Fluphenazine Side Effects

Not all side effects for fluphenazine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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

Nervous system

The drowsiness associated with fluphenazine therapy may resolve after several doses.

Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women receiving fluphenazine. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

One study has suggested that the prevalence of tardive dyskinesia in patients receiving fluphenazine for more than two years is approximately 50% and is not different form the prevalence of tardive dyskinesia in patients taking other neuroleptics. Other studies have reported a lower prevalence.

Dystonias frequently involve tongue protrusions, muscle rigidity, torticollis, and opisthotonus. Dystonias usually resolve after neuroleptic discontinuation, but may require antihistamine and antiparkinsonian therapy if symptoms are severe of if respiration is compromised. Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Pseudoparkinsonism involves flat facies, pill-rolling, shuffling gait, and cogwheel rigidity. Pseudoparkinsonism symptoms may respond to judicious use of one or more of the following: benztropine, trihexyphenidyl, biperiden or diphenhydramine.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy, consideration of dantrolene (or bromocriptine) administration as well as intensive monitoring and supportive care are indicated. (Case reports have suggested an association between the neuroleptic malignant syndrome and malignant hyperpyrexia.)

Cases of suicide associated with fluphenazine induced akathisia have been reported rarely. Other authors have suggested that an association between neuroleptic use and suicide risk is uncertain.[Ref]

Nervous system side effects have been common and most often included sedation and drowsiness. Tardive dyskinesia, dystonia, akathisia, pseudoparkinsonism, stuttering, increased neuromuscular excitability, tremors, seizures, and the neuroleptic malignant syndrome have also been reported.[Ref]

Other

Other side effects have included anticholinergic effects such as constipation, dry mouth, urinary retention, and blurred vision which have been reported.

Abrupt discontinuation has been reported to result in recurrence of psychosis. A case of severe debilitating rhinorrhea has also been reported following abrupt discontinuation.

Elevated body temperature and cases of prolonged fever (without the extrapyramidal symptoms associated with the neuroleptic malignant syndrome) have been reported.

A case of finger clubbing has been reported.[Ref]

Hepatic

Hepatic side effects including transient elevations in liver function tests and cases of cholestatic jaundice have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including hypotension, hypertension, and arrhythmias have been reported rarely.[Ref]

General

General side effects including weight gain and obesity have been reported frequently.[Ref]

Endocrine

Endocrine side effects including hyperprolactinemia and galactorrhea have been reported. These effects have been reported to result in female menstrual irregularities and male sexual dysfunction in patients taking other phenothiazines. Cases of the syndrome of inappropriate secretion of antidiuretic hormone have also been reported.[Ref]

Respiratory

Respiratory side effects have included rare cases of sudden death thought to be due to fluphenazine induced bulbar palsy, laryngeal dysfunction, and consequent aspiration have been reported.[Ref]

Hematologic

Hematologic side effects including thrombocytopenia have been reported rarely.[Ref]

Genitourinary

Genitourinary side effects including priapism have been reported rarely. Hypersexuality, impotence, and loss of libido have also been reported.[Ref]

Ocular

Ocular side effects including cases of maculopathy have been associated with long-term fluphenazine therapy (and exposure to potential causes of photic damage).[Ref]

References

1. Mukherjee S, Rosen AM, Cardenas C, Varia V, Olarte S "Tardive dyskinesia in psychiatric outpatients: a study of prevalence and association with demographic, clinical, and drug history variables." Arch Gen Psychiatry 39 (1982): 466-9

2. Oyewumi LK, Lapierre YD, Gray R, Batth S, Gelfand R "Abnormal involuntary movements in patients on long-acting neuroleptics." Prog Neuropsychopharmacol Biol Psychiatry 7 (1983): 719-23

3. Hogan TP, Awad AG "Pharmacotherapy and suicide risk in schizophrenia." Can J Psychiatry 28 (1983): 277-81

4. Bailie GR, Nelson MV, Krenzelok EP, Lesar T "Unusual treatment response of a severe dystonia to diphenhydramine." Ann Emerg Med 16 (1987): 705-8

5. Idzorek S "Antiparkinsonian agents and fluphenazine decanoate." Am J Psychiatry 133 (1976): 80-2

6. Kosten TR, Camp W "Inappropriate secretion of antidiuretic hormone in a patient receiving piperazine phenothiazines." Psychosomatics 21 (1980): 351,354-5

7. Zubenko G, Pope HG, Jr "Management of a case of neuroleptic malignant syndrome with bromocriptine." Am J Psychiatry 140 (1983): 1619-20

8. Caroff S, Rosenberg H, Gerber JC "Neuroleptic malignant syndrome and malignant hyperthermia" Lancet 1 (1983): 244

9. West D "Dangers of fluphenazine." Br J Psychiatry 117 (1970): 718-9

10. Granato JE, Stern BJ, Ringel A, Karim AH, Krumholz A, Coyle J, Adler S "Neuroleptic malignant syndrome: successful treatment with dantrolene and bromocriptine." Ann Neurol 14 (1983): 89-90

11. Grunhaus L, Sancovici S, Rimon R "Neuroleptic malignant syndrome due to depot fluphenazine." J Clin Psychiatry 40 (1979): 99-100

12. Nurnberg HG, Greenwald B "Stuttering: an unusual side effect of phenothiazines." Am J Psychiatry 138 (1981): 386-7

13. Singh H, Levinson DF, Simpson GM, Lo ES, Friedman E "Acute dystonia during fixed-dose neuroleptic treatment." J Clin Psychopharmacol 10 (1990): 389-96

