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PROPOFOL (CIVICA) Adverse Reactions (propofol injectable emulsion)

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 Injectable Emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 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 Injectable Emulsion 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 Injectable Emulsion 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 Injectable Emulsion 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 Injectable Emulsion 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 SedationICU Sedation
Events without an * or % had an incidence of 1% to 3%
*
Incidence of events 3% to 10%
Cardiovascular:BradycardiaBradycardia
Arrhythmia
Tachycardia Nodal
Hypotension*
(see also CLINICAL PHARMACOLOGY)
Decreased Cardiac Output
Hypertension Hypotension 26%
Central Nervous System:Movement*
Injection Site:Burning/Stinging or Pain, 17.6%
Metabolic/Nutritional:Hyperlipemia*
Respiratory:Apnea
(see also CLINICAL PHARMACOLOGY)
Respiratory Acidosis During Weaning*
Skin and Appendages:Rash
Pruritus
Incidence less than 1% - Probably Causally Related
Anesthesia/MAC SedationICU 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, ParesthesiaAgitation
Digestive:Hypersalivation
Nausea
Hemic/Lymphatic:Leukocytosis
Injection Site:Phlebitis
Pruritus
Metabolic:Hypomagnesemia
Musculoskeletal:Myalgia
Nervous:Dizziness
Agitation
Chills
Somnolence
Delirium
Respiratory:Wheezing
Cough
Laryngospasm
Hypoxia
Decreased Lung Function
Skin and Appendages:Flushing, Pruritus
Special Senses:Amblyopia
Vision Abnormal
Urogenital:Cloudy UrineGreen Urine
Incidence less than 1% - Causal Relationship Unknown
Anesthesia/MAC SedationICU Sedation
Body as a Whole:Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, Neck Rigidity/Stiffness, Trunk PainFever, Sepsis, Trunk Pain, Whole Body Weakness
Cardiovascular:Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart 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, TwitchingChills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal
Digestive:Cramping, Diarrhea, Dry Mouth, Enlarged Parotid, Nausea, Swallowing, VomitingIleus, Liver Function Abnormal
Hematologic/Lymphatic:Coagulation Disorder, Leukocytosis
Injection Site:Hives/Itching, Phlebitis, Redness/Discoloration
Metabolic/Nutritional:Hyperkalemia, HyperlipemiaBUN 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 ObstructionHypoxia
Skin and Appendages:Conjunctival Hyperemia, Diaphoresis, UrticariaRash
Special Senses:Diplopia, Ear Pain, Eye Pain, Nystagmus, Taste Perversion, Tinnitus
Urogenital:Oliguria, Urine RetentionKidney Failure
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