Applies to meropenem / vaborbactam: intravenous powder for solution.
Serious side effects
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
Other side effects
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, infusion site phlebitis, diarrhea, and nausea. 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
Uncommon (0.1% to 1%): Dizziness, tremor, paresthesia, lethargy
Meropenem:
-Rare (0.01% to 0.1%): Convulsions[Ref]
Local
Common (1% to 10%): Phlebitis/infusion site reactions (included infusion/injection site phlebitis, infusion site thrombosis, infusion site erythema), infusion site phlebitis
Uncommon (0.1% to 1%): Infusion site erythema, injection site phlebitis, infusion site thrombosis, infusion related reaction[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, vomiting
Uncommon (0.1% to 1%): Abdominal distension, Clostridioides difficile colitis, oral candidiasis
Frequency not reported: C difficile-associated diarrhea
Meropenem:
-Uncommon (0.1% to 1%): Abdominal pain[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity (included hypersensitivity, drug hypersensitivity, anaphylactic reaction, rash, urticaria, bronchospasm)
Uncommon (0.1% to 1%): Anaphylactic reaction[Ref]
Hepatic
Common (1% to 10%): Increased ALT, increased AST
Meropenem:
-Uncommon (0.1% to 1%): Increased blood bilirubin
-Frequency not reported: Jaundice[Ref]
Other
Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Chest discomfort
Meropenem:
-Common (1% to 10%): Increased blood alkaline phosphatase, increased blood LDH
-Uncommon (0.1% to 1%): Pain[Ref]
Metabolic
Common (1% to 10%): Hypokalemia, hypoglycemia
Uncommon (0.1% to 1%): Decreased appetite, hyperkalemia, hyperglycemia[Ref]
Cardiovascular
Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Vascular pain
Frequency not reported: Deep vein thrombosis[Ref]
Dermatologic
Uncommon (0.1% to 1%): Rash, urticaria
Meropenem:
-Uncommon (0.1% to 1%): Pruritus
-Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, erythema multiforme, angioedema[Ref]
Hematologic
Uncommon (0.1% to 1%): Leukopenia
Meropenem:
-Common (1% to 10%): Thrombocytosis/thrombocythemia
-Uncommon (0.1% to 1%): Neutropenia, eosinophilia, thrombocytopenia
-Frequency not reported: Decreased blood thromboplastin, decreased prothrombin time
-Postmarketing reports: Agranulocytosis, hemolytic anemia, positive direct and indirect Coombs test[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Increased blood creatine phosphokinase[Ref]
Psychiatric
Uncommon (0.1% to 1%): Hallucination, insomnia[Ref]
Renal
Uncommon (0.1% to 1%): Renal impairment
Frequency not reported: Azotemia
Meropenem:
-Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea[Ref]
Respiratory
Uncommon (0.1% to 1%): Bronchospasm
Frequency not reported: Pharyngitis[Ref]
Genitourinary
Uncommon (0.1% to 1%): Vulvovaginal candidiasis, incontinence[Ref]
