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

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]

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]

Dermatologic

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]

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

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

Psychiatric

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

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]

Other

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]

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

Hematologic

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

Ocular

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

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