Procanbid Side Effects

Generic Name: procainamide

Note: This page contains side effects data for the generic drug procainamide. It is possible that some of the dosage forms included below may not apply to the brand name Procanbid.

It is possible that some side effects of Procanbid may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to procainamide: intravenous solution

As well as its needed effects, procainamide (the active ingredient contained in Procanbid) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking procainamide, check with your doctor or nurse immediately:

Less common
  • Fever and chills
  • joint pain or swelling
  • pains with breathing
  • skin rash or itching
Rare
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
  • Confusion
  • fever or sore mouth, gums, or throat
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • mental depression
  • unusual bleeding or bruising
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking procainamide, get emergency help immediately:

Symptoms of overdose
  • Decrease in urination
  • dizziness (severe) or fainting
  • drowsiness
  • fast or irregular heartbeat
  • nausea and vomiting

Some procainamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Diarrhea
  • hardening or thickening of the skin where the needle is placed
  • loss of appetite
Less common
  • Dizziness or lightheadedness

For Healthcare Professionals

Applies to procainamide: compounding powder, injectable solution, oral capsule, oral tablet, oral tablet extended release

General

Some side effects of procainamide (the active ingredient contained in Procanbid) are related to serum levels of the parent compound and its metabolite, N-acetylprocainamide (NAPA). Side effects are uncommon at levels less than 4 mg per liter, more common at 7 to 8 mg per liter, and expected at 16 mg per liter. Side effects may be more likely and more severe in patients with renal insufficiency.[Ref]

Cardiovascular

Cardiovascular side effects may be acute and serious, such as hypotension, polymorphous ventricular tachycardia, or asystole. Administration of intravenous procainamide (the active ingredient contained in Procanbid) in dosages that do not exceed 20 mg/min minimizes the risk of hypotension, and should be considered in patients with low blood pressure and/or cardiac dysfunction. Procainamide may induce QT interval lengthening and torsades de pointes, although less commonly than with quinidine. The possible negative inotropic side effects of procainamide, especially with high serum levels, may be deleterious to some patients with compromised cardiac function.[Ref]

Procainamide may induce the formation of a circulating immunoglobulin directed against some coagulation factors, which has been associated with deep venous thrombosis. This may induce an elevation in the partial thromboplastin time.

A case of myocarditis without pericarditis and several cases of pericarditis associated with procainamide is reported in association with a lupus-like syndrome.[Ref]

Hematologic

Many of the cases of procainamide-induced agranulocytosis presented with complaints of sore throat, malaise, or fever. Prompt evaluation of the complete blood count and differential cell count is recommended since rare cases of serious infection, and even death, associated with this problem have been reported.

A case of pure red cell aplasia associated with procainamide (the active ingredient contained in Procanbid) and confirmed by rechallenge, has been reported.[Ref]

Hematologic side effects are rare, but may be severe. The overall incidence of blood dyscrasias (1980 to 1992) was 0.0022% (90% of affected patients were receiving Procan SR). "Blood dyscrasia" was defined as any diagnosis of agranulocytosis, granulocytopenia, neutropenia, leukopenia, thrombocytopenia, pancytopenia, bone marrow suppression, or aplastic anemia--regardless of severity. These reversible dyscrasias do not appear to be related to drug levels. Periodic monitoring of the complete blood count and careful attention to even minor signs of infection during procainamide therapy is recommended. In addition, lupus anticoagulants, which are evident in 25% to 35% of patients with systemic lupus erythematosus, have been reported in patients treated with procainamide in the absence of other lupus-like symptoms. The presence of such immunoglobulins can lead to thromboembolic complications.[Ref]

Hypersensitivity

Hypersensitivity reactions include reports of angioedema, urticarial rash, and pruritus. Such reactions may be more likely in patients with a sulfite sensitivity. Though not proven, procainamide-induced hepatitis is believed to be hypersensitivity-mediated.[Ref]

