dextromethorphan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 842 125-71-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dextromethorphan HBr
  • dextromethorphan hydrochloride
  • dextromethorphan hydrobromide hydrate
  • dextromethorphan
  • (+)-Dextromethorphan
  • d-Methorphan
  • dextromethorphan hydrobromide
  • dextromethorphan hydriodide
  • dextromethorphan hydrobromide monohydrate
  • dextromethorphan polistirex
Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • Molecular weight: 271.40
  • Formula: C18H25NO
  • CLOGP: 3.94
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -4.50
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O
90 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 15 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.19 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.88 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 11 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma) 0.24 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Dec. 3, 1957 FDA ANI PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 2354.78 10.23 5663 492864 241587 62748908
Completed suicide 2266.17 10.23 4084 494443 141589 62848906
Infusion related reaction 862.75 10.23 4015 494512 241506 62748989
Exposure to toxic agent 862.21 10.23 541 497986 5046 62985449
Sinusitis 686.21 10.23 3553 494974 223100 62767395
Muscle injury 560.97 10.23 1441 497086 63904 62926591
Folliculitis 547.17 10.23 1495 497032 68822 62921673
Acute hepatic failure 501.64 10.23 668 497859 17659 62972836
Irritable bowel syndrome 485.57 10.23 1588 496939 80824 62909671
Lower respiratory tract infection 466.32 10.23 2167 496360 130140 62860355
Intentional overdose 455.09 10.23 1449 497078 72703 62917792
Blood pressure fluctuation 421.07 10.23 1044 497483 45273 62945222
Blister 397.14 10.23 2042 496485 127772 62862723
Overdose 381.55 10.23 1852 496675 113226 62877269
Sleep disorder due to general medical condition, insomnia type 380.35 10.23 1084 497443 51133 62939362
Duodenal ulcer perforation 375.09 10.23 1517 497010 85692 62904803
Helicobacter infection 373.93 10.23 1582 496945 91203 62899292
Ill-defined disorder 370.00 10.23 1445 497082 80310 62910185
Injection site pain 367.77 10.23 288 498239 129512 62860983
Intentional product misuse 349.97 10.23 1164 497363 59753 62930742
Anti-cyclic citrullinated peptide antibody positive 336.79 10.23 1801 496726 114411 62876084
Pericarditis 336.78 10.23 1972 496555 129607 62860888
Impaired healing 316.32 10.23 1617 496910 100925 62889570
Nasopharyngitis 314.74 10.23 3215 495312 251042 62739453
Rheumatoid arthritis 307.78 10.23 3196 495331 250623 62739872
Metabolic acidosis 301.77 10.23 908 497619 44161 62946334
Hepatic enzyme increased 295.68 10.23 2650 495877 199678 62790817
Hepatic cytolysis 286.24 10.23 468 498059 14939 62975556
Product dose omission issue 280.32 10.23 924 497603 233389 62757106
Joint swelling 249.67 10.23 3783 494744 323883 62666612
Therapeutic product effect decreased 234.21 10.23 2433 496094 190754 62799741
Analgesic drug level increased 231.23 10.23 173 498354 2199 62988296
Hepatotoxicity 220.05 10.23 716 497811 36325 62954170
Intentional product use issue 218.99 10.23 1736 496791 126156 62864339
Device expulsion 218.63 10.23 14 498513 34908 62955587
Injection site erythema 216.62 10.23 200 498327 82974 62907521
Gastrointestinal disorder 214.71 10.23 1763 496764 129476 62861019
Diarrhoea 213.37 10.23 4149 494378 711217 62279278
Synovitis 208.85 10.23 2316 496211 184602 62805893
Anion gap 206.91 10.23 129 498398 1188 62989307
Medication error 192.63 10.23 868 497659 51416 62939079
Stomatitis 192.36 10.23 1797 496730 136928 62853567
Hypersensitivity 189.51 10.23 3290 495237 289395 62701100
Discomfort 182.92 10.23 2065 496462 165309 62825186
Weight increased 182.90 10.23 2970 495557 257822 62732673
Hand deformity 182.33 10.23 1985 496542 157472 62833023
Wrong technique in product usage process 179.45 10.23 136 498391 62204 62928291
Depressed level of consciousness 173.59 10.23 953 497574 61125 62929370
Psoriasis 171.95 10.23 260 498267 86697 62903798
Body temperature increased 169.49 10.23 659 497868 36533 62953962
Anaemia 161.33 10.23 1499 497028 291931 62698564
Swelling 161.16 10.23 3047 495480 272331 62718164
Drug ineffective 159.87 10.23 6650 491877 1038115 61952380
Wound 156.68 10.23 1965 496562 161298 62829197
Suicide attempt 151.20 10.23 906 497621 60012 62930483
Sedation complication 146.67 10.23 331 498196 13491 62977004
Injection site reaction 145.09 10.23 147 498380 58377 62932118
Infusion site pain 143.62 10.23 371 498156 16498 62973997
Blood pressure systolic abnormal 138.09 10.23 317 498210 13069 62977426
Blood pressure diastolic abnormal 135.51 10.23 331 498196 14211 62976284
Heart rate decreased 134.54 10.23 710 497817 44850 62945645
Injection site bruising 130.44 10.23 84 498443 41826 62948669
Injection site pruritus 129.11 10.23 99 498428 45017 62945478
Rheumatic fever 125.36 10.23 669 497858 42442 62948053
Creatinine renal clearance decreased 125.03 10.23 345 498182 15963 62974532
Respiratory arrest 124.79 10.23 548 497979 32097 62958398
Rheumatoid factor positive 123.32 10.23 1106 497421 83300 62907195
Peripheral swelling 122.68 10.23 2842 495685 263100 62727395
Coagulopathy 120.10 10.23 395 498132 20149 62970346
Cardio-respiratory arrest 119.59 10.23 844 497683 59115 62931380
Infusion site extravasation 118.90 10.23 257 498270 10169 62980326
Infection 118.34 10.23 2489 496038 226684 62763811
Blood pressure diastolic decreased 118.22 10.23 420 498107 22286 62968209
Neutropenia 118.07 10.23 846 497681 174159 62816336
Infusion site swelling 117.39 10.23 246 498281 9524 62980971
Confusional state 112.71 10.23 2538 495989 233842 62756653
Disease progression 112.37 10.23 538 497989 122220 62868275
Ear pain 111.58 10.23 570 497957 35548 62954947
Blood pressure systolic increased 110.72 10.23 694 497833 46703 62943792
Poisoning deliberate 110.62 10.23 261 498266 10957 62979538
Throat irritation 101.26 10.23 572 497955 37075 62953420
Injection site swelling 100.19 10.23 136 498391 47436 62943059
Cardiac failure congestive 100.02 10.23 380 498147 92053 62898442
Swollen joint count increased 99.77 10.23 552 497975 35502 62954993
Drug abuse 99.24 10.23 937 497590 71581 62918914
Oxygen saturation decreased 96.25 10.23 1092 497435 87493 62903002
Myocardial infarction 96.03 10.23 430 498097 99463 62891032
Blood pressure increased 94.93 10.23 1794 496733 160268 62830227
Hospitalisation 94.52 10.23 346 498181 84735 62905760
Osteonecrosis of jaw 93.16 10.23 83 498444 35040 62955455
Muscle spasticity 92.73 10.23 378 498149 21416 62969079
Nausea 91.50 10.23 5639 492888 848832 62141663
Drug resistance 91.10 10.23 33 498494 22900 62967595
Blood calcium decreased 89.93 10.23 429 498098 26022 62964473
Therapy cessation 89.51 10.23 65 498462 30392 62960103
Infusion site erythema 89.46 10.23 247 498280 11432 62979063
Neuropathy peripheral 86.96 10.23 529 497998 113138 62877357
Cardiac failure 84.91 10.23 385 498142 88757 62901738
Drug hypersensitivity 84.68 10.23 1827 496700 308860 62681635
Glossodynia 84.08 10.23 1917 496610 176959 62813536
Infusion site pruritus 83.31 10.23 161 498366 5874 62984621
Product substitution issue 83.13 10.23 13 498514 15983 62974512
Malignant neoplasm progression 82.90 10.23 347 498180 81774 62908721
Pancytopenia 82.88 10.23 435 498092 96498 62893997
Poisoning 81.51 10.23 265 498262 13435 62977060
Dizziness 80.53 10.23 2668 495859 427257 62563238
Pyroglutamic acidosis 79.63 10.23 54 498473 581 62989914
White blood cell count decreased 79.20 10.23 704 497823 138400 62852095
Drug interaction 78.61 10.23 1295 497232 227836 62762659
Acute lung injury 78.19 10.23 78 498449 1493 62989002
Pruritus 78.02 10.23 3527 495000 357926 62632569
Device dislocation 77.99 10.23 53 498474 25652 62964843
Respiratory depression 77.76 10.23 261 498266 13454 62977041
Product quality issue 75.05 10.23 103 498424 35762 62954733
Decreased appetite 74.10 10.23 1457 497070 249595 62740900
Sopor 73.78 10.23 41 498486 22123 62968372
Hepatic failure 73.49 10.23 506 498021 35150 62955345
Bone marrow failure 73.24 10.23 73 498454 29217 62961278
Arthropathy 72.46 10.23 2383 496144 232409 62758086
Device malfunction 72.12 10.23 25 498502 17832 62972663
Feeling abnormal 71.89 10.23 781 497746 147611 62842884
Therapeutic product effect incomplete 71.59 10.23 632 497895 124424 62866071
Coma 71.52 10.23 797 497730 63567 62926928
Abortion spontaneous 71.31 10.23 166 498361 47029 62943466
Injection site warmth 71.18 10.23 16 498511 15179 62975316
Pemphigus 70.84 10.23 1917 496610 181809 62808686
Pyrexia 70.67 10.23 4437 494090 466041 62524454
Paraesthesia 70.23 10.23 841 497686 156125 62834370
Mobility decreased 70.16 10.23 1339 497188 119820 62870675
Diabetes mellitus 69.47 10.23 216 498311 55594 62934901
Neoplasm progression 69.06 10.23 112 498415 36316 62954179
COVID-19 68.61 10.23 1259 497268 111844 62878651
Suspected suicide 68.25 10.23 156 498371 6412 62984083
Poor venous access 68.18 10.23 263 498264 14522 62975973
Orthostatic hypotension 68.05 10.23 502 498025 35658 62954837
Exposure via ingestion 66.12 10.23 97 498430 2812 62987683
Muscle spasms 65.95 10.23 847 497680 155303 62835192
Hepatic necrosis 65.79 10.23 141 498386 5546 62984949
Contusion 64.98 10.23 1590 496937 148454 62842041
Cerebrovascular accident 64.02 10.23 541 497986 107483 62883012
Contraindicated product administered 63.59 10.23 2195 496332 215453 62775042
Renal impairment 63.06 10.23 420 498107 87935 62902560
Surgery 62.98 10.23 116 498411 35796 62954699
Product storage error 62.04 10.23 20 498507 14936 62975559
Cognitive disorder 61.95 10.23 691 497836 55124 62935371
Pyroglutamate increased 61.34 10.23 40 498487 401 62990094
Night sweats 60.56 10.23 618 497909 48196 62942299
Bone pain 59.51 10.23 224 498303 54417 62936078
Injection site rash 59.49 10.23 37 498490 18772 62971723
Accidental overdose 59.31 10.23 349 498178 22960 62967535
Palmar-plantar erythrodysaesthesia syndrome 59.13 10.23 56 498471 22959 62967536
Infusion site bruising 58.84 10.23 107 498420 3725 62986770
Vision blurred 58.78 10.23 451 498076 91473 62899022
Red blood cell sedimentation rate abnormal 58.41 10.23 42 498485 19740 62970755
Electric shock 57.49 10.23 61 498466 1259 62989236
Blood cholesterol increased 56.08 10.23 1044 497483 92988 62897507
Respiratory disorder 55.98 10.23 510 498017 38572 62951923
Device difficult to use 55.09 10.23 16 498511 12780 62977715
Sedation 54.86 10.23 505 498022 38304 62952191
No adverse event 54.59 10.23 156 498371 41249 62949246
Infusion site haemorrhage 54.19 10.23 122 498405 4964 62985531
Therapy interrupted 54.15 10.23 108 498419 32347 62958148
Ear pruritus 53.78 10.23 105 498422 3860 62986635
Anion gap abnormal 53.66 10.23 36 498491 380 62990115
Seizure 53.24 10.23 727 497800 131907 62858588
Injection site urticaria 53.00 10.23 22 498505 14051 62976444
Hyperkalaemia 52.87 10.23 232 498295 53971 62936524
Injection site haemorrhage 52.73 10.23 68 498459 24246 62966249
Heart rate increased 52.68 10.23 1036 497491 93202 62897293
Type 2 diabetes mellitus 52.61 10.23 748 497779 63120 62927375
Leukopenia 51.41 10.23 375 498152 76915 62913580
Platelet count decreased 50.84 10.23 625 497902 115497 62874998
Dehydration 50.83 10.23 1007 497520 172347 62818148
Injection site mass 50.79 10.23 43 498484 18613 62971882
Blood parathyroid hormone decreased 50.78 10.23 8 498519 9783 62980712
Arthralgia 50.65 10.23 5160 493367 564550 62425945
Device issue 50.06 10.23 68 498459 23713 62966782
Thrombocytopenia 49.62 10.23 861 497666 150296 62840199
Multiple sclerosis relapse 49.44 10.23 204 498323 48274 62942221
Drug intolerance 49.05 10.23 2926 495601 305735 62684760
Depression 48.52 10.23 1173 497354 195319 62795176
Heart rate irregular 47.88 10.23 321 498206 22100 62968395
Oedema peripheral 47.71 10.23 1128 497399 188383 62802112
Epistaxis 47.34 10.23 355 498172 72370 62918125
Transient ischaemic attack 47.06 10.23 146 498381 37607 62952888
Liver injury 46.77 10.23 701 497826 59819 62930676
Schizoaffective disorder 46.71 10.23 93 498434 3469 62987026
Hypokalaemia 46.47 10.23 556 497971 103248 62887247
Hyponatraemia 46.12 10.23 610 497917 111290 62879205
Blood pressure diastolic increased 46.11 10.23 178 498349 9832 62980663
Product prescribing error 46.02 10.23 85 498442 26204 62964291
Drug use disorder 45.96 10.23 113 498414 4871 62985624
Systemic lupus erythematosus 45.94 10.23 2043 496484 206875 62783620
Jaundice cholestatic 45.69 10.23 144 498383 7180 62983315
Gastrointestinal haemorrhage 45.67 10.23 412 498115 80764 62909731
Foetal exposure during pregnancy 45.47 10.23 116 498411 31846 62958649
Accidental exposure to product 45.03 10.23 92 498435 27313 62963182
Dry skin 44.94 10.23 262 498265 56625 62933870
Myalgia 43.91 10.23 848 497679 145681 62844814
Suicidal ideation 43.89 10.23 298 498229 62123 62928372
Myelosuppression 43.88 10.23 74 498453 23629 62966866
Dyspnoea exertional 43.85 10.23 285 498242 60017 62930478
Hypocalcaemia 43.66 10.23 117 498410 31596 62958899
Granuloma skin 43.52 10.23 7 498520 8430 62982065
Basal cell carcinoma 42.65 10.23 98 498429 27893 62962602
Breast cancer stage I 42.42 10.23 3 498524 6886 62983609
Rash pruritic 42.29 10.23 285 498242 59514 62930981
Full blood count abnormal 42.18 10.23 119 498408 31598 62958897
Hyperlipidaemia 42.17 10.23 55 498472 19516 62970979
Hypomania 41.85 10.23 127 498400 6203 62984292
Urine leukocyte esterase positive 41.70 10.23 89 498438 3490 62987005
Hypercalcaemia 41.68 10.23 101 498426 28221 62962274
Unevaluable event 41.49 10.23 235 498292 51151 62939344
Full blood count decreased 41.38 10.23 89 498438 25935 62964560
Interstitial lung disease 41.35 10.23 300 498227 61608 62928887
Body temperature decreased 41.07 10.23 287 498240 20032 62970463
Cytokine release syndrome 40.83 10.23 221 498306 14093 62976402
Methaemoglobinaemia 40.64 10.23 70 498457 2333 62988162
Myelodysplastic syndrome 40.48 10.23 43 498484 16711 62973784
Posterior reversible encephalopathy syndrome 40.27 10.23 46 498481 17299 62973196
Syncope 40.02 10.23 664 497863 116721 62873774
Mucosal inflammation 39.87 10.23 211 498316 46717 62943778
Breast cancer female 39.76 10.23 29 498498 13530 62976965
Tremor 39.71 10.23 765 497762 131474 62859021
Atrial fibrillation 39.69 10.23 660 497867 115976 62874519
Visual acuity reduced 39.62 10.23 69 498458 21757 62968738
Drug withdrawal syndrome 39.22 10.23 98 498429 27096 62963399
Weight fluctuation 39.18 10.23 167 498360 9652 62980843
Osteonecrosis 38.92 10.23 84 498443 24446 62966049
Incorrect drug administration rate 38.87 10.23 92 498435 3870 62986625
Pain in extremity 38.73 10.23 2168 496359 329318 62661177
Loss of consciousness 38.38 10.23 674 497853 117447 62873048
Skin necrosis 38.17 10.23 32 498495 13918 62976577
Haematotoxicity 38.08 10.23 13 498514 9363 62981132
Renal failure 38.02 10.23 672 497855 116980 62873515
Therapeutic response decreased 37.86 10.23 305 498222 61220 62929275
Urine abnormality 37.54 10.23 131 498396 6888 62983607
Acute kidney injury 37.49 10.23 1688 496839 261727 62728768
Crystal urine present 37.37 10.23 55 498472 1599 62988896
Blood glucose increased 37.34 10.23 449 498078 83307 62907188
Injection site induration 37.12 10.23 13 498514 9213 62981282
Inappropriate schedule of product administration 37.02 10.23 1074 497453 102891 62887604
Administration site swelling 36.31 10.23 48 498479 1259 62989236
Memory impairment 36.12 10.23 588 497939 103670 62886825
Injury 35.95 10.23 790 497737 72457 62918038
Coronary artery disease 35.73 10.23 132 498395 32245 62958250
Panniculitis 35.18 10.23 23 498504 11362 62979133
Hypotension 35.14 10.23 2539 495988 270065 62720430
Underdose 35.06 10.23 105 498422 27351 62963144
Epilepsy 34.93 10.23 103 498424 26962 62963533
