ondansetron Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
serotonin receptor antagonists (5-HT3) 1992 99614-02-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GR-38032F
  • GR38032F
  • ondansetron
  • ondansetron hydrochloride
  • ondansetron hydrochloride dihydrate
  • ondansetron HCl
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
  • Molecular weight: 293.37
  • Formula: C18H19N3O
  • CLOGP: 2.72
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 39.82
  • ALOGS: -3.07
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
16 mg O
16 mg P
16 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 5.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.17 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.27 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 4, 1991 FDA NOVARTIS PHARMS CORP

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
Maternal exposure during pregnancy 1022.69 28.31 292 3619 14571 2339603
Emotional distress 874.76 28.31 201 3710 4094 2350080
Nausea 820.87 28.31 427 3484 111762 2242412
Injury 724.45 28.31 184 3727 5770 2348404
Electrocardiogram QT prolonged 619.07 28.31 172 3739 7642 2346532
Vomiting 590.45 28.31 297 3614 71305 2282869
Anxiety 581.69 28.31 226 3685 29133 2325041
Serotonin syndrome 502.69 28.31 124 3787 3416 2350758
Product use in unapproved indication 457.70 28.31 148 3763 11052 2343122
Pain 425.95 28.31 228 3683 61629 2292545
Torsade de pointes 423.64 28.31 99 3812 2147 2352027
Constipation 418.43 28.31 164 3747 21465 2332709
Abdominal pain 417.68 28.31 187 3724 34187 2319987
Foetal exposure during pregnancy 398.74 28.31 112 3799 5140 2349034
Cardiac arrest 370.81 28.31 136 3775 14794 2339380
Completed suicide 363.13 28.31 147 3764 20887 2333287
Exposure during pregnancy 337.38 28.31 147 3764 25072 2329102
Drug hypersensitivity 331.62 28.31 176 3735 46467 2307707
Dystonia 321.97 28.31 79 3832 2115 2352059
Hypotension 314.12 28.31 151 3760 32285 2321889
Dyspnoea 306.32 28.31 201 3710 78532 2275642
Ventricular tachycardia 301.91 28.31 80 3831 2931 2351243
Anhedonia 296.31 28.31 66 3845 1141 2353033
Pyrexia 278.95 28.31 165 3746 53543 2300631
Diarrhoea 278.73 28.31 194 3717 83370 2270804
Product use issue 240.72 28.31 94 3817 12075 2342099
Heart disease congenital 239.39 28.31 45 3866 312 2353862
Erythema 236.74 28.31 115 3796 25044 2329130
Unresponsive to stimuli 234.03 28.31 73 3838 4803 2349371
Headache 229.91 28.31 170 3741 80009 2274165
Drug interaction 214.91 28.31 113 3798 29050 2325124
Toxicity to various agents 210.85 28.31 116 3795 32638 2321536
Premature baby 209.94 28.31 61 3850 3143 2351031
Premature delivery 205.58 28.31 60 3851 3140 2351034
Dilatation intrahepatic duct acquired 204.04 28.31 32 3879 56 2354118
Tachycardia 203.88 28.31 91 3820 16318 2337856
Anaphylactic reaction 195.47 28.31 76 3835 9629 2344545
Fatigue 195.21 28.31 158 3753 84715 2269459
Pruritus 193.27 28.31 121 3790 43219 2310955
Malaise 191.48 28.31 132 3779 55453 2298721
Rash 190.19 28.31 135 3776 59423 2294751
Left-to-right cardiac shunt 184.33 28.31 26 3885 9 2354165
Congenital anomaly 184.09 28.31 38 3873 447 2353727
Drug ineffective 182.28 28.31 164 3747 101460 2252714
Cough 179.88 28.31 105 3806 33012 2321162
Hypersensitivity 178.16 28.31 93 3818 23500 2330674
Ventricular fibrillation 176.14 28.31 49 3862 2152 2352022
Gastrointestinal disorder 173.07 28.31 68 3843 8849 2345325
Oculogyric crisis 171.22 28.31 34 3877 324 2353850
Decreased appetite 165.86 28.31 95 3816 28796 2325378
Asthenia 165.11 28.31 113 3798 46813 2307361
Tremor 163.29 28.31 84 3827 20577 2333597
Bradycardia 155.48 28.31 65 3846 9916 2344258
Atrial septal defect 155.26 28.31 40 3871 1304 2352870
Atelectasis 153.81 28.31 43 3868 1922 2352252
Back pain 150.05 28.31 92 3819 31567 2322607
Cardiac murmur 147.10 28.31 40 3871 1611 2352563
Hepatotoxicity 137.61 28.31 45 3866 3436 2350738
Apnoea 134.21 28.31 36 3875 1375 2352799
Seizure 133.79 28.31 78 3833 24388 2329786
Cardio-respiratory arrest 130.56 28.31 56 3855 9090 2345084
Urticaria 129.10 28.31 76 3835 24185 2329989
Weight decreased 128.15 28.31 80 3831 28291 2325883
Febrile neutropenia 121.22 28.31 56 3855 10826 2343348
Clonus 120.69 28.31 28 3883 582 2353592
Hypoxia 119.03 28.31 47 3864 6180 2347994
Chest pain 118.71 28.31 76 3835 28061 2326113
Generalised tonic-clonic seizure 118.51 28.31 45 3866 5327 2348847
Oxygen saturation decreased 116.73 28.31 49 3862 7537 2346637
Dyskinesia 116.14 28.31 43 3868 4746 2349428
Rash erythematous 113.86 28.31 45 3866 5931 2348243
Somnolence 113.06 28.31 69 3842 23416 2330758
Long QT syndrome 111.77 28.31 26 3885 547 2353627
Neutropenia 110.66 28.31 66 3845 21482 2332692
Venoocclusive liver disease 110.23 28.31 26 3885 582 2353592
Hypokalaemia 109.91 28.31 52 3859 10602 2343572
Ventricular extrasystoles 109.35 28.31 33 3878 1933 2352241
Ventricular septal defect 107.72 28.31 27 3884 785 2353389
Dizziness 107.22 28.31 96 3815 58569 2295605
Blood pressure decreased 104.31 28.31 48 3863 9188 2344986
Dehydration 103.46 28.31 64 3847 22231 2331943
Neonatal respiratory distress syndrome 101.46 28.31 24 3887 544 2353630
Respiratory distress 99.02 28.31 39 3872 5090 2349084
Respiratory arrest 98.70 28.31 41 3870 6137 2348037
Off label use 97.73 28.31 101 3810 73497 2280677
Chest discomfort 97.20 28.31 53 3858 14542 2339632
Confusional state 95.85 28.31 63 3848 24281 2329893
Jaundice neonatal 94.37 28.31 19 3892 195 2353979
Intestinal obstruction 94.00 28.31 36 3875 4357 2349817
Condition aggravated 93.67 28.31 69 3842 31910 2322264
Upper respiratory tract infection 90.65 28.31 43 3868 8808 2345366
Sinus bradycardia 90.29 28.31 29 3882 2087 2352087
Alopecia 89.19 28.31 58 3853 21943 2332231
Akathisia 88.39 28.31 27 3884 1647 2352527
Right ventricular hypertrophy 88.01 28.31 17 3894 138 2354036
Patent ductus arteriosus 87.36 28.31 22 3889 652 2353522
Cardiomegaly 86.75 28.31 29 3882 2367 2351807
Encephalopathy 85.65 28.31 34 3877 4527 2349647
Extrapyramidal disorder 83.36 28.31 28 3883 2319 2351855
Dysuria 83.26 28.31 32 3879 3909 2350265
Migraine 83.09 28.31 43 3868 10610 2343564
Depression 83.03 28.31 61 3850 28071 2326103
Loss of consciousness 82.30 28.31 52 3859 18715 2335459
Abdominal pain upper 81.67 28.31 55 3856 22045 2332129
Liver function test abnormal 81.66 28.31 38 3873 7452 2346722
Computerised tomogram thorax abnormal 80.30 28.31 16 3895 155 2354019
Leukopenia 79.07 28.31 41 3870 10155 2344019
Discomfort 78.24 28.31 33 3878 5126 2349048
Chills 78.12 28.31 47 3864 15505 2338669
Sinus tachycardia 77.46 28.31 29 3882 3296 2350878
Urinary tract infection 77.44 28.31 60 3851 29882 2324292
Otitis media acute 77.41 28.31 15 3896 124 2354050
Type I hypersensitivity 76.10 28.31 19 3892 543 2353631
Muscle twitching 75.09 28.31 27 3884 2738 2351436
Cholestasis 74.29 28.31 29 3882 3692 2350482
Pallor 74.13 28.31 29 3882 3713 2350461
Respiratory syncytial virus infection 72.62 28.31 19 3892 657 2353517
Otitis media chronic 71.74 28.31 12 3899 37 2354137
Toxic epidermal necrolysis 71.70 28.31 27 3884 3117 2351057
Feeling abnormal 71.52 28.31 52 3859 23529 2330645
Speech disorder 71.09 28.31 33 3878 6431 2347743
Hyperhidrosis 70.78 28.31 44 3867 15378 2338796
Pharyngitis 68.96 28.31 24 3887 2211 2351963
Blood bilirubin increased 67.34 28.31 30 3881 5315 2348859
Syncope 67.15 28.31 44 3867 16831 2337343
Anaphylactic shock 66.94 28.31 28 3883 4258 2349916
Wheezing 65.30 28.31 31 3880 6353 2347821
Agitation 64.98 28.31 37 3874 11014 2343160
Pain in extremity 64.78 28.31 63 3848 42477 2311697
Toxic encephalopathy 64.43 28.31 18 3893 800 2353374
