dextromethorphan 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: 3.95
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -4.50
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O
90 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 15 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.19 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.88 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 11 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 3, 1957 FDA ANI PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 2578.03 9.64 3586 308365 134615 52902500
Toxicity to various agents 2088.17 9.64 4211 307740 215387 52821728
Infusion related reaction 785.98 9.64 2346 309605 153611 52883504
Sinusitis 603.65 9.64 2260 309691 166304 52870811
Acute hepatic failure 462.23 9.64 529 311422 16191 53020924
Overdose 453.59 9.64 1524 310427 106212 52930903
Muscle injury 443.14 9.64 696 311255 29070 53008045
Folliculitis 439.95 9.64 718 311233 30991 53006124
Intentional product misuse 361.19 9.64 854 311097 48538 52988577
Irritable bowel syndrome 358.49 9.64 790 311161 42842 52994273
Blood pressure fluctuation 317.54 9.64 665 311286 34805 53002310
Lower respiratory tract infection 317.04 9.64 1210 310741 89771 52947344
Ill-defined disorder 301.72 9.64 798 311153 48646 52988469
Metabolic acidosis 294.45 9.64 717 311234 41525 52995590
Sleep disorder due to general medical condition, insomnia type 268.14 9.64 498 311453 23851 53013264
Joint swelling 262.17 9.64 2301 309650 232337 52804778
Blister 248.18 9.64 1015 310936 77738 52959377
Anti-cyclic citrullinated peptide antibody positive 241.50 9.64 810 311141 56362 52980753
Exposure to toxic agent 240.05 9.64 145 311806 1735 53035380
Nasopharyngitis 235.45 9.64 1925 310026 190370 52846745
Injection site pain 232.20 9.64 193 311758 113198 52923917
Hepatotoxicity 230.33 9.64 506 311445 27374 53009741
Duodenal ulcer perforation 229.19 9.64 582 311369 34601 53002514
Intentional overdose 226.04 9.64 884 311067 66321 52970794
Helicobacter infection 223.72 9.64 616 311335 38453 52998662
Product dose omission issue 221.71 9.64 495 311456 191125 52845990
Impaired healing 213.87 9.64 842 311109 63363 52973752
Hepatic enzyme increased 207.62 9.64 1356 310595 124839 52912276
Anion gap 205.70 9.64 111 311840 1053 53036062
Pericarditis 205.21 9.64 833 311118 63573 52973542
Therapeutic product effect decreased 185.12 9.64 1314 310637 124341 52912774
Respiratory arrest 181.39 9.64 518 311433 33022 53004093
Psoriasis 172.46 9.64 153 311798 86936 52950179
Body temperature increased 160.62 9.64 489 311462 32310 53004805
Cardio-respiratory arrest 157.97 9.64 722 311229 58036 52979079
Gastrointestinal disorder 149.10 9.64 969 310982 89035 52948080
Intentional product use issue 147.85 9.64 824 311127 71670 52965445
Diarrhoea 139.54 9.64 2700 309251 622846 52414269
Depressed level of consciousness 136.20 9.64 655 311296 53773 52983342
Synovitis 134.51 9.64 1085 310866 106808 52930307
Device expulsion 132.98 9.64 11 311940 29802 53007313
Hypersensitivity 132.37 9.64 1844 310107 208821 52828294
Coagulopathy 128.42 9.64 326 311625 19372 53017743
Heart rate decreased 128.26 9.64 491 311460 36456 53000659
Hand deformity 127.06 9.64 891 311060 83958 52953157
Weight increased 125.05 9.64 1782 310169 202785 52834330
Peripheral swelling 124.23 9.64 1791 310160 204317 52832798
Injection site erythema 122.70 9.64 163 311788 77086 52960029
Swelling 122.15 9.64 1678 310273 189427 52847688
Stomatitis 114.79 9.64 973 310978 97185 52939930
Drug abuse 113.76 9.64 714 311237 64812 52972303
Ear pain 111.90 9.64 405 311546 29268 53007847
Sedation complication 108.61 9.64 169 311782 6997 53030118
Wrong technique in product usage process 105.57 9.64 117 311834 59915 52977200
Medication error 105.38 9.64 457 311494 35908 53001207
Blood pressure diastolic abnormal 105.34 9.64 186 311765 8559 53028556
Poisoning 105.03 9.64 243 311708 13607 53023508
Wound 104.65 9.64 903 311048 90654 52946461
Discomfort 103.12 9.64 930 311021 94542 52942573
Injection site reaction 102.35 9.64 89 311862 51077 52986038
Infusion site pain 101.41 9.64 218 311733 11615 53025500
Analgesic drug level increased 98.93 9.64 83 311868 1717 53035398
Anaemia 93.99 9.64 1100 310851 275618 52761497
Muscle spasticity 91.15 9.64 270 311681 17568 53019547
Hepatic failure 90.36 9.64 432 311519 35374 53001741
Acute lung injury 87.90 9.64 71 311880 1390 53035725
Infusion site swelling 85.18 9.64 149 311802 6805 53030310
Hepatic necrosis 84.91 9.64 134 311817 5616 53031499
Creatinine renal clearance decreased 84.23 9.64 190 311761 10461 53026654
Injection site pruritus 83.60 9.64 72 311879 41517 52995598
Exposure via ingestion 83.29 9.64 99 311852 3156 53033959
Blood pressure increased 83.08 9.64 1217 310734 139262 52897853
Neutropenia 82.96 9.64 567 311384 158618 52878497
Oxygen saturation decreased 82.13 9.64 746 311205 75979 52961136
Rheumatoid factor positive 80.48 9.64 463 311488 40735 52996380
Respiratory depression 80.43 9.64 209 311742 12597 53024518
Blood pressure diastolic decreased 79.91 9.64 248 311703 16555 53020560
Blood pressure systolic abnormal 79.82 9.64 147 311804 6992 53030123
Injection site bruising 79.61 9.64 62 311889 37584 52999531
Sopor 76.71 9.64 15 311936 21069 53016046
Disease progression 76.47 9.64 321 311630 101599 52935516
Osteonecrosis of jaw 74.59 9.64 61 311890 36085 53001030
Infection 73.95 9.64 1416 310535 170789 52866326
Hepatic cytolysis 71.90 9.64 149 311802 7736 53029379
Pruritus 71.37 9.64 2235 309716 291597 52745518
Drug resistance 70.97 9.64 15 311936 19947 53017168
Infusion site erythema 70.46 9.64 158 311793 8664 53028451
Psoriatic arthropathy 70.26 9.64 108 311843 48082 52989033
Throat irritation 67.84 9.64 365 311586 31316 53005799
Infusion site extravasation 65.53 9.64 125 311826 6107 53031008
Accidental overdose 65.37 9.64 274 311677 21205 53015910