Anticipatory anxiety 34.84 10.23 46 498481 1205 62989290
White blood cells urine positive 34.58 10.23 104 498423 5054 62985441
Vaginal haemorrhage 34.47 10.23 106 498421 27381 62963114
Macular degeneration 34.35 10.23 317 498210 24059 62966436
Fall 34.27 10.23 2634 495893 389700 62600795
Hypertensive crisis 33.93 10.23 42 498485 15244 62975251
Pulmonary hypertension 33.77 10.23 163 498364 36960 62953535
Gastrooesophageal reflux disease 33.59 10.23 538 497989 95101 62895394
Therapeutic response unexpected 33.42 10.23 60 498467 18699 62971796
Metastases to bone 33.33 10.23 72 498455 20947 62969548
Respiratory rate increased 33.22 10.23 202 498325 13446 62977049
Femur fracture 33.15 10.23 192 498335 41564 62948931
Diabetic ketoacidosis 32.71 10.23 70 498457 20435 62970060
Alanine aminotransferase increased 32.67 10.23 1056 497471 102714 62887781
Extrapyramidal disorder 32.20 10.23 34 498493 13250 62977245
Spinal stenosis 32.10 10.23 42 498485 14883 62975612
Drug-induced liver injury 31.90 10.23 468 498059 39754 62950741
Genital haemorrhage 31.87 10.23 9 498518 7323 62983172
Burning sensation 31.54 10.23 274 498253 54133 62936362
Device use error 31.54 10.23 4 498523 5757 62984738
Skin exfoliation 31.19 10.23 204 498323 42898 62947597
Multiple drug therapy 30.84 10.23 80 498447 3566 62986929
Lactic acidosis 30.42 10.23 176 498351 38111 62952384
Haemorrhage 30.40 10.23 319 498208 60703 62929792
International normalised ratio increased 30.34 10.23 523 498004 45902 62944593
Breast cancer 30.16 10.23 239 498288 48144 62942351
Fluid retention 30.15 10.23 311 498216 59375 62931120
Urticaria 30.04 10.23 1591 496936 164211 62826284
Infusion site mass 29.57 10.23 56 498471 2012 62988483
Palpitations 29.54 10.23 667 497860 112103 62878392
Administration site pain 29.54 10.23 35 498492 819 62989676
Urinary sediment present 29.47 10.23 58 498469 2145 62988350
Pathogen resistance 29.44 10.23 7 498520 6391 62984104
Ageusia 29.15 10.23 39 498488 13689 62976806
Ascites 28.85 10.23 194 498333 40534 62949961
Neurotoxicity 28.80 10.23 56 498471 16934 62973561
Complication associated with device 28.75 10.23 56 498471 16922 62973573
Gestational diabetes 28.72 10.23 15 498512 8381 62982114
Infusion site nodule 28.63 10.23 46 498481 1446 62989049
Disease recurrence 28.55 10.23 118 498409 27912 62962583
Electrolyte imbalance 28.45 10.23 73 498454 20003 62970492
Chronic kidney disease 28.42 10.23 224 498303 45174 62945321
Injection site discolouration 28.40 10.23 13 498514 7835 62982660
Metastases to lung 28.34 10.23 35 498492 12715 62977780
Cytomegalovirus infection 28.31 10.23 78 498449 20874 62969621
Heavy menstrual bleeding 28.08 10.23 61 498466 17712 62972783
Cerebral infarction 27.97 10.23 95 498432 23798 62966697
Transplant rejection 27.96 10.23 26 498501 10754 62979741
Facet joint syndrome 27.88 10.23 177 498350 11961 62978534
Hypothyroidism 27.79 10.23 208 498319 42424 62948071
Irritability 27.77 10.23 141 498386 31553 62958942
Metastases to liver 27.67 10.23 94 498433 23545 62966950
Second primary malignancy 27.52 10.23 14 498513 7939 62982556
Intervertebral discitis 27.48 10.23 71 498456 3157 62987338
Hyperglycaemia 27.42 10.23 204 498323 41663 62948832
Toxicologic test abnormal 27.37 10.23 31 498496 690 62989805
Prothrombin time shortened 27.27 10.23 53 498474 1942 62988553
Infusion site irritation 27.15 10.23 35 498492 895 62989600
Drug dose omission by device 27.11 10.23 3 498524 4798 62985697
Respiratory failure 27.10 10.23 601 497926 101257 62889238
Disturbance in attention 27.00 10.23 182 498345 38007 62952488
Blood potassium decreased 26.94 10.23 206 498321 41820 62948675
Premature delivery 26.94 10.23 134 498393 30147 62960348
Thrombotic microangiopathy 26.77 10.23 26 498501 10535 62979960
Soft tissue disorder 26.72 10.23 86 498441 4336 62986159
Complication of device insertion 26.65 10.23 13 498514 7551 62982944
Sepsis 26.54 10.23 959 497568 152164 62838331
Labelled drug-drug interaction medication error 26.53 10.23 40 498487 13359 62977136
Neutrophil percentage increased 26.37 10.23 66 498461 2877 62987618
COVID-19 pneumonia 26.02 10.23 196 498331 14013 62976482
Cardiac disorder 25.99 10.23 264 498263 50552 62939943
Anion gap increased 25.72 10.23 50 498477 1832 62988663
Fear of injection 25.72 10.23 12 498515 7152 62983343
Pulmonary arterial hypertension 25.60 10.23 91 498436 22486 62968009
Rash 25.59 10.23 4885 493642 555986 62434509
Acute myocardial infarction 25.34 10.23 148 498379 31976 62958519
Specific gravity urine decreased 25.33 10.23 31 498496 751 62989744
Thrombosis 25.23 10.23 357 498170 64398 62926097
Fibromyalgia 25.21 10.23 818 497709 79602 62910893
Gait disturbance 25.20 10.23 1178 497349 182000 62808495
Bursitis 25.19 10.23 420 498107 36621 62953874
Withdrawal syndrome 25.16 10.23 77 498450 19920 62970575
Septic shock 25.03 10.23 370 498157 66259 62924236
Dysgeusia 25.01 10.23 240 498287 46470 62944025
Akathisia 25.00 10.23 21 498506 9125 62981370
Complication of device removal 24.93 10.23 5 498522 5137 62985358
Skin ulcer 24.85 10.23 217 498310 42828 62947667
Red blood cells urine positive 24.83 10.23 67 498460 3059 62987436
Polyneuropathy 24.81 10.23 48 498479 14541 62975954
Lymphocyte percentage decreased 24.74 10.23 65 498462 2920 62987575
Sensitivity to weather change 24.65 10.23 13 498514 7224 62983271
Pneumocystis jirovecii pneumonia 24.36 10.23 61 498466 16853 62973642
Musculoskeletal disorder 24.22 10.23 82 498445 20562 62969933
Post transplant lymphoproliferative disorder 24.17 10.23 5 498522 5026 62985469
Hepatic cirrhosis 24.04 10.23 106 498421 24628 62965867
Sexual dysfunction 23.93 10.23 3 498524 4356 62986139
Tardive dyskinesia 23.89 10.23 19 498508 8483 62982012
Incorrect dose administered by device 23.85 10.23 3 498524 4345 62986150
Systemic infection 23.74 10.23 4 498523 4656 62985839
Aphasia 23.47 10.23 157 498370 32843 62957652
Ear infection 23.37 10.23 426 498101 37787 62952708
Lymphocyte count decreased 23.19 10.23 350 498177 29907 62960588
Intermenstrual bleeding 23.18 10.23 17 498510 7909 62982586
Ventricular extrasystoles 23.03 10.23 35 498492 11652 62978843
Infusion site discomfort 23.00 10.23 41 498486 1405 62989090
Neuroleptic malignant syndrome 22.91 10.23 37 498490 12019 62978476
Renal disorder 22.89 10.23 158 498369 32816 62957679
Hypocoagulable state 22.87 10.23 37 498490 1170 62989325
Multiple allergies 22.85 10.23 186 498341 13616 62976879
Hepatitis acute 22.85 10.23 136 498391 8984 62981511
Thinking abnormal 22.84 10.23 30 498497 10613 62979882
Product complaint 22.79 10.23 41 498486 12768 62977727
Deep vein thrombosis postoperative 22.64 10.23 160 498367 11209 62979286
Hepatic encephalopathy 22.59 10.23 159 498368 11123 62979372
Infusion site rash 22.56 10.23 49 498478 1945 62988550
Vital capacity decreased 22.52 10.23 45 498482 1683 62988812
Dermatitis atopic 22.35 10.23 26 498501 9698 62980797
Device breakage 22.33 10.23 35 498492 11507 62978988
Laboratory test abnormal 22.31 10.23 122 498405 26790 62963705
Cardiotoxicity 22.30 10.23 20 498507 8418 62982077
Carpal tunnel syndrome 22.23 10.23 86 498441 20731 62969764
Schizophrenia 22.17 10.23 144 498383 9808 62980687
Insurance issue 22.07 10.23 101 498426 6020 62984475
Product adhesion issue 22.04 10.23 5 498522 4714 62985781
Sputum culture positive 22.00 10.23 51 498476 2116 62988379
Metastases to lymph nodes 21.97 10.23 19 498508 8139 62982356
Abdominal distension 21.92 10.23 515 498012 86100 62904395
Cardiac arrest 21.88 10.23 912 497615 91633 62898862
Drug ineffective for unapproved indication 21.82 10.23 167 498360 33896 62956599
Forced expiratory volume decreased 21.78 10.23 6 498521 4962 62985533
Right ventricular failure 21.76 10.23 66 498461 17122 62973373
Substance abuse 21.75 10.23 85 498442 4722 62985773
Brain oedema 21.75 10.23 188 498339 14007 62976488
Rheumatoid nodule 21.62 10.23 66 498461 17089 62973406
Analgesic drug level above therapeutic 21.62 10.23 15 498512 168 62990327
Skin burning sensation 21.56 10.23 42 498485 12692 62977803
Drug level increased 21.49 10.23 273 498254 22463 62968032
Dyskinesia 21.40 10.23 155 498372 31847 62958648
Disturbance in social behaviour 21.31 10.23 3 498524 3990 62986505
Multiple-drug resistance 21.29 10.23 7 498520 5163 62985332
Body temperature fluctuation 21.28 10.23 52 498475 2233 62988262
Brain death 21.23 10.23 67 498460 3343 62987152
Abnormal dreams 21.21 10.23 31 498496 10485 62980010
Generalised tonic-clonic seizure 21.16 10.23 137 498390 28879 62961616
Acute myeloid leukaemia 20.89 10.23 67 498460 17080 62973415
Low density lipoprotein increased 20.81 10.23 12 498515 6345 62984150
Treatment noncompliance 20.74 10.23 190 498337 37135 62953360
Product preparation error 20.67 10.23 11 498516 6081 62984414
Acidosis 20.59 10.23 155 498372 11078 62979417
Low turnover osteopathy 20.44 10.23 4 498523 4181 62986314
Anti-cyclic citrullinated peptide antibody 20.41 10.23 106 498421 6652 62983843
Status epilepticus 20.37 10.23 57 498470 15176 62975319
Neutrophil count decreased 20.24 10.23 316 498211 56090 62934405
Fracture 20.22 10.23 82 498445 19502 62970993
Upper respiratory tract infection 20.19 10.23 812 497715 81235 62909260
Skin toxicity 20.10 10.23 6 498521 4708 62985787
Blood pH decreased 20.10 10.23 55 498472 2532 62987963
Pharyngeal paraesthesia 20.09 10.23 47 498480 1962 62988533
Sleep apnoea syndrome 20.02 10.23 140 498387 28993 62961502
Cerebral haemorrhage 19.99 10.23 150 498377 30579 62959916
Unintended pregnancy 19.76 10.23 12 498515 6167 62984328
Angina unstable 19.75 10.23 16 498511 7079 62983416
Caesarean section 19.75 10.23 68 498459 16964 62973531
Lip dry 19.73 10.23 197 498330 15273 62975222
Hepatitis cholestatic 19.49 10.23 106 498421 6772 62983723
Hallucination, auditory 19.45 10.23 45 498482 12779 62977716
Pain in jaw 19.45 10.23 233 498294 43263 62947232
Transplant dysfunction 19.37 10.23 7 498520 4865 62985630
Hypomagnesaemia 19.31 10.23 139 498388 28598 62961897
Unresponsive to stimuli 19.31 10.23 373 498154 33443 62957052
Amenorrhoea 19.24 10.23 30 498497 9884 62980611
Ductus arteriosus premature closure 19.20 10.23 18 498509 318 62990177
Blood creatine increased 19.15 10.23 91 498436 5510 62984985
Iron deficiency anaemia 19.15 10.23 86 498441 19883 62970612
Inappropriate antidiuretic hormone secretion 19.12 10.23 60 498467 15402 62975093
Administration site bruise 19.11 10.23 20 498507 406 62990089
X-ray abnormal 19.09 10.23 119 498408 7991 62982504
Infusion site urticaria 18.96 10.23 40 498487 1556 62988939
Disorientation 18.94 10.23 208 498319 39244 62951251
Deep vein thrombosis 18.85 10.23 507 498020 83293 62907202
Brain stem glioma 18.71 10.23 14 498513 178 62990317
Drug eruption 18.70 10.23 140 498387 28554 62961941
Plasma cell myeloma 18.58 10.23 186 498341 35719 62954776
Prothrombin time ratio decreased 18.53 10.23 22 498505 516 62989979
Macular oedema 18.33 10.23 4 498523 3873 62986622
Dystonia 18.26 10.23 52 498475 13767 62976728
Adjustment disorder with depressed mood 18.26 10.23 140 498387 10064 62980431
Galactorrhoea 18.25 10.23 5 498522 4150 62986345
Pregnancy with contraceptive device 18.23 10.23 7 498520 4687 62985808
Ankylosing spondylitis 18.21 10.23 34 498493 10440 62980055
Blood immunoglobulin E increased 18.13 10.23 4 498523 3845 62986650
Rheumatoid lung 18.13 10.23 4 498523 3844 62986651
Liver transplant 18.09 10.23 49 498478 2242 62988253
Haemophagocytic lymphohistiocytosis 18.04 10.23 35 498492 10592 62979903
Malaise 18.04 10.23 2930 495597 413024 62577471
Tinnitus 17.85 10.23 186 498341 35442 62955053
Hypothermia 17.83 10.23 174 498353 13407 62977088
Atypical femur fracture 17.79 10.23 10 498517 5362 62985133
Pulmonary embolism 17.76 10.23 742 497785 115942 62874553
Ventricular fibrillation 17.72 10.23 42 498485 11825 62978670
Oral discomfort 17.71 10.23 28 498499 9173 62981322
Pneumonia streptococcal 17.71 10.23 42 498485 1769 62988726
Haemoglobin decreased 17.60 10.23 948 497579 144537 62845958
Coagulation factor X level decreased 17.52 10.23 10 498517 77 62990418
Therapeutic response shortened 17.46 10.23 156 498371 11732 62978763
Flatulence 17.45 10.23 181 498346 34521 62955974
Wound infection 17.33 10.23 250 498277 21160 62969335
Diplopia 17.32 10.23 112 498415 23616 62966879
Cardiomyopathy 17.31 10.23 75 498452 17509 62972986
Mitral valve incompetence 17.26 10.23 87 498440 19507 62970988
Reversible airways obstruction 17.24 10.23 42 498485 1800 62988695
Torsade de pointes 17.09 10.23 51 498476 13300 62977195
Aplasia pure red cell 16.92 10.23 7 498520 4480 62986015
Peripheral venous disease 16.89 10.23 191 498336 15286 62975209
Post cholecystectomy syndrome 16.88 10.23 19 498508 420 62990075
Dysphoria 16.80 10.23 9 498518 4957 62985538
Dyspnoea 16.78 10.23 4783 493744 656530 62333965
Colorectal cancer 16.75 10.23 4 498523 3641 62986854
Renal failure neonatal 16.70 10.23 13 498514 176 62990319
Uterine perforation 16.68 10.23 18 498509 6945 62983550
Invasive ductal breast carcinoma 16.65 10.23 18 498509 6940 62983555
Pleural effusion 16.54 10.23 582 497945 92628 62897867
Tricuspid valve incompetence 16.53 10.23 59 498468 14562 62975933
Postmortem blood drug level increased 16.50 10.23 22 498505 582 62989913
SARS-CoV-2 test positive 16.41 10.23 114 498413 7942 62982553
Febrile bone marrow aplasia 16.39 10.23 20 498507 7305 62983190
Cryopyrin associated periodic syndrome 16.33 10.23 17 498510 343 62990152
Device leakage 16.28 10.23 19 498508 7077 62983418
Deafness 16.24 10.23 79 498448 17878 62972617
Ischaemic stroke 16.24 10.23 79 498448 17878 62972617
Ketoacidosis 16.24 10.23 7 498520 4371 62986124
Coagulation factor VII level decreased 16.23 10.23 10 498517 90 62990405
Aspergillus infection 16.18 10.23 24 498503 8069 62982426
Mood swings 16.09 10.23 81 498446 18167 62972328
Post procedural pulmonary embolism 16.00 10.23 15 498512 265 62990230
Joint range of motion decreased 15.98 10.23 350 498177 32078 62958417
Skin lesion 15.96 10.23 159 498368 30562 62959933
Haematuria 15.95 10.23 149 498378 29008 62961487
Abdominal pain lower 15.93 10.23 127 498400 25551 62964944
Congestive cardiomyopathy 15.93 10.23 15 498512 6167 62984328
Red cell distribution width increased 15.92 10.23 139 498388 10385 62980110
Pancreatic carcinoma 15.86 10.23 22 498505 7606 62982889
Vein collapse 15.84 10.23 29 498498 1015 62989480
Lupus-like syndrome 15.82 10.23 64 498463 15231 62975264
Vertigo 15.74 10.23 354 498173 59533 62930962
Autoimmune disorder 15.71 10.23 205 498322 16972 62973523
Embedded device 15.66 10.23 4 498523 3479 62987016
Skin discolouration 15.65 10.23 206 498321 37622 62952873
Cardiac failure acute 15.62 10.23 32 498495 9491 62981004
Thyroid neoplasm 15.60 10.23 6 498521 4013 62986482
Blood urine present 15.57 10.23 184 498343 14885 62975610
Dysphagia 15.52 10.23 554 497973 88031 62902464
Maternal exposure timing unspecified 15.45 10.23 102 498425 6985 62983510
Movement disorder 15.43 10.23 103 498424 21558 62968937
Product residue present 15.34 10.23 6 498521 3973 62986522
Polycystic ovaries 15.28 10.23 8 498519 4463 62986032
Aspartate aminotransferase 15.27 10.23 18 498509 419 62990076
Ventricular arrhythmia 15.19 10.23 65 498462 3763 62986732
Dislocation of vertebra 15.19 10.23 118 498409 8517 62981978
Gastrointestinal pain 15.08 10.23 34 498493 9742 62980753
Mood altered 15.05 10.23 62 498465 14681 62975814
Asthenia 15.04 10.23 2717 495810 380887 62609608
Band neutrophil count increased 15.02 10.23 17 498510 378 62990117
Epstein-Barr virus infection 15.02 10.23 25 498502 8025 62982470
Device failure 15.01 10.23 15 498512 5996 62984499
Enthesopathy 14.95 10.23 28 498499 8586 62981909
Aspartate aminotransferase increased 14.90 10.23 859 497668 89418 62901077
Osmolar gap 14.87 10.23 10 498517 106 62990389
Prothrombin time prolonged 14.83 10.23 127 498400 9437 62981058
