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

Stem definitionDrug idCAS RN
1336 93-14-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • guaifenesin
  • glycerin guaiacolate
  • glycerol guaiacolate
  • guaifenesine
  • guaiphenesin
  • guaiphenesine
  • myocain
  • myocaine
  • myoscain
An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • Molecular weight: 198.22
  • Formula: C10H14O4
  • CLOGP: 0.10
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 58.92
  • ALOGS: -1.12
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.90 g O
0.90 g P

ADMET properties:

PropertyValueReference
S (Water solubility) 40.40 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 12, 2002 FDA RECKITT BENCKISER

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
Irritable bowel syndrome 492.20 9.88 1094 272788 81318 63133822
Sinusitis 490.78 9.88 2107 271775 224546 62990594
Muscle injury 483.26 9.88 947 272935 64398 63150742
Folliculitis 478.14 9.88 984 272898 69333 63145807
Lower respiratory tract infection 456.45 9.88 1431 272451 130876 63084264
Drug interaction 451.16 9.88 212 273670 228919 62986221
Nasopharyngitis 416.43 9.88 2180 271702 252077 62963063
Peripheral swelling 387.61 9.88 2209 271673 263733 62951407
Ill-defined disorder 342.71 9.88 948 272934 80807 63134333
Toxicity to various agents 332.03 9.88 346 273536 246904 62968236
Sleep disorder due to general medical condition, insomnia type 330.79 9.88 710 273172 51507 63163633
Impaired healing 319.10 9.88 1071 272811 101471 63113669
Gastrointestinal disorder 309.45 9.88 1253 272629 129986 63085154
Pruritus 278.89 9.88 2577 271305 358876 62856264
Ear pain 278.60 9.88 533 273349 35585 63179555
Body temperature increased 271.23 9.88 536 273346 36656 63178484
Weight increased 268.50 9.88 1985 271897 258807 62956333
Stomatitis 266.25 9.88 1245 272637 137480 63077660
Completed suicide 263.95 9.88 150 273732 145523 63069617
Blister 260.95 9.88 1181 272701 128633 63086507
Muscle spasticity 243.52 9.88 379 273503 21415 63193725
Acute kidney injury 209.74 9.88 521 273361 262894 62952246
Night sweats 199.51 9.88 561 273321 48253 63166887
Respiratory disorder 177.55 9.88 467 273415 38615 63176525
Blood pressure fluctuation 170.71 9.88 513 273369 45804 63169336
Infusion related reaction 170.52 9.88 1713 272169 243808 62971332
Joint swelling 157.44 9.88 2129 271753 325537 62889603
Back pain 157.34 9.88 1787 272095 262358 62952782
Blood pressure diastolic abnormal 155.69 9.88 248 273634 14294 63200846
Fatigue 155.54 9.88 4964 268918 883064 62332076
Contusion 154.69 9.88 1143 272739 148901 63066239
Infection 142.62 9.88 1564 272318 227609 62987531
Rheumatoid arthritis 141.29 9.88 1695 272187 252124 62963016
Blood pressure increased 140.38 9.88 1186 272696 160876 63054264
Insomnia 136.70 9.88 1475 272407 213777 63001363
Blood pressure systolic increased 133.38 9.88 479 273403 46918 63168222
Blood pressure systolic abnormal 130.73 9.88 219 273663 13167 63201973
Urticaria 129.43 9.88 1186 272696 164616 63050524
Pain 115.30 9.88 4085 269797 736543 62478597
Bursitis 115.21 9.88 387 273495 36654 63178486
Neutropenia 112.29 9.88 383 273499 174622 63040518
Headache 112.06 9.88 3546 270336 629695 62585445
Heart rate increased 111.19 9.88 742 273140 93496 63121644
Cardiac failure 110.45 9.88 133 273749 89009 63126131
Anaemia 109.56 9.88 778 273104 292652 62922488
Hyponatraemia 107.53 9.88 199 273683 111701 63103439
Temperature regulation disorder 106.66 9.88 132 273750 6000 63209140
Therapeutic product effect decreased 106.50 9.88 1288 272594 191899 63023241
Arthralgia 104.36 9.88 3204 270678 566506 62648634
Electrocardiogram QT prolonged 101.20 9.88 66 273816 59464 63155676
General physical health deterioration 95.60 9.88 495 273387 200907 63014233
Hypersensitivity 94.76 9.88 1781 272101 290904 62924236
Thrombocytopenia 94.14 9.88 335 273547 150822 63064318
Device expulsion 92.34 9.88 19 273863 34903 63180237
Food allergy 91.30 9.88 171 273711 11230 63203910
Lactic acidosis 91.13 9.88 26 273856 38261 63176879
Rhabdomyolysis 87.40 9.88 40 273842 43911 63171229
Pancytopenia 86.54 9.88 180 273702 96753 63118387
Hepatocellular injury 85.97 9.88 9 273873 27372 63187768
Sopor 82.24 9.88 3 273879 22161 63192979
Dyspnoea 82.12 9.88 3560 270322 657753 62557387
Confusional state 79.81 9.88 1448 272434 234932 62980208
Oxygen saturation decreased 78.61 9.88 652 273230 87933 63127207
Leukopenia 77.34 9.88 134 273748 77156 63137984
Drug reaction with eosinophilia and systemic symptoms 76.88 9.88 25 273857 33811 63181329
Drug resistance 76.13 9.88 6 273876 22927 63192213
Asthenia 74.83 9.88 2175 271707 381429 62833711
Seizure 74.16 9.88 307 273575 132327 63082813
Cholestasis 73.83 9.88 18 273864 29416 63185724
Coma 73.57 9.88 102 273780 64262 63150878
Cardiac arrest 73.56 9.88 183 273699 92362 63122778
Toxic epidermal necrolysis 73.05 9.88 11 273871 25323 63189817
Agranulocytosis 72.27 9.88 11 273871 25123 63190017
Drug abuse 71.41 9.88 127 273755 72391 63142749
Oropharyngeal pain 69.22 9.88 667 273215 93820 63121320
Hypotension 69.21 9.88 797 273085 271807 62943333
Hyperkalaemia 69.14 9.88 79 273803 54124 63161016
Sleep disorder 69.01 9.88 594 273288 80972 63134168
Maternal exposure during pregnancy 68.85 9.88 612 273270 219450 62995690
Exposure during pregnancy 68.44 9.88 392 273490 155155 63059985
Depressed level of consciousness 68.36 9.88 101 273781 61977 63153163
Multiple organ dysfunction syndrome 67.85 9.88 87 273795 56665 63158475
Epilepsy 67.02 9.88 17 273865 27048 63188092
Myelosuppression 66.74 9.88 11 273871 23692 63191448
Angioedema 66.69 9.88 65 273817 47900 63167240
Bone marrow failure 65.92 9.88 22 273860 29268 63185872
C-reactive protein increased 65.77 9.88 200 273682 94507 63120633
Hypoglycaemia 63.95 9.88 100 273782 59965 63155175
Osteonecrosis of jaw 63.80 9.88 36 273846 35087 63180053
Pleural fibrosis 62.42 9.88 76 273806 3396 63211744
Bronchial secretion retention 62.14 9.88 68 273814 2705 63212435
Presbyacusis 62.03 9.88 69 273813 2796 63212344
Hepatic function abnormal 62.02 9.88 42 273840 37100 63178040
Blood pressure diastolic increased 60.94 9.88 134 273748 9876 63205264
Mucosal inflammation 60.29 9.88 68 273814 46860 63168280
Pleural thickening 58.27 9.88 67 273815 2816 63212324
Metabolic acidosis 58.24 9.88 65 273817 45004 63170136
Cardio-respiratory arrest 58.14 9.88 106 273776 59853 63155287
Orthostatic hypotension 57.60 9.88 43 273839 36117 63179023
Helicobacter infection 57.50 9.88 633 273249 92152 63122988
Drug-induced liver injury 56.51 9.88 54 273828 40168 63174972
Blood magnesium increased 55.43 9.88 67 273815 2971 63212169
Coeliac disease 54.16 9.88 149 273733 12648 63202492
Circulatory collapse 53.90 9.88 14 273868 21924 63193216
Condition aggravated 53.66 9.88 1323 272559 400894 62814246
Septic shock 53.54 9.88 131 273751 66498 63148642
Hypocalcaemia 52.76 9.88 36 273846 31677 63183463
Serotonin syndrome 52.67 9.88 29 273853 28653 63186487
Malignant neoplasm progression 52.44 9.88 180 273702 81941 63133199
Cytomegalovirus infection 52.19 9.88 13 273869 20939 63194201
Illness 51.78 9.88 376 273506 48683 63166457
Duodenal ulcer perforation 51.33 9.88 589 273293 86620 63128520
Hypokalaemia 50.99 9.88 252 273630 103552 63111588
Altered state of consciousness 50.10 9.88 23 273859 25207 63189933
Suicide attempt 49.55 9.88 119 273763 60799 63154341
Cough 48.58 9.88 1628 272254 291115 62924025
Chest discomfort 48.39 9.88 704 273178 109265 63105875
Renal failure 47.80 9.88 304 273578 117348 63097792
Gamma-glutamyltransferase increased 47.44 9.88 46 273836 33985 63181155
Abdominal pain upper 47.41 9.88 1196 272686 205248 63009892
Swelling 46.86 9.88 1536 272346 273842 62941298
Scoliosis 46.23 9.88 104 273778 7784 63207356
Intentional self-injury 45.70 9.88 27 273855 25660 63189480
Pyrexia 45.42 9.88 2472 271410 468006 62747134
Drug ineffective 45.15 9.88 3889 269993 1040876 62174264
Blood pressure diastolic decreased 45.12 9.88 206 273676 22500 63192640
Sedation 44.85 9.88 61 273821 38748 63176392
Rash maculo-papular 44.60 9.88 43 273839 31853 63183287
Urine abnormality 43.91 9.88 95 273787 6924 63208216
Bacterial disease carrier 43.39 9.88 40 273842 1291 63213849
Abortion spontaneous 42.65 9.88 87 273795 47108 63168032
Throat irritation 42.33 9.88 293 273589 37354 63177786
Immunodeficiency 41.93 9.88 186 273696 20068 63195072
Deafness neurosensory 41.62 9.88 75 273807 4780 63210360
Sinus disorder 41.05 9.88 212 273670 24341 63190799
Skin necrosis 40.35 9.88 6 273876 13944 63201196
Pancreatitis acute 39.91 9.88 35 273847 27131 63188009
Febrile neutropenia 39.89 9.88 323 273559 118126 63097014
Generalised tonic-clonic seizure 39.55 9.88 40 273842 28976 63186164
Epigastric discomfort 39.30 9.88 89 273793 6691 63208449
Injection site pain 39.24 9.88 364 273518 129436 63085704
Rash 39.24 9.88 2866 271016 558005 62657135
Syncope 39.12 9.88 321 273561 117064 63098076
Lip dry 39.05 9.88 151 273731 15319 63199821
Neovascularisation 38.48 9.88 35 273847 1110 63214030
Flushing 38.46 9.88 494 273388 74593 63140547
Foetal exposure during pregnancy 38.20 9.88 49 273833 31913 63183227
Influenza 38.04 9.88 670 273212 108052 63107088
Osteonecrosis 38.01 9.88 30 273852 24500 63190640
Panniculitis 37.73 9.88 3 273879 11382 63203758
Heart rate decreased 37.59 9.88 330 273552 45230 63169910
Asthma 37.39 9.88 765 273117 126796 63088344
Myoclonus 37.35 9.88 11 273871 15857 63199283
Poisoning deliberate 37.05 9.88 3 273879 11215 63203925
Melaena 36.87 9.88 46 273836 30319 63184821
Rhinorrhoea 36.85 9.88 439 273443 65138 63150002
Rheumatoid factor positive 36.42 9.88 214 273668 84192 63130948
Alanine aminotransferase increased 36.32 9.88 280 273602 103490 63111650
Sedation complication 35.56 9.88 8 273874 13814 63201326
Dyskinesia 35.29 9.88 52 273830 31950 63183190
Bradycardia 35.25 9.88 179 273703 73048 63142092
Upper respiratory tract infection 34.81 9.88 522 273360 81525 63133615
Renal impairment 34.51 9.88 231 273651 88124 63127016
Lymphopenia 34.43 9.88 18 273864 18309 63196831
Urine leukocyte esterase positive 34.21 9.88 58 273824 3521 63211619
Hepatotoxicity 33.71 9.88 68 273814 36973 63178167
Bone cyst 33.67 9.88 45 273837 2209 63212931
Nasal congestion 33.64 9.88 432 273450 65228 63149912
Aspartate aminotransferase increased 33.30 9.88 240 273642 90037 63125103
Peptic ulcer haemorrhage 32.71 9.88 31 273851 1037 63214103
Lower limb fracture 32.43 9.88 197 273685 24024 63191116
Injection site erythema 32.21 9.88 218 273664 82956 63132184
