Applies to cilastatin / imipenem: powder for solution.

Serious side effects

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

• Confusion
• convulsions (seizures)
• dizziness
• pain at place of injection
• skin rash, hives, itching, fever, or wheezing
• tremors

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)

Other side effects

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

• Diarrhea
• nausea and vomiting

For Healthcare Professionals

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