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Meropenem / vaborbactam Side Effects

For the Consumer

Applies to meropenem / vaborbactam: 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Seizures.
  • Stiff muscles, shakiness, or muscle movements that are not normal.
  • A burning, numbness, or tingling feeling that is not normal.
  • Feeling confused.
  • It is common to have diarrhea when taking this drug. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this drug or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

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:

  • Headache.
  • Irritation where this drug is given.
  • Loose stools (diarrhea).

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to meropenem / vaborbactam: intravenous powder for injection

General

The most common side effects were headache, phlebitis/infusion site reactions, and diarrhea. This drug was discontinued due to a side effect in 2.9% (8/272) of patients (compared to 5.1% [14/273] of patients using piperacillin-tazobactam); therapy was discontinued most commonly due to hypersensitivity and infusion-related reactions. Death occurred in 0.7% of patients using this drug and in 0.7% of patients using piperacillin-tazobactam.[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Dizziness, tremor, paresthesia, lethargy

Meropenem:
-Frequency not reported: Convulsions[Ref]

Local

Common (1% to 10%): Phlebitis/infusion site reactions (included infusion/injection site phlebitis, infusion site thrombosis, infusion site erythema)[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea
Frequency not reported: Oral candidiasis

Meropenem:
-Frequency not reported: Abdominal pain[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity (included hypersensitivity, drug hypersensitivity, anaphylactic reaction, rash, urticaria, bronchospasm)[Ref]

Hepatic

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

Meropenem:
-Frequency not reported: Jaundice, increased blood bilirubin[Ref]

Other

Common (1% to 10%): Pyrexia
Frequency not reported: Chest discomfort

Meropenem:
-Frequency not reported: Increased blood alkaline phosphatase, increased blood LDH, pain[Ref]

Metabolic

Common (1% to 10%): Hypokalemia
Frequency not reported: Decreased appetite, hyperkalemia, hyperglycemia, hypoglycemia[Ref]

Cardiovascular

Frequency not reported: Deep vein thrombosis, hypotension, vascular pain[Ref]

Hematologic

Frequency not reported: Leukopenia

Meropenem:
-Frequency not reported: Thrombocytosis, neutropenia, eosinophilia, thrombocytopenia, agranulocytosis, hemolytic anemia, decreased blood thromboplastin, decreased prothrombin time, positive direct and indirect Coombs test[Ref]

Musculoskeletal

Frequency not reported: Increased creatine phosphokinase[Ref]

Psychiatric

Frequency not reported: Hallucination, insomnia[Ref]

Renal

Frequency not reported: Azotemia, renal impairment

Meropenem:
-Frequency not reported: Increased blood creatinine, increased blood urea[Ref]

Genitourinary

Frequency not reported: Vulvovaginal candidiasis[Ref]

Respiratory

Frequency not reported: Pharyngitis[Ref]

Dermatologic

Meropenem:
-Frequency not reported: Pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, erythema multiforme, angioedema[Ref]

References

1. "Product Information. Vabomere (meropenem-vaborbactam)." The Medicines Company, Parsippany, NJ.

Some side effects of meropenem / vaborbactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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