Imipenem and cilastatin Side Effects

Please note - some side effects for Imipenem and cilastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: injectable powder for injection; intramuscular powder for injection

General

Imipenem is generally well tolerated.

Local

Local side effects associated with IV administration have included phlebitis or thrombophlebitis at the injection site (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4%), vein induration (0.2%), infused vein infection (0.1%), and injection site reaction.

Gastrointestinal

Gastrointestinal side effects have included nausea (2%), vomiting (1.5%), and diarrhea (1.8%). Pseudomembranous colitis, hemorrhagic colitis, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth or tongue, heartburn, pharyngeal pain, and increased salivation have been reported in less than 0.2% of patients. Constipation has also been reported.

Nervous system

Seizures may be dose-related and are generally reported in patients with renal insufficiency, central nervous system pathology (stroke or neoplasm), or a history of seizure disorder, head trauma, or alcoholism.

A 49-year-old woman with advanced ovarian adenocarcinoma experienced severe myoclonus of the upper extremities while receiving imipenem 500 mg every 6 hours. The myoclonus started to improve within 12 hours of imipenem discontinuation.

Neurologic side effects have included seizures (0.4%), dizziness (0.3%), and somnolence (0.2%). Encephalopathy, tremors, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances, including hallucinations have been reported in less than 0.2% of patients. Exacerbation of myasthenia gravis has also been reported.

Dermatologic

Dermatologic side effects have included rash (0.9%), pruritus (0.3%), and urticaria (0.2%). Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneurotic edema, flushing cyanosis, hyperhidrosis, skin texture changes and candidiasis have been reported in less than 0.2% of patients.

Hypersensitivity

One study demonstrated an increased incidence of allergic reactions in patients with cystic fibrosis who were given imipenem.

Hypersensitivity to imipenem is unusual. However, fever, pruritus, rash, eosinophilia, or positive direct Coombs' test may indicate the presence of hypersensitivity. Patients allergic to other beta-lactam antibiotics may be allergic to imipenem.

Cardiovascular

Cardiovascular side effects have rarely included hypotension, palpitations, and tachycardia.

Genitourinary

Genitourinary side effects have included pruritus vulvae and urine discoloration in less than 0.2% of patients. Urine protein, red and/or white blood cells, casts, bacteria, bilirubin, and urobilinogen have also been reported.

Hematologic

Hematologic side effects have included pancytopenia, bone marrow depression, neutropenia, thrombocytosis, thrombocytopenia, leukopenia, and hemolytic anemia in less than 0.2% of patients. Increased eosinophils, positive Coombs test, increased white blood cells, increased platelets, decreased hemoglobin and hematocrit, anemia, agranulocytosis, increased monocytes, abnormal prothrombin time, increased lymphocytes, and increased basophils have also been reported.

Hepatic

Hepatic side effects have included hepatitis (including fulminant hepatitis) and jaundice in less than 0.2% of patients. Transient elevations in liver function tests (ALT, AST, alkaline phosphatase, bilirubin, and LDH) and hepatic failure have also been reported.

Metabolic

Metabolic side effects have included decreased serum sodium, increased potassium, and increased chloride.

Musculoskeletal

Musculoskeletal side effects have included polyarthralgia in less than 0.2% of patients.

Renal

Renal side effects have included acute renal failure, oliguria, anuria, and polyuria in less than 0.2% of patients. Increased BUN and creatinine have also been reported.

Respiratory

Respiratory side effects have included chest discomfort, dyspnea, hyperventilation, and thoracic spine pain in less than 0.2% of patients.

Other

Up to 4% of patients treated with imipenem develop superinfection during therapy. The most common organisms are Enterococcus faecium, Stenotrophomonas maltophilia, methicillin-resistant Staphylococcus aureus, and Candida species.

Other

Other side effects have included hearing loss, tinnitus, taste perversion, drug fever, and asthenia/weakness in less than 0.2% of patients. Pain has also been reported.

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