diphenhydramine 🐶 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 µM/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 2930.30 10.51 5126 585047 128707 55573187
Toxicity to various agents 2485.34 10.51 6515 583658 218049 55483845
Infusion related reaction 1188.83 10.51 4834 585339 204097 55497797
Sinusitis 527.02 10.51 3712 586461 193869 55508025
Overdose 461.33 10.51 2264 587909 103566 55598328
Urticaria 454.51 10.51 2832 587341 141844 55560050
Blood pressure fluctuation 413.41 10.51 1140 589033 39220 55662674
Exposure to toxic agent 410.67 10.51 327 589846 3351 55698543
Drug abuse 395.14 10.51 1579 588594 66031 55635863
Pruritus 389.63 10.51 5047 585126 311576 55390318
Acute hepatic failure 369.55 10.51 641 589532 15937 55685957
Intentional product misuse 365.20 10.51 1280 588893 50224 55651670
Muscle injury 318.75 10.51 1241 588932 51259 55650635
Folliculitis 313.23 10.51 1274 588899 53705 55648189
Flushing 312.05 10.51 1509 588664 68591 55633303
Product dose omission issue 278.48 10.51 1152 589021 203601 55498293
Irritable bowel syndrome 271.85 10.51 1427 588746 67031 55634863
Respiratory arrest 270.14 10.51 820 589353 29805 55672089
Lower respiratory tract infection 255.09 10.51 2067 588106 112727 55589167
Psoriasis 253.63 10.51 361 589812 92331 55609563
Intentional overdose 250.23 10.51 1390 588783 66727 55635167
Injection site pain 246.33 10.51 538 589635 116580 55585314
Cardio-respiratory arrest 229.93 10.51 1168 589005 54153 55647741
Drug ineffective 229.65 10.51 7624 582549 911365 54790529
Impaired healing 226.70 10.51 1624 588549 85217 55616677
Device expulsion 223.16 10.51 28 590145 30421 55671473
Ill-defined disorder 208.93 10.51 1332 588841 67211 55634683
Diarrhoea 207.52 10.51 5106 585067 633401 55068493
Throat irritation 206.90 10.51 783 589390 31900 55669994
Hypersensitivity 204.54 10.51 3800 586373 252608 55449286
Sleep disorder due to general medical condition, insomnia type 203.05 10.51 947 589226 42391 55659503
Blister 200.90 10.51 1882 588291 107005 55594889
Anaemia 197.99 10.51 1821 588352 265690 55436204
Cardiac failure 187.98 10.51 359 589814 81734 55620160
Nasopharyngitis 185.76 10.51 3302 586871 217657 55484237
Metabolic acidosis 183.69 10.51 876 589297 39578 55662316
Anion gap 178.15 10.51 124 590049 1015 55700879
Intentional product use issue 174.17 10.51 1704 588469 98029 55603865
Body temperature increased 172.15 10.51 764 589409 33478 55668416
Acute kidney injury 167.86 10.51 1663 588510 239100 55462794
Drug interaction 165.63 10.51 1404 588769 208351 55493543
Exposure via ingestion 164.61 10.51 174 589999 2634 55699260
Oxygen saturation decreased 164.50 10.51 1403 588770 77664 55624230
Blood pressure increased 160.30 10.51 2271 587902 142905 55558989
Blood pressure diastolic abnormal 160.06 10.51 367 589806 11231 55690663
Cardiac failure congestive 159.95 10.51 434 589739 87286 55614608
Helicobacter infection 158.21 10.51 1311 588862 71957 55629937
Duodenal ulcer perforation 155.76 10.51 1238 588935 67104 55634790
Blood pressure systolic increased 153.07 10.51 838 589335 39998 55661896
Neutropenia 149.33 10.51 1007 589166 157160 55544734
Heart rate increased 147.45 10.51 1427 588746 81846 55620048
Wrong technique in product usage process 143.36 10.51 243 589930 57925 55643969
Infusion site pain 138.18 10.51 386 589787 13376 55688518
Poisoning 134.22 10.51 365 589808 12448 55689446
Urine abnormality 132.62 10.51 246 589927 6453 55695441
Malignant neoplasm progression 131.22 10.51 368 589805 73219 55628675
Blood pressure systolic abnormal 131.21 10.51 306 589867 9471 55692423
Hepatotoxicity 130.99 10.51 660 589513 30493 55671401
Sopor 129.70 10.51 30 590143 20892 55681002
Heart rate decreased 127.12 10.51 792 589381 39635 55662259
Osteonecrosis of jaw 127.11 10.51 98 590075 33260 55668634
Infusion site swelling 125.57 10.51 265 589908 7656 55694238
Renal impairment 123.90 10.51 432 589741 80281 55621613
Medication error 122.43 10.51 812 589361 41523 55660371
Drug resistance 120.49 10.51 33 590140 20509 55681385
Stomatitis 120.06 10.51 1856 588317 118954 55582940
Pericarditis 118.22 10.51 1699 588474 107224 55594670
Gastrointestinal disorder 117.62 10.51 1746 588427 110956 55590938
Anti-cyclic citrullinated peptide antibody positive 117.16 10.51 1563 588610 97037 55604857
Hereditary angioedema 115.78 10.51 235 589938 6600 55695294
Synovitis 115.35 10.51 2352 587821 158953 55542941
Weight increased 113.30 10.51 3182 586991 226521 55475373
Injection site bruising 111.42 10.51 144 590029 38377 55663517
Throat tightness 110.41 10.51 497 589676 21910 55679984
Infusion site erythema 109.10 10.51 282 589891 9324 55692570
Injection site erythema 106.86 10.51 433 589740 77015 55624879
Therapy cessation 106.58 10.51 78 590095 27186 55674708
Urine leukocyte esterase positive 106.33 10.51 147 590026 2981 55698913
Hepatic cytolysis 105.69 10.51 302 589871 10604 55691290
Analgesic drug level increased 105.20 10.51 112 590061 1710 55700184
Pancytopenia 103.29 10.51 528 589645 88187 55613707
Hospitalisation 103.04 10.51 420 589753 74580 55627314
Hepatic enzyme increased 102.85 10.51 2437 587736 168947 55532947
Peripheral swelling 100.18 10.51 3194 586979 231532 55470362
Hyperkalaemia 98.57 10.51 244 589929 50621 55651273
Therapeutic product effect incomplete 98.57 10.51 678 589495 105353 55596541
Infusion site extravasation 95.29 10.51 243 589930 7967 55693927
Blood pressure diastolic decreased 94.01 10.51 427 589746 18896 55682998
Myocardial infarction 92.81 10.51 581 589592 92289 55609605
Rash 92.39 10.51 6172 584001 486875 55215019
Joint swelling 91.36 10.51 3811 586362 285989 55415905
Interstitial lung disease 90.57 10.51 301 589872 56762 55645132
Sedation complication 89.63 10.51 298 589875 11374 55690520
Infusion site pruritus 89.55 10.51 172 590001 4635 55697259
Abortion spontaneous 87.85 10.51 206 589967 43547 55658347
Pulmonary arterial hypertension 86.43 10.51 90 590083 26413 55675481
Plasma cell myeloma 86.35 10.51 229 589944 46417 55655477
Therapeutic product effect decreased 85.91 10.51 2356 587817 167096 55534798
Thrombocytopenia 85.85 10.51 963 589210 135261 55566633
Hyponatraemia 85.40 10.51 673 589500 101466 55600428
Food allergy 85.17 10.51 244 589929 8580 55693314
Lymphocyte count decreased 80.84 10.51 536 589637 27403 55674491
Suspected suicide 79.93 10.51 177 589996 5289 55696605
Chest discomfort 79.28 10.51 1467 588706 97390 55604504
Discomfort 78.48 10.51 1994 588179 139767 55562127
Cerebrovascular accident 78.46 10.51 664 589509 98606 55603288
Ear pain 78.43 10.51 574 589599 30316 55671578
Depressed level of consciousness 78.33 10.51 921 589252 55512 55646382
Poor venous access 78.01 10.51 295 589878 12011 55689883
Disease progression 77.18 10.51 717 589456 104456 55597438
Renal failure 76.99 10.51 763 589410 109737 55592157
White blood cells urine positive 76.52 10.51 161 590012 4641 55697253
Epilepsy 76.45 10.51 91 590082 25140 55676754
Product substitution issue 75.83 10.51 29 590144 14570 55687324
Crystal urine present 74.95 10.51 88 590085 1505 55700389
Pneumonia 73.38 10.51 3504 586669 403594 55298300
Posterior reversible encephalopathy syndrome 71.54 10.51 39 590134 15921 55685973
Ear infection 71.32 10.51 567 589606 30728 55671166
Neoplasm progression 70.68 10.51 143 590030 31873 55670021
Ear pruritus 70.25 10.51 117 590056 2811 55699083
Deafness transitory 70.16 10.51 94 590079 1848 55700046
Diabetes mellitus 70.14 10.51 299 589874 52436 55649458
Pharyngitis 69.84 10.51 381 589792 18157 55683737
Urinary sediment present 69.44 10.51 97 590076 1987 55699907
Anticholinergic syndrome 68.93 10.51 93 590080 1841 55700053
Coagulopathy 68.73 10.51 382 589791 18334 55683560
Foetal exposure during pregnancy 68.10 10.51 159 590014 33664 55668230
Suicide attempt 67.92 10.51 915 589258 56921 55644973
Erythema 67.53 10.51 2126 588047 153813 55548081
Creatinine renal clearance decreased 67.33 10.51 317 589856 14242 55687652
Oedema peripheral 67.14 10.51 1328 588845 169926 55531968
Neuropathy peripheral 66.95 10.51 722 589451 102171 55599723
Product prescribing error 64.68 10.51 89 590084 23097 55678797
Temperature regulation disorder 64.57 10.51 144 590029 4324 55697570
Acute lung injury 64.24 10.51 78 590095 1384 55700510
Swelling 64.09 10.51 3101 587072 236670 55465224
Chills 63.65 10.51 1466 588707 101138 55600756
Product storage error 62.64 10.51 30 590143 13183 55688711
Pulmonary hypertension 62.41 10.51 182 589991 35762 55666132
Injury 61.92 10.51 926 589247 58925 55642969
Bone marrow failure 61.88 10.51 127 590046 28159 55673735
Cardiac arrest 61.12 10.51 1257 588916 85057 55616837
Fall 60.33 10.51 3098 587075 354412 55347482
Hepatic necrosis 59.28 10.51 155 590018 5161 55696733
Respiratory failure 59.09 10.51 674 589499 94388 55607506
Red blood cells urine positive 59.08 10.51 109 590064 2847 55699047
No adverse event 58.32 10.51 191 589982 36183 55665711
Lactic acidosis 57.78 10.51 184 589989 35162 55666732
Atrial fibrillation 57.62 10.51 799 589374 108098 55593796
Tachycardia 57.33 10.51 1485 588688 104391 55597503
Feeling hot 56.67 10.51 679 589494 41108 55660786
Leukopenia 56.27 10.51 474 589699 70466 55631428
Anaphylactic reaction 56.15 10.51 900 589273 58095 55643799
Blood calcium decreased 56.01 10.51 434 589739 23335 55678559
Device malfunction 55.84 10.51 52 590121 16084 55685810
Respiratory rate increased 55.54 10.51 265 589908 11972 55689922
Myelodysplastic syndrome 55.45 10.51 54 590119 16352 55685542
Heart rate irregular 55.24 10.51 389 589784 20290 55681604
Pyrexia 55.05 10.51 5101 585072 413672 55288222
Muscle spasticity 54.21 10.51 377 589796 19583 55682311
Septic shock 54.07 10.51 394 589779 60441 55641453
Infection 54.04 10.51 2592 587581 197614 55504280
Cytomegalovirus infection 53.89 10.51 74 590099 19222 55682672
Breast cancer stage I 53.08 10.51 3 590170 6227 55695667
Sepsis 52.82 10.51 1091 589082 138749 55563145
Product quality issue 52.73 10.51 164 590009 31572 55670322
Syncope 52.67 10.51 807 589366 107392 55594502
Cholecystitis chronic 52.43 10.51 222 589951 9526 55692368
Osteoarthritis 52.40 10.51 563 589610 79733 55622161
Infusion site bruising 51.70 10.51 100 590073 2709 55699185
Cognitive disorder 50.36 10.51 759 589414 48374 55653520
Diabetic ketoacidosis 50.11 10.51 75 590098 18796 55683098
Breast cancer female 49.93 10.51 34 590139 12304 55689590
Pneumocystis jirovecii pneumonia 49.33 10.51 55 590118 15646 55686248
Blood pressure diastolic increased 49.21 10.51 199 589974 8362 55693532
Device dislocation 49.02 10.51 102 590071 22504 55679390
Gastrointestinal haemorrhage 48.98 10.51 534 589639 75417 55626477
Hypokalaemia 48.16 10.51 698 589475 93739 55608155
Red cell distribution width increased 48.15 10.51 210 589963 9130 55692764
Blood urine present 47.36 10.51 273 589900 13282 55688612
Headache 47.27 10.51 6617 583556 552427 55149467
Psoriatic arthropathy 47.06 10.51 522 589651 73486 55628408
Lymphocyte percentage decreased 47.01 10.51 97 590076 2757 55699137
Dyspnoea exertional 46.32 10.51 359 589814 54330 55647564
Pyroglutamate increased 46.16 10.51 37 590136 383 55701511
Full blood count abnormal 45.93 10.51 134 590039 26328 55675566
Injection site reaction 45.82 10.51 348 589825 52899 55648995
Hepatic failure 45.79 10.51 545 589628 32941 55668953
Therapy interrupted 45.77 10.51 128 590045 25497 55676397
Premature delivery 45.55 10.51 139 590034 26921 55674973
Haematotoxicity 44.64 10.51 16 590157 8367 55693527
Visual acuity reduced 44.54 10.51 94 590079 20632 55681262
Pyroglutamic acidosis 44.13 10.51 38 590135 438 55701456
Hypocalcaemia 44.07 10.51 154 590019 28606 55673288
Arthralgia 43.24 10.51 5945 584228 495724 55206170
Respiratory depression 43.15 10.51 250 589923 12185 55689709
Urine ketone body present 42.99 10.51 84 590089 2293 55699601
Body temperature decreased 42.87 10.51 331 589842 17777 55684117
Mucosal inflammation 42.66 10.51 268 589905 42542 55659352
Postmortem blood drug level increased 42.61 10.51 41 590132 551 55701343
Accidental overdose 42.48 10.51 363 589810 20098 55681796
Administration site swelling 42.26 10.51 55 590118 1050 55700844
Gastrooesophageal reflux disease 42.23 10.51 616 589557 82641 55619253
Neutrophil percentage increased 42.10 10.51 92 590081 2724 55699170
Surgery 42.09 10.51 186 589987 32300 55669594
Hand deformity 41.45 10.51 1765 588408 132727 55569167
Osteonecrosis 41.44 10.51 116 590057 23099 55678795
Bone erosion 41.25 10.51 58 590115 14916 55686978
Hypertensive crisis 41.07 10.51 52 590121 13984 55687910
Infusion site nodule 40.95 10.51 58 590115 1204 55700690
Pathogen resistance 40.54 10.51 7 590166 5993 55695901
Injection site haemorrhage 40.32 10.51 110 590063 22091 55679803
Multiple organ dysfunction syndrome 39.89 10.51 357 589816 52413 55649481
Right ventricular failure 39.82 10.51 69 590104 16310 55685584
Second primary malignancy 39.63 10.51 14 590159 7388 55694506
Injection site pruritus 39.50 10.51 267 589906 41664 55660230
Cerebral haemorrhage 39.40 10.51 160 590013 28446 55673448
Transient ischaemic attack 38.97 10.51 200 589973 33377 55668517
Night sweats 38.94 10.51 628 589545 40585 55661309
Product use in unapproved indication 38.67 10.51 1152 589021 139670 55562224
Dehydration 38.64 10.51 1320 588853 157505 55544389
Decreased appetite 38.60 10.51 1891 588282 217340 55484554
Accidental death 38.45 10.51 69 590104 1763 55700131
Pain 38.23 10.51 7690 582483 655494 55046400
Intentional self-injury 38.18 10.51 134 590039 24858 55677036
Suicidal ideation 38.02 10.51 404 589769 57338 55644556
Breast cancer 37.96 10.51 328 589845 48505 55653389
Body temperature fluctuation 37.93 10.51 74 590099 2018 55699876
Memory impairment 37.69 10.51 659 589514 85898 55615996
Gait disturbance 37.52 10.51 1367 588806 161954 55539940
Coronary artery disease 37.13 10.51 181 589992 30615 55671279
Incorrect drug administration rate 36.97 10.51 94 590079 3076 55698818
Anion gap abnormal 36.78 10.51 30 590143 319 55701575
Arthropathy 36.60 10.51 2503 587670 197772 55504122
Electric shock 36.53 10.51 51 590122 1044 55700850
Inappropriate antidiuretic hormone secretion 36.21 10.51 55 590118 13701 55688193
