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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 2012-07-26
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 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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