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Recarbrio Side Effects

Generic Name: cilastatin / imipenem / relebactam

Medically reviewed by Drugs.com. Last updated on Sep 21, 2020.

Note: This document contains side effect information about cilastatin / imipenem / relebactam. Some of the dosage forms listed on this page may not apply to the brand name Recarbrio.

For the Consumer

Applies to cilastatin/imipenem/relebactam: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Seizures.
  • Feeling confused.
  • Trouble controlling body movements.
  • Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to cilastatin / imipenem / relebactam: intravenous powder for injection

Hepatic

Very common (10% or more): Increased AST (up to 11.7%)

Common (1% to 10%): Increased ALT

Imipenem-cilastatin:

-Common (1% to 10%): Increased ALT, increased AST

-Uncommon (0.1% to 1%): Increased serum bilirubin

-Rare (0.01% to 0.1%): Hepatic failure, hepatitis

-Very rare (less than 0.01%): Fulminant hepatitis

-Frequency not reported: Jaundice[Ref]

Hematologic

Very common (10% or more): Anemia (included anemia, decreased hemoglobin; up to 10.5%)

Frequency not reported: Thrombocytopenia

Imipenem-cilastatin:

-Common (1% to 10%): Anemia, eosinophilia

-Uncommon (0.1% to 1%): Pancytopenia, neutropenia, leukopenia, thrombocytopenia, thrombocytosis, positive Coombs test, prolonged prothrombin time, decreased hemoglobin

-Rare (0.01% to 0.1%): Agranulocytosis

-Very rare (less than 0.01%): Hemolytic anemia, bone marrow depression

-Frequency not reported: Increased eosinophils, increased eosinophil count[Ref]

Metabolic

Common (1% to 10%): Hypokalemia (included hypokalemia, decreased blood potassium), hyponatremia (included hyponatremia, decreased blood sodium)

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, increased lipase, constipation

Frequency not reported: Clostridioides difficile-associated diarrhea

Imipenem-cilastatin:

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

-Rare (0.01% to 0.1%): Pseudomembranous colitis, staining of teeth and/or tongue

-Very rare (less than 0.01%): Gastroenteritis, hemorrhagic colitis, abdominal pain, heartburn, glossitis, tongue papilla hypertrophy, increased salivation[Ref]

Dermatologic

Common (1% to 10%): Rash (included rash, erythematous rash, generalized rash)

Imipenem-cilastatin:

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

-Uncommon (0.1% to 1%): Urticaria, pruritus

-Rare (0.01% to 0.1%): Toxic epidermal necrolysis, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis

-Very rare (less than 0.01%): Hyperhidrosis, skin texture changes[Ref]

Other

Common (1% to 10%): Pyrexia

Imipenem-cilastatin:

-Common (1% to 10%): Pyrexia, increased serum alkaline phosphatase

-Rare (0.01% to 0.1%): Candidiasis

-Very rare (less than 0.01%): Chest discomfort, asthenia/weakness

-Frequency not reported: Increased blood lactate dehydrogenase[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Central nervous system (CNS) adverse reactions (included agitation, apathy, confusional states, delirium, disorientation, slow speech, somnolence)

Imipenem-cilastatin:

-Common (1% to 10%): Headache, CNS adverse reactions

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

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

-Very rare (less than 0.01%): Aggravation of myasthenia gravis, vertigo, tinnitus

-Frequency not reported: Dyskinesia[Ref]

Local

Common (1% to 10%): Phlebitis/infusion site reactions (included infusion site phlebitis, infusion site erythema, infusion site pain)

Imipenem-cilastatin:

-Common (1% to 10%): Phlebitis/infusion site reactions

-Uncommon (0.1% to 1%): Local pain and induration at injection site[Ref]

Cardiovascular

Common (1% to 10%): Hypertension (included hypertension, increased blood pressure)

Imipenem-cilastatin:

-Common (1% to 10%): Hypertension, thrombophlebitis

-Uncommon (0.1% to 1%): Hypotension

-Very rare (less than 0.01%): Cyanosis, tachycardia, palpitations, flushing[Ref]

Renal

Uncommon (0.1% to 1%): Increased blood creatinine, decreased creatinine renal clearance

Imipenem-cilastatin:

-Common (1% to 10%): Increased blood creatinine

-Uncommon (0.1% to 1%): Increased blood urea nitrogen

-Rare (0.01% to 0.1%): Acute renal failure[Ref]

Psychiatric

Imipenem-cilastatin:

-Uncommon (0.1% to 1%): Hallucinations, confusional states

-Frequency not reported: Agitation[Ref]

Hypersensitivity

Imipenem-cilastatin:

-Rare (0.01% to 0.1%): Anaphylactic reactions

Beta-lactams:

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

Genitourinary

Imipenem-cilastatin:

-Rare (0.01% to 0.1%): Oliguria/anuria, polyuria, urine discoloration

-Very rare (less than 0.01%): Pruritus vulvae[Ref]

Urine discoloration was harmless (not to be confused with hematuria).[Ref]

Respiratory

Imipenem-cilastatin:

-Very rare (less than 0.01%): Dyspnea, hyperventilation, pharyngeal pain[Ref]

Musculoskeletal

Imipenem-cilastatin:

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Recarbrio (imipenem/cilastatin/relebactam)." Merck & Company Inc, Whitehouse Station, NJ.

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.