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Amisulpride Side Effects

Common Amisulpride Side Effects


The most commonly reported Amisulpride side effects (click to view or check a box to report):

Platelet Count Decreased (32)
Breast Abscess (30)
Metastases To Spine (28)
White Blood Cell Count Increased (26)
Breast Cancer (25)
Mental Impairment (19)
Blood Prolactin Increased (16)
Neuroleptic Malignant Syndrome (16)
Haemoglobin Decreased (16)
Abscess (12)
Blood Creatine Phosphokinase Increased (11)
Neutrophil Count Increased (11)
Alanine Aminotransferase Increased (9)
Neutropenia (9)
Overdose (9)
Weight Decreased (9)
Rhabdomyolysis (8)
Electrocardiogram Qt Prolonged (8)
Pneumonia (8)
Lower Respiratory Tract Infection (7)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Amisulpride Side Effects Reported to FDA

The following Amisulpride reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Amisulpride on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Diabetes Insipidus, Hypernatraemia
This is a report of a 59-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: schizophrenia,depression, who was treated with Amisulpride (dosage: NA, start time: 2010), combined with:
  • Citalopram (citalopram)
  • Clozaril
  • Lithium (lithium)
  • Amlodipine (amlodipine)
  • Amoxicillin (amoxicillin)
  • Docusate (docusate)
  • Senna /00142201/ (senna Alexandria)
  • Simvastatin (simvastatin)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Diabetes Insipidus
  • Hypernatraemia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in male patients, resulting in diabetes insipidus side effect.

Electrocardiogram Qt Prolonged, Electrocardiogram Qt Shortened
This report suggests a potential Amisulpride Electrocardiogram Qt Prolonged, Electrocardiogram Qt Shortened side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Amisulpride (dosage: NA) starting NS. Soon after starting Amisulpride the patient began experiencing various side effects, including:
  • Electrocardiogram Qt Prolonged
  • Electrocardiogram Qt Shortened
Drugs used concurrently:
  • Amlodipine (amlodipine)
  • Aripiprazole
  • Bendroflumethiazide (bendroflumethiazide)
  • Depakote (valproate Semisodium)
Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as electrocardiogram qt prolonged, may still occur.

Neuroleptic Malignant Syndrome, Fall
This Neuroleptic Malignant Syndrome, Fall problem was reported by a physician from GB. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia. On NS this consumer started treatment with Amisulpride (amisulpride) (dosage: 1200 Mg (1200 Mg, 1 In 1 D), Oral). The following drugs were being taken at the same time:
  • Paroxetine (paroxetine) (50 Mg, (50 Mg, 1 In 1 D), Oral)
  • Olanzapine (olanzapine) (7.5 Mg (7.5 Mg, 1 N 1 D), Oral)
  • Metformin (metformin)
  • Pioglitazone (pioglitazone)
  • Simvastatin (simvastatin)
  • Zopiclone (zopiclone)
When commencing Amisulpride (amisulpride), the patient experienced the following unwanted symptoms/side effects:
  • Neuroleptic Malignant Syndrome
  • Fall
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as neuroleptic malignant syndrome, may become evident only after a product is in use by the general population.

Convulsion, Feeling Abnormal, Hypomania, Oromandibular Dystonia, Insomnia, Suspected Counterfeit Product, Weight Decreased
This is a report of a 36-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Amisulpride (dosage: NA) starting 1997. Concurrently used drugs:
  • Paroxetine
  • Sertraline
  • Zopiclone
  • Chlorpromazine
  • Lithium
  • Quetiapine Fumarate
  • Venlafaxine
Soon after that, the consumer experienced the following side effects:
  • Convulsion
  • Feeling Abnormal
  • Hypomania
  • Oromandibular Dystonia
  • Insomnia
  • Suspected Counterfeit Product
  • Weight Decreased
This opens a possibility that Amisulpride treatment could cause the above reactions, including convulsion, and some male subjects may be more susceptible.


Feeling Abnormal, Hypomania, Oromandibular Dystonia, Convulsion, Insomnia, Weight Decreased, Suspected Counterfeit Product
A 36-year-old male patient (weight: NA) from GB with the following symptoms/conditions: NA started Amisulpride treatment (dosage: Unk) on 2012. Soon after starting Amisulpride treatment, the subject experienced various side effects, including:
  • Feeling Abnormal
  • Hypomania
  • Oromandibular Dystonia
  • Convulsion
  • Insomnia
  • Weight Decreased
  • Suspected Counterfeit Product
Concurrently used drugs:
  • Paroxetine
  • Sertraline (Unk)
  • Venlafaxine (Unk)
  • Zopiclone (Unk)
  • Chlorpromazine (Unk)
  • Lithium (Unk)
  • Seroquel Xl (700 Mg, Qd)
  • Seroquel Xl (600 Mg, Qd)
This finding indicates that some male patients could be more vulnerable to Amisulpride.

