Prescription medicine
Bupivacaine and epinephrine Brand names: Sensorcaine, Marcaine
Bupivacaine and epinephrine (Marcaine) is a prescription medicine with an FDA approval on record since 1972. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the bupivacaine and epinephrine FDA label on DailyMed (effective February 2, 2024, Hospira, Inc.); the NDA 16964 record on Drugs@FDA; every bupivacaine and epinephrine label on DailyMed.
Highlights of the record
FDA label of February 2, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA.
There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of MARCAINE is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. […]
Used for
From the label: indications and usageMARCAINE / 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.
Forms and strengths
- 2.5 mg/ml / 0.0091 mg/ml
- 2.5 mg/ml / 0.005 mg/ml
- 2.5 mg/ml
- 5 mg/ml / 0.0091 mg/ml
- 5 mg/ml / 0.005 mg/ml
- 5 mg/ml
- 7.5 mg/ml / 0.005 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- October 3, 1972 Marcaine Hydrochloride W/ Epinephrine Preservative Free, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first October 13, 1987; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2013 3 Class I among all firms' recalls; latest November 22, 2022
- FAERS reports
- 3,123 through July 30, 2026
What is bupivacaine and epinephrine used for?
From the label: indications and usageMARCAINE / 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. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. […]
FDA pharmacologic class: Amide Local Anesthetic, Catecholamine, alpha-Adrenergic Agonist and beta-Adrenergic Agonist.
Source: FDA drug label (Marcaine with Epinephrine), Hospira, Inc., effective February 2, 2024 (SPL set 93cf0914-de08-4ec6-8f8c-d663243b9958), via openFDA; the full label on DailyMed
Is there a generic for bupivacaine and epinephrine (Marcaine)?
The FDA approved the first generic bupivacaine and epinephrine on October 13, 1987. 11 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bupivacaine and epinephrine from 5 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1972 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bupivacaine and epinephrine been recalled?
The FDA's Enforcement Report lists 10 recalls naming bupivacaine and epinephrine since 2013: 3 Class I (the most serious), 7 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 22, 2022 | Class II | Fresenius Kabi USA, LLC | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. |
| December 10, 2020 | Class II | Fresenius Kabi USA, LLC | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. |
| September 16, 2016 | Class II | Hospira Inc., A Pfizer Company | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product … |
| June 17, 2014 | Class I | Hospira Inc. | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the … |
| April 21, 2014 | Class I | Hospira Inc. | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the … |
| October 18, 2013 | Class I | Hospira Inc. | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be … |
| October 11, 2013 | Class II | Hospira Inc. | Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. |
| September 5, 2013 | Class II | Hospira Inc. | Lack of Assurance of Sterility; potential for vial breakage |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bupivacaine and epinephrine label say about other medicines?
The bupivacaine and epinephrine label names 25 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Benzocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Chloroquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Cyclophosphamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ifosfamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Lidocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Mepivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Methylene blue | warnings and precautions | A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. |
| Metoclopramide | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Nitric oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Nitrofurantoin | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
Every other medicine the bupivacaine and epinephrine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nitroglycerin | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Nitrous oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Phenobarbital | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Phenytoin | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Prilocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Primaquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Quinine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Rasburicase | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ropivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Sulfasalazine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Tetracaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
Source: FDA drug label (Marcaine with Epinephrine), Hospira, Inc., effective February 2, 2024 (SPL set 93cf0914-de08-4ec6-8f8c-d663243b9958), via openFDA; the full label on DailyMed
What do FAERS reports show for bupivacaine and epinephrine?
The FDA Adverse Event Reporting System holds 3,123 reports that list bupivacaine and epinephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 100 are coded as a death and 543 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other amide local anesthetics
- the pharmacologic class, with prices and generics
- Bupivacaine and epinephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other