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
Nausea 886.80 9.65 5449 192852 682005 45805756
Drug ineffective 747.44 9.65 1081 197220 676757 45811004
Febrile neutropenia 585.75 9.65 1262 197039 93365 46394396
Rheumatoid arthritis 584.65 9.65 150 198151 240065 46247696
Vomiting 570.90 9.65 3574 194727 449220 46038541
Dehydration 325.30 9.65 1441 196860 158099 46329662
Constipation 304.70 9.65 1504 196797 172593 46315168
Abdominal pain 255.59 9.65 1762 196539 228269 46259492
Contraindicated product administered 249.61 9.65 25 198276 79922 46407839
Joint swelling 242.79 9.65 209 198092 165864 46321897
Diarrhoea 242.40 9.65 3520 194781 556082 45931679
Treatment failure 226.35 9.65 58 198243 93029 46394732
Synovitis 220.33 9.65 9 198292 61066 46426695
Disease progression 208.53 9.65 854 197447 90446 46397315
Completed suicide 204.44 9.65 191 198110 145729 46342032
Toxicity to various agents 204.20 9.65 367 197934 211399 46276362
Neutropenia 203.11 9.65 1168 197133 142036 46345725
Drug abuse 185.05 9.65 25 198276 63383 46424378
Drug intolerance 181.80 9.65 214 198087 146835 46340926
Arthralgia 178.15 9.65 870 197431 363733 46124028
Emotional distress 175.51 9.65 397 197904 30310 46457451
Therapeutic product effect decreased 173.13 9.65 67 198234 82534 46405227
Drug hypersensitivity 167.23 9.65 507 197794 243318 46244443
Injury 165.39 9.65 486 197815 43541 46444220
Arthropathy 137.12 9.65 96 198205 84604 46403157
Mucosal inflammation 136.72 9.65 420 197881 38556 46449205
Systemic lupus erythematosus 134.72 9.65 54 198247 65126 46422635
Thrombocytopenia 130.58 9.65 953 197348 125628 46362133
Hypoxia 122.34 9.65 490 197811 51348 46436413
Intentional overdose 119.93 9.65 63 198238 64881 46422880
Hand deformity 118.60 9.65 7 198294 34567 46453194
Neuropathy peripheral 118.22 9.65 725 197576 90168 46397593
Injection site pain 114.03 9.65 174 198127 106978 46380783
Small intestinal obstruction 113.09 9.65 227 198074 15945 46471816
Encephalopathy 111.40 9.65 355 197946 33234 46454527
White blood cell count decreased 111.20 9.65 837 197464 111394 46376367
Torsade de pointes 110.55 9.65 191 198110 11963 46475798
Decreased appetite 109.56 9.65 1282 197019 192554 46295207
Therapeutic product effect incomplete 107.39 9.65 104 198197 78049 46409712
Overdose 107.17 9.65 167 198134 101812 46385949
Psoriasis 106.39 9.65 106 198195 78498 46409263
Left-to-right cardiac shunt 103.30 9.65 33 198268 94 46487667
Heart disease congenital 102.61 9.65 65 198236 1196 46486565
Musculoskeletal stiffness 101.52 9.65 162 198139 97831 46389930
Febrile bone marrow aplasia 99.59 9.65 134 198167 6728 46481033
Pyrexia 98.11 9.65 2050 196251 346752 46141009
Erythema 96.54 9.65 979 197322 141841 46345920
Serotonin syndrome 96.38 9.65 273 198028 23947 46463814
Fall 85.78 9.65 939 197362 328158 46159603
Electrocardiogram QT prolonged 85.72 9.65 438 197863 50887 46436874
Abortion spontaneous 84.10 9.65 40 198261 43606 46444155
Injection site erythema 83.94 9.65 116 198185 74311 46413450
Hereditary angioedema 83.56 9.65 110 198191 5406 46482355
Condition aggravated 82.40 9.65 656 197645 244396 46243365
Colitis 80.22 9.65 343 197958 37004 46450757
Fatigue 79.80 9.65 3249 195052 605448 45882313
Flushing 79.37 9.65 508 197793 64106 46423655
Intentional self-injury 76.87 9.65 7 198294 24159 46463602
Injection site swelling 76.12 9.65 38 198263 40289 46447472
Mobility decreased 76.09 9.65 87 198214 60507 46427254
Myocardial infarction 75.51 9.65 191 198110 97337 46390424
Asthma 74.23 9.65 175 198126 91367 46396394
Malignant neoplasm progression 73.41 9.65 500 197801 64426 46423335
Anhedonia 72.18 9.65 145 198156 10190 46477571
Suicide attempt 70.22 9.65 78 198223 54958 46432803
Neutrophil count decreased 69.33 9.65 366 197935 43060 46444701
Injection site reaction 68.88 9.65 61 198240 47788 46439973
C-reactive protein abnormal 68.09 9.65 6 198295 21264 46466497
Device expulsion 67.22 9.65 17 198284 27525 46460236
Laryngospasm 66.24 9.65 71 198230 2802 46484959
Weight increased 65.60 9.65 419 197882 164054 46323707
Oculogyric crisis 63.58 9.65 48 198253 1185 46486576
Pleural effusion 63.57 9.65 584 197717 82368 46405393
Therapeutic response decreased 62.11 9.65 55 198246 43090 46444671
Ventricular tachycardia 60.57 9.65 184 198117 16783 46470978
Plasma cell myeloma 60.47 9.65 359 197942 44119 46443642
Dystonia 58.24 9.65 140 198161 11117 46476644
Red blood cell sedimentation rate increased 58.08 9.65 13 198288 22876 46464885
Death 57.73 9.65 1848 196453 333700 46154061
Platelet count decreased 57.50 9.65 664 197637 99360 46388401
Cytokine release syndrome 56.86 9.65 98 198203 6125 46481636
Atelectasis 55.51 9.65 191 198110 18599 46469162
Congenital anomaly 55.35 9.65 49 198252 1523 46486238
Neutropenic sepsis 55.10 9.65 145 198156 12179 46475582
Intestinal obstruction 54.85 9.65 238 198063 25837 46461924
Carbohydrate antigen 125 increased 54.59 9.65 59 198242 2351 46485410
Blood cholesterol increased 54.08 9.65 54 198247 39959 46447802
Palmar-plantar erythrodysaesthesia syndrome 53.69 9.65 200 198101 20251 46467510
Knee arthroplasty 53.33 9.65 17 198284 23648 46464113
Injection site pruritus 53.30 9.65 54 198247 39689 46448072
Sepsis 52.69 9.65 841 197460 135173 46352588
Full blood count decreased 52.41 9.65 210 198091 22001 46465760
Femur fracture 52.25 9.65 48 198253 36949 46450812
Pancytopenia 52.21 9.65 572 197729 84486 46403275
Drug interaction 52.21 9.65 581 197720 202513 46285248
Arthritis 52.00 9.65 162 198139 77154 46410607
Loss of personal independence in daily activities 51.58 9.65 103 198198 57080 46430681
Swelling 50.76 9.65 315 197986 124196 46363565
Intentional product misuse 50.61 9.65 76 198225 47052 46440709
Glossodynia 50.18 9.65 69 198232 44304 46443457
Chills 50.15 9.65 626 197675 95406 46392355
Pulmonary embolism 50.11 9.65 692 197609 107893 46379868
Wound 49.98 9.65 65 198236 42737 46445024
Osteoarthritis 49.93 9.65 119 198182 61906 46425855
Accidental exposure to product 49.58 9.65 14 198287 21067 46466694
Hypomagnesaemia 49.25 9.65 206 198095 22004 46465757
Failure to thrive 48.34 9.65 95 198206 6569 46481192
Inflammation 48.31 9.65 83 198218 48698 46439063
C-reactive protein increased 48.29 9.65 111 198190 58479 46429282
Hepatic enzyme increased 47.16 9.65 183 198118 81604 46406157
Osteoporosis 47.08 9.65 62 198239 40546 46447215
Sopor 46.94 9.65 13 198288 19815 46467946
Dysgeusia 46.46 9.65 313 197988 40178 46447583
Asthenia 46.34 9.65 1685 196616 309390 46178371
Pericarditis 45.98 9.65 22 198279 23905 46463856
Drug resistance 45.85 9.65 9 198292 17359 46470402
Diabetes mellitus 43.61 9.65 92 198209 49973 46437788
Hypokalaemia 43.50 9.65 568 197733 87456 46400305
Nasopharyngitis 43.02 9.65 432 197869 153566 46334195
