Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ondansetron
Drug ID BADD_D01617
Description 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. Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis [L5221].
Indications and Usage For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, postoperation, and radiation. Also used for the treatment of postoperative nausea and vomiting.
Marketing Status Prescription; Discontinued
ATC Code A04AA01
DrugBank ID DB00904
KEGG ID D00456
MeSH ID D017294
PubChem ID 4595
TTD Drug ID D0K7WK
NDC Product Code 68788-7565; 65862-391; 63850-2706; 72572-520; 63187-670; 72266-123; 71872-7068; 62135-122; 0143-9890; 57237-077; 16729-298; 63187-002; 55111-050; 0404-9930; 51662-1469; 68071-5021; 16714-159; 43063-770; 71335-1314; 68071-2284; 68071-4570; 68071-3028; 61919-545; 23155-547; 71872-7107; 63629-7951; 60760-277; 0378-7734; 68788-7705; 63629-4306; 71872-7162; 52584-069; 71335-0496; 68071-4834; 71930-018; 61919-087; 61919-986; 71335-0650; 55154-4567; 68071-5230; 16714-160; 63187-483; 23155-549; 0409-4759; 68083-113; 71335-1731; 63187-526; 67296-1294; 68462-158; 71335-0657; 55154-2876; 16714-201; 63187-693; 70518-2895; 71930-017; 71872-7140; 43063-870; 45865-598; 51662-1246; 55700-952; 68071-4566; 50436-0390; 0904-7073; 68071-4190; 68462-106; 63629-4014; 55700-672; 16714-200; 50090-4632; 71872-7138; 80425-0113; 63187-256; 68071-4513; 68071-1804; 52482-019; 68071-4717; 53002-0570; 76420-056; 62756-356; 51662-1539; 63187-379; 70518-2650; 61919-565; 50090-1201; 50090-1200; 17856-0691; 80425-0073; 51662-1377; 0641-6080; 55154-3680; 68071-4409; 43063-857; 53002-0590; 67184-0507; 50090-1658; 63739-333; 63187-266; 50090-1659; 63629-5083; 68788-9559; 68083-114; 51662-1366; 0143-9891; 0641-6078; 71335-1071; 68462-157; 53002-0580; 60760-313; 23155-550; 68071-1987; 65162-691; 68071-2584; 0409-4755; 68071-4810; 23155-548; 63187-236; 65862-390; 60760-305; 68788-9670; 54348-819; 68071-2652; 51662-1245; 68071-4594; 60760-306; 62135-121; 70518-0829; 45963-539; 50090-4935; 43063-273; 68788-7644; 72266-124; 62756-240; 63304-458; 53002-0582; 60505-6130; 57237-078; 45963-538; 0641-6079; 0378-7732; 55154-2877; 70518-3075; 68071-5167; 50090-1660; 50090-1128; 70166-486; 71335-0132; 63187-065; 66651-904; 63304-459; 45865-105; 67457-440; 68462-105; 70934-809; 51846-1033; 45865-563; 68071-1904; 68071-4426; 68001-247; 70518-1551; 68001-246; 63187-199; 68071-1730; 65129-2118; 50090-5346; 16729-297; 60687-252; 51662-1514; 89141-444; 68071-4881; 57451-1191; 53002-0591
Synonyms Ondansetron | Ondansetron, (+,-)-Isomer | 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)- | Ondansetron Hydrochloride | Hydrochloride, Ondansetron | Ondansetron Monohydrochloride | Monohydrochloride, Ondansetron | Ondansetron Monohydrochloride Dihydrate | Dihydrate, Ondansetron Monohydrochloride | Monohydrochloride Dihydrate, Ondansetron | GR38032F | GR-38032F | GR 38032F | Ondansetron, (S)-Isomer | SN-307 | SN 307 | SN307 | Zofran | Ondansetron, (R)-Isomer
Chemical Information
Molecular Formula C18H19N3O
CAS Registry Number 99614-02-5
SMILES CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cystic fibrosis22.03.01.015; 07.18.03.001; 03.16.01.0020.000039%Not Available
Cystitis20.03.02.002; 11.01.14.0010.000549%
Dacryostenosis congenital06.06.04.008; 03.01.04.0010.000065%Not Available
Deafness04.02.01.0010.001198%Not Available
Death08.04.01.001--
Death neonatal18.04.01.002; 08.04.01.0020.000026%
Dehydration14.05.05.0010.001448%
Dental caries07.09.01.0010.000350%
Depressed mood19.15.02.0010.000200%Not Available
Depression19.15.01.0010.001947%
Dermatitis23.03.04.0020.000649%Not Available
Dermatitis atopic23.03.04.016; 10.01.04.0040.000549%Not Available
Dermatitis contact12.03.01.040; 10.01.01.003; 23.03.04.0040.000300%Not Available
Dermatitis diaper23.03.04.0050.000274%Not Available
Developmental coordination disorder19.22.01.001; 17.02.02.0110.000026%Not Available
Developmental delay08.01.03.0370.001947%Not Available
Diarrhoea07.02.01.0010.002647%
Dilatation atrial02.04.02.0190.000100%Not Available
Dilatation ventricular02.04.02.0260.001548%Not Available
Discomfort08.01.08.0030.000200%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.000150%
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.0030.001148%
Drooling17.02.05.0050.000150%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry eye06.08.02.0010.000100%
Dry mouth07.06.01.002--
Dry skin23.03.03.0010.000100%
Dysarthria17.02.08.001; 19.19.03.0010.000150%
Dysfunctional uterine bleeding21.01.01.001; 05.05.01.0030.000150%Not Available
Dysgeusia17.02.07.003; 07.14.03.0010.000150%
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