Metastases to bone 35.93 10.51 96 590077 19412 55682482
Maternal exposure during pregnancy 35.55 10.51 1624 588549 187929 55513965
Injection site swelling 35.54 10.51 289 589884 43289 55658605
Polyneuropathy 35.50 10.51 51 590122 12999 55688895
Alopecia 35.40 10.51 2623 587550 290835 55411059
Infusion site mass 34.97 10.51 59 590114 1433 55700461
Pneumonia viral 34.68 10.51 158 590015 7000 55694894
Hepatic cirrhosis 34.53 10.51 111 590062 21152 55680742
Sedation 34.40 10.51 535 589638 34319 55667575
Gestational diabetes 34.30 10.51 21 590152 8043 55693851
Immunodeficiency 34.26 10.51 288 589885 15869 55686025
Chronic kidney disease 34.26 10.51 279 589894 41777 55660117
Febrile bone marrow aplasia 34.22 10.51 13 590160 6559 55695335
Palmar-plantar erythrodysaesthesia syndrome 34.19 10.51 110 590063 20955 55680939
Lung neoplasm malignant 34.05 10.51 83 590090 17313 55684581
Depression 33.81 10.51 1543 588630 178574 55523320
Disease recurrence 33.78 10.51 132 590041 23728 55678166
Myelosuppression 33.60 10.51 84 590089 17371 55684523
Device difficult to use 33.47 10.51 38 590135 10723 55691171
Accidental exposure to product 33.23 10.51 139 590034 24508 55677386
Transplant rejection 33.23 10.51 33 590140 9901 55691993
Acute myeloid leukaemia 33.20 10.51 81 590092 16891 55685003
Treatment noncompliance 33.14 10.51 203 589970 32420 55669474
Fracture 32.93 10.51 89 590084 17929 55683965
Injection site warmth 32.83 10.51 62 590111 14181 55687713
Administration site pain 32.76 10.51 40 590133 714 55701180
Exposure during pregnancy 32.72 10.51 1135 589038 135207 55566687
Infusion site haemorrhage 32.63 10.51 99 590074 3596 55698298
Cardiac failure acute 32.63 10.51 27 590146 8846 55693048
Post transplant lymphoproliferative disorder 32.57 10.51 5 590168 4667 55697227
Ischaemic stroke 32.46 10.51 81 590092 16761 55685133
Renal disorder 32.32 10.51 180 589993 29425 55672469
Agranulocytosis 32.31 10.51 125 590048 22534 55679360
Pharyngeal paraesthesia 32.21 10.51 61 590112 1626 55700268
Therapeutic response shortened 32.12 10.51 188 589985 9198 55692696
Wound 32.10 10.51 1771 588402 137033 55564861
Unintentional medical device removal 31.83 10.51 10 590163 5684 55696210
Labelled drug-drug interaction medication error 31.79 10.51 45 590128 11541 55690353
Breast cancer metastatic 31.72 10.51 72 590101 15397 55686497
Culture urine positive 31.60 10.51 95 590078 3433 55698461
Platelet count decreased 31.55 10.51 861 589312 105522 55596372
Specific gravity urine decreased 31.53 10.51 39 590134 706 55701188
Rheumatic fever 31.38 10.51 450 589723 28377 55673517
Contusion 31.37 10.51 1647 588526 126783 55575111
Full blood count decreased 31.28 10.51 132 590041 23217 55678677
Hyperglycaemia 31.16 10.51 254 589919 38027 55663867
White blood cell count decreased 31.12 10.51 1045 589128 124945 55576949
Rash erythematous 31.10 10.51 556 589617 36665 55665229
Metastases to liver 30.83 10.51 119 590054 21467 55680427
Thrombotic microangiopathy 30.64 10.51 32 590141 9379 55692515
Infusion site discomfort 30.50 10.51 47 590126 1055 55700839
Bursitis 30.20 10.51 431 589742 27151 55674743
Chronic obstructive pulmonary disease 30.10 10.51 422 589751 56993 55644901
Blood glucose increased 29.65 10.51 582 589591 74569 55627325
Heart rate abnormal 29.42 10.51 109 590064 4394 55697500
Cerebral infarction 29.07 10.51 129 590044 22376 55679518
Breast cancer stage II 28.98 10.51 12 590161 5746 55696148
Haemoglobin urine present 28.91 10.51 39 590134 772 55701122
Complication associated with device 28.68 10.51 75 590098 15275 55686619
Infusion site rash 28.48 10.51 56 590117 1536 55700358
Injection site mass 28.45 10.51 86 590087 16707 55685187
Haemorrhage 28.34 10.51 418 589755 55979 55645915
Mydriasis 28.26 10.51 206 589967 10865 55691029
Hepatocellular injury 27.98 10.51 163 590010 26351 55675543
Seizure 27.67 10.51 1052 589121 124067 55577827
Therapeutic response decreased 27.57 10.51 388 589785 52370 55649524
Asthma 27.47 10.51 937 589236 111833 55590061
Soft tissue disorder 27.43 10.51 103 590070 4179 55697715
Neurotoxicity 27.40 10.51 80 590093 15715 55686179
Urine analysis abnormal 27.40 10.51 110 590063 4607 55697287
Infusion site urticaria 27.39 10.51 48 590125 1203 55700691
Brain death 27.36 10.51 81 590092 2902 55698992
Spinal stenosis 27.32 10.51 67 590106 13947 55687947
Injection site rash 27.21 10.51 89 590084 16869 55685025
Confusional state 27.18 10.51 2535 587638 205620 55496274
Transplant dysfunction 27.14 10.51 8 590165 4738 55697156
Epistaxis 27.06 10.51 517 589656 66506 55635388
Alanine aminotransferase increased 26.82 10.51 1220 588953 92442 55609452
Orthostatic hypotension 26.71 10.51 493 589680 32706 55669188
Ascites 26.65 10.51 258 589915 37286 55664608
Incorrect dose administered by device 26.65 10.51 4 590169 3796 55698098
Mobility decreased 26.54 10.51 1281 588892 97710 55604184
Swollen joint count increased 26.51 10.51 378 589795 23806 55678088
C-reactive protein abnormal 26.35 10.51 537 589636 36272 55665622
Diffuse large B-cell lymphoma 26.24 10.51 21 590152 6995 55694899
Multiple-drug resistance 26.06 10.51 5 590168 3969 55697925
Abortion induced 25.93 10.51 38 590135 9607 55692287
Hypotension 25.92 10.51 3003 587170 247505 55454389
Unevaluable event 25.89 10.51 348 589825 47339 55654555
Respiratory disorder 25.85 10.51 500 589673 33457 55668437
Bacterial test positive 25.84 10.51 112 590061 4856 55697038
Gastrointestinal pain 25.76 10.51 169 590004 8608 55693286
Bacterial test 25.67 10.51 45 590128 1128 55700766
Colorectal cancer 25.50 10.51 3 590170 3426 55698468
Toxicologic test abnormal 25.32 10.51 34 590139 670 55701224
Unresponsive to stimuli 25.14 10.51 470 589703 31255 55670639
Sexual dysfunction 25.11 10.51 3 590170 3385 55698509
Acute myocardial infarction 25.04 10.51 201 589972 30192 55671702
Device use error 24.94 10.51 13 590160 5443 55696451
Device issue 24.90 10.51 125 590048 20981 55680913
Bronchopulmonary aspergillosis 24.83 10.51 30 590143 8234 55693660
Electrolyte imbalance 24.75 10.51 101 590072 17932 55683962
Atypical femur fracture 24.64 10.51 11 590162 5036 55696858
Serum sickness 24.48 10.51 72 590101 2570 55699324
Hypothyroidism 24.44 10.51 269 589904 37927 55663967
Meningitis aseptic 24.29 10.51 101 590072 4298 55697596
Substance abuse 24.29 10.51 103 590070 4422 55697472
Anticipatory anxiety 24.15 10.51 41 590132 1001 55700893
Blood pH decreased 24.10 10.51 69 590104 2425 55699469
Inappropriate schedule of product administration 24.05 10.51 1087 589086 82300 55619594
Hypoglycaemia 23.95 10.51 426 589747 55389 55646505
Hip fracture 23.81 10.51 175 589998 26798 55675096
Haemophagocytic lymphohistiocytosis 23.56 10.51 40 590133 9532 55692362
Anion gap increased 23.56 10.51 51 590122 1500 55700394
Oral pruritus 23.50 10.51 56 590117 1758 55700136
Metastases to lymph nodes 23.32 10.51 26 590147 7397 55694497
Hyperlipidaemia 23.27 10.51 104 590069 18005 55683889
Rheumatoid factor positive 23.25 10.51 915 589258 68145 55633749
Pancreatic carcinoma 23.15 10.51 25 590148 7216 55694678
Opiates positive 23.03 10.51 24 590149 357 55701537
Iron deficiency anaemia 22.97 10.51 103 590070 17816 55684078
Endophthalmitis 22.76 10.51 3 590170 3140 55698754
Cytokine release syndrome 22.61 10.51 193 589980 10682 55691212
Drug use disorder 22.58 10.51 103 590070 4566 55697328
Emotional distress 22.57 10.51 438 589735 29325 55672569
Macular oedema 22.43 10.51 6 590167 3788 55698106
Analgesic drug level above therapeutic 22.34 10.51 17 590156 162 55701732
Acute graft versus host disease 22.18 10.51 8 590165 4167 55697727
Graft versus host disease 22.14 10.51 23 590150 6758 55695136
Joint stiffness 22.06 10.51 251 589922 35174 55666720
Altered state of consciousness 21.97 10.51 146 590027 22875 55679019
Poisoning deliberate 21.95 10.51 179 589994 9774 55692120
Vitamin K deficiency 21.86 10.51 25 590148 415 55701479
Systemic infection 21.68 10.51 4 590169 3265 55698629
Ageusia 21.64 10.51 63 590110 12388 55689506
Myalgia 21.64 10.51 1147 589026 130878 55571016
Pleural effusion 21.57 10.51 707 589466 84773 55617121
Chronic graft versus host disease 21.56 10.51 4 590169 3252 55698642
Haematocrit decreased 21.53 10.51 522 589651 36307 55665587
Vaginal haemorrhage 21.51 10.51 169 590004 25504 55676390
Muscle spasms 21.48 10.51 1199 588974 136172 55565722
Metastases to lung 21.33 10.51 58 590115 11660 55690234
Mast cell activation syndrome 21.28 10.51 31 590142 661 55701233
Immune reconstitution inflammatory syndrome 21.20 10.51 17 590156 5657 55696237
Upper respiratory tract infection 21.15 10.51 932 589241 70356 55631538
Drug screen positive 21.10 10.51 82 590091 3382 55698512
Electrocardiogram QRS complex prolonged 21.02 10.51 113 590060 5354 55696540
Subdural haematoma 20.87 10.51 72 590101 13427 55688467
Brain oedema 20.87 10.51 222 589951 13049 55688845
Tongue disorder 20.81 10.51 178 589995 9858 55692036
Complication of device insertion 20.74 10.51 22 590151 6402 55695492
Multiple drug therapy 20.30 10.51 70 590103 2722 55699172
Invasive ductal breast carcinoma 20.27 10.51 25 590148 6801 55695093
Pneumonia aspiration 20.05 10.51 230 589943 32181 55669713
Malaise 19.98 10.51 3472 586701 364388 55337506
Cardiomyopathy 19.92 10.51 95 590078 16163 55685731
Administration site erythema 19.92 10.51 28 590145 577 55701317
Cardiac disorder 19.76 10.51 350 589823 45537 55656357
Kidney infection 19.65 10.51 316 589857 20409 55681485
Intermenstrual bleeding 19.57 10.51 27 590146 7000 55694894
Administration site bruise 19.55 10.51 21 590152 324 55701570
Epstein-Barr virus infection 19.49 10.51 30 590143 7433 55694461
Infusion site irritation 19.45 10.51 30 590143 674 55701220
Ventricular fibrillation 19.34 10.51 55 590118 10897 55690997
Lung adenocarcinoma 19.33 10.51 12 590161 4562 55697332
Metastases to central nervous system 19.26 10.51 64 590109 12072 55689822
Rhabdomyolysis 19.18 10.51 305 589868 40353 55661541
Low turnover osteopathy 19.15 10.51 9 590164 3999 55697895
Product residue present 18.96 10.51 8 590165 3787 55698107
Mitral valve incompetence 18.94 10.51 112 590061 18041 55683853
Serum sickness-like reaction 18.84 10.51 24 590149 448 55701446
Left ventricular dysfunction 18.82 10.51 57 590116 11066 55690828
Cardiotoxicity 18.80 10.51 32 590141 7618 55694276
Treatment failure 18.79 10.51 1534 588639 168858 55533036
Shoulder arthroplasty 18.77 10.51 83 590090 3630 55698264
Pericardial effusion 18.76 10.51 188 589985 26987 55674907
Secondary amyloidosis 18.75 10.51 12 590161 84 55701810
Aphasia 18.75 10.51 216 589957 30199 55671695
Arrhythmia 18.69 10.51 257 589916 34826 55667068
Graft versus host disease in skin 18.64 10.51 3 590170 2704 55699190
Drug level below therapeutic 18.57 10.51 92 590081 4221 55697673
Therapeutic response unexpected 18.40 10.51 104 590069 16940 55684954
Spinal fracture 18.40 10.51 99 590074 16325 55685569
Carpal tunnel syndrome 18.38 10.51 113 590060 18031 55683863
Pain in jaw 18.33 10.51 302 589871 39734 55662160
Status epilepticus 18.25 10.51 89 590084 15052 55686842
Galactorrhoea 18.23 10.51 9 590164 3886 55698008
Nitrite urine present 18.17 10.51 36 590137 993 55700901
Hypomania 17.96 10.51 100 590073 4802 55697092
Specific gravity urine increased 17.94 10.51 16 590157 194 55701700
Jaundice cholestatic 17.89 10.51 109 590064 5410 55696484
Drug withdrawal syndrome 17.80 10.51 179 589994 25678 55676216
Injection site induration 17.74 10.51 40 590133 8575 55693319
Extrapyramidal disorder 17.72 10.51 68 590105 12288 55689606
Coagulation factor X level decreased 17.66 10.51 11 590162 73 55701821
Bone pain 17.63 10.51 396 589777 49789 55652105
Congestive cardiomyopathy 17.61 10.51 21 590152 5798 55696096
Varicella zoster virus infection 17.49 10.51 3 590170 2581 55699313
General physical health deterioration 17.48 10.51 1539 588634 168471 55533423
Forced expiratory volume decreased 17.36 10.51 14 590159 4646 55697248
Product adhesion issue 17.29 10.51 13 590160 4470 55697424
Vein rupture 17.29 10.51 36 590137 1030 55700864
Device leakage 17.25 10.51 25 590148 6350 55695544
Coeliac disease 17.22 10.51 175 589998 10164 55691730
Infusion site streaking 17.21 10.51 23 590150 451 55701443
Rheumatoid arthritis 17.18 10.51 3647 586526 378957 55322937
Lumbar vertebral fracture 17.17 10.51 16 590157 4948 55696946
Blood iron abnormal 17.06 10.51 7 590166 3370 55698524
Dysgeusia 17.01 10.51 314 589859 40601 55661293
Oropharyngeal discomfort 16.94 10.51 92 590081 4376 55697518
Obstructive airways disorder 16.80 10.51 109 590064 17173 55684721
Ketoacidosis 16.80 10.51 11 590162 4064 55697830
Aspergillus infection 16.77 10.51 33 590140 7432 55694462
Disturbance in attention 16.76 10.51 240 589933 32300 55669594
Cardiac failure chronic 16.74 10.51 11 590162 4056 55697838
Blood creatinine decreased 16.73 10.51 102 590071 5064 55696830
Hepatic function abnormal 16.72 10.51 258 589915 34300 55667594
Ankylosing spondylitis 16.72 10.51 51 590122 9879 55692015
Adrenergic syndrome 16.60 10.51 8 590165 29 55701865
Toxic skin eruption 16.58 10.51 65 590108 11674 55690220
Personality change 16.56 10.51 22 590151 5795 55696099
Coagulation factor VII level decreased 16.52 10.51 11 590162 83 55701811
Drug reaction with eosinophilia and systemic symptoms 16.50 10.51 221 589952 30083 55671811
Ejection fraction decreased 16.44 10.51 131 590042 19710 55682184
Angina pectoris 16.35 10.51 201 589972 27775 55674119
Human herpesvirus 6 infection 16.32 10.51 4 590169 2678 55699216
Dysphoria 16.29 10.51 16 590157 4826 55697068
Drug specific antibody present 16.29 10.51 79 590094 3593 55698301
Pre-eclampsia 16.21 10.51 41 590132 8445 55693449
Lupus-like syndrome 16.19 10.51 71 590102 12356 55689538
Haematuria 16.11 10.51 193 589980 26794 55675100
Large intestine polyp 16.05 10.51 35 590138 7592 55694302
Device deployment issue 16.03 10.51 9 590164 3615 55698279
Malignant melanoma 16.02 10.51 58 590115 10661 55691233
Cytomegalovirus viraemia 16.01 10.51 18 590155 5102 55696792
Lactobacillus infection 16.01 10.51 9 590164 48 55701846
Thyroid cancer 15.98 10.51 18 590155 5098 55696796
