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

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
Completed suicide 2242.08 10.05 3754 413665 130079 55744569
Toxicity to various agents 2046.81 10.05 4882 412537 219682 55654966
Infusion related reaction 859.22 10.05 3442 413977 205489 55669159
Sinusitis 722.09 10.05 3140 414279 194441 55680207
Muscle injury 582.09 10.05 1236 416183 51264 55823384
Folliculitis 575.97 10.05 1265 416154 53714 55820934
Irritable bowel syndrome 508.66 10.05 1380 416039 67078 55807570
Lower respiratory tract infection 485.39 10.05 1909 415510 112885 55761763
Exposure to toxic agent 483.07 10.05 315 417104 3363 55871285
Acute hepatic failure 474.39 10.05 600 416819 15978 55858670
Blister 405.97 10.05 1742 415677 107145 55767503
Sleep disorder due to general medical condition, insomnia type 392.89 10.05 942 416477 42396 55832252
Overdose 388.32 10.05 1685 415734 104145 55770503
Ill-defined disorder 384.70 10.05 1251 416168 67292 55807356
Duodenal ulcer perforation 372.50 10.05 1235 416184 67107 55807541
Helicobacter infection 370.35 10.05 1291 416128 71977 55802671
Blood pressure fluctuation 363.42 10.05 875 416544 39485 55835163
Anti-cyclic citrullinated peptide antibody positive 352.67 10.05 1558 415861 97042 55777606
Intentional product misuse 343.97 10.05 999 416420 50505 55824143
Pericarditis 340.09 10.05 1654 415765 107269 55767379
Impaired healing 325.69 10.05 1392 416027 85449 55789199
Injection site pain 320.27 10.05 240 417179 116878 55757770
Hepatic enzyme increased 295.92 10.05 2230 415189 169154 55705494
Nasopharyngitis 295.52 10.05 2714 414705 218245 55656403
Joint swelling 286.25 10.05 3346 414073 286454 55588194
Product dose omission issue 281.01 10.05 695 416724 204058 55670590
Metabolic acidosis 263.70 10.05 778 416641 39676 55834972
Intentional overdose 258.55 10.05 1096 416323 67021 55807627
Therapeutic product effect decreased 254.78 10.05 2136 415283 167316 55707332
Gastrointestinal disorder 234.58 10.05 1535 415884 111167 55763481
Psoriasis 232.19 10.05 207 417212 92485 55782163
Synovitis 222.46 10.05 1995 415424 159310 55715338
Stomatitis 212.93 10.05 1580 415839 119230 55755418
Hand deformity 203.50 10.05 1698 415721 132794 55741854
Hypersensitivity 201.94 10.05 2840 414579 253568 55621080
Diarrhoea 197.50 10.05 3441 413978 635066 55239582
Intentional product use issue 197.06 10.05 1341 416078 98392 55776256
Discomfort 195.28 10.05 1753 415666 140008 55734640
Swelling 190.50 10.05 2660 414759 237111 55637537
Hepatotoxicity 186.94 10.05 582 416837 30571 55844077
Anion gap 185.96 10.05 112 417307 1027 55873621
Injection site erythema 184.49 10.05 181 417238 77267 55797381
Weight increased 184.37 10.05 2553 414866 227150 55647498
Device expulsion 178.63 10.05 12 417407 30437 55844211
Body temperature increased 176.09 10.05 607 416812 33635 55841013
Wound 174.86 10.05 1684 415735 137120 55737528
Hepatic cytolysis 171.59 10.05 298 417121 10608 55864040
Medication error 162.79 10.05 684 416735 41651 55832997
Wrong technique in product usage process 155.38 10.05 122 417297 58046 55816602
Depressed level of consciousness 150.96 10.05 821 416598 55612 55819036
Sedation complication 149.68 10.05 292 417127 11380 55863268
Peripheral swelling 145.74 10.05 2498 414921 232228 55642420
Respiratory arrest 139.66 10.05 522 416897 30103 55844545
Anaemia 133.18 10.05 1304 416115 266207 55608441
Injection site reaction 132.01 10.05 120 417299 53127 55821521
Creatinine renal clearance decreased 127.12 10.05 312 417107 14247 55860401
Analgesic drug level increased 125.88 10.05 106 417313 1716 55872932
Rheumatoid factor positive 124.33 10.05 908 416511 68152 55806496
Infection 122.91 10.05 2127 415292 198079 55676569
Heart rate decreased 120.42 10.05 606 416813 39821 55834827
Blood pressure diastolic abnormal 120.39 10.05 266 417153 11332 55863316
Ear pain 120.25 10.05 501 416918 30389 55844259
Cardio-respiratory arrest 119.00 10.05 760 416659 54561 55820087
Injection site bruising 118.68 10.05 69 417350 38452 55836196
Infusion site pain 117.07 10.05 292 417127 13470 55861178
Coagulopathy 113.52 10.05 351 417068 18365 55856283
Injection site pruritus 111.91 10.05 88 417331 41843 55832805
Neutropenia 110.29 10.05 703 416716 157464 55717184
Confusional state 109.49 10.05 2159 415260 205996 55668652
Blood pressure systolic abnormal 109.22 10.05 231 417188 9546 55865102
Drug ineffective 104.15 10.05 5667 411752 913322 54961326
Pruritus 103.14 10.05 3075 414344 313548 55561100
Infusion site swelling 102.59 10.05 199 417220 7722 55866926
Disease progression 100.11 10.05 420 416999 104753 55769895
Rheumatic fever 98.06 10.05 449 416970 28378 55846270
Glossodynia 96.88 10.05 1629 415790 150829 55723819
Drug resistance 95.90 10.05 18 417401 20524 55854124
Muscle spasticity 95.87 10.05 346 417073 19614 55855034
Osteonecrosis of jaw 95.53 10.05 65 417354 33293 55841355
Drug hypersensitivity 95.27 10.05 1451 415968 273754 55600894
Infusion site extravasation 95.24 10.05 197 417222 8013 55866635
Blood calcium decreased 94.47 10.05 388 417031 23381 55851267
Blood pressure diastolic decreased 93.70 10.05 336 417083 18987 55855661
Injection site swelling 88.35 10.05 116 417303 43462 55831186
Poisoning 86.91 10.05 250 417169 12563 55862085
Drug abuse 85.90 10.05 822 416597 66788 55807860
Suicide attempt 85.14 10.05 726 416693 57110 55817538
Arthropathy 84.99 10.05 2014 415405 198261 55676387
Pyrexia 84.45 10.05 3854 413565 414919 55459729
Myocardial infarction 84.03 10.05 378 417041 92492 55782156
Infusion site erythema 81.90 10.05 204 417215 9402 55865246
Decreased appetite 81.37 10.05 1140 416279 218091 55656557
Blood pressure systolic increased 81.13 10.05 550 416869 40286 55834362
Swollen joint count increased 79.54 10.05 373 417046 23811 55850837
Nausea 79.32 10.05 4751 412668 759427 55115221
Cardiac failure congestive 78.79 10.05 358 417061 87362 55787286
Neuropathy peripheral 78.72 10.05 444 416975 102449 55772199
Oxygen saturation decreased 78.69 10.05 915 416504 78152 55796496
Hospitalisation 78.05 10.05 289 417130 74711 55799937
Blood pressure increased 78.04 10.05 1511 415908 143665 55730983
Hepatic failure 77.62 10.05 469 416950 33017 55841631
Pemphigus 77.43 10.05 1615 415804 155597 55719051
Acute lung injury 77.07 10.05 73 417346 1389 55873259
Contraindicated product administered 76.20 10.05 1864 415555 184422 55690226
Therapy cessation 75.60 10.05 55 417364 27209 55847439
Orthostatic hypotension 75.07 10.05 462 416957 32737 55841911
Cardiac failure 74.35 10.05 334 417085 81759 55792889
Hepatic necrosis 74.34 10.05 138 417281 5178 55869470
Throat irritation 73.38 10.05 454 416965 32229 55842419
Exposure via ingestion 73.08 10.05 97 417322 2711 55871937
Sopor 72.64 10.05 32 417387 20890 55853758
Dizziness 71.44 10.05 2184 415235 373956 55500692
Product quality issue 71.23 10.05 78 417341 31658 55842990
Night sweats 70.25 10.05 535 416884 40678 55833970
Infusion site pruritus 70.02 10.05 127 417292 4680 55869968
Arthralgia 69.82 10.05 4460 412959 497209 55377439
Drug interaction 69.80 10.05 1114 416305 208641 55666007
Therapeutic product effect incomplete 69.49 10.05 480 416939 105551 55769097
Cognitive disorder 69.31 10.05 611 416808 48522 55826126
Product substitution issue 67.71 10.05 13 417406 14586 55860062
Sedation 66.03 10.05 464 416955 34390 55840258
Abortion spontaneous 65.98 10.05 141 417278 43612 55831036
Injection site warmth 65.39 10.05 13 417406 14230 55860418
Feeling abnormal 64.81 10.05 655 416764 132947 55741701
Cerebrovascular accident 64.75 10.05 450 416969 98820 55775828
Contusion 64.09 10.05 1322 416097 127108 55747540
Bone marrow failure 64.06 10.05 69 417350 28217 55846431
Respiratory depression 63.54 10.05 220 417199 12215 55862433
Drug intolerance 63.16 10.05 2481 414938 262337 55612311
Malignant neoplasm progression 62.74 10.05 306 417113 73281 55801367
Device malfunction 62.12 10.05 21 417398 16115 55858533
Suspected suicide 62.05 10.05 130 417289 5336 55869312
Paraesthesia 61.20 10.05 645 416774 129869 55744779
Diabetes mellitus 60.40 10.05 195 417224 52540 55822108
Device dislocation 59.62 10.05 48 417371 22558 55852090
White blood cell count decreased 58.93 10.05 623 416796 125367 55749281
Pancytopenia 58.43 10.05 401 417018 88314 55786334
Pyroglutamate increased 57.69 10.05 37 417382 383 55874265
Respiratory disorder 56.31 10.05 438 416981 33519 55841129
Pyroglutamic acidosis 55.83 10.05 38 417381 438 55874210
Muscle spasms 53.93 10.05 706 416713 136665 55737983
Neoplasm progression 53.61 10.05 97 417322 31919 55842729
Seizure 52.88 10.05 633 416786 124486 55750162
Mucosal inflammation 52.81 10.05 153 417266 42657 55831991
Plasma cell myeloma 52.38 10.05 174 417245 46472 55828176
Heart rate increased 52.20 10.05 888 416531 82385 55792263
Palmar-plantar erythrodysaesthesia syndrome 51.58 10.05 48 417371 21017 55853631
Injection site rash 51.35 10.05 31 417388 16927 55857721
Product storage error 51.21 10.05 17 417402 13196 55861452
Renal impairment 51.11 10.05 369 417050 80344 55794304
Mobility decreased 51.04 10.05 1024 416395 97967 55776681
Electric shock 50.84 10.05 51 417368 1044 55873604
Systemic lupus erythematosus 50.67 10.05 1719 415700 178359 55696289
Bone pain 50.51 10.05 196 417223 49989 55824659
Infusion site bruising 49.84 10.05 81 417338 2728 55871920
Surgery 49.56 10.05 104 417315 32382 55842266
Oedema peripheral 49.40 10.05 933 416486 170321 55704327
Injection site mass 49.05 10.05 32 417387 16761 55857887
Acute kidney injury 48.86 10.05 1385 416034 239378 55635270
Red blood cell sedimentation rate abnormal 48.81 10.05 40 417379 18633 55856015
No adverse event 48.61 10.05 125 417294 36249 55838399
Injection site urticaria 48.58 10.05 17 417402 12766 55861882
Accidental overdose 48.33 10.05 288 417131 20173 55854475
Epilepsy 48.29 10.05 70 417349 25161 55849487
Device issue 47.22 10.05 52 417367 21054 55853594
Injection site haemorrhage 47.18 10.05 57 417362 22144 55852504
Poor venous access 46.65 10.05 198 417221 12108 55862540
Hyperkalaemia 46.01 10.05 207 417212 50658 55823990
Rash 45.80 10.05 4247 413172 488800 55385848
Heart rate irregular 45.64 10.05 286 417133 20393 55854255
Coma 45.30 10.05 657 416762 58998 55815650
Depression 45.20 10.05 1004 416415 179113 55695535
Transient ischaemic attack 45.17 10.05 115 417304 33462 55841186
Accidental exposure to product 44.65 10.05 71 417348 24576 55850072
Blood parathyroid hormone decreased 44.44 10.05 5 417414 8359 55866289
Suicidal ideation 44.23 10.05 249 417170 57493 55817155
Epistaxis 44.10 10.05 303 417116 66720 55807928
Methaemoglobinaemia 43.43 10.05 66 417353 2096 55872552
Device difficult to use 43.21 10.05 13 417406 10748 55863900
Interstitial lung disease 43.21 10.05 247 417172 56816 55817832
Poisoning deliberate 43.18 10.05 167 417252 9786 55864862
Multiple sclerosis relapse 42.90 10.05 179 417240 44724 55829924
Product prescribing error 42.75 10.05 66 417353 23120 55851528
Memory impairment 42.10 10.05 424 416995 86133 55788515
Leukopenia 41.75 10.05 331 417088 70609 55804039
Rash pruritic 41.27 10.05 225 417194 52369 55822279
Anion gap abnormal 41.27 10.05 28 417391 321 55874327
Dehydration 41.09 10.05 881 416538 157944 55716704
Breast cancer female 41.09 10.05 20 417399 12318 55862330
Breast cancer 41.08 10.05 204 417215 48629 55826019
Pain 40.98 10.05 5562 411857 657622 55217026
Body temperature decreased 40.94 10.05 252 417167 17856 55856792
Foetal exposure during pregnancy 40.91 10.05 122 417297 33701 55840947
Posterior reversible encephalopathy syndrome 40.72 10.05 35 417384 15925 55858723
Myelodysplastic syndrome 40.62 10.05 37 417382 16369 55858279
Blood cholesterol increased 40.19 10.05 759 416660 71820 55802828
Crystal urine present 39.89 10.05 54 417365 1539 55873109
Administration site swelling 39.84 10.05 45 417374 1060 55873588
Pulmonary arterial hypertension 39.47 10.05 86 417333 26417 55848231
Vision blurred 39.23 10.05 409 417010 82534 55792114
White blood cells urine positive 38.87 10.05 100 417319 4702 55869946
Liver injury 38.86 10.05 478 416941 41370 55833278
Blood pressure diastolic increased 38.26 10.05 145 417274 8416 55866232
Granuloma skin 38.01 10.05 4 417415 7047 55867601
Hypokalaemia 37.92 10.05 483 416936 93954 55780694
Myelosuppression 36.90 10.05 45 417374 17410 55857238