Alanine aminotransferase increased 64.30 28.31 40 3871 13992 2340182
Pulmonary oedema 64.03 28.31 32 3879 7331 2346843
Sinusitis 63.11 28.31 42 3869 16484 2337690
Respiratory failure 63.09 28.31 39 3872 13489 2340685
Hepatitis 62.46 28.31 30 3881 6307 2347867
Post procedural complication 62.43 28.31 24 3887 2930 2351244
Respiratory depression 61.97 28.31 22 3889 2148 2352026
Hyponatraemia 61.09 28.31 38 3873 13287 2340887
Movement disorder 59.85 28.31 23 3888 2805 2351369
Febrile bone marrow aplasia 59.10 28.31 17 3894 840 2353334
Electrocardiogram T wave inversion 59.07 28.31 16 3895 633 2353541
Insomnia 58.77 28.31 48 3863 25739 2328435
Neuropathy peripheral 58.55 28.31 35 3876 11397 2342777
Cleft palate 58.26 28.31 13 3898 225 2353949
Neonatal tachypnoea 57.76 28.31 10 3901 40 2354134
Gastrooesophageal reflux disease 57.66 28.31 32 3879 9063 2345111
Blister 57.62 28.31 29 3882 6742 2347432
Muscular weakness 57.21 28.31 38 3873 14859 2339315
Hypertonia 57.18 28.31 18 3893 1212 2352962
Stevens-Johnson syndrome 57.18 28.31 25 3886 4234 2349940
Arthralgia 57.06 28.31 66 3845 54219 2299955
Ear pain 56.90 28.31 22 3889 2727 2351447
Eustachian tube dysfunction 56.23 28.31 11 3900 96 2354078
Anaemia 55.72 28.31 53 3858 34739 2319435
Anticholinergic syndrome 55.44 28.31 13 3898 283 2353891
Hallucination 55.33 28.31 30 3881 8118 2346056
Hepatocellular injury 55.08 28.31 24 3887 4031 2350143
Bronchospasm 54.87 28.31 22 3889 3002 2351172
Flushing 54.78 28.31 34 3877 11837 2342337
Otitis media 54.74 28.31 15 3896 620 2353554
Dermatitis diaper 54.69 28.31 10 3901 58 2354116
Developmental delay 54.51 28.31 13 3898 305 2353869
Electrocardiogram QRS complex 53.53 28.31 8 3903 8 2354166
Left ventricular dysfunction 52.91 28.31 17 3894 1223 2352951
Burkholderia cepacia complex infection 52.39 28.31 9 3902 34 2354140
Coma 52.37 28.31 30 3881 9026 2345148
Live birth 52.24 28.31 17 3894 1274 2352900
Human herpesvirus 6 infection 52.21 28.31 13 3898 367 2353807
Sialoadenitis 52.14 28.31 12 3899 240 2353934
Angioedema 51.75 28.31 29 3882 8367 2345807
Venoocclusive disease 51.40 28.31 12 3899 256 2353918
Anorectal disorder 50.59 28.31 12 3899 275 2353899
Aspartate aminotransferase increased 50.43 28.31 33 3878 12579 2341595
Blood lactic acid increased 50.39 28.31 15 3896 836 2353338
Mydriasis 50.38 28.31 19 3892 2200 2351974
Bronchitis 50.29 28.31 34 3877 13680 2340494
Metabolic acidosis 49.01 28.31 25 3886 5973 2348201
Dysgeusia 48.85 28.31 28 3883 8431 2345743
Congenital anomaly in offspring 48.82 28.31 9 3902 55 2354119
Lower respiratory tract infection 48.41 28.31 24 3887 5400 2348774
Hypoglycaemia neonatal 48.38 28.31 11 3900 208 2353966
Myoclonus 48.31 28.31 19 3892 2464 2351710
Hyperemesis gravidarum 48.30 28.31 10 3901 119 2354055
Muscle spasticity 48.12 28.31 17 3894 1636 2352538
Premature labour 47.70 28.31 18 3893 2088 2352086
Gestational diabetes 47.08 28.31 16 3895 1371 2352803
Hepatic steatosis 46.86 28.31 20 3891 3193 2350981
Muscle spasms 46.73 28.31 39 3872 21527 2332647
Sense of oppression 46.63 28.31 11 3900 246 2353928
Desmoplastic small round cell tumour 46.36 28.31 7 3904 8 2354166
Skin abrasion 46.27 28.31 15 3896 1110 2353064
Stress cardiomyopathy 46.27 28.31 16 3895 1445 2352729
Multiple congenital abnormalities 46.03 28.31 10 3901 152 2354022
Ventricular arrhythmia 45.96 28.31 13 3898 604 2353570
Accidental overdose 45.91 28.31 21 3890 3951 2350223
Caesarean section 45.37 28.31 21 3890 4060 2350114
Sinus arrhythmia 45.34 28.31 11 3900 278 2353896
Acute kidney injury 45.31 28.31 43 3868 28079 2326095
Oral candidiasis 45.25 28.31 17 3894 1948 2352226
Gastroenteritis 44.47 28.31 19 3892 3041 2351133
Pulse absent 44.43 28.31 14 3897 945 2353229
Tricuspid valve incompetence 44.31 28.31 16 3895 1640 2352534
Suicidal ideation 44.30 28.31 29 3882 11058 2343116