Immunologic

Immunologic side effects include a lupus-like syndrome. Chronic use of procainamide (the active ingredient contained in Procanbid) may induce production of an antinuclear antibody (ANA) in up to 70% of asymptomatic patients after 6 weeks of therapy. This antibody may be associated with a reversible lupus-like syndrome (myalgias, arthralgias, arthritis, and pulmonary or pericardial serositis) in rare cases. Symptoms appear in only approximately 30% of affected patients. Checking the ANA titer every other month or quarterly is recommended, although many clinicians opt to continue the drug in some patients with a positive ANA titer, taking into account the need for procainamide therapy.[Ref]

The lupus-like syndrome may manifest as arthralgias (most common), fever, chills, myalgias, pericarditis, pleuritis, pleural effusion, hepatomegaly, and hemorrhagic cardiac tamponade. Nephritis and cerebritis are not reported. If periodic monitoring reveals a high antinuclear antibody (ANA) titer, or if the patient develops lupus-like symptoms, reevaluation of the use of procainamide and consideration of aspirin and/or corticosteroid therapy is recommended.

The lupus-like syndrome associated with procainamide shows no predilection for females, is reversible upon discontinuation of procainamide, and is more common among slow acetylators.[Ref]

Gastrointestinal

Gastrointestinal side effects are usually minor, and include nausea, vomiting, anorexia, and diarrhea.[Ref]

Nervous system

Nervous system side effects are uncommon, and include case reports of dizziness and tremors.[Ref]

Rare cases of reversible peripheral neuropathy have been associated with a procainamide-induced lupus-like syndrome.[Ref]

Musculoskeletal

Musculoskeletal weakness is unusual, but may be more likely in patients with underlying myasthenia gravis (MG). At least one case of respiratory failure due to necrotizing myopathy with diaphragmatic involvement in an elderly patient without evidence of MG has been reported.[Ref]

A 74-year-old man with post-coronary artery bypass grafting supraventricular arrhythmias developed upper body symmetrical muscle weakness and tenderness two weeks after beginning procainamide. Associated findings included a sterile, exudative pleural effusion, elevated creatinine kinase levels, and positive anti-double stranded DNA and anti-histone antibodies. Renal function and antinuclear antibodies were normal. Procainamide was withdrawn. The patient's weakness progressed over the next seven days. He developed diaphragmatic weakness, respiratory acidosis, and the need for mechanical ventilation. An extensive neuromuscular work-up revealed a necrotizing myopathy and no evidence of impaired neuromuscular junction transmission. The muscle biopsy showed no inflammatory infiltrates and antinuclear antibodies were not present. The patient recovered over the next month.[Ref]

Psychiatric

A case of reversible mania has been reported in a patient with nontoxic serum procainamide (the active ingredient contained in Procanbid) levels.

A 45-year-old female undergoing a mitral valve replacement and tricuspid valve repair began experiencing visual hallucinations and other symptoms suggestive of psychosis four days after beginning procainamide. Within 24 hours of discontinuing procainamide, the patient returned to normal sensorium.[Ref]

Psychiatric side effects include euphoria, hallucinations, psychosis, and mental depression.[Ref]

Hepatic

Only approximately five cases of procainamide-induced granulomatous hepatitis or intrahepatic cholestasis have been reported. Of the five reported cases, all experienced fever, two had vomiting, one pruritus, and none had lymphadenopathy. The onset of signs and symptoms of liver dysfunction began 1 to 17 days after drug administration, and normalized as soon as one day to as long as several months after drug withdrawal. While the mechanism of injury is not known, most believe procainamide-induced hepatitis to be hypersensitivity-mediated.[Ref]

Hepatic side effects are rare. Rare cases of reversible cholestatic jaundice associated with procainamide have been reported. These cases were thought to be due to hypersensitivity reactions. Frequent monitoring of liver function tests is recommended in patients with hepatic insufficiency.[Ref]