Clostridium test positive 14.81 10.23 57 498470 3144 62987351
Sudden infant death syndrome 14.75 10.23 15 498512 294 62990201
Impaired quality of life 14.68 10.23 57 498470 13726 62976769
Bacterial test 14.62 10.23 30 498497 1144 62989351
Joint stiffness 14.54 10.23 236 498291 41633 62948862
Cardiovascular disorder 14.49 10.23 46 498481 11766 62978729
Speech disorder 14.44 10.23 228 498299 40401 62950094
Dysphonia 14.42 10.23 275 498252 47339 62943156
Dysstasia 14.41 10.23 102 498425 21064 62969431
Cytopenia 14.36 10.23 45 498482 11556 62978939
Sensory disturbance 14.27 10.23 57 498470 13615 62976880
Therapy change 14.26 10.23 16 498511 6065 62984430
Oral pruritus 14.25 10.23 45 498482 2246 62988249
Head injury 14.14 10.23 142 498385 27254 62963241
Congestive hepatopathy 14.11 10.23 53 498474 2889 62987606
Tendonitis 14.11 10.23 93 498434 19522 62970973
Metastases to central nervous system 14.09 10.23 54 498473 13051 62977444
White coat hypertension 13.96 10.23 22 498505 680 62989815
Haemoglobin urine present 13.95 10.23 24 498503 799 62989696
Osteoarthritis 13.94 10.23 609 497918 94734 62895761
Abortion induced 13.94 10.23 38 498489 10204 62980291
Drug screen positive 13.93 10.23 61 498466 3568 62986927
Device related thrombosis 13.92 10.23 38 498489 1747 62988748
Vaginal flatulence 13.91 10.23 57 498470 3236 62987259
Hip fracture 13.91 10.23 156 498371 29318 62961177
Small for dates baby 13.91 10.23 6 498521 3745 62986750
Granulocyte count increased 13.90 10.23 25 498502 863 62989632
Pre-eclampsia 13.89 10.23 32 498495 9101 62981394
Administration site erythema 13.89 10.23 23 498504 742 62989753
Drug level below therapeutic 13.79 10.23 75 498452 4791 62985704
Dysarthria 13.77 10.23 244 498283 42467 62948028
Dyslipidaemia 13.76 10.23 23 498504 7370 62983125
Coagulation factor decreased 13.74 10.23 9 498518 91 62990404
Snoring 13.66 10.23 8 498519 4194 62986301
Eosinophil percentage increased 13.66 10.23 27 498500 1002 62989493
Personality change 13.63 10.23 21 498506 6952 62983543
Psoriatic arthropathy 13.50 10.23 584 497943 90936 62899559
Device related infection 13.47 10.23 118 498409 23274 62967221
Accidental death 13.40 10.23 40 498487 1936 62988559
Osteomyelitis 13.38 10.23 135 498392 25885 62964610
Limb discomfort 13.35 10.23 159 498368 29557 62960938
Seasonal allergy 13.32 10.23 235 498292 20715 62969780
Device deployment issue 13.31 10.23 7 498520 3895 62986600
Eczema 13.30 10.23 176 498351 32115 62958380
Skin cancer 13.26 10.23 46 498481 11449 62979046
Anticholinergic syndrome 13.21 10.23 45 498482 2337 62988158
Immune reconstitution inflammatory syndrome 13.21 10.23 17 498510 6067 62984428
Coronary arterial stent insertion 13.21 10.23 3 498524 2826 62987669
Potentiating drug interaction 13.19 10.23 9 498518 4347 62986148
Cells in urine 13.18 10.23 12 498515 204 62990291
Allergy to chemicals 13.13 10.23 53 498474 2989 62987506
Hypersensitivity vasculitis 13.13 10.23 8 498519 4104 62986391
Bundle branch block left 13.10 10.23 22 498505 7037 62983458
Pelvic pain 13.10 10.23 58 498469 13461 62977034
Sleep disorder 13.06 10.23 774 497753 80792 62909703
Hallucination 13.03 10.23 329 498198 54488 62936007
Concomitant disease aggravated 13.01 10.23 33 498494 9079 62981416
Foot operation 13.00 10.23 23 498504 7208 62983287
Respiratory symptom 12.99 10.23 5 498522 3342 62987153
Intestinal haemorrhage 12.97 10.23 7 498520 3840 62986655
Asthma 12.97 10.23 845 497682 126716 62863779
COVID-19 immunisation 12.91 10.23 37 498490 1750 62988745
Thyroid cancer 12.90 10.23 15 498512 5596 62984899
Muscle disorder 12.87 10.23 12 498515 4957 62985538
Small fibre neuropathy 12.86 10.23 17 498510 446 62990049
Blood creatinine decreased 12.82 10.23 81 498446 5464 62985031
Product monitoring error 12.80 10.23 10 498517 4506 62985989
Supraventricular tachycardia 12.78 10.23 63 498464 14208 62976287
Uterine cancer 12.77 10.23 11 498516 4722 62985773
Haemorrhage intracranial 12.74 10.23 58 498469 13361 62977134
Ductus arteriosus stenosis foetal 12.72 10.23 11 498516 174 62990321
Pericardial effusion 12.69 10.23 163 498364 29895 62960600
Uterine leiomyoma 12.61 10.23 34 498493 9164 62981331
Patent ductus arteriosus 12.58 10.23 9 498518 4241 62986254
Body height decreased 12.54 10.23 39 498488 10039 62980456
Myelocyte count increased 12.53 10.23 15 498512 355 62990140
Product use in unapproved indication 12.52 10.23 1223 497304 177857 62812638
Mean cell haemoglobin concentration increased 12.50 10.23 18 498509 513 62989982
Fixed eruption 12.49 10.23 28 498499 1136 62989359
Shoulder arthroplasty 12.48 10.23 8 498519 3994 62986501
Prescribed overdose 12.47 10.23 354 498173 33799 62956696
Oesophageal stenosis 12.47 10.23 5 498522 3261 62987234
Renal papillary necrosis 12.46 10.23 13 498514 263 62990232
Blood triglycerides increased 12.45 10.23 53 498474 12435 62978060
Tongue disorder 12.43 10.23 42 498485 10538 62979957
Visual impairment 12.43 10.23 539 497988 83907 62906588
Exposure to SARS-CoV-2 12.40 10.23 36 498491 1715 62988780
Diffuse large B-cell lymphoma 12.38 10.23 21 498506 6691 62983804
Mental impairment 12.37 10.23 63 498464 14088 62976407
Oral pain 12.35 10.23 153 498374 28241 62962254
Lupus vulgaris 12.31 10.23 85 498442 5909 62984586
Glutathione decreased 12.31 10.23 6 498521 32 62990463
Agranulocytosis 12.27 10.23 132 498395 25002 62965493
Arrhythmia 12.26 10.23 218 498309 37922 62952573
Cardiac failure chronic 12.25 10.23 10 498517 4408 62986087
Administration site pruritus 12.24 10.23 14 498513 315 62990180
Suspected COVID-19 12.16 10.23 46 498481 2516 62987979
Multiple organ dysfunction syndrome 12.08 10.23 346 498181 56406 62934089
Large intestine polyp 12.07 10.23 29 498498 8128 62982367
Skin infection 12.07 10.23 175 498352 14827 62975668
Chest pain 12.05 10.23 1498 497029 214461 62776034
Pancreatitis 12.04 10.23 293 498234 48762 62941733
Injection site haematoma 12.04 10.23 22 498505 6810 62983685
Haematochezia 12.03 10.23 324 498203 53220 62937275
Opiates positive 12.02 10.23 15 498512 371 62990124
Lymphoproliferative disorder 11.99 10.23 5 498522 3185 62987310
Vitamin K deficiency 11.98 10.23 16 498511 424 62990071
Central nervous system lesion 11.97 10.23 43 498484 10592 62979903
Focal dyscognitive seizures 11.95 10.23 4 498523 2917 62987578
Dissociation 11.94 10.23 4 498523 2915 62987580
Inflammation 11.93 10.23 774 497753 81499 62908996
Injury associated with device 11.89 10.23 7 498520 3659 62986836
Pneumonia aspiration 11.89 10.23 195 498332 34345 62956150
Nail bed inflammation 11.83 10.23 15 498512 377 62990118
Blood loss anaemia 11.80 10.23 34 498493 8967 62981528
Product physical issue 11.79 10.23 13 498514 4967 62985528
Bronchopulmonary aspergillosis 11.78 10.23 32 498495 8603 62981892
Band neutrophil percentage increased 11.77 10.23 12 498515 236 62990259
Spinal pain 11.77 10.23 58 498469 13081 62977414
Anxiety 11.76 10.23 1512 497015 216029 62774466
Gastritis 11.74 10.23 214 498313 37089 62953406
Aortic valve incompetence 11.74 10.23 18 498509 5970 62984525
Drug tolerance 11.70 10.23 23 498504 6926 62983569
Lymphadenopathy 11.68 10.23 222 498305 38236 62952259
Smear cervix abnormal 11.67 10.23 50 498477 2896 62987599
Obstructive airways disorder 11.66 10.23 105 498422 20594 62969901
Bradypnoea 11.65 10.23 57 498470 3493 62987002
Osteolysis 11.65 10.23 4 498523 2870 62987625
Fungal rhinitis 11.60 10.23 6 498521 37 62990458
Alpha 1 microglobulin increased 11.55 10.23 7 498520 61 62990434
Somnambulism 11.51 10.23 16 498511 5527 62984968
Injection site nodule 11.51 10.23 8 498519 3827 62986668
Inhibitory drug interaction 11.49 10.23 4 498523 2845 62987650
Cystitis 11.46 10.23 535 497992 54456 62936039
Chronic graft versus host disease 11.44 10.23 5 498522 3097 62987398
Blood bilirubin increased 11.44 10.23 377 498150 36763 62953732
Urine analysis abnormal 11.43 10.23 73 498454 4943 62985552
Nerve injury 11.34 10.23 40 498487 9906 62980589
Left ventricular dysfunction 11.27 10.23 52 498475 11936 62978559
Tooth extraction 11.22 10.23 42 498485 10222 62980273
Eye haemorrhage 11.20 10.23 32 498495 8464 62982031
Pneumonia viral 11.15 10.23 103 498424 7819 62982676
Hip arthroplasty 11.13 10.23 469 498058 47177 62943318
Encephalopathy 11.13 10.23 389 498138 38231 62952264
Cystic fibrosis 11.11 10.23 6 498521 3290 62987205
Acute graft versus host disease 11.11 10.23 11 498516 4417 62986078
Nervous system disorder 11.10 10.23 94 498433 18672 62971823
Haemolysis 11.09 10.23 91 498436 6677 62983818
Necrotic lymphadenopathy 11.09 10.23 7 498520 66 62990429
Infective pulmonary exacerbation of cystic fibrosis 11.06 10.23 34 498493 8783 62981712
Blood immunoglobulin A increased 11.04 10.23 21 498506 757 62989738
Erysipelas 11.00 10.23 29 498498 7876 62982619
Application site rash 10.98 10.23 3 498524 2495 62988000
Laryngospasm 10.98 10.23 5 498522 3023 62987472
Hypoacusis 10.94 10.23 129 498398 24022 62966473
Blood prolactin increased 10.93 10.23 7 498520 3496 62986999
Lung neoplasm malignant 10.88 10.23 100 498427 19533 62970962
Glucose tolerance impaired 10.87 10.23 22 498505 6555 62983940
Diffuse axonal injury 10.87 10.23 8 498519 99 62990396
Aggression 10.84 10.23 125 498402 23373 62967122
Staphylococcal infection 10.80 10.23 244 498283 41012 62949483
Breast cancer metastatic 10.79 10.23 53 498474 11965 62978530
Infusion site discolouration 10.79 10.23 22 498505 835 62989660
Paradoxical drug reaction 10.79 10.23 10 498517 4142 62986353
Abnormal loss of weight 10.75 10.23 18 498509 5764 62984731
Taste disorder 10.75 10.23 63 498464 13599 62976896
Necrosis ischaemic 10.74 10.23 22 498505 838 62989657
Pallor 10.71 10.23 172 498355 30396 62960099
Transfusion-related acute lung injury 10.69 10.23 9 498518 137 62990358
Hypoaesthesia 10.68 10.23 1158 497369 167235 62823260
Orbital compartment syndrome 10.67 10.23 7 498520 71 62990424
Injection site vesicles 10.67 10.23 5 498522 2972 62987523
Granuloma 10.65 10.23 18 498509 5743 62984752
Catheter site bruise 10.63 10.23 16 498511 475 62990020
Asthma-chronic obstructive pulmonary disease overlap syndrome 10.62 10.23 38 498489 2023 62988472
Femoral neck fracture 10.59 10.23 33 498494 8490 62982005
Erythema 10.57 10.23 1213 497314 174538 62815957
Jaw disorder 10.56 10.23 16 498511 5333 62985162
Gout 10.54 10.23 61 498466 13210 62977285
Human herpesvirus 6 infection 10.54 10.23 5 498522 2952 62987543
Anosognosia 10.51 10.23 6 498521 3190 62987305
Hyperhidrosis 10.51 10.23 717 497810 107119 62883376
Stress fracture 10.50 10.23 30 498497 7933 62982562
Cellulitis 10.48 10.23 531 497996 81427 62909068
Bipolar disorder 10.48 10.23 30 498497 7930 62982565
Epilepsy with myoclonic-atonic seizures 10.48 10.23 8 498519 105 62990390
Eating disorder 10.48 10.23 97 498430 18919 62971576
Tumour marker increased 10.40 10.23 14 498513 4901 62985594
Autonomic dysreflexia 10.37 10.23 13 498514 323 62990172
Base excess 10.35 10.23 7 498520 75 62990420
Abdominal pain upper 10.32 10.23 1807 496720 204637 62785858
Haemarthrosis 10.30 10.23 6 498521 3155 62987340
Left ventricular failure 10.30 10.23 18 498509 5669 62984826
Hysterectomy 10.30 10.23 39 498488 9460 62981035
Subdural haematoma 10.27 10.23 68 498459 14260 62976235
Blood immunoglobulin G increased 10.25 10.23 42 498485 2385 62988110
Malignant melanoma 10.25 10.23 50 498477 11306 62979189

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 1333.18 10.35 3240 192174 197122 34564395
Completed suicide 1204.96 10.35 2049 193365 96119 34665398
Exposure to toxic agent 503.76 10.35 292 195122 3383 34758134
Infusion related reaction 474.76 10.35 968 194446 52089 34709428
Blood pressure fluctuation 433.37 10.35 616 194798 24633 34736884
Overdose 386.14 10.35 1253 194161 89806 34671711
Intentional product misuse 346.71 10.35 779 194635 44832 34716685
Intentional overdose 301.24 10.35 718 194696 42956 34718561
Acute hepatic failure 283.27 10.35 371 195043 13703 34747814
Drug ineffective 274.71 10.35 1470 193944 455281 34306236
Drug abuse 255.96 10.35 1165 194249 97931 34663586
Heart rate decreased 220.05 10.35 523 194891 31222 34730295
Blood pressure increased 168.48 10.35 952 194462 87150 34674367
Hepatic cytolysis 166.03 10.35 294 195120 14202 34747315
Cytokine release syndrome 137.52 10.35 357 195057 22520 34738997
Metabolic acidosis 132.19 10.35 539 194875 43141 34718376
Oxygen saturation decreased 120.86 10.35 608 194806 53210 34708307
Myocardial infarction 110.12 10.35 330 195084 120755 34640762
Respiratory arrest 108.08 10.35 374 195040 27669 34733848
COVID-19 106.14 10.35 770 194644 76780 34684737
Anion gap 106.01 10.35 64 195350 803 34760714
Coagulopathy 104.08 10.35 294 195120 19495 34742022
Blood pressure systolic increased 102.69 10.35 322 195092 22630 34738887
Analgesic drug level increased 101.61 10.35 62 195352 794 34760723
Blood pressure diastolic abnormal 100.03 10.35 129 195285 4689 34756828
Hepatotoxicity 98.51 10.35 304 195110 21181 34740336
Intentional product use issue 98.02 10.35 621 194793 59195 34702322
Methaemoglobinaemia 97.46 10.35 110 195304 3471 34758046
Drug resistance 95.96 10.35 15 195399 25912 34735605
Poisoning 91.89 10.35 208 195206 12018 34749499
Sinusitis 91.02 10.35 465 194949 40937 34720580
Treatment failure 90.12 10.35 77 195337 46620 34714897
Product dose omission issue 82.57 10.35 366 195048 119345 34642172
Suicide attempt 82.29 10.35 434 194980 38682 34722835
Accidental overdose 81.46 10.35 273 195141 19867 34741650
Cardio-respiratory arrest 75.70 10.35 549 194865 54724 34706793
Diarrhoea 75.03 10.35 1636 193778 388276 34373241
Pyroglutamic acidosis 72.42 10.35 39 195375 387 34761130
Cardiac failure congestive 72.08 10.35 232 195182 83038 34678479
Body temperature decreased 71.85 10.35 197 195217 12837 34748680
Medication error 70.72 10.35 307 195107 25258 34736259
Infusion site extravasation 70.13 10.35 103 195311 4241 34757276
Blood pressure systolic abnormal 68.69 10.35 97 195317 3851 34757666
Blood pressure diastolic increased 68.26 10.35 110 195304 4915 34756602
Febrile neutropenia 66.63 10.35 1105 194309 135744 34625773
Respiratory depression 65.52 10.35 220 195194 16025 34745492
Heart rate irregular 64.58 10.35 215 195199 15592 34745925
Cardiac failure 58.74 10.35 286 195128 90962 34670555
Hypotension 56.45 10.35 1630 193784 220019 34541498
Suspected suicide 55.27 10.35 97 195317 4651 34756866
Poisoning deliberate 54.07 10.35 129 195285 7715 34753802
Blood pressure diastolic decreased 53.70 10.35 141 195273 8953 34752564
Substance abuse 53.03 10.35 126 195288 7515 34754002
Therapeutic product effect incomplete 51.68 10.35 130 195284 50411 34711106
Infusion site pain 50.55 10.35 83 195331 3768 34757749
Depressed level of consciousness 50.54 10.35 411 195003 42430 34719087
Alanine aminotransferase increased 50.38 10.35 681 194733 80134 34681383
Exposure via ingestion 49.41 10.35 61 195353 2120 34759397
Hepatic necrosis 48.76 10.35 81 195333 3713 34757804
Chills 48.11 10.35 677 194737 80366 34681151
Coronary artery disease 48.04 10.35 126 195288 48179 34713338
Wrong technique in product usage process 47.44 10.35 80 195334 35906 34725611
Appendicolith 45.43 10.35 128 195286 8473 34753044
Infusion site swelling 45.38 10.35 63 195351 2461 34759056
Anaemia 45.02 10.35 978 194436 232357 34529160
Renal cortical necrosis 44.81 10.35 23 195391 205 34761312
Liver injury 44.51 10.35 183 195231 14695 34746822
Dizziness 43.58 10.35 911 194503 217610 34543907
Inappropriate schedule of product administration 43.04 10.35 535 194879 61761 34699756
Toxic epidermal necrolysis 42.69 10.35 236 195178 21410 34740107
Body temperature increased 42.38 10.35 201 195213 17167 34744350
Myelosuppression 41.99 10.35 28 195386 19237 34742280
Disease progression 39.73 10.35 399 195015 107678 34653839
Prostate cancer 38.23 10.35 105 195309 39544 34721973
Ear infection 38.15 10.35 135 195279 10096 34751421
Tachycardia 38.12 10.35 676 194738 84096 34677421