Infusion site warmth 15.98 10.51 43 590130 1457 55700437
Systemic lupus erythematosus rash 15.97 10.51 51 590122 1905 55699989
Infusion site scar 15.96 10.51 20 590153 367 55701527
Infective pulmonary exacerbation of cystic fibrosis 15.90 10.51 39 590134 8118 55693776
Hypervolaemia 15.88 10.51 189 589984 26269 55675625
Concomitant disease aggravated 15.87 10.51 41 590132 8385 55693509
Death 15.80 10.51 3920 586253 337506 55364388
Pulmonary alveolar haemorrhage 15.65 10.51 13 590160 4251 55697643
Periorbital swelling 15.61 10.51 56 590117 2222 55699672
Body height decreased 15.59 10.51 47 590126 9138 55692756
Joint dislocation 15.58 10.51 99 590074 15674 55686220
Aspartate aminotransferase increased 15.53 10.51 1035 589138 81567 55620327
Acute respiratory failure 15.47 10.51 230 589943 30764 55671130
Anuria 15.43 10.51 67 590106 11693 55690201
Thinking abnormal 15.38 10.51 53 590120 9888 55692006
Rhinitis allergic 15.38 10.51 42 590131 8432 55693462
Spinal compression fracture 15.37 10.51 78 590095 13056 55688838
Cardiogenic shock 15.35 10.51 104 590069 16221 55685673
Neutrophil count decreased 15.35 10.51 401 589772 49421 55652473
Dizziness 15.33 10.51 3602 586571 372538 55329356
Monocyte percentage increased 15.33 10.51 35 590138 1068 55700826
Visual impairment 15.29 10.51 629 589544 73573 55628321
Administration site reaction 15.28 10.51 15 590158 207 55701687
Femoral neck fracture 15.27 10.51 37 590136 7734 55694160
Eosinophil percentage increased 15.23 10.51 33 590140 971 55700923
Blood loss anaemia 15.15 10.51 41 590132 8256 55693638
Ductus arteriosus premature closure 15.15 10.51 18 590155 312 55701582
Bradyphrenia 15.10 10.51 29 590144 6591 55695303
Vertigo 15.07 10.51 446 589727 54126 55647768
Glycosylated haemoglobin increased 15.03 10.51 63 590110 11102 55690792
Aplasia pure red cell 15.02 10.51 14 590159 4328 55697566
Low density lipoprotein increased 14.97 10.51 24 590149 5850 55696044
Schizoaffective disorder 14.97 10.51 66 590107 2883 55699011
Coma 14.95 10.51 767 589406 58888 55643006
Nephropathy toxic 14.93 10.51 43 590130 8484 55693410
Akathisia 14.88 10.51 44 590129 8608 55693286
Drug ineffective for unapproved indication 14.87 10.51 185 589988 25508 55676386
Vision blurred 14.85 10.51 714 589459 82229 55619665
Genital haemorrhage 14.85 10.51 31 590142 6831 55695063
Skin cancer 14.84 10.51 57 590116 10298 55691596
Uterine cancer 14.84 10.51 15 590158 4464 55697430
Migraine 14.83 10.51 1079 589094 85718 55616176
Pulmonary tuberculosis 14.82 10.51 15 590158 4461 55697433
Product monitoring error 14.72 10.51 9 590164 3450 55698444
Latent tuberculosis 14.71 10.51 4 590169 2498 55699396
Exostosis 14.65 10.51 94 590079 14849 55687045
Sinus bradycardia 14.62 10.51 83 590090 13503 55688391
Angina unstable 14.60 10.51 31 590142 6790 55695104
Long QT syndrome 14.56 10.51 7 590166 3069 55698825
Cystic fibrosis pancreatic 14.53 10.51 9 590164 59 55701835
Amenorrhoea 14.53 10.51 47 590126 8939 55692955
Renal papillary necrosis 14.45 10.51 15 590158 222 55701672
Melaena 14.45 10.51 209 589964 28081 55673813
Vaginal flatulence 14.42 10.51 26 590147 667 55701227
Unintended pregnancy 14.40 10.51 20 590153 5171 55696723
Heavy menstrual bleeding 14.39 10.51 105 590068 16104 55685790
Sleep disorder due to a general medical condition 14.38 10.51 48 590125 9042 55692852
Pancreatitis 14.37 10.51 361 589812 44719 55657175
Urticaria thermal 14.35 10.51 16 590157 258 55701636
Cardiovascular disorder 14.31 10.51 62 590111 10827 55691067
Vascular rupture 14.30 10.51 42 590131 1498 55700396
Haemarthrosis 14.29 10.51 7 590166 3037 55698857
Taste disorder 14.23 10.51 53 590120 9662 55692232
Left ventricular failure 14.11 10.51 19 590154 4977 55696917
Compartment syndrome 14.08 10.51 50 590123 1974 55699920
Myopathy 14.07 10.51 54 590119 9758 55692136
Cellulitis 14.06 10.51 642 589531 74307 55627587
Focal dyscognitive seizures 14.04 10.51 6 590167 2819 55699075
Product dispensing error 13.93 10.51 50 590123 9214 55692680
Small for dates baby 13.92 10.51 10 590163 3520 55698374
Complication of device removal 13.91 10.51 16 590157 4488 55697406
Cells in urine 13.77 10.51 14 590159 202 55701692
Peripheral sensory neuropathy 13.76 10.51 33 590140 6923 55694971
Hallucination, auditory 13.74 10.51 68 590105 11456 55690438
Blood thyroid stimulating hormone decreased 13.68 10.51 85 590088 4248 55697646
Wrong patient received product 13.68 10.51 3 590170 2168 55699726
Liver transplant 13.68 10.51 53 590120 2183 55699711
Spinal pain 13.67 10.51 71 590102 11813 55690081
Ovarian hyperstimulation syndrome 13.66 10.51 11 590162 3653 55698241
Skin toxicity 13.66 10.51 14 590159 4139 55697755
Impaired work ability 13.62 10.51 93 590080 14479 55687415
Mucormycosis 13.61 10.51 6 590167 2768 55699126
Gallbladder injury 13.58 10.51 37 590136 1263 55700631
Mean cell haemoglobin concentration increased 13.58 10.51 21 590152 473 55701421
Hemiplegia 13.56 10.51 44 590129 8360 55693534
Electric shock sensation 13.48 10.51 21 590152 476 55701418
Urinary casts 13.45 10.51 26 590147 704 55701190
Renal failure neonatal 13.44 10.51 13 590160 176 55701718
Peritonitis 13.42 10.51 107 590066 16095 55685799
Pancreatitis acute 13.40 10.51 184 589989 24940 55676954
Pulmonary infarction 13.35 10.51 57 590116 2455 55699439
Mean cell haemoglobin concentration decreased 13.35 10.51 68 590105 3155 55698739
Osmolar gap 13.17 10.51 10 590163 95 55701799
Oropharyngeal spasm 13.15 10.51 13 590160 181 55701713
Immunosuppressant drug level increased 13.12 10.51 9 590164 3244 55698650
Prothrombin time prolonged 13.07 10.51 149 590024 8911 55692983
Meniscus injury 13.06 10.51 31 590142 6527 55695367
Caesarean section 12.99 10.51 107 590066 15984 55685910
Coronary artery bypass 12.95 10.51 4 590169 2299 55699595
Haematoma 12.92 10.51 247 589926 31772 55670122
Drug-induced liver injury 12.89 10.51 462 589711 34000 55667894
Intervertebral discitis 12.89 10.51 61 590112 2746 55699148
Anoxia 12.89 10.51 14 590159 219 55701675
Thyroxine free increased 12.86 10.51 28 590145 827 55701067
Disorientation 12.83 10.51 289 589884 36324 55665570
Cystitis 12.81 10.51 633 589540 48405 55653489
Oesophageal carcinoma 12.78 10.51 3 590170 2068 55699826
Movement disorder 12.76 10.51 134 590039 19064 55682830
Brain stem glioma 12.74 10.51 14 590159 222 55701672
Post procedural pulmonary embolism 12.67 10.51 15 590158 259 55701635
Withdrawal syndrome 12.63 10.51 128 590045 18334 55683560
Loss of consciousness 12.58 10.51 981 589192 108368 55593526
Corneal reflex decreased 12.56 10.51 11 590162 130 55701764
Blindness 12.48 10.51 128 590045 18293 55683601
Injection site extravasation 12.45 10.51 136 590037 8048 55693846
Oedema 12.44 10.51 717 589456 81203 55620691
Nervous system disorder 12.44 10.51 115 590058 16774 55685120
Injection site discolouration 12.42 10.51 37 590136 7222 55694672
Anxiety 12.40 10.51 2253 587920 190919 55510975
Product physical issue 12.37 10.51 18 590155 4564 55697330
Transfusion-related acute lung injury 12.36 10.51 10 590163 105 55701789
Administration site pruritus 12.32 10.51 15 590158 267 55701627
Tremor 12.32 10.51 1097 589076 119992 55581902
Enthesopathy 12.27 10.51 134 590039 7929 55693965
Oropharyngeal pain 12.24 10.51 1029 589144 82759 55619135
Patent ductus arteriosus 12.24 10.51 14 590159 3937 55697957
Chondropathy 12.21 10.51 4 590169 2213 55699681
Multiple sclerosis relapse 12.15 10.51 368 589805 44535 55657359
Low birth weight baby 12.14 10.51 30 590143 6228 55695666
Multiple fractures 12.11 10.51 124 590049 7217 55694677
Intentional dose omission 12.08 10.51 29 590144 6081 55695813
Graft versus host disease in gastrointestinal tract 12.03 10.51 8 590165 2931 55698963
Device breakage 12.02 10.51 60 590113 10087 55691807
Myelocyte count increased 12.00 10.51 17 590156 353 55701541
Vein collapse 11.97 10.51 28 590145 868 55701026
Muscle twitching 11.97 10.51 238 589935 16004 55685890
Band neutrophil count increased 11.96 10.51 17 590156 354 55701540
Impaired quality of life 11.92 10.51 47 590126 8427 55693467
Infusion site discolouration 11.90 10.51 24 590149 671 55701223
Accidental exposure to product by child 11.87 10.51 33 590140 1140 55700754
Petit mal epilepsy 11.84 10.51 12 590161 3566 55698328
Asthenia 11.82 10.51 3309 586864 339664 55362230
Vasodilation procedure 11.82 10.51 6 590167 25 55701869
Transfusion 11.80 10.51 88 590085 13432 55688462
Contraindicated product administered 11.77 10.51 2171 588002 184115 55517779
Upper gastrointestinal haemorrhage 11.76 10.51 118 590055 16936 55684958
Vitamin D deficiency 11.71 10.51 77 590096 12093 55689801
Fluid retention 11.66 10.51 456 589717 53622 55648272
Premature rupture of membranes 11.65 10.51 20 590153 4745 55697149
Creatinine urine decreased 11.65 10.51 12 590161 176 55701718
Coronary arterial stent insertion 11.61 10.51 7 590166 2703 55699191
Circulatory collapse 11.59 10.51 151 590022 20652 55681242
Administration site extravasation 11.55 10.51 25 590148 735 55701159
Affective disorder 11.55 10.51 26 590147 5577 55696317
Psychomotor skills impaired 11.54 10.51 4 590169 2136 55699758
Tri-iodothyronine free increased 11.50 10.51 13 590160 213 55701681
Erysipelas 11.47 10.51 38 590135 7175 55694719
Hepatitis C 11.45 10.51 26 590147 5560 55696334
Lymphoproliferative disorder 11.40 10.51 9 590164 3019 55698875
Blood creatine increased 11.39 10.51 93 590080 5080 55696814
Red blood cells urine 11.36 10.51 20 590153 503 55701391
Neuroleptic malignant syndrome 11.36 10.51 72 590101 11406 55690488
Device related thrombosis 11.35 10.51 40 590133 1573 55700321
Hallucinations, mixed 11.35 10.51 18 590155 4406 55697488
Stress fracture 11.29 10.51 38 590135 7139 55694755
Sputum culture positive 11.28 10.51 42 590131 1697 55700197
Cytomegalovirus infection reactivation 11.27 10.51 10 590163 3166 55698728
Somnolence 11.25 10.51 1913 588260 161500 55540394
Squamous cell carcinoma of skin 11.19 10.51 25 590148 5377 55696517
COVID-19 immunisation 11.16 10.51 37 590136 1410 55700484
Catheter management 11.15 10.51 8 590165 2818 55699076
Dyslipidaemia 11.15 10.51 32 590141 6321 55695573
Band neutrophil percentage increased 11.13 10.51 13 590160 221 55701673
Partial seizures 11.12 10.51 25 590148 5365 55696529
Pupil fixed 11.12 10.51 41 590132 1649 55700245
Feeling cold 11.12 10.51 296 589877 20891 55681003
Limb mass 11.10 10.51 61 590112 2915 55698979
Blood prolactin increased 11.06 10.51 11 590162 3298 55698596
Leukoencephalopathy 11.06 10.51 16 590157 4066 55697828
Product complaint 11.01 10.51 75 590098 11685 55690209
Mastocytosis 10.98 10.51 20 590153 517 55701377
Hyperammonaemia 10.96 10.51 22 590151 4918 55696976
Potentiating drug interaction 10.95 10.51 16 590157 4050 55697844
Pharyngeal swelling 10.94 10.51 94 590079 5212 55696682
Kidney transplant rejection 10.94 10.51 17 590156 4196 55697698
Malnutrition 10.92 10.51 94 590079 13914 55687980
Disseminated tuberculosis 10.83 10.51 8 590165 2775 55699119
Maternal exposure before pregnancy 10.82 10.51 36 590137 6787 55695107
Ear swelling 10.81 10.51 33 590140 1203 55700691
Normal newborn 10.78 10.51 41 590132 7429 55694465
Intramedullary rod insertion 10.78 10.51 4 590169 2047 55699847
Post-traumatic stress disorder 10.77 10.51 83 590090 4455 55697439
Maculopathy 10.72 10.51 4 590169 2040 55699854
White blood cells urine 10.72 10.51 16 590157 349 55701545
Condition aggravated 10.71 10.51 3342 586831 341556 55360338
Dyskinesia 10.71 10.51 228 589945 28880 55673014
Perineal rash 10.71 10.51 3 590170 0 55701894
Analgesic drug level below therapeutic 10.71 10.51 3 590170 0 55701894
Hypomagnesaemia 10.71 10.51 191 589982 24824 55677070
Oocyte harvest 10.71 10.51 3 590170 0 55701894
Sucrose intolerance 10.71 10.51 3 590170 0 55701894
Pregnancy 10.67 10.51 264 589909 32769 55669125
Adenovirus infection 10.64 10.51 12 590161 3396 55698498
Dissociation 10.63 10.51 7 590166 2578 55699316
Pneumothorax 10.62 10.51 102 590071 14765 55687129
Back pain 10.59 10.51 2719 587454 234451 55467443
Dysstasia 10.59 10.51 141 590032 19213 55682681
Mucosal dryness 10.55 10.51 53 590120 2445 55699449
Ductus arteriosus stenosis foetal 10.54 10.51 11 590162 164 55701730
Dysmorphism 10.53 10.51 5 590168 2208 55699686
Procedural anxiety 10.52 10.51 23 590150 681 55701213
Intestinal haemorrhage 10.52 10.51 13 590160 3533 55698361
Infusion site induration 10.51 10.51 27 590146 889 55701005

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 1761.54 10.72 2763 237129 88751 31368701
Toxicity to various agents 1753.09 10.72 4082 235810 177405 31280047
Infusion related reaction 1194.16 10.72 1638 238254 46417 31411035
Drug abuse 520.44 10.72 1653 238239 86105 31371347
Blood pressure fluctuation 395.80 10.72 657 239235 22079 31435373
Intentional product misuse 389.90 10.72 877 239015 37074 31420378
Overdose 317.55 10.72 1376 238516 83288 31374164
Urticaria 299.23 10.72 1037 238855 56480 31400972
Exposure to toxic agent 238.47 10.72 180 239712 2415 31455037
Drug ineffective 232.86 10.72 1899 237993 393674 31063778
Respiratory arrest 230.70 10.72 571 239321 25686 31431766
Blood pressure increased 221.62 10.72 1188 238704 78445 31379007
Intentional overdose 211.51 10.72 742 239150 40647 31416805
Flushing 209.79 10.72 601 239291 29527 31427925
Chills 201.44 10.72 1099 238793 73051 31384401
Heart rate decreased 197.91 10.72 565 239327 27701 31429751
Acute hepatic failure 176.54 10.72 335 239557 12524 31444928
Oxygen saturation decreased 162.08 10.72 769 239123 48346 31409106
Cardio-respiratory arrest 141.30 10.72 768 239124 50958 31406494
Myocardial infarction 132.35 10.72 429 239463 113025 31344427
Heart rate increased 130.08 10.72 636 239256 40474 31416978
Blood pressure diastolic abnormal 124.22 10.72 152 239740 3827 31453625
Accidental overdose 123.80 10.72 362 239530 17988 31439464
Respiratory depression 123.69 10.72 312 239580 14198 31443254
Cardiac failure 123.29 10.72 294 239598 85659 31371793
Drug resistance 118.36 10.72 18 239874 23435 31434017
Blood pressure systolic increased 117.19 10.72 369 239523 19101 31438351
Exposure via ingestion 116.28 10.72 107 239785 1918 31455534