Nausea 64.96 9.64 3690 308261 752401 52284714
Hospitalisation 64.90 9.64 206 311745 70806 52966309
Suicide attempt 64.00 9.64 569 311382 57599 52979516
Myocardial infarction 63.85 9.64 331 311620 99023 52938092
Injection site swelling 63.63 9.64 94 311857 42534 52994581
Suspected suicide 63.41 9.64 101 311850 4267 53032848
Product quality issue 63.08 9.64 74 311877 36949 53000166
Pyroglutamate increased 62.24 9.64 37 311914 429 53036686
Drug ineffective 62.21 9.64 4034 307917 813211 52223904
Blood pressure systolic increased 61.46 9.64 384 311567 34793 53002322
Coma 61.24 9.64 591 311360 61192 52975923
Product prescribing error 59.64 9.64 30 311921 23001 53014114
Decreased appetite 59.60 9.64 891 311060 214083 52823032
Mucosal inflammation 59.43 9.64 99 311852 42685 52994430
Paraesthesia 58.85 9.64 470 311481 127045 52910070
Respiratory disorder 58.82 9.64 371 311580 33726 53003389
Confusional state 57.51 9.64 1515 310436 192706 52844409
Contraindicated product administered 57.09 9.64 1112 310839 134517 52902598
Product substitution issue 56.24 9.64 12 311939 15854 53021261
Cardiac arrest 55.55 9.64 812 311139 92855 52944260
Heart rate increased 55.47 9.64 730 311221 81585 52955530
Blood calcium decreased 55.25 9.64 246 311705 19548 53017567
Drug interaction 55.11 9.64 926 311025 218403 52818712
Abortion spontaneous 55.05 9.64 119 311832 46516 52990599
Drug hypersensitivity 53.99 9.64 1161 310790 264081 52773034
Electric shock 53.28 9.64 46 311905 991 53036124
Cerebrovascular accident 53.10 9.64 378 311573 104796 52932319
Arthralgia 53.08 9.64 3109 308842 436674 52600441
Glossodynia 52.42 9.64 851 311100 99440 52937675
Cardiac failure 52.38 9.64 291 311660 85553 52951562
Therapy cessation 52.20 9.64 52 311899 27973 53009142
Neuropathy peripheral 51.54 9.64 372 311579 102815 52934300
Injection site warmth 51.50 9.64 10 311941 14118 53022997
Infusion site pruritus 50.42 9.64 84 311867 3686 53033429
Therapeutic product effect incomplete 50.27 9.64 322 311629 91462 52945653
Bone marrow failure 49.39 9.64 62 311889 30053 53007062
Liver injury 48.93 9.64 257 311694 21846 53015269
Crystal urine present 48.70 9.64 51 311900 1409 53035706
International normalised ratio increased 48.38 9.64 459 311492 47302 52989813
Methaemoglobinaemia 48.35 9.64 63 311888 2209 53034906
Night sweats 48.25 9.64 360 311591 34587 53002528
Pyrexia 47.99 9.64 2847 309104 400346 52636769
Arthropathy 47.99 9.64 1124 310827 140329 52896786
Pancytopenia 47.77 9.64 323 311628 90605 52946510
Dizziness 47.61 9.64 1739 310212 370520 52666595
Device malfunction 47.14 9.64 17 311934 15891 53021224
Anion gap abnormal 46.78 9.64 28 311923 329 53036786
Hyperkalaemia 46.41 9.64 162 311789 54094 52983021
Muscle spasms 44.84 9.64 538 311413 134257 52902858
Pain 44.78 9.64 4007 307944 584391 52452724
Hyponatraemia 44.44 9.64 413 311538 108194 52928921
Orthostatic hypotension 44.24 9.64 312 311639 29441 53007674
Palmar-plantar erythrodysaesthesia syndrome 43.91 9.64 37 311914 21569 53015546
Heart rate irregular 43.74 9.64 235 311716 20149 53016966
White blood cells urine positive 42.76 9.64 87 311864 4458 53032657
Cardiac failure congestive 42.73 9.64 342 311609 92415 52944700
No adverse event 42.47 9.64 105 311846 39160 52997955
Alanine aminotransferase increased 41.82 9.64 785 311166 94310 52942805
Soft tissue disorder 41.41 9.64 83 311868 4207 53032908
Cognitive disorder 41.29 9.64 422 311529 44356 52992759
Infusion site bruising 40.87 9.64 56 311895 2063 53035052
Device dislocation 40.38 9.64 47 311904 23550 53013565
Death 40.14 9.64 2510 309441 354722 52682393
Body temperature decreased 40.07 9.64 198 311753 16429 53020686
Drug intolerance 40.00 9.64 1524 310427 203969 52833146
Red blood cell sedimentation rate abnormal 39.78 9.64 21 311930 15668 53021447
Diabetes mellitus 39.64 9.64 171 311780 53728 52983387
Rash 39.52 9.64 3074 308877 443117 52593998
Injection site mass 39.24 9.64 23 311928 16191 53020924
Neoplasm progression 39.04 9.64 72 311879 29847 53007268
Administration site swelling 38.57 9.64 41 311910 1153 53035962
Pemphigus 38.52 9.64 837 311114 103194 52933921
Injection site urticaria 38.17 9.64 13 311938 12594 53024521
Sedation 37.79 9.64 300 311651 29375 53007740
Product storage error 37.29 9.64 15 311936 13115 53024000
Interstitial lung disease 36.15 9.64 198 311753 58424 52978691
Urine abnormality 36.11 9.64 101 311850 6359 53030756
Hypotension 36.08 9.64 1824 310127 252252 52784863
Feeling abnormal 36.02 9.64 565 311386 134736 52902379
Urinary sediment present 34.76 9.64 51 311900 2003 53035112
Rheumatic fever 34.69 9.64 156 311795 12448 53024667
Blood pressure diastolic increased 34.67 9.64 106 311845 7018 53030097
Infusion site nodule 34.54 9.64 38 311913 1112 53036003
Epilepsy 34.53 9.64 61 311890 25706 53011409
Injection site haemorrhage 34.52 9.64 47 311904 22004 53015111
Hypertensive crisis 34.51 9.64 21 311930 14485 53022630
Substance abuse 34.24 9.64 79 311872 4415 53032700
Unresponsive to stimuli 34.23 9.64 322 311629 33104 53004011
Fracture 34.06 9.64 33 311918 17986 53019129
Malignant neoplasm progression 33.77 9.64 262 311689 71279 52965836
Oedema peripheral 33.72 9.64 751 311200 170036 52867079
Malaise 33.36 9.64 1730 310221 355887 52681228
Administration site pain 33.23 9.64 30 311921 687 53036428
Respiratory rate increased 33.14 9.64 152 311799 12231 53024884
Toxicologic test abnormal 33.12 9.64 29 311922 637 53036478
Acute kidney injury 33.07 9.64 1183 310768 252685 52784430
Device issue 33.07 9.64 47 311904 21611 53015504
Injection site rash 32.95 9.64 29 311922 16550 53020565
Foetal exposure during pregnancy 32.92 9.64 99 311852 34616 53002499
Transient ischaemic attack 32.38 9.64 104 311847 35621 53001494
Vision blurred 32.29 9.64 332 311619 85272 52951843
Bone pain 32.00 9.64 170 311781 50552 52986563
Epistaxis 31.80 9.64 253 311698 68457 52968658
