dextromethorphan ๐Ÿถ 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 ยตM/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 2469.55 9.78 3717 341211 128172 50132024
Toxicity to various agents 2131.06 9.78 4559 340369 207940 50052256
Infusion related reaction 783.78 9.78 2739 342189 166818 50093378
Sinusitis 683.57 9.78 2631 342297 167927 50092269
Muscle injury 526.66 9.78 924 344004 36187 50224009
Folliculitis 522.51 9.78 950 343978 38275 50221921
Exposure to toxic agent 509.01 9.78 315 344613 3343 50256853
Acute hepatic failure 468.15 9.78 556 344372 15121 50245075
Irritable bowel syndrome 447.52 9.78 1045 343883 50396 50209800
Lower respiratory tract infection 430.66 9.78 1528 343400 93673 50166523
Overdose 399.44 9.78 1539 343389 98188 50162008
Intentional product misuse 367.43 9.78 913 344015 45821 50214375
Ill-defined disorder 344.85 9.78 984 343944 53670 50206526
Sleep disorder due to general medical condition, insomnia type 344.32 9.78 701 344227 30746 50229450
Blister 336.95 9.78 1312 343616 84106 50176090
Blood pressure fluctuation 322.81 9.78 738 344190 35085 50225111
Metabolic acidosis 307.83 9.78 761 344167 38064 50222132
Injection site pain 279.26 9.78 209 344719 110815 50149381
Duodenal ulcer perforation 276.91 9.78 810 344118 44801 50215395
Impaired healing 276.88 9.78 1074 343854 68712 50191484
Helicobacter infection 272.00 9.78 851 344077 48851 50211345
Anti-cyclic citrullinated peptide antibody positive 269.27 9.78 1073 343855 69514 50190682
Joint swelling 263.21 9.78 2691 342237 242595 50017601
Product dose omission issue 250.89 9.78 550 344378 183288 50076908
Nasopharyngitis 249.86 9.78 2203 342725 190724 50069472
Pericarditis 248.92 9.78 1130 343798 77559 50182637
Hepatic enzyme increased 233.35 9.78 1670 343258 135710 50124486
Rheumatoid arthritis 222.35 9.78 2233 342695 200317 50059879
Therapeutic product effect decreased 209.55 9.78 1616 343312 134434 50125762
Hepatotoxicity 206.71 9.78 525 344403 26701 50233495
Gastrointestinal disorder 197.74 9.78 1210 343718 93246 50166950
Anion gap 194.90 9.78 112 344816 1025 50259171
Intentional overdose 186.88 9.78 883 344045 61621 50198575
Stomatitis 176.68 9.78 1240 343688 100104 50160092
Diarrhoea 173.59 9.78 2896 342032 585580 49674616
Body temperature increased 169.93 9.78 535 344393 30806 50229390
Respiratory arrest 168.01 9.78 518 344410 29491 50230705
Intentional product use issue 162.01 9.78 987 343941 75931 50184265
Hypersensitivity 160.35 9.78 2202 342726 212959 50047237
Injection site erythema 158.37 9.78 166 344762 74770 50185426
Weight increased 155.68 9.78 2079 342849 199812 50060384
Cardio-respiratory arrest 151.47 9.78 748 344180 53144 50207052
Device expulsion 150.96 9.78 12 344916 28810 50231386
Swelling 148.52 9.78 2053 342875 198819 50061377
Synovitis 147.74 9.78 1390 343538 122475 50137721
Hand deformity 144.22 9.78 1172 343756 99027 50161169
Depressed level of consciousness 143.82 9.78 718 344210 51235 50208961
Medication error 140.97 9.78 553 344375 35551 50224645
Peripheral swelling 136.09 9.78 2064 342864 203872 50056324
Discomfort 133.64 9.78 1225 343703 107155 50153041
Wrong technique in product usage process 131.34 9.78 111 344817 55399 50204797
Injection site reaction 129.89 9.78 91 344837 49941 50210255
Psoriasis 125.42 9.78 172 344756 68828 50191368
Coagulopathy 124.92 9.78 335 344593 17609 50242587
Ear pain 124.34 9.78 450 344478 27833 50232363
Wound 123.04 9.78 1181 343747 104613 50155583
Sedation complication 122.66 9.78 217 344711 8549 50251647
Hepatic cytolysis 120.43 9.78 206 344722 7897 50252299
Heart rate decreased 119.00 9.78 529 344399 35968 50224228
Infusion site pain 109.69 9.78 253 344675 12093 50248103
Analgesic drug level increased 106.71 9.78 91 344837 1640 50258556
Creatinine renal clearance decreased 105.04 9.78 243 344685 11638 50248558
Injection site pruritus 102.94 9.78 75 344853 40336 50219860
Infection 102.33 9.78 1702 343226 171252 50088944
Blood pressure diastolic abnormal 100.45 9.78 207 344721 9154 50251042
Drug ineffective 100.45 9.78 4567 340361 814766 49445430
Drug abuse 100.02 9.78 725 344203 59121 50201075
Pruritus 99.73 9.78 2584 342344 280984 49979212
Infusion site swelling 99.58 9.78 177 344751 6999 50253197
Injection site bruising 99.30 9.78 64 344864 36704 50223492
Poisoning 98.87 9.78 244 344684 12185 50248011
Anaemia 97.55 9.78 1176 343752 251280 50008916
Muscle spasticity 94.67 9.78 295 344633 16889 50243307
Neutropenia 94.09 9.78 606 344322 147359 50112837
Rheumatoid factor positive 89.73 9.78 615 344313 49244 50210952
Hepatic failure 89.21 9.78 446 344482 31837 50228359
Confusional state 88.01 9.78 1767 343161 184161 50076035
Sopor 87.50 9.78 15 344913 19864 50240332
Acute lung injury 85.40 9.78 73 344855 1320 50258876
Infusion site extravasation 85.38 9.78 163 344765 6813 50253383
Drug hypersensitivity 83.17 9.78 1207 343721 249803 50010393
Drug resistance 82.12 9.78 15 344913 18974 50241222
Blood pressure systolic abnormal 81.04 9.78 169 344759 7537 50252659
Disease progression 80.75 9.78 357 344571 95509 50164687
Blood pressure diastolic decreased 80.66 9.78 275 344653 16506 50243690
Exposure via ingestion 79.71 9.78 97 344831 2706 50257490
Osteonecrosis of jaw 79.47 9.78 63 344865 32463 50227733
Blood calcium decreased 79.08 9.78 315 344613 20391 50239805
Hepatic necrosis 78.76 9.78 134 344794 5114 50255082
Hospitalisation 78.67 9.78 221 344707 67716 50192480
Blood pressure increased 78.65 9.78 1310 343618 131822 50128374
Infusion site erythema 77.71 9.78 179 344749 8548 50251648
Injection site swelling 76.03 9.78 104 344824 41669 50218527
Myocardial infarction 74.70 9.78 332 344596 88695 50171501
Respiratory depression 74.49 9.78 215 344713 11795 50248401
Oxygen saturation decreased 72.84 9.78 792 344136 72456 50187740
Nausea 72.83 9.78 4001 340927 701397 49558799
Suspected suicide 71.61 9.78 130 344798 5227 50254969
Therapeutic product effect incomplete 69.91 9.78 353 344575 91162 50169034
Decreased appetite 68.33 9.78 961 343967 199962 50060234
Therapy cessation 66.60 9.78 48 344880 25963 50234233
Neuropathy peripheral 65.78 9.78 388 344540 96369 50163827
Throat irritation 65.52 9.78 391 344537 29848 50230348
Dizziness 64.64 9.78 1832 343096 344537 49915659
Paraesthesia 64.05 9.78 518 344410 119725 50140471
Respiratory disorder 62.99 9.78 396 344532 30791 50229405
Glossodynia 62.41 9.78 1121 343807 114448 50145748
Injection site warmth 62.06 9.78 10 344918 13856 50246340
Blood pressure systolic increased 61.86 9.78 434 344494 35015 50225181
Drug interaction 61.25 9.78 974 343954 198647 50061549
Product quality issue 61.17 9.78 72 344856 30786 50229410
Pyroglutamate increased 60.55 9.78 37 344891 383 50259813
Orthostatic hypotension 59.95 9.78 375 344553 29106 50231090
Abortion spontaneous 59.37 9.78 122 344806 41650 50218546
Pyrexia 58.51 9.78 3159 341769 377044 49883152
Infusion site pruritus 58.39 9.78 100 344828 3837 50256359
Cardiac failure congestive 57.03 9.78 339 344589 84043 50176153
Cognitive disorder 57.03 9.78 504 344424 43619 50216577
Arthropathy 56.87 9.78 1444 343484 156462 50103734
Product substitution issue 56.86 9.78 13 344915 14044 50246152
Feeling abnormal 56.18 9.78 565 344363 124927 50135269
Bone marrow failure 55.25 9.78 64 344864 27560 50232636
Muscle spasms 55.08 9.78 568 344360 124985 50135211
Contraindicated product administered 55.07 9.78 1367 343561 147591 50112605
Mucosal inflammation 54.74 9.78 120 344808 40022 50220174
Cerebrovascular accident 54.59 9.78 399 344529 94281 50165915
Night sweats 54.51 9.78 404 344524 33170 50227026
Device malfunction 53.67 9.78 18 344910 15103 50245093
Coma 53.34 9.78 608 344320 56271 50203925
Electric shock 53.31 9.78 49 344879 979 50259217
Cardiac failure 53.25 9.78 302 344626 75738 50184458
Accidental overdose 52.66 9.78 268 344660 19265 50240931
Red blood cell sedimentation rate abnormal 52.12 9.78 23 344905 16320 50243876
Pyroglutamic acidosis 51.34 9.78 34 344894 409 50259787
Device dislocation 51.06 9.78 43 344885 21503 50238693
Sedation 50.65 9.78 370 344558 30240 50229956
Rheumatic fever 50.16 9.78 238 344690 16629 50243567
Heart rate increased 50.04 9.78 772 344156 76478 50183718
Pancytopenia 48.49 9.78 354 344574 83676 50176520
Arthralgia 48.14 9.78 3540 341388 435162 49825034
Liver injury 47.64 9.78 311 344617 24495 50235701
Methaemoglobinaemia 47.57 9.78 64 344864 1978 50258218
Cardiac arrest 47.14 9.78 817 344111 82834 50177362
Pemphigus 46.88 9.78 1111 343817 119055 50141141
Contusion 46.18 9.78 1045 343883 111138 50149058
Infusion site bruising 46.11 9.78 67 344861 2228 50257968
Malignant neoplasm progression 45.86 9.78 274 344654 67850 50192346
Surgery 45.71 9.78 85 344843 30120 50230076
Injection site mass 45.57 9.78 25 344903 15655 50244541
Injection site rash 45.28 9.78 27 344901 16150 50244046
No adverse event 45.27 9.78 101 344827 33477 50226719
Swollen joint count increased 45.06 9.78 211 344717 14662 50245534
Oedema peripheral 45.06 9.78 781 344147 157180 50103016
Psoriatic arthropathy 44.70 9.78 167 344761 46865 50213331
Product storage error 44.36 9.78 14 344914 12210 50247986
Injection site urticaria 44.32 9.78 14 344914 12203 50247993
Rash 44.32 9.78 3508 341420 433963 49826233
Palmar-plantar erythrodysaesthesia syndrome 44.18 9.78 43 344885 20055 50240141
International normalised ratio increased 43.54 9.78 468 344460 42684 50217512
Crystal urine present 43.54 9.78 52 344876 1422 50258774
Diabetes mellitus 43.48 9.78 179 344749 48854 50211342
Anion gap abnormal 43.42 9.78 28 344900 321 50259875
Neoplasm progression 43.29 9.78 83 344845 29074 50231122
Injection site haemorrhage 43.18 9.78 49 344879 21297 50238899
Heart rate irregular 43.01 9.78 252 344676 19108 50241088
Alanine aminotransferase increased 42.49 9.78 842 344086 87517 50172679
Device issue 41.33 9.78 45 344883 19927 50240269
Bone pain 40.90 9.78 174 344754 47055 50213141
White blood cells urine positive 40.87 9.78 94 344834 4484 50255712
Product prescribing error 40.39 9.78 50 344878 20911 50239285
Body temperature decreased 40.11 9.78 219 344709 16176 50244020
Hypotension 38.87 9.78 1970 342958 233499 50026697
White blood cell count decreased 38.33 9.78 562 344366 116160 50144036
Hyperkalaemia 38.15 9.78 183 344745 47906 50212290
Transient ischaemic attack 37.86 9.78 104 344824 32106 50228090
Administration site swelling 37.82 9.78 41 344887 1006 50259190
Memory impairment 37.74 9.78 352 344576 79008 50181188
Blood parathyroid hormone decreased 37.14 9.78 3 344925 7111 50253085
Malaise 36.69 9.78 1891 343037 333641 49926555
Epistaxis 36.62 9.78 270 344658 63684 50196512
Device difficult to use 36.45 9.78 11 344917 9875 50250321
Posterior reversible encephalopathy syndrome 36.36 9.78 29 344899 14899 50245297
