Applies to meropenem: intravenous powder for solution.

Serious side effects of Meropenem

Along with its needed effects, meropenem 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:

Less common

• Bluish lips or skin
• chills
• cold, clammy skin
• confusion
• dizziness
• fainting
• fast heartbeat
• fast, weak pulse
• fever
• itching, skin rash
• lightheadedness
• rapid, shallow breathing
• sweating

Rare

• Agitation
• black, bloody, or tarry stools
• black, bloody vomit
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• burning sensation while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cough
• dark urine
• decreased awareness or responsiveness
• decreased urine output
• depression
• diarrhea (watery and severe), which may also be bloody
• difficult or painful urination
• difficulty with breathing
• dilated neck veins
• extreme tiredness or weakness
• fever with or without chills
• headache
• hives or welts
• hostility
• irregular breathing
• irritability
• light-colored stools
• loss of consciousness
• muscle twitching
• nausea
• no blood pressure or pulse
• nosebleed
• pale skin
• pounding in the ears
• rapid weight gain
• seizures
• severe constipation
• severe vomiting
• severe sleepiness
• slow, irregular heartbeat
• stomach cramps, severe
• tightness in the chest
• troubled breathing with exertion
• unconsciousness
• unpleasant breath odor
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weight gain or loss
• vomiting of blood or material that looks like coffee grounds
• weight gain
• white patches in the mouth, tongue, or throat
• yellow eyes or skin

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• chest pain
• confusion as to time, place, or person
• cough
• general body swelling
• general feeling of tiredness or weakness
• hoarseness
• holding false beliefs that cannot be changed by fact
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• lower back or side pain
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual excitement, nervousness, or restlessness

Other side effects of Meropenem

Some side effects of meropenem 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:

More common

• Constipation
• redness and swelling at the injection site

Less common

• Body aches or pain
• cold hands and feet
• cold sweats
• congestion
• cool pale skin
• dryness or soreness of the throat
• increased hunger
• indigestion
• nightmares
• passing of gas
• redness, swelling, or soreness of the tongue
• runny nose
• shakiness
• slurred speech
• sneezing
• stomach pain, fullness, or discomfort
• trouble swallowing
• vaginal yeast infection
• voice changes

Rare

• Belching
• excess air or gas in the stomach or bowels
• full feeling
• heartburn
• redness of the skin
• sleepiness or unusual drowsiness
• trouble sleeping

For Healthcare Professionals

Applies to meropenem: intravenous powder for injection, intravenous solution.

General

In clinical trials (n=2904), this drug was discontinued in 1.2% of patients due to side effects; 5 deaths were possibly drug-related. In a review of 4872 patients, diarrhea, rash, nausea/vomiting, injection site inflammation, thrombocytosis and increased hepatic enzymes were reported most often.^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, constipation, gastrointestinal disorder, abdominal pain

Uncommon (0.1% to 1%): Oral moniliasis/candidiasis, flatulence, ileus, dyspepsia, intestinal obstruction

Frequency not reported: Clostridium difficile associated diarrhea, antibiotic-associated colitis, pseudomembranous colitis^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness, seizure, paresthesia, somnolence, syncope, asthenia

Frequency not reported: Hearing loss, other adverse central nervous system (CNS) experiences^[Ref]

Seizures and other adverse CNS experiences have been reported. They have occurred most commonly in patients with CNS disorders (e.g., history of seizures, brain lesions) or with bacterial meningitis and/or renal dysfunction.

Seizures occurred more often in patients with moderately severe renal dysfunction.^[Ref]

Hematologic

Common (1% to 10%): Anemia, hypochromic anemia, bleeding events (including gastrointestinal hemorrhage, melena, epistaxis, hemoperitoneum), thrombocythemia

Uncommon (0.1% to 1%): Increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased white blood cells, decreased prothrombin time, decreased partial thromboplastin time, leukocytosis, eosinophilia, thrombocytopenia, leukopenia, neutropenia

Postmarketing reports: Agranulocytosis, positive Coombs test (direct or indirect), hemolytic anemia^[Ref]

Other

Shock occurred more often in patients with moderately severe renal dysfunction.^[Ref]

Common (1% to 10%): Pain, inflammation, sepsis/septicemia, shock, accidental injury

Uncommon (0.1% to 1%): Chest pain, fever, back pain, chills, pelvic pain, peripheral edema, abdominal enlargement^[Ref]

Local

Common (1% to 10%): Inflammation at the injection site, phlebitis/thrombophlebitis, pain at the injection site

Uncommon (0.1% to 1%): Injection site reactions, edema at the injection site^[Ref]

Dermatologic

Common (1% to 10%): Rash (including diaper/nappy area moniliasis), pruritus

Uncommon (0.1% to 1%): Urticaria, sweating, skin ulcer

Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, severe skin reactions^[Ref]

Respiratory

Common (1% to 10%): Apnea, pharyngitis, pneumonia

Uncommon (0.1% to 1%): Respiratory disorder, dyspnea, pleural effusion, asthma, increased cough, hypoxia, lung edema

Frequency not reported: Respiratory failure^[Ref]

Cardiovascular

Heart failure occurred more often in patients with moderately severe renal dysfunction.^[Ref]

Common (1% to 10%): Peripheral vascular disorder

Uncommon (0.1% to 1%): Heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension^[Ref]

Hepatic

Common (1% to 10%): Increased transaminases

Uncommon (0.1% to 1%): Increased AST, increased ALT, increased bilirubin, hepatic failure, cholestatic jaundice/jaundice^[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia, increased alkaline phosphatase, increased lactate dehydrogenase

Uncommon (0.1% to 1%): Anorexia, hypervolemia, hypokalemia^[Ref]

Renal

Uncommon (0.1% to 1%): Kidney failure, increased creatinine, increased BUN^[Ref]

Kidney failure occurred more often in patients with moderately severe renal dysfunction.^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, agitation/delirium, confusion, nervousness, hallucinations, anxiety, depression

Genitourinary

Uncommon (0.1% to 1%): Dysuria, vaginal moniliasis/candidiasis, urinary incontinence, red blood cells in urine^[Ref]

Hypersensitivity

Frequency not reported: Serum sickness-like reactions, cross-sensitivity in penicillin-allergic and cephalosporin-allergic patients, anaphylaxis^[Ref]

Musculoskeletal

Frequency not reported: Myalgia, arthralgia^[Ref]