FDA label 70a9f0af-c155-45a3-912f-155a53711650

WARNINGS Use of propofol has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. For general anesthesia or monitored anesthesia care (MAC) sedation, propofol should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), propofol should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Use of propofol infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, cardiac and renal failure. The syndrome is most often associated with prolonged, high-dose infusions (>5 mg/kg/h for >48h) but has also been reported following large-dose,short-term infusions during surgical anesthesia. In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation. Abrupt discontinuation of propofol prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Infusions of propofol injectable emulsion should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level. (See PRECAUTIONS .) Propofol injectable emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals. The clinical significance of these findings is not known. There have been reports in which failure to use aseptic technique when handling propofol injectable emulsion was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (See DOSAGE AND ADMINISTRATION - Handling Procedures .)

ADVERSE REACTIONS General Adverse event information is derived from controlled clinical trials and worldwide marketing experience. In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. Anesthesia and MAC Sedation in Adults The following estimates of adverse events for propofol include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship. The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with Propofol during anesthesia (see below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea. Anesthesia in Pediatric Patients Generally the adverse experience profile from reports of 506 propofol pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with propofol during anesthesia in adults (see Pediatric percentages [Peds %] below). Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients. ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship. INCIDENCE GREATER THAN 1% - PROBABLY CAUSALLY RELATED Anesthesia/MAC Sedation ICU Sedation Cardiovascular: Bradycardia Bradycardia Arrhythmia [Peds: 1.2%] Tachycardia Nodal [Peds: 1.6%] Hypotension* [Peds: 17%] Decreased Cardiac Output (see also CLINICAL PHARMACOLOGY ) [Hypertension Peds: 8%] Hypotension 26% Central Nervous System: Movement* [Peds: 17%] Injection Site: Burning/Stinging or Pain, 17.6% [Peds: 10%] Metabolic/Nutritional: Hyperlipemia* Respiratory: Apnea (see also CLINICAL PHARMACOLOGY ) Respiratory Acidosis During Weaning* Skin and Appendages: Rash [Peds: 5%] Pruritus [Peds: 2%] Events without an * or % had an incidence of 1% to 3% *Incidence of events 3% to 10% INCIDENCE LESS THAN 1% - PROBABLY CAUSALLY RELATED Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Anaphylaxis/Anaphylactoid Reaction Perinatal Disorder [Tachycardia] [Bigeminy] [Bradycardia] [Premature Ventricular Contractions] [Hemorrhage] [ECG Abnormal] [Arrhythmia Atrial] [Fever] [Extremities Pain] [Anticholinergic Syndrome] Cardiovascular: Premature Atrial Contractions Syncope Central Nervous System: Hypertonia/Dystonia, Paresthesia Agitation Digestive: [Hypersalivation] [Nausea] Hemic/Lymphatic: [Leukocytosis] Injection Site: [Phlebitis] [Pruritus] Metabolic: [Hypomagnesemia] Musculoskeletal: Myalgia Nervous: [Dizziness] [Agitation] [Chills] [Somnolence] [Delirium] Respiratory: Wheezing [Cough] Decreased Lung Function [Laryngospasm] [Hypoxia] Skin and Appendages: Flushing, Pruritus Special Senses: Amblyopia [Vision Abnormal] Urogenital: Cloudy Urine Green Urine INCIDENCE LESS THAN 1% - CAUSAL RELATIONSHIP UNKNOWN Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, neck Rigidity/Stiffness, Trunk pain Fever, Sepsis, Trunk Pain, Whole Body Weakness Cardiovascular: Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Block, Hypertension, Myocardial Infarction, Myocardial Ischemia, Premature Ventricular Contractions, ST Segment Depression, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, ventricular Tachycardia Central Nervous System: Abnormal Dreams, Agitation, Amorous Behavior, Anxiety, Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/Myoclonic Movement, Combativeness, Confusion, Delirium, Depression, Dizziness, Emotional Lability, Euphoria, Fatigue, Hallucinations, Headache, Hypotonia, Hysteria, Insomnia, Moaning, Neuropathy, Opisthotonos, Rigidity, Seizures, Somnolence, Tremor, Twitching Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal Digestive: Cramping, Diarrhea, Dry Mouth, Enlarged Parotid, Nausea, Swallowing, Vomiting Ileus, Liver Function Abnormal Hematologic/Lymphatic: Coagulation Disorder, Leukocytosis Injection Site: Hives/Itching, Phlebitis, Redness/Discoloration Metabolic/Nutritional: Hyperkalemia, Hyperlipemia BUN Increased, Creatinine Increased, Dehydration, Hyperglycemia, Metabolic Acidosis, Osmolality Increased Respiratory: Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction Hypoxia Skin and Appendages: Conjunctival Hyperemia, Diaphoresis, Urticaria Rash Special Senses: Diplopia, Ear Pain, Eye Pain, Nystagmus, Taste Perversion, Tinnitus Urogenital: Oliguria, Urine Retention Kidney Failure

