 152 216451 8195 29349729
Substance abuse 45.67 10.20 131 216472 6656 29351268
Hepatic necrosis 45.44 10.20 88 216515 3454 29354470
Hypotension 45.31 10.20 1796 214807 192558 29165366
Body temperature increased 45.28 10.20 218 216385 14247 29343677
Hepatotoxicity 44.03 10.20 252 216351 17615 29340309
Infusion site erythema 43.12 10.20 57 216546 1607 29356317
Coronary artery disease 42.34 10.20 173 216430 44017 29313907
Sopor 41.68 10.20 14 216589 10920 29347004
Bone marrow failure 41.20 10.20 87 216516 27362 29330562
Product use in unapproved indication 41.10 10.20 422 216181 86453 29271471
Wrong technique in product usage process 40.49 10.20 108 216495 31320 29326604
Malignant neoplasm progression 40.41 10.20 346 216257 73513 29284411
Respiratory rate increased 39.54 10.20 147 216456 8561 29349363
Diabetes mellitus 39.38 10.20 154 216449 39677 29318247
Cytokine release syndrome 39.12 10.20 195 216408 12924 29345000
Lymphocyte percentage decreased 38.87 10.20 60 216543 1957 29355967
Cerebrovascular accident 38.29 10.20 369 216234 76542 29281382
Pulmonary oedema 37.88 10.20 479 216124 42256 29315668
Neutrophil percentage increased 37.19 10.20 55 216548 1726 29356198
Aspartate aminotransferase increased 36.62 10.20 628 215975 59097 29298827
Analgesic drug level increased 36.30 10.20 32 216571 560 29357364
Fall 35.24 10.20 1008 215595 176170 29181754
Blood pressure diastolic decreased 34.83 10.20 122 216481 6900 29351024
Cerebral infarction 34.74 10.20 81 216522 24594 29333330
Injection site pain 34.33 10.20 122 216481 32324 29325600
Body temperature decreased 34.31 10.20 162 216441 10502 29347422
Alanine aminotransferase increased 34.23 10.20 719 215884 70225 29287699
Medication error 34.07 10.20 269 216334 20942 29336982
Septic shock 33.80 10.20 294 216309 62266 29295658
Leukopenia 33.70 10.20 251 216352 54952 29302972
Hospitalisation 33.67 10.20 198 216405 45790 29312134
Tongue disorder 33.67 10.20 92 216511 4544 29353380
Psoriasis 32.89 10.20 123 216480 32104 29325820
Feeling hot 32.79 10.20 210 216393 15278 29342646
Glycosylated haemoglobin increased 32.71 10.20 14 216589 9412 29348512
Treatment failure 32.70 10.20 149 216454 36790 29321134
Labelled drug-drug interaction medication error 32.30 10.20 25 216578 12134 29345790
Ear infection 32.11 10.20 131 216472 7969 29349955
Pancytopenia 31.96 10.20 423 216180 82745 29275179
Poor venous access 31.72 10.20 71 216532 3090 29354834
Hereditary angioedema 31.27 10.20 33 216570 728 29357196
Renal cortical necrosis 31.13 10.20 18 216585 154 29357770
Body temperature fluctuation 30.60 10.20 45 216558 1405 29356519
Osteonecrosis of jaw 30.47 10.20 46 216557 16464 29341460
Infusion site reaction 30.10 10.20 32 216571 712 29357212
Chest discomfort 29.83 10.20 488 216115 45495 29312429
Infusion site pruritus 29.65 10.20 27 216576 494 29357430
Accident 29.64 10.20 76 216527 3612 29354312
Infusion site rash 29.23 10.20 23 216580 341 29357583
Therapeutic response shortened 28.93 10.20 89 216514 4702 29353222
Haematotoxicity 28.44 10.20 7 216596 6692 29351232
Headache 28.03 10.20 1550 215053 172457 29185467
Urine abnormality 28.01 10.20 47 216556 1647 29356277
Angina pectoris 27.96 10.20 107 216496 27743 29330181
Visual acuity reduced 27.89 10.20 41 216562 14835 29343089
Neuropathy peripheral 27.74 10.20 360 216243 70667 29287257
Pyroglutamic acidosis 27.67 10.20 20 216583 259 29357665
Hypersensitivity 27.44 10.20 542 216061 52361 29305563
Blood pH decreased 27.37 10.20 53 216550 2080 29355844
Renal failure 26.89 10.20 662 215941 117937 29239987
Liver injury 26.83 10.20 172 216431 12518 29345406
Victim of child abuse 26.77 10.20 32 216571 813 29357111
Drug hypersensitivity 26.70 10.20 673 215930 67733 29290191
Pneumonia 26.51 10.20 2003 214600 318169 29039755
Myopathy 26.32 10.20 23 216580 10510 29347414
Hyperkalaemia 25.92 10.20 306 216297 61086 29296838
Progressive multifocal leukoencephalopathy 25.72 10.20 16 216587 8703 29349221
Graft versus host disease 25.32 10.20 20 216583 9608 29348316
Fluid retention 25.31 10.20 88 216515 23472 29334452
Pathogen resistance 25.20 10.20 14 216589 8102 29349822
Pallor 25.16 10.20 250 216353 20774 29337150
Depressed level of consciousness 25.06 10.20 395 216208 36547 29321377
Hyperhidrosis 24.90 10.20 634 215969 63906 29294018
Immune reconstitution inflammatory syndrome 24.90 10.20 13 216590 7789 29350135
Aplastic anaemia 24.83 10.20 115 216488 7395 29350529
Post transplant lymphoproliferative disorder 24.81 10.20 5 216598 5488 29352436
Memory impairment 24.63 10.20 161 216442 36309 29321615
Mental status changes 24.28 10.20 375 216228 34552 29323372
Rash 24.27 10.20 1657 214946 188162 29169762
Serum sickness 24.06 10.20 45 216558 1720 29356204
Oedema peripheral 23.48 10.20 578 216025 102979 29254945
Cardiac failure chronic 23.42 10.20 9 216594 6458 29351466
Monocyte percentage increased 23.24 10.20 31 216572 882 29357042
Tenosynovitis 23.15 10.20 70 216533 3663 29354261
Accidental death 22.87 10.20 49 216554 2069 29355855
Cytomegalovirus infection 22.79 10.20 90 216513 23125 29334799
Myelosuppression 22.63 10.20 34 216569 12193 29345731
Myocardial fibrosis 22.33 10.20 33 216570 1035 29356889
Acute lung injury 22.06 10.20 37 216566 1296 29356628
Pulmonary congestion 21.81 10.20 161 216442 12275 29345649
Acute myocardial infarction 21.79 10.20 238 216365 48200 29309724
Febrile neutropenia 21.57 10.20 1017 215586 111223 29246701
Inappropriate schedule of product administration 21.53 10.20 451 216152 44021 29313903
Atrial fibrillation 21.48 10.20 599 216004 105047 29252877
Pulse absent 21.31 10.20 84 216519 5029 29352895
Nasopharyngitis 21.25 10.20 580 216023 59085 29298839
Bladder cancer 20.92 10.20 26 216577 10101 29347823
Asthenia 20.85 10.20 1328 215275 213922 29144002
Urine sodium decreased 20.83 10.20 14 216589 160 29357764
Alanine aminotransferase abnormal 20.80 10.20 58 216545 2899 29355025
Hepatocellular carcinoma 20.64 10.20 13 216590 7025 29350899
Crohn's disease 20.17 10.20 58 216545 2951 29354973
Lip swelling 19.72 10.20 157 216446 12253 29345671
Epilepsy 19.70 10.20 69 216534 18363 29339561
Enthesopathy 19.41 10.20 66 216537 3677 29354247
Methaemoglobinaemia 19.39 10.20 53 216550 2618 29355306
Mydriasis 19.25 10.20 92 216511 5993 29351931
Visual impairment 19.13 10.20 133 216470 29575 29328349
Brain oedema 19.09 10.20 154 216449 12066 29345858
Hypertriglyceridaemia 19.07 10.20 16 216587 7459 29350465
Granulomatosis with polyangiitis 18.95 10.20 28 216575 878 29357046
Therapeutic product effect decreased 18.89 10.20 132 216471 29319 29328605
Multiple-drug resistance 18.80 10.20 3 216600 3897 29354027
Disease progression 18.35 10.20 458 216145 81458 29276466
Oxygen saturation abnormal 18.30 10.20 32 216571 1160 29356764
Depression 18.29 10.20 479 216124 84668 29273256
Stevens-Johnson syndrome 18.23 10.20 193 216410 16304 29341620
Infusion site bruising 18.03 10.20 18 216585 371 29357553
Anion gap abnormal 18.01 10.20 12 216591 135 29357789
Lung neoplasm malignant 17.99 10.20 50 216553 14307 29343617
Drug screen positive 17.96 10.20 65 216538 3736 29354188
Death 17.91 10.20 2809 213794 339275 29018649
Rheumatoid arthritis 17.89 10.20 333 216270 31819 29326105
Polyneuropathy 17.83 10.20 39 216564 12113 29345811
Accidental exposure to product by child 17.81 10.20 34 216569 1320 29356604
Red cell distribution width increased 17.77 10.20 75 216528 4632 29353292
Infusion site nodule 17.75 10.20 10 216593 81 29357843
Therapy cessation 17.65 10.20 51 216552 14411 29343513
Haematuria 17.49 10.20 223 216380 43916 29314008
Pemphigus 17.47 10.20 31 216572 1137 29356787
Hepatocellular injury 17.45 10.20 88 216515 21155 29336769
Palmar-plantar erythrodysaesthesia syndrome 17.33 10.20 53 216550 14706 29343218
Upper respiratory tract infection 17.27 10.20 289 216314 27060 29330864
Specific gravity urine decreased 17.25 10.20 10 216593 86 29357838
Pharyngeal paraesthesia 17.24 10.20 19 216584 441 29357483
Myalgia 17.08 10.20 412 216191 73607 29284317
Renal papillary necrosis 17.02 10.20 12 216591 149 29357775
Eosinophilia 16.98 10.20 94 216509 22067 29335857
Vomiting 16.97 10.20 1789 214814 210471 29147453
Blood pressure decreased 16.74 10.20 444 216159 45033 29312891
Decreased appetite 16.70 10.20 882 215721 144460 29213464
Chronic gastrointestinal bleeding 16.67 10.20 15 216588 270 29357654
