Sparine Side Effects
Generic Name: promazine
Note: This document contains side effect information about promazine. Some of the dosage forms listed on this page may not apply to the brand name Sparine.
Applies to promazine: injectable solution, oral tablet
Involuntary rhythmical movements of the tongue, face and mouth characterize tardive dyskinesia. Early recognition of premonitory symptoms of tardive dyskinesia (like hyperkinetic dysarthria and fine vermiform movements of the tongue) may allow discontinuation of promazine (the active ingredient contained in Sparine) before irreversible dyskinesia ensues.
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 and intensive monitoring and supportive care are indicated.
Other side effects including tardive dyskinesia have been reported after administration of other phenothiazines and may be irreversible.
The neuroleptic malignant syndrome has been reported to occur in as many as 0.5 to 1% of patients taking other neuroleptic agents.
Withdrawal symptoms after abrupt discontinuation of promazine and other neuroleptics have been reported.
Sudden death after parenteral administration of other neuroleptics has been rarely reported in patients without underlying medical illness.[Ref]
Local side effects including intravenous and inadvertent intra-arterial injection of promazine (the active ingredient contained in Sparine) have been associated with distal necrosis requiring amputation of the affected limb.[Ref]
Some investigators have suggested that endometrial sampling be performed in women taking neuroleptics if warranted by clinical suspicion.[Ref]
1. Marcotte DB "Neuroleptics and neurologic reactions." South Med J 66 (1973): 321-4
2. Hu OY, Tang H-S, Sheeng T-Y, et al "Pharmacokinetics of promazine I: disposition in patients with acute viral hepatitis B." Biopharm Drug Dispos 11 (1990): 557-68
3. Behrman S "Mutism induced by phenothiazines." Br J Psychiatry 121 (1972): 599-604
4. "Product Information. Sparine (promazine)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
5. Yesavage JA, Tanke ED, Sheikh JI "Tardive dyskinesia and steady-state serum levels of thiothixene." Arch Gen Psychiatry 44 (1987): 913-5
6. Fisher TL "Intravenous promazine: a cautionary note." Can Med Assoc J 95 (1966): 367
7. Ash PR, Bouma D "Exaggerated hyperprolactinemia in response to thiothixene ." Arch Neurol 38 (1981): 534-5
8. Akintonwa DA "A new concept in the relationship between biochemical reaction mechanisms and molecular basis of agranulocytosis." Biochem Med 32 (1984): 151-60
9. Balon R, Berchou R, Han H "Priapism associated with thiothixene, chlorpromazine, and thioridazine." J Clin Psychiatry 48 (1987): 216
10. Keitner GI, Selub S "Spontaneous ejaculations and neuroleptics." J Clin Psychopharmacol 3 (1983): 34-6
11. Shenoy RS "Nocturnal enuresis caused by psychotropic drugs." Am J Psychiatry 137 (1980): 739-40
Some side effects may not be reported. You may report them to the FDA.