Immune system disorders
Hypersensitivity reactions.
Excessive administration of magnesium leads to the development of symptoms of hypermagnesaemia which may include:
Metabolism and Nutritional disorders
Electrolyte/fluid abnormalities (hypophosphataemia, hyperosmolar dehydration)
There have been isolated reports of maternal and fetal hypocalcaemia with high doses of magnesium sulfate (see section 4.6).
Nervous system disorders
Respiratory depression
Nausea, vomiting, drowsiness and confusion
Coma
Slurred speech, double vision
Cardiac disorders
Cardiac arrhythmias, cardiac arrest
ECG changes (prolonged PR, QRS and QT intervals), bradycardia
Vascular disorders
Flushing of the skin and hypotension due to peripheral vasodilatation
Musculoskeletal and connective tissue disorders
Loss of tendon reflexes due to neuromuscular blockade, muscle weakness
Other undesirable effects
Thirst
There have been isolated reports of maternal and foetal hypocalcaemia with high doses of magnesium sulfate.
Especially in patients with impaired renal function, there may be sufficient accumulation of magnesium sulfate to produce toxic effects.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.