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Haloperidol Decanoate Side Effects

Common Haloperidol Decanoate Side Effects


The most commonly reported Haloperidol Decanoate side effects are:
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If you have experienced a side effect listed above, you can check a box to report it.


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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.

Haloperidol Decanoate Side Effects Reported to FDA

The following Haloperidol Decanoate 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 Haloperidol Decanoate 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.
Electrocardiogram Qt Prolonged, Atrioventricular Block
This is a report of a 66-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: agitation,delirium, who was treated with Haloperidol Decanoate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Electrocardiogram Qt Prolonged
  • Atrioventricular Block
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haloperidol Decanoate treatment in female patients, resulting in electrocardiogram qt prolonged side effect.

Sinus Arrest, Bradycardia
This report suggests a potential Haloperidol Decanoate Sinus Arrest, Bradycardia side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: aggression,agitation and used Haloperidol Decanoate (dosage: NA) starting NS. Soon after starting Haloperidol Decanoate the patient began experiencing various side effects, including:
  • Sinus Arrest
  • Bradycardia
Drugs used concurrently: NA. Although Haloperidol Decanoate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as sinus arrest, may still occur.


This problem was reported by a health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Haloperidol Decanoate (dosage: NA). The following drugs were being taken at the same time:
  • Phenelzine Sulfate
  • Salbutamol
When commencing Haloperidol Decanoate, 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.


    This is a report of a 37-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Haloperidol Decanoate (dosage: NA) starting NS. Concurrently used drugs:
    • Valproic Acid
    • Lorazepam
    • Clozapine
    Soon after that, the consumer experienced the following side effects:
      This opens a possibility that Haloperidol Decanoate treatment could cause the above reactions, including death, and some male subjects may be more susceptible.


      Atrial Flutter, Hypoxia
      A 60-year-old male patient (weight: NA) from US with the following symptoms/conditions: aggression started Haloperidol Decanoate treatment (dosage: NA) on NS. Soon after starting Haloperidol Decanoate treatment, the subject experienced various side effects, including:
      • Atrial Flutter
      • Hypoxia
      Concurrently used drugs:
      • Lorazepam
      • Kava-kava Rhizoma
      The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Haloperidol Decanoate.

      Neuroleptic Malignant Syndrome, Pyrexia, Muscle Rigidity, Tremor, Salivary Hypersecretion, Blood Creatine Phosphokinase Increased, Blood Lactate Dehydrogenase Increased, Leukocytosis, Catatonia
      A 15-year-old female patient from PT (weight: NA) experienced symptoms, such as: psychotic disorder and was treated with Haloperidol Decanoate(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
      • Neuroleptic Malignant Syndrome
      • Pyrexia
      • Muscle Rigidity
      • Tremor
      • Salivary Hypersecretion
      • Blood Creatine Phosphokinase Increased
      • Blood Lactate Dehydrogenase Increased
      • Leukocytosis
      • Catatonia
      Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Haloperidol Decanoate efficacy:
      • Paliperidone
      • Risperidone
      • Olanzapine
      The patient was hospitalized.

      Aplasia
      In this report, Haloperidol Decanoate was administered for the following condition: NA.A 56-year-old male consumer from PT (weight: NA) started Haloperidol Decanoate treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
      • Aplasia
      A possible interaction with other drugs could have contributed to this reaction:
      • Risperdal (Dose 2 Drops)
      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 Haloperidol Decanoate treatment could be related to the listed above side effect(s).

      Parkinsonism, Tardive Dyskinesia, Erectile Dysfunction
      This is a report of the following Haloperidol Decanoate side effect(s):
      • Parkinsonism
      • Tardive Dyskinesia
      • Erectile Dysfunction
      A 54-year-old male patient from US (weight: NA) presented with the following condition: schizophrenia and received a treatment with Haloperidol Decanoate (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
      • Risperidone
      • Divalproex
      This report suggests that a Haloperidol Decanoate treatment could be associated with the listed above side effect(s).

