Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ondansetron hydrochloride
Drug ID BADD_D01618
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 D00678
MeSH ID D017294
PubChem ID 68647
TTD Drug ID D0K7WK
NDC Product Code 17856-0555; 70860-776; 53808-1121; 68071-1816; 64679-726; 50090-4671; 43063-746; 63323-373; 0054-0064; 70934-148; 0078-0675; 55154-4453; 51672-4109; 55111-154; 71872-7069; 63629-4023; 58118-7500; 63187-513; 55154-6976; 38779-2415; 59115-807; 68071-4966; 67046-346; 50090-3185; 65862-189; 63629-7781; 66651-903; 60760-637; 68071-1649; 65862-187; 59116-1850; 68071-4208; 50268-621; 36000-012; 42708-044; 70860-777; 53104-7540; 65691-0035; 50436-1880; 59116-1853; 67835-5014; 68094-763; 63629-6709; 68071-2053; 43063-792; 16714-671; 55154-8329; 45865-509; 65862-188; 71610-119; 68788-9368; 76045-103; 71335-0205; 50090-3839; 55700-631; 62756-130; 0904-6551; 68071-4705; 50090-3178; 57237-076; 51672-4091; 68071-4206; 59116-1852; 70934-264; 67296-0902; 55150-126; 63187-709; 71335-0815; 51927-4320; 55700-627; 68788-9402; 55154-8176; 60760-636; 51672-4108; 59116-1851; 71335-1596; 50436-0187; 67877-169; 71205-109; 53002-0571; 65862-208; 67877-170; 0527-1726; 64679-727; 63323-374; 67184-0001; 63629-8111; 72789-034; 53002-0601; 25021-777; 70518-1585; 70934-318; 57237-075; 42708-059; 68084-220; 51927-0075; 70934-193; 0078-0676; 65129-2161; 51846-1025; 68071-2147; 0615-8185; 65862-377; 71335-1357; 71335-1855; 62756-131; 57451-1153; 68071-2547; 50268-622; 68071-4911; 68071-4328; 63629-4093; 51672-4110; 54348-821; 55111-155; 53002-0600; 53002-1633; 0904-6552; 55111-156; 70518-1394; 68071-5047; 55111-153; 67296-1562; 63187-636; 64567-0005; 66022-0204; 68084-221; 55150-125; 54838-555
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 C18H20ClN3O
CAS Registry Number 99614-01-4
SMILES CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C.Cl
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)
Laryngeal oedema22.04.02.001; 10.01.05.003; 23.04.01.005--
Laryngospasm22.04.02.002--
Malaise08.01.01.003--
Oculogyric crisis17.01.03.002; 06.05.02.002--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Sedation17.02.04.005--Not Available
Shock24.06.02.002--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stridor22.04.02.003--
Tachycardia02.03.02.007--Not Available
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
Wound12.01.08.009--Not Available
Vascular occlusion24.04.02.015--Not Available
Gynaecological examination abnormal13.15.01.021--Not Available
Electrocardiogram change13.14.05.014--Not Available
Psychiatric symptom19.01.02.001--Not Available
Hepatic enzyme abnormal13.03.01.020--Not Available
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