Creatinine renal clearance decreased 32.17 9.88 15 273867 16293 63198847
Torsade de pointes 31.89 9.88 9 273873 13342 63201798
Overdose 31.73 9.88 330 273552 114748 63100392
Anxiety 31.65 9.88 1192 272690 216349 62998791
Osteoarthritis 31.05 9.88 581 273301 94762 63120378
Hypothermia 30.91 9.88 10 273872 13571 63201569
Weight fluctuation 30.89 9.88 103 273779 9716 63205424
Accidental exposure to product 30.74 9.88 44 273838 27361 63187779
Labelled drug-drug interaction medication error 30.26 9.88 10 273872 13389 63201751
Premature baby 30.11 9.88 27 273855 20708 63194432
Nephropathy toxic 30.06 9.88 3 273879 9476 63205664
Interstitial lung disease 29.99 9.88 151 273731 61757 63153383
Product tampering 29.93 9.88 20 273862 398 63214742
Premature delivery 29.83 9.88 53 273829 30228 63184912
Disorientation 29.81 9.88 80 273802 39372 63175768
Facet joint syndrome 29.44 9.88 117 273765 12021 63203119
Inappropriate antidiuretic hormone secretion 29.32 9.88 15 273867 15447 63199693
Shock haemorrhagic 29.22 9.88 4 273878 9891 63205249
Wrong technique in product usage process 29.10 9.88 154 273728 62186 63152954
Red blood cells urine positive 29.01 9.88 50 273832 3076 63212064
COVID-19 28.89 9.88 665 273217 112438 63102702
Agitation 28.80 9.88 146 273736 59611 63155529
Chills 28.77 9.88 666 273216 112712 63102428
Product prescribing error 28.72 9.88 43 273839 26246 63188894
Drug eruption 28.47 9.88 50 273832 28644 63186496
Transplant rejection 28.22 9.88 6 273876 10774 63204366
Poisoning 27.97 9.88 12 273870 13688 63201452
Osteopenia 27.82 9.88 163 273719 19622 63195518
Fluid retention 27.80 9.88 386 273496 59300 63155840
Systemic lupus erythematosus 27.58 9.88 688 273194 208230 63006910
Drug tolerance decreased 27.54 9.88 21 273861 17452 63197688
Sinus operation 27.54 9.88 44 273838 2542 63212598
Intentional overdose 27.41 9.88 197 273685 73955 63141185
Colitis microscopic 27.05 9.88 4 273878 9335 63205805
Parkinsonism 26.94 9.88 6 273876 10433 63204707
Ejection fraction decreased 26.93 9.88 34 273848 22298 63192842
Neutropenic sepsis 26.89 9.88 19 273863 16419 63198721
Peripheral venous disease 26.83 9.88 135 273747 15342 63199798
Blood creatine phosphokinase increased 26.73 9.88 57 273825 30373 63184767
Therapeutic response decreased 26.53 9.88 156 273726 61369 63153771
Haemodynamic instability 26.47 9.88 4 273878 9186 63205954
Pemphigus 26.47 9.88 597 273285 183129 63032011
Deep vein thrombosis postoperative 26.31 9.88 108 273774 11261 63203879
Stevens-Johnson syndrome 26.12 9.88 42 273840 24908 63190232
Haematoma 26.02 9.88 71 273811 34749 63180391
Posterior reversible encephalopathy syndrome 25.90 9.88 22 273860 17323 63197817
Product substitution issue 25.50 9.88 19 273863 15977 63199163
Thrombotic microangiopathy 25.45 9.88 7 273875 10554 63204586
Psychotic disorder 25.33 9.88 45 273837 25667 63189473
Rheumatoid nodule 25.32 9.88 22 273860 17133 63198007
Respiratory depression 24.99 9.88 14 273868 13701 63201439
Macular degeneration 24.62 9.88 42 273840 24334 63190806
Superinfection 24.59 9.88 42 273840 2565 63212575
Device dislocation 24.42 9.88 46 273836 25659 63189481
Lupus vasculitis 24.41 9.88 20 273862 549 63214591
Status epilepticus 24.41 9.88 18 273864 15215 63199925
Productive cough 24.09 9.88 395 273487 62813 63152327
Sinus congestion 24.01 9.88 147 273735 17976 63197164
Constipation 23.87 9.88 1193 272689 223750 62991390
Injection site reaction 23.87 9.88 151 273731 58373 63156767
Cestode infection 23.66 9.88 15 273867 272 63214868
Granuloma skin 23.57 9.88 4 273878 8433 63206707
Pneumocystis jirovecii pneumonia 23.42 9.88 23 273859 16891 63198249
Jaundice 23.11 9.88 58 273824 29193 63185947
Spinal meningioma benign 23.05 9.88 11 273871 110 63215030
Alopecia 22.94 9.88 1206 272676 336330 62878810
Haematemesis 22.73 9.88 62 273820 30350 63184790
Hyperglycaemia 22.71 9.88 98 273784 41769 63173371
Adulterated product 22.56 9.88 14 273868 244 63214896
Suicidal ideation 22.51 9.88 167 273715 62254 63152886
Neurotoxicity 22.50 9.88 24 273858 16966 63198174
Hypercalcaemia 22.50 9.88 56 273826 28266 63186874
Acute respiratory distress syndrome 22.46 9.88 42 273840 23492 63191648
Polyneuropathy 22.41 9.88 18 273864 14571 63200569
Hepatic enzyme increased 22.29 9.88 1077 272805 201251 63013889
Haemophagocytic lymphohistiocytosis 22.19 9.88 9 273873 10618 63204522
Disease progression 22.18 9.88 384 273498 122374 63092766
Akathisia 22.16 9.88 6 273876 9140 63206000
Treatment failure 22.00 9.88 672 273210 198371 63016769
Oliguria 21.99 9.88 6 273876 9095 63206045
Cerebral haemorrhage 21.97 9.88 64 273818 30665 63184475
Ear pruritus 21.82 9.88 51 273831 3914 63211226
Seasonal allergy 21.78 9.88 160 273722 20790 63194350
Cyst 21.70 9.88 119 273763 13980 63201160
Magnesium deficiency 21.69 9.88 19 273863 573 63214567
Cerebral infarction 21.62 9.88 44 273838 23849 63191291
Feeling hot 21.60 9.88 321 273561 50033 63165107
Schizophrenia 21.49 9.88 8 273874 9944 63205196
Tubulointerstitial nephritis 21.31 9.88 33 273849 19870 63195270
Diabetic ketoacidosis 21.01 9.88 35 273847 20470 63194670
Pain in extremity 20.96 9.88 1681 272201 329805 62885335
Hepatic failure 20.88 9.88 81 273801 35575 63179565
Acute generalised exanthematous pustulosis 20.70 9.88 11 273871 11088 63204052
Mydriasis 20.66 9.88 13 273869 11943 63203197
Red cell distribution width increased 20.55 9.88 95 273787 10429 63204711
Breast cancer female 20.49 9.88 17 273865 13542 63201598
Bronchopulmonary aspergillosis 20.30 9.88 6 273876 8629 63206511
Infusion site extravasation 20.27 9.88 94 273788 10332 63204808
Disseminated intravascular coagulation 20.01 9.88 32 273850 19019 63196121
White blood cells urine positive 19.82 9.88 58 273824 5100 63210040
Cognitive disorder 19.81 9.88 150 273732 55665 63159475
Peritonitis 19.78 9.88 27 273855 17127 63198013
Jaundice cholestatic 19.33 9.88 4 273878 7320 63207820
Injection site swelling 19.27 9.88 123 273759 47449 63167691
Drug withdrawal syndrome 19.18 9.88 57 273825 27137 63188003
Dry mouth 19.02 9.88 455 273427 77408 63137732
Glossodynia 18.78 9.88 608 273274 178268 63036872
Ventricular tachycardia 18.76 9.88 36 273846 19943 63195197
Hepatitis 18.73 9.88 98 273784 39690 63175450
Aplastic anaemia 18.57 9.88 9 273873 9560 63205580
Sudden death 18.56 9.88 11 273871 10438 63204702
Face oedema 18.48 9.88 37 273845 20175 63194965
Neuroleptic malignant syndrome 18.36 9.88 15 273867 12041 63203099
SARS-CoV-2 test positive 18.22 9.88 76 273806 7980 63207160
Foetal growth restriction 18.21 9.88 5 273877 7548 63207592
Left ventricular dysfunction 18.15 9.88 15 273867 11973 63203167
Dermatitis bullous 18.11 9.88 7 273875 8501 63206639
Diarrhoea 17.87 9.88 3422 270460 711944 62503196
Claustrophobia 17.84 9.88 22 273860 996 63214144
Off label use 17.83 9.88 2595 271287 671867 62543273
Dystonia 17.77 9.88 20 273862 13799 63201341
Autoimmune disorder 17.75 9.88 131 273751 17046 63198094
Ascites 17.70 9.88 103 273779 40625 63174515
Hypomagnesaemia 17.66 9.88 64 273818 28673 63186467
Miosis 17.48 9.88 5 273877 7348 63207792
Genital haemorrhage 17.41 9.88 5 273877 7327 63207813
Vein collapse 17.40 9.88 22 273860 1022 63214118
Abnormal behaviour 17.31 9.88 42 273840 21384 63193756
Rib fracture 17.27 9.88 161 273721 22436 63192704
Blood bilirubin increased 17.19 9.88 92 273790 37048 63178092
Ischaemic stroke 17.18 9.88 32 273850 17925 63197215
Hallucination, auditory 17.11 9.88 18 273864 12806 63202334
Rash erythematous 17.08 9.88 268 273614 42242 63172898
Infusion site pain 17.06 9.88 128 273754 16741 63198399
Femur fracture 16.89 9.88 108 273774 41648 63173492
Proteinuria 16.70 9.88 36 273846 19109 63196031
Aspergillus infection 16.67 9.88 7 273875 8086 63207054
Sneezing 16.64 9.88 135 273747 18083 63197057
Femoral neck fracture 16.57 9.88 8 273874 8515 63206625
Epstein-Barr virus infection 16.52 9.88 7 273875 8043 63207097
Vital capacity decreased 16.51 9.88 28 273854 1700 63213440
Large intestine perforation 16.43 9.88 8 273874 8474 63206666
Urinary sediment present 16.36 9.88 32 273850 2171 63212969
Cardiogenic shock 16.25 9.88 33 273849 17899 63197241
Respiratory tract congestion 16.21 9.88 132 273750 17700 63197440
Blood calcium decreased 16.20 9.88 59 273823 26392 63188748
Therapeutic response shortened 16.11 9.88 97 273785 11791 63203349
Muscle spasms 16.11 9.88 826 273056 155324 63059816
Transaminases increased 16.06 9.88 75 273807 31292 63183848
Sputum discoloured 15.95 9.88 123 273759 16224 63198916
Pathogen resistance 15.88 9.88 4 273878 6394 63208746
Weight decreased 15.79 9.88 1393 272489 275405 62939735
Drug level increased 15.78 9.88 48 273834 22688 63192452
Oligohydramnios 15.76 9.88 4 273878 6362 63208778
Arteriovenous fistula occlusion 15.59 9.88 13 273869 366 63214774
Chronic obstructive pulmonary disease 15.51 9.88 367 273515 62319 63152821
Sputum culture positive 15.51 9.88 31 273851 2136 63213004
Muscle rigidity 15.51 9.88 16 273866 11484 63203656
Stress cardiomyopathy 15.36 9.88 11 273871 9439 63205701
Graft versus host disease 15.36 9.88 5 273877 6758 63208382
Osteosclerosis 15.21 9.88 44 273838 3844 63211296
Menstruation delayed 15.19 9.88 27 273855 1702 63213438
Injection site pruritus 15.19 9.88 123 273759 44993 63170147
Purpura 15.17 9.88 16 273866 11369 63203771
Haemodialysis 15.09 9.88 10 273872 8937 63206203
Product use issue 14.94 9.88 788 273094 219732 62995408
Hypothyroidism 14.92 9.88 115 273767 42517 63172623
Type 2 diabetes mellitus 14.92 9.88 190 273692 63678 63151462
Pulmonary embolism 14.91 9.88 386 273496 116298 63098842
Concussion 14.89 9.88 79 273803 9165 63205975
Exposure to toxic agent 14.85 9.88 3 273879 5584 63209556
Sputum culture 14.72 9.88 11 273871 263 63214877
Injection site warmth 14.60 9.88 27 273855 15168 63199972
Swollen tongue 14.60 9.88 89 273793 34711 63180429
Eye infection viral 14.55 9.88 9 273873 156 63214984
Dry eye 14.54 9.88 252 273630 40509 63174631
Specific gravity urine increased 14.50 9.88 10 273872 210 63214930
Libido increased 14.48 9.88 23 273859 1322 63213818
Migraine 14.46 9.88 564 273318 102782 63112358
Bradyphrenia 14.43 9.88 6 273876 6974 63208166
Ventricular fibrillation 14.38 9.88 18 273864 11849 63203291
Body temperature fluctuation 14.38 9.88 31 273851 2254 63212886
Acute myeloid leukaemia 14.34 9.88 33 273849 17114 63198026
Enteritis 14.33 9.88 9 273873 8277 63206863
Corneal epithelium defect 14.33 9.88 12 273870 340 63214800
Urogenital prolapse 14.29 9.88 5 273877 20 63215120