Poor venous access 37.64 10.35 87 195327 5096 34756421
Renal impairment 37.25 10.35 343 195071 94170 34667347
Product prescribing error 37.14 10.35 44 195370 22883 34738634
Heart rate increased 36.89 10.35 409 195005 45934 34715583
Anion gap abnormal 36.31 10.35 19 195395 177 34761340
Bone marrow failure 35.88 10.35 68 195346 29185 34732332
Injection site pain 35.62 10.35 106 195308 38899 34722618
Body temperature fluctuation 35.18 10.35 45 195369 1622 34759895
Serotonin syndrome 35.17 10.35 211 195203 19722 34741795
Aspartate aminotransferase increased 34.67 10.35 552 194862 67231 34694286
Asthenia 34.52 10.35 1076 194338 244175 34517342
Abdominal pain 34.39 10.35 1176 194238 162442 34599075
Infusion site erythema 33.99 10.35 52 195362 2221 34759296
Mydriasis 33.72 10.35 103 195311 7134 34754383
Bladder cancer 33.71 10.35 25 195389 16253 34745264
Therapeutic response decreased 33.51 10.35 71 195343 29242 34732275
Therapeutic response shortened 33.22 10.35 104 195310 7300 34754217
Neuropathy peripheral 32.88 10.35 302 195112 82961 34678556
Drug interaction 32.84 10.35 987 194427 224959 34536558
Infusion site pruritus 32.74 10.35 31 195383 792 34760725
Foetal exposure during pregnancy 32.36 10.35 107 195307 37994 34723523
Pharyngeal paraesthesia 31.54 10.35 28 195386 657 34760860
Depression 31.46 10.35 369 195045 96729 34664788
Coma 31.42 10.35 392 195022 45286 34716231
Appendicitis 30.25 10.35 163 195251 14644 34746873
Memory impairment 30.09 10.35 132 195282 43186 34718331
Cerebral haemorrhage 29.75 10.35 98 195316 34839 34726678
Stevens-Johnson syndrome 28.96 10.35 191 195223 18448 34743069
Balance disorder 28.78 10.35 123 195291 40531 34720986
Hypoxia 28.30 10.35 449 194965 54646 34706871
Hepatitis fulminant 27.90 10.35 68 195346 4122 34757395
Hospitalisation 27.71 10.35 195 195219 56707 34704810
Cerebrovascular accident 27.59 10.35 322 195092 84489 34677028
Infusion site bruising 27.54 10.35 27 195387 721 34760796
Respiratory rate increased 27.50 10.35 119 195295 9775 34751742
Sopor 27.32 10.35 17 195397 12119 34749398
Full blood count abnormal 26.98 10.35 39 195375 18629 34742888
Head discomfort 26.56 10.35 66 195348 4050 34757467
Psoriasis 26.52 10.35 119 195295 38693 34722824
Feeling abnormal 26.44 10.35 226 195188 63009 34698508
Myocardial fibrosis 26.35 10.35 33 195381 1164 34760353
Nasopharyngitis 26.33 10.35 543 194871 69425 34692092
Diabetes mellitus 26.21 10.35 154 195260 46719 34714798
Acute myocardial infarction 26.20 10.35 184 195230 53535 34707982
Hepatic failure 25.78 10.35 301 195113 34230 34727287
Cardiac arrest 25.74 10.35 712 194702 95447 34666070
Therapy non-responder 25.57 10.35 122 195292 39024 34722493
Glycosylated haemoglobin increased 25.45 10.35 16 195398 11344 34750173
Throat irritation 24.74 10.35 121 195293 10464 34751053
Neutrophil percentage increased 24.73 10.35 40 195374 1793 34759724
Therapeutic product effect decreased 24.66 10.35 105 195309 34638 34726879
Progressive multifocal leukoencephalopathy 24.41 10.35 12 195402 9752 34751765
Pyrexia 24.33 10.35 2169 193245 330844 34430673
Fatigue 24.20 10.35 1765 193649 368888 34392629
Oesophageal carcinoma 23.93 10.35 11 195403 9293 34752224
Haematotoxicity 23.85 10.35 8 195406 8186 34753331
Ductus arteriosus premature closure 23.78 10.35 16 195398 245 34761272
Generalised bullous fixed drug eruption 23.55 10.35 11 195403 78 34761439
Urine sodium decreased 23.51 10.35 14 195400 171 34761346
Dyspnoea exertional 23.25 10.35 144 195270 43135 34718382
Immune reconstitution inflammatory syndrome 23.08 10.35 10 195404 8749 34752768
Fixed eruption 22.80 10.35 37 195377 1663 34759854
Agitation 22.77 10.35 449 194965 56950 34704567
Pemphigus 22.56 10.35 36 195378 1595 34759922
Blood pH decreased 22.54 10.35 44 195370 2290 34759227
Asthma 22.36 10.35 143 195271 42513 34719004
Vital functions abnormal 22.25 10.35 16 195398 274 34761243
International normalised ratio increased 22.19 10.35 380 195034 46947 34714570
Graft versus host disease 22.19 10.35 16 195398 10553 34750964
Blood phosphorus increased 21.56 10.35 93 195321 7628 34753889
Post transplant lymphoproliferative disorder 21.56 10.35 5 195409 6523 34754994
Haemolysis 21.47 10.35 96 195318 7998 34753519
Cerebral infarction 21.37 10.35 80 195334 27375 34734142
C-reactive protein abnormal 21.33 10.35 11 195403 8699 34752818
Dyspnoea 21.21 10.35 1816 193598 374966 34386551
Infusion site rash 21.00 10.35 20 195394 515 34761002
Therapy partial responder 20.92 10.35 14 195400 9602 34751915
Malignant neoplasm progression 20.92 10.35 356 195058 87690 34673827
Pathogen resistance 20.37 10.35 14 195400 9468 34752049
Chronic gastrointestinal bleeding 20.24 10.35 16 195398 318 34761199
SARS-CoV-2 test positive 20.19 10.35 76 195338 5857 34755660
Decreased appetite 20.10 10.35 744 194670 165648 34595869
Flushing 20.10 10.35 273 195141 32147 34729370
Oedema peripheral 20.04 10.35 513 194901 119299 34642218
Gait inability 19.99 10.35 55 195359 20703 34740814
Throat tightness 19.86 10.35 96 195318 8262 34753255
Hyperaesthesia 19.83 10.35 64 195350 4566 34756951
Osteonecrosis 19.71 10.35 33 195381 14857 34746660
Erectile dysfunction 19.63 10.35 55 195359 20582 34740935
Infusion site haemorrhage 19.47 10.35 26 195388 978 34760539
Acidosis 19.40 10.35 116 195298 10829 34750688
Acute lung injury 19.09 10.35 32 195382 1478 34760039
Osteonecrosis of jaw 19.08 10.35 45 195369 17844 34743673
Prostatic specific antigen increased 19.01 10.35 33 195381 14647 34746870
Labelled drug-drug interaction medication error 18.96 10.35 34 195380 14905 34746612
Cytopenia 18.96 10.35 26 195388 12697 34748820
Enterocolitis infectious 18.92 10.35 34 195380 1661 34759856
Pancytopenia 18.83 10.35 397 195017 94760 34666757
Lymphocyte count abnormal 18.75 10.35 28 195386 1170 34760347
Inadequate analgesia 18.46 10.35 47 195367 2928 34758589
Immune effector cell-associated neurotoxicity syndrome 18.39 10.35 54 195360 3659 34757858
Syncope 18.25 10.35 381 195033 91070 34670447
Somnolence 18.16 10.35 777 194637 110339 34651178
Delusion of grandeur 18.00 10.35 27 195387 1133 34760384
Lymphocyte percentage decreased 17.98 10.35 38 195376 2094 34759423
Diabetic ketoacidosis 17.95 10.35 47 195367 17985 34743532
Cytomegalovirus infection 17.93 10.35 80 195334 26055 34735462
Dry skin 17.91 10.35 102 195312 31185 34730332
Insomnia 17.88 10.35 443 194971 103464 34658053
Product substitution issue 17.87 10.35 18 195396 10077 34751440
Myopathy 17.84 10.35 23 195391 11531 34749986
Aminoaciduria 17.81 10.35 14 195400 276 34761241
Visual impairment 17.77 10.35 122 195292 35680 34725837
Visual acuity reduced 17.72 10.35 40 195374 16109 34745408
Consciousness fluctuating 17.53 10.35 27 195387 1160 34760357
Incorrect drug administration rate 17.52 10.35 33 195381 1672 34759845
Hypertriglyceridaemia 17.46 10.35 13 195401 8435 34753082
Obstructive airways disorder 17.31 10.35 38 195376 15456 34746061
Psoriatic arthropathy 17.22 10.35 55 195359 19743 34741774
Granulomatosis with polyangiitis 17.22 10.35 27 195387 1178 34760339
Cardiac disorder 17.20 10.35 156 195258 42970 34718547
Contraindicated product administered 17.11 10.35 62 195352 21419 34740098
Unresponsive to stimuli 17.03 10.35 232 195182 27337 34734180
Insurance issue 16.80 10.35 36 195378 2003 34759514
Venoocclusive liver disease 16.80 10.35 12 195402 7954 34753563
Stress 16.60 10.35 250 195164 30097 34731420
Angina pectoris 16.51 10.35 105 195309 31258 34730259
COVID-19 pneumonia 16.48 10.35 156 195258 16811 34744706
Cerebral artery thrombosis 16.37 10.35 21 195393 759 34760758
Injection site reaction 16.24 10.35 30 195384 13003 34748514
Oxygen saturation abnormal 16.20 10.35 30 195384 1500 34760017
Hypoaesthesia 16.07 10.35 244 195170 61200 34700317
Drug ineffective for unapproved indication 16.02 10.35 73 195341 23642 34737875
Gynaecomastia 16.00 10.35 20 195394 10160 34751357
Brain scan abnormal 15.87 10.35 22 195392 858 34760659
Accidental exposure to product by child 15.70 10.35 29 195385 1447 34760070
Sulphaemoglobinaemia 15.63 10.35 6 195408 24 34761493
Blood glucose increased 15.44 10.35 271 195143 66447 34695070
Incorrect dose administered 15.42 10.35 315 195099 40200 34721317
Mixed liver injury 15.41 10.35 43 195371 2830 34758687
Ductus arteriosus stenosis foetal 15.37 10.35 11 195403 187 34761330
Aplastic anaemia 15.36 10.35 100 195314 9616 34751901
Systemic infection 15.33 10.35 5 195409 5207 34756310
Sudden infant death syndrome 15.29 10.35 12 195402 236 34761281
Dehydration 15.27 10.35 583 194831 129386 34632131
Vomiting 15.26 10.35 1594 193820 246027 34515490
Drug-induced liver injury 15.19 10.35 236 195178 28596 34732921
Cardiac failure chronic 15.18 10.35 13 195401 7866 34753651
Device leakage 15.09 10.35 9 195405 6566 34754951
Upper respiratory tract infection 14.98 10.35 264 195150 32795 34728722
Bilirubin urine present 14.87 10.35 10 195404 153 34761364
Acute generalised exanthematous pustulosis 14.81 10.35 76 195338 6700 34754817
Muscle spasms 14.80 10.35 313 195101 74688 34686829
Blood triglycerides increased 14.79 10.35 36 195378 14123 34747394
Deep vein thrombosis 14.79 10.35 266 195148 64982 34696535
Fall 14.70 10.35 957 194457 201928 34559589
Gait disturbance 14.64 10.35 363 195051 84777 34676740
Failure to suspend medication 14.64 10.35 15 195399 423 34761094
Pulmonary congestion 14.61 10.35 129 195285 13636 34747881
Infusion site nodule 14.57 10.35 9 195405 118 34761399
Electrocardiogram QRS complex prolonged 14.48 10.35 60 195354 4834 34756683
BK virus infection 14.42 10.35 7 195407 5731 34755786
Renal papillary necrosis 14.38 10.35 10 195404 162 34761355
Encephalopathy 14.24 10.35 277 195137 35042 34726475
Brain death 14.24 10.35 40 195374 2643 34758874
Rhinalgia 14.23 10.35 23 195391 1030 34760487
Atrial fibrillation 14.16 10.35 550 194864 121843 34639674
Clostridium test positive 14.13 10.35 46 195368 3296 34758221
Dependent personality disorder 14.07 10.35 8 195406 89 34761428
Cardiogenic shock 14.07 10.35 218 195196 26400 34735117
Urticaria 14.01 10.35 452 194962 61925 34699592
Injection site swelling 13.96 10.35 27 195387 11500 34750017
Sexual dysfunction 13.95 10.35 9 195405 6294 34755223
Bezoar 13.94 10.35 24 195390 1133 34760384
Parkinsonism 13.85 10.35 15 195399 8123 34753394
Anal fissure 13.82 10.35 54 195360 4236 34757281
Peripheral swelling 13.80 10.35 324 195090 76217 34685300
Urethral valves 13.79 10.35 12 195402 274 34761243
Hepatitis C 13.75 10.35 21 195393 9809 34751708
Product quality issue 13.68 10.35 49 195365 16986 34744531
Suicidal ideation 13.65 10.35 152 195262 40236 34721281
Injection site haemorrhage 13.54 10.35 21 195393 9747 34751770
Transaminases increased 13.54 10.35 218 195196 26605 34734912
Therapy cessation 13.51 10.35 49 195365 16924 34744593
Rheumatoid arthritis 13.48 10.35 294 195120 37944 34723573
Tooth infection 13.47 10.35 74 195340 6697 34754820
Vanishing bile duct syndrome 13.44 10.35 22 195392 996 34760521
Severe invasive streptococcal infection 13.28 10.35 6 195408 39 34761478
Immunoglobulin G4 related disease 13.25 10.35 9 195405 140 34761377
Loss of personal independence in daily activities 13.24 10.35 120 195294 33059 34728458
Prothrombin time prolonged 13.19 10.35 94 195320 9312 34752205
Rhinitis 13.10 10.35 70 195344 6268 34755249
Self-medication 13.09 10.35 39 195375 2664 34758853
Erythema multiforme 13.06 10.35 88 195326 8561 34752956
Hypotensive crisis 12.95 10.35 7 195407 70 34761447
Ejection fraction decreased 12.92 10.35 59 195355 19095 34742422
Epilepsy 12.89 10.35 69 195345 21426 34740091
Intraocular pressure increased 12.89 10.35 7 195407 5376 34756141
Hyperchloraemia 12.85 10.35 15 195399 491 34761026
Administration site erythema 12.78 10.35 7 195407 72 34761445
Thrombotic microangiopathy 12.78 10.35 25 195389 10605 34750912
COVID-19 immunisation 12.75 10.35 11 195403 248 34761269
Lung neoplasm malignant 12.70 10.35 52 195362 17343 34744174
Akathisia 12.67 10.35 16 195398 8093 34753424
Pemphigoid 12.63 10.35 18 195396 8648 34752869
Hepatocellular carcinoma 12.61 10.35 14 195400 7495 34754022
Burn of internal organs 12.58 10.35 3 195411 0 34761517
Drug intolerance 12.53 10.35 246 195168 59324 34702193
Status epilepticus 12.46 10.35 33 195381 12581 34748936
Eye infection 12.46 10.35 47 195367 3626 34757891
Maple syrup disease 12.42 10.35 4 195410 8 34761509
Trichoglossia 12.38 10.35 12 195402 316 34761201
Anti-erythrocyte antibody positive 12.35 10.35 6 195408 47 34761470
Myalgia 12.28 10.35 367 195047 83743 34677774
Product complaint 12.25 10.35 9 195405 5881 34755636
Electrocardiogram QT prolonged 11.98 10.35 159 195255 40793 34720724
Tooth injury 11.98 10.35 23 195391 1182 34760335
Leukopenia 11.92 10.35 264 195150 62592 34698925
Wound infection 11.89 10.35 74 195340 7005 34754512
Second primary malignancy 11.87 10.35 16 195398 7870 34753647
Infusion site mass 11.84 10.35 12 195402 334 34761183
Fibrin D dimer increased 11.76 10.35 51 195363 4193 34757324
Obesity 11.75 10.35 35 195379 12843 34748674
Multiple organ dysfunction syndrome 11.75 10.35 532 194882 76034 34685483
Injection site bruising 11.65 10.35 19 195395 8644 34752873
Environmental exposure 11.62 10.35 11 195403 281 34761236
Drug level below therapeutic 11.59 10.35 62 195352 5553 34755964
Alopecia 11.59 10.35 84 195330 24271 34737246
Migraine 11.59 10.35 149 195265 17329 34744188
Hypothermia 11.55 10.35 101 195313 10647 34750870
Pyroglutamate increased 11.52 10.35 11 195403 284 34761233
Platelet transfusion 11.51 10.35 26 195388 1500 34760017
Prostate infection 11.47 10.35 20 195394 954 34760563
Crystal urine present 11.47 10.35 14 195400 481 34761036
Testicular infarction 11.46 10.35 6 195408 56 34761461
Acute phase reaction 11.45 10.35 7 195407 90 34761427
Nocturia 11.44 10.35 25 195389 10185 34751332
Blood testosterone decreased 11.44 10.35 5 195409 4352 34757165
Endocardial fibrosis 11.40 10.35 5 195409 30 34761487
Acid-base balance disorder mixed 11.37 10.35 6 195408 57 34761460
Syringe issue 11.34 10.35 9 195405 5655 34755862
Accident 11.30 10.35 57 195357 4990 34756527
Nocardiosis 11.25 10.35 4 195410 3947 34757570
Graft versus host disease in skin 11.13 10.35 4 195410 3921 34757596
Angina unstable 11.13 10.35 31 195383 11622 34749895
Illness 11.03 10.35 120 195294 13409 34748108
No adverse event 10.95 10.35 79 195335 22848 34738669
Protein urine 10.91 10.35 19 195395 905 34760612
Hyperlipidaemia 10.88 10.35 43 195371 14486 34747031
Sleep disorder due to a general medical condition 10.83 10.35 8 195406 5213 34756304
Anion gap increased 10.79 10.35 29 195385 1867 34759650
SJS-TEN overlap 10.77 10.35 11 195403 309 34761208
Acute myeloid leukaemia 10.76 10.35 59 195355 18211 34743306
Increased viscosity of upper respiratory secretion 10.74 10.35 8 195406 145 34761372
Disturbance in attention 10.72 10.35 93 195321 25852 34735665
Product use in unapproved indication 10.71 10.35 542 194872 116957 34644560
Myasthenia gravis 10.71 10.35 71 195343 6869 34754648
Injection site pruritus 10.68 10.35 14 195400 6969 34754548
Kidney transplant rejection 10.50 10.35 16 195398 7481 34754036
Blood pressure decreased 10.48 10.35 369 195045 51146 34710371
Dissociative disorder 10.44 10.35 13 195401 456 34761061
Infusion site discomfort 10.43 10.35 9 195405 203 34761314
Adenocarcinoma of colon 10.43 10.35 3 195411 3388 34758129
Renal cancer 10.37 10.35 17 195397 7718 34753799
Proctalgia 10.36 10.35 61 195353 5662 34755855

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 3621.87 9.99 6402 567362 239365 78931259
Toxicity to various agents 3451.70 9.99 8627 565137 412913 78757711
Exposure to toxic agent 1336.59 9.99 829 572935 8329 79162295
Infusion related reaction 1127.93 9.99 3932 569832 226305 78944319
Blood pressure fluctuation 820.70 9.99 1617 572147 65528 79105096
Intentional overdose 796.84 9.99 2105 571659 103855 79066769
