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 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).
Not known:        Myocardial ischemia*
ZOF INJ API MAR22 V2.0                                                           UK PI 12Jan2022 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 Zofran 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