Renal impairment 36.23 9.78 335 344593 75326 50184870
Suicide attempt 36.23 9.78 524 344404 51208 50208988
Therapy interrupted 35.84 9.78 51 344877 20101 50240095
Interstitial lung disease 35.72 9.78 214 344714 52962 50207234
Rash pruritic 35.71 9.78 186 344742 47660 50212536
Seizure 35.49 9.78 577 344351 117297 50142899
Infusion site nodule 35.35 9.78 41 344887 1086 50259110
Urine abnormality 35.20 9.78 108 344820 6130 50254066
Administration site pain 34.95 9.78 32 344896 636 50259560
Soft tissue disorder 34.87 9.78 84 344844 4130 50256066
Fracture 34.75 9.78 38 344890 16795 50243401
Product use in unapproved indication 34.52 9.78 568 344360 115251 50144945
Acute kidney injury 34.12 9.78 1241 343687 226817 50033379
Respiratory rate increased 34.11 9.78 161 344767 11224 50248972
Foetal exposure during pregnancy 33.93 9.78 86 344842 27273 50232923
Dyspnoea exertional 33.47 9.78 208 344720 51025 50209171
Drug intolerance 33.11 9.78 1818 343110 217286 50042910
Suicidal ideation 33.08 9.78 231 344697 55154 50205042
Multiple sclerosis relapse 32.64 9.78 166 344762 42798 50217398
Gait disturbance 32.51 9.78 776 344152 149229 50110967
Off label use 32.08 9.78 2791 342137 471635 49788561
Myelosuppression 32.00 9.78 27 344901 13490 50246706
Blood pressure diastolic increased 31.51 9.78 117 344811 7326 50252870
Urinary sediment present 31.43 9.78 52 344876 1939 50258257
Accidental exposure to product 31.37 9.78 69 344859 22988 50237208
Urticaria 31.28 9.78 1128 343800 128433 50131763
Fall 31.23 9.78 1917 343011 333015 49927181
Jaundice cholestatic 31.22 9.78 91 344837 5020 50255176
Depression 31.01 9.78 874 344054 164549 50095647
Toxicologic test abnormal 30.96 9.78 29 344899 594 50259602
Substance abuse 30.75 9.78 79 344849 4045 50256151
Vision blurred 30.43 9.78 366 344562 78281 50181915
Myelodysplastic syndrome 30.32 9.78 35 344893 15097 50245099
Lymphocyte count decreased 30.21 9.78 293 344635 26014 50234182
Poor venous access 30.09 9.78 145 344783 10195 50250001
Underdose 29.86 9.78 58 344870 20220 50239976
Injection site induration 29.79 9.78 10 344918 8387 50251809
Epilepsy 29.79 9.78 64 344864 21503 50238693
Drug ineffective for unapproved indication 29.52 9.78 63 344865 21218 50238978
Disturbance in attention 29.46 9.78 111 344817 31075 50229121
Leukopenia 29.39 9.78 306 344622 67222 50192974
Red blood cells urine positive 29.35 9.78 61 344867 2714 50257482
Hyponatraemia 29.14 9.78 470 344458 95669 50164527
Hypertensive crisis 29.08 9.78 28 344900 13126 50247070
Dehydration 28.69 9.78 805 344123 151644 50108552
Systemic lupus erythematosus 28.01 9.78 1199 343729 139423 50120773
Pain in extremity 27.70 9.78 1549 343379 271316 49988880
Hypercalcaemia 27.00 9.78 76 344852 23276 50236920
Intervertebral discitis 26.48 9.78 57 344871 2599 50257597
Unresponsive to stimuli 26.39 9.78 322 344606 30287 50229909
Hypokalaemia 26.39 9.78 431 344497 87561 50172635
Hypomania 26.36 9.78 79 344849 4426 50255770
Gestational diabetes 26.29 9.78 9 344919 7456 50252740
Tremor 26.12 9.78 590 344338 114313 50145883
Femur fracture 26.11 9.78 149 344779 37315 50222881
Musculoskeletal disorder 26.09 9.78 49 344879 17300 50242896
Blood pH decreased 26 9.78 54 344874 2401 50257795
Dry skin 25.86 9.78 180 344748 43011 50217185
Mobility decreased 25.84 9.78 721 344207 79227 50180969
Hyperlipidaemia 25.78 9.78 50 344878 17440 50242756
Red cell distribution width increased 25.62 9.78 121 344807 8438 50251758
Myalgia 25.60 9.78 648 344280 123671 50136525
Diabetic ketoacidosis 25.56 9.78 52 344876 17820 50242376
Urine leukocyte esterase positive 25.52 9.78 59 344869 2824 50257372
Neutrophil percentage increased 25.46 9.78 57 344871 2670 50257526
Thrombocytopenia 25.36 9.78 669 344259 127004 50133192
Upper respiratory tract infection 25.30 9.78 608 344320 65290 50194906
Body temperature fluctuation 25.26 9.78 47 344881 1926 50258270
Ageusia 25.21 9.78 25 344903 11558 50248638
Lymphocyte percentage decreased 25.00 9.78 57 344871 2703 50257493
Disease recurrence 25.00 9.78 63 344865 20018 50240178
Infusion site haemorrhage 24.99 9.78 60 344868 2944 50257252
Lupus-like syndrome 24.98 9.78 17 344911 9474 50250722
Ear pruritus 24.95 9.78 54 344874 2472 50257724
Second primary malignancy 24.94 9.78 8 344920 6906 50253290
Basal cell carcinoma 24.85 9.78 79 344849 23277 50236919
Osteonecrosis 24.78 9.78 75 344853 22442 50237754
Brain death 24.69 9.78 57 344871 2726 50257470
Multiple drug therapy 24.62 9.78 46 344882 1891 50258305
Aspartate aminotransferase increased 24.54 9.78 701 344227 77297 50182899
Gastrooesophageal reflux disease 24.38 9.78 370 344558 76058 50184138
Brain oedema 24.31 9.78 156 344772 12214 50247982
Infusion site mass 24.24 9.78 35 344893 1157 50259039
Palpitations 24.20 9.78 476 344452 94030 50166166
Burning sensation 24.07 9.78 196 344732 45250 50214946
Therapeutic response decreased 23.98 9.78 206 344722 47025 50213171
Liver transplant 23.89 9.78 48 344880 2084 50258112
Analgesic drug level above therapeutic 23.86 9.78 15 344913 164 50260032
Haematotoxicity 23.81 9.78 12 344916 7883 50252313
Incorrect drug administration rate 23.81 9.78 54 344874 2552 50257644
Hypocalcaemia 23.71 9.78 98 344830 26718 50233478
Syncope 23.67 9.78 528 344400 102474 50157722
Breast cancer 23.64 9.78 183 344745 42707 50217489
Anion gap increased 23.46 9.78 39 344889 1460 50258736
Bone erosion 23.45 9.78 27 344901 11660 50248536
Blood creatine increased 23.41 9.78 80 344848 4807 50255389
Acidosis 23.29 9.78 134 344794 10093 50250103
Specific gravity urine decreased 23.25 9.78 26 344902 661 50259535
Drug withdrawal syndrome 23.22 9.78 90 344838 24991 50235205
Lactic acidosis 23.06 9.78 133 344795 33222 50226974
Administration site erythema 23.01 9.78 23 344905 512 50259684
Osteoarthritis 22.97 9.78 329 344599 68277 50191919
Cytokine release syndrome 22.95 9.78 118 344810 8516 50251680
Visual acuity reduced 22.95 9.78 66 344862 20073 50240123
Prothrombin time prolonged 22.94 9.78 120 344808 8718 50251478
Withdrawal syndrome 22.83 9.78 54 344874 17536 50242660
Infusion site urticaria 22.56 9.78 31 344897 978 50259218
Spinal stenosis 22.45 9.78 36 344892 13514 50246682
Complication associated with device 22.38 9.78 41 344887 14614 50245582
Aphasia 22.27 9.78 109 344819 28385 50231811
Skin ulcer 22.24 9.78 145 344783 35173 50225023
Therapeutic response unexpected 22.17 9.78 47 344881 15868 50244328
Macular degeneration 22.15 9.78 171 344757 14217 50245979
Full blood count decreased 22.12 9.78 78 344850 22268 50237928
Metastases to bone 21.98 9.78 57 344871 17938 50242258
Dysgeusia 21.94 9.78 165 344763 38751 50221445
Coronary artery disease 21.93 9.78 116 344812 29610 50230586
Atrial fibrillation 21.85 9.78 527 344401 101218 50158978
Tinnitus 21.76 9.78 108 344820 28024 50232172
Iron deficiency anaemia 21.59 9.78 52 344876 16782 50243414
Metastases to liver 21.39 9.78 68 344860 20036 50240160
Genital haemorrhage 21.36 9.78 9 344919 6565 50253631
Hepatic cirrhosis 21.22 9.78 56 344872 17521 50242675
Cytomegalovirus infection 21.11 9.78 58 344870 17904 50242292
Full blood count abnormal 20.97 9.78 85 344843 23303 50236893
Skin necrosis 20.85 9.78 26 344902 10841 50249355
Hypoaesthesia 20.73 9.78 685 344243 126572 50133624
Gastrointestinal haemorrhage 20.73 9.78 363 344565 72958 50187238
Extrapyramidal disorder 20.72 9.78 30 344898 11740 50248456
Pain 20.66 9.78 4354 340574 574549 49685647
Platelet count decreased 20.47 9.78 526 344402 100200 50159996
Accidental death 20.43 9.78 40 344888 1704 50258492
Panniculitis 20.11 9.78 17 344911 8486 50251710
Forced expiratory volume decreased 20.05 9.78 3 344925 4391 50255805
Infusion site irritation 20.04 9.78 23 344905 602 50259594
Unevaluable event 19.94 9.78 209 344719 45857 50214339
Loss of consciousness 19.89 9.78 550 344378 103803 50156393
Blood glucose increased 19.88 9.78 354 344574 70970 50189226
Drug-induced liver injury 19.83 9.78 285 344643 27810 50232386
Joint stiffness 19.82 9.78 123 344805 30185 50230011
Ductus arteriosus premature closure 19.81 9.78 17 344911 309 50259887
Pathogen resistance 19.80 9.78 7 344921 5682 50254514
Hypothermia 19.73 9.78 145 344783 11871 50248325
Cerebral haemorrhage 19.72 9.78 106 344822 26946 50233250
Polyneuropathy 19.38 9.78 33 344895 12098 50248098
Neurotoxicity 19.33 9.78 45 344883 14695 50245501
Irritability 19.30 9.78 114 344814 28312 50231884
Haemorrhage 19.06 9.78 253 344675 53188 50207008
Pneumocystis jirovecii pneumonia 19.04 9.78 45 344883 14618 50245578
Bradypnoea 19.03 9.78 55 344873 3019 50257177
Sepsis 18.81 9.78 728 344200 132197 50127999
Transplant rejection 18.43 9.78 23 344905 9586 50250610
Febrile bone marrow aplasia 18.43 9.78 10 344918 6301 50253895
Heavy menstrual bleeding 18.38 9.78 50 344878 15487 50244709
Drug screen positive 18.36 9.78 58 344870 3344 50256852
Ventricular extrasystoles 18.32 9.78 27 344901 10489 50249707
Swollen tongue 18.30 9.78 117 344811 28513 50231683
Inappropriate antidiuretic hormone secretion 18.15 9.78 39 344889 13104 50247092
Blood cholesterol increased 18.13 9.78 499 344429 54716 50205480
C-reactive protein abnormal 18.11 9.78 113 344815 27696 50232500
Postmortem blood drug level increased 17.96 9.78 21 344907 561 50259635
Metastases to lymph nodes 17.93 9.78 13 344915 7011 50253185
Abdominal distension 17.82 9.78 370 344558 72533 50187663
Oral discomfort 17.80 9.78 17 344911 8000 50252196
Injection site discolouration 17.68 9.78 13 344915 6961 50253235
Electrolyte imbalance 17.62 9.78 59 344869 17110 50243086
Vaginal haemorrhage 17.45 9.78 97 344831 24454 50235742
Pneumonia streptococcal 17.42 9.78 36 344892 1595 50258601
Fear of injection 17.35 9.78 10 344918 6093 50254103
Osmolar gap 17.09 9.78 10 344918 95 50260101
Hyperglycaemia 17.07 9.78 162 344766 36243 50223953
Blood creatinine decreased 16.88 9.78 73 344855 4903 50255293
Vertigo 16.85 9.78 250 344678 51582 50208614
Band neutrophil count increased 16.80 9.78 16 344912 335 50259861
Blood urine present 16.79 9.78 147 344781 12686 50247510
Post procedural pulmonary embolism 16.76 9.78 14 344914 245 50259951
Temperature regulation disorder 16.70 9.78 65 344863 4162 50256034
Bacterial test 16.65 9.78 29 344899 1128 50259068
Thrombosis 16.56 9.78 274 344654 55559 50204637
Haemolysis 16.53 9.78 83 344845 5933 50254263
Asphyxia 16.45 9.78 77 344851 5350 50254846
Skin exfoliation 16.44 9.78 148 344780 33464 50226732
Pulmonary hypertension 16.41 9.78 147 344781 33270 50226926
Hallucination, auditory 16.40 9.78 30 344898 10698 50249498
Cardiomyopathy 16.39 9.78 53 344875 15533 50244663
Mean cell haemoglobin concentration increased 16.34 9.78 18 344910 450 50259746
Renal failure neonatal 16.30 9.78 12 344916 173 50260023
Angioedema 16.28 9.78 171 344757 37505 50222691
