Meropenem Side Effects

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

For the Consumer

Applies to meropenem: intravenous powder for injection

If you experience a rare but serious side effects, stop taking meropenem and seek emergency medical attention or contact your doctor immediately:

• allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)

• seizures;

• severe or watery diarrhea;

• a skin rash;

• unusual tiredness or weakness; or

• unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Continue to use meropenem and talk to your doctor if you experience:

• nausea or vomiting;

• diarrhea or constipation;

• headache; or

• soreness, redness, or mild swelling at the injection site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to meropenem: intravenous powder for injection

Gastrointestinal

Clostridium difficile associated diarrhea (CDAD) has been reported in patients treated with carbapenem antibiotics. If diarrhea occurs and it is unresponsive to discontinuation of the drug and/or standard therapy, CDAD should be considered.

Gastrointestinal side effects have included diarrhea (4.8%), nausea/vomiting (3.6%), and constipation (1.4%). Oral moniliasis, anorexia, flatulence, ileus, dyspepsia, and intestinal obstruction have been reported in greater than 0.1% to 1% of patients.

Hepatic

Hepatic side effects have included increased AST, ALT, alkaline phosphatase, LDH, and bilirubin in greater than 0.2% of patients. Hepatic failure, cholestatic jaundice, and jaundice have been reported in greater than 0.1% to 1% of patients.

Nervous system

Seizures have been infrequently reported in clinical trials (0.5% of patients). They have occurred most commonly in patients with renal insufficiency, history of seizure, or CNS abnormality.

Nervous system side effects have included headache (2.3%) and hearing loss (9% greater than 60 dB; 8% 40 to 60 dB; 20% 20 to 40 dB). Insomnia, agitation/delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, and asthenia have been reported in greater than 0.1% to 1% of patients. Seizures occur more commonly in patients with moderately severe renal dysfunction.

Local

Local side effects have included inflammation at the injection site (2.4%), injection site reactions (0.9%), phlebitis/thrombophlebitis (0.8%), pain at the injection site (0.4%), and edema at the injection site (0.2%).

Hypersensitivity

A 75-year-old female developed toxic epidermal necrolysis (TEN) over 40% of her body surface area after receiving cefotaxime. After cefotaxime discontinuation and some improvement, meropenem was started. The TEN immediately recurred and spread to previously unaffected areas of the skin, and the patient died. The authors recommend avoiding chemically similar drugs to the precipitating drug when treating patients with drug-induced TEN.

Hypersensitivity side effects including rash and pruritus were reported in 1.7% and 1.6% of patients (respectively) receiving meropenem. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and serum sickness-like reactions have also been reported. Cross-sensitivity may occur in penicillin-allergic and cephalosporin-allergic patients.

Hematologic

Hematologic side effects have included epistaxis (0.2%), gastrointestinal hemorrhage (0.5%), melena (0.3%), and hemoperitoneum (0.2%). Anemia, hypochromic anemia, and hypervolemia have been reported in greater than 0.1% to 1%. Increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased WBC, decreased prothrombin time, decreased partial thromboplastin time, and leukocytosis have been reported in more than 0.2% of patients. Agranulocytosis, neutropenia, leukopenia, a positive Coombs test (direct or indirect), and hemolytic anemia have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia and arthralgia.

Dermatologic

Dermatologic side effects have included rash (1.9%), pruritus (1.2%), and diaper area moniliasis (3.1% of pediatric patients). Urticaria, sweating, and skin ulcer have been reported in greater than 0.1% to 1% of patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, and erythema multiforme have been reported during postmarketing experience.

Renal

Renal side effects have included kidney failure in greater than 0.1% to 1% of patients. Increased creatinine and BUN have been reported in more than 0.2% of patients. Kidney failure occurs more commonly in patients with moderately severe renal dysfunction.

Respiratory

Respiratory side effects have included apnea (1.3%), and respiratory disorder, dyspnea, pleural effusion, asthma, increased cough, and lung edema in greater than 0.1% to 1% of patients.

Genitourinary

Genitourinary side effects have included dysuria, vaginal moniliasis, and urinary incontinence in greater than 0.1% to 1% of patients. Urine RBCs have been reported in more than 0.2%.

General

In clinical trials (n=2904), meropenem was discontinued in 1.2% due to adverse events and 5 deaths were possibly related to meropenem.

Other

Other side effects have included sepsis (1.6%) and shock (1.2%). Pain, abdominal pain, chest pain, back pain, chills, pelvic pain, and abdominal enlargement have been reported in greater than 0.1% to 1% of patients. Shock occurs more commonly in patients with moderately severe renal dysfunction.

Cardiovascular

Cardiovascular side effects have included heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, and syncope in greater than 0.1% to 1% of patients. Heart failure occurs more commonly in patients with moderately severe renal dysfunction.

Metabolic

Metabolic side effects have included peripheral edema and hypoxia in greater than 0.1% to 1% of patients and hypokalemia in more than 0.2%.

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