Diprivan (Propofol) - Side Effects and Adverse Reactions

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 DIPRIVAN Injectable Emulsion 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 DIPRIVAN 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 DIPRIVAN 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 DIPRIVAN 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 DIPRIVAN 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 Sedation	ICU Sedation
Cardiovascular:	Bradycardia	Bradycardia
	Arrhythmia [Peds: 1.2%]
	Tachycardia Nodal [Peds: 1.6%]
	Hypotension* [Peds: 17%] (see also CLINICAL PHARMACOLOGY )	Decreased Cardiac Output
	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] [Laryngospasm] [Hypoxia]	Decreased Lung Function
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, 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, 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

REPORTS OF SUSPECTED DIPRIVAN SIDE EFFECTS / ADVERSE REACTIONS

Possible Diprivan side effects / adverse reactions in 52 year old female

Reported by a physician from France on 2011-10-03

Patient: 52 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Diprivan
    Indication: Anaesthesia
    Start date: 2011-04-18
    End date: 2011-04-18

Celocurine
    Indication: Anaesthesia
    Start date: 2011-04-18
    End date: 2011-04-18

Sufentanil Citrate
    Indication: Anaesthesia
    Start date: 2011-04-18
    End date: 2011-04-18

Possible Diprivan side effects / adverse reactions in 16 year old male

Reported by a physician from Japan on 2011-10-03

Patient: 16 year old male

Reactions: Anaphylactic Shock

Suspect drug(s):
Diprivan

Other drugs received by patient: Rocuronium Bromide; Remifentanil Hydrochloride; Oxygen; Sevoflurane; Cefotiam Hydrochloride

Possible Diprivan side effects / adverse reactions in 18 year old male

Reported by a pharmacist from Canada on 2011-10-04

Patient: 18 year old male weighing 73.0 kg (160.6 pounds)

Reactions: Anaphylactic Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Fentanyl Citrate
    Dosage: intravenous (not otherwise specified),(^same day^)
    Indication: Product Used FOR Unknown Indication

Rocuronium Bromide
    Dosage: intravenous (not otherwise specified) (same day)
    Indication: Product Used FOR Unknown Indication

Diprivan
    Dosage: ntravenous (not otherwise specified), same day