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Cilastatin / imipenem Side Effects

For the Consumer

Applies to cilastatin / imipenem: powder for solution

Side effects requiring immediate medical attention

Along with its needed effects, cilastatin / imipenem may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cilastatin / imipenem:

More common

Less common

  • Dizziness
  • increased sweating
  • nausea or vomiting
  • unusual tiredness or weakness

Rare

  • Fever
  • severe abdominal or stomach cramps and pain
  • watery and severe diarrhea, which may also be bloody (these side effects may also occur up to several weeks after you stop receiving this medicine)

Side effects not requiring immediate medical attention

Some side effects of cilastatin / imipenem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to cilastatin / imipenem: injectable powder for injection, intramuscular powder for injection

Local

Common (1% to 10%): Phlebitis/thrombophlebitis at the injection site

Uncommon (0.1% to 1%): Pain at the injection site, erythema at the injection site, vein induration, local pain and induration at the injection site

Frequency not reported: Infused vein infection, injection site irritation, injection site reaction[Ref]

Gastrointestinal

Drug-related nausea and/or vomiting appeared to occur more often in granulocytopenic patients than in nongranulocytopenic patients.[Ref]

Common (1% to 10%): Nausea, vomiting, diarrhea

Rare (0.01% to 0.1%): Pseudomembranous colitis

Very rare (less than 0.01%): Hemorrhagic colitis, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, heartburn, increased salivation

Frequency not reported: Clostridium difficile-associated diarrhea, oral candidiasis, constipation

Postmarketing reports: Staining of the teeth and/or tongue[Ref]

Dermatologic

Common (1% to 10%): Rash (e.g., exanthematous)

Uncommon (0.1% to 1%): Pruritus, urticaria

Rare (0.01% to 0.1%): Erythema multiforme, angioedema/angioneurotic edema, exfoliative dermatitis

Very rare (less than 0.01%): Hyperhidrosis, skin texture changes, candidiasis

Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

Beta-lactams:

-Frequency not reported: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS], acute generalized exanthematous pustulosis)[Ref]

Hematologic

Common (1% to 10%): Eosinophilia

Uncommon (0.1% to 1%): Thrombocytosis, positive Coombs test, prolonged prothrombin time, decreased hemoglobin

Frequency not reported: Increased eosinophils, increased WBC, increased platelets, decreased hemoglobin and hematocrit, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils, decreased neutrophils, increased/decreased platelet count, increased/decreased hematocrit, anemia

Postmarketing reports: Pancytopenia, bone marrow depression, neutropenia, thrombocytopenia, leukopenia, hemolytic anemia, agranulocytosis[Ref]

Hepatic

Common (1% to 10%): Increased serum transaminases

Uncommon (0.1% to 1%): Increased bilirubin

Frequency not reported: Elevated ALT, elevated AST, increased/decreased bilirubin

Postmarketing reports: Hepatitis (including fulminant hepatitis), jaundice, hepatic failure[Ref]

Other

Common (1% to 10%): Increased alkaline phosphatase

Uncommon (0.1% to 1%): Fever

Very rare (less than 0.01%): Flushing, asthenia/weakness

Frequency not reported: Increased LDH, decreased serum sodium, increased potassium, increased chloride, facial edema, pain, superinfection

Postmarketing reports: Drug fever[Ref]

Nervous system

Uncommon (0.1% to 1%): Seizures, myoclonic activity, dizziness, somnolence

Rare (0.01% to 0.1%): Encephalopathy, paresthesia, focal tremor, hearing loss

Very rare (less than 0.01%): Exacerbation of myasthenia gravis, headache, vertigo, tinnitus

Frequency not reported: Myoclonus

Postmarketing reports: Tremor, dyskinesia, taste perversion[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension

Very rare (less than 0.01%): Palpitations, tachycardia, cyanosis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Confusion

Postmarketing reports: Psychic disturbances (including hallucinations), agitation

Renal

Uncommon (0.1% to 1%): Increased BUN, increased creatinine

Rare (0.01% to 0.1%): Oliguria/anuria

Postmarketing reports: Acute renal failure[Ref]

Genitourinary

Rare (0.01% to 0.1%): Polyuria

Very rare (less than 0.01%): Pruritus vulvae

Frequency not reported: Presence of urine protein, presence of urine red blood cells, presence of urine white blood cells, presence of urine casts, presence of urine bilirubin, presence of urine urobilinogen, increased urine protein, presence of urine bacteria

Postmarketing reports: Urine discoloration[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions

Beta-lactams:

-Frequency not reported: Hypersensitivity (anaphylactic) reactions[Ref]

Respiratory

Very rare (less than 0.01%): Chest discomfort, dyspnea, hyperventilation, pharyngeal pain[Ref]

Musculoskeletal

Very rare (less than 0.01%): Polyarthralgia, thoracic spine pain[Ref]

References

1. "Product Information. Primaxin (imipenem)." Merck & Co, Inc, West Point, PA.

2. Zhanel GG, Wiebe R, Dilay L, et al. "Comparative Review of the Carbapenems." Drugs 67 (2007): 1027-1052

3. Embil JM, Soto NE, Melnick DA "A post hoc subgroup analysis of meropenem versus imipenem/cilastatin in a multicenter, double-blind, randomized study of complicated skin and skin-structure infections in patients with diabetes mellitus." Clin Ther 28 (2006): 1164-74

4. Chastre J, Wunderink R, Prokocimer P, Lee M, Kaniga K, Friedland I "Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study." Crit Care Med 36 (2008): 1089-96

5. Calandra GB, Brown KR, Grad LC, et al "Review of adverse experiences and tolerability in the first 2,516 patients treated with imipenem/cilastatin." Am J Med 78 (1985): 73-8

6. Clissold SP, Todd PA, Campoli-Richards DM "Imipenem/cilastatin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic efficacy." Drugs 33 (1987): 185-241

7. Calandra GB, Hesney M, Grad C "A multiclinic randomized study of the comparative efficacy, safety and tolerance of imipenem/cilastatin and moxalactam." Eur J Clin Microbiol 3 (1984): 478-87

8. Wang C, Calandra GB, Aziz MA, Brown KR "Efficacy and safety of imipenem/cilastatin: a review of worldwide clinical experience." Rev Infect Dis 7 (1985): s528-36

9. Schmitt DV, Leitner E, Welte T, Lode H "Piperacillin/Tazobactam vs Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia-a Double Blind Prospective Multicentre Study." Infection 34 (2006): 127-34

10. Rivera M, Crespo M, Teruel JL, Marcen R, Ortuno J "Neurotoxicity due to imipenem/cilastatin in patients on continuous ambulatory peritoneal dialysis." Nephrol Dial Transplant 14 (1999): 258-9

11. Young K "Imipenem/cilastatin." Pharm Ther Forum 34 (1986): 1-3

12. Lyon JA "Imipenem/cilastatin: the first carbapenem antibiotic." Drug Intell Clin Pharm 19 (1985): 894-8

13. Patel SA, Braun HL, Fine MS, et al "Imipenem-associated elevation of amylase and lipase." Am J Gastroenterol 84 (1989): 80-1

14. Larsen JW, Gabel-Hughes K, Kreter B "Efficacy and tolerability of imipenem-cilastatin versus clindamycin + gentamicin for serious pelvic infections." Clin Ther 14 (1992): 90-6

15. Zazgornik J, Schein W, Heimberger K, et al "Potentiation of neurotoxic side effects by coadministration of imipenem to cyclosporine therapy in a kidney transplant recipient: synergism of side effects or drug." Clin Nephrol 26 (1986): 265-6

16. Eng RH, Munsif AN, Yangco BG, et al "Seizure propensity with imipenem." Arch Intern Med 149 (1989): 1881-3

17. Lane M, Kania D, Rapp RP "Seizures related to use of imipenem-cilastatin." Am J Health Syst Pharm 53 (1996): 1605-6

18. Guglielmo BJ, Jacobs RA "Impact of dosage-monitoring system on frequency of seizures associated with imipenem-cilastatin." Am J Health Syst Pharm 53 (1996): 1097-8

19. Frucht S, Eidelberg D "Imipenem-induced myoclonus." Mov Disord 12 (1997): 621-2

20. Campise M "Neurological complication during imipenem/cilastatin therapy in uraemic patients." Nephrol Dialysis Transplant 13 (1998): 1895-6

21. Roberts JA, Lipman J "Antibacterial Dosing in Intensive Care : Pharmacokinetics, Degree of Disease and Pharmacodynamics of Sepsis." Clin Pharmacokinet 45 (2006): 755-773

22. Job ML, Dretler RH "Seizure activity with imipenem therapy: incidence and risk factors." DICP 24 (1990): 467-9

23. Oriordan J, Javed M, Doherty C, Hutchinson M "Worsening of myasthenia gravis on treatment with imipenem/cilastatin." J Neurol Neurosurg Psychiatry 57 (1994): 383

24. Guglielmo BJ, Jacobs RA "Impact of dosage-monitoring system on frequency of seizures associated with imipenem-cilastatin." Am J Health Syst Pharm 53 (1996): 2097-8

25. Semel JD, Allen N "Seizures in patients simultaneously receiving theophylline and imipenem or ciprofloxacin or metronidazole." South Med J 84 (1991): 465-8

26. Duque A, Altimiras J, Garcia-Cases C, Vidal P "Vertigo caused by intravenous imipenem/cilastatin." DICP 25 (1991): 1009

27. Leo RJ, Ballow CH "Seizure activity associated with imipenem use: clinical case reports and review of the literature." DICP 25 (1991): 351-4

28. Hantson P, de Coninck B, Horn JL, Mahieu P "Immediate hypersensitivity to aztreonam and imipenem." Br Med J 302 (1991): 294-5

29. Romano A, Viola M, Gueant-Rodriguez RM, Gaeta F, Pettinato R, Gueant JL "Imipenem in patients with immediate hypersensitivity to penicillins." N Engl J Med 354 (2006): 2835-7

30. Pleasants RA, Walker TR, Samuelson WM "Allergic reactions to parenteral beta-lactam antibiotics in patients with cystic fibrosis." Chest 106 (1994): 1124-8

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.