Intentional product misuse 749.85 9.99 1924 571840 93241 79077383
Acute hepatic failure 737.44 9.99 994 572770 29119 79141505
Overdose 699.08 9.99 2901 570863 181305 78989319
Rheumatoid arthritis 394.84 9.99 2711 571053 205759 78964865
Hepatic cytolysis 391.52 9.99 702 573062 26449 79144175
Metabolic acidosis 361.34 9.99 1360 572404 81169 79089455
Sinusitis 360.54 9.99 2526 571238 192975 78977649
Muscle injury 342.97 9.99 943 572821 47618 79123006
Heart rate decreased 341.04 9.99 1198 572566 69118 79101506
Duodenal ulcer perforation 340.26 9.99 1150 572614 65061 79105563
Hepatotoxicity 331.22 9.99 965 572799 50387 79120237
Helicobacter infection 324.73 9.99 1172 572592 68532 79102092
Analgesic drug level increased 321.54 9.99 229 573535 2949 79167675
Folliculitis 314.33 9.99 995 572769 54385 79116239
Product dose omission issue 302.30 9.99 851 572913 246686 78923938
Irritable bowel syndrome 301.47 9.99 1060 572704 61181 79109443
Injection site pain 297.20 9.99 297 573467 129541 79041083
Anion gap 292.09 9.99 187 573577 1994 79168630
Anti-cyclic citrullinated peptide antibody positive 284.69 9.99 1270 572494 81873 79088751
Blood pressure increased 276.91 9.99 2525 571239 208835 78961789
Sleep disorder due to general medical condition, insomnia type 275.63 9.99 813 572951 42743 79127881
Intentional product use issue 261.59 9.99 1933 571831 150179 79020445
Drug abuse 260.48 9.99 2033 571731 160658 79009966
Hepatic enzyme increased 256.41 9.99 2215 571549 180395 78990229
Medication error 254.51 9.99 1074 572690 67568 79103056
Nasopharyngitis 248.01 9.99 2856 570908 251025 78919599
Pemphigus 246.70 9.99 1388 572376 98194 79072430
Pericarditis 244.57 9.99 1432 572332 102804 79067820
Hand deformity 239.54 9.99 1421 572343 102498 79068126
Anaemia 237.17 9.99 2054 571710 442961 78727663
Lower respiratory tract infection 231.29 9.99 1658 572106 127562 79043062
Myocardial infarction 225.47 9.99 632 573132 183497 78987127
Blood pressure diastolic abnormal 221.99 9.99 452 573312 18750 79151874
Suicide attempt 216.83 9.99 1173 572591 81759 79088865
Respiratory arrest 214.55 9.99 902 572862 56648 79113976
Blister 212.67 9.99 1531 572233 117945 79052679
Depressed level of consciousness 212.17 9.99 1305 572459 95347 79075277
Coagulopathy 209.90 9.99 653 573111 35353 79135271
Blood pressure systolic increased 209.17 9.99 996 572768 65990 79104634
Diarrhoea 207.77 9.99 4791 568973 875698 78294926
Glossodynia 207.51 9.99 1364 572400 101973 79068651
Ill-defined disorder 206.07 9.99 980 572784 64895 79105729
Blood pressure systolic abnormal 202.97 9.99 409 573355 16838 79153786
Injection site erythema 197.83 9.99 163 573601 78034 79092590
Wound 192.69 9.99 1464 572300 114715 79055909
Drug interaction 192.21 9.99 1984 571780 413199 78757425
Oxygen saturation decreased 190.42 9.99 1583 572181 127464 79043160
Cardio-respiratory arrest 189.96 9.99 1385 572379 107125 79063499
Discomfort 187.53 9.99 1545 572219 124072 79046552
Drug ineffective 187.05 9.99 6145 567619 1074768 78095856
Systemic lupus erythematosus 180.29 9.99 1489 572275 119660 79050964
Drug resistance 176.72 9.99 43 573721 42170 79128454
Wrong technique in product usage process 175.98 9.99 163 573601 73712 79096912
Cardiac failure congestive 174.88 9.99 488 573276 141914 79028710
Blood pressure diastolic decreased 174.29 9.99 546 573218 29670 79140954
Impaired healing 169.94 9.99 1147 572617 86508 79084116
Poisoning 163.98 9.99 476 573288 24796 79145828
Weight increased 161.10 9.99 2848 570916 274538 78896086
Cardiac failure 157.71 9.99 577 573187 154265 79016359
Synovitis 157.18 9.99 1718 572046 149016 79021608
Poisoning deliberate 152.66 9.99 385 573379 18443 79152181
Throat irritation 150.46 9.99 639 573125 40307 79130317
Pyroglutamic acidosis 145.94 9.99 93 573671 983 79169641
Body temperature increased 143.43 9.99 667 573097 43753 79126871
Sedation complication 142.62 9.99 335 573429 15334 79155290
Joint swelling 141.65 9.99 2888 570876 285758 78884866
Liver injury 140.09 9.99 789 572975 55825 79114799
Cytokine release syndrome 139.49 9.99 571 573193 35427 79135197
Device expulsion 138.50 9.99 13 573751 25848 79144776
Hepatic necrosis 134.67 9.99 238 573526 8862 79161762
Respiratory depression 131.55 9.99 468 573296 27162 79143462
Accidental overdose 126.81 9.99 593 573171 38988 79131636
Bone marrow failure 126.24 9.99 109 573655 50998 79119626
Disease progression 123.21 9.99 798 572966 183564 78987060
Pancytopenia 120.36 9.99 699 573065 165046 79005578
Arthropathy 119.91 9.99 1865 571899 175246 78995378
Psoriasis 118.33 9.99 296 573468 89291 79081333
Creatinine renal clearance decreased 117.65 9.99 352 573412 18650 79151974
Therapeutic product effect decreased 116.52 9.99 1740 572024 162123 79008501
COVID-19 115.92 9.99 1684 572080 155990 79014634
Neutropenia 114.83 9.99 1421 572343 286289 78884335
Renal impairment 113.72 9.99 667 573097 157116 79013508
Swelling 113.54 9.99 2190 571574 214521 78956103
Injection site pruritus 113.46 9.99 83 573681 42200 79128424
Methaemoglobinaemia 113.16 9.99 168 573596 5389 79165235
Suspected suicide 112.95 9.99 241 573523 10335 79160289
Heart rate irregular 112.43 9.99 500 573264 32179 79138445
Exposure via ingestion 109.09 9.99 159 573605 5015 79165609
Injection site reaction 108.28 9.99 141 573623 54644 79115980
Sopor 108.08 9.99 51 573713 32959 79137665
Heart rate increased 107.57 9.99 1335 572429 119389 79051235
Injection site bruising 106.79 9.99 83 573681 40919 79129705
Osteonecrosis of jaw 105.78 9.99 93 573671 43133 79127491
Injection site swelling 104.20 9.99 111 573653 47021 79123603
Blood pressure diastolic increased 103.25 9.99 283 573481 14259 79156365
Gastrointestinal disorder 103.20 9.99 1338 572426 120867 79049757
Blood calcium decreased 97.77 9.99 471 573293 31348 79139276
Coma 96.21 9.99 1128 572636 99521 79071103
Body temperature decreased 96.03 9.99 472 573292 31673 79138951
Coronary artery disease 93.11 9.99 208 573556 65266 79105358
Contraindicated product administered 91.17 9.99 1617 572147 155921 79014703
Hypersensitivity 90.08 9.99 2498 571266 259741 78910883
Rheumatic fever 89.65 9.99 425 573339 28100 79142524
Poor venous access 89.49 9.99 311 573453 17838 79152786
Hospitalisation 88.95 9.99 362 573402 93874 79076750
Product prescribing error 86.86 9.99 117 573647 44696 79125928
Myelosuppression 86.76 9.99 97 573667 40199 79130425
Cerebrovascular accident 85.54 9.99 710 573054 154582 79016042
Anion gap abnormal 85.01 9.99 55 573709 598 79170026
Infusion site extravasation 84.37 9.99 209 573555 9899 79160725
Acute lung injury 81.53 9.99 106 573658 2994 79167630
Decreased appetite 79.52 9.99 1866 571898 340552 78830072
Malignant neoplasm progression 78.46 9.99 614 573150 135376 79035248
Hepatic failure 77.86 9.99 727 573037 60485 79110139
Dehydration 77.43 9.99 1287 572477 246900 78923724
Therapy cessation 75.96 9.99 95 573669 37467 79133157
Inappropriate schedule of product administration 75.33 9.99 1366 572398 132262 79038362
Diabetes mellitus 74.69 9.99 300 573464 78090 79092534
Hyperkalaemia 73.96 9.99 500 573264 113898 79056726
Acute kidney injury 73.50 9.99 3023 570741 516381 78654243
Infusion site pain 73.47 9.99 247 573517 13929 79156695
Therapeutic product effect incomplete 73.37 9.99 658 573106 140987 79029637
Dizziness 72.58 9.99 3073 570691 523368 78647256
Neoplasm progression 72.01 9.99 166 573598 51516 79119108
Neuropathy peripheral 71.21 9.99 661 573103 140644 79029980
Hypotension 69.62 9.99 3853 569911 436464 78734160
Leukopenia 69.12 9.99 522 573242 115991 79054633
Ear pain 69.09 9.99 439 573325 32430 79138194
Acute myocardial infarction 68.34 9.99 303 573461 76733 79093891
Product substitution issue 68.34 9.99 30 573734 20226 79150398
Prostate cancer 67.42 9.99 84 573680 33184 79137440
Rheumatoid factor positive 66.51 9.99 691 573073 59148 79111476
Atrial fibrillation 66.45 9.99 1012 572752 196874 78973750
Substance abuse 65.17 9.99 195 573569 10331 79160293
Injection site warmth 64.13 9.99 14 573750 14793 79155831
Dyspnoea 63.98 9.99 5304 568460 851721 78318903
Cerebral infarction 63.40 9.99 147 573617 45529 79125095
Syncope 63.27 9.99 909 572855 178540 78992084
Haematotoxicity 62.67 9.99 17 573747 15502 79155122
Interstitial lung disease 61.91 9.99 515 573249 112085 79058539
Alanine aminotransferase increased 60.76 9.99 1566 572198 161004 79009620
Swollen joint count increased 60.37 9.99 325 573439 22602 79148022
Infusion site swelling 60.31 9.99 157 573607 7669 79162955
Infusion site pruritus 60.03 9.99 107 573657 4011 79166613
Stomatitis 60.01 9.99 1431 572333 145326 79025298
Cerebral haemorrhage 59.95 9.99 213 573551 57460 79113164
Thrombocytopenia 59.21 9.99 1454 572310 263805 78906819
Dyspnoea exertional 59.09 9.99 375 573389 86698 79083926
Ear pruritus 58.81 9.99 106 573658 4009 79166615
Cytomegalovirus infection 58.59 9.99 138 573626 42506 79128118
Device issue 57.54 9.99 66 573698 27042 79143582
Respiratory rate increased 57.43 9.99 307 573457 21293 79149331
Gastrointestinal haemorrhage 57.22 9.99 734 573030 146985 79023639
Oedema peripheral 56.55 9.99 1382 572382 250906 78919718
Transient ischaemic attack 56.53 9.99 192 573572 52503 79118121
Pyroglutamate increased 56.46 9.99 44 573720 655 79169969
Therapeutic response shortened 56.30 9.99 245 573519 15618 79155006
Injection site mass 56.29 9.99 38 573726 20146 79150478
Injection site haemorrhage 55.82 9.99 71 573693 27799 79142825
Feeling abnormal 55.21 9.99 809 572955 158390 79012234
Diabetic ketoacidosis 54.82 9.99 101 573663 34021 79136603
Labelled drug-drug interaction medication error 54.80 9.99 71 573693 27579 79143045
Sedation 54.28 9.99 592 573172 51303 79119321
Hypocalcaemia 54.18 9.99 181 573583 49743 79120881
Injection site rash 53.94 9.99 31 573733 17923 79152701
Electric shock 53.82 9.99 58 573706 1336 79169288
Pathogen resistance 53.77 9.99 18 573746 14324 79156300
Neutrophil percentage increased 53.75 9.99 110 573654 4579 79166045
Body temperature fluctuation 53.05 9.99 97 573667 3710 79166914
Red blood cell sedimentation rate abnormal 52.63 9.99 44 573720 20919 79149705
Full blood count abnormal 52.45 9.99 135 573629 40339 79130285
Infusion site erythema 51.86 9.99 168 573596 9292 79161332
Urine abnormality 51.59 9.99 153 573611 8066 79162558
Post transplant lymphoproliferative disorder 51.39 9.99 10 573754 11454 79159170
Oesophageal carcinoma 51.12 9.99 9 573755 11075 79159549
Weight fluctuation 50.73 9.99 192 573572 11483 79159141
Hyperlipidaemia 50.70 9.99 68 573696 26025 79144599
Contusion 50.69 9.99 1416 572348 147360 79023264
Epistaxis 50.59 9.99 535 573229 110980 79059644
Urine leukocyte esterase positive 50.52 9.99 99 573665 3992 79166632
Bladder cancer 50.25 9.99 40 573724 19486 79151138
Osteonecrosis 49.99 9.99 92 573672 31003 79139621
Crystal urine present 49.40 9.99 69 573695 2091 79168533
Renal failure 49.19 9.99 1086 572678 199882 78970742
Product quality issue 48.92 9.99 107 573657 33833 79136791
Septic shock 48.74 9.99 607 573157 122194 79048430
Surgery 48.31 9.99 102 573662 32664 79137960
Device difficult to use 48.12 9.99 18 573746 13367 79157257
Paraesthesia 48.12 9.99 936 572828 175387 78995237
Therapy interrupted 47.53 9.99 96 573668 31245 79139379
Product storage error 47.37 9.99 29 573735 16197 79154427
Palmar-plantar erythrodysaesthesia syndrome 47.32 9.99 105 573659 33029 79137595
Systemic infection 47.04 9.99 7 573757 9745 79160879
Visual acuity reduced 46.66 9.99 88 573676 29381 79141243
Cognitive disorder 46.38 9.99 734 573030 69192 79101432
Arthralgia 46.13 9.99 4743 569021 567060 78603564
White blood cells urine positive 45.92 9.99 121 573643 5954 79164670
Blood parathyroid hormone decreased 45.56 9.99 10 573754 10526 79160098
Asthenia 45.14 9.99 3122 570642 508567 78662057
Lymphocyte percentage decreased 44.86 9.99 106 573658 4870 79165754
Device malfunction 44.69 9.99 53 573711 21395 79149229
Electrocardiogram QT prolonged 44.58 9.99 425 573339 89961 79080663
Immune reconstitution inflammatory syndrome 44.37 9.99 22 573742 13819 79156805
Platelet count decreased 44.25 9.99 1064 572700 193600 78977024
Loss of consciousness 44.17 9.99 897 572867 167046 79003578
Pharyngeal paraesthesia 43.98 9.99 74 573690 2647 79167977
Posterior reversible encephalopathy syndrome 43.83 9.99 76 573688 26205 79144419
Epilepsy 43.75 9.99 149 573615 40711 79129913
Unintentional medical device removal 43.74 9.99 3 573761 7709 79162915
Orthostatic hypotension 43.70 9.99 606 573158 55558 79115066
Mucosal inflammation 43.69 9.99 341 573423 75239 79095385
Muscle spasms 43.39 9.99 942 572822 173788 78996836
Myelodysplastic syndrome 43.29 9.99 96 573668 30205 79140419
Mobility decreased 43.08 9.99 1168 572596 121007 79049617
White blood cell count decreased 42.84 9.99 1029 572735 187259 78983365
Muscle spasticity 42.79 9.99 283 573481 21192 79149432
Status epilepticus 42.14 9.99 72 573692 24969 79145655
Sudden infant death syndrome 42.09 9.99 26 573738 259 79170365
Haematuria 41.96 9.99 306 573458 68530 79102094
Thrombotic microangiopathy 41.85 9.99 50 573714 20119 79150505
Fibromyalgia 41.41 9.99 672 573092 63668 79106956
Second primary malignancy 41.40 9.99 26 573738 14324 79156300
Gait disturbance 41.37 9.99 1156 572608 206350 78964274
Multiple-drug resistance 40.96 9.99 7 573757 8801 79161823
Drug intolerance 40.85 9.99 2307 571457 261812 78908812
Nausea 40.84 9.99 6155 567609 951041 78219583
Vision blurred 40.70 9.99 527 573237 105371 79065253
Lactic acidosis 40.41 9.99 318 573446 70041 79100583
Injection site urticaria 40.20 9.99 21 573743 12805 79157819
Myalgia 39.93 9.99 1023 572741 184618 78986006
Infusion site bruising 39.61 9.99 74 573690 2878 79167746
Anticipatory anxiety 39.47 9.99 46 573718 1158 79169466
Acute myeloid leukaemia 39.27 9.99 104 573660 30781 79139843
Aspergillus infection 39.23 9.99 48 573716 19113 79151511
Dry skin 39.20 9.99 307 573457 67688 79102936
Drug use disorder 39.03 9.99 144 573620 8507 79162117
Seizure 38.93 9.99 1047 572717 187787 78982837
Underdose 38.91 9.99 116 573648 33035 79137589
Basal cell carcinoma 38.86 9.99 138 573626 37237 79133387
Peripheral swelling 38.64 9.99 2339 571425 267278 78903346
Abortion spontaneous 38.56 9.99 98 573666 29409 79141215
Fall 38.53 9.99 3003 570761 484626 78685998
Cytopenia 37.72 9.99 55 573709 20328 79150296
Night sweats 37.70 9.99 555 573209 51540 79119084
Injection site induration 37.38 9.99 12 573752 9807 79160817
Graft versus host disease 37.16 9.99 32 573732 14994 79155630
Breast cancer stage I 36.88 9.99 3 573761 6697 79163927
Blood pH decreased 36.81 9.99 95 573669 4616 79166008
Hypokalaemia 36.79 9.99 773 572991 143267 79027357
Drug-induced liver injury 36.23 9.99 673 573091 65444 79105180
Bursitis 36.16 9.99 406 573358 35438 79135186
Jaundice cholestatic 36.09 9.99 169 573595 11115 79159509
Pain 35.69 9.99 5674 568090 698128 78472496
Drug ineffective for unapproved indication 35.62 9.99 219 573545 51019 79119605
Disturbance in attention 35.39 9.99 217 573547 50584 79120040
Granuloma skin 35.30 9.99 11 573753 9163 79161461
Hypomania 35.24 9.99 127 573637 7417 79163207
Infusion site mass 35.11 9.99 50 573714 1543 79169081
Urticaria 35.00 9.99 1649 572115 183552 78987072
Product use in unapproved indication 34.92 9.99 1459 572305 248900 78921724
Alopecia 34.64 9.99 2015 571749 229340 78941284
Blood glucose increased 34.59 9.99 600 573164 114375 79056249
Facet joint syndrome 34.50 9.99 167 573597 11135 79159489
Sexual dysfunction 34.32 9.99 7 573757 7756 79162868
International normalised ratio increased 34.28 9.99 825 572939 83896 79086728
Hepatic cirrhosis 34.25 9.99 132 573632 34774 79135850
Therapeutic response decreased 33.98 9.99 312 573452 66541 79104083
Aspartate aminotransferase increased 33.81 9.99 1268 572496 137373 79033251
Hypertensive crisis 33.79 9.99 61 573703 20709 79149915
