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Haldol (Haloperidol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Haldol (Haloperidol) 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 (512)
Death (67)
Life Threatening Events (37)
Disability (13)

Reports by Reaction Type

Somnolence (40)Self Injurious Behaviour (38)Fall (34)Multiple Drug Overdose Intentional (34)Sopor (29)Psychotic Disorder (27)Suicide Attempt (27)Electrocardiogram QT Prolonged (21)Extrapyramidal Disorder (21)Death (20)Tremor (20)Aggression (20)

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

Possible Haldol side effects in male

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

Patient: male

Reactions: Dysarthria, Tachycardia, Snoring, Drug Abuse, Sopor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anafranil
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Clonazepam
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Haldol
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Lantanon
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Olanzapine
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Trazodone HCL
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Valproic Acid
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13



Possible Haldol side effects in 70 year old female

Reported by a physician from Switzerland on 2012-08-23

Patient: 70 year old female

Reactions: Renal Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in male

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

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Haldol
    Indication: Psychotic Disorder
    Start date: 2012-07-12
    End date: 2012-07-12

Haloperidol Lactate
    Indication: Agitation
    Start date: 2012-07-12
    End date: 2012-07-12

Nozinan
    Indication: Psychotic Disorder
    Start date: 2012-07-12
    End date: 2012-07-12

Tercian
    Indication: Psychotic Disorder
    Start date: 2012-07-11
    End date: 2012-07-11



Possible Haldol side effects in male

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

Patient: male

Reactions: Colitis Ischaemic, Intestinal Obstruction, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-01-11

Haldol
    Administration route: Oral
    Indication: Schizophrenia
    End date: 2012-01-01



Possible Haldol side effects in 70 year old female

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

Patient: 70 year old female

Reactions: Renal Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Dyspnoea, Headache

Drug(s) suspected as cause:
Haldol

Other drugs received by patient: Depamide



Possible Haldol side effects in 25 year old male

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

Patient: 25 year old male

Reactions: Dysphagia, Cerebral Disorder, Tremor

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in female

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

Patient: female

Reactions: Weight Increased, Fatigue, Increased Appetite, Depression, Suicidal Ideation

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in 29 year old male

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

Patient: 29 year old male

Reactions: Priapism

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

Invega Sustenna
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-01



Possible Haldol side effects in male

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

Patient: male

Reactions: Drug Abuse, Sopor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anafranil
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Clonazepam
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Haldol
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Lantanon
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Olanzapine
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Trazodone HCL
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13

Valproate Sodium
    Administration route: Oral
    Indication: Drug Abuse
    Start date: 2012-07-13
    End date: 2012-07-13



Possible Haldol side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Psychotic Disorder, Judgement Impaired, Somnambulism, Feeling Abnormal, Amnesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ativan
    Dosage: unk unk, see text
    Indication: Product Used FOR Unknown Indication

Haldol
    Dosage: 25 mg, see text
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Versed
    Dosage: unk unk, see text
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Oxycodone HCL; Xanax; Valium



Possible Haldol side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: male

Reactions: Ischaemia, Volvulus

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clozapine
    Dosage: long-term
    Administration route: Oral
    Indication: Schizophrenia, Disorganised Type

Haldol
    Dosage: long-term
    Administration route: Oral
    Indication: Schizophrenia, Disorganised Type

Lepticur
    Dosage: long-term
    Administration route: Oral
    Indication: Dyskinesia

Other drugs received by patient: Tranxene



Possible Haldol side effects in female

Reported by a pharmacist from Italy on 2012-08-09

Patient: female

Reactions: Alcohol Use, Overdose, Self Injurious Behaviour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Haldol
    Indication: Psychomotor Hyperactivity
    Start date: 2011-04-27
    End date: 2011-04-27

Paroxetine Hydrochloride
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Depression
    Start date: 2011-04-20
    End date: 2011-04-27



Possible Haldol side effects in female

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

Patient: female, weighing 97.5 kg (214.6 pounds)

Reactions: Pain in Extremity, Dyskinesia, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Haldol
    Dosage: 25 mg every 2 weeks butt : 50mg every 2 weeks butt
    Indication: Psychotic Disorder
    Start date: 2008-05-01
    End date: 2009-02-01

Haldol
    Dosage: 25 mg every 2 weeks butt : 50mg every 2 weeks butt
    Indication: Delusion
    Start date: 2008-05-01
    End date: 2009-02-01



Possible Haldol side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Tinnitus, Adverse Drug Reaction, Completed Suicide, Depression, Suicidal Ideation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Haldol
    Indication: Schizophrenia
    Start date: 2011-01-01
    End date: 2011-01-01

Haldol
    Indication: Bipolar Disorder
    Start date: 2011-01-01
    End date: 2011-01-01

Invega Sustenna
    Start date: 2011-01-01

Invega Sustenna
    Indication: Bipolar Disorder

Invega Sustenna
    Indication: Schizophrenia

Invega Sustenna
    Start date: 2011-01-01



Possible Haldol side effects in 48 year old female

Reported by a physician from Switzerland on 2012-08-07

Patient: 48 year old female

Reactions: Psychotic Disorder, Encephalopathy, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clotiapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-18
    End date: 2012-05-24

Clozapine
    Indication: Product Used FOR Unknown Indication

Haldol
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-18

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-18
    End date: 2012-05-24

Trazodone HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-18
    End date: 2012-05-24

Other drugs received by patient: Lamictal



Possible Haldol side effects in female

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

Patient: female

Reactions: Abdominal Pain, Pancreatitis, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

