Exparel Side Effects Center

Last updated on RxList: 4/26/2021
Exparel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Exparel?

Exparel (bupivacaine liposome) is a non-opioid postsurgical analgesic used in the management of postsurgical pain. Exparel provides prolonged postsurgical analgesia for up to 72 hours with a single-dose local administration at the surgical site.

What Are Side Effects of Exparel?

Side effects of Exparel include:

  • dizziness,
  • drowsiness,
  • nausea,
  • constipation,
  • vomiting,
  • itching,
  • headache,
  • back pain, or
  • swelling in your hands or feet.

Tell your doctor if you have serious side effects of Exparel including:

  • ringing in your ears;
  • feeling restless or anxious;
  • feeling like you might pass out;
  • speech or vision problems, a metallic taste in your mouth;
  • numbness or tingling around your mouth;
  • tremors, twitching, mood changes;
  • fast heart rate, feeling short of breath, feeling unusually hot or cold;
  • numbness, weakness, or loss of movement where the injection was given; or
  • if you still feel numb several hours after your surgery.

Dosage for Exparel

Exparel is available in two sizes: 10 mL and 20 mL single use vials in a strength of 1.3% (1.33 mg/ml). Exparel is intended for single-dose administration only. The recommended dose of Exparel is based on the surgical site and the volume required to cover the area.

What Drugs, Substances, or Supplements Interact with Exparel?

Exparel may interact with other drugs. Tell your doctor all medications and supplements you use.

Exparel During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Exparel; it is unknown if it will harm a fetus. Exparel can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Exparel 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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Exparel Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

You will be watched closely after receiving bupivacaine liposome, to make sure you do not have a reaction to the medicine. Tell your caregivers at once if you have any of these signs of a serious side effect:

  • ringing in your ears;
  • drowsiness, feeling restless or anxious;
  • feeling like you might pass out;
  • speech or vision problems, a metallic taste in your mouth;
  • numbness or tingling around your mouth;
  • fast or slow heart rate, feeling short of breath, feeling unusually hot or cold;
  • tremors, twitching, mood changes;
  • ongoing numbness, weakness, or loss of movement where the medicine was injected; or
  • joint pain or stiffness, or weakness in any part of your body for months after your surgery.

You may still feel numb or be unable to move the numbed area for up to 5 days after you are treated with bupivacaine liposome.

Common side effects include:

  • nausea, vomiting;
  • constipation; or
  • fever.

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.

Read the entire detailed patient monograph for Exparel (Bupivacaine Liposome Injectable Suspension)

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Exparel Professional Information

SIDE EFFECTS

The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling:

  • Central Nervous System Reactions [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular System Reactions [see WARNINGS AND PRECAUTIONS]
  • Allergic Reactions [see WARNINGS AND PRECAUTIONS]
  • Chondrolysis [see WARNINGS AND PRECAUTIONS]
  • Methemoglobinemia [see WARNINGS AND PRECAUTIONS]
  • Accidental intravascular injection [see WARNINGS AND PRECAUTIONS]

Clinical Trials

Adverse Reactions Reported In All Local Infiltration Clinical Studies

Because clinical studies 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 studies of another drug and may not reflect the rates observed in practice.

The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

The less common/rare adverse reactions (incidence less than 2%) following EXPAREL administration were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, dizziness postural, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, pruritus generalized, rash pruritic, hyperhidrosis, cold sweat, urticaria, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, body temperature increased, blood pressure increased, blood pressure decreased, oxygen saturation decreased, urinary incontinence, vision blurred, tinnitus, drug hypersensitivity, and hypersensitivity.

Neurological And Cardiac Adverse Reactions

In the EXPAREL surgical site infiltration studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following EXPAREL administration were dizziness (6.2%), headache (3.8%), somnolence (2.1%), hypoesthesia (1.5%), and lethargy (1.3%). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following EXPAREL administration were tachycardia (3.9%) and bradycardia (1.6%).

Adverse Reactions Reported In All Local Infiltration Placebo-Controlled Trials

Adverse reactions with an incidence greater than or equal to 2% reported by patients in clinical studies comparing 8 mL EXPAREL 1.3% (106 mg) to placebo and 20 mL EXPAREL 1.3% (266 mg) to placebo are shown in Table 1.