Haemorrhage 16.66 10.20 231 216372 44841 29313083
Exposure via inhalation 16.60 10.20 7 216596 27 29357897
Cardiac failure acute 16.59 10.20 26 216577 9166 29348758
Crystal urine present 16.56 10.20 18 216585 411 29357513
Neutropenia 16.53 10.20 792 215811 130919 29227005
Product use issue 16.36 10.20 493 216110 50951 29306973
Erectile dysfunction 16.32 10.20 72 216531 17937 29339987
Prostatic specific antigen increased 16.31 10.20 43 216560 12521 29345403
Thrombocytopenia 16.28 10.20 814 215789 134009 29223915
Pyrexia 16.23 10.20 2372 214231 285250 29072674
Back pain 16.22 10.20 910 215693 101374 29256550
Therapy partial responder 16.10 10.20 9 216594 5190 29352734
White blood cells urine positive 16.09 10.20 30 216573 1144 29356780
Diabetic ketoacidosis 15.97 10.20 62 216541 16011 29341913
Low birth weight baby 15.83 10.20 15 216588 6593 29351331
Parkinsonism 15.77 10.20 18 216585 7260 29350664
Specific gravity urine increased 15.64 10.20 11 216592 136 29357788
Ischaemic stroke 15.64 10.20 62 216541 15915 29342009
Cerebral artery thrombosis 15.62 10.20 23 216580 719 29357205
Prostate cancer 15.60 10.20 116 216487 25411 29332513
Hypoglycaemia 15.40 10.20 255 216348 48091 29309833
Tuberculosis 15.37 10.20 18 216585 7178 29350746
Syncope 15.37 10.20 466 216137 80905 29277019
Coma 15.34 10.20 388 216215 39062 29318862
Melaena 15.32 10.20 150 216453 31026 29326898
Hypoxia 15.32 10.20 455 216148 46924 29311000
Enterocolitis infectious 15.30 10.20 31 216572 1258 29356666
Ductus arteriosus premature closure 15.30 10.20 13 216590 216 29357708
Prothrombin time prolonged 15.29 10.20 114 216489 8718 29349206
Acid-base balance disorder mixed 15.29 10.20 8 216595 55 29357869
Rhabdomyolysis 15.28 10.20 334 216269 60474 29297450
Thrombotic microangiopathy 15.25 10.20 25 216578 8656 29349268
Administration site pruritus 15.12 10.20 6 216597 19 29357905
Abdominal pain 15.12 10.20 1169 215434 134188 29223736
Lactic acidosis 15.09 10.20 145 216458 30102 29327822
Pulmonary embolism 15.03 10.20 436 216167 76098 29281826
Acute myeloid leukaemia 14.98 10.20 66 216537 16447 29341477
Circulatory collapse 14.97 10.20 78 216525 18595 29339329
Hepatic function abnormal 14.95 10.20 200 216403 39059 29318865
Osteonecrosis 14.86 10.20 50 216553 13469 29344455
Blood creatine phosphokinase increased 14.78 10.20 209 216394 40435 29317489
Renal disorder 14.63 10.20 101 216502 22494 29335430
Brain scan abnormal 14.61 10.20 24 216579 826 29357098
Drug level below therapeutic 14.56 10.20 66 216537 4205 29353719
Agitation 14.56 10.20 485 216118 50819 29307105
Shock haemorrhagic 14.56 10.20 30 216573 9521 29348403
Haemolysis 14.53 10.20 94 216509 6862 29351062
Cytomegalovirus chorioretinitis 14.51 10.20 3 216600 3235 29354689
Hepatitis C 14.43 10.20 27 216576 8883 29349041
Chronic obstructive pulmonary disease 14.40 10.20 212 216391 40743 29317181
Appendicolith 14.37 10.20 57 216546 3423 29354501
Pancreatitis acute 14.34 10.20 112 216491 24273 29333651
Mean cell haemoglobin concentration decreased 14.33 10.20 27 216576 1038 29356886
Suicide attempt 14.32 10.20 339 216264 33771 29324153
Apparent death 14.23 10.20 4 216599 3500 29354424
Tooth infection 14.22 10.20 79 216524 5460 29352464
Pemphigoid 14.11 10.20 21 216582 7560 29350364
Injection site bruising 14.10 10.20 21 216582 7559 29350365
Second primary malignancy 14.08 10.20 17 216586 6688 29351236
Premature baby 13.95 10.20 72 216531 17208 29340716
Chronic graft versus host disease 13.95 10.20 6 216597 4023 29353901
Injection site haemorrhage 13.95 10.20 25 216578 8361 29349563
Acidosis 13.93 10.20 120 216483 9585 29348339
Posterior reversible encephalopathy syndrome 13.85 10.20 28 216575 8948 29348976
Intraocular pressure increased 13.83 10.20 9 216594 4780 29353144
Ejection fraction decreased 13.81 10.20 65 216538 15913 29342011
Anti-erythrocyte antibody positive 13.63 10.20 7 216596 46 29357878
Incorrect drug administration rate 13.62 10.20 28 216575 1148 29356776
Full blood count abnormal 13.62 10.20 60 216543 14953 29342971
Administration site erythema 13.59 10.20 8 216595 71 29357853
Swelling face 13.57 10.20 217 216386 20133 29337791
Vertigo 13.53 10.20 99 216504 21762 29336162
Administration site swelling 13.44 10.20 11 216592 173 29357751
Administration site pain 13.19 10.20 11 216592 178 29357746
Coronary arterial stent insertion 13.19 10.20 6 216597 3891 29354033
Urine analysis abnormal 13.10 10.20 36 216567 1784 29356140
Febrile bone marrow aplasia 13.07 10.20 21 216582 7330 29350594
Acute graft versus host disease 13.06 10.20 14 216589 5810 29352114
Toxic epidermal necrolysis 13.03 10.20 196 216407 17957 29339967
Sinus tachycardia 12.96 10.20 168 216435 14901 29343023
Dysmorphism 12.82 10.20 3 216600 2968 29354956
Dizziness 12.73 10.20 1206 215397 188478 29169446
Bacterial test positive 12.72 10.20 48 216555 2815 29355109
Graft versus host disease in gastrointestinal tract 12.72 10.20 4 216599 3254 29354670
Pupil fixed 12.66 10.20 34 216569 1662 29356262
Prescribed overdose 12.63 10.20 28 216575 8655 29349269
Anaphylactoid reaction 12.56 10.20 37 216566 1908 29356016
Eosinophil percentage increased 12.45 10.20 17 216586 495 29357429
Anticholinergic syndrome 12.45 10.20 23 216580 871 29357053
Aspergillus infection 12.42 10.20 38 216565 10543 29347381
Bacterial test 12.40 10.20 10 216593 154 29357770
Gynaecomastia 12.36 10.20 26 216577 8191 29349733
Malignant neoplasm of spinal cord 12.34 10.20 5 216598 17 29357907
Infusion site irritation 12.32 10.20 11 216592 196 29357728
Myelodysplastic syndrome 12.29 10.20 78 216525 17716 29340208
Ultrasound liver abnormal 12.23 10.20 9 216594 120 29357804
Inadequate analgesia 12.21 10.20 45 216558 2609 29355315
Product substitution issue 12.21 10.20 31 216572 9141 29348783
Adverse event 12.19 10.20 64 216539 15227 29342697
Balance disorder 12.11 10.20 189 216414 35981 29321943
Dependent personality disorder 12.08 10.20 8 216595 89 29357835
Haematocrit decreased 12.05 10.20 288 216315 28734 29329190
Cardiac disorder 12.04 10.20 196 216407 37067 29320857
Post embolisation syndrome 11.90 10.20 7 216596 62 29357862
Gastrointestinal haemorrhage 11.89 10.20 469 216134 79064 29278860
Infusion site urticaria 11.86 10.20 8 216595 92 29357832
Ear infection viral 11.77 10.20 3 216600 0 29357924
Deep vein thrombosis 11.77 10.20 325 216278 57074 29300850
Pulmonary arterial hypertension 11.69 10.20 23 216580 7426 29350498
Oropharyngeal pain 11.68 10.20 289 216314 28996 29328928
Inappropriate antidiuretic hormone secretion 11.63 10.20 41 216562 10891 29347033
Hypoxic-ischaemic encephalopathy 11.61 10.20 62 216541 4222 29353702
Brain death 11.60 10.20 41 216562 2329 29355595
Rash erythematous 11.54 10.20 222 216381 21340 29336584
Antineutrophil cytoplasmic antibody positive 11.53 10.20 18 216585 593 29357331
Liver disorder 11.44 10.20 139 216464 27610 29330314
Respiratory distress 11.39 10.20 312 216291 31794 29326130
Acute coronary syndrome 11.34 10.20 49 216554 12276 29345648
Agranulocytosis 11.24 10.20 95 216508 20245 29337679
Self-medication 11.18 10.20 38 216565 2116 29355808
Venoocclusive liver disease 11.17 10.20 21 216582 6896 29351028
Urethral valves 11.15 10.20 12 216591 271 29357653
Nocardiosis 11.06 10.20 5 216598 3255 29354669
Croup infectious 11.04 10.20 12 216591 274 29357650
Febrile nonhaemolytic transfusion reaction 11.03 10.20 6 216597 45 29357879
Right ventricular failure 11.02 10.20 26 216577 7864 29350060
Leukoencephalopathy 10.99 10.20 7 216596 3760 29354164
Hallucinations, mixed 10.99 10.20 41 216562 2392 29355532
Injection site extravasation 10.99 10.20 41 216562 2392 29355532
pH urine increased 10.87 10.20 7 216596 74 29357850
Gait disturbance 10.86 10.20 433 216170 72916 29285008
Product prescribing error 10.84 10.20 82 216521 17894 29340030
Electrocardiogram QRS complex prolonged 10.81 10.20 59 216544 4051 29353873
Blood magnesium abnormal 10.80 10.20 10 216593 187 29357737
Systemic mastocytosis 10.79 10.20 8 216595 108 29357816
Fasting 10.76 10.20 4 216599 10 29357914
Administration site irritation 10.76 10.20 4 216599 10 29357914
Angina unstable 10.74 10.20 42 216561 10823 29347101
Bilirubin urine present 10.72 10.20 9 216594 147 29357777
Urine leukocyte esterase positive 10.69 10.20 14 216589 391 29357533
