Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon ((≥1/1000 and <1/100), rare ((≥11/10000 and <1/1000) and very rare (<1/10000) including isolated reports. Very common, common and uncommon events were generally determined from post marketing spontaneous data.
The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.
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 have been observed without definitive evidence of persistent clinical sequelae. Rare: Dizziness during i. v. administration, which in most cases is prevented or resolved by lengthening the infusion period.
Eye disorders: Rare: Transient visual disturbances (eg. Blurred vision) during intravenous administration. The majority of 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.
Cardiac disorders: Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Vascular disorders: Common: Sensation of warmth or flushing. Uncommon: Hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Hiccups.
Gastrointestinal disorders: Common: Constipation.
Hepatobiliary disorders: Uncommon: Asymptomatic increases in liver function tests. These events were observed commonly in patients receiving chemotherapy with cisplatin.
General disorders and administration site conditions: Common: Local i.v. injection site reactions.