Lip pruritus 14.29 9.88 19 273863 928 63214212
Cardiovascular disorder 14.23 9.88 18 273864 11794 63203346
Myelodysplastic syndrome 14.21 9.88 32 273850 16722 63198418
Skin ulcer 14.20 9.88 118 273764 42927 63172213
Hyperthyroidism 14.17 9.88 26 273856 14647 63200493
Enthesopathy 14.03 9.88 10 273872 8604 63206536
Reversible airways obstruction 13.97 9.88 27 273855 1815 63213325
Hallucination, visual 13.93 9.88 40 273842 19258 63195882
Bacterial test 13.93 9.88 21 273861 1153 63213987
Injection site haematoma 13.92 9.88 6 273876 6826 63208314
Tooth disorder 13.89 9.88 184 273698 27973 63187167
Infusion site erythema 13.78 9.88 92 273790 11587 63203553
International normalised ratio increased 13.67 9.88 131 273751 46294 63168846
Metastases to liver 13.65 9.88 54 273828 23585 63191555
Stillbirth 13.64 9.88 6 273876 6744 63208396
Cushingoid 13.63 9.88 10 273872 8475 63206665
Soft tissue injury 13.50 9.88 25 273857 1627 63213513
Loss of consciousness 13.49 9.88 397 273485 117724 63097416
Pyelonephritis 13.47 9.88 36 273846 17742 63197398
Lichen sclerosus 13.39 9.88 20 273862 1089 63214051
Premenstrual syndrome 13.35 9.88 16 273866 703 63214437
Shock 13.29 9.88 54 273828 23409 63191731
Second primary malignancy 13.27 9.88 9 273873 7944 63207196
Oedema peripheral 13.25 9.88 675 273207 188836 63026304
Dysarthria 13.23 9.88 119 273763 42592 63172548
Hyperthermia 13.20 9.88 12 273870 9144 63205996
Limb injury 13.20 9.88 168 273714 25309 63189831
Hypoalbuminaemia 13.19 9.88 19 273863 11786 63203354
Hepatitis acute 13.10 9.88 12 273870 9108 63206032
Unintentional medical device removal 13.06 9.88 5 273877 6110 63209030
Neuralgia 13.03 9.88 170 273712 25756 63189384
Multiple allergies 13.00 9.88 103 273779 13699 63201441
No adverse event 12.99 9.88 115 273767 41290 63173850
Creatinine urine decreased 12.97 9.88 9 273873 191 63214949
Device malfunction 12.90 9.88 37 273845 17820 63197320
Post-traumatic neck syndrome 12.89 9.88 28 273854 2046 63213094
Muscle strain 12.84 9.88 70 273812 8204 63206936
Tenosynovitis 12.83 9.88 25 273857 13770 63201370
Blue toe syndrome 12.82 9.88 12 273870 395 63214745
Eczema 12.82 9.88 84 273798 32207 63182933
Musculoskeletal pain 12.77 9.88 503 273379 91774 63123366
Mite allergy 12.77 9.88 15 273867 645 63214495
Breast cancer stage I 12.60 9.88 7 273875 6882 63208258
Rheumatic fever 12.55 9.88 122 273760 42989 63172151
Device related infection 12.53 9.88 55 273827 23337 63191803
Liver function test abnormal 12.53 9.88 140 273742 48041 63167099
Staphylococcal sepsis 12.52 9.88 10 273872 8118 63207022
Respiratory failure 12.48 9.88 339 273543 101519 63113621
Blood urea increased 12.40 9.88 65 273817 26314 63188826
Blood urine present 12.35 9.88 109 273773 14960 63200180
Stress 12.27 9.88 378 273504 66789 63148351
Body height decreased 12.27 9.88 80 273802 9998 63205142
Pancreatitis 12.19 9.88 144 273738 48911 63166229
Hypercholesterolaemia 12.15 9.88 49 273833 21285 63193855
Atelectasis 12.14 9.88 144 273738 21339 63193801
Live birth 12.13 9.88 63 273819 25567 63189573
Limb mass 12.09 9.88 36 273846 3196 63211944
C-reactive protein abnormal 12.06 9.88 272 273610 45824 63169316
Nervous system disorder 12.06 9.88 41 273841 18725 63196415
Faecaloma 11.94 9.88 10 273872 7931 63207209
Ulcer 11.90 9.88 65 273817 26042 63189098
Culture urine positive 11.89 9.88 39 273843 3648 63211492
Hyperbilirubinaemia 11.88 9.88 19 273863 11295 63203845
Mania 11.86 9.88 22 273860 12345 63202795
Device use error 11.84 9.88 5 273877 5756 63209384
Caesarean section 11.79 9.88 36 273846 16996 63198144
Ileus 11.79 9.88 29 273853 14696 63200444
Asphyxia 11.72 9.88 6 273876 6175 63208965
Peripheral sensory neuropathy 11.69 9.88 9 273873 7442 63207698
Hyperammonaemia 11.65 9.88 4 273878 5228 63209912
Skin toxicity 11.60 9.88 3 273879 4711 63210429
Full blood count decreased 11.59 9.88 167 273715 25857 63189283
Nerve compression 11.59 9.88 73 273809 9014 63206126
Pulse abnormal 11.51 9.88 29 273853 2335 63212805
Electrolyte imbalance 11.50 9.88 46 273836 20030 63195110
Cataract 11.48 9.88 325 273557 56728 63158412
Endometrial disorder 11.42 9.88 15 273867 724 63214416
Red blood cell sedimentation rate increased 11.36 9.88 128 273754 43854 63171286
Platelet count decreased 11.18 9.88 399 273483 115723 63099417
Blood alkaline phosphatase increased 11.12 9.88 125 273757 42842 63172298
Salivary hypersecretion 11.11 9.88 10 273872 7656 63207484
Nonspecific reaction 11.04 9.88 28 273854 2264 63212876
Gait inability 11.03 9.88 303 273579 52656 63162484
Nephrogenic systemic fibrosis 11.02 9.88 3 273879 4553 63210587
Human papilloma virus test positive 11.02 9.88 13 273869 562 63214578
Finger deformity 11.01 9.88 64 273818 7681 63207459
Haematuria 11.00 9.88 77 273805 29080 63186060
Sepsis 10.97 9.88 544 273338 152579 63062561
Adrenal insufficiency 10.94 9.88 40 273842 17875 63197265
Swollen joint count increased 10.93 9.88 101 273781 35953 63179187
Obstruction 10.92 9.88 34 273848 3093 63212047
Rebound effect 10.91 9.88 3 273879 4523 63210617
Necrosis 10.90 9.88 5 273877 5482 63209658
Blood creatinine increased 10.85 9.88 292 273590 87552 63127588
Mobility decreased 10.84 9.88 420 273462 120739 63094401
Flail chest 10.82 9.88 6 273876 84 63215056
Progressive multifocal leukoencephalopathy 10.82 9.88 25 273857 12946 63202194
Dermatitis exfoliative 10.80 9.88 5 273877 5454 63209686
Feeling abnormal 10.78 9.88 761 273121 147631 63067509
Lower respiratory tract congestion 10.66 9.88 32 273850 2854 63212286
Palmar-plantar erythrodysaesthesia syndrome 10.66 9.88 57 273825 22958 63192182
Upper-airway cough syndrome 10.64 9.88 85 273797 11333 63203807
Acute graft versus host disease 10.55 9.88 3 273879 4425 63210715
Gastrointestinal haemorrhage 10.51 9.88 268 273614 80908 63134232
Hepatic cirrhosis 10.51 9.88 63 273819 24671 63190469
Urine ketone body present 10.45 9.88 29 273853 2474 63212666
Device difficult to use 10.40 9.88 25 273857 12771 63202369
Bronchitis 10.38 9.88 648 273234 124287 63090853
Hypertransaminasaemia 10.34 9.88 8 273874 6601 63208539
Metastases to central nervous system 10.34 9.88 26 273856 13079 63202061
Lung perforation 10.34 9.88 6 273876 92 63215048
Sternal fracture 10.30 9.88 27 273855 2227 63212913
Metastases to lung 10.29 9.88 25 273857 12725 63202415
Blood lactate dehydrogenase increased 10.29 9.88 58 273824 23058 63192082
Toxic encephalopathy 10.25 9.88 8 273874 6571 63208569
C-reactive protein 10.23 9.88 45 273837 4837 63210303
Personality change 10.22 9.88 9 273873 6964 63208176
Hostility 10.22 9.88 24 273858 1848 63213292
Encephalitis 10.22 9.88 14 273868 8866 63206274
Aphasia 10.20 9.88 92 273790 32908 63182232
Tardive dyskinesia 10.19 9.88 13 273869 8489 63206651
Poor quality sleep 10.14 9.88 131 273751 19804 63195336
Hyperadrenalism 10.12 9.88 4 273878 24 63215116
Respiratory arrest 10.09 9.88 91 273791 32554 63182586
Paradoxical drug reaction 10.05 9.88 40 273842 4112 63211028
Basal cell carcinoma 10.04 9.88 75 273807 27916 63187224
Hepatic encephalopathy 10.02 9.88 21 273861 11261 63203879
Rectal haemorrhage 9.97 9.88 150 273732 48880 63166260
Head discomfort 9.96 9.88 95 273787 13320 63201820
Cytomegalovirus viraemia 9.96 9.88 6 273876 5643 63209497
Product use in unapproved indication 9.96 9.88 652 273230 178428 63036712
Anterior chamber cell 9.93 9.88 12 273870 532 63214608

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
Infusion related reaction 304.71 10.59 538 97082 52519 34806792
Drug interaction 253.96 10.59 159 97461 225787 34633524
Fatigue 157.38 10.59 1652 95968 369001 34490310
Toxicity to various agents 134.76 10.59 220 97400 200142 34659169
Blood pressure increased 128.62 10.59 537 97083 87565 34771746
Blood pressure diastolic abnormal 124.23 10.59 105 97515 4713 34854598
Chills 117.52 10.59 493 97127 80550 34778761
Back pain 106.46 10.59 642 96978 121147 34738164
Heart rate decreased 96.94 10.59 249 97371 31496 34827815
Cough 89.06 10.59 720 96900 149420 34709891
Acute kidney injury 87.64 10.59 497 97123 304491 34554820
Arthralgia 82.94 10.59 781 96839 169260 34690051
Blood pressure systolic increased 77.40 10.59 187 97433 22765 34836546
Blood pressure systolic abnormal 76.04 10.59 73 97547 3875 34855436
Blood pressure fluctuation 73.95 10.59 195 97425 25054 34834257
Pain 72.25 10.59 881 96739 203794 34655517
General physical health deterioration 71.91 10.59 157 97463 128112 34731199
Cardiac failure 69.23 10.59 92 97528 91156 34768155
Sinusitis 67.24 10.59 261 97359 41141 34818170
Rhabdomyolysis 64.71 10.59 57 97563 68106 34791205
Completed suicide 62.02 10.59 112 97508 98056 34761255
Pain in extremity 60.58 10.59 579 97041 125934 34733377
Oxygen saturation decreased 55.71 10.59 297 97323 53521 34805790
Hyperkalaemia 52.58 10.59 70 97550 69319 34789992
Drug resistance 51.48 10.59 6 97614 25921 34833390
Flushing 50.71 10.59 202 97418 32218 34827093
C-reactive protein increased 50.43 10.59 46 97574 54052 34805259
Throat irritation 50.25 10.59 99 97521 10486 34848825
Chest discomfort 49.83 10.59 291 97329 54239 34805072
Cholestasis 49.35 10.59 8 97612 26940 34832371
Thrombocytopenia 46.72 10.59 251 97369 155996 34703315
Drug reaction with eosinophilia and systemic symptoms 46.48 10.59 17 97603 32995 34826316
Pulmonary function test decreased 46.15 10.59 63 97557 4912 34854399
Agranulocytosis 46.11 10.59 6 97614 23815 34835496
Multiple organ dysfunction syndrome 44.31 10.59 92 97528 76474 34782837
Weight decreased 41.78 10.59 708 96912 175593 34683718
Joint swelling 40.89 10.59 297 97323 59593 34799718
Headache 39.60 10.59 783 96837 199852 34659459
Vitamin D deficiency 39.16 10.59 68 97552 6540 34852771
Rhinorrhoea 38.60 10.59 158 97462 25510 34833801
Lactic acidosis 38.21 10.59 25 97595 34747 34824564
Neutropenia 37.94 10.59 269 97351 156509 34702802
Cytomegalovirus infection 37.57 10.59 13 97607 26122 34833189
Product used for unknown indication 37.47 10.59 27 97593 956 34858355
Renal impairment 36.53 10.59 138 97482 94375 34764936
Peripheral swelling 35.95 10.59 349 97271 76192 34783119
Heart rate increased 35.87 10.59 237 97383 46106 34813205
Urticaria 35.74 10.59 297 97323 62080 34797231
Coma 35.71 10.59 45 97575 45633 34813678
Rheumatoid arthritis 35.54 10.59 205 97415 38033 34821278
Myelosuppression 34.65 10.59 6 97614 19259 34840052
Hepatic function abnormal 34.37 10.59 44 97576 44319 34814992
Hypoglycaemia 33.90 10.59 63 97557 54577 34804734
Nausea 33.77 10.59 1212 96408 338696 34520615
Altered state of consciousness 33.59 10.59 11 97609 22882 34836429
