Ondansetron-Teva Adverse Reactions

Tabulated list of adverse reactions: Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <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 predominantly during rapid IV administration.
Eye disorders: Rare: Transient visual disturbances (e.g. blurred vision) predominantly during IV administration.
Very rare: Transient blindness predominantly during IV administration⁽²⁾.
Cardiac disorders: Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Rare: QTc prolongation (including torsade de pointes).
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⁽³⁾.
⁽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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.