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Chlorpromazine (Chlorpromazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Chlorpromazine 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 (54)
Death (16)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Completed Suicide (10)Cleft Palate (9)Maternal Drugs Affecting Foetus (6)Toxicity To Various Agents (6)Head Injury (5)Contusion (4)Drug Abuse (4)Laceration (4)Atrial Fibrillation (4)Pyrexia (3)Sydenham's Chorea (3)Dystonia (3)

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

Possible Chlorpromazine side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male, weighing 2.2 kg (4.8 pounds)

Reactions: Neonatal Respiratory Distress Syndrome, Premature Baby, Hypocalcaemia, Pneumothorax, Drug Withdrawal Syndrome Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 25mg per day
    Indication: Anxiety
    Start date: 2011-09-22

Citalopram Hydrobromide
    Dosage: 20mg per day
    Indication: Depression
    Start date: 2011-10-04

Dihydrocodeine
    Dosage: 60mg per day
    Indication: Pain
    Start date: 2010-03-15

Fluoxetine
    Dosage: 60mg per day
    Indication: Depression
    Start date: 2010-06-21
    End date: 2011-10-04

Omeprazole
    Dosage: 20mg per day
    Indication: Dyspepsia
    Start date: 2008-09-19

Propranolol
    Dosage: 20mg per day
    Indication: Anxiety
    Start date: 2009-05-05

Propranolol
    Dosage: 20mg per day
    Indication: Palpitations
    Start date: 2009-05-05

Seroquel
    Dosage: 400mg per day
    Indication: Anxiety
    Start date: 2011-03-23
    End date: 2011-09-10

Seroquel
    Dosage: 400mg per day
    Indication: Depression
    Start date: 2011-03-23
    End date: 2011-09-10



Possible Chlorpromazine side effects in female

Reported by a physician from Japan on 2012-08-06

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

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

Chlorpromazine
    Dosage: unk

Mirtazapine
    Dosage: unk

Zoloft
    Dosage: unk

Zolpidem
    Dosage: unk



Possible Chlorpromazine side effects in 34 year old female

Reported by a physician from Taiwan, Province of China on 2012-07-13

Patient: 34 year old female

Reactions: Respiratory Rate Increased, Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Blood Chloride Decreased, Tongue DRY, Blood Potassium Increased, Blood PH Decreased, Body Temperature Decreased, Mucosal Dryness, Muscle Rigidity, Heart Rate Increased, Depressed Level of Consciousness, Blood Sodium Decreased, Blood Creatinine Increased, Diabetic Hyperosmolar Coma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 100 mg, qd
    Indication: Binge Drinking

Haloperidol
    Dosage: 20 mg, qd
    Indication: Binge Drinking

Lithium Carbonate
    Indication: Bipolar Disorder

Trihexyphenidyl HCL
    Dosage: 4 mg, qd
    Indication: Binge Drinking



Possible Chlorpromazine side effects in 31 year old male

Reported by a pharmacist from United States on 2012-07-05

Patient: 31 year old male, weighing 92.1 kg (202.6 pounds)

Reactions: Priapism

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 100 mg hs po
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-02-10
    End date: 2012-03-07

Citalopram 10 MG Torrent Pharma
    Dosage: 30 mg am po
    Administration route: Oral
    Indication: Depression
    Start date: 2012-02-09
    End date: 2012-03-04



Possible Chlorpromazine side effects in 80 year old female

Reported by a physician from United States on 2012-06-25

Patient: 80 year old female

Reactions: Eyelid Oedema, Corneal Neovascularisation, Conjunctival Oedema, Lagophthalmos, Conjunctival Hyperaemia, Keratopathy, Corneal Oedema, Erythema, Eye Pain

Drug(s) suspected as cause:
Chlorpromazine



Possible Chlorpromazine side effects in female

Reported by a physician from India on 2012-06-20

Patient: female

Reactions: Weight Increased, Blood Prolactin Increased, Amenorrhoea, Polycystic Ovaries, Decreased Appetite

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 200 mg, 1 d, unknown
    Indication: Product Used FOR Unknown Indication

Risperidone
    Dosage: 6 mg, 1 d, unknown
    Indication: Product Used FOR Unknown Indication

Topiramate
    Dosage: 25 mg, 1 d, unknown
    Indication: Product Used FOR Unknown Indication

Trihexyphenidyl HCL
    Dosage: 4 mg, 1 d, unknown
    Indication: Product Used FOR Unknown Indication



Possible Chlorpromazine side effects in 64 year old

Reported by a pharmacist from United States on 2012-06-11

Patient: 64 year old

Reactions: Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Calan
    Administration route: Oral
    Indication: Hypertension

Chlorpromazine
    Administration route: Oral
    Indication: Ill-Defined Disorder



Possible Chlorpromazine side effects in 64 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: 64 year old

Reactions: Completed Suicide

Adverse event resulted in: death

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

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



Possible Chlorpromazine side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-30