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

Loxapine HCL
    Administration route: Oral
    Indication: Schizophrenia

Other drugs received by patient: AN Unknown Medication; Valium; Lexomil; Imovane



Possible Haldol side effects in female

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

Patient: female, weighing 82.6 kg (181.6 pounds)

Reactions: Agitation, Hypersensitivity, Hallucination, Auditory, Drug Ineffective, Restless Legs Syndrome, Headache, Constipation, Suicidal Ideation, Groin Pain, Delusion, Myalgia, Hospitalisation, Obesity, Sedation, Irritable Bowel Syndrome, Depression, Back Pain, Blood Cortisol Increased, Injection Site Pain, Rash, Cognitive Disorder, Stress, Apathy, Incorrect Drug Administration Rate, Hallucination, Visual, Diarrhoea, Rash Erythematous, Insomnia, Dehydration, Disturbance in Attention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Haldol
    Start date: 2000-01-01

Haldol
    Indication: Schizophrenia, Paranoid Type
    Start date: 2012-06-01

Haldol



Possible Haldol side effects in 33 year old female

Reported by a physician from United States on 2012-08-02

Patient: 33 year old female

Reactions: Galactorrhoea, Psychotic Behaviour

Drug(s) suspected as cause:
Haldol
    Indication: Schizophrenia

Invega Sustenna
    Indication: Schizophrenia
    Start date: 2012-01-01



Possible Haldol side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

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

Aranesp

Haldol
    Administration route: Oral

Seroquel
    Administration route: Oral

Other drugs received by patient: Bronchodual; Repaglinide; Renagel; Irbesartan; Amlodipine Besylate; Omeprazole; Aspirin; Sodium Bicarbonate; Lasix; Spiriva



Possible Haldol side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-01

Patient: 37 year old male

Reactions: Confusional State, Hepatic Pain, Dyskinesia, Pyrexia, Tongue Paralysis, Speech Disorder, Diarrhoea, Gait Disturbance

Drug(s) suspected as cause:
Dapotum

Haldol

Pipamperone

Risperdal

Tegretol
    Start date: 1997-01-01

Truxal

Zyprexa



Possible Haldol side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 62 year old male

Reactions: Tremor, Delusion

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-30

Patient: 63 year old female

Reactions: Tachycardia, Drug Interaction, Hyperreflexia, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Haldol

Other drugs received by patient possibly interacting with the suspect drug:
Escitalopram
    Administration route: Oral
    Indication: Depression
    Start date: 2012-02-10

Escitalopram
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-08

Tramadol Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-08



Possible Haldol side effects in

Reported by a physician from France on 2012-07-30

Patient:

Reactions: Aortic Dissection

Drug(s) suspected as cause:
Haldol



Possible Haldol side effects in male

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

Patient: male

Reactions: Adverse Drug Reaction, Tardive Dyskinesia, Tremor

Drug(s) suspected as cause:
Haldol
    Indication: Psychotic Disorder

Seroquel
    Administration route: Oral
    Indication: Psychotic Disorder



Possible Haldol side effects in male

Reported by a physician from Germany on 2012-07-27

Patient: male, weighing 150.0 kg (330.0 pounds)

Reactions: Fatigue, Sluggishness, Drug Abuse

Adverse event resulted in: hospitalization

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

Dipiperon
    Start date: 2012-06-04
    End date: 2012-06-04

Haldol
    Start date: 2012-06-04
    End date: 2012-06-04

Haldol
    Indication: Product Used FOR Unknown Indication

Koffein
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-04
    End date: 2012-06-04

Koffein

Lorazepam
    Start date: 2012-06-04
    End date: 2012-06-04

Lorazepam
    Indication: Product Used FOR Unknown Indication



Possible Haldol side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-27

Patient: 63 year old female

Reactions: Tachycardia, Hyperreflexia, Drug Interaction, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: 10 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2012-02-01
    End date: 2012-02-08

Escitalopram
    Administration route: Oral
    Start date: 2012-02-10

Haldol
    Dosage: 20 mg/ml
    Administration route: Oral

Tramadol Hydrochloride
    Administration route: Oral
    End date: 2012-02-08



Possible Haldol side effects in 42 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 42 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Agitation, Drug Dose Omission, Hypersomnia

Drug(s) suspected as cause:
Geodon
    Administration route: Oral
    Indication: Craniocerebral Injury

Haldol
    Administration route: Oral
    Indication: Craniocerebral Injury

Seroquel
    Administration route: Oral
    Indication: Craniocerebral Injury
    Start date: 2011-08-04



Possible Haldol side effects in 28 year old male

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

Patient: 28 year old male

Reactions: Weight Decreased, Weight Increased, Panic Attack, Social Avoidant Behaviour, Medication Error, Pigmentation Disorder, Drug Prescribing Error

Drug(s) suspected as cause:
Haldol
    Indication: Depression
    Start date: 2009-11-01

Haldol
    Start date: 2000-01-01
    End date: 2009-04-01

Other drugs received by patient: Imipramine HCL; Biperiden Hydrochloride TAB



Possible Haldol side effects in 63 year old female

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

Patient: 63 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Dementia, Schizoaffective Disorder, Tremor

Drug(s) suspected as cause:
Haldol
    Indication: Agitation
    Start date: 2012-06-22
    End date: 2012-06-22

Haldol Decoanate 50mg
    Indication: Schizophrenia
    Start date: 2010-06-15
    End date: 2011-11-15

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