Adverse reactions : תופעות לוואי

4.8 Undesirable effects


The most frequent adverse reactions observed with Prostin VR infusion in neonates with ductal-dependent congenital heart defects are related to the drug's known pharmacological effects.
The following undesirable effects have been observed and reported during treatment with alprostadil (436 neonates treated) with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Rare (≥1/10,000 to ≤1/1,000); Very rare (≤1/10,000).


System Organ Class              Frequency                 Undesirable effects Nervous system                  Common                    Seizures disorders

Cardiac disorders               Common                    Bradycardia, hypotension, tachycardia

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Vascular disorders            Uncommon                 Vascular fragility 

Respiratory, thoracic         Very                     Apnoea and mediastinal               common disorders
Metabolism and nutrition      Common                   Hypokalaemia disorders

Gastrointestinal              Common                   Diarrhoea disorders

Uncommon                 Gastric obstruction,
gastric mucosal hypertrophy
Musculoskeletal and           Uncommon                 Exostosis connective tissue disorders


General disorders and         Very                     Transient pyrexia administration site           common conditions
Common                   Cutaneous vasodilatation
(flushing)*

*This is the only adverse event directly related to the route of administration, being more frequent with intra-arterial administration.

The relationship of the following adverse events to the drug, in decreasing frequency, is unknown: sepsis, cardiac arrest, disseminated intravascular coagulation, and oedema.
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/