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Diazepam (Diazepam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diazepam 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 (1546)
Death (752)
Life Threatening Events (80)
Disability (32)

Reports by Reaction Type

Toxicity To Various Agents (259)Completed Suicide (248)Cardiac Arrest (220)Respiratory Arrest (199)Drug Abuse (153)Cardio-Respiratory Arrest (144)Death (110)Overdose (88)Malaise (81)Drug Interaction (68)Visual Acuity Reduced (66)Pyrexia (66)

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

Possible Diazepam side effects in female

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

Patient: female

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Albuterol Sulate
    Dosage: two puffs when required. dose - 2, units - not specified

Aspirin
    Dosage: dose + daily dose - 75, units - not specified

Cyclizine
    Dosage: dose- 50, daily dose - 150, units - not specified.

Diazepam
    Dosage: dose- 5 + daily dose - 10, units - nbot specified

Felodipine
    Dosage: dose + daily dose- 10, units - nopt specified

Furosemide
    Dosage: dose + daily dose - 40 , units -not specified

Gliclazide
    Dosage: dose - 160, units - not specified, daily dose - 320, units- not specified

Hyoscine Butylbromide
    Dosage: dose -20, daily dose-40 , units - not specified

Isosorbide Mononitrate
    Dosage: dose + daily dose - 60, units - not specified

Lansoprazole
    Dosage: dose + daily dose - 30, units - not specified

Paroxetine
    Dosage: dose + daily dose - 30 , units - not specified

Simvastatin
    Dosage: dose + daily dose - 40 , units not specified.



Possible Diazepam side effects in 36 year old female

Reported by a physician from United Kingdom on 2012-08-27

Patient: 36 year old female

Reactions: Body Mass Index Decreased, Diabetes Mellitus, Pyrexia, Mean Cell Volume Decreased, Constipation, Abdominal Tenderness, Malaise, Iron Deficiency Anaemia, White Blood Cell Count Increased, Neutrophil Count Increased, Hiatus Hernia, Cardiac Murmur, Urinary Tract Infection, Physical Assault, Skin Disorder, Monocyte Count Increased, White Blood Cell Disorder, Staphylococcal Infection, Thrombocytosis, Hypertension, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2005-05-01
    End date: 2005-05-19

Clozapine
    Administration route: Oral
    Start date: 2008-06-05

Clozapine
    Administration route: Oral
    Start date: 2008-05-19

Clozapine
    Administration route: Oral
    Start date: 2006-06-05
    End date: 2006-07-13

Diazepam
    Indication: Product Used FOR Unknown Indication

Ferrous Sulfate TAB
    Indication: Product Used FOR Unknown Indication

Folic Acid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lactulose
    Indication: Product Used FOR Unknown Indication

Lansoprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Perindopril
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Trimethoprim
    Indication: Urinary Tract Infection

Zopiclone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Furosemide; Ramipril; Atorvastatin; Bendroflumethiazide; Aripiprazole



Possible Diazepam side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-24

Patient: female

Reactions: Pregnancy

Drug(s) suspected as cause:
Clonazepam
    Indication: Insomnia Related To Another Mental Condition

Diazepam
    Indication: Insomnia Related To Another Mental Condition

Isotretinoin
    Indication: Acne

Vesanoid
    Indication: Acne



Possible Diazepam side effects in 32 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-23

Patient: 32 year old male

Reactions: Morbid Thoughts

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

Drug(s) suspected as cause:
Diazepam



Possible Diazepam side effects in male

Reported by a physician from Korea, Republic of on 2012-08-22

Patient: male

Reactions: Dyspnoea, Decreased Activity, Maternal Exposure Timing Unspecified

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Indication: Product Used FOR Unknown Indication

Olanzapine
    Indication: Product Used FOR Unknown Indication

Zolpidem
    Indication: Product Used FOR Unknown Indication



Possible Diazepam side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Urinary Incontinence, Mental Disorder, Eye Movement Disorder, Suicidal Ideation, Convulsion

Drug(s) suspected as cause:
Ampyra

Bupropion Hydrochloride

Diazepam

Gabapentin

Rebif

Zocor
    Administration route: Oral



Possible Diazepam side effects in 32 year old female

Reported by a physician from Korea, Republic of on 2012-08-22

Patient: 32 year old female

Reactions: Vomiting, Maternal Exposure During Pregnancy, Toxicity To Various Agents, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Indication: Product Used FOR Unknown Indication

