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Amisulpride Side Effects

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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.

Amisulpride Side Effects Reported to FDA



Amisulpride Side Effect Report#9887887
Diabetes Insipidus, Hypernatraemia
This is a report of a 59-year-old male patient (weight: NA) from GB, suffering from the following health 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): Diabetes Insipidus, Hypernatraemia 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.
Amisulpride Side Effect Report#9870852
Electrocardiogram Qt Prolonged, Electrocardiogram Qt Shortened
This report suggests a potential Amisulpride Electrocardiogram Qt Prolonged 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. After starting Amisulpride the patient began experiencing various side effects, including: Electrocardiogram Qt Prolonged, Electrocardiogram Qt ShortenedAdditional 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.
Amisulpride Side Effect Report#9858240
Neuroleptic Malignant Syndrome, Fall
This Neuroleptic Malignant Syndrome 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 using Amisulpride (amisulpride), the patient experienced the following unwanted symptoms/side effects: Neuroleptic Malignant Syndrome, FallThe 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.
Amisulpride Side Effect Report#9678119
Convulsion, Feeling Abnormal, Hypomania, Oromandibular Dystonia, Insomnia, Suspected Counterfeit Product, Weight Decreased
This Convulsion side effect was reported by a consumer or non-health professional from GB. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amisulpride (drug dosage: NA), which was initiated on 1997. Concurrently used drugs:
  • Paroxetine
  • Sertraline
  • Zopiclone
  • Chlorpromazine
  • Lithium
  • Quetiapine Fumarate
  • Venlafaxine
.After starting to take Amisulpride the consumer reported adverse symptoms, such as: Convulsion, Feeling Abnormal, Hypomania, Oromandibular Dystonia, Insomnia, Suspected Counterfeit Product, Weight DecreasedThese side effects may potentially be related to Amisulpride.
Amisulpride Side Effect Report#9676987
Feeling Abnormal, Hypomania, Oromandibular Dystonia, Convulsion, Insomnia, Weight Decreased, Suspected Counterfeit Product
This is a report of a 36-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Amisulpride (dosage: Unk, start time: 2012), combined with:
  • Paroxetine
  • Sertraline (Unk)
  • Venlafaxine (Unk)
  • Zopiclone (Unk)
  • Chlorpromazine (Unk)
  • Lithium (Unk)
  • Seroquel Xl (700 Mg, Qd)
  • Seroquel Xl (600 Mg, Qd)
and developed a serious reaction and side effect(s): Feeling Abnormal, Hypomania, Oromandibular Dystonia, Convulsion, Insomnia, Weight Decreased, Suspected Counterfeit Product after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in male patients, resulting in Feeling Abnormal side effect.
Amisulpride Side Effect Report#9670899
Hormone Level Abnormal, Blood Oestrogen Increased, Blood Prolactin Increased, Dystonia, Insomnia
This report suggests a potential Amisulpride (amisulpride) Hormone Level Abnormal 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: NA and used Amisulpride (amisulpride) (dosage: NA) starting 1997. After starting Amisulpride (amisulpride) the patient began experiencing various side effects, including: Hormone Level Abnormal, Blood Oestrogen Increased, Blood Prolactin Increased, Dystonia, InsomniaAdditional drugs used concurrently:
  • Paroxetine (paroxetine)
  • Sertraline (sertraline)
  • Chlorpromazine
  • Lithium (lithium)
  • Seroquel Xl (600 Mg (600 Mg, 1 In 1 D), Oral)
  • Venlafaxine (venlafaxine)
  • Zopiclone (zopiclone)
  • Sondate Xl
Although Amisulpride (amisulpride) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hormone Level Abnormal, may still occur.
Amisulpride Side Effect Report#9586185
Blood Creatine Phosphokinase Increased, Neuroleptic Malignant Syndrome, Fall
This Blood Creatine Phosphokinase Increased problem was reported by a health professional 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 (dosage: NA). The following drugs were being taken at the same time:
  • Paroxetine
  • Olanzapine
  • Metformin (metformin)
  • Pioglitazone (pioglitazone)
  • Simvastatin (simvastatin)
  • Zopiclone (zopiclone)
When using Amisulpride, the patient experienced the following unwanted symptoms/side effects: Blood Creatine Phosphokinase Increased, Neuroleptic Malignant Syndrome, FallThe 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 Blood Creatine Phosphokinase Increased, may become evident only after a product is in use by the general population.
Amisulpride Side Effect Report#9558552
Fall, Neuroleptic Malignant Syndrome, Blood Creatine Phosphokinase Increased
This Fall side effect was reported by a health professional from GB. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizophrenia.The patient was prescribed Amisulpride (drug dosage: 1200 Mg (400mg In The Morning And 800mg At Night)), which was initiated on NS. Concurrently used drugs:
  • Olanzapine (7.5 Mg Qd)
  • Paroxetine (50 Mg Qd)
  • Metformin