Tachycardia 42.81 9.65 627 197674 98995 46388766
Dilatation intrahepatic duct acquired 42.50 9.65 31 198270 725 46487036
Opisthotonus 42.30 9.65 23 198278 314 46487447
Clonus 42.30 9.65 68 198233 4012 46483749
Lactic acidosis 42.22 9.65 49 198252 33860 46453901
Injection site bruising 41.73 9.65 54 198247 35582 46452179
Psoriatic arthropathy 40.70 9.65 57 198244 36322 46451439
Neoplasm progression 40.62 9.65 222 198079 26461 46461300
Wrong technique in product usage process 40.26 9.65 109 198192 54313 46433448
Mental status changes 39.92 9.65 288 198013 37800 46449961
Dyspnoea 39.84 9.65 2618 195683 512930 45974831
Gait disturbance 39.13 9.65 411 197890 144852 46342909
Hypotension 38.64 9.65 1276 197025 231313 46256448
Ascites 38.55 9.65 277 198024 36307 46451454
Long QT syndrome 38.52 9.65 56 198245 3024 46484737
Otitis media chronic 38.30 9.65 16 198285 115 46487646
Respiratory distress 37.99 9.65 249 198052 31667 46456094
Dermatitis diaper 37.90 9.65 18 198283 181 46487580
Hospice care 37.83 9.65 75 198226 5220 46482541
Neutropenic colitis 37.73 9.65 47 198254 2185 46485576
Coronary artery disease 37.64 9.65 53 198248 33699 46454062
Basal cell carcinoma 37.62 9.65 20 198281 20467 46467294
Osteonecrosis of jaw 37.40 9.65 55 198246 34347 46453414
Anaemia 36.97 9.65 1381 196920 254398 46233363
Ventricular fibrillation 36.74 9.65 120 198181 11376 46476385
Hepatic function abnormal 36.48 9.65 56 198245 34365 46453396
Atrial septal defect 36.31 9.65 82 198219 6250 46481511
Hip arthroplasty 35.82 9.65 16 198285 18096 46469665
Off label use 35.77 9.65 1287 197014 378554 46109207
Electrocardiogram QRS complex 35.73 9.65 8 198293 0 46487761
Renal impairment 35.27 9.65 179 198122 74193 46413568
Oxygen saturation decreased 34.46 9.65 447 197854 68717 46419044
Drug reaction with eosinophilia and systemic symptoms 34.37 9.65 45 198256 29503 46458258
Interstitial lung disease 34.21 9.65 116 198185 53833 46433928
Anxiety 34.09 9.65 1013 197288 180944 46306817
Ileus 34.01 9.65 134 198167 13930 46473831
Segmental diverticular colitis 33.71 9.65 15 198286 128 46487633
Rhabdomyolysis 33.26 9.65 81 198220 41828 46445933
Impaired gastric emptying 33.10 9.65 92 198209 7980 46479781
Hypophagia 32.11 9.65 224 198077 29082 46458679
Right ventricular hypertrophy 32.01 9.65 25 198276 650 46487111
Unresponsive to stimuli 31.84 9.65 240 198061 31934 46455827
Stomatitis 31.79 9.65 436 197865 67861 46419900
Impaired healing 31.59 9.65 68 198233 36675 46451086
Hyperemesis gravidarum 31.05 9.65 22 198279 491 46487270
Anaphylactic reaction 30.68 9.65 353 197948 52759 46435002
Lupus vasculitis 30.29 9.65 21 198280 452 46487309
Retching 29.65 9.65 122 198179 12935 46474826
Pain in extremity 29.44 9.65 855 197446 257825 46229936
Abdominal discomfort 29.43 9.65 458 197843 150707 46337054
Bone erosion 29.33 9.65 3 198298 9440 46478321
Product use in unapproved indication 28.74 9.65 541 197760 89732 46398029
Blood pressure systolic increased 28.48 9.65 49 198252 28738 46459023
Lower respiratory tract infection 28.20 9.65 129 198172 54960 46432801
Clostridium difficile infection 28.16 9.65 193 198108 24910 46462851
Bone density decreased 28.08 9.65 4 198297 9748 46478013
Joint stiffness 27.88 9.65 45 198256 27063 46460698
Cholecystitis chronic 27.83 9.65 103 198198 10396 46477365
Rheumatoid nodule 27.67 9.65 3 198298 9017 46478744
Apnoea 27.53 9.65 81 198220 7258 46480503
Bronchospasm 26.88 9.65 135 198166 15572 46472189
Laevocardia 26.79 9.65 6 198295 0 46487761
Procedural vomiting 26.73 9.65 20 198281 487 46487274
Poisoning 26.69 9.65 13 198288 13981 46473780
Clostridium difficile colitis 26.67 9.65 152 198149 18401 46469360
Pedal pulse abnormal 26.52 9.65 13 198288 141 46487620
Sinus tachycardia 26.44 9.65 170 198131 21479 46466282
Fracture 26.20 9.65 19 198282 16452 46471309
Respiratory syncytial virus infection 25.95 9.65 61 198240 4774 46482987
Schizophrenia 25.91 9.65 3 198298 8565 46479196
Blood potassium decreased 25.70 9.65 261 198040 37802 46449959
Type I hypersensitivity 25.56 9.65 40 198261 2306 46485455
Type 2 diabetes mellitus 25.53 9.65 28 198273 19847 46467914
Neonatal tachypnoea 25.32 9.65 10 198291 61 46487700
Computerised tomogram thorax abnormal 25.18 9.65 30 198271 1331 46486430
Feeling hot 25.10 9.65 259 198042 37669 46450092
Jaundice neonatal 24.76 9.65 24 198277 839 46486922
Deep vein thrombosis 24.68 9.65 476 197825 79297 46408464
Sense of oppression 24.53 9.65 26 198275 1013 46486748
Acute respiratory failure 24.29 9.65 209 198092 28929 46458832
Lip pruritus 24.23 9.65 19 198282 497 46487264
Coma 24.08 9.65 147 198154 58202 46429559
Pancreatitis 23.89 9.65 287 198014 43340 46444421
Cestode infection 23.87 9.65 15 198286 272 46487489
Right ventricular enlargement 23.77 9.65 15 198286 274 46487487
Leukopenia 23.65 9.65 415 197886 67928 46419833
Eustachian tube dysfunction 23.59 9.65 17 198284 390 46487371
Bursitis 23.30 9.65 30 198271 19812 46467949
Hypercholesterolaemia 23.09 9.65 10 198291 11520 46476241
Therapy interrupted 23.08 9.65 99 198202 10692 46477069
Product substitution issue 23.06 9.65 18 198283 15013 46472748
Calcium ionised decreased 23.01 9.65 14 198287 239 46487522
Somnolence 23.01 9.65 498 197803 156023 46331738
Intestinal perforation 22.79 9.65 99 198202 10752 46477009
Osteonecrosis 22.67 9.65 47 198254 25697 46462064
Back pain 22.63 9.65 1100 197201 208939 46278822
Metastases to meninges 22.61 9.65 34 198267 1893 46485868
Poor feeding infant 22.55 9.65 13 198288 200 46487561
Aplastic anaemia 22.26 9.65 74 198227 7079 46480682
Otitis media acute 22.10 9.65 23 198278 877 46486884
Medication error 22.05 9.65 63 198238 30848 46456913
Gastroenteritis radiation 22.03 9.65 18 198283 500 46487261
Blood bilirubin increased 21.94 9.65 232 198069 33952 46453809
Sedation 21.76 9.65 40 198261 22870 46464891
Blood pressure fluctuation 21.76 9.65 62 198239 30386 46457375
Injection site haemorrhage 21.65 9.65 34 198267 20675 46467086
Bacteraemia 21.60 9.65 118 198183 14061 46473700
Paranoia 21.53 9.65 9 198292 10588 46477173
Drug dependence 21.45 9.65 32 198269 19869 46467892
Cerebrovascular accident 21.43 9.65 301 198000 100738 46387023
Pulmonary artery stenosis congenital 21.42 9.65 13 198288 221 46487540
Aplasia 21.28 9.65 47 198254 3529 46484232
Duodenal ulcer perforation 21.23 9.65 5 198296 8497 46479264
Stress 21.21 9.65 130 198171 51421 46436340
Procedural nausea 21.14 9.65 20 198281 678 46487083
Troponin increased 20.98 9.65 77 198224 7739 46480022
Malnutrition 20.97 9.65 116 198185 13887 46473874
Glaucoma 20.93 9.65 22 198279 15899 46471862
Joint range of motion decreased 20.91 9.65 20 198281 15104 46472657
Hypoglycaemia 20.85 9.65 140 198161 54209 46433552
Herpes zoster 20.81 9.65 186 198115 67686 46420075