Mood swings 16.26 9.78 55 344873 15899 50244297
Thinking abnormal 16.24 9.78 25 344903 9542 50250654
Product adhesion issue 15.99 9.78 5 344923 4387 50255809
Smear cervix abnormal 15.98 9.78 48 344880 2693 50257503
Galactorrhoea 15.97 9.78 3 344925 3720 50256476
Taste disorder 15.89 9.78 20 344908 8304 50251892
Cardiac disorder 15.87 9.78 202 344726 42777 50217419
Loss of personal independence in daily activities 15.83 9.78 360 344568 69690 50190506
Ejection fraction decreased 15.56 9.78 69 344859 18451 50241745
Low turnover osteopathy 15.55 9.78 4 344924 3990 50256206
Premature delivery 15.49 9.78 96 344832 23567 50236629
Akathisia 15.47 9.78 20 344908 8209 50251987
Infusion site discomfort 15.32 9.78 24 344904 854 50259342
COVID-19 immunisation 15.31 9.78 22 344906 724 50259472
Anaphylactic shock 15.23 9.78 78 344850 20077 50240119
Device breakage 15.22 9.78 26 344902 9521 50250675
Opiates positive 15.22 9.78 15 344913 328 50259868
Pneumonia viral 15.21 9.78 89 344839 6745 50253451
Schizoaffective disorder 15.17 9.78 41 344887 2165 50258031
Weight decreased 15.12 9.78 1300 343628 219945 50040251
Treatment noncompliance 15.08 9.78 132 344796 30018 50230178
Metastases to lung 14.97 9.78 33 344895 10987 50249209
Post transplant lymphoproliferative disorder 14.93 9.78 5 344923 4199 50255997
Injury 14.91 9.78 438 344490 48487 50211709
Complication of device removal 14.70 9.78 5 344923 4159 50256037
Bursitis 14.63 9.78 222 344706 21913 50238283
Caesarean section 14.55 9.78 56 344872 15583 50244613
Labelled drug-drug interaction medication error 14.55 9.78 31 344897 10446 50249750
Parosmia 14.53 9.78 6 344922 4430 50255766
Intermenstrual bleeding 14.49 9.78 15 344913 6799 50253397
Transfusion-related acute lung injury 14.42 9.78 9 344919 97 50260099
Shoulder arthroplasty 14.33 9.78 3 344925 3445 50256751
Electrocardiogram QT prolonged 14.31 9.78 258 344670 51628 50208568
Transplant dysfunction 14.31 9.78 7 344921 4677 50255519
Laboratory test abnormal 14.25 9.78 96 344832 23112 50237084
Anxiety 14.24 9.78 1030 343898 176576 50083620
Haemophagocytic lymphohistiocytosis 14.24 9.78 23 344905 8610 50251586
Pregnancy with contraceptive device 14.23 9.78 5 344923 4074 50256122
Sensitivity to weather change 14.19 9.78 12 344916 5989 50254207
Necrosis ischaemic 14.16 9.78 22 344906 777 50259419
Pulmonary arterial hypertension 14.05 9.78 81 344847 20238 50239958
Haemoglobin urine present 14.02 9.78 22 344906 784 50259412
Renal failure 14.01 9.78 589 344339 106044 50154152
Hepatic encephalopathy 14.00 9.78 113 344815 9523 50250673
Thrombotic microangiopathy 13.96 9.78 24 344904 8767 50251429
Renal papillary necrosis 13.95 9.78 12 344916 219 50259977
Death 13.92 9.78 2470 342458 322909 49937287
Concomitant disease aggravated 13.88 9.78 21 344907 8070 50252126
Flatulence 13.85 9.78 131 344797 29327 50230869
Administration site pruritus 13.85 9.78 13 344915 267 50259929
Hepatitis cholestatic 13.83 9.78 80 344848 6037 50254159
Ascites 13.82 9.78 167 344761 35694 50224502
Therapeutic response shortened 13.80 9.78 92 344836 7297 50252899
Eosinophil percentage increased 13.77 9.78 24 344904 934 50259262
Low density lipoprotein increased 13.71 9.78 11 344917 5635 50254561
Chest pain 13.67 9.78 1029 343899 175853 50084343
Infusion site rash 13.61 9.78 29 344899 1313 50258883
Rheumatoid nodule 13.60 9.78 43 344885 12692 50247504
Macular oedema 13.59 9.78 4 344924 3650 50256546
Culture urine positive 13.58 9.78 53 344875 3398 50256798
Dysphonia 13.55 9.78 185 344743 38707 50221489
Acute graft versus host disease 13.55 9.78 5 344923 3953 50256243
Nail bed inflammation 13.55 9.78 15 344913 377 50259819
Multiple-drug resistance 13.53 9.78 3 344925 3311 50256885
Cerebral infarction 13.45 9.78 89 344839 21515 50238681
Tardive dyskinesia 13.37 9.78 18 344910 7261 50252935
Dysphoria 13.32 9.78 8 344920 4766 50255430
Pain in jaw 13.32 9.78 183 344745 38245 50221951
Nervous system disorder 13.30 9.78 61 344867 16162 50244034
Vitamin D deficiency 13.26 9.78 37 344891 11365 50248831
Complication of device insertion 13.19 9.78 13 344915 6028 50254168
Schizophrenia 13.16 9.78 91 344837 7306 50252890
Status epilepticus 13.13 9.78 47 344881 13359 50246837
Neuroleptic malignant syndrome 13.03 9.78 36 344892 11094 50249102
Rhinitis allergic 13.02 9.78 18 344910 7182 50253014
Acute myocardial infarction 13.00 9.78 132 344796 29141 50231055
Administration site extravasation 12.99 9.78 20 344908 701 50259495
Carpal tunnel syndrome 12.98 9.78 65 344863 16828 50243368
Blindness 12.96 9.78 67 344861 17202 50242994
Pharyngeal paraesthesia 12.93 9.78 30 344898 1439 50258757
Angina unstable 12.92 9.78 16 344912 6690 50253506
Unintended pregnancy 12.83 9.78 9 344919 4937 50255259
Product complaint 12.75 9.78 38 344890 11428 50248768
Eructation 12.68 9.78 18 344910 7103 50253093
Pancreatitis 12.68 9.78 209 344719 42405 50217791
Atypical femur fracture 12.68 9.78 9 344919 4907 50255289
Ductus arteriosus stenosis foetal 12.66 9.78 10 344918 161 50260035
Urine analysis abnormal 12.66 9.78 61 344867 4289 50255907
Invasive ductal breast carcinoma 12.63 9.78 13 344915 5908 50254288
Vitamin K deficiency 12.62 9.78 15 344913 408 50259788
Gait inability 12.59 9.78 177 344751 36850 50223346
Beta haemolytic streptococcal infection 12.57 9.78 34 344894 1796 50258400
Breast cancer female 12.57 9.78 17 344911 6845 50253351
Lip swelling 12.50 9.78 108 344820 24628 50235568
Erysipelas 12.48 9.78 16 344912 6592 50253604
Alpha 1 microglobulin increased 12.47 9.78 7 344921 61 50260135
Coma hepatic 12.40 9.78 18 344910 598 50259598
Blood uric acid decreased 12.40 9.78 19 344909 663 50259533
Fluid retention 12.39 9.78 257 344671 50392 50209804
Injury associated with device 12.37 9.78 3 344925 3114 50257082
Coagulation factor X level decreased 12.37 9.78 7 344921 62 50260134
Dyskinesia 12.22 9.78 126 344802 27735 50232461
Hypomagnesaemia 12.20 9.78 100 344828 23056 50237140
Chronic kidney disease 12.19 9.78 194 344734 39577 50220619
Diplopia 12.16 9.78 79 344849 19181 50241015
Epstein-Barr virus infection 12.15 9.78 18 344910 6979 50253217
Antidepressant drug level above therapeutic 12.12 9.78 14 344914 369 50259827
Septic shock 12.04 9.78 297 344631 56878 50203318
Administration site bruise 12.01 9.78 12 344916 267 50259929
Abnormal dreams 12.00 9.78 29 344899 9348 50250848
Product residue present 11.98 9.78 5 344923 3667 50256529
Traumatic liver injury 11.97 9.78 12 344916 268 50259928
Impaired work ability 11.96 9.78 50 344878 13590 50246606
Blood lactic acid increased 11.96 9.78 72 344856 5513 50254683
Pericardial effusion 11.94 9.78 114 344814 25475 50234721
Congestive cardiomyopathy 11.90 9.78 12 344916 5506 50254690
Skin burning sensation 11.88 9.78 33 344895 10152 50250044
Aplasia pure red cell 11.85 9.78 7 344921 4208 50255988
Arrhythmia 11.76 9.78 157 344771 32975 50227221
Coagulation factor VII level decreased 11.74 9.78 7 344921 69 50260127
Encephalopathy 11.74 9.78 307 344621 33404 50226792
Skin toxicity 11.72 9.78 6 344922 3907 50256289
Ear infection 11.65 9.78 245 344683 25725 50234471
Cells in urine 11.60 9.78 10 344918 183 50260013
Acute myeloid leukaemia 11.58 9.78 58 344870 15016 50245180
Post-traumatic stress disorder 11.57 9.78 59 344869 4244 50255952
Eczema 11.53 9.78 99 344829 22603 50237593
Blood bilirubin increased 11.51 9.78 293 344635 31745 50228451
Sputum culture positive 11.50 9.78 28 344900 1386 50258810
Urinary casts 11.40 9.78 18 344910 645 50259551
Gout 11.38 9.78 40 344888 11430 50248766
Infusion site reaction 11.35 9.78 37 344891 2169 50258027
Ischaemic stroke 11.34 9.78 63 344865 15885 50244311
Myelocyte count increased 11.34 9.78 13 344915 340 50259856
Cardiotoxicity 11.33 9.78 19 344909 7008 50253188
Therapy non-responder 11.30 9.78 263 344665 50759 50209437
Vital capacity decreased 11.29 9.78 22 344906 934 50259262
Base excess 11.25 9.78 7 344921 75 50260121
Glycosylated haemoglobin increased 11.20 9.78 36 344892 10570 50249626
Right ventricular failure 11.18 9.78 63 344865 15830 50244366
Partial seizures 11.17 9.78 10 344918 4855 50255341
Haemarthrosis 11.16 9.78 3 344925 2905 50257291
Maternal exposure before pregnancy 11.16 9.78 13 344915 5584 50254612
Priapism 11.10 9.78 7 344921 77 50260119
Disturbance in social behaviour 11.08 9.78 3 344925 2891 50257305
Adverse drug reaction 11.05 9.78 289 344639 54933 50205263
Gastrointestinal pain 11.05 9.78 24 344904 8032 50252164
Body height decreased 11.05 9.78 28 344900 8880 50251316
Amenorrhoea 11.05 9.78 26 344902 8458 50251738
Speech disorder 11.03 9.78 173 344755 35375 50224821
Frequent bowel movements 11.01 9.78 53 344875 13865 50246331
Intestinal haemorrhage 10.92 9.78 4 344924 3176 50257020
Skin infection 10.90 9.78 130 344798 12161 50248035
COVID-19 pneumonia 10.90 9.78 96 344832 8299 50251897
Diaphragmatic rupture 10.89 9.78 11 344917 248 50259948
Metastases to central nervous system 10.76 9.78 40 344888 11242 50248954
Metastases to peritoneum 10.72 9.78 3 344925 2830 50257366
Pupillary light reflex tests abnormal 10.70 9.78 9 344919 159 50260037
Administration site reaction 10.63 9.78 10 344918 206 50259990
Muscular weakness 10.63 9.78 534 344394 94479 50165717
Deafness 10.61 9.78 63 344865 15628 50244568
Precancerous cells present 10.60 9.78 25 344903 1212 50258984
Lung neoplasm malignant 10.56 9.78 62 344866 15422 50244774
Abdominal pain lower 10.55 9.78 96 344832 21660 50238536
Skin lesion 10.48 9.78 124 344804 26603 50233593
Hallucination 10.47 9.78 240 344688 46417 50213779
Oedema 10.45 9.78 382 344546 69799 50190397
Band neutrophil percentage increased 10.44 9.78 10 344918 211 50259985
Congestive hepatopathy 10.39 9.78 39 344889 2455 50257741
Breast cancer metastatic 10.38 9.78 36 344892 10328 50249868
Drug use disorder 10.37 9.78 45 344883 3027 50257169
Haematuria 10.36 9.78 118 344810 25495 50234701
Impaired gastric emptying 10.36 9.78 28 344900 8690 50251506
Eating disorder 10.35 9.78 62 344866 15347 50244849
Eye pruritus 10.35 9.78 47 344881 12487 50247709
Device leakage 10.33 9.78 15 344913 5863 50254333
Swelling face 10.33 9.78 276 344652 52319 50207877
Hepatocellular injury 10.32 9.78 120 344808 25827 50234369
Autonomic dysreflexia 10.31 9.78 12 344916 319 50259877
Intervertebral disc degeneration 10.23 9.78 52 344876 13409 50246787
Ketoacidosis 10.22 9.78 7 344921 3888 50256308
Corneal epithelium defect 10.20 9.78 12 344916 323 50259873
Malignant melanoma 10.19 9.78 35 344893 10073 50250123
Left ventricular dysfunction 10.18 9.78 37 344891 10469 50249727
Urine ketone body present 10.15 9.78 37 344891 2296 50257900
Bone density decreased 10.09 9.78 40 344888 11035 50249161
Drug level increased 10.07 9.78 186 344742 19082 50241114
Product preparation error 10.03 9.78 9 344919 4363 50255833
