Skip to Content

Stelazine Side Effects

Generic Name: trifluoperazine

Note: This page contains side effects data for the generic drug trifluoperazine. It is possible that some of the dosage forms included below may not apply to the brand name Stelazine.

For the Consumer

Applies to trifluoperazine: oral tablets

Side effects include:

Extrapyramidal reactions (e.g., Parkinson-like symptoms, dystonia, akathisia), drowsiness, fatigue, muscular weakness, insomnia, blurred vision, skin reactions or rash, anorexia, dry mouth, hypotension, amenorrhea, galactorrhea.

For Healthcare Professionals

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

Nervous system

Frequency not reported: Drowsiness, dizziness, tremulousness, extrapyramidal symptoms, parkinsonism, acute dystonia/dyskinesia, facial grimacing, opisthotonos, hyperreflexia, tardive dyskinesia/tardive dyskinesia of the facial muscles, involuntary movement of the extremities, neuroleptic malignant syndrome, altered consciousness, autonomic instability, grand/petite mal convulsions, altered cerebrospinal fluid proteins, cerebral edema, headache, akathisia (with motor restlessness and difficulty sitting still)[Ref]

Extrapyramidal symptoms were more common in doses of over 6 mg/day. Symptoms included parkinsonism, torticollis, facial grimacing, trismus, tongue protrusion, abnormal eye movements, akathisia with motor restlessness and difficulty sitting still.

Acute dystonia/dyskinesia typically occurred early in treatment and was likely to be severe in children; this side effect included torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements.

Neuroleptic malignant syndrome was characterized by hyperpyrexia, muscle rigidity, altered consciousness and autonomic instability.

Grand/petite mal convulsions occurred in patients with/a history of EEG abnormalities.[Ref]

Cardiovascular

Severe hypotension occurred in patients with specific medical problems (e.g., mitral insufficiency, pheochromocytoma).

ECG changes, including QT prolongation and T-wave distortions, were typically reversible and occurred in patients taking phenothiazine antipsychotics.[Ref]

Frequency not reported: Mild postural hypotension/hypotension, edema/peripheral edema, tachycardia, ECG changes, QT prolongation, T-wave changes, ventricular arrhythmias/fibrillation/tachycardia, atrioventricular block, paroxysmal tachycardia, serious arrhythmias, cardiac arrest, Torsade de pointes, venous thromboembolism, deep vein thrombosis, severe hypotension/fatal hypotension[Ref]

Dermatologic

Skin pigmentation and epithelial keratopathy occurred in patients receiving substantial doses for a prolonged duration.

Contact dermatitis occurred in patients who handled phenothiazines.[Ref]

Frequency not reported: Skin reactions/disorders, photosensitivity reactions, skin pigmentation, epithelial keratopathy, itching/pruritus, erythema, urticaria, angioneurotic edema, erythema multiforme, contact dermatitis, eczema (up to exfoliative dermatitis)[Ref]

Psychiatric

Frequency not reported: Transient restlessness, stimulation, insomnia, confusion/toxic confusional states, feelings dulled, agitation, increased aggressiveness, withdrawal reactions, reactivation of the psychotic processes, catatonic-like states[Ref]

Dulled feelings and/or agitation have occurred at low doses, especially in non-psychotic patients.[Ref]

Other

Sudden death from cardiac arrest or asphyxia (cough reflex failure) has been reported in patients receiving phenothiazines.[Ref]

Frequency not reported: Lassitude, fatigue, hyperpyrexia, sudden, unexplained death, signs of persistent infection, neonatal drug withdrawal syndrome, autonomic reactions, reversed epinephrine effect, intensification/prolongation of the action of atropine/heat/organophosphorous insecticides/central nervous system depressants (e.g., opiates, analgesics, antihistamines, barbiturates, alcohol)[Ref]

Hematologic

Frequency not reported: Blood dyscrasias, agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, hemolytic anemia, aplastic anemia[Ref]

Ocular

Lenticular and corneal deposits occurred in patients receiving substantial doses for a prolonged duration.[Ref]

Frequency not reported: Blurred vision, abnormal eye movements, oculogyric crisis, lenticular opacities, pigmentary retinopathy, lacrimation, keratoconjunctivitis, miosis and mydriasis, lenticular and corneal deposits[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, constipation, tongue protrusion, nausea, vomiting, obstipation, ileus/adynamic ileus, atonic colon[Ref]

Genitourinary

Frequency not reported: Urinary hesitancy/retention, lactation, galactorrhea, menstrual irregularities, false-positive pregnancy tests, amenorrhea, ejaculation disorders/impotence, priapism[Ref]

Musculoskeletal

Frequency not reported: Muscular weakness, torticollis, trismus, muscle rigidity, systemic lupus erythematosus-like syndrome[Ref]

Metabolic

Frequency not reported: Anorexia, weight gain/change, hyperglycemia, hypoglycemia, increased appetite[Ref]

Respiratory

Frequency not reported: Pulmonary embolism, nasal congestion, asthma, bronchospasm, laryngeal edema[Ref]

Hepatic

Frequency not reported: Mild cholestatic jaundice, liver damage, jaundice, biliary stasis[Ref]

Endocrine

Hyperprolactinemia occurred in patients given higher doses, and was associated with the development of galactorrhea, amenorrhea, and/or gynecomastia.[Ref]

Frequency not reported: Gynecomastia, hyperprolactinemia/elevated prolactin levels, endocrine disturbances[Ref]

Hypersensitivity

Frequency not reported: Other allergic reactions, anaphylaxis/anaphylactoid reactions[Ref]

Oncologic

Frequency not reported: Hormone-dependent breast neoplasms[Ref]

Renal

Frequency not reported: Glycosuria[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Stelazine (trifluoperazine)" SmithKline Beecham, Philadelphia, PA.

4. "Product Information. Stelazine (trifluoperazine)" SmithKline Beecham, Philadelphia, PA.

It is possible that some side effects of Stelazine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide