PCE Dispertab Side Effects

Generic Name: erythromycin

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

It is possible that some side effects of PCE Dispertab 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 erythromycin: capsule, powder for suspension, suspension, tablet, tablet chewable

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

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

Less common
  • Fever
  • nausea
  • skin rash, redness, or itching
  • stomach pain (severe)
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)
Less common - with erythromycin injection only
  • Pain, swelling, or redness at place of injection
Rare
  • Fainting (repeated)
  • irregular or slow heartbeat
  • loss of hearing (temporary)

Some erythromycin 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
  • Abdominal or stomach cramping and discomfort
  • diarrhea
  • nausea or vomiting
Less common
  • Sore mouth or tongue
  • vaginal itching and discharge

For Healthcare Professionals

Applies to erythromycin: compounding powder, injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral granule for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet coated particles

General

The most common side effects associated with oral erythromycin (the active ingredient contained in PCE Dispertab) were gastrointestinal and were dose-related.[Ref]

Gastrointestinal

Onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.[Ref]

Rare (less than 0.1%): Pancreatitis, pancreatitis without biliary obstruction
Frequency not reported: Nausea, abdominal pain, diarrhea, vomiting, anorexia, infantile hypertrophic pyloric stenosis, pseudomembranous colitis, Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis)[Ref]

Cardiovascular

Life-threatening episodes of ventricular tachycardia associated with prolonged QT interval (torsades de pointes) have been reported following IV administration of erythromycin (the active ingredient contained in PCE Dispertab) lactobionate.

QT prolongation has been reported both in otherwise healthy patients and in patients with a history of heart disease or who were on other potentially arrhythmogenic drugs. Most affected patients were receiving erythromycin intravenously. In a recent retrospective study of 278 consecutive patients who had received IV erythromycin lactobionate, 39% of 49 evaluable patients developed moderate to severe delay in ventricular repolarization (QTc interval greater than or equal to 500 msec) during treatment. Of the 278 patients, torsade de pointes was observed in one patient (less than 0.4%).

Arrhythmias and hypotension have been reported following IV administration.

One case of erythromycin-related polymorphous ventricular tachycardia reported in a patient treated for pneumonia was characterized by a normal QT interval.[Ref]

Frequency not reported: QT prolongation, ventricular arrhythmias, ventricular tachycardia, torsades de pointes, arrhythmias, hypotension, polymorphous ventricular tachycardia
Postmarketing reports: Torsades de pointes[Ref]

Hepatic

Rare (less than 0.1%): Hepatotoxicity, fulminant hepatic necrosis, false isolated elevations of serum glutamic oxaloacetic transaminase (SGOT) enzymes
Frequency not reported: Hepatic dysfunction (including increased liver enzymes), hepatocellular and/or cholestatic hepatitis (with or without jaundice), transient elevations of liver function tests, hepatitis, abnormal liver function test results, intrahepatic cholestasis[Ref]

Hepatic dysfunction (including increased liver enzymes) and hepatocellular and/or cholestatic hepatitis (with or without jaundice) have been reported with oral erythromycin.[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions (ranging from urticaria to anaphylaxis), hypersensitivity reactions (presented as rash, eosinophilia, fever), hypersensitivity with noninfectious hepatitis[Ref]

Dermatologic

Rare (less than 0.1%): Skin rash, maculopapular rashes (generalized, pruritic)
Frequency not reported: Skin reactions (ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)[Ref]

Nervous system

Rare (less than 0.1%): Convulsions, reversible hearing loss, reversible ototoxicity
Frequency not reported: Exacerbation of myasthenia gravis symptoms, new onset of myasthenic syndrome[Ref]

Reversible hearing loss was reported primarily in patients with renal dysfunction and in patients receiving high doses of erythromycin.