Hormone Level Abnormal, Blood Oestrogen Increased, Blood Prolactin Increased, Dystonia, Insomnia
A 36-year-old male patient from GB (weight: NA) experienced symptoms, such as: NA and was treated with Amisulpride (amisulpride)(dosage: NA). The treatment was initiated on 1997. After that a consumer reported the following side effect(s):
  • Hormone Level Abnormal
  • Blood Oestrogen Increased
  • Blood Prolactin Increased
  • Dystonia
  • Insomnia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Amisulpride (amisulpride) efficacy:
  • Paroxetine (paroxetine)
  • Sertraline (sertraline)
  • Chlorpromazine
  • Lithium (lithium)
  • Seroquel Xl (600 Mg (600 Mg, 1 In 1 D), Oral)
  • Venlafaxine (venlafaxine)
  • Zopiclone (zopiclone)
  • Sondate Xl


Blood Creatine Phosphokinase Increased, Neuroleptic Malignant Syndrome, Fall
In this report, Amisulpride was administered for the following condition: schizophrenia.A 64-year-old male consumer from GB (weight: NA) started Amisulpride treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Blood Creatine Phosphokinase Increased
  • Neuroleptic Malignant Syndrome
  • Fall
A possible interaction with other drugs could have contributed to this reaction:
  • Paroxetine
  • Olanzapine
  • Metformin (metformin)
  • Pioglitazone (pioglitazone)
  • Simvastatin (simvastatin)
  • Zopiclone (zopiclone)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Amisulpride treatment could be related to the listed above side effect(s).

Fall, Neuroleptic Malignant Syndrome, Blood Creatine Phosphokinase Increased
This is a report of the following Amisulpride side effect(s):
  • Fall
  • Neuroleptic Malignant Syndrome
  • Blood Creatine Phosphokinase Increased
A 64-year-old male patient from GB (weight: NA) presented with the following condition: schizophrenia and received a treatment with Amisulpride (dosage: 1200 Mg (400mg In The Morning And 800mg At Night)) starting: NS.The following concurrently used drugs could have generated interactions:
  • Olanzapine (7.5 Mg Qd)
  • Paroxetine (50 Mg Qd)
  • Metformin
  • Pioglitazone
  • Simvastatin
  • Zopiclone
The patient was hospitalized.This report suggests that a Amisulpride treatment could be associated with the listed above side effect(s).

Overdose, Cardiovascular Disorder, Respiratory Depression
This Amisulpride report was submitted by a 49-year-old male consumer from GB (weight: NA). The patient was diagnosed with: NA and Amisulpride was administered (dosage: (3150mg, Total)) starting: Aug 02, 2011. The consumer developed a set of symptoms:
  • Overdose
  • Cardiovascular Disorder
  • Respiratory Depression
Other drugs used simultaneously:
  • Citalopram (citalopram) ((280mg, Total))
  • Metformin (metformin) ((10500 Mg, Total))
  • Omeprazole (omeprazole) ((140mg, Total))
  • Acamprosate ((13860mg, Total))
  • Aspirin (acetylsalicylic Acid) ((525mg, Total))
  • Atorvastatin (atorvastatin) ((210mg, Total))
  • Zaponex
The patient was hospitalized.Those unexpected symptoms could be linked to a Amisulpride treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Cardiovascular Disorder, Overdose, Hypoventilation
This is a report of a possible correlation between Amisulpride use and the following symptoms/side effect(s):
  • Cardiovascular Disorder
  • Overdose
  • Hypoventilation
which could contribute to an assessment of Amisulpride risk profile.A 49-year-old male consumer from GB (weight: NA) was suffering from NA and was treated with Amisulpride (dosage: 3150 Mg, Unk) starting Aug 02, 2011.Other concurrent medications:
  • Aspirin (525 Mg, Unk)
  • Atorvastatin (210 Mg, Unk)
  • Citalopram (280 Mg, Unk)
  • Metformin (10500 Mg, Unk)
  • Omeprazole (140 Mg, Unk)
  • Acamprosate (13860 Mg, Unk)
  • Zaponex (Unk)
  • Zaponex (4.9 G, Unk)
The patient was hospitalized.


A 54-year-old male patient from GB (weight: NA) presented with the following symptoms: NA and after a treatment with Amisulpride (dosage: NA) experienced the following side effect(s):
    The treatment was started on Jun 23, 2012. Amisulpride was used in combination with the following drugs:
    • Amitriptyline (5 Df, Once/single)
    • Diazepam (4 Df, Bid)
    • Zopiclone (2 Df, At Night)
    • Procyclidine (0.5 Df)
    • Tramadol/paracetamol (2 Df, Qid)
    • Seretide (1 Df, Bid)
    • Ventolin (200 Ug)
    • Depakote (250 Mg, Bid)
    This report could alert potential Amisulpride consumers.

