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Diprivan (Propofol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diprivan (Propofol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (217)
Death (30)
Life Threatening Events (119)
Disability (3)

Reports by Reaction Type

Anaphylactic Shock (73)Bronchospasm (19)Erythema (17)Cardiac Arrest (14)Hypotension (13)Circulatory Collapse (12)Bradycardia (12)Shock (12)Blood Pressure Decreased (11)Tachycardia (10)Cardio-Respiratory Arrest (10)Cytolytic Hepatitis (10)

Below are a few examples of reports where side effects / adverse reactions may be related to Diprivan (Propofol). For a complete list or a specific selection of reports, please use the links above.

Possible Diprivan side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 45 year old male

Reactions: Hypotension, Urticaria, Anaphylactic Reaction, Skin Test Negative, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Augmentin '500'
    Dosage: single
    Indication: Tooth Extraction
    Start date: 2011-11-15
    End date: 2011-11-15

Diprivan
    Dosage: single
    Indication: General Anaesthesia
    Start date: 2011-11-15
    End date: 2011-11-15

Solu-Medrol
    Dosage: single
    Indication: Tooth Extraction
    Start date: 2011-11-15
    End date: 2011-11-15

Sufentanil Citrate
    Dosage: single
    Indication: General Anaesthesia
    Start date: 2011-11-15
    End date: 2011-11-15

Other drugs received by patient: Pantoprazole Sodium; Sevoflurane; Symbicort



Possible Diprivan side effects in

Reported by a individual with unspecified qualification from France on 2012-08-23

Patient:

Reactions: Cardio-Respiratory Arrest, Anaphylactic Shock, Circulatory Collapse

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Dosage: 200 mg, once
    Indication: General Anaesthesia
    Start date: 2012-03-20
    End date: 2012-03-20

Rocuronium Bromide
    Dosage: 40 mg, once
    Indication: General Anaesthesia
    Start date: 2012-03-20
    End date: 2012-03-20

Ultiva
    Dosage: 50 ?g, once
    Indication: General Anaesthesia
    Start date: 2012-03-20
    End date: 2012-03-20



Possible Diprivan side effects in 37 year old female

Reported by a physician from Japan on 2012-08-21

Patient: 37 year old female

Reactions: Acidosis, Respiratory Depression, Delayed Recovery From Anaesthesia, Convulsion, Respiration Abnormal

Drug(s) suspected as cause:
Buprenorphine HCL
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28

Diprivan
    Dosage: unit dose unknown
    Indication: Sedation
    Start date: 2012-06-28
    End date: 2012-06-28

Ultiva
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28

Other drugs received by patient: Zonisamide; Phenytoin



Possible Diprivan side effects in male

Reported by a physician from France on 2012-08-20

Patient: male

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Start date: 2012-07-02
    End date: 2012-07-02

Diprivan
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Sevoflurane
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Sufentanyl Mylan
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02

Tracrium
    Indication: General Anaesthesia
    Start date: 2012-07-02
    End date: 2012-07-02



Possible Diprivan side effects in 37 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 37 year old female

Reactions: Respiratory Depression, Acidosis, Delayed Recovery From Anaesthesia, Convulsion, Respiration Abnormal

Drug(s) suspected as cause:
Buprenorphine HCL
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28

Diprivan
    Dosage: unit dose unknown
    Indication: Sedation
    Start date: 2012-06-28
    End date: 2012-06-28

Ultiva
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28

Other drugs received by patient: Phenytoin; Zonisamide



Possible Diprivan side effects in female

Reported by a physician from France on 2012-08-16

Patient: female

Reactions: Tachycardia, Circulatory Collapse, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Celocurine
    Dosage: once/single administration
    Indication: Induction of Anaesthesia
    Start date: 2012-03-27
    End date: 2012-03-27

Diprivan
    Dosage: once/single administration
    Indication: Induction of Anaesthesia
    Start date: 2012-03-27
    End date: 2012-03-27

Midazolam HCL
    Dosage: once/single administration
    Start date: 2012-03-27
    End date: 2012-03-27

