Ertapenem Side Effects

Brand Names: Invanz

Please note - some side effects for Ertapenem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ertapenem - for the Consumer

Ertapenem

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ertapenem:

Diarrhea; dizziness; headache; indigestion; nausea; sleeplessness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; breathing problems; chest pain; fast heartbeat; fever, chills, or sore throat; mental or mood changes (eg, agitation, anxiety, confusion); pain, swelling, or redness at the injection site; seizures; severe or persistent diarrhea; severe stomach cramps or pain; swelling of hands or feet; tremors or abnormal muscle movements; unusual vaginal odor or discharge; white patches in the mouth.

Side Effects by Body System

General

In general, the most common side effects associated with ertapenem have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).

Side effects in pediatric patients were similar to those in adults, with the most common adverse reactions including diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), and vomiting (2.1%).

Local

Local side effects have included infused vein complication (up to 7.1%), extravasation (up to 1.9%), and phlebitis/thrombophlebitis (up to 1.9%). Side effects reported in more than 0.1% of patients have included injection site induration and injection site pain. Tenderness and ecchymosis have also been reported.

Nervous system

In clinical trials, seizures were reported in 0.5% of patients. Patients with end-stage renal disease may be at a greater risk of developing seizures. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem.

Nervous system side effects have included headache (up to 6.8%), altered mental status (agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, and stupor; up to 5.1%), insomnia (3.2%), dizziness (up to 2.1%), anxiety (up to 1.4%), and asthenia/fatigue (1.2%). Side effects reported in more than 0.1% of patients have included nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, and vertigo. Hallucinations have been reported during postmarketing experience.

Side effects reported in more than 0.5% and less than 1.0% of patients have included cerebrovascular accident in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 10.3%), nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), acid regurgitation (up to 1.6%), dyspepsia (up to 1.1%), and oral candidiasis (up to 1.4%). Side effects reported in more than 0.1% of patients have included gastrointestinal hemorrhage, anorexia, flatulence, Clostridium difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, and taste perversion.

Small intestinal obstruction (2.1%) and C difficile infection or colitis (1.7%) have been reported in a study using 1 gram dosage of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included dry mouth and hematochezia.

Cardiovascular

Cardiovascular side effects have included edema/swelling (up to 3.4%), chest pain (up to 1.5%), hypotension (up to 2%), hypertension (up to 1.6%), and tachycardia (up to 1.6%). Side effects reported in more than 0.1% of patients have included syncope, heart failure, hematoma, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, and subdural hemorrhage.

Respiratory

Respiratory side effects have included dyspnea (up to 2.6%), cough (up to 1.6%), pharyngitis (up to 1.1%), rales/rhonchi (up to 1.1%), and respiratory distress (up to 1%). Side effects reported in more than 0.1% of patients have included pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, and voice disturbance.

Pneumonia (2.1%) and atelectasis (3.4%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing.

Dermatologic

Dermatologic side effects have included rash (up to 2.5%), pruritus (up to 2%), and erythema (up to 1.6%). Side effects reported in more than 0.1% of patients have included sweating, dermatitis, desquamation, flushing, and urticaria.

Cellulitis (1.5%) has been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Hematologic

Hematologic side effects have included increased platelet count (up to 6.5%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%), decreased segmented neutrophils (up to 1.5%), increased prothrombin time (up to 1.2%), decreased platelet count (1.1%), and decreased WBCs (up to 1.5%). Side effects reported in more than 0.1% of patients have included increased monocytes and PTT.

Anemia (5.7%) and increased WBCs have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Genitourinary

Genitourinary side effects have included vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), and increased urine WBCs (up to 2.5%). Side effects reported in more than 0.1% of patients have included vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis, and increased urine epithelial cells.

Urinary tract infection (3.8%) and dysuria (1.1%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Other

In clinical trials, death occurred in 1.6% of all patients (n=1954). In patients with intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem; however, these were considered not drug-related.

Side effects affecting the body as a whole have included fever (up to 5%) and death (up to 2.5%). Side effects reported in more than 0.1% of patients have included abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, necrosis, candidiasis, weight loss, facial edema, and flank pain.

Postoperative infection (2.3%), wound infection (6.5%), anastomotic leak (1.5%), seroma (1.3%), wound complication (2.9%), wound dehiscence (1.3%), and wound secretion (1.9%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication.

Musculoskeletal

Musculoskeletal side effects have included leg pain (up to 1.1%).

Side effects reported in more than 0.5% and less than 1.0% of patients have included muscle spasms in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Hepatic

Hepatic side effects have included increased ALT (up to 8.8%), AST (up to 8.4%), and alkaline phosphatase (up to 6.6%).

Metabolic

Metabolic side effects have included decreased serum potassium (up to 1.8%), decreased serum albumin (up to 1.7%), increased serum glucose (up to 1.7%), increased serum bilirubin (up to 1.7%), and increased serum potassium (up to 1.3%). Side effects reported in more than 0.1% of patients have included increased BUN, increased direct and indirect serum bilirubin, increased serum sodium, and decreased serum bicarbonate.

Increased urine protein has been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Renal

Renal side effects have included increased serum creatinine (up to 1.1%). Side effects reported in more than 0.1% of patients have included renal insufficiency and oliguria/anuria.

Side effects reported in more than 0.5% and less than 1.0% of patients have included pollakiuria in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Hypersensitivity

Hypersensitivity reactions have included postmarketing reports of anaphylaxis and anaphylactoid reactions.

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