Olanzapine
    Indication: Product Used FOR Unknown Indication

Zolpidem
    Indication: Product Used FOR Unknown Indication



Possible Diazepam side effects in 39 year old male

Reported by a physician from United Kingdom on 2012-08-21

Patient: 39 year old male

Reactions: Withdrawal Syndrome, Drug Dependence

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Diazepam
    Dosage: 2 mg, 1x/day
    End date: 2012-02-03

Diazepam
    Dosage: 30 mg, unk

Lyrica
    Dosage: 900 mg, 2x/day
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-02-01

Other drugs received by patient: Mirtazapine; Nicotine; Methadone; Amphetamines; Cannabis



Possible Diazepam side effects in 45 year old female

Reported by a consumer/non-health professional from Netherlands on 2012-08-21

Patient: 45 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Pupils Unequal, Joint Stiffness, Myalgia, Balance Disorder, Vision Blurred, Gait Disturbance, Muscle Disorder, Hypertonia

Drug(s) suspected as cause:
Diazepam
    Dosage: unk
    Start date: 2009-09-03

Diazepam
    Dosage: unk
    Start date: 2009-09-03

Venlafaxine HCL
    Dosage: 150 mg, unk

Venlafaxine HCL
    Dosage: 120 mg, unk

Venlafaxine HCL
    Dosage: 37 mg, unk
    Start date: 2010-04-15

Venlafaxine HCL
    Dosage: 75 mg, unk



Possible Diazepam side effects in female

Reported by a physician from United Kingdom on 2012-08-21

Patient: female

Reactions: Body Mass Index Decreased, Diabetes Mellitus, Mean Cell Volume Decreased, Pyrexia, Constipation, Abdominal Tenderness, Malaise, Iron Deficiency Anaemia, White Blood Cell Count Increased, Hiatus Hernia, Cardiac Murmur, Neutrophil Count Increased, Urinary Tract Infection, Skin Disorder, Monocyte Count Increased, Aggression, White Blood Cell Disorder, Staphylococcal Infection, Thrombocytosis, Sinus Tachycardia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Dosage: unk ukn, qd

Clozapine
    Dosage: unk ukn, unk
    Start date: 2008-05-19

Clozaril
    Administration route: Oral
    Start date: 2008-06-05

Clozaril
    Dosage: unk ukn, unk
    Administration route: Oral
    Start date: 2006-06-05
    End date: 2006-07-13

Clozaril
    Dosage: 250 mg, qd
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2005-05-01
    End date: 2005-05-19

Clozaril
    Dosage: 250 mg, daily
    Administration route: Oral
    Start date: 2008-05-19

Diazepam
    Dosage: unk ukn, prn

Ferrous Sulfate TAB
    Dosage: 200 mg, bid
    Administration route: Oral

Folic Acid
    Dosage: 5 mg, qd
    Administration route: Oral

Lactulose
    Dosage: 10 ml, prn

Lansoprazole
    Dosage: 30 mg, qd
    Administration route: Oral

Perindopril Erbumine
    Dosage: 2 mg, qd
    Administration route: Oral

Trimethoprim
    Dosage: unk ukn, unk
    Indication: Urinary Tract Infection

Zopiclone
    Dosage: 3.75 mg, qhs

Other drugs received by patient: Furosemide; Atorvastatin; Abilify; Ramipril; Bendrofluazide



Possible Diazepam side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21

Patient: male

Reactions: LOW Birth Weight Baby, Death, Premature Baby, Drug Level Increased, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Cocaine

Diacetylmorphine

Diazepam

Methadone Hydrochloride



Possible Diazepam side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-17

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Mental Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Dosage: 5 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2010-12-27
    End date: 2011-01-06

Flupentixol+melitracen
    Dosage: 20 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2010-12-30
    End date: 2011-01-06

Ipratropium Bromide
    Dosage: 2 ml
    Indication: Dyspnoea
    Start date: 2011-01-02
    End date: 2011-01-02

Other drugs received by patient: Buffered Physiological Saline



Possible Diazepam side effects in 19 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 19 year old female

Reactions: Accidental Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Diazepam
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication

Temazepam
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Indication: Product Used FOR Unknown Indication



Possible Diazepam side effects in 6 year old female

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

Patient: 6 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Ethosuximide; Zonisamide



Possible Diazepam side effects in 8 year old female

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

Patient: 8 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Benzodiazepine Derivatives; Corticotropin; Potassium Bromide



