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Valium (Diazepam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Valium (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 (257)
Death (24)
Life Threatening Events (26)
Disability (11)

Reports by Reaction Type

Drug Ineffective (31)Insomnia (27)Somnolence (21)Toxicity To Various Agents (21)Headache (20)Coma (16)Sopor (16)Fatigue (15)Anxiety (15)Suicide Attempt (15)Dizziness (13)Drug Hypersensitivity (13)

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

Possible Valium side effects in 34 year old male

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

Patient: 34 year old male

Reactions: Intestinal Ischaemia, Ileus, Gastrointestinal Necrosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Dosage: 275 drops daily
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Quetiapine
    Dosage: daily
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01
    End date: 2012-06-25



Possible Valium side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-27

Patient: male

Reactions: Mental Impairment, Drug Interaction, General Physical Health Deterioration

Drug(s) suspected as cause:
Propranolol
    Dosage: not stated
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: not stated
    Indication: Product Used FOR Unknown Indication



Possible Valium side effects in 45 year old female

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

Patient: 45 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Confusional State, Rhabdomyolysis, Pneumonia Aspiration, Metabolic Acidosis, Intentional Overdose, Hypotension, Coma, Sinus Bradycardia, Hypophosphataemia, Suicide Attempt, Hypocalcaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prazepam
    Dosage: 8 mg
    Administration route: Oral
    End date: 2012-01-05

Propranolol
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-05

Tercian
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    End date: 2012-01-05

Valium
    Dosage: 10 mg, 3x/day
    End date: 2012-01-05

Xanax
    Dosage: 0.5 mg,
    Administration route: Oral
    End date: 2012-01-05

Other drugs received by patient: Propylthiouracil



Possible Valium side effects in 39 year old female

Reported by a physician from France on 2012-08-27

Patient: 39 year old female

Reactions: Drug Level Increased, Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2011-05-05
    End date: 2011-05-05

Valium
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2011-05-05
    End date: 2011-05-05



Possible Valium side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Intestinal Ischaemia, Pseudomonas Infection, Shock Haemorrhagic, Gastrointestinal Necrosis, Intestinal Obstruction, Multi-Organ Failure, Staphylococcal Abscess, Septic Shock, Cardiac Arrest, Candidiasis

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

Drug(s) suspected as cause:
Depakine
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Seroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-25



Possible Valium side effects in female

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

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Cardiac Failure, Restlessness, Insomnia

Drug(s) suspected as cause:
Valium

Other drugs received by patient: Amiodarone Hydrochloride; Naprix



Possible Valium side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: 37 year old male

Reactions: Dependence, Suicidal Ideation

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

Oxycontin
    Indication: Product Used FOR Unknown Indication

Valium
    Indication: Product Used FOR Unknown Indication



Possible Valium side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 65 year old male

Reactions: Psychotic Disorder, Somnambulism, Judgement Impaired, Amnesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium

Other drugs received by patient: Versed; Ativan; Haloperidol Lactate; Oxycontin; Oxycodone HCL; Xanax



Possible Valium side effects in 34 year old male

Reported by a physician from France on 2012-08-22

Patient: 34 year old male

Reactions: Intestinal Ischaemia, Gastrointestinal Necrosis, Intestinal Obstruction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Quetiapine Fumarate
    Dosage: drug reported as xeroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-25



Possible Valium side effects in 68 year old female

Reported by a consumer/non-health professional from Australia on 2012-08-20

Patient: 68 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Sedation

Adverse event resulted in: disablity

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

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-10

Other drugs received by patient: Codeine Phosphate; Xanax



Possible Valium side effects in 33 year old female

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

Patient: 33 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Catatonia, Drug Interaction, Neuroleptic Malignant Syndrome, Pyrexia, Accidental Overdose, Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium

Other drugs received by patient possibly interacting with the suspect drug:
Clopixol
    Dosage: drug withdrawn
    Administration route: Oral
    Indication: Mania
    Start date: 2012-06-30
    End date: 2012-07-06

Clopixol-Acutard
    Dosage: drug withdrawn
    Indication: Mania
    Start date: 2012-06-23
    End date: 2012-06-29

Other drugs received by patient: Akineton



Possible Valium side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male

Reactions: Microcytosis, Iron Deficiency Anaemia, Hypercapnia, Pulmonary Oedema, Mental Status Changes, Anaemia Folate Deficiency, Hypoxia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Indication: Diabetes Mellitus
    Start date: 2011-09-23

