Diprivan Side Effects

Generic Name: propofol

Please note - some side effects for Diprivan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Diprivan - for the Consumer

Diprivan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Diprivan:

Change in mood or emotions; dizziness; drowsiness; lack of coordination.

Seek medical attention right away if any of these SEVERE side effects occur when using Diprivan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough; feeling faint; itching; pain, redness, or swelling at the injection site; wheezing.

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Diprivan Side Effects - for the Professional

Diprivan

General

Adverse event information is derived from controlled clinical trials and worldwide marketing experience.  In the description below, rates of the more common events represent US/Canadian clinical study results.  Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates.  These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents.  Most adverse events were mild and transient.

Anesthesia and MAC Sedation in Adults

The following estimates of adverse events for Diprivan Injectable Emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients).  The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with Diprivan Injectable Emulsion was greater than the comparator incidence rate in these trials.  Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.

The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with Diprivan Injectable Emulsion during anesthesia.  During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.

Anesthesia in Pediatric Patients

Generally the adverse experience profile from reports of 506 Diprivan Injectable Emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with Diprivan Injectable Emulsion during anesthesia in adults.  Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.

ICU Sedation in Adults

The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients).  Probably related incidence rates for ICU sedation were determined by individual case report form review.  Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge.  In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown.  Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.

Incidence greater than 1% - Probably Causally Related

	Anesthesia/MAC Sedation	ICU Sedation
Cardiovascular:	Bradycardia	Bradycardia
	Arrhythmia [Peds: 1.2%]
	Tachycardia Nodal [Peds: 1.6%]
	Hypotension* [Peds: 17%]	Decreased Cardiac Output
	Hypertension [Peds: 8%]	Hypotension 26%
Central Nervous System:
	Movement* [Peds: 17%]
Injection Site:	Burning/Stinging or Pain, 17.6% [Peds: 10%]
Metabolic/Nutritional:		Hyperlipemia*
Respiratory:	Apnea	Respiratory Acidosis During Weaning*
Skin and Appendages:	Rash [Peds: 5%] Pruritus [Peds: 2%]
Events without an * or % had an incidence of 1% to 3% *Incidence of events 3% to 10%

 

                      Incidence less than 1% - Probably Causally Related

	Anesthesia/MAC Sedation	ICU Sedation
Body as a Whole:	Anaphylaxis/Anaphylactoid Reaction
	Perinatal Disorder
	[Tachycardia]
	[Bigeminy]
	[Bradycardia]
	[Premature Ventricular Contractions]
	[Hemorrhage]
	[ECG Abnormal]
	[Arrhythmia Atrial]
	[Fever]
	[Extremities Pain]
	[Anticholinergic Syndrome]
Cardiovascular:	Premature Atrial Contractions
	Syncope
Central Nervous System:	Hypertonia/Dystonia, Paresthesia	Agitation
Digestive:	[Hypersalivation]
	[Nausea]
Hemic/Lymphatic:	[Leukocytosis]
Injection Site:	[Phlebitis]
	[Pruritus]
Metabolic:	[Hypomagnesemia]
Musculoskeletal:	Myalgia
Nervous:	[Dizziness] [Agitation] [Chills] [Somnolence] [Delirium]
Respiratory:	Wheezing [Cough] [Laryngospasm] [Hypoxia]	Decreased Lung Function
Skin and Appendages:	Flushing, Pruritus
Special Senses:	Amblyopia [Vision Abnormal]
Urogenital:	Cloudy Urine	Green Urine

Incidence less than 1% - Causal Relationship Unknown

	Anesthesia/MAC Sedation	ICU Sedation
Body as a Whole:	Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, Neck Rigidity/Stiffness, Trunk Pain	Fever, Sepsis, Trunk Pain, Whole Body Weakness
Cardiovascular:	Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart Block, Hypertension, Myocardial Infarction, Myocardial Ischemia, Premature Ventricular Contractions, ST Segment Depression, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation	Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, Ventricular Tachycardia
Central Nervous System:	Abnormal Dreams, Agitation, Amorous Behavior, Anxiety, Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/Myoclonic Movement, Combativeness, Confusion, Delirium, Depression, Dizziness, Emotional Lability, Euphoria, Fatigue, Hallucinations, Headache, Hypotonia, Hysteria, Insomnia, Moaning, Neuropathy, Opisthotonos, Rigidity, Seizures, Somnolence, Tremor, Twitching	Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal
Digestive:	Cramping, Diarrhea, Dry Mouth, Enlarged Parotid, Nausea, Swallowing, Vomiting	Ileus, Liver Function Abnormal
Hematologic/Lymphatic:	Coagulation Disorder, Leukocytosis
Injection Site:	Hives/Itching, Phlebitis, Redness/Discoloration
Metabolic/Nutritional:	Hyperkalemia, Hyperlipemia	BUN Increased, Creatinine Increased, Dehydration, Hyperglycemia, Metabolic Acidosis, Osmolality Increased
Respiratory:	Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction	Hypoxia
Skin and Appendages:	Conjunctival Hyperemia, Diaphoresis, Urticaria	Rash
Special Senses:	Diplopia, Ear Pain, Eye Pain, Nystagmus, Taste Perversion, Tinnitus
Urogenital:	Oliguria, Urine Retention	Kidney Failure

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Side Effects by Body System

General

Phase IV data from over 25,000 patients report a 10.8% incidence of adverse effects associated with propofol. 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 at induction.

Metabolic

Metabolic side effects including lactic acidosis have been reported with propofol 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

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.

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.

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.

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

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.

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.

Hypersensitivity

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

Hypersensitivity side effects including anaphylaxis have occurred rarely (less than 1%) during propofol infusion.

Gastrointestinal

Nausea and vomiting are less frequent (compared to other anesthetics) as propofol 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 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. 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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