Possible Diazepam side effects in 36 year old female

Reported by a physician from United Kingdom on 2012-08-16

Patient: 36 year old female

Reactions: Body Mass Index Decreased, Diabetes Mellitus, Pyrexia, Mean Cell Volume Decreased, Constipation, Abdominal Tenderness, Malaise, Iron Deficiency Anaemia, White Blood Cell Count Increased, Hiatus Hernia, Cardiac Murmur, Neutrophil Count Increased, Urinary Tract Infection, Physical Assault, Skin Disorder, Monocyte Count Increased, White Blood Cell Disorder, Staphylococcal Infection, Thrombocytosis, Hypertension, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Administration route: Oral
    Start date: 2006-06-05
    End date: 2006-07-13

Clozapine
    Administration route: Oral
    Start date: 2008-05-19

Clozapine
    Administration route: Oral
    Start date: 2008-06-05

Clozapine
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2005-05-01
    End date: 2005-05-19

Diazepam
    Indication: Product Used FOR Unknown Indication

Ferrous Sulfate TAB
    Indication: Product Used FOR Unknown Indication

Folic Acid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lactulose
    Indication: Product Used FOR Unknown Indication

Lansoprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Perindopril Erbumine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Trimethoprim
    Indication: Urinary Tract Infection

Zopiclone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Atorvastatin; Bendroflumethiazide; Furosemide; Aripiprazole; Ramipril



Possible Diazepam side effects in

Reported by a individual with unspecified qualification from Germany on 2012-08-16

Patient:

Reactions: Agitation, Panic Attack, Delusion, Aggression

Drug(s) suspected as cause:
Diazepam
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: }= 900 mg, / day
    Indication: Product Used FOR Unknown Indication

Methadone Hydrochloride
    Dosage: unk, unknown
    Indication: Drug Abuse



Possible Diazepam side effects in 34 year old female

Reported by a consumer/non-health professional from Australia on 2012-08-16

Patient: 34 year old female

Reactions: Drug Level Above Therapeutic, Psychotic Disorder, Drug Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Indication: Depression
    End date: 2012-03-01

Endep
    Indication: Depression
    Start date: 2012-03-01
    End date: 2012-03-03

Lithium Carbonate
    Indication: Depression

Risperidone
    Indication: Depression
    End date: 2012-03-01

Temazepam
    Indication: Depression
    End date: 2012-03-01



Possible Diazepam side effects in 54 year old female

Reported by a physician from Italy on 2012-08-15

Patient: 54 year old female

Reactions: Electrocardiogram QT Prolonged, Off Label Use, Electrocardiogram Delta Waves Abnormal, Hypothermia, Hypernatraemia, Sinus Bradycardia

Drug(s) suspected as cause:
Diazepam
    Indication: Psychomotor Hyperactivity

Quetiapine
    Administration route: Oral
    Indication: Psychomotor Hyperactivity



Possible Diazepam side effects in 62 year old male

Reported by a physician from Portugal on 2012-08-15

Patient: 62 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Product Quality Issue, Product Substitution Issue, Ischaemic Stroke, Drug Interaction, Hemiparesis, Hemianopia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Transient Ischaemic Attack

Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Captopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Hypertension

Diazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enalapril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enoxaparin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: 30 mg, 2x/day
    Indication: Product Used FOR Unknown Indication

Potassium Chloride
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Warfarin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lisinopril Dihydrate; Irbesartan and Hydrochlorothiazide; Rilmenidine



Possible Diazepam side effects in 55 year old female

Reported by a pharmacist from United Kingdom on 2012-08-15

Patient: 55 year old female

Reactions: White Blood Cell Count Decreased, Neutropenia

Drug(s) suspected as cause:
Diazepam
    Dosage: 2 mg, qid
    Administration route: Oral

Trimethoprim
    Dosage: 200 mg, bid
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-04-07

Other drugs received by patient: Acetaminophen; Levothyroxine Sodium; Pregabalin; Zopiclone



Possible Diazepam side effects in 24 year old female

Reported by a physician from United States on 2012-08-14

Patient: 24 year old female

Reactions: Coma Blister, Pneumonia, Respiratory Failure, Mental Status Changes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Indication: Product Used FOR Unknown Indication

Diazepam
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication



Possible Diazepam side effects in 23 year old female

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

Patient: 23 year old female

Reactions: Tubulointerstitial Nephritis

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk

Diazepam
    Dosage: unk

Lorazepam
    Dosage: unk

Paraldehyde
    Dosage: unk

Phenobarbital TAB
    Dosage: unk

Phenytoin
    Dosage: unk



Possible Diazepam side effects in

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

Patient:

