Loxitane Side Effects

Generic name: loxapine

Medically reviewed by Drugs.com. Last updated on Feb 19, 2024.

Note: This document contains side effect information about loxapine. Some dosage forms listed on this page may not apply to the brand name Loxitane.

Applies to loxapine: inhalation powder. Other dosage forms:

oral capsule

Serious side effects of Loxitane

Along with its needed effects, loxapine (the active ingredient contained in Loxitane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking loxapine:

Less common

Blurred vision
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
seizures
sweating
unusual tiredness or weakness

Rare

Inability to sit still
need to keep moving
restlessness

Incidence not known

Chest tightness
cough
decrease in the frequency of urination
decrease in urine volume
decreased vision
difficulty in passing urine (dribbling)
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
eye pain
fast, pounding, or irregular heartbeat or pulse
headache
high fever
inability to move the eyes
increased blinking or spasms of the eyelid
increased sweating
loss of balance control
loss of bladder control
mask-like face
nausea or vomiting
nervousness
noisy breathing
painful urination
pounding in the ears
severe muscle stiffness
shuffling walk
slowed movements
slurred speech
sticking out of tongue
tearing of eyes
tic-like (jerky) movements of the head, face, mouth, and neck
tiredness
trembling and shaking of the fingers and hands
trouble breathing, speaking, or swallowing
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual facial expressions
unusually pale skin

Other side effects of Loxitane

Some side effects of loxapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste
drowsiness
loss of taste
sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to loxapine: inhalation powder, intramuscular solution, oral capsule, oral concentrate.

General

The most common adverse reactions reported with use of the inhaler were dysgeusia, sedation and throat irritation. Drowsiness, extrapyramidal reactions and akathisia have been reported frequently, especially during the first few days of oral therapy.^[Ref]

Gastrointestinal

Very common (10% or more): Dysgeusia (up to 14%)

Common (1% to 10%): Dry mouth, throat irritation

Frequency not reported: Constipation, excessive salivation, paralytic ileus, nausea, tongue protrusion, vomiting^[Ref]

Dysgeusia and throat irritation occurred with inhaled formulations.^[Ref]

Nervous system

Very common (10% or more): Sedation/somnolence (up to 12%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Akathisia/restlessness, dystonia, dyskinesia, neck dystonia, tremor

Frequency not reported: Akinesia, drowsiness, extrapyramidal symptoms, faintness, headache, involuntary muscle contractions, lightheadedness, masked facies, numbness, paresthesia, neuroleptic malignant syndrome, parkinsonian-like symptoms, seizures, shuffling gait, slurred speech, staggering gait, tardive dyskinesia^[Ref]

Sedation occurred in up to 12% of patients who used inhaled formulations.

Drowsiness occurred in patients who used oral formulations.

Drowsiness has been frequently reported at the beginning of therapy or when the dosage is increased. It is generally mild and usually subsides with continued therapy. The incidence of sedation has been reported as less than certain aliphatic phenothiazines, and more than the piperazine phenothiazines.^[Ref]

Other

Common (1% to 10%): Fatigue, weakness

Frequency not reported: Hyperpyrexia^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension

Frequency not reported: Tachycardia, hypertension, orthostatic hypotension, syncope, ECG changes, flushed facies^[Ref]

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

Psychiatric

Uncommon (0.1% to 1%): Restlessness

Frequency not reported: Agitation, confusional state, insomnia, tension^[Ref]

Ocular

Uncommon (0.1% to 1%): Oculogyration

Frequency not reported: Blurred vision, dry eyes, ptosis^[Ref]

Respiratory

Bronchospasm occurred with inhaled formulations.

Use of the inhaler was shown to cause bronchospasm in clinical pulmonary safety trials as measured by FEV1 and respiratory signs and symptoms. Additionally, patients with asthma or other pulmonary diseases were shown to be at higher risk and the effect of FEV1 was greater following the second dose (administered 10 hours later).^[Ref]

Uncommon (0.1% to 1%): Bronchospasm/shortness of breath

Frequency not reported: Dyspnea, nasal congestion^[Ref]

Endocrine

Rare (less than 0.1%): Galactorrhea, amenorrhea, gynecomastia, menstrual irregularity^[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia, neutropenia, agranulocytosis^[Ref]

Hepatic

Rare (less than 0.1%): Jaundice and/or hepatitis

Frequency not reported: Hepatocellular injury^[Ref]

Hepatocellular injury described as AST/ALT elevation has been reported in association with loxapine administration; rarely, jaundice and/or hepatitis has been reported as possibly related to treatment.^[Ref]