Prolixin Decanoate Side Effects
Generic Name: fluphenazine
Note: This page contains side effects data for the generic drug fluphenazine. It is possible that some of the dosage forms included below may not apply to the brand name Prolixin Decanoate.
For the Consumer
Applies to fluphenazine: oral elixir, oral solution concentrate, oral tablets, parenteral injection
Side effects include:
Extrapyramidal reactions (e.g., pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia), drowsiness, lethargy, weight gain.
For Healthcare Professionals
Applies to fluphenazine: injectable solution, oral concentrate, oral elixir, oral tablet
The most commonly reported side effects include extrapyramidal symptoms (e.g., pseudoparkinsonism, dystonia, dyskinesia).[Ref]
Rare (0.01% to 0.1%): Blood dyscrasias
Frequency not reported: Transient leukopenia/leukopenia, thrombocytopenia, leukocytosis, agranulocytosis/fatal agranulocytosis, cellular depression, eosinophilia, pancytopenia, aplastic/hemolytic anemia, thrombocytopenic or nonthrombocytopenic purpura[Ref]
Rare (0.01% to 0.1%): Increased serum cholesterol
Frequency not reported: Hyponatremia, loss of appetite, weight changes, blood glucose level alterations and loss of diabetic control[Ref]
Rare (0.01% to 0.1%): Jaundice
Frequency not reported: Cholestatic jaundice, hepatitis, increased cephalin flocculation and transient liver function test abnormalities (in the absence of jaundice)[Ref]
Acute, distressing muscle spasms usually occurred within 24 hours of injection, and required immediate administration of an anticholinergic agent.[Ref]
Very rare (less than 0.01%): Systemic lupus erythematosus
Frequency not reported: Muscular rigidity, altered creatine phosphokinase, acute, distressing muscle spasms in the face, neck, eyes, tongue, and back[Ref]
Very rare (less than 0.01%): Antinuclear antibodies[Ref]
Frequency not reported: Opisthotonos, parkinsonism, pseudoparkinsonism/parkinsonian-like states, dyskinesia, tardive dyskinesia, drowsiness, lethargy, headache, dystonia, acute dystonia/acute dystonic reactions, epileptiform attacks, altered consciousness, stupor, coma, neuroleptic malignant syndrome, autonomic instability, hyperreflexia, akinesia, electroencephalographic tracing alterations, alterations in cerebrospinal fluid proteins, cerebral edema, impairment in judgement and mental skills[Ref]
Parkinsonism/parkinsonian-like states tended to occur 2 to 5 days after each injection, with a decreased frequency in subsequent injections. This side effect may be reduced by using smaller, more frequent doses or adding an anti-parkinsonism agent temporarily.[Ref]
Frequency not reported: Mild hypotension/hypotension, hypertension, arrhythmias, ventricular tachycardia/fibrillation, venous thromboembolism, deep vein thrombosis, edema, peripheral edema, labile blood pressure, tachycardia, ECG changes, fatal cardiac arrest, QT and T-wave changes[Ref]
ECG changes (including QT and T-wave changes) were dose-related side effects that usually occurred at moderate to high doses. These changes may preclude serious arrhythmias.[Ref]
Frequency not reported: Galactorrhea, abnormal lactation, oligomenorrhea, amenorrhea, menstrual irregularities, impotence, priapism, inhibition of ejaculation (men), increased libido (women), impaired sexual function, bladder paralysis, polyuria, urinary hesitance and/or incontinency[Ref]
Frequency not reported: Abnormal skin pigmentation, skin rashes, diaphoresis/perspiration, itching, erythema multiforme, contact sensitivity, urticaria, seborrhea, photosensitivity, eczema, exfoliative dermatitis, angioneurotic edema[Ref]
Abnormal skin pigmentation occurred in patients receiving high doses for long durations of time.[Ref]
Frequency not reported: Tongue protrusion, dry mouth, constipation, vomiting, nausea, gastric irritation, salivation, fecal impaction, paralytic ileus, difficulty swallowing, aspiration of gastric contents, hypertrophic papillae of the tongue[Ref]
Lens opacities occurred in patients receiving high doses for long durations of time.[Ref]
Frequency not reported: Oculogyric crises, blurred vision, lens opacities, glaucoma, mydriasis, corneal opacity, pigmentation of the eyes, pigmentary retinopathy, defective color vision, night blindness, deposition of particulate matter in the lens and cornea[Ref]
Frequency not reported: Neonatal drug withdrawal syndrome
Postmarketing reports: Sudden, unexplained/unexpected deaths, body temperature dysregulation, hypothermia, hyperthermia[Ref]
Sudden, unexplained/unexpected death occurred in hospitalized patients with psychosis.[Ref]
Frequency not reported: Agitation, restlessness, excitement, insomnia, bizarre dreams, increased aggressiveness, reactivation/aggravation of psychotic processes, catatonic and confusional states[Ref]
Frequency not reported: Nasal congestion, pulmonary embolism, laryngeal dystonia, asthma, throat tightness, difficulty breathing, active fulminating pneumonia or pneumonitis[Ref]
Frequency not reported: Hyperprolactinemia, gynecomastia, false positive pregnancy test, syndrome of inappropriate antidiuretic hormone secretion[Ref]
Frequency not reported: Anaphylactic and hypersensitivity reactions[Ref]
Frequency not reported: Acute renal failure[Ref]
Frequency not reported: Local tissue reactions[Ref]
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Prolixin (fluphenazine)." Bristol-Myers Squibb, Princeton, NJ.
4. "Product Information. Prolixin (fluphenazine)." Apothecon Inc, Plainsboro, NJ.
It is possible that some side effects of Prolixin Decanoate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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