Cardiac failure chronic 33.78 9.99 19 573745 11116 79159508
Haemorrhage 33.72 9.99 457 573307 90661 79079963
Product monitoring error 33.70 9.99 11 573753 8895 79161729
Suicidal ideation 33.51 9.99 369 573395 75971 79094653
Urinary sediment present 33.33 9.99 63 573701 2472 79168152
Confusional state 33.23 9.99 2688 571076 315309 78855315
Death 33.17 9.99 4605 569159 561909 78608715
Haematochezia 33.01 9.99 438 573326 87207 79083417
Hypercalcaemia 32.97 9.99 153 573611 38277 79132347
Specific gravity urine decreased 32.97 9.99 36 573728 842 79169782
Hyponatraemia 32.88 9.99 1001 572763 176847 78993777
Rash pruritic 32.74 9.99 343 573421 71286 79099338
Joint range of motion decreased 32.68 9.99 375 573389 32907 79137717
Maternal exposure during pregnancy 32.63 9.99 1246 572518 135292 79035332
Transplant rejection 32.60 9.99 56 573708 19381 79151243
Cardiac failure acute 32.25 9.99 54 573710 18875 79151749
Angina unstable 32.18 9.99 43 573721 16484 79154140
Renal cortical necrosis 32.02 9.99 24 573740 336 79170288
Unresponsive to stimuli 32.02 9.99 572 573192 55216 79115408
Device dislocation 31.85 9.99 89 573675 25881 79144743
Injury 31.77 9.99 756 573008 76740 79093884
Ventricular tachycardia 31.41 9.99 175 573589 41760 79128864
Breast cancer female 31.40 9.99 22 573742 11439 79159185
Mydriasis 31.31 9.99 226 573538 17417 79153207
Diplopia 31.29 9.99 129 573635 33337 79137287
Brain death 31.29 9.99 101 573663 5576 79165048
Panniculitis 31.02 9.99 26 573738 12345 79158279
Deep vein thrombosis 30.85 9.99 649 573115 120270 79050354
Lymphocyte count decreased 30.84 9.99 495 573269 46794 79123830
Spinal stenosis 30.83 9.99 41 573723 15750 79154874
Acidosis 30.50 9.99 245 573519 19517 79151107
Pain in extremity 30.50 9.99 2234 571530 362304 78808320
Toxicologic test abnormal 30.44 9.99 43 573721 1317 79169307
Memory impairment 30.21 9.99 594 573170 111140 79059484
Anion gap increased 30.08 9.99 76 573688 3644 79166980
Full blood count decreased 29.95 9.99 96 573668 26723 79143901
Extrapyramidal disorder 29.88 9.99 75 573689 22604 79148020
Hypomagnesaemia 29.83 9.99 206 573558 46705 79123919
Multiple drug therapy 29.59 9.99 80 573684 3998 79166626
Skin necrosis 29.53 9.99 53 573711 18034 79152590
Neurotoxicity 29.38 9.99 127 573637 32391 79138233
Depression 29.25 9.99 1268 572496 215522 78955102
Congestive cardiomyopathy 29.24 9.99 25 573739 11755 79158869
Incorrect drug administration rate 29.23 9.99 79 573685 3947 79166677
Drug dose omission by device 28.99 9.99 5 573759 6245 79164379
Chronic kidney disease 28.94 9.99 320 573444 65834 79104790
Fixed eruption 28.92 9.99 65 573699 2889 79167735
Colorectal cancer 28.86 9.99 13 573751 8634 79161990
Multiple sclerosis relapse 28.77 9.99 206 573558 46327 79124297
Gastric cancer 28.61 9.99 19 573745 10160 79160464
Akathisia 28.45 9.99 32 573732 13227 79157397
Device leakage 28.24 9.99 22 573742 10834 79159790
Haemolysis 28.10 9.99 173 573591 12639 79157985
Skin exfoliation 28.06 9.99 257 573507 54843 79115781
Deep vein thrombosis postoperative 28.03 9.99 152 573612 10600 79160024
Infusion site haemorrhage 28.02 9.99 74 573690 3646 79166978
Polyneuropathy 27.99 9.99 85 573679 24066 79146558
Dermatitis atopic 27.95 9.99 19 573745 10037 79160587
Renal cancer 27.92 9.99 28 573736 12198 79158426
Torsade de pointes 27.74 9.99 61 573703 19251 79151373
Drug withdrawal syndrome 27.60 9.99 142 573622 34576 79136048
Pneumocystis jirovecii pneumonia 27.55 9.99 130 573634 32378 79138246
Pruritus 27.54 9.99 3243 570521 391405 78779219
Cardiac arrest 27.52 9.99 1508 572256 170588 79000036
SARS-CoV-2 test positive 27.48 9.99 161 573603 11555 79159069
Transplant dysfunction 27.18 9.99 9 573755 7212 79163412
Blood cholesterol increased 27.16 9.99 792 572972 82928 79087696
Metastases to lymph nodes 27.13 9.99 21 573743 10376 79160248
Myopathy 27.10 9.99 68 573696 20495 79150129
Infection 26.85 9.99 2053 571711 239659 78930965
Red blood cell sedimentation rate 26.83 9.99 4 573760 5561 79165063
Appendicolith 26.57 9.99 127 573637 8424 79162200
Cardiac disorder 26.47 9.99 324 573440 65433 79105191
Tremor 26.35 9.99 979 572785 169104 79001520
Multiple allergies 26.01 9.99 146 573618 10314 79160310
Subdural haematoma 25.89 9.99 127 573637 31307 79139317
Graft versus host disease in skin 25.78 9.99 6 573758 6067 79164557
General physical health deterioration 25.78 9.99 1670 572094 273568 78897056
Drug screen positive 25.76 9.99 99 573665 5964 79164660
Wound infection 25.69 9.99 275 573489 23716 79146908
Bilirubin urine present 25.69 9.99 21 573743 336 79170288
Coronary arterial stent insertion 25.60 9.99 6 573758 6038 79164586
Analgesic drug level above therapeutic 25.60 9.99 24 573740 465 79170159
Skin toxicity 25.49 9.99 14 573750 8300 79162324
Bronchopulmonary aspergillosis 25.46 9.99 79 573685 22215 79148409
Incorrect dose administered by device 25.45 9.99 3 573761 4986 79165638
Lip dry 25.37 9.99 194 573570 15224 79155400
Nocardiosis 25.36 9.99 5 573759 5674 79164950
Cytomegalovirus viraemia 25.33 9.99 33 573731 12788 79157836
Sputum culture positive 25.28 9.99 72 573692 3709 79166915
Accidental exposure to product by child 24.95 9.99 61 573703 2865 79167759
Gynaecomastia 24.94 9.99 12 573752 7669 79162955
Thinking abnormal 24.86 9.99 35 573729 13126 79157498
Metastases to lung 24.77 9.99 59 573705 18104 79152520
Prothrombin time prolonged 24.73 9.99 207 573557 16692 79153932
Rhabdomyolysis 24.73 9.99 559 573205 102572 79068052
Acute graft versus host disease 24.72 9.99 22 573742 10145 79160479
Bone pain 24.64 9.99 269 573495 55473 79115151
Anti-cyclic citrullinated peptide antibody 24.41 9.99 95 573669 5757 79164867
COVID-19 pneumonia 24.39 9.99 316 573448 28533 79142091
Generalised bullous fixed drug eruption 24.35 9.99 16 573748 179 79170445
Loss of personal independence in daily activities 24.32 9.99 557 573207 102023 79068601
Renal papillary necrosis 24.25 9.99 22 573742 408 79170216
Abdominal discomfort 24.21 9.99 2107 571657 248620 78922004
Forced expiratory volume decreased 24.19 9.99 13 573751 7801 79162823
Maternal exposure timing unspecified 24.14 9.99 94 573670 5698 79164926
Oral pruritus 24.11 9.99 54 573710 2394 79168230
Dyskinesia 24.05 9.99 206 573558 44567 79126057
Intervertebral discitis 24.03 9.99 83 573681 4745 79165879
Hypertriglyceridaemia 23.95 9.99 34 573730 12706 79157918
Clostridium test positive 23.92 9.99 101 573663 6353 79164271
Hepatocellular carcinoma 23.82 9.99 18 573746 9003 79161621
No adverse event 23.80 9.99 163 573601 37029 79133595
Mitral valve incompetence 23.76 9.99 115 573649 28450 79142174
Epstein-Barr virus infection 23.76 9.99 42 573722 14374 79156250
Pulmonary hypertension 23.74 9.99 226 573538 47854 79122770
Blood triglycerides increased 23.71 9.99 75 573689 20965 79149659
Thrombosis 23.68 9.99 444 573320 83656 79086968
Red blood cells urine positive 23.57 9.99 84 573680 4879 79165745
Venoocclusive liver disease 23.56 9.99 30 573734 11741 79158883
Bacterial test 23.52 9.99 36 573728 1187 79169437
Ageusia 23.51 9.99 53 573711 16579 79154045
Neuroleptic malignant syndrome 23.48 9.99 110 573654 27449 79143175
Brain stem glioma 23.41 9.99 16 573748 192 79170432
Hepatitis fulminant 23.40 9.99 109 573655 7153 79163471
Drug level below therapeutic 23.40 9.99 135 573629 9635 79160989
Iron deficiency anaemia 23.36 9.99 100 573664 25572 79145052
Diffuse large B-cell lymphoma 23.26 9.99 32 573732 12117 79158507
Obstructive airways disorder 23.17 9.99 132 573632 31327 79139297
Melaena 23.03 9.99 304 573460 60586 79110038
Respiratory failure 23 9.99 1065 572699 179846 78990778
Right ventricular failure 22.96 9.99 89 573675 23408 79147216
Drug hypersensitivity 22.92 9.99 1845 571919 297071 78873553
Tachycardia 22.85 9.99 1528 572236 176240 78994384
Treatment noncompliance 22.80 9.99 253 573511 52015 79118609
Visual impairment 22.77 9.99 497 573267 91634 79078990
Pulmonary embolism 22.74 9.99 1006 572758 170648 78999976
Adjustment disorder with depressed mood 22.71 9.99 127 573637 8959 79161665
Dysarthria 22.61 9.99 346 573418 67276 79103348
Urine analysis abnormal 22.61 9.99 100 573664 6420 79164204
Vital capacity decreased 22.49 9.99 44 573720 1772 79168852
Osmolar gap 22.37 9.99 15 573749 174 79170450
Prostatic specific antigen increased 22.36 9.99 25 573739 10361 79160263
Glycosylated haemoglobin increased 22.17 9.99 68 573696 19192 79151432
Tardive dyskinesia 22.15 9.99 26 573738 10545 79160079
Cystitis haemorrhagic 22.12 9.99 20 573744 9152 79161472
Coronary artery bypass 22.05 9.99 8 573756 6054 79164570
White coat hypertension 21.99 9.99 29 573735 831 79169793
Hepatic cancer 21.95 9.99 26 573738 10503 79160121
Angina pectoris 21.94 9.99 252 573512 51480 79119144
Actinic keratosis 21.93 9.99 8 573756 6034 79164590
Hallucination 21.93 9.99 460 573304 85285 79085339
Acute graft versus host disease in skin 21.92 9.99 14 573750 7644 79162980
Varicella zoster virus infection 21.86 9.99 3 573761 4438 79166186
Therapeutic response unexpected 21.85 9.99 72 573692 19874 79150750
Prothrombin time ratio decreased 21.83 9.99 30 573734 895 79169729
Withdrawal syndrome 21.82 9.99 109 573655 26745 79143879
Ischaemic stroke 21.80 9.99 144 573620 32987 79137637
Hypothermia 21.75 9.99 255 573509 22491 79148133
Kidney transplant rejection 21.69 9.99 25 573739 10221 79160403
Injection site discolouration 21.68 9.99 14 573750 7600 79163024
Ketoacidosis 21.62 9.99 15 573749 7839 79162785
BK virus infection 21.47 9.99 19 573745 8785 79161839
Infusion site discomfort 21.46 9.99 37 573727 1350 79169274
Chronic graft versus host disease 21.41 9.99 11 573753 6770 79163854
Immunosuppressant drug level increased 21.39 9.99 20 573744 9007 79161617
Lung neoplasm malignant 21.35 9.99 115 573649 27677 79142947
Metastases to liver 21.29 9.99 118 573646 28196 79142428
Aphasia 21.27 9.99 224 573540 46508 79124116
Lipodystrophy acquired 21.10 9.99 3 573761 4322 79166302
Pancreatic carcinoma 21.09 9.99 41 573723 13536 79157088
Tricuspid valve incompetence 21.02 9.99 72 573692 19640 79150984
Flushing 20.96 9.99 805 572959 87463 79083161
Fear of injection 20.94 9.99 14 573750 7460 79163164
Pulmonary arterial hypertension 20.91 9.99 119 573645 28247 79142377
Toxic epidermal necrolysis 20.81 9.99 443 573321 44138 79126486
Soft tissue disorder 20.71 9.99 64 573700 3451 79167173
Hepatitis B reactivation 20.68 9.99 9 573755 6099 79164525
Low density lipoprotein increased 20.56 9.99 19 573745 8603 79162021
Graft versus host disease in gastrointestinal tract 20.53 9.99 10 573754 6346 79164278
Cardiovascular disorder 20.49 9.99 64 573700 17961 79152663
Hepatitis acute 20.47 9.99 186 573578 15356 79155268
Fluid retention 20.45 9.99 366 573398 69443 79101181
Electrolyte imbalance 20.43 9.99 134 573630 30747 79139877
Fracture 20.40 9.99 84 573680 21717 79148907
Bundle branch block left 20.40 9.99 32 573732 11481 79159143
Tendonitis 20.37 9.99 95 573669 23735 79146889
Pyrexia 20.36 9.99 5334 568430 673375 78497249
Macular oedema 20.29 9.99 7 573757 5467 79165157
Product complaint 20.15 9.99 41 573723 13308 79157316
Aplasia pure red cell 20.10 9.99 16 573748 7794 79162830
Exposure to SARS-CoV-2 20.03 9.99 45 573719 1999 79168625
Cardiomyopathy 19.99 9.99 123 573641 28651 79141973
Genital haemorrhage 19.96 9.99 10 573754 6245 79164379
Red cell distribution width increased 19.87 9.99 182 573582 15060 79155564
Urine bilirubin decreased 19.81 9.99 13 573751 145 79170479
Ear infection 19.74 9.99 353 573411 34079 79136545
Erectile dysfunction 19.71 9.99 48 573716 14616 79156008
Blood potassium decreased 19.56 9.99 227 573537 46285 79124339
Sinus node dysfunction 19.54 9.99 16 573748 7685 79162939
Autoimmune disorder 19.49 9.99 194 573570 16418 79154206
Circulatory collapse 19.48 9.99 175 573589 37493 79133131
Hypocoagulable state 19.47 9.99 46 573718 2113 79168511
Lymphoproliferative disorder 19.45 9.99 8 573756 5607 79165017
Disease recurrence 19.44 9.99 213 573551 43896 79126728
Acute coronary syndrome 19.42 9.99 82 573682 21051 79149573
Hepatitis C 19.42 9.99 35 573729 11890 79158734
Hepatic encephalopathy 19.30 9.99 262 573502 23904 79146720
Hypothyroidism 19.30 9.99 263 573501 52129 79118495
Respiratory disorder 19.12 9.99 440 573324 44416 79126208
Disturbance in social behaviour 19.05 9.99 6 573758 4964 79165660
Enthesopathy 18.97 9.99 34 573730 11574 79159050
Carotid artery stenosis 18.94 9.99 21 573743 8737 79161887
Fungal rhinitis 18.89 9.99 10 573754 72 79170552
Sensitivity to weather change 18.87 9.99 18 573746 8029 79162595
Skin lesion 18.87 9.99 201 573563 41643 79128981
Skin ulcer 18.82 9.99 275 573489 53875 79116749
Gestational diabetes 18.72 9.99 11 573753 6282 79164342
Musculoskeletal stiffness 18.69 9.99 1482 572282 173526 78997098
COVID-19 immunisation 18.68 9.99 35 573729 1364 79169260
Asthma 18.66 9.99 788 572976 134307 79036317
Lymphadenopathy 18.65 9.99 270 573494 52977 79117647
Speech disorder 18.40 9.99 278 573486 54167 79116457
Therapy partial responder 18.24 9.99 64 573700 17333 79153291
JC virus infection 18.23 9.99 3 573761 3878 79166746
Hypersensitivity vasculitis 18.15 9.99 14 573750 6929 79163695
Abnormal dreams 18.13 9.99 34 573730 11378 79159246
Cerebral ischaemia 18.10 9.99 33 573731 11162 79159462
Human herpesvirus 6 infection 18.04 9.99 8 573756 5362 79165262
Osteolysis 18.03 9.99 5 573759 4493 79166131
Febrile bone marrow aplasia 17.99 9.99 42 573722 12978 79157646
Renal disorder 17.89 9.99 205 573559 41900 79128724
Dystonia 17.89 9.99 86 573678 21313 79149311
Blood urine present 17.88 9.99 233 573531 21064 79149560
Left ventricular dysfunction 17.87 9.99 75 573689 19286 79151338
Consciousness fluctuating 17.81 9.99 42 573722 1927 79168697
Liver transplant 17.80 9.99 71 573693 4352 79166272
Concomitant disease aggravated 17.77 9.99 43 573721 13124 79157500
Transaminases increased 17.75 9.99 493 573271 51250 79119374
Osteomyelitis 17.75 9.99 151 573613 32714 79137910
Arrhythmia 17.71 9.99 322 573442 60950 79109674
Aplastic anaemia 17.69 9.99 202 573562 17703 79152921
Complication of device insertion 17.65 9.99 12 573752 6338 79164286
Type 2 diabetes mellitus 17.61 9.99 537 573227 56585 79114039
Gastritis erosive 17.52 9.99 32 573732 10815 79159809
Inappropriate antidiuretic hormone secretion 17.50 9.99 114 573650 26199 79144425
Generalised tonic-clonic seizure 17.43 9.99 217 573547 43693 79126931
Laboratory test abnormal 17.42 9.99 124 573640 27924 79142700
Blood creatine phosphokinase increased 17.36 9.99 353 573411 65737 79104887
Self-medication 17.26 9.99 78 573686 5054 79165570
Pain in jaw 17.24 9.99 231 573533 45920 79124704
Metastases to bone 17.19 9.99 104 573660 24323 79146301
Ventricular extrasystoles 17.17 9.99 78 573686 19626 79150998
Ascites 17.15 9.99 413 573351 75149 79095475
Vaginal haemorrhage 16.91 9.99 90 573674 21727 79148897
Hemiparesis 16.89 9.99 158 573606 33575 79137049
Injection site discomfort 16.88 9.99 8 573756 5158 79165466
Accidental exposure to product 16.87 9.99 144 573620 31178 79139446
Somnolence 16.80 9.99 1965 571799 237016 78933608
Nocturia 16.69 9.99 47 573717 13634 79156990
Granulomatosis with polyangiitis 16.68 9.99 52 573712 2818 79167806
Staphylococcal infection 16.64 9.99 307 573457 57988 79112636
Skin burning sensation 16.64 9.99 45 573719 13227 79157397
Disorientation 16.58 9.99 335 573429 62441 79108183
Prothrombin time shortened 16.51 9.99 56 573708 3172 79167452
Dyslipidaemia 16.50 9.99 37 573727 11596 79159028
Cardiotoxicity 16.50 9.99 40 573724 12199 79158425
Unevaluable event 16.41 9.99 291 573473 55294 79115330
Aortic valve incompetence 16.41 9.99 27 573737 9503 79161121
Retinal haemorrhage 16.39 9.99 21 573743 8196 79162428
Burning sensation 16.36 9.99 310 573454 58322 79112302
Post cholecystectomy syndrome 16.36 9.99 17 573747 375 79170249
Sepsis 16.31 9.99 1693 572071 267735 78902889
Brain oedema 16.30 9.99 264 573500 24999 79145625
