Stelazine Side Effects

Generic name: trifluoperazine

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

Some side effects of Stelazine 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 trifluoperazine: oral tablet

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

Stop using trifluoperazine and call your doctor at once if you have a serious side effect such as:

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;

• feeling restless, jittery, or agitated;

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

• decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;

• seizure (black-out or convulsions);

• nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);

• urinating less than usual or not at all;

• pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;

• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects of trifluoperazine may include:

• dizziness, drowsiness, anxiety, sleep problems (insomnia);

• blurred vision, headache;

• dry mouth, stuffy nose;

• constipation;

• breast swelling or discharge;

• missed menstrual periods;

• weight gain, swelling in your hands or feet; or

• impotence, trouble having an orgasm.

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 trifluoperazine: compounding powder, intramuscular solution, oral concentrate, oral tablet

Nervous system

Nervous system side effects including motor restlessness, jitteriness, spasm of the neck muscles, rigidity of back muscles, opisthotonos, carpopedal spasm, hyperreflexia, dystonia, akathisia, dyskinesia, grand mal and petit mal seizures, trismus, protrusion of the tongue, drooling, tremors, shuffling gait, and chewing movements have been frequently reported.

Cardiovascular

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

Hematologic

Hematologic side effects including agranulocytosis, thrombocytopenia, pancytopenia, eosinophilia, hemolytic anemia, aplastic anemia, and leukopenia have rarely been reported.

Hepatic

Hepatic side effects including hepatocellular injury, jaundice, biliary stasis, and hepatitis have rarely been reported.

Respiratory

Respiratory side effects including dyspnea, laryngeal edema, and asthma have been infrequently reported.

Genitourinary

Genitourinary side effects including urinary retention, increase in prolactin levels, galactorrhea, amenorrhea, gynecomastia, false-positive pregnancy tests, menstrual irregularity, ejaculatory disorders, and impotence have been reported.

Gastrointestinal

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

Dermatologic

Dermatologic side effects including dermatitis, photosensitivity, itching, erythema, urticaria, eczema, exfoliative dermatitis, edema, pruritus, rash, alopecia, skin pigmentation, epithelial keratopathy, and seborrhea have been reported.

Endocrine

Endocrine side effects including hyperglycemia, hypoglycemia, and glycosuria have been reported.

Ocular

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

General

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

Psychiatric

Psychiatric side effects including reactivation of psychotic processes and catatonic-like states have been infrequently reported.

Musculoskeletal

Musculoskeletal side effects including a case of laryngeal dystonia have been reported.

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