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)
Abdominal discomfort07.01.06.0010.000350%Not Available
Abdominal distension07.01.04.0010.000350%
Abdominal pain07.01.05.0020.002896%
Abdominal pain lower07.01.05.0100.000250%Not Available
Abdominal pain upper07.01.05.0030.000949%
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.000300%Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.0020.000100%
Acne23.02.01.0010.000200%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.0010.000100%Not Available
Acute respiratory failure22.02.06.001; 14.01.04.0040.000143%Not Available
Acute sinusitis22.07.03.013; 11.01.13.0120.001148%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.000026%Not Available
Akathisia19.06.02.006; 17.01.02.002--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.0020.000150%
Anaemia01.03.02.0010.001198%
Anaemia neonatal18.04.03.002; 01.03.02.0110.000549%Not Available
Anal atresia07.13.05.001; 03.04.06.0010.000100%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000150%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000100%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anencephaly17.19.03.001; 03.10.03.0010.000100%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anhedonia19.15.02.0070.005692%Not Available
Anxiety19.06.02.0020.010486%
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