Propoven Side Effects
Generic name: propofol
Medically reviewed by Drugs.com. Last updated on Aug 24, 2020.
Note: This document contains side effect information about propofol. Some of the dosage forms listed on this page may not apply to the brand name Propoven.
For the Consumer
Applies to propofol: parenteral injectable emulsion
Emergency Use Authorization (EUA) for Propoven:758 On May 8, 2020, FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients older than 16 years of age who require mechanical ventilation in an intensive care unit (ICU) setting during the COVID-19 pandemic. Because Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion has a concentration twice that of the FDA-approved propofol product, there is a risk of unintentional overdose. There are also important differences in the formulation and labeling between the two products. Healthcare providers should review the EUA and the differences between the two products prior to administering Propoven. Documents related to the EUA can be found on the FDA website at [Web], including the most recent letter of authorization ([Web]), a fact sheet on the EUA for healthcare providers ([Web]), and a wall chart outlining the key differences between the two products ([Web]).
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency:756 During the COVID-19 public health emergency, FDA has received several inquiries from healthcare professionals concerning the unavailability of propofol drug products used in the treatment and management of patients with complications related to COVID-19. FDA is issuing this guidance to communicate its temporary policy regarding the repackaging or combining of propofol drug products by a licensed pharmacist in a State licensed pharmacy, a Federal facility, or an outsourcing facility registered pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) as outlined in this guidance for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, or for such shorter time as FDA may announce through updated guidance. This policy is intended to remain in effect for no longer than the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). FDA is continually assessing the needs and circumstances that make issuance of this guidance appropriate. As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw policies in this guidance as appropriate. For additional information, please see the full guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-repackaging-or-combining-propofol-drug-products-during-covid-19-public-health.
Side effects include:
ICU sedation: Bradycardia, decreased cardiac output, hypotension, hyperlipidemia, respiratory acidosis (during weaning).
For Healthcare Professionals
Applies to propofol: intravenous emulsion
Very common (10% or more): Hypotension (75%)
Common (1% to 10%): Hypertension, bradycardia
Uncommon (0.1% to 1%): Arrhythmias, atrial fibrillation, atrioventricular heart block, bigeminy, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, myocardial infarction, myocardial ischemia, premature ventricular contractions, ST segment depression, supraventricular tachycardia, tachycardia, ventricular fibrillation, extrasystole, syncope, chest pain, right heart failure
Rare (0.01% to 0.1%): Pulmonary edema, asystole, syncope, perioperative arrhythmias, cardiac arrest
Very rare (less than 0.01%): Cardiac failure
Very common (10% or more): Pruritus (28%)
Common (1% to 10%): Transient flush, rash
Uncommon (0.1% to 1%): Urinary retention oliguria
Rare (Less than 0.1%): Discoloration of the urine following prolonged use[Ref]
Frequency not reported: Hepatomegaly[Ref]
Common (1% to 10%): Pain during injection (e.g., burning, tingling/slinging)
Very rare (less than 0.01%): Tissue necrosis following accidental extravascular administration
Uncommon (0.1% to 1%): Pain in extremities, trunk pain, whole body weakness, pain in extremities, neck rigidity/stiffness
Very rare (less than 0.01%): Rhabdomyolysis (when administered at doses greater than 4 mg/kg/hour for ICU sedation)[Ref]
Paresthesias (including burning, tingling, stinging) and/or pruritus, usually manifested in the perineal region, were the most frequently recorded adverse reactions in clinical trials. Paresthesias and pruritus generally occurred within 5 minutes after administration of the initial dose and were generally transient and mild to moderate in intensity. The pharmacologic basis of these sensory phenomena is unknown. No pretreatments, including the use of nonsteroidal anti-inflammatory drugs, opioids, or lidocaine, are known to have an effect on or to reduce the incidence of these sensations.[Ref]
Very common (10% or more): Paresthesia (74%), excitation phenomena such as involuntary movements, twitches, tremors, hypertonus, hiccup
Common (1% to 10%): Headache, shivering
Rare (0.01% to 0.1%): Convulsions and seizures of the epileptic type
Very rare (less than 0.01%): Postoperative unconsciousness
Frequency not reported: Involuntary movements[Ref]
Very common (10% or more): Hypoxemia (11%)
Common (1% to 10%): Procedural pain (bronchoscopy), transient apnea, cough, respiratory acidosis during weaning
Uncommon (0.1% to 1%): Bronchospasm, burning in throat, cough, dyspnea, hiccough, hyperventilation, hypoventilation, hypoxia, laryngospasm, pharyngitis, sneezing, tachypnea, upper airway obstruction, apnea
Very rare (less than 0.01%): Pulmonary edema[Ref]
Very rare (less than 0.01%): Renal failure[Ref]
Common (1% to 10%): Thrombosis, phlebitis
Common (1% to 10%): Elation/euphoria
1. "Product Information. Propofol (propofol)." Hospira Inc, Lake Forest, IL.
2. "Product Information. Diprivan (propofol)." Zeneca Pharmaceuticals, Wilmington, DE.
More about Propoven (propofol)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- Drug class: general anesthetics
- Other brands
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Some side effects may not be reported. You may report them to the FDA.