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Disulfiram (Disulfiram) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Disulfiram 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 (28)
Death (11)
Life Threatening Events (2)

Reports by Reaction Type

Completed Suicide (9)Respiratory Arrest (7)Cardiac Arrest (7)Toxicity To Various Agents (4)Jaundice (3)Drug Interaction (3)Poisoning (3)Flushing (3)Alcohol Interaction (3)Infection (2)Intentional Overdose (2)Tachycardia (2)

Possible Disulfiram side effects in 36 year old male

Reported by a physician from United States on 2012-08-01

Patient: 36 year old male

Reactions: Hyperammonaemic Encephalopathy, Drug Interaction, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lithium Carbonate
    Dosage: 450 mg;qd
    Indication: Product Used FOR Unknown Indication

Topiramate
    Dosage: 300 mg;qd
    Indication: Product Used FOR Unknown Indication

Divalproex Sodium
    Dosage: 1000 mg
    Indication: Product Used FOR Unknown Indication

Clonazepam
    Dosage: 3 mg;qd
    Indication: Product Used FOR Unknown Indication

Clozapine
    Dosage: 300 mg;qd
    Indication: Product Used FOR Unknown Indication

Risperidone
    Dosage: 3 mg;qd
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: 250 mg;qd
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from Montenegro on 2012-07-31

Patient:

Reactions: Acute Polyneuropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-09

Patient: female

Reactions: Jaundice, Asterixis, Hepatic Failure, Encephalopathy, Hepatitis Toxic, Liver Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Progesterone
    Administration route: Oral
    Indication: Hormone Replacement Therapy

Escitalopram
    Indication: Major Depression

Disulfiram
    Indication: Alcoholism
    Start date: 2011-05-01
    End date: 2011-06-01

Other drugs received by patient: Levothyroxine Sodium; Milnacipran; Oxazepam; Estradiol



Possible Disulfiram side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-09

Patient: female

Reactions: Jaundice, Asterixis, Encephalopathy, Hepatic Failure, Hepatitis Toxic, Liver Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Progesterone
    Administration route: Oral
    Indication: Hormone Replacement Therapy

Escitalopram
    Indication: Major Depression

Disulfiram
    Indication: Alcoholism
    Start date: 2011-05-01
    End date: 2011-06-01

Other drugs received by patient: Oxazepam; Levothyroxine Sodium; Estradiol; Milnacipran



Possible Disulfiram side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-09

Patient: 29 year old female

Reactions: Agranulocytosis, Viral Upper Respiratory Tract Infection, Asthenia, Infection

Drug(s) suspected as cause:
Disulfiram
    Dosage: 500 mg;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-20
    End date: 2011-11-22

Escitalopram
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01
    End date: 2011-11-22

Estradiol Valerate / Dienogest
    Dosage: 1 df;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-01
    End date: 2011-11-20

Celestamine TAB
    Dosage: 1 df;qd;po
    Administration route: Oral
    Indication: Rhinitis
    Start date: 2011-11-14
    End date: 2011-11-16

Other drugs received by patient: Desloratadine; Augmentin '125'



Possible Disulfiram side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from Belgium on 2012-04-06

Patient:

Reactions: Weight Decreased, Posterior Reversible Encephalopathy Syndrome, Abnormal Behaviour, Toxicity To Various Agents, Radiculopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram

Other drugs received by patient: Thiamine HCL



Possible Disulfiram side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-02

Patient: 40 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Bupropion HCL
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sumatriptan Succinate
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from France on 2012-03-22

Patient:

Reactions: Toxic Optic Neuropathy

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from France on 2012-03-13

Patient:

Reactions: Toxic Optic Neuropathy

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in 36 year old female

Reported by a individual with unspecified qualification from United States on 2012-02-27

Patient: 36 year old female, weighing 84.2 kg (185.2 pounds)

Reactions: Abdominal Pain, Jaundice, Vomiting, Nausea, Amphetamines Positive, Headache, Pyrexia, Malaise, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram

Other drugs received by patient: OXY-Elite; Acetaminophen; Flonase; Hydoxycut



Possible Disulfiram side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-01-25