Reactions: Overdose, Cognitive Disorder

Drug(s) suspected as cause:
Alprazolam
    Indication: Product Used FOR Unknown Indication

Clonazepam
    Indication: Product Used FOR Unknown Indication

Codeine Sulfate
    Indication: Product Used FOR Unknown Indication

Diazepam
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Indication: Product Used FOR Unknown Indication

Methadone Hydrochloride
    Indication: Product Used FOR Unknown Indication

Morphine
    Indication: Product Used FOR Unknown Indication

Olanzapine
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication

Propoxyphene Hydrochloride
    Indication: Product Used FOR Unknown Indication

Quetiapine Fumarate
    Indication: Product Used FOR Unknown Indication

Risperidone
    Indication: Product Used FOR Unknown Indication

Temazepam
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication



Possible Diazepam side effects in 24 year old male

Reported by a physician from United States on 2012-08-13

Patient: 24 year old male

Reactions: Hypoxic-Ischaemic Encephalopathy, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Dosage: unk

Methadose
    Dosage: unk



Possible Diazepam side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-10

Patient: 38 year old female

Reactions: Oligohydramnios, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Acetaminophen
    Indication: Renal Colic

Diazepam
    Indication: Renal Colic

Diclofenac Sodium
    Dosage: 6 doses
    Indication: Renal Colic

Dipyrone TAB
    Indication: Renal Colic

Meperidine HCL
    Indication: Renal Colic

Scopolamine
    Indication: Renal Colic



Possible Diazepam side effects in 50 year old male

Reported by a physician from United States on 2012-08-09

Patient: 50 year old male

Reactions: Unresponsive To Stimuli, Accidental Death, Intentional Drug Misuse, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: po
    Administration route: Oral
    Indication: Intentional Drug Misuse

Diazepam
    Dosage: po
    Administration route: Oral
    Indication: Intentional Drug Misuse

Kadian
    Dosage: po
    Administration route: Oral
    Indication: Intentional Drug Misuse

Methamphetamine Hydrochloride
    Dosage: po
    Administration route: Oral
    Indication: Intentional Drug Misuse

Oxycodone HCL
    Dosage: po
    Administration route: Oral
    Indication: Intentional Drug Misuse



Possible Diazepam side effects in 6 year old female

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

Patient: 6 year old female

Reactions: Drug Ineffective, Fall, Convulsion

Drug(s) suspected as cause:
Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Ethosuximide; Zonisamide



Possible Diazepam side effects in 38 year old male

Reported by a physician from United States on 2012-08-09

Patient: 38 year old male

Reactions: Pneumonia Aspiration, Rhabdomyolysis, Hepatic Enzyme Increased, Loss of Consciousness, Drug Diversion, Hypoxic-Ischaemic Encephalopathy, Blood Pressure Decreased, Hallucination, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amantadine HCL
    Dosage: unk
    Indication: Hypoxic-Ischaemic Encephalopathy

Diazepam
    Indication: Neck Pain

Diazepam
    Indication: Back Pain

Methadose
    Dosage: unk
    Indication: Back Pain

Methadose
    Indication: Neck Pain

Methylin
    Dosage: unk
    Indication: Rehabilitation Therapy



Possible Diazepam side effects in 25 year old female

Reported by a physician from United States on 2012-08-09

Patient: 25 year old female

Reactions: Abdominal Pain, Agitation, Pain, Acidosis, Treatment Noncompliance, Drug Abuse, Intentional Self-Injury, Hepatomegaly, Blood Fibrinogen Decreased, Dialysis, Hepatorenal Syndrome, Pleural Effusion, Gallbladder Disorder, Electrolyte Imbalance, Blood Glucose Increased, Vomiting, International Normalised Ratio Increased, Laceration, Blood Potassium Increased, Blood Fibrinogen Increased, Alcohol Use, Dysarthria, Renal Failure, Depressed Level of Consciousness, Suicide Attempt

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

Drug(s) suspected as cause:
Acetaminophen and Diphenhydramine Hydrochloride

Cocaine

Diazepam

Ethanol

Kadian

Salicylates - Opiods

Other drugs received by patient: Piperacillin and Tazobactam; Trimethoprim + Sulfamethoxazole; Ampicillin

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