Fibromyalgia 20.75 9.65 82 198219 36381 46451380
Long QT syndrome congenital 20.73 9.65 7 198294 25 46487736
Ventricular septal defect 20.68 9.65 50 198251 3984 46483777
Cerebral microhaemorrhage 20.60 9.65 10 198291 106 46487655
Respiratory failure 20.58 9.65 538 197763 94278 46393483
Injection site warmth 20.49 9.65 17 198284 13755 46474006
Multiple sclerosis 20.40 9.65 47 198254 24744 46463017
Cardiac failure 20.39 9.65 229 198072 79719 46408042
Cerebral infarction 20.29 9.65 43 198258 23323 46464438
Gallbladder injury 20.20 9.65 27 198274 1347 46486414
Administration site oedema 20.11 9.65 7 198294 28 46487733
Venoocclusive liver disease 20.01 9.65 51 198250 4200 46483561
Plantar erythema 19.98 9.65 13 198288 251 46487510
Product prescribing error 19.94 9.65 34 198267 20013 46467748
Amputation stump pain 19.73 9.65 7 198294 30 46487731
Vascular access site thrombosis 19.73 9.65 7 198294 30 46487731
Pneumonitis 19.73 9.65 196 198105 28224 46459537
Breast cancer 19.67 9.65 113 198188 45405 46442356
Treatment noncompliance 19.48 9.65 63 198238 29668 46458093
Insomnia 19.27 9.65 543 197758 164381 46323380
Hyperkalaemia 19.27 9.65 131 198170 50578 46437183
Blood magnesium decreased 19.18 9.65 95 198206 10897 46476864
Vasculitis 19.11 9.65 18 198283 13693 46474068
Glioblastoma multiforme 19.06 9.65 21 198280 855 46486906
Proctalgia 19.02 9.65 54 198247 4742 46483019
Infusion site streaking 18.78 9.65 14 198287 339 46487422
Hair colour changes 18.76 9.65 30 198271 1762 46485999
Laryngeal discomfort 18.67 9.65 13 198288 282 46487479
Product quality issue 18.53 9.65 83 198218 35565 46452196
Red blood cell count decreased 18.47 9.65 216 198085 32407 46455354
Taste disorder 18.46 9.65 61 198240 5817 46481944
Oral pain 18.19 9.65 173 198128 24624 46463137
Transplant rejection 18.17 9.65 9 198292 9587 46478174
Feeding intolerance 18.16 9.65 16 198285 494 46487267
Suicidal ideation 17.95 9.65 153 198148 56229 46431532
Product complaint 17.93 9.65 15 198286 12086 46475675
Burkholderia cepacia complex infection 17.93 9.65 10 198291 144 46487617
Cholecystitis 17.91 9.65 114 198187 14352 46473409
Fever neonatal 17.86 9.65 4 198297 0 46487761
Cytomegalovirus infection 17.84 9.65 31 198270 18113 46469648
Adenoidal hypertrophy 17.82 9.65 7 198294 42 46487719
Congenital pulmonary valve atresia 17.81 9.65 8 198293 70 46487691
Magnesium deficiency 17.76 9.65 15 198286 437 46487324
Neutropenic infection 17.71 9.65 23 198278 1115 46486646
Myalgia 17.69 9.65 393 197908 122695 46365066
Drug level increased 17.69 9.65 32 198269 18409 46469352
No adverse event 17.61 9.65 80 198221 34151 46453610
Desmoplastic small round cell tumour 17.57 9.65 10 198291 150 46487611
Melaena 17.41 9.65 60 198241 27712 46460049
Cervix neoplasm 17.29 9.65 11 198290 204 46487557
Bulimia nervosa 17.25 9.65 16 198285 529 46487232
Aggression 17.23 9.65 45 198256 22699 46465062
Congenital anomaly in offspring 17.23 9.65 10 198291 156 46487605
Hydronephrosis 17.21 9.65 77 198224 8468 46479293
Transmission of an infectious agent via product 17.21 9.65 9 198292 113 46487648
Vein discolouration 17.11 9.65 10 198291 158 46487603
Drug eruption 17.10 9.65 41 198260 21288 46466473
Lupus-like syndrome 17.03 9.65 6 198295 7838 46479923
Pulmonary valve stenosis 16.98 9.65 13 198288 328 46487433
Electrolyte depletion 16.95 9.65 10 198291 161 46487600
Osteopenia 16.66 9.65 29 198272 16932 46470829
Pulmonary fibrosis 16.60 9.65 38 198263 20054 46467707
Depressed level of consciousness 16.56 9.65 126 198175 47443 46440318
Irritability 16.53 9.65 65 198236 28881 46458880
Foot deformity 16.44 9.65 25 198276 15400 46472361
Toxic encephalopathy 16.32 9.65 53 198248 5009 46482752
Pathogen resistance 16.29 9.65 3 198298 6057 46481704
Inappropriate schedule of product administration 16.27 9.65 187 198114 64826 46422935
Coronary artery occlusion 16.27 9.65 7 198294 8095 46479666
Vascular access site infection 16.17 9.65 6 198295 30 46487731
Cerebellar stroke 16.12 9.65 10 198291 177 46487584
Eating disorder 16.04 9.65 112 198189 14542 46473219
IIIrd nerve paresis 15.99 9.65 8 198293 91 46487670
Pneumonia 15.88 9.65 1828 196473 374492 46113269
Immune effector cell-associated neurotoxicity syndrome 15.74 9.65 17 198284 677 46487084
Pharyngeal paraesthesia 15.70 9.65 22 198279 1148 46486613
Nail pigmentation 15.69 9.65 10 198291 186 46487575
Carpal tunnel syndrome 15.68 9.65 27 198274 15832 46471929
Bone disorder 15.67 9.65 39 198262 19994 46467767
Helicobacter infection 15.67 9.65 16 198285 11720 46476041
Electrolyte imbalance 15.66 9.65 126 198175 17100 46470661
Haematoma 15.51 9.65 76 198225 31796 46455965
Glycosylated haemoglobin increased 15.49 9.65 14 198287 10862 46476899
Drug clearance decreased 15.47 9.65 21 198280 1063 46486698
Skin ulcer 15.45 9.65 78 198223 32380 46455381
Hallucination, visual 15.43 9.65 33 198268 17840 46469921
Epiglottic oedema 15.41 9.65 6 198295 35 46487726
Seizure like phenomena 15.32 9.65 20 198281 975 46486786
Sinusitis 15.22 9.65 427 197874 129341 46358420
Biliary obstruction 15.14 9.65 33 198268 2456 46485305
Right ventricle outflow tract obstruction 15.11 9.65 4 198297 4 46487757
Right ventricular dilatation 15.06 9.65 19 198282 895 46486866
Device related infection 15.04 9.65 146 198155 20895 46466866
Gangrene 14.99 9.65 49 198252 4646 46483115
Chest discomfort 14.89 9.65 495 197806 89774 46397987
Liver disorder 14.76 9.65 95 198206 37151 46450610
Delirium 14.73 9.65 95 198206 37133 46450628
Haemoglobin decreased 14.65 9.65 679 197622 128270 46359491
Eosinophilia 14.58 9.65 38 198263 19179 46468582
Enteritis 14.47 9.65 62 198239 6693 46481068
Premenstrual syndrome 14.42 9.65 16 198285 657 46487104
Tendonitis 14.40 9.65 24 198277 14253 46473508
Pityriasis rosea 14.35 9.65 7 198294 75 46487686
Chronic obstructive pulmonary disease 14.33 9.65 166 198135 57467 46430294
Venoocclusive disease 14.33 9.65 28 198273 1928 46485833
Infection 14.32 9.65 445 197856 133147 46354614
Colitis microscopic 14.26 9.65 5 198296 6551 46481210
Rotator cuff syndrome 14.14 9.65 17 198284 11566 46476195
Psychotic disorder 14.09 9.65 49 198252 22572 46465189
Developmental delay 14.07 9.65 21 198280 1161 46486600
Hallucination, auditory 13.98 9.65 15 198286 10741 46477020
Ageusia 13.95 9.65 90 198211 11382 46476379
Bone pain 13.89 9.65 278 198023 46612 46441149
Injection site rash 13.81 9.65 29 198272 15784 46471977
Metastases to peritoneum 13.77 9.65 33 198268 2615 46485146
Epilepsy 13.75 9.65 53 198248 23685 46464076
Injection site phlebitis 13.71 9.65 8 198293 126 46487635
Cardiac murmur 13.59 9.65 89 198212 11315 46476446
Uterine perforation 13.54 9.65 64 198237 7203 46480558
Dacryostenosis congenital 13.50 9.65 4 198297 8 46487753