Several published reviews have indicated that ototoxicity was associated with erythromycin dosages greater than 4 grams per day, preexisting liver or kidney disease, and advanced age. Recovery generally occurred within two weeks.[Ref]

Hematologic

A case of hemolytic anemia has been reported in a patient with severe underlying diseases and erythromycin-associated hepatitis.[Ref]

Rare (less than 0.1%): Reversible agranulocytosis
Frequency not reported: Hemolytic anemia[Ref]

Renal

Frequency not reported: Interstitial nephritis[Ref]

Psychiatric

Rare (less than 0.1%): Recurrent nightmares[Ref]

Local

Slow infusion of diluted erythromycin (the active ingredient contained in PCE Dispertab) (continuously or intermittently over no less than 20 to 60 minutes) almost invariably alleviated venous irritation.[Ref]

Rare (less than 0.1%): Venous irritation with IV administration[Ref]

References

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

2. Putzi R, Blaser J, Luthy R, et al "Side-effects due to the intravenous infusion of erythromycin lactobionate." Infection 11 (1982): 45-7

3. Saloranta P, Roos L, Elonen E, Allonen H "Erythromycin ethylsuccinate, base and acistrate in the treatment of upper respiratory tract infection: two comparative studies of tolerability." J Antimicrob Chemother 24 (1989): 455-62

4. Bowler WA, Hostettler C, Samuelson D, et al "Gastrointestinal side effects of intravenous erythromycin: incidence and reduction with prolonged infusion time and glycopyrrolate pretreatment." Am J Med 92 (1992): 249-53

5. McComb JM, Campbell NP, Cleland J "Recurrent ventricular tachycardia associated with QT prolongation after mitral valve replacement with intravenous administration of erythromycin." Am J Cardiol 54 (1984): 922-3

6. Oberg KC, Bauman JL "QT interval prolongation and torsades de pointes due to erythromycin lactobionate." Pharmacotherapy 15 (1995): 687-92

7. Freedman RA, Anderson KP, Green LS, Mason JW "Effect of erythromycin on ventricular arrhythmias and ventricular repolarization in ideopathic long T syndrome." Am J Cardiol 59 (1987): 168-9

8. Chennareddy SB, Siddique M, Karim MY, Kudesia V "Erythromycin-induced polymorphous ventricular tachycardia with normal QT interval." Am Heart J 132 (1996): 691-4

9. Orban Z, Macdonald LL, Peters MA, Guslits B "Erythromycin-induced cardiac toxicity." Am J Cardiol 75 (1995): 859-61

10. Brown GR "Erythromycin-induced hypotension." Ann Pharmacother 29 (1995): 934-5

11. Tschida SJ, Guay DRP, Straka RJ, Hoey LL, Johanning R, Vancebryan K "QT(c)-interval prolongation associated with slow intravenous erythromycin lactobionate infusions in critically ill patients: a prospective evaluation and review of the literature." Pharmacotherapy 16 (1996): 663-74

12. Nattel S, Ranger S, Talajic M, et al "Erythromycin-induced long QT syndrome: concordance with quinidine and underlying cellular electrophysiologic mechanism." Am J Med 89 (1990): 235-8

13. Brandriss MW, Richardson WS, Barold SS "Erythromycin-induced QT prolongation and polymorphic ventricular tachycardia (torsades de pointes): case report and review." Clin Infect Dis 18 (1994): 995-8

14. Granberry MC, Gardner SF "Erythromycin monotherapy associated with torsade de pointes." Ann Pharmacother 30 (1996): 77-8

15. Guelon D, Bedock B, Chartier C, Haberer JP "QT prolongation and recurrent "torsades de pointes" during erythromycin lactobionate infusion." Am J Cardiol 58 (1986): 666

16. Diehl AM, Latham P, Boitnott JK, et al "Cholestatic hepatitis from erythromycin ethylsuccinate." Am J Med 76 (1984): 931-4

17. Gomezlechon MJ, Carrasquer J, Berenguer J, Castell JV "Evidence of antibodies to erythromycin in serum of a patient following an episode of acute drug-induced hepatitis." Clin Exp Allergy 26 (1996): 590-6

18. Howe E, Howe E, Benn RA "Hepatotoxicity due to erythromycin ethylsuccinate." Med J Aust 158 (1993): 142-4

19. Gumaste VV "Erythromycin-induced pancreatitis." Am J Med 86 (1989): 725

20. Inman WH, Rawson NS "Erythromycin estolate and jaundice." Br Med J 286 (1983): 1954-5

21. Sullivan D, Csuka ME, Blanchard B "Erythromycin ethylsuccinate hepatotoxicity." JAMA 243 (1980): 1074

22. Fang CC, Wang HP, Lin JT "Erythromycin-induced acute pancreatitis." J Toxicol Clin Toxicol 34 (1996): 93-5

23. Keeffe EB, Reis TC, Berland JE "Hepatotoxicity to both erythromycin estolate and erythromycin ethylsuccinate." Dig Dis Sci 27 (1982): 701-4

