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Haldol Side Effects

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Common Haldol Side Effects


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

Self Injurious Behaviour (194)
Somnolence (173)
Suicide Attempt (127)
Intentional Overdose (104)
Tremor (100)
Extrapyramidal Disorder (99)
Dyskinesia (81)
Agitation (71)
Overdose (70)
Coma (63)
Sopor (58)
Accidental Exposure (57)
Sluggishness (57)
Dyspnoea (55)
Dystonia (54)
Tachycardia (54)
Parkinsonism (53)
Fall (52)
Neuroleptic Malignant Syndrome (51)
Weight Increased (51)

➢ 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.

Haldol Side Effects Reported to FDA



Haldol Side Effect Report#9994822
Sopor
This is a report of a 41-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Haldol (dosage: NA, start time:
Feb 08, 2014), combined with: NA. and developed a serious reaction and side effect(s): Sopor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in male patients, resulting in Sopor side effect.
Haldol Side Effect Report#9992507
Self Injurious Behaviour, Confusional State, Intentional Overdose, Nausea
This report suggests a potential Haldol Self Injurious Behaviour side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Haldol (dosage: NA) starting
Mar 01, 2014. After starting Haldol the patient began experiencing various side effects, including: Self Injurious Behaviour, Confusional State, Intentional Overdose, NauseaAdditional drugs used concurrently:
  • Antra
  • Silodyx
  • Agomelatine
Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Self Injurious Behaviour, may still occur.
Haldol Side Effect Report#9989226
Urinary Retention, Renal Failure Acute
This Urinary Retention problem was reported by a health professional from FR. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: psychotic disorder,bone marrow failure. On 201208 this consumer started treatment with Haldol (dosage: NA). The following drugs were being taken at the same time:
  • Neoral
  • Danatrol
  • Lepticur
  • Largactil
When using Haldol, the patient experienced the following unwanted symptoms/side effects: Urinary Retention, Renal Failure AcuteThe 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 Urinary Retention, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9989225
Extrapyramidal Disorder, Pneumonia, Urinary Tract Infection, Hyperthermia
This Extrapyramidal Disorder side effect was reported by a health professional from FR. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Seropram
  • Reminyl
  • Coversyl
  • Corvasal
  • Seresta
  • Fluvoxamine Maleate
.After starting to take Haldol the consumer reported adverse symptoms, such as: Extrapyramidal Disorder, Pneumonia, Urinary Tract Infection, HyperthermiaThese side effects may potentially be related to Haldol. The patient was hospitalized.
Haldol Side Effect Report#9983540
Migraine, Renal Artery Stenosis, Hypotension, Bradycardia, Electrocardiogram Qt Prolonged, Malaise, Cortisol Free Urine Increased, Blood Cortisol Increased
This is a report of a 85-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: mental disorder,hypertension, who was treated with Haldol (dosage: NA, start time:
Dec 31, 2013), combined with:
  • Amlodipine
  • Perindopril
  • Tiapridal
  • Arixtra
  • Paracetamol
and developed a serious reaction and side effect(s): Migraine, Renal Artery Stenosis, Hypotension, Bradycardia, Electrocardiogram Qt Prolonged, Malaise, Cortisol Free Urine Increased, Blood Cortisol Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in female patients, resulting in Migraine side effect. The patient was hospitalized.
Haldol Side Effect Report#9981417
Eosinophilic Myocarditis, Cardiac Arrest, Hypoxic-ischaemic Encephalopathy, Brain Oedema, Eosinophilic Pneumonia, Alveolitis, Allergic Hepatitis, Bone Marrow Eosinophilic Leukocyte Count Increased
This report suggests a potential Haldol Eosinophilic Myocarditis side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: delirium,pneumonia,cardiovascular disorder and used Haldol (dosage: NA) starting
Nov 16, 2013. After starting Haldol the patient began experiencing various side effects, including: Eosinophilic Myocarditis, Cardiac Arrest, Hypoxic-ischaemic Encephalopathy, Brain Oedema, Eosinophilic Pneumonia, Alveolitis, Allergic Hepatitis, Bone Marrow Eosinophilic Leukocyte Count IncreasedAdditional drugs used concurrently:
  • Invanz
  • Lasix
  • Seroquel
  • Fragmin
  • Augmentin
  • Augmentin
  • Morphine
  • Novalgin
Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eosinophilic Myocarditis, may still occur.
Haldol Side Effect Report#9980923
Myalgia, Agitation, Hyperthermia, Muscle Spasms, Tachycardia, Clonus
This Myalgia problem was reported by a physician from IT. A 46-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: psychomotor hyperactivity,alcoholism,postoperative analgesia. On
Feb 18, 2014 this consumer started treatment with Haldol (dosage: NA). The following drugs were being taken at the same time:
  • Sereprile
  • Morphine Hydrochloride
When using Haldol, the patient experienced the following unwanted symptoms/side effects: Myalgia, Agitation, Hyperthermia, Muscle Spasms, Tachycardia, ClonusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myalgia, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9978893
Incorrect Dose Administered, Injection Site Pain, Injection Site Haemorrhage