Hyponatraemia 36.83 10.05 534 416885 101605 55773043
Gastrooesophageal reflux disease 36.80 10.05 417 417002 82840 55791808
Gastrointestinal haemorrhage 36.55 10.05 373 417046 75578 55799070
Urine abnormality 36.41 10.05 121 417298 6578 55868070
Infusion site haemorrhage 36.39 10.05 83 417336 3612 55871036
Psoriatic arthropathy 36.21 10.05 362 417057 73646 55801002
Platelet count decreased 36.02 10.05 563 416856 105820 55768828
Dry skin 35.62 10.05 204 417215 46905 55827743
Disturbance in attention 35.43 10.05 123 417296 32417 55842231
Thrombocytopenia 35.42 10.05 755 416664 135469 55739179
Alanine aminotransferase increased 35.24 10.05 927 416492 92735 55781913
Anticipatory anxiety 35.15 10.05 41 417378 1001 55873647
Myalgia 35.12 10.05 729 416690 131296 55743352
Dyspnoea exertional 35.11 10.05 249 417170 54440 55820208
Ear pruritus 34.84 10.05 71 417348 2857 55871791
Macular degeneration 34.81 10.05 250 417169 18658 55855990
Administration site pain 34.79 10.05 35 417384 719 55873929
Underdose 34.63 10.05 78 417341 23679 55850969
Hypercalcaemia 34.21 10.05 87 417332 25324 55849324
International normalised ratio increased 33.82 10.05 486 416933 43555 55831093
Injection site induration 33.54 10.05 11 417408 8604 55866044
Therapeutic response decreased 33.49 10.05 241 417178 52517 55822131
Infusion site nodule 33.47 10.05 44 417375 1218 55873430
Hypotension 33.42 10.05 2220 415199 248288 55626360
Tremor 33.29 10.05 665 416754 120424 55754224
Pain in extremity 33.19 10.05 1835 415584 295596 55579052
Hyperlipidaemia 32.96 10.05 52 417367 18057 55856591
Syncope 32.58 10.05 585 416834 107614 55767034
Drug use disorder 32.54 10.05 92 417327 4577 55870071
Type 2 diabetes mellitus 32.43 10.05 508 416911 46354 55828294
Atrial fibrillation 32.40 10.05 590 416829 108307 55766341
Multiple drug therapy 32.39 10.05 67 417352 2725 55871923
Respiratory rate increased 32.01 10.05 177 417242 12060 55862588
Hypocalcaemia 31.79 10.05 108 417311 28652 55845996
Diabetic ketoacidosis 31.75 10.05 57 417362 18814 55855834
Fracture 31.61 10.05 53 417366 17965 55856683
Burning sensation 31.61 10.05 221 417198 48475 55826173
Basal cell carcinoma 31.21 10.05 90 417329 25131 55849517
Visual acuity reduced 31.07 10.05 67 417352 20659 55853989
Incorrect drug administration rate 30.99 10.05 71 417348 3099 55871549
Therapeutic response unexpected 30.96 10.05 49 417370 16995 55857653
Cytomegalovirus infection 30.95 10.05 60 417359 19236 55855412
Femur fracture 30.89 10.05 168 417251 39127 55835521
Osteonecrosis 30.85 10.05 80 417339 23135 55851513
Urticaria 30.67 10.05 1339 416080 143337 55731311
Urine leukocyte esterase positive 30.52 10.05 70 417349 3058 55871590
Gait disturbance 30.49 10.05 950 416469 162371 55712277
Soft tissue disorder 30.45 10.05 85 417334 4197 55870451
Gestational diabetes 30.18 10.05 11 417408 8053 55866595
Drug withdrawal syndrome 30.03 10.05 95 417324 25762 55848886
Therapy interrupted 29.87 10.05 94 417325 25531 55849117
Full blood count decreased 29.86 10.05 82 417337 23267 55851381
Palpitations 29.66 10.05 540 416879 99132 55775516
Second primary malignancy 29.62 10.05 9 417410 7393 55867255
Blood glucose increased 29.56 10.05 386 417033 74765 55799883
Toxicologic test abnormal 29.45 10.05 31 417388 673 55873975
Lymphocyte count decreased 29.43 10.05 327 417092 27612 55847036
Jaundice cholestatic 29.38 10.05 99 417320 5420 55869228
Skin necrosis 29.29 10.05 29 417390 12332 55862316
Infusion site mass 29.20 10.05 45 417374 1447 55873201
Urinary sediment present 29.02 10.05 54 417365 2030 55872618
Complication associated with device 28.97 10.05 43 417376 15307 55859341
Cytokine release syndrome 28.92 10.05 158 417261 10717 55863931
Full blood count abnormal 28.83 10.05 100 417319 26362 55848286
Injury 28.82 10.05 613 416806 59238 55815410
Haematotoxicity 28.82 10.05 13 417406 8370 55866278
Hypertensive crisis 28.82 10.05 37 417382 13999 55860649
Pulmonary hypertension 28.62 10.05 153 417266 35791 55838857
Metastases to bone 28.47 10.05 64 417355 19444 55855204
Panniculitis 28.42 10.05 19 417400 9823 55864825
Cardiac arrest 28.19 10.05 839 416580 85475 55789173
Disease recurrence 28.18 10.05 87 417332 23773 55850875
Spinal stenosis 27.69 10.05 38 417381 13976 55860672
Red blood cells urine positive 27.58 10.05 65 417354 2891 55871757
Ageusia 27.50 10.05 31 417388 12420 55862228
Neutrophil percentage increased 27.45 10.05 63 417356 2753 55871895
Coronary artery disease 27.45 10.05 126 417293 30670 55843978
Lactic acidosis 27.30 10.05 152 417267 35194 55839454
Sepsis 27.19 10.05 809 416610 139031 55735617
Extrapyramidal disorder 27.03 10.05 31 417388 12325 55862323
Unevaluable event 26.91 10.05 225 417194 47462 55827186
Lymphocyte percentage decreased 26.89 10.05 63 417356 2791 55871857
Metastases to liver 26.73 10.05 77 417342 21509 55853139
Breast cancer metastatic 26.68 10.05 46 417373 15423 55859225
Schizoaffective disorder 26.60 10.05 64 417355 2885 55871763
Bursitis 26.45 10.05 317 417102 27265 55847383
Fall 26.38 10.05 2287 415132 355223 55519425
Genital haemorrhage 26.30 10.05 9 417410 6853 55867795
Malaise 26.01 10.05 2361 415058 365499 55509149
Haemorrhage 25.89 10.05 280 417139 56117 55818531
Loss of consciousness 25.87 10.05 615 416804 108734 55765914
Substance abuse 25.73 10.05 83 417336 4442 55870206
Vaginal haemorrhage 25.36 10.05 101 417318 25572 55849076
Pneumocystis jirovecii pneumonia 25.03 10.05 49 417370 15652 55858996
Renal failure 24.91 10.05 626 416793 109874 55764774
Asthma 24.85 10.05 641 416778 112129 55762519
Hepatic cirrhosis 24.78 10.05 78 417341 21185 55853463
Product use in unapproved indication 24.64 10.05 826 416593 139996 55734652
Specific gravity urine decreased 24.61 10.05 29 417390 716 55873932
Pathogen resistance 24.55 10.05 7 417412 5993 55868655
Dysgeusia 24.49 10.05 190 417229 40725 55833923
Intervertebral discitis 24.34 10.05 60 417359 2747 55871901
Lupus-like syndrome 24.25 10.05 34 417385 12393 55862255
Irritability 24.09 10.05 125 417294 29463 55845185
Dermatitis atopic 23.99 10.05 16 417403 8283 55866365
Musculoskeletal disorder 23.93 10.05 68 417351 19079 55855569
Transplant rejection 23.89 10.05 23 417396 9911 55864737
Heavy menstrual bleeding 23.80 10.05 53 417366 16156 55858492
Red cell distribution width increased 23.70 10.05 134 417285 9206 55865442
Withdrawal syndrome 23.49 10.05 65 417354 18397 55856251
Blood pH decreased 23.44 10.05 55 417364 2439 55872209
Aphasia 23.38 10.05 131 417288 30284 55844364
Metastases to lymph nodes 23.28 10.05 13 417406 7410 55867238
Facet joint syndrome 23.12 10.05 105 417314 6612 55868036
Joint stiffness 22.88 10.05 161 417258 35264 55839384
Drug-induced liver injury 22.87 10.05 371 417048 34091 55840557
Body temperature fluctuation 22.87 10.05 49 417370 2043 55872605
Premature delivery 22.78 10.05 113 417306 26947 55847701
Analgesic drug level above therapeutic 22.70 10.05 15 417404 164 55874484
Infusion site irritation 22.59 10.05 27 417392 677 55873971
Electrolyte imbalance 22.57 10.05 64 417355 17969 55856679
Fear of injection 22.56 10.05 10 417409 6505 55868143
Unresponsive to stimuli 22.36 10.05 345 417074 31380 55843268
Injection site discolouration 22.36 10.05 13 417406 7246 55867402
Skin ulcer 22.31 10.05 181 417238 38427 55836221
Skin exfoliation 22.25 10.05 171 417248 36729 55837919
Ascites 22.16 10.05 175 417244 37369 55837279
Therapeutic response shortened 22.09 10.05 132 417287 9254 55865394
Metastases to lung 21.95 10.05 33 417386 11685 55862963
Forced expiratory volume decreased 21.93 10.05 4 417415 4656 55869992
Inappropriate antidiuretic hormone secretion 21.86 10.05 43 417376 13713 55860935
Tinnitus 21.70 10.05 132 417287 29910 55844738
Cardiomyopathy 21.62 10.05 56 417363 16202 55858446
Iron deficiency anaemia 21.40 10.05 65 417354 17854 55856794
Neurotoxicity 21.32 10.05 54 417365 15741 55858907
Cerebral infarction 21.32 10.05 90 417329 22415 55852233
Vaginal flatulence 21.29 10.05 26 417393 667 55873981
Drug ineffective for unapproved indication 21.22 10.05 108 417311 25585 55849063
Upper respiratory tract infection 21.17 10.05 685 416734 70603 55804045
Hypomania 21.06 10.05 82 417337 4820 55869828
Status epilepticus 21.03 10.05 51 417368 15090 55859558
Cardiac disorder 20.99 10.05 228 417191 45659 55828989
Blood creatine increased 20.99 10.05 85 417334 5088 55869560
Akathisia 20.85 10.05 20 417399 8632 55866016
Treatment noncompliance 20.71 10.05 149 417270 32474 55842174
Liver transplant 20.68 10.05 49 417370 2187 55872461
Thrombosis 20.61 10.05 313 417106 59114 55815534
Aspartate aminotransferase increased 20.61 10.05 778 416641 81824 55792824
Acidosis 20.59 10.05 141 417278 10360 55864288
Ductus arteriosus premature closure 20.37 10.05 18 417401 312 55874336
Sensitivity to weather change 20.35 10.05 12 417407 6637 55868011
Abdominal distension 20.23 10.05 430 416989 77196 55797452
Anion gap increased 20.13 10.05 39 417380 1512 55873136
Hyperglycaemia 20.10 10.05 184 417235 38097 55836551
Tardive dyskinesia 20.02 10.05 18 417401 8013 55866635
Ventricular extrasystoles 19.98 10.05 31 417388 10839 55863809
Post transplant lymphoproliferative disorder 19.97 10.05 5 417414 4667 55869981
Infusion site discomfort 19.86 10.05 32 417387 1070 55873578
Cerebral haemorrhage 19.47 10.05 128 417291 28478 55846170
Carpal tunnel syndrome 19.47 10.05 69 417350 18075 55856573
Infusion site urticaria 19.44 10.05 34 417385 1217 55873431
Oral discomfort 19.34 10.05 20 417399 8335 55866313
Acute myeloid leukaemia 19.26 10.05 63 417356 16909 55857739
Brain oedema 19.21 10.05 166 417253 13105 55861543
Acute myocardial infarction 19.21 10.05 139 417280 30254 55844394
Osteoarthritis 19.16 10.05 451 416968 79845 55794803
Administration site erythema 19.08 10.05 23 417396 582 55874066
Brain death 19.08 10.05 57 417362 2926 55871722
Fluid retention 19.04 10.05 284 417135 53794 55820854
Complication of device removal 18.90 10.05 5 417414 4499 55870149
Bone erosion 18.84 10.05 53 417366 14921 55859727
Product adhesion issue 18.77 10.05 5 417414 4478 55870170
Thinking abnormal 18.61 10.05 28 417391 9913 55864735
Labelled drug-drug interaction medication error 18.60 10.05 36 417383 11550 55863098
Prothrombin time prolonged 18.57 10.05 123 417296 8937 55865711
Ankylosing spondylitis 18.56 10.05 28 417391 9902 55864746
Febrile bone marrow aplasia 18.56 10.05 13 417406 6559 55868089
Chronic kidney disease 18.43 10.05 211 417208 41845 55832803
Rheumatoid nodule 18.39 10.05 53 417366 14804 55859844
Coagulation factor X level decreased 18.38 10.05 10 417409 74 55874574
Anxiety 18.30 10.05 1210 416209 191962 55682686
Thrombotic microangiopathy 18.12 10.05 26 417393 9385 55865263
Hypothermia 18.06 10.05 156 417263 12314 55862334
Septic shock 17.96 10.05 330 417089 60505 55814143
Postmortem blood drug level increased 17.85 10.05 22 417397 570 55874078
Complication of device insertion 17.76 10.05 13 417406 6411 55868237
Low turnover osteopathy 17.70 10.05 4 417415 4004 55870644
Device breakage 17.66 10.05 30 417389 10117 55864531
Deafness 17.52 10.05 63 417356 16431 55858217
Multiple-drug resistance 17.48 10.05 4 417415 3970 55870678
Vital capacity decreased 17.47 10.05 33 417386 1255 55873393
Renal failure neonatal 17.36 10.05 13 417406 176 55874472
Coagulation factor VII level decreased 17.33 10.05 10 417409 84 55874564
Polyneuropathy 17.32 10.05 45 417374 13005 55861643
Blood urine present 17.30 10.05 165 417254 13390 55861258
Neuroleptic malignant syndrome 17.29 10.05 37 417382 11441 55863207
Intermenstrual bleeding 17.22 10.05 16 417403 7011 55867637
Epstein-Barr virus infection 17.13 10.05 18 417401 7445 55867203
Skin burning sensation 17.09 10.05 35 417384 10996 55863652
Infusion site rash 17.07 10.05 37 417382 1555 55873093
Laboratory test abnormal 17.06 10.05 110 417309 24585 55850063
Sputum culture positive 17.06 10.05 39 417380 1700 55872948
Post procedural pulmonary embolism 17.02 10.05 15 417404 259 55874389
Blood potassium decreased 16.96 10.05 194 417225 38478 55836170
Cardiotoxicity 16.95 10.05 19 417400 7631 55867017
Transplant dysfunction 16.89 10.05 7 417412 4739 55869909
Accidental death 16.78 10.05 40 417379 1792 55872856
Caesarean section 16.73 10.05 62 417357 16029 55858619
Pharyngeal paraesthesia 16.73 10.05 38 417381 1649 55872999