Lantus
    Indication: Diabetes Mellitus

Morphine
    Indication: Pain

Placebo
    Indication: Diabetes Mellitus
    Start date: 2010-07-06

Saxagliptin
    Indication: Diabetes Mellitus
    Start date: 2012-07-06

Valium
    Indication: Pain

Other drugs received by patient: Aspirin; Prednisone TAB; Azithromycin; Ezetimibe; Ferrous Sulfate TAB; Folic Acid



Possible Valium side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Laceration, Lower Limb Fracture, Drug Abuse, Grand MAL Convulsion, Road Traffic Accident, Visual Impairment, Insomnia, Gait Disturbance, Feeling Abnormal

Drug(s) suspected as cause:
Buprenorphine
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Klonopin
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Phenobarbital TAB
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Xanax
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication



Possible Valium side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Bronchopneumopathy, Drug Level Increased, Miosis, Coma, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium

Other drugs received by patient: Buprenorphine; Methadone Hydrochloride



Possible Valium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Abilify

Adderall

Antidepressants

Beta Blocking Agents

Buspar

Darvocet-N 50

Daytrana

Depakote

Desyrel

Effexor

Elavil

Erythromycin

Lunesta

MAO Inhibitors

Neurontin

Pamelor

Paxil

Prozac

Reglan

Remeron

Requip

Ritalin

Seroquel

Sinequan

Skelaxin

Steroids NOS

Sumatriptan

Tegretol

Tizanidine Hydrochloride
    Indication: Migraine

Tofranil

Topamax

Trileptal

Valium
    Indication: Agitation

Wellbutrin

Zoloft

Zonegran

Zyprexa

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Valium side effects in male

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

Patient: male

Reactions: Coma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium
    Administration route: Oral
    Indication: Depression
    End date: 2012-07-12

Valium
    Dosage: 0.750 mg/l
    Start date: 2012-07-14

Valium
    Dosage: 0.420 mg/l
    Start date: 2012-07-17

Other drugs received by patient: Paroxetine HCL



Possible Valium side effects in 80 year old female

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

Patient: 80 year old female

Reactions: Encephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium
    Administration route: Oral
    Start date: 2012-02-05

Valium
    Start date: 2012-02-05

Valium
    Start date: 2012-02-06

Valium
    Administration route: Oral
    Indication: Agitation
    Start date: 2012-02-04

Other drugs received by patient: Propranolol; Ramipril; Stablon; Duphalac; Bumetanide



Possible Valium side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-09

Patient: male, weighing 100.0 kg (220.0 pounds)

Reactions: Eye Haemorrhage, Diarrhoea, Skin Exfoliation

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

Valium
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Venlafaxine



Possible Valium side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-06

Patient: 66 year old female

Reactions: Confusional State, Medication Error, Bradypnoea, Drug Interaction, Somnolence, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valium

Other drugs received by patient possibly interacting with the suspect drug:
Buprenorphine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-27
    End date: 2012-03-28

Lorazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-27

Zolpidem Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-27

Other drugs received by patient: Heparin Calcium; Acetaminophen; Acemetacin; Esomeprazole Magnesium



Possible Valium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 53.5 kg (117.7 pounds)

Reactions: Panic Attack, Surgery, Tablet Physical Issue, Drug Ineffective, Depression

Drug(s) suspected as cause:
Alprazolam
    Indication: Panic Disorder

Alprazolam
    Indication: Insomnia

Alprazolam
    Dosage: unk
    Indication: Anxiety

Valium
    Dosage: unk

Xanax
    Indication: Panic Disorder

Xanax
    Dosage: 1mg four times a day and 2mg at night
    Administration route: Oral
    Indication: Anxiety

Xanax
    Indication: Insomnia



Possible Valium side effects in male

Reported by a consumer/non-health professional from France on 2012-07-27

Patient: male, weighing 3.0 kg (6.6 pounds)

Reactions: Macrosomia

Drug(s) suspected as cause:
Abilify

Chlorpromazine HCL

Risperdal
    Dosage: period of exposure: 0-4 route: 4 im

Valium



Possible Valium side effects in 39 year old female

Reported by a consumer/non-health professional from France on 2012-07-27

Patient: 39 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Oligohydramnios, Normal Newborn, Gestational Diabetes, Pregnancy