Hypomagnesaemia 44.26 28.31 18 3893 2546 2351628
Procedural hypertension 43.66 28.31 8 3903 47 2354127
Dysphagia 42.83 28.31 30 3881 12775 2341399
Muscle rigidity 42.74 28.31 16 3895 1815 2352359
C-reactive protein increased 42.37 28.31 23 3888 6232 2347942
Thrombocytopenia 42.28 28.31 35 3876 19096 2335078
Heart rate increased 41.83 28.31 28 3883 11077 2343097
Maternal drugs affecting foetus 41.59 28.31 15 3896 1532 2352642
Vaginal haemorrhage 41.39 28.31 21 3890 4959 2349215
Brain injury 40.85 28.31 13 3898 906 2353268
Depressed level of consciousness 40.80 28.31 24 3887 7580 2346594
Mucosal inflammation 40.45 28.31 21 3890 5203 2348971
Transmission of an infectious agent via product 40.28 28.31 8 3903 76 2354098
Feeling hot 40.18 28.31 23 3888 6905 2347269
Nasal congestion 40.06 28.31 23 3888 6943 2347231
Bacteraemia 39.95 28.31 15 3896 1715 2352459
Hypophagia 39.59 28.31 19 3892 3981 2350193
Pulseless electrical activity 39.58 28.31 13 3898 1002 2353172
Neonatal respiratory distress 39.50 28.31 7 3904 33 2354141
Oral pain 39.39 28.31 18 3893 3379 2350795
Hot flush 39.36 28.31 23 3888 7176 2346998
Infusion site streaking 39.22 28.31 6 3905 8 2354166
Bruxism 39.18 28.31 12 3899 737 2353437
Intentional overdose 38.97 28.31 27 3884 11294 2342880
Pulmonary artery stenosis congenital 38.73 28.31 8 3903 94 2354080
Panic reaction 38.60 28.31 12 3899 775 2353399
Eye movement disorder 38.25 28.31 13 3898 1114 2353060
Palpitations 38.23 28.31 31 3880 16425 2337749
Opisthotonus 38.13 28.31 8 3903 102 2354072
Gaze palsy 38.09 28.31 10 3901 350 2353824
Torticollis 37.85 28.31 10 3901 359 2353815
Food intolerance 37.71 28.31 10 3901 364 2353810
Prescription drug used without a prescription 37.54 28.31 9 3902 216 2353958
Peritonitis 37.46 28.31 16 3895 2558 2351616
Pancreatitis acute 37.22 28.31 18 3893 3835 2350339
Hyperreflexia 37.00 28.31 12 3899 889 2353285
Gestational hypertension 36.80 28.31 10 3901 400 2353774
Otorrhoea 36.42 28.31 9 3902 246 2353928
Ill-defined disorder 36.36 28.31 17 3894 3361 2350813
Stridor 36.16 28.31 11 3900 660 2353514
Ear infection 36.06 28.31 17 3894 3424 2350750
Restless legs syndrome 35.99 28.31 15 3896 2256 2351918
Contusion 35.97 28.31 27 3884 12783 2341391
Eating disorder 35.93 28.31 15 3896 2266 2351908
Right ventricular dilatation 35.89 28.31 7 3904 60 2354114
Inappropriate antidiuretic hormone secretion 35.75 28.31 15 3896 2294 2351880
Vascular pain 35.35 28.31 8 3903 148 2354026
Pulmonary valve stenosis congenital 35.20 28.31 7 3904 67 2354107
Acute sinusitis 35.16 28.31 10 3901 474 2353700
Dyspepsia 35.11 28.31 24 3887 9820 2344354
Cardiac failure 35.10 28.31 26 3885 12068 2342106
Rhinitis allergic 34.81 28.31 11 3900 749 2353425
Cestode infection 34.57 28.31 5 3906 3 2354171
Ovarian cyst 34.56 28.31 14 3897 1959 2352215
Poor feeding infant 34.40 28.31 7 3904 76 2354098
Cyanosis neonatal 34.31 28.31 7 3904 77 2354097
Foetal growth restriction 34.23 28.31 12 3899 1128 2353046
Electrolyte imbalance 34.13 28.31 14 3897 2023 2352151
Cerebral microhaemorrhage 34.08 28.31 6 3905 27 2354147
Administration site oedema 33.98 28.31 5 3906 4 2354170
Dry mouth 33.97 28.31 22 3889 8231 2345943
Viral infection 33.93 28.31 18 3893 4658 2349516
Death 33.88 28.31 64 3847 81404 2272770
Periorbital cellulitis 33.45 28.31 7 3904 88 2354086
Hyperventilation 33.35 28.31 12 3899 1217 2352957
Disturbance in attention 33.30 28.31 19 3892 5666 2348508
Pneumonia 32.99 28.31 48 3863 49248 2304926
Congenital pulmonary valve atresia 32.93 28.31 6 3905 34 2354140
Premature rupture of membranes 32.91 28.31 11 3900 895 2353279
Selective eating disorder 32.88 28.31 9 3902 370 2353804
Feeding intolerance 32.50 28.31 6 3905 37 2354137
Failure to thrive 32.49 28.31 11 3900 931 2353243
Conjunctivitis 31.96 28.31 14 3897 2379 2351795
