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Loxitane Side Effects

Generic Name: loxapine

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

Not all side effects for Loxitane may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to loxapine: oral capsule, oral solution, oral tablet

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by loxapine (the active ingredient contained in Loxitane). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking loxapine:

More common
  • Difficulty with speaking or swallowing
  • lip smacking or puckering
  • loss of balance control
  • mask-like face
  • puffing of the cheeks
  • rapid or fine, worm-like movements of the tongue
  • restlessness or desire to keep moving
  • shuffling walk
  • slowed movements
  • stiffness of the arms and legs
  • trembling and shaking of the fingers and hands
  • uncontrolled chewing movements
  • uncontrolled movements of the arms or legs
Less common
  • Constipation (severe)
  • difficult urination
  • inability to move the eyes
  • muscle spasms, especially of the neck and back
  • skin rash
  • twisting movements of the body
Rare
  • Convulsions (seizures)
  • difficult or fast breathing
  • fast heartbeat or irregular pulse
  • fever (high)
  • high or low blood pressure
  • increased blinking or spasms of the eyelid
  • increased sweating
  • loss of bladder control
  • muscle stiffness (severe)
  • sore throat and fever
  • uncontrolled twisting movements of neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions or body positions
  • unusual tiredness or weakness
  • unusually pale skin
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking loxapine, get emergency help immediately:

Symptoms of overdose
  • Dizziness (severe)
  • drowsiness (severe)
  • muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
  • troubled breathing (severe)
  • unusual tiredness or weakness (severe)

Some of the side effects that can occur with loxapine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Blurred vision
  • confusion
  • dizziness, lightheadedness, or fainting
  • drowsiness
  • dryness of the mouth
Less common
  • Constipation (mild)
  • decreased sexual ability
  • enlargement of breasts (males and females)
  • headache
  • increased sensitivity of the skin to sun
  • missing menstrual periods
  • nausea or vomiting
  • trouble with sleeping
  • unusual secretion of milk
  • weight gain

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]

Nervous system

Very common (10% or more): Sedation (inhaler 12%)
Common (1% to 10%): Drowsiness, extrapyramidal reactions, akathisia
Uncommon (0.1% to 1%): Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, confusional state
Frequency not reported: Headache, lightheadedness, paresthesia, neuroleptic malignant syndrome, seizures, dystonia, tardive dyskinesia[Ref]

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]

Respiratory

Rare (less than 0.1%): Bronchospasm (inhaler)
Frequency not reported: Dyspnea, nasal congestion[Ref]

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]

Metabolic

Frequency not reported: Weight gain, weight loss, polydipsia[Ref]

Gastrointestinal

Very common (10% or more): Dysgeusia (inhaler, 14%)
Common (1% to 10%): Throat irritation (inhaler)
Frequency not reported: Dry mouth, constipation, paralytic ileus, nausea, vomiting[Ref]

Hematologic

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

Hypersensitivity

Frequency not reported: Serious skin reactions[Ref]

Cardiovascular

Frequency not reported: Tachycardia, hypotension, 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]

Genitourinary

Frequency not reported: Urinary retention[Ref]

Ocular

Frequency not reported: Ptosis, blurred vision[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]

Dermatologic

Frequency not reported: Dermatitis, facial edema, pruritus, rash, alopecia, seborrhea[Ref]

Endocrine

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

References

1. "Product Information. Loxapine Succinate (loxapine)." Mylan Pharmaceuticals Inc, Morgantown, WV.

2. "Product Information. Adasuve (loxapine)." Teva Pharmaceuticals USA, North Wales, PA.

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