Musculoskeletal pain 13.46 9.65 213 198088 69915 46417846
Cleft palate 13.45 9.65 18 198283 899 46486862
Right ventricular hypertension 13.40 9.65 3 198298 0 46487761
Pulmonary oedema neonatal 13.40 9.65 3 198298 0 46487761
Wolff-Parkinson-White syndrome congenital 13.40 9.65 3 198298 0 46487761
Univentricular heart 13.40 9.65 3 198298 0 46487761
Oedema neonatal 13.40 9.65 3 198298 0 46487761
Neonatal respiratory distress 13.39 9.65 8 198293 132 46487629
Foetal exposure during pregnancy 13.38 9.65 194 198107 30553 46457208
Dementia 13.36 9.65 27 198274 14903 46472858
Neutrophil count abnormal 13.25 9.65 31 198270 2419 46485342
Tracheal injury 13.21 9.65 6 198295 54 46487707
Peripheral swelling 13.19 9.65 543 197758 157528 46330233
Food intolerance 13.15 9.65 30 198271 2302 46485459
Obstructive airways disorder 13.11 9.65 23 198278 13389 46474372
Pericardial effusion 13.10 9.65 166 198135 25377 46462384
Discomfort 12.98 9.65 131 198170 46539 46441222
Meningitis streptococcal 12.98 9.65 8 198293 140 46487621
Tumour lysis syndrome 12.96 9.65 63 198238 7173 46480588
Wrist fracture 12.89 9.65 18 198283 11485 46476276
Cardiac failure congestive 12.88 9.65 294 198007 91456 46396305
Cataract 12.83 9.65 127 198174 45288 46442473
Laboratory test abnormal 12.81 9.65 151 198150 22696 46465065
Poisoning deliberate 12.79 9.65 9 198292 7917 46479844
Blood count abnormal 12.75 9.65 124 198177 17754 46470007
Sleep disorder 12.75 9.65 132 198169 46663 46441098
Periorbital cellulitis 12.68 9.65 13 198288 487 46487274
Sciatica 12.67 9.65 40 198261 18980 46468781
Subchorionic haemorrhage 12.66 9.65 6 198295 60 46487701
Pneumonia respiratory syncytial viral 12.65 9.65 15 198286 662 46487099
Incorrect dose administered 12.61 9.65 128 198173 45422 46442339
Transverse sinus thrombosis 12.60 9.65 15 198286 665 46487096
Gastroenteritis viral 12.59 9.65 125 198176 17994 46469767
Epistaxis 12.56 9.65 360 197941 63945 46423816
Labelled drug-drug interaction medication error 12.50 9.65 12 198289 9049 46478712
Cyanosis 12.50 9.65 113 198188 15858 46471903
Morning sickness 12.49 9.65 15 198286 671 46487090
Right atrial dilatation 12.44 9.65 13 198288 498 46487263
Cyanosis neonatal 12.43 9.65 9 198292 208 46487553
Blood glucose increased 12.42 9.65 223 198078 71790 46415971
Non-cardiac chest pain 12.42 9.65 55 198246 6023 46481738
Sensitivity to weather change 12.36 9.65 4 198297 5512 46482249
Skin necrosis 12.34 9.65 11 198290 8593 46479168
Pulmonary valve stenosis congenital 12.31 9.65 8 198293 154 46487607
Osteomyelitis 12.31 9.65 51 198250 22332 46465429
Arteriosclerosis coronary artery 12.22 9.65 10 198291 8146 46479615
Disease recurrence 12.20 9.65 39 198262 18432 46469329
Intraocular pressure increased 12.20 9.65 5 198296 5952 46481809
Injection site urticaria 12.18 9.65 20 198281 11947 46475814
Blood creatine increased 12.14 9.65 45 198256 4545 46483216
Sputum abnormal 12.13 9.65 11 198290 353 46487408
Stridor 12.06 9.65 35 198266 3112 46484649
Joint dislocation 12.04 9.65 18 198283 11168 46476593
Grunting 12.00 9.65 9 198292 220 46487541
Gait inability 11.90 9.65 94 198207 35109 46452652
Muscle injury 11.88 9.65 3 198298 4863 46482898
Protein urine 11.88 9.65 14 198287 614 46487147
Macular degeneration 11.87 9.65 8 198293 7197 46480564
Haemorrhoids 11.84 9.65 127 198174 18650 46469111
Cardiac arrest 11.82 9.65 483 197818 89916 46397845
Product storage error 11.73 9.65 20 198281 11772 46475989
Neonatal tachycardia 11.69 9.65 4 198297 15 46487746
Therapy non-responder 11.66 9.65 115 198186 41037 46446724
Haemophagocytic lymphohistiocytosis 11.57 9.65 11 198290 8331 46479430
Acute myeloid leukaemia 11.53 9.65 110 198191 15668 46472093
Jugular vein thrombosis 11.52 9.65 31 198270 2639 46485122
Vascular device infection 11.50 9.65 37 198264 3480 46484281
Sleep disorder due to general medical condition, insomnia type 11.42 9.65 4 198297 5245 46482516
Hypothyroidism 11.39 9.65 82 198219 31256 46456505
Chest pain 11.39 9.65 883 197418 175441 46312320
Intercepted product administration error 11.36 9.65 6 198295 77 46487684
Tumour marker increased 11.35 9.65 37 198264 3504 46484257
Electrocardiogram QT shortened 11.33 9.65 7 198294 123 46487638
Congenital tongue anomaly 11.33 9.65 3 198298 3 46487758
Hypofibrinogenaemia 11.32 9.65 18 198283 1052 46486709
Superior sagittal sinus thrombosis 11.32 9.65 16 198285 842 46486919
Splinter haemorrhages 11.30 9.65 4 198297 17 46487744
Meningioma malignant 11.30 9.65 4 198297 17 46487744
International normalised ratio increased 11.29 9.65 136 198165 46747 46441014
Palmar erythema 11.23 9.65 21 198280 1399 46486362
Transplant dysfunction 11.21 9.65 3 198298 4679 46483082
Injection site haematoma 11.17 9.65 6 198295 6106 46481655
Altered state of consciousness 11.17 9.65 56 198245 23292 46464469
Onychalgia 11.17 9.65 14 198287 655 46487106
Multiple congenital abnormalities 11.17 9.65 12 198289 475 46487286
Chronic hepatitis B 11.14 9.65 9 198292 246 46487515
Teething 11.12 9.65 4 198297 18 46487743
Neutrophil percentage abnormal 11.12 9.65 4 198297 18 46487743
Alopecia 11.11 9.65 570 197731 161844 46325917
Fluid replacement 11.10 9.65 5 198296 44 46487717
Eye irritation 11.03 9.65 35 198266 16579 46471182
Congenital tricuspid valve atresia 11.01 9.65 5 198296 45 46487716
Neuroleptic malignant syndrome 10.94 9.65 19 198282 11103 46476658
Anaphylactic shock 10.93 9.65 133 198168 20141 46467620
Plasmacytoma 10.93 9.65 29 198272 2448 46485313
Pregnancy 10.87 9.65 69 198232 27068 46460693
Right atrial enlargement 10.84 9.65 6 198295 85 46487676
Dysphemia 10.80 9.65 28 198273 2330 46485431
Anaesthetic complication neurological 10.79 9.65 8 198293 192 46487569
Peripheral sensory neuropathy 10.77 9.65 56 198245 6547 46481214
Haemorrhage 10.75 9.65 166 198135 54703 46433058
High density lipoprotein abnormal 10.73 9.65 5 198296 48 46487713
Depression 10.70 9.65 602 197699 169502 46318259
Calcium ionised increased 10.63 9.65 7 198294 138 46487623
Dextrocardia 10.62 9.65 4 198297 21 46487740
Tuberculosis 10.59 9.65 17 198284 10248 46477513
Incorrect route of product administration 10.54 9.65 35 198266 16348 46471413
Hyperbilirubinaemia neonatal 10.50 9.65 10 198291 342 46487419
Pulseless electrical activity 10.49 9.65 59 198242 7108 46480653
Small intestine operation 10.48 9.65 3 198298 5 46487756
Lymphorrhoea 10.47 9.65 5 198296 51 46487710
Hypermagnesaemia 10.44 9.65 16 198285 906 46486855
Left ventricular dysfunction 10.43 9.65 77 198224 10178 46477583
Ankylosing spondylitis 10.42 9.65 8 198293 6729 46481032
Complication of device insertion 10.37 9.65 4 198297 4940 46482821
Bone lesion 10.36 9.65 45 198256 4886 46482875
Stress fracture 10.36 9.65 9 198292 7118 46480643
Monocyte count decreased 10.35 9.65 23 198278 1734 46486027
