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.
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 <1/1000), 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 angiooedema,
bronchospasm, erythema and hypotension. Very rare: Allergic reactions
caused by soya-bean oil.
Metabolism and Nutrition Disorders:
Rare: Euphoria, sexual phantasies 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
hrs to several days. Risk of convulsions in epileptic patients after
administration of propofol. Cases of postoperative unconsciousness (see
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 IV 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.
Respiratory, Thoracic and Mediastinal Disorders:
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
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 below.
The local pain which may occur during the initial injection of Fresofol
1% MCT/LCT can be minimised by the co-administration of lidocaine (see
"Infusion of diluted Fresofol 1% MCT/LCT” under Dosage and
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
<1/1000): Giddiness, vomiting, drowsiness, convulsions, bradycardia,
cardiac arrhythmia and shock. Rare: Cases of postoperative 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
Most of these effects have been observed in patients in intensive care
with doses exceeding 4 mg/kg body weight/hr. (see