Product use in unapproved indication 31.56 9.64 464 311487 111825 52925290
Swollen joint count increased 31.27 9.64 140 311811 11150 53025965
Surgery 31.15 9.64 90 311861 31874 53005241
Myelodysplastic syndrome 30.93 9.64 31 311920 16629 53020486
Device difficult to use 30.81 9.64 11 311940 10348 53026767
Contusion 30.25 9.64 855 311096 109877 52927238
Posterior reversible encephalopathy syndrome 30.08 9.64 30 311921 16130 53020985
Red blood cells urine positive 29.95 9.64 58 311893 2866 53034249
Off label use 29.83 9.64 2367 309584 469845 52567270
Poor venous access 29.38 9.64 126 311825 9849 53027266
Brain death 28.80 9.64 58 311893 2950 53034165
Osteonecrosis 28.79 9.64 71 311880 26504 53010611
Fall 28.67 9.64 1760 310191 356680 52680435
Jaundice cholestatic 28.49 9.64 84 311867 5450 53031665
Pyroglutamic acidosis 28.49 9.64 21 311930 357 53036758
Renal impairment 28.29 9.64 331 311620 82987 52954128
Prothrombin time prolonged 28.11 9.64 123 311828 9699 53027416
Depression 27.86 9.64 836 311115 182216 52854899
Intervertebral discitis 27.79 9.64 55 311896 2762 53034353
Body temperature fluctuation 27.67 9.64 46 311905 2015 53035100
Lymphocyte count decreased 27.62 9.64 268 311683 27784 53009331
Rash pruritic 27.60 9.64 175 311776 49835 52987280
Dyspnoea exertional 27.59 9.64 198 311753 54802 52982313
Accidental exposure to product 27.45 9.64 61 311890 23613 53013502
Suicidal ideation 27.00 9.64 225 311726 60286 52976829
Dry skin 26.89 9.64 157 311794 45603 52991512
Brain oedema 26.88 9.64 153 311798 13405 53023710
Blood parathyroid hormone decreased 26.41 9.64 3 311948 6315 53030800
Red cell distribution width increased 26.25 9.64 113 311838 8847 53028268
Myelosuppression 26.03 9.64 22 311929 12806 53024309
Hypokalaemia 26.03 9.64 402 311549 96115 52941000
Memory impairment 25.67 9.64 345 311606 84412 52952703
Labelled drug-drug interaction medication error 25.62 9.64 16 311935 10883 53026232
Analgesic drug level above therapeutic 25.52 9.64 15 311936 170 53036945
Seizure 25.40 9.64 570 311381 128939 52908176
Femur fracture 25.35 9.64 132 311819 39453 52997662
Urticaria 25.29 9.64 1003 310948 134882 52902233
Upper respiratory tract infection 25.27 9.64 555 311396 68542 52968573
Plasma cell myeloma 25.17 9.64 170 311781 47704 52989411
Breast cancer 25.09 9.64 177 311774 49181 52987934
Urine leukocyte esterase positive 25.05 9.64 54 311897 2882 53034233
Aspartate aminotransferase increased 24.98 9.64 656 311295 83373 52953742
Lymphocyte percentage decreased 24.82 9.64 53 311898 2810 53034305
Ejection fraction decreased 24.81 9.64 49 311902 19799 53017316
Neutrophil percentage increased 24.78 9.64 53 311898 2813 53034302
Hyperlipidaemia 24.55 9.64 48 311903 19467 53017648
Accidental death 24.53 9.64 40 311911 1724 53035391
Injection site induration 24.41 9.64 10 311941 8648 53028467
Hypomania 24.09 9.64 73 311878 4809 53032306
Ear pruritus 24.08 9.64 48 311903 2423 53034692
Administration site erythema 23.85 9.64 23 311928 574 53036541
Blood count abnormal 23.84 9.64 52 311899 20263 53016852
Thrombocytopenia 23.80 9.64 623 311328 138104 52899011
Liver transplant 23.77 9.64 48 311903 2446 53034669
Hypothermia 23.73 9.64 144 311807 12912 53024203
Acidosis 23.54 9.64 130 311821 11262 53025853
White blood cell count decreased 23.52 9.64 551 311400 123924 52913191
Gastrooesophageal reflux disease 23.43 9.64 341 311610 82322 52954793
Lactic acidosis 23.42 9.64 125 311826 37128 52999987
Syncope 23.38 9.64 488 311463 111505 52925610
Diabetic ketoacidosis 23.35 9.64 51 311900 19864 53017251
Polyneuropathy 23.03 9.64 26 311925 13207 53023908
Disturbance in attention 22.96 9.64 113 311838 34270 53002845
Specific gravity urine decreased 22.87 9.64 23 311928 605 53036510
Gait disturbance 22.80 9.64 731 311220 158111 52879004
Therapy interrupted 22.60 9.64 50 311901 19386 53017729
Forced expiratory volume decreased 22.50 9.64 3 311948 5582 53031533
Hypocalcaemia 22.23 9.64 92 311859 29245 53007870
Second primary malignancy 22.21 9.64 7 311944 7125 53029990
Underdose 22.16 9.64 59 311892 21463 53015652
Asthma 22.12 9.64 477 311474 108495 52928620
Hypercalcaemia 21.98 9.64 71 311880 24277 53012838
Leukopenia 21.90 9.64 300 311651 73163 52963952
Multiple sclerosis relapse 21.76 9.64 163 311788 44690 52992425
Coronary artery disease 21.69 9.64 111 311840 33326 53003789
Palpitations 21.65 9.64 445 311506 101903 52935212
Gestational diabetes 21.53 9.64 10 311941 8029 53029086
Dehydration 21.40 9.64 787 311164 167623 52869492
Postmortem blood drug level increased 21.24 9.64 21 311930 541 53036574
Drug screen positive 21.12 9.64 60 311891 3812 53033303
Complication associated with device 21.00 9.64 39 311912 16126 53020989
Ductus arteriosus premature closure 20.91 9.64 17 311934 336 53036779
Bradypnoea 20.90 9.64 54 311897 3243 53033872
Blood pH decreased 20.89 9.64 47 311904 2583 53034532
Breast cancer metastatic 20.80 9.64 36 311915 15292 53021823
Blood creatine increased 20.71 9.64 70 311881 4887 53032228
Pulmonary arterial hypertension 20.59 9.64 85 311866 27037 53010078
Withdrawal syndrome 20.57 9.64 52 311899 19249 53017866
Vertigo 20.53 9.64 219 311732 55862 52981253
Drug ineffective for unapproved indication 20.44 9.64 58 311893 20662 53016453
Tremor 20.44 9.64 569 311382 125167 52911948
Hypoaesthesia 20.07 9.64 608 311343 132387 52904728
Infusion site urticaria 20.03 9.64 25 311926 839 53036276
Visual acuity reduced 20.00 9.64 66 311885 22419 53014696
Pneumocystis jirovecii pneumonia 19.99 9.64 41 311910 16337 53020778
Transplant rejection 19.88 9.64 18 311933 10133 53026982
Device use error 19.82 9.64 4 311947 5495 53031620
Product adhesion issue 19.81 9.64 4 311947 5493 53031622
Cytomegalovirus infection 19.79 9.64 54 311897 19485 53017630
Disease recurrence 19.67 9.64 60 311891 20886 53016229
Anaphylactic shock 19.65 9.64 64 311887 21829 53015286
Ageusia 19.63 9.64 27 311924 12587 53024528