Abdominal discomfort 33.27 10.59 283 97337 59552 34799759
Nephrolithiasis 33.17 10.59 170 97450 30163 34829148
Hyperhidrosis 33.07 10.59 340 97280 75352 34783959
Blood pressure diastolic increased 32.81 10.59 54 97566 4971 34854340
Pancreatitis acute 32.63 10.59 19 97601 28122 34831189
Rash 32.53 10.59 833 96787 221919 34637392
Leukopenia 31.93 10.59 81 97539 62775 34796536
Nasopharyngitis 31.86 10.59 317 97303 69651 34789660
Neck pain 31.24 10.59 147 97473 25202 34834109
Circulatory collapse 31.06 10.59 10 97610 21028 34838283
Interstitial lung disease 30.99 10.59 87 97533 65195 34794116
Bone marrow failure 30.85 10.59 22 97598 29231 34830080
Sleep disorder due to general medical condition, insomnia type 30.52 10.59 27 97593 1289 34858022
Gamma-glutamyltransferase increased 29.51 10.59 23 97597 29208 34830103
Bronchitis 29.15 10.59 209 97411 41754 34817557
Septic shock 28.99 10.59 103 97517 71731 34787580
Maternal exposure before pregnancy 28.50 10.59 21 97599 770 34858541
Pancytopenia 28.33 10.59 153 97467 95004 34764307
Musculoskeletal stiffness 27.67 10.59 224 97396 46456 34812855
Cerebral infarction 27.22 10.59 22 97598 27433 34831878
Dyspnoea 27.02 10.59 1298 96322 375484 34483827
Contusion 26.36 10.59 183 97437 36181 34823130
Bone pain 26.25 10.59 121 97499 20565 34838746
Hospice care 26.07 10.59 59 97561 6881 34852430
Melaena 25.48 10.59 37 97583 35343 34823968
Throat tightness 24.92 10.59 65 97555 8293 34851018
Mucosal inflammation 24.43 10.59 44 97576 38578 34820733
Depressed level of consciousness 24.33 10.59 52 97568 42789 34816522
Muscle spasms 24.30 10.59 318 97302 74683 34784628
Bradycardia 24.29 10.59 118 97502 75300 34784011
Osteonecrosis 23.97 10.59 6 97614 14884 34844427
Foetal exposure during pregnancy 23.57 10.59 44 97576 38057 34821254
Dental caries 23.44 10.59 44 97576 4495 34854816
Chronic obstructive pulmonary disease 23.42 10.59 224 97396 48694 34810617
Pleural thickening 23.01 10.59 14 97606 371 34858940
Drug ineffective 22.89 10.59 1043 96577 455708 34403603
Anxiety 22.68 10.59 397 97223 99031 34760280
Labelled drug-drug interaction medication error 22.23 10.59 7 97613 14932 34844379
Emotional distress 22.20 10.59 92 97528 14934 34844377
Weight increased 22.13 10.59 374 97246 92659 34766652
Pharyngeal paraesthesia 22.05 10.59 17 97603 668 34858643
Metabolic acidosis 21.64 10.59 57 97563 43623 34815688
Productive cough 21.63 10.59 180 97440 37633 34821678
Condition aggravated 21.34 10.59 393 97227 191803 34667508
Drug hypersensitivity 21.12 10.59 329 97291 80200 34779111
Body temperature decreased 21.01 10.59 82 97538 12952 34846359
Epilepsy 20.36 10.59 18 97602 21477 34837834
Eosinophilia 20.32 10.59 26 97594 26196 34833115
Asthenia 19.94 10.59 856 96764 244395 34614916
Hyponatraemia 19.91 10.59 142 97478 82549 34776762
Constipation 19.58 10.59 511 97109 136471 34722840
Post concussion syndrome 19.56 10.59 9 97611 132 34859179
Neutropenic sepsis 19.53 10.59 7 97613 13760 34845551
Ascites 19.31 10.59 66 97554 46505 34812806
Hypoaesthesia 19.27 10.59 259 97361 61185 34798126
Unevaluable event 19.10 10.59 156 97464 32434 34826877
Pneumonia 19.02 10.59 1214 96406 361413 34497898
Dyspepsia 18.99 10.59 171 97449 36561 34822750
Pruritus 18.97 10.59 525 97095 141456 34717855
Feeling hot 18.74 10.59 105 97515 19267 34840044
Nephropathy toxic 18.55 10.59 6 97614 12582 34846729
Toxic epidermal necrolysis 18.34 10.59 20 97600 21626 34837685
Blood creatine phosphokinase increased 18.31 10.59 64 97556 44793 34814518
Oropharyngeal pain 18.25 10.59 165 97455 35320 34823991
Pneumocystis jirovecii pneumonia 18.08 10.59 17 97603 19693 34839618
C-reactive protein decreased 18.04 10.59 25 97595 1977 34857334
Product use issue 18.02 10.59 262 97358 62954 34796357
Anaemia 18.00 10.59 505 97115 232830 34626481
Injury 17.99 10.59 109 97511 20578 34838733
Upper-airway cough syndrome 17.77 10.59 34 97586 3524 34855787
Cerebral haemorrhage 17.76 10.59 45 97575 34892 34824419
Extrapyramidal disorder 17.52 10.59 7 97613 12873 34846438
Osteoarthritis 17.46 10.59 108 97512 20534 34838777
Nightmare 17.40 10.59 83 97537 14308 34845003
Infusion site pruritus 17.35 10.59 16 97604 807 34858504
Drug eruption 17.28 10.59 18 97602 19880 34839431
Hypoxia 17.17 10.59 232 97388 54863 34804448
Delirium 17.13 10.59 64 97556 43927 34815384
Overdose 17.11 10.59 167 97453 90892 34768419
Illness 17.06 10.59 79 97541 13450 34845861
Electrocardiogram QT prolonged 17 10.59 58 97562 40894 34818417
Wheezing 16.67 10.59 183 97437 41219 34818092
Paranasal sinus hypersecretion 16.60 10.59 17 97603 976 34858335
Intentional self-injury 16.39 10.59 9 97611 13762 34845549
Dry skin 16.35 10.59 146 97474 31141 34828170
Jaundice 16.25 10.59 41 97579 31841 34827470
Bladder cancer 16.19 10.59 13 97607 16265 34843046
Tubulointerstitial nephritis 16.13 10.59 21 97599 21003 34838308
Joint effusion 16.12 10.59 41 97579 5152 34854159
Hip fracture 16.06 10.59 71 97549 11854 34847457
Hypocalcaemia 15.97 10.59 27 97593 24262 34835049
Therapy non-responder 15.87 10.59 56 97564 39090 34820221
Nervous system neoplasm 15.62 10.59 8 97612 150 34859161
Progressive multifocal leukoencephalopathy 15.59 10.59 4 97616 9760 34849551
Hot flush 15.58 10.59 95 97525 17971 34841340
Death 15.48 10.59 1301 96319 396748 34462563
Diabetes mellitus 15.29 10.59 73 97547 46800 34812511
Peritonitis 15.14 10.59 14 97606 16351 34842960
Hypertension 15.11 10.59 493 97127 135950 34723361
Miosis 15.05 10.59 4 97616 9531 34849780
Nasal congestion 14.96 10.59 113 97507 22944 34836367
Red blood cell count decreased 14.82 10.59 135 97485 28955 34830356
Drug intolerance 14.72 10.59 241 97379 59329 34799982
Treatment failure 14.49 10.59 74 97546 46623 34812688
Acute respiratory failure 14.49 10.59 141 97479 30787 34828524
Cardio-respiratory arrest 14.26 10.59 93 97527 55180 34804131
Poor venous access 14.13 10.59 39 97581 5144 34854167
Graft versus host disease 13.96 10.59 6 97614 10563 34848748
Type IIa hyperlipidaemia 13.93 10.59 8 97612 190 34859121
Haematotoxicity 13.79 10.59 3 97617 8191 34851120
Arthritis 13.77 10.59 141 97479 31205 34828106
Haemarthrosis 13.71 10.59 29 97591 3230 34856081
Aplastic anaemia 13.68 10.59 5 97615 9711 34849600
Urinary tract infection 13.60 10.59 319 97301 83762 34775549
Anuria 13.55 10.59 6 97614 10379 34848932
Plasma cell myeloma 13.51 10.59 178 97442 41859 34817452
Influenza 13.43 10.59 204 97416 49462 34809849
Lymphocyte count 13.29 10.59 6 97614 84 34859227
Ill-defined disorder 13.20 10.59 75 97545 13834 34845477
Snapping hip syndrome 13.14 10.59 4 97616 16 34859295
Aggression 13.11 10.59 60 97560 38904 34820407
Cardiogenic shock 12.98 10.59 35 97585 26583 34832728
Failure to thrive 12.97 10.59 53 97567 8548 34850763
Haematochezia 12.92 10.59 192 97428 46342 34812969
Angioedema 12.90 10.59 57 97563 37317 34821994
Urethral meatus stenosis 12.84 10.59 5 97615 47 34859264
Psychotic disorder 12.81 10.59 31 97589 24421 34834890
Dizziness 12.80 10.59 739 96881 217782 34641529
Vitello-intestinal duct remnant 12.79 10.59 7 97613 151 34859160
Rash maculo-papular 12.71 10.59 39 97581 28412 34830899
Flatulence 12.71 10.59 102 97518 21096 34838215
Tooth disorder 12.60 10.59 62 97558 10820 34848491
Increased tendency to bruise 12.54 10.59 32 97588 4029 34855282
Anhedonia 12.45 10.59 48 97572 7537 34851774
Drug level increased 12.40 10.59 27 97593 22069 34837242
Lymphocyte count abnormal 12.39 10.59 16 97604 1182 34858129
Polyneuropathy 12.36 10.59 14 97606 14882 34844429
Musculoskeletal pain 12.29 10.59 140 97480 31823 34827488
Chest pain 12.27 10.59 451 97169 126311 34733000
Ischaemic stroke 12.26 10.59 20 97600 18230 34841081
Liver disorder 12.21 10.59 49 97571 32948 34826363
Infusion site extravasation 12.16 10.59 33 97587 4311 34855000
Anaphylactic shock 12.15 10.59 16 97604 15925 34843386
Hypomagnesaemia 12.01 10.59 27 97593 21824 34837487
Hepatic encephalopathy 11.97 10.59 14 97606 14671 34844640
Cytomegalovirus viraemia 11.95 10.59 3 97617 7427 34851884
Joint stiffness 11.92 10.59 61 97559 10812 34848499
Respiratory rate increased 11.91 10.59 57 97563 9837 34849474
Poisoning 11.87 10.59 10 97610 12216 34847095
Thymic cancer metastatic 11.84 10.59 5 97615 59 34859252
Discomfort 11.83 10.59 92 97528 18846 34840465
Hypokalaemia 11.69 10.59 105 97515 58109 34801202
Prostate cancer 11.65 10.59 64 97556 39585 34819726
Fear 11.65 10.59 59 97561 10417 34848894
Paranasal sinus discomfort 11.61 10.59 13 97607 827 34858484
Hypersensitivity 11.59 10.59 237 97383 60798 34798513
Pathogen resistance 11.57 10.59 6 97614 9476 34849835
Cardiac arrest 11.49 10.59 194 97426 95965 34763346
Blood pressure diastolic decreased 11.39 10.59 53 97567 9041 34850270
White blood cell count decreased 11.38 10.59 348 97272 95097 34764214
Photophobia 11.38 10.59 44 97576 6920 34852391
Febrile neutropenia 11.36 10.59 293 97327 136556 34722755
Hepatitis cholestatic 11.34 10.59 4 97616 7943 34851368
Pemphigus 11.29 10.59 18 97602 1613 34857698
Body temperature increased 11.20 10.59 85 97535 17283 34842028
Feeling abnormal 11.19 10.59 243 97377 62992 34796319
Bile output abnormal 11.06 10.59 4 97616 30 34859281
Generalised tonic-clonic seizure 10.97 10.59 27 97593 21147 34838164
Parkinsonian rest tremor 10.94 10.59 6 97614 130 34859181
Sputum discoloured 10.89 10.59 47 97573 7765 34851546
Arthropathy 10.86 10.59 119 97501 26788 34832523
Gait disturbance 10.85 10.59 313 97307 84827 34774484
Gastroenteritis viral 10.82 10.59 44 97576 7080 34852231
Lip ulceration 10.80 10.59 12 97608 757 34858554
Rhinalgia 10.79 10.59 14 97606 1039 34858272
Aspergillus infection 10.74 10.59 11 97609 12243 34847068
Gastrooesophageal reflux disease 10.73 10.59 157 97463 37767 34821544
Oliguria 10.69 10.59 5 97615 8375 34850936
Hepatotoxicity 10.67 10.59 28 97592 21457 34837854
Appendix disorder 10.59 10.59 11 97609 642 34858669

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
Drug interaction 755.75 9.84 299 296018 414884 79033187
Infusion related reaction 508.32 9.84 1943 294374 228294 79219777
Toxicity to various agents 500.79 9.84 497 295820 421043 79027028
Sinusitis 404.65 9.84 1617 294700 193884 79254187
Nasopharyngitis 352.96 9.84 1868 294449 252013 79196058
Irritable bowel syndrome 341.93 9.84 731 295586 61510 79386561
Acute kidney injury 338.37 9.84 909 295408 518495 78929576
Muscle injury 332.23 9.84 625 295692 47936 79400135
Rheumatoid arthritis 332.01 9.84 1594 294723 206876 79241195
Completed suicide 326.06 9.84 261 296056 245506 79202565
Folliculitis 302.56 9.84 649 295668 54731 79393340
Peripheral swelling 292.07 9.84 1857 294460 267760 79180311
Fatigue 277.59 9.84 4919 291398 924808 78523263
Blood pressure diastolic abnormal 276.50 9.84 349 295968 18853 79429218
Sleep disorder due to general medical condition, insomnia type 276.37 9.84 543 295774 43013 79405058
Pain 264.59 9.84 3870 292447 699932 78748139
Blood pressure increased 262.04 9.84 1508 294809 209852 79238219
Blood pressure fluctuation 257.66 9.84 686 295631 66459 79381612
Lower respiratory tract infection 242.14 9.84 1037 295280 128183 79319888
Weight increased 231.37 9.84 1793 294524 275593 79172478
Blood pressure systolic increased 224.07 9.84 651 295666 66335 79381736
Ill-defined disorder 219.19 9.84 639 295678 65236 79382835
Blood pressure systolic abnormal 213.48 9.84 291 296026 16956 79431115
Gastrointestinal disorder 210.22 9.84 956 295361 121249 79326822
Back pain 201.69 9.84 1868 294449 302312 79145759
Joint swelling 198.16 9.84 1786 294531 286860 79161211
Impaired healing 194.92 9.84 742 295575 86913 79361158
Arthralgia 192.10 9.84 3086 293231 568717 78879354
Pruritus 191.15 9.84 2274 294043 392374 79055697
Ear pain 189.72 9.84 394 295923 32475 79415596
Contusion 176.82 9.84 1050 295267 147726 79300345
Body temperature increased 176.67 9.84 460 295857 43960 79404111
Cardiac failure 172.89 9.84 192 296125 154650 79293421
Headache 171.52 9.84 3393 292924 650379 78797692
Neutropenia 167.69 9.84 530 295787 287180 79160891
Heart rate increased 167.30 9.84 888 295429 119836 79328235
Muscle spasticity 164.09 9.84 290 296027 21185 79426886
Blister 163.64 9.84 876 295441 118600 79329471
Rhabdomyolysis 161.53 9.84 91 296226 103040 79345031
Thrombocytopenia 151.52 9.84 493 295824 264766 79183305
Anaemia 143.42 9.84 1016 295301 443999 79004072
Night sweats 142.40 9.84 472 295845 51623 79396448
Hepatocellular injury 138.17 9.84 10 296307 47583 79400488
Oxygen saturation decreased 137.13 9.84 885 295432 128162 79319909
Drug reaction with eosinophilia and systemic symptoms 136.59 9.84 35 296282 64209 79383862
Hyperkalaemia 136.53 9.84 134 296183 114264 79333807
Bursitis 133.23 9.84 362 295955 35482 79412589
Lactic acidosis 132.16 9.84 48 296269 70311 79377760
Pancytopenia 130.16 9.84 262 296055 165483 79282588
Helicobacter infection 128.66 9.84 557 295760 69147 79378924
Urticaria 127.49 9.84 1147 295170 184054 79264017
Cholestasis 126.03 9.84 21 296296 52088 79395983
Drug resistance 125.09 9.84 8 296309 42205 79405866
Hyponatraemia 124.94 9.84 299 296018 177549 79270522
General physical health deterioration 124.01 9.84 563 295754 274675 79173396
Multiple organ dysfunction syndrome 121.61 9.84 161 296156 120085 79327986
Temperature regulation disorder 118.88 9.84 127 296190 5726 79442345
Heart rate decreased 118.57 9.84 547 295770 69769 79378302
Stomatitis 116.87 9.84 939 295378 145818 79302253
Hypersensitivity 116.80 9.84 1488 294829 260751 79187320
Agranulocytosis 116.19 9.84 15 296302 45015 79403056
Duodenal ulcer perforation 111.59 9.84 515 295802 65696 79382375
Leukopenia 107.93 9.84 166 296151 116347 79331724
Coma 106.72 9.84 130 296187 100519 79347552
Hepatic function abnormal 102.79 9.84 73 296244 73034 79375037
Electrocardiogram QT prolonged 99.85 9.84 113 296204 90273 79357798
Food allergy 98.42 9.84 158 296159 10666 79437405
Myelosuppression 97.98 9.84 16 296301 40280 79407791
Oropharyngeal pain 97.25 9.84 718 295599 108635 79339436
Septic shock 96.49 9.84 194 296123 122607 79325464
Respiratory disorder 95.83 9.84 375 295942 44481 79403590
Bone marrow failure 95.76 9.84 35 296282 51072 79396999
Depressed level of consciousness 95.11 9.84 132 296185 96520 79351551
Blood pressure diastolic increased 94.30 9.84 183 296134 14359 79433712
Pain in extremity 93.94 9.84 1888 294429 362650 79085421
Cytomegalovirus infection 93.05 9.84 22 296295 42622 79405449
Chest discomfort 91.94 9.84 849 295468 137195 79310876
Hypoglycaemia 90.08 9.84 149 296168 101445 79346626
Cardiac arrest 90.01 9.84 332 295985 171764 79276307
Circulatory collapse 89.29 9.84 16 296301 37652 79410419
Altered state of consciousness 89.17 9.84 26 296291 43796 79404275
Mucosal inflammation 88.49 9.84 90 296227 75490 79372581
C-reactive protein increased 88.18 9.84 220 296097 128807 79319264
Insomnia 88.00 9.84 1339 294978 243831 79204240
Cough 87.09 9.84 1877 294440 364912 79083159
Renal impairment 84.09 9.84 302 296015 157481 79290590
Chills 83.02 9.84 936 295381 159298 79288773
Toxic epidermal necrolysis 82.73 9.84 31 296286 44550 79403521
Flushing 81.02 9.84 584 295733 87684 79360387
Osteoarthritis 80.92 9.84 579 295738 86730 79361341
Metabolic acidosis 80.91 9.84 113 296204 82416 79365655
Discomfort 80.85 9.84 767 295550 124850 79323221
Epilepsy 79.98 9.84 26 296291 40834 79407237
Swelling 79.87 9.84 1189 295128 215522 79232549
Pleural thickening 79.51 9.84 75 296242 2907 79445164
Cardio-respiratory arrest 78.12 9.84 180 296137 108330 79339741
Angioedema 75.65 9.84 103 296214 75932 79372139
Throat irritation 75.39 9.84 327 295990 40619 79407452
Bradycardia 75.23 9.84 255 296062 135302 79312769
Pancreatitis acute 73.13 9.84 47 296270 49557 79398514
Abdominal discomfort 72.18 9.84 1321 294996 249406 79198665
Therapeutic product effect decreased 70.86 9.84 925 295392 162938 79285133
Gamma-glutamyltransferase increased 70.03 9.84 60 296257 54620 79393451
Pleural fibrosis 68.52 9.84 81 296236 4086 79443985
Melaena 68.48 9.84 75 296242 60815 79387256
Illness 67.75 9.84 347 295970 46164 79401907
Presbyacusis 67.31 9.84 65 296252 2595 79445476
Overdose 67.08 9.84 405 295912 183801 79264270
Hepatic enzyme increased 66.91 9.84 1001 295316 181609 79266462
Toxic skin eruption 66.73 9.84 4 296313 22289 79425782
Blood pressure diastolic decreased 66.49 9.84 255 296062 29961 79418110
Anxiety 64.24 9.84 1288 295029 247224 79200847
Coeliac disease 63.09 9.84 134 296183 11217 79436854
Hypotension 62.90 9.84 1205 295112 439112 79008959
Rash maculo-papular 62.05 9.84 70 296247 56008 79392063
Interstitial lung disease 61.67 9.84 213 296104 112387 79335684
Scoliosis 61.20 9.84 104 296213 7360 79440711
Rhinorrhoea 61.20 9.84 488 295829 75586 79372485
Osteonecrosis of jaw 60.98 9.84 43 296274 43183 79404888
Influenza 60.87 9.84 743 295574 128863 79319208
Seizure 60.26 9.84 432 295885 188402 79259669
Hypocalcaemia 60.10 9.84 58 296259 49866 79398205
Dyspnoea 59.69 9.84 3817 292500 853208 78594863
Drug abuse 59.60 9.84 357 295960 162334 79285737
Poisoning deliberate 57.52 9.84 3 296314 18825 79429246
Labelled drug-drug interaction medication error 57.00 9.84 16 296301 27634 79420437
Hypokalaemia 56.02 9.84 310 296007 143730 79304341
Arthropathy 55.89 9.84 947 295370 176164 79271907
Blood magnesium increased 55.75 9.84 67 296250 3439 79444632
Jaundice 54.36 9.84 71 296246 53278 79394793
Infection 54.14 9.84 1227 295090 240485 79207586
Orthostatic hypotension 53.96 9.84 78 296239 56086 79391985
Rash 52.43 9.84 2639 293678 575719 78872352
Renal failure 51.69 9.84 487 295830 200481 79247590
Lip dry 50.72 9.84 149 296168 15269 79432802
Blood creatine phosphokinase increased 50.55 9.84 106 296211 65984 79382087
Cerebral infarction 50.55 9.84 57 296260 45619 79402452
Febrile neutropenia 50.35 9.84 582 295735 230417 79217654
Intentional self-injury 48.77 9.84 30 296287 32389 79415682
Drug eruption 48.44 9.84 55 296262 43880 79404191
Drug-induced liver injury 48.13 9.84 109 296208 66008 79382063
Nasal congestion 48.04 9.84 465 295852 76087 79371984
Device expulsion 47.96 9.84 18 296299 25843 79422228
Nephropathy toxic 47.70 9.84 9 296308 20410 79427661
Skin necrosis 46.72 9.84 6 296311 18081 79429990
Osteonecrosis 46.47 9.84 29 296288 31066 79417005
Weight decreased 46.14 9.84 1683 294634 353515 79094556
Asthenia 45.98 9.84 2333 293984 509356 78938715
Bronchial secretion retention 45.95 9.84 66 296251 4038 79444033
Haematotoxicity 45.80 9.84 3 296314 15516 79432555
Urine abnormality 45.65 9.84 97 296220 8122 79439949
Bacterial disease carrier 45.32 9.84 41 296276 1505 79446566
Suicide attempt 45.32 9.84 157 296160 82775 79365296
Hepatotoxicity 44.87 9.84 76 296241 51276 79396795
Ascites 44.79 9.84 138 296179 75424 79372647
Immunodeficiency 44.09 9.84 179 296138 21589 79426482
Anti-cyclic citrullinated peptide antibody positive 44.09 9.84 488 295829 82655 79365416
Parkinsonism 44.07 9.84 5 296312 16579 79431492
Cerebral haemorrhage 43.69 9.84 93 296224 57580 79390491
Contraindicated product administered 43.55 9.84 825 295492 156713 79291358
Feeling hot 43.14 9.84 374 295943 59360 79388711
Facet joint syndrome 42.85 9.84 115 296202 11187 79436884
Asthma 42.84 9.84 723 295594 134372 79313699
Wound 42.59 9.84 637 295680 115542 79332529
Neovascularisation 42.49 9.84 36 296281 1209 79446862
Neutropenic sepsis 42.19 9.84 24 296293 27040 79421031
Generalised tonic-clonic seizure 42.16 9.84 61 296256 43849 79404222
Hand deformity 42.16 9.84 580 295737 103339 79344732
Torsade de pointes 42.06 9.84 10 296307 19302 79428769
Inappropriate antidiuretic hormone secretion 41.50 9.84 23 296294 26290 79421781
Poisoning 41.46 9.84 21 296296 25251 79422820
Productive cough 41.30 9.84 506 295811 87825 79360246
Malignant neoplasm progression 41.03 9.84 316 296001 135674 79312397
Pericarditis 40.77 9.84 578 295739 103658 79344413
Shock haemorrhagic 40.63 9.84 12 296305 20048 79428023
Haemodynamic instability 39.89 9.84 8 296309 17374 79430697
Tubulointerstitial nephritis 39.87 9.84 50 296267 38185 79409886
Hepatic failure 39.79 9.84 107 296210 61105 79386966
Syncope 39.14 9.84 452 295865 178997 79269074
Pneumocystis jirovecii pneumonia 38.86 9.84 38 296279 32470 79415601
Sleep disorder 38.85 9.84 488 295829 85189 79362882
Lower limb fracture 38.68 9.84 180 296137 23035 79425036
Abdominal pain upper 38.55 9.84 1097 295220 222722 79225349
Disorientation 38.39 9.84 113 296204 62663 79385408
Lymphopenia 37.37 9.84 35 296282 30522 79417549
Miosis 36.79 9.84 7 296310 15782 79432289
Graft versus host disease 36.46 9.84 6 296311 15020 79433051
Psychotic disorder 36.43 9.84 61 296256 41341 79406730
Drug level increased 36.22 9.84 57 296260 39594 79408477
Migraine 36.18 9.84 490 295827 87003 79361068
Posterior reversible encephalopathy syndrome 35.95 9.84 27 296290 26254 79421817
Weight fluctuation 35.74 9.84 110 296207 11565 79436506
Upper respiratory tract infection 35.04 9.84 504 295813 90664 79357407
Haematemesis 35.00 9.84 90 296227 52174 79395897
Urine leukocyte esterase positive 34.87 9.84 58 296259 4033 79444038
