Adverse reactions : תופעות לוואי

4.8.      Undesirable Effects

Tabulated list of adverse reactions
Adverse events are listed below 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) ,very rare (<1/10,000) and not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare, very rare and not known 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                Headache common
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)

Not known         Myocardial ischemia*

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).
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.
* These types of adverse drug reactions have been derived from post-marketing experience with ondansetron via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known.


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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il