Propofol Side Effects Center

Last updated on RxList: 9/20/2022
Propofol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Propofol?

Propofol Injectable Emulsion 1%, 10 mg/mL is an I.V. sedative-hypnotic agent indicated for initiation and maintenance of Monitored Anesthesia Care (MAC) sedation, combined sedation and regional anesthesia, induction and/or maintenance of general anesthesia, and Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients. Propofol is available in generic form.

What Are Side Effects of Propofol?

Propofol may cause serious side effects including:

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of propofol include: 

  • fast or slow heart rate,
  • high or low blood pressure,
  • injection site reactions (burning, stinging, or pain),
  • apnea,
  • rash, and
  • itching.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Propofol

Most adult patients under 55 years of age and classified as ASA-PS I or II require 2 to 2.5 mg/kg of propofol injectable emulsion for induction when unpremedicated or when premedicated with oral benzodiazepines or intramuscular opioids.

What Drugs, Substances, or Supplements Interact with Propofol?

Propofol may interact with narcotics, combinations of opioids and sedatives, and inhaled anesthetics. Tell your doctor all medications and supplements you use.

Propofol During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before receiving propofol; it is unknown if it would affect a fetus. Propofol passes into breast milk. Breastfeeding while receiving propofol is not recommended.

Additional Information

Our Propofol Injectable Emulsion 1%, 10 mg/mL Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • slow or uneven heartbeats;
  • a light-headed feeling, like you might pass out;
  • wheezing or trouble breathing;
  • sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head);
  • cold feeling in your hands and feet;
  • depression, confusion, hallucinations;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
  • low blood sugar in a baby--pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness.

Common side effects may include:

  • dizziness, tiredness;
  • nausea, vomiting, diarrhea, constipation, stomach cramps;
  • sleep problems (insomnia); or
  • runny or stuffy nose, cough, sore throat, hoarse voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Propofol Professional Information

SIDE EFFECTS

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

  • Hypersensitivity reaction [see WARNINGS AND PRECAUTIONS]
  • Hypotension and/or bradycardia [see WARNINGS AND PRECAUTIONS]
  • Propofol Infusion Syndrome [see WARNINGS AND PRECAUTIONS]

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.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Anesthesia and MAC Sedation in Adults

The following estimates of adverse events for DIPRIVAN 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 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 during anesthesia (see Table 3 below). 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 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 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.

Table 2. Treatment Emergent Adverse Events Observed from Clinical Trials

Anesthesia/MAC Sedation ICU Sedation
Body as a Whole: Anaphylaxis/Anaphylactoid reaction perinatal disorder, tachycardia , bigeminy, bradycardia, premature ventricular contractions , hemorrhage, ECG abnormal Fever, sepsis, trunk pain, whole body weakness
arrhythmia atrial, fever, extremities pain , anticholinergic syndrome, asthenia, awareness, chest pain, extremities pain, fever, increased drug effect, neck rigidity/stiffness, trunk pain
Cardiovascular: Premature atrial contractions Syncope, hypotension [see also CLINICAL PHARMACOLOGY], tachycardia Nodal, arrhythmia Bradycardia, 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 Bradycardia, decreased cardiac output, arrhythmia, atrial fibrillation, bigeminy, cardiac arrest, extrasystole, right heart failure, ventricular tachycardia
Central Nervous System: Hypertonia/Dystonia, paresthesia, movement, 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 Agitation, hypotension, hills/shivering, intracranial hypertension, seizures, somnolence, thinking abnormal
Digestive: Hypersalivation, nausea, cramping, diarrhea, dry mouth, enlarged parotid, nausea, swallowing, vomiting Ileus, liver function abnormal
Hemic/Lymphatic: Leukocytosis, coagulation disorder, leukocytosis
Injection Site: Phlebitis, pruritus, burning/Stinging or pain, hives/itching, phlebitis, redness/discoloration
Metabolic/Nutritional: hypomagnesemia, hyperkalemia, hyperlipemia BUN increased, creatinine increased, dehydration, hyperglycemia, metabolic acidosis, osmolality increased, hyperlipemia
Musculoskeletal: Myalgia
Nervous: Dizziness, agitation, chills, somnolence Delirium
Respiratory: Wheezing, cough, laryngospasm, hypoxia, apnea, bronchospasm, burning in throat, dyspnea, hiccough, hyperventilation, hypoventilation, pharyngitis, sneezing, tachypnea, upper airway obstruction Decreased lung function, respiratory acidosis during weaning, hypoxia
Skin and Appendages: Flushing, Pruritus, rash, conjunctival hyperemia, diaphoresis, urticaria Rash
Special Senses: Amblyopia, vision abnormal, diplopia, ear pain, eye pain, nystagmus, taste perversion, tinnitus
Urogenital: Cloudy urine, oliguria, urine retention Green urine, kidney failure

Postmarketing Experience

During the post-marketing period, there have been rare reports of local pain, swelling, blisters, and/or tissue necrosis following accidental extravasation of DIPRIVAN [see WARNINGS AND PRECAUTIONS].

Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (<1%).

DRUG INTERACTIONS

Opioids And Sedatives

The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These agents may increase the anesthetic or sedative effects of DIPRIVAN and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output.

In pediatric patients, administration of fentanyl concomitantly with DIPRIVAN may result in serious bradycardia.

Analgesic Agents

During maintenance of anesthesia or sedation, the rate of DIPRIVAN administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids).

The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with DIPRIVAN are routinely used. These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of DIPRIVAN.

Valproate

The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression.

Common Neuromuscular Blocking Agents

DIPRIVAN does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants).

Common Drugs Used As Premedication Or Drugs Used During Anesthesia Or Sedation

No significant adverse interactions with commonly used premedications or drugs used during anesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents, and local anesthetic agents) have been observed in adults.

Drug Abuse And Dependence

Abuse

There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of DIPRIVAN by health care professionals have also been reported, which have resulted in fatalities and other injuries. Inventories of DIPRIVAN should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

Read the entire FDA prescribing information for Propofol (Propofol Injectable Emulsion)

© Propofol Patient Information is supplied by Cerner Multum, Inc. and Propofol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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