24. Bachman BA, Boyd WP Jr, Brady PG "Erythromycin ethylsuccinate-induced cholestasis." Am J Gastroenterol 77 (1982): 397-400

25. Gholson CF, Warren GH "Fulminant hepatic failure associated with intravenous erythromycin lactobionate." Arch Intern Med 150 (1990): 215-6

26. Hawksworth CR "Acute pancreatitis associated with infusion of erythromycin lactobionate." Br Med J 298 (1989): 190

27. Lestico MR, Smith AD "Stevens-johnson syndrome following erythromycin administration." Am J Health Syst Pharm 52 (1995): 1805-7

28. Lopez JF, Serrano MC, Hernandez JB, Rodriguez JL "Fixed eruption due to erythromycin." Allergy 46 (1991): 77-8

29. Pendleton N, Mallik LJ, Williams JG "Erythromycin rash in glandular fever." Br J Clin Pract 43 (1989): 464-5

30. Igea JM, Quirce S, de la Hoz B, et al "Adverse cutaneous reactions due to macrolides." Ann Allergy 66 (1991): 216-8

31. Agusti C, Ferran F, Gea J, Picado C "Ototoxic reaction to erythromycin." Arch Intern Med 151 (1991): 380

32. May EF, Calvert PC "Aggravation of myasthenia gravis by erythromycin." Ann Neurol 28 (1990): 577-9

33. Krobeth PD, McNeil MA, Kreeger A, et al "Hearing loss and erythromycin pharmacokinetics in a patient receiving hemodialysis." Arch Intern Med 143 (1983): 1263-5

34. Schweitzer VG, Olson NR "Ototoxic effect of erythromycin therapy." Arch Otolaryngol 110 (1984): 258-60

35. Mery JP, Kanfer A "Alterations in pharmacokinetics and ototoxicity of erythromycin in renal failure." Am J Kidney Dis 4 (1984): 95

36. Swanson DJ, Sung RJ, Fine MJ, et al "Erythromycin ototoxicity: prospective assessment with serum concentrations and audiograms in a study of patients with pneumonia." Am J Med 92 (1992): 61-8

37. Umstead GS, Neumann KH "Erythromycin ototoxicity and acute psychotic reaction in cancer patients with hepatic dysfunction." Arch Intern Med 146 (1986): 897-9

38. Sacristan JA, Soto JA, de Cos MA "Erythromycin-induced hypoacusis: 11 new cases and literature review." Ann Pharmacother 27 (1993): 950-5

39. Haydon RC, Thelin JW, Davis WE "Erythromycin ototoxicity: analysis and conclusions based on 22 case reports." Otolaryngol Head Neck Surg 92 (1984): 678-84

40. Williams NR "Erythromycin: a case of nightmares." Br Med J 296 (1988): 214

41. Black RJ, Dawson TAJ "Erythromycin and nightmares." Br Med J 296 (1988): 1070

42. Kemp E, Keidar S, Brook JG "Sensorineural hearing loss with low dose erythromycin." Br Med J 302 (1991): 1341

43. Schwartz JI, Maggini GA "Erythromycin-induced ototoxicity substantiated by rechallenge." Clin Pharm 1 (1982): 374-6

44. Vasquez EM, Maddux MS, Sanchez J, Pollak R "Clinically significant hearing loss in renal allograft recipients treated with intravenous erythromycin." Arch Intern Med 153 (1993): 879-82

45. Taylor R, Schofield IS, Ramos JM, et al "Ototoxicity of erythromycin in peritoneal dialysis patients." Lancet 10/24/81 (1981): 935-6

46. Pastor E, LInares M, Grau E "Erythromycin-induced agranulocytosis." DICP 25 (1991): 1136

47. Rosenfeld J, Gura V, Boner G, et al "Interstitial nephritis with acute renal failure after erythromycin." Br Med J 286 (1983): 938-9

48. Vandersande FM, Hoorntje SJ "Acute interstitial nephritis with septicemia and erythromycin." Nephron 67 (1994): 244

49. "Product Information. ERYC (erythromycin)." Parke-Davis, Morris Plains, NJ.

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