Impaired quality of life 16.72 10.05 23 417396 8451 55866197
Band neutrophil count increased 16.71 10.05 17 417402 354 55874294
Maternal exposure timing unspecified 16.64 10.05 82 417337 5341 55869307
Hypothyroidism 16.60 10.05 192 417227 38004 55836644
Drug screen positive 16.59 10.05 60 417359 3404 55871244
Unintended pregnancy 16.41 10.05 9 417410 5182 55869466
Nervous system disorder 16.33 10.05 67 417352 16822 55857826
Macular oedema 16.33 10.05 4 417415 3790 55870858
Osmolar gap 16.31 10.05 10 417409 95 55874553
Temperature regulation disorder 16.25 10.05 71 417348 4397 55870251
Lung neoplasm malignant 16.21 10.05 70 417349 17326 55857322
Invasive ductal breast carcinoma 16.19 10.05 16 417403 6810 55867838
Angina unstable 16.17 10.05 16 417403 6805 55867843
Renal disorder 16.11 10.05 141 417278 29464 55845184
Low density lipoprotein increased 16.09 10.05 12 417407 5862 55868786
Drug level below therapeutic 16.04 10.05 69 417350 4244 55870404
Product complaint 16.03 10.05 40 417379 11720 55862928
Colorectal cancer 16.02 10.05 3 417416 3426 55871222
Diffuse large B-cell lymphoma 16.01 10.05 17 417402 6999 55867649
Dysphoria 15.89 10.05 8 417411 4834 55869814
Administration site bruise 15.89 10.05 16 417403 329 55874319
Ear infection 15.87 10.05 323 417096 30972 55843676
Hallucination, auditory 15.86 10.05 39 417380 11485 55863163
Bacterial test 15.84 10.05 30 417389 1143 55873505
Right ventricular failure 15.82 10.05 65 417354 16314 55858334
Vertigo 15.81 10.05 297 417122 54275 55820373
Taste disorder 15.76 10.05 30 417389 9685 55864963
Pneumonia streptococcal 15.62 10.05 37 417382 1651 55872997
COVID-19 pneumonia 15.62 10.05 138 417281 10964 55863684
Respiratory failure 15.60 10.05 562 416857 94500 55780148
Dysphonia 15.57 10.05 218 417201 41729 55832919
Hypoaesthesia 15.55 10.05 874 416545 140617 55734031
Concomitant disease aggravated 15.52 10.05 24 417395 8402 55866246
Breast cancer stage II 15.47 10.05 12 417407 5746 55868902
Neutrophil count decreased 15.42 10.05 268 417151 49554 55825094
Pregnancy with contraceptive device 15.26 10.05 6 417413 4193 55870455
Parosmia 15.14 10.05 8 417411 4703 55869945
Acute graft versus host disease 15.11 10.05 6 417413 4169 55870479
Galactorrhoea 15.11 10.05 5 417414 3890 55870758
Hypomagnesaemia 15.05 10.05 116 417303 24899 55849749
Skin toxicity 14.98 10.05 6 417413 4147 55870501
Diplopia 14.97 10.05 89 417330 20280 55854368
Hepatitis cholestatic 14.97 10.05 90 417329 6324 55868324
Bradypnoea 14.94 10.05 55 417364 3148 55871500
Pain in jaw 14.88 10.05 208 417211 39828 55834820
Brain stem glioma 14.82 10.05 13 417406 223 55874425
Vein collapse 14.77 10.05 25 417394 871 55873777
Renal papillary necrosis 14.77 10.05 13 417406 224 55874424
Abnormal dreams 14.62 10.05 31 417388 9618 55865030
Chest pain 14.59 10.05 1210 416209 188587 55686061
Congestive cardiomyopathy 14.55 10.05 13 417406 5806 55868842
Pericardial effusion 14.54 10.05 130 417289 27045 55847603
Aplasia pure red cell 14.52 10.05 7 417412 4335 55870313
Product residue present 14.50 10.05 5 417414 3790 55870858
Drug level increased 14.46 10.05 225 417194 20500 55854148
Pancreatitis 14.44 10.05 241 417178 44839 55829809
Ischaemic stroke 14.37 10.05 70 417349 16772 55857876
Amenorrhoea 14.36 10.05 28 417391 8958 55865690
Mean cell haemoglobin concentration increased 14.32 10.05 18 417401 476 55874172
Haemophagocytic lymphohistiocytosis 14.30 10.05 31 417388 9541 55865107
Atypical femur fracture 14.23 10.05 10 417409 5037 55869611
Balance disorder 14.22 10.05 699 416720 75821 55798827
Mood swings 14.06 10.05 70 417349 16677 55857971
Disorientation 14.05 10.05 189 417230 36424 55838224
Smear cervix abnormal 14.03 10.05 49 417370 2732 55871916
Shoulder arthroplasty 14.00 10.05 5 417414 3708 55870940
Eosinophil percentage increased 13.96 10.05 26 417393 978 55873670
Device leakage 13.94 10.05 16 417403 6359 55868289
Rhinitis allergic 13.90 10.05 26 417393 8448 55866200
Drug eruption 13.89 10.05 123 417296 25640 55849008
Arrhythmia 13.86 10.05 180 417239 34903 55839745
Generalised tonic-clonic seizure 13.83 10.05 134 417285 27432 55847216
Ductus arteriosus stenosis foetal 13.81 10.05 11 417408 164 55874484
Hallucination 13.77 10.05 269 417150 48880 55825768
Cells in urine 13.77 10.05 12 417407 204 55874444
Swollen tongue 13.74 10.05 151 417268 30173 55844475
Blood creatinine decreased 13.70 10.05 75 417344 5091 55869557
COVID-19 immunisation 13.70 10.05 32 417387 1415 55873233
Dyskinesia 13.57 10.05 144 417275 28964 55845684
Urine analysis abnormal 13.54 10.05 70 417349 4647 55870001
Haemarthrosis 13.52 10.05 3 417416 3041 55871607
Disturbance in social behaviour 13.50 10.05 3 417416 3038 55871610
Affective disorder 13.44 10.05 13 417406 5590 55869058
Prothrombin time shortened 13.41 10.05 36 417383 1737 55872911
Ejection fraction decreased 13.39 10.05 89 417330 19752 55854896
Off label use 13.38 10.05 3798 413621 552382 55322266
Haematochezia 13.27 10.05 236 417183 43482 55831166
Metastases to peritoneum 13.26 10.05 3 417416 3001 55871647
Myelocyte count increased 13.23 10.05 15 417404 355 55874293
Haematuria 13.20 10.05 132 417287 26855 55847793
Speech disorder 13.16 10.05 197 417222 37296 55837352
Transfusion-related acute lung injury 13.06 10.05 9 417410 106 55874542
Aspergillus infection 13.06 10.05 22 417397 7443 55867205
Systemic infection 13.03 10.05 4 417415 3265 55871383
Product preparation error 12.98 10.05 10 417409 4806 55869842
Pancreatic carcinoma 12.98 10.05 21 417398 7220 55867428
Ketoacidosis 12.98 10.05 7 417412 4068 55870580
Head injury 12.94 10.05 121 417298 24945 55849703
Flatulence 12.93 10.05 159 417260 31129 55843519
Hepatitis acute 12.87 10.05 106 417313 8251 55866397
Opiates positive 12.87 10.05 15 417404 366 55874282
Thyroid neoplasm 12.86 10.05 6 417413 3787 55870861
Erysipelas 12.85 10.05 21 417398 7192 55867456
Administration site pruritus 12.85 10.05 13 417406 269 55874379
Dystonia 12.82 10.05 48 417371 12373 55862275
COVID-19 12.79 10.05 680 416739 74378 55800270
White coat hypertension 12.75 10.05 19 417400 593 55874055
Malignant melanoma 12.72 10.05 39 417380 10680 55863968
Vitamin K deficiency 12.70 10.05 16 417403 424 55874224
Anti-cyclic citrullinated peptide antibody 12.67 10.05 58 417361 3665 55870983
Lip dry 12.65 10.05 119 417300 9621 55865027
Vitamin D deficiency 12.59 10.05 47 417372 12123 55862525
Haemoglobin urine present 12.55 10.05 22 417397 789 55873859
Peripheral venous disease 12.53 10.05 122 417297 9957 55864691
Sleep apnoea syndrome 12.52 10.05 128 417291 25933 55848715
Nail bed inflammation 12.52 10.05 15 417404 377 55874271
Device failure 12.50 10.05 14 417405 5625 55869023
Uterine perforation 12.49 10.05 18 417401 6487 55868161
Reversible airways obstruction 12.44 10.05 30 417389 1354 55873294
Skin lesion 12.39 10.05 141 417278 27994 55846654
Necrosis ischaemic 12.39 10.05 22 417397 797 55873851
Cystic fibrosis 12.39 10.05 5 417414 3439 55871209
Foot operation 12.38 10.05 17 417402 6250 55868398
Partial seizures 12.37 10.05 13 417406 5377 55869271
Electrocardiogram QT prolonged 12.36 10.05 309 417110 54279 55820369
Intervertebral disc degeneration 12.30 10.05 59 417360 14195 55860453
Pre-eclampsia 12.25 10.05 28 417391 8458 55866190
Blindness 12.25 10.05 83 417336 18338 55856310
Torsade de pointes 12.25 10.05 49 417370 12391 55862257
Rheumatoid lung 12.24 10.05 4 417415 3136 55871512
Ventricular fibrillation 12.19 10.05 41 417378 10911 55863737
X-ray abnormal 12.17 10.05 64 417355 4277 55870371
Thyroid cancer 12.13 10.05 12 417407 5104 55869544
Culture urine positive 12.03 10.05 55 417364 3473 55871175
Device related infection 12.00 10.05 104 417315 21776 55852872
Mitral valve incompetence 11.97 10.05 82 417337 18071 55856577
Cardiovascular disorder 11.96 10.05 41 417378 10848 55863800
Body height decreased 11.94 10.05 32 417387 9153 55865495
Obstructive airways disorder 11.93 10.05 77 417342 17205 55857443
Alpha 1 microglobulin increased 11.92 10.05 7 417412 61 55874587
Haemoglobin decreased 11.90 10.05 845 416574 133292 55741356
Device deployment issue 11.88 10.05 6 417413 3618 55871030
Haemolysis 11.84 10.05 84 417335 6244 55868404
Fibromyalgia 11.82 10.05 548 416871 59055 55815593
Weight decreased 11.81 10.05 1584 415835 239130 55635518
Dyslipidaemia 11.79 10.05 18 417401 6335 55868313
Deep vein thrombosis 11.76 10.05 459 416960 76518 55798130
Therapy change 11.76 10.05 14 417405 5474 55869174
Injury associated with device 11.73 10.05 5 417414 3328 55871320
Pleural effusion 11.72 10.05 516 416903 84964 55789684
Mood altered 11.69 10.05 55 417364 13300 55861348
Glycosylated haemoglobin increased 11.62 10.05 43 417376 11122 55863526
Immune reconstitution inflammatory syndrome 11.60 10.05 15 417404 5659 55868989
Eczema 11.54 10.05 131 417288 26022 55848626
Juvenile idiopathic arthritis 11.54 10.05 11 417408 4762 55869886
Osteomyelitis 11.53 10.05 120 417299 24226 55850422
Asphyxia 11.51 10.05 78 417341 5711 55868937
Left ventricular dysfunction 11.47 10.05 43 417376 11080 55863568
Cardiac failure acute 11.47 10.05 31 417388 8842 55865806
Device related thrombosis 11.45 10.05 32 417387 1581 55873067
Hypersensitivity vasculitis 11.44 10.05 8 417411 4040 55870608
Lip swelling 11.44 10.05 132 417287 26140 55848508
Blood immunoglobulin E increased 11.44 10.05 4 417415 3005 55871643
Intestinal haemorrhage 11.43 10.05 6 417413 3540 55871108
Coronary arterial stent insertion 11.39 10.05 3 417416 2707 55871941
Embedded device 11.34 10.05 4 417415 2989 55871659
Small for dates baby 11.34 10.05 6 417413 3524 55871124
Chronic graft versus host disease 11.27 10.05 5 417414 3251 55871397
Metastases to central nervous system 11.21 10.05 49 417370 12087 55862561
Pneumonia aspiration 11.14 10.05 171 417248 32240 55842408
Pneumonia viral 11.14 10.05 91 417328 7067 55867581
Bradyphrenia 11.13 10.05 20 417399 6600 55868048
Maternal exposure before pregnancy 11.13 10.05 21 417398 6802 55867846
Movement disorder 11.09 10.05 90 417329 19108 55855540
Coma hepatic 11.06 10.05 18 417401 607 55874041
Band neutrophil percentage increased 11.05 10.05 11 417408 223 55874425
Beta haemolytic streptococcal infection 11.00 10.05 35 417384 1859 55872789
Administration site extravasation 10.97 10.05 20 417399 740 55873908
Graft versus host disease 10.95 10.05 21 417398 6760 55867888
Deep vein thrombosis postoperative 10.94 10.05 59 417360 3982 55870666
Patent ductus arteriosus 10.91 10.05 8 417411 3943 55870705
Gout 10.89 10.05 50 417369 12171 55862477
Hypocoagulable state 10.88 10.05 24 417395 1021 55873627
Peripheral sensory neuropathy 10.84 10.05 22 417397 6934 55867714
Traumatic liver injury 10.82 10.05 12 417407 277 55874371
Abortion induced 10.81 10.05 36 417383 9609 55865039
Base excess 10.71 10.05 7 417412 75 55874573
Skin cancer 10.70 10.05 40 417379 10315 55864333
Allergy to chemicals 10.70 10.05 41 417378 2392 55872256
Inflammation 10.64 10.05 620 416799 68451 55806197
Cardiogenic shock 10.64 10.05 74 417345 16251 55858397
Nightmare 10.61 10.05 77 417342 16749 55857899
Bronchopulmonary aspergillosis 10.58 10.05 29 417390 8235 55866413
Enthesopathy 10.55 10.05 28 417391 8035 55866613
Priapism 10.48 10.05 7 417412 78 55874570
Eye pruritus 10.48 10.05 62 417357 14144 55860504
Eating disorder 10.44 10.05 79 417340 17026 55857622
Hip fracture 10.43 10.05 139 417280 26834 55847814
Loss of personal independence in daily activities 10.39 10.05 495 416924 80874 55793774
Limb discomfort 10.37 10.05 137 417282 26485 55848163
Gastrointestinal pain 10.37 10.05 32 417387 8745 55865903
Dysphagia 10.37 10.05 499 416920 81448 55793200
Spinal pain 10.37 10.05 49 417370 11835 55862813
Antidepressant drug level above therapeutic 10.34 10.05 14 417405 399 55874249
Intentional self-injury 10.33 10.05 127 417292 24865 55849783
Focal dyscognitive seizures 10.33 10.05 4 417415 2821 55871827
Haemorrhage intracranial 10.32 10.05 54 417365 12701 55861947
Skin infection 10.28 10.05 146 417273 13049 55861599
Potentiating drug interaction 10.27 10.05 9 417410 4057 55870591
Tricuspid valve incompetence 10.23 10.05 57 417362 13196 55861452
Urine oxalate increased 10.23 10.05 11 417408 245 55874403
Bronchospasm 10.22 10.05 71 417348 15598 55859050
Paradoxical drug reaction 10.21 10.05 8 417411 3812 55870836