Sufentanil Citrate
    Indication: Induction of Anaesthesia
    Start date: 2012-03-27
    End date: 2012-03-27

Other drugs received by patient: Levothyroxine Sodium; Atarax; Lexomil



Possible Diprivan side effects in male

Reported by a physician from France on 2012-08-14

Patient: male

Reactions: Electrocardiogram QRS Complex Prolonged, Anaphylactoid Reaction, Tachycardia, Bradycardia, Hypokalaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Nimbex
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Sufentanil Citrate
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Other drugs received by patient: Midazolam HCL



Possible Diprivan side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient: 38 year old female

Reactions: Ventricular Extrasystoles, Supraventricular Extrasystoles, Bradycardia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: Induction of Anaesthesia

Diprivan
    Indication: General Anaesthesia

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



Possible Diprivan side effects in 58 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 58 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Ventricular Fibrillation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: Induction of Anaesthesia

Ropivacaine Hydrochloride
    Indication: Epidural Anaesthesia

Other drugs received by patient: Fentanyl; Rocuronium Bromide



Possible Diprivan side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-14

Patient: 30 year old female

Reactions: Lactic Acidosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan

Other drugs received by patient: Erythromycin; Albuterol; Aminophyllin; Ofloxacin; Methylprednisolone



Possible Diprivan side effects in male

Reported by a physician from France on 2012-08-13

Patient: male

Reactions: Electrocardiogram QRS Complex Prolonged, Tachycardia, Anaphylactoid Reaction, Bradycardia, Hypokalaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Nimbex
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Sufentanil Citrate
    Indication: General Anaesthesia
    Start date: 2012-04-06
    End date: 2012-04-06

Other drugs received by patient: Midazolam HCL



Possible Diprivan side effects in 70 year old male

Reported by a physician from France on 2012-08-13

Patient: 70 year old male

Reactions: Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased, Hepatotoxicity, Haemoptysis, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diprivan
    Dosage: once/single administration
    Start date: 2012-07-02
    End date: 2012-07-02

Diprivan
    Start date: 2012-06-29
    End date: 2012-06-29

Diprivan
    Indication: Anaesthesia
    Start date: 2012-06-22
    End date: 2012-06-22

Other drugs received by patient: Ranitidine; Xylocaine; Celocurine; Ultiva; Celocurine; Sufentanil Citrate



Possible Diprivan side effects in female

Reported by a pharmacist from Brazil on 2012-08-10

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Cardio-Respiratory Arrest, Drug Interaction, Bradycardia

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Diprivan

Other drugs received by patient possibly interacting with the suspect drug:
Dexmedetomodine Hydrochloride
    Dosage: 100mcg/ml, 63.4 mcg via continuous infusion
    Indication: Sedative Therapy
    Start date: 2012-06-26
    End date: 2012-06-26

Other drugs received by patient: Omeprazole; Losartan Potassium; Sufentanil Citrate; Metronidazole; Dipyrone INJ; NPH Insulin; Digoxin; Lidocaine; Ciprofloxacin; Enoxaparin



Possible Diprivan side effects in 60 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 60 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Diprivan
    Indication: Induction of Anaesthesia

Fentanyl
    Indication: General Anaesthesia

Fentanyl
    Dosage: dose unknown

Ketamine HCL
    Indication: General Anaesthesia

Ketamine HCL

Remifentanil Hydrochloride
    Dosage: dose unknown

Sevoflurane
    Dosage: dose unknown

Other drugs received by patient: Rocuronium Bromide



Possible Diprivan side effects in 70 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 70 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Dosage: dose unknown

Diprivan
    Dosage: 1%

Other drugs received by patient: Pancuronium Bromide; Adsorbed Tetanus Toxoid; Penicillin G; Midazolam



Possible Diprivan side effects in female

Reported by a physician from France on 2012-08-06

Patient: female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Augmentin '500'
    Start date: 2011-11-24

Diprivan
    Dosage: one single administration
    Indication: Induction of Anaesthesia
    Start date: 2011-11-24

Ketamine HCL
    Dosage: one single administration
    Indication: Induction of Anaesthesia
    Start date: 2011-11-24