Alanine aminotransferase increased 34.86 9.84 411 295906 162159 79285912
Panniculitis 34.78 9.84 3 296314 12368 79435703
Muscle spasms 34.54 9.84 872 295445 173858 79274213
Musculoskeletal stiffness 34.48 9.84 873 295444 174135 79273936
Oliguria 34.44 9.84 9 296308 16300 79431771
Sedation complication 34.35 9.84 8 296309 15661 79432410
Osteopenia 34.06 9.84 147 296170 18217 79429854
Peripheral venous disease 33.97 9.84 133 296184 15776 79432295
Cyst 33.97 9.84 121 296196 13719 79434352
Creatinine renal clearance decreased 33.96 9.84 14 296303 18988 79429083
Neck pain 33.95 9.84 429 295888 74988 79373083
Status epilepticus 33.91 9.84 26 296291 25015 79423056
Hypomagnesaemia 33.61 9.84 78 296239 46833 79401238
Myoclonus 33.45 9.84 32 296285 27628 79420443
Dyskinesia 33.25 9.84 73 296244 44700 79403371
Cardiogenic shock 33.09 9.84 66 296251 41848 79406223
Sinus disorder 32.99 9.84 168 296149 22296 79425775
Disease progression 32.98 9.84 484 295833 183878 79264193
Hyperglycaemia 32.75 9.84 142 296175 70193 79377878
Hepatitis cholestatic 32.58 9.84 6 296311 13846 79434225
Stevens-Johnson syndrome 32.38 9.84 60 296257 39106 79408965
Epstein-Barr virus infection 32.33 9.84 7 296310 14409 79433662
Aplastic anaemia 32.31 9.84 13 296304 17892 79430179
Fluid retention 32.24 9.84 399 295918 69410 79378661
Product tampering 32.23 9.84 20 296297 408 79447663
Product prescribing error 31.71 9.84 75 296242 44738 79403333
Bronchopulmonary aspergillosis 31.68 9.84 22 296295 22272 79425799
Deafness neurosensory 31.16 9.84 75 296242 6823 79441248
Acute respiratory distress syndrome 30.99 9.84 74 296243 43993 79404078
Ischaemic stroke 30.86 9.84 47 296270 33084 79414987
Deep vein thrombosis postoperative 30.79 9.84 99 296218 10653 79437418
Musculoskeletal pain 30.72 9.84 543 295774 101811 79346260
Red cell distribution width increased 30.60 9.84 125 296192 15117 79432954
Disseminated intravascular coagulation 30.45 9.84 54 296263 35788 79412283
Hypothermia 30.31 9.84 24 296293 22722 79425349
Pathogen resistance 30.13 9.84 8 296309 14334 79433737
Thrombotic microangiopathy 29.88 9.84 19 296298 20150 79427921
Epigastric discomfort 29.59 9.84 80 296237 7816 79440255
Condition aggravated 29.41 9.84 1542 294775 499582 78948489
Wrong technique in product usage process 29.25 9.84 158 296159 73717 79374354
Dystonia 29.25 9.84 22 296295 21377 79426694
Transplant rejection 29.22 9.84 18 296299 19419 79428652
Hepatic encephalopathy 29.17 9.84 28 296289 24138 79423933
COVID-19 29.16 9.84 780 295537 156894 79291177
Polyneuropathy 29.14 9.84 28 296289 24123 79423948
Pemphigus 29.07 9.84 526 295791 99056 79349015
Peritonitis 28.88 9.84 37 296280 27999 79420072
Rib fracture 28.64 9.84 190 296127 27757 79420314
Ejection fraction decreased 28.56 9.84 53 296264 34524 79413547
Glossodynia 28.49 9.84 541 295776 102796 79345275
Aspergillus infection 28.45 9.84 18 296299 19143 79428928
Eosinophilia 28.18 9.84 81 296236 45264 79402807
Hypoaesthesia 28.14 9.84 869 295448 178483 79269588
Purpura 28.11 9.84 19 296298 19508 79428563
Aspartate aminotransferase increased 28.02 9.84 355 295962 138286 79309785
Neuroleptic malignant syndrome 27.75 9.84 37 296280 27522 79420549
Serotonin syndrome 27.57 9.84 81 296236 44946 79403125
Sputum discoloured 27.45 9.84 156 296161 21587 79426484
Haematuria 27.38 9.84 147 296170 68689 79379382
Ventricular fibrillation 27.21 9.84 48 296269 31878 79416193
Acute graft versus host disease 27.18 9.84 3 296314 10164 79437907
Product use in unapproved indication 27.17 9.84 715 295602 249644 79198427
Infusion site extravasation 27.09 9.84 91 296226 10017 79438054
Agitation 26.76 9.84 239 296078 99476 79348595
Blood creatinine increased 26.72 9.84 410 295907 154647 79293424
Cestode infection 26.17 9.84 15 296302 263 79447808
Drug intolerance 26.13 9.84 1216 295101 262903 79185168
Bladder cancer 25.52 9.84 21 296296 19505 79428566
Dry eye 25.51 9.84 229 296088 36702 79411369
Myelodysplastic syndrome 25.42 9.84 46 296271 30255 79417816
Ventricular tachycardia 25.27 9.84 76 296241 41859 79406212
Rheumatoid nodule 25.05 9.84 17 296300 17421 79430650
Intentional overdose 25.04 9.84 262 296055 105698 79342373
Prostate cancer 24.90 9.84 54 296263 33214 79414857
Hyperhidrosis 24.83 9.84 738 295579 150754 79297317
Lupus vasculitis 24.69 9.84 19 296298 555 79447516
Colitis microscopic 24.62 9.84 5 296312 10763 79437308
SARS-CoV-2 test positive 24.25 9.84 97 296220 11619 79436452
Body temperature decreased 24.12 9.84 203 296114 31942 79416129
Intentional product use issue 24.12 9.84 738 295579 151374 79296697
Sinus congestion 23.97 9.84 141 296176 19755 79428316
Hepatitis 23.87 9.84 116 296201 55611 79392460
Product substitution issue 23.84 9.84 24 296293 20232 79427839
Hallucination, auditory 23.81 9.84 25 296292 20668 79427403
Granuloma skin 23.80 9.84 3 296314 9171 79438900
Asphyxia 23.76 9.84 7 296310 11713 79436358
Cognitive disorder 23.76 9.84 157 296160 69769 79378302
Cytomegalovirus viraemia 23.65 9.84 9 296308 12812 79435259
Oesophageal carcinoma 23.63 9.84 6 296311 11078 79436993
Progressive multifocal leukoencephalopathy 23.58 9.84 25 296292 20575 79427496
Platelet count decreased 23.54 9.84 547 295770 194117 79253954
Ear pruritus 23.36 9.84 49 296268 4066 79444005
Akathisia 23.32 9.84 10 296307 13249 79434822
Feeling abnormal 23.30 9.84 765 295552 158434 79289637
Hepatocellular carcinoma 23.28 9.84 3 296314 9018 79439053
Bone cyst 23.24 9.84 44 296273 3389 79444682
Acute myocardial infarction 23.23 9.84 179 296138 76857 79371214
White blood cells urine positive 23.22 9.84 62 296255 6013 79442058
Hyperthyroidism 23.20 9.84 29 296288 22180 79425891
Stress 23.06 9.84 420 295897 79192 79368879
Limb mass 22.98 9.84 45 296272 3554 79444517
Adulterated product 22.80 9.84 14 296303 280 79447791
Upper-airway cough syndrome 22.77 9.84 95 296222 11598 79436473
Spinal meningioma benign 22.74 9.84 10 296307 96 79447975
Suicidal ideation 22.74 9.84 178 296139 76162 79371909
Diabetic ketoacidosis 22.66 9.84 59 296258 34063 79414008
Enteritis 22.63 9.84 13 296304 14570 79433501
Neuralgia 22.54 9.84 206 296111 33178 79414893
Jaundice cholestatic 22.40 9.84 7 296310 11277 79436794
Haemophagocytic lymphohistiocytosis 22.31 9.84 29 296288 21808 79426263
Dry mouth 22.31 9.84 455 295862 87564 79360507
Synovitis 22.24 9.84 725 295592 150009 79298062
Delirium 22.20 9.84 204 296113 84423 79363648
Autoimmune disorder 22.17 9.84 121 296196 16491 79431580
Bronchitis 22.11 9.84 639 295678 130005 79318066
Dysarthria 21.89 9.84 154 296163 67468 79380603
Respiratory tract congestion 21.88 9.84 138 296179 19816 79428255
Off label use 21.81 9.84 2997 293320 904218 78543853
Sinus operation 21.79 9.84 36 296281 2489 79445582
Accidental exposure to product 21.70 9.84 53 296264 31269 79416802
Hyperthermia 21.66 9.84 21 296296 18016 79430055
Pulmonary function test decreased 21.58 9.84 70 296247 7567 79440504
Exposure to toxic agent 21.47 9.84 4 296313 9154 79438917
Respiratory depression 21.39 9.84 44 296273 27586 79420485
Throat tightness 21.34 9.84 177 296140 27730 79420341
Systemic lupus erythematosus 21.17 9.84 595 295722 120554 79327517
Injection site pain 21.13 9.84 347 295970 129491 79318580
Osteosclerosis 21.06 9.84 46 296271 3925 79444146
Haematoma 21.02 9.84 111 296206 52084 79395987
Proteinuria 20.98 9.84 57 296260 32445 79415626
Schizophrenia 20.94 9.84 16 296301 15424 79432647
Skin toxicity 20.90 9.84 3 296314 8311 79439760
Sneezing 20.89 9.84 135 296182 19548 79428523
Shock 20.84 9.84 87 296230 43461 79404610
Infusion site pain 20.81 9.84 106 296211 14070 79434001
Superinfection 20.77 9.84 52 296265 4850 79443221
Subarachnoid haemorrhage 20.65 9.84 37 296280 24428 79423643
Acute coronary syndrome 20.64 9.84 29 296288 21104 79426967
Product used for unknown indication 20.56 9.84 27 296290 1517 79446554
Immune reconstitution inflammatory syndrome 20.56 9.84 13 296304 13828 79434243
Congestive cardiomyopathy 20.54 9.84 9 296308 11771 79436300
Cholangitis 20.39 9.84 11 296306 12765 79435306
Nephrotic syndrome 20.35 9.84 8 296309 11166 79436905
Red blood cells urine positive 20.35 9.84 52 296265 4911 79443160
Dermatitis bullous 20.32 9.84 14 296303 14231 79433840
BK virus infection 20.31 9.84 4 296313 8800 79439271
Neurotoxicity 20.27 9.84 58 296259 32460 79415611
Hypercalcaemia 20.16 9.84 74 296243 38356 79409715
Wheezing 20.12 9.84 572 295745 116092 79331979
Hypoalbuminaemia 20.04 9.84 30 296287 21267 79426804
Therapy partial responder 20.04 9.84 21 296296 17376 79430695
Pulse abnormal 20.03 9.84 41 296276 3343 79444728
Tenosynovitis 20.00 9.84 17 296300 15537 79432534
Death 19.65 9.84 1825 294492 564689 78883382
Drug tolerance decreased 19.54 9.84 12 296305 12966 79435105
Left ventricular dysfunction 19.48 9.84 26 296291 19335 79428736
Drug withdrawal syndrome 19.46 9.84 65 296252 34653 79413418
Hypertransaminasaemia 19.42 9.84 10 296307 11914 79436157
Hallucination, visual 19.23 9.84 60 296257 32669 79415402
Face oedema 19.19 9.84 48 296269 28088 79419983
Magnesium deficiency 19.19 9.84 17 296300 607 79447464
Arrhythmia 19.13 9.84 141 296176 61131 79386940
Urinary sediment present 19.06 9.84 34 296283 2501 79445570
Injection site erythema 19.03 9.84 192 296125 78005 79370066
Immunosuppressant drug level increased 19.03 9.84 5 296312 9022 79439049
Gastric cancer 19.02 9.84 7 296310 10172 79437899
Sepsis 18.97 9.84 813 295504 268615 79179456
Nervous system disorder 18.96 9.84 45 296272 26811 79421260
X-ray abnormal 18.95 9.84 56 296261 5757 79442314
Arteriovenous fistula occlusion 18.92 9.84 16 296301 536 79447535
Type IIa hyperlipidaemia 18.82 9.84 12 296305 257 79447814
Hepatitis acute 18.77 9.84 18 296299 15524 79432547
Transaminases increased 18.69 9.84 114 296203 51629 79396442
Chronic obstructive pulmonary disease 18.59 9.84 432 295885 84987 79363084
Acute myeloid leukaemia 18.59 9.84 56 296261 30829 79417242
Premenstrual syndrome 18.57 9.84 16 296301 550 79447521
Blood bilirubin increased 18.55 9.84 157 296160 66075 79381996
Hyperammonaemia 18.53 9.84 9 296308 11084 79436987
Liver function test abnormal 18.43 9.84 152 296165 64323 79383748
Potentiating drug interaction 18.37 9.84 5 296312 8814 79439257
Poor venous access 18.36 9.84 123 296194 18026 79430045
Concussion 18.34 9.84 77 296240 9426 79438645
Influenza like illness 18.28 9.84 371 295946 71336 79376735
Gait inability 18.19 9.84 314 296003 58603 79389468
Claustrophobia 18.15 9.84 23 296294 1247 79446824
Pulmonary alveolar haemorrhage 18.09 9.84 10 296307 11447 79436624