References

1. Gold MR, Ogara PT, Buckley MJ, Desanctis RW "Efficacy and safety of procainamide in preventing arrhythmias after coronary artery bypass surgery." Am J Cardiol 78 (1996): 975-9

2. "Multum Information Services, Inc. Expert Review Panel"

3. Stratmann H, Walter K, Kennedy H "Torsade de pointes associated with elevated N-acetylprocainamide levels." Am Heart J 109 (1985): 375-6

4. Yang BB, Abel RB, Uprichard ACG, Smithers JA, Forgue ST "Pharmacokinetic and pharmacodynamic comparisons of twice daily and four times daily formulations of procainamide in patients with frequent ventricular premature depolarization." J Clin Pharmacol 36 (1996): 623-33

5. Boccardo D, Pitchon R, Wiener I "Adverse Reactions and Efficacy of High-Dose Procainamide Therapy in Resistant Tachyarrhythmias." Am Heart J 102 (1981): 797-8

6. Koch-Weser J, Klein S "Procainamide dosage schedules, plasma concentrations, and clinical effects." JAMA 215 (1971): 1454-61

7. Li G, Greenberg C, Currie M "Procainamide-induced lupus anticoagulants and thrombosis." South Med J 81 (1988): 262-4

8. Schwartz A, Klausner S, Yee S, Turchyn M "Cerebellar ataxia due to procainamide toxicity." Arch Intern Med 144 (1984): 2260-1

9. Giardina E, Fenster P, Bigger J, et al "Efficacy, plasma concentrations and adverse effects of a new sustained release procainamide preparation." Am J Cardiol 46 (1980): 855-62

10. Strasberg B, Sclarovsky S, Erdberg A, et al "Procainamide-induced polymorphous ventricular tachycardia." Am J Cardiol 47 (1981): 1309-14

11. Lawson D, Jick H "Adverse reactions to procainamide." Br J Clin Pharmacol 4 (1977): 507-11

12. Koch-Weser J, Klein S, Foo-Canto L, et al "Antiarrhythmic prophylaxis with procainamide in acute myocardial infarction." N Engl J Med 281 (1969): 1253-60

13. Fleet S "Agranulocytosis, procainamide, and phenytoin." Ann Intern Med 100 (1984): 616-7

14. Starkebaum G, Kenyon CM, Simrell CR, Creamer JI, Rubin RL "Procainamide-induced agranulocytosis differs serologically and clinically from procainamide-induced lupus." Clin Immunol Immunopathol 78 (1996): 112-9

15. Reidy T, Upshaw J "Procainamide-induced agranulocytosis." South Med J 77 (1984): 1582-4

16. Metzdorff MT, Hanses KS, Wright GL, Fried SJ "Interference with anticoagulation monitoring by procainamide-induced lupus anticoagulant." Ann Thorac Surg 61 (1996): 994-5

17. Danielly J, Dejong R, Radkemitchell LC, Uprichard ACG "Procainamide-associated blood dyscrasias." Am J Cardiol 74 (1994): 1179-80

18. Christensen D, Palma L, Phelps K "Agranulocytosis, thrombocytopenia, and procainamide." Ann Intern Med 100 (1984): 918

19. Scifman R, Garewal H, Shillinton D "Reticulocytopenic, Coombs' positive anemia induced by procainamide." Am J Clin Pathol 80 (1983): 66-8

20. Hoyt R "Severe neutropenia due to sustained-release procainamide." South Med J 80 (1987): 1196-7

21. Rubinstein A, Cabili S "Tremor induced by procainamide." Am J Cardiol 57 (1986): 340-1

22. Berger B, Hauser D "Agranulocytosis due to new sustained-release procainamide." Am Heart J 105 (1983): 1035-6

23. Meisner DJ, Carlson RJ, Gottlieb AJ "Thrombocytopenia following sustained-release procainamide." Arch Intern Med 145 (1985): 700-2