Pathogen resistance 19.45 9.64 7 311944 6553 53030562
Dysgeusia 19.43 9.64 159 311792 42772 52994343
Haematotoxicity 19.40 9.64 11 311940 7886 53029229
Abdominal distension 19.31 9.64 339 311612 79451 52957664
Infusion site irritation 19.21 9.64 21 311930 610 53036505
Anion gap increased 18.74 9.64 33 311918 1515 53035600
Asphyxia 18.52 9.64 76 311875 5825 53031290
Genital haemorrhage 18.50 9.64 9 311942 7035 53030080
Iron deficiency anaemia 18.33 9.64 52 311899 18528 53018587
Band neutrophil count increased 18.33 9.64 16 311935 350 53036765
Haemolysis 18.33 9.64 81 311870 6415 53030700
Haemorrhage 18.30 9.64 234 311717 57753 52979362
Sepsis 18.22 9.64 686 311265 145743 52891372
Atrial fibrillation 18.21 9.64 505 311446 111147 52925968
Drug withdrawal syndrome 18.19 9.64 93 311858 27929 53009186
Basal cell carcinoma 18.16 9.64 73 311878 23396 53013719
Bacterial test 18.12 9.64 29 311922 1230 53035885
Hepatic cirrhosis 18.11 9.64 50 311901 17972 53019143
Pneumonia streptococcal 18.09 9.64 35 311916 1728 53035387
Osmolar gap 18.00 9.64 10 311941 101 53037014
Systemic lupus erythematosus 17.90 9.64 901 311050 124513 52912602
Inappropriate antidiuretic hormone secretion 17.77 9.64 38 311913 14913 53022202
Febrile bone marrow aplasia 17.68 9.64 10 311941 7179 53029936
Infusion site haemorrhage 17.61 9.64 46 311905 2781 53034334
Renal failure neonatal 17.38 9.64 12 311939 183 53036932
Aphasia 17.34 9.64 107 311844 30671 53006444
Post procedural pulmonary embolism 17.33 9.64 14 311937 274 53036841
Eosinophil percentage increased 17.32 9.64 25 311926 967 53036148
Blood creatinine decreased 17.30 9.64 68 311883 5110 53032005
Blood urine present 17.30 9.64 135 311816 13150 53023965
Peritonitis bacterial 17.29 9.64 18 311933 9487 53027628
Lupus-like syndrome 17.26 9.64 17 311934 9195 53027920
Tinnitus 17.25 9.64 106 311845 30413 53006702
Musculoskeletal disorder 17.25 9.64 49 311902 17450 53019665
Bone erosion 17.22 9.64 24 311927 11128 53025987
Smear cervix abnormal 17.02 9.64 45 311906 2741 53034374
Metastases to bone 17.01 9.64 57 311894 19271 53017844
Hepatic encephalopathy 16.81 9.64 115 311836 10744 53026371
Opiates positive 16.74 9.64 15 311936 340 53036775
Pneumonia viral 16.65 9.64 84 311867 7028 53030087
Oral discomfort 16.55 9.64 16 311935 8730 53028385
Cerebral haemorrhage 16.53 9.64 105 311846 29891 53007224
Myalgia 16.47 9.64 626 311325 132865 52904250
Ventricular extrasystoles 16.40 9.64 27 311924 11697 53025418
Intermenstrual bleeding 16.36 9.64 16 311935 8682 53028433
Haemoglobin urine present 16.33 9.64 22 311929 797 53036318
Osteoarthritis 16.26 9.64 302 311649 70184 52966931
Spinal stenosis 16.26 9.64 37 311914 14204 53022911
Acute myeloid leukaemia 16.26 9.64 48 311903 16884 53020231
Mean cell haemoglobin concentration increased 16.25 9.64 17 311934 469 53036646
Extrapyramidal disorder 16.04 9.64 30 311921 12372 53024743
Chest pain 15.85 9.64 930 311021 189255 52847860
Mood swings 15.78 9.64 51 311900 17435 53019680
Swollen tongue 15.53 9.64 112 311839 30968 53006147
Necrosis ischaemic 15.52 9.64 22 311929 837 53036278
Burning sensation 15.43 9.64 193 311758 47820 52989295
Dysphoria 15.37 9.64 6 311945 5343 53031772
Skin ulcer 15.35 9.64 136 311815 35983 53001132
Metastases to liver 15.32 9.64 69 311882 21427 53015688
Serotonin syndrome 15.28 9.64 228 311723 26178 53010937
Ischaemic stroke 15.20 9.64 54 311897 17939 53019176
Neurotoxicity 15.11 9.64 43 311908 15306 53021809
Transplant dysfunction 15.11 9.64 5 311946 4933 53032182
Multiple drug therapy 15.10 9.64 29 311922 1424 53035691
Electrolyte imbalance 15.08 9.64 58 311893 18826 53018289
Hepatocellular injury 15.01 9.64 108 311843 29878 53007237
Urine analysis abnormal 14.96 9.64 59 311892 4441 53032674
Mobility decreased 14.89 9.64 566 311385 75705 52961410
Hyperglycaemia 14.89 9.64 156 311795 39928 52997187
Pain in extremity 14.83 9.64 1450 310501 283600 52753515
Metastases to lymph nodes 14.80 9.64 13 311938 7427 53029688
Haemophagocytic lymphohistiocytosis 14.79 9.64 19 311932 9118 53027997
Angioedema 14.73 9.64 166 311785 41910 52995205
Temperature regulation disorder 14.67 9.64 56 311895 4151 53032964
Therapeutic response decreased 14.63 9.64 193 311758 47376 52989739
Transfusion-related acute lung injury 14.60 9.64 9 311942 112 53037003
Taste disorder 14.59 9.64 15 311936 7953 53029162
Infusion site mass 14.54 9.64 24 311927 1045 53036070
Cardiovascular disorder 14.38 9.64 32 311919 12381 53024734
Therapeutic response shortened 14.33 9.64 80 311871 6959 53030156
Irritability 14.30 9.64 114 311837 30839 53006276
Vaginal haemorrhage 14.26 9.64 95 311856 26746 53010369
Joint stiffness 14.24 9.64 111 311840 30172 53006943
Galactorrhoea 14.20 9.64 3 311948 3992 53033123
Device breakage 14.17 9.64 25 311926 10542 53026573
Heavy menstrual bleeding 14.12 9.64 53 311898 17323 53019792
Ductus arteriosus stenosis foetal 14.08 9.64 10 311941 160 53036955
Premature delivery 14.07 9.64 92 311859 26012 53011103
Renal failure 14.06 9.64 558 311393 117894 52919221
Low turnover osteopathy 13.99 9.64 4 311947 4336 53032779
Cardiomyopathy 13.96 9.64 52 311899 17036 53020079
Administration site pruritus 13.90 9.64 13 311938 312 53036803
Left ventricular dysfunction 13.83 9.64 28 311923 11209 53025906
Infusion site discomfort 13.76 9.64 20 311931 779 53036336
Akathisia 13.69 9.64 18 311933 8553 53028562
Beta haemolytic streptococcal infection 13.68 9.64 34 311917 1993 53035122
Administration site extravasation 13.68 9.64 19 311932 709 53036406
Culture urine positive 13.65 9.64 49 311902 3526 53033589
Coma hepatic 13.60 9.64 18 311933 641 53036474
Antidepressant drug level above therapeutic 13.60 9.64 14 311937 379 53036736
Thrombotic microangiopathy 13.53 9.64 21 311930 9316 53027799
Incorrect drug administration rate 13.53 9.64 38 311913 2398 53034717
Alpha 1 microglobulin increased 13.48 9.64 7 311944 61 53037054