Cardiovascular disorder 10.01 9.78 37 344891 10417 50249779
Obstructive airways disorder 9.98 9.78 64 344864 15588 50244608
Corneal reflex decreased 9.96 9.78 8 344920 132 50260064
Balint's syndrome 9.93 9.78 3 344925 3 50260193
Urine bilirubin decreased 9.93 9.78 3 344925 3 50260193
Balance disorder 9.92 9.78 582 344346 70008 50190188
Lumbar vertebral fracture 9.91 9.78 10 344918 4587 50255609
Drug level below therapeutic 9.86 9.78 51 344877 3689 50256507
Injection site extravasation 9.85 9.78 86 344842 7415 50252781
Urine oxalate increased 9.85 9.78 10 344918 227 50259969
Device related infection 9.84 9.78 92 344836 20643 50239553
Device failure 9.82 9.78 14 344914 5514 50254682
Brain stem glioma 9.82 9.78 8 344920 135 50260061

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 1263.43 9.99 1897 148241 88349 29336040
Toxicity to various agents 1123.23 9.99 2618 147520 171043 29253346
Infusion related reaction 402.51 9.99 765 149373 43121 29381268
Blood pressure fluctuation 319.31 9.99 447 149691 19447 29404942
Overdose 313.38 9.99 1004 149134 78815 29345574
Intentional product misuse 295.52 9.99 586 149552 34075 29390314
Exposure to toxic agent 284.40 9.99 172 149966 2403 29421986
Drug abuse 282.53 9.99 970 149168 78913 29345476
Acute hepatic failure 243.55 9.99 302 149836 11650 29412739
Drug ineffective 223.96 9.99 1017 149121 362153 29062236
Intentional overdose 190.31 9.99 526 149612 38002 29386387
Heart rate decreased 138.05 9.99 355 149783 24557 29399832
Respiratory arrest 134.85 9.99 360 149778 25473 29398916
Metabolic acidosis 112.34 9.99 433 149705 37229 29387160
Blood pressure increased 110.05 9.99 696 149442 73107 29351282
Oxygen saturation decreased 94.46 9.99 465 149673 44472 29379917
Anion gap 93.97 9.99 54 150084 682 29423707
Cardio-respiratory arrest 92.09 9.99 503 149635 50098 29374291
Coagulopathy 87.90 9.99 244 149894 17663 29406726
Myocardial infarction 86.15 9.99 280 149858 110016 29314373
Hepatic cytolysis 84.57 9.99 152 149986 8195 29416194
Hepatotoxicity 83.34 9.99 239 149899 17628 29406761
Product dose omission issue 79.98 9.99 238 149900 96145 29328244
Sinusitis 74.72 9.99 359 149779 33991 29390398
Poisoning 74.55 9.99 160 149978 9833 29414556
Accidental overdose 73.19 9.99 226 149912 17367 29407022
Respiratory depression 71.10 9.99 189 149949 13334 29411055
Drug resistance 68.70 9.99 13 150125 21527 29402862
Diarrhoea 67.11 9.99 1238 148900 331460 29092929
Treatment failure 65.12 9.99 55 150083 36884 29387505
Substance abuse 61.74 9.99 118 150020 6669 29417720
Methaemoglobinaemia 60.12 9.99 71 150067 2600 29421789
Hepatic necrosis 58.91 9.99 81 150057 3461 29420928
Exposure via ingestion 58.09 9.99 61 150077 1957 29422432
Heart rate irregular 55.02 9.99 169 149969 12948 29411441
Hypotension 53.91 9.99 1329 148809 193025 29231364
Intentional product use issue 52.66 9.99 383 149755 42115 29382274
Suspected suicide 52.47 9.99 82 150056 3938 29420451
Blood pressure systolic increased 52.12 9.99 196 149942 16649 29407740
Liver injury 51.84 9.99 162 149976 12528 29411861
Blood pressure diastolic abnormal 51.22 9.99 64 150074 2487 29421902
Alanine aminotransferase increased 49.71 9.99 565 149573 70379 29354010
Chills 49.58 9.99 567 149571 70733 29353656
Cardiac failure congestive 44.76 9.99 218 149920 76363 29348026
Depressed level of consciousness 44.66 9.99 331 149807 36611 29387778
Cardiac failure 42.78 9.99 232 149906 79055 29345334
Aspartate aminotransferase increased 41.99 9.99 476 149662 59249 29365140
Serotonin syndrome 41.73 9.99 188 149950 17324 29407065
Medication error 40.01 9.99 213 149925 20998 29403391
Analgesic drug level increased 39.75 9.99 29 150109 563 29423826
Infusion site extravasation 39.72 9.99 63 150075 3064 29421325
Heart rate increased 39.45 9.99 335 149803 38603 29385786
Cardiac arrest 38.68 9.99 630 149508 84961 29339428
Foetal exposure during pregnancy 38.17 9.99 71 150067 33796 29390593
Therapeutic product effect incomplete 37.92 9.99 90 150048 39215 29385174
Anaemia 36.64 9.99 760 149378 200191 29224198
Tachycardia 36.15 9.99 542 149596 71868 29352521
Blood pressure diastolic increased 35.91 9.99 66 150072 3620 29420769
Toxic epidermal necrolysis 35.41 9.99 184 149954 17969 29406420
Drug interaction 34.67 9.99 751 149387 196634 29227755
Pyroglutamic acidosis 34.37 9.99 20 150118 259 29424130
Blood pressure systolic abnormal 33.82 9.99 48 150090 2113 29422276
Body temperature decreased 33.75 9.99 125 150013 10539 29413850
International normalised ratio increased 33.64 9.99 359 149779 44013 29380376
Psoriasis 33.36 9.99 71 150067 32156 29392233
Infusion site pain 33.19 9.99 56 150082 2869 29421520
Product use in unapproved indication 32.11 9.99 284 149854 86591 29337798
Sopor 32.02 9.99 8 150130 10926 29413463
Blood pressure diastolic decreased 31.84 9.99 93 150045 6929 29417460
Neuropathy peripheral 31.45 9.99 221 149917 70806 29353583
Renal cortical necrosis 31.41 9.99 16 150122 156 29424233
Contraindicated product administered 31.21 9.99 28 150110 18238 29406151
Stevens-Johnson syndrome 30.66 9.99 165 149973 16332 29408057
Coronary artery disease 30.56 9.99 118 150020 44072 29380317
Therapeutic response shortened 30.47 9.99 72 150066 4719 29419670
Product prescribing error 30.19 9.99 28 150110 17948 29406441
Bone marrow failure 29.66 9.99 59 150079 27390 29396999
Wrong technique in product usage process 29.50 9.99 73 150065 31355 29393034
Neutrophil percentage increased 28.53 9.99 40 150098 1741 29422648
Blood pH decreased 28.52 9.99 44 150094 2089 29422300
Cytokine release syndrome 28.43 9.99 137 150001 12982 29411407
Dizziness 27.97 9.99 741 149397 188943 29235446
Anion gap abnormal 27.79 9.99 14 150124 133 29424256
Appendicolith 27.44 9.99 57 150081 3423 29420966
Diabetes mellitus 27.14 9.99 107 150031 39724 29384665
Infusion site swelling 27.03 9.99 40 150098 1830 29422559
Unresponsive to stimuli 26.42 9.99 218 149920 24908 29399481
Coma 26.19 9.99 311 149827 39139 29385250
Suicide attempt 25.86 9.99 276 149862 33834 29390555
Urine sodium decreased 25.57 9.99 14 150124 160 29424229
Glycosylated haemoglobin increased 25.55 9.99 8 150130 9418 29414971
Hospitalisation 25.10 9.99 134 150004 45854 29378535
Injection site pain 24.85 9.99 83 150055 32363 29392026
Body temperature increased 24.44 9.99 141 149997 14324 29410065
Hepatic failure 24.37 9.99 256 149882 31256 29393133
Rheumatoid arthritis 24.30 9.99 260 149878 31892 29392497
Respiratory rate increased 24.23 9.99 98 150040 8610 29415779
Balance disorder 24.11 9.99 98 150040 36072 29388317
Ear infection 24.03 9.99 93 150045 8007 29416382
Disease progression 23.99 9.99 283 149855 81633 29342756
Hypoxia 23.77 9.99 355 149783 47024 29377365
Myocardial fibrosis 23.39 9.99 28 150110 1040 29423349
Depression 23.11 9.99 299 149839 84848 29339541
Infusion site pruritus 23.11 9.99 20 150118 501 29423888
Asthenia 22.79 9.99 878 149260 214372 29210017
Body temperature fluctuation 22.39 9.99 32 150106 1418 29422971
Lymphocyte percentage decreased 22.07 9.99 38 150100 1979 29422410
Feeling abnormal 21.91 9.99 174 149964 54271 29370118
Therapeutic response decreased 21.21 9.99 60 150078 24651 29399738
Memory impairment 21.18 9.99 104 150034 36366 29388023
Cerebral haemorrhage 21.04 9.99 85 150053 31341 29393048
Progressive multifocal leukoencephalopathy 20.93 9.99 9 150129 8710 29415679
Acute lung injury 19.97 9.99 29 150109 1304 29423085
Accidental exposure to product by child 19.62 9.99 29 150109 1325 29423064
Urticaria 19.60 9.99 388 149750 54272 29370117
Poor venous access 19.56 9.99 47 150091 3114 29421275
Ductus arteriosus premature closure 19.55 9.99 13 150125 216 29424173
Cerebrovascular accident 19.45 9.99 274 149864 76637 29347752
Haematotoxicity 19.43 9.99 5 150133 6694 29417695
Blood triglycerides increased 19.27 9.99 22 150116 12812 29411577
Haemolysis 19.13 9.99 78 150060 6878 29417511
Throat tightness 19.10 9.99 79 150059 7012 29417377
Renal impairment 19.10 9.99 294 149844 81039 29343350
Mydriasis 18.98 9.99 71 150067 6014 29418375
Brain death 18.90 9.99 39 150099 2331 29422058
Therapeutic product effect decreased 18.88 9.99 81 150057 29370 29395019
Cerebral artery thrombosis 18.85 9.99 21 150117 721 29423668
Immune reconstitution inflammatory syndrome 18.81 9.99 8 150130 7794 29416595
Graft versus host disease 18.67 9.99 13 150125 9615 29414774
Granulomatosis with polyangiitis 18.62 9.99 23 150115 883 29423506
Myelosuppression 18.32 9.99 21 150117 12206 29412183
Prothrombin time prolonged 18.26 9.99 91 150047 8741 29415648
Abdominal pain 18.23 9.99 851 149287 134506 29289883
Angina pectoris 18.22 9.99 76 150062 27774 29396615
Aplastic anaemia 18.17 9.99 81 150057 7429 29416960
Brain scan abnormal 18.15 9.99 22 150116 828 29423561
Pyrexia 18.14 9.99 1695 148443 285927 29138462
Nasopharyngitis 17.99 9.99 413 149725 59252 29365137
Infusion site erythema 17.75 9.99 31 150107 1633 29422756
Febrile neutropenia 17.40 9.99 716 149422 111524 29312865
Pulmonary congestion 17.11 9.99 115 150023 12321 29412068
Oedema peripheral 17.00 9.99 398 149740 103159 29321230
Chronic gastrointestinal bleeding 16.99 9.99 13 150125 272 29424117
General physical health deterioration 16.98 9.99 395 149743 102462 29321927
Fatigue 16.91 9.99 1382 148756 315439 29108950
Pemphigus 16.90 9.99 25 150113 1143 29423246
Flushing 16.86 9.99 223 149915 28769 29395620
Mental status changes 16.86 9.99 260 149878 34667 29389722
Venoocclusive liver disease 16.83 9.99 7 150131 6910 29417479
Acute myocardial infarction 16.74 9.99 161 149977 48277 29376112
Throat irritation 16.41 9.99 88 150050 8697 29415692
Psoriatic arthropathy 16.37 9.99 31 150107 14660 29409729
Cerebral infarction 16.35 9.99 67 150071 24608 29399781
Loss of personal independence in daily activities 16.29 9.99 70 150068 25370 29399019
Post transplant lymphoproliferative disorder 16.12 9.99 4 150134 5489 29418900
Transaminases increased 16.08 9.99 181 149957 22481 29401908
Inappropriate schedule of product administration 16.05 9.99 316 149822 44156 29380233
Leukopenia 16.04 9.99 191 149947 55012 29369377
Cytomegalovirus infection 16.04 9.99 62 150076 23153 29401236
Pulmonary oedema 15.87 9.99 305 149833 42430 29381959
Renal papillary necrosis 15.86 9.99 10 150128 151 29424238
Acidosis 15.36 9.99 93 150045 9612 29414777
Prostate cancer 15.29 9.99 72 150066 25455 29398934
Mucosal inflammation 15.13 9.99 96 150042 31499 29392890
Oxygen saturation abnormal 15.12 9.99 24 150114 1168 29423221
Urethral valves 14.91 9.99 12 150126 271 29424118
Myopathy 14.82 9.99 19 150119 10514 29413875
Dependent personality disorder 14.80 9.99 8 150130 89 29424300
Therapy non-responder 14.77 9.99 94 150044 30817 29393572
Osteonecrosis 14.65 9.99 29 150109 13490 29410899
