Summary

More frequently reported side effects include: diarrhea. Continue reading for a comprehensive list of adverse effects.

Applies to ertapenem: injection powder for solution.

Serious side effects of Ertapenem

Along with its needed effects, ertapenem 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 immediately if any of the following side effects occur while taking ertapenem:

More common

• Bleeding
• blistering
• burning
• coldness
• diarrhea
• discoloration of skin
• feeling of pressure
• hives
• infection
• inflammation
• itching skin
• lumps
• numbness
• pain
• redness of skin
• scarring
• skin rash
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• unusually warm skin

Less common

• Bluish color changes in skin color
• dry, red, hot, or irritated skin
• fast, pounding, or irregular heartbeat or pulse
• pain, tenderness, or swelling of foot or leg

Rare

• Abdominal or stomach cramps
• abdominal tenderness
• bloating
• convulsions
• diarrhea, watery and severe, which may also be bloody
• fainting or loss of consciousness
• fast or irregular breathing
• fever
• increased thirst
• loss of bladder control
• muscle spasm or jerking of all extremities
• nausea
• sudden loss of consciousness
• swelling of eyes or eyelids
• tightness in chest
• trouble in breathing
• unusual tiredness or weakness
• unusual weight loss
• vomiting
• wheezing

Incidence not known

• Cough
• difficulty swallowing
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• seeing, hearing, or feeling things that are not there
• shortness of breath

Other side effects of Ertapenem

Some side effects of ertapenem 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

• Agitation
• chest pain
• confusion about identity, place, and time
• drowsiness
• headache
• mental depression

Less common

• Acid or sour stomach
• belching
• blurred vision
• body aches or pain
• congestion
• difficult or labored breathing
• difficulty having a bowel movement (stool)
• dizziness
• dryness or soreness of throat
• faintness or lightheadedness when getting up from a lying or sitting position
• fear
• flushing
• heartburn
• hoarseness
• indigestion
• itching of the vagina or genital area
• lack or loss of strength
• leg pain
• nervousness
• pain during sexual intercourse
• pounding in the ears
• runny nose
• sleeplessness
• slow heartbeat
• sore mouth or tongue
• stomach discomfort, upset, or pain
• sudden sweating
• tender, swollen glands in neck
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in chest
• trouble sleeping
• unable to sleep
• voice changes
• white patches in mouth and/or on tongue

For Healthcare Professionals

Applies to ertapenem: injectable powder for injection.

General

In general, most side effects were considered mild to moderate. The most common side effects were diarrhea, infused vein complication, nausea, headache, and vaginitis in females.^[Ref]

Gastrointestinal

Small intestinal obstruction, C difficile infection or colitis, dry mouth, and hematochezia were reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Very common (10% or more): Diarrhea (up to 10.3%)

Common (1% to 10%): Nausea, abdominal pain, constipation, vomiting, small intestinal obstruction

Uncommon (0.1% to 1%): Clostridium difficile infection or colitis, dry mouth, hematochezia, gastrointestinal hemorrhage, acid regurgitation, dyspepsia, oral candidiasis, flatulence, C difficile-associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, duodenitis, esophagitis, gastritis, mouth ulcer, pancreatitis, pyloric stenosis, pseudomembranous enterocolitis

Rare (0.01% to 0.1%): Fecal incontinence, pelvic peritonitis

Frequency not reported: Feces discolored, melena

Postmarketing reports: Teeth staining^[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased direct serum bilirubin, increased total serum bilirubin

Uncommon (0.1% to 1%): Increased indirect serum bilirubin, cholelithiasis, jaundice, increased direct and indirect serum bilirubin

Rare (0.01% to 0.1%): Cholecystitis, liver disorder, increased urobilinogen^[Ref]

Local

Common (1% to 10%): Infused vein complication, phlebitis/thrombophlebitis

Uncommon (0.1% to 1%): Injection site induration, injection site pain

Frequency not reported: Tenderness, ecchymosis, infusion site pain, infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth, infusion site phlebitis, infusion site swelling^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Cerebrovascular accident, syncope, somnolence, seizure, tremor, hypesthesia, spasm, paresthesia, vertigo, taste perversion

Postmarketing reports: Coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor^[Ref]

Cerebrovascular accident was reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.