Gastrointestinal haemorrhage 13.44 9.64 362 311589 79968 52957147
Drug-induced liver injury 13.43 9.64 243 311708 28990 53008125
Fear of injection 13.42 9.64 8 311943 5581 53031534
Unevaluable event 13.39 9.64 206 311745 49292 52987823
Vitamin K deficiency 13.36 9.64 15 311936 449 53036666
Sputum culture positive 13.31 9.64 28 311923 1469 53035646
Skin necrosis 13.30 9.64 26 311925 10546 53026569
Full blood count decreased 13.30 9.64 84 311867 23945 53013170
Flatulence 13.25 9.64 119 311832 31398 53005717
Low density lipoprotein increased 13.23 9.64 10 311941 6156 53030959
Ear infection 13.23 9.64 219 311732 25681 53011434
Metastases to central nervous system 13.23 9.64 32 311919 12025 53025090
Application site pain 13.22 9.64 4 311947 4179 53032936
Therapeutic response unexpected 13.19 9.64 54 311897 17216 53019899
Transaminases increased 12.98 9.64 248 311703 29884 53007231
Adverse drug reaction 12.92 9.64 228 311723 53397 52983718
Injection site extravasation 12.91 9.64 82 311869 7470 53029645
Precancerous cells present 12.90 9.64 25 311926 1236 53035879
Blood glucose increased 12.84 9.64 349 311602 77012 52960103
Cells in urine 12.81 9.64 10 311941 186 53036929
Skin exfoliation 12.77 9.64 142 311809 35941 53001174
Unintended pregnancy 12.76 9.64 10 311941 6043 53031072
Cerebral infarction 12.75 9.64 87 311864 24357 53012758
Priapism 12.66 9.64 7 311944 70 53037045
Blood uric acid decreased 12.63 9.64 18 311933 688 53036427
Encephalopathy 12.62 9.64 293 311658 36515 53000600
Cardiac disorder 12.53 9.64 196 311755 46770 52990345
Pain in jaw 12.51 9.64 165 311786 40504 52996611
Maternal exposure before pregnancy 12.49 9.64 9 311942 5677 53031438
Pregnancy with contraceptive device 12.45 9.64 6 311945 4715 53032400
Congestive hepatopathy 12.44 9.64 39 311912 2617 53034498
Renal papillary necrosis 12.44 9.64 11 311940 245 53036870
Post-traumatic stress disorder 12.43 9.64 58 311893 4700 53032415
Post transplant lymphoproliferative disorder 12.40 9.64 5 311946 4366 53032749
Vital capacity decreased 12.39 9.64 22 311929 1017 53036098
Urinary casts 12.29 9.64 17 311934 632 53036483
Thinking abnormal 12.24 9.64 27 311924 10481 53026634
Lip swelling 12.19 9.64 101 311850 27100 53010015
Bursitis 12.17 9.64 192 311759 22300 53014815
Acute graft versus host disease 12.15 9.64 5 311946 4312 53032803
Parosmia 12.12 9.64 6 311945 4644 53032471
Adverse event 12.12 9.64 168 311783 40893 52996222
Metastases to lung 12.11 9.64 32 311919 11672 53025443
Caesarean section 12.10 9.64 56 311895 17264 53019851
Loss of consciousness 12.09 9.64 545 311406 113667 52923448
Platelet count decreased 12.02 9.64 513 311438 107586 52929529
Base excess 12.01 9.64 7 311944 78 53037037
Oedema 11.93 9.64 337 311614 74009 52963106
Bronchitis 11.93 9.64 783 311168 111116 52925999
Pulmonary hypertension 11.91 9.64 150 311801 37120 52999995
Status epilepticus 11.89 9.64 47 311904 15137 53021978
Panniculitis 11.89 9.64 17 311934 7797 53029318
Myelocyte count increased 11.83 9.64 13 311938 380 53036735
Blood bilirubin increased 11.82 9.64 283 311668 35447 53001668
Dyskinesia 11.78 9.64 124 311827 31709 53005406
Urine oxalate increased 11.75 9.64 10 311941 211 53036904
Injection site discolouration 11.74 9.64 15 311936 7215 53029900
Rhinitis allergic 11.73 9.64 17 311934 7756 53029359
Device related thrombosis 11.69 9.64 25 311926 1327 53035788
Weight decreased 11.68 9.64 1199 310752 233749 52803366
Hypomagnesaemia 11.64 9.64 91 311860 24720 53012395
Neuroleptic malignant syndrome 11.64 9.64 34 311917 11999 53025116
C-reactive protein abnormal 11.62 9.64 96 311855 25774 53011341
Anxiety 11.61 9.64 991 310960 195713 52841402
Nail bed inflammation 11.58 9.64 13 311938 389 53036726
Band neutrophil percentage increased 11.56 9.64 10 311941 216 53036899
Macular oedema 11.44 9.64 5 311946 4160 53032955
Peripheral sensory neuropathy 11.43 9.64 15 311936 7133 53029982
Pupillary light reflex tests abnormal 11.41 9.64 9 311942 170 53036945
Product residue present 11.40 9.64 5 311946 4151 53032964
Arrhythmia 11.39 9.64 149 311802 36630 53000485
Acute myocardial infarction 11.29 9.64 132 311819 33103 53004012
Ascites 11.22 9.64 164 311787 39571 52997544
Blindness 11.22 9.64 64 311887 18699 53018416
Accidental exposure to product by child 11.22 9.64 23 311928 1185 53035930
Gait inability 11.22 9.64 157 311794 38154 52998961
Corneal epithelium defect 11.22 9.64 12 311939 340 53036775
Partial seizures 11.20 9.64 9 311942 5371 53031744
Infective pulmonary exacerbation of cystic fibrosis 11.17 9.64 31 311920 11125 53025990
Schizoaffective disorder 11.17 9.64 33 311918 2144 53034971
Pharyngeal paraesthesia 11.16 9.64 25 311926 1370 53035745
Administration site reaction 11.15 9.64 10 311941 227 53036888
Ketoacidosis 11.11 9.64 6 311945 4420 53032695
Traumatic liver injury 11.11 9.64 11 311940 284 53036831
Vein collapse 11.01 9.64 16 311935 623 53036492
Mitral valve incompetence 11.00 9.64 68 311883 19483 53017632
Erysipelas 10.99 9.64 16 311935 7285 53029830
Atypical femur fracture 10.87 9.64 9 311942 5292 53031823
Hallucination, auditory 10.86 9.64 34 311917 11739 53025376
Administration site bruise 10.86 9.64 11 311940 292 53036823
Invasive ductal breast carcinoma 10.80 9.64 14 311937 6693 53030422
Diplopia 10.78 9.64 74 311877 20691 53016424
Congestive cardiomyopathy 10.75 9.64 12 311939 6126 53030989
Sensitivity to weather change 10.68 9.64 12 311939 6110 53031005
Obstructive airways disorder 10.67 9.64 59 311892 17370 53019745
Angina unstable 10.63 9.64 17 311934 7451 53029664
Procedural pain 10.63 9.64 47 311904 14670 53022445
Gout 10.61 9.64 37 311914 12362 53024753
Ventricular arrhythmia 10.60 9.64 46 311905 3614 53033501
PCO2 decreased 10.58 9.64 24 311927 1326 53035789
Haemarthrosis 10.57 9.64 3 311948 3267 53033848
Therapy non-responder 10.55 9.64 213 311738 48907 52988208