Drug interaction 112.80 10.72 1022 238870 207521 31249931
Sinusitis 111.33 10.72 561 239331 36135 31421317
Cardiac failure congestive 106.49 10.72 281 239611 79106 31378346
Pruritus 99.35 10.72 1412 238480 123755 31333697
Anaemia 94.61 10.72 1097 238795 212425 31245027
Poisoning 94.45 10.72 229 239663 10162 31447290
Anion gap 92.90 10.72 62 239830 675 31456777
Intentional product use issue 91.17 10.72 663 239229 48684 31408768
Anaphylactic reaction 89.07 10.72 451 239441 29102 31428350
Product dose omission issue 80.94 10.72 468 239424 105118 31352334
Blood pressure systolic abnormal 79.20 10.72 107 239785 2980 31454472
Cardiac arrest 78.10 10.72 1023 238869 88039 31369413
Unresponsive to stimuli 77.24 10.72 393 239499 25407 31432045
Diarrhoea 76.33 10.72 2058 237834 350351 31107101
Psoriasis 75.91 10.72 149 239743 46570 31410882
Throat tightness 74.01 10.72 173 239719 7496 31449956
Heart rate irregular 73.66 10.72 257 239635 14032 31443420
Cytokine release syndrome 72.92 10.72 284 239608 16358 31441094
Renal impairment 72.07 10.72 372 239520 85977 31371475
Suspected suicide 69.18 10.72 117 239775 3990 31453462
Hepatic cytolysis 68.72 10.72 209 239683 10614 31446838
Throat irritation 67.93 10.72 189 239703 9125 31448327
Blood pressure diastolic increased 67.10 10.72 118 239774 4155 31453297
Infusion site swelling 64.56 10.72 80 239812 2041 31455411
Infusion site extravasation 64.46 10.72 106 239786 3531 31453921
Metabolic acidosis 64.28 10.72 516 239376 39061 31418391
Erythema 64.10 10.72 908 238984 79497 31377955
Acute kidney injury 61.11 10.72 1631 238261 278083 31179369
Interstitial lung disease 61.07 10.72 248 239644 61155 31396297
Plasma cell myeloma 60.94 10.72 221 239671 56310 31401142
General physical health deterioration 60.29 10.72 558 239334 112877 31344575
Foetal exposure during pregnancy 60.02 10.72 138 239754 40738 31416714
Environmental exposure 58.42 10.72 32 239860 235 31457217
Analgesic drug level increased 58.20 10.72 45 239847 627 31456825
Tachycardia 56.56 10.72 850 239042 75357 31382095
Infusion site pain 56.23 10.72 93 239799 3113 31454339
Therapeutic product effect incomplete 53.87 10.72 161 239731 43535 31413917
Prostate cancer 53.56 10.72 129 239763 37472 31419980
Blood pressure diastolic decreased 52.06 10.72 156 239736 7857 31449595
Body temperature increased 51.79 10.72 240 239652 14933 31442519
Cerebral haemorrhage 51.28 10.72 107 239785 32705 31424747
Body temperature decreased 50.87 10.72 200 239692 11570 31445882
Coagulopathy 49.91 10.72 274 239618 18241 31439211
Wrong technique in product usage process 47.01 10.72 115 239777 33228 31424224
Coronary artery disease 46.54 10.72 185 239707 45902 31411550
Infusion site erythema 46.39 10.72 64 239828 1819 31455633
Inappropriate schedule of product administration 45.44 10.72 586 239306 50237 31407215
Malignant neoplasm progression 44.85 10.72 382 239510 78616 31378836
Diabetes mellitus 44.79 10.72 168 239724 42388 31415064
Bone marrow failure 44.05 10.72 91 239801 27917 31429535
Respiratory rate increased 43.99 10.72 162 239730 9083 31448369
Hypotension 43.83 10.72 1930 237962 202688 31254764
Hepatic necrosis 43.71 10.72 90 239802 3573 31453879
Substance abuse 43.37 10.72 136 239756 7022 31450430
Pyroglutamic acidosis 43.28 10.72 29 239863 318 31457134
Hepatotoxicity 42.48 10.72 269 239623 18857 31438595
Suicide attempt 42.42 10.72 450 239442 36798 31420654
Body temperature fluctuation 41.79 10.72 56 239836 1547 31455905
Cerebrovascular accident 40.92 10.72 394 239498 79090 31378362
Bladder cancer 40.79 10.72 31 239861 14694 31442758
Renal cortical necrosis 40.36 10.72 23 239869 184 31457268
Headache 39.93 10.72 1735 238157 181917 31275535
Cerebral infarction 39.52 10.72 86 239806 25891 31431561
Poor venous access 39.33 10.72 92 239800 3988 31453464
Pancytopenia 39.18 10.72 447 239445 86869 31370583
Alanine aminotransferase increased 38.58 10.72 786 239106 73870 31383582
Medication error 38.11 10.72 299 239593 22473 31434979
Treatment failure 37.93 10.72 169 239723 40623 31416829
Aspartate aminotransferase increased 37.77 10.72 676 239216 62043 31395409
Poisoning deliberate 37.77 10.72 132 239760 7212 31450240
Hypersensitivity 37.63 10.72 612 239280 55131 31402321
Labelled drug-drug interaction medication error 37.38 10.72 27 239865 13136 31444316
Lymphocyte percentage decreased 36.74 10.72 60 239832 1987 31455465
Neutrophil percentage increased 35.64 10.72 55 239837 1734 31455718
Injection site pain 35.62 10.72 138 239754 34496 31422956
Fall 35.50 10.72 1105 238787 184984 31272468
Drug hypersensitivity 35.12 10.72 757 239135 71842 31385610
Infusion site pruritus 34.94 10.72 32 239860 570 31456882
Hospitalisation 34.87 10.72 227 239665 49580 31407872
Tongue disorder 34.82 10.72 100 239792 4917 31452535
Osteonecrosis of jaw 34.69 10.72 47 239845 17024 31440428
Ear infection 34.48 10.72 146 239746 8735 31448717
Sopor 33.72 10.72 23 239869 11529 31445923
Febrile neutropenia 33.72 10.72 1182 238710 120667 31336785
Therapeutic response shortened 33.63 10.72 109 239783 5728 31451724
Myelosuppression 33.55 10.72 38 239854 14882 31442570
Aplastic anaemia 33.22 10.72 148 239744 9055 31448397
Haematotoxicity 32.72 10.72 7 239885 7130 31450322
Leukopenia 32.65 10.72 280 239612 57548 31399904
Pulmonary oedema 32.46 10.72 495 239397 44007 31413445
Infusion site rash 32.10 10.72 26 239866 389 31457063
Accident 31.16 10.72 82 239810 3829 31453623
Oesophageal carcinoma 31.00 10.72 11 239881 8022 31449430
Hepatocellular carcinoma 30.51 10.72 14 239878 8742 31448710
Feeling hot 30.47 10.72 219 239673 16014 31441438
Progressive multifocal leukoencephalopathy 30.18 10.72 16 239876 9197 31448255
Pathogen resistance 30.18 10.72 14 239878 8687 31448765
Epilepsy 30.11 10.72 72 239820 20969 31436483
Renal failure 30.10 10.72 707 239185 122623 31334829
Glycosylated haemoglobin increased 29.97 10.72 21 239871 10379 31447073
Angina pectoris 29.91 10.72 119 239773 29522 31427930
Post transplant lymphoproliferative disorder 29.89 10.72 5 239887 6071 31451381
Infusion site reaction 29.70 10.72 34 239858 796 31456656
Depressed level of consciousness 29.57 10.72 433 239459 38168 31419284
Septic shock 29.54 10.72 339 239553 65819 31391633
Atrial fibrillation 29.54 10.72 646 239246 113137 31344315
Visual acuity reduced 29.43 10.72 44 239848 15299 31442153
Rash 29.05 10.72 1831 238061 199655 31257797
Graft versus host disease 28.93 10.72 22 239870 10425 31447027
Cytomegalovirus infection 28.36 10.72 94 239798 24613 31432839
Hyperkalaemia 28.24 10.72 331 239561 64020 31393432
Nasopharyngitis 28.23 10.72 652 239240 62593 31394859
Cardiac failure chronic 28.18 10.72 10 239882 7293 31450159
Pallor 27.96 10.72 276 239616 22148 31435304
Lip swelling 27.52 10.72 184 239708 13139 31444313
Pyrexia 27.45 10.72 2662 237230 301178 31156274
Pharyngeal paraesthesia 27.32 10.72 27 239865 531 31456921
Victim of child abuse 27.12 10.72 34 239858 878 31456574
Immune reconstitution inflammatory syndrome 27.09 10.72 14 239878 8164 31449288
Neuropathy peripheral 27.04 10.72 406 239486 75243 31382209
Oedema peripheral 26.70 10.72 630 239262 109209 31348243
Depression 26.42 10.72 506 239386 90309 31367143
Asthenia 26.25 10.72 1412 238480 223343 31234109
Acute myocardial infarction 26.11 10.72 252 239640 50571 31406881
Myocardial fibrosis 25.60 10.72 37 239855 1099 31456353
Urine abnormality 25.49 10.72 48 239844 1783 31455669
Blood pH decreased 25.44 10.72 53 239839 2122 31455330
Pneumonia 25.39 10.72 2189 237703 333123 31124329
Hyperhidrosis 25.38 10.72 679 239213 66714 31390738
Chest discomfort 25.24 10.72 519 239373 48850 31408602
Disease progression 25.12 10.72 508 239384 89956 31367496
Myopathy 25.10 10.72 27 239865 10825 31446627
Migraine 24.73 10.72 188 239704 13992 31443460
Back pain 24.48 10.72 1037 238855 108376 31349076
Lung neoplasm malignant 24.46 10.72 54 239838 16176 31441276
Serum sickness 24.43 10.72 47 239845 1775 31455677
Infusion site bruising 24.17 10.72 25 239867 520 31456932
Product use in unapproved indication 24.05 10.72 569 239323 98602 31358850
Hereditary angioedema 23.67 10.72 34 239858 1004 31456448
Memory impairment 23.64 10.72 180 239712 37950 31419502
Multiple-drug resistance 23.63 10.72 3 239889 4477 31452975
Acute myeloid leukaemia 23.59 10.72 68 239824 18604 31438848
Pulmonary arterial hypertension 23.20 10.72 24 239868 9797 31447655
Vomiting 23.19 10.72 1982 237910 221991 31235461
Hepatitis C 22.90 10.72 28 239864 10602 31446850
Tenosynovitis 22.81 10.72 77 239815 4133 31453319
Accidental death 22.48 10.72 51 239841 2166 31455286
Abdominal pain 22.44 10.72 1334 238558 144618 31312834
Monocyte percentage increased 22.23 10.72 31 239861 890 31456562
Therapy partial responder 22.09 10.72 11 239881 6551 31450901
Thrombocytopenia 22.04 10.72 870 239022 141877 31315575
Enthesopathy 22.00 10.72 77 239815 4210 31453242
Oxygen saturation abnormal 21.87 10.72 38 239854 1325 31456127
Pulse absent 21.35 10.72 89 239803 5288 31452164
Appendicolith 21.32 10.72 93 239799 5638 31451814
Asthma 21.17 10.72 213 239679 42398 31415054
Acute lung injury 20.89 10.72 37 239855 1310 31456142
Hypertriglyceridaemia 20.86 10.72 17 239875 7781 31449671
Mental status changes 20.70 10.72 385 239507 35583 31421869
Visual impairment 20.67 10.72 145 239747 31134 31426318
Syncope 20.57 10.72 489 239403 84693 31372759
Drug level below therapeutic 20.39 10.72 84 239808 4964 31452488
Liver injury 20.33 10.72 173 239719 13319 31444133
Urine sodium decreased 20.19 10.72 14 239878 163 31457289
Fluid retention 20.02 10.72 108 239784 24694 31432758
Polyneuropathy 19.90 10.72 43 239849 12979 31444473
Haematuria 19.64 10.72 240 239652 46074 31411378
Therapy cessation 19.63 10.72 54 239838 15001 31442451
Decreased appetite 19.50 10.72 954 238938 152263 31305189
Upper respiratory tract infection 19.46 10.72 322 239570 29100 31428352
Granulomatosis with polyangiitis 19.26 10.72 32 239860 1075 31456377
Enterocolitis infectious 19.13 10.72 37 239855 1403 31456049
Neutropenia 19.04 10.72 868 239024 139496 31317956
Methaemoglobinaemia 19.03 10.72 58 239834 2948 31454504
Deep vein thrombosis 19.03 10.72 334 239558 60402 31397050
Erectile dysfunction 18.91 10.72 78 239814 19157 31438295
Ejection fraction decreased 18.88 10.72 68 239824 17366 31440086
Prostatic specific antigen increased 18.84 10.72 47 239845 13491 31443961
Circulatory collapse 18.84 10.72 81 239811 19663 31437789
Pulmonary congestion 18.80 10.72 165 239727 12818 31444634
Infusion site nodule 18.70 10.72 11 239881 94 31457358
Tooth infection 18.66 10.72 93 239799 5961 31451491
Cardiac failure acute 18.62 10.72 28 239864 9713 31447739
Mydriasis 18.35 10.72 98 239794 6454 31450998
Pemphigus 18.29 10.72 36 239856 1383 31456069
Diabetic ketoacidosis 18.26 10.72 66 239826 16839 31440613
Blood pressure decreased 18.24 10.72 485 239407 47606 31409846
Chronic obstructive pulmonary disease 18.05 10.72 237 239655 44929 31412523
Swelling face 18.01 10.72 244 239648 21146 31436306
Blood creatine phosphokinase increased 17.99 10.72 217 239675 41757 31415695
Osteonecrosis 17.95 10.72 50 239842 13834 31443618
Incorrect drug administration rate 17.95 10.72 35 239857 1335 31456117
Tuberculosis 17.94 10.72 22 239870 8319 31449133
Thrombotic microangiopathy 17.76 10.72 27 239865 9324 31448128
Parkinsonism 17.66 10.72 19 239873 7617 31449835
Anion gap abnormal 17.65 10.72 12 239880 135 31457317
Stevens-Johnson syndrome 17.55 10.72 205 239687 17167 31440285
Gastrointestinal haemorrhage 17.50 10.72 483 239409 82066 31375386
Therapeutic product effect decreased 17.45 10.72 154 239738 31468 31425984
Oropharyngeal pain 17.43 10.72 335 239557 31148 31426304
Hepatic function abnormal 17.33 10.72 214 239678 41008 31416444
Chronic gastrointestinal bleeding 17.24 10.72 16 239876 290 31457162
Melaena 17.16 10.72 161 239731 32493 31424959
Myelodysplastic syndrome 17.15 10.72 81 239811 19170 31438282
Chronic graft versus host disease 16.97 10.72 6 239886 4386 31453066
Specific gravity urine decreased 16.95 10.72 10 239882 86 31457366
Aspergillus infection 16.85 10.72 39 239853 11489 31445963
Alanine aminotransferase abnormal 16.81 10.72 67 239825 3900 31453552
Rhabdomyolysis 16.77 10.72 360 239532 63221 31394231
Renal papillary necrosis 16.67 10.72 12 239880 149 31457303
Ischaemic stroke 16.57 10.72 69 239823 16902 31440550
Toxic epidermal necrolysis 16.55 10.72 223 239669 19301 31438151
Head discomfort 16.53 10.72 64 239828 3675 31453777
Generalised bullous fixed drug eruption 16.49 10.72 8 239884 44 31457408
Cytomegalovirus chorioretinitis 16.47 10.72 3 239889 3425 31454027
Pulmonary embolism 16.47 10.72 481 239411 81165 31376287
Exposure via inhalation 16.38 10.72 7 239885 27 31457425
Agitation 16.36 10.72 531 239361 53638 31403814
Haemolysis 16.34 10.72 102 239790 7114 31450338
Drug screen positive 16.28 10.72 65 239827 3787 31453665
Injection site bruising 16.16 10.72 22 239870 7953 31449499
Drug specific antibody present 16.06 10.72 53 239839 2812 31454640
Renal disorder 15.92 10.72 109 239783 23536 31433916
Gynaecomastia 15.92 10.72 28 239864 9126 31448326
Haemorrhage 15.90 10.72 257 239635 47077 31410375
Crystal urine present 15.80 10.72 18 239874 419 31457033
Acute graft versus host disease 15.74 10.72 14 239878 6139 31451313
Apparent death 15.61 10.72 4 239888 3601 31453851
Pemphigoid 15.59 10.72 24 239868 8247 31449205
Intraocular pressure increased 15.58 10.72 10 239882 5177 31452275
Low birth weight baby 15.40 10.72 18 239874 6952 31450500
Specific gravity urine increased 15.32 10.72 11 239881 136 31457316
Shock haemorrhagic 15.22 10.72 34 239858 10143 31447309
COVID-19 15.19 10.72 532 239360 54289 31403163
Gastric cancer 15.17 10.72 14 239878 6031 31451421
Hypoxia 15.14 10.72 493 239399 49820 31407632
White blood cells urine positive 15.14 10.72 30 239862 1158 31456294
Myalgia 15.12 10.72 457 239435 76801 31380651
Acid-base balance disorder mixed 15.04 10.72 8 239884 55 31457397
Red cell distribution width increased 15.03 10.72 81 239811 5353 31452099
Full blood count abnormal 15.03 10.72 68 239824 16279 31441173
