Propoven Side Effects

Generic Name: propofol

Note: This page contains side effects data for the generic drug propofol. It is possible that some of the dosage forms included below may not apply to the brand name Propoven.

It is possible that some side effects of Propoven may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to propofol: parenteral injectable emulsion

Side effects include:

Use for anesthesia or MAC sedation: Bradycardia, arrhythmia, tachycardia, hypotension, hypertension, movement, burning/stinging, pain at injection site, apnea, rash, pruritus.

Use for critical care setting sedation: Bradycardia, decreased cardiac output, hypotension, hyperlipidemia, respiratory acidosis (during weaning).

For Healthcare Professionals

Applies to propofol: intravenous emulsion

General

Phase IV data from over 25,000 patients report a 10.8% incidence of adverse effects associated with propofol (the active ingredient contained in Propoven) 0.9% of these patients reported serious hypotension nausea/vomiting, bradycardia and/or hypertension.

Cardiovascular

Fifty-three percent of patients experienced a decrease in systolic blood pressure of 15% to 35% during the maintenance period. Heart rate decreased to less than 50 beats per minute in approximately 2% of patients at induction. The manufacturer recommends that anticholinergic agents (i.e. atropine or glycopyrrolate) be administered when increases in vagal tone are anticipated.

Despite the marked decreases in arterial pressure, several small studies have noted no accompanying signs of ischemia detected on the electrocardiogram.

Cardiovascular side effects associated with propofol include hypotension after induction (53%), and bradycardia at induction (2%). Hypotension has been reported in 26% of ICU patients. Cardiac output may decline. Decreased intracranial pressure and cerebral blood flow independent of changes in arterial pressure have been reported. Pulmonary edema, asystole, syncope, perioperative arrhythmias and cardiac arrest have been reported rarely in association with propofol. A case of propofol-associated fatal myocardial failure and rhabdomyolysis has also been reported.

Respiratory

Respiratory side effects including cough, upper airway obstruction, hypoventilation, respiratory acidosis, and dyspnea have occurred, although causality has not been established in each of these effects. Beneficial bronchodilation has been reported.

Apnea, possibly lasting longer than 60 seconds, may occur in patients receiving propofol (the active ingredient contained in Propoven) at induction.

Metabolic

Metabolic side effects including lactic acidosis have been reported with propofol (the active ingredient contained in Propoven) use, possibly due to the lipid base impairing hepatic lactate metabolism.

Hyperlipidemia may occur, particularly in patients with disorders of lipid metabolism (the propofol base is a lipid emulsion).

Dermatologic

Dermatologic side effects including rash (1% to 3%) and pruritus (less than 1%) have been reported.

Ocular

Ocular side effects including decrease in intraocular pressure has been reported in patients with normal and abnormal intraocular pressure. Ophthalmoplegia (inability to open eyes) was reported in 19% of patients in one study.

Propofol is associated with a decrease in intraocular pressure in 31% to 60% of adults and elderly patients. The effect occurs immediately after induction and is sustained during intubation.

Local

Local side effects including injection site pain (28% to 90%), phlebitis (less than 1%), flushing (less than 1%), and extravasation have been reported. Increased oral and nasal secretions have been rarely associated with propofol (the active ingredient contained in Propoven)

Injection site pain is less if the venous catheter is placed in a larger vein (e.g. the dorsum of the hand rather than the antecubital fossa). Pain can be abolished in most patients by adding one milliliter of lidocaine 1% to the propofol emulsion immediately prior to administration.

One case of inadvertent intra-arterial injection (into the left brachial artery) has been reported. Blanching and severe pain radiating down the arm occurred, and the injection was halted and resumed in the other forearm. No residual effects were observed on follow-up.

Nervous system

Nervous system side effects including perioperative myoclonia, seizures, and opisthotonos have been reported rarely. Neuroexcitatory events are most often observed during emergence. Delayed awakening (less than 15 minutes) has been reported (7%). Patients may report unusual dreams upon awakening.

Propofol-induced neurologic reactions can be divided into dystonic and seizure-like. Benztropine can be used to treat dystonic reactions.

One report suggests that the incidence of seizures in association with propofol is 1 in 47,000, and delayed reactions (4 hours to 5 days) tend to occur in about one-third of these patients. Most reported episodes have been transient. Propofol has also been shown to have anticonvulsant properties. Myotonia has been reported.

Propofol-induced dyskinesias (chorea and dystonia) have been reported in Parkinson's disease patients undergoing pallidotomy, which subsided with discontinuation of the propofol or the use of 2 mg intravenous midazolam.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have occurred rarely (less than 1%) during propofol (the active ingredient contained in Propoven) infusion.

One report suggests to avoid the use of propofol in patients with a history of anaphylaxis to muscle relaxants.

Gastrointestinal

Nausea and vomiting are less frequent (compared to other anesthetics) as propofol (the active ingredient contained in Propoven) has intrinsic antiemetic properties. An unusual taste, occurring immediately after injection has been reported. A case of pancreatitis and a case of hiccups have also been reported.

The association between the reported case of pancreatitis and the use of propofol has been questioned by other authors. Prolonged use of propofol sedation in the intensive care unit has been associated with possible pancreatitis.

Musculoskeletal

Musculoskeletal side effects have included depression of the swallowing reflex, but recovery was rapid.

Hepatic

Hepatic side effects have included several case reports of acute pancreatitis associated with the use of propofol (the active ingredient contained in Propoven) for induction during general anesthesia. Causality has not been determined.

Between 1991 and 1996, 8 cases of postoperative acute pancreatitis in association with propofol use have been reported to the FDA, of which 3 cases had complicating processes that might account for development of pancreatitis. It is speculated that pancreatitis due to hypertriglyceridemia induced by the propofol emulsion may be the mechanism; however, this is controversial. Patients receiving prolonged and high-dose infusions of propofol may be at greater risk for increased serum lipids. Although this association has not been proven, clinicians should be aware of these case reports, and review the patient's drug history if acute pancreatitis develops postoperatively in association with the use propofol.

Other

Other side effects including sneezing have been reported.

Unexpected patient movement with a needle near the eye can lead to catastrophic outcomes. Therefore, sneezing can be a highly clinically relevant side effect if a patient is receiving periocular injections of anesthetic along with intravenous sedation.

Renal

Renal side effects including green urine have been reported after induction or prolonged use of propofol (the active ingredient contained in Propoven) This coloring effect is well known of phenol compounds, and does not adversely affect renal function. Elevated porphyrins have been reported in one patient, although the patient remained clinically well. Milky pink urine has also been reported.

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