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Meropenem / vaborbactam Side Effects

For the Consumer

Applies to meropenem / vaborbactam: intravenous powder for solution

Along with its needed effects, meropenem/vaborbactam 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 or nurse immediately if any of the following side effects occur while taking meropenem / vaborbactam:

Less common
  • Bluish color
  • changes in skin color
  • decreased urine
  • diarrhea
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • seizures
  • swelling of the foot or leg
  • unusual tiredness or weakness
  • vomiting
Rare
  • Anxiety
  • black, tarry stools
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chest discomfort
  • chest pain
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficulty breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dryness or soreness of the throat
  • fast heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • hoarseness
  • increased hunger
  • increased urination
  • itching of the vagina or genitals
  • loss of consciousness
  • nervousness
  • nightmares
  • pain in the lower back or side
  • pain, redness, or swelling in the arm or leg
  • painful or difficult urination
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • shakiness
  • slurred speech
  • sore mouth, throat, or tongue
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • sweating
  • tender, swollen glands in the neck
  • thick, white vaginal discharge with mild or no odor
  • trouble in swallowing
  • unexplained weight loss
  • unusual bleeding or bruising
  • voice changes
  • weakness or heaviness of the legs

Some side effects of meropenem / vaborbactam 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:

Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • decreased appetite

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.

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.

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