FDA label 1fc058f3-8582-9be2-e063-6294a90aff54

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION OF OMNIPAQUE injection 140 and 350 mg iodine/mL See full prescribing information for complete boxed warning . Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema ( 4 , 5.1 ).

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.9 ) 5.1 Risks Associated with Inadvertent Intrathecal Administration OMNIPAQUE injection 140 and 350 are contraindicated for intrathecal use [ see Contraindications (4) and Dosage and Administration (2.1) ] . Inadvertent intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Risks Associated with Inadvertent Parenteral Administration OMNIPAQUE oral solution 9 and 12 are contraindicated for parenteral administration [ see Contraindications (4) and Dosage and Administration (2.1) ]. Adverse reactions such as hemolysis may occur if administered intravascularly. Do not administer OMNIPAQUE oral solution 9 and 12 parenterally. 5.3 Hypersensitivity Reactions OMNIPAQUE can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to OMNIPAQUE administration. Monitor all patients for hypersensitivity reactions. 5.4 Contrast-Induced Acute Kidney Injury Acute kidney injury, including renal failure, may occur after parenteral administration of OMNIPAQUE. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent. Use the lowest necessary dose of OMNIPAQUE in patients with renal impairment. Adequately hydrate patients prior to and following parenteral administration of OMNIPAQUE. Do not use laxatives, diuretics, or preparatory dehydration prior to OMNIPAQUE administration. 5.5 Cardiovascular Adverse Reactions Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the parenteral administration of OMNIPAQUE. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Based upon clinical literature reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%). Use the lowest necessary dose of OMNIPAQUE in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions. 5.6 Thromboembolic Events Angiocardiography Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast media. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications. To minimize thromboembolic events, use meticulous angiographic techniques, and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism. 5.7 Extravasation and Injection Site Reactions Extravasation of OMNIPAQUE during intravascular injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms. 5.8 Thyroid Storm in Patients with Hyperthyroidism Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of OMNIPAQUE. 5.9 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age. Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures. ​ An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. ​​ ​ 5.10 Hypertensive Crisis in Patients with Pheochromocytoma Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Monitor patients when administering OMNIPAQUE intravascularly if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available. 5.11 Sickle Cell Crisis in Patients with Sickle Cell Disease Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following OMNIPAQUE administration and use OMNIPAQUE only if the necessary imaging information cannot be obtained with alternative imaging modalities. 5.12 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering OMNIPAQUE to patients with a history of a severe cutaneous adverse reaction to OMNIPAQUE.

5.9 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age. Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures. ​ An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. ​​ ​