Administration site pruritus 14.93 10.72 6 239886 19 31457433
Pancreatitis acute 14.87 10.72 123 239769 25477 31431975
Graft versus host disease in gastrointestinal tract 14.79 10.72 4 239888 3475 31453977
Accidental exposure to product by child 14.62 10.72 34 239858 1468 31455984
Anaphylactoid reaction 14.60 10.72 42 239850 2067 31455385
Ductus arteriosus premature closure 14.59 10.72 13 239879 223 31457229
Cerebral artery thrombosis 14.56 10.72 23 239869 740 31456712
Product substitution issue 14.53 10.72 31 239861 9401 31448051
Child abuse 14.51 10.72 16 239876 359 31457093
Adverse event 14.47 10.72 71 239821 16634 31440818
Hypocalcaemia 14.46 10.72 102 239790 21876 31435576
Premature baby 14.40 10.72 79 239813 17987 31439465
Product use issue 14.31 10.72 545 239347 56214 31401238
Brain oedema 14.12 10.72 154 239738 12678 31444774
Dysmorphism 14.11 10.72 3 239889 3069 31454383
Coma 13.92 10.72 409 239483 40741 31416711
Brain scan abnormal 13.87 10.72 24 239868 834 31456618
Hypoglycaemia 13.86 10.72 287 239605 50659 31406793
Eosinophilia 13.84 10.72 111 239781 23142 31434310
Renal cancer 13.80 10.72 23 239869 7656 31449796
Hepatocellular injury 13.69 10.72 101 239791 21443 31436009
Second primary malignancy 13.65 10.72 20 239872 7012 31450440
Self-medication 13.62 10.72 43 239849 2228 31455224
Dizziness 13.58 10.72 1310 238582 197837 31259615
Prescribed overdose 13.51 10.72 31 239861 9161 31448291
Injection site extravasation 13.50 10.72 47 239845 2563 31454889
Posterior reversible encephalopathy syndrome 13.44 10.72 32 239860 9335 31448117
Sinus tachycardia 13.43 10.72 181 239711 15668 31441784
Anti-erythrocyte antibody positive 13.42 10.72 7 239885 46 31457406
Administration site erythema 13.35 10.72 8 239884 71 31457381
Palmar-plantar erythrodysaesthesia syndrome 13.30 10.72 66 239826 15417 31442035
Prothrombin time prolonged 13.29 10.72 116 239776 8996 31448456
Transplant rejection 13.28 10.72 34 239858 9674 31447778
Cytopenia 13.25 10.72 41 239851 10969 31446483
Nocardiosis 13.20 10.72 5 239887 3502 31453950
Skin lesion 13.16 10.72 90 239802 19437 31438015
Injection site haemorrhage 13.07 10.72 31 239861 9054 31448398
Croup infectious 12.99 10.72 14 239878 306 31457146
Administration site swelling 12.97 10.72 11 239881 176 31457276
Consciousness fluctuating 12.91 10.72 27 239865 1084 31456368
Systemic infection 12.84 10.72 5 239887 3444 31454008
Appendicitis 12.81 10.72 138 239754 11327 31446125
Dyspnoea exertional 12.67 10.72 212 239680 38625 31418827
Inappropriate antidiuretic hormone secretion 12.60 10.72 44 239848 11343 31446109
Pain 12.51 10.72 1605 238287 185154 31272298
Congestive cardiomyopathy 12.47 10.72 21 239871 6961 31450491
Bronchopulmonary aspergillosis 12.36 10.72 57 239835 13577 31443875
Rash pruritic 12.34 10.72 252 239640 23686 31433766
Mean cell haemoglobin concentration decreased 12.34 10.72 27 239865 1119 31456333
Acidosis 12.19 10.72 122 239770 9824 31447628
Bilirubin urine present 12.16 10.72 10 239882 153 31457299
Chronic kidney disease 12.16 10.72 208 239684 37767 31419685
Fixed eruption 12.13 10.72 31 239861 1422 31456030
Bacterial test 12.11 10.72 10 239882 154 31457298
Mucosal erosion 12.11 10.72 22 239870 795 31456657
Blood glucose increased 12.03 10.72 361 239531 60722 31396730
Kidney transplant rejection 12.02 10.72 23 239869 7259 31450193
Eosinophil percentage increased 12.01 10.72 17 239875 495 31456957
Ultrasound liver abnormal 11.97 10.72 9 239883 120 31457332
Febrile bone marrow aplasia 11.91 10.72 26 239866 7820 31449632
Cardiac disorder 11.85 10.72 217 239675 38997 31418455
Dependent personality disorder 11.84 10.72 8 239884 89 31457363
Depressed mood 11.84 10.72 81 239811 17494 31439958
Antineutrophil cytoplasmic antibody positive 11.84 10.72 19 239873 620 31456832
Inadequate analgesia 11.83 10.72 46 239846 2647 31454805
Pupil fixed 11.82 10.72 34 239858 1673 31455779
Adenocarcinoma of colon 11.81 10.72 5 239887 3275 31454177
Hepatic cirrhosis 11.71 10.72 70 239822 15604 31441848
Ear infection viral 11.67 10.72 3 239889 0 31457452
Electrocardiogram QRS complex prolonged 11.67 10.72 63 239829 4166 31453286
Infusion site urticaria 11.66 10.72 9 239883 125 31457327
Diffuse large B-cell lymphoma recurrent 11.61 10.72 4 239888 2971 31454481
Angioedema 11.60 10.72 335 239557 33283 31424169
Subdural haematoma 11.55 10.72 90 239802 18881 31438571
Bacterial test positive 11.52 10.72 49 239843 2937 31454515
Neoplasm progression 11.50 10.72 98 239794 20174 31437278
Pulmonary alveolar haemorrhage 11.49 10.72 21 239871 6745 31450707
Urine analysis abnormal 11.45 10.72 36 239856 1861 31455591
Infusion site irritation 11.43 10.72 11 239881 209 31457243
BK virus infection 11.43 10.72 13 239879 5082 31452370
Immune effector cell-associated neurotoxicity syndrome 11.43 10.72 43 239849 2436 31455016
Haematocrit decreased 11.34 10.72 303 239589 29758 31427694
Balance disorder 11.34 10.72 207 239685 37215 31420237
Right ventricular failure 11.33 10.72 29 239863 8253 31449199
Post embolisation syndrome 11.33 10.72 7 239885 66 31457386
Dermatitis exfoliative generalised 11.33 10.72 5 239887 3194 31454258
Trichoglossia 11.29 10.72 12 239880 258 31457194
Rash erythematous 11.27 10.72 237 239655 22390 31435062
Angina unstable 11.26 10.72 45 239847 11150 31446302
Infusion site haemorrhage 11.25 10.72 22 239870 841 31456611
Ischaemic cardiomyopathy 11.22 10.72 17 239875 5880 31451572
Somnolence 11.21 10.72 886 239006 98559 31358893
Acute graft versus host disease in skin 11.20 10.72 12 239880 4820 31452632
Lactic acidosis 11.20 10.72 172 239720 31765 31425687
Protein urine 11.20 10.72 22 239870 844 31456608
Administration site pain 11.18 10.72 11 239881 215 31457237
Gait inability 11.11 10.72 92 239800 19052 31438400
Sleep disorder due to a general medical condition 11.08 10.72 8 239884 3894 31453558
Leukoencephalopathy 11.08 10.72 8 239884 3894 31453558
COVID-19 immunisation 10.90 10.72 11 239881 222 31457230
Venoocclusive liver disease 10.89 10.72 25 239867 7387 31450065
Transplant failure 10.89 10.72 5 239887 3121 31454331
Hypoxic-ischaemic encephalopathy 10.87 10.72 63 239829 4278 31453174
Obstructive airways disorder 10.87 10.72 54 239838 12610 31444842
Oral pruritus 10.86 10.72 12 239880 270 31457182
Febrile nonhaemolytic transfusion reaction 10.85 10.72 6 239886 45 31457407
Disturbance in attention 10.83 10.72 113 239779 22337 31435115
Urethral valves 10.82 10.72 12 239880 271 31457181
Osteoporosis 10.76 10.72 48 239844 11535 31445917
Gait disturbance 10.74 10.72 478 239414 77017 31380435

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 4970.07 10.32 8235 666634 218900 70034675
Toxicity to various agents 4064.25 10.32 10272 664597 371900 69881675
Infusion related reaction 1858.21 10.32 5080 669789 192454 70061121
Intentional product misuse 851.09 10.32 2149 672720 77446 70176129
Drug abuse 806.13 10.32 3151 671718 144105 70109470
Blood pressure fluctuation 805.32 10.32 1753 673116 57259 70196316
Overdose 731.27 10.32 3377 671492 166368 70087207
Urticaria 637.14 10.32 3154 671715 159895 70093680
Exposure to toxic agent 632.45 10.32 502 674367 5692 70247883
Acute hepatic failure 527.55 10.32 946 673923 26726 70226849
Intentional overdose 517.95 10.32 2081 672788 96354 70157221
Flushing 481.93 10.32 1798 673071 80374 70173201
Respiratory arrest 469.50 10.32 1350 673519 52583 70200992
Blood pressure increased 393.80 10.32 3105 671764 185412 70068163
Cardio-respiratory arrest 384.83 10.32 1936 672933 98741 70154834
Pruritus 373.04 10.32 4969 669900 340591 69912984
Anaemia 363.80 10.32 2297 672572 401126 69852449
Drug interaction 362.67 10.32 2136 672733 379305 69874270
Heart rate decreased 324.45 10.32 1309 673560 60706 70192869
Acute kidney injury 320.70 10.32 2929 671940 471695 69781880
Cardiac failure 313.28 10.32 553 674316 142988 70110587
Oxygen saturation decreased 288.75 10.32 1998 672871 114431 70139144
Heart rate increased 278.41 10.32 1847 673022 104301 70149274
Throat irritation 275.24 10.32 850 674019 34454 70219121
Product dose omission issue 273.58 10.32 1102 673767 216366 70037209
Blood pressure diastolic abnormal 269.01 10.32 509 674360 14995 70238580
Exposure via ingestion 267.91 10.32 280 674589 4635 70248940
Blood pressure systolic increased 267.83 10.32 1168 673701 56091 70197484
Anion gap 254.36 10.32 180 674689 1690 70251885
Sinusitis 253.58 10.32 2593 672276 166602 70086973
Cardiac failure congestive 253.37 10.32 571 674298 134886 70118689
Intentional product use issue 246.93 10.32 1972 672897 118170 70135405
Myocardial infarction 233.15 10.32 843 674026 170802 70082773
Diarrhoea 232.65 10.32 5679 669190 777662 69475913
Drug resistance 228.67 10.32 43 674826 38147 70215428
Poisoning 227.38 10.32 597 674272 22025 70231550
Psoriasis 225.05 10.32 368 674501 98065 70155510
Renal impairment 213.09 10.32 681 674188 143256 70110319
Blood pressure systolic abnormal 208.30 10.32 411 674458 12498 70241077
Injection site pain 202.36 10.32 518 674351 117101 70136474
Metabolic acidosis 198.14 10.32 1299 673570 73047 70180528
Hypersensitivity 192.00 10.32 3163 671706 226649 70026926
Neutropenia 186.13 10.32 1558 673311 255598 69997977
Muscle injury 185.97 10.32 793 674076 37701 70215874
Interstitial lung disease 183.99 10.32 456 674413 104229 70149346
Drug ineffective 179.31 10.32 7222 667647 932530 69321045
Urine abnormality 173.04 10.32 286 674583 7552 70246023
Hepatotoxicity 170.19 10.32 849 674020 43137 70210438
Folliculitis 166.36 10.32 824 674045 41746 70211829
Irritable bowel syndrome 166.30 10.32 937 673932 49913 70203662
Sopor 165.67 10.32 46 674823 31221 70222354
Pancytopenia 165.57 10.32 806 674063 150301 70103274
Body temperature increased 163.53 10.32 782 674087 39052 70214523
Medication error 159.39 10.32 1007 673862 55905 70197670
Nasopharyngitis 159.00 10.32 2984 671885 219222 70034353
Duodenal ulcer perforation 158.75 10.32 929 673940 50183 70203392
Osteonecrosis of jaw 158.19 10.32 97 674772 40905 70212670
Blood pressure diastolic decreased 155.15 10.32 569 674300 25211 70228364
Pneumonia 154.07 10.32 4408 670461 591824 69661751
Analgesic drug level increased 152.94 10.32 150 674719 2293 70251282
Hepatic cytolysis 147.65 10.32 460 674409 18732 70234843
Helicobacter infection 147.41 10.32 971 673898 54685 70198890
Hyperkalaemia 147.00 10.32 520 674349 106071 70147504
Malignant neoplasm progression 146.69 10.32 627 674242 121112 70132463
Sleep disorder due to general medical condition, insomnia type 146.33 10.32 701 674168 35031 70218544
Synovitis 145.18 10.32 1873 672996 127355 70126220
Throat tightness 144.51 10.32 545 674324 24477 70229098
Respiratory depression 142.71 10.32 540 674329 24291 70229284
Accidental overdose 142.37 10.32 687 674182 34434 70219141
Wrong technique in product usage process 140.66 10.32 275 674594 68423 70185152
Suspected suicide 137.42 10.32 277 674592 8557 70245018
Chills 136.88 10.32 2035 672834 142751 70110824
Device expulsion 135.45 10.32 24 674845 22222 70231353
Heart rate irregular 134.72 10.32 601 674268 29142 70224433
Bone marrow failure 132.06 10.32 163 674706 48847 70204728
Urine leukocyte esterase positive 127.05 10.32 165 674704 3480 70250095
Thrombocytopenia 126.45 10.32 1561 673308 237549 70016026
Renal failure 126.35 10.32 1169 673700 187901 70065674
Impaired healing 124.59 10.32 1167 673702 73207 70180368
Pain 121.96 10.32 7225 667644 621591 69631984
Plasma cell myeloma 121.60 10.32 328 674541 72873 70180702
Hepatic necrosis 119.19 10.32 258 674611 8388 70245187
Anti-cyclic citrullinated peptide antibody positive 118.43 10.32 1103 673766 69082 70184493
Disease progression 116.09 10.32 943 673926 155729 70097846
Hepatic enzyme increased 115.97 10.32 2119 672750 154871 70098704
Septic shock 114.32 10.32 614 674255 111644 70141931
Discomfort 113.32 10.32 1516 673353 103920 70149655
Ill-defined disorder 112.65 10.32 899 673970 53842 70199733
Cardiac arrest 112.39 10.32 2141 672728 157693 70095882
Coagulopathy 110.25 10.32 615 674254 32634 70220941
Weight increased 108.52 10.32 3047 671822 239284 70014291
Suicide attempt 107.98 10.32 1195 673674 78315 70175260
Lower respiratory tract infection 107.33 10.32 1577 673292 110336 70143239
Rash 107.13 10.32 5909 668960 504653 69748922
Cerebrovascular accident 107.00 10.32 862 674007 142608 70110967
Hand deformity 106.79 10.32 1276 673593 85206 70168369
Anaphylactic reaction 106.52 10.32 1137 673732 73837 70179738
Blister 104.99 10.32 1438 673431 99088 70154487
Blood pressure diastolic increased 104.73 10.32 307 674562 12084 70241491
Cerebral haemorrhage 104 10.32 223 674646 53641 70199934
Food allergy 103.68 10.32 242 674627 8282 70245293
White blood cells urine positive 102.63 10.32 189 674680 5451 70248124
Oedema peripheral 101.89 10.32 1541 673328 226550 70027025
Atrial fibrillation 101.82 10.32 1192 673677 183156 70070419
Depressed level of consciousness 100.18 10.32 1272 673597 86159 70167416
Erythema 99.86 10.32 2546 672323 197017 70056558
Arthropathy 99.40 10.32 1992 672877 148065 70105510
Epilepsy 99.32 10.32 134 674735 38650 70214925
Poor venous access 99.14 10.32 341 674528 14630 70238945
Therapeutic product effect incomplete 99.00 10.32 700 674169 119182 70134393
General physical health deterioration 98.58 10.32 1615 673254 234416 70019159
Feeling hot 97.27 10.32 794 674075 47876 70205699
Leukopenia 97.16 10.32 604 674265 105956 70147619
Injection site bruising 96.79 10.32 132 674737 37900 70215675
Cytomegalovirus infection 95.25 10.32 144 674725 39614 70213961
Pericarditis 93.54 10.32 1224 673645 83481 70170094
Pulmonary arterial hypertension 93.09 10.32 105 674764 32750 70220825
Crystal urine present 92.44 10.32 106 674763 1956 70251619
Hereditary angioedema 91.39 10.32 169 674700 4890 70248685
Therapy cessation 90.73 10.32 112 674757 33564 70220011
Injection site erythema 90.66 10.32 371 674498 72553 70181022
Sedation complication 90.16 10.32 307 674562 13103 70240472
Chest discomfort 90.14 10.32 1674 673195 122707 70130868
Diabetes mellitus 89.55 10.32 365 674504 71459 70182116
Hospitalisation 89.48 10.32 442 674427 82126 70171449