Patient: 27 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Myoglobinuria, Pneumonia, Incorrect Dose Administered, Neuroleptic Malignant Syndrome, Joint Ankylosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine



Possible Chlorpromazine side effects in 38 year old female

Reported by a consumer/non-health professional from Brazil on 2012-05-16

Patient: 38 year old female

Reactions: Overdose, Suicide Attempt, Somnolence

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 4tab single dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-09
    End date: 2012-05-09

Clonazepam
    Dosage: 15tab single dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-09
    End date: 2012-05-09

Zofran
    Dosage: 1tab single dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-09
    End date: 2012-05-09



Possible Chlorpromazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: male

Reactions: Cataract, Drug Ineffective, Adverse Drug Reaction, Squamous Cell Carcinoma of Skin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Indication: Hallucination

Chlorpromazine
    Indication: Schizophrenia

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01
    End date: 2011-01-01

Risperdal
    Dosage: began 15 years ago on an unspecified date in 1997

Risperdal
    Start date: 2011-01-01

Risperdal
    Dosage: began 15 years ago on an unspecified date in 1997
    Indication: Hallucination

Risperdal
    Start date: 2011-01-01

Risperdal
    Indication: Schizophrenia
    Start date: 2011-01-01

Risperdal
    Dosage: began 15 years ago on an unspecified date in 1997
    Indication: Autism

Risperdal Consta
    Indication: Product Used FOR Unknown Indication

Risperdal Consta

Other drugs received by patient: Levothyroxine Sodium; Depakote; Diphenhydramine HCL; Fluvoxamine Maleate; Paxil; Benztropine Mesylate; Benztropine Mesylate; Lorazepam



Possible Chlorpromazine side effects in 52 year old female

Reported by a physician from Turkey on 2012-04-20

Patient: 52 year old female

Reactions: Pneumonia Aspiration, Supraventricular Tachycardia, Coma, Toxicity To Various Agents, Electroencephalogram Abnormal, Neurotoxicity, Renal Failure, Respiratory Failure, Dehydration, Acute Respiratory Distress Syndrome, Hyperthyroidism

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 200 mg
    Indication: Bipolar Disorder

Dexamethasone
    Indication: Supraventricular Tachycardia

Dexamethasone
    Dosage: 2 mg
    Indication: Hyperthyroidism

Diuretics
    Indication: Hypertension

Insuline Glargine
    Indication: Diabetes Mellitus

Irbesartane
    Indication: Hypertension

Lithium Carbonate
    Indication: Bipolar Disorder

Phenytoin
    Dosage: 300 mg
    Indication: Convulsion

Propranolol
    Indication: Supraventricular Tachycardia

Propranolol
    Dosage: 160 mg
    Indication: Hyperthyroidism

Propyl-Thiouracil
    Indication: Supraventricular Tachycardia

Propyl-Thiouracil
    Dosage: 600 mg
    Indication: Hyperthyroidism



Possible Chlorpromazine side effects in 55 year old male

Reported by a physician from Turkey on 2012-04-02

Patient: 55 year old male

Reactions: Hepatitis C, Increased Appetite, Cerebral Atrophy, Treatment Noncompliance

Drug(s) suspected as cause:
Biperiden Hydrochloride TAB
    Indication: Hypomania

Chlorpromazine
    Indication: Hypomania

Clonazepam
    Indication: Hypomania

Haloperidol
    Indication: Hypomania

Risperdal Consta
    Indication: Hypomania

Risperidone
    Administration route: Oral

Risperidone
    Administration route: Oral
    Indication: Hypomania

Other drugs received by patient: Enalapril; Pioglitazone; Metformin HCL



Possible Chlorpromazine side effects in 25 year old female

Reported by a pharmacist from Japan on 2012-03-30

Patient: 25 year old female

Reactions: Intentional Overdose, Toxicity To Various Agents

Adverse event resulted in: death

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

Chlorpromazine
    Dosage: unk

Levomepromazine
    Dosage: unk

Paroxetine HCL
    Dosage: unk

Phenobarbital TAB
    Dosage: unk

Promethazine
    Dosage: unk

Triazolam
    Dosage: unk



Possible Chlorpromazine side effects in 35 year old male

Reported by a physician from Iran (Islamic Republic OF) on 2012-02-17

Patient: 35 year old male

Reactions: Treatment Failure, Priapism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 50 mg;hs
    Indication: Insomnia

Risperidone
    Dosage: 3 mg;qd
    Indication: Borderline Personality Disorder

Risperidone
    Dosage: 3 mg;qd
    Indication: Schizophrenia

Other drugs received by patient: Biperiden Hydrochloride TAB; Clonazepam



Possible Chlorpromazine side effects in 38 year old female

Reported by a pharmacist from United States on 2012-01-24

Patient: 38 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Chlorpromazine



Possible Chlorpromazine side effects in 57 year old female

Reported by a physician from United States on 2012-01-24

Patient: 57 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

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

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



Possible Chlorpromazine side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-01-23

Patient: male, weighing 3.8 kg (8.4 pounds)

Reactions: Regurgitation, Maternal Drugs Affecting Foetus, Dystonia, Retching, Flatulence, Agitation Neonatal, Hypertonia Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 1 dosage form (1 dosage forms, 1 in 1 d), transplacental

Chlorpromazine
    Dosage: 75 mg daily before third quarter of pregnancy (75 mg, 1 in 1 d), transplacental, daily dose decrease

Escitalopram Oxalate
    Dosage: transplacental
    End date: 2011-11-26

Oxazepam
    Dosage: 20 mg (20 mg, 1 in 1 d), transplacental

Prazepam
    Dosage: switched to oxazepam at the third quarter, transplacental



Possible Chlorpromazine side effects in 82 year old female

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

Patient: 82 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Chlorpromazine

Clopidogrel

Diltiazem Hydrochloride

Metformin / Sitagliptin (Metformin, Sitagliptin)



Possible Chlorpromazine side effects in male

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

Patient: male, weighing 3.8 kg (8.4 pounds)

Reactions: Regurgitation, Maternal Drugs Affecting Foetus, Dystonia, Retching, Flatulence, Agitation Neonatal, Hypertonia Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 1 dosage form (1 dosage forms, 1 in 1 d), transplacental

Chlorpromazine
    Dosage: 75 mg daily before third quarter of pregnancy (75 mg, 1 in 1 d), transplacental

Escitalopram Oxalate
    Dosage: transplacental
    End date: 2011-11-26

Oxazepam
    Dosage: 20 mg daily up to third quarter (20 mg, 1 in 1 d), transplacental

Prazepam
    Dosage: switched to oxazepam at the third quarter, transplacental



Possible Chlorpromazine side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-10

Patient: 5 year old male

Reactions: Speech Disorder, Trismus, Dyskinesia, Coordination Abnormal, Tongue Paralysis, Sydenham's Chorea, Aggression

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 200 mg, qd
    Indication: Abnormal Behaviour

Dextroamphetamine
    Dosage: 2.5 mg, tid



Possible Chlorpromazine side effects in 56 year old female

Reported by a physician from United States on 2012-01-04

Patient: 56 year old female

Reactions: Death, Cardio-Respiratory Arrest, Completed Suicide

Adverse event resulted in: death

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

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

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



Possible Chlorpromazine side effects in 67 year old male

Reported by a pharmacist from United States on 2012-01-04

Patient: 67 year old male, weighing 83.5 kg (183.6 pounds)

Reactions: Corneal Opacity

Drug(s) suspected as cause:
Chlorpromazine



Possible Chlorpromazine side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04

Patient: 82 year old female

Reactions: Incorrect Dose Administered, Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Clopidogrel
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

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

Metformin HCL
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication



Possible Chlorpromazine side effects in 23 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-29

Patient: 23 year old male

Reactions: Pyrexia, Neutropenia

Adverse event resulted in: hospitalization

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

Valproate Sodium
    Dosage: 500mg daily, 250mg, twice a day
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Lactulose



Possible Chlorpromazine side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-28

Patient: 82 year old female

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

Adverse event resulted in: death

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

Clopidogrel Bisulfate
    Administration route: Oral

Diltiazem
    Administration route: Oral

Sitagliptin and Metformin Hydrochloride
    Administration route: Oral



Possible Chlorpromazine side effects in male

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

Patient: male

Reactions: Contusion, Head Injury, Atrial Fibrillation, Laceration, Drug Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: unk
    Administration route: Oral
    Indication: Abnormal Behaviour
    Start date: 2010-09-18
    End date: 2010-09-18

Paroxetine Hydrochloride
    Dosage: 20 mg, single
    Administration route: Oral
    Indication: Abnormal Behaviour
    Start date: 2010-09-18
    End date: 2010-09-18

Ramipril
    Dosage: unk
    Administration route: Oral
    Start date: 2010-09-18
    End date: 2010-09-18



Possible Chlorpromazine side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20

Patient: 41 year old male

Reactions: Antipsychotic Drug Level Increased, Drug Level Increased, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Bupropion HCL

Chlorpromazine
    Administration route: Oral

Clozapine
    Administration route: Oral

Zolpidem



Possible Chlorpromazine side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20

Patient: 41 year old male

Reactions: Antipsychotic Drug Level Increased, Drug Level Increased, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Bupropion HCL

Chlorpromazine
    Administration route: Oral

Clozapine
    Administration route: Oral

Zolpidem



Possible Chlorpromazine side effects in 15 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-12-14

Patient: 15 year old male

Reactions: Head Injury, Multiple Drug Overdose Intentional, Self Injurious Behaviour, Injury

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: half bottle
    Administration route: Oral
    Indication: Ill-Defined Disorder
    Start date: 2011-12-06

Haldol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-06

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