Magnesium deficiency 10.53 9.64 14 311937 501 53036614
Device leakage 10.52 9.64 12 311939 6068 53031047
Chemical poisoning 10.52 9.64 6 311945 64 53037051
Diffuse large B-cell lymphoma 10.49 9.64 14 311937 6611 53030504
Respiratory syncytial virus infection 10.48 9.64 60 311891 5268 53031847
Muscular weakness 10.47 9.64 483 311468 100509 52936606
Aplasia pure red cell 10.46 9.64 7 311944 4589 53032526
Epstein-Barr virus infection 10.45 9.64 17 311934 7401 53029714
Hemiparesis 10.43 9.64 78 311873 21397 53015718
Embedded device 10.42 9.64 3 311948 3238 53033877
Obesity 10.42 9.64 56 311895 16606 53020509
Thrombosis 10.42 9.64 273 311678 60520 52976595
Multiple-drug resistance 10.39 9.64 3 311948 3232 53033883
Balint's syndrome 10.38 9.64 3 311948 3 53037112
Urine bilirubin decreased 10.38 9.64 3 311948 3 53037112
Eating disorder 10.37 9.64 54 311897 16143 53020972
Cystic fibrosis 10.36 9.64 5 311946 3926 53033189
Osmolar gap abnormal 10.31 9.64 5 311946 37 53037078
Injury associated with device 10.29 9.64 3 311948 3212 53033903
Complication of device insertion 10.28 9.64 12 311939 6005 53031110
Dyspnoea 10.22 9.64 3168 308783 583064 52454051
Abnormal dreams 10.22 9.64 30 311921 10571 53026544
Autonomic dysreflexia 10.22 9.64 11 311940 314 53036801
Pericardial effusion 10.19 9.64 106 311845 27172 53009943
Vitamin D deficiency 10.18 9.64 37 311914 12211 53024904
Immunodeficiency 10.18 9.64 133 311818 14834 53022281
Bone density decreased 10.17 9.64 32 311919 11032 53026083
Eructation 10.16 9.64 19 311932 7836 53029279
Drug level below therapeutic 10.12 9.64 46 311905 3687 53033428
General physical health deterioration 10.11 9.64 731 311220 146211 52890904
Blood cholesterol increased 10.05 9.64 392 311559 52597 52984518
Infusion site oedema 10.03 9.64 14 311937 525 53036590
Complication of device removal 10.02 9.64 6 311945 4176 53032939
Swelling face 9.99 9.64 256 311695 56912 52980203
Hemiplegia 9.97 9.64 19 311932 7781 53029334
Product preparation error 9.94 9.64 7 311944 4468 53032647
Impaired gastric emptying 9.92 9.64 24 311927 9019 53028096
Activated partial thromboplastin time prolonged 9.90 9.64 73 311878 6986 53030129
Dysphonia 9.89 9.64 179 311772 41759 52995356
Eczema 9.86 9.64 92 311859 24090 53013025
Treatment noncompliance 9.81 9.64 135 311816 32900 53004215
Renal disorder 9.79 9.64 116 311835 29023 53008092
Decerebrate posture 9.75 9.64 7 311944 114 53037001
Electrocardiogram QT prolonged 9.74 9.64 253 311698 56150 52980965
Concomitant disease aggravated 9.74 9.64 23 311928 8715 53028400
Corneal reflex decreased 9.72 9.64 8 311943 161 53036954
Gastric infection 9.72 9.64 40 311911 3070 53034045
Skin burning sensation 9.70 9.64 35 311916 11575 53025540
Hypoxia 9.66 9.64 408 311543 55272 52981843

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 1230.98 10.25 1761 141380 90756 32279629
Toxicity to various agents 1108.26 10.25 2426 140715 175615 32194770
Infusion related reaction 401.27 10.25 720 142421 44879 32325506
Drug abuse 341.31 10.25 947 142194 79296 32291089
Overdose 314.11 10.25 969 142172 86108 32284277
Blood pressure fluctuation 302.34 10.25 407 142734 19728 32350657
Intentional product misuse 290.31 10.25 548 142593 35503 32334882
Acute hepatic failure 243.47 10.25 293 142848 12676 32357709
Intentional overdose 215.67 10.25 529 142612 41072 32329313
Drug ineffective 184.23 10.25 967 142174 382510 31987875
Respiratory arrest 150.21 10.25 368 142773 28540 32341845
Exposure to toxic agent 119.87 10.25 69 143072 1019 32369366
Heart rate decreased 118.60 10.25 309 142832 24891 32345494
Blood pressure increased 104.49 10.25 652 142489 78702 32291683
Anion gap 99.94 10.25 54 143087 700 32369685
Coagulopathy 94.12 10.25 242 142899 19335 32351050
Cardio-respiratory arrest 91.99 10.25 488 142653 55501 32314884
Oxygen saturation decreased 90.81 10.25 436 142705 47663 32322722
Hepatotoxicity 89.85 10.25 236 142905 19101 32351284
Metabolic acidosis 85.76 10.25 381 142760 40318 32330067
Myocardial infarction 85.61 10.25 276 142865 125400 32244985
Accidental overdose 78.86 10.25 225 142916 19114 32351271
Poisoning 75.75 10.25 158 142983 11000 32359385
Product dose omission issue 75.75 10.25 217 142924 102358 32268027
Psoriasis 68.77 10.25 61 143080 46062 32324323
Sinusitis 68.70 10.25 331 142810 36229 32334156
Exposure via ingestion 68.35 10.25 67 143074 2290 32368095
Drug resistance 68.00 10.25 10 143131 22955 32347430
Respiratory depression 67.35 10.25 167 142974 13044 32357341
Substance abuse 67.31 10.25 116 143025 6991 32363394
Methaemoglobinaemia 62.37 10.25 70 143071 2806 32367579
Hepatic necrosis 60.63 10.25 81 143060 3894 32366491
Treatment failure 60.57 10.25 50 143091 39113 32331272
Diarrhoea 60.48 10.25 1188 141953 363614 32006771
Heart rate irregular 54.71 10.25 161 142980 13917 32356468
Liver injury 53.78 10.25 160 142981 13914 32356471
Alanine aminotransferase increased 53.71 10.25 555 142586 77924 32292461
Cardiac failure 53.32 10.25 215 142926 91458 32278927
Serotonin syndrome 53.05 10.25 195 142946 18922 32351463
Hypotension 47.70 10.25 1267 141874 214843 32155542
Hepatic cytolysis 47.49 10.25 110 143031 8223 32362162
Cardiac arrest 47.04 10.25 641 142500 96135 32274250
Aspartate aminotransferase increased 46.98 10.25 473 142668 65956 32304429
Blood pressure diastolic abnormal 46.71 10.25 54 143087 2236 32368149
Blood pressure systolic increased 45.41 10.25 174 142967 17222 32353163
Chills 45.09 10.25 534 142607 77550 32292835
Depressed level of consciousness 44.32 10.25 320 142821 40527 32329858
Analgesic drug level increased 43.74 10.25 30 143111 611 32369774
Intentional product use issue 43.13 10.25 326 142815 41885 32328500
Anaemia 39.79 10.25 719 142422 222905 32147480
Suicide attempt 39.43 10.25 296 142845 37948 32332437
Product use in unapproved indication 38.78 10.25 225 142916 86979 32283406
Medication error 38.76 10.25 199 142942 22336 32348049