This Incorrect Dose Administered side effect was reported by a consumer or non-health professional from Country Not Specified. A 20-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: NA), which was initiated on
Nov 20, 2013. Concurrently used drugs:
  • Benztropine
  • Humira
  • Humira
  • Prednisone
  • Zoloft
.After starting to take Haldol the consumer reported adverse symptoms, such as: Incorrect Dose Administered, Injection Site Pain, Injection Site HaemorrhageThese side effects may potentially be related to Haldol.
Haldol Side Effect Report#9973126
Bone Marrow Failure, Dyskinesia
This is a report of a 67-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: psychotic disorder, who was treated with Haldol (dosage: NA, start time: 201208), combined with:
  • Largactil
  • Lepticur
and developed a serious reaction and side effect(s): Bone Marrow Failure, Dyskinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in male patients, resulting in Bone Marrow Failure side effect. The patient was hospitalized.
Haldol Side Effect Report#9961274
Self Injurious Behaviour, Intentional Overdose
This report suggests a potential Haldol Self Injurious Behaviour side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Haldol (dosage: NA) starting
Feb 25, 2014. After starting Haldol the patient began experiencing various side effects, including: Self Injurious Behaviour, Intentional OverdoseAdditional drugs used concurrently: NA. Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Self Injurious Behaviour, may still occur.
Haldol Side Effect Report#9938142
Pneumonia Aspiration, Confusional State, Overdose, Enterococcal Bacteraemia, Hyperthermia
This Pneumonia Aspiration problem was reported by a health professional from FR. A 79-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: agitation. On
Dec 03, 2013 this consumer started treatment with Haldol (dosage: NA). The following drugs were being taken at the same time: NA. When using Haldol, the patient experienced the following unwanted symptoms/side effects: Pneumonia Aspiration, Confusional State, Overdose, Enterococcal Bacteraemia, HyperthermiaThe 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 Pneumonia Aspiration, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9933160
Malaise, Neuralgia, Muscular Weakness, Insomnia, Treatment Noncompliance
This Malaise side effect was reported by a consumer or non-health professional from BR. A 37-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: NA), which was initiated on
Jan 05, 2014. Concurrently used drugs: NA..After starting to take Haldol the consumer reported adverse symptoms, such as: Malaise, Neuralgia, Muscular Weakness, Insomnia, Treatment NoncomplianceThese side effects may potentially be related to Haldol. The patient was hospitalized.
Haldol Side Effect Report#9919231
Parkinsonism, Salivary Hypersecretion, Dysphagia, Mutism, Sluggishness, Decreased Appetite, Urinary Incontinence
This is a report of a 20-year-old male patient (weight: NA) from CH, suffering from the following health symptoms/conditions: schizophrenia, catatonic type, who was treated with Haldol (dosage: NA, start time: 201401), combined with: NA. and developed a serious reaction and side effect(s): Parkinsonism, Salivary Hypersecretion, Dysphagia, Mutism, Sluggishness, Decreased Appetite, Urinary Incontinence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in male patients, resulting in Parkinsonism side effect. The patient was hospitalized.
Haldol Side Effect Report#9912952
Decreased Appetite
This report suggests a potential Haldol Decreased Appetite side effect(s) that can have serious consequences. A 88-year-old female patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Haldol (dosage: NA) starting NS. After starting Haldol the patient began experiencing various side effects, including: Decreased AppetiteAdditional drugs used concurrently: NA. Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Decreased Appetite, may still occur.
Haldol Side Effect Report#9912946
Hypotension, Somnolence, Fall
This Hypotension problem was reported by a physician from CH. A 94-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: restlessness. On
Jan 17, 2014 this consumer started treatment with Haldol (dosage: 2 Drops-2 Drops-2 Drops). The following drugs were being taken at the same time: NA. When using Haldol, the patient experienced the following unwanted symptoms/side effects: Hypotension, Somnolence, FallAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypotension, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9908333
Hypoglycaemia, Fall
This Hypoglycaemia side effect was reported by a health professional from FR. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: 3 Drops Twice A Day), which was initiated on
Dec 09, 2013. Concurrently used drugs:
  • Metformin
  • Mianserin Hydrochloride
  • Mianserin Hydrochloride
  • Ebixa
  • Amlor
  • Tardyferon
  • Procoralan
.After starting to take Haldol the consumer reported adverse symptoms, such as: Hypoglycaemia, FallThese side effects may potentially be related to Haldol. The patient was hospitalized.
Haldol Side Effect Report#9899296
Hallucination, Aggression
This is a report of a 90-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: confusional state, who was treated with Haldol (dosage: NA, start time: 201301), combined with: NA. and developed a serious reaction and side effect(s): Hallucination, Aggression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in female patients, resulting in Hallucination side effect.