Agranulocytosis 10.20 10.05 113 417306 22546 55852102
Eructation 10.20 10.05 26 417393 7562 55867086
Diaphragmatic rupture 10.12 10.05 11 417408 248 55874400
Respiratory symptom 10.12 10.05 4 417415 2786 55871862
Jaw fracture 10.08 10.05 3 417416 2497 55872151
Uterine cancer 10.06 10.05 11 417408 4468 55870180

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1198.75 10.30 1913 166604 89601 31439226
Toxicity to various agents 1173.14 10.30 2814 165703 178673 31350154
Infusion related reaction 433.14 10.30 854 167663 47201 31481626
Blood pressure fluctuation 392.68 10.30 542 167975 22194 31506633
Overdose 342.41 10.30 1109 167408 83555 31445272
Intentional product misuse 325.77 10.30 661 167856 37290 31491537
Exposure to toxic agent 275.84 10.30 172 168345 2423 31526404
Drug abuse 273.38 10.30 1055 167462 86703 31442124
Acute hepatic failure 259.65 10.30 331 168186 12528 31516299
Intentional overdose 242.78 10.30 620 167897 40769 31488058
Drug ineffective 233.91 10.30 1197 167320 394376 31134451
Heart rate decreased 187.54 10.30 444 168073 27822 31501005
Blood pressure increased 136.74 10.30 806 167711 78827 31450000
Respiratory arrest 124.61 10.30 364 168153 25893 31502934
Oxygen saturation decreased 118.86 10.30 547 167970 48568 31480259
Hepatic cytolysis 118.19 10.30 209 168308 10614 31518213
Metabolic acidosis 111.18 10.30 461 168056 39116 31489711
Myocardial infarction 96.04 10.30 297 168220 113157 31415670
Anion gap 91.59 10.30 54 168463 683 31528144
Blood pressure diastolic abnormal 86.01 10.30 106 168411 3873 31524954
Coagulopathy 84.34 10.30 253 168264 18262 31510565
Product dose omission issue 83.38 10.30 285 168232 105301 31423526
Sinusitis 83.14 10.30 401 168116 36295 31492532
Intentional product use issue 82.41 10.30 496 168021 48851 31479976
Hepatotoxicity 80.28 10.30 254 168263 18872 31509955
Drug resistance 80.11 10.30 14 168503 23439 31505388
Cardio-respiratory arrest 78.93 10.30 508 168009 51218 31477609
Accidental overdose 77.30 10.30 244 168273 18106 31510721
Blood pressure systolic increased 76.69 10.30 253 168264 19217 31509610
Respiratory depression 75.51 10.30 208 168309 14302 31514525
Treatment failure 74.83 10.30 64 168453 40728 31488099
Cytokine release syndrome 71.68 10.30 223 168294 16419 31512408
Poisoning 69.73 10.30 164 168353 10227 31518600
Diarrhoea 69.30 10.30 1390 167127 351019 31177808
Methaemoglobinaemia 68.09 10.30 82 168435 2924 31525903
Heart rate irregular 66.73 10.30 197 168320 14092 31514735
Psoriasis 65.08 10.30 92 168425 46627 31482200
Analgesic drug level increased 62.63 10.30 41 168476 631 31528196
Substance abuse 59.37 10.30 123 168394 7035 31521792
Blood pressure diastolic increased 58.02 10.30 91 168426 4182 31524645
Cardiac failure congestive 57.55 10.30 222 168295 79165 31449662
Infusion site extravasation 57.27 10.30 83 168434 3554 31525273
Suicide attempt 56.92 10.30 366 168151 36882 31491945
Cardiac failure 56.91 10.30 249 168268 85704 31443123
Blood pressure systolic abnormal 56.91 10.30 76 168441 3011 31525816
Exposure via ingestion 55.58 10.30 61 168456 1964 31526863
Alanine aminotransferase increased 54.04 10.30 621 167896 74035 31454792
Hepatic necrosis 53.94 10.30 81 168436 3582 31525245
Body temperature decreased 53.76 10.30 161 168356 11609 31517218
Pyroglutamic acidosis 52.74 10.30 29 168488 318 31528509
Hypotension 52.62 10.30 1442 167075 203176 31325651
Suspected suicide 52.38 10.30 85 168432 4022 31524805
Depressed level of consciousness 51.63 10.30 367 168150 38234 31490593
Poisoning deliberate 50.47 10.30 117 168400 7227 31521600
COVID-19 48.07 10.30 474 168043 54347 31474480
Medication error 46.03 10.30 241 168276 22531 31506296
Chills 45.52 10.30 598 167919 73552 31455275
Prostate cancer 43.99 10.30 83 168434 37518 31491309
Liver injury 42.55 10.30 163 168354 13329 31515498
Renal cortical necrosis 42.03 10.30 21 168496 186 31528641
Anaemia 41.87 10.30 842 167675 212680 31316147
Blood pressure diastolic decreased 41.82 10.30 115 168402 7898 31520929
Aspartate aminotransferase increased 41.54 10.30 513 168004 62206 31466621
Heart rate increased 41.33 10.30 366 168151 40744 31488083
Appendicolith 41.26 10.30 93 168424 5638 31523189
Toxic epidermal necrolysis 41.11 10.30 209 168308 19315 31509512
Therapeutic product effect incomplete 40.87 10.30 109 168408 43587 31485240
Infusion site pain 39.06 10.30 65 168452 3141 31525686
Wrong technique in product usage process 38.65 10.30 74 168443 33269 31495558
Infusion site swelling 37.25 10.30 51 168466 2070 31526757
Foetal exposure during pregnancy 36.71 10.30 104 168413 40772 31488055
Tachycardia 36.26 10.30 588 167929 75619 31453208
Serotonin syndrome 36.11 10.30 196 168321 18577 31510250
Coronary artery disease 35.93 10.30 125 168392 45962 31482865
Drug interaction 35.78 10.30 840 167677 207703 31321124
Body temperature fluctuation 35.12 10.30 43 168474 1560 31527267
Inappropriate schedule of product administration 34.65 10.30 418 168099 50405 31478422
Therapeutic response shortened 33.73 10.30 87 168430 5750 31523077
Diabetes mellitus 32.79 10.30 116 168401 42440 31486387
Febrile neutropenia 32.47 10.30 863 167654 120986 31407841
Depression 32.10 10.30 318 168199 90497 31438330
Bone marrow failure 31.74 10.30 63 168454 27945 31500882
Pyrexia 31.51 10.30 1943 166574 301897 31226930
Plasma cell myeloma 31.49 10.30 174 168343 56357 31472470
Cardiac arrest 30.49 10.30 653 167864 88409 31440418
International normalised ratio increased 29.98 10.30 370 168147 44853 31483974
Dizziness 29.89 10.30 818 167699 198329 31330498
Neuropathy peripheral 29.26 10.30 259 168258 75390 31453437
Injection site pain 29.02 10.30 91 168426 34543 31494284
Renal impairment 28.62 10.30 307 168210 86042 31442785
Bladder cancer 28.37 10.30 22 168495 14703 31514124
Product prescribing error 28.03 10.30 38 168479 19604 31509223
Abdominal pain 28.01 10.30 993 167524 144959 31383868
Stevens-Johnson syndrome 27.96 10.30 173 168344 17199 31511628
Asthenia 27.89 10.30 947 167570 223808 31305019
Disease progression 27.86 10.30 327 168190 90137 31438690
Myelosuppression 27.86 10.30 23 168494 14897 31513930
Psoriatic arthropathy 27.83 10.30 39 168478 19844 31508983
Respiratory rate increased 27.78 10.30 110 168407 9135 31519692
Ear infection 27.76 10.30 107 168410 8774 31520053
Infusion site pruritus 27.56 10.30 24 168493 578 31528249
Myocardial fibrosis 27.40 10.30 32 168485 1104 31527723
Anion gap abnormal 27.18 10.30 14 168503 133 31528694
Neutrophil percentage increased 26.97 10.30 40 168477 1749 31527078
Body temperature increased 26.91 10.30 155 168362 15018 31513809
Blood pH decreased 26.37 10.30 44 168473 2131 31526696
Asthma 26.07 10.30 127 168390 42484 31486343
Poor venous access 25.87 10.30 63 168454 4017 31524810
Hospitalisation 25.76 10.30 157 168360 49650 31479177
Appendicitis 25.74 10.30 125 168392 11340 31517487
Contraindicated product administered 25.53 10.30 41 168476 19731 31509096
Hypoxia 25.35 10.30 392 168125 49921 31478906
Nasopharyngitis 25.06 10.30 474 168043 62771 31466056
Therapeutic response decreased 24.88 10.30 66 168451 26443 31502384
Urine sodium decreased 24.74 10.30 14 168503 163 31528664
Progressive multifocal leukoencephalopathy 24.74 10.30 9 168508 9204 31519623
Coma 24.46 10.30 330 168187 40820 31488007
Cerebrovascular accident 23.82 10.30 289 168228 79195 31449632
Balance disorder 23.79 10.30 110 168407 37312 31491515
Hepatic failure 23.18 10.30 271 168246 32431 31496396
Cerebral haemorrhage 22.97 10.30 93 168424 32719 31496108
Haematotoxicity 22.81 10.30 5 168512 7132 31521695
Infusion site erythema 22.70 10.30 38 168479 1845 31526982
Sopor 22.59 10.30 17 168500 11535 31517292
Head discomfort 21.88 10.30 56 168461 3683 31525144
Unresponsive to stimuli 21.60 10.30 221 168296 25579 31503248
Memory impairment 21.43 10.30 117 168400 38013 31490814
Graft versus host disease 20.91 10.30 15 168502 10432 31518395
Glycosylated haemoglobin increased 20.73 10.30 15 168502 10385 31518442
Acute myocardial infarction 20.54 10.30 172 168345 50651 31478176
Throat tightness 20.48 10.30 88 168429 7581 31521246
Accidental exposure to product by child 20.41 10.30 32 168485 1470 31527357
Lymphocyte percentage decreased 20.40 10.30 38 168479 2009 31526818
Immune reconstitution inflammatory syndrome 20.31 10.30 9 168508 8169 31520658
Granulomatosis with polyangiitis 20.02 10.30 27 168490 1080 31527747
Feeling abnormal 19.97 10.30 200 168317 56802 31472025
Post transplant lymphoproliferative disorder 19.95 10.30 4 168513 6072 31522755
Cytomegalovirus infection 19.94 10.30 66 168451 24641 31504186
Oesophageal carcinoma 19.70 10.30 9 168508 8024 31520803
Product use in unapproved indication 19.41 10.30 391 168126 98780 31430047
Generalised bullous fixed drug eruption 19.20 10.30 8 168509 44 31528783
Mydriasis 18.92 10.30 77 168440 6475 31522352
Therapeutic product effect decreased 18.91 10.30 95 168422 31527 31497300
Acute lung injury 18.72 10.30 29 168488 1318 31527509
Ductus arteriosus premature closure 18.65 10.30 13 168504 223 31528604
Cerebral infarction 18.58 10.30 73 168444 25904 31502923
Throat irritation 18.42 10.30 98 168419 9216 31519611
Angina pectoris 18.33 10.30 88 168429 29553 31499274
Therapy non-responder 18.32 10.30 105 168412 33706 31495121
Full blood count abnormal 18.32 10.30 37 168480 16310 31512517
Oedema peripheral 18.08 10.30 445 168072 109394 31419433
Pathogen resistance 18.07 10.30 12 168505 8689 31520138
Haemolysis 17.90 10.30 81 168436 7135 31521692
Infusion site bruising 17.78 10.30 18 168499 527 31528300
Chronic gastrointestinal bleeding 17.76 10.30 14 168503 292 31528535
Osteonecrosis 17.73 10.30 29 168488 13855 31514972
Pemphigus 17.60 10.30 29 168488 1390 31527437
Cerebral artery thrombosis 17.59 10.30 21 168496 742 31528085
Loss of personal independence in daily activities 17.48 10.30 84 168433 28204 31500623
Pharyngeal paraesthesia 17.42 10.30 18 168499 540 31528287
Fatigue 17.27 10.30 1541 166976 333665 31195162
Brain scan abnormal 17.18 10.30 22 168495 836 31527991
Epilepsy 17.13 10.30 56 168461 20985 31507842
C-reactive protein abnormal 17.12 10.30 10 168507 7759 31521068
Venoocclusive liver disease 17.12 10.30 9 168508 7403 31521424
Oxygen saturation abnormal 17.10 10.30 28 168489 1335 31527492
Hepatocellular carcinoma 16.97 10.30 13 168504 8743 31520084
Aplastic anaemia 16.97 10.30 95 168422 9108 31519719
Flushing 16.84 10.30 239 168278 29889 31498938
Hepatitis C 16.81 10.30 19 168498 10611 31518216
Osteonecrosis of jaw 16.40 10.30 42 168475 17029 31511798
Brain death 16.33 10.30 39 168478 2456 31526371
Gait inability 16.25 10.30 50 168467 19094 31509733
Prothrombin time prolonged 16.10 10.30 93 168424 9019 31519808
Transaminases increased 16.06 10.30 199 168318 24142 31504685
Urticaria 15.77 10.30 409 168108 57108 31471719
Prostatic specific antigen increased 15.73 10.30 30 168487 13508 31515319
Consciousness fluctuating 15.56 10.30 24 168493 1087 31527740
Infusion site haemorrhage 15.53 10.30 21 168496 842 31527985
Renal papillary necrosis 15.44 10.30 10 168507 151 31528676
Agitation 15.38 10.30 387 168130 53782 31475045
Visual acuity reduced 15.33 10.30 37 168480 15306 31513521
Bilirubin urine present 15.33 10.30 10 168507 153 31528674
Leukopenia 15.22 10.30 216 168301 57612 31471215
Prescribed overdose 15.01 10.30 16 168501 9176 31519651
Malignant neoplasm progression 14.99 10.30 313 168204 78685 31450142
Decreased appetite 14.93 10.30 664 167853 152553 31376274
Trichoglossia 14.92 10.30 12 168505 258 31528569
Dyspnoea 14.90 10.30 1599 166918 341880 31186947
Pulmonary congestion 14.85 10.30 119 168398 12864 31515963
Pancytopenia 14.85 10.30 352 168165 86964 31441863
Hypoaesthesia 14.83 10.30 209 168308 55813 31473014
Dyspnoea exertional 14.56 10.30 134 168383 38703 31490124
Incorrect dose administered 14.52 10.30 269 168248 35483 31493344
Myopathy 14.49 10.30 22 168495 10830 31517997
Dependent personality disorder 14.45 10.30 8 168509 89 31528738
Blood triglycerides increased 14.44 10.30 31 168486 13366 31515461
Urethral valves 14.42 10.30 12 168505 271 31528556
Dermatitis atopic 14.39 10.30 4 168513 4858 31523969
COVID-19 immunisation 14.26 10.30 11 168506 222 31528605
Infusion site rash 14.08 10.30 14 168503 401 31528426
Mental status changes 14.04 10.30 269 168248 35699 31493128
