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The drugs you may hear about: what their FDA labels say

Propofol, midazolam, fentanyl, ketamine, dexmedetomidine, sevoflurane, rocuronium and sugammadex, and local anesthetics, in the words of their FDA labels.

5 minute read10 sources, each checked word for wordLibrary checked October 18, 2026

In short

  • Muscle relaxants such as rocuronium have no known effect on consciousness, so the label says they must be given with adequate anesthesia or sedation.Official text1
  • The propofol label lists anaphylaxis to eggs, egg products, soybeans or soy products as a contraindication.Official text2
  • The sugammadex label says that anyone taking an oral contraceptive on the day it is given must use a back-up non-hormonal method for the next 7 days.Official text3
  • Labels for midazolam and fentanyl warn that combining benzodiazepines and opioids can cause profound sedation, slowed breathing, coma and death.Official text4,5

How sure each claim is:E1StrongE2GoodOfficial textReviewWhat the grades mean

Propofol (Diprivan)

The label describes propofol as an intravenous general anesthetic and sedation drug. It is used to start and maintain general anesthesia and for MAC sedation in adults. It is also used for sedation with regional anesthesia and for sedation in intensive care.Official text2

Its contraindications, quoted as written:

DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components. DIPRIVAN is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products.

Quoted word for word from DIPRIVAN (propofol) injectable emulsion, Prescribing Information Official text2

Any history of anaphylaxis to egg or soy, or any other allergy, belongs on the list for the anesthesia team before the day of surgery. The team weighs the label and the history together.

Midazolam

The label lists midazolam, given into a muscle or a vein, for sedation, anxiety relief and memory loss before surgery.Official text4

It warns that intravenous midazolam has been linked with slowed and stopped breathing, especially when used for sedation outside critical care settings.Official text4

It warns that combining benzodiazepines and opioids may cause profound sedation, slowed breathing, coma and death.Official text4

Fentanyl

The label describes fentanyl as an opioid for short pain relief during anesthesia and in the recovery room. It also describes it as a pain-relieving supplement to general or regional anesthesia.Official text5

It warns that serious, life-threatening or fatal slowed breathing has been reported with opioids, even when used as recommended.Official text5

It warns that combining opioids with benzodiazepines or other sedating drugs, including alcohol, may cause profound sedation, slowed breathing, coma and death.Official text5

Ketamine (Ketalar)

The label lists ketamine as a sole anesthetic for procedures that do not need muscle relaxation. It also lists it to start anesthesia and as a supplement to other anesthetics.Official text6

It reports emergence reactions in about 12% of patients during recovery, usually lasting a few hours. They range from pleasant dream-like states to vivid imagery, hallucinations and delirium.Official text6

Dexmedetomidine (Precedex)

The label lists dexmedetomidine for sedating adults who are not intubated before or during surgery and other procedures.Official text7

It reports low blood pressure and slow heart rate with the infusion, some cases fatal.Official text7

Sevoflurane (Ultane)

The label lists sevoflurane, an inhaled gas, to start and maintain general anesthesia in adults and children, for inpatient and outpatient surgery.Official text8

It warns that in susceptible people, volatile anesthetics including sevoflurane may trigger malignant hyperthermia, and fatal outcomes have been reported.Official text8

Rocuronium and sugammadex (Bridion)

Rocuronium is a muscle relaxant used with general anesthesia to help place a breathing tube and to relax muscles during surgery.Official text1

Its label says it has no known effect on consciousness, pain or thinking, so it must be given with adequate anesthesia or sedation.Official text1

It warns that severe anaphylactic reactions to muscle relaxants, including rocuronium, have been reported, some life-threatening or fatal.Official text1

Sugammadex reverses the muscle relaxation from rocuronium and vecuronium in adults and children.Official text3

Its label carries this instruction about birth control pills, quoted as written:

If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

Quoted word for word from BRIDION (sugammadex) injection, Prescribing Information Official text3

The label also reports serious hypersensitivity reactions, including anaphylaxis, with sugammadex.Official text3

Local anesthetics such as bupivacaine (Marcaine)

The label lists bupivacaine for local or regional anesthesia and pain relief in surgery, dental and oral surgery, diagnostic procedures and childbirth.Official text9