Haldol Side Effect Report#9893306
Type I Hypersensitivity, Rash Erythematous, Delirium, Renal Failure Chronic, Hyperkalaemia
This report suggests a potential Haldol Type I Hypersensitivity side effect(s) that can have serious consequences. A 85-year-old male patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: dementia,pain and used Haldol (dosage: NA) starting
Dec 09, 2013. After starting Haldol the patient began experiencing various side effects, including: Type I Hypersensitivity, Rash Erythematous, Delirium, Renal Failure Chronic, HyperkalaemiaAdditional drugs used concurrently:
  • Tilur
  • Pantoprazole
  • Metformine
  • Mst
  • Mst
  • Cymbalta
  • Cymbalta
  • Seroquel
The patient was hospitalized. Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Type I Hypersensitivity, may still occur.
Haldol Side Effect Report#9888168
Self Injurious Behaviour, Intentional Overdose, Sopor
This Self Injurious Behaviour problem was reported by a health professional from IT. A 52-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 04, 2014 this consumer started treatment with Haldol (dosage: NA). The following drugs were being taken at the same time: NA. When using Haldol, the patient experienced the following unwanted symptoms/side effects: Self Injurious Behaviour, Intentional Overdose, SoporAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Self Injurious Behaviour, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9885023
Self Injurious Behaviour, Sopor
This Self Injurious Behaviour side effect was reported by a health professional from IT. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: Dose:10 Mg/ml), which was initiated on
Feb 03, 2014. Concurrently used drugs:
  • Akineton
  • Tegretol
  • Largactil
.After starting to take Haldol the consumer reported adverse symptoms, such as: Self Injurious Behaviour, SoporThese side effects may potentially be related to Haldol.
Haldol Side Effect Report#9885021
Self Injurious Behaviour, Intentional Overdose, Sopor
This is a report of a 52-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Haldol (dosage: NA, start time:
Feb 03, 2014), combined with:
  • Venlafaxine Hydrochloride
  • Xanax
and developed a serious reaction and side effect(s): Self Injurious Behaviour, Intentional Overdose, Sopor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in male patients, resulting in Self Injurious Behaviour side effect.
Haldol Side Effect Report#9880540
Urinary Retention, Tachycardia, Altered State Of Consciousness, Onychomycosis, Speech Disorder, Dysarthria, Hyperhidrosis, Somnolence, Tachypnoea
This report suggests a potential Haldol Urinary Retention side effect(s) that can have serious consequences. A 22-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: bipolar disorder and used Haldol (dosage: NA) starting NS. After starting Haldol the patient began experiencing various side effects, including: Urinary Retention, Tachycardia, Altered State Of Consciousness, Onychomycosis, Speech Disorder, Dysarthria, Hyperhidrosis, Somnolence, TachypnoeaAdditional drugs used concurrently:
  • Largactil
  • Largactil (Apart From 3 Times A Day, Dose In Evening If The Patient Demands)
  • Noroxine
  • Teralithe (3.5 Tablets In The Evening)
  • Valium (10 Mg In The Evening And 20 Mg 3 Times A Day On Demand)
The patient was hospitalized. Although Haldol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Retention, may still occur.
Haldol Side Effect Report#9870189
Coma, Somnolence, Intentional Overdose
This Coma problem was reported by a health professional from FR. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Haldol Decanoas (dosage: NA). The following drugs were being taken at the same time:
  • Nozinan
  • Lexomil (1/4 Of Tablet)
  • Stilnox
  • Temesta
  • Zopiclone
When using Haldol Decanoas, the patient experienced the following unwanted symptoms/side effects: Coma, Somnolence, Intentional OverdoseThe 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 Coma, may become evident only after a product is in use by the general population.
Haldol Side Effect Report#9861999
Self Injurious Behaviour, Intentional Overdose
This Self Injurious Behaviour side effect was reported by a health professional from IT. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Haldol (drug dosage: NA), which was initiated on
Jan 26, 2014. Concurrently used drugs:
  • Serenase
.After starting to take Haldol the consumer reported adverse symptoms, such as: Self Injurious Behaviour, Intentional OverdoseThese side effects may potentially be related to Haldol.
Haldol Side Effect Report#9858109
Memory Impairment, Dyskinesia, Hallucination, Auditory, Weight Increased, Depression, Nausea, Nervousness, Malaise, Formication
This is a report of a 25-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: mental disorder, who was treated with Haldol (dosage: NA, start time:
Jan 19, 2014), combined with: NA. and developed a serious reaction and side effect(s): Memory Impairment, Dyskinesia, Hallucination, Auditory, Weight Increased, Depression, Nausea, Nervousness, Malaise, Formication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Haldol treatment in female patients, resulting in Memory Impairment side effect.