Kidney transplant rejection 10.68 10.20 22 216581 6983 29350941
Hepatic cirrhosis 10.67 10.20 62 216541 14382 29343542
Dermatitis exfoliative generalised 10.66 10.20 4 216599 2912 29355012
Skin lesion 10.60 10.20 86 216517 18486 29339438
Subdural haematoma 10.50 10.20 84 216519 18109 29339815
Osteoporosis 10.41 10.20 42 216561 10727 29347197
Protein urine 10.38 10.20 20 216583 782 29357142
Feeling cold 10.38 10.20 108 216495 9083 29348841
Analgesic drug level above therapeutic 10.27 10.20 11 216592 247 29357677
Contraindicated product administered 10.23 10.20 85 216518 18181 29339743

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
Completed suicide 5225.37 10.33 8143 575820 216271 63698498
Toxicity to various agents 4165.90 10.33 9750 574213 353763 63561006
Infusion related reaction 1813.74 10.33 4354 579609 160113 63754656
Drug abuse 922.81 10.33 2966 580997 129408 63785361
Intentional product misuse 851.15 10.33 1965 581998 70330 63844439
Overdose 703.22 10.33 3086 580877 156480 63758289
Blood pressure fluctuation 703.16 10.33 1492 582471 50379 63864390
Exposure to toxic agent 657.08 10.33 502 583461 5657 63909112
Urticaria 593.61 10.33 2775 581188 144542 63770227
Respiratory arrest 518.89 10.33 1342 582621 51643 63863126
Acute hepatic failure 506.82 10.33 875 583088 25237 63889532
Flushing 486.17 10.33 1693 582270 76955 63837814
Cardio-respiratory arrest 441.54 10.33 1914 582049 96479 63818290
Intentional overdose 404.60 10.33 1751 582212 88193 63826576
Blood pressure increased 377.63 10.33 2766 581197 169786 63744983
Drug interaction 328.92 10.33 1927 582036 360156 63554613
Anaemia 306.08 10.33 2089 581874 376591 63538178
Pruritus 303.42 10.33 4232 579731 308168 63606601
Acute kidney injury 297.28 10.33 2619 581344 446621 63468148
Heart rate decreased 283.74 10.33 1118 582845 53949 63860820
Exposure via ingestion 280.18 10.33 280 583683 4622 63910147
Oxygen saturation decreased 269.64 10.33 1778 582185 105398 63809371
Product dose omission issue 262.67 10.33 894 583069 193853 63720916
Anion gap 260.34 10.33 179 583784 1688 63913081
Cardiac failure 260.06 10.33 502 583461 131871 63782898
Heart rate increased 258.63 10.33 1654 582309 97021 63817748
Throat irritation 257.31 10.33 765 583198 31946 63882823
Rheumatoid arthritis 255.84 10.33 2440 581523 161854 63752915
Poisoning 244.55 10.33 583 583380 21296 63893473
Diarrhoea 232.92 10.33 4885 579078 717819 63196950
Blood pressure diastolic abnormal 230.78 10.33 399 583564 11518 63903251
Metabolic acidosis 226.12 10.33 1252 582711 69706 63845063
Blood pressure systolic increased 221.71 10.33 962 583001 48491 63866278
Myocardial infarction 217.64 10.33 770 583193 165051 63749718
Sinusitis 215.75 10.33 2144 581819 143784 63770985
Cardiac failure congestive 211.70 10.33 550 583413 130030 63784739
Drug resistance 197.06 10.33 39 583924 35063 63879706
Sopor 194.08 10.33 21 583942 29640 63885129
Drug ineffective 191.05 10.33 5977 577986 834270 63080499
Injection site pain 189.33 10.33 458 583505 110950 63803819
Intentional product use issue 185.66 10.33 1488 582475 93876 63820893
Urine abnormality 180.02 10.33 274 583689 7088 63907681
Blood pressure systolic abnormal 173.40 10.33 318 583645 9624 63905145
Hepatotoxicity 172.76 10.33 769 583194 39193 63875576
Renal impairment 172.47 10.33 634 583329 134383 63780386
Neutropenia 167.54 10.33 1376 582587 238248 63676521
Interstitial lung disease 162.75 10.33 406 583557 97326 63817443
Body temperature increased 151.34 10.33 696 583267 35970 63878799
Cardiac arrest 150.40 10.33 2090 581873 151974 63762795
Accidental overdose 149.80 10.33 652 583311 32905 63881864
Muscle injury 149.52 10.33 553 583410 25884 63888885
Suspected suicide 148.66 10.33 275 583688 8379 63906390
Hypersensitivity 148.49 10.33 2552 581411 193900 63720869
Respiratory depression 145.92 10.33 506 583457 22937 63891832
Medication error 145.63 10.33 861 583102 49105 63865664
Pancytopenia 145.62 10.33 734 583229 142575 63772194
Pneumonia 142.66 10.33 3917 580046 555659 63359110
Chills 141.31 10.33 1880 582083 135384 63779385
Osteonecrosis of jaw 140.26 10.33 94 583869 39731 63875038
Throat tightness 135.66 10.33 490 583473 22670 63892099
Folliculitis 134.72 10.33 585 583378 29492 63885277
Irritable bowel syndrome 129.64 10.33 675 583288 36694 63878075
Hyperkalaemia 129.05 10.33 475 583488 100654 63814115
Wrong technique in product usage process 127.89 10.33 246 583717 64728 63850041
Nasopharyngitis 127.83 10.33 2489 581474 193584 63721185
Bone marrow failure 125.87 10.33 149 583814 47803 63866966
Hepatic necrosis 125.65 10.33 253 583710 8220 63906549
Blood pressure diastolic decreased 124.05 10.33 464 583499 21837 63892932
Urine leukocyte esterase positive 123.02 10.33 153 583810 3250 63911519
Sleep disorder due to general medical condition, insomnia type 122.32 10.33 517 583446 25753 63889016
Malignant neoplasm progression 120.50 10.33 568 583395 112303 63802466
Coagulopathy 119.45 10.33 589 583374 31331 63883438
Heart rate irregular 118.09 10.33 527 583436 26886 63887883
Device expulsion 117.56 10.33 24 583939 21112 63893657
Analgesic drug level increased 115.85 10.33 122 583841 2148 63912621
Therapeutic product effect incomplete 115.68 10.33 512 583451 102970 63811799
Duodenal ulcer perforation 114.34 10.33 617 583346 34008 63880761
Product use in unapproved indication 113.66 10.33 1036 582927 175582 63739187
Psoriasis 111.64 10.33 308 583655 71395 63843374
Septic shock 108.25 10.33 538 583425 104899 63809870
Synovitis 108.17 10.33 1372 582591 97718 63817051
White blood cells urine positive 107.50 10.33 183 583780 5215 63909554
General physical health deterioration 107.41 10.33 1258 582705 203167 63711602
Hereditary angioedema 107.39 10.33 153 583810 3723 63911046
Renal failure 107.07 10.33 1089 582874 180599 63734170
Food allergy 104.21 10.33 224 583739 7627 63907142
Helicobacter infection 103.52 10.33 648 583315 37714 63877055
Thrombocytopenia 103.51 10.33 1415 582548 222386 63692383
Cerebral haemorrhage 102.68 10.33 191 583772 50899 63863870
Chest discomfort 99.83 10.33 1541 582422 114565 63800204
Crystal urine present 99.03 10.33 104 583859 1825 63912944
Cerebrovascular accident 96.54 10.33 789 583174 136794 63777975
Feeling hot 96.30 10.33 726 583237 44937 63869832
Injection site erythema 96.03 10.33 324 583639 70476 63844293
Tachycardia 95.82 10.33 1894 582069 147685 63767084
Rash 95.14 10.33 5068 578895 453481 63461288
Hepatic cytolysis 94.28 10.33 311 583652 13738 63901031
Impaired healing 93.93 10.33 898 583065 59575 63855194
Erythema 93.54 10.33 2286 581677 184784 63729985
Death 93.08 10.33 5299 578664 477406 63437363
Oedema peripheral 92.55 10.33 1343 582620 208974 63705795
Anti-cyclic citrullinated peptide antibody positive 92.45 10.33 766 583197 48796 63865973
Depressed level of consciousness 92.06 10.33 1135 582828 80301 63834468
Disease progression 92.04 10.33 829 583134 140851 63773918
Hepatic enzyme increased 91.68 10.33 1670 582293 128273 63786496
Ill-defined disorder 90.44 10.33 696 583267 43356 63871413
Fall 90.13 10.33 2982 580981 413844 63500925
Lymphocyte percentage decreased 89.16 10.33 155 583808 4494 63910275
Blood pressure diastolic increased 88.89 10.33 256 583707 10496 63904273
Leukopenia 87.87 10.33 546 583417 100696 63814073
Hospitalisation 87.79 10.33 366 583597 74841 63839928
Lymphocyte count decreased 87.48 10.33 650 583313 40049 63874720
Injection site bruising 87.21 10.33 121 583842 36252 63878517
Hyponatraemia 86.60 10.33 891 583072 147448 63767321
Respiratory rate increased 86.31 10.33 362 583601 17969 63896800
Discomfort 85.79 10.33 1114 582849 79764 63835005
Unresponsive to stimuli 85.68 10.33 763 583200 49630 63865139
Therapy cessation 85.22 10.33 101 583862 32388 63882381
Anaphylactic reaction 85.10 10.33 974 582989 67690 63847079
Lower respiratory tract infection 84.90 10.33 1265 582698 93349 63821420
Lactic acidosis 83.31 10.33 281 583682 61129 63853640
Neutrophil percentage increased 82.40 10.33 146 583817 4299 63910470
Urinary sediment present 81.65 10.33 101 583862 2133 63912636
Coronary artery disease 80.30 10.33 279 583684 60154 63854615
Atrial fibrillation 79.69 10.33 1080 582883 170009 63744760
Acute lung injury 78.92 10.33 110 583853 2621 63912148
Weight increased 78.81 10.33 2508 581455 210840 63703929
Poor venous access 78.13 10.33 269 583694 12148 63902621
Neuropathy peripheral 77.93 10.33 684 583279 116841 63797928
Posterior reversible encephalopathy syndrome 77.05 10.33 57 583906 22889 63891880
Red cell distribution width increased 76.88 10.33 266 583697 12043 63902726
Temperature regulation disorder 76.37 10.33 137 583826 4074 63910695
Infusion site pain 75.06 10.33 236 583727 10161 63904608
Cytomegalovirus infection 74.81 10.33 139 583824 37060 63877709
Blister 74.78 10.33 1088 582875 79879 63834890
Diabetes mellitus 74.21 10.33 329 583634 66145 63848624
Hand deformity 74.05 10.33 882 583081 61889 63852880
Pain 72.08 10.33 5881 578082 547630 63367139
Anticholinergic syndrome 71.96 10.33 104 583859 2565 63912204
Body temperature decreased 69.97 10.33 438 583525 25490 63889279
Product prescribing error 69.86 10.33 133 583830 35136 63879633
Cerebral infarction 69.48 10.33 169 583794 40875 63873894
Sedation complication 69.29 10.33 229 583734 10125 63904644
Neoplasm progression 69.09 10.33 169 583794 40795 63873974
Decreased appetite 67.86 10.33 1983 581980 279306 63635463
Arthropathy 67.76 10.33 1502 582461 119465 63795304
Epilepsy 67.69 10.33 125 583838 33406 63881363
Labelled drug-drug interaction medication error 67.60 10.33 60 583903 22002 63892767
Haematotoxicity 67.01 10.33 17 583946 12879 63901890
Infusion site extravasation 66.71 10.33 173 583790 6664 63908105
Infusion site swelling 65.85 10.33 150 583813 5315 63909454
Pyroglutamic acidosis 65.65 10.33 54 583909 682 63914087
Hepatocellular injury 65.53 10.33 201 583762 45034 63869735
Sepsis 65.47 10.33 1586 582377 228755 63686014
Substance abuse 65.33 10.33 209 583754 9083 63905686
Syncope 65.05 10.33 1019 582944 156616 63758153
Infusion site erythema 64.10 10.33 171 583792 6702 63908067
Body temperature fluctuation 63.30 10.33 110 583853 3188 63911581
Red blood cells urine positive 63.19 10.33 131 583832 4347 63910422
Pathogen resistance 62.42 10.33 18 583945 12525 63902244
Gastrointestinal haemorrhage 61.68 10.33 835 583128 131477 63783292
Myelosuppression 61.52 10.33 75 583888 23755 63891014
Agranulocytosis 61.16 10.33 162 583801 38067 63876702
Therapeutic response shortened 61.12 10.33 217 583746 9953 63904816
Pericarditis 60.49 10.33 847 583116 61669 63853100
Cholecystitis chronic 60.02 10.33 203 583760 9084 63905685
Diabetic ketoacidosis 57.85 10.33 114 583849 29731 63885038
Pemphigus 57.77 10.33 820 583143 59881 63854888
Liver injury 57.64 10.33 466 583497 29466 63885303
Dyspnoea exertional 56.78 10.33 412 583551 73318 63841451
Environmental exposure 56.34 10.33 37 583926 321 63914448
Myelodysplastic syndrome 55.51 10.33 103 583860 27476 63887293
Hypotension 55.46 10.33 4084 579879 376890 63537879
Haematuria 55.15 10.33 321 583642 60150 63854619
Visual acuity reduced 54.95 10.33 101 583862 27040 63887729
Alanine aminotransferase increased 54.92 10.33 1648 582315 137383 63777386
Tongue disorder 54.89 10.33 236 583727 11844 63902925
Post transplant lymphoproliferative disorder 54.85 10.33 10 583953 9534 63905235
Mucosal inflammation 54.04 10.33 338 583625 62246 63852523
Acute myocardial infarction 53.96 10.33 389 583574 69329 63845440
Anion gap abnormal 53.22 10.33 42 583921 498 63914271
Creatinine renal clearance decreased 52.46 10.33 264 583699 14157 63900612
Asthenia 52.18 10.33 3259 580704 424785 63489984
Blood calcium decreased 52.03 10.33 403 583560 25151 63889618
Rhabdomyolysis 51.86 10.33 555 583408 91171 63823598
Urine ketone body present 51.75 10.33 101 583862 3206 63911563
Immune reconstitution inflammatory syndrome 51.75 10.33 24 583939 12446 63902323
Ear pruritus 51.42 10.33 89 583874 2571 63912198
Multiple organ dysfunction syndrome 51.33 10.33 629 583334 100784 63813985
Blood urine present 50.85 10.33 312 583651 18028 63896741
Cardiac failure acute 50.62 10.33 44 583919 16300 63898469
Urine analysis abnormal 50.47 10.33 140 583823 5616 63909153
Infusion site pruritus 50.12 10.33 87 583876 2519 63912250
Injury 49.58 10.33 747 583216 55245 63859524
Second primary malignancy 49.28 10.33 25 583938 12312 63902457
Accidental death 49.12 10.33 106 583857 3619 63911150
Polyneuropathy 48.88 10.33 65 583898 19829 63894940
Mydriasis 48.63 10.33 270 583693 15042 63899727
Product substitution issue 48.49 10.33 54 583909 17807 63896962
Rash erythematous 48.30 10.33 662 583301 47971 63866798
Graft versus host disease 48.10 10.33 33 583930 13780 63900989
Blood pH decreased 47.79 10.33 116 583847 4286 63910483
Hypocalcaemia 46.99 10.33 206 583757 41547 63873222
Acute myeloid leukaemia 46.55 10.33 113 583850 27350 63887419
Palmar-plantar erythrodysaesthesia syndrome 46.20 10.33 122 583841 28697 63886072
Inappropriate antidiuretic hormone secretion 45.97 10.33 82 583881 22207 63892562
Swelling 45.91 10.33 1830 582133 158388 63756381
Wound 45.83 10.33 959 583004 75518 63839251
Pulmonary arterial hypertension 45.71 10.33 101 583862 25266 63889503
Specific gravity urine decreased 45.26 10.33 45 583918 738 63914031
Aspartate aminotransferase increased 45.19 10.33 1412 582551 118376 63796393
Ear pain 45.01 10.33 385 583578 24751 63890018
Respiratory failure 44.90 10.33 1113 582850 160070 63754699
Therapy interrupted 44.76 10.33 70 583893 19966 63894803
Cytokine release syndrome 44.38 10.33 332 583631 20497 63894272
Melaena 44.29 10.33 293 583670 53255 63861514
Ischaemic stroke 44.23 10.33 126 583837 28909 63885860
Product storage error 43.54 10.33 34 583929 13284 63901485
Osteonecrosis 43.38 10.33 122 583841 28107 63886662
Subdural haematoma 43.29 10.33 121 583842 27933 63886836
Arthralgia 43.15 10.33 4604 579359 437656 63477113
Glossodynia 42.67 10.33 823 583140 63873 63850896
Joint swelling 42.63 10.33 2371 581592 213011 63701758
Chronic kidney disease 42.52 10.33 328 583635 57591 63857178
Hypertensive crisis 42.46 10.33 62 583901 18186 63896583
Gait disturbance 42.39 10.33 1210 582753 170945 63743824
Thrombotic microangiopathy 42.38 10.33 53 583910 16602 63898167
Pneumocystis jirovecii pneumonia 42.04 10.33 120 583843 27514 63887255
Febrile bone marrow aplasia 41.78 10.33 25 583938 11230 63903539
Haemorrhage 41.74 10.33 488 583475 78863 63835906
Acute graft versus host disease 41.72 10.33 15 583948 9069 63905700
Transplant rejection 41.60 10.33 58 583905 17343 63897426
Multiple-drug resistance 41.54 10.33 5 583958 6497 63908272
Immunodeficiency 41.41 10.33 269 583694 15855 63898914
Cardiac failure chronic 41.41 10.33 15 583948 9026 63905743
Postmortem blood drug level increased 40.81 10.33 42 583921 719 63914050
Aspergillus infection 40.77 10.33 53 583910 16326 63898443
Dehydration 40.75 10.33 1577 582386 215186 63699583
Pyroglutamate increased 40.74 10.33 39 583924 609 63914160
Angina pectoris 40.74 10.33 240 583723 44841 63869928
Bacterial test positive 40.42 10.33 143 583820 6547 63908222
Monocyte percentage increased 40.09 10.33 68 583895 1932 63912837
Bacterial test 40.05 10.33 52 583911 1155 63913614
Pulmonary hypertension 39.87 10.33 228 583735 42911 63871858
Haematocrit decreased 39.78 10.33 706 583257 53949 63860820
Myopathy 39.27 10.33 62 583901 17618 63897151
Full blood count abnormal 39.11 10.33 138 583825 29619 63885150
Injection site swelling 39.07 10.33 217 583746 41136 63873633
Epistaxis 38.58 10.33 640 583323 97491 63817278
Culture urine positive 38.43 10.33 103 583860 4048 63910721
Specific gravity urine increased 38.28 10.33 32 583931 414 63914355
Lung neoplasm malignant 38.15 10.33 86 583877 21362 63893407
Device malfunction 38.08 10.33 63 583900 17570 63897199
Electric shock 38.02 10.33 49 583914 1080 63913689
Hepatic failure 38.02 10.33 709 583254 54685 63860084
Serum sickness 37.84 10.33 87 583876 3102 63911667
Drug screen positive 37.71 10.33 126 583837 5603 63909166
Hypokalaemia 37.50 10.33 829 583134 121074 63793695
Right ventricular failure 37.46 10.33 87 583876 21384 63893385
Endophthalmitis 37.22 10.33 3 583960 5362 63909407
Pharyngeal paraesthesia 36.87 10.33 64 583899 1853 63912916
Glycosylated haemoglobin increased 36.71 10.33 55 583908 15964 63898805
Brain death 36.63 10.33 112 583851 4749 63910020
Toxic skin eruption 36.23 10.33 75 583888 19209 63895560
Hypoglycaemia 36.09 10.33 584 583379 89308 63825461
Bronchopulmonary aspergillosis 36.05 10.33 74 583889 19011 63895758
Memory impairment 35.96 10.33 552 583411 85130 63829639