Morning sickness 31.94 28.31 7 3904 111 2354063
Atrioventricular block second degree 31.85 28.31 10 3901 667 2353507
Blood potassium decreased 31.80 28.31 18 3893 5287 2348887
Right aortic arch 31.71 28.31 6 3905 43 2354131
Ventricular hypoplasia 31.71 28.31 6 3905 43 2354131
General physical health deterioration 31.50 28.31 26 3885 14113 2340061
Blood pressure increased 31.27 28.31 28 3883 16958 2337216
Pre-eclampsia 30.99 28.31 12 3899 1492 2352682
Mental status changes 30.94 28.31 18 3893 5564 2348610
Myalgia 30.75 28.31 32 3879 23301 2330873
Shock 30.72 28.31 16 3895 3988 2350186
Vision blurred 30.66 28.31 26 3885 14642 2339532
Rash papular 30.62 28.31 14 3897 2630 2351544
Craniofacial deformity 30.52 28.31 5 3906 13 2354161
Retching 30.30 28.31 13 3898 2101 2352073
Tryptase increased 30.02 28.31 6 3905 59 2354115
Defaecation disorder 29.99 28.31 5 3906 15 2354159
Coma scale abnormal 29.99 28.31 10 3901 808 2353366
Cardiomyopathy 29.82 28.31 14 3897 2793 2351381
Atrioventricular block 29.74 28.31 11 3900 1206 2352968
Tongue oedema 29.61 28.31 10 3901 840 2353334
Laevocardia 29.54 28.31 4 3907 0 2354174
Oropharyngeal pain 29.53 28.31 23 3888 11495 2342679
Pancreatitis 29.53 28.31 20 3891 8059 2346115
Orthostatic intolerance 29.40 28.31 7 3904 163 2354011
Abdominal distension 29.35 28.31 22 3889 10389 2343785
Overdose 29.33 28.31 29 3882 19878 2334296
Photophobia 29.30 28.31 13 3898 2276 2351898
Haemorrhoids 29.26 28.31 13 3898 2284 2351890
Sepsis 29.23 28.31 28 3883 18460 2335714
Metastases to liver 29.20 28.31 14 3897 2927 2351247
Hyponatraemic seizure 29.17 28.31 6 3905 69 2354105
Thrombocytopenic purpura 29.13 28.31 8 3903 333 2353841
Heart rate decreased 29.09 28.31 15 3896 3661 2350513
Blood phosphorus decreased 29.05 28.31 9 3902 574 2353600
Normal newborn 29.03 28.31 11 3900 1289 2352885
Transposition of the great vessels 29.01 28.31 6 3905 71 2354103
Hypoaesthesia 28.95 28.31 29 3882 20186 2333988
Circulatory collapse 28.92 28.31 15 3896 3705 2350469
Hepatomegaly 28.84 28.31 12 3899 1797 2352377
Pollakiuria 28.79 28.31 15 3896 3741 2350433
Sinus rhythm 28.71 28.31 6 3905 75 2354099
Segmental diverticular colitis 28.64 28.31 4 3907 1 2354173
Vena cava thrombosis 28.57 28.31 8 3903 358 2353816
Malignant neoplasm progression 28.48 28.31 23 3888 12105 2342069

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
Serotonin syndrome 760.59 39.50 163 2019 2625 1741974
Foetal exposure during pregnancy 559.28 39.50 149 2033 6210 1738389
Electrocardiogram QT prolonged 525.88 39.50 138 2044 5407 1739192
Drug interaction 316.74 39.50 141 2041 27817 1716782
Injury 300.57 39.50 78 2104 2882 1741717
Vomiting 297.97 39.50 149 2033 38166 1706433
Nausea 281.83 39.50 158 2024 51038 1693561
Congenital anomaly 272.85 39.50 51 2131 377 1744222
Heart disease congenital 267.96 39.50 49 2133 316 1744283
Cardiac arrest 258.68 39.50 104 2078 15826 1728773
Hypersensitivity 236.69 39.50 87 2095 10357 1734242
Torsade de pointes 210.22 39.50 50 2132 1274 1743325
Anhedonia 200.27 39.50 44 2138 777 1743822
Hypotension 193.97 39.50 103 2079 29551 1715048
Erythema 193.90 39.50 82 2100 14106 1730493
Left-to-right cardiac shunt 192.30 39.50 26 2156 2 1744597
Ventricular tachycardia 191.92 39.50 58 2124 3740 1740859
Tachycardia 182.58 39.50 76 2106 12552 1732047
Atrial septal defect 178.24 39.50 44 2138 1314 1743285
Pain 175.33 39.50 93 2089 26564 1718035
Diarrhoea 167.45 39.50 116 2066 53736 1690863
Constipation 163.59 39.50 74 2108 14926 1729673
Emotional distress 159.36 39.50 43 2139 1835 1742764
Pyrexia 153.64 39.50 104 2078 46296 1698303
Anxiety 148.65 39.50 70 2112 15457 1729142
Hypertension 139.46 39.50 72 2110 19376 1725223
Myoclonus 137.42 39.50 40 2142 2255 1742344
Hyperhidrosis 137.28 39.50 62 2120 12426 1732173
Cardiac murmur 132.51 39.50 34 2148 1188 1743411