General physical health deterioration 14.02 10.30 478 168039 112957 31415870
Cardiac disorder 13.97 10.30 137 168380 39077 31489750
Parkinsonism 13.97 10.30 12 168505 7624 31521203
Failure to suspend medication 13.93 10.30 14 168503 406 31528421
Infusion site nodule 13.86 10.30 8 168509 97 31528730
Gynaecomastia 13.79 10.30 17 168500 9137 31519690
Erectile dysfunction 13.79 10.30 54 168463 19181 31509646
Product substitution issue 13.71 10.30 18 168499 9414 31519413
Therapy partial responder 13.70 10.30 9 168508 6553 31522274
Sudden infant death syndrome 13.61 10.30 10 168507 187 31528640
Upper respiratory tract infection 13.60 10.30 226 168291 29196 31499631
Deep vein thrombosis 13.57 10.30 234 168283 60502 31468325
Gait disturbance 13.57 10.30 311 168206 77184 31451643
Pulmonary oedema 13.55 10.30 321 168196 44181 31484646
Acidosis 13.54 10.30 95 168422 9851 31518976
Enterocolitis infectious 13.45 10.30 26 168491 1414 31527413
Inadequate analgesia 13.41 10.30 38 168479 2655 31526172
Hypertriglyceridaemia 13.38 10.30 13 168504 7785 31521042
Cytopenia 13.14 10.30 24 168493 10986 31517841
Administration site erythema 13.11 10.30 7 168510 72 31528755
Diabetic ketoacidosis 13.07 10.30 46 168471 16859 31511968
Insomnia 13.07 10.30 394 168123 94442 31434385
Anal fissure 13.00 10.30 44 168473 3385 31525442
Environmental exposure 12.94 10.30 11 168506 256 31528571
Tooth infection 12.88 10.30 65 168452 5989 31522838
Cardiac failure chronic 12.74 10.30 12 168505 7291 31521536
Burn of internal organs 12.73 10.30 3 168514 0 31528827
Drug ineffective for unapproved indication 12.71 10.30 50 168467 17740 31511087
Anti-erythrocyte antibody positive 12.63 10.30 6 168511 47 31528780
Fall 12.62 10.30 836 167681 185253 31343574
Maple syrup disease 12.62 10.30 4 168513 8 31528819
Migraine 12.61 10.30 123 168394 14057 31514770
Hypocalcaemia 12.59 10.30 67 168450 21911 31506916
Infusion site mass 12.55 10.30 12 168505 327 31528500
Injection site haemorrhage 12.54 10.30 18 168499 9067 31519760
Injection site reaction 12.53 10.30 27 168490 11624 31517203
Syncope 12.46 10.30 351 168166 84831 31443996
Electrocardiogram QRS complex prolonged 12.45 10.30 50 168467 4179 31524648
Hepatitis fulminant 12.43 10.30 46 168471 3700 31525127
Administration site pain 12.39 10.30 10 168507 216 31528611
Somnolence 12.39 10.30 647 167870 98798 31430029
Mucosal inflammation 12.38 10.30 120 168397 34307 31494520
Immune effector cell-associated neurotoxicity syndrome 12.37 10.30 35 168482 2444 31526383
Obstructive airways disorder 12.29 10.30 31 168486 12633 31516194
Pyroglutamate increased 12.29 10.30 11 168506 275 31528552
Labelled drug-drug interaction medication error 12.18 10.30 33 168484 13130 31515697
Haematocrit decreased 12.14 10.30 226 168291 29835 31498992
Visual impairment 12.13 10.30 107 168410 31172 31497655
Drug intolerance 12.10 10.30 199 168318 51834 31476993
Fixed eruption 12.09 10.30 25 168492 1428 31527399
Labelled drug-drug interaction issue 12.09 10.30 10 168507 224 31528603
Drug level below therapeutic 12.03 10.30 56 168461 4992 31523835
Pemphigoid 11.80 10.30 16 168501 8255 31520572
Pallor 11.79 10.30 176 168341 22248 31506579
Hyperchloraemia 11.78 10.30 13 168504 421 31528406
Second primary malignancy 11.75 10.30 12 168505 7020 31521807
Testicular infarction 11.74 10.30 6 168511 56 31528771
Dissociative disorder 11.72 10.30 10 168507 234 31528593
Acid-base balance disorder mixed 11.65 10.30 6 168511 57 31528770
Endocardial fibrosis 11.64 10.30 5 168512 30 31528797
Blood phosphorus increased 11.64 10.30 51 168466 4431 31524396
Sexual dysfunction 11.39 10.30 9 168508 5959 31522868
Lung neoplasm malignant 11.36 10.30 46 168471 16184 31512643
Renal injury 11.26 10.30 96 168421 10569 31518258
Pain in extremity 11.23 10.30 504 168013 115699 31413128
Injection site swelling 11.16 10.30 23 168494 10064 31518763
Protein urine 11.15 10.30 18 168499 848 31527979
Nocturia 11.14 10.30 20 168497 9215 31519612
SARS-CoV-2 test positive 11.13 10.30 50 168467 4391 31524436
Atrial fibrillation 11.10 10.30 493 168024 113290 31415537
Eye infection 11.04 10.30 39 168478 3066 31525761
Intraocular pressure increased 10.98 10.30 7 168510 5180 31523647
Stress 10.95 10.30 190 168327 24751 31504076
Acidosis hyperchloraemic 10.94 10.30 12 168505 386 31528441
Increased viscosity of upper respiratory secretion 10.90 10.30 7 168510 104 31528723
Fungal rhinitis 10.88 10.30 5 168512 36 31528791
Myalgia 10.88 10.30 320 168197 76938 31451889
Alopecia 10.82 10.30 65 168452 20630 31508197
Hangover 10.72 10.30 19 168498 966 31527861
Acute myeloid leukaemia 10.65 10.30 57 168460 18615 31510212
BK virus infection 10.62 10.30 7 168510 5088 31523739
Bacterial test 10.60 10.30 8 168509 156 31528671
Anion gap increased 10.54 10.30 26 168491 1671 31527156
Device leakage 10.54 10.30 8 168509 5405 31523422
PCO2 decreased 10.53 10.30 26 168491 1672 31527155
Akathisia 10.38 10.30 14 168503 7239 31521588
Erythema multiforme 10.36 10.30 76 168441 7995 31520832
Bronchial dysplasia 10.33 10.30 5 168512 41 31528786

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 3668.66 9.97 5951 473346 221184 70227963
Toxicity to various agents 3050.35 9.97 7450 471847 374722 70074425
Infusion related reaction 1097.61 9.97 3378 475919 194156 70254991
Intentional product misuse 744.31 9.97 1655 477642 77940 70371207
Exposure to toxic agent 740.37 9.97 483 478814 5711 70443436
Blood pressure fluctuation 737.96 9.97 1384 477913 57628 70391519
Acute hepatic failure 704.86 9.97 902 478395 26770 70422377
Overdose 665.43 9.97 2586 476711 167159 70281988
Intentional overdose 543.70 9.97 1681 477616 96754 70352393
Sinusitis 361.08 9.97 2164 477133 167031 70282116
Muscle injury 340.26 9.97 783 478514 37711 70411436
Duodenal ulcer perforation 326.08 9.97 919 478378 50193 70398954
Metabolic acidosis 320.26 9.97 1168 478129 73178 70375969
Helicobacter infection 313.25 9.97 957 478340 54699 70394448
Folliculitis 311.33 9.97 805 478492 41765 70407382
Irritable bowel syndrome 308.59 9.97 898 478399 49952 70399195
Heart rate decreased 305.88 9.97 1019 478278 60996 70388151
Anti-cyclic citrullinated peptide antibody positive 298.41 9.97 1098 478199 69087 70380060
Product dose omission issue 290.83 9.97 649 478648 216819 70232328
Sleep disorder due to general medical condition, insomnia type 282.50 9.97 696 478601 35036 70414111
Hepatotoxicity 279.72 9.97 790 478507 43196 70405951
Drug abuse 272.84 9.97 1817 477480 145439 70303708
Anion gap 258.83 9.97 160 479137 1710 70447437
Injection site pain 258.28 9.97 248 479049 117371 70331776
Hepatic enzyme increased 255.57 9.97 1877 477420 155113 70294034
Hand deformity 250.35 9.97 1203 478094 85279 70363868
Pericarditis 248.62 9.97 1183 478114 83522 70365625
Hepatic cytolysis 248.41 9.97 457 478840 18735 70430412
Respiratory arrest 248.23 9.97 866 478431 53067 70396080
Pemphigus 240.31 9.97 1155 478142 81881 70367266
Blood pressure increased 234.44 9.97 2120 477177 186397 70262750
Lower respiratory tract infection 230.74 9.97 1419 477878 110494 70338653
Intentional product use issue 228.91 9.97 1493 477804 118649 70330498
Nasopharyngitis 222.31 9.97 2388 476909 219818 70229329
Blister 209.99 9.97 1279 478018 99247 70349900
Glossodynia 209.79 9.97 1145 478152 85342 70363805
Anaemia 204.99 9.97 1742 477555 401681 70047466
Ill-defined disorder 203.68 9.97 821 478476 53920 70395227
Wound 198.58 9.97 1244 478053 97488 70351659
Cardio-respiratory arrest 197.83 9.97 1261 478036 99416 70349731
Depressed level of consciousness 197.81 9.97 1136 478161 86295 70362852
Myocardial infarction 197.65 9.97 553 478744 171092 70278055
Diarrhoea 197.64 9.97 3921 475376 779420 69669727
Medication error 197.15 9.97 835 478462 56077 70393070
Blood pressure diastolic abnormal 196.66 9.97 366 478931 15138 70434009
Psoriasis 190.05 9.97 231 479066 98202 70350945
Discomfort 188.63 9.97 1290 478007 104146 70345001
Coagulopathy 183.59 9.97 568 478729 32681 70416466
Analgesic drug level increased 177.95 9.97 141 479156 2302 70446845
Oxygen saturation decreased 174.20 9.97 1365 477932 115064 70334083
Injection site erythema 171.75 9.97 144 479153 72780 70376367
Systemic lupus erythematosus 171.28 9.97 1228 478069 100674 70348473
Drug resistance 167.94 9.97 28 479269 38162 70410985
Synovitis 166.59 9.97 1465 477832 127763 70321384
Blood pressure systolic abnormal 165.32 9.97 306 478991 12603 70436544
Drug interaction 165.01 9.97 1714 477583 379727 70069420
Impaired healing 164.09 9.97 960 478337 73414 70375733
Poisoning 157.43 9.97 420 478877 22202 70426945
Blood pressure systolic increased 156.73 9.97 784 478513 56475 70392672
Joint swelling 156.24 9.97 2491 476806 250720 70198427
Hepatic necrosis 150.54 9.97 235 479062 8411 70440736
Weight increased 149.89 9.97 2385 476912 239946 70209201
Sedation complication 149.80 9.97 300 478997 13110 70436037
Cardiac failure 146.30 9.97 489 478808 143052 70306095
Wrong technique in product usage process 146.00 9.97 149 479148 68549 70380598
Blood pressure diastolic decreased 140.10 9.97 438 478859 25342 70423805
Drug ineffective 138.66 9.97 5078 474219 934674 69514473
Cardiac failure congestive 136.31 9.97 464 478833 134993 70314154
Body temperature increased 133.75 9.97 579 478718 39255 70409892
Respiratory depression 130.47 9.97 417 478880 24414 70424733
Therapeutic product effect decreased 128.35 9.97 1505 477792 141513 70307634
Suicide attempt 127.76 9.97 948 478349 78562 70370585
Arthropathy 123.75 9.97 1554 477743 148503 70300644
Creatinine renal clearance decreased 123.41 9.97 323 478974 16877 70432270
Exposure via ingestion 123.22 9.97 159 479138 4756 70444391
Swelling 122.01 9.97 1870 477427 186669 70262478
Liver injury 121.73 9.97 575 478722 40460 70408687
Neutropenia 117.53 9.97 1140 478157 256016 70193131
Heart rate irregular 115.37 9.97 452 478845 29291 70419856
Heart rate increased 113.66 9.97 1157 478140 104991 70344156
Device expulsion 113.25 9.97 10 479287 22236 70426911
Accidental overdose 112.98 9.97 504 478793 34617 70414530
Bone marrow failure 111.49 9.97 100 479197 48910 70400237
Throat irritation 110.10 9.97 502 478795 34802 70414345
Osteonecrosis of jaw 106.75 9.97 73 479224 40929 70408218
Blood calcium decreased 105.98 9.97 431 478866 28415 70420732
Gastrointestinal disorder 105.27 9.97 1133 478164 104294 70344853
Suspected suicide 105.18 9.97 203 479094 8631 70440516
Pyroglutamic acidosis 104.28 9.97 67 479230 770 70448377
Sopor 101.46 9.97 42 479255 31225 70417922
Injection site pruritus 100.50 9.97 71 479226 39139 70410008
Injection site reaction 100.49 9.97 113 479184 49739 70399408
Injection site bruising 98.63 9.97 68 479229 37964 70411183
Injection site swelling 97.05 9.97 89 479208 43068 70406079
Disease progression 96.25 9.97 641 478656 156031 70293116
Methaemoglobinaemia 91.69 9.97 136 479161 4650 70444497
Blood pressure diastolic increased 89.21 9.97 233 479064 12158 70436989
Renal impairment 88.87 9.97 588 478709 143349 70305798
Contraindicated product administered 88.53 9.97 1339 477958 133273 70315874
Hypersensitivity 88.53 9.97 2105 477192 227707 70221440
Pancytopenia 87.99 9.97 628 478669 150479 70298668
Body temperature decreased 85.21 9.97 402 478895 28270 70420877
Poisoning deliberate 83.78 9.97 280 479017 16780 70432367
Acute lung injury 81.85 9.97 98 479199 2711 70446436
Cerebrovascular accident 80.77 9.97 602 478695 142868 70306279
Cytokine release syndrome 80.06 9.97 373 478924 26094 70423053
Hepatic failure 79.84 9.97 664 478633 56961 70392186
Rheumatoid arthritis 78.37 9.97 2552 476745 289253 70159894
Pain 77.84 9.97 5084 474213 623732 69825415
Acute kidney injury 76.92 9.97 2533 476764 472091 69977056
Substance abuse 76.03 9.97 190 479107 9647 70439500
Decreased appetite 75.39 9.97 1529 477768 303251 70145896
Diabetes mellitus 73.61 9.97 244 479053 71580 70377567
Product prescribing error 72.46 9.97 94 479203 38858 70410289
Coronary artery disease 72.24 9.97 202 479095 62534 70386613
Hypotension 69.79 9.97 3371 475926 401010 70048137
Prostate cancer 69.20 9.97 65 479232 31098 70418049
Hospitalisation 68.21 9.97 306 478991 82262 70366885
Therapeutic product effect incomplete 67.96 9.97 502 478795 119380 70329767
Alanine aminotransferase increased 67.57 9.97 1385 477912 146095 70303052
Leukopenia 66.93 9.97 433 478864 106127 70343020