Injection site haemorrhage 35.79 10.33 107 583856 24171 63890598
Coeliac disease 35.38 10.33 147 583816 7265 63907504
Hepatic function abnormal 35.20 10.33 392 583571 63921 63850848
Injection site pruritus 34.92 10.33 200 583763 37626 63877143
Enthesopathy 34.75 10.33 176 583787 9462 63905307
Brain oedema 34.36 10.33 328 583635 21747 63893022
Extrapyramidal disorder 34.29 10.33 79 583884 19473 63895296
Drug ineffective for unapproved indication 34.19 10.33 155 583808 30978 63883791
Gastrointestinal disorder 33.97 10.33 1058 582905 88651 63826118
Eosinophilia 33.72 10.33 204 583759 37872 63876897
Coma 33.63 10.33 1035 582928 86580 63828189
Hyperhidrosis 33.52 10.33 1417 582546 123503 63791266
Drug hypersensitivity 33.47 10.33 2543 581420 235272 63679497
Abortion spontaneous 33.45 10.33 116 583847 25027 63889742
Tenosynovitis 33.25 10.33 202 583761 11631 63903138
Hepatic cirrhosis 33.21 10.33 124 583839 26174 63888595
Haemoglobin urine present 33.14 10.33 40 583923 823 63913946
Transplant dysfunction 32.70 10.33 10 583953 6698 63908071
Coronary arterial stent insertion 32.63 10.33 6 583957 5686 63909083
Altered state of consciousness 32.56 10.33 205 583758 37697 63877072
Bursitis 32.34 10.33 317 583646 21168 63893601
Inappropriate schedule of product administration 32.25 10.33 1078 582885 91208 63823561
Transient ischaemic attack 32.06 10.33 251 583712 43931 63870838
Ascites 31.95 10.33 383 583580 61618 63853151
Pancreatitis acute 31.78 10.33 242 583721 42613 63872156
Neurotoxicity 31.57 10.33 134 583829 27270 63887499
Bone erosion 31.54 10.33 35 583928 11560 63903209
Drug reaction with eosinophilia and systemic symptoms 31.47 10.33 326 583637 53891 63860878
Anxiety 31.24 10.33 2183 581780 200466 63714303
Chronic graft versus host disease 31.24 10.33 9 583954 6267 63908502
Contraindicated product administered 31.19 10.33 1233 582730 106596 63808173
Unintentional medical device removal 31.13 10.33 11 583952 6723 63908046
Therapeutic product effect decreased 31.07 10.33 1309 582654 114042 63800727
Condition aggravated 30.76 10.33 2928 581035 369498 63545271
Hepatocellular carcinoma 30.72 10.33 19 583944 8384 63906385
Headache 30.48 10.33 5342 578621 524125 63390644
Iron deficiency anaemia 30.48 10.33 99 583864 21790 63892979
Oedema 30.38 10.33 618 583345 91317 63823452
Peripheral swelling 30.34 10.33 2242 581721 206911 63707858
Cognitive disorder 30.19 10.33 682 583281 54405 63860364
Heart rate abnormal 29.88 10.33 107 583856 4928 63909841
Suicide attempt 29.74 10.33 848 583115 70159 63844610
Electrocardiogram QRS complex prolonged 29.35 10.33 163 583800 9081 63905688
Infusion site bruising 29.28 10.33 51 583912 1481 63913288
Malaise 29.20 10.33 3141 580822 393106 63521663
Injection site warmth 29.16 10.33 48 583915 13414 63901355
Systemic lupus erythematosus 29.03 10.33 914 583049 76698 63838071
Analgesic drug level above therapeutic 28.97 10.33 27 583936 407 63914362
Renal papillary necrosis 28.95 10.33 25 583938 339 63914430
Product monitoring error 28.71 10.33 7 583956 5447 63909322
Circulatory collapse 28.69 10.33 183 583780 33549 63881220
Prothrombin time prolonged 28.66 10.33 242 583721 15499 63899270
Anion gap increased 28.65 10.33 76 583887 2968 63911801
Shock haemorrhagic 28.52 10.33 69 583894 16722 63898047
Congestive cardiomyopathy 28.38 10.33 31 583932 10313 63904456
Pulmonary alveolar haemorrhage 28.05 10.33 28 583935 9710 63905059
Renal disorder 28.01 10.33 196 583767 35169 63879600
Left ventricular dysfunction 27.76 10.33 71 583892 16883 63897886
Injection site mass 27.76 10.33 73 583890 17197 63897572
Pharyngitis 27.73 10.33 279 583684 18760 63896009
Injection site reaction 27.32 10.33 280 583683 46384 63868385
Prostate cancer 27.24 10.33 90 583873 19705 63895064
Alanine aminotransferase abnormal 27.13 10.33 129 583834 6759 63908010
Metastases to liver 27.01 10.33 118 583845 23823 63890946
Cytomegalovirus viraemia 26.99 10.33 35 583928 10793 63903976
Mean cell haemoglobin concentration decreased 26.94 10.33 84 583879 3600 63911169
Platelet count decreased 26.91 10.33 1242 582721 166469 63748300
Chronic obstructive pulmonary disease 26.74 10.33 467 583496 70581 63844188
Epstein-Barr virus infection 26.61 10.33 45 583918 12443 63902326
Incorrect dose administered by device 26.55 10.33 3 583960 4094 63910675
Sedation 26.51 10.33 525 583438 40937 63873832
Oropharyngeal pain 26.13 10.33 1018 582945 87849 63826920
Upper gastrointestinal haemorrhage 26.06 10.33 199 583764 35021 63879748
Sexual dysfunction 26.02 10.33 13 583950 6458 63908311
Drug specific antibody present 26.02 10.33 104 583859 5050 63909719
Ear infection 25.92 10.33 325 583638 23079 63891690
Incorrect drug administration rate 25.71 10.33 68 583895 2651 63912118
Disturbance in attention 25.50 10.33 243 583720 40831 63873938
Eosinophil percentage increased 25.41 10.33 46 583917 1378 63913391
Device dislocation 25.37 10.33 102 583861 21076 63893693
Drug level below therapeutic 25.34 10.33 133 583830 7251 63907518
Emotional distress 25.33 10.33 463 583500 35575 63879194
Myalgia 25.18 10.33 1176 582787 157441 63757328
Angina unstable 25.15 10.33 65 583898 15402 63899367
Lung disorder 25.14 10.33 392 583571 60308 63854461
Toxicologic test abnormal 25.02 10.33 42 583921 1183 63913586
Treatment noncompliance 25.01 10.33 262 583701 43220 63871549
Infusion site mass 24.68 10.33 37 583926 944 63913825
Electrolyte imbalance 24.65 10.33 131 583832 25112 63889657
Device use error 24.55 10.33 14 583949 6457 63908312
Accidental exposure to product by child 24.37 10.33 63 583900 2422 63912347
Hepatitis B reactivation 24.36 10.33 7 583956 4882 63909887
Macular oedema 24.19 10.33 7 583956 4860 63909909
Haematoma 24.10 10.33 285 583678 45965 63868804
Surgery 24.03 10.33 153 583810 28060 63886709
Leukoencephalopathy 23.79 10.33 17 583946 6950 63907819
Aphasia 23.72 10.33 246 583717 40660 63874109
Parkinsonism 23.68 10.33 60 583903 14313 63900456
Mental status changes 23.60 10.33 723 583240 60439 63854330
Visual impairment 23.57 10.33 501 583462 73576 63841193
Nitrite urine present 23.57 10.33 38 583925 1034 63913735
Blood creatinine decreased 23.52 10.33 126 583837 6924 63907845
Candida infection 23.50 10.33 177 583786 31242 63883527
Hypoglycaemic coma 23.47 10.33 5 583958 4269 63910500
Cardiomyopathy 23.44 10.33 134 583829 25222 63889547
Nocardiosis 23.43 10.33 7 583956 4760 63910009
Oral pruritus 23.39 10.33 51 583912 1754 63913015
Liver disorder 23.31 10.33 341 583622 53010 63861759
Hypertriglyceridaemia 23.31 10.33 41 583922 11164 63903605
Hyperlipidaemia 23.13 10.33 118 583845 22858 63891911
Device difficult to use 23.08 10.33 33 583930 9765 63905004
Acute graft versus host disease in skin 23.05 10.33 17 583946 6838 63907931
Mitral valve incompetence 23.05 10.33 136 583827 25402 63889367
Haemolysis 22.98 10.33 175 583788 10864 63903905
Bladder cancer 22.97 10.33 40 583923 10934 63903835
Red blood cell sedimentation rate 22.97 10.33 80 583883 3634 63911135
Metastases to lymph nodes 22.96 10.33 27 583936 8690 63906079
Renal cortical necrosis 22.94 10.33 20 583943 275 63914494
Coronary artery bypass 22.91 10.33 12 583951 5803 63908966
Sinus node dysfunction 22.87 10.33 17 583946 6811 63907958
Ejection fraction decreased 22.78 10.33 159 583804 28548 63886221
Rash maculo-papular 22.54 10.33 295 583668 46731 63868038
Varicella zoster virus infection 22.50 10.33 4 583959 3884 63910885
Gastrointestinal toxicity 22.46 10.33 10 583953 5312 63909457
Pancreatic carcinoma 22.45 10.33 37 583926 10336 63904433
Disease recurrence 22.40 10.33 180 583783 31330 63883439
Infusion site discomfort 22.35 10.33 31 583932 735 63914034
Meningitis aseptic 22.34 10.33 107 583856 5623 63909146
Aplastic anaemia 22.25 10.33 208 583755 13712 63901057
Prostatic specific antigen increased 22.16 10.33 28 583935 8732 63906037
Victim of child abuse 22.12 10.33 33 583930 838 63913931
Treatment failure 22.12 10.33 849 583114 115967 63798802
Deafness transitory 22.09 10.33 32 583931 791 63913978
Pleural effusion 21.99 10.33 929 583034 125630 63789139
Pulmonary tuberculosis 21.84 10.33 20 583943 7224 63907545
Sinus tachycardia 21.74 10.33 411 583552 31777 63882992
Systemic lupus erythematosus rash 21.67 10.33 43 583920 1382 63913387
Pneumonia viral 21.64 10.33 133 583830 7689 63907080
Haemophagocytic lymphohistiocytosis 21.61 10.33 84 583879 17525 63897244