Hip arthroplasty 16.27 9.99 354 573410 35402 79135222
Hypoglycaemic coma 16.14 9.99 7 573757 4753 79165871
Potentiating drug interaction 16.12 9.99 24 573740 8795 79161829
Cryopyrin associated periodic syndrome 16.11 9.99 17 573747 382 79170242
Application site pain 16.06 9.99 7 573757 4740 79165884
Adenocarcinoma of colon 16.04 9.99 10 573754 5531 79165093
Hyperammonaemia 15.96 9.99 35 573729 11058 79159566
Pneumonia 15.96 9.99 4368 569396 655878 78514746
Peripheral venous disease 15.95 9.99 180 573584 15729 79154895
Agranulocytosis 15.89 9.99 228 573536 44802 79125822
Chest pain 15.88 9.99 1783 571981 280521 78890103
Candida infection 15.87 9.99 187 573577 38027 79132597
Partial seizures 15.87 9.99 25 573739 8953 79161671
Erysipelas 15.81 9.99 34 573730 10816 79159808
Pulmonary alveolar haemorrhage 15.80 9.99 37 573727 11420 79159204
Cells in urine 15.75 9.99 13 573751 211 79170413
Coagulation factor X level decreased 15.75 9.99 10 573754 105 79170519
Smear cervix abnormal 15.72 9.99 47 573717 2489 79168135
Band neutrophil count increased 15.72 9.99 22 573742 668 79169956
Inflammation 15.67 9.99 825 572939 92928 79077696
Sulphaemoglobinaemia 15.66 9.99 8 573756 53 79170571
Pupillary light reflex tests abnormal 15.61 9.99 15 573749 300 79170324
Antipsychotic drug level increased 15.59 9.99 12 573752 5945 79164679
Long QT syndrome 15.58 9.99 12 573752 5943 79164681
Muscle disorder 15.57 9.99 11 573753 5696 79164928
Post-traumatic stress disorder 15.54 9.99 73 573691 4808 79165816
Blood creatinine decreased 15.52 9.99 103 573661 7722 79162902
Haemoglobin decreased 15.51 9.99 1381 572383 220738 78949886
Immune effector cell-associated neurotoxicity syndrome 15.46 9.99 83 573681 5765 79164859
Glutathione decreased 15.42 9.99 8 573756 55 79170569
Dermatitis 15.41 9.99 90 573674 21231 79149393
Shock haemorrhagic 15.41 9.99 83 573681 19977 79150647
Nephrogenic systemic fibrosis 15.38 9.99 13 573751 6147 79164477
Culture urine positive 15.36 9.99 68 573696 4367 79166257
Skin cancer 15.33 9.99 56 573708 14984 79155640
Pneumonia streptococcal 15.28 9.99 49 573715 2696 79167928
Rheumatoid nodule 15.21 9.99 69 573695 17369 79153255
Complications of transplanted kidney 15.21 9.99 14 573750 6352 79164272
Dysstasia 15.20 9.99 127 573637 27619 79143005
Blood immunoglobulin E increased 15.20 9.99 12 573752 5870 79164754
Acute myeloid leukaemia recurrent 15.06 9.99 3 573761 3380 79167244
Heavy menstrual bleeding 15.06 9.99 51 573713 13960 79156664
Anal fissure 15.04 9.99 101 573663 7602 79163022
Intraocular pressure increased 15.01 9.99 27 573737 9178 79161446
Hyperglycaemia 15.00 9.99 388 573376 69947 79100677
Allergy to chemicals 14.99 9.99 47 573717 2555 79168069
Carpal tunnel syndrome 14.89 9.99 81 573683 19447 79151177
Serotonin syndrome 14.89 9.99 427 573337 44600 79126024
Administration site bruise 14.84 9.99 12 573752 189 79170435
Rheumatoid lung 14.78 9.99 6 573758 4239 79166385
Metastases to central nervous system 14.76 9.99 64 573700 16311 79154313
Squamous cell carcinoma 14.74 9.99 60 573704 15562 79155062
Bacterial test positive 14.74 9.99 98 573666 7351 79163273
Neutrophil count decreased 14.73 9.99 540 573224 93419 79077205
Aortic valve stenosis 14.72 9.99 10 573754 5284 79165340
Galactorrhoea 14.71 9.99 4 573760 3642 79166982
Device failure 14.69 9.99 14 573750 6247 79164377
Retinal vein occlusion 14.68 9.99 3 573761 3320 79167304
Drug eruption 14.62 9.99 225 573539 43710 79126914
Monocyte percentage increased 14.54 9.99 41 573723 2100 79168524
Sciatica 14.51 9.99 327 573437 32895 79137729
Squamous cell carcinoma of skin 14.47 9.99 52 573712 13981 79156643
Coronary artery stenosis 14.42 9.99 44 573720 12440 79158184
Eosinophil percentage increased 14.41 9.99 33 573731 1485 79169139
Necrotic lymphadenopathy 14.38 9.99 9 573755 92 79170532
Complication of device removal 14.37 9.99 5 573759 3884 79166740
Asphyxia 14.30 9.99 138 573626 11582 79159042
Schizophrenia 14.28 9.99 172 573592 15268 79155356
Insurance issue 14.24 9.99 80 573684 5653 79164971
Parkinsonism 14.24 9.99 66 573698 16518 79154106
Dyspnoea at rest 14.21 9.99 19 573745 7283 79163341
Atypical femur fracture 14.16 9.99 10 573754 5179 79165445
Brain abscess 14.16 9.99 9 573755 4927 79165697
Administration site swelling 14.16 9.99 18 573746 497 79170127
Reversible airways obstruction 14.13 9.99 41 573723 2135 79168489
Polydipsia 14.11 9.99 16 573748 6589 79164035
High density lipoprotein decreased 14.04 9.99 8 573756 4647 79165977
Dislocation of vertebra 14.02 9.99 101 573663 7779 79162845
Application site pruritus 13.91 9.99 5 573759 3805 79166819
Monoparesis 13.89 9.99 4 573760 3507 79167117
Klebsiella infection 13.83 9.99 62 573702 15658 79154966
Infusion site irritation 13.82 9.99 22 573742 751 79169873
Acute generalised exanthematous pustulosis 13.76 9.99 187 573577 17067 79153557
Syringe issue 13.73 9.99 15 573749 6283 79164341
Infective pulmonary exacerbation of cystic fibrosis 13.66 9.99 47 573717 12804 79157820
Vein collapse 13.57 9.99 27 573737 1101 79169523
Encephalopathy 13.56 9.99 604 573160 66793 79103831
Femur fracture 13.53 9.99 196 573568 38456 79132168
Cystitis 13.50 9.99 485 573279 52247 79118377
Hepatocellular injury 13.47 9.99 251 573513 47342 79123282
Infusion site urticaria 13.47 9.99 27 573737 1107 79169517
Delusion of grandeur 13.45 9.99 31 573733 1401 79169223
Ankylosing spondylitis 13.41 9.99 44 573720 12161 79158463
Paresis 13.32 9.99 7 573757 4254 79166370
Abnormal loss of weight 13.27 9.99 25 573739 8351 79162273
Intestinal haemorrhage 13.26 9.99 16 573748 6410 79164214
Cytomegalovirus chorioretinitis 13.20 9.99 12 573752 5478 79165146
Anti-erythrocyte antibody positive 13.18 9.99 8 573756 77 79170547
Suspected COVID-19 13.18 9.99 51 573713 3082 79167542
Limb discomfort 13.17 9.99 162 573602 32688 79137936
Left ventricular failure 13.16 9.99 31 573733 9550 79161074
Large intestine polyp 13.16 9.99 47 573717 12661 79157963
Leukoencephalopathy 13.16 9.99 23 573741 7906 79162718
Blood immunoglobulin A decreased 13.15 9.99 31 573733 1422 79169202
Pleural effusion 13.14 9.99 884 572880 144378 79026246
Pneumatosis intestinalis 13.12 9.99 16 573748 6381 79164243
Blood loss anaemia 13.12 9.99 62 573702 15436 79155188
Blood glucose abnormal 13.11 9.99 36 573728 10530 79160094
Palpitations 13.10 9.99 761 573003 125849 79044775
Mycobacterial infection 13.07 9.99 5 573759 3663 79166961
Postmortem blood drug level increased 13.07 9.99 22 573742 787 79169837
Ischaemic cardiomyopathy 13.06 9.99 22 573742 7673 79162951
Pre-eclampsia 13.03 9.99 19 573745 7022 79163602
Diffuse large B-cell lymphoma recurrent 13.02 9.99 7 573757 4200 79166424
Post procedural pulmonary embolism 12.98 9.99 13 573751 274 79170350
Peripheral sensory neuropathy 12.97 9.99 49 573715 12984 79157640
Infusion site rash 12.97 9.99 34 573730 1668 79168956
Tooth injury 12.96 9.99 38 573726 1990 79168634
Plasma cell myeloma 12.96 9.99 288 573476 52971 79117653
Electrocardiogram QRS complex prolonged 12.95 9.99 127 573637 10706 79159918
Vital functions abnormal 12.91 9.99 22 573742 795 79169829
Haemoglobin urine present 12.89 9.99 24 573740 931 79169693
Pulmonary tuberculosis 12.88 9.99 23 573741 7842 79162782
Upper respiratory tract infection 12.86 9.99 790 572974 90378 79080246
Dysgeusia 12.84 9.99 313 573451 56864 79113760
Therapy non-responder 12.83 9.99 538 573226 91767 79078857
Aminoaciduria 12.83 9.99 15 573749 379 79170245
Accidental death 12.81 9.99 63 573701 4228 79166396
Gastrooesophageal reflux disease 12.78 9.99 616 573148 103630 79066994
Peripheral arterial occlusive disease 12.78 9.99 25 573739 8233 79162391
Sleep disorder due to a general medical condition 12.75 9.99 56 573708 14221 79156403
Upper gastrointestinal haemorrhage 12.74 9.99 215 573549 41165 79129459
Granulocytopenia 12.71 9.99 41 573723 11390 79159234
Ductus arteriosus stenosis foetal 12.68 9.99 8 573756 83 79170541
Physical disability 12.61 9.99 4 573760 3294 79167330
Rash papular 12.61 9.99 99 573665 21817 79148807
Catheter site bruise 12.58 9.99 16 573748 442 79170182
Mean cell haemoglobin concentration increased 12.57 9.99 23 573741 880 79169744
Serum sickness 12.54 9.99 56 573708 3610 79167014
Left ventricular hypertrophy 12.54 9.99 40 573724 11151 79159473
Oedema 12.51 9.99 718 573046 118862 79051762
Subarachnoid haemorrhage 12.50 9.99 114 573650 24351 79146273
Eye infection 12.47 9.99 136 573628 11784 79158840
Hernia 12.44 9.99 182 573582 16877 79153747
Injection site extravasation 12.37 9.99 115 573649 9554 79161070
Personality change 12.36 9.99 35 573729 10135 79160489
Precancerous cells present 12.31 9.99 27 573737 1180 79169444
B-cell lymphoma 12.27 9.99 16 573748 6199 79164425
Abdominal pain lower 12.27 9.99 158 573606 31624 79139000
Dysuria 12.26 9.99 276 573488 50675 79119949
Endophthalmitis 12.24 9.99 17 573747 6411 79164213
Hepatitis B 12.23 9.99 26 573738 8306 79162318
Secondary immunodeficiency 12.23 9.99 4 573760 3230 79167394
Ejection fraction decreased 12.22 9.99 175 573589 34402 79136222
Cyanosis neonatal 12.21 9.99 7 573757 60 79170564
Focal dyscognitive seizures 12.17 9.99 5 573759 3507 79167117
Myocardial ischaemia 12.15 9.99 121 573643 25398 79145226
Injection site nodule 12.13 9.99 6 573758 3774 79166850
Postoperative delirium 12.12 9.99 14 573750 349 79170275
Oxygen saturation abnormal 12.09 9.99 65 573699 4517 79166107
Granuloma 12.09 9.99 26 573738 8271 79162353
Glucose tolerance impaired 12.06 9.99 25 573739 8059 79162565
Rhinalgia 12.05 9.99 41 573723 2326 79168298
Bone erosion 12.03 9.99 77 573687 17770 79152854
Stress 12.01 9.99 694 573070 78918 79091706
Dependent personality disorder 12.01 9.99 9 573755 126 79170498
Atrioventricular block 11.99 9.99 56 573708 13985 79156639
Mucormycosis 11.96 9.99 27 573737 8442 79162182
Psychomotor skills impaired 11.95 9.99 12 573752 5225 79165399
Bone lesion 11.94 9.99 15 573749 5904 79164720
Breast cancer 11.93 9.99 171 573593 33610 79137014
Caesarean section 11.92 9.99 48 573716 12487 79158137
Total lung capacity increased 11.87 9.99 40 573724 2258 79168366
Small fibre neuropathy 11.83 9.99 17 573747 529 79170095
Therapy change 11.80 9.99 22 573742 7377 79163247
Fanconi syndrome 11.78 9.99 3 573761 2853 79167771
Intermenstrual bleeding 11.77 9.99 15 573749 5869 79164755
Transfusion-related circulatory overload 11.75 9.99 14 573750 361 79170263
Tachyarrhythmia 11.73 9.99 20 573744 6942 79163682
Aggression 11.71 9.99 278 573486 50680 79119944
Congestive hepatopathy 11.66 9.99 64 573700 4483 79166141
Urobilinogen urine increased 11.61 9.99 19 573745 664 79169960
Arteriospasm coronary 11.59 9.99 19 573745 6697 79163927
Peritonitis bacterial 11.57 9.99 33 573731 9534 79161090
Alpha 1 microglobulin increased 11.57 9.99 7 573757 67 79170557
Product use issue 11.55 9.99 1700 572064 208122 78962502
Bezoar 11.51 9.99 44 573720 2644 79167980
Anticholinergic syndrome 11.49 9.99 54 573710 3557 79167067
Movement disorder 11.47 9.99 133 573631 27126 79143498
Maple syrup disease 11.43 9.99 4 573760 8 79170616
Urethral obstruction 11.43 9.99 12 573752 268 79170356
C-reactive protein 11.41 9.99 68 573696 4911 79165713
Delusion 11.40 9.99 93 573671 20330 79150294
Product preparation error 11.35 9.99 15 573749 5778 79164846
Allergy test negative 11.35 9.99 13 573751 321 79170303
Mood swings 11.34 9.99 90 573674 19790 79150834
Toxic skin eruption 11.34 9.99 104 573660 22189 79148435
Monocyte count increased 11.32 9.99 122 573642 10539 79160085
Premature delivery 11.29 9.99 111 573653 23356 79147268
Diabetic neuropathy 11.28 9.99 17 573747 6199 79164425
Product dispensing error 11.26 9.99 53 573711 13210 79157414
Pneumonia viral 11.26 9.99 108 573656 9050 79161574
Severe invasive streptococcal infection 11.24 9.99 6 573758 44 79170580
Head injury 11.24 9.99 195 573569 37174 79133450
Ventricular hypokinesia 11.23 9.99 32 573732 9247 79161377
Hypoacusis 11.23 9.99 151 573613 29999 79140625
Haematemesis 11.23 9.99 288 573476 51976 79118648
Angiokeratoma 11.21 9.99 11 573753 226 79170398
Deafness 11.20 9.99 97 573667 20940 79149684
Total lung capacity decreased 11.19 9.99 46 573718 2859 79167765
Diastolic dysfunction 11.18 9.99 40 573724 10771 79159853
Mixed liver injury 11.18 9.99 93 573671 7485 79163139
Acidosis hyperchloraemic 11.16 9.99 21 573743 821 79169803
Skin mass 11.15 9.99 26 573738 8037 79162587
Blood uric acid decreased 11.14 9.99 27 573737 1261 79169363
Diabetic metabolic decompensation 11.14 9.99 5 573759 3327 79167297
Pollakiuria 11.13 9.99 195 573569 37122 79133502
Nasal necrosis 11.12 9.99 9 573755 142 79170482
Embedded device 11.06 9.99 5 573759 3314 79167310
Malaise 11.05 9.99 3250 570514 486619 78684005
Complication associated with device 11.04 9.99 77 573687 17419 79153205
Irritability 11.03 9.99 219 573545 40925 79129699
Urinary casts 11.03 9.99 26 573738 1193 79169431
Sensitisation 11.02 9.99 5 573759 3306 79167318
Nerve block 11.01 9.99 19 573745 694 79169930
Decerebrate posture 11.00 9.99 10 573754 186 79170438
Aspartate aminotransferase 10.98 9.99 17 573747 566 79170058
Osteogenesis imperfecta 10.97 9.99 16 573748 505 79170119
Leukocytosis 10.96 9.99 399 573365 43056 79127568
Leukaemia 10.95 9.99 16 573748 5909 79164715
Haemorrhage intracranial 10.95 9.99 128 573636 26065 79144559
Epilepsy with myoclonic-atonic seizures 10.92 9.99 8 573756 108 79170516
Coronary artery occlusion 10.88 9.99 65 573699 15250 79155374
Cardiac operation 10.86 9.99 12 573752 5000 79165624
Oral discomfort 10.85 9.99 35 573729 9725 79160899
Vertigo 10.83 9.99 397 573367 68685 79101939
Specific gravity urine increased 10.83 9.99 15 573749 451 79170173
Plasma cell myeloma recurrent 10.81 9.99 12 573752 4989 79165635
Urine oxalate increased 10.76 9.99 11 573753 238 79170386
Epstein-Barr virus associated lymphoproliferative disorder 10.75 9.99 6 573758 3526 79167098
Mania 10.73 9.99 82 573682 18178 79152446
Uterine perforation 10.72 9.99 18 573746 6285 79164339
Polycystic ovaries 10.69 9.99 7 573757 3772 79166852
Eyelid ptosis 10.68 9.99 42 573722 11002 79159622
Orbital compartment syndrome 10.68 9.99 7 573757 78 79170546
Leukocyturia 10.68 9.99 35 573729 1948 79168676
Vaccination site pain 10.66 9.99 10 573754 194 79170430
PCO2 decreased 10.65 9.99 48 573716 3106 79167518
Proteinuria 10.63 9.99 167 573597 32335 79138289
Blindness 10.62 9.99 142 573622 28241 79142383
Lupus vulgaris 10.62 9.99 50 573714 3296 79167328
Fibrin D dimer increased 10.61 9.99 102 573662 8552 79162072
Febrile neutropenia 10.60 9.99 1853 571911 229146 78941478
Pericardial haemorrhage 10.60 9.99 10 573754 4485 79166139
Cytomegalovirus infection reactivation 10.59 9.99 30 573734 8686 79161938
Faecaloma 10.55 9.99 45 573719 11519 79159105
Acute respiratory failure 10.54 9.99 337 573427 59204 79111420
Metastasis 10.50 9.99 21 573743 6859 79163765
Device deployment issue 10.46 9.99 5 573759 3207 79167417
Thyroid cancer 10.42 9.99 15 573749 5573 79165051
Chronic gastrointestinal bleeding 10.41 9.99 15 573749 468 79170156
Hydroxyprolinuria 10.41 9.99 6 573758 52 79170572
Temperature regulation disorder 10.40 9.99 75 573689 5778 79164846
Inhibitory drug interaction 10.40 9.99 10 573754 4443 79166181
Beta haemolytic streptococcal infection 10.40 9.99 36 573728 2061 79168563
Cytomegalovirus colitis 10.39 9.99 11 573753 4674 79165950
Diffuse axonal injury 10.38 9.99 8 573756 117 79170507
Base excess 10.38 9.99 7 573757 82 79170542
Pemphigoid 10.36 9.99 66 573698 15249 79155375
Thirst 10.30 9.99 85 573679 18534 79152090
End stage renal disease 10.28 9.99 49 573715 12171 79158453
Terminal state 10.27 9.99 12 573752 4877 79165747
Band neutrophil percentage increased 10.25 9.99 14 573750 415 79170209
Exposure via inhalation 10.22 9.99 8 573756 120 79170504
Pharyngitis streptococcal 10.20 9.99 120 573644 10594 79160030
Transplant failure 10.18 9.99 11 573753 4630 79165994
