Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare and very rare events were generally determined from post-marketing spontaneous data.
The following frequencies are estimated at the standard recommended doses of ondansetron. The adverse event profiles in children and adolescents were comparable to that seen in adults.
Immune system disorders: Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.
Nervous system disorders: Very common: Headache.
Uncommon: Seizures, movement disorders (including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia)(1).
Rare: Dizziness during rapid i.v. administration.
Eye disorders: Rare: Transient visual disturbances (eg. blurred vision) predominantly during IV administration.
Very rare: Transient blindness predominantly during intravenous administration(2).
Cardiac disorders: Rare: QTc prolongation (including Torsade de Pointes).
Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Vascular disorders: Common: Sensation of warmth or flushing.
Respiratory, thoracic and mediastinal disorders: Uncommon: Hiccups.
Gastrointestinal disorders: Common: Constipation.
Hepatobiliary disorders: Uncommon: Asymptomatic increases in liver function tests(3).
General disorders and administration site conditions: Common: Local IV injection site reactions.
(1) Observed without definitive evidence of persistent clinical sequelae.
(2) The majority of the blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.
(3) These events were observed commonly in patients receiving chemotherapy with cisplatin.