ADVERSE REACTIONS
Cardiovascular System
: Hypotension and serious disturbances of cardiorhythm such as ventricular asystole or fibrillation are more common with intravenous administration of PA than with intramuscular administration. Because PA is a peripheral vasodilator in concentrations higher than the usual therapeutic range, transient high plasma levels which may occur especially during intravenous administration may produce temporary but at times severe lowering of blood pressure (see
OVERDOSAGE
and
PRECAUTIONS
).
Multisystem:
A lupus erythematosus-like syndrome of arthralgia, pleural or abdominal pain, and sometimes arthritis, pleural effusion, pericarditis, fever, chills, myalgia, and possibly related hematologic or skin lesions (see below) is fairly common after prolonged PA administration, perhaps more often in patients who are slow acetylators (See Boxed Warning and
PRECAUTIONS
). While some series have reported less than 1 in 500, others have reported the syndrome in up to 30 percent of patients on long term oral PA therapy. If discontinuation of PA does not reverse the lupoid symptoms, corticosteroid treatment may be effective.
Hematologic:
Neutropenia, thrombocytopenia, or hemolytic anemia may rarely be encountered. Agranulocytosis has occurred after repeated use of PA, and deaths have been reported. (See Boxed Warning,
WARNINGS
section.)
Skin:
Angioneurotic edema, urticaria, pruritus, flushing, and maculopapular rash have also occurred.
Gastrointestinal System:
Anorexia, nausea, vomiting, abdominal pain, diarrhea or bitter taste may occur in 3 to 4 percent of patients taking oral procainamide.
Nervous System:
Dizziness or giddiness, weakness, mental depression and psychosis with hallucinations have been reported.
Elevated Liver Enzymes
: Elevations of transaminase with and without elevations of alkaline phosphatase and bilirubin have been reported. Some patients have had clinical symptoms (e.g., malaise, right upper quadrant pain). Deaths from liver failure have been reported.
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REPORTS OF SUSPECTED PROCAINAMIDE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Procainamide. The information is not vetted and should not be considered as verified clinical evidence.
Possible Procainamide side effects / adverse reactions in 41 year old female
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-03-28
Patient: 41 year old female
Reactions: Sudden Cardiac Death, Drug Ineffective, Ventricular Tachycardia
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Procainamide
Possible Procainamide side effects / adverse reactions in 41 year old female
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-06-07
Patient: 41 year old female
Reactions: Sudden Cardiac Death, Drug Ineffective, Ventricular Tachycardia
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Procainamide
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