It lists early warning signs of local anesthetic toxicity in the brain. They are restlessness, anxiety, slurred speech, lightheadedness, numbness and tingling of the mouth and lips, and metallic taste. Others are ringing in the ears, dizziness, blurred vision, tremors, twitching and drowsiness.Official text9

A regional anesthesia society advisory notes a trend toward delayed toxicity, and that small body size and low muscle mass add risk.E2Good10

Questions you might bring to your anesthesia team

  1. Which of these drugs are likely to be used for my procedure?
  2. I take birth control pills: does the plan include sugammadex, and what back-up method would I need?
  3. I have had a reaction to eggs, soy, a muscle relaxant or any anesthesia drug: how does that change the plan?
  4. Will I receive both a sedative and an opioid, and how will my breathing be watched?

Every claim in this guide was written from its sources and checked against them word for word. Its clinical review by Dr. Recio, a practicing nurse anesthesiologist (CRNA), is pending. This line changes when the review is done.

Sources

Each source opens on PubMed, DailyMed or the publisher's page. Under each one are the exact words from it that this page relies on, copied word for word and checked against the original.

  1. Rocuronium Bromide Injection, Prescribing Information. Fresenius Kabi USA, LLC, 2026. Official text FDA label
    The words this page rests on
    Rocuronium Bromide Injection has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.
    Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
    Severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported. These reactions have, in some cases (including cases with Rocuronium Bromide Injection), been life threatening and fatal.
  2. DIPRIVAN (propofol) injectable emulsion, Prescribing Information. Fresenius Kabi USA, LLC, 2025. Official text FDA label
    The words this page rests on
    DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components. DIPRIVAN is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products.
    DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: (1) • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients • Sedation for Adult Patients in Combination with Regional Anesthesia • Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
  3. BRIDION (sugammadex) injection, Prescribing Information. Merck Sharp & Dohme LLC, 2026. Official text FDA label
    The words this page rests on
    If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.
    BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.
    Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION.
  4. Midazolam Injection, USP, Prescribing Information. Hospira, Inc., 2024. Official text FDA label
    The words this page rests on
    Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
    Midazolam injection is indicated: • intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
    Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted.
  5. Fentanyl Citrate Injection, USP, Prescribing Information. Hospira, Inc., 2026. Official text FDA label
    The words this page rests on
    Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
    Fentanyl Citrate Injection is an opioid agonist indicated for (1): • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia.
    Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
  6. KETALAR (ketamine hydrochloride) injection, Prescribing Information. Par Health USA, LLC, 2026. Official text FDA label
    The words this page rests on
    KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents.
    Emergence delirium (postoperative confusional states or agitation) has occurred in approximately 12% of patients during the recovery period, and the duration is generally a few hours. The neuropsychological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium.
  7. PRECEDEX (dexmedetomidine hydrochloride) injection, Prescribing Information. Hospira, Inc., 2026. Official text FDA label
    The words this page rests on
    PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
    Reports of hypotension and bradycardia have been associated with PRECEDEX infusion. Some of these cases have resulted in fatalities.
  8. ULTANE (sevoflurane) volatile liquid for inhalation, Prescribing Information. AbbVie Inc., 2025. Official text FDA label
    The words this page rests on
    ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia.
    In susceptible individuals, volatile anesthetic agents, including sevoflurane, may trigger malignant hyperthermia, a skeletal muscle hypermetabolic state leading to high oxygen demand. Fatal outcomes of malignant hyperthermia have been reported.
  9. MARCAINE (bupivacaine hydrochloride) and MARCAINE WITH EPINEPHRINE injection, Prescribing Information. Hospira, Inc., 2023. Official text FDA label
    The words this page rests on
    MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
    Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.
  10. The Third American Society of Regional Anesthesia and Pain Medicine Practice Advisory on Local Anesthetic Systemic Toxicity: Executive Summary 2017. Neal JM, Reg Anesth Pain Med, 2018. E2Good Consensus statement
    The words this page rests on
    Contemporary case reports suggest a trend toward delayed presentation, which may mirror the increased use of ultrasound guidance (fewer intravascular injections), local infiltration techniques (slower systemic uptake), and continuous local anesthetic infusions. Small patient size and sarcopenia are additional factors that increase potential risk for LAST.