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CHLORPROMAZINE

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Chlorpromazine Adverse Events Reported to the FDA Over Time

How are Chlorpromazine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Chlorpromazine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Chlorpromazine is flagged as the suspect drug causing the adverse event.

Most Common Chlorpromazine Adverse Events Reported to the FDA

What are the most common Chlorpromazine adverse events reported to the FDA?

Neuroleptic Malignant Syndrome
93 (1.88%)
Completed Suicide
78 (1.58%)
Somnolence
47 (.95%)
Drug Interaction
45 (.91%)
Pyrexia
45 (.91%)
Drug Toxicity
42 (.85%)
Overdose
42 (.85%)
Multiple Drug Overdose
40 (.81%)
Intentional Overdose
38 (.77%)
Drug Exposure During Pregnancy
35 (.71%)
Aggression
34 (.69%)
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Drug Ineffective
33 (.67%)
Loss Of Consciousness
31 (.63%)
Rhabdomyolysis
31 (.63%)
Death
30 (.61%)
Suicide Attempt
30 (.61%)
Tremor
30 (.61%)
Blood Creatine Phosphokinase Increa...
29 (.59%)
Cardio-respiratory Arrest
28 (.57%)
Insomnia
28 (.57%)
Coma
27 (.55%)
Depressed Level Of Consciousness
27 (.55%)
Tachycardia
25 (.51%)
Urinary Retention
25 (.51%)
Vomiting
25 (.51%)
Confusional State
24 (.49%)
Convulsion
24 (.49%)
Depression
24 (.49%)
Pneumonia
24 (.49%)
Agitation
23 (.47%)
Catatonia
23 (.47%)
Fall
23 (.47%)
Respiratory Depression
23 (.47%)
Dyspnoea
22 (.44%)
Liver Disorder
22 (.44%)
Alanine Aminotransferase Increased
21 (.42%)
Blood Pressure Decreased
21 (.42%)
Cholestasis
21 (.42%)
Pulmonary Oedema
21 (.42%)
Renal Failure Acute
21 (.42%)
Asthenia
20 (.4%)
Dyskinesia
20 (.4%)
Intestinal Obstruction
20 (.4%)
Aspartate Aminotransferase Increase...
19 (.38%)
Diarrhoea
19 (.38%)
Drug Withdrawal Syndrome Neonatal
19 (.38%)
Dystonia
19 (.38%)
Heart Rate Increased
19 (.38%)
Mental Status Changes
19 (.38%)
Muscle Rigidity
19 (.38%)
Salivary Hypersecretion
19 (.38%)
Extrapyramidal Disorder
18 (.36%)
Fatigue
18 (.36%)
Hepatitis
18 (.36%)
Psychotic Disorder
18 (.36%)
Pulmonary Embolism
18 (.36%)
Serotonin Syndrome
18 (.36%)
Blood Alkaline Phosphatase Increase...
17 (.34%)
Maternal Drugs Affecting Foetus
17 (.34%)
Suicidal Ideation
17 (.34%)
Weight Increased
17 (.34%)
Accidental Overdose
16 (.32%)
Dehydration
16 (.32%)
Dizziness
16 (.32%)
Hypotension
16 (.32%)
Pneumonia Aspiration
16 (.32%)
Cogwheel Rigidity
15 (.3%)
Hypoaesthesia
15 (.3%)
Nausea
15 (.3%)
Renal Impairment
15 (.3%)
Anxiety
14 (.28%)
Cardiac Arrest
14 (.28%)
Condition Aggravated
14 (.28%)
Decreased Appetite
14 (.28%)
Delirium
14 (.28%)
Lethargy
14 (.28%)
Metabolic Acidosis
14 (.28%)
Multiple Drug Overdose Intentional
14 (.28%)
Myocarditis
14 (.28%)
Neonatal Respiratory Distress Syndr...
14 (.28%)
Oedema Peripheral
14 (.28%)
Orthostatic Hypotension
14 (.28%)
Premature Baby
14 (.28%)
Snoring
14 (.28%)
Toxic Epidermal Necrolysis
14 (.28%)
Aspiration
13 (.26%)
Feeling Jittery
13 (.26%)
Hypokalaemia
13 (.26%)
Ileus
13 (.26%)
Medication Error
13 (.26%)
Neonatal Disorder
13 (.26%)
Speech Disorder
13 (.26%)
Blood Bilirubin Increased
12 (.24%)
Blood Glucose Increased
12 (.24%)
Cleft Palate
12 (.24%)
Hyponatraemia
12 (.24%)
Irritability
12 (.24%)
Multi-organ Failure
12 (.24%)
Psychomotor Hyperactivity
12 (.24%)
Respiratory Failure
12 (.24%)
Sedation
12 (.24%)

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This graph shows the top adverse events submitted to the FDA for Chlorpromazine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Chlorpromazine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Chlorpromazine

What are the most common Chlorpromazine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Chlorpromazine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Chlorpromazine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Chlorpromazine According to Those Reporting Adverse Events

Why are people taking Chlorpromazine, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
201
Schizophrenia
170
Product Used For Unknown Indication
161
Hiccups
120
Psychotic Disorder
78
Bipolar Disorder
74
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Depression
51
Agitation
39
Insomnia
39
Ill-defined Disorder
37
Anxiety
37
Mental Disorder
26
Mania
23
Bipolar I Disorder
17
Abnormal Behaviour
17
Schizophrenia, Paranoid Type
15
Schizoaffective Disorder
14
Sleep Disorder
11
Drug Withdrawal Syndrome
10
Nausea
9
Hallucination
8
Aggression
8
Sedation
8
Major Depression
7
Acute Psychosis
7
Drug Exposure During Pregnancy
7
Suicide Attempt
6
Paranoia
6
Overdose
6
Delusion
6
Alcoholic Psychosis
5
Multiple Sclerosis
5
Hallucination, Auditory
5
Irritability
5
Parkinsonism
4
Self Injurious Behaviour
4
Diabetes Mellitus
4
Pain
4
Post-traumatic Stress Disorder
4
Rash
4
Binge Drinking
4
Foetal Exposure During Pregnancy
4
Restlessness
3
Sedative Therapy
3
Extrapyramidal Disorder
3
Vomiting
3
Premedication
3
Dystonia
3
Personality Disorder
3
Medication Error
3
Eye Pain
3

Drug Labels

LabelLabelerEffective
Chlorpromazine HydrochlorideContract Pharmacy Services-PA25-FEB-10
Chlorpromazine HydrochlorideState of Florida DOH Central Pharmacy21-MAY-10
Chlorpromazine HydrochlorideAmerican Health Packaging28-MAY-10
Chlorpromazine HydrochlorideAmerican Health Packaging28-MAY-10
Chlorpromazine HydrochlorideREMEDYREPACK INC. 04-AUG-10
Chlorpromazine HydrochlorideREMEDYREPACK INC. 16-DEC-10
Chlorpromazine HydrochlorideREMEDYREPACK INC. 16-DEC-10
Chlorpromazine HydrochlorideUpsher-Smith Laboratories, Inc.25-JUL-11
Chlorpromazine HydrochlorideREMEDYREPACK INC. 16-AUG-11
Chlorpromazine HydrochlorideSandoz Inc07-OCT-11
Chlorpromazine HydrochlorideCardinal Health15-MAY-12
Chlorpromazine HydrochlorideSandoz Inc25-MAY-12
Chlorpromazine HydrochlorideWest-ward Pharmaceutical Corp.13-JUN-12
Chlorpromazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs02-AUG-12
Chlorpromazine HydrochlorideMylan Institutional Inc.08-FEB-13
Chlorpromazine HydrochlorideREMEDYREPACK INC. 21-FEB-13
ChlorpromazineNCS HealthCare of KY, Inc dba Vangard Labs26-FEB-13
Chlorpromazine HydrochloridePhysicians Total Care, Inc.04-MAR-13
Chlorpromazine HydrochlorideREMEDYREPACK INC. 13-MAR-13
Chlorpromazine HydrochlorideREMEDYREPACK INC. 06-MAY-13

Chlorpromazine Case Reports

What Chlorpromazine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Chlorpromazine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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