Lipodystrophy acquired 21.53 10.33 5 583958 4022 63910747
Cytopenia 21.52 10.33 70 583893 15401 63899368
Hypertransaminasaemia 21.50 10.33 20 583943 7171 63907598
Graft versus host disease in gastrointestinal tract 21.49 10.33 12 583951 5600 63909169
Back pain 21.43 10.33 2583 581380 247588 63667181
Infusion site rash 21.37 10.33 37 583926 1069 63913700
Cholestasis 21.32 10.33 282 583681 44590 63870179
Vertigo 21.22 10.33 391 583572 58620 63856149
Pupil fixed 21.20 10.33 71 583892 3161 63911608
Obstructive airways disorder 21.18 10.33 123 583840 23062 63891707
Long QT syndrome 21.15 10.33 10 583953 5129 63909640
Cytomegalovirus infection reactivation 21.07 10.33 13 583950 5743 63909026
Granulomatosis with polyangiitis 21.05 10.33 54 583909 2066 63912703
Bilirubin urine present 21.01 10.33 20 583943 310 63914459
Human herpesvirus 6 infection 20.85 10.33 8 583955 4646 63910123
Spinal stenosis 20.82 10.33 61 583902 13870 63900899
Immunosuppressant drug level increased 20.77 10.33 21 583942 7238 63907531
Metastases to central nervous system 20.73 10.33 61 583902 13851 63900918
Cystitis haemorrhagic 20.58 10.33 25 583938 7931 63906838
BK virus infection 20.57 10.33 22 583941 7390 63907379
Venoocclusive liver disease 20.51 10.33 37 583926 9978 63904791
Large intestine polyp 20.48 10.33 42 583921 10795 63903974
Ischaemic cardiomyopathy 20.47 10.33 19 583944 6819 63907950
Disturbance in social behaviour 20.44 10.33 5 583958 3882 63910887
Red cell distribution width decreased 20.39 10.33 36 583927 1057 63913712
Status epilepticus 20.28 10.33 114 583849 21549 63893220
Device issue 20.23 10.33 121 583842 22527 63892242
Haematochezia 20.22 10.33 452 583511 65921 63848848
Intentional self-injury 20.15 10.33 167 583796 28877 63885892
Gynaecomastia 20.13 10.33 15 583948 6001 63908768
Systemic infection 20.08 10.33 7 583956 4314 63910455
Injection site rash 20.03 10.33 74 583889 15668 63899101
Metastases to bone 19.98 10.33 106 583857 20329 63894440
Gestational diabetes 19.94 10.33 13 583950 5577 63909192
Urticaria thermal 19.93 10.33 15 583948 165 63914604
Metastases to lung 19.92 10.33 71 583892 15193 63899576
pH urine increased 19.83 10.33 22 583941 412 63914357
Dizziness 19.78 10.33 3510 580453 426653 63488116
Hepatitis C 19.73 10.33 44 583919 10971 63903798
Hepatic cancer 19.70 10.33 23 583940 7425 63907344
Graft versus host disease in skin 19.67 10.33 12 583951 5335 63909434
Kidney transplant rejection 19.60 10.33 35 583928 9476 63905293
Compartment syndrome 19.48 10.33 83 583880 4149 63910620
Full blood count decreased 19.47 10.33 122 583841 22460 63892309
Infusion site urticaria 19.44 10.33 26 583937 595 63914174
Lymphoproliferative disorder 19.42 10.33 11 583952 5092 63909677
Muscle spasms 19.40 10.33 1061 582902 139962 63774807
Osteoarthritis 19.39 10.33 431 583532 62905 63851864
Urinary casts 19.36 10.33 35 583928 1047 63913722
Device leakage 19.31 10.33 28 583935 8238 63906531
Infusion site streaking 19.29 10.33 22 583941 425 63914344
Hemiparesis 19.14 10.33 175 583788 29652 63885117
Migraine 19.14 10.33 721 583242 61956 63852813
Disorientation 19.12 10.33 373 583590 55455 63859314
Product quality issue 19.05 10.33 175 583788 29624 63885145
Bradyphrenia 19.04 10.33 35 583928 9371 63905398
Injection site extravasation 19.02 10.33 132 583831 7954 63906815
Premature delivery 18.98 10.33 95 583868 18494 63896275
Arrhythmia 18.98 10.33 351 583612 52593 63862176
Acute coronary syndrome 18.97 10.33 100 583863 19210 63895559
Soft tissue disorder 18.92 10.33 69 583894 3207 63911562
Partial seizures 18.86 10.33 23 583940 7284 63907485
Serum sickness-like reaction 18.73 10.33 24 583939 526 63914243
Blood creatine phosphokinase increased 18.64 10.33 396 583567 58162 63856607
Fracture 18.50 10.33 97 583866 18658 63896111
Pulmonary fibrosis 18.44 10.33 177 583786 29701 63885068
Forced expiratory volume decreased 18.38 10.33 21 583942 6846 63907923
Oesophageal carcinoma 18.37 10.33 10 583953 4733 63910036
Band neutrophil count increased 18.36 10.33 26 583937 629 63914140
Ketoacidosis 18.36 10.33 21 583942 6842 63907927
Hyperglycaemia 18.34 10.33 416 583547 60552 63854217
Personality change 18.28 10.33 31 583932 8562 63906207
Rheumatoid nodule 18.24 10.33 185 583778 12466 63902303
Hypothyroidism 18.23 10.33 257 583706 40200 63874569
Akinesia 18.19 10.33 3 583960 3076 63911693
Peripheral arterial occlusive disease 18.02 10.33 22 583941 6965 63907804
Acidosis 17.98 10.33 243 583720 17552 63897217
Breast cancer 17.85 10.33 173 583790 28975 63885794
Subarachnoid haemorrhage 17.83 10.33 96 583867 18342 63896427
No adverse event 17.71 10.33 169 583794 28392 63886377
Rectal haemorrhage 17.70 10.33 425 583538 61392 63853377
Neuroleptic malignant syndrome 17.67 10.33 143 583820 24853 63889916
Concomitant disease aggravated 17.64 10.33 50 583913 11492 63903277
Vitamin K deficiency 17.64 10.33 26 583937 653 63914116
Adrenergic syndrome 17.64 10.33 12 583951 111 63914658
Sudden death 17.62 10.33 108 583855 19988 63894781
Hypovolaemic shock 17.59 10.33 42 583921 10224 63904545
Carotid artery stenosis 17.49 10.33 28 583935 7913 63906856
Night sweats 17.24 10.33 438 583525 35608 63879161
Infusion site nodule 17.12 10.33 16 583947 242 63914527
Actinic keratosis 17.12 10.33 13 583950 5152 63909617
Suicidal ideation 17.05 10.33 465 583498 66077 63848692
Muscle spasticity 17.00 10.33 228 583735 16441 63898328
Cardiovascular disorder 16.89 10.33 80 583883 15801 63898968
Post-traumatic stress disorder 16.74 10.33 79 583884 4126 63910643
Contusion 16.74 10.33 1223 582740 112742 63802027
Atypical femur fracture 16.66 10.33 11 583952 4687 63910082
Diffuse large B-cell lymphoma recurrent 16.63 10.33 4 583959 3142 63911627
Neutropenic sepsis 16.51 10.33 133 583830 23139 63891630
Diffuse large B-cell lymphoma 16.50 10.33 44 583919 10317 63904452
Erysipelas 16.49 10.33 36 583927 9045 63905724
Squamous cell carcinoma 16.49 10.33 67 583896 13802 63900967
Hot flush 16.38 10.33 541 583422 45694 63869075
Biliary dyskinesia 16.36 10.33 53 583910 2319 63912450
JC virus infection 16.36 10.33 5 583958 3350 63911419
Eyelid ptosis 16.29 10.33 39 583924 9486 63905283
Cardiac disorder 16.19 10.33 383 583580 55433 63859336
Aplasia pure red cell 16.15 10.33 24 583939 6990 63907779
Mean cell haemoglobin concentration increased 16.09 10.33 27 583936 760 63914009
Cardiotoxicity 16.08 10.33 44 583919 10230 63904539
Band neutrophil percentage increased 16.04 10.33 19 583944 383 63914386
Blood loss anaemia 15.96 10.33 68 583895 13824 63900945
Cystic fibrosis pancreatic 15.76 10.33 9 583954 59 63914710
C-reactive protein abnormal 15.72 10.33 359 583604 28688 63886081
Mean cell haemoglobin increased 15.67 10.33 64 583899 3138 63911631
Squamous cell carcinoma of skin 15.66 10.33 55 583908 11821 63902948
Jaundice cholestatic 15.63 10.33 133 583830 8537 63906232
Unevaluable event 15.62 10.33 343 583620 50146 63864623
Sensation of foreign body 15.57 10.33 81 583882 4401 63910368
Anuria 15.56 10.33 104 583859 18860 63895909
Stomatitis 15.56 10.33 1173 582790 108432 63806337
Organising pneumonia 15.55 10.33 37 583926 9018 63905751
Gallbladder injury 15.52 10.33 33 583930 1115 63913654
Hepatitis B 15.52 10.33 29 583934 7716 63907053
Dysarthria 15.52 10.33 414 583549 58992 63855777
Femoral neck fracture 15.50 10.33 35 583928 8689 63906080
Aggression 15.50 10.33 310 583653 45922 63868847
Pulmonary congestion 15.48 10.33 303 583660 23577 63891192
Accidental poisoning 15.47 10.33 38 583925 1415 63913354
Red blood cells urine 15.43 10.33 24 583939 633 63914136
Tooth infection 15.42 10.33 201 583762 14400 63900369
Depression 15.39 10.33 1439 582524 181852 63732917
Joint laxity 15.32 10.33 51 583912 2263 63912506
Hypomagnesaemia 15.27 10.33 242 583721 37134 63877635
Dyspnoea at rest 15.22 10.33 21 583942 6308 63908461
Mucormycosis 15.14 10.33 27 583936 7314 63907455
Plasma cell myeloma 15.13 10.33 310 583653 45765 63869004
Underdose 15.11 10.33 155 583808 25674 63889095
Toothache 15.09 10.33 232 583731 17227 63897542
Petit mal epilepsy 15.04 10.33 14 583949 5018 63909751
Agitation 15.04 10.33 960 583003 87407 63827362
Ageusia 15.03 10.33 69 583894 13744 63901025
Blood glucose increased 14.98 10.33 730 583233 97343 63817426
Dermatitis allergic 14.98 10.33 78 583885 15031 63899738