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Risks Associated with Inadvertent Parenteral Administration [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.9) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥ 1.0%) in adult patients after OMNIPAQUE administration. ( 6.1 ) Intrathecal: Headaches, Pain including backache, neckache, stiffness and neuralgia, nausea, vomiting and dizziness Intravascular: Pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea Oral: Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache Body Cavity: Pain, swelling and heat sensation Post-marketing adverse reactions ( 6.2 ): Hypersensitivity and manifestations like rash, pruritus, urticaria, and dyspnea, in addition chest pain, and swelling. To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials 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 trials of another drug and may not reflect the rates observed in practice. Intrathecal Administration Adults TABLE 23 ADVERSE REACTIONS – INTRATHECAL ADMINISTRATION In controlled clinical studies involving 1531 patients using OMNIPAQUE the following adverse reactions were reported: System Organ Class Adverse Reaction Incidence Nervous System Headaches 18% Musculoskeletal and Connective Tissue Pain including backache, neckache, stiffness and neuralgia 8% Gastrointestinal System Nausea 6% Vomiting 3% Nervous System Dizziness 2% Other Reactions Feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes <0.1% Pediatric Patients TABLE 24 ADVERSE REACTIONS – INTRATHECAL ADMINISTRATION In clinical studies involving 152 patients for pediatric myelography by lumbar puncture, adverse events following the use of OMNIPAQUE 180 were generally similar to those reported in adults. Procedure System Organ Class Adverse Reaction Incidence Myelography by Lumbar Puncture Nervous System Headache 9% Gastrointestinal System Vomiting 6% Musculoskeletal and Connective Tissue Backache 1.3% Other Reactions All were transient and mild with no clinical sequelae. Fever <0.7% Hives Stomachache Visual Hallucination Neurological Changes Intravascular Administration Immediately following intravascular injection of contrast medium, a transient sensation of mild warmth is not unusual. Warmth is less frequent with OMNIPAQUE than with ionic contrast media. Adults In controlled clinical studies involving 1485 patients, the following adverse reactions occurred (Table 25). TABLE 25 ADVERSE REACTIONS – INTRAVASCULAR ADMINISTRATION System Organ Class Adverse Reaction Incidence Cardiovascular System Arrhythmias including PVCs and PACs 2% Hypotension 0.7% Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction ≤ 0.3% Nervous System Vertigo (including dizziness and lightheadedness) 0.5% Pain 3% Vision Abnormalities (including blurred vision and photomas) 2% Taste Perversion 1% Other Reactions Anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus Individual incidence of 0.3% or less Respiratory System Dyspnea, rhinitis, coughing, and laryngitis Individual incidence of 0.2% or less Gastrointestinal System Nausea 2% Vomiting 0.7% Others including diarrhea, dyspepsia, cramp, and dry mouth Individual incidence of less than 0.1%. Skin and Subcutaneous Tissues Urticaria 0.3% Purpura 0.1% Abscess 0.1% Pruritus 0.1% Pediatric Patients In controlled clinical studies involving 391 patients for pediatric angiocardiography, urography, and CT head imaging, adverse reactions following the use of OMNIPAQUE 240, 300, and 350 were generally similar in quality and frequency to those reported in adults (Table 26). TABLE 26 ADVERSE REACTIONS – INTRAVASCULAR ADMINISTRATION System Organ Class Adverse Reaction Incidence Cardiovascular System Ventricular Tachycardia 0.5% 2:1 Heart Block 0.5% Hypertension 0.3% Anemia 0.3% General Disorders and Administration Site Conditions Pain 0.8% Fever 0.5% Nervous System Convulsion 0.3% Taste Abnormality 0.5% Respiratory System Congestion 0.3% Apnea 0.3% Gastrointestinal System Nausea 1% Vomiting 2% Endocrine System Hypoglycemia 0.3% Skin and Subcutaneous Tissue Rash 0.3% Oral Administration for Examination of the Gastrointestinal Tract Adults Nausea, vomiting, and diarrhea have been most frequently reported following orally administered undiluted OMNIPAQUE for radiographic examination of the gastrointestinal tract. In controlled clinical studies involving 54 adult patients for oral radiographic examination of the gastrointestinal tract using undiluted OMNIPAQUE 350 the following adverse reactions were reported (Table 27). TABLE 27 ADVERSE REACTIONS – ORAL ADMINISTRATION OF UNDILUTED OMNIPAQUE 350 System Organ Class Adverse Reaction Incidence Gastrointestinal System Diarrhea 42% Nausea 15% Vomiting 11% Abdominal Pain 7% Flatulence 2% Nervous System Headache 2% Pediatrics Patients (Oral and Rectal Administration) In clinical studies involving 58 pediatric patients, the adverse reactions were found to mostly affect the gastrointestinal system with diarrhea (36%), vomiting (9%), nausea (5%) and abdominal pain (2%). However, fever (5%), hypotension (2%) and urticaria (2%) were also reported. Oral Administration for CT of the Abdomen in Conjunction with Intravenous Administration Adults In a controlled clinical study involving 44 adult patients receiving oral administration of diluted OMNIPAQUE (4-9 mg iodine/mL) in conjunction with intravenously injected OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting. Pediatric Patients In clinical studies involving 69 pediatric patients receiving oral administration of diluted OMNIPAQUE (9-29 mg iodine/mL) in conjunction with intravenously administered OMNIPAQUE 240 and OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting (1.4%). Body Cavity Use Adults Arthrography : In controlled clinical studies involving 285 adult patients for various body cavity examinations using OMNIPAQUE 240, 300 and 350, the most frequent adverse reactions were administration site reactions: pain 26% and swelling 22%, were exclusively reported for arthrography and were generally related to the procedure rather than the contrast medium. Patients also experienced heat (7%). All other adverse reaction occurred at a rate less than or equal to 1%. Pediatric Patients No adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied. 6.2 Post-marketing Experience The following additional reactions listed by indication have been identified during post-approval use of OMNIPAQUE. Because these reactions 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. General Immune System Disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis General Disorders and Administration Site Conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation Intrathecal Administration Nervous System Disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Musculoskeletal and Connective Tissue Disorders: Pain, muscle spasms or spasticity Psychiatric Disorders: Confusional state, agitation, anxiety Eye Disorders: Transient visual impairment including cortical blindness Renal Reactions: Acute kidney injury Intravascular Administration Cardiovascular Disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain Hemodynamic Reactions: Vasospasm and thrombophlebitis following intravenous injection Blood and Lymphatic System Disorders: Neutropenia Nervous System Disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Psychiatric Disorders: Confusional state, agitation Eye Disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation Renal Reactions: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine Gastrointestinal Disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement Endocrin e Reactions: Hyperthyroidism, hypothyroidism Respiratory; Thoracic, and Mediastinal Disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack Skin and Subcutaneous Tissue Disorders: Contrast media reactions range from mild (e.g., pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe: [e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)] Oral Administration Gastrointestinal Disorders: Dysphagia, abdominal pain Body Cavity Administration Gastrointestinal Disorders: Pancreatitis Musculoskeletal and Connective Tissue Disorders: Arthritis (arthrography) Hysterosalpingography : Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes Fluoroscopic monitoring is recommended. Nervous system : Pain (49%), somnolence and fever each with an individual incidence of 3% Gastrointestinal system : Nausea (3%)