Eye haemorrhage 10.16 9.99 36 573728 9721 79160903
Immunoglobulin G4 related disease 10.15 9.99 11 573753 255 79170369
Allergy to plants 10.15 9.99 19 573745 740 79169884
Eczema 10.14 9.99 220 573544 40598 79130026
Granulocyte count increased 10.13 9.99 26 573738 1259 79169365
Anger 10.12 9.99 77 573687 17085 79153539
Dysphagia 10.11 9.99 749 573015 121387 79049237
Catheter management 10.08 9.99 7 573757 3656 79166968
Petit mal epilepsy 10.07 9.99 16 573748 5711 79164913
Splenomegaly 10.05 9.99 98 573666 20656 79149968
Testicular infarction 10.04 9.99 6 573758 56 79170568
Pregnancy with contraceptive device 10.03 9.99 7 573757 3647 79166977
Chills 10.02 9.99 1308 572456 158926 79011698
Obsessive-compulsive disorder 10.01 9.99 17 573747 5910 79164714

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N07XX59 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
OTHER NERVOUS SYSTEM DRUGS
Other nervous system drugs
ATC R05DA09 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50910 agente neurotoxico
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:60643 N-methyl-D-aspartate receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:146270 oneirogens
MeSH PA D000996 Antitussive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D019141 Respiratory System Agents
FDA MoA N0000181819 Uncompetitive NMDA Receptor Antagonists
FDA EPC N0000181821 Uncompetitive N-methyl-D-aspartate Receptor Antagonist
FDA MoA N0000182147 Sigma-1 Receptor Agonists
FDA EPC N0000182149 Sigma-1 Agonist

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Headache disorder indication 230461009
Sore throat symptom indication 267102003
Influenza-like symptoms indication 315642008
Major depressive disorder indication 370143000
Fever indication 386661006
Pseudobulbar affect indication 432776007
Mouth Irritation indication
Opioid withdrawal off-label use 87132004
Neurotoxicity caused by methotrexate off-label use 129666005
Metabolic alkalosis contraindication 1388004
Brain damage contraindication 2470005
Anuria contraindication 2472002 DOID:2983
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Hypocalcemia contraindication 5291005
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Hyperbilirubinemia contraindication 14783006 DOID:2741
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Mood swings contraindication 18963009
Pulmonary edema contraindication 19242006 DOID:11396
Lowered convulsive threshold contraindication 19260006
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Disorder of the central nervous system contraindication 23853001 DOID:331
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Methemoglobinemia contraindication 38959009 DOID:10783
Hypernatremia contraindication 39355002
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Paralytic ileus contraindication 55525008 DOID:8442
Left ventricular hypertrophy contraindication 55827005
Peptic reflux disease contraindication 57643001
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Poisoning by acetaminophen contraindication 70273001
Arteriosclerotic vascular disease contraindication 72092001
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Urethral stricture contraindication 76618002
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Oliguria contraindication 83128009
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Epilepsy contraindication 84757009 DOID:1826
Left heart failure contraindication 85232009
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Prolonged QT interval contraindication 111975006
Acute abdominal pain contraindication 116290004
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Deficiency of cytochrome-b>5< reductase contraindication 124184009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Hypomagnesemia contraindication 190855004
Drug-induced psychosis contraindication 191483003 DOID:1742
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Hyporeninemic hypoaldosteronism contraindication 236464008
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Rhabdomyolysis contraindication 240131006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Drowsy contraindication 271782001
Peripheral edema contraindication 271809000
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Bone marrow depression contraindication 307762000
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Traumatic injury contraindication 417746004
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Congenital long QT syndrome contraindication 442917000
Hypertensive urgency contraindication 443482000
Azotemia contraindication 445009001
Severe dehydration contraindication 450316000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20MG;10MG NUEDEXTA AVANIR PHARMS N021879 Oct. 29, 2010 RX CAPSULE ORAL 8227484 July 17, 2023 TREATMENT OF PSEUDOBULBAR AFFECT
20MG;10MG NUEDEXTA AVANIR PHARMS N021879 Oct. 29, 2010 RX CAPSULE ORAL 7659282 Aug. 13, 2026 TREATMENT OF PSEUDOBULBAR AFFECT
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 8569328 Oct. 29, 2033 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10058518 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10064857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10080727 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092560 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092561 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105327 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105361 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10251879 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10463634 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10512643 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10548857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10596167 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10772850 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786469 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786496 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10799497 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10806710 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10864209 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874663 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874664 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881624 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881657 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894046 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894047 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10898453 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10933034 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10945973 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966941 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966974 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11020389 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11058648 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11090300 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11096937 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11123343 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11129826 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141388 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141416 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11147808 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11185515 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11191739 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11197839 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11207281 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11213521 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11229640 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11234946 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253491 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253492 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273133 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273134 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285118 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285146 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291638 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298351 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298352 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11311534 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11344544 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11357744 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11364233 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11382874 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11419867 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426370 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426401 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11433067 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11439636 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11478468 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11497721 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11510918 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517542 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517543 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524007 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524008 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11534414 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541021 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541048 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11596627 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617728 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617747 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO INCREASE DEXTROMETHORPHAN PLASMA LEVELS
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9168234 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9198905 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9205083 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9238032 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9278095 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9314462 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9370513 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9375429 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9408815 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9421176 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457023 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457025 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9474731 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9486450 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700528 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700553 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9707191 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9763932 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9861595 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9867819 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9968568 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780066 Nov. 9, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780064 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10925842 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10940124 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966942 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL Aug. 18, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sigma non-opioid intracellular receptor 1 Membrane receptor AGONIST D2 6.46 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 8.84 DRUG MATRIX
Cytochrome P450 2D6 Enzyme Ks 4.48 WOMBAT-PK
Glutamate receptor ionotropic, NMDA 3A Ion channel ANTAGONIST IC50 5.70 WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2C Ion channel BLOCKER IC50 6.33 IUPHAR
Solute carrier family 22 member 1 Transporter IC50 4.98 CHEMBL
Taste receptor type 2 member 46 GPCR EC50 4.51 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.29 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane other IC50 7.82 CHEMBL
Glutamate NMDA receptor Ion channel Ki 5.65 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.89 CHEMBL

External reference:

IDSource
4020116 VUID
N0000179729 NUI
D00848 KEGG_DRUG
18609-21-7 SECONDARY_CAS_RN
6700-34-1 SECONDARY_CAS_RN
7487-74-3 SECONDARY_CAS_RN
102490 RXNORM
4018051 VANDF
4018052 VANDF
4020116 VANDF
C0011816 UMLSCUI
CHEBI:4470 CHEBI
CHEMBL52440 ChEMBL_ID
DB00514 DRUGBANK_ID
CHEMBL1256818 ChEMBL_ID
CHEMBL1201004 ChEMBL_ID
D003915 MESH_DESCRIPTOR_UI
5360696 PUBCHEM_CID
6953 IUPHAR_LIGAND_ID
166 INN_ID
7355X3ROTS UNII
18766 MMSL
44093 MMSL
4565 MMSL
4566 MMSL
73044 MMSL
d00207 MMSL
001653 NDDF
004427 NDDF
005215 NDDF
2016004 SNOMEDCT_US
387114001 SNOMEDCT_US
387237004 SNOMEDCT_US
CHEMBL1201461 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2097 SOLUTION 20 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Elderberry Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2098 SOLUTION 20 mg ORAL OTC monograph final 15 sections
CHILDRENS DIMETAPP COLD AND COUGH HUMAN OTC DRUG LABEL 3 0031-2234 LIQUID 5 mg ORAL OTC monograph final 16 sections
Robitussin Tos Seca HUMAN OTC DRUG LABEL 1 0031-8652 SYRUP 10 mg ORAL Export only 1 sections
Robitussin Tos Seca HUMAN OTC DRUG LABEL 1 0031-8652 SYRUP 10 mg ORAL Export only 1 sections
Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8655 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8655 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Robitussin CF HUMAN OTC DRUG LABEL 3 0031-8678 LIQUID 10 mg ORAL Export only 15 sections
Robitussin CF HUMAN OTC DRUG LABEL 3 0031-8678 LIQUID 10 mg ORAL Export only 15 sections
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 15 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 15 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 15 mg ORAL OTC monograph final 17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING HUMAN OTC DRUG LABEL 2 0031-8693 LIQUID 7.50 mg ORAL OTC monograph final 17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING HUMAN OTC DRUG LABEL 2 0031-8693 LIQUID 15 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Cough Long-Acting HUMAN OTC DRUG LABEL 1 0031-8694 LIQUID 7.50 mg ORAL OTC monograph final 14 sections
Childrens Robitussin Cough Long-Acting HUMAN OTC DRUG LABEL 1 0031-8694 LIQUID 7.50 mg ORAL OTC monograph final 14 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8702 LIQUID 20 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8702 LIQUID 20 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8715 LIQUID 5 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8715 LIQUID 5 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 5 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 5 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 5 mg ORAL OTC monograph final 17 sections
Robitussin Maximum Strength Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8718 SOLUTION 30 mg ORAL OTC monograph final 17 sections
Robitussin Maximum Strength Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8718 SOLUTION 30 mg ORAL OTC monograph final 17 sections
Robitussin Maximum Strength Cough Plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8719 CAPSULE, LIQUID FILLED 10 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8725 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Childrens Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8725 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Childrens Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8726 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Childrens Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8726 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections