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Propofol

Propofol is an intravenous (IV) anesthetic and sedation medicine given by trained professionals for general anesthesia, procedural sedation, and sedation of adults on a breathing machine in the ICU.

Brand names DiprivanPropovanPropovenPropofol Injectable Emulsion
Drug class General Anesthetic
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 18 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Propofol at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Propofol (Diprivan) is a fast-acting IV anesthetic, thought to work by boosting GABA, a brain chemical that calms nerve activity, and one of the most widely used drugs for general anesthesia, procedure sedation and ICU sedation, on the market since about 1994 and available generically. Most people tolerate it well and wake up quickly, though many feel a brief sting in the arm as it goes in, and because it lowers blood pressure and can pause breathing, your team watches your breathing and heart throughout. Tell your care team about any severe allergy to propofol, eggs or soy (it should not be used then), any seizure history and every medicine you take.

Clinical pearls

  • Propofol looks milky white because it is a fat emulsion, so mention high triglycerides or past pancreatitis beforehand.
  • Long or high-dose ICU infusions can cause propofol infusion syndrome (severe acid buildup, muscle breakdown), so ICU teams watch labs closely.
  • If you take valproate, say so by name, because it raises propofol levels and the dose needs lowering.
  • Propofol is not recommended for Cesarean delivery because it crosses the placenta and can leave newborns sleepy and floppy.
How you get itPrescription only
Comes asInjection, Oral solution
Earliest FDA record1989
Companies listing it with the FDA14
FDA label last updatedApr 18, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Propofol, written from its FDA label.

What Propofol is used for

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Propofol is an IV anesthetic and sedation medicine with several approved uses.

  • Starting general anesthesia in patients 3 years and older
  • Keeping general anesthesia going in patients 2 months and older
  • Starting and maintaining monitored anesthesia care (MAC) sedation in adults only
  • Sedation in adults combined with regional anesthesia
  • ICU sedation of intubated, mechanically ventilated adults only

It is not recommended for MAC sedation in children, for starting anesthesia under age 3, or for maintenance under 2 months. It is not indicated for pediatric ICU sedation.

How Propofol works

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Propofol is thought to work by enhancing GABA, the brain’s main calming chemical, through GABA-A receptors. This slows nerve activity and causes sedation or anesthesia. Like all general anesthetics, its exact mechanism is not well understood.

Propofol dosage

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Propofol is given only through a vein, as an injection or a continuous infusion, by trained professionals. Your care team adjusts the amount based on your response, age, and health, and other medicines you receive.

  • It is given in a monitored setting with airway and resuscitation equipment on hand.
  • Vials are single-use and must be handled with strict sterile technique.
  • There is no missed-dose concept, since it is given during a procedure or in the ICU.

Dosing details from the FDA-approved label

From the Propofol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Induction of general anesthesia - Adult patients (most under 55 years of age, ASA-PS I or II)
    • 2 mg/kg to 2.5 mg/kg of DIPRIVAN for induction when unpremedicated or when premedicated with oral benzodiazepines or intramuscular opioids
    • Titrated (approximately 40 mg every 10 seconds) against the response of the patient until the clinical signs show the onset of anesthesia
    • Amount of intravenous opioid and/or benzodiazepine premedication will influence the response to the induction dose
  • Induction of general anesthesia - Elderly, debilitated, or ASA-PS III or IV patients
    • Approximately 1 mg/kg to 1.5 mg/kg (approximately 20 mg every 10 seconds) of DIPRIVAN for induction of anesthesia according to their condition and responses
    • Reduced clearance and higher blood concentrations; a rapid bolus should not be used
  • Induction of general anesthesia - Pediatric patients aged 3 years through 16 years, ASA-PS I or II
    • 2.5 mg/kg to 3.5 mg/kg of DIPRIVAN for induction when unpremedicated or when lightly premedicated with oral benzodiazepines or intramuscular opioids
    • Younger pediatric patients may require higher induction doses than older ones; a lower dosage is recommended for ASA-PS III or IV
  • Neurosurgical patients
    • Slower induction using boluses of 20 mg every 10 seconds
    • Slower boluses or infusions titrated to clinical responses will generally result in reduced induction dosage requirements (1 mg/kg to 2 mg/kg)
  • Cardiac anesthesia
    • Slow rate of approximately 20 mg every 10 seconds until induction onset (0.5 mg/kg to 1.5 mg/kg)
    • Maintenance infusion rates should not be less than 100 mcg/kg/min when DIPRIVAN is the primary agent, supplemented with analgesic levels of continuous opioid
    • Avoid rapid bolus induction; rate determined by premedication and adjusted to clinical response
  • Maintenance of anesthesia - adults
    • Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min should be achieved during maintenance to optimize recovery times
    • Incremental boluses of 25 mg (2.5 mL) to 50 mg (5 mL) and/or increased infusion rate may be used for changes in vital signs indicating stress response
    • Allow 3 minutes to 5 minutes between dose adjustments; titrate downward in absence of signs of light anesthesia
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION: Propofol blood concentrations at steady-state are generally proportional to infusion rates, especially in individual patients. Undesirable effects such as cardiorespiratory depression are likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in the infusion rate. An adequate interval (3 minutes to 5 minutes) must be allowed between dose adjustments to allow for and assess the clinical effects. Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. When administering DIPRIVAN by infusion, syringe or volumetric pumps are recommended to provide controlled infusion rates. When infusing DIPRIVAN to patients undergoing magnetic resonance imaging, metered control devices may be utilized if mechanical pumps are impractical. Changes in vital signs indicating a stress response to surgical stimulation or the emergence from anesthesia may be controlled by the administration of 25 mg (2.5 mL) to 50 mg (5 mL) incremental boluses and/or by increasing the infusion rate of DIPRIVAN. For minor surgical procedures (e.g., body surface) nitrous oxide (60% to 70%) can be combined with a variable rate DIPRIVAN infusion to provide satisfactory anesthesia. With more stimulating surgical procedures (e.g., intra-abdominal), or if supplementation with nitrous oxide is not provided, administration rate(s) of DIPRIVAN and/or opioids should be increased in order to provide adequate anesthesia. Infusion rates should always be titrated downward in the absence of clinical signs of light anesthesia until a mild response to surgical stimulation is obtained in order to avoid administration of DIPRIVAN at rates higher than are clinically necessary. Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min in adults should be achieved during maintenance in order to optimize recovery times. Other drugs that cause CNS depression (e.g., sedatives, anesthetics, and opioids) can increase CNS depression induced by propofol.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Propofol side effects

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Most side effects are mild and short-lived. Common ones include:

Common side effects

  • Low blood pressure
  • Slow heart rate
  • Pauses in breathing (apnea)
  • Burning, stinging, or pain at the injection site
  • Involuntary movements
  • Rash or itching
  • High blood fat levels (hyperlipemia) with longer use
  • Burning, stinging, or pain where the IV goes in
  • Raised blood fats with longer use

When to get medical help

  • Signs of a severe allergic reaction, such as swelling, wheezing, or a sudden drop in blood pressure (staff will treat this right away)
  • Very slow heart rate or cardiac arrest (rare)
  • Serious breathing problems or low oxygen
  • Seizures during recovery, especially in people with epilepsy
  • Propofol infusion syndrome with long or high-dose ICU infusions: severe acid buildup in the blood, muscle breakdown, kidney failure, liver enlargement, or heart failure
  • Fever or infection if the product was contaminated

Serious reactions include severe allergic reactions, very slow heart rate or cardiac arrest, seizures, and propofol infusion syndrome. Your care team monitors for these.

Propofol warnings and precautions

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  • Breathing and heart effects: low blood pressure, apnea, airway blockage, and low oxygen can occur, especially after rapid doses and in older or very ill patients.
  • Propofol infusion syndrome: a rare, sometimes fatal reaction linked to prolonged or high-dose ICU infusions.
  • Allergic reactions: serious and sometimes fatal reactions have occurred.
  • Contamination: the product can support bacterial growth, so vials must be single-use and discarded within 12 hours of opening.
  • Seizures: risk during recovery in people with epilepsy.
  • Triglycerides: longer use can raise blood fats.
  • Young children: long or repeated anesthesia early in life may affect brain development, based on animal data.