Patient: 44 year old male, weighing 131.5 kg (289.4 pounds)

Reactions: Flushing, Food Interaction, Confusional State, Dyspnoea, Nausea, Pain of Skin, Coordination Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in

Reported by a physician from United States on 2012-01-23

Patient:

Reactions: Flushing, Intentional Overdose, Hypotension, Tachycardia, Drug Interaction, Alcohol Interaction

Drug(s) suspected as cause:
Disulfiram

Other drugs received by patient possibly interacting with the suspect drug:
Ethanol
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in

Reported by a physician from United States on 2012-01-20

Patient:

Reactions: Flushing, LIP Swelling, Intentional Overdose, Tachycardia, Hypotension, Suicide Attempt, Drug Interaction, Alcohol Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram

Other drugs received by patient possibly interacting with the suspect drug:
Ethanol
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-17

Patient: 40 year old female

Reactions: Cardio-Respiratory Arrest, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Disulfiram
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bupropion Hydrochloride
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sumatriptan Succinate
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2012-01-17

Patient: 40 year old female

Reactions: Completed Suicide, Respiratory Arrest, Intentional Drug Misuse, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Sumatriptan Succinate
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Bupropion HCL
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Hydroxyzine
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Disulfiram
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Lorazepam
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2012-01-12

Patient: 40 year old female

Reactions: Poisoning, Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Sumatriptan
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bupropion Hydrochloride
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2012-01-12

Patient: 40 year old female

Reactions: Completed Suicide, Poisoning, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Bupropion Hydrochloride
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sumatriptan
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2012-01-12

Patient: 40 year old female

Reactions: Poisoning, Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Sumatriptan
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bupropion Hydrochloride
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2012-01-05

Patient: 40 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Sumatriptan Succinate

Bupropion Hydrochloride

Disulfiram

Hydroxyzine

Lorazepam



Possible Disulfiram side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-05

Patient: 29 year old female

Reactions: Agranulocytosis, Sinus Headache, Rhinitis, Headache, Asthenia, Cough, Infection

Drug(s) suspected as cause:
Escitalopram
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01
    End date: 2011-11-22

Celestamine TAB
    Dosage: 1 df;qd;po
    Administration route: Oral
    Indication: Rhinitis
    Start date: 2011-11-14
    End date: 2011-11-16

Disulfiram
    Dosage: 500 mg;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-20
    End date: 2011-11-22

Estradiol Valerate / Dienogest
    Dosage: 1 df;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-01
    End date: 2011-11-20

Other drugs received by patient: Desloratadine; Augmentin '125'



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2011-12-29

Patient: 40 year old female

Reactions: Completed Suicide, Respiratory Arrest, Toxicity To Various Agents, Intentional Drug Misuse, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Lorazepam

Sumatriptan Succinate

Bupropion HCL

Disulfiram

Hydroxyzine



Possible Disulfiram side effects in 40 year old female

Reported by a physician from United States on 2011-12-26

Patient: 40 year old female

Reactions: Death, Cardio-Respiratory Arrest, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Buproprion HCL
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sumatriptan
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in

Reported by a physician from Italy on 2011-12-22

Patient:

Reactions: Hepatotoxicity

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from Italy on 2011-12-08

Patient:

Reactions: Hepatotoxicity

Drug(s) suspected as cause:
Disulfiram



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from United States on 2011-12-02

Patient:

Reactions: Alcohol Interaction, Ketoacidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alcohol
    Dosage: 2 l of vodka on the day of adveres reaction, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: unk, unknown
    Indication: Alcoholism

Other drugs received by patient: Naltrexone Hydrochloride



Possible Disulfiram side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-20

Patient: 39 year old male

Reactions: Renal Failure, Acute Hepatic Failure, Intracranial Pressure Increased, Adverse Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Disulfiram
    Dosage: unk, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Disulfiram side effects in

Reported by a individual with unspecified qualification from Belgium on 2011-10-19

Patient:

Reactions: Posterior Reversible Encephalopathy Syndrome, Toxicity To Various Agents, Radiculopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disulfiram

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