<table width="90%"><caption>TABLE 23 ADVERSE REACTIONS &#x2013; INTRATHECAL ADMINISTRATION</caption><col align="left" valign="top" width="30%"/><col align="left" valign="top" width="50%"/><col align="center" valign="top" width="20%"/><thead><tr styleCode="Botrule"><th colspan="3" styleCode="Lrule Rrule">In controlled clinical studies involving 1531 patients using OMNIPAQUE the following adverse reactions were reported:</th></tr><tr><th align="center" styleCode="Lrule Rrule">System Organ Class</th><th align="center" styleCode="Rrule">Adverse Reaction</th><th styleCode="Rrule">Incidence</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nervous System</td><td styleCode="Rrule">Headaches</td><td styleCode="Rrule">18%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Musculoskeletal and Connective Tissue</td><td styleCode="Rrule">Pain including backache, neckache, stiffness and neuralgia</td><td styleCode="Rrule">8%</td></tr><tr styleCode="Botrule"><td rowspan="2" styleCode="Lrule Rrule">Gastrointestinal System</td><td styleCode="Rrule">Nausea</td><td styleCode="Rrule">6%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Vomiting</td><td align="center" styleCode="Rrule">3%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nervous System</td><td styleCode="Rrule">Dizziness</td><td styleCode="Rrule">2%</td></tr><tr><td styleCode="Lrule Rrule">Other Reactions</td><td styleCode="Rrule">Feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes</td><td styleCode="Rrule">&lt;0.1%</td></tr></tbody></table>

