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)
Gastrointestinal pain07.01.05.005--
Generalised anxiety disorder19.06.01.0040.000100%Not Available
Generalised tonic-clonic seizure17.12.01.0020.000100%Not Available
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.0080.000749%Not Available
Haemangioma24.03.06.004; 16.02.01.0020.000100%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.000499%Not Available
Haematoma24.07.01.0010.000100%
Haematuria24.07.01.047; 20.02.01.0060.000300%
Blood urine present13.13.02.0020.000150%Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.0080.000026%
Haemorrhoids24.10.02.002; 07.15.03.0010.000200%
Hand fracture12.04.01.014; 15.08.03.0140.000150%Not Available
Headache17.14.01.0010.002547%
Heart disease congenital03.07.07.001; 02.01.01.0090.001264%Not Available
Heart rate decreased13.14.04.0010.000100%Not Available
Heart rate increased13.14.04.0020.000100%Not Available
Heart rate irregular13.14.04.0030.000150%Not Available
Hepatic failure09.01.03.0020.000026%
Hepatocellular injury09.01.07.008--Not Available
Hepatomegaly09.01.05.0010.000100%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.000100%
Hiatus hernia22.09.02.004; 07.16.01.0010.000150%Not Available
Hiccups22.02.04.002; 07.01.06.009--
High arched palate07.05.01.011; 03.04.02.0020.000100%Not Available
Hydrocele21.12.02.003; 03.03.01.0040.000039%Not Available
Hydrocephalus17.07.01.0010.000150%
Hydronephrosis20.01.05.0010.000399%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000150%Not Available
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