Hyperlipidaemia 10.35 9.65 42 198259 18497 46469264
Dysuria 10.35 9.65 171 198130 27662 46460099
Pulmonary air leakage 10.32 9.65 4 198297 23 46487738
Eczema 10.30 9.65 48 198253 20352 46467409
Lipase decreased 10.30 9.65 5 198296 53 46487708
Craniofacial deformity 10.26 9.65 6 198295 95 46487666
Pulse absent 10.24 9.65 45 198256 4911 46482850
Bronchitis 10.17 9.65 358 197943 105621 46382140
Metastases to central nervous system 10.16 9.65 82 198219 11139 46476622
Hair growth rate abnormal 10.13 9.65 3 198298 6 46487755
Atelectasis neonatal 10.13 9.65 3 198298 6 46487755
Stoma obstruction 10.13 9.65 3 198298 6 46487755
Post procedural diarrhoea 10.11 9.65 8 198293 212 46487549
Vena cava thrombosis 10.11 9.65 26 198275 2153 46485608
Clostridial infection 10.08 9.65 41 198260 4324 46483437
Productive cough 10.08 9.65 153 198148 50562 46437199
Gastroenteropancreatic neuroendocrine tumour disease 10.06 9.65 5 198296 56 46487705
Renal function test abnormal 10.05 9.65 30 198271 2709 46485052
Hospitalisation 10.05 9.65 346 197955 63039 46424722
Streptococcal sepsis 10.04 9.65 22 198279 1643 46486118
Foetal hypokinesia 10.00 9.65 11 198290 447 46487314
Portal vein thrombosis 10 9.65 28 198273 2439 46485322
Intensive care 9.95 9.65 8 198293 217 46487544
Cerebral haemorrhage 9.95 9.65 75 198226 28296 46459465
Embolism 9.94 9.65 58 198243 7080 46480681
Septic shock 9.94 9.65 319 197982 57574 46430187
Anticholinergic syndrome 9.93 9.65 23 198278 1783 46485978
Oral candidiasis 9.89 9.65 116 198185 17416 46470345
Panniculitis 9.85 9.65 6 198295 5698 46482063
Myopathy 9.85 9.65 14 198287 8867 46478894
Anomalous pulmonary venous connection 9.83 9.65 5 198296 59 46487702
Congenital anaemia 9.82 9.65 3 198298 7 46487754
Postural orthostatic tachycardia syndrome 9.78 9.65 13 198288 645 46487116
Abdominal pain upper 9.77 9.65 730 197571 144575 46343186
Device malfunction 9.73 9.65 27 198274 13347 46474414
Product use issue 9.72 9.65 317 197984 94327 46393434
Aphasia 9.71 9.65 173 198128 28394 46459367
Joint effusion 9.66 9.65 23 198278 11972 46475789

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
Nausea 564.19 10.29 2497 116336 294460 29539185
Febrile neutropenia 482.57 10.29 1206 117627 105487 29728158
Vomiting 454.55 10.29 1898 116935 217920 29615725
Drug ineffective 321.97 10.29 536 118297 339851 29493794
Completed suicide 275.47 10.29 35 118798 99457 29734188
Drug abuse 258.82 10.29 17 118816 82055 29751590
Toxicity to various agents 220.32 10.29 227 118606 176956 29656689
Dehydration 202.89 10.29 998 117835 122541 29711104
Serotonin syndrome 137.14 10.29 251 118582 17640 29816005
Left-to-right cardiac shunt 134.94 10.29 32 118801 12 29833633
Neutropenia 131.14 10.29 916 117917 127624 29706021
Myocardial infarction 130.47 10.29 185 118648 125440 29708205
Pyrexia 121.96 10.29 1738 117095 292751 29540894
Diarrhoea 121.07 10.29 1927 116906 332176 29501469
Rheumatoid arthritis 110.35 10.29 16 118817 41181 29792464
Abdominal pain 102.03 10.29 901 117932 134753 29698892
Febrile bone marrow aplasia 99.74 10.29 141 118692 7956 29825689
Rhabdomyolysis 99.25 10.29 65 118768 63515 29770130
Chills 97.01 10.29 553 118280 71785 29761860
Overdose 96.98 10.29 115 118718 84222 29749423
Heart disease congenital 96.70 10.29 61 118772 1197 29832448
Suicide attempt 96.57 10.29 15 118818 36682 29796963
Disease progression 92.69 10.29 588 118245 79286 29754359
Coronary artery disease 91.93 10.29 41 118792 49671 29783974
Fatigue 91.47 10.29 1781 117052 318892 29514753
Intentional overdose 87.06 10.29 28 118805 41453 29792192
Failure to thrive 85.83 10.29 131 118702 7923 29825722
Constipation 84.37 10.29 749 118084 112157 29721488
Thrombocytopenia 84.08 10.29 872 117961 136172 29697473
Mucosal inflammation 83.76 10.29 289 118544 30205 29803440
Cytokine release syndrome 82.06 10.29 144 118689 9789 29823856
Condition aggravated 78.44 10.29 282 118551 137584 29696061
Otitis media chronic 77.88 10.29 24 118809 64 29833581
Congenital anomaly 77.17 10.29 54 118779 1268 29832377
Blood creatine phosphokinase increased 76.72 10.29 39 118794 43809 29789836
Psoriasis 74.08 10.29 38 118795 42468 29791177
Electrocardiogram QT prolonged 70.08 10.29 305 118528 35530 29798115
Decreased appetite 68.81 10.29 902 117931 149008 29684637
Flushing 68.74 10.29 265 118568 29227 29804418
Small intestinal obstruction 63.18 10.29 156 118677 13503 29820142
Drug resistance 61.04 10.29 5 118828 20128 29813517
Treatment failure 58.96 10.29 32 118801 34647 29798998
Tachycardia 58.05 10.29 495 118338 73244 29760401
Hypoxia 55.90 10.29 353 118480 47501 29786144
Torsade de pointes 55.24 10.29 101 118732 7089 29826556
Erythema 54.83 10.29 508 118325 76943 29756702
White blood cell count decreased 54.69 10.29 541 118292 83406 29750239
Sepsis 54.05 10.29 848 117985 145547 29688098
Therapeutic product effect incomplete 53.59 10.29 34 118799 33800 29799845
Intentional product misuse 50.70 10.29 38 118795 34629 29799016
Interstitial lung disease 49.28 10.29 103 118730 60094 29773551
Arthralgia 48.67 10.29 327 118506 135464 29698181
Hepatic function abnormal 48.39 10.29 57 118776 41888 29791757
Aggression 48.38 10.29 45 118788 36862 29796783
Plasma cell myeloma 46.98 10.29 368 118465 53094 29780551
Myalgia 44.77 10.29 155 118678 76512 29757133
Wrong technique in product usage process 44.48 10.29 35 118798 31120 29802525
Musculoskeletal stiffness 43.31 10.29 47 118786 35834 29797811
Aplasia 42.08 10.29 65 118768 3972 29829673
Suicidal ideation 41.74 10.29 49 118784 36065 29797580
Hospice care 41.34 10.29 68 118765 4384 29829261
Pancytopenia 41.16 10.29 517 118316 84535 29749110
Malignant neoplasm progression 40.53 10.29 452 118381 71835 29761810
Malignant catatonia 40.46 10.29 16 118817 106 29833539
Ventricular tachyarrhythmia 40.40 10.29 21 118812 280 29833365
Right ventricular hypertrophy 40.35 10.29 26 118807 530 29833115
Hypotension 40.29 10.29 1061 117772 199504 29634141
Depression 40.28 10.29 203 118630 90234 29743411
Asthma 39.79 10.29 51 118782 36123 29797522
Hypophagia 38.79 10.29 183 118650 22053 29811592
Right ventricular enlargement 37.89 10.29 16 118817 128 29833517
Cardiac failure 37.86 10.29 186 118647 83232 29750413
Cerebrovascular accident 37.39 10.29 187 118646 83290 29750355
Intentional self-injury 36.83 10.29 5 118828 13527 29820118
Neuropathy peripheral 36.52 10.29 434 118399 70041 29763604
Diabetes mellitus 36.52 10.29 69 118764 41796 29791849
Laevocardia 36.27 10.29 8 118825 0 29833645
Platelet count decreased 36.22 10.29 607 118226 105522 29728123
Fall 36.19 10.29 506 118327 181366 29652279
Drug interaction 35.32 10.29 568 118265 199000 29634645
Foetal exposure during pregnancy 35.30 10.29 259 118574 36612 29797033