  • Pioglitazone
  • Simvastatin
  • Zopiclone
.After starting to take Amisulpride the consumer reported adverse symptoms, such as: Fall, Neuroleptic Malignant Syndrome, Blood Creatine Phosphokinase IncreasedThese side effects may potentially be related to Amisulpride. The patient was hospitalized.
Amisulpride Side Effect Report#9486915
Overdose, Cardiovascular Disorder, Respiratory Depression
This is a report of a 49-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Amisulpride (dosage: (3150mg, Total), start time:
Aug 02, 2011), combined with:
  • 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
and developed a serious reaction and side effect(s): Overdose, Cardiovascular Disorder, Respiratory Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in male patients, resulting in Overdose side effect. The patient was hospitalized.
Amisulpride Side Effect Report#9476407
Cardiovascular Disorder, Overdose, Hypoventilation
This report suggests a potential Amisulpride Cardiovascular Disorder side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Amisulpride (dosage: 3150 Mg, Unk) starting
Aug 02, 2011. After starting Amisulpride the patient began experiencing various side effects, including: Cardiovascular Disorder, Overdose, HypoventilationAdditional drugs used concurrently:
  • 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. Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiovascular Disorder, may still occur.
Amisulpride Side Effect Report#9338949
This Death problem was reported by a health professional from GB. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 23, 2012 this consumer started treatment with Amisulpride (dosage: NA). The following drugs were being taken at the same time:
  • 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)
When using Amisulpride, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Amisulpride Side Effect Report#9317894
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 (drug dosage: NA), which was initiated on
Mar 09, 2005. Concurrently used drugs:
  • Clomipramine Hydrochloride
  • Clonazepam
  • Clozaril (clozapine)
  • Clozaril (clozapine)
  • Scopolamine Hydrobromide
.After starting to take Amisulpride the consumer reported adverse symptoms, such as: Emotional Distress, Incorrect Dose AdministeredThese side effects may potentially be related to Amisulpride. The patient was hospitalized.
Amisulpride Side Effect Report#9293838
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 (weight: NA) from GB, suffering from the following health symptoms/conditions: schizophrenia, paranoid type,oedema peripheral, who was treated with Amisulpride (dosage: 600 Mg, start time: 201103), combined with:
  • Furosemide
  • Zaponex (175 Mg, Qd)
  • Bisoprolol (1.25 Mg, Qd)
  • Bisoprolol (5 Mg)
  • Terbinafine
  • Chlorhexidine
  • Clexane
and developed a serious reaction and side effect(s): Iatrogenic Injury, Oedema Peripheral, Glucose Tolerance Impaired, Right Atrial Dilatation, Sinus Tachycardia, Speech Disorder, Choking, Hypoacusis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in female patients, resulting in Iatrogenic Injury side effect.
Amisulpride Side Effect Report#9293127
Fall
This report suggests a potential Amisulpride Fall side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: schizophrenia,depression and used Amisulpride (dosage: NA) starting
Nov 28, 2011. After starting Amisulpride the patient began experiencing various side effects, including: FallAdditional drugs used concurrently:
  • Citalopram
Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Amisulpride Side Effect Report#9173436
Gastritis, Tardive Dyskinesia, Depression, Condition Aggravated
This Gastritis problem was reported by a physician from IN. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety,depression. On NS this consumer started treatment with Amisulpride (dosage: NA). The following drugs were being taken at the same time: NA. When using Amisulpride, the patient experienced the following unwanted symptoms/side effects: Gastritis, Tardive Dyskinesia, Depression, Condition AggravatedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastritis, may become evident only after a product is in use by the general population.
Amisulpride Side Effect Report#9098492
Neutropenia, Leukopenia, Schizophrenia, Treatment Noncompliance, Neutrophil Count Decreased
This Neutropenia side effect was reported by a health professional from GB. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amisulpride (drug dosage: NA), which was initiated on
Mar 09, 2007. Concurrently used drugs: NA..After starting to take Amisulpride the consumer reported adverse symptoms, such as: Neutropenia, Leukopenia, Schizophrenia, Treatment Noncompliance, Neutrophil Count DecreasedThese side effects may potentially be related to Amisulpride. The patient was hospitalized.
Amisulpride Side Effect Report#9057367
Neutropenia, Schizophrenia, Treatment Noncompliance, Leukopenia, Neutrophil Count Decreased
This is a report of a 48-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Amisulpride (dosage: NA, start time:
Mar 09, 2007), combined with:
  • Valproic Acid
  • Zaponex
and developed a serious reaction and side effect(s): Neutropenia, Schizophrenia, Treatment Noncompliance, Leukopenia, Neutrophil Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in female patients, resulting in Neutropenia side effect. The patient was hospitalized.
Amisulpride Side Effect Report#8993259
Hepatitis Fulminant, Hypertransaminasaemia, Oropharyngeal Pain
This report suggests a potential Amisulpride Hepatitis Fulminant side effect(s) that can have serious consequences. A 23-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: schizoaffective disorder and used Amisulpride (dosage: NA) starting NS. After starting Amisulpride the patient began experiencing various side effects, including: Hepatitis Fulminant, Hypertransaminasaemia, Oropharyngeal PainAdditional drugs used concurrently:
  • Orphenadrine
  • Lithium Carbonate
  • Fluphenazine Decanoate
Although Amisulpride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatitis Fulminant, may still occur.
Amisulpride Side Effect Report#8959415
Pulmonary Embolism, Akathisia
This Pulmonary Embolism problem was reported by a physician from IE. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: schizoaffective disorder. On NS this consumer started treatment with Amisulpride (dosage: NA). The following drugs were being taken at the same time: NA. When using Amisulpride, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, AkathisiaThe 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 Pulmonary Embolism, may become evident only after a product is in use by the general population.
Amisulpride Side Effect Report#8927505
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 (drug dosage: NA), which was initiated on
Mar 09, 2005. Concurrently used drugs:
  • Clomipramine Hydrochloride
  • Clonazepam
  • Clozaril
  • Clozaril
  • Scopolamine Hydrobromide
.After starting to take Amisulpride the consumer reported adverse symptoms, such as: Emotional Distress, Incorrect Dose AdministeredThese side effects may potentially be related to Amisulpride. The patient was hospitalized.
Amisulpride Side Effect Report#8818017
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 health 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): Atrioventricular Block First Degree, Blood Prolactin Increased 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.
Amisulpride Side Effect Report#8816437
Atrioventricular Block First Degree, Blood Prolactin Increased
This report suggests a potential Amisulpride Atrioventricular Block First Degree 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. After starting Amisulpride the patient began experiencing various side effects, including: Atrioventricular Block First Degree, Blood Prolactin IncreasedAdditional 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.
Amisulpride Side Effect Report#8814286
Atrioventricular Block First Degree, Blood Prolactin Increased, Blood Pressure Diastolic Increased
This Atrioventricular Block First Degree 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 using Amisulpride, the patient experienced the following unwanted symptoms/side effects: Atrioventricular Block First Degree, Blood Prolactin Increased, Blood Pressure Diastolic IncreasedAlthough 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.
Amisulpride Side Effect Report#8435461-4
Electrocardiogram Qt Prolonged, Cardiac Ventricular Disorder
This Electrocardiogram Qt Prolonged side effect was reported by a physician from United Kingdom. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: psychotic disorder.The patient was prescribed Amisulpride (drug dosage: 1600 Mg, 1x/day), which was initiated on
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)
.After starting to take Amisulpride the consumer reported adverse symptoms, such as: Electrocardiogram Qt Prolonged, Cardiac Ventricular DisorderThese side effects may potentially be related to Amisulpride.
Amisulpride Side Effect Report#8418965-X
Blood Count Abnormal, Schizophrenia, Paranoid Type, Tuberculosis, Eosinophil Count Increased, Malaise
This is a report of a male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Amisulpride (dosage: 300 Mg, Daily, start time:
Jul 08, 2011), combined with:
  • Clozaril (225 Mg)
  • Valproate Sodium (1.6 G, Qd)
  • Clozaril (250 Mg, Qd)
and developed a serious reaction and side effect(s): Blood Count Abnormal, Schizophrenia, Paranoid Type, Tuberculosis, Eosinophil Count Increased, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amisulpride treatment in male patients, resulting in Blood Count Abnormal side effect. The patient was hospitalized.


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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.

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

    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.

    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.

    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.

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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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