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Loxapine (Loxapine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

CNS Effects

Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued loxapine therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported (see WARNINGS).

Extrapyramidal Symptoms

Neuromuscular (extrapyramidal) reactions during the administration of loxapine have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of loxapine dosage or by administration of antiparkinson drugs in usual dosage.

Dystonia

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.

Persistent Tardive Dyskinesia

As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear 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 to be irreversible. The syndrome is characterized by rhythmical involuntary movement of the 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.

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, the syndrome may be masked. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time the syndrome may not develop.

Cardiovascular Effects

Tachycardia, hypotension, hypertension, orthostatic hypotension, lightheadedness, and syncope have been reported.

A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to loxapine administration.

Hematologic

Rarely, agranulocytosis, thrombocytopenia, leukopenia.

Skin

Dermatitis, edema (puffiness of face), pruritus, rash, alopecia, and seborrhea have been reported with loxapine.

Anticholinergic Effects

Dry mouth, nasal congestion, constipation, blurred vision, urinary retention, and paralytic ileus have occurred.

Gastrointestinal

Nausea and vomiting have been reported in some patients. Hepatocellular injury (i.e., SGOT/SGPT elevation) has been reported in association with loxapine administration and rarely, jaundice and/or hepatitis questionably related to loxapine treatment.

Other Adverse Reactions

Weight gain, weight loss, dyspnea, ptosis, hyperpyrexia, flushed facies, headache, paresthesia, and polydipsia have been reported in some patients. Rarely, galactorrhea, amenorrhea, gynecomastia, and menstrual irregularity of uncertain etiology have been reported.



REPORTS OF SUSPECTED LOXAPINE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Loxapine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Loxapine side effects / adverse reactions in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: 37 year old female

Reactions: Blood Potassium Decreased, Disseminated Intravascular Coagulation, Finger Amputation, Toxicity TO Various Agents, Extremity Necrosis, Cardiogenic Shock, Blood Glucose Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Tramadol HCL
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Insulin (Insulin)
    Indication: Cardiogenic Shock

Amlodipine
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Loxapine
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Carbamazepine



Possible Loxapine side effects / adverse reactions in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 37 year old female

Reactions: Cardiogenic Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Loxapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Loxapine side effects / adverse reactions in 37 year old female

Reported by a physician from United States on 2011-10-10

Patient: 37 year old female

Reactions: Cardiogenic Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Amlodipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Loxapine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



See index of all Loxapine side effect reports >>

Drug label data at the top of this Page last updated: 2012-12-07

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