Drug(s) suspected as cause:
Abilify
    Administration route: Oral
    Indication: Schizophrenia

Chlorpromazine HCL
    Administration route: Oral
    Indication: Anxiolytic Therapy

Risperdal
    Dosage: period of exposure: 0-4 route: 4 im
    Indication: Schizophrenia

Valium
    Administration route: Oral
    Indication: Anxiolytic Therapy



Possible Valium 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 Valium side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female

Reactions: Movement Disorder, Weight Decreased, Headache, Cardiac Disorder, Abnormal Dreams, Abdominal Discomfort, Apparent Death, Sensation of Foreign Body, Malaise, Palpitations, DRY Mouth, Nervousness, Aphagia, Supraventricular Tachycardia, Drug Intolerance, Ataxia, Abnormal Behaviour, Apathy, Insomnia, Drug Ineffective, Periarthritis, Somnolence, Sneezing, Depression, Lethargy, Nightmare, Nausea, Condition Aggravated, Anxiety, Panic Attack, Heart Rate Increased, Alopecia, Hypervigilance, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Antidepressants
    Start date: 2009-12-09

Benzodiazepines

Klonopin
    Dosage: 0.25 mg, unk
    Start date: 2009-12-09

Lopressor
    Dosage: 25 mg, q6h

Lopressor
    Dosage: 25 mg, unk

Lopressor
    Dosage: 50 mg, unk

Lopressor
    Dosage: 50 mg, q12h
    Indication: Panic Attack

Metoprolol Succinate

Toprol-XL

Valium
    Dosage: 1 tablet of 0.25 mg, three times daily

Valium
    Dosage: 1/2 tablet of 0.25 mg, three times daily

Valium
    Dosage: 1/2 tablet, four times daily

Zenex

Other drugs received by patient: Activella; Xanax; Femhrt



Possible Valium side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female

Reactions: Movement Disorder, Weight Decreased, Headache, Cardiac Disorder, Apparent Death, Abnormal Dreams, Abdominal Discomfort, Sensation of Foreign Body, Malaise, Palpitations, DRY Mouth, Nervousness, Aphagia, Supraventricular Tachycardia, Drug Intolerance, Ataxia, Abnormal Behaviour, Apathy, Insomnia, Drug Ineffective, Somnolence, Periarthritis, Sneezing, Depression, Lethargy, Nightmare, Nausea, Condition Aggravated, Anxiety, Panic Attack, Alopecia, Heart Rate Increased, Hypervigilance, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Antidepressants
    Start date: 2009-12-09

Benzodiazepines

Klonopin
    Dosage: 0.25 mg, unk
    Start date: 2009-12-09

Lopressor
    Dosage: 25 mg, unk

Lopressor
    Dosage: 50 mg, unk

Lopressor
    Dosage: 50 mg, q12h
    Indication: Panic Attack

Lopressor
    Dosage: 25 mg, q6h

Metoprolol Succinate

Toprol-XL

Valium
    Dosage: 1/2 tablet, four times daily

Valium
    Dosage: 1/2 tablet of 0.25 mg, three times daily

Valium
    Dosage: 1 tablet of 0.25 mg, three times daily

Zenex

Other drugs received by patient: Activella; Xanax; Femhrt



Possible Valium side effects in 69 year old male

Reported by a physician from France on 2012-07-26

Patient: 69 year old male

Reactions: Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Loxapine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Tranxene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03



Possible Valium side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Drug Hypersensitivity

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

Reglan
    Dosage: unk

Valium
    Dosage: unk

Vibramycin
    Dosage: unk



Possible Valium side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: male

Reactions: Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Loxapine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Tranxene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-03
    End date: 2012-05-03



Possible Valium side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: female

Reactions: Back Pain, Impaired Work Ability

Drug(s) suspected as cause:
Fluoxetine
    Dosage: 20 mg, 1x/day
    Administration route: Oral

Neurontin
    Dosage: 300 mg, 3x/day
    Administration route: Oral

Synthroid
    Dosage: 125 ug, 1x/day
    Administration route: Oral

Valium
    Dosage: 10 mg, 3x/day
    Administration route: Oral



Possible Valium 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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