Nimbex
    Dosage: one single administration
    Indication: Induction of Anaesthesia
    Start date: 2011-11-24

Sufentanil Citrate
    Dosage: one single administration
    Indication: Induction of Anaesthesia
    Start date: 2011-11-24

Other drugs received by patient: Anti-Histamic Drugs



Possible Diprivan side effects in male

Reported by a physician from China on 2012-08-06

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Pruritus, Sleep Disorder DUE To General Medical Condition, Insomnia Type, Rash Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diprivan



Possible Diprivan side effects in male

Reported by a physician from China on 2012-08-06

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Drug Eruption, Tongue Oedema

Drug(s) suspected as cause:
Diprivan



Possible Diprivan side effects in 37 year old female

Reported by a physician from Japan on 2012-08-03

Patient: 37 year old female

Reactions: Respiratory Depression, Acidosis, Delayed Recovery From Anaesthesia, Convulsion, Respiration Abnormal

Drug(s) suspected as cause:
Buprenorphine HCL
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28

Diprivan
    Dosage: unit dose unknown
    Indication: Sedation
    Start date: 2012-06-28
    End date: 2012-06-28

Ultiva
    Dosage: unit dose unknown
    Indication: Analgesic Therapy
    Start date: 2012-06-28
    End date: 2012-06-28



Possible Diprivan side effects in 80 year old male

Reported by a physician from Japan on 2012-08-03

Patient: 80 year old male

Reactions: Atelectasis, Pneumonia, Interstitial Lung Disease, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diprivan

Other drugs received by patient: Midazolam; Adsorbed Tetanus Toxoid; Penicillin G; Pancuronium Bromide



Possible Diprivan side effects in male

Reported by a physician from France on 2012-08-03

Patient: male, weighing 92.0 kg (202.4 pounds)

Reactions: Arrhythmia Supraventricular, Hypokalaemia, Multi-Organ Failure, Cardio-Respiratory Arrest, Respiratory Failure, Ventricular Tachycardia, Bronchospasm, Ventricular Fibrillation, Bradycardia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Celocurine
    Indication: Endoscopy
    Start date: 2012-05-30
    End date: 2012-05-30

Diprivan
    Indication: Endoscopy
    Start date: 2012-05-30
    End date: 2012-05-30

Other drugs received by patient: Zofran; Remifentanyl; Acetaminophen; Lansoprazole; Duragesic-100



Possible Diprivan side effects in

Reported by a individual with unspecified qualification from France on 2012-08-02

Patient:

Reactions: Hypotension, Hypercapnia, Anaphylactic Shock, Hyperhidrosis, Cardio-Respiratory Arrest, Respiratory Acidosis, Cyanosis, Bronchospasm, Bradycardia, Myocardial Infarction, Hypovolaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 50 mg, once
    Administration route: Oral
    Indication: Anaesthetic Premedication
    Start date: 2010-06-17
    End date: 2010-06-17

Diprivan
    Dosage: 100 mg, once
    Start date: 2010-06-17
    End date: 2010-06-17

Diprivan
    Dosage: 200 mg, once
    Indication: General Anaesthesia
    Start date: 2010-06-17
    End date: 2010-06-17

Diprivan
    Dosage: 100 mg, once
    Start date: 2010-06-17
    End date: 2010-06-17

Lyrica
    Dosage: 150 mg, once
    Administration route: Oral
    Indication: Anaesthetic Premedication
    Start date: 2010-06-17
    End date: 2010-06-17

Naropin
    Dosage: 20 mg, once
    Indication: Neuromuscular Blockade
    Start date: 2010-06-17
    End date: 2010-06-17

Rocuronium Bromide
    Dosage: 50 mg, once
    Indication: General Anaesthesia
    Start date: 2010-06-17
    End date: 2010-06-17

Sufentanil Citrate
    Dosage: 10 ?g, once
    Start date: 2010-06-17
    End date: 2010-06-17

Sufentanil Citrate
    Dosage: 40 ?g, once
    Indication: Gait Disturbance
    Start date: 2010-06-17
    End date: 2010-06-17