Coronary artery disease 89.22 10.32 302 674567 62434 70191141
Pemphigus 88.83 10.32 1193 673676 81843 70171732
Respiratory rate increased 88.71 10.32 397 674472 19275 70234300
Hyponatraemia 87.28 10.32 1038 673831 159049 70094526
Infusion site pain 86.96 10.32 275 674594 11289 70242286
Tachycardia 86.88 10.32 2048 672821 156498 70097077
Prostate cancer 86.77 10.32 101 674768 31062 70222513
Lymphocyte count decreased 86.31 10.32 709 674160 42830 70210745
Gastrointestinal haemorrhage 86.08 10.32 863 674006 136545 70117030
Cerebral infarction 85.61 10.32 175 674694 42834 70210741
Lymphocyte percentage decreased 85.52 10.32 159 674710 4620 70248955
Product use in unapproved indication 84.21 10.32 1427 673442 206051 70047524
Pyroglutamic acidosis 83.66 10.32 67 674802 770 70252805
Neuropathy peripheral 82.84 10.32 789 674080 126107 70127468
Body temperature decreased 82.55 10.32 511 674358 28161 70225414
Infusion site extravasation 82.17 10.32 213 674656 7795 70245780
Posterior reversible encephalopathy syndrome 81.93 10.32 67 674802 24335 70229240
Neoplasm progression 81.02 10.32 195 674674 45033 70208542
Lactic acidosis 80.09 10.32 332 674537 64692 70188883
Neutrophil percentage increased 79.89 10.32 150 674719 4392 70249183
Syncope 79.05 10.32 1105 673764 164604 70088971
Fall 78.46 10.32 3440 671429 440656 69812919
Decreased appetite 78.27 10.32 2254 672615 302526 69951049
Labelled drug-drug interaction medication error 77.64 10.32 69 674800 24058 70229517
Therapeutic response shortened 76.94 10.32 283 674586 12555 70241020
Urinary sediment present 76.80 10.32 103 674766 2244 70251331
Anticholinergic syndrome 75.78 10.32 116 674753 2864 70250711
Infusion site swelling 75.42 10.32 176 674693 6022 70247553
Myelosuppression 75.33 10.32 106 674763 30039 70223536
Temperature regulation disorder 74.75 10.32 144 674725 4300 70249275
Body temperature fluctuation 74.75 10.32 127 674742 3432 70250143
Haematotoxicity 74.56 10.32 19 674850 13655 70239920
Unresponsive to stimuli 74.43 10.32 789 674080 51142 70202433
Arthralgia 73.57 10.32 5650 669219 497740 69755835
Wound 73.34 10.32 1334 673535 97398 70156177
Pathogen resistance 73.28 10.32 18 674851 13261 70240314
Sepsis 72.63 10.32 1771 673098 242774 70010801
Acute lung injury 72.36 10.32 110 674759 2699 70250876
Glossodynia 71.96 10.32 1190 673679 85297 70168278
Cytokine release syndrome 71.43 10.32 464 674405 26003 70227572
Myelodysplastic syndrome 71.23 10.32 108 674761 29677 70223898
Inappropriate schedule of product administration 70.60 10.32 1426 673443 106129 70147446
Ear pruritus 70.45 10.32 114 674755 2956 70250619
Swelling 70.24 10.32 2318 672551 186221 70067354
Infusion site erythema 69.83 10.32 193 674676 7342 70246233
Diabetic ketoacidosis 68.15 10.32 122 674747 31390 70222185
Creatinine renal clearance decreased 67.95 10.32 334 674535 16866 70236709
Acute myocardial infarction 67.54 10.32 411 674458 72476 70181099
Post transplant lymphoproliferative disorder 67.28 10.32 10 674859 10535 70243040
Red cell distribution width increased 67.23 10.32 283 674586 13374 70240201
Acute myeloid leukaemia 66.72 10.32 120 674749 30820 70222755
Visual acuity reduced 65.14 10.32 103 674766 27827 70225748
Product prescribing error 65.08 10.32 174 674695 38778 70214797
Blood calcium decreased 63.92 10.32 482 674387 28364 70225211
Haematuria 63.45 10.32 350 674519 63223 70190352
Agranulocytosis 62.90 10.32 186 674683 40112 70213463
Respiratory failure 62.59 10.32 1179 673690 167556 70086019
Infusion site pruritus 62.11 10.32 111 674758 3126 70250449
Hypocalcaemia 61.05 10.32 220 674649 44639 70208936
Rhabdomyolysis 60.55 10.32 600 674269 95160 70158415
Graft versus host disease 60.12 10.32 34 674835 14989 70238586
Cardiac failure acute 59.98 10.32 47 674822 17440 70236135
Dyspnoea exertional 59.94 10.32 468 674401 77962 70175613
Substance abuse 59.08 10.32 217 674652 9620 70243955
Red blood cells urine positive 58.71 10.32 135 674734 4574 70249001
Immune reconstitution inflammatory syndrome 58.65 10.32 25 674844 12965 70240610
Bladder cancer 58.31 10.32 47 674822 17195 70236380
Dehydration 58.13 10.32 1672 673197 224470 70029105
Pulmonary hypertension 57.68 10.32 237 674632 46299 70207276
Oesophageal carcinoma 57.25 10.32 10 674859 9356 70244219
Liver injury 57.20 10.32 620 674249 40415 70213160
Product substitution issue 57.14 10.32 55 674814 18458 70235117
Contraindicated product administered 56.17 10.32 1678 673191 132934 70120641
Environmental exposure 55.92 10.32 38 674831 332 70253243
Multiple organ dysfunction syndrome 55.21 10.32 714 674155 107801 70145774
Alanine aminotransferase increased 54.34 10.32 1811 673058 145669 70107906
Pharyngeal paraesthesia 54.13 10.32 85 674784 2147 70251428
Cholecystitis chronic 53.95 10.32 204 674665 9172 70244403
Pneumocystis jirovecii pneumonia 53.64 10.32 130 674739 29952 70223623
Gastrointestinal disorder 53.55 10.32 1348 673521 104079 70149496
Joint swelling 53.41 10.32 2933 671936 250278 70003297
Lung neoplasm malignant 53.32 10.32 96 674773 24646 70228929
Headache 53.19 10.32 6303 668566 574102 69679473
Tongue disorder 53.07 10.32 258 674611 12969 70240606
Second primary malignancy 53.01 10.32 29 674840 13022 70240553
Aspergillus infection 52.95 10.32 55 674814 17813 70235762
Cardiac failure chronic 52.76 10.32 16 674853 10253 70243322
Systemic lupus erythematosus 51.78 10.32 1303 673566 100599 70152976
Chronic kidney disease 51.63 10.32 354 674515 60703 70192872
Poisoning deliberate 51.62 10.32 308 674561 16752 70236823
Anion gap abnormal 51.38 10.32 42 674827 498 70253077
Inappropriate antidiuretic hormone secretion 51.34 10.32 89 674780 23187 70230388
Melaena 51.06 10.32 320 674549 56035 70197540
Injury 50.73 10.32 888 673981 64357 70189218
Hypotension 50.56 10.32 4486 670383 399895 69853680
Transplant rejection 50.47 10.32 59 674810 18112 70235463
Osteonecrosis 50.45 10.32 128 674741 29032 70224543
Asthenia 50.24 10.32 3712 671157 453954 69799621
Death 50.07 10.32 5564 669305 504497 69749078
Hepatocellular injury 49.78 10.32 247 674622 45844 70207731
Ischaemic stroke 49.75 10.32 140 674729 30680 70222895
Blood urine present 49.63 10.32 335 674534 19018 70234557
Thrombotic microangiopathy 49.52 10.32 58 674811 17790 70235785
Hypokalaemia 49.46 10.32 914 673955 130274 70123301
Multiple-drug resistance 49.25 10.32 6 674863 7349 70246226
Urine ketone body present 49.08 10.32 103 674766 3276 70250299
Polyneuropathy 48.98 10.32 80 674789 21335 70232240
Haemorrhage 48.57 10.32 536 674333 83279 70170296
Full blood count abnormal 48.22 10.32 163 674706 33715 70219860
Therapeutic product effect decreased 47.89 10.32 1737 673132 141281 70112294
Endophthalmitis 47.56 10.32 3 674866 6252 70247323
Product storage error 47.50 10.32 41 674828 14500 70239075
Subdural haematoma 47.36 10.32 133 674736 29165 70224410
Acute graft versus host disease 47.18 10.32 16 674853 9546 70244029
Palmar-plantar erythrodysaesthesia syndrome 46.93 10.32 140 674729 30107 70223468
Urine analysis abnormal 46.87 10.32 147 674722 6007 70247568
Bronchopulmonary aspergillosis 46.61 10.32 80 674789 20922 70232653
Mucosal inflammation 46.36 10.32 417 674452 67433 70186142
Breast cancer stage I 46.17 10.32 3 674866 6099 70247476
Ear pain 46.17 10.32 433 674436 27166 70226409
Specific gravity urine decreased 46.00 10.32 48 674821 793 70252782
Epistaxis 45.89 10.32 693 674176 101934 70151641
Mydriasis 45.32 10.32 286 674583 15867 70237708
Accidental death 44.34 10.32 108 674761 3800 70249775
Hepatic function abnormal 44.26 10.32 423 674446 67573 70186002
Aspartate aminotransferase increased 44.19 10.32 1549 673320 125429 70128146
Right ventricular failure 44.01 10.32 91 674778 22183 70231392
Hepatocellular carcinoma 43.97 10.32 21 674848 10187 70243388
Blood pH decreased 43.83 10.32 117 674752 4359 70249216
Angina pectoris 43.18 10.32 276 674593 48107 70205468
Device malfunction 42.99 10.32 72 674797 19012 70234563
Gait disturbance 42.55 10.32 1389 673480 183717 70069858
Peripheral swelling 42.43 10.32 2701 672168 233862 70019713
Bursitis 42.41 10.32 414 674455 26259 70227316
Hypertensive crisis 42.17 10.32 74 674795 19188 70234387
Myopathy 42.13 10.32 70 674799 18542 70235033
Colorectal cancer 42.09 10.32 14 674855 8456 70245119
Hepatic cirrhosis 41.63 10.32 151 674718 30580 70222995
Pyroglutamate increased 41.58 10.32 41 674828 631 70252944
Cognitive disorder 41.26 10.32 812 674057 60144 70193431
Systemic infection 40.92 10.32 7 674862 6650 70246925
Hypoglycaemia 40.90 10.32 641 674228 93723 70159852
Injection site haemorrhage 40.44 10.32 117 674752 25410 70228165
Memory impairment 40.25 10.32 629 674240 92012 70161563
Breast cancer female 40.18 10.32 25 674844 10461 70243114
Febrile bone marrow aplasia 40.16 10.32 33 674836 11958 70241617
Rash erythematous 39.88 10.32 703 674166 51015 70202560
Postmortem blood drug level increased 39.83 10.32 43 674826 740 70252835
Therapy interrupted 39.79 10.32 113 674756 24689 70228886
Chronic obstructive pulmonary disease 39.44 10.32 511 674358 77130 70176445
Monocyte percentage increased 39.08 10.32 70 674799 1975 70251600
Bacterial test 38.99 10.32 53 674816 1170 70252405
Platelet count decreased 38.93 10.32 1346 673523 176876 70076699
Injection site swelling 38.61 10.32 246 674623 42911 70210664
Toxic skin eruption 38.48 10.32 84 674785 20078 70233497
Transient ischaemic attack 38.04 10.32 268 674601 45676 70207899
Altered state of consciousness 37.96 10.32 224 674645 39798 70213777
Chronic graft versus host disease 37.70 10.32 9 674860 6761 70246814
Bacterial test positive 37.22 10.32 149 674720 6882 70246693
Infusion site bruising 37.07 10.32 67 674802 1904 70251671
Glycosylated haemoglobin increased 37.01 10.32 68 674801 17323 70236252
Renal disorder 36.98 10.32 211 674658 37798 70215777
Electric shock 36.91 10.32 51 674818 1144 70252431
Transplant dysfunction 36.91 10.32 10 674859 6899 70246676
Specific gravity urine increased 36.90 10.32 32 674837 414 70253161
Ascites 36.77 10.32 438 674431 67109 70186466
Serum sickness 36.50 10.32 91 674778 3250 70250325
Drug hypersensitivity 36.12 10.32 2933 671936 259526 69994049
Sedation 35.96 10.32 635 674234 46096 70207479
Immunodeficiency 35.94 10.32 288 674581 17267 70236308
Product monitoring error 35.84 10.32 10 674859 6766 70246809
Culture urine positive 35.83 10.32 105 674764 4132 70249443
Neurotoxicity 35.66 10.32 154 674715 29672 70223903
Drug level below therapeutic 35.61 10.32 171 674698 8552 70245023
Abortion spontaneous 35.28 10.32 131 674738 26348 70227227
Drug screen positive 35.22 10.32 129 674740 5711 70247864
Diffuse large B-cell lymphoma 35.04 10.32 45 674824 13257 70240318
Unintentional medical device removal 35.01 10.32 12 674857 7112 70246463
Haematocrit decreased 34.89 10.32 751 674118 56507 70197068
Injection site pruritus 34.82 10.32 224 674645 38986 70214589
Enthesopathy 34.68 10.32 199 674670 10670 70242905
Hepatic cancer 34.53 10.32 25 674844 9658 70243917
Congestive cardiomyopathy 34.26 10.32 32 674837 10894 70242681
Pulmonary alveolar haemorrhage 34.16 10.32 29 674840 10340 70243235
Pancreatitis acute 33.56 10.32 272 674597 44952 70208623
Iron deficiency anaemia 33.53 10.32 110 674759 22962 70230613
Bone erosion 33.48 10.32 58 674811 15115 70238460
Cytomegalovirus viraemia 33.48 10.32 37 674832 11648 70241927
Hepatitis C 33.04 10.32 44 674825 12763 70240812
Eosinophilia 32.99 10.32 236 674633 40083 70213492
Status epilepticus 32.90 10.32 121 674748 24405 70229170
Pancreatic carcinoma 32.62 10.32 45 674824 12859 70240716
Coronary arterial stent insertion 32.45 10.32 8 674861 5879 70247696
Epstein-Barr virus infection 32.39 10.32 47 674822 13151 70240424
Tenosynovitis 32.37 10.32 236 674633 13740 70239835
Circulatory collapse 32.36 10.32 201 674668 35273 70218302
Drug specific antibody present 32.08 10.32 124 674745 5634 70247941
Metastases to liver 31.94 10.32 132 674737 25746 70227829
Ear infection 31.91 10.32 411 674458 27925 70225650
Hepatic failure 31.72 10.32 745 674124 56880 70196695
Pharyngitis 31.44 10.32 314 674555 20037 70233538
Haemoglobin urine present 31.40 10.32 40 674829 827 70252748
Oropharyngeal pain 31.32 10.32 1166 673703 95144 70158431
Hyperlipidaemia 31.18 10.32 119 674750 23744 70229831
Heart rate abnormal 31.06 10.32 121 674748 5518 70248057
Treatment noncompliance 31.05 10.32 288 674581 46286 70207289
Asthma 31.03 10.32 893 673976 119900 70133675
Infusion site mass 31.01 10.32 47 674822 1150 70252425
Renal cancer 30.97 10.32 40 674829 11756 70241819
Gastric cancer 30.80 10.32 24 674845 8931 70244644
Coeliac disease 30.55 10.32 168 674701 8865 70244710
Pleural effusion 30.52 10.32 997 673872 131867 70121708
Hyperhidrosis 30.49 10.32 1538 673331 130048 70123527
Mitral valve incompetence 30.16 10.32 141 674728 26587 70226988
Left ventricular dysfunction 30.16 10.32 80 674789 17877 70235698
Extrapyramidal disorder 30.10 10.32 99 674770 20651 70232924
Brain death 30.07 10.32 113 674756 5065 70248510
Renal cortical necrosis 29.94 10.32 25 674844 306 70253269
Sexual dysfunction 29.94 10.32 13 674856 6668 70246907
Upper gastrointestinal haemorrhage 29.87 10.32 221 674648 37256 70216319
Oral pruritus 29.70 10.32 61 674808 1910 70251665
C-reactive protein abnormal 29.60 10.32 524 674345 38055 70215520
Renal papillary necrosis 29.51 10.32 26 674843 344 70253231
Incorrect drug administration rate 29.47 10.32 81 674788 3071 70250504
Coma 29.40 10.32 1110 673759 90734 70162841
Device difficult to use 29.31 10.32 36 674833 10813 70242762
Injection site mass 29.11 10.32 84 674785 18259 70235316
Metastases to lymph nodes 29.03 10.32 27 674842 9211 70244364
Angina unstable 28.88 10.32 68 674801 15825 70237750
Incorrect dose administered by device 28.72 10.32 4 674865 4425 70249150
Anxiety 28.52 10.32 2451 672418 217879 70035696
Device use error 28.50 10.32 14 674855 6682 70246893
Drug ineffective for unapproved indication 28.50 10.32 232 674637 38306 70215269
Macular oedema 28.48 10.32 7 674862 5155 70248420
Cytopenia 28.47 10.32 78 674791 17245 70236330
Anticipatory anxiety 28.47 10.32 41 674828 957 70252618
Electrolyte imbalance 28.40 10.32 145 674724 26716 70226859
