Haldol Decanoate Side Effects

Generic Name: haloperidol

Please note - some side effects for Haldol Decanoate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Haldol Decanoate - for the Consumer

Haldol Decanoate

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Haldol Decanoate:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; stomach upset; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased urination; difficulty speaking or swallowing; drooling; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); vision problems or changes; yellowing of skin or eyes.

Haldol Decanoate Side Effects - for the Professional

Haldol Decanoate

Adverse reactions following the administration of Haldol Decanoate 50 or Haldol 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.

Cardiovascular Effects

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.

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.

CNS Effects

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.

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.

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

Neuroleptic malignant syndrome (NMS), hyperpyrexia and heat stroke have been reported with HALDOL.

Hematologic Effects

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.

Liver Effects

Impaired liver function and/or jaundice have been reported.

Dermatologic Reactions

Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.

Endocrine Disorders

Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

Gastrointestinal Effects

Anorexia, constipation, diarrhea, hypersalivation, dyspepsia, nausea and vomiting.

Autonomic Reactions

Dry mouth, blurred vision, urinary retention, diaphoresis and priapism.

Respiratory Effects

Laryngospasm, bronchospasm and increased depth of respiration.

Special Senses

Cataracts, retinopathy and visual disturbances.

Postmarketing Events

Hyperammonemia has been reported in a 5 1 /2 year old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with HALDOL.

Side Effects by Body System

Local

Local side effects have included noninfectious, edematous, pruritic, tender masses after intramuscular injection of haloperidol decanoate. These resolved slowly over months.

Nervous system

The drowsiness associated with haloperidol therapy may resolve after several doses.

Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women receiving haloperidol. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

A study of 19 Veteran Administration hospital patients receiving haloperidol decanoate has reported a prevalence rate for tardive dyskinesia of 42%.

Dystonias frequently involve tongue protrusions, muscle rigidity, torticollis, and opisthotonos. Dystonias usually resolve after neuroleptic discontinuation, but may require antihistamine and antiparkinsonian therapy if symptoms are severe or if respiration is compromised. Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Pseudo- parkinsonism involves flat facies, pill- rolling tremor, shuffling gait, and cogwheel rigidity. Pseudo- parkinsonian symptoms may respond to judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy, consideration of dantrolene administration as well as intensive monitoring and supportive care are indicated.

Seizures associated with haloperidol have been reported, but many of the reports involved patients with a history of seizures or underlying organic brain disease.

Nervous system side effects are common and have included sedation, drowsiness and rarely seizures. Tardive dyskinesia, dystonia, pseudo-parkinsonism, increased neuromuscular excitability, and the neuroleptic malignant syndrome (NMS) have also been reported.

Other

Other side effects including the anticholinergic effects constipation, dry mouth, urinary retention, and blurred vision have been reported.

Hepatic

Baseline and periodic monitoring of liver function tests during haloperidol therapy is recommended for patients with liver disease.

Hepatic side effect including transient elevations in liver function tests have been reported.

Cardiovascular

Cardiovascular side effects including hypotension, hypertension, tachycardia, and cardiac arrest associated with haloperidol therapy have been reported rarely (although many of these patients have had serious underlying diseases). A number of cases of prolonged QT interval and torsades de pointes have been reported in patients treated with parenteral haloperidol. Sudden death and unexpected death have also been associated with haloperidol administration.

Most of the cases of prolonged QT interval and torsades de pointes have involved patients treated for intensive care unit delirium. Cardiac monitoring is recommended for intensive care unit patients who must receive haloperidol for delirium.

Endocrine

Endocrinologic side effects including hyperprolactinemia and galactorrhea have been reported. Haloperidol- induced hyperprolactinemia has been associated with sexual dysfunction in some male patients.

One in vitro study has suggested that haloperidol may increase sperm motility.

According to one report involving patients on long-term haloperidol use (mean dose 15.7 mg/day; mean duration of illness 15.5 years), the mean prolactin level and the prevalence of chronic hyperprolactinemia were significantly higher in women than in men (74 vs 24 ng/mL and 93% vs 47%, respectively).

Respiratory

Respiratory side effects including bronchospasm and pneumonitis have been reported rarely.

Hematologic

Hematologic side effects including reversible leukopenia and leukocytosis have been reported.

Musculoskeletal

Musculoskeletal side effects including two cases of rhabdomyolysis (without evidence of overt NMS) have been reported. A case of laryngeal dystonia secondary to haloperidol has also been reported.

Genitourinary

Genitourinary side effects including priapism have been reported.

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