Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most common adverse events of phenylephrine are bradycardia, hypertensive episodes, nausea and vomiting. Hypertension is more frequent with high doses.
Bradycardia is likely due to baroreceptor-mediated vagal stimulation and consistent with the pharmacological effect of phenylephrine.

List of adverse reactions

Frequency: Not known (cannot be estimated from available data)
Immune system disorders:
Not known: hypersensitivity

Psychiatric disorders:
Not known: Anxiety, excitability, agitation, psychotic states, confusion.
Nervous system disorders
Not known: Headache, nervousness, insomnia, paresthesia, tremor.
Eye disorders:
Not known: Mydriasis, aggravation of pre-existing angle-closure glaucoma 
Cardiac disorders:
Not known: Reflex bradycardia, tachycardia, palpitations, hypertension, arrhythmia, angina pectoris, myocardial ischemia.

Vascular disorders:
Not known: Cerebral haemorrhage, hypertensive crisis

Respiratory, thoracic and mediastinal disorders:
Not known: Dyspnoea, pulmonary oedema
Gastrointestinal disorders:
Not known: Nausea, vomiting

Skin and subcutaneous tissue disorders:
Not known: Sweating, pallor or skin blanching, piloerection, skin necrosis with extravasation 
Musculoskeletal and connective tissue disorders:
Not known: muscular weakness

Renal and urinary disorders:
Not known: Difficulty in micturition and urinary retention
Description of selected adverse reactions
As phenylephrine has been frequently used in the critical care setting in patients with hypotension and shock, some of the reported serious adverse events and deaths are probably related to the underlying disease and not related to the use of phenylephrine.

Other special population(s)
Elderly: risk for phenylephrine toxicity is increased in elderly patients (see section 4.4).

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/