Table 1: Treatment-Emergent Adverse Reactions (TEAE) with an Incidence Greater than or Equal to 2%: Local Infiltration Placebo-Controlled Studies

System Organ Class Preferred Term STUDY 1a STUDY 2b
EXPAREL 8 mL/1.3% (106 mg)
(N=97)n (%)
Placebo
(N=96) n (%)
EXPAREL 20 mL/1.3% (266 mg)
(N=95)n (%)
Placebo
(N=94) n (%)
Any TEAE 53 (54.6) 59 (61.5) 10 (10.5) 17 (18.1)
Gastrointestinal Disorders 41 (42.3) 38 (39.6) 7 (7.4) 13 (13.8)
Nausea 39 (40.2) 36 (37.5) 2 (2.1) 1 (11)
Vomiting 27 (27.8) 17 (17.7) 2 (2.1) 4 (4.3)
Constipation 2 (2.1) 1 (1.0) 2 (2.1) 2 (2.1)
Anal Hemorrhage 0 (0.0) 0 (0.0) 3 (3.2) 4 (4.3)
Painful Defecation 0 (0.0) 0 (0.0) 2 (2.1) 5 (5.3)
Rectal Discharge 0 (0.0) 0 (0.0) 1 (11) 3 (3.2)
Nervous System Disorders 20 (20.6) 30 (31.3) 0 (0.0) 0 (0.0)
Dizziness 11 (11.3) 25 (26.0) 0 (0.0) 0 (0.0)
Headache 5 (5.2) 8 (8.3) 0 (0.0) 0 (0.0)
Somnolence 5 (5.2) 1 (1.0) 0 (0.0) 0 (0.0)
Syncope 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)
Skin And Subcutaneous Tissue Disorders 8 (8.2) 7 (7.3) 0 (0.0) 0 (0.0)
Pruritus Generalized 5 (5.2) 6 (6.3) 0 (0.0) 0 (0.0)
Pruritus 3 (3.1) 1 (1.0) 0 (0.0) 0 (0.0)
Investigations 5 (5.2) 3 (3.1) 4 (4.2) 3 (3.2)
Alanine Aminotransferase Increased 3 (3.1) 3 (3.1) 1 (11) 0 (0.0)
Aspartate Aminotransferase Increased 3 (3.1) 2 (2.1) 0 (0.0) 0 (0.0)
Blood Creatinine Increased 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)
Body Temperature Increased 0 (0.0) 0 (0.0) 3 (3.2) 3 (3.2)
General Disorders And Administration Site Conditions 4 (4.1) 0 (0.0) 1 (11) 1 (11)
Feeling Hot 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)
Pyrexia 2 (2.1) 0 (0.0) 1 (1.1) 1 (11)
Infections And Infestations 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0)
Fungal Infection 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0)
Injury, Poisoning And Procedural Complications 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)
Post Procedural Swelling 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0)
Metabolism And Nutrition Disorders 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0)
Decreased Appetite 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0)
a Study 1: Bunionectomy
b Study 2: Hemorrhoidectomy
At each level of summation (overall, system organ class, preferred term), patients are only counted once. Preferred terms are included where at least 2% of patients reported the event in any treatment group. TEAE = treatment-emergent adverse event.

Adverse Reactions Reported In All Local Infiltration Clinical Studies In Pediatric Patients Aged 6 To Less Than 17 Years

The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing spine or cardiac surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment.

The less common or rare adverse reactions (incidence less than 2%) following EXPAREL administration were flatulence, abdominal pain, dyspepsia, lip swelling, pain in extremity, musculoskeletal pain, flank pain, musculoskeletal chest pain, hypertension, sinus tachycardia, ventricular extrasystoles, dysgeusia, paresthesia, burning sensation, syncope, diplopia, eye swelling, dyspnea, atelectasis, hypopnea, hypoxia, chest pain, face edema, gait disturbance, pruritus generalized, rash, delayed recovery from anesthesia, fall, incision site hemorrhage, joint dislocation, seroma, hypomagnesemia, acidosis, hyperglycemia, metabolic acidosis, ear discomfort, urine output decreased, heart rate increased, anxiety, panic attack, ear infection, and wound infection fungal.

Neurological And Cardiac Adverse Reactions

In the EXPAREL infiltration studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following EXPAREL administration were dizziness (6.3%, n=5), and dysgeusia (1.3%, n=1). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following EXPAREL administration were tachycardia (11.3%, n=9), bradycardia (8.8%, n=7), sinus tachycardia (1.3%, n=1), and ventricular extrasystoles (1.3%, n=1).

Adverse Reactions Reported In All Local Infiltration Trials In Pediatric Patients Aged 6 To Less Than 17 Years Old

Adverse reactions with an incidence greater than or equal to 2% reported by patients in clinical studies studying 4 mg/kg EXPAREL are shown in Table 2.