Second primary malignancy 18.06 9.84 16 296301 14334 79433737
Tooth disorder 17.78 9.84 162 296155 26071 79422000
Alopecia 17.77 9.84 1040 295277 230315 79217756
Muscle rigidity 17.76 9.84 29 296288 19853 79428218
Skin ulcer 17.69 9.84 123 296194 54027 79394044
Intestinal ischaemia 17.69 9.84 14 296303 13256 79434815
Blood lactate dehydrogenase increased 17.68 9.84 80 296237 39090 79408981
Cystitis haemorrhagic 17.66 9.84 6 296311 9166 79438905
Liver disorder 17.54 9.84 178 296139 72239 79375832
Joint range of motion decreased 17.48 9.84 195 296122 33087 79414984
Leukoencephalopathy 17.48 9.84 4 296313 7925 79440146
Blood urine present 17.33 9.84 137 296180 21160 79426911
Mucormycosis 17.27 9.84 5 296312 8464 79439607
Stress cardiomyopathy 17.26 9.84 10 296307 11156 79436915
Bradyphrenia 17.22 9.84 9 296308 10631 79437440
Vital capacity decreased 17.19 9.84 27 296290 1789 79446282
Corneal epithelium defect 17.13 9.84 17 296300 702 79447369
Gait disturbance 16.94 9.84 938 295379 206568 79241503
Drug ineffective for unapproved indication 16.92 9.84 116 296201 51122 79396949
Limb injury 16.90 9.84 176 296141 29352 79418719
Hepatitis B 16.85 9.84 5 296312 8327 79439744
Drug dependence 16.81 9.84 86 296231 40683 79407388
Body temperature fluctuation 16.78 9.84 41 296276 3766 79444305
Hot flush 16.77 9.84 292 296025 54585 79393486
Respiratory failure 16.75 9.84 528 295789 180383 79267688
Sternal fracture 16.60 9.84 32 296285 2498 79445573
Anterior chamber cell 16.53 9.84 19 296298 930 79447141
Gastrointestinal haemorrhage 16.51 9.84 420 295897 147299 79300772
Catatonia 16.39 9.84 6 296311 8750 79439321
Finger deformity 16.38 9.84 63 296254 7411 79440660
International normalised ratio increased 16.35 9.84 219 296098 84502 79363569
Therapeutic response shortened 16.35 9.84 108 296209 15755 79432316
Nausea 16.35 9.84 3901 292416 953295 78494776
Hypersensitivity vasculitis 16.35 9.84 3 296314 6940 79441131
Eczema 16.32 9.84 87 296230 40731 79407340
Tumour lysis syndrome 16.20 9.84 41 296276 23898 79424173
Oedema peripheral 16.18 9.84 769 295548 251519 79196552
Body height decreased 16.16 9.84 69 296248 8511 79439560
Pharyngeal paraesthesia 16.15 9.84 33 296284 2688 79445383
Dyspepsia 16.09 9.84 523 295794 108164 79339907
Menstruation delayed 16.06 9.84 23 296294 1403 79446668
Abortion spontaneous 16.02 9.84 56 296261 29451 79418620
Pemphigoid 16.00 9.84 20 296297 15295 79432776
Sedation 15.92 9.84 120 296197 51775 79396296
Chronic graft versus host disease 15.81 9.84 3 296314 6778 79441293
Lichen sclerosus 15.81 9.84 19 296298 975 79447096
Disturbance in attention 15.81 9.84 117 296200 50684 79397387
Encephalopathy 15.78 9.84 167 296150 67230 79380841
Ileus paralytic 15.77 9.84 8 296309 9612 79438459
Culture urine positive 15.69 9.84 44 296273 4391 79443680
Bacterial test 15.69 9.84 21 296296 1202 79446869
Post-traumatic neck syndrome 15.64 9.84 28 296289 2066 79446005
Tardive dyskinesia 15.60 9.84 10 296307 10561 79437510
Aggression 15.56 9.84 118 296199 50840 79397231
Fibromyalgia 15.45 9.84 330 295987 64010 79384061
Lip pruritus 15.45 9.84 18 296299 894 79447177
Pulmonary tuberculosis 15.40 9.84 5 296312 7860 79440211
Maternal exposure timing unspecified 15.40 9.84 52 296265 5740 79442331
Injury 15.37 9.84 387 295930 77109 79370962
Large intestine perforation 15.24 9.84 19 296298 14548 79433523
Hyperbilirubinaemia 15.08 9.84 44 296273 24474 79423597
Dental caries 15.05 9.84 85 296232 11735 79436336
Urogenital prolapse 15.02 9.84 5 296312 20 79448051
Failure to thrive 14.96 9.84 85 296232 11759 79436312
Specific gravity urine increased 14.94 9.84 13 296304 453 79447618
Haemodialysis 14.87 9.84 28 296289 18140 79429931
Renal tubular disorder 14.85 9.84 3 296314 6483 79441588
Soft tissue injury 14.85 9.84 25 296292 1756 79446315
Cataract 14.72 9.84 318 295999 61802 79386269
Hip fracture 14.71 9.84 177 296140 30584 79417487
Diabetes mellitus 14.64 9.84 204 296113 78186 79369885
Urinary tract infection 14.59 9.84 1197 295120 273315 79174756
Pancreatitis 14.45 9.84 174 296143 68401 79379670
Acute pulmonary oedema 14.43 9.84 19 296298 14211 79433860
C-reactive protein 14.40 9.84 46 296271 4933 79443138
Atelectasis 14.30 9.84 183 296134 32074 79415997
Ulcer 14.26 9.84 60 296257 29912 79418159
Nerve compression 14.21 9.84 70 296247 9169 79438902
Mania 14.20 9.84 29 296288 18231 79429840
Myocardial ischaemia 14.15 9.84 48 296269 25471 79422600
Cushingoid 14.15 9.84 9 296308 9543 79438528
Sudden death 14.14 9.84 40 296277 22471 79425600
Myocarditis 14.11 9.84 38 296279 21695 79426376
Rash erythematous 14.10 9.84 297 296020 57472 79390599
Polymenorrhoea 14.09 9.84 18 296299 984 79447087
Infusion site erythema 14.07 9.84 71 296246 9389 79438682
Scratch 14.05 9.84 65 296252 8298 79439773
Nephrolithiasis 14.01 9.84 277 296040 53014 79395057
C-reactive protein abnormal 13.94 9.84 255 296062 48112 79399959
Disability assessment scale score increased 13.94 9.84 36 296281 3422 79444649
Partial seizures 13.94 9.84 8 296309 8970 79439101
Vein collapse 13.91 9.84 19 296298 1109 79446962
Constipation 13.90 9.84 1227 295090 281823 79166248
Adenovirus infection 13.89 9.84 7 296310 8440 79439631
Joint stiffness 13.85 9.84 221 296096 40609 79407462
Urinary retention 13.80 9.84 139 296178 56491 79391580
Encephalitis 13.69 9.84 21 296296 14739 79433332
Noninfective gingivitis 13.68 9.84 23 296294 1613 79446458
Arteriospasm coronary 13.63 9.84 4 296313 6712 79441359
Endometrial disorder 13.62 9.84 14 296303 603 79447468
Staphylococcal sepsis 13.61 9.84 21 296296 14705 79433366
Lower respiratory tract congestion 13.50 9.84 39 296278 3958 79444113
Hepatosplenomegaly 13.50 9.84 3 296314 6066 79442005
Respiratory rate increased 13.44 9.84 131 296186 21469 79426602
Hypothyroidism 13.44 9.84 127 296190 52265 79395806
Oligomenorrhoea 13.43 9.84 15 296302 711 79447360
Exposure during pregnancy 13.42 9.84 280 296037 100852 79347219
Cutaneous vasculitis 13.32 9.84 7 296310 8245 79439826
Human papilloma virus test positive 13.30 9.84 13 296304 527 79447544
Abnormal behaviour 13.28 9.84 80 296237 36341 79411730
Unintentional medical device removal 13.28 9.84 6 296311 7706 79440365
Loss of consciousness 13.27 9.84 500 295817 167443 79280628
Sputum culture 13.19 9.84 9 296308 217 79447854
Gynaecomastia 13.19 9.84 6 296311 7675 79440396
Tongue oedema 13.12 9.84 5 296312 7112 79440959
Hepatic cirrhosis 13.09 9.84 76 296241 34830 79413241
Device use error 13.07 9.84 5 296312 7096 79440975
Uterine leiomyoma 13.06 9.84 53 296264 6390 79441681
Muscle strain 13.03 9.84 70 296247 9485 79438586
Chest pain 12.99 9.84 1218 295099 281086 79166985
White coat hypertension 12.97 9.84 16 296301 844 79447227
Toxic encephalopathy 12.96 9.84 14 296303 11426 79436645
Blood lactic acid increased 12.94 9.84 17 296300 12727 79435344
Hypertriglyceridaemia 12.93 9.84 17 296300 12723 79435348
Ligament sprain 12.88 9.84 90 296227 13374 79434697
Hypovolaemic shock 12.85 9.84 16 296301 12260 79435811
Multiple sclerosis 12.84 9.84 133 296184 22149 79425922
Electrolyte imbalance 12.81 9.84 65 296252 30816 79417255
Head discomfort 12.75 9.84 95 296222 14407 79433664
Palpitations 12.74 9.84 584 295733 126026 79322045
Metastases to liver 12.67 9.84 58 296259 28256 79419815
Necrosis 12.67 9.84 10 296307 9483 79438588
Pulmonary haemorrhage 12.66 9.84 22 296295 14695 79433376
Renal tubular necrosis 12.62 9.84 49 296268 24990 79423081
Pneumonia aspiration 12.60 9.84 174 296143 66793 79381278
Myopathy 12.58 9.84 37 296280 20526 79427545
Blood alkaline phosphatase increased 12.49 9.84 164 296153 63500 79384571
Gastric disorder 12.47 9.84 202 296115 37231 79410840
Cerebral haematoma 12.44 9.84 7 296310 7935 79440136
Band sensation 12.43 9.84 15 296302 773 79447298
Behaviour disorder 12.38 9.84 4 296313 6309 79441762
Metastases to lung 12.38 9.84 31 296286 18132 79429939
Poor quality sleep 12.33 9.84 134 296183 22588 79425483
Emotional distress 12.33 9.84 213 296104 39756 79408315
Feeling cold 12.33 9.84 162 296155 28567 79419504
Blue toe syndrome 12.31 9.84 13 296304 578 79447493
Dermatitis allergic 12.31 9.84 31 296286 18099 79429972
Inappropriate schedule of product administration 12.30 9.84 611 295706 133017 79315054
Euglycaemic diabetic ketoacidosis 12.30 9.84 5 296312 6839 79441232
Dry throat 12.29 9.84 59 296258 7647 79440424
Urine ketone body present 12.25 9.84 35 296282 3530 79444541
Enterocolitis 12.20 9.84 22 296295 14490 79433581
Klebsiella infection 12.20 9.84 25 296292 15695 79432376
Post concussion syndrome 12.19 9.84 13 296304 585 79447486
Faecaloma 12.18 9.84 15 296302 11549 79436522
Urethral meatus stenosis 12.16 9.84 5 296312 40 79448031
Snapping hip syndrome 12.02 9.84 4 296313 16 79448055
Eye infection viral 12.00 9.84 7 296310 127 79447944
Hepatitis fulminant 11.96 9.84 6 296311 7256 79440815
Multiple sclerosis relapse 11.94 9.84 241 296076 46292 79401779
Creatinine urine decreased 11.93 9.84 9 296308 255 79447816
Drug ineffective 11.92 9.84 3713 292604 1077200 78370871
Nephrogenic systemic fibrosis 11.91 9.84 4 296313 6156 79441915
Pharyngeal disorder 11.90 9.84 26 296291 2219 79445852
Oral pain 11.90 9.84 175 296142 31623 79416448
Red blood cell sedimentation rate 11.89 9.84 3 296314 5562 79442509
Infusion site swelling 11.82 9.84 59 296258 7767 79440304
Pregnancy 11.77 9.84 152 296165 26699 79421372
Hyperuricaemia 11.72 9.84 16 296301 11783 79436288
Hyperpyrexia 11.70 9.84 4 296313 6088 79441983
Duodenal ulcer haemorrhage 11.68 9.84 6 296311 7157 79440914
Anhedonia 11.67 9.84 95 296222 14803 79433268
Cytomegalovirus chorioretinitis 11.65 9.84 3 296314 5487 79442584
Musculoskeletal chest pain 11.63 9.84 142 296175 24622 79423449
Cardiac failure acute 11.62 9.84 34 296283 18895 79429176
Salivary hypersecretion 11.57 9.84 22 296295 14202 79433869
Diffuse large B-cell lymphoma 11.54 9.84 17 296300 12132 79435939
Confusional state 11.51 9.84 1350 294967 316647 79131424
Nitrite urine present 11.48 9.84 18 296299 1191 79446880
Electrocardiogram QRS complex prolonged 11.47 9.84 14 296303 10819 79437252
Hypogammaglobulinaemia 11.47 9.84 19 296298 12932 79435139
Swollen joint count 11.41 9.84 18 296299 1197 79446874
Blood cholesterol increased 11.41 9.84 399 295918 83321 79364750
Peripheral ischaemia 11.37 9.84 11 296306 9446 79438625
Reversible airways obstruction 11.31 9.84 25 296292 2151 79445920
Hiatus hernia strangulated 11.26 9.84 8 296309 206 79447865
Adrenal insufficiency 11.24 9.84 61 296256 28426 79419645