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The appearance of Haldol 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.

What are common Haldol Side Effects for Women?

Women Side EffectsReports
Self Injurious Behaviour 108
Somnolence 90
Suicide Attempt 70
Intentional Overdose 62
Tremor 51
Extrapyramidal Disorder 44
Overdose 39
Dyskinesia 37
Sopor 34
Accidental Exposure 31

What are common Haldol Side Effects for Men?

Men Side EffectsReports
Self Injurious Behaviour 86
Somnolence 79
Suicide Attempt 55
Extrapyramidal Disorder 53
Tremor 48
Dyskinesia 44
Agitation 43
Intentional Overdose 42
Dystonia 39
Coma 38

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

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

    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.

    Haldol 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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    Haldol Safety Alerts, Active Ingredients, Usage Information

    NDC50458-253
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameHaldol Decanoate
    NameHaloperidol Decanoate
    Dosage FormINJECTION
    RouteINTRAMUSCULAR
    On market since19860114
    LabelerJanssen Pharmaceuticals, Inc.
    Active Ingredient(s)HALOPERIDOL DECANOATE
    Strength(s)50
    Unit(s)mg/mL
    Pharma ClassTypical Antipsychotic [EPC]

    Haldol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1807

    Haldol safety alerts: 2007

    Reported deaths: 199

    Reported hospitalizations: 808

    Haloperidol (Haldol, Haldol decanoate, and Haldol lactate)

    Audience: Neuropsychiatric and cardiovascular specialists, other healthcare professionals

    [Posted 09/17/2007] Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.

    There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.

    [September 17, 2007 - Healthcare Professional Sheet - FDA]

    Latest Haldol clinical trials