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.
The most commonly reported cardiovascular adverse event appears to be bradycardia, 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 Precautions).
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.