Electrocardiogram QRS complex prolonged 14.57 9.99 50 150088 4060 29420329
Bladder cancer 14.52 9.99 18 150120 10109 29414280
Renal injury 14.43 9.99 95 150043 10107 29414282
Pathogen resistance 14.40 9.99 12 150126 8104 29416285
Administration site pain 14.40 9.99 10 150128 179 29424210
Visual acuity reduced 14.39 9.99 34 150104 14842 29409547
Agitation 14.21 9.99 351 149787 50953 29373436
Injection site haemorrhage 14.15 9.99 13 150125 8373 29416016
Drug ineffective for unapproved indication 14.14 9.99 32 150106 14182 29410207
Gait inability 14.07 9.99 47 150091 18328 29406061
Prescribed overdose 14.03 9.99 14 150124 8669 29415720
Full blood count abnormal 13.98 9.99 35 150103 14978 29409411
Inadequate analgesia 13.85 9.99 37 150101 2617 29421772
C-reactive protein abnormal 13.80 9.99 8 150130 6528 29417861
Gait disturbance 13.74 9.99 276 149862 73073 29351316
Bilirubin urine present 13.67 9.99 9 150129 147 29424242
Prostatic specific antigen increased 13.58 9.99 27 150111 12537 29411852
Osteonecrosis of jaw 13.50 9.99 41 150097 16469 29407920
Myalgia 13.43 9.99 280 149858 73739 29350650
Administration site erythema 13.42 9.99 7 150131 72 29424317
Failure to suspend medication 13.39 9.99 13 150125 379 29424010
Environmental exposure 13.39 9.99 11 150127 256 29424133
Hypoaesthesia 13.33 9.99 191 149947 53276 29371113
Dissociative disorder 13.33 9.99 10 150128 203 29424186
Labelled drug-drug interaction issue 13.31 9.99 9 150129 154 29424235
Cardiac disorder 13.24 9.99 123 150015 37140 29387249
Hepatitis fulminant 13.15 9.99 44 150094 3527 29420862
Upper respiratory tract infection 12.97 9.99 203 149935 27146 29397243
Anti-erythrocyte antibody positive 12.90 9.99 6 150132 47 29424342
Burn of internal organs 12.87 9.99 3 150135 0 29424389
Maple syrup disease 12.80 9.99 4 150134 8 29424381
Tendonitis 12.67 9.99 13 150125 7948 29416441
Parkinsonism 12.62 9.99 11 150127 7267 29417122
Erectile dysfunction 12.50 9.99 48 150090 17961 29406428
Infusion site nodule 12.49 9.99 7 150131 84 29424305
Malignant neoplasm progression 12.36 9.99 283 149855 73576 29350813
COVID-19 12.36 9.99 254 149884 35760 29388629
Infusion site rash 12.30 9.99 12 150126 352 29424037
Erythema multiforme 12.24 9.99 74 150064 7643 29416746
Hypertriglyceridaemia 12.13 9.99 12 150126 7463 29416926
Haematocrit decreased 12.13 9.99 211 149927 28811 29395578
Acid-base balance disorder mixed 11.91 9.99 6 150132 57 29424332
Crohn's disease 11.91 9.99 38 150100 2971 29421418
COVID-19 immunisation 11.87 9.99 8 150130 136 29424253
Endocardial fibrosis 11.86 9.99 5 150133 30 29424359
Liver transplant 11.80 9.99 32 150106 2284 29422105
Hepatocellular carcinoma 11.77 9.99 11 150127 7027 29417362
Incorrect dose administered 11.77 9.99 234 149904 32750 29391639
Decreased appetite 11.64 9.99 611 149527 144731 29279658
Infusion site bruising 11.63 9.99 12 150126 377 29424012
Drug screen positive 11.57 9.99 44 150094 3757 29420632
Hangover 11.48 9.99 19 150119 958 29423431
Product substitution issue 11.46 9.99 18 150120 9154 29415235
Anion gap increased 11.44 9.99 25 150113 1555 29422834
Anhedonia 11.40 9.99 69 150069 7131 29417258
Pemphigoid 11.38 9.99 13 150125 7568 29416821
Appendicitis 11.37 9.99 80 150058 8699 29415690
Fall 11.32 9.99 761 149377 176417 29247972
Injection site reaction 11.29 9.99 25 150113 11163 29413226
Infusion site haemorrhage 11.28 9.99 16 150122 704 29423685
Pancytopenia 11.17 9.99 329 149809 82839 29341550
Fluid retention 11.07 9.99 72 150066 23488 29400901
Diabetic ketoacidosis 11.06 9.99 43 150095 16030 29408359
Drug level below therapeutic 11.05 9.99 47 150091 4224 29420165
Visual impairment 11.02 9.99 97 150041 29611 29394778
Bacterial test 10.93 9.99 8 150130 156 29424233
Cytopenia 10.81 9.99 21 150117 9838 29414551
Hyperchloraemia 10.80 9.99 12 150126 411 29423978
Alopecia 10.75 9.99 55 150083 19029 29405360
Pallor 10.72 9.99 158 149980 20866 29403523
Muscle spasms 10.71 9.99 250 149888 64832 29359557
Tooth infection 10.70 9.99 56 150082 5483 29418906
Dyspnoea exertional 10.70 9.99 126 150012 36364 29388025
Pneumonia aspiration 10.67 9.99 253 149885 36484 29387905
Crystal urine present 10.66 9.99 12 150126 417 29423972
Hepatitis C 10.65 9.99 18 150120 8892 29415497
Bronchial dysplasia 10.55 9.99 5 150133 41 29424348
Enthesopathy 10.47 9.99 3 150135 3740 29420649
Leukocytosis 10.44 9.99 158 149980 20984 29403405
Injection site swelling 10.38 9.99 20 150118 9397 29414992
Vessel puncture site bruise 10.35 9.99 5 150133 43 29424346
Urobilinogen urine increased 10.27 9.99 11 150127 361 29424028
Somnolence 10.24 9.99 579 149559 93376 29331013
Pupillary light reflex tests abnormal 10.24 9.99 7 150131 122 29424267
Ultrasound liver abnormal 10.24 9.99 7 150131 122 29424267
Sudden infant death syndrome 10.23 9.99 8 150130 173 29424216
Administration site swelling 10.12 9.99 8 150130 176 29424213

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 3995.42 9.60 5896 397469 218518 63876849
Toxicity to various agents 3118.38 9.60 6951 396414 356562 63738805
Infusion related reaction 1005.56 9.60 2769 400596 161698 63933669
Exposure to toxic agent 777.22 9.60 483 402882 5676 64089691
Intentional product misuse 753.59 9.60 1501 401864 70794 64024573
Acute hepatic failure 686.55 9.60 832 402533 25280 64070087
Overdose 674.20 9.60 2363 401002 157203 63938164
Blood pressure fluctuation 636.98 9.60 1155 402210 50716 64044651
Intentional overdose 420.02 9.60 1378 401987 88566 64006801
Metabolic acidosis 366.80 9.60 1126 402239 69832 64025535
Rheumatoid arthritis 327.95 9.60 1950 401415 162344 63933023
Drug abuse 321.55 9.60 1657 401708 130717 63964650
Sinusitis 302.19 9.60 1749 401616 144179 63951188
Respiratory arrest 290.96 9.60 859 402506 52126 64043241
Hepatotoxicity 289.93 9.60 718 402647 39244 64056123
Anion gap 270.53 9.60 160 403205 1707 64093660
Heart rate decreased 269.03 9.60 857 402508 54210 64041157
Muscle injury 268.22 9.60 543 402822 25894 64069473
Product dose omission issue 261.98 9.60 513 402852 194234 63901133
Cardio-respiratory arrest 248.92 9.60 1246 402119 97147 63998220
Folliculitis 246.90 9.60 567 402798 29510 64065857
Duodenal ulcer perforation 236.43 9.60 608 402757 34017 64061350
Irritable bowel syndrome 235.64 9.60 637 402728 36732 64058635
Anti-cyclic citrullinated peptide antibody positive 235.45 9.60 764 402601 48798 64046569
Sleep disorder due to general medical condition, insomnia type 233.29 9.60 511 402854 25759 64069608
Injection site pain 229.23 9.60 215 403150 111193 63984174
Helicobacter infection 224.16 9.60 636 402729 37726 64057641
Blood pressure increased 214.26 9.60 1826 401539 170726 63924641
Coagulopathy 201.14 9.60 544 402821 31376 64063991
Hepatic enzyme increased 198.69 9.60 1443 401922 128500 63966867
Diarrhoea 186.50 9.60 3291 400074 719413 63375954
Depressed level of consciousness 185.01 9.60 1001 402364 80435 64014932
Hand deformity 185.00 9.60 831 402534 61940 64033427
Lower respiratory tract infection 182.25 9.60 1113 402252 93501 64001866
Poisoning 177.97 9.60 411 402954 21468 64073899
Pemphigus 175.45 9.60 799 402566 59902 64035465
Pericarditis 174.13 9.60 814 402551 61702 64033665
Myocardial infarction 172.63 9.60 500 402865 165321 63930046
Medication error 172.43 9.60 694 402671 49272 64046095
Intentional product use issue 170.09 9.60 1100 402265 94264 64001103
Nasopharyngitis 168.63 9.60 1922 401443 194151 63901216
Hepatic cytolysis 166.26 9.60 308 403057 13741 64081626
Ill-defined disorder 163.46 9.60 626 402739 43426 64051941
Hepatic necrosis 162.14 9.60 231 403134 8242 64087125
Anaemia 156.97 9.60 1562 401803 377118 63718249
Oxygen saturation decreased 154.05 9.60 1173 402192 106003 63989364
Blister 149.98 9.60 943 402422 80024 64015343
Blood pressure diastolic abnormal 149.57 9.60 268 403097 11649 64083718
Injection site erythema 147.54 9.60 135 403230 70665 64024702
Glossodynia 147.45 9.60 796 402569 63900 64031467
Drug ineffective 145.64 9.60 4074 399291 836173 63259194
Wound 142.45 9.60 892 402473 75585 64019782
Drug resistance 142.45 9.60 24 403341 35078 64060289
Drug interaction 141.23 9.60 1515 401850 360568 63734799
Respiratory depression 141.20 9.60 393 402972 23050 64072317
Analgesic drug level increased 137.70 9.60 114 403251 2156 64093211
Exposure via ingestion 133.40 9.60 159 403206 4743 64090624
Joint swelling 130.63 9.60 1981 401384 213401 63881966
Discomfort 130.45 9.60 910 402455 79968 64015399
Sopor 127.90 9.60 17 403348 29644 64065723
Liver injury 121.61 9.60 438 402927 29494 64065873
Body temperature increased 121.53 9.60 503 402862 36163 64059204
Accidental overdose 121.33 9.60 473 402892 33084 64062283
Wrong technique in product usage process 120.48 9.60 137 403228 64837 64030530
Systemic lupus erythematosus 118.63 9.60 862 402503 76750 64018617
Impaired healing 118.07 9.60 714 402651 59759 64035608
Sedation complication 117.55 9.60 223 403142 10131 64085236
Blood pressure diastolic decreased 117.13 9.60 356 403009 21945 64073422
Suspected suicide 116.88 9.60 201 403164 8453 64086914
Blood pressure systolic increased 115.77 9.60 613 402752 48840 64046527
Blood pressure systolic abnormal 115.19 9.60 216 403149 9726 64085641
Death 111.76 9.60 3873 399492 478832 63616535
Weight increased 110.21 9.60 1911 401454 211437 63883930
Synovitis 107.69 9.60 1019 402346 98071 63997296
Heart rate increased 106.88 9.60 1014 402351 97661 63997706
Cardiac failure 104.32 9.60 449 402916 131924 63963443
Psoriasis 103.30 9.60 181 403184 71522 64023845
Neutropenia 103.11 9.60 979 402386 238645 63856722
Heart rate irregular 102.05 9.60 390 402975 27023 64068344
Injection site reaction 102.03 9.60 85 403280 46579 64048788
Cardiac failure congestive 101.64 9.60 445 402920 130135 63965232
Bone marrow failure 99.23 9.60 92 403273 47860 64047507
Throat irritation 98.57 9.60 436 402929 32275 64063092
Creatinine renal clearance decreased 98.19 9.60 253 403112 14168 64081199
Device expulsion 96.38 9.60 10 403355 21126 64074241
Therapeutic product effect decreased 93.84 9.60 1119 402246 114232 63981135
Methaemoglobinaemia 92.88 9.60 125 403240 4223 64091144
Hepatic failure 91.51 9.60 627 402738 54767 64040600
Acute lung injury 90.30 9.60 98 403267 2633 64092734
Osteonecrosis of jaw 90.26 9.60 70 403295 39755 64055612
Injection site pruritus 88.93 9.60 64 403301 37762 64057605
Injection site swelling 87.16 9.60 78 403287 41275 64054092
Blood calcium decreased 86.60 9.60 353 403012 25201 64070166
Substance abuse 86.21 9.60 184 403181 9108 64086259
Product use in unapproved indication 85.47 9.60 700 402665 175918 63919449
Injection site bruising 83.62 9.60 63 403302 36310 64059057
Pyroglutamic acidosis 83.57 9.60 54 403311 682 64094685
Swelling 80.50 9.60 1429 401936 158789 63936578
Hypotension 80.01 9.60 3024 400341 377950 63717417