Cough 131.68 39.50 69 2113 19128 1725471
Ventricular fibrillation 125.95 39.50 39 2143 2717 1741882
Developmental delay 122.25 39.50 27 2155 487 1744112
Otitis media chronic 119.75 39.50 19 2163 42 1744557
Abdominal pain 116.17 39.50 66 2116 21424 1723175
Decreased appetite 112.33 39.50 67 2115 23804 1720795
Tremor 109.76 39.50 54 2128 13077 1731522
Otitis media acute 108.90 39.50 19 2163 89 1744510
Premature baby 107.03 39.50 35 2147 2907 1741692
Upper respiratory tract infection 106.99 39.50 38 2144 4055 1740544
Ventricular septal defect 106.01 39.50 26 2156 752 1743847
Toxic epidermal necrolysis 105.99 39.50 33 2149 2338 1742261
Oxygen saturation decreased 105.44 39.50 41 2141 5634 1738965
Muscle rigidity 105.26 39.50 31 2151 1817 1742782
Patent ductus arteriosus 104.34 39.50 25 2157 654 1743945
Rhinorrhoea 100.99 39.50 36 2146 3881 1740718
Right ventricular hypertrophy 98.86 39.50 18 2164 112 1744487
Cardiomegaly 98.13 39.50 31 2151 2303 1742296
Sinus tachycardia 95.64 39.50 31 2151 2501 1742098
Ventricular tachyarrhythmia 89.80 39.50 15 2167 51 1744548
Clonus 86.24 39.50 20 2162 452 1744147
Dystonia 85.69 39.50 27 2155 1987 1742612
Multiple congenital abnormalities 85.26 39.50 17 2165 181 1744418
Neonatal respiratory distress syndrome 84.65 39.50 22 2160 807 1743792
Seizure 82.31 39.50 52 2130 20389 1724210
Paraesthesia 81.39 39.50 41 2141 10410 1734189
Dyspnoea 81.03 39.50 75 2107 51984 1692615
Cleft palate 80.79 39.50 16 2166 164 1744435
Cardio-respiratory arrest 79.90 39.50 39 2143 9254 1735345
Gastrooesophageal reflux disease 77.26 39.50 31 2151 4616 1739983
Pruritus 76.25 39.50 52 2130 23170 1721429
Loss of consciousness 75.71 39.50 44 2138 14831 1729768
Change of bowel habit 75.54 39.50 15 2167 156 1744443
Atelectasis 74.33 39.50 24 2158 1910 1742689
Hyperbilirubinaemia neonatal 74.26 39.50 14 2168 108 1744491
Malaise 73.72 39.50 56 2126 29509 1715090
Agitation 73.59 39.50 39 2143 10987 1733612
Sepsis neonatal 70.83 39.50 13 2169 85 1744514
Mydriasis 70.10 39.50 21 2161 1303 1743296
Drug hypersensitivity 69.77 39.50 42 2140 15093 1729506
Jaundice neonatal 69.62 39.50 15 2167 239 1744360
Emotional disorder 69.24 39.50 20 2162 1092 1743507
Right ventricular dilatation 66.64 39.50 11 2171 34 1744565
Rash 66.46 39.50 59 2123 38634 1705965
Hepatocellular injury 65.87 39.50 25 2157 3206 1741393
Coarctation of the aorta 64.88 39.50 13 2169 142 1744457
Thrombocytopenia 63.65 39.50 45 2137 21204 1723395
Right ventricular enlargement 62.73 39.50 10 2172 23 1744576
Neutropenia 62.53 39.50 42 2140 18218 1726381
Selective eating disorder 62.08 39.50 15 2167 406 1744193
Acute kidney injury 61.41 39.50 54 2128 34890 1709709
Otitis media 61.39 39.50 15 2167 426 1744173
Respiratory distress 60.96 39.50 27 2155 5130 1739469
Eustachian tube dysfunction 60.56 39.50 10 2172 31 1744568
Unresponsive to stimuli 60.45 39.50 26 2156 4603 1739996
Mouth ulceration 60.25 39.50 20 2162 1735 1742864
Poor feeding infant 59.79 39.50 11 2171 73 1744526
Phimosis 59.09 39.50 12 2170 141 1744458
Flushing 58.92 39.50 28 2154 6251 1738348
Dyskinesia 58.39 39.50 24 2158 3795 1740804
Supraventricular tachycardia 57.28 39.50 19 2163 1644 1742955
Arrhythmia 56.98 39.50 27 2155 5989 1738610
Drug ineffective 56.30 39.50 68 2114 63733 1680866
Failure to thrive 56.22 39.50 17 2165 1088 1743511
Nasal congestion 56.03 39.50 22 2160 3089 1741510
Long QT syndrome 55.53 39.50 13 2169 306 1744293
Speech disorder 54.35 39.50 24 2158 4524 1740075
Extrapyramidal disorder 54.31 39.50 20 2162 2357 1742242
Tricuspid valve incompetence 54.21 39.50 17 2165 1229 1743370
Human herpesvirus 6 infection 53.04 39.50 13 2169 374 1744225
Trismus 52.94 39.50 14 2168 549 1744050
Chills 52.69 39.50 32 2150 11655 1732944
Rash maculo-papular 52.32 39.50 22 2160 3681 1740918