Pain in jaw 14.98 10.33 269 583694 40486 63874283
Hemiplegia 14.98 10.33 62 583901 12706 63902063
Blood pressure decreased 14.95 10.33 938 583025 85261 63829508
Injection site induration 14.94 10.33 37 583926 8895 63905874
Hypomania 14.93 10.33 95 583868 5559 63909210
Skin toxicity 14.81 10.33 23 583940 6579 63908190
Urobilinogen urine increased 14.72 10.33 23 583940 609 63914160
Transplant failure 14.69 10.33 8 583955 3786 63910983
Intestinal haemorrhage 14.61 10.33 17 583946 5497 63909272
Smear cervix abnormal 14.56 10.33 51 583912 2323 63912446
Retinal haemorrhage 14.56 10.33 28 583935 7370 63907399
Product use issue 14.54 10.33 1578 582385 150137 63764632
Blood thyroid stimulating hormone decreased 14.52 10.33 89 583874 5141 63909628
Cells in urine 14.49 10.33 13 583950 186 63914583
Tachyarrhythmia 14.49 10.33 20 583943 6006 63908763
Limb mass 14.49 10.33 60 583903 2961 63911808
Bradyarrhythmia 14.44 10.33 8 583955 3750 63911019
Antipsychotic drug level increased 14.40 10.33 15 583948 5100 63909669
Proteinuria 14.38 10.33 171 583792 27552 63887217
Gastritis erosive 14.35 10.33 42 583921 9553 63905216
Hyperammonaemia 14.35 10.33 44 583919 9860 63904909
Multiple drug therapy 14.33 10.33 49 583914 2205 63912564
Rebound effect 14.32 10.33 14 583949 4903 63909866
Retinal deposits 14.32 10.33 11 583952 125 63914644
Abnormal dreams 14.31 10.33 47 583916 10309 63904460
Pneumonia cytomegaloviral 14.28 10.33 11 583952 4328 63910441
Colitis 14.27 10.33 413 583550 58261 63856508
Adenocarcinoma of colon 14.27 10.33 14 583949 4894 63909875
Procedural anxiety 14.26 10.33 23 583940 626 63914143
Tuberculosis 14.26 10.33 65 583898 12973 63901796
Bundle branch block left 14.24 10.33 45 583918 9989 63904780
Gastric cancer 14.20 10.33 23 583940 6470 63908299
Cytomegalovirus colitis 14.20 10.33 9 583954 3919 63910850
Oxygen saturation abnormal 14.15 10.33 67 583896 3504 63911265
Haemorrhage intracranial 14.11 10.33 143 583820 23741 63891028
Monocyte count increased 14.07 10.33 123 583840 7956 63906813
Haematemesis 14.05 10.33 321 583642 46678 63868091
Thyroxine free increased 14.03 10.33 31 583932 1076 63913693
Vein rupture 14.00 10.33 38 583925 1505 63913264
Left ventricular failure 13.97 10.33 35 583928 8382 63906387
Pulse absent 13.96 10.33 133 583830 8813 63905956
Lipaemic index score 13.90 10.33 11 583952 131 63914638
Administration site swelling 13.88 10.33 16 583947 313 63914456
Nocturia 13.87 10.33 53 583910 11112 63903657
Sleep disorder due to a general medical condition 13.86 10.33 34 583929 8200 63906569
Erectile dysfunction 13.78 10.33 63 583900 12564 63902205
Impaired work ability 13.76 10.33 81 583882 15138 63899631
Terminal state 13.72 10.33 12 583951 4432 63910337
Uterine perforation 13.69 10.33 95 583868 5725 63909044
White blood cells urine 13.67 10.33 17 583946 361 63914408
Urine bilirubin decreased 13.63 10.33 11 583952 135 63914634
Dyspnoea 13.59 10.33 6093 577870 712581 63202188
Acute respiratory failure 13.57 10.33 346 583617 49588 63865181
Liver transplant 13.56 10.33 73 583890 4019 63910750
Intestinal obstruction 13.50 10.33 239 583724 36047 63878722
Gastrooesophageal reflux disease 13.47 10.33 615 583348 82528 63832241
Osmolar gap 13.43 10.33 11 583952 138 63914631
Dyslipidaemia 13.43 10.33 41 583922 9201 63905568
PCO2 decreased 13.42 10.33 57 583906 2845 63911924
Lymphopenia 13.40 10.33 158 583805 25499 63889270
Loss of consciousness 13.29 10.33 1159 582804 147206 63767563
Staphylococcal infection 13.28 10.33 353 583610 50325 63864444
Exposure via inhalation 13.25 10.33 9 583954 83 63914686
B-cell lymphoma 13.23 10.33 18 583945 5439 63909330
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.23 10.33 5 583958 2931 63911838
Ventricular fibrillation 13.22 10.33 145 583818 23715 63891054
Peritonitis bacterial 13.22 10.33 40 583923 9003 63905766
Monoparesis 13.21 10.33 5 583958 2929 63911840
Cytomegalovirus chorioretinitis 13.17 10.33 15 583948 4897 63909872
Self-medication 13.10 10.33 73 583890 4072 63910697
Gait inability 13.05 10.33 288 583675 42080 63872689
Periorbital swelling 13.01 10.33 42 583921 1834 63912935
Pneumonia aspiration 12.99 10.33 423 583540 58848 63855921
Muscle twitching 12.98 10.33 243 583720 18755 63896014
Euglycaemic diabetic ketoacidosis 12.96 10.33 18 583945 5392 63909377
Pneumatosis intestinalis 12.93 10.33 17 583946 5212 63909557
Somnolence 12.93 10.33 2066 581897 201579 63713190
Muscular weakness 12.89 10.33 985 582978 126353 63788416
Mastocytosis 12.88 10.33 18 583945 430 63914339
Affective disorder 12.87 10.33 25 583938 6555 63908214
Prescribed underdose 12.76 10.33 103 583860 17912 63896857
Delusion 12.76 10.33 103 583860 17911 63896858
Cardiac tamponade 12.75 10.33 35 583928 8129 63906640
Peritonitis 12.73 10.33 155 583808 24868 63889901
Feeling cold 12.62 10.33 292 583671 23386 63891383
Pharyngitis streptococcal 12.61 10.33 127 583836 8541 63906228
Thrombosis 12.59 10.33 517 583446 70125 63844644
Gastric haemorrhage 12.59 10.33 71 583892 13410 63901359
Cerebral ischaemia 12.56 10.33 47 583916 9915 63904854
Blindness 12.53 10.33 133 583830 21886 63892883
Lumbar vertebral fracture 12.50 10.33 19 583944 5483 63909286
Acid-base balance disorder mixed 12.50 10.33 9 583954 92 63914677
Nephropathy toxic 12.47 10.33 100 583863 17414 63897355
Tri-iodothyronine free increased 12.38 10.33 13 583950 228 63914541
Opiates positive 12.36 10.33 26 583937 872 63913897
Vitamin B12 deficiency 12.33 10.33 19 583944 5453 63909316
Peripheral sensory neuropathy 12.28 10.33 57 583906 11321 63903448
Malignant melanoma 12.26 10.33 68 583895 12896 63901873
Acute pulmonary oedema 12.21 10.33 67 583896 12742 63902027
Inhibitory drug interaction 12.19 10.33 9 583954 3618 63911151
Prerenal failure 12.18 10.33 7 583956 3215 63911554
Sputum culture positive 12.16 10.33 57 583906 2969 63911800
Kidney infection 12.13 10.33 228 583735 17610 63897159
Leukaemia 12.12 10.33 17 583946 5071 63909698
Pneumonia bacterial 12.07 10.33 83 583880 14952 63899817
Temperature intolerance 12.04 10.33 121 583842 8134 63906635
Pleurothotonus 12.03 10.33 3 583960 2299 63912470
Potentiating drug interaction 12.01 10.33 34 583929 7818 63906951
Tubulointerstitial nephritis 12.01 10.33 202 583761 30707 63884062
Mean cell haemoglobin decreased 11.99 10.33 71 583892 4051 63910718
COVID-19 immunisation 11.97 10.33 20 583943 561 63914208
Myositis 11.90 10.33 93 583870 16284 63898485
Physical disability 11.90 10.33 3 583960 2282 63912487
Therapy partial responder 11.87 10.33 50 583913 10198 63904571
Cystitis 11.87 10.33 486 583477 42189 63872580
International normalised ratio increased 11.87 10.33 851 583112 78316 63836453
Brain scan abnormal 11.86 10.33 30 583933 1138 63913631
Blood uric acid decreased 11.85 10.33 29 583934 1077 63913692
Portal hypertension 11.84 10.33 24 583939 6195 63908574
Cerebral haematoma 11.83 10.33 30 583933 7155 63907614
Pancreatitis 11.77 10.33 431 583532 59176 63855593
Diastolic dysfunction 11.77 10.33 41 583922 8834 63905935
Pericardial effusion 11.76 10.33 268 583695 38986 63875783
Haemoptysis 11.74 10.33 346 583617 48702 63866067
Fanconi syndrome 11.71 10.33 4 583959 2497 63912272
Metastasis 11.70 10.33 21 583942 5674 63909095
Gallbladder disorder 11.69 10.33 218 583745 16812 63897957
Mucosal dryness 11.67 10.33 56 583907 2945 63911824
Anoxia 11.66 10.33 15 583948 330 63914439
Fungal rhinitis 11.66 10.33 7 583956 51 63914718
Infective pulmonary exacerbation of cystic fibrosis 11.64 10.33 61 583902 11735 63903034
Viral load increased 11.61 10.33 4 583959 2483 63912286
Mobility decreased 11.57 10.33 915 583048 84925 63829844
Fluid retention 11.55 10.33 432 583531 59174 63855595
Needle issue 11.53 10.33 44 583919 9228 63905541
Hyperthyroidism 11.52 10.33 107 583856 18072 63896697
Pharyngeal swelling 11.50 10.33 88 583875 5471 63909298
Anti-erythrocyte antibody positive 11.50 10.33 8 583955 77 63914692
Epstein-Barr virus associated lymphoproliferative disorder 11.48 10.33 7 583956 3112 63911657
Product dispensing error 11.41 10.33 59 583904 11391 63903378
Fibromyalgia 11.38 10.33 413 583550 35318 63879451
Atrioventricular block complete 11.37 10.33 80 583883 14338 63900431
Infusion site scar 11.37 10.33 13 583950 252 63914517
Upper respiratory tract infection 11.36 10.33 785 583178 72000 63842769
Immune-mediated myositis 11.35 10.33 5 583958 2673 63912096