Arthropathy 79.30 9.60 1128 402237 119839 63975528
Disease progression 76.82 9.60 544 402821 141136 63954231
Coma 76.63 9.60 862 402503 86753 64008614
Product prescribing error 73.77 9.60 67 403298 35202 64060165
Alanine aminotransferase increased 72.69 9.60 1248 402117 137783 63957584
Pancytopenia 71.62 9.60 563 402802 142746 63952621
Therapeutic product effect incomplete 70.95 9.60 369 402996 103113 63992254
Hospitalisation 68.93 9.60 240 403125 74967 64020400
Body temperature decreased 68.82 9.60 333 403032 25595 64069772
Gastrointestinal disorder 68.07 9.60 859 402506 88850 64006517
Anion gap abnormal 67.25 9.60 42 403323 498 64094869
Cerebrovascular accident 67.14 9.60 544 402821 137039 63958328
Cardiac arrest 65.68 9.60 1340 402025 152724 63942643
Ear pain 64.69 9.60 320 403045 24816 64070551
Blood pressure diastolic increased 64.50 9.60 180 403185 10572 64084795
Mucosal inflammation 62.70 9.60 192 403173 62392 64032975
Decreased appetite 61.44 9.60 1316 402049 279973 63815394
Neuropathy peripheral 61.41 9.60 456 402909 117069 63978298
Coronary artery disease 60.83 9.60 185 403180 60248 64035119
Renal impairment 60.01 9.60 547 402818 134470 63960897
Injection site warmth 59.79 9.60 7 403358 13455 64081912
Acute kidney injury 59.55 9.60 2253 401112 446987 63648380
International normalised ratio increased 59.19 9.60 756 402609 78411 64016956
Neutrophil percentage increased 57.11 9.60 101 403264 4344 64091023
Hypersensitivity 56.53 9.60 1619 401746 194833 63900534
Respiratory rate increased 56.49 9.60 246 403119 18085 64077282
Leukopenia 56.21 9.60 386 402979 100856 63994511
Diabetes mellitus 55.76 9.60 220 403145 66254 64029113
White blood cells urine positive 54.89 9.60 111 403254 5287 64090080
Crystal urine present 54.86 9.60 64 403301 1865 64093502
Oedema peripheral 54.12 9.60 957 402408 209360 63886007
Pyroglutamate increased 53.36 9.60 39 403326 609 64094758
Electric shock 52.99 9.60 49 403316 1080 64094287
Aspartate aminotransferase increased 52.41 9.60 1046 402319 118742 63976625
Cerebral haemorrhage 51.70 9.60 156 403209 50934 64044433
Hyperkalaemia 51.12 9.60 396 402969 100733 63994634
Therapy cessation 50.52 9.60 78 403287 32411 64062956
Lymphocyte percentage decreased 50.16 9.60 98 403267 4551 64090816
Dizziness 49.58 9.60 2192 401173 427971 63667396
Sedation 49.39 9.60 435 402930 41027 64054340
Contraindicated product administered 49.34 9.60 948 402417 106881 63988486
Suicide attempt 49.29 9.60 669 402696 70338 64025029
Neoplasm progression 49.10 9.60 115 403250 40849 64054518
Blood pH decreased 48.97 9.60 94 403271 4308 64091059
Myelosuppression 48.97 9.60 46 403319 23784 64071583
Urine abnormality 48.93 9.60 128 403237 7234 64088133
Injection site mass 47.91 9.60 24 403341 17246 64078121
Body temperature fluctuation 47.72 9.60 79 403286 3219 64092148
Rheumatoid factor positive 47.17 9.60 377 402988 34561 64060806
Interstitial lung disease 46.95 9.60 388 402977 97344 63998023
Cognitive disorder 46.81 9.60 539 402826 54548 64040819
Therapeutic response shortened 46.68 9.60 155 403210 10015 64085352
Gait disturbance 46.00 9.60 778 402587 171377 63923990
Cytomegalovirus infection 45.74 9.60 103 403262 37096 64058271
Infusion site extravasation 45.57 9.60 119 403246 6718 64088649
Unresponsive to stimuli 45.51 9.60 499 402866 49894 64045473
Feeling abnormal 44.62 9.60 578 402787 133024 63962343
Poor venous access 44.05 9.60 174 403191 12243 64083124
Haematotoxicity 43.93 9.60 13 403352 12883 64082484
Device issue 43.92 9.60 46 403319 22602 64072765
Drug ineffective for unapproved indication 43.56 9.60 80 403285 31053 64064314
Injection site haemorrhage 43.06 9.60 53 403312 24225 64071142
Cytokine release syndrome 42.61 9.60 249 403116 20580 64074787
Product substitution issue 42.27 9.60 30 403335 17831 64077536
General physical health deterioration 41.58 9.60 967 402398 203458 63891909
Muscle spasms 41.44 9.60 626 402739 140397 63954970
Paraesthesia 40.62 9.60 594 402771 133928 63961439
Injection site rash 40.58 9.60 24 403341 15718 64079649
Red blood cell sedimentation rate abnormal 40.45 9.60 26 403339 16280 64079087
Loss of personal independence in daily activities 39.83 9.60 277 403088 72177 64023190
Malignant neoplasm progression 39.68 9.60 483 402882 112388 63982979
Cerebral infarction 39.64 9.60 128 403237 40916 64054451
Brain death 39.18 9.60 91 403274 4770 64090597
Acute myocardial infarction 39.09 9.60 265 403100 69453 64025914
Diabetic ketoacidosis 38.89 9.60 80 403285 29765 64065602
Prothrombin time prolonged 38.82 9.60 198 403167 15543 64079824
Posterior reversible encephalopathy syndrome 38.73 9.60 52 403313 22894 64072473
Palmar-plantar erythrodysaesthesia syndrome 38.62 9.60 76 403289 28743 64066624
Muscle spasticity 38.57 9.60 206 403159 16463 64078904
Dehydration 38.52 9.60 1046 402319 215717 63879650
Epistaxis 38.38 9.60 410 402955 97721 63997646
Epilepsy 37.93 9.60 97 403268 33434 64061933
Nausea 37.66 9.60 4322 399043 781478 63313889
Abortion spontaneous 37.55 9.60 62 403303 25081 64070286
Device malfunction 37.47 9.60 33 403332 17600 64077767
Peripheral swelling 37.30 9.60 1632 401733 207521 63887846
Lactic acidosis 37.19 9.60 228 403137 61182 64034185
Urinary sediment present 37.12 9.60 57 403308 2177 64093190
Pathogen resistance 37.01 9.60 16 403349 12527 64082840
Stomatitis 36.86 9.60 922 402443 108683 63986684
Surgery 36.44 9.60 76 403289 28137 64067230
Septic shock 36.38 9.60 453 402912 104984 63990383
Infusion site pain 36.32 9.60 145 403220 10252 64085115
Product quality issue 36.24 9.60 83 403282 29716 64065651
Dyspnoea exertional 36.19 9.60 291 403074 73439 64021928
Electrocardiogram QT prolonged 36.10 9.60 320 403045 79128 64016239
Fall 35.99 9.60 2187 401178 414639 63680728
Second primary malignancy 35.99 9.60 16 403349 12321 64083046
Orthostatic hypotension 35.64 9.60 448 402917 46290 64049077
Therapy interrupted 35.26 9.60 44 403321 19992 64075375
Device difficult to use 35.02 9.60 9 403356 9789 64085578
Blood parathyroid hormone decreased 34.87 9.60 3 403362 7363 64088004
Product storage error 34.76 9.60 20 403345 13298 64082069
Transient ischaemic attack 34.70 9.60 150 403215 44032 64051335
Atrial fibrillation 34.59 9.60 810 402555 170279 63925088
Syncope 34.52 9.60 737 402628 156898 63938469
Dyspnoea 34.38 9.60 3953 399412 714721 63380646
Red cell distribution width increased 34.05 9.60 160 403205 12149 64083218
Pain 34.05 9.60 3956 399409 549555 63545812
Hypocalcaemia 33.87 9.60 140 403225 41613 64053754
Toxicologic test abnormal 33.77 9.60 40 403325 1185 64094182
Post transplant lymphoproliferative disorder 33.66 9.60 9 403356 9535 64085832
Drug hypersensitivity 33.61 9.60 1183 402182 236632 63858735
Drug screen positive 33.47 9.60 95 403270 5634 64089733
Urine leukocyte esterase positive 33.45 9.60 69 403296 3334 64092033
Arthralgia 33.25 9.60 3204 400161 439056 63656311
Infusion site pruritus 33.21 9.60 59 403306 2547 64092820
Haemolysis 33.15 9.60 147 403218 10892 64084475
Flushing 32.81 9.60 682 402683 77966 64017401
Device dislocation 32.78 9.60 51 403314 21127 64074240
Lymphocyte count decreased 32.71 9.60 394 402971 40305 64055062
Asthenia 32.67 9.60 2271 401094 425773 63669594
Osteonecrosis 32.44 9.60 81 403284 28148 64067219
Hyperlipidaemia 32.18 9.60 59 403306 22917 64072450
Urticaria 31.94 9.60 1174 402191 146143 63949224
Injection site urticaria 31.84 9.60 15 403350 11166 64084201
Contusion 31.60 9.60 935 402430 113030 63982337
Memory impairment 31.51 9.60 363 403002 85319 64010048
Infusion site swelling 31.32 9.60 90 403275 5375 64089992
Extrapyramidal disorder 31.31 9.60 46 403319 19506 64075861
Hypertensive crisis 31.16 9.60 41 403324 18207 64077160
Specific gravity urine decreased 31.11 9.60 31 403334 752 64094615
Analgesic drug level above therapeutic 31.02 9.60 24 403341 410 64094957
Infusion site erythema 30.88 9.60 104 403261 6769 64088598
Immune reconstitution inflammatory syndrome 30.77 9.60 20 403345 12450 64082917
Injection site induration 30.43 9.60 9 403356 8923 64086444
Rheumatic fever 30.40 9.60 127 403238 9167 64086200
Myelodysplastic syndrome 30.27 9.60 81 403284 27498 64067869
Malaise 30.11 9.60 2103 401262 394144 63701223
Red blood cells urine positive 29.91 9.60 78 403287 4400 64090967
Multiple-drug resistance 29.84 9.60 3 403362 6499 64088868
Pruritus 29.83 9.60 2304 401061 310096 63785271
Hyponatraemia 29.78 9.60 703 402662 147636 63947731
Acidosis 29.72 9.60 202 403163 17593 64077774
Disturbance in attention 29.55 9.60 144 403221 40930 64054437
C-reactive protein abnormal 29.17 9.60 89 403276 28958 64066409
Anion gap increased 29.07 9.60 61 403304 2983 64092384
Haematuria 29.07 9.60 240 403125 60231 64035136
Underdose 29.00 9.60 75 403290 25754 64069613
Thrombocytopenia 28.99 9.60 1125 402240 222676 63872691
Labelled drug-drug interaction medication error 28.86 9.60 59 403306 22003 64073364
Visual acuity reduced 28.82 9.60 81 403284 27060 64068307
Myalgia 28.80 9.60 763 402602 157854 63937513
Jaundice cholestatic 28.77 9.60 119 403246 8551 64086816
Ear pruritus 28.61 9.60 56 403309 2604 64092763
Renal papillary necrosis 27.94 9.60 21 403344 343 64095024
Glycosylated haemoglobin increased 27.34 9.60 36 403329 15983 64079384
Fracture 27.32 9.60 47 403318 18708 64076659
Psoriatic arthropathy 27.10 9.60 159 403206 43122 64052245
Graft versus host disease 26.84 9.60 28 403337 13785 64081582
Night sweats 26.84 9.60 344 403021 35702 64059665
Urine analysis abnormal 26.66 9.60 88 403277 5668 64089699
Inappropriate antidiuretic hormone secretion 26.37 9.60 63 403302 22226 64073141
Bacterial test 26.24 9.60 35 403330 1172 64094195
Acute graft versus host disease 26.16 9.60 12 403353 9072 64086295
Liver transplant 26.03 9.60 70 403295 4022 64091345
Status epilepticus 25.81 9.60 61 403304 21602 64073765
Serotonin syndrome 25.60 9.60 366 402999 38916 64056451
Angina pectoris 25.45 9.60 171 403194 44910 64050457
Rash pruritic 25.30 9.60 233 403132 57171 64038196
Bilirubin urine present 25.24 9.60 19 403346 311 64095056
Sexual dysfunction 25.02 9.60 5 403360 6466 64088901
Granuloma skin 24.98 9.60 4 403361 6070 64089297
Hepatic cirrhosis 24.71 9.60 83 403282 26215 64069152
Full blood count abnormal 24.62 9.60 99 403266 29658 64065709
Seizure 24.53 9.60 826 402539 166066 63929301
Pain in extremity 24.26 9.60 1601 401764 301484 63793883
Prostate cancer 24.18 9.60 55 403310 19740 64075627
Brain oedema 23.95 9.60 227 403138 21848 64073519
Mydriasis 23.92 9.60 171 403194 15141 64080226
Infusion site mass 23.75 9.60 30 403335 951 64094416
Basal cell carcinoma 23.42 9.60 106 403259 30732 64064635
Haematochezia 23.33 9.60 284 403081 66089 64029278
Gastrointestinal haemorrhage 23.09 9.60 640 402725 131672 63963695
Polyneuropathy 22.93 9.60 57 403308 19837 64075530