Right-to-left cardiac shunt 35.11 10.29 10 118823 18 29833627
Melaena 34.38 10.29 47 118786 32390 29801255
Drug dependence 34.27 10.29 21 118812 21274 29812371
Psoriatic arthropathy 34.21 10.29 10 118823 15751 29817894
Hypoplastic left heart syndrome 33.78 10.29 17 118816 211 29833434
Asthenia 33.67 10.29 1131 117702 220159 29613486
Renal impairment 33.60 10.29 196 118637 83988 29749657
Angina pectoris 33.10 10.29 41 118792 29477 29804168
Acute myocardial infarction 32.98 10.29 104 118729 52835 29780810
Pulmonary artery stenosis congenital 32.41 10.29 22 118811 491 29833154
Angioedema 32.40 10.29 54 118779 34330 29799315
Stomatitis 32.40 10.29 256 118577 37023 29796622
Encephalopathy 31.85 10.29 228 118605 31977 29801668
Inappropriate schedule of product administration 31.65 10.29 69 118764 39659 29793986
Eustachian tube dysfunction 31.59 10.29 11 118822 48 29833597
Therapeutic response decreased 31.54 10.29 30 118803 24319 29809326
Atrial septal defect 31.48 10.29 77 118756 6624 29827021
Hypersensitivity 31.27 10.29 340 118493 53688 29779957
Weight increased 31.20 10.29 172 118661 74741 29758904
Hypokalaemia 30.99 10.29 320 118513 49872 29783773
Therapeutic product effect decreased 30.94 10.29 42 118791 29034 29804611
Neutrophil count decreased 30.80 10.29 280 118553 42174 29791471
Poor feeding infant 30.61 10.29 19 118814 362 29833283
Erectile dysfunction 30.34 10.29 17 118816 18085 29815560
Otitis media acute 30.07 10.29 19 118814 374 29833271
Cardiac failure congestive 29.84 10.29 204 118629 84203 29749442
Blood cholesterol increased 29.82 10.29 15 118818 16955 29816690
Full blood count decreased 29.37 10.29 132 118701 15585 29818060
Pneumonia 29.31 10.29 1613 117220 332693 29500952
Injection site pain 29.12 10.29 47 118786 30263 29803382
Neoplasm progression 29.04 10.29 145 118688 17878 29815767
Developmental delay 28.94 10.29 39 118794 2102 29831543
Colitis 28.65 10.29 215 118618 30605 29803040
Bacteraemia 28.57 10.29 130 118703 15430 29818215
Negative pressure pulmonary oedema 28.41 10.29 15 118818 207 29833438
Angina unstable 28.25 10.29 7 118826 12303 29821342
Cerebral infarction 28.16 10.29 38 118795 26335 29807310
Hallucination, auditory 28.16 10.29 3 118830 9786 29823859
Diabetes mellitus inadequate control 27.88 10.29 8 118825 12754 29820891
Atelectasis 27.55 10.29 132 118701 16006 29817639
Infusion related reaction 27.15 10.29 263 118570 40301 29793344
Oral pain 27.09 10.29 91 118742 9378 29824267
Coma 26.23 10.29 78 118755 40371 29793274
Sepsis neonatal 26.08 10.29 15 118818 247 29833398
Deep vein thrombosis 26.01 10.29 360 118473 60141 29773504
Impaired gastric emptying 25.86 10.29 46 118787 3160 29830485
Synovitis 25.73 10.29 4 118829 9779 29823866
Product dose omission issue 25.64 10.29 236 118597 91395 29742250
Mental status changes 25.61 10.29 242 118591 36837 29796808
Schizophrenia 25.46 10.29 3 118830 9045 29824600
Pleural effusion 25.39 10.29 424 118409 73642 29760003
Anaphylactic reaction 25.33 10.29 194 118639 27788 29805857
Chemotherapeutic drug level increased 25.31 10.29 14 118819 213 29833432
Blood triglycerides increased 25.22 10.29 12 118821 14005 29819640
Oxygen saturation immeasurable 24.86 10.29 9 118824 45 29833600
Adenoidal hypertrophy 24.84 10.29 11 118822 100 29833545
Hypoglycaemia 24.69 10.29 111 118722 50870 29782775
Dry skin 24.59 10.29 163 118670 22291 29811354
Hyperbilirubinaemia 24.32 10.29 132 118701 16810 29816835
Blood pressure measurement 24.05 10.29 12 118821 146 29833499
Malnutrition 23.57 10.29 99 118734 11350 29822295
Multiple congenital abnormalities 23.33 10.29 18 118815 493 29833152
Oxygen saturation decreased 23.15 10.29 269 118564 43171 29790474
Univentricular heart 23.07 10.29 6 118827 6 29833639
Appendicolith 23.01 10.29 23 118810 896 29832749
Psychotic disorder 22.97 10.29 31 118802 21484 29812161
Atelectasis neonatal 22.67 10.29 5 118828 0 29833645
Cleft palate 22.63 10.29 19 118814 589 29833056
Coronary artery occlusion 22.58 10.29 8 118825 11149 29822496
Type 2 diabetes mellitus 22.53 10.29 13 118820 13609 29820036
Oropharyngeal discomfort 22.47 10.29 29 118804 1498 29832147
Product substitution issue 22.46 10.29 6 118827 10029 29823616
Tumour lysis syndrome 22.44 10.29 106 118727 12779 29820866
Labelled drug-drug interaction medication error 22.30 10.29 7 118826 10531 29823114
Aplastic anaemia 22.13 10.29 60 118773 5496 29828149
Palmar erythema 22.09 10.29 13 118820 224 29833421
Altered state of consciousness 21.99 10.29 28 118805 19891 29813754
Abnormal behaviour 21.67 10.29 43 118790 25580 29808065
Testicular germ cell cancer metastatic 21.64 10.29 9 118824 69 29833576
Periorbital swelling 21.62 10.29 12 118821 184 29833461
Cytomegalovirus infection 21.55 10.29 38 118795 23636 29810009
Painful respiration 21.35 10.29 26 118807 1266 29832379
Right ventricular dilatation 21.24 10.29 17 118816 492 29833153
Hyperthermia malignant 21.21 10.29 31 118802 1803 29831842
Right aortic arch 21.20 10.29 7 118826 25 29833620
Endocardial fibroelastosis 21.00 10.29 6 118827 11 29833634
Tubulointerstitial nephritis 20.97 10.29 24 118809 17867 29815778
Bradycardia 20.45 10.29 164 118669 65362 29768283
Feeling hot 20.40 10.29 118 118715 15386 29818259
Klebsiella bacteraemia 20.34 10.29 23 118810 1034 29832611
Poisoning 20.09 10.29 10 118823 11372 29822273
Coarctation of the aorta 20.05 10.29 16 118817 461 29833184
Joint swelling 19.97 10.29 107 118726 46839 29786806
Incorrect dose administered 19.90 10.29 62 118771 31624 29802021
Impetigo 19.89 10.29 20 118813 785 29832860
Respiratory distress 19.77 10.29 209 118624 32763 29800882
Hypomagnesaemia 19.71 10.29 123 118710 16475 29817170
Lactic acidosis 19.66 10.29 61 118772 31152 29802493
Prostate cancer 19.59 10.29 41 118792 23916 29809729
Tendonitis 19.58 10.29 4 118829 8032 29825613
Hypoplastic right heart syndrome 19.47 10.29 6 118827 16 29833629
Dermatitis diaper 19.43 10.29 13 118820 283 29833362
Clonus 19.25 10.29 35 118798 2446 29831199
Infusion site urticaria 19.24 10.29 9 118824 94 29833551
Treatment noncompliance 19.18 10.29 45 118788 25208 29808437
Death 18.96 10.29 1654 117179 355629 29478016
Somnolence 18.92 10.29 270 118563 96493 29737152
Liver disorder 18.78 10.29 58 118775 29664 29803981
Laryngeal discomfort 18.69 10.29 10 118823 142 29833503
C-reactive protein increased 18.54 10.29 99 118734 43374 29790271
Fear 18.38 10.29 10 118823 10815 29822830
Feeding disorder 18.21 10.29 58 118775 5813 29827832
Gastrointestinal malformation 18.14 10.29 7 118826 43 29833602
Poor weight gain neonatal 18.14 10.29 4 118829 0 29833645
Osteoarthritis 18.05 10.29 28 118805 18321 29815324
Nasopharyngitis 18.04 10.29 148 118685 58701 29774944
Platelet transfusion 18.00 10.29 21 118812 977 29832668
