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 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 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 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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