    Emotional Distress, Incorrect Dose Administered
    In this report, a 47-year-old female patient from GB (weight: NA) was affected by a possible Amisulpride side effect.The patient was diagnosed with NA. After a treatment with Amisulpride (dosage: NA, start date: Mar 09, 2005), the patient experienced the following side effect(s):
    • Emotional Distress
    • Incorrect Dose Administered
    The following simultaneously used drugs could have led to this reaction:
    • Clomipramine Hydrochloride
    • Clonazepam
    • Clozaril (clozapine)
    • Clozaril (clozapine)
    • Scopolamine Hydrobromide
    The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Amisulpride treatment.

    Iatrogenic Injury, Oedema Peripheral, Glucose Tolerance Impaired, Right Atrial Dilatation, Sinus Tachycardia, Speech Disorder, Choking, Hypoacusis
    This is a report of a 52-year-old female patient from GB (weight: NA), who used Amisulpride (dosage: 600 Mg) for a treatment of schizophrenia, paranoid type,oedema peripheral. After starting a treatment on 201103, the patient experienced the following side effect(s):
    • Iatrogenic Injury
    • Oedema Peripheral
    • Glucose Tolerance Impaired
    • Right Atrial Dilatation
    • Sinus Tachycardia
    • Speech Disorder
    • Choking
    • Hypoacusis
    The following drugs could possibly have interacted with the Amisulpride treatment
    • Furosemide
    • Zaponex (175 Mg, Qd)
    • Bisoprolol (1.25 Mg, Qd)
    • Bisoprolol (5 Mg)
    • Terbinafine
    • Chlorhexidine
    • Clexane
    Taken together, these observations suggest that a Amisulpride treatment could be related to side effect(s), such as Iatrogenic Injury, Oedema Peripheral, Glucose Tolerance Impaired, Right Atrial Dilatation, Sinus Tachycardia, Speech Disorder, Choking, Hypoacusis.

    Fall
    This fall side effect was reported by a consumer or non-health professional from GB. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizophrenia,depression. The patient was prescribed Amisulpride (dosage: NA), which was started on Nov 28, 2011. Concurrently used drugs:
    • Citalopram
    When starting to take Amisulpride the consumer reported the following symptoms:
    • Fall
    These side effects may potentially be related to Amisulpride.

    Gastritis, Tardive Dyskinesia, Depression, Condition Aggravated
    This is a Amisulpride side effect report of a 56-year-old female patient (weight:NA) from IN, suffering from the following symptoms/conditions: anxiety,depression, who was treated with Amisulpride (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a gastritis side effect. The patient presented with:
    • Gastritis
    • Tardive Dyskinesia
    • Depression
    • Condition Aggravated
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Amisulpride treatment in female patients suffering from anxiety,depression, resulting in gastritis.

    Neutropenia, Leukopenia, Schizophrenia, Treatment Noncompliance, Neutrophil Count Decreased
    This report suggests a potential Amisulpride neutropenia side effect(s) that can have serious consequences. A 48-year-old female patient from GB (weight:NA) was diagnosed with the following health condition(s): NA and used Amisulpride (dosage: NA) starting Mar 09, 2007. Soon after starting Amisulpride the patient began experiencing various side effects, including:
    • Neutropenia
    • Leukopenia
    • Schizophrenia
    • Treatment Noncompliance
    • Neutrophil Count Decreased
    Drugs used concurrently:NA. The patient was hospitalized. Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as neutropenia, may still occur.

    Neutropenia, Schizophrenia, Treatment Noncompliance, Leukopenia, Neutrophil Count Decreased
    This neutropenia problem was reported by a health professional from GB. A 48-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Mar 09, 2007 a consumer started treatment with Amisulpride (dosage: NA). The following drugs/medications were being taken at the same time:
    • Valproic Acid
    • Zaponex
    When commencing Amisulpride, the patient experienced the following unwanted symptoms /side effects:
    • Neutropenia
    • Schizophrenia
    • Treatment Noncompliance
    • Leukopenia
    • Neutrophil Count Decreased
    The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as neutropenia, may become evident only after a product is in use by the general population.

    Hepatitis Fulminant, Hypertransaminasaemia, Oropharyngeal Pain
    This is a Amisulpride side effect report of a 23-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: schizoaffective disorder and was treated with Amisulpride (dosage: NA) starting NS. Concurrently used drugs:
    • Orphenadrine
    • Lithium Carbonate
    • Fluphenazine Decanoate
    Soon after that, the consumer experienced the following of symptoms:
    • Hepatitis Fulminant
    • Hypertransaminasaemia
    • Oropharyngeal Pain
    This opens a possibility that Amisulpride could cause hepatitis fulminant and that some male patients may be more susceptible.

