Commonly observed side effects of propofol are hypotension and respiratory depression. These effects depend on the propofol dose administered but also on the type of premedication and other concomitant medication.
In this section undesirable effects are defined 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 (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders:
Rare: Clinical features of anaphylaxis, which may include Quincke's oedema, bronchospasm, erythema and hypotension.
Very rare: Allergic reactions caused by soya-bean oil.
Metabolism and nutrition disorders:
Rare: Euphoria and sexual disinhibition during the recovery period.
Nervous system disorders:
Common: During induction of anaesthesia spontaneous movements and myocloni, minimal excitation.
Rare: Headache, vertigo, shivering and sensations of cold during the recovery period.
Epileptiform movements including convulsions and opisthotonus.
Very rare: Delayed epileptiform attacks, the delay period ranging from a few hours to several days. Risk of convulsions in epileptic patients after administration of propofol. Cases of postoperative unconsciousness (see Precautions).
Cardiac disorders/Vascular disorders:
Common: During induction of anaesthesia, hypotension, bradycardia, tachycardia, hot flushes.
Uncommon: Marked hypotension. This may require a lowering of the administration rate of Fresofol 1% MCT/LCT and/or fluid replacement therapy, if necessary vasoconstrictive medicinal products. Account should be taken of the possibility of a severe drop in blood pressure in patients with impaired coronary or cerebral perfusion or those with hypovolaemia.
Bradycardia during general anaesthesia with progressive severity (asystole). The intravenous administration of an anticholinergic medicinal product prior to induction or during maintenance of anaesthesia should be considered (see Precautions).
Rare: Arrhythmia during the recovery period. Thrombosis and phlebitis.
Rare: Thrombosis and phlebitis.
Respiratorv, thoracic and mediastinal disorders:
Common: During induction of anaesthesia hyperventilation, transient apnoea, coughing, singultus.
Uncommon: Coughing during maintenance of anaesthesia.
Rare: Coughing during the recovery period.
Very rare: Pulmonary oedema.
Rare: Nausea or vomiting during the recovery period.
Very rare: Pancreatitis has been reported after administration of propofol. A causal relationship, however, could not be established.
Skin and subcutaneous tissue disorders:
Very rare: Severe tissue responses after accidental paravenous application.
Renal and urinary disorders:
Rare: Cases of discoloration of urine following prolonged administration of propofol.
General disorders and administration site conditions:
Very common: Local pain occurring during the initial injection. Prophylaxis or treatment see as follows.
The local pain which may occur during the initial injection of Fresofol 1% MCT/LCT/Fresofol PFS MCT/LCT can be minimised by the co-administration of lidocaine (see Dosage & Administration) and by injection or infusion into the larger veins of the forearm and antecubital fossa. Upon co-administration of lidocaine the following undesirable effects may occur rarely (≥1:10,000 to <1:1,000): giddiness, vomiting, drowsiness, convulsions, bradycardia, cardiac arrhythmia and shock.
Rare: Cases of post-operative fever.
Very rare: There have been reports of isolated cases of severe undesirable effects presenting as a complex of symptoms including: rhabdomyolysis, metabolic acidosis, hyperkalaemia, and cardiac failure, sometimes with fatal outcome. Most of these effects have been observed in patients in intensive care with doses exceeding 4 mg/kg body weight/h. For more detail, 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.