Rheumatoid factor positive 66.67 9.97 557 478740 47843 70401304
Ear pain 66.62 9.97 365 478932 27234 70421913
Coma 66.46 9.97 929 478368 90915 70358232
Hyperkalaemia 66.00 9.97 435 478862 106156 70342991
Myelosuppression 65.63 9.97 64 479233 30081 70419066
Sedation 65.02 9.97 539 478758 46192 70402955
Plasma cell myeloma 64.94 9.97 264 479033 72937 70376210
Anion gap abnormal 64.27 9.97 42 479255 498 70448649
Neuropathy peripheral 64.23 9.97 548 478749 126348 70322799
Stomatitis 63.95 9.97 1222 478075 127289 70321858
Poor venous access 63.41 9.97 234 479063 14737 70434410
Rheumatic fever 63.39 9.97 262 479035 17398 70431749
Cytomegalovirus infection 62.27 9.97 108 479189 39650 70409497
Therapeutic response shortened 61.54 9.97 209 479088 12629 70436518
Arthralgia 61.31 9.97 4065 475232 499325 69949822
Product use in unapproved indication 61.27 9.97 1009 478288 206469 70242678
Epilepsy 61.06 9.97 105 479192 38679 70410468
Infusion site extravasation 60.14 9.97 153 479144 7855 70441292
Interstitial lung disease 59.99 9.97 437 478860 104248 70344899
Injection site warmth 58.90 9.97 11 479286 13814 70435333
Neoplasm progression 58.73 9.97 137 479160 45091 70404056
Death 58.61 9.97 4099 475198 505962 69943185
Dehydration 58.15 9.97 1127 478170 225015 70224132
Therapy cessation 57.90 9.97 86 479211 33590 70415557
Mucosal inflammation 57.53 9.97 249 479048 67601 70381546
Neutrophil percentage increased 57.32 9.97 107 479190 4435 70444712
Respiratory rate increased 57.13 9.97 274 479023 19398 70429749
Cognitive disorder 57.12 9.97 647 478650 60309 70388838
Malignant neoplasm progression 56.26 9.97 538 478759 121201 70327946
Oedema peripheral 56.15 9.97 1145 478152 226946 70222201
Body temperature fluctuation 55.49 9.97 92 479205 3467 70445680
Dizziness 53.88 9.97 2575 476722 461566 69987581
Cerebral haemorrhage 53.82 9.97 185 479112 53679 70395468
Pyroglutamate increased 53.76 9.97 41 479256 631 70448516
Acute myocardial infarction 52.76 9.97 283 479014 72604 70376543
Atrial fibrillation 52.63 9.97 902 478395 183446 70265701
White blood cells urine positive 52.35 9.97 117 479180 5523 70443624
Product substitution issue 52.27 9.97 30 479267 18483 70430664
Cerebral infarction 52.14 9.97 135 479162 42874 70406273
Haematotoxicity 51.99 9.97 14 479283 13660 70435487
Injection site mass 51.40 9.97 30 479267 18313 70430834
Device issue 51.16 9.97 52 479245 23973 70425174
Electric shock 51.07 9.97 51 479246 1144 70448003
Crystal urine present 50.59 9.97 66 479231 1996 70447151
Urine abnormality 50.03 9.97 141 479156 7697 70441450
Lymphocyte percentage decreased 49.93 9.97 104 479193 4675 70444472
Peripheral swelling 49.78 9.97 2013 477284 234550 70214597
Orthostatic hypotension 49.29 9.97 551 478746 51192 70397955
Syncope 48.87 9.97 806 478491 164903 70284244
Contusion 48.70 9.97 1171 478126 126865 70322282
Diabetic ketoacidosis 48.08 9.97 87 479210 31425 70417722
Drug intolerance 48.08 9.97 1923 477374 223764 70225383
Aspartate aminotransferase increased 47.90 9.97 1160 478137 125818 70323329
Feeling abnormal 47.85 9.97 675 478622 141644 70307503
Hypocalcaemia 47.63 9.97 150 479147 44709 70404438
Infusion site pain 47.52 9.97 179 479118 11385 70437762
Gait disturbance 47.42 9.97 923 478374 184183 70264964
Injection site haemorrhage 47.07 9.97 62 479235 25465 70423682
Pathogen resistance 46.15 9.97 16 479281 13263 70435884
International normalised ratio increased 45.92 9.97 784 478513 79942 70369205
Injection site rash 45.75 9.97 27 479270 16383 70432764
Infusion site pruritus 45.62 9.97 80 479217 3157 70445990
Epistaxis 45.54 9.97 458 478839 102169 70346978
Transient ischaemic attack 45.09 9.97 159 479138 45785 70403362
Product quality issue 44.32 9.97 87 479210 30474 70418673
Blood pH decreased 43.98 9.97 95 479202 4381 70444766
Night sweats 43.82 9.97 470 478827 43214 70405933
Post transplant lymphoproliferative disorder 43.64 9.97 9 479288 10536 70438611
Septic shock 43.42 9.97 517 478780 111741 70337406
Second primary malignancy 43.21 9.97 17 479280 13034 70436113
Thrombocytopenia 43.04 9.97 1258 478039 237852 70211295
Myelodysplastic syndrome 43.02 9.97 85 479212 29700 70419447
Electrocardiogram QT prolonged 43.01 9.97 359 478938 83158 70365989
Dyspnoea 42.67 9.97 4555 474742 765505 69683642
Muscle spasticity 42.66 9.97 253 479044 19436 70429711
Posterior reversible encephalopathy syndrome 42.26 9.97 62 479235 24340 70424807
Gastrointestinal haemorrhage 41.95 9.97 664 478633 136744 70312403
Hyperlipidaemia 41.95 9.97 60 479237 23803 70425344
Dyspnoea exertional 41.82 9.97 334 478963 78096 70371051
Swollen joint count increased 41.37 9.97 193 479104 13507 70435640
Device malfunction 40.99 9.97 41 479256 19043 70430104
Oesophageal carcinoma 40.88 9.97 7 479290 9359 70439788
Red blood cell sedimentation rate abnormal 40.85 9.97 42 479255 19261 70429886
Urine leukocyte esterase positive 40.06 9.97 81 479216 3564 70445583
Seizure 39.82 9.97 907 478390 177055 70272092
Palmar-plantar erythrodysaesthesia syndrome 39.77 9.97 91 479206 30156 70418991
Osteonecrosis 39.76 9.97 86 479211 29074 70420073
Anticipatory anxiety 39.75 9.97 41 479256 957 70448190
Device difficult to use 39.60 9.97 12 479285 10837 70438310
Ear pruritus 39.59 9.97 73 479224 2997 70446150
Bladder cancer 39.43 9.97 35 479262 17207 70431940
Cardiac arrest 39.33 9.97 1384 477913 158450 70290697
Infusion site swelling 39.07 9.97 111 479186 6087 70443060
Product storage error 39.05 9.97 25 479272 14516 70434631
Blood parathyroid hormone decreased 38.83 9.97 7 479290 9017 70440130
Lactic acidosis 38.43 9.97 269 479028 64755 70384392
Paraesthesia 38.40 9.97 722 478575 144815 70304332
Pruritus 38.39 9.97 2770 476527 342790 70106357
Status epilepticus 38.06 9.97 67 479230 24459 70424688
Inappropriate schedule of product administration 38.01 9.97 974 478323 106581 70342566
Abortion spontaneous 37.87 9.97 76 479221 26403 70422744
Haematuria 37.57 9.97 263 479034 63310 70385837
Visual acuity reduced 37.56 9.97 83 479214 27847 70421300
Labelled drug-drug interaction medication error 37.36 9.97 66 479231 24061 70425086
Injection site urticaria 37.17 9.97 16 479281 11622 70437525
Unintentional medical device removal 36.82 9.97 3 479294 7121 70442026
Immune reconstitution inflammatory syndrome 36.75 9.97 21 479276 12969 70436178
Underdose 36.57 9.97 91 479206 29292 70419855
Muscle spasms 36.50 9.97 778 478519 153268 70295879
Surgery 36.45 9.97 94 479203 29895 70419252
Graft versus host disease 36.19 9.97 29 479268 14994 70434153
Acute myeloid leukaemia 36.08 9.97 99 479198 30841 70418306
Memory impairment 36.08 9.97 426 478871 92215 70356932
Unresponsive to stimuli 35.84 9.97 521 478776 51410 70397737
Bursitis 35.69 9.97 305 478992 26368 70422779
Nausea 35.63 9.97 5133 474164 846955 69602192
Multiple-drug resistance 35.62 9.97 4 479293 7351 70441796
Asthma 35.12 9.97 589 478708 120204 70328943
Alopecia 35.07 9.97 1659 477638 196831 70252316
Disturbance in attention 34.80 9.97 160 479137 42734 70406413
Infusion site erythema 34.66 9.97 121 479176 7414 70441733
Device dislocation 34.46 9.97 62 479235 22445 70426702
Urinary sediment present 34.37 9.97 59 479238 2288 70446859
Full blood count abnormal 34.08 9.97 116 479181 33762 70415385
Injection site induration 33.72 9.97 10 479287 9158 70439989
Toxicologic test abnormal 33.38 9.97 43 479254 1284 70447863
Lymphocyte count decreased 33.36 9.97 445 478852 43094 70406053
Myalgia 33.10 9.97 872 478425 167020 70282127
Drug ineffective for unapproved indication 32.93 9.97 141 479156 38397 70410750
Haematochezia 32.90 9.97 325 478972 72756 70376391
Pulmonary arterial hypertension 32.71 9.97 113 479184 32742 70416405
Drug hypersensitivity 32.62 9.97 1445 477852 261014 70188133
Breast cancer female 32.57 9.97 15 479282 10471 70438676
Specific gravity urine decreased 32.51 9.97 34 479263 807 70448340
Asthenia 32.44 9.97 2657 476640 455009 69994138
Urticaria 32.35 9.97 1379 477918 161670 70287477
Aspergillus infection 32.33 9.97 44 479253 17824 70431323
Abdominal discomfort 32.16 9.97 1766 477531 212892 70236255
Infusion site mass 32.03 9.97 40 479257 1157 70447990
Extrapyramidal disorder 31.92 9.97 57 479240 20693 70428454
Prothrombin time prolonged 31.90 9.97 203 479094 15987 70433160
Loss of personal independence in daily activities 31.34 9.97 395 478902 84515 70364632
Pharyngeal paraesthesia 31.24 9.97 55 479242 2177 70446970
Brain death 30.97 9.97 91 479206 5087 70444060
Granuloma skin 30.89 9.97 7 479290 7675 70441472
Basal cell carcinoma 30.85 9.97 120 479177 33578 70415569
Acute graft versus host disease 30.77 9.97 13 479284 9549 70439598
Inappropriate antidiuretic hormone secretion 30.63 9.97 70 479227 23206 70425941
Drug screen positive 30.61 9.97 98 479199 5742 70443405
Fall 30.59 9.97 2584 476713 441512 70007635
Renal failure 30.54 9.97 1009 478288 188061 70261086
Renal cortical necrosis 30.53 9.97 22 479275 309 70448838
Maternal exposure during pregnancy 30.19 9.97 1006 478291 114339 70334808
COVID-19 30.18 9.97 932 478365 104825 70344322
Confusional state 30.09 9.97 2271 477026 282127 70167020
Pneumocystis jirovecii pneumonia 29.59 9.97 104 479193 29978 70419169
Hypertensive crisis 29.55 9.97 53 479244 19209 70429938
Sudden infant death syndrome 29.55 9.97 18 479279 187 70448960
Multiple drug therapy 29.38 9.97 66 479231 3126 70446021
Thrombotic microangiopathy 29.32 9.97 47 479250 17801 70431346
Pyrexia 29.29 9.97 4599 474698 602353 69846794
Red cell distribution width increased 29.27 9.97 175 479122 13482 70435665
Sexual dysfunction 29.15 9.97 5 479292 6676 70442471
Hepatic cirrhosis 29.07 9.97 108 479189 30623 70418524
Metastases to lymph nodes 29.03 9.97 13 479284 9225 70439922
Pain in extremity 28.99 9.97 1869 477428 326213 70122934
Mobility decreased 28.95 9.97 906 478391 102093 70347054
Depression 28.89 9.97 1076 478221 197898 70251249
Fracture 28.73 9.97 57 479240 19887 70429260
Suicidal ideation 28.67 9.97 316 478981 69280 70379867
Hyponatraemia 28.60 9.97 843 478454 159244 70289903
General physical health deterioration 28.41 9.97 1304 477993 234727 70214420
Renal papillary necrosis 28.34 9.97 22 479275 348 70448799
Hepatocellular carcinoma 28.17 9.97 17 479280 10191 70438956
Platelet count decreased 28.10 9.97 954 478343 177268 70271879
Colorectal cancer 28.10 9.97 11 479286 8459 70440688
Hypercalcaemia 28.05 9.97 128 479169 34257 70414890
Transplant rejection 27.87 9.97 50 479247 18121 70431026
Loss of consciousness 27.81 9.97 820 478477 154896 70294251
Dermatitis atopic 27.80 9.97 13 479284 8994 70440153
Therapy interrupted 27.71 9.97 81 479216 24721 70424426
Analgesic drug level above therapeutic 27.54 9.97 24 479273 450 70448697
Red blood cells urine positive 27.44 9.97 82 479215 4627 70444520
Hypokalaemia 27.29 9.97 676 478621 130512 70318635
Bilirubin urine present 27.17 9.97 21 479276 330 70448817
Rash pruritic 27.16 9.97 283 479014 62708 70386439
Therapeutic response decreased 27.13 9.97 258 479039 58195 70390952
Facet joint syndrome 27.12 9.97 97 479200 6016 70443131
Cardiac failure chronic 27.11 9.97 18 479279 10251 70438896
Diffuse large B-cell lymphoma 26.97 9.97 30 479267 13272 70435875
Haemorrhage 26.94 9.97 401 478896 83414 70365733
Appendicolith 26.81 9.97 92 479205 5588 70443559
White blood cell count decreased 26.76 9.97 911 478386 169230 70279917
Dry skin 26.76 9.97 245 479052 55686 70393461
Urine analysis abnormal 26.74 9.97 97 479200 6057 70443090
Angina pectoris 26.74 9.97 204 479093 48179 70400968
Haemolysis 26.70 9.97 151 479146 11400 70437747
Drug level below therapeutic 26.43 9.97 123 479174 8600 70440547
Maternal exposure timing unspecified 26.10 9.97 77 479220 4314 70444833
Angina unstable 25.97 9.97 42 479255 15851 70433296
Injury 25.80 9.97 600 478697 64645 70384502
Glycosylated haemoglobin increased 25.66 9.97 49 479248 17342 70431805
Spinal stenosis 25.60 9.97 37 479260 14616 70434531
Acidosis 25.59 9.97 211 479086 18052 70431095
Rhabdomyolysis 25.58 9.97 474 478823 95286 70353861
Lung neoplasm malignant 25.38 9.97 84 479213 24658 70424489
Bacterial test 25.24 9.97 36 479261 1187 70447960
Infection 25.18 9.97 1700 477597 209085 70240062
Cardiac failure acute 25.17 9.97 50 479247 17437 70431710
Fibromyalgia 25.10 9.97 459 478838 47415 70401732
Systemic infection 24.96 9.97 7 479290 6650 70442497
Drug use disorder 24.74 9.97 115 479182 8036 70441111
Anion gap increased 24.73 9.97 62 479235 3154 70445993
Renal cancer 24.59 9.97 26 479271 11770 70437377
Transplant dysfunction 24.58 9.97 8 479289 6901 70442246
Flushing 24.48 9.97 728 478569 81444 70367703
Coronary arterial stent insertion 24.41 9.97 5 479292 5882 70443265
Infusion site bruising 24.34 9.97 46 479251 1925 70447222
Blood glucose increased 24.13 9.97 521 478776 102461 70346686
Cardiomyopathy 24.09 9.97 94 479203 26279 70422868
Panniculitis 24.02 9.97 22 479275 10654 70438493
Congestive cardiomyopathy 24.01 9.97 23 479274 10903 70438244
Jaundice cholestatic 23.89 9.97 124 479173 9060 70440087
Accidental exposure to product by child 23.61 9.97 56 479241 2750 70446397
Multiple sclerosis relapse 23.48 9.97 182 479115 42835 70406312
Skin necrosis 23.09 9.97 47 479250 16244 70432903
Metastases to lung 22.99 9.97 48 479249 16436 70432711
Red blood cell sedimentation rate 22.97 9.97 3 479294 4907 70444240
Hypomagnesaemia 22.94 9.97 171 479126 40593 70408554
Cytopenia 22.87 9.97 52 479245 17271 70431876
Soft tissue disorder 22.83 9.97 62 479235 3312 70445835
Coronary artery bypass 22.62 9.97 6 479291 5914 70443233
Iron deficiency anaemia 22.54 9.97 80 479217 22992 70426155
Akathisia 22.52 9.97 30 479267 12263 70436884
Polyneuropathy 22.46 9.97 72 479225 21343 70427804
Vision blurred 22.41 9.97 480 478817 94504 70354643
Device leakage 22.38 9.97 18 479279 9290 70439857
Myopathy 22.12 9.97 59 479238 18553 70430594
Sputum culture positive 22.06 9.97 61 479236 3293 70445854
Gastric cancer 21.93 9.97 17 479280 8938 70440209
Forced expiratory volume decreased 21.90 9.97 11 479286 7303 70441844
Drug-induced liver injury 21.87 9.97 515 478782 55598 70393549
Ventricular tachycardia 21.86 9.97 150 479147 36273 70412874
Liver transplant 21.83 9.97 71 479226 4195 70444952
Epstein-Barr virus infection 21.45 9.97 35 479262 13163 70435984
Chronic kidney disease 21.43 9.97 287 479010 60770 70388377
Full blood count decreased 21.37 9.97 86 479211 23832 70425315
Mydriasis 21.24 9.97 184 479113 15969 70433178
Febrile bone marrow aplasia 21.22 9.97 30 479267 11961 70437186
Blood urine present 21.20 9.97 212 479085 19141 70430006
Subdural haematoma 21.06 9.97 114 479183 29184 70419963
Deep vein thrombosis 21.03 9.97 580 478717 110462 70338685
Graft versus host disease in skin 20.96 9.97 6 479291 5624 70443523
Neurotoxicity 20.93 9.97 117 479180 29709 70419438
Gynaecomastia 20.82 9.97 10 479287 6813 70442334
Hepatitis C 20.78 9.97 34 479263 12773 70436374
Product monitoring error 20.58 9.97 10 479287 6766 70442381
Urine bilirubin decreased 20.56 9.97 13 479284 145 70449002
Bronchopulmonary aspergillosis 20.39 9.97 73 479224 20929 70428218
Agranulocytosis 20.39 9.97 174 479123 40124 70409023
Torsade de pointes 20.36 9.97 59 479238 18057 70431090
Skin exfoliation 20.34 9.97 220 479077 48406 70400741
Tremor 20.32 9.97 852 478445 154772 70294375
Pancreatic carcinoma 20.25 9.97 35 479262 12869 70436278
Obstructive airways disorder 20.25 9.97 99 479198 26014 70423133
Cardiac disorder 20.24 9.97 281 479016 59134 70390013
Treatment noncompliance 20.18 9.97 209 479088 46365 70402782
Ageusia 20.12 9.97 44 479253 14818 70434329
Disorientation 20.07 9.97 273 479024 57650 70391497
Drug withdrawal syndrome 19.99 9.97 134 479163 32581 70416566
Nocardiosis 19.98 9.97 5 479292 5124 70444023
Diplopia 19.97 9.97 110 479187 28037 70421110
COVID-19 immunisation 19.75 9.97 30 479267 1048 70448099
White coat hypertension 19.63 9.97 24 479273 679 70448468
Venoocclusive liver disease 19.62 9.97 26 479271 10652 70438495
Joint range of motion decreased 19.52 9.97 265 479032 25761 70423386
Hypertriglyceridaemia 19.50 9.97 31 479266 11780 70437367
No adverse event 19.50 9.97 132 479165 32021 70417126
Culture urine positive 19.45 9.97 68 479229 4169 70444978
Serotonin syndrome 19.43 9.97 396 478901 41718 70407429
Breast cancer stage II 19.36 9.97 6 479291 5340 70443807
Temperature regulation disorder 19.27 9.97 70 479227 4374 70444773
Toxic epidermal necrolysis 19.27 9.97 375 478922 39182 70409965
Aphasia 19.18 9.97 193 479104 43056 70406091
Burning sensation 19.11 9.97 247 479050 52623 70396524
Chronic graft versus host disease 19.07 9.97 11 479286 6759 70442388
Cytomegalovirus viraemia 18.98 9.97 31 479266 11654 70437493
Actinic keratosis 18.98 9.97 7 479290 5583 70443564
Sepsis 18.96 9.97 1409 477888 243136 70206011
Bone pain 18.91 9.97 236 479061 50586 70398561
Pulmonary hypertension 18.89 9.97 212 479085 46324 70402823
Concomitant disease aggravated 18.88 9.97 33 479264 12081 70437066
Lipodystrophy acquired 18.74 9.97 3 479294 4213 70444934
Drug dose omission by device 18.71 9.97 3 479294 4209 70444938
Blood triglycerides increased 18.67 9.97 69 479228 19595 70429552
Therapeutic response unexpected 18.63 9.97 62 479235 18169 70430978
Thinking abnormal 18.63 9.97 33 479264 12018 70437129
Skin ulcer 18.50 9.97 222 479075 47923 70401224
Skin toxicity 18.49 9.97 13 479284 7185 70441962
Prostatic specific antigen increased 18.49 9.97 22 479275 9444 70439703
Enthesopathy 18.45 9.97 28 479269 10841 70438306
Metastases to liver 18.43 9.97 101 479196 25777 70423370
Tardive dyskinesia 18.42 9.97 24 479273 9905 70439242
Withdrawal syndrome 18.41 9.97 96 479201 24808 70424339
Hepatic cancer 18.39 9.97 23 479274 9660 70439487
Thrombosis 18.39 9.97 379 478918 75026 70374121
Partial seizures 18.35 9.97 17 479280 8188 70440959
Macular oedema 18.32 9.97 6 479291 5156 70443991
Fungal rhinitis 18.23 9.97 9 479288 59 70449088
Smear cervix abnormal 18.23 9.97 46 479251 2350 70446797
Mitral valve incompetence 18.13 9.97 106 479191 26622 70422525
Hypothermia 18.13 9.97 216 479081 20378 70428769
Respiratory disorder 18.09 9.97 368 478929 38755 70410392
Gestational diabetes 18.00 9.97 9 479288 5992 70443155
Injection site discolouration 17.97 9.97 13 479284 7079 70442068
Brain stem glioma 17.80 9.97 14 479283 226 70448921
Aplastic anaemia 17.78 9.97 182 479115 16534 70432613
Left ventricular dysfunction 17.72 9.97 62 479235 17895 70431252
Graft versus host disease in gastrointestinal tract 17.71 9.97 9 479288 5935 70443212
Kidney transplant rejection 17.55 9.97 25 479272 9936 70439211
Ketoacidosis 17.55 9.97 14 479283 7255 70441892
Vital capacity decreased 17.54 9.97 33 479264 1376 70447771
Ischaemic stroke 17.48 9.97 129 479168 30691 70418456
Electrolyte imbalance 17.45 9.97 108 479189 26753 70422394
Monocyte percentage increased 17.41 9.97 41 479256 2004 70447143
BK virus infection 17.34 9.97 17 479280 7972 70441175
Carotid artery stenosis 17.34 9.97 18 479279 8218 70440929
Ejection fraction decreased 17.33 9.97 129 479168 30633 70418514
Tachycardia 17.24 9.97 1269 478028 157277 70291870
Fear of injection 17.20 9.97 12 479285 6660 70442487
Neuroleptic malignant syndrome 17.19 9.97 104 479193 25903 70423244
Band neutrophil count increased 17.13 9.97 22 479275 655 70448492
Tendonitis 17.08 9.97 84 479213 22038 70427109
Sinus node dysfunction 17.07 9.97 14 479283 7155 70441992
Brain oedema 16.98 9.97 237 479060 23181 70425966
Melaena 16.96 9.97 273 479024 56082 70393065
Candida infection 16.93 9.97 150 479147 34323 70414824
Acute graft versus host disease in skin 16.91 9.97 14 479283 7123 70442024
Granulomatosis with polyangiitis 16.80 9.97 47 479250 2555 70446592
Hemiparesis 16.78 9.97 134 479163 31335 70417812
Cystitis haemorrhagic 16.75 9.97 20 479277 8573 70440574
Circulatory collapse 16.71 9.97 156 479141 35318 70413829
Bone erosion 16.63 9.97 50 479247 15123 70434024
Incorrect drug administration rate 16.62 9.97 53 479244 3099 70446048
Coagulation factor X level decreased 16.57 9.97 10 479287 102 70449045
Antipsychotic drug level increased 16.56 9.97 8 479289 5432 70443715
Low density lipoprotein increased 16.56 9.97 18 479279 8047 70441100
Arrhythmia 16.56 9.97 273 479024 55870 70393277
Pupillary light reflex tests abnormal 16.50 9.97 15 479282 298 70448849
Accidental death 16.48 9.97 61 479236 3847 70445300
Cells in urine 16.47 9.97 13 479284 211 70448936
Pneumonia 16.44 9.97 3672 475625 592560 69856587
Erysipelas 16.43 9.97 26 479271 9898 70439249
Pulmonary alveolar haemorrhage 16.39 9.97 28 479269 10341 70438806
Dyskinesia 16.32 9.97 188 479109 40886 70408261
Osmolar gap 16.31 9.97 11 479286 138 70449009
Dyslipidaemia 16.16 9.97 26 479271 9834 70439313
Anti-cyclic citrullinated peptide antibody 16.13 9.97 55 479242 3330 70445817
Hepatitis B reactivation 16.11 9.97 8 479289 5347 70443800
Accidental exposure to product 16.11 9.97 117 479180 27934 70421213
Infusion site discomfort 16.04 9.97 26 479271 961 70448186
Ascites 16.03 9.97 341 478956 67206 70381941
Malaise 15.98 9.97 2626 476671 430306 70018841
Lymphoproliferative disorder 15.98 9.97 8 479289 5321 70443826
Intervertebral discitis 15.94 9.97 63 479234 4098 70445049
Immunosuppressant drug level increased 15.85 9.97 18 479279 7889 70441258
Right ventricular failure 15.83 9.97 87 479210 22187 70426960
Nocturia 15.82 9.97 37 479260 12167 70436980
Visual impairment 15.75 9.97 417 478880 79833 70369314
Skin lesion 15.69 9.97 175 479122 38285 70410862
Eosinophil percentage increased 15.67 9.97 32 479265 1418 70447729
Aplasia pure red cell 15.65 9.97 16 479281 7358 70441789
Bacterial test positive 15.65 9.97 91 479206 6940 70442207
Blood creatinine decreased 15.64 9.97 94 479203 7255 70441892
Acute coronary syndrome 15.64 9.97 76 479221 20003 70429144
Genital haemorrhage 15.61 9.97 10 479287 5805 70443342
Metastases to bone 15.58 9.97 88 479209 22288 70426859
Transaminases increased 15.51 9.97 422 478875 46596 70402551
Cardiovascular disorder 15.49 9.97 59 479238 16611 70432536
Anal fissure 15.42 9.97 83 479214 6150 70442997
Hypersensitivity vasculitis 15.42 9.97 14 479283 6808 70442339
Disease recurrence 15.38 9.97 171 479126 37432 70411715
Ventricular extrasystoles 15.38 9.97 67 479230 18159 70430988
Psoriatic arthropathy 15.37 9.97 327 478970 64444 70384703
Lip dry 15.33 9.97 116 479181 9669 70439478
Gastritis erosive 15.29 9.97 28 479269 10067 70439080
Oedema 15.27 9.97 559 478738 103022 70346125
Musculoskeletal stiffness 15.12 9.97 1177 478120 146583 70302564
Renal disorder 15.09 9.97 174 479123 37835 70411312
Dysarthria 14.96 9.97 314 478983 61999 70387148
Adenocarcinoma of colon 14.85 9.97 9 479288 5383 70443764
Altered state of consciousness 14.83 9.97 186 479111 39836 70409311
Generalised bullous fixed drug eruption 14.79 9.97 10 479287 126 70449021
Cerebral ischaemia 14.79 9.97 30 479267 10382 70438765
Hallucination 14.78 9.97 397 478900 75863 70373284
Pulmonary embolism 14.78 9.97 882 478415 154985 70294162
JC virus infection 14.76 9.97 3 479294 3548 70445599
Fluid retention 14.75 9.97 321 478976 63064 70386083
Obsessive-compulsive disorder 14.74 9.97 9 479288 5361 70443786
Sensitivity to weather change 14.69 9.97 17 479280 7388 70441759
Infusion site haemorrhage 14.54 9.97 47 479250 2768 70446379
Chest pain 14.53 9.97 1481 477816 249779 70199368
Consciousness fluctuating 14.46 9.97 35 479262 1741 70447406
Hypomania 14.45 9.97 80 479217 5992 70443155
Osteomyelitis 14.42 9.97 133 479164 30185 70418962
Inflammation 14.41 9.97 660 478637 78005 70371142
Rash 14.41 9.97 3769 475528 506793 69942354
Gastrooesophageal reflux disease 14.36 9.97 486 478811 90353 70358794
Breast cancer 14.35 9.97 151 479146 33398 70415749
Blood cholesterol increased 14.32 9.97 553 478744 64051 70385096
Speech disorder 14.25 9.97 248 479049 50332 70398815
Post procedural pulmonary embolism 14.19 9.97 13 479284 261 70448886
Tricuspid valve incompetence 14.13 9.97 67 479230 17750 70431397
Precancerous cells present 14.04 9.97 26 479271 1071 70448076
B-cell lymphoma 14.01 9.97 13 479284 6256 70442891
Dystonia 13.99 9.97 77 479220 19629 70429518
Post-traumatic stress disorder 13.99 9.97 63 479234 4344 70444803
Serum sickness 13.96 9.97 52 479245 3289 70445858
Administration site swelling 13.95 9.97 15 479282 368 70448779
Retinal haemorrhage 13.94 9.97 19 479278 7691 70441456
Mean cell haemoglobin concentration increased 13.92 9.97 22 479275 796 70448351
Bundle branch block left 13.90 9.97 31 479266 10368 70438779
Skin cancer 13.85 9.97 46 479251 13490 70435657
Shock haemorrhagic 13.83 9.97 69 479228 18037 70431110
Vertigo 13.79 9.97 320 478977 62323 70386824
Chills 13.79 9.97 1147 478150 143639 70305508
Ankylosing spondylitis 13.78 9.97 37 479260 11609 70437538
Hepatic encephalopathy 13.75 9.97 218 479079 21900 70427247
Staphylococcal infection 13.75 9.97 266 479031 53138 70396009
Anti-erythrocyte antibody positive 13.65 9.97 8 479289 77 70449070
Product complaint 13.62 9.97 40 479257 12191 70436956
Carpal tunnel syndrome 13.61 9.97 64 479233 16993 70432154
PCO2 decreased 13.61 9.97 48 479249 2956 70446191
Labelled drug-drug interaction issue 13.60 9.97 25 479272 1024 70448123
SARS-CoV-2 test positive 13.55 9.97 103 479194 8598 70440549
Human herpesvirus 6 infection 13.54 9.97 8 479289 4851 70444296
Squamous cell carcinoma 13.37 9.97 52 479245 14552 70434595
Exposure to SARS-CoV-2 13.35 9.97 27 479270 1188 70447959
Laryngospasm 13.35 9.97 4 479293 3639 70445508
Injection site extravasation 13.32 9.97 103 479194 8643 70440504
Pneumonia streptococcal 13.32 9.97 42 479255 2441 70446706
Wound infection 13.32 9.97 179 479118 17363 70431784
Pancreatitis acute 13.31 9.97 220 479077 45004 70404143
Laboratory test abnormal 13.29 9.97 111 479186 25712 70423435
Erectile dysfunction 13.26 9.97 47 479250 13515 70435632
Impaired quality of life 13.26 9.97 25 479272 8891 70440256
Postmortem blood drug level increased 13.24 9.97 21 479276 762 70448385
Intraocular pressure increased 13.20 9.97 25 479272 8876 70440271
Long QT syndrome 13.19 9.97 10 479287 5317 70443830
Vein collapse 13.18 9.97 23 479274 904 70448243
Trichoglossia 13.16 9.97 17 479280 509 70448638
Leukoencephalopathy 13.16 9.97 18 479279 7276 70441871
Dyspnoea at rest 13.16 9.97 16 479281 6803 70442344
Toxic skin eruption 13.13 9.97 81 479216 20081 70429066
Cytomegalovirus chorioretinitis 13.05 9.97 10 479287 5288 70443859
Nephrogenic systemic fibrosis 13.00 9.97 13 479284 6039 70443108
Juvenile idiopathic arthritis 12.99 9.97 12 479285 5788 70443359
Heavy menstrual bleeding 12.99 9.97 43 479254 12622 70436525
Haemoglobin urine present 12.97 9.97 22 479275 845 70448302
Rheumatoid nodule 12.95 9.97 55 479242 15012 70434135
Allergy to chemicals 12.83 9.97 36 479261 1960 70447187
Eyelid ptosis 12.79 9.97 31 479266 10071 70439076
Dependent personality disorder 12.76 9.97 9 479288 122 70449025
Weight fluctuation 12.71 9.97 109 479188 9432 70439715
Polydipsia 12.70 9.97 13 479284 5975 70443172
Aortic valve stenosis 12.68 9.97 9 479288 4950 70444197
Urobilinogen urine increased 12.65 9.97 19 479278 657 70448490
Dermatitis 12.65 9.97 78 479219 19339 70429808
Urinary casts 12.64 9.97 26 479271 1158 70447989
Application site pain 12.62 9.97 7 479290 4395 70444752
Upper respiratory tract infection 12.61 9.97 656 478641 78618 70370529
Ear infection 12.60 9.97 265 479032 28071 70421076
Injection site discomfort 12.57 9.97 8 479289 4661 70444486
Pulmonary tuberculosis 12.57 9.97 21 479276 7824 70441323
Mean cell haemoglobin concentration decreased 12.54 9.97 58 479239 4045 70445102
Eczema 12.51 9.97 157 479140 33624 70415523
Peripheral sensory neuropathy 12.50 9.97 41 479256 12069 70437078
Upper gastrointestinal haemorrhage 12.49 9.97 178 479119 37299 70411848
Mycobacterial infection 12.48 9.97 4 479293 3484 70445663
Diffuse large B-cell lymphoma recurrent 12.41 9.97 4 479293 3472 70445675
Hypoglycaemic coma 12.41 9.97 7 479290 4354 70444793
Malignant melanoma 12.41 9.97 50 479247 13850 70435297
Blood uric acid decreased 12.40 9.97 26 479271 1174 70447973
Prescribed underdose 12.37 9.97 89 479208 21296 70427851
Hypothyroidism 12.36 9.97 226 479071 45529 70403618
Aortic valve incompetence 12.35 9.97 26 479271 8878 70440269
Disturbance in social behaviour 12.35 9.97 6 479291 4061 70445086
Nasal necrosis 12.34 9.97 9 479288 129 70449018
Deafness 12.34 9.97 78 479219 19225 70429922
Abnormal dreams 12.31 9.97 34 479263 10569 70438578
Skin burning sensation 12.27 9.97 38 479259 11388 70437759
Pneumonia viral 12.27 9.97 97 479200 8195 70440952
Femur fracture 12.26 9.97 171 479126 35961 70413186
Immune-mediated myositis 12.21 9.97 3 479294 3113 70446034
Retinal vein occlusion 12.21 9.97 3 479294 3113 70446034
Beta haemolytic streptococcal infection 12.18 9.97 35 479262 1932 70447215
Eye infection 12.15 9.97 113 479184 10005 70439142
Oral pruritus 12.14 9.97 35 479262 1936 70447211
Diabetic neuropathy 12.11 9.97 13 479284 5845 70443302
Pain in jaw 12.09 9.97 209 479088 42460 70406687
Specific gravity urine increased 12.09 9.97 15 479282 431 70448716
Focal dyscognitive seizures 12.08 9.97 4 479293 3413 70445734
Oral discomfort 12.08 9.97 26 479271 8805 70440342
Hip arthroplasty 12.07 9.97 261 479036 27779 70421368
Pneumonia cytomegaloviral 12.03 9.97 8 479289 4553 70444594
Dysgeusia 12.01 9.97 249 479048 49253 70399894
Alpha 1 microglobulin increased 11.97 9.97 7 479290 67 70449080
Lupus-like syndrome 11.88 9.97 39 479258 11476 70437671
Galactorrhoea 11.86 9.97 4 479293 3374 70445773
Acute myeloid leukaemia recurrent 11.85 9.97 3 479294 3051 70446096
Hepatitis B 11.85 9.97 23 479274 8091 70441056
Deep vein thrombosis postoperative 11.78 9.97 52 479245 3555 70445592
Cardiotoxicity 11.76 9.97 37 479260 11033 70438114
Atrioventricular block 11.73 9.97 45 479252 12643 70436504
Pre-eclampsia 11.70 9.97 16 479281 6469 70442678
Maple syrup disease 11.68 9.97 4 479293 8 70449139
Metastases to central nervous system 11.65 9.97 57 479240 14977 70434170
Self-medication 11.57 9.97 60 479237 4383 70444764
Urine oxalate increased 11.56 9.97 11 479286 232 70448915
Decerebrate posture 11.54 9.97 10 479287 186 70448961
Brain scan abnormal 11.51 9.97 25 479272 1157 70447990
Product dispensing error 11.49 9.97 42 479255 11966 70437181
Muscle disorder 11.48 9.97 11 479286 5214 70443933
Bradyphrenia 11.46 9.97 32 479265 9914 70439233
Acidosis hyperchloraemic 11.46 9.97 19 479278 716 70448431
Abnormal loss of weight 11.42 9.97 22 479275 7762 70441385
Oxygen saturation abnormal 11.42 9.97 54 479243 3800 70445347
Application site pruritus 11.42 9.97 5 479292 3596 70445551
Lymphadenopathy 11.38 9.97 247 479050 48544 70400603
Parkinsonism 11.37 9.97 59 479238 15266 70433881
Complications of transplanted kidney 11.37 9.97 14 479283 5920 70443227
Palpitations 11.35 9.97 622 478675 110131 70339016
Petit mal epilepsy 11.35 9.97 12 479285 5432 70443715
Reversible airways obstruction 11.35 9.97 30 479267 1577 70447570
Drug eruption 11.34 9.97 193 479104 39303 70409844
Blood potassium decreased 11.32 9.97 210 479087 42211 70406936
Tachyarrhythmia 11.26 9.97 16 479281 6366 70442781
Ductus arteriosus stenosis foetal 11.23 9.97 7 479290 76 70449071
Peripheral arterial occlusive disease 11.22 9.97 21 479276 7488 70441659
Potentiating drug interaction 11.19 9.97 24 479273 8140 70441007
Squamous cell carcinoma of skin 11.17 9.97 46 479251 12666 70436481
High density lipoprotein decreased 11.17 9.97 7 479290 4112 70445035
Hypoxia 11.16 9.97 753 478544 92591 70356556
Vaginal haemorrhage 11.16 9.97 86 479211 20266 70428881
Drug level above therapeutic 11.14 9.97 90 479207 7652 70441495
Hepatocellular injury 11.13 9.97 232 479065 45859 70403288
Transplant failure 11.11 9.97 7 479290 4100 70445047
Hypoaesthesia 11.09 9.97 891 478406 152848 70296299
Multiple allergies 11.06 9.97 90 479207 7670 70441477
Nervous system disorder 11.02 9.97 107 479190 24039 70425108
Monoparesis 11.01 9.97 4 479293 3220 70445927
Leukocyturia 10.99 9.97 30 479267 1607 70447540
Traumatic liver injury 10.98 9.97 16 479281 538 70448609
Osteolysis 10.98 9.97 5 479292 3514 70445633
COVID-19 pneumonia 10.95 9.97 209 479088 21760 70427387
Administration site bruise 10.95 9.97 8 479289 115 70449032
Device failure 10.93 9.97 14 479283 5821 70443326
Atypical femur fracture 10.87 9.97 10 479287 4833 70444314
Complication of device insertion 10.84 9.97 12 479285 5320 70443827
Infusion site urticaria 10.81 9.97 20 479277 823 70448324
Base excess 10.78 9.97 7 479290 82 70449065
Premature delivery 10.77 9.97 92 479205 21212 70427935
Brain abscess 10.77 9.97 9 479288 4557 70444590
Intestinal haemorrhage 10.72 9.97 15 479282 6005 70443142
Mania 10.67 9.97 70 479227 17104 70432043
Necrosis ischaemic 10.67 9.97 22 479275 982 70448165
Rheumatoid lung 10.66 9.97 5 479292 3454 70445693
Gait inability 10.66 9.97 240 479057 46935 70402212
Cystic fibrosis 10.65 9.97 8 479289 4273 70444874
Complication of device removal 10.64 9.97 5 479292 3449 70445698
Personality change 10.63 9.97 28 479269 8842 70440305
Hernia 10.62 9.97 150 479147 14710 70434437
Vitamin K deficiency 10.56 9.97 18 479279 694 70448453
Hyperammonaemia 10.52 9.97 35 479262 10258 70438889
Therapy non-responder 10.48 9.97 419 478878 76496 70372651
Transfusion-related circulatory overload 10.46 9.97 12 479285 317 70448830
Latent tuberculosis 10.44 9.97 4 479293 3117 70446030
Therapy partial responder 10.43 9.97 46 479251 12428 70436719
Large intestine polyp 10.42 9.97 41 479256 11435 70437712
Jaw disorder 10.42 9.97 10 479287 4736 70444411
Coagulation factor VII level decreased 10.39 9.97 10 479287 214 70448933
Testicular infarction 10.39 9.97 6 479291 56 70449091
Cyanosis neonatal 10.39 9.97 6 479291 56 70449091
Angiokeratoma 10.36 9.97 10 479287 215 70448932
Proteinuria 10.33 9.97 138 479159 29236 70419911
Coronary artery stenosis 10.32 9.97 42 479255 11602 70437545
Myocardial ischaemia 10.32 9.97 109 479188 24091 70425056
Complication associated with device 10.30 9.97 63 479234 15650 70433497
Hypocoagulable state 10.24 9.97 33 479264 1940 70447207
Balance disorder 10.24 9.97 724 478573 89404 70359743
Left ventricular hypertrophy 10.22 9.97 35 479262 10167 70438980
Caesarean section 10.20 9.97 42 479255 11565 70437582
Injection site nodule 10.19 9.97 5 479292 3365 70445782
Incorrect dose administered 10.19 9.97 550 478747 66169 70382978
Pneumatosis intestinalis 10.15 9.97 15 479282 5872 70443275
Dermatitis acneiform 10.15 9.97 29 479268 8916 70440231
Food allergy 10.14 9.97 95 479202 8429 70440718
Diaphragmatic rupture 10.13 9.97 10 479287 221 70448926
Neonatal respiratory acidosis 10.13 9.97 6 479291 59 70449088
Blood glucose abnormal 10.11 9.97 32 479265 9525 70439622
Eructation 10.10 9.97 33 479264 9727 70439420
Head injury 10.07 9.97 166 479131 33975 70415172
Teething 10.04 9.97 7 479290 93 70449054
Retinal deposits 10.03 9.97 8 479289 132 70449015
Hyperglycaemia 9.99 9.97 347 478950 64325 70384822
Terminal state 9.98 9.97 10 479287 4642 70444505
Generalised tonic-clonic seizure 9.98 9.97 210 479087 41451 70407696

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 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
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
7487-74-3 SECONDARY_CAS_RN
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 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
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 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 0031-8715 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
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 0031-8726 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8739 SOLUTION 20 mg ORAL OTC monograph final 15 sections
ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS HUMAN OTC DRUG LABEL 1 0031-8741 CAPSULE, LIQUID FILLED 15 mg ORAL OTC monograph final 14 sections
Robitussin Peak Cold Multi-Symptom Cold HUMAN OTC DRUG LABEL 3 0031-8742 LIQUID 10 mg ORAL OTC MONOGRAPH FINAL 17 sections
ROBITUSSIN LONG-ACTING COUGHGELS HUMAN OTC DRUG LABEL 1 0031-8743 CAPSULE, LIQUID FILLED 15 mg ORAL OTC MONOGRAPH FINAL 15 sections
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime HUMAN OTC DRUG LABEL 3 0031-8744 CAPSULE, LIQUID FILLED 15 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Maximum Strength Severe Cough Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8750 LIQUID 20 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 20 mg ORAL OTC monograph final 17 sections
Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8753 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8754 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Robitussin 12 Hour Cough Relief HUMAN OTC DRUG LABEL 1 0031-8755 SUSPENSION, EXTENDED RELEASE 30 mg ORAL ANDA 15 sections
Robitussin Honey Maximum Strength Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8756 SOLUTION 20 mg ORAL OTC monograph final 15 sections
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8757 SOLUTION 20 mg ORAL OTC monograph final 15 sections