<table width="90%"><caption>TABLE 24 ADVERSE REACTIONS &#x2013; INTRATHECAL ADMINISTRATION</caption><col align="left" valign="top" width="25%"/><col align="left" valign="top" width="30%"/><col align="left" valign="top" width="25%"/><col align="left" valign="top" width="20%"/><thead><tr styleCode="Botrule"><th colspan="4" styleCode="Lrule Rrule">In clinical studies involving 152 patients for pediatric myelography by lumbar puncture, adverse events following the use of OMNIPAQUE 180 were generally similar to those reported in adults.</th></tr><tr><th styleCode="Lrule Rrule">Procedure</th><th styleCode="Rrule">System Organ Class</th><th styleCode="Rrule">Adverse Reaction</th><th styleCode="Rrule">Incidence</th></tr></thead><tbody><tr styleCode="Botrule"><td rowspan="8" styleCode="Lrule Rrule">Myelography by Lumbar Puncture</td><td styleCode="Rrule">Nervous System</td><td styleCode="Rrule">Headache</td><td styleCode="Rrule">9%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Gastrointestinal System</td><td styleCode="Rrule">Vomiting</td><td styleCode="Rrule">6%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Musculoskeletal and Connective Tissue</td><td styleCode="Rrule">Backache</td><td styleCode="Rrule">1.3%</td></tr><tr styleCode="Botrule"><td rowspan="5" styleCode="Rrule">Other Reactions <content styleCode="italics">All were transient and mild with no clinical sequelae.</content></td><td styleCode="Rrule">Fever</td><td rowspan="5" styleCode="Rrule">&lt;0.7%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Hives</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Stomachache</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Visual Hallucination</td></tr><tr><td styleCode="Rrule">Neurological Changes</td></tr></tbody></table>

<table width="90%"><caption>TABLE 25 ADVERSE REACTIONS &#x2013; INTRAVASCULAR ADMINISTRATION</caption><col align="left" valign="top" width="30%"/><col align="left" valign="top" width="50%"/><col align="center" valign="top" width="20%"/><thead><tr><th align="center" styleCode="Lrule Rrule">System Organ Class</th><th align="center" styleCode="Rrule">Adverse Reaction</th><th align="center" styleCode="Rrule">Incidence</th></tr></thead><tbody><tr styleCode="Botrule"><td rowspan="3" styleCode="Lrule Rrule">Cardiovascular System</td><td styleCode="Rrule">Arrhythmias including PVCs and PACs</td><td styleCode="Rrule">2%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Hypotension</td><td align="center" styleCode="Rrule">0.7%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction</td><td align="center" styleCode="Rrule">&#x2264; 0.3%</td></tr><tr styleCode="Botrule"><td rowspan="4" styleCode="Lrule Rrule">Nervous System</td><td styleCode="Rrule">Vertigo (including dizziness and lightheadedness)</td><td styleCode="Rrule">0.5%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Pain</td><td align="center" styleCode="Rrule">3%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Vision Abnormalities (including blurred vision and photomas)</td><td align="center" styleCode="Rrule">2%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Taste Perversion</td><td align="center" styleCode="Rrule">1%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Other Reactions</td><td styleCode="Rrule">Anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus</td><td align="left" styleCode="Rrule">Individual incidence of 0.3% or less</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Respiratory System</td><td styleCode="Rrule">Dyspnea, rhinitis, coughing, and laryngitis</td><td align="left" styleCode="Rrule">Individual incidence of 0.2% or less</td></tr><tr styleCode="Botrule"><td rowspan="3" styleCode="Lrule Rrule">Gastrointestinal System</td><td styleCode="Rrule">Nausea</td><td styleCode="Rrule">2%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Vomiting</td><td align="center" styleCode="Rrule">0.7%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Others including diarrhea, dyspepsia, cramp, and dry mouth</td><td align="left" styleCode="Rrule">Individual incidence of less than 0.1%.</td></tr><tr styleCode="Botrule"><td rowspan="4" styleCode="Lrule Rrule">Skin and Subcutaneous Tissues</td><td styleCode="Rrule">Urticaria</td><td styleCode="Rrule">0.3%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Purpura</td><td align="center" styleCode="Rrule">0.1%</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Abscess</td><td align="center" styleCode="Rrule">0.1%</td></tr><tr><td styleCode="Rrule">Pruritus</td><td align="center" styleCode="Rrule">0.1%</td></tr></tbody></table>