24. Ellrodt A, Murata G, Riedinger M, et al "Severe neutropenia associated with sustained-release procainamide." Ann Intern Med 100 (1984): 197-201

25. Heyman MR, Flores RH, Edelman BB, Carliner NH "Procainamide-induced lupus anticoagulant." South Med J 81 (1988): 934-6

26. Gabrielson RM, Leininger NR "Procainamide and neutropenia." Ann Intern Med 100 (1984): 766-7

27. Landrum EM, Siegert EA, Hanlon JT, Currie MS "Prolonged thrombocytopenia associated with procainamide in an elderly patient." Ann Pharmacother 28 (1994): 1172-6

28. Chuang LC, Tunier AP, Akhtar N, Levine SM "Possible case of procainamide-induced intrahepatic cholestatic jaundice." Ann Pharmacother 27 (1993): 434-7

29. Ahn C, Tow D "Intrahepatic cholestasis due to hypersensitivity reaction to procainamide." Arch Intern Med 150 (1990): 2589-90

30. Worman HJ, Ip JH, Winters SL, et al "Hypersensitivity reaction associated with acute hepatic dysfunction following a single intravenous dose of procainamide." J Intern Med 232 (1992): 361-3

31. Eisner E, Shahidi N "Immune thrombocytopenia due to a drug metabolite." N Engl J Med 287 (1972): 376-81

32. McDonald E, Marino C "Procainamide-induced lupus in the elderly." Hosp Pract (Off Ed) 28 (1993): 95-8

33. Woosley R, Drayer D, Reidenberg M, et al "Effect of acetylator phenotype on the rate at which procainamide induces antinuclear antibodies and the lupus syndrome." N Engl J Med 298 (1978): 1157-9

34. Miller CD, Oleshansky MA, Gibson KF, Cantilena LR "Procainamide-induced myasthenia-like weakness and dysphagia." Ther Drug Monit 15 (1993): 251-4

35. Myers DF, O'Connell JB, Subramanian R "Myocarditis resolving after discontinuation of procainamide." Int J Cardiol 4 (1983): 322-4

36. Sheikh S, Seggiv J "Procainamide-induced pleural fibrosis." Am J Med 91 (1991): 313-5

37. Ahmad S "Procainamide and peripheral neuropathy." South Med J 74 (1981): 509-10

38. Amadio P, Cummings D, Dashow L "Procainamide, quinidine, and lupus erythematosus." Ann Intern Med 102 (1985): 419-20

39. Zech P, Colon S, Labeeuw M, et al "Nephrotic syndrome in procainamide induced lupus nephritis." Clin Nephrol 11 (1979): 218-21

40. Katsutani N, Shionoya H "Popliteal lymph node enlargement induced by procainamide." Int J Immunopharmacol 14 (1992): 681-6

41. Rubin RL, Nusinow SR, Johnson AD, et al "Serologic changes during induction of lupus-like disease by procainamide." Am J Med 80 (1986): 999-1002

42. Venkayya RV, Poole RM, Pentz WH "Respiratory failure from procainamide-induced myopathy." Ann Intern Med 119 (1993): 345-6

43. Gold MR, O'Gara PT, Buckley MJ, DeSanctis RW "Efficacy and safety of procainamide in preventing arrhythmias after coronary artery bypass surgery." Am J Cardiol 78 (1996): 975-9

44. Lewis C, Boheimer N, Rose P, Jackson G "Myopathy after short term administration of procainamide." Br Med J 292 (1986): 593-4

45. Rice H, Haltzman S, Tucek C "Mania associated with procainamide." Am J Psychiatry 145 (1988): 129-30

46. Niakan E, Bertorini T, Acchirardo S, Werner M "Procainamide-induced myasthenia-like weakness in a patient with periperal neuropathy." Arch Neurol 38 (1981): 378-9

47. Bizjak ED, Nolan PE, Brody EA, Galloway JM "Procainamide-induced psychosis: A case report and review of the literature." Ann Pharmacother 33 (1999): 948-51

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