Dehydration 51.93 39.50 37 2145 17621 1726978
Chest discomfort 51.91 39.50 27 2155 7304 1737295
Cleft lip 51.86 39.50 10 2172 88 1744511
Cardiomyopathy 51.46 39.50 20 2162 2732 1741867
Laevocardia 51.33 39.50 7 2175 1 1744598
Ill-defined disorder 51.13 39.50 18 2164 1863 1742736
Hypoxia 51.12 39.50 25 2157 5938 1738661
Cardiac failure 50.47 39.50 32 2150 12570 1732029
Off label use 49.32 39.50 50 2132 38521 1706078
Stoma site pain 48.75 39.50 9 2173 61 1744538
Lung cancer metastatic 48.09 39.50 13 2169 555 1744044
Extrasystoles 48.05 39.50 14 2168 787 1743812
Malignant catatonia 47.93 39.50 8 2174 27 1744572
Bradycardia 47.88 39.50 29 2153 10505 1734094
Contraindicated product administered 47.74 39.50 16 2166 1428 1743171
Hyperreflexia 46.94 39.50 13 2169 608 1743991
Pulmonary valve incompetence 46.48 39.50 10 2172 158 1744441
Testicular germ cell cancer metastatic 46.48 39.50 7 2175 9 1744590
Hypoplastic left heart syndrome 45.91 39.50 9 2173 87 1744512
Bronchial hyperreactivity 45.74 39.50 10 2172 171 1744428
Hypoglycaemia 45.63 39.50 26 2156 8412 1736187
Product use in unapproved indication 45.57 39.50 27 2155 9395 1735204
Hyperthermia malignant 44.82 39.50 11 2171 318 1744281
Asthenia 44.40 39.50 45 2137 34625 1709974
Hypertransaminasaemia 44.14 39.50 12 2170 523 1744076
Oculogyric crisis 43.69 39.50 11 2171 354 1744245
Ear pain 43.51 39.50 13 2169 798 1743801
Right-to-left cardiac shunt 43.35 39.50 7 2175 18 1744581
Rhinitis allergic 43.33 39.50 11 2171 366 1744233
Toxicity to various agents 43.23 39.50 41 2141 29100 1715499
Leukopenia 42.85 39.50 25 2157 8455 1736144
Adenoidal hypertrophy 42.50 39.50 8 2174 61 1744538
Febrile bone marrow aplasia 42.49 39.50 13 2169 865 1743734
Infantile apnoea 42.37 39.50 10 2172 244 1744355
Right atrial enlargement 42.31 39.50 7 2175 22 1744577
Anaphylactic reaction 41.80 39.50 22 2160 6091 1738508
Septic shock 41.21 39.50 24 2158 8085 1736514
Generalised tonic-clonic seizure 40.88 39.50 19 2163 4027 1740572
Atelectasis neonatal 40.64 39.50 6 2176 6 1744593
Gait disturbance 40.60 39.50 28 2154 12642 1731957
Muscle spasms 40.37 39.50 27 2155 11594 1733005
Haematochezia 40.25 39.50 20 2162 4912 1739687
Tachypnoea 40.09 39.50 16 2166 2342 1742257
Restlessness 39.69 39.50 19 2163 4302 1740297

Pharmacologic Action:

SourceCodeDescription
ATC A04AA01 ALIMENTARY TRACT AND METABOLISM
ANTIEMETICS AND ANTINAUSEANTS
ANTIEMETICS AND ANTINAUSEANTS
Serotonin (5HT3) antagonists
FDA MoA N0000175817 Serotonin 3 Receptor Antagonists
FDA EPC N0000175818 Serotonin-3 Receptor Antagonist
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000932 Antiemetics
MeSH PA D000982 Antipruritics
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D003879 Dermatologic Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chemotherapy-induced nausea and vomiting indication 236084000
Prevention of Radiation-Induced Nausea and Vomiting indication
Prevention of Post-Operative Nausea and Vomiting indication
Excessive vomiting in pregnancy off-label use 14094001
Torsades de pointes contraindication 31722008
Hepatic failure contraindication 59927004
Extrapyramidal disease contraindication 76349003
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Congenital long QT syndrome contraindication 442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.13 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 7.80 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.34 DRUG MATRIX
Solute carrier family 22 member 3 Transporter IC50 4.76 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.69 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel Ki 4.34 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.80 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 7.52 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.77 CHEMBL