Back pain 28.36 10.32 2971 671898 268181 69985394
Nocardiosis 28.21 10.32 7 674862 5122 70248453
Hepatitis B reactivation 28.14 10.32 8 674861 5347 70248228
Cardiomyopathy 28.09 10.32 142 674727 26231 70227344
Hypertriglyceridaemia 28.07 10.32 43 674826 11768 70241807
Breast cancer stage II 28.07 10.32 8 674861 5338 70248237
Disease recurrence 27.97 10.32 226 674643 37377 70216198
Stomatitis 27.93 10.32 1493 673376 127018 70126557
Injection site warmth 27.72 10.32 56 674813 13769 70239806
Breast cancer 27.63 10.32 196 674673 33353 70220222
Immunosuppressant drug level increased 27.44 10.32 21 674848 7886 70245689
Acute graft versus host disease in skin 27.37 10.32 17 674852 7120 70246455
Aplastic anaemia 27.33 10.32 261 674608 16455 70237120
Metastases to lung 27.26 10.32 74 674795 16410 70237165
Shock haemorrhagic 27.23 10.32 85 674784 18021 70235554
Rheumatoid arthritis 27.18 10.32 3173 671696 288632 69964943
Deafness transitory 27.12 10.32 39 674830 909 70252666
Device dislocation 27.04 10.32 116 674753 22391 70231184
Disturbance in attention 27.00 10.32 269 674600 42625 70210950
Brain oedema 26.93 10.32 341 674528 23077 70230498
Drug dose omission by device 26.86 10.32 4 674865 4208 70249367
BK virus infection 26.74 10.32 22 674847 7967 70245608
Parkinsonism 26.72 10.32 67 674802 15258 70238317
Oedema 26.54 10.32 766 674103 102815 70150760
Obstructive airways disorder 26.47 10.32 143 674726 25970 70227605
Migraine 26.32 10.32 886 673983 71352 70182223
Sinus node dysfunction 26.23 10.32 18 674851 7151 70246424
Contusion 26.16 10.32 1479 673390 126557 70127018
Varicella zoster virus infection 26.07 10.32 4 674865 4116 70249459
Myalgia 26.07 10.32 1318 673551 166574 70087001
Graft versus host disease in gastrointestinal tract 25.95 10.32 12 674857 5932 70247643
Infusion site discomfort 25.92 10.32 39 674830 948 70252627
Hypoglycaemic coma 25.91 10.32 5 674864 4356 70249219
Analgesic drug level above therapeutic 25.83 10.32 27 674842 447 70253128
Leukoencephalopathy 25.79 10.32 19 674850 7275 70246300
Coronary artery bypass 25.77 10.32 12 674857 5908 70247667
Pulmonary tuberculosis 25.77 10.32 22 674847 7823 70245752
Haematochezia 25.75 10.32 515 674354 72566 70181009
Eosinophil percentage increased 25.64 10.32 48 674821 1402 70252173
Disorientation 25.59 10.32 392 674477 57531 70196044
Anion gap increased 25.59 10.32 78 674791 3138 70250437
Visual impairment 25.50 10.32 575 674294 79675 70173900
Full blood count decreased 25.35 10.32 129 674740 23789 70229786
Systemic lupus erythematosus rash 25.29 10.32 51 674818 1576 70251999
Device issue 25.23 10.32 130 674739 23895 70229680
Large intestine polyp 25.20 10.32 44 674825 11432 70242143
Gynaecomastia 25.14 10.32 17 674852 6806 70246769
Night sweats 25.04 10.32 568 674301 43116 70210459
Prostatic specific antigen increased 24.96 10.32 32 674837 9434 70244141
Blood creatine phosphokinase increased 24.93 10.32 421 674448 60842 70192733
Premature delivery 24.86 10.32 111 674758 21193 70232382
Nitrite urine present 24.85 10.32 42 674827 1130 70252445
Haematoma 24.83 10.32 318 674551 48100 70205475
Toxicologic test abnormal 24.82 10.32 45 674824 1282 70252293
Surgery 24.79 10.32 175 674694 29814 70223761
Ejection fraction decreased 24.71 10.32 181 674688 30581 70222994
Lipodystrophy acquired 24.70 10.32 5 674864 4211 70249364
Aphasia 24.49 10.32 278 674591 42971 70210604
Long QT syndrome 24.46 10.32 10 674859 5317 70248258
Mobility decreased 24.29 10.32 1206 673663 101793 70151782
Mean cell haemoglobin concentration decreased 24.21 10.32 90 674779 4013 70249562
Human herpesvirus 6 infection 24.20 10.32 8 674861 4851 70248724
Metastases to bone 24.11 10.32 120 674749 22256 70231319
Spinal stenosis 24.07 10.32 66 674803 14587 70238988
Device leakage 23.99 10.32 32 674837 9276 70244299
Kidney transplant rejection 23.93 10.32 36 674833 9925 70243650
Blood glucose increased 23.83 10.32 772 674097 102210 70151365
Cystitis haemorrhagic 23.76 10.32 28 674841 8565 70245010
Depression 23.70 10.32 1602 673267 197372 70056203
Prothrombin time prolonged 23.67 10.32 247 674622 15943 70237632
Graft versus host disease in skin 23.62 10.32 12 674857 5618 70247957
Injection site reaction 23.54 10.32 333 674536 49519 70204056
Electrocardiogram QRS complex prolonged 23.53 10.32 167 674702 9639 70243936
Product quality issue 23.51 10.32 182 674687 30379 70223196
Candida infection 23.49 10.32 212 674657 34261 70219314
Partial seizures 23.48 10.32 26 674843 8179 70245396
Disturbance in social behaviour 23.47 10.32 5 674864 4062 70249513
Arrhythmia 23.44 10.32 384 674485 55759 70197816
Venoocclusive liver disease 23.40 10.32 41 674828 10637 70242938
Rheumatic fever 23.31 10.32 264 674605 17396 70236179
Ischaemic cardiomyopathy 23.24 10.32 20 674849 7084 70246491
Ketoacidosis 23.13 10.32 21 674848 7248 70246327
Hyperglycaemia 23.01 10.32 455 674414 64217 70189358
Lymphoproliferative disorder 22.90 10.32 11 674858 5318 70248257
Suicidal ideation 22.88 10.32 496 674373 69100 70184475
Drug reaction with eosinophilia and systemic symptoms 22.86 10.32 401 674468 57612 70195963
Bilirubin urine present 22.81 10.32 22 674847 329 70253246
Fibromyalgia 22.80 10.32 607 674262 47267 70206308
Tooth infection 22.60 10.32 248 674621 16215 70237360
Neuroleptic malignant syndrome 22.37 10.32 150 674719 25857 70227718
Forced expiratory volume decreased 22.26 10.32 22 674847 7292 70246283
Infusion site rash 22.21 10.32 43 674826 1289 70252286
Tuberculosis 22.12 10.32 70 674799 14778 70238797
Gestational diabetes 22.05 10.32 15 674854 5986 70247589
Hypothyroidism 21.83 10.32 305 674564 45450 70208125
Haemophagocytic lymphohistiocytosis 21.81 10.32 104 674765 19508 70234067
Acute respiratory failure 21.77 10.32 369 674500 53296 70200279
Victim of child abuse 21.75 10.32 35 674834 903 70252672
Metastases to central nervous system 21.62 10.32 72 674797 14962 70238613
Meningitis aseptic 21.45 10.32 119 674750 6300 70247275
Accidental exposure to product by child 21.35 10.32 67 674802 2739 70250836
Injection site rash 21.33 10.32 82 674787 16328 70237247
Cytomegalovirus infection reactivation 21.10 10.32 20 674849 6761 70246814
Injection site extravasation 21.01 10.32 149 674720 8597 70244978
Alanine aminotransferase abnormal 20.96 10.32 140 674729 7919 70245656
Acute coronary syndrome 20.88 10.32 109 674760 19970 70233605
Blood loss anaemia 20.88 10.32 69 674800 14372 70239203
Unevaluable event 20.79 10.32 359 674510 51704 70201871
Haemolysis 20.73 10.32 184 674685 11367 70242208
Diffuse large B-cell lymphoma recurrent 20.62 10.32 4 674865 3472 70250103
Actinic keratosis 20.50 10.32 14 674855 5576 70247999
Aggression 20.35 10.32 331 674538 48115 70205460
Infusion site urticaria 20.30 10.32 32 674837 811 70252764
Bradyphrenia 20.19 10.32 40 674829 9906 70243669
Hypovolaemic shock 19.98 10.32 46 674823 10791 70242784
Blood creatinine decreased 19.93 10.32 129 674740 7220 70246355
Sudden death 19.92 10.32 118 674751 20946 70232629
Soft tissue disorder 19.90 10.32 74 674795 3300 70250275
Hepatitis B 19.81 10.32 29 674840 8085 70245490
Rheumatoid nodule 19.78 10.32 225 674644 14842 70238733
Cardiac disorder 19.66 10.32 423 674446 58992 70194583
Squamous cell carcinoma of skin 19.60 10.32 59 674810 12653 70240922
Concomitant disease aggravated 19.57 10.32 55 674814 12059 70241516
Carotid artery stenosis 19.56 10.32 30 674839 8206 70245369
Personality change 19.49 10.32 34 674835 8836 70244739
Cholestasis 19.47 10.32 329 674540 47543 70206032
Aplasia pure red cell 19.37 10.32 25 674844 7349 70246226
Hypomagnesaemia 19.35 10.32 272 674597 40492 70213083
Skin toxicity 19.32 10.32 24 674845 7174 70246401
Fracture 19.24 10.32 111 674758 19833 70233742
JC virus infection 19.23 10.32 5 674864 3546 70250029
Pneumonia viral 19.19 10.32 140 674729 8152 70245423
Adenocarcinoma of colon 19.12 10.32 14 674855 5378 70248197
B-cell lymphoma 18.91 10.32 19 674850 6250 70247325
Sleep disorder due to a general medical condition 18.89 10.32 45 674824 10431 70243144
Infusion site streaking 18.87 10.32 23 674846 454 70253121
pH urine increased 18.85 10.32 22 674847 414 70253161
Multiple drug therapy 18.82 10.32 70 674799 3122 70250453
Hyperammonaemia 18.73 10.32 44 674825 10249 70243326
Emotional distress 18.73 10.32 475 674394 36713 70216862
Subarachnoid haemorrhage 18.58 10.32 109 674760 19395 70234180
Serum sickness-like reaction 18.56 10.32 25 674844 547 70253028
Tachyarrhythmia 18.51 10.32 20 674849 6362 70247213
Red blood cell sedimentation rate 18.44 10.32 94 674775 4816 70248759
Transplant failure 18.39 10.32 8 674861 4099 70249476
Compartment syndrome 18.36 10.32 88 674781 4398 70249177
Squamous cell carcinoma 18.33 10.32 74 674795 14530 70239045
Loss of consciousness 18.33 10.32 1255 673614 154461 70099114
Mucormycosis 18.27 10.32 30 674839 7984 70245591
Sinus tachycardia 18.22 10.32 437 674432 33476 70220099
Petit mal epilepsy 18.21 10.32 15 674854 5429 70248146
Antipsychotic drug level increased 18.18 10.32 15 674854 5425 70248150
Mast cell activation syndrome 18.18 10.32 26 674843 603 70252972
Peripheral arterial occlusive disease 18.17 10.32 27 674842 7482 70246093
Band neutrophil count increased 18.14 10.32 27 674842 650 70252925
Erectile dysfunction 18.13 10.32 67 674802 13495 70240080
Intentional self-injury 18.09 10.32 203 674666 31447 70222128
No adverse event 18.08 10.32 207 674662 31946 70221629
Dizziness 18.07 10.32 4024 670845 460117 69793458
Pharyngeal swelling 17.95 10.32 114 674755 6339 70247236
Atypical femur fracture 17.94 10.32 12 674857 4831 70248744
Muscle spasticity 17.91 10.32 275 674594 19414 70234161
Granulomatosis with polyangiitis 17.87 10.32 60 674809 2542 70251033
Nocturia 17.86 10.32 58 674811 12146 70241429
Therapy partial responder 17.76 10.32 60 674809 12414 70241161
Akinesia 17.76 10.32 4 674865 3127 70250448
Cytomegalovirus colitis 17.74 10.32 9 674860 4217 70249358
Bundle branch block left 17.71 10.32 46 674823 10353 70243222
Gastritis erosive 17.70 10.32 44 674825 10051 70243524
Administration site swelling 17.70 10.32 20 674849 363 70253212
Injection site induration 17.66 10.32 38 674831 9130 70244445
Cardiovascular disorder 17.62 10.32 90 674779 16580 70236995
Ageusia 17.61 10.32 77 674792 14785 70238790
Erysipelas 17.60 10.32 43 674826 9881 70243694
Gastrooesophageal reflux disease 17.59 10.32 696 674173 90143 70163432
Anuria 17.59 10.32 112 674757 19541 70234034
Rectal haemorrhage 17.58 10.32 484 674385 65347 70188228
Pneumatosis intestinalis 17.58 10.32 18 674851 5869 70247706
Hemiparesis 17.53 10.32 203 674666 31266 70222309
Dysarthria 17.46 10.32 455 674414 61858 70191717
Pupil fixed 17.46 10.32 71 674798 3303 70250272
Hypervolaemia 17.44 10.32 269 674600 39437 70214138
Dyspnoea 17.43 10.32 6830 668039 763230 69490345
Cardiotoxicity 17.34 10.32 51 674818 11019 70242556
Anal fissure 17.26 10.32 110 674759 6123 70247452
Cytomegalovirus chorioretinitis 17.23 10.32 15 674854 5283 70248292
Pneumonia aspiration 17.15 10.32 456 674413 61833 70191742
Vitamin K deficiency 17.11 10.32 27 674842 685 70252890
Urinary casts 17.09 10.32 36 674833 1148 70252427
Product use issue 17.05 10.32 1959 672910 177978 70075597
Mental status changes 17.05 10.32 749 674120 62352 70191223
Adrenergic syndrome 17.01 10.32 12 674857 112 70253463
Osteoarthritis 16.87 10.32 557 674312 73590 70179985
Infusion site nodule 16.82 10.32 17 674852 270 70253305
Thrombosis 16.80 10.32 568 674301 74837 70178738
Periorbital swelling 16.74 10.32 53 674816 2177 70251398
Self-medication 16.65 10.32 85 674784 4358 70249217
Proteinuria 16.56 10.32 189 674680 29185 70224390
Haematemesis 16.55 10.32 346 674523 48451 70205124
Retinal haemorrhage 16.54 10.32 30 674839 7680 70245895
Dyslipidaemia 16.50 10.32 44 674825 9816 70243759
Abnormal dreams 16.50 10.32 49 674820 10554 70243021
Cells in urine 16.40 10.32 15 674854 209 70253366
Band neutrophil percentage increased 16.40 10.32 20 674849 395 70253180
Vein rupture 16.32 10.32 44 674825 1649 70251926
Cerebral ischaemia 16.29 10.32 48 674821 10364 70243211
Haemorrhage intracranial 16.18 10.32 154 674715 24623 70228952
Left ventricular failure 16.13 10.32 37 674832 8691 70244884
Peritonitis bacterial 16.13 10.32 40 674829 9144 70244431
Weight fluctuation 16.11 10.32 150 674719 9391 70244184
Vertigo 16.11 10.32 463 674406 62180 70191395
Oropharyngeal discomfort 16.05 10.32 106 674763 5973 70247602
White coat hypertension 15.99 10.32 26 674843 677 70252898
Pneumonia cytomegaloviral 15.97 10.32 12 674857 4549 70249026
Haemoptysis 15.97 10.32 370 674499 51082 70202493
Pain in jaw 15.85 10.32 298 674571 42371 70211204
COVID-19 immunisation 15.82 10.32 33 674836 1045 70252530
Coagulation factor X level decreased 15.74 10.32 11 674858 101 70253474
Bradyarrhythmia 15.74 10.32 9 674860 3944 70249631
Complications of transplanted kidney 15.71 10.32 20 674849 5914 70247661
Peritonitis 15.66 10.32 166 674703 25993 70227582
Product dispensing error 15.61 10.32 60 674809 11948 70241627
Post-traumatic stress disorder 15.61 10.32 83 674786 4324 70249251
Physical disability 15.60 10.32 4 674865 2863 70250712
Urticaria thermal 15.59 10.32 16 674853 259 70253316
Brain stem glioma 15.52 10.32 15 674854 225 70253350
Muscle spasms 15.50 10.32 1258 673611 152788 70100787
Eyelid ptosis 15.50 10.32 47 674822 10055 70243520
Staphylococcal infection 15.48 10.32 388 674481 53016 70200559
Progressive multifocal leukoencephalopathy 15.46 10.32 113 674756 19101 70234474
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.45 10.32 6 674863 3291 70250284
Acidosis 15.44 10.32 252 674617 18011 70235564
Pericardial effusion 15.44 10.32 292 674577 41484 70212091
Leukaemia 15.42 10.32 17 674852 5358 70248217
Urobilinogen urine increased 15.37 10.32 25 674844 651 70252924
Sputum culture positive 15.36 10.32 68 674801 3286 70250289
Cystic fibrosis pancreatic 15.34 10.32 9 674860 59 70253516
Fungal rhinitis 15.34 10.32 9 674860 59 70253516
Terminal state 15.34 10.32 13 674856 4639 70248936
Oxygen saturation abnormal 15.34 10.32 75 674794 3779 70249796
Mycobacterial infection 15.29 10.32 7 674862 3481 70250094