    Pulmonary Embolism, Akathisia
    A 42-year-old female patient (weight: NA) from IE with the following symptoms: schizoaffective disorder started Amisulpride treatment (dosage: NA) on NS. Soon after starting Amisulpride treatment, the consumer experienced several side effects, including:
    • Pulmonary Embolism
    • Akathisia
    . Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Amisulpride side effects, such as pulmonary embolism.

    Emotional Distress, Incorrect Dose Administered
    This emotional distress side effect was reported by a health professional from GB. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amisulpride (dosage: NA), which was started on Mar 09, 2005. Concurrently used drugs:
    • Clomipramine Hydrochloride
    • Clonazepam
    • Clozaril
    • Clozaril
    • Scopolamine Hydrobromide
    .When starting to take Amisulpride the consumer reported symptoms, such as:
    • Emotional Distress
    • Incorrect Dose Administered
    These side effects may potentially be related to Amisulpride. The patient was hospitalized.

    Atrioventricular Block First Degree, Blood Prolactin Increased
    This is a report of a 36-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: mental disorder, who was treated with Amisulpride (dosage: 800 Mg, Qd, start time: NS), combined with:
    • Fluoxetine (40 Mg, Qd)
    • Olanzapine (20 Mg, Qd)
    and developed a serious reaction and side effect(s). The consumer presented with:
    • Atrioventricular Block First Degree
    • Blood Prolactin Increased
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in male patients, resulting in atrioventricular block first degree side effect.

    Atrioventricular Block First Degree, Blood Prolactin Increased
    This report suggests a potential Amisulpride Atrioventricular Block First Degree, Blood Prolactin Increased side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: mental disorder and used Amisulpride (dosage: NA) starting NS. Soon after starting Amisulpride the patient began experiencing various side effects, including:
    • Atrioventricular Block First Degree
    • Blood Prolactin Increased
    Drugs used concurrently:
    • Olanzapine
    • Fluoxetine
    Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as atrioventricular block first degree, may still occur.

    Atrioventricular Block First Degree, Blood Prolactin Increased, Blood Pressure Diastolic Increased
    This Atrioventricular Block First Degree, Blood Prolactin Increased, Blood Pressure Diastolic Increased problem was reported by a physician from COUNTRY NOT SPECIFIED. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: mental disorder. On NS this consumer started treatment with Amisulpride (dosage: NA). The following drugs were being taken at the same time:
    • Fluoxetine
    • Olanzapine
    When commencing Amisulpride, the patient experienced the following unwanted symptoms/side effects:
    • Atrioventricular Block First Degree
    • Blood Prolactin Increased
    • Blood Pressure Diastolic Increased
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as atrioventricular block first degree, may become evident only after a product is in use by the general population.

    Electrocardiogram Qt Prolonged, Cardiac Ventricular Disorder
    This is a report of a 36-year-old female patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: psychotic disorder and was treated with Amisulpride (dosage: 1600 Mg, 1x/day) starting May 02, 2012. Concurrently used drugs:
    • Orphenadrine Citrate (100 Mg, 1x/day)
    • Fluoxetine (20 Mg Unit Dose)
    • Varenicline Tartrate
    • Omeprazole (20 Mg Unit Dose)
    • Ferrous Gluconate (600 Mg, 1x/day)
    Soon after that, the consumer experienced the following side effects:
    • Electrocardiogram Qt Prolonged
    • Cardiac Ventricular Disorder
    This opens a possibility that Amisulpride treatment could cause the above reactions, including electrocardiogram qt prolonged, and some female subjects may be more susceptible.

    Blood Count Abnormal, Schizophrenia, Paranoid Type, Tuberculosis, Eosinophil Count Increased, Malaise
    A male patient (weight: NA) from UNITED KINGDOM with the following symptoms/conditions: NA started Amisulpride treatment (dosage: 300 Mg, Daily) on Jul 08, 2011. Soon after starting Amisulpride treatment, the subject experienced various side effects, including:
    • Blood Count Abnormal
    • Schizophrenia, Paranoid Type
    • Tuberculosis
    • Eosinophil Count Increased
    • Malaise
    Concurrently used drugs:
    • Clozaril (225 Mg)
    • Valproate Sodium (1.6 G, Qd)
    • Clozaril (250 Mg, Qd)
    The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Amisulpride.

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    Why Your Notes are Important

    Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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    More About Amisulpride

    Side Effects reported to FDA: 150

    Amisulpride safety alerts: No

    Reported deaths: 14

    Reported hospitalizations: 58

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