Urine analysis abnormal 11.19 9.84 51 296266 6469 79441602
Respiratory distress 11.19 9.84 151 296166 58188 79389883
Injection site reaction 11.17 9.84 140 296177 54645 79393426
Drug hypersensitivity 11.09 9.84 1271 295046 297645 79150426
Sputum culture positive 11.00 9.84 35 296282 3746 79444325
Infusion site pruritus 10.97 9.84 37 296280 4081 79443990
Tachycardia 10.97 9.84 544 295773 177224 79270847
Mycobacterial disease carrier 10.84 9.84 4 296313 23 79448048
Erectile dysfunction 10.81 9.84 24 296293 14640 79433431
Flail chest 10.79 9.84 6 296311 99 79447972
Lip oedema 10.74 9.84 5 296312 6311 79441760
Substance abuse 10.73 9.84 14 296303 10512 79437559
Polyuria 10.72 9.84 25 296292 14989 79433082
Hangover 10.68 9.84 24 296293 2088 79445983
Knee deformity 10.66 9.84 18 296299 1267 79446804
Cardiovascular disorder 10.62 9.84 33 296284 17992 79430079
Vitello-intestinal duct remnant 10.62 9.84 7 296310 159 79447912
Rash pustular 10.58 9.84 16 296301 11295 79436776
Hepatitis toxic 10.57 9.84 3 296314 5144 79442927
Genital haemorrhage 10.56 9.84 5 296312 6250 79441821
Paraesthesia 10.54 9.84 776 295541 175547 79272524
Maternal exposure before pregnancy 10.53 9.84 38 296279 4335 79443736
Foreign body 10.52 9.84 29 296288 2865 79445206
Personality disorder 10.49 9.84 48 296269 6098 79441973
Endodontic procedure 10.49 9.84 28 296289 2715 79445356
Toothache 10.48 9.84 117 296200 19853 79428218
Femoral neck fracture 10.47 9.84 13 296304 9971 79438100
Sinus headache 10.47 9.84 42 296275 5038 79443033
Hospice care 10.46 9.84 70 296247 10254 79437817
Subdural haematoma 10.46 9.84 71 296246 31363 79416708
Palmar-plantar erythrodysaesthesia syndrome 10.46 9.84 76 296241 33058 79415013
Seasonal allergy 10.46 9.84 100 296217 16306 79431765
Extrapyramidal disorder 10.43 9.84 46 296271 22633 79425438
Lung perforation 10.38 9.84 6 296311 107 79447964
Hostility 10.31 9.84 25 296292 2285 79445786
Respiratory arrest 10.31 9.84 151 296166 57399 79390672
Tuberculosis 10.31 9.84 26 296291 15172 79432899
Appendicitis 10.29 9.84 41 296276 20753 79427318
Biopsy kidney 10.28 9.84 7 296310 168 79447903
Coagulopathy 10.24 9.84 85 296232 35921 79412150
Arthritis infective 10.21 9.84 59 296258 8212 79439859
Cytopenia 10.21 9.84 40 296277 20343 79427728
Device related infection 10.19 9.84 80 296237 34214 79413857
Restlessness 10.17 9.84 117 296200 46375 79401696
Swollen tongue 10.16 9.84 105 296212 42465 79405606
Post procedural discharge 10.06 9.84 13 296304 719 79447352
Complex regional pain syndrome 10.05 9.84 23 296294 2025 79446046
Device dislocation 10.03 9.84 56 296261 25914 79422157
Disturbance in social behaviour 10.02 9.84 3 296314 4967 79443104
Areflexia 10.02 9.84 4 296313 5530 79442541
Breast cancer female 9.98 9.84 17 296300 11444 79436627
Premature delivery 9.96 9.84 49 296268 23418 79424653
Mydriasis 9.91 9.84 33 296284 17610 79430461
Foot fracture 9.87 9.84 125 296192 21856 79426215

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R05CA03 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
Expectorants
FDA PE N0000008867 Decreased Respiratory Secretion Viscosity
FDA PE N0000009560 Increased Respiratory Secretions
MeSH PA D005100 Expectorants
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000193956 Expectorant

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

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Common cold indication 82272006 DOID:10459
Headache disorder indication 230461009
Influenza-like symptoms indication 315642008
Fever indication 386661006
Asthma off-label use 195967001 DOID:2841
Asthma-chronic obstructive pulmonary disease overlap syndrome off-label use 10692761000119107
COPD Associated with Chronic Bronchitis off-label use
Chronic Obstructive Pulmonary Disease with Bronchospasms off-label use
Metabolic alkalosis contraindication 1388004
Brain damage contraindication 2470005
Anuria contraindication 2472002 DOID:2983
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
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
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Pulmonary edema contraindication 19242006 DOID:11396
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypernatremia contraindication 39355002
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Alcoholic liver damage contraindication 41309000
Third trimester pregnancy contraindication 41587001
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
Heart disease contraindication 56265001 DOID:114
Peptic reflux disease contraindication 57643001
Multiple organ failure contraindication 57653000
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by phenobarbital contraindication 64921004
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Hepatic coma contraindication 72836002 DOID:12550
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
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
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Cystic fibrosis contraindication 190905008 DOID:1485
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Angina pectoris contraindication 194828000
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
Sepsis syndrome contraindication 238150007
Rhabdomyolysis contraindication 240131006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Dyspnea contraindication 267036007
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Continuous fever contraindication 271751000
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
Neutropenic disorder contraindication 303011007 DOID:1227
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Smoking cessation assistance contraindication 384742004
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Pseudomembranous enterocolitis contraindication 397683000
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Traumatic injury contraindication 417746004
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Fever greater than 100.4 Fahrenheit contraindication 426000000
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Azotemia contraindication 445009001
Smokes tobacco daily contraindication 449868002
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Severe Hypoxemia contraindication
Theophylline Toxicity contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

ProductApplicantIngredients
Gecolate Summit Hill Laboratories 1
Gecolate, Glycodex Injection Summit Hill Laboratories 1
Guailaxin Zoetis Inc. 1
Guaifenesin Injection Elanco US Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG/5ML;2.5MG/5ML OBREDON SOVEREIGN PHARMS N205474 Nov. 14, 2014 DISCN SOLUTION ORAL 10105324 Nov. 13, 2035 A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4
200MG/5ML;2.5MG/5ML OBREDON SOVEREIGN PHARMS N205474 Nov. 14, 2014 DISCN SOLUTION ORAL 9549907 Nov. 13, 2035 A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4
200MG/5ML;2.5MG/5ML OBREDON SOVEREIGN PHARMS N205474 Nov. 14, 2014 DISCN SOLUTION ORAL 9808431 Nov. 13, 2035 A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4018147 VUID
N0000146484 NUI
D00337 KEGG_DRUG
4018147 VANDF
C0018305 UMLSCUI
CHEBI:5551 CHEBI
CHEMBL980 ChEMBL_ID
DB00874 DRUGBANK_ID
D006140 MESH_DESCRIPTOR_UI
3516 PUBCHEM_CID
968 INN_ID
7617 IUPHAR_LIGAND_ID
495W7451VQ UNII
5032 RXNORM
2461 MMSL
4805 MMSL
d00797 MMSL
000724 NDDF
386184000 SNOMEDCT_US
87174009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2097 SOLUTION 400 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Elderberry Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-2098 SOLUTION 400 mg ORAL OTC monograph final 15 sections
Robitussin CF HUMAN OTC DRUG LABEL 3 0031-8678 LIQUID 100 mg ORAL Export only 15 sections
Robitussin CF HUMAN OTC DRUG LABEL 3 0031-8678 LIQUID 100 mg ORAL Export only 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8702 LIQUID 200 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8702 LIQUID 200 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8715 LIQUID 100 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8715 LIQUID 100 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 50 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 50 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Cough and Cold CF HUMAN OTC DRUG LABEL 3 0031-8716 LIQUID 50 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 200 mg ORAL OTC MONOGRAPH FINAL 15 sections
Robitussin Mucus Plus Chest Congestion HUMAN OTC DRUG LABEL 1 0031-8724 LIQUID 200 mg ORAL OTC MONOGRAPH FINAL 14 sections
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8739 SOLUTION 400 mg ORAL OTC monograph final 15 sections
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8739 SOLUTION 400 mg ORAL OTC monograph final 15 sections
Robitussin Peak Cold Multi-Symptom Cold HUMAN OTC DRUG LABEL 3 0031-8742 LIQUID 100 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Peak Cold Multi-Symptom Cold HUMAN OTC DRUG LABEL 3 0031-8742 LIQUID 100 mg ORAL OTC MONOGRAPH FINAL 17 sections
ROBITUSSIN CHEST CONGESTION HUMAN OTC DRUG LABEL 1 0031-8748 LIQUID 100 mg ORAL EXPORT ONLY 1 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 400 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 400 mg ORAL OTC monograph final 17 sections
Robitussin Honey Maximum Strength Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8756 SOLUTION 400 mg ORAL OTC monograph final 15 sections
Robitussin Honey Maximum Strength Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8756 SOLUTION 400 mg ORAL OTC monograph final 15 sections
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8757 SOLUTION 200 mg ORAL OTC monograph final 15 sections
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM HUMAN OTC DRUG LABEL 2 0031-8757 SOLUTION 200 mg ORAL OTC monograph final 15 sections
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8759 SOLUTION 200 mg ORAL OTC monograph final 15 sections
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8759 SOLUTION 200 mg ORAL OTC monograph final 15 sections
Childrens Robitussin Honey Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8760 SOLUTION 100 mg ORAL OTC MONOGRAPH FINAL 15 sections
Childrens Robitussin Honey Cough and Chest Congestion DM HUMAN OTC DRUG LABEL 2 0031-8760 SOLUTION 100 mg ORAL OTC MONOGRAPH FINAL 15 sections
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief HUMAN OTC DRUG LABEL 2 0031-8765 TABLET, EXTENDED RELEASE 1200 mg ORAL ANDA 16 sections
Robitussin Direct Chest Congestion HUMAN OTC DRUG LABEL 1 0031-9303 TABLET, COATED 400 mg ORAL OTC monograph final 14 sections