Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse reactions may be classified per frequency as follows: 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), not known (frequency cannot be estimated from the available data).

Some side effects have been observed during treatment with Phenylephrine; however, its frequency has not been established accurately:

Cardiac disorders
Reflex bradycardia, reflex tachycardia, cardiac arrhythmias, angina pain, palpitations, cardiac arrest.
Vascular disorders
Hypertension, hypotension, flushing

Nervous system disorders:
Headache, cerebral haemorrhage, vertigo, fainting, dullness.
Phenylephrine lacks significant stimulant effects on the central nervous system at the usual doses.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea, pulmonary oedema.

Gastrointestinal disorders:
Vomiting, sialorrhea.

Renal and urinary disorders:
Difficulty urinating, urinary retention.
Skin and subcutaneous tissue disorders:
Sweating, transient tingling, cold sensation on the skin.

Metabolism and nutrition disorders:
Alterations in glucose metabolism.

General disorders and alterations at the administration site:
Extravasation of phenylephrine hydrochloride can cause tissue necrosis.
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