Malignant melanoma 15.29 10.32 74 674795 13826 70239749
Lower gastrointestinal haemorrhage 15.26 10.32 80 674789 14640 70238935
Pulmonary fibrosis 15.22 10.32 232 674637 34078 70219497
Intestinal haemorrhage 15.21 10.32 21 674848 5999 70247576
Swollen joint count increased 15.13 10.32 198 674671 13502 70240073
Dyspnoea at rest 15.11 10.32 26 674843 6793 70246782
Electrocardiogram QT prolonged 15.09 10.32 645 674224 82872 70170703
Joint injury 15.07 10.32 349 674520 26583 70226992
Cystitis 14.94 10.32 567 674302 46374 70207201
Monoparesis 14.89 10.32 6 674863 3218 70250357
Femoral neck fracture 14.80 10.32 41 674828 9032 70244543
Diplopia 14.75 10.32 184 674685 27963 70225612
Drug use disorder 14.71 10.32 130 674739 8021 70245554
Thyroxine free increased 14.65 10.32 34 674835 1159 70252416
Pemphigoid 14.65 10.32 76 674793 13946 70239629
Lung disorder 14.65 10.32 527 674342 68957 70184618
Jaundice 14.54 10.32 364 674505 49744 70203831
Biliary dyskinesia 14.47 10.32 53 674816 2346 70251229
Urine bilirubin decreased 14.43 10.32 12 674857 146 70253429
Somnolence 14.42 10.32 2299 672570 213307 70040268
Diastolic dysfunction 14.39 10.32 44 674825 9389 70244186
Joint laxity 14.39 10.32 52 674817 2287 70251288
Mean cell haemoglobin concentration increased 14.37 10.32 27 674842 791 70252784
Tri-iodothyronine free increased 14.37 10.32 15 674854 248 70253327
Nephropathy toxic 14.36 10.32 110 674759 18404 70235171
Blood thyroid stimulating hormone decreased 14.34 10.32 95 674774 5359 70248216
Gallbladder injury 14.33 10.32 33 674836 1119 70252456
Atrioventricular block complete 14.31 10.32 85 674784 15078 70238497
Red blood cells urine 14.27 10.32 24 674845 643 70252932
Spinal compression fracture 14.25 10.32 88 674781 15465 70238110
Infusion site scar 14.22 10.32 16 674853 289 70253286
Peripheral sensory neuropathy 14.19 10.32 63 674806 12047 70241528
Euglycaemic diabetic ketoacidosis 14.15 10.32 22 674847 5985 70247590
Colon cancer 14.14 10.32 79 674790 14227 70239348
Diverticulum intestinal 14.14 10.32 35 674834 8006 70245569
Blood pressure decreased 14.11 10.32 1032 673837 90483 70163092
Disseminated tuberculosis 14.09 10.32 11 674858 4089 70249486
Klebsiella infection 14.08 10.32 79 674790 14213 70239362
Limb mass 14.00 10.32 66 674803 3276 70250299
Hip fracture 13.99 10.32 187 674682 28076 70225499
Intraocular pressure increased 13.95 10.32 41 674828 8860 70244715
Malaise 13.94 10.32 3786 671083 429146 69824429
Rash maculo-papular 13.92 10.32 370 674499 50175 70203400
Viral load increased 13.90 10.32 4 674865 2652 70250923
Uterine cancer 13.89 10.32 8 674861 3491 70250084
Cerebral haematoma 13.86 10.32 31 674838 7347 70246228
Generalised bullous fixed drug eruption 13.84 10.32 11 674858 125 70253450
Metastasis 13.83 10.32 23 674846 6091 70247484
Epstein-Barr virus associated lymphoproliferative disorder 13.81 10.32 7 674862 3282 70250293
Abdominal discomfort 13.80 10.32 2284 672585 212374 70041201
Skin cancer 13.79 10.32 74 674795 13462 70240113
Head injury 13.77 10.32 235 674634 33906 70219669
Accidental poisoning 13.71 10.32 40 674829 1570 70252005
Gastric haemorrhage 13.66 10.32 79 674790 14106 70239469
White blood cells urine 13.63 10.32 18 674851 386 70253189
Embolism venous 13.62 10.32 10 674859 3835 70249740
Acute myeloid leukaemia recurrent 13.59 10.32 6 674863 3048 70250527
Brain abscess 13.59 10.32 14 674855 4552 70249023
Feeling cold 13.59 10.32 329 674540 25241 70228334
Procedural anxiety 13.58 10.32 24 674845 670 70252905
Retinal deposits 13.56 10.32 11 674858 129 70253446
Toxoplasmosis 13.53 10.32 4 674865 2606 70250969
Adenovirus infection 13.51 10.32 34 674835 7734 70245841
Hot flush 13.50 10.32 589 674280 48995 70204580
Pleurothotonus 13.47 10.32 3 674866 2363 70251212
Stress 13.47 10.32 783 674086 67183 70186392
Abdominal pain 13.46 10.32 3555 671314 338572 69915003
Colitis 13.45 10.32 484 674385 63330 70190245
Lipaemic index score 13.42 10.32 11 674858 131 70253444
Electric shock sensation 13.42 10.32 22 674847 577 70252998
Acute graft versus host disease in intestine 13.41 10.32 10 674859 3806 70249769
Ear swelling 13.35 10.32 37 674832 1410 70252165
Leukocyturia 13.30 10.32 40 674829 1597 70251978
Focal dyscognitive seizures 13.30 10.32 8 674861 3409 70250166
Tricuspid valve incompetence 13.29 10.32 107 674762 17710 70235865
Portal hypertension 13.27 10.32 26 674843 6466 70247109
Underdose 13.27 10.32 198 674671 29185 70224390
Bradycardia 13.26 10.32 1013 673856 123602 70129973
Eosinophilic granulomatosis with polyangiitis 13.25 10.32 7 674862 3206 70250369
Left ventricular hypertrophy 13.25 10.32 51 674818 10151 70243424
Potentiating drug interaction 13.24 10.32 37 674832 8127 70245448
Infective pulmonary exacerbation of cystic fibrosis 13.21 10.32 65 674804 12093 70241482
Mastocytosis 13.21 10.32 19 674850 443 70253132
Idiopathic pulmonary fibrosis 13.21 10.32 16 674853 4835 70248740
Condition aggravated 13.16 10.32 3747 671122 423888 69829687
Abortion induced 13.14 10.32 27 674842 6598 70246977
PCO2 decreased 13.08 10.32 60 674809 2944 70250631
Agitation 13.07 10.32 1045 673824 92330 70161245
Hemiplegia 13.05 10.32 78 674791 13817 70239758
Syringe issue 13.05 10.32 19 674850 5309 70248266
Invasive ductal breast carcinoma 13.01 10.32 22 674847 5787 70247788
Delusion 13.00 10.32 118 674751 19047 70234528
Toothache 12.97 10.32 247 674622 18183 70235392
Osmolar gap 12.96 10.32 11 674858 138 70253437
Thyroid cancer 12.95 10.32 18 674851 5127 70248448
Chronic spontaneous urticaria 12.92 10.32 31 674838 1080 70252495
Renal tubular disorder 12.90 10.32 24 674845 6086 70247489
Eye swelling 12.90 10.32 305 674564 23309 70230266
Blood creatinine increased 12.87 10.32 1178 673691 141823 70111752
Smear cervix abnormal 12.86 10.32 51 674818 2345 70251230
Fluid retention 12.85 10.32 483 674386 62902 70190673
Exposure via inhalation 12.85 10.32 9 674860 83 70253492
Pneumonia bacterial 12.85 10.32 99 674770 16542 70237033
Pancreatitis 12.83 10.32 477 674392 62191 70191384
Pericardial haemorrhage 12.80 10.32 13 674856 4255 70249320
Coronary artery stenosis 12.80 10.32 62 674807 11582 70241993
Monocyte count increased 12.77 10.32 139 674730 9070 70244505
Impaired work ability 12.71 10.32 97 674772 16243 70237332
Coronary artery occlusion 12.71 10.32 82 674787 14263 70239312
Muscle twitching 12.71 10.32 262 674607 19565 70234010
Skin lesion 12.67 10.32 274 674595 38186 70215389
Fanconi syndrome 12.61 10.32 5 674864 2708 70250867
Embolic stroke 12.60 10.32 32 674837 7257 70246318
Nephrogenic systemic fibrosis 12.58 10.32 24 674845 6028 70247547
Secondary amyloidosis 12.58 10.32 12 674857 177 70253398
Concomitant disease progression 12.57 10.32 8 674861 3307 70250268
Immune-mediated myositis 12.54 10.32 7 674862 3109 70250466
Muscle haemorrhage 12.53 10.32 23 674846 5861 70247714
Dry throat 12.50 10.32 108 674761 6620 70246955
Blindness 12.49 10.32 151 674718 23076 70230499
Maternal exposure timing unspecified 12.48 10.32 78 674791 4313 70249262
Cardiac tamponade 12.47 10.32 41 674828 8554 70245021
Mean cell haemoglobin increased 12.45 10.32 67 674802 3506 70250069
Jaundice cholestatic 12.44 10.32 138 674731 9046 70244529
Kidney infection 12.44 10.32 257 674612 19198 70234377
Facial paresis 12.40 10.32 18 674851 5035 70248540
Pre-eclampsia 12.39 10.32 27 674842 6458 70247117
Paradoxical drug reaction 12.37 10.32 28 674841 6608 70246967
Lung adenocarcinoma 12.36 10.32 35 674834 7655 70245920
Facet joint syndrome 12.36 10.32 100 674769 6013 70247562
Pyrexia 12.34 10.32 6155 668714 600797 69652778
Drug intolerance 12.31 10.32 2381 672488 223306 70030269
Dysstasia 12.31 10.32 167 674702 25012 70228563
Lymphopenia 12.14 10.32 185 674684 27174 70226401
Inhibitory drug interaction 12.11 10.32 11 674858 3796 70249779
Precancerous cells present 12.11 10.32 30 674839 1067 70252508
Dermatitis allergic 12.11 10.32 99 674770 16332 70237243
Inflammation 12.11 10.32 887 673982 77778 70175797
Pulse absent 12.10 10.32 139 674730 9191 70244384
Hypomania 12.10 10.32 99 674770 5973 70247602
Infusion site haemorrhage 12.09 10.32 56 674813 2759 70250816
Injection site discomfort 12.09 10.32 16 674853 4653 70248922
Therapeutic response unexpected 12.04 10.32 113 674756 18118 70235457
Tardive dyskinesia 12.03 10.32 51 674818 9878 70243697
Allergy to chemicals 11.96 10.32 44 674825 1952 70251623
Mycobacterium avium complex infection 11.94 10.32 14 674855 4292 70249283
Withdrawal syndrome 11.88 10.32 166 674703 24738 70228837
Hyperthyroidism 11.83 10.32 128 674741 19963 70233612
Gait inability 11.80 10.32 350 674519 46825 70206750
Acid-base balance disorder mixed 11.78 10.32 9 674860 96 70253479
Sudden infant death syndrome 11.75 10.32 12 674857 193 70253382
Prerenal failure 11.74 10.32 9 674860 3377 70250198
Acute pulmonary oedema 11.71 10.32 77 674792 13335 70240240
Hyperuricaemia 11.70 10.32 59 674810 10907 70242668
Ankylosing spondylitis 11.68 10.32 64 674805 11582 70241993
Sensation of foreign body 11.65 10.32 82 674787 4720 70248855
Vascular rupture 11.64 10.32 36 674833 1460 70252115
Seizure 11.63 10.32 1499 673370 176463 70077112
Orthopnoea 11.60 10.32 48 674821 9360 70244215
Muscular weakness 11.54 10.32 1146 673723 137190 70116385
Atrioventricular block 11.51 10.32 72 674797 12616 70240959
Pharyngitis streptococcal 11.48 10.32 139 674730 9309 70244266
Pulmonary congestion 11.43 10.32 317 674552 24837 70228738
Cutaneous T-cell lymphoma 11.39 10.32 5 674864 2548 70251027
Lumbar vertebral fracture 11.38 10.32 25 674844 5962 70247613
Vital functions abnormal 11.37 10.32 22 674847 659 70252916
Consciousness fluctuating 11.37 10.32 40 674829 1736 70251839
Temperature intolerance 11.33 10.32 130 674739 8593 70244982
Affective disorder 11.33 10.32 35 674834 7444 70246131
Cachexia 11.30 10.32 52 674817 9848 70243727
Suspected COVID-19 11.29 10.32 49 674820 2347 70251228
Hypogammaglobulinaemia 11.25 10.32 64 674805 11474 70242101
Atrioventricular block first degree 11.25 10.32 65 674804 11608 70241967
Protein urine 11.24 10.32 34 674835 1362 70252213
Complication of device insertion 11.21 10.32 21 674848 5311 70248264
Latent tuberculosis 11.20 10.32 8 674861 3113 70250462
Uterine perforation 11.18 10.32 95 674774 5796 70247779
Device deployment issue 11.16 10.32 7 674862 2917 70250658
Lupus-like syndrome 11.16 10.32 64 674805 11451 70242124
Carpal tunnel syndrome 11.14 10.32 106 674763 16951 70236624
Anti-erythrocyte antibody positive 11.14 10.32 8 674861 77 70253498
Ventricular fibrillation 11.13 10.32 186 674683 26925 70226650
Head discomfort 11.12 10.32 180 674689 12843 70240732
Febrile infection 11.12 10.32 8 674861 3101 70250474
Anoxia 11.07 10.32 15 674854 330 70253245
Infective exacerbation of chronic obstructive airways disease 11.07 10.32 5 674864 2506 70251069
Vessel puncture site bruise 11.06 10.32 18 674851 469 70253106
Liver transplant 11.03 10.32 74 674795 4192 70249383
Mucosal dryness 11.00 10.32 60 674809 3156 70250419
Catheter management 11 10.32 10 674859 3449 70250126
Burn of internal organs 10.99 10.32 3 674866 0 70253575
Appendicolith 10.99 10.32 92 674777 5588 70247987
Deep vein thrombosis 10.99 10.32 908 673961 110134 70143441
Myocardial ischaemia 10.95 10.32 163 674706 24037 70229538
Pulmonary embolism 10.91 10.32 1307 673562 154560 70099015
Aortic valve stenosis 10.90 10.32 19 674850 4940 70248635
Hepatitis E 10.88 10.32 6 674863 2682 70250893
Infusion site warmth 10.86 10.32 30 674839 1141 70252434
Treatment failure 10.82 10.32 1203 673666 142939 70110636
Nervous system disorder 10.80 10.32 163 674706 23983 70229592
Atrioventricular block second degree 10.78 10.32 31 674838 6747 70246828
High density lipoprotein decreased 10.78 10.32 14 674855 4105 70249470
Psychomotor skills impaired 10.77 10.32 15 674854 4269 70249306
Dysgeusia 10.76 10.32 374 674495 49128 70204447
Lip swelling 10.76 10.32 411 674458 33643 70219932
Anaphylactoid reaction 10.72 10.32 83 674786 4924 70248651
Red cell distribution width decreased 10.69 10.32 37 674832 1592 70251983
Opiates positive 10.69 10.32 26 674843 914 70252661
Brain scan abnormal 10.68 10.32 30 674839 1152 70252423
Allergy to immunoglobulin therapy 10.66 10.32 5 674864 19 70253556
Cerebellar syndrome 10.65 10.32 21 674848 5210 70248365
Rheumatoid factor positive 10.65 10.32 563 674306 47837 70205738
Neutropenic sepsis 10.64 10.32 169 674700 24661 70228914
Ataxia 10.64 10.32 156 674713 23061 70230514
Aortic valve incompetence 10.63 10.32 46 674823 8858 70244717
Gastrointestinal perforation 10.57 10.32 24 674845 5657 70247918
Complication associated with device 10.54 10.32 97 674772 15616 70237959
Autoimmune haemolytic anaemia 10.53 10.32 38 674831 7708 70245867
Administration site bruise 10.53 10.32 9 674860 114 70253461
Psychotic symptom 10.52 10.32 5 674864 2433 70251142
Intestinal obstruction 10.48 10.32 285 674584 38540 70215035
Dissociation 10.45 10.32 10 674859 3366 70250209
Ulcer 10.45 10.32 320 674549 25434 70228141
Haemorrhagic stroke 10.43 10.32 56 674813 10186 70243389
Upper respiratory tract infection 10.42 10.32 883 673986 78391 70175184
White blood cell count decreased 10.41 10.32 1439 673430 168702 70084873
Blood uric acid decreased 10.40 10.32 30 674839 1170 70252405
Liver disorder 10.40 10.32 479 674390 61089 70192486
Stent placement 10.38 10.32 27 674842 6074 70247501
Cardiac dysfunction 10.35 10.32 11 674858 3526 70250049

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Incorrect route of product administration 22.41 20.24 6 364 7 89415

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




🐶 Veterinary Drug Use

None

🐶 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
Robitussin Direct Runny Nose HUMAN OTC DRUG LABEL 1 0031-9304 TABLET, COATED 25 mg ORAL OTC monograph final 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 16 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 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
Childrens Night Time Cold and Cough HUMAN OTC DRUG LABEL 2 0113-0808 SOLUTION 6.25 mg ORAL OTC monograph final 15 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