Other drugs received by patient: Rivotril; [composition Unspecified]; Aluminum Hydroxide (+) Magnesium Carbonate; Acetaminophen; Oxycontin; Nexium; Olmesartan Medoxomil; Desloratadine; Cymbalta



Possible Diprivan side effects in 26 year old female

Reported by a pharmacist from Japan on 2012-07-31

Patient: 26 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan

Other drugs received by patient: General Anesthetics



Possible Diprivan side effects in

Reported by a consumer/non-health professional from Japan on 2012-07-30

Patient:

Reactions: Pharyngeal Oedema, Cardio-Respiratory Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Dosage: 100 mg, once
    Indication: Anaesthesia Procedure
    Start date: 2011-11-24
    End date: 2011-11-24

Rocuronium Bromide
    Indication: Neuromuscular Blocking Therapy
    Start date: 2011-11-24
    End date: 2011-11-24

Rocuronium Bromide
    Dosage: 50 mg, once
    Start date: 2011-11-24
    End date: 2011-11-24

Ultiva
    Dosage: perpetuation administering during 0.5mcg/kg/minute
    Indication: Analgesic Therapy
    Start date: 2011-11-24
    End date: 2011-11-24

Ultiva



Possible Diprivan side effects in female

Reported by a physician from France on 2012-07-27

Patient: female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Alfentanil
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-11
    End date: 2012-06-11

Celocurine
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-11
    End date: 2012-06-11

Diprivan
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-11
    End date: 2012-06-11

Sevoflurane
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-11
    End date: 2012-06-11

Valium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-11
    End date: 2012-06-11



Possible Diprivan side effects in

Reported by a pharmacist from Japan on 2012-07-25

Patient:

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: General Anaesthesia

Rocuronium Bromide

Ultiva



Possible Diprivan side effects in 78 year old female

Reported by a physician from France on 2012-07-24

Patient: 78 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: Induction of Anaesthesia
    Start date: 2012-06-15
    End date: 2012-06-15

Sufentanil Citrate
    Indication: Induction of Anaesthesia
    Start date: 2012-06-15
    End date: 2012-06-15

Suxamethonium
    Indication: Induction of Anaesthesia
    Start date: 2012-06-15
    End date: 2012-06-15

Other drugs received by patient: Ciprofloxacin Hydrochloride; Rocephin; Gentamicin



Possible Diprivan side effects in male

Reported by a physician from France on 2012-07-24

Patient: male

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diprivan
    Indication: Anaesthesia
    Start date: 2012-06-12
    End date: 2012-06-12

Sufentanyl Mylan
    Indication: Anaesthesia
    Start date: 2012-06-12
    End date: 2012-06-12

Tracrium
    Indication: Anaesthesia
    Start date: 2012-06-12
    End date: 2012-06-12



Possible Diprivan side effects in female

Reported by a physician from France on 2012-07-23

Patient: female

Reactions: Tachycardia, Circulatory Collapse, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cefazolin
    Administration route: Oral
    Indication: Antibiotic Prophylaxis
    Start date: 2011-11-17
    End date: 2011-11-17

Diprivan
    Indication: Induction of Anaesthesia
    Start date: 2011-11-17
    End date: 2011-11-17

Sufentanil Citrate
    Indication: Induction of Anaesthesia
    Start date: 2011-11-17
    End date: 2011-11-17

Tracrium
    Indication: Induction of Anaesthesia
    Start date: 2011-11-17
    End date: 2011-11-17



Possible Diprivan side effects in female

Reported by a physician from France on 2012-07-23

Patient: female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Alfentanil
    Indication: Induction of Anaesthesia
    Start date: 2012-06-11
    End date: 2012-06-11

Celocurine
    Indication: Induction of Anaesthesia
    Start date: 2012-06-11
    End date: 2012-06-11

Diprivan
    Indication: Induction of Anaesthesia
    Start date: 2012-06-11
    End date: 2012-06-11

Sevoflurane
    Indication: Induction of Anaesthesia
    Start date: 2012-06-11
    End date: 2012-06-11

Valium
    Indication: Induction of Anaesthesia
    Start date: 2012-06-11
    End date: 2012-06-11

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