Propofol information

Safety warnings | messages in brief | 04/11/2011

The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product warning, but a reference to the approved use.

Propofol belongs to the group of drugs known as general anesthetics. General anesthetics are used to induce unconsciousness (deep sleep) during the performance of surgical operations or other procedures. They can also be used for sedation. Sedation means making patients drowsy, but not necessarily putting them into deep sleep. It is used in intensive care to provide patients with pain- and stress-free ventilation and intensive care treatment.

The drug was reevaluated in 2010 for use in children and adolescents. The approved uses of propofol are:

  • To induce and maintain general anesthesia in adults, adolescents and children older than one month;
  • To sedate patients older than 16 years who are receiving artificial respiration as part of intensive care;
  • Sedate adults and children over one month of age during the performance of diagnostic or surgical procedures, alone or in combination with local or regional anesthesia.

Propofol is specifically not to be used in children 16 years of age and younger for sedation in the setting of intensive care.

Propofol is a drug with an appropriate benefit-risk profile and is therefore in principle suitable for use in the approved indications (in children, adolescents, and adults).

Of course, the benefits and any risks of the drug must be carefully weighed before use. The risks should be known to the user or can be found in the expert information. The typical side effects are:

Very common (affects more than one in ten people treated).

  • Local pain during injection

Frequently (affects one to ten out of every 100 people treated)

  • Low blood pressure (hypotension)
  • Shallow breathing (respiratory depression)
  • Involuntary movements
  • Slow heartbeat (bradycardia)
  • Rapid heartbeat (tachycardia)
  • Flushes of heat
  • Temporary cessation of breathing (temporary apnea)
  • Coughing after anesthesia
  • Hiccups (singultus)
  • Increased breathing (hyperventilation)
  • Hypertriglyceridemia (high levels of cholesterol or triglycerides in the blood)

Occasionally (affects one to ten out of every 1,000 people treated)

  • Severe drop in blood pressure (hypotension)
  • Cough during anesthesia

Rarely (affects one to ten in 10,000 people treated)

  • Anaphylaxis (severe allergic reaction)
  • Euphoria (feeling of happiness) and sexual excitement during the recovery phase
  • Headache
  • Vertigo (spinning dizziness)
  • shivering and cold feeling during the recovery phase
  • convulsive movements (similar to epilepsy)
  • Irregular heartbeat (arrhythmia) during the recovery phase
  • Coughing during the recovery phase
  • Discoloration of urine
  • Fever after the operation
  • Formation of blood clots (thrombosis) and inflammation of blood vessels (phlebitis)
  • Skin inflammation with redness (erythema)
  • Low blood pressure (hypotension)
  • Bronchospasm (a spasmodic narrowing of the airways that causes breathing problems)
  • Nausea or vomiting

Very rarely (affects less than one in 10,000 people treated).

  • Delayed epileptiform seizures (epilepsy-like symptoms after the recovery period)
  • Fluid accumulation in the lungs (pulmonary edema)
  • Inflammation of the pancreas (pancreatitis)
  • Severe tissue reactions after accidental injection into tissues
  • Decay of muscle fibers (rhabdomyolysis)
  • Acidosis of the blood (metabolic acidosis)
  • High blood potassium level (hyperkalemia)
  • Weakness of the heart muscle (cardiac insufficiency)
  • Unconsciousness after surgery



Further inquiry note