Infusion site extravasation 38.68 10.25 57 143084 3004 32367381
Heart rate increased 38.31 10.25 315 142826 41513 32328872
Contraindicated product administered 38.27 10.25 18 143123 19058 32351327
Blood pressure diastolic increased 37.20 10.25 61 143080 3529 32366856
Cardiac failure congestive 37.16 10.25 220 142921 84632 32285753
Drug interaction 36.49 10.25 709 142432 217476 32152909
Therapeutic product effect incomplete 35.46 10.25 81 143060 41260 32329125
Foetal exposure during pregnancy 35.37 10.25 81 143060 41220 32329165
Blood pressure systolic abnormal 35.06 10.25 45 143096 2079 32368306
Suspected suicide 33.49 10.25 53 143088 2975 32367410
Renal cortical necrosis 33.48 10.25 16 143125 157 32370228
Coronary artery disease 33.21 10.25 110 143031 49596 32320789
International normalised ratio increased 33.16 10.25 346 142795 48689 32321696
Body temperature decreased 32.82 10.25 115 143026 10899 32359486
Tachycardia 32.55 10.25 509 142632 78579 32291806
Stevens-Johnson syndrome 31.34 10.25 164 142977 18545 32351840
Nasopharyngitis 31.18 10.25 423 142718 63364 32307021
Neutrophil percentage increased 30.00 10.25 40 143101 1919 32368466
Anion gap abnormal 29.60 10.25 14 143127 134 32370251
Bone marrow failure 29.08 10.25 56 143085 30348 32340037
Blood pH decreased 28.85 10.25 43 143098 2290 32368095
Sopor 28.80 10.25 8 143133 11741 32358644
Infusion site pain 28.62 10.25 49 143092 2937 32367448
Product prescribing error 28.29 10.25 27 143114 19690 32350695
Blood pressure diastolic decreased 27.67 10.25 82 143059 7115 32363270
Coma 27.55 10.25 298 142843 42314 32328071
Unresponsive to stimuli 27.51 10.25 212 142929 27397 32342988
Diabetes mellitus 27.48 10.25 104 143037 45069 32325316
Infusion site pruritus 26.92 10.25 23 143118 656 32369729
Hypoxia 26.83 10.25 349 142792 51783 32318602
Neuropathy peripheral 26.58 10.25 214 142927 76768 32293617
Urine sodium decreased 26.15 10.25 14 143127 178 32370207
Therapeutic response shortened 25.48 10.25 61 143080 4659 32365726
Depression 24.96 10.25 290 142851 96770 32273615
Wrong technique in product usage process 24.53 10.25 76 143065 34983 32335402
Ear infection 24.13 10.25 87 143054 8361 32362024
Lymphocyte percentage decreased 23.80 10.25 38 143103 2149 32368236
Hepatic failure 23.75 10.25 251 142890 35429 32334956
Body temperature fluctuation 23.64 10.25 31 143110 1463 32368922
Accidental exposure to product by child 23.31 10.25 32 143109 1579 32368806
Toxic epidermal necrolysis 23.30 10.25 163 142978 20430 32349955
General physical health deterioration 22.91 10.25 363 142778 114896 32255489
Appendicolith 22.88 10.25 46 143095 3119 32367266
Renal impairment 22.80 10.25 277 142864 91695 32278690
Mydriasis 22.50 10.25 71 143070 6375 32364010
Acute lung injury 22.44 10.25 29 143112 1349 32369036
Psoriatic arthropathy 21.73 10.25 28 143113 17832 32352553
Pyrexia 21.59 10.25 1661 141480 318307 32052078
Respiratory rate increased 21.54 10.25 90 143051 9267 32361118
Ductus arteriosus premature closure 21.20 10.25 13 143128 217 32370168
Mental status changes 20.72 10.25 259 142882 38078 32332307
Angina pectoris 20.68 10.25 70 143071 31356 32339029
Glycosylated haemoglobin increased 20.54 10.25 10 143131 10379 32360006
Cerebral haemorrhage 20.49 10.25 81 143060 34666 32335719
Brain death 20.41 10.25 39 143102 2547 32367838
Poor venous access 20.32 10.25 43 143098 3023 32367362
Flushing 20.27 10.25 218 142923 30909 32339476
Balance disorder 20.22 10.25 97 143044 39362 32331023
Hepatocellular carcinoma 20.13 10.25 10 143131 10260 32360125
Infusion site swelling 20.01 10.25 32 143109 1812 32368573
Dizziness 20.01 10.25 738 142403 208880 32161505
Hospitalisation 19.86 10.25 130 143011 48841 32321544
Haemolysis 19.85 10.25 77 143064 7664 32362721
Agitation 19.74 10.25 358 142783 56878 32313507
Osteonecrosis 19.27 10.25 27 143114 16595 32353790
Immune reconstitution inflammatory syndrome 19.21 10.25 9 143132 9550 32360835
Progressive multifocal leukoencephalopathy 19.11 10.25 9 143132 9522 32360863
Body temperature increased 19.06 10.25 127 143014 15664 32354721
Graft versus host disease 19.05 10.25 12 143129 10794 32359591
Throat tightness 18.91 10.25 76 143065 7690 32362695
Urticaria 18.88 10.25 368 142773 59246 32311139
Hepatitis C 18.83 10.25 19 143122 13499 32356886
Blood triglycerides increased 18.75 10.25 22 143119 14597 32355788
Chronic gastrointestinal bleeding 18.57 10.25 13 143128 274 32370111
Cerebrovascular accident 18.47 10.25 268 142873 86052 32284333
Asthma 18.37 10.25 116 143025 43949 32326436
Prothrombin time prolonged 18.08 10.25 88 143053 9667 32360718
Venoocclusive liver disease 18.08 10.25 5 143136 7360 32363025
Infusion site erythema 17.79 10.25 30 143111 1776 32368609
Granulomatosis with polyangiitis 17.71 10.25 22 143119 983 32369402
Cytokine release syndrome 17.65 10.25 111 143030 13424 32356961
Asthenia 17.23 10.25 856 142285 235088 32135297
Environmental exposure 17.22 10.25 12 143129 251 32370134
Disease progression 17.11 10.25 274 142867 86588 32283797
Injection site pain 17.09 10.25 81 143060 32977 32337408
Feeling abnormal 16.93 10.25 177 142964 60246 32310139
Plasma cell myeloma 16.88 10.25 167 142974 57447 32312938
Therapeutic response decreased 16.87 10.25 58 143083 25862 32344523
Renal papillary necrosis 16.78 10.25 10 143131 158 32370227
Acidosis 16.75 10.25 93 143048 10753 32359632
Transaminases increased 16.62 10.25 176 142965 24852 32345533
Cytomegalovirus infection 16.56 10.25 57 143084 25407 32344978
Apparent life threatening event 16.38 10.25 11 143130 216 32370169
Haematotoxicity 15.90 10.25 5 143136 6771 32363614
Erythema multiforme 15.87 10.25 80 143061 8912 32361473
Peritonitis bacterial 15.82 10.25 19 143122 12477 32357908
Mycoplasma test positive 15.81 10.25 9 143132 130 32370255
Oedema peripheral 15.77 10.25 382 142759 113709 32256676