Table 2: Treatment-Emergent Adverse Reactions (TEAE) with an Incidence Greater than or Equal to 2%: Local Infiltration Studies in Pediatric Patients Aged 6 to Less than 17 Years Old

System Organ Class Preferred Term Study1 a Study 2b
Spine Surgery EXPAREL 4 mg/kgc
(N=36) n (%)
Cardiac Surgery EXPAREL 4 mg/kgc
(N=29) n (%)
Spine Surgery EXPAREL 4 mg/kgc
(N=15) n (%)
Subjects with at least one TEAE 24 (66.7) 9 (31.0) 15 (100.0)
Blood and lymphatic system disorders 0 0 15 (100)
Anemia 0 0 15 (100)
Cardiac disorders 3 (8.3) 1 (3.4) 12 (80.0)
Bradycardia 2 (5.6) 0 5 (33.3)
Sinus tachycardia 0 1 (3.4) 0
Tachycardia 1 (2.8) 0 8 (53.3)
Ventricular extrasystoles 0 0 1 (6.7)
Ear and labyrinth disorders 2 (5.6) 0 2 (13.3)
Ear discomfort 0 0 1 (6.7)
Hypoacusis 2 (5.6) 0 1 (6.7)
Eye disorders 10 (27.8) 1 (3.4) 4 (26.7)
Diplopia 1 (2.8) 0 0
Eye swelling 0 0 1 (6.7)
Lacrimation increased 0 0 0
Vision blurred 7 (19.4) 1 (3.4) 3 (20.0)
Visual impairment 2 (5.6) 0 0
Gastrointestinal disorders 18 (50.0) 7 (24.1) 14 (93.3)
Abdominal Pain 0 0 1 (6.7)
Constipation 9 (25.0) 4 (13.8) 7 (46.7)
Nausea 11 (30.6) 2 (6.9) 9 (60.0)
Diarrhea 3 (8.3) 0 0
Dyspepsia 1 (2.8) 0 0
Flatulence 0 0 1 (6.7)
Hypoesthesia oral 4 (11.1) 0 2 (13.3)
Lip Swelling 0 0 1 (6.7)
Vomiting 10 (27.8) 4 (13.8) 8 (53.3)
General disorders and administration site conditions 0 1 (3.4) 3 (20.0)
Chest pain 1 (2.8) 0 0
Face edema 0 1 (3.4) 0
Gait disturbance 0 0 1 (6.7)
Generalized edema 0 0 0
Pyrexia 0 0 3 (20.0)
Infections and infestations 1 (2.8) 1 (3.4) 0
Ear infection 1 (2.8) 11 0 0
Wound infection fungal 0 1 (3.4) 0
Injury, poisoning and procedural complications 8 (22.2) 0 1 (6.7)
Anemia postoperative 5 (13.9) 0 0
Delayed recovery from anesthesia 1 (2.8) 0 0
Fall 0 0 1 (6.7)
Incision site hemorrhage 1 (2.8) 0 0
Joint dislocation 1 (2.8) 0 0
Procedural hemorrhage 0 0 0
Seroma 1 (2.8) 0 0
Metabolism and nutrition disorders 0 3 (10.3) 0
Acidosis 0 1 (3.4) 0
Hyperglycemia 0 1 (3.4) 0
Hypomagnesaemia 0 1 (3.4) 0
Metabolic acidosis 0 1 (3.4) 0
Musculoskeletal and connective tissue disorders 8 (22.2) 1 (3.4) 12 (80.0)
Back pain 0 0 2 (13.3)
Flank pain 0 0 1 (6.7)
Muscle twitching 3 (8.3) 1 (3.4) 9 (60.0)
Muscle spasms 4 (11.1) 0 3 (20.0)
Muscular weakness 0 14 0 2 (13.3)
Musculoskeletal pain 1 (2.8) 0 0
Musculoskeletal chest pain 0 0 1 (6.7)
Pain in extremity 0 0 1 (6.7)
Nervous system disorders 3 (8.3) 0 7 (46.7)
Burning sensation 0 0 1 (6.7)
Dizziness 2 (5.6) 0 3 (20.0)
Dysgeusia 1 (2.8) 0 0
Headache 0 0 0
Hypoesthesia 0 0 3 (20.0)
Paresthesia 0 0 1 (6.7)
Syncope 1 (2.8) 0 0
Psychiatric disorders 0 0 2 (13.3)
Anxiety 0 0 1 (6.7)
Panic attack 0 0 1 (6.7)
Renal and urinary disorders 0 0 2 (13.3)
Hematuria 0 0 2 (13.3)
Respiratory, thoracic and mediastinal disorders 3 (8.3) 1 (3.4) 7 (46.7)
Atelectasis 0 0 1 (6.7)
Bradypnea 0 0 0
Dyspnea 0 1 (3.4) 0
Hypopnea 1 (2.8) 15 0 0
Hypoxia 1 (2.8) 0 0
Pleural effusion 0 0 0
Tachypnea 1 (2.8) 0 6 (40.0)
Skin and subcutaneous tissue disorders 4 (11.1) 0 6 (40.0)
Pruritus 3 (8.3) 0 6 (40.0)
Pruritus generalized 1 (2.8) 0 0
Rash 0 0 1 (6.7)
Vascular disorders 4 (11.1) 1 (3.4) 14 (93.3)
Hot flush 0 0 0
Hypotension 4 (11.1) 0 14 (93.3)
Hypertension 0 1 (3.4) 0
Systolic hypertension 0 0 0
a Study 1: Includes spine surgery subjects aged 6 to less than 17 years old, and cardiac surgery subjects aged 6 to less than 12 years old.
b Study 2: Includes spine surgery subjects aged 12 to less than 17 years old.
c Patients received EXPAREL 4 mg/kg, not to exceed 266 mg.
At each level of summation (overall, system organ class, preferred term), patients are only counted once.
Preferred terms are included where at least 2% of patients reported the event in any treatment group.
TEAE = treatment-emergent adverse event.