      Neuroleptic Malignant Syndrome, Muscle Rigidity, Pyrexia, Autonomic Nervous System Imbalance, Blood Creatine Phosphokinase Increased, Leukocytosis, Sedation, Catatonia, Stupor
      This Haloperidol Decanoate report was submitted by a 22-year-old female consumer from CL (weight: NA). The patient was diagnosed with: psychotic disorder and Haloperidol Decanoate was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
      • Neuroleptic Malignant Syndrome
      • Muscle Rigidity
      • Pyrexia
      • Autonomic Nervous System Imbalance
      • Blood Creatine Phosphokinase Increased
      • Leukocytosis
      • Sedation
      • Catatonia
      • Stupor
      Other drugs used simultaneously:
      • Risperidone
      • Lorazepam
      • Zolpidem Tartrate
      • Chlorpromazine
      The patient was hospitalized.Those unexpected symptoms could be linked to a Haloperidol Decanoate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

      Pulmonary Embolism
      This is a report of a possible correlation between Haloperidol Decanoate use and the following symptoms/side effect(s):
      • Pulmonary Embolism
      which could contribute to an assessment of Haloperidol Decanoate risk profile.A 25-year-old male consumer from COUNTRY NOT SPECIFIED (weight: NA) was suffering from psychotic disorder and was treated with Haloperidol Decanoate (dosage: NA) starting NS.Other concurrent medications:
      • Ceftriaxone
      • Diazepam
      • Carbamazepine
      • Carbamazepine
      • Carbamazepine


      Pulmonary Embolism
      A 59-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) presented with the following symptoms: psychotic disorder and after a treatment with Haloperidol Decanoate (dosage: NA) experienced the following side effect(s):
      • Pulmonary Embolism
      The treatment was started on NS. Haloperidol Decanoate was used in combination with the following drugs:
      • Diazepam
      • Ceftriaxone
      • Moduretic
      This report could alert potential Haloperidol Decanoate consumers.

      Pulmonary Embolism
      In this report, a 43-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) was affected by a possible Haloperidol Decanoate side effect.The patient was diagnosed with psychotic disorder. After a treatment with Haloperidol Decanoate (dosage: NA, start date: NS), the patient experienced the following side effect(s):
      • Pulmonary Embolism
      The following simultaneously used drugs could have led to this reaction:
      • Diazepam
      The findings here stress that side effects should be taken into consideration when evaluating a Haloperidol Decanoate treatment.

      Hyperpyrexia
      This is a report of a 22-year-old male patient from US (weight: NA), who used Haloperidol Decanoate (dosage: Q Monthly/8/16/10 2/5) for a treatment of schizophrenia, paranoid type. After starting a treatment on NS, the patient experienced the following side effect(s):
      • Hyperpyrexia
      The following drugs could possibly have interacted with the Haloperidol Decanoate treatment
      • Olanzapine
      • Lithium Carbonate
      Taken together, these observations suggest that a Haloperidol Decanoate treatment could be related to side effect(s), such as Hyperpyrexia.

      Hypothermia, Weight Decreased, Chills, Fatigue
      This hypothermia side effect was reported by a health professional from IT. A 24-year-old male patient (weight:NA) experienced the following symptoms/conditions: thinking abnormal. The patient was prescribed Haloperidol Decanoate (dosage: NA), which was started on NS. Concurrently used drugs:
      • Valproate Sodium
      When starting to take Haloperidol Decanoate the consumer reported the following symptoms:
      • Hypothermia
      • Weight Decreased
      • Chills
      • Fatigue
      These side effects may potentially be related to Haloperidol Decanoate.

      Toxicity To Various Agents, Gastrointestinal Necrosis
      This is a Haloperidol Decanoate side effect report of a 53-year-old female patient (weight:NA) from CZ, suffering from the following symptoms/conditions: NA, who was treated with Haloperidol Decanoate (dosage:NA, start time: NS), combined with:
      • Zotepine
      • Chlorprothixene
      , and developed a serious reaction and a toxicity to various agents side effect. The patient presented with:
      • Toxicity To Various Agents
      • Gastrointestinal Necrosis
      which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Haloperidol Decanoate treatment in female patients suffering from NA, resulting in toxicity to various agents.