Oropharyngeal discomfort 11.34 10.33 85 583878 5250 63909519
Eye swelling 11.33 10.33 273 583690 22008 63892761
Injection site discomfort 11.32 10.33 13 583950 4228 63910541
Hypervolaemia 11.30 10.33 262 583701 38023 63876746
Toxoplasmosis 11.29 10.33 4 583959 2440 63912329
Pemphigoid 11.28 10.33 70 583893 12916 63901853
Creatinine urine decreased 11.27 10.33 12 583951 214 63914555
Focal dyscognitive seizures 11.27 10.33 8 583955 3282 63911487
Progressive multifocal leukoencephalopathy 11.26 10.33 108 583855 18124 63896645
Hip fracture 11.22 10.33 175 583788 26924 63887845
Complications of transplanted kidney 11.20 10.33 20 583943 5415 63909354
Leukocyturia 11.18 10.33 35 583928 1503 63913266
Administration site warmth 11.14 10.33 3 583960 0 63914769
Burn of internal organs 11.14 10.33 3 583960 0 63914769
Concomitant disease progression 11.13 10.33 8 583955 3261 63911508
Stent placement 11.04 10.33 21 583942 5550 63909219
Facial paresis 11.01 10.33 17 583946 4875 63909894
Nephrogenic systemic fibrosis 11.00 10.33 23 583940 5869 63908900
Dysstasia 10.99 10.33 146 583817 23069 63891700
Brain stem glioma 10.99 10.33 10 583953 146 63914623
Red blood cell elliptocytes present 10.99 10.33 10 583953 146 63914623
Dry throat 10.92 10.33 95 583868 6137 63908632
Protein urine 10.88 10.33 31 583932 1263 63913506
Methaemoglobinaemia 10.84 10.33 72 583891 4276 63910493
Acute graft versus host disease in intestine 10.84 10.33 10 583953 3599 63911170
Diplopia 10.70 10.33 174 583789 26591 63888178
Pericardial haemorrhage 10.69 10.33 13 583950 4123 63910646
Spinal compression fracture 10.69 10.33 84 583879 14691 63900078
Electrocardiogram QT prolonged 10.69 10.33 599 583364 78849 63835920
Jaundice 10.69 10.33 346 583617 48166 63866603
Vessel puncture site bruise 10.68 10.33 16 583947 408 63914361
Pneumocystis jirovecii infection 10.67 10.33 4 583959 2357 63912412
Lower gastrointestinal haemorrhage 10.67 10.33 78 583885 13861 63900908
Skin lesion 10.67 10.33 250 583713 36232 63878537
Pulmonary oedema 10.67 10.33 839 583124 77835 63836934
Pulmonary mass 10.67 10.33 153 583810 23863 63890906
Renal tubular disorder 10.65 10.33 24 583939 5963 63908806
Acute myeloid leukaemia recurrent 10.59 10.33 6 583957 2778 63911991
Mycobacterial infection 10.59 10.33 7 583956 2981 63911788
Mean cell volume decreased 10.59 10.33 61 583902 3445 63911324
Coagulation factor X level decreased 10.55 10.33 8 583955 89 63914680
Allergy to immunoglobulin therapy 10.53 10.33 4 583959 8 63914761
Vascular rupture 10.47 10.33 31 583932 1291 63913478
Precancerous cells present 10.47 10.33 26 583937 975 63913794
Infusion site reaction 10.45 10.33 42 583921 2044 63912725
Dependent personality disorder 10.43 10.33 9 583954 122 63914647
Traumatic liver injury 10.42 10.33 18 583945 519 63914250
Drug abuser 10.42 10.33 89 583874 5719 63909050
Anaphylactoid reaction 10.37 10.33 76 583887 4662 63910107
Retinitis 10.36 10.33 3 583960 2082 63912687

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D04AA32 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AA02 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA52 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:36333 local anesthetics
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48876 muscarinic antagonists
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:59683 antipruritic drugs
CHEBI has role CHEBI:66956 antidyskinetic agent
CHEBI has role CHEBI:146270 oneirogens
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Insomnia indication 193462001
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Migraine off-label use 37796009 DOID:6364
Anxiety disorder off-label use 197480006 DOID:2030
Local anesthesia off-label use 386761002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT ADVIL PM GLAXOSMITHKLINE N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 7.81 WOMBAT-PK CHEMBL
Sodium-dependent noradrenaline transporter Transporter Kd 6.02 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.43 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.15 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.29 DRUG MATRIX
Histamine H4 receptor GPCR Ki 4.37 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 7 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.92 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 6.64 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 6.95 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 6.59 WOMBAT-PK
Cytochrome P450 2D6 Enzyme Ki 4.93 WOMBAT-PK
Solute carrier family 22 member 2 Transporter IC50 4.68 WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 5.42 SCIENTIFIC LITERATURE
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.59 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.66 SCIENTIFIC LITERATURE
Histamine H1 receptor GPCR IC50 9 CHEMBL

External reference:

IDSource
4019724 VUID
N0000147816 NUI
D00300 KEGG_DRUG
7491-10-3 SECONDARY_CAS_RN
103659-13-8 SECONDARY_CAS_RN
147-24-0 SECONDARY_CAS_RN
88637-37-0 SECONDARY_CAS_RN
1362 RXNORM
4017866 VANDF
4019724 VANDF
4020653 VANDF
C0012522 UMLSCUI
CHEBI:4636 CHEBI
2PM PDB_CHEM_ID
CHEMBL657 ChEMBL_ID
CHEMBL1201089 ChEMBL_ID
CHEMBL1620 ChEMBL_ID
DB01075 DRUGBANK_ID
D004155 MESH_DESCRIPTOR_UI
3100 PUBCHEM_CID
1224 IUPHAR_LIGAND_ID
1774 INN_ID
8GTS82S83M UNII
1676 MMSL
4611 MMSL
4612 MMSL
899 MMSL
d00212 MMSL
003369 NDDF
004787 NDDF
005115 NDDF
19510001 SNOMEDCT_US
26458009 SNOMEDCT_US
372682005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 12.50 mg ORAL Unapproved drug other 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 25 mg ORAL OTC MONOGRAPH FINAL 17 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 16 sections
THERAFLUPOWERPODS NIGHTTIME SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 16 sections
THERAFLUNIGHTTIME SEVERE COLD AND COUGH HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 17 sections
TRIAMINICNight Time Cold and Cough HUMAN OTC DRUG LABEL 2 0067-8106 SYRUP 6.25 mg ORAL OTC monograph final 15 sections
Theraflu Nighttime Multi-Symptom Severe Cold Powder HUMAN OTC DRUG LABEL 3 0067-8124 POWDER 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8137 TABLET, FILM COATED 12.50 mg ORAL OTC monograph final 16 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 38 mg ORAL ANDA 16 sections
good sense sleep time HUMAN OTC DRUG LABEL 1 0113-0052 CAPSULE, LIQUID FILLED 25 mg ORAL OTC monograph final 16 sections
Good Sense Sleep Time HUMAN OTC DRUG LABEL 1 0113-0186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
good sense allergy HUMAN OTC DRUG LABEL 1 0113-0379 SOLUTION 12.50 mg ORAL OTC monograph final 14 sections
good sense nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-0431 TABLET, FILM COATED 25 mg ORAL OTC monograph final 16 sections
good sense pain relief pmextra strength HUMAN OTC DRUG LABEL 2 0113-0437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 16 sections
Good Sense Allergy Relief HUMAN OTC DRUG LABEL 1 0113-0462 CAPSULE 25 mg ORAL OTC monograph final 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0479 TABLET 25 mg ORAL OTC monograph final 15 sections
good sense itch relief HUMAN OTC DRUG LABEL 2 0113-0622 CREAM 2 g TOPICAL OTC monograph not final 14 sections
Good Sense Pain Relief PMExtra Strength HUMAN OTC DRUG LABEL 2 0113-0837 TABLET, COATED 25 mg ORAL OTC monograph not final 15 sections
good sense flu and severe cold and coughnighttime HUMAN OTC DRUG LABEL 3 0113-0964 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 16 sections
good sense sleep aid HUMAN OTC DRUG LABEL 1 0113-1909 CAPSULE, LIQUID FILLED 50 mg ORAL OTC monograph final 16 sections
basic care nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-7186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 25 mg ORAL ANDA 16 sections
basic care childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-7379 SOLUTION 12.50 mg ORAL OTC monograph final 14 sections
basic care acetaminophen PM HUMAN OTC DRUG LABEL 2 0113-7437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 16 sections
basic care allergy relief HUMAN OTC DRUG LABEL 1 0113-7479 TABLET 25 mg ORAL OTC monograph final 15 sections
basic care nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-7506 CAPSULE, LIQUID FILLED 50 mg ORAL OTC monograph final 16 sections