Propofol interactions

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Other sedating medicines can add to propofol’s effects.

  • Opioids and sedatives (such as benzodiazepines): more sedation and lower blood pressure and heart output.
  • Fentanyl in children: may cause serious slowing of heart rate.
  • Inhaled anesthetics: increase sedation and heart and breathing effects.
  • Valproate: can raise propofol levels, so the dose should be reduced.

Interactions listed in the FDA-approved label

From the Propofol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Opioids and sedatives (e.g., morphine, meperidine, fentanyl; benzodiazepines, barbiturates, chloral hydrate, droperidol): Induction dose requirements of propofol may be reduced; these agents may increase the anesthetic or sedative effects of propofol and result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output.
  • Fentanyl in pediatric patients: Concomitant administration with propofol may result in serious bradycardia in pediatric patients.
  • Analgesic agents (e.g., nitrous oxide or opioids): Propofol administration rate may be reduced in the presence of supplemental analgesic agents. Adjust the propofol rate according to the desired level of anesthesia or sedation.
  • Potent inhalational agents (isoflurane, sevoflurane, desflurane, enflurane, halothane): These agents can be expected to increase the anesthetic or sedative and cardiorespiratory effects of propofol.
  • Valproate: Concomitant use 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 (e.g., succinylcholine and nondepolarizing muscle relaxants): Propofol does not cause a clinically significant change in onset, intensity or duration of action of these agents.
  • Common premedications or drugs used during anesthesia or sedation (muscle relaxants, inhalational agents, analgesic agents, local anesthetic agents): No significant adverse interactions have been observed in adults.
Read the label’s full interactions text

7 DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of propofol injectable emulsion 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 propofol injectable emulsion 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 propofol injectable emulsion may result in serious bradycardia. Analgesic Agents During maintenance of anesthesia or sedation, the rate of propofol injectable emulsion 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 propofol injectable emulsion are routinely used. These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of propofol injectable emulsion. 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 Propofol injectable emulsion 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).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Propofol

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  • Do not use if you have a known allergy to propofol, or a history of anaphylaxis to eggs, egg products, soybeans, or soy products.
  • Tell your team about epilepsy, lipid disorders, or pancreatitis.
  • Older or debilitated patients need lower doses and slower administration.
  • Not recommended for obstetrics, including Cesarean delivery; it crosses the placenta and can cause newborn sleepiness.
  • It passes into breast milk; discuss breastfeeding with your care team.
  • Some products contain benzyl alcohol, which can cause serious reactions in newborns and infants.

Propofol overdose

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Too much propofol is likely to cause depression of breathing and the heart. The label says to stop it right away, support breathing with oxygen and artificial ventilation, and treat low blood pressure with positioning, IV fluids, and medicines as needed.

What Propofol does in the body

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Propofol’s effects depend on its blood level, and higher levels from rapid doses raise the chance of heart and breathing depression. It commonly lowers blood pressure during induction and often causes a brief pause in breathing. It also lowers pressure inside the skull and eye and does not appear to suppress the adrenal response.

How your body processes Propofol

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Propofol starts working quickly, with anesthesia usually within about 40 seconds of an IV dose. It is cleared mainly by the liver into inactive products that the kidneys remove. After short use, people wake up quickly, but after very long infusions, propofol builds up in tissues and waking can take longer. Older adults reach higher peak levels, so they need lower doses.

How to store Propofol

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Store between 4° to 25°C (40° to 77°F). Do not freeze.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Propofol: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Propofol — the kind of thing our pharmacy team would talk through with you at the counter.

What is propofol used for?

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Propofol is given through a vein to put you under general anesthesia or to provide sedation during procedures. It is also used to sedate adults in the ICU who are on a breathing machine. A trained clinician gives it and watches you closely.

Will I feel anything when it is given?

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Some people feel burning, stinging, or pain at the IV site, and this is one of the more common effects. Your team can reduce it by using a larger vein or giving lidocaine first. Anesthesia usually begins within about a minute.

What side effects might I have?

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Low blood pressure, a slower heart rate, and a short pause in breathing are the most common. Your team watches for these and treats them. You may also get a rash, itching, or involuntary movements.