      Schizophrenia
      This report suggests a potential Haloperidol Decanoate schizophrenia side effect(s) that can have serious consequences. A 52-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): schizoaffective disorder and used Haloperidol Decanoate (dosage: 250 Mg Every 21 Days) starting NS. Soon after starting Haloperidol Decanoate the patient began experiencing various side effects, including:
      • Schizophrenia
      Drugs used concurrently:NA. The patient was hospitalized. Although Haloperidol Decanoate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as schizophrenia, may still occur.

      Neuroleptic Malignant Syndrome, Lobar Pneumonia, Mental Status Changes, Stupor, Tachycardia, Confusional State, Liver Function Test Abnormal, Influenza A Virus Test Positive
      This neuroleptic malignant syndrome problem was reported by a health professional from US. A 60-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): schizophrenia.On NS a consumer started treatment with Haloperidol Decanoate (dosage: NA). The following drugs/medications were being taken at the same time:
      • Olanzapine
      • Divalproex (valproate Semisodium)
      • Ampicillin
      • Lorazepam
      • Oseltamivir
      When commencing Haloperidol Decanoate, the patient experienced the following unwanted symptoms /side effects:
      • Neuroleptic Malignant Syndrome
      • Lobar Pneumonia
      • Mental Status Changes
      • Stupor
      • Tachycardia
      • Confusional State
      • Liver Function Test Abnormal
      • Influenza A Virus Test Positive
      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 neuroleptic malignant syndrome, may become evident only after a product is in use by the general population.

      H1n1 Influenza, Neuroleptic Malignant Syndrome, Confusional State, Mental Status Changes, Tachycardia, Stupor, Pyrexia, White Blood Cell Count Increased, Blood Creatine Phosphokinase Increased
      This is a Haloperidol Decanoate side effect report of a 60-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Haloperidol Decanoate (dosage: 200 Mg, Every 4 Weeks) starting NS. Concurrently used drugs:
      • Olanzapine (20 Mg, Per Day)
      Soon after that, the consumer experienced the following of symptoms:
      • H1n1 Influenza
      • Neuroleptic Malignant Syndrome
      • Confusional State
      • Mental Status Changes
      • Tachycardia
      • Stupor
      • Pyrexia
      • White Blood Cell Count Increased
      • Blood Creatine Phosphokinase Increased
      The patient was hospitalized. This opens a possibility that Haloperidol Decanoate could cause h1n1 influenza and that some male patients may be more susceptible.

      Long Qt Syndrome, Torsade De Pointes, Ventricular Fibrillation, Altered State Of Consciousness, Water Intoxication
      A 46-year-old female patient (weight: NA) from US with the following symptoms: schizophrenia started Haloperidol Decanoate treatment (dosage: NA) on NS. Soon after starting Haloperidol Decanoate treatment, the consumer experienced several side effects, including:
      • Long Qt Syndrome
      • Torsade De Pointes
      • Ventricular Fibrillation
      • Altered State Of Consciousness
      • Water Intoxication
      . Concurrently used drugs:
      • Benidipine
      • Tizanidine
      • Fludiazepam
      • Aspirin
      • Sennoside A
      • Chlorpromazine
      • Promethazine
      • Biperiden
      The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Haloperidol Decanoate side effects, such as long qt syndrome.

      Ventricular Fibrillation, Cardiac Arrest, Ventricular Tachycardia, Ventricular Extrasystoles
      This ventricular fibrillation side effect was reported by a consumer or non-health professional from US. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: agitation.The patient was prescribed Haloperidol Decanoate (dosage: NA), which was started on NS. Concurrently used drugs:
      • Dexmedetomidine
      • Dexmedetomidine
      • Milrinone
      • Fentanyl
      .When starting to take Haloperidol Decanoate the consumer reported symptoms, such as:
      • Ventricular Fibrillation
      • Cardiac Arrest
      • Ventricular Tachycardia
      • Ventricular Extrasystoles
      These side effects may potentially be related to Haloperidol Decanoate.