<table ID="_RefID_5B0C5999-E101-47E5-8F3B-9F4623B65"> <caption>INCIDENCE GREATER THAN 1% - PROBABLY CAUSALLY RELATED</caption> <col width="25%"/> <col width="43%"/> <col width="32%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">Anesthesia/MAC Sedation</content> </paragraph> </td> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">ICU Sedation</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Bradycardia</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Bradycardia</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Arrhythmia [Peds: 1.2%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Tachycardia Nodal [Peds: 1.6%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hypotension* [Peds: 17%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Decreased Cardiac Output</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>(see also <content styleCode="bold"> <linkHtml href="#i4i_clinical_pharmacology_ID_D11A05FE-685E-40B7-BA55-44312EB5D89E">CLINICAL PHARMACOLOGY</linkHtml> </content>)</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Hypertension Peds: 8%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hypotension 26%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Movement* [Peds: 17%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Burning/Stinging or Pain, 17.6% [Peds: 10%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Metabolic/Nutritional:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hyperlipemia*</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Respiratory:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Apnea (see also <content styleCode="bold"> <linkHtml href="#i4i_clinical_pharmacology_ID_D11A05FE-685E-40B7-BA55-44312EB5D89E">CLINICAL PHARMACOLOGY</linkHtml> </content>)</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Respiratory Acidosis During Weaning*</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Skin and Appendages:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Rash [Peds: 5%]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Botrule Lrule "/> <td styleCode="Rrule Botrule Lrule "> <paragraph>Pruritus [Peds: 2%]</paragraph> </td> <td styleCode="Rrule Botrule Lrule "/> </tr> </tbody> </table>

<table ID="_RefID_EEBB0984-9C78-40F8-9F28-3EC4F0566"> <caption>INCIDENCE LESS THAN 1% - PROBABLY CAUSALLY RELATED</caption> <col width="25%"/> <col width="37%"/> <col width="26%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">Anesthesia/MAC Sedation</content> </paragraph> </td> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">ICU Sedation</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Body as a Whole:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Anaphylaxis/Anaphylactoid Reaction</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Perinatal Disorder</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Tachycardia]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Bigeminy]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Bradycardia]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Premature Ventricular Contractions]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Hemorrhage]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[ECG Abnormal]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Arrhythmia Atrial]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Fever]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Extremities Pain]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Anticholinergic Syndrome]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Premature Atrial Contractions</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>Syncope</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hypertonia/Dystonia, Paresthesia</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Agitation</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Digestive:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Hypersalivation]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Nausea]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hemic/Lymphatic:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Leukocytosis]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Phlebitis]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Pruritus]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Metabolic:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Hypomagnesemia]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Musculoskeletal:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Myalgia</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Nervous:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Dizziness]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Agitation]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Chills]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Somnolence]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Delirium]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Respiratory:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Wheezing</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Cough]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Decreased Lung Function</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Laryngospasm]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Hypoxia]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Skin and Appendages:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Flushing, Pruritus</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Special Senses:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Amblyopia</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "/> <td styleCode="Rrule Lrule Botrule "> <paragraph>[Vision Abnormal]</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Botrule Lrule "> <paragraph>Urogenital:</paragraph> </td> <td styleCode="Rrule Botrule Lrule "> <paragraph>Cloudy Urine</paragraph> </td> <td styleCode="Rrule Botrule Lrule "> <paragraph>Green Urine</paragraph> </td> </tr> </tbody> </table>

<table ID="_RefID_DD954682-4E51-4FB8-AA8E-E8CCC6FBA"> <caption>INCIDENCE LESS THAN 1% - CAUSAL RELATIONSHIP UNKNOWN</caption> <col width="25%"/> <col width="52%"/> <col width="23%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">Anesthesia/MAC Sedation</content> </paragraph> </td> <td styleCode="Rrule Botrule Lrule Toprule "> <paragraph> <content styleCode="underline">ICU Sedation</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Body as a Whole:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, neck Rigidity/Stiffness, </paragraph> <paragraph>Trunk pain</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Fever, Sepsis, Trunk Pain, Whole Body Weakness</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Cardiovascular:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch </paragraph> <paragraph>Block, Cardiac Arrest, ECG Abnormal, Block, Hypertension, Myocardial Infarction, Myocardial Ischemia, Premature Ventricular Contractions, ST Segment Depression, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, ventricular Tachycardia</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Central Nervous System:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Abnormal Dreams, Agitation, Amorous Behavior, Anxiety, Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/Myoclonic Movement, Combativeness, Confusion, Delirium, Depression, Dizziness, Emotional Lability, Euphoria, Fatigue, Hallucinations, Headache, Hypotonia, Hysteria, Insomnia, Moaning, Neuropathy, Opisthotonos, Rigidity, Seizures, </paragraph> <paragraph>Somnolence, Tremor, Twitching</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Digestive:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Cramping, Diarrhea, Dry Mouth,</paragraph> <paragraph>Enlarged Parotid, Nausea, Swallowing, Vomiting</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Ileus, Liver Function Abnormal</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hematologic/Lymphatic:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Coagulation Disorder, Leukocytosis</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Injection Site:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hives/Itching, Phlebitis, </paragraph> <paragraph>Redness/Discoloration</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Metabolic/Nutritional:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hyperkalemia, Hyperlipemia</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>BUN Increased, Creatinine Increased, Dehydration,</paragraph> <paragraph>Hyperglycemia, Metabolic Acidosis, Osmolality Increased</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Respiratory:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, </paragraph> <paragraph>Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Hypoxia</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Skin and Appendages:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Conjunctival Hyperemia, Diaphoresis, Urticaria</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Rash</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Special Senses:</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>Diplopia, Ear Pain, Eye Pain, Nystagmus, Taste Perversion, </paragraph> <paragraph>Tinnitus</paragraph> </td> <td styleCode="Rrule Lrule Botrule "/> </tr> <tr> <td styleCode="Rrule Botrule Lrule "> <paragraph>Urogenital:</paragraph> </td> <td styleCode="Rrule Botrule Lrule "> <paragraph>Oliguria, Urine Retention</paragraph> </td> <td styleCode="Rrule Botrule Lrule "> <paragraph>Kidney Failure</paragraph> </td> </tr> </tbody> </table>