Adverse Reactions Reported In All Nerve Block Clinical Studies

The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, and post-procedural hematoma.

The less common/rare adverse reactions (incidence less than 2%) following EXPAREL administration as a nerve block were arrhythmia, atrial fibrillation, atrioventricular block first degree, bradycardia, bundle branch block left, bundle branch block right, cardiac arrest, hearing impaired, vision blurred, visual impairment, asthenia, chills, hyperthermia, cellulitis, lung infection, pneumonia, procedural nausea, wound dehiscence, wound secretion, electrocardiogram QT prolonged, white blood cell count increased, arthralgia, back pain, joint swelling, mobility decreased, muscle spasms, muscular weakness, musculoskeletal pain, paraesthesia, presyncope, sedation, somnolence, syncope, delirium, dysuria, urinary incontinence, atelectasis, cough, dyspnea, lung infiltration, blister, drug eruption, erythema, rash, urticaria, deep vein thrombosis, hematoma, and orthostatic hypotension.

Adverse reactions with an incidence greater than or equal to 2% reported by patients in clinical studies comparing 10 mL EXPAREL 1.3% (133 mg) and 20 mL EXPAREL 1.3% (266 mg) to placebo are shown in Table 3.

Neurological And Cardiac Adverse Reactions

In the EXPAREL nerve block studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following EXPAREL administration were motor dysfunction (14.9%), dysgeusia (7.2%), headache (5.1%), hypoesthesia (2.3%), and sensory loss (2.3%). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following EXPAREL administration were tachycardia (3.0%), sinus tachycardia (2.3%), and bradycardia (1.3%).

Table 3: Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Nerve Block Placebo-Controlled Studies