Oxygen saturation abnormal 15.74 10.25 23 143118 1203 32369182
Fatigue 15.72 10.25 1330 141811 349371 32021014
Pyroglutamic acidosis 15.70 10.25 10 143131 179 32370206
Leukopenia 15.70 10.25 179 142962 59943 32310442
Acute myocardial infarction 15.68 10.25 161 142980 54988 32315397
Electrocardiogram QRS complex prolonged 15.61 10.25 50 143091 4524 32365861
Myelosuppression 15.60 10.25 17 143124 11659 32358726
Epilepsy 15.41 10.25 48 143093 22061 32348324
Febrile neutropenia 15.29 10.25 658 142483 118908 32251477
Pemphigus 15.28 10.25 24 143117 1338 32369047
Cerebral infarction 15.27 10.25 66 143075 27548 32342837
Administration site pain 15.09 10.25 10 143131 192 32370193
Upper respiratory tract infection 15.03 10.25 197 142944 29276 32341109
Bilirubin urine present 15.01 10.25 9 143132 144 32370241
Pathogen resistance 14.88 10.25 12 143129 9498 32360887
Myopathy 14.62 10.25 17 143124 11324 32359061
Dissociative disorder 14.56 10.25 10 143131 204 32370181
Throat irritation 14.55 10.25 83 143058 9695 32360690
Osteonecrosis of jaw 14.53 10.25 40 143101 19126 32351259
Abdominal pain 14.53 10.25 801 142340 148728 32221657
Mucosal inflammation 14.46 10.25 87 143054 33347 32337038
Anti-erythrocyte antibody positive 14.41 10.25 6 143135 41 32370344
Post transplant lymphoproliferative disorder 14.25 10.25 4 143137 5830 32364555
Haematocrit decreased 13.87 10.25 206 142935 31456 32338929
Memory impairment 13.75 10.25 113 143028 40366 32330019
Prescribed overdose 13.69 10.25 13 143128 9506 32360879
Prostate cancer 13.67 10.25 68 143073 27338 32343047
Ureteric obstruction 13.63 10.25 22 143119 1256 32369129
Administration site erythema 13.57 10.25 7 143134 82 32370303
Maple syrup disease 13.36 10.25 4 143137 8 32370377
Burn of internal organs 13.29 10.25 3 143138 0 32370385
Drug screen positive 13.26 10.25 45 143096 4196 32366189
Hypoaesthesia 13.25 10.25 179 142962 58174 32312211
Hangover 13.22 10.25 20 143121 1079 32369306
Fluid retention 13.17 10.25 66 143075 26484 32343901
Injection site haemorrhage 13.04 10.25 11 143130 8517 32361868
Renal injury 12.81 10.25 94 143047 11961 32358424
Visual acuity reduced 12.71 10.25 34 143107 16411 32353974
Acid-base balance disorder mixed 12.63 10.25 6 143135 58 32370327
Endocardial fibrosis 12.55 10.25 5 143136 30 32370355
Myalgia 12.33 10.25 268 142873 80962 32289423
Delirium 12.33 10.25 267 142874 43779 32326606
Crystal urine present 12.29 10.25 12 143129 408 32369977
Therapeutic product effect decreased 12.24 10.25 83 143058 30934 32339451
Anion gap increased 12.22 10.25 25 143116 1716 32368669
Pancytopenia 12.18 10.25 307 142834 90928 32279457
Product substitution issue 12.05 10.25 17 143124 10419 32359966
Infusion site bruising 12.00 10.25 11 143130 345 32370040
Prostatic specific antigen increased 12.00 10.25 25 143116 13162 32357223
Sudden infant death syndrome 11.92 10.25 8 143133 157 32370228
Death 11.91 10.25 1887 141254 380630 31989755
Aplastic anaemia 11.91 10.25 64 143077 7309 32363076
Erectile dysfunction 11.85 10.25 46 143095 19793 32350592
Pneumonia aspiration 11.69 10.25 250 142891 40906 32329479
Bacterial test 11.45 10.25 8 143133 168 32370217
Inadequate analgesia 11.37 10.25 33 143108 2830 32367555
Tendonitis 11.36 10.25 13 143128 8722 32361663
Labelled drug-drug interaction issue 11.35 10.25 7 143134 118 32370267
Drug ineffective for unapproved indication 11.34 10.25 28 143113 13884 32356501
Hypertriglyceridaemia 11.31 10.25 13 143128 8706 32361679
C-reactive protein abnormal 11.28 10.25 7 143134 6349 32364036
Polyneuropathy 11.24 10.25 26 143115 13189 32357196
Bronchial dysplasia 11.23 10.25 5 143136 41 32370344
Cerebral artery thrombosis 11.18 10.25 14 143127 631 32369754
Urobilinogen urine increased 11.15 10.25 11 143130 379 32370006
Diabetic ketoacidosis 11.09 10.25 41 143100 17891 32352494
Tooth infection 11.08 10.25 53 143088 5781 32364604
Brain oedema 11.01 10.25 96 143045 12864 32357521
Monocyte percentage increased 10.98 10.25 17 143124 936 32369449
Brain scan abnormal 10.94 10.25 15 143126 739 32369646
Administration site swelling 10.90 10.25 8 143133 182 32370203
Infusion site nodule 10.83 10.25 6 143135 82 32370303
Hyperchloraemia 10.81 10.25 12 143129 475 32369910
Leukocytosis 10.80 10.25 154 142987 23313 32347072
Ultrasound liver abnormal 10.76 10.25 7 143134 130 32370255
Vessel puncture site bruise 10.74 10.25 5 143136 46 32370339
Pupillary light reflex tests abnormal 10.72 10.25 7 143134 131 32370254
Red blood cell elliptocytes present 10.64 10.25 6 143135 85 32370300
Bladder cancer 10.60 10.25 18 143123 10238 32360147
Interstitial lung disease 10.59 10.25 212 142929 64789 32305596
Liver transplant 10.58 10.25 32 143109 2808 32367577
Wrong product administered 10.57 10.25 47 143094 4973 32365412
Analgesic drug level above therapeutic 10.56 10.25 9 143132 256 32370129
Blood ethanol increased 10.55 10.25 11 143130 405 32369980
Gynaecomastia 10.55 10.25 14 143127 8805 32361580
Loss of personal independence in daily activities 10.49 10.25 72 143069 26761 32343624
Gait inability 10.43 10.25 49 143092 19998 32350387
Hallucinations, mixed 10.41 10.25 31 143110 2696 32367689
Cardiac disorder 10.40 10.25 126 143015 41740 32328645
Intraocular pressure increased 10.37 10.25 6 143135 5652 32364733
Sputum culture positive 10.36 10.25 25 143116 1919 32368466

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 cough suppressant
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

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

External reference:

IDSource
4020116 VUID
N0000179729 NUI
D00848 KEGG_DRUG
18609-21-7 SECONDARY_CAS_RN
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
102490 RXNORM
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 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
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8759 SOLUTION 20 mg ORAL OTC monograph final 15 sections