Loxapine Side Effects

Brand Names: Loxitane

Please note - some side effects for Loxapine 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 Loxapine - for the Consumer

Loxapine

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 Loxapine:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; nausea; stuffy nose; trouble sleeping; vomiting; weight gain or loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; altered mental abilities, including lack of response to your surroundings; chills or persistent sore throat; confusion; dark urine; decreased urination; fainting or faintness; fast or irregular heartbeat; hyperactivity; increased saliva production; increased thirst; involuntary, uncontrolled muscle movements; menstrual changes; mental or mood changes; muscle twitching; numbness or tingling of the skin; restlessness; seizures; shortness of breath; severe constipation; slurred speech; staggering or shuffling gait; stiff or rigid muscles; sweating; tremor; unexplained fever; vision changes; yellowing of the eyes or skin.

Loxapine Side Effects - for the Professional

Loxapine

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.

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.

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.

Side Effects by Body System

Nervous system

Nervous system side effects including Neuroleptic malignant syndrome (NMS), agitation, drowsiness, dizziness, faintness, staggering gait, tremor, shuffling gait, muscle twitching, weakness, insomnia, tension, rigidity, excessive salivation, akathisia, muscle spasms in neck and face, tongue protrusion, seizures, akinesia, paresthesia, slurred speech, numbness, and confusion have been frequently reported.

Cardiovascular

Cardiovascular side effects including tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, increased pulse rate, and syncope have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported.

Hematologic

Hematologic side effects including agranulocytosis, thrombocytopenia, and leukopenia have rarely been reported.

Genitourinary

Genitourinary side effects including urinary retention, increase in prolactin levels, galactorrhea, amenorrhea, gynecomastia, and menstrual irregularity have been reported.

Ocular

Ocular side effects including blurred vision, oculogyric movement, ptosis, pigmentary retinopathy, and lenticular pigmentation have been reported.

Hepatic

Hepatic side effects including hepatocellular injury, increased SGOT/SGPT levels, jaundice, and hepatitis have rarely been reported.

Dermatologic

Dermatologic side effects including dermatitis, edema, pruritus, rash, alopecia, and seborrhea have been reported.

Respiratory

Respiratory side effects including dyspnea have been infrequently reported.

General

General side effects including dry mouth, weight gain, weight loss, headache, hyperpyrexia, and polydipsia have been reported.

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