Should I tell my team about allergies?

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Yes. Tell them if you have ever had a severe allergic reaction to eggs, egg products, soybeans, or soy products, because propofol should not be used in that case. Also mention epilepsy, high triglycerides, or pancreatitis.

Is propofol safe in pregnancy or for children?

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It is not recommended for obstetrics, including Cesarean delivery, because it crosses the placenta and can make newborns sleepy. It is approved for starting anesthesia in children 3 and older and for maintaining it from 2 months. Long or repeated anesthesia in very young children is being studied for effects on brain development.

Can I take other medicines with it?

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Tell your team about everything you take. Opioids, sedatives, and inhaled anesthetics can add to propofol’s effects, and valproate can raise its levels. Your team adjusts the dose to account for this.

Is Propofol available over the counter?

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No. Propofol is a prescription medicine: every Propofol product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Propofol first available?

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The earliest FDA record we hold for Propofol is from 1989: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Propofol was first used.

Who makes Propofol?

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14 companies currently list Propofol products in the FDA's NDC Directory, including Hospira, Inc., Amneal Pharmaceuticals Private Limited, Civica, Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Propofol on HelloPharmacist

Detailed data & references for Propofol Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Propofol forms and strengths (how it comes)

Propofol is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Propofol inactive ingredients by manufacturer.

Injection

Into a vein
Brands Diprivan Propofol Injectable Emulsion
How this form is used
What it may be used for
  • Diprivan is used for general anesthesia induction (ages 3 and up) and maintenance (ages 2 months and up).
  • Diprivan is used for sedation in adults during procedures and with regional anesthesia.
  • Diprivan is used for ICU sedation of intubated, mechanically ventilated adults only.
Important instructions
  • Diprivan is given IV and should be shaken well before use; it should not be used if the emulsion has separated.
  • Propofol Injectable Emulsion vials are single-dose and for one person only, and administration should be completed within 12 hours of opening.
  • Diprivan should not run through the same IV line as blood or plasma.
Available strengths 1 strength
95 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 2 strengths
7 FDA-listed product records ⓘ

Propofol on the U.S. market: products, makers and brands

How Propofol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

14 companies list 35 Propofol product records with the FDA, mostly as injection, oral solution; the earliest marketing or approval year on record is 1989. Brand names on the directory include Diprivan, Propovan, Propoven and 1 more; the rest are generics.

2
Dose forms ⓘ
14
Labelers (makers, repackagers, distributors)
3
Brand names
35
FDA-listed product records ⓘ
1989
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hospira, Inc.14%
Amneal Pharmaceuticals Private Limited9%
Civica, Inc9%
Dr. Reddy's Laboratories, Inc.9%
HF Acquisition Co LLC, DBA HealthFirst9%
Hikma Pharmaceuticals USA Inc.9%
Other makers43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Propofol is used (Medicaid data)

A general measure of how commonly Propofol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Propofol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

520,319
Medicaid prescriptions filled (Q1–Q4 2025)
$55.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Propofol prescribed? Of the 1,601 medications we measure, Propofol ranks #258 by Medicaid prescriptions — more than 84% of them.

Where Propofol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Propofol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mL / 10 mg/mL injection is the most-dispensed Propofol product — about 76% of these Medicaid prescriptions.

20 ML propofol 10 MG/ML Injection Most dispensed

393,137 Medicaid prescriptions (Q1–Q4 2025) 76% of Propofol prescriptions shown $38.7M gross reimbursement (before rebates) ≈ $99 per prescription (gross)

Summed across the 18 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808224

100 ML propofol 10 MG/ML Injection

63,532 Medicaid prescriptions (Q1–Q4 2025) 12% of Propofol prescriptions shown $8.3M gross reimbursement (before rebates) ≈ $131 per prescription (gross)

Summed across the 12 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808217

50 ML propofol 10 MG/ML Injection

56,907 Medicaid prescriptions (Q1–Q4 2025) 11% of Propofol prescriptions shown $7.2M gross reimbursement (before rebates) ≈ $127 per prescription (gross)

Summed across the 13 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808222

10 ML propofol 10 MG/ML Injection

6,313 Medicaid prescriptions (Q1–Q4 2025) 1% of Propofol prescriptions shown $853,597 gross reimbursement (before rebates) ≈ $135 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808234

Other Propofol products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

430 Medicaid prescriptions (Q1–Q4 2025) <1% of Propofol prescriptions shown $14,475 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 1 of 23 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Propofol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 46 of 134 listed Propofol NDCs with Medicaid activity.