Necrotising retinitis 17.89 10.29 18 118815 707 29832938
Road traffic accident 17.82 10.29 25 118808 17046 29816599
Immune-mediated hepatitis 17.70 10.29 22 118811 1094 29832551
Change of bowel habit 17.68 10.29 21 118812 996 29832649
Eosinophil count increased 17.64 10.29 4 118829 7469 29826176
Immune reconstitution inflammatory syndrome 17.63 10.29 7 118826 9094 29824551
Walking aid user 17.52 10.29 25 118808 1422 29832223
Laryngospasm 17.45 10.29 24 118809 1319 29832326
Clostridium difficile colitis 17.34 10.29 98 118735 12670 29820975
Tachypnoea 17.26 10.29 110 118723 14842 29818803
Disturbance in attention 17.16 10.29 39 118794 22090 29811555
Drug ineffective for unapproved indication 17.13 10.29 11 118822 10869 29822776
Faeces discoloured 17.12 10.29 18 118815 13928 29819717
Gait disturbance 17.07 10.29 202 118631 74575 29759070
Blood pressure fluctuation 16.94 10.29 27 118806 17476 29816169
Accidental overdose 16.94 10.29 29 118804 18246 29815399
Gynaecomastia 16.88 10.29 6 118827 8345 29825300
Upper respiratory tract infection 16.87 10.29 175 118658 27301 29806344
Electrocardiogram T wave biphasic 16.80 10.29 7 118826 54 29833591
Congenital aortic stenosis 16.74 10.29 8 118825 88 29833557
Fixed eruption 16.67 10.29 22 118811 1162 29832483
Perihepatic abscess 16.66 10.29 8 118825 89 29833556
Unresponsive to stimuli 16.56 10.29 169 118664 26250 29807395
Enteritis 16.54 10.29 61 118772 6584 29827061
Urine sodium decreased 16.51 10.29 10 118823 182 29833463
Large intestinal obstruction 16.42 10.29 24 118809 1396 29832249
Croup infectious 16.14 10.29 11 118822 247 29833398
Pulmonary embolism 16.11 10.29 415 118418 77720 29755925
Sinus tachycardia 16.05 10.29 111 118722 15393 29818252
Ventricular fibrillation 16.04 10.29 109 118724 15029 29818616
Pulse absent 16.01 10.29 53 118780 5420 29828225
Pulmonary oedema neonatal 15.91 10.29 4 118829 3 29833642
Loss of personal independence in daily activities 15.86 10.29 39 118794 21496 29812149
Cleft lip 15.80 10.29 12 118821 321 29833324
Glycosylated haemoglobin increased 15.78 10.29 9 118824 9482 29824163
Blood glucose increased 15.72 10.29 162 118671 61368 29772277
Cyanosis neonatal 15.44 10.29 11 118822 266 29833379
Insomnia 15.37 10.29 269 118564 93067 29740578
Septic shock 15.28 10.29 345 118488 63262 29770383
Myocardial oedema 15.23 10.29 7 118826 70 29833575
Bone marrow transplant 15.22 10.29 19 118814 949 29832696
Electrocardiogram QT shortened 15.19 10.29 9 118824 157 29833488
Osteoporosis 15.19 10.29 12 118821 10651 29822994
Hepatitis C 15.16 10.29 18 118815 13187 29820458
Velopharyngeal incompetence 15.11 10.29 5 118828 18 29833627
Paranoia 15.11 10.29 11 118822 10177 29823468
Stridor 15.07 10.29 30 118803 2244 29831401
Pain in extremity 15.01 10.29 328 118505 109893 29723752
Hyperaemia 14.99 10.29 19 118814 964 29832681
Transplant rejection 14.92 10.29 9 118824 9197 29824448
Right ventricle outflow tract obstruction 14.91 10.29 4 118829 5 29833640
Procedural nausea 14.81 10.29 7 118826 75 29833570
Hyperkalaemia 14.80 10.29 179 118654 65831 29767814
Erythropenia 14.74 10.29 10 118823 223 29833422
Oral candidiasis 14.39 10.29 84 118749 10987 29822658
Cataract 14.23 10.29 42 118791 21793 29811852
Arteriosclerosis coronary artery 14.20 10.29 14 118819 11162 29822483
International normalised ratio increased 14.20 10.29 121 118712 47618 29786027
Atrioventricular block complete 14.15 10.29 8 118825 8469 29825176
Chronic obstructive pulmonary disease 14.14 10.29 116 118717 46010 29787635
Congenital torticollis 14.12 10.29 4 118829 7 29833638
Depressed mood 14.04 10.29 29 118804 17000 29816645
Cardiac murmur 13.99 10.29 59 118774 6775 29826870
Right atrial enlargement 13.96 10.29 10 118823 244 29833401
Pathogen resistance 13.94 10.29 8 118825 8402 29825243
Cardiac ventricular disorder 13.94 10.29 9 118824 184 29833461
Visual acuity reduced 13.92 10.29 26 118807 15820 29817825
Intestinal ischaemia 13.70 10.29 59 118774 6838 29826807
Hypoalbuminaemia 13.68 10.29 83 118750 11009 29822636
Dyslipidaemia 13.65 10.29 3 118830 5724 29827921
Adenoiditis 13.60 10.29 3 118830 0 29833645
Cardiomyopathy neonatal 13.60 10.29 3 118830 0 29833645
Cardiac malposition 13.60 10.29 3 118830 0 29833645
Cystic fibrosis pancreatic 13.60 10.29 3 118830 0 29833645
Hemiplegic migraine 13.60 10.29 3 118830 0 29833645
Hyponatraemia 13.58 10.29 356 118477 66846 29766799
Anomalous pulmonary venous connection 13.56 10.29 7 118826 92 29833553
Capillary leak syndrome 13.50 10.29 24 118809 1648 29831997
Locked-in syndrome 13.48 10.29 10 118823 258 29833387
Underdose 13.47 10.29 17 118816 12124 29821521
Thrombosis 13.46 10.29 239 118594 41992 29791653
Hallucination 13.43 10.29 127 118706 48932 29784713
Aorta hypoplasia 13.42 10.29 7 118826 94 29833551
Neurotoxicity 13.42 10.29 94 118739 13088 29820557
Patent ductus arteriosus 13.41 10.29 35 118798 3134 29830511
Palmar-plantar erythrodysaesthesia syndrome 13.40 10.29 103 118730 14767 29818878
Atrial fibrillation 13.32 10.29 540 118293 107584 29726061
Gastrointestinal haemorrhage 13.26 10.29 242 118591 83204 29750441
Speech sound disorder 13.23 10.29 6 118827 58 29833587
Inflammation 13.20 10.29 44 118789 21982 29811663
Extravasation 13.19 10.29 25 118808 1803 29831842
Trismus 13.11 10.29 29 118804 2336 29831309
Product quality issue 13.06 10.29 35 118798 18739 29814906
Obesity 13.00 10.29 9 118824 8546 29825099
Subileus 12.97 10.29 34 118799 3053 29830592
Tuberculosis 12.95 10.29 8 118825 8069 29825576
Cardiac arrest 12.93 10.29 470 118363 92380 29741265
Vitamin B1 deficiency 12.80 10.29 9 118824 213 29833432
Ventricular hypoplasia 12.80 10.29 6 118827 63 29833582
Supraventricular tachycardia 12.75 10.29 77 118756 10195 29823450
Fracture 12.69 10.29 4 118829 6002 29827643
Leukopenia 12.68 10.29 302 118531 55857 29777788
Sexual dysfunction 12.68 10.29 4 118829 5997 29827648
Kidney transplant rejection 12.66 10.29 7 118826 7502 29826143
Myopathy 12.62 10.29 14 118819 10572 29823073
Tympanic membrane perforation 12.51 10.29 9 118824 221 29833424
Therapy interrupted 12.49 10.29 43 118790 4486 29829159
Accidental exposure to product 12.48 10.29 13 118820 10102 29823543
Parainfluenzae virus infection 12.46 10.29 26 118807 2012 29831633
Phimosis 12.37 10.29 14 118819 630 29833015
Ventricular tachycardia 12.37 10.29 147 118686 23715 29809930
Poisoning deliberate 12.36 10.29 4 118829 5900 29827745
Mobility decreased 12.35 10.29 57 118776 25942 29807703
Injection site haemorrhage 12.29 10.29 8 118825 7847 29825798
Catheter site pain 12.28 10.29 18 118815 1050 29832595
Anaemia 12.28 10.29 971 117862 207021 29626624
Dementia 12.27 10.29 19 118814 12442 29821203
Congenital genitourinary abnormality 12.17 10.29 4 118829 14 29833631
Neonatal tachycardia 12.17 10.29 4 118829 14 29833631
Oesophageal irritation 12.17 10.29 6 118827 71 29833574
Seminoma 12.17 10.29 9 118824 231 29833414
Joint range of motion decreased 12.16 10.29 4 118829 5841 29827804
Osteonecrosis 12.06 10.29 29 118804 16106 29817539
Hyperlipidaemia 12.05 10.29 23 118810 13884 29819761
Product complaint 12.03 10.29 4 118829 5802 29827843
Neonatal tachypnoea 12.03 10.29 7 118826 118 29833527
Atrioventricular septal defect 12.03 10.29 6 118827 73 29833572
Neutropenic colitis 11.97 10.29 27 118806 2203 29831442
Parkinsonism 11.93 10.29 7 118826 7262 29826383
Respiratory depression 11.85 10.29 17 118816 11486 29822159
Hot flush 11.77 10.29 99 118734 14581 29819064
Congenital hypothyroidism 11.76 10.29 4 118829 16 29833629
Congenital pulmonary artery anomaly 11.76 10.29 4 118829 16 29833629
Skin ulcer 11.75 10.29 37 118796 18812 29814833
Cytokine storm 11.74 10.29 13 118820 571 29833074
Ageusia 11.68 10.29 68 118765 8885 29824760
Dysgeusia 11.65 10.29 150 118683 24651 29808994
Epilepsy 11.61 10.29 41 118792 20128 29813517
Hyperbilirubinaemia neonatal 11.59 10.29 14 118819 676 29832969
Ischaemic stroke 11.58 10.29 30 118803 16245 29817400
Chest injury 11.56 10.29 20 118813 1344 29832301
Urinary tract infection neonatal 11.53 10.29 3 118830 3 29833642
Anaesthetic complication neurological 11.51 10.29 10 118823 325 29833320
Glomerular filtration rate decreased 11.50 10.29 17 118816 11345 29822300
Knee arthroplasty 11.46 10.29 4 118829 5626 29828019
Sleep disorder 11.43 10.29 54 118779 24425 29809220
Product administration error 11.42 10.29 25 118808 14352 29819293
Photosensitivity reaction 11.36 10.29 13 118820 9681 29823964
Cerebral haemorrhage 11.35 10.29 80 118753 32807 29800838
Nightmare 11.34 10.29 19 118814 12057 29821588
Blood culture positive 11.29 10.29 44 118789 4875 29828770
Drug eruption 11.21 10.29 34 118799 17492 29816153
Memory impairment 11.16 10.29 94 118739 37080 29796565
No reaction on previous exposure to drug 11.10 10.29 6 118827 87 29833558
Mitral valve atresia 11.08 10.29 3 118830 4 29833641
Ventricular septal defect 11.07 10.29 35 118798 3494 29830151
Enterovirus test positive 11.05 10.29 5 118828 48 29833597
Diaphragmatic rupture 11.05 10.29 4 118829 20 29833625
Vasospasm 11.01 10.29 10 118823 345 29833300
Congenital pulmonary hypertension 10.97 10.29 5 118828 49 29833596
Infusion site pain 10.94 10.29 29 118804 2621 29831024
Anger 10.91 10.29 17 118816 11103 29822542
Clostridium difficile infection 10.89 10.29 103 118730 15680 29817965
Device issue 10.88 10.29 9 118824 7807 29825838
Hypoperfusion 10.83 10.29 17 118816 1053 29832592
Pseudomonal bacteraemia 10.82 10.29 15 118818 831 29832814
Coronary artery stenosis 10.81 10.29 12 118821 9058 29824587
Micrognathia 10.80 10.29 9 118824 276 29833369
Therapeutic product effect prolonged 10.77 10.29 9 118824 277 29833368
Back pain 10.77 10.29 504 118329 102092 29731553
Device related infection 10.74 10.29 109 118724 16906 29816739
Hypospadias 10.74 10.29 29 118804 2650 29830995
Bronchial hyperreactivity 10.72 10.29 18 118815 1180 29832465
Arthritis 10.72 10.29 55 118778 24346 29809299
Cold type haemolytic anaemia 10.69 10.29 6 118827 94 29833551
Eye pain 10.66 10.29 19 118814 11770 29821875
Pseudomonal sepsis 10.58 10.29 31 118802 2969 29830676
Alcohol abuse 10.56 10.29 4 118829 5349 29828296
Biliary tract infection 10.53 10.29 11 118822 452 29833193
Haematoma 10.52 10.29 54 118779 23899 29809746
Jaundice neonatal 10.52 10.29 17 118816 1080 29832565
Depressed level of consciousness 10.44 10.29 99 118734 38123 29795522
Taste disorder 10.43 10.29 34 118799 3449 29830196
Tryptase increased 10.41 10.29 8 118825 218 29833427
Inflammatory pain 10.38 10.29 5 118828 56 29833589
Antithrombin III deficiency 10.37 10.29 6 118827 100 29833545
Abdominal compartment syndrome 10.35 10.29 15 118818 866 29832779
Foreign body embolism 10.33 10.29 3 118830 6 29833639
Neutrophilic panniculitis 10.31 10.29 4 118829 25 29833620
Appendicitis 10.30 10.29 50 118783 6094 29827551
Middle insomnia 10.30 10.29 5 118828 5768 29827877

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
D00456 KEGG_DRUG
103639-04-9 SECONDARY_CAS_RN
4019563 VANDF
4019865 VANDF
C0733434 UMLSCUI
CHEBI:7773 CHEBI
S87 PDB_CHEM_ID
CHEMBL46 ChEMBL_ID
CHEMBL1201111 ChEMBL_ID
CHEMBL3186492 ChEMBL_ID
CHEMBL428411 ChEMBL_ID
CHEMBL399705 ChEMBL_ID
D017294 MESH_DESCRIPTOR_UI
DB00904 DRUGBANK_ID
2290 IUPHAR_LIGAND_ID
5965 INN_ID
4AF302ESOS UNII
59774 PUBCHEM_CID
203148 RXNORM
27290 MMSL
5202 MMSL
90631 MMSL
d00867 MMSL
003568 NDDF
004807 NDDF
108418007 SNOMEDCT_US
108419004 SNOMEDCT_US
372487007 SNOMEDCT_US
830157000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0064 SOLUTION 4 mg ORAL ANDA 26 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0675 TABLET, FILM COATED 4 mg ORAL NDA 30 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0676 TABLET, FILM COATED 8 mg ORAL NDA 30 sections
Ondansetron Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0143-9771 INJECTION, SOLUTION 32 mg INTRAVENOUS ANDA 24 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9890 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9891 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7732 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7734 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4755 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4759 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1726 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8185 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0904-7073 SOLUTION 4 mg ORAL ANDA 26 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-575 TABLET, FILM COATED 8 mg ORAL ANDA 22 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-365 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-371 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16590-545 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 12 sections
Ondansetron Human Prescription Drug Label 1 16714-159 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
Ondansetron Human Prescription Drug Label 1 16714-160 TABLET, FILM COATED 8 mg ORAL ANDA 26 sections
Ondansetron Human Prescription Drug Label 1 16714-200 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 26 sections
Ondansetron Human Prescription Drug Label 1 16714-201 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 26 sections
Ondansetron Human Prescription Drug Label 1 16714-671 SOLUTION 4 mg ORAL ANDA 26 sections
ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16729-297 INJECTION 2 mg INTRAVENOUS ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16729-298 INJECTION 2 mg INTRAVENOUS ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 17856-0555 SOLUTION 4 mg ORAL ANDA 26 sections