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 In the adult patient population: i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and - the prevention and treatment of postoperative nausea and vomiting ii) intravenously administered ondansetron injection formulations are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and - the prevention and treatment of postoperative nausea and vomiting In the pediatric (4-18 years of age) patient population: i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting, ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger, iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting In the geriatric (>65 years of age) patient population: i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population
Marketing Status approved
ATC Code A04AA01
DrugBank ID DB00904
KEGG ID D00678
MeSH ID D017294
PubChem ID 68647
TTD Drug ID D0K7WK
NDC Product Code 38779-2415; 59115-807; 66022-0204; 42708-044; 51655-933; 51672-4091; 51672-4109; 53002-0601; 55111-155; 55111-156; 60760-636; 60760-658; 63187-636; 63187-709; 67296-1562; 70860-776; 71335-1596; 54838-555; 55150-126; 63629-4093; 68094-763; 53104-7540; 65862-187; 65862-189; 36000-012; 42708-059; 50268-622; 53002-0571; 53002-0600; 55111-154; 68071-2547; 68788-9402; 70934-264; 0615-8185; 55154-4453; 55154-6976; 55154-7879; 63187-513; 63323-373; 63629-8111; 67877-170; 68071-1742; 71335-0205; 71335-1855; 67835-5014; 16714-671; 43063-746; 55154-8176; 57237-076; 67877-169; 0054-0064; 71205-744; 76045-103; 57451-1153; 65691-0035; 42708-179; 51655-016; 55700-627; 58118-7500; 60760-637; 62756-131; 68071-4328; 68084-221; 70860-777; 70934-318; 0904-6551; 0904-6552; 64567-0005; 50268-621; 55111-153; 68071-2855; 68788-9368; 71872-7069; 76045-216; 59116-1852; 59116-1853; 53002-1633; 55150-125; 63629-7781; 65862-208; 67457-769; 68084-220; 70934-148; 43063-792; 50090-6342; 51655-813; 54348-821; 62135-555; 62756-130; 68071-2053; 68788-8365; 70934-193; 71205-109; 71335-0815; 71335-1357; 71610-119; 51927-0075; 51927-4320; 59116-1850; 59116-1851; 65129-2161; 65862-377; 25021-777; 50090-3185; 50090-4671; 51655-415; 51672-4108; 51672-4110; 53808-1121; 55700-631; 63323-374; 63629-4023; 65862-188; 72789-034; 51846-1025; 66651-903; 45865-509; 50090-3178; 57237-075
UNII NMH84OZK2B
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.04.005--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009---
Anxiety19.06.02.002--
Aspartate aminotransferase increased13.03.04.011--
Blindness transient06.02.10.006; 17.17.01.004---
Bradycardia02.03.02.002---
Bronchospasm22.03.01.004; 10.01.03.012--
Cardio-respiratory arrest22.02.06.007; 02.03.04.002---
Chest pain02.02.02.011; 22.12.02.003; 08.01.08.002---
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Death08.04.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Electrocardiogram QT prolonged13.14.05.004--
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Generalised tonic-clonic seizure17.12.01.002---
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hiccups22.12.01.001; 07.01.06.009--
Hypersensitivity10.01.03.003--
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
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