Compare Propofol products

A representative set of FDA-listed product records for Propofol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Propofol NDCs →

Propofol side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Propofol — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Propofol are hypotension, anaphylactic shock, cardiac arrest; about 94% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

36,431
Reports mentioning it
94%
Reported as serious
12
Distinct effects shown
Most reported effects
Hypotension
2,932
Anaphylactic Shock
2,108
Cardiac Arrest
1,829
Anaphylactic Reaction
1,722
Drug Interaction
1,567
Tachycardia
1,228
Bradycardia
1,191
Pyrexia
1,009
Acute Kidney Injury
994
Rhabdomyolysis
914
Age groups
Adult · 3,585Elderly · 1,423Child · 317Neonate · 274Adolescent · 199Infant · 94

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Propofol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Propofol FDA approval history

How Propofol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Propofol was first approved by the FDA in 1989 (Brand: DIPRIVAN · Fresenius Kabi Usa); the first generic version was approved in 1999. It remains available in U.S. pharmacies today.

1989
Brand approved
Brand: DIPRIVAN · Fresenius Kabi Usa
1999
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Propofol recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 3 Propofol recalls since July 2021, covering 4 product listings. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class I Aug 22, 2022 · Terminated · Pfizer Inc.
Presence of particulate matter
  • PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed b… Lots: Lot#: EA7470, Exp 6/1/2023 FDA record D-1540-2022 →
Class I Jul 13, 2022 · Terminated · Pfizer Inc.
Presence of particulate matter: particulate identified as a beetle.
  • Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distribut… Lots: Lot #: DX9067, Exp 5/1/2023 FDA record D-1301-2022 →
Class II Apr 13, 2022 · Terminated · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
  • Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1116-2022 →
  • Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1115-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Propofol RxCUI 8782 2 dose forms · 7 strengths
  1. Dose form (SCDF) Injectable Suspension RxCUI 377483 In current FDA listings
    Clinical drug / strength (SCD) lipid emulsion 10 MG/ML RxCUI 2561291 10 MG/ML RxCUI 312674

Look up RxCUI 8782 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Propofol brand names

Propofol is sold under 4 brand names in the FDA directory — Diprivan, Propovan, Propoven, Propofol Injectable Emulsion. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Diprivan Propovan Propoven Propofol Injectable Emulsion

Who makes Propofol: manufacturers and labelers

14 companies list Propofol products with the FDA. By number of product records, the largest are Hospira, Inc., Amneal Pharmaceuticals Private Limited, Civica, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hospira, Inc. 5 Amneal Pharmaceuticals Private Limited 3 Civica, Inc 3 Dr. Reddy's Laboratories, Inc. 3 HF Acquisition Co LLC, DBA HealthFirst 3 Hikma Pharmaceuticals USA Inc. 3 Meitheal Pharmaceuticals Inc. 3 NorthStar Rx LLC 3 Pfizer Laboratories Div Pfizer Inc 3 Fresenius Kabi USA, LLC 2 Anthea Pharma Private Limited 1 Avenacy, LLC 1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 1 Sagent Pharmaceuticals 1

Propofol drug class (RxNorm)

Propofol belongs to the General Anesthetic class.

Pharmacologic class General Anesthetic
Drug family (ATC) Other general anesthetics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Propofol page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 18, 2024
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Propofol.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Propofol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
18
Finished products in the current FDA directory
35
Companies listing them (makers, repackagers, distributors)
14
FDA labeler codes behind them ⓘ
15
Linked representative label ⓘ
Fresenius Kabi USA, LLC
Linked label effective
Apr 18, 2024
Composite sections available
24
Linked SPL Set ID
5cec3b97-5183-4a9d-accd-21e76c99d3dd
Linked SPL Document ID
8d8838c0-3c0c-4732-ade1-12f76001c50b
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →