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Amisulpride Adverse Events Reported to the FDA Over Time

How are Amisulpride adverse event reports trending over time?

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

Most Common Amisulpride Adverse Events Reported to the FDA

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

White Blood Cell Count Increased
143 (2.9%)
Platelet Count Decreased
137 (2.78%)
Breast Abscess
110 (2.23%)
Mental Impairment
104 (2.11%)
Metastases To Spine
103 (2.09%)
Drug Interaction
100 (2.03%)
Breast Cancer
91 (1.84%)
Haemoglobin Decreased
74 (1.5%)
Neutropenia
73 (1.48%)
Neutrophil Count Increased
72 (1.46%)
Neuroleptic Malignant Syndrome
66 (1.34%)
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Blood Prolactin Increased
63 (1.28%)
Blood Creatine Phosphokinase Increa...
62 (1.26%)
Abscess
61 (1.24%)
White Blood Cell Count Decreased
59 (1.2%)
Psychotic Disorder
56 (1.13%)
Vomiting
53 (1.07%)
Pneumonia
52 (1.05%)
Alanine Aminotransferase Increased
49 (.99%)
Blood Alkaline Phosphatase Increase...
47 (.95%)
Neutrophil Count Decreased
46 (.93%)
Overdose
46 (.93%)
General Physical Health Deteriorati...
43 (.87%)
Agitation
39 (.79%)
Liver Function Test Abnormal
38 (.77%)
Drug Toxicity
36 (.73%)
Hypertension
36 (.73%)
International Normalised Ratio Incr...
36 (.73%)
Electrocardiogram Qt Prolonged
35 (.71%)
Hyperhidrosis
35 (.71%)
Hypothyroidism
35 (.71%)
Weight Decreased
35 (.71%)
Blood Bilirubin Increased
33 (.67%)
Drug Ineffective
33 (.67%)
Hallucination, Auditory
33 (.67%)
Ovarian Adenoma
33 (.67%)
Body Temperature Increased
32 (.65%)
Malaise
31 (.63%)
Tachycardia
30 (.61%)
Speech Disorder
29 (.59%)
Salivary Hypersecretion
27 (.55%)
Schizophrenia
27 (.55%)
C-reactive Protein Increased
25 (.51%)
Diarrhoea
25 (.51%)
Paranoia
25 (.51%)
Renal Impairment
25 (.51%)
Chest Pain
24 (.49%)
Extrapyramidal Disorder
24 (.49%)
Pyrexia
24 (.49%)
Somnolence
24 (.49%)
Aggression
22 (.45%)
Rash
22 (.45%)
Dyspnoea
21 (.43%)
Abnormal Behaviour
20 (.41%)
Confusional State
20 (.41%)
Death
20 (.41%)
Impaired Self-care
20 (.41%)
Sedation
20 (.41%)
Lower Respiratory Tract Infection
19 (.38%)
Rhabdomyolysis
19 (.38%)
Body Temperature Fluctuation
18 (.36%)
Leukopenia
18 (.36%)
Nocturia
18 (.36%)
Electrocardiogram Abnormal
17 (.34%)
Influenza Like Illness
17 (.34%)
Nausea
17 (.34%)
Sudden Death
17 (.34%)
Dehydration
16 (.32%)
Hypomania
16 (.32%)
Insomnia
16 (.32%)
Mental Disorder
16 (.32%)
Physical Assault
16 (.32%)
Posturing
16 (.32%)
Antisocial Behaviour
15 (.3%)
Blood Pressure Systolic Increased
15 (.3%)
Cholinergic Syndrome
15 (.3%)
Disturbance In Attention
15 (.3%)
Eosinophilia
15 (.3%)
Suicide Attempt
15 (.3%)
Condition Aggravated
14 (.28%)
Disinhibition
14 (.28%)
Muscle Rigidity
14 (.28%)
Pollakiuria
14 (.28%)
Waxy Flexibility
14 (.28%)
Breast Cancer Female
13 (.26%)
Breast Cancer Metastatic
13 (.26%)
Cardiac Arrest
13 (.26%)
Constipation
13 (.26%)
Eosinophil Count Increased
13 (.26%)
Hypotension
13 (.26%)
Illusion
13 (.26%)
Subacute Endocarditis
13 (.26%)
Antipsychotic Drug Level Increased
12 (.24%)
Anxiety
12 (.24%)
Mutism
12 (.24%)
Parkinsonism
12 (.24%)
Posture Abnormal
12 (.24%)
Respiratory Failure
12 (.24%)
Schizophrenia, Catatonic Type
12 (.24%)
Circulatory Collapse
11 (.22%)
Depression
11 (.22%)

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This graph shows the top adverse events submitted to the FDA for Amisulpride, 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 Amisulpride 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 Amisulpride

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

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This graph shows the top categories of adverse events submitted to the FDA for Amisulpride, 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 Amisulpride 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 Amisulpride According to Those Reporting Adverse Events

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

Schizophrenia
418
Psychotic Disorder
94
Product Used For Unknown Indication
93
Drug Use For Unknown Indication
82
Schizoaffective Disorder
23
Depression
20
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Schizophrenia, Paranoid Type
17
Abnormal Behaviour
10
Mental Disorder
10
Ill-defined Disorder
10
Major Depression
10
Bipolar Disorder
8
Hallucination
8
Affective Disorder
7
Psychiatric Symptom
7
Mania
4
Schizophrenia, Disorganised Type
4
Paranoia
4
Suicide Attempt
4
Bipolar I Disorder
3
Intentional Overdose
3
Anxiety
3
Depressed Mood
3
Anxiolytic Therapy
2
Disease Recurrence
2
Dementia
2
Acute Psychosis
2
Disturbance In Attention
1
Asthenia
1
Weight Decreased
1
Psychotic Behaviour
1
Tic
1
Obsessive-compulsive Disorder
1
Mood Swings
1
Agitation
1
Salivary Hypersecretion
1
Vomiting
1
Delusion
1
Mammoplasty
1
Overdose
1
Delusional Disorder, Unspecified Ty...
1
Anorexia
1
Schizophrenia, Undifferentiated Typ...
1
Irritability
1
Somnolence
1
Nausea
1
Cotards Syndrome
1

Amisulpride Case Reports

What Amisulpride 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 Amisulpride. 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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