"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
Haldol Decanoate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Haldol Decanoate (haloperidol decanoate) is an antipsychotic used to treat schizophrenia. It is available in generic form. Common side effects of Haldol Decanoate include dizziness, drowsiness, difficulty urinating, trouble sleeping, headache, anxiety, and pain at the injection site.
Dosage of Haldol Decanoate should not exceed 3 mL per injection. Talk to your doctor about your individual dosage recommendation. Other drugs such as amiodarone, erythromycin, belladonna alkaloids, warfarin, lithium, levodopa, rifampin, diphenhydramine, codeine, risperidone and trazodone may interact with Haldol Decanoate. Tell your doctor all medications you use. Do not stop taking Haldol Decanoate suddenly without consulting with your doctor. Caution should be exercised when taking Haldol Decanoate if you are elderly. If you are pregnant only take Haldol Decanoate if the benefit outweighs the potential risk to the fetus. Do not use Haldol Decanoate if you are breastfeeding.
Our Haldol Decanoate (haloperidol decanoate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Haldol Decanoate Overview - Patient Information: Side Effects
Tell your doctor promptly if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like facial expression, drooling. Your doctor may prescribe another medication for you to take with haloperidol to decrease these side effects.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
In rare cases, haloperidol may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
For males, in the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems may occur.
This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any facial/muscle twitching such as tongue thrusting, chewing movements, puffing or puckering of your mouth, or uncontrollable shaking.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin, seizures, signs of infection (such as fever, persistent sore throat).
Seek immediate medical attention if any of these rare but very serious side effects occur: slow heartbeat, severe dizziness, chest pain, fainting.
A very severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Haldol Decanoate (Haloperidol Decanoate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Haldol Decanoate FDA Prescribing Information: Side Effects
Adverse reactions following the administration of HALDOL Decanoate (haloperidol decanoate) 50 or HALDOL Decanoate (haloperidol decanoate) 100 are those of HALDOL (haloperidol). Since vast experience has accumulated with HALDOL, the adverse reactions are reported for that compound as well as for haloperidol decanoate. As with all injectable medications, local tissue reactions have been reported with haloperidol decanoate.
Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Cases of sudden and unexpected death have been reported in association with the administration of HALDOL. The nature of the evidence makes it impossible to determine definitively what role, if any, HALDOL played in the outcome of the reported cases. The possibility that HALDOL caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.
Extrapyramidal Symptoms (EPS)
EPS during the administration of HALDOL (haloperidol) have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl hydrochloride USP. It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases.
Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Withdrawal Emergent Neurological Signs
Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under "Tardive Dyskinesia" except for duration. Although the long- acting properties of haloperidol decanoate provide gradual withdrawal, it is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs.
As with all antipsychotic agents HALDOL has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy with haloperidol decanoate or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked.
It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the full syndrome may not develop.
Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible.
Other CNS Effects
Insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, headache, confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations, and catatonic-like behavioral states which may be responsive to drug withdrawal and/or treatment with anticholinergic drugs.
Body as a Whole
Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis. Agranulocytosis has rarely been reported to have occurred with the use of HALDOL, and then only in association with other medication.
Impaired liver function and/or jaundice have been reported.
Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.
Laryngospasm, bronchospasm and increased depth of respiration.
Cataracts, retinopathy and visual disturbances.
Hyperammonemia has been reported in a 5 1 /2 year old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with HALDOL.
Read the entire FDA prescribing information for Haldol Decanoate (Haloperidol Decanoate) »
Additional Haldol Decanoate Information
- Haldol Decanoate Drug Interactions Center: haloperidol decanoate im
- Haldol Decanoate Side Effects Center
- Haldol Decanoate Overview including Precautions
- Haldol Decanoate FDA Approved Prescribing Information including Dosage
Haldol Decanoate - User Reviews
Haldol Decanoate User Reviews
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