Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defi ed as: e y o      o     / , o        o      /    to < / , u o       o     /      to < /     , ae    / ,      to < /        , ey ae < / ,           a d ot k o      a ot e 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 and very rare 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.

Very       Common       Uncommon               Rare                Very rare        Not known Common       /   to       /    to                / ,   to          <1/10,000 /        <1/10        <1/100                 <1/1000
Immune system disorders
Immediate hypersensitivity reactions sometimes severe,
including anaphylaxis
Nervous system disorders
Headache                 Seizures,             Dizziness during movement              rapid IV disorders             administration
(including extrapyramidal reactions such
as dystonic reactions,
oculogyric crisis and dyskinesia)1
Eye disorders
Transient visual   Transient disturbances       blindness
(e.g. blurred      predominantly vision)            during predominantly      intravenous during IV          administration
2 administration
Cardiac disorders
Arrhythmias,        QTc                                 Myocardial chest pain with     prolongation                        ischemia or without ST       (including                          (see segment             Torsade de                          section depression,         pointes)                            4.4) bradycardia
Vascular disorders
Sensation of Hypotension warmth or flushing
Respiratory, thoracic and mediastinal disorders
Hiccups
Gastrointestinal disorders
Constipation
Hepatobiliary disorders
Asymptomatic increases in liver function tests3
General disorders and administration site conditions
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.

Paediatric population
The adverse event profiles in children and adolescents were comparable to that seen in adults.

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/ a d e ailed to the Regist atio Holde s Patie t Safety U it at: drugsafety@neopharmgroup.com