      Teratoma, Mental Status Changes, Psychotic Disorder, Unresponsive To Stimuli, Respiratory Failure, Neuroleptic Malignant Syndrome
      This is a report of a 20-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Haloperidol Decanoate (dosage: NA, start time: NS), combined with:
      • Aciclovir
      and developed a serious reaction and side effect(s). The consumer presented with:
      • Teratoma
      • Mental Status Changes
      • Psychotic Disorder
      • Unresponsive To Stimuli
      • Respiratory Failure
      • Neuroleptic Malignant Syndrome
      which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haloperidol Decanoate treatment in female patients, resulting in teratoma side effect.

      Foetal Exposure During Pregnancy, Small For Dates Baby, Convulsion Neonatal, Developmental Delay, Nervous System Disorder, Tremor, Hyperprolactinaemia, Hepatic Function Abnormal
      This report suggests a potential Haloperidol Decanoate Foetal Exposure During Pregnancy, Small For Dates Baby, Convulsion Neonatal, Developmental Delay, Nervous System Disorder, Tremor, Hyperprolactinaemia, Hepatic Function Abnormal side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Haloperidol Decanoate (dosage: NA) starting NS. Soon after starting Haloperidol Decanoate the patient began experiencing various side effects, including:
      • Foetal Exposure During Pregnancy
      • Small For Dates Baby
      • Convulsion Neonatal
      • Developmental Delay
      • Nervous System Disorder
      • Tremor
      • Hyperprolactinaemia
      • Hepatic Function Abnormal
      Drugs used concurrently:
      • Risperidone
      • Olanzapine
      • Quetiapine
      • Chlorpromazine Hydrochloride
      • Triazolam
      • Bromazepam
      • Flunitrazepam
      • Valproate Sodium
      The patient was hospitalized. Although Haloperidol Decanoate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as foetal exposure during pregnancy, may still occur.

      Pallor, Malaise, Abnormal Behaviour, Blunted Affect, Decreased Appetite, Drooling, Neuroleptic Malignant Syndrome, Rhabdomyolysis
      This Pallor, Malaise, Abnormal Behaviour, Blunted Affect, Decreased Appetite, Drooling, Neuroleptic Malignant Syndrome, Rhabdomyolysis problem was reported by a pharmacist from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia, paranoid type,dementia. On Apr 18, 2013 this consumer started treatment with Haloperidol Decanoate (dosage: Q28 Days). The following drugs were being taken at the same time:
      • Donepezil
      When commencing Haloperidol Decanoate, the patient experienced the following unwanted symptoms/side effects:
      • Pallor
      • Malaise
      • Abnormal Behaviour
      • Blunted Affect
      • Decreased Appetite
      • Drooling
      • Neuroleptic Malignant Syndrome
      • Rhabdomyolysis
      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 pallor, may become evident only after a product is in use by the general population.

      Parkinsonian Gait
      This is a report of a 81-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: psychotic disorder and was treated with Haloperidol Decanoate (dosage: NA) starting Aug 27, 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
      • Parkinsonian Gait
      This opens a possibility that Haloperidol Decanoate treatment could cause the above reactions, including death, and some male subjects may be more susceptible.

      Akathisia
      A 24-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Haloperidol Decanoate treatment (dosage: NA) on NS. Soon after starting Haloperidol Decanoate treatment, the subject experienced various side effects, including:
      • Akathisia
      Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Haloperidol Decanoate.

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      Medicine Name and Dosage:
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      Haloperidol Decanoate Safety Alerts, Active Ingredients, Usage Information

      NDC0703-7011
      TypeHUMAN PRESCRIPTION DRUG
      Proprietary NameHaloperidol Decanoate
      NameHaloperidol Decanoate
      Dosage FormINJECTION
      RouteINTRAMUSCULAR
      On market since19990604
      LabelerTeva Parenteral Medicines, Inc.
      Active Ingredient(s)HALOPERIDOL DECANOATE
      Strength(s)50
      Unit(s)mg/mL
      Pharma ClassTypical Antipsychotic [EPC]

      More About Haloperidol decanoate

      Side Effects reported to FDA: 305

      Haloperidol Decanoate safety alerts: No

      Reported deaths: 22

      Reported hospitalizations: 93

      Latest Haloperidol Decanoate clinical trials

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