5-hydroxytryptamine receptor 3B Ion channel Ki 8.30 CHEMBL
Aldehyde oxidase Enzyme IC50 5.68 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.09 WOMBAT-PK
5-hydroxytryptamine receptor 3A Ion channel Ki 9.11 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 5 CHEMBL
Serotonin 3 receptor (5HT3) Ion channel Ki 7.92 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 5.43 CHEMBL
5-hydroxytryptamine receptor 1D GPCR Ki 4.70 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 9.11 CHEMBL
Gastrin/cholecystokinin type B receptor GPCR Ki 6.17 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 5 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.60 CHEMBL
Mu-type opioid receptor GPCR Ki 5.54 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 5.30 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 5.92 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.17 CHEMBL

External reference:

IDSource
4019865 VUID
N0000147951 NUI
C0061851 UMLSCUI
D00456 KEGG_DRUG
4AF302ESOS UNII
5965 INN_ID
108418007 SNOMEDCT_US
4019865 VANDF
27290 MMSL
004807 NDDF
26225 RXNORM
372487007 SNOMEDCT_US
d00867 MMSL
CHEBI:7773 CHEBI
CHEMBL46 ChEMBL_ID
DB00904 DRUGBANK_ID
103639-04-9 SECONDARY_CAS_RN
4595 PUBCHEM_CID
CHEMBL1201111 ChEMBL_ID
D017294 MESH_DESCRIPTOR_UI
CHEMBL3186492 ChEMBL_ID
2290 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0064 SOLUTION 4 mg ORAL ANDA 17 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0675 TABLET, FILM COATED 4 mg ORAL NDA 17 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0676 TABLET, FILM COATED 8 mg ORAL NDA 17 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0679 TABLET, ORALLY DISINTEGRATING 4 mg ORAL NDA 17 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0680 TABLET, ORALLY DISINTEGRATING 8 mg ORAL NDA 17 sections
Ondansetron Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0143-9771 INJECTION, SOLUTION 32 mg INTRAVENOUS ANDA 14 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9890 INJECTION 2 mg INTRAMUSCULAR ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9891 INJECTION 2 mg INTRAMUSCULAR ANDA 17 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0179-0247 TABLET, FILM COATED 4 mg ORAL ANDA 17 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0179-0248 TABLET, FILM COATED 8 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7732 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7734 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4755 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 18 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4759 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 18 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1726 INJECTION 2 mg INTRAMUSCULAR ANDA 18 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8185 TABLET, FILM COATED 4 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0781-5238 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0781-5239 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 17 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 15 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 15 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-575 TABLET, FILM COATED 8 mg ORAL ANDA 13 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-365 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 14 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-371 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16590-545 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 12 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16714-671 SOLUTION 4 mg ORAL ANDA 17 sections
ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16729-297 INJECTION 2 mg INTRAVENOUS ANDA 17 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16729-298 INJECTION 2 mg INTRAVENOUS ANDA 17 sections