14. Yassa R, Iskandar H, Ally J "The prevalence of tardive dyskinesia in fluphenazine-treated patients." J Clin Psychopharmacol 8 (1988): 17S-20S

15. Csernansky JG, Grabowski K, Cervantes J, Kaplan J, Yesavage JA "Fluphenazine decanoate and tardive dyskinesia: a possible association." Am J Psychiatry 138 (1981): 1362-5

16. Denborough MA, Collins SP, Hopkinson KC "Rhabdomyolysis and malignant hyperpyrexia." Br Med J (Clin Res Ed) 288 (1984): 1878

17. Rampertaap MP "Neuroleptic malignant syndrome." South Med J 79 (1986): 331-6

18. Cape G "Neuroleptic malignant syndrome--a cautionary tale and a surprising outcome." Br J Psychiatry 164 (1994): 120-2

19. Lamb P, Mindham RH, Ezzat MA "Letter: Parkinsonism induced by fluphenazine decanoate." Lancet 1 (1976): 484

20. Dhib-Jalbut S, Hesselbrock R, Brott T, Silbergeld D "Treatment of the neuroleptic malignant syndrome with bromocriptine" JAMA 250 (1983): 484-5

21. Glazer WM, Moore DC "The diagnosis of rapid abnormal involuntary movements associated with fluphenazine decanoate." J Nerv Ment Dis 168 (1980): 439-41

22. Drake RE, Ehrlich J "Suicide attempts associated with akathisia." Am J Psychiatry 142 (1985): 499-501

23. Kolakowska T, Williams AO, Ardern M "Tardive dyskinesia and current dose of neuroleptic drugs" Arch Gen Psychiatry 42 (1985): 925

24. McClelland HA, Metcalfe AV, Kerr TA, Dutta D, Watson P "Facial dyskinesia: a 16-year follow-up study" Br J Psychiatry 158 (1991): 691-6

25. Friedman JH ""Rubral" tremor induced by a neuroleptic drug." Mov Disord 7 (1992): 281-2

26. Perenyi A, Arato M "Fluphenazine and tardive dyskinesia" Arch Gen Psychiatry 41 (1984): 727

27. Curson DA, Barnes TR, Bamber RW, Platt SD, Hirsch SR, Duffy JC "Long-term depot maintenance of chronic schizophrenic out-patients: the seven year follow-up of the Medical Research Council fluphenazine/placebo trial. II. The incidence of compliance problems,side-effects, neurotic symptoms and depression" Br J Psychiatry 146 (1985): 469-74

28. Weiner WJ, Luby ED "Persistent akathisia following neuroleptic withdrawal" Ann Neurol 13 (1983): 466-7

29. Shear MK, Frances A, Weiden P "Suicide associated with akathisia and depot fluphenazine treatment." J Clin Psychopharmacol 3 (1983): 235-6

30. "Product Information. Prolixin (fluphenazine)." Bristol-Myers Squibb, Princeton, NJ.

31. Snyder S "Fluphenazine jaundice. Report of a case." Am J Gastroenterol 73 (1980): 336-40

32. Holt RJ "Fluphenazine decanoate-induced cholestatic jaundice and thrombocytopenia." Pharmacotherapy 4 (1984): 227-9

33. Silverstone T, Smith G, Goodall E "Prevalence of obesity in patients receiving depot antipsychotics." Br J Psychiatry 153 (1988): 214-7

34. Zuniga JS, Hazan T "Letter: Fluphenazine and inappropriate secretion of antidiuretic hormone." Ann Intern Med 83 (1975): 735-7

35. Gift T, Plum K, Price M "Depot fluphenazine and plasma prolactin." Prog Neuropsychopharmacol Biol Psychiatry 9 (1985): 407-12

36. Rivera JL, de "Letter: Inappropriate secretion of antidiuretic hormone from fluphenazine therapy." Ann Intern Med 82 (1975): 811-2

37. Kane JM "Antipsychotic drug side effects: their relationship to dose." J Clin Psychiatry 46 (1985): 16-21

38. Solomon K "Phenothiazine-induced bulbar palsy-like syndrome and sudden death." Am J Psychiatry 134 (1977): 308-11

39. Zengotita HE, Holt RJ "Neuroleptic drug-induced coagulopathy: mechanism of reaction and duration of effect." J Clin Psychiatry 47 (1986): 35-7

40. Holt RJ "Neuroleptic drug-induced changes in platelet levels." J Clin Psychopharmacol 4 (1984): 130-2

41. Fishbain DA "Priapism with antipsychotic" Psychosomatics 27 (1986): 538

42. Compton MT, Miller AH "Priapism associated with conventional and atypical antipsychotic medications: A review." J Clin Psychiatry 62 (2001): 362-6

43. Gomez EA "Hypersexuality in men receiving fluphenazine decanoate" Am J Psychiatry 138 (1981): 1263

44. Fishbain DA "Priapism resulting from fluphenazine hydrochloride treatment reversed by diphenhydramine." Ann Emerg Med 14 (1985): 600-2

45. Power WJ, Travers SP, Mooney DJ "Welding arc maculopathy and fluphenazine" Br J Ophthalmol 75 (1991): 433-5

46. Neki AS "Fluphenazine induced welding arc maculopathy" Br J Ophthalmol 76 (1992): 255

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