Adasuve Side Effects

Generic name: loxapine

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

Some side effects of Adasuve may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to loxapine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking loxapine (the active ingredient contained in Adasuve) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using loxapine and call your doctor at once if you have:

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• tremor (uncontrolled shaking);

• trouble swallowing;

• seizure (convulsions);

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• vision changes;

• severe constipation; or

• little or no urinating.

Other common side effects may include:

• dizziness or drowsiness;

• blurred vision;

• puffiness in your face;

• feeling restless or agitated;

• sleep problems (insomnia);

• breast swelling or discharge;

• changes in your menstrual periods;

• nausea, vomiting, constipation;

• changes in weight;

• dry mouth, stuffy nose; or

• mild skin rash, itching, or flaking.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

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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