Metastases to lymph nodes 22.88 9.60 13 403352 8704 64086663
Coronary arterial stent insertion 22.85 9.60 4 403361 5688 64089679
Soft tissue disorder 22.85 9.60 58 403307 3218 64092149
Febrile bone marrow aplasia 22.81 9.60 22 403343 11233 64084134
Hypercalcaemia 22.68 9.60 110 403255 31306 64064061
Renal cortical necrosis 22.60 9.60 17 403348 278 64095089
Acute myeloid leukaemia 22.33 9.60 92 403273 27371 64067996
Angina unstable 22.31 9.60 39 403326 15428 64079939
Thrombotic microangiopathy 22.25 9.60 44 403321 16611 64078756
Swollen joint count increased 22.05 9.60 101 403264 7588 64087779
Accidental exposure to product by child 21.67 9.60 48 403317 2437 64092930
Drug intolerance 21.64 9.60 1408 401957 186584 63908783
Pneumocystis jirovecii pneumonia 21.59 9.60 94 403271 27540 64067827
Culture urine positive 21.55 9.60 66 403299 4085 64091282
Suicidal ideation 21.43 9.60 290 403075 66252 64029115
Pharyngeal paraesthesia 21.40 9.60 41 403324 1876 64093491
Multiple drug therapy 21.33 9.60 45 403320 2209 64093158
Aspergillus infection 21.26 9.60 44 403321 16335 64079032
Spinal stenosis 21.13 9.60 34 403331 13897 64081470
Transaminases increased 21.05 9.60 394 402971 44200 64051167
Haemorrhage 21.04 9.60 359 403006 78992 64016375
Blood triglycerides increased 21.01 9.60 55 403310 18811 64076556
Hypomagnesaemia 20.98 9.60 142 403223 37234 64058133
Tachycardia 20.95 9.60 1140 402225 148439 63946928
Smear cervix abnormal 20.87 9.60 46 403319 2328 64093039
Transplant rejection 20.73 9.60 49 403316 17352 64078015
Transplant dysfunction 20.70 9.60 8 403357 6700 64088667
No adverse event 20.62 9.60 100 403265 28461 64066906
Blood urine present 20.60 9.60 190 403175 18150 64077217
Loss of consciousness 20.49 9.60 740 402625 147625 63947742
Drug-induced liver injury 20.48 9.60 415 402950 47228 64048139
Drug level below therapeutic 20.44 9.60 96 403269 7288 64088079
Respiratory disorder 20.26 9.60 328 403037 35783 64059584
Hepatocellular carcinoma 20.04 9.60 14 403351 8389 64086978
Bursitis 19.97 9.60 214 403151 21271 64074096
Cardiomyopathy 19.96 9.60 86 403279 25270 64070097
Urine bilirubin decreased 19.82 9.60 12 403353 134 64095233
Coronary artery bypass 19.56 9.60 6 403359 5809 64089558
Hemiparesis 19.52 9.60 108 403257 29719 64065648
Dry skin 19.50 9.60 215 403150 50946 64044421
Renal failure 19.42 9.60 933 402432 180755 63914612
Aphasia 19.36 9.60 163 403202 40743 64054624
Angioedema 19.34 9.60 271 403094 61550 64033817
Myopathy 19.34 9.60 52 403313 17628 64077739
Iron deficiency anaemia 19.28 9.60 71 403294 21818 64073549
Aplastic anaemia 19.22 9.60 151 403214 13769 64081598
Neurotoxicity 19.18 9.60 97 403268 27307 64068060
Temperature regulation disorder 19.17 9.60 64 403301 4147 64091220
Skin ulcer 19.15 9.60 179 403186 43795 64051572
Accidental death 19.12 9.60 59 403306 3666 64091701
Cardiac failure chronic 19.11 9.60 17 403348 9024 64086343
Blood creatinine decreased 19.03 9.60 91 403274 6959 64088408
Congestive cardiomyopathy 18.96 9.60 22 403343 10322 64085045
Oedema 18.92 9.60 434 402931 91501 64003866
Hepatocellular injury 18.91 9.60 186 403179 45049 64050318
Cytopenia 18.89 9.60 43 403322 15428 64079939
Bone erosion 18.84 9.60 27 403338 11568 64083799
Appendicolith 18.80 9.60 56 403309 3413 64091954
Intervertebral discitis 18.80 9.60 60 403305 3797 64091570
Confusional state 18.71 9.60 1886 401479 259258 63836109
Vertigo 18.71 9.60 258 403107 58753 64036614
Cardiac failure acute 18.70 9.60 47 403318 16297 64079070
Hypokalaemia 18.70 9.60 600 402765 121303 63974064
Vision blurred 18.68 9.60 426 402939 89890 64005477
Granulomatosis with polyangiitis 18.55 9.60 41 403324 2079 64093288
Panniculitis 18.41 9.60 17 403348 8862 64086505
Forced expiratory volume decreased 18.37 9.60 10 403355 6857 64088510
Hepatic encephalopathy 18.29 9.60 207 403158 20859 64074508
Hypomania 18.29 9.60 77 403288 5577 64089790
Depression 18.28 9.60 948 402417 182343 63913024
Agranulocytosis 18.25 9.60 152 403213 38077 64057290
Subdural haematoma 18.13 9.60 102 403263 27952 64067415
Hypothermia 18.10 9.60 197 403168 19659 64075708
Sudden infant death syndrome 18.08 9.60 12 403353 159 64095208
Therapeutic response decreased 18.07 9.60 224 403141 51964 64043403
Rhabdomyolysis 18.04 9.60 436 402929 91290 64004077
Ageusia 18.02 9.60 37 403328 13776 64081591
Monocyte percentage increased 17.86 9.60 39 403326 1961 64093406
Bacterial test positive 17.81 9.60 86 403279 6604 64088763
Ejection fraction decreased 17.69 9.60 106 403259 28601 64066766
Pupillary light reflex tests abnormal 17.63 9.60 15 403350 295 64095072
Akathisia 17.55 9.60 28 403337 11482 64083885
Sputum culture positive 17.51 9.60 50 403315 2976 64092391
Band neutrophil count increased 17.42 9.60 21 403344 634 64094733
Infusion site bruising 17.39 9.60 33 403332 1499 64093868
Enthesopathy 17.13 9.60 21 403344 9617 64085750
Graft versus host disease in skin 17.13 9.60 6 403359 5341 64090026
Osmolar gap 17.09 9.60 11 403354 138 64095229
Chills 17.07 9.60 1035 402330 136229 63959138
Toxic epidermal necrolysis 16.73 9.60 326 403039 36840 64058527
Gestational diabetes 16.70 9.60 7 403358 5583 64089784
Post-traumatic stress disorder 16.63 9.60 61 403304 4144 64091223
Platelet count decreased 16.61 9.60 868 402497 166843 63928524
Injury 16.51 9.60 463 402902 55529 64039838
Left ventricular dysfunction 16.28 9.60 53 403312 16901 64078466
Actinic keratosis 16.20 9.60 6 403359 5159 64090208
Abdominal discomfort 16.13 9.60 1337 402028 180985 63914382
Product monitoring error 16.02 9.60 7 403358 5447 64089920
Cardiac disorder 15.96 9.60 249 403116 55567 64039800
Maternal exposure timing unspecified 15.92 9.60 45 403320 2662 64092705
Erysipelas 15.92 9.60 20 403345 9061 64086306
Thinking abnormal 15.90 9.60 30 403335 11526 64083841
Nocardiosis 15.89 9.60 5 403360 4762 64090605
Precancerous cells present 15.88 9.60 25 403340 976 64094391
Diplopia 15.88 9.60 100 403265 26665 64068702
Mean cell haemoglobin concentration increased 15.86 9.60 22 403343 765 64094602
Concomitant disease aggravated 15.84 9.60 30 403335 11512 64083855
Epstein-Barr virus infection 15.83 9.60 34 403331 12454 64082913
Lipodystrophy acquired 15.80 9.60 3 403362 4024 64091343
Device leakage 15.79 9.60 17 403348 8249 64087118
Full blood count decreased 15.76 9.60 80 403285 22502 64072865
Blood glucose increased 15.70 9.60 480 402885 97593 63997774
Injection site discolouration 15.68 9.60 12 403353 6863 64088504
Prostatic specific antigen increased 15.67 9.60 19 403346 8741 64086626
Venoocclusive liver disease 15.61 9.60 24 403341 9991 64085376
Haematocrit decreased 15.57 9.60 450 402915 54205 64041162
Carotid artery stenosis 15.54 9.60 16 403349 7925 64087442
Hypertriglyceridaemia 15.49 9.60 29 403336 11176 64084191
Withdrawal syndrome 15.41 9.60 85 403280 23407 64071960
Gastrointestinal toxicity 15.37 9.60 7 403358 5315 64090052
Eosinophil percentage increased 15.34 9.60 30 403335 1394 64093973
Treatment noncompliance 15.30 9.60 186 403179 43296 64052071
Multiple sclerosis relapse 15.23 9.60 174 403191 40961 64054406
Metastases to lung 15.16 9.60 47 403318 15217 64080150
Obstructive airways disorder 15.15 9.60 84 403281 23101 64072266
Partial seizures 15.14 9.60 14 403351 7293 64088074
Hypoaesthesia 15.13 9.60 713 402652 138395 63956972
Skin necrosis 15.04 9.60 43 403322 14286 64081081
Lung neoplasm malignant 14.96 9.60 76 403289 21372 64073995
Thrombosis 14.95 9.60 332 403033 70310 64025057
Inappropriate schedule of product administration 14.89 9.60 713 402652 91573 64003794
Beta haemolytic streptococcal infection 14.77 9.60 35 403330 1859 64093508
Lupus-like syndrome 14.76 9.60 20 403345 8771 64086596
Anaphylactic shock 14.74 9.60 120 403245 30208 64065159
Bone pain 14.72 9.60 209 403156 47363 64048004
Tremor 14.71 9.60 767 402598 147463 63947904
Macular oedema 14.70 9.60 6 403359 4861 64090506
Low density lipoprotein increased 14.69 9.60 16 403349 7724 64087643
Hypoxia 14.64 9.60 683 402682 87466 64007901
Gait inability 14.62 9.60 182 403183 42186 64053181
Dyspnoea at rest 14.50 9.60 11 403354 6318 64089049
Skin toxicity 14.46 9.60 12 403353 6590 64088777
Shock haemorrhagic 14.44 9.60 55 403310 16736 64078631
Urinary casts 14.44 9.60 25 403340 1057 64094310
COVID-19 immunisation 14.44 9.60 18 403347 563 64094804
Circulatory collapse 14.40 9.60 138 403227 33594 64061773
Burning sensation 14.39 9.60 221 403144 49443 64045924
Gynaecomastia 14.37 9.60 10 403355 6006 64089361
Leukocytosis 14.37 9.60 323 403042 37417 64057950
Cardiovascular disorder 14.33 9.60 51 403314 15830 64079537
Haemoglobin urine present 14.31 9.60 22 403343 841 64094526
Acute coronary syndrome 14.29 9.60 67 403298 19243 64076124
Chronic graft versus host disease 14.26 9.60 11 403354 6265 64089102
Sinus node dysfunction 14.24 9.60 13 403352 6815 64088552
Anti-erythrocyte antibody positive 14.22 9.60 8 403357 77 64095290
Torsade de pointes 14.22 9.60 58 403307 17305 64078062
Cells in urine 14.22 9.60 11 403354 188 64095179
Cytomegalovirus viraemia 14.13 9.60 29 403336 10799 64084568
Serum sickness 14.10 9.60 48 403317 3141 64092226
Fungal rhinitis 14.08 9.60 7 403358 51 64095316
Tendonitis 14.07 9.60 72 403293 20210 64075157
Ischaemic stroke 14.06 9.60 115 403250 28920 64066447
PCO2 decreased 14.01 9.60 45 403320 2857 64092510
Skin exfoliation 13.96 9.60 197 403168 44688 64050679
Hypersensitivity vasculitis 13.95 9.60 13 403352 6748 64088619
Metastases to liver 13.92 9.60 90 403275 23851 64071516
Graft versus host disease in gastrointestinal tract 13.85 9.60 9 403356 5603 64089764
Sepsis 13.82 9.60 1246 402119 229095 63866272
Ascites 13.81 9.60 289 403076 61712 64033655
Bladder cancer 13.81 9.60 30 403335 10944 64084423
Chronic kidney disease 13.79 9.60 267 403098 57652 64037715
Pneumonia viral 13.79 9.60 90 403275 7732 64087635
Drug withdrawal syndrome 13.79 9.60 127 403238 31164 64064203
Visual impairment 13.79 9.60 355 403010 73722 64021645
Off label use 13.73 9.60 3634 399731 629172 63466195
Obesity 13.71 9.60 74 403291 20488 64074879
Kidney transplant rejection 13.70 9.60 24 403341 9487 64085880
Bronchopulmonary aspergillosis 13.67 9.60 67 403298 19018 64076349
Candida infection 13.64 9.60 128 403237 31291 64064076
Dysarthria 13.50 9.60 276 403089 59130 64036237
Postmortem blood drug level increased 13.47 9.60 20 403345 741 64094626
Pneumonia streptococcal 13.47 9.60 39 403326 2339 64093028
Cystitis haemorrhagic 13.46 9.60 18 403347 7938 64087429
Dependent personality disorder 13.39 9.60 9 403356 122 64095245
Mean cell haemoglobin concentration decreased 13.37 9.60 52 403313 3632 64091735
Chest pain 13.37 9.60 1282 402083 234698 63860669
Maternal exposure during pregnancy 13.26 9.60 730 402635 95154 64000213
Hepatitis B reactivation 13.26 9.60 7 403358 4882 64090485