SYSTEM ORGAN CLASS Preferred Term 133 mg
(N=168) n (%)
266 mg
(N=301) n (%)
Placebo
(N=357) n (%)
Number of Subjects with at Least One TEAE 152 (90.5) 260 (86.4) 299 (83.8)
Blood and Lymphatic System Disorders 2 (1.2) 22 (7.3) 15 (4.2)
Anemia 2 (1.2) 18 (6.0) 13 (3.6)
Cardiac Disorders 13 (7.7) 34 (11.3) 38 (10.6)
Atrial Fibrillation 1 (0.6) 4 (1.3) 8 (2.2)
Sinus Tachycardia 3 (1.8) 8 (2.7) 4 (1.1)
Tachycardia 3 (1.8) 11 (3.7) 10 (2.8)
Gastrointestinal Disorders 84 (50.0) 154 (51.2) 184 (51.5)
Constipation 29 (17.3) 66 (21.9) 68 (19.0)
Dyspepsia 3 (1.8) 7 (2.3) 7 (2.0)
Hypoesthesia Oral 6 (3.6) 8 (2.7) 7 (2.0)
Nausea 62 (36.9) 111 (36.9) 133 (37.3)
Vomiting 17 (10.1) 55 (18.3) 73 (20.4)
General Disorders And Administration Site Conditions 52 (31.0) 102 (33.9) 91 (25.5)
Fatigue 7 (4.2) 15 (5.0) 15 (4.2)
Feeling Cold 0 10 (3.3) 8 (2.2)
Edema Peripheral 4 (2.4) 6 (2.0) 8 (2.2)
Peripheral Swelling 3 (1.8) 8 (2.7) 4 (1.1)
Pyrexia 36 (21.4) 70 (23.3) 64 (17.9)
Injury, Poisoning And Procedural Complications 18 (10.7) 44 (14.6) 32
Anemia Postoperative 0 8 (2.7) 10
Contusion 4 (2.4) 1 (0.3) 0
Fall 4 (2.4) 8 (2.7) 1
Post Procedural Hematoma 4 (2.4) 1 (0.3) 0
Procedural Hypotension 2 (1.2) 13 (4.3) 7
Investigations 18 (10.7) 31 (10.3) 31 (8.7)
Body Temperature Increased 1 (0.6) 10 (3.3) 4 (1.1)
Hepatic Enzyme Increased 7 (4.2) 1 (0.3) 3 (0.8)
Metabolism and Nutrition Disorders 13 (7.7) 18 (6.0) 25 (7.0)
Hypokalemia 7 (4.2) 9 (3.0) 14 (3.9)
Musculoskeletal And Connective Tissue Disorders 22 (13.1) 47 (15.6) 41 (11.5)
Mobility Decreased 0 6 (2.0) 5 (1.4)
Muscle Twitching 14 (8.3) 21 (7.0) 25 (7.0)
Nervous System Disorders 72 (42.9) 101 (33.6) 112 (31.4)
Dizziness 8 (4.8) 28 (9.3) 40 (11.2)
Dysgeusia 12 (7.1) 22 (7.3) 21 (5.9)
Headache 14 ( 8.3) 10 (3.3) 10 (2.8)
Hypoesthesia 6 (3.6) 5 (1.7) 2 (0.6)
Motor Dysfunction 35 (20.8) 35 (11.6) 37 (10.4)
Sensory Loss 4 (2.4) 7 (2.3) 1 (0.3)
Psychiatric Disorders 10 (6.0) 33 (11.0) 44 (12.3)
Anxiety 3 (1.8) 9 (3.0) 6 (1.7)
Confusional State 3 (1.8) 15 (5.0) 14 (3.9)
Insomnia 5 (3.0) 10 (3.3) 19 (5.3)
Renal And Urinary Disorders 9 (5.4) 31 (10.3) 31 (8.7)
Urinary Retention 5 (3.0) 23 (7.6) 22 (6.2)
Respiratory, Thoracic And Mediastinal Disorders 18 (10.7) 30 (10.0) 31 (8.7)
Dyspnea 1 Q 2 (1.2) 4 (1.3) 8 (2.2)
Hiccups 4 (2.4) 4 (1.3) 1 (0.3)
Hypoxia 4 (2.4) 3 (1.0) 3 (0.8)
Skin And Subcutaneous Tissue Disorders 24 (14.3) 63 (20.9) 84 (23.5)
Hyperhidrosis 1 (0.6) 14 (4.7) 15 (4.2)
Pruritus 10 (6.0) 45 (15.0) 55 (15.4)
Pruritus Generalized 6 (3.6) 7 (2.3) 14 (3.9)
Vascular Disorders 16 (9.5) 30 (10.0) 44 (12.3)
Hypertension 3 (1.8) 15 (5.0) 21 (5.9)
Hypotension 11 (6.5) 8 (2.7) 19 (5.3)
At each level of summation (overall, system organ class, preferred term), patients are only counted once. Preferred terms are included where at least 2% of patients reported the event in any treatment group. TEAE = treatment-emergent adverse event.

Postmarketing Experience

Because adverse reactions reported during postmarketing are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin And Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).

DRUG INTERACTIONS

The toxic effects of local anesthetics are additive and their co-administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [See DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and OVERDOSAGE]. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.

Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:

Examples of Drugs Associated with Methemoglobinemia:

Class Examples
Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide
Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine
Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase
Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides
Antimalarials chloroquine, primaquine
Anticonvulsants Phenobarbital, phenytoin, sodium valproate
Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

Bupivacaine

Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

Non-Bupivacaine Local Anesthetics

EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL.

Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration.

Water And Hypotonic Agents

Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles.

Read the entire FDA prescribing information for Exparel (Bupivacaine Liposome Injectable Suspension)

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

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