White blood cell count decreased 13.25 9.60 830 402535 157007 63938360
Ketoacidosis 13.24 9.60 14 403351 6849 64088518
Acute graft versus host disease in skin 13.20 9.60 14 403351 6841 64088526
Brain scan abnormal 13.07 9.60 25 403340 1143 64094224
Neuroleptic malignant syndrome 13.04 9.60 97 403268 24899 64070468
Injection site extravasation 13.04 9.60 91 403274 7995 64087372
Specific gravity urine increased 13.02 9.60 15 403350 431 64094936
Stevens-Johnson syndrome 13.00 9.60 293 403072 33956 64061411
Incorrect drug administration rate 12.98 9.60 42 403323 2677 64092690
Nasal necrosis 12.96 9.60 9 403356 129 64095238
Antipsychotic drug level increased 12.90 9.60 8 403357 5107 64090260
Squamous cell carcinoma 12.88 9.60 44 403321 13825 64081542
Eyelid ptosis 12.86 9.60 25 403340 9500 64085867
Nocturia 12.86 9.60 32 403333 11133 64084234
Lymphoproliferative disorder 12.85 9.60 8 403357 5095 64090272
Metastases to bone 12.83 9.60 75 403290 20360 64075007
Disorientation 12.80 9.60 259 403106 55569 64039798
Bradypnoea 12.79 9.60 65 403300 5094 64090273
Aplasia pure red cell 12.77 9.60 15 403350 6999 64088368
Therapy non-responder 12.75 9.60 314 403051 65585 64029782
Upper respiratory tract infection 12.75 9.60 567 402798 72218 64023149
Dyslipidaemia 12.71 9.60 24 403341 9218 64086149
Ventricular tachycardia 12.66 9.60 145 403220 34120 64061247
Fear of injection 12.64 9.60 11 403354 5901 64089466
Oxygen saturation abnormal 12.63 9.60 50 403315 3521 64091846
Decerebrate posture 12.63 9.60 10 403355 177 64095190
Leukoencephalopathy 12.58 9.60 15 403350 6952 64088415
Therapeutic response unexpected 12.58 9.60 59 403306 16942 64078425
Dyskinesia 12.56 9.60 172 403193 39216 64056151
Oesophageal carcinoma 12.56 9.60 7 403358 4736 64090631
Pancreatic carcinoma 12.53 9.60 29 403336 10344 64085023
Eczema 12.51 9.60 122 403243 29598 64065769
Poisoning deliberate 12.49 9.60 134 403231 13324 64082043
Diffuse large B-cell lymphoma 12.48 9.60 29 403336 10332 64085035
Alpha 1 microglobulin increased 12.48 9.60 7 403358 67 64095300
Tardive dyskinesia 12.47 9.60 24 403341 9154 64086213
Mitral valve incompetence 12.43 9.60 101 403264 25437 64069930
Melaena 12.40 9.60 248 403117 53300 64042067
Traumatic liver injury 12.34 9.60 16 403349 521 64094846
Encephalopathy 12.32 9.60 467 402898 58352 64037015
BK virus infection 12.30 9.60 17 403348 7395 64087972
Ventricular extrasystoles 12.29 9.60 62 403303 17467 64077900
Anterior chamber cell 12.28 9.60 20 403345 804 64094563
Rash 12.27 9.60 3136 400229 455413 63639954
Pyrexia 12.25 9.60 3789 399576 554855 63540512
Post procedural pulmonary embolism 12.22 9.60 11 403354 234 64095133
Necrosis ischaemic 12.20 9.60 22 403343 961 64094406
JC virus infection 12.15 9.60 3 403362 3352 64092015
Genital haemorrhage 12.14 9.60 10 403355 5512 64089855
Frequent bowel movements 12.13 9.60 66 403299 18239 64077128
Skin lesion 12.11 9.60 158 403207 36324 64059043
Arrhythmia 12.03 9.60 246 403119 52698 64042669
Infusion site urticaria 11.98 9.60 17 403348 604 64094763
Maple syrup disease 11.98 9.60 4 403361 8 64095359
Brain stem glioma 11.97 9.60 9 403356 147 64095220
Pulmonary alveolar haemorrhage 11.94 9.60 27 403338 9711 64085656
Infection 11.93 9.60 1326 402039 183554 63911813
Food allergy 11.87 9.60 87 403278 7764 64087603
Laboratory test abnormal 11.79 9.60 95 403270 23968 64071399
Aortic valve stenosis 11.78 9.60 7 403358 4573 64090794
Urobilinogen urine increased 11.75 9.60 17 403348 615 64094752
Impaired work ability 11.75 9.60 52 403313 15167 64080200
Limb discomfort 11.67 9.60 111 403254 27064 64068303
Pancreatitis acute 11.65 9.60 193 403172 42662 64052705
Pulmonary tuberculosis 11.64 9.60 17 403348 7227 64088140
Application site pain 11.64 9.60 6 403359 4242 64091125
Speech disorder 11.63 9.60 223 403142 48218 64047149
Mood swings 11.57 9.60 63 403302 17405 64077962
Blood uric acid decreased 11.55 9.60 23 403342 1083 64094284
Electrocardiogram QRS complex prolonged 11.54 9.60 98 403267 9146 64086221
Obsessive-compulsive disorder 11.52 9.60 8 403357 4810 64090557
Toxic skin eruption 11.46 9.60 72 403293 19212 64076155
Dystonia 11.44 9.60 70 403295 18795 64076572
Oral discomfort 11.41 9.60 22 403343 8384 64086983
Asthma 11.39 9.60 483 402882 94742 64000625
Mobility decreased 11.38 9.60 651 402714 85189 64010178
Eye infection 11.38 9.60 98 403267 9183 64086184
Prescribed underdose 11.37 9.60 66 403299 17949 64077418
Right ventricular failure 11.35 9.60 83 403282 21388 64073979
Application site pruritus 11.29 9.60 4 403361 3535 64091832
Base excess 11.28 9.60 7 403358 82 64095285
Retinal haemorrhage 11.27 9.60 18 403347 7380 64087987
Fluid retention 11.26 9.60 285 403080 59321 64036046
Respiratory syncytial virus infection 11.25 9.60 81 403284 7187 64088180
Pulmonary mass 11.23 9.60 96 403269 23920 64071447
Anticipatory anxiety 11.13 9.60 11 403354 264 64095103
Polydipsia 11.09 9.60 12 403353 5809 64089558
Metastases to central nervous system 11.06 9.60 47 403318 13865 64081502
Product complaint 11.05 9.60 38 403327 11916 64083451
Angiokeratoma 11.02 9.60 10 403355 215 64095152
Affective disorder 11.01 9.60 15 403350 6565 64088802
Disease recurrence 11.00 9.60 135 403230 31375 64063992
Fibromyalgia 10.96 9.60 297 403068 35434 64059933
Femur fracture 10.90 9.60 149 403216 33986 64061381
Electrolyte imbalance 10.89 9.60 103 403262 25140 64070227
Hepatitis C 10.88 9.60 34 403331 10981 64084386
Allergy to plants 10.88 9.60 16 403349 588 64094779
Vital capacity decreased 10.85 9.60 22 403343 1050 64094317
Blood creatine increased 10.84 9.60 88 403277 8104 64087263
Urine oxalate increased 10.83 9.60 10 403355 220 64095147
Vitamin K deficiency 10.83 9.60 17 403348 662 64094705
Laryngospasm 10.81 9.60 4 403361 3441 64091926
Monocyte count increased 10.81 9.60 87 403278 7992 64087375
Bradyphrenia 10.80 9.60 27 403338 9379 64085988
Diaphragmatic rupture 10.79 9.60 10 403355 221 64095146
Retinal deposits 10.78 9.60 8 403357 128 64095239
Human herpesvirus 6 infection 10.77 9.60 8 403357 4646 64090721
Immunosuppressant drug level increased 10.75 9.60 18 403347 7241 64088126
Coagulation factor X level decreased 10.73 9.60 7 403358 90 64095277
Gastritis erosive 10.66 9.60 28 403337 9567 64085800
Adenocarcinoma of colon 10.65 9.60 9 403356 4899 64090468
Activated partial thromboplastin time prolonged 10.65 9.60 125 403240 12706 64082661
Pneumonia cytomegaloviral 10.65 9.60 7 403358 4332 64091035
Peripheral arterial occlusive disease 10.65 9.60 17 403348 6970 64088397
Peripheral sensory neuropathy 10.63 9.60 36 403329 11342 64084025
Infusion site discomfort 10.62 9.60 18 403347 748 64094619
Bundle branch block left 10.61 9.60 30 403335 10004 64085363
Pain in jaw 10.60 9.60 185 403180 40570 64054797
Autonomic dysreflexia 10.59 9.60 13 403352 400 64094967
Systemic infection 10.57 9.60 7 403358 4314 64091053
Sensitivity to weather change 10.55 9.60 16 403349 6698 64088669
Red cell distribution width decreased 10.55 9.60 22 403343 1071 64094296
Renal injury 10.55 9.60 145 403220 15284 64080083
Pneumonia 10.50 9.60 3233 400132 556343 63539024
Urinary retention 10.48 9.60 231 403134 48970 64046397
Acid-base balance disorder mixed 10.47 9.60 7 403358 94 64095273
Long QT syndrome 10.46 9.60 10 403355 5129 64090238
Dermatitis exfoliative generalised 10.40 9.60 13 403352 5903 64089464
Cerebral ischaemia 10.38 9.60 30 403335 9932 64085435
Abnormal loss of weight 10.37 9.60 19 403346 7381 64087986
Hypoglycaemic coma 10.35 9.60 7 403358 4267 64091100
Vessel puncture site bruise 10.32 9.60 13 403352 411 64094956
Swollen tongue 10.31 9.60 155 403210 34799 64060568
Caesarean section 10.31 9.60 36 403329 11238 64084129
Nephrogenic systemic fibrosis 10.30 9.60 13 403352 5879 64089488
Altered state of consciousness 10.20 9.60 171 403194 37731 64057636
Injection site discomfort 10.20 9.60 7 403358 4234 64091133
High density lipoprotein decreased 10.19 9.60 6 403359 3940 64091427
Heavy menstrual bleeding 10.10 9.60 40 403325 12037 64083330
Deep vein thrombosis 10.10 9.60 546 402819 104636 63990731
Myelocyte percentage increased 10.09 9.60 10 403355 241 64095126
Eructation 10.08 9.60 27 403338 9164 64086203
pH urine increased 10.08 9.60 13 403352 421 64094946
Focal dyscognitive seizures 10.02 9.60 4 403361 3286 64092081
Anti-neutrophil cytoplasmic antibody positive vasculitis 9.93 9.60 3 403362 2933 64092434
Atrioventricular block 9.92 9.60 40 403325 11975 64083392
Monoparesis 9.92 9.60 3 403362 2931 64092436
Disturbance in social behaviour 9.92 9.60 6 403359 3881 64091486
Rheumatoid nodule 9.90 9.60 43 403322 12608 64082759
Blood lactic acid increased 9.86 9.60 104 403261 10297 64085070
Tricuspid valve incompetence 9.84 9.60 64 403301 16939 64078428
Erectile dysfunction 9.83 9.60 43 403322 12584 64082783
Hallucination 9.83 9.60 364 403001 72424 64022943
Red blood cell elliptocytes present 9.81 9.60 8 403357 148 64095219
Lumbar vertebral fracture 9.77 9.60 12 403353 5490 64089877
Hepatitis fulminant 9.76 9.60 70 403295 6204 64089163
Cytomegalovirus infection reactivation 9.76 9.60 13 403352 5743 64089624
Drug abuser 9.74 9.60 66 403299 5742 64089625
Atypical femur fracture 9.73 9.60 9 403356 4689 64090678
Injection site nodule 9.72 9.60 4 403361 3226 64092141
Drug use disorder 9.68 9.60 68 403297 5986 64089381
Muscle disorder 9.66 9.60 10 403355 4941 64090426
Oral pruritus 9.65 9.60 29 403336 1776 64093591
Immunodeficiency 9.63 9.60 148 403217 15976 64079391
Personality change 9.61 9.60 25 403340 8568 64086799

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 (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
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Taste receptor type 2 member 46 GPCR EC50 4.51 CHEMBL
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
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.29 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane other IC50 7.82 CHEMBL
Glutamate NMDA receptor Ion channel Ki 5.65 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.89 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2097 SOLUTION 20 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Elderberry Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2098 SOLUTION 20 mg ORAL OTC monograph final 15 sections
CHILDRENS DIMETAPP COLD AND COUGH HUMAN OTC DRUG LABEL 3 0031-2234 LIQUID 5 mg ORAL OTC monograph final 16 sections
Robitussin Tos Seca HUMAN OTC DRUG LABEL 1 0031-8652 SYRUP 10 mg ORAL Export only 1 sections
Robitussin 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 16 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
Robitussin Honey Maximum Strength Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8758 SOLUTION 30 mg ORAL OTC monograph final 17 sections