In clinical trials, seizures were reported in 0.5% of patients, most often in patients with central nervous system disorders (e.g., brain lesions, seizure history) and/or renal dysfunction. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of this drug.^[Ref]

Other

Common (1% to 10%): Wound infection, increased serum alkaline phosphatase, fever, edema/swelling, wound complication, death, postoperative infection

Uncommon (0.1% to 1%): Crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion, abdominal distention, abdominal pain, chest pain, pain, chills, septicemia, septic shock, malaise, asthenia/fatigue, necrosis, candidiasis, fungal infection, positive Clostridium difficile toxin, increased urine bacteria, urine yeast present, weight loss, decreased serum potassium, decreased serum albumin, increased serum potassium, increased serum sodium, facial edema, extravasation, flank pain, flushing

Rare (0.01% to 0.1%): Decreased serum bicarbonate, postoperative wound infection, abortion, increased serum LDH, increased serum phosphorus

Frequency not reported: Hot flush^[Ref]

Postoperative infection, wound infection, anastomotic leak, seroma, wound complication, wound dehiscence, wound secretion, crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication were reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.

In patients with complicated intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving this drug and 2.6% of patients receiving comparator drug; however, these deaths were considered not drug-related.^[Ref]

Hematologic

Anemia was reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Common (1% to 10%): Increased platelet count, anemia, decreased hemoglobin, decreased hematocrit, increased eosinophils, decreased absolute neutrophil count, decreased platelet count

Uncommon (0.1% to 1%): Decreased segmented neutrophils, increased prothrombin time, increased activated partial thromboplastin time, decreased WBCs, increased segmented neutrophils, increased WBCs

Rare (0.01% to 0.1%): Increased monocytes, neutropenia, thrombocytopenia, decreased lymphocytes, increased band neutrophils, increased lymphocytes, increased metamyelocytes, increased myelocytes, atypical lymphocytes^[Ref]

Psychiatric

Common (1% to 10%): Altered mental status (includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor), insomnia

Uncommon (0.1% to 1%): Anxiety, nervousness, depression, aggressive behavior, confusion

Rare (0.01% to 0.1%): Agitation

Postmarketing reports: Altered mental status (including agitation, aggression, delirium, disorientation, mental status changes), hallucinations

Genitourinary

Urinary tract infection, dysuria, and pollakiuria were reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Common (1% to 10%): Urinary tract infection, vaginitis, increased urine RBCs, increased urine WBCs

Uncommon (0.1% to 1%): Dysuria, pollakiuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis, increased urine epithelial cells

Rare (0.01% to 0.1%): Genital bleeding

Frequency not reported: Presence of urine protein^[Ref]

Respiratory

Pneumonia, atelectasis, lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing were reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Common (1% to 10%): Atelectasis, dyspnea, pneumonia

Uncommon (0.1% to 1%): Lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing, cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance

Rare (0.01% to 0.1%): Nasal congestion^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Cellulitis, erythema, sweating, dermatitis, desquamation, urticaria

Rare (0.01% to 0.1%): Dermatomycosis

Frequency not reported: Diaper dermatitis, petechiae

Postmarketing reports: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms [DRESS syndrome], acute generalized exanthematous pustulosis)^[Ref]

Cellulitis was reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension

Uncommon (0.1% to 1%): Heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage, sinus bradycardia

Rare (0.01% to 0.1%): Hemorrhage, increased blood pressure^[Ref]

Renal

Common (1% to 10%): Increased serum creatinine

Uncommon (0.1% to 1%): Renal impairment, oliguria/anuria, increased BUN/serum urea

Rare (0.01% to 0.1%): Renal insufficiency, acute renal insufficiency, decreased serum creatinine^[Ref]

Musculoskeletal

Muscle spasms were reported in a study using 1 g of this drug for prophylaxis of surgical site infection after elective colorectal surgery.^[Ref]

Uncommon (0.1% to 1%): Muscle spasms (greater than 0.5%), gout (greater than 0.1%), leg pain (greater than 0.1%)

Postmarketing reports: Muscular weakness^[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration, anorexia, increased serum glucose

Rare (0.01% to 0.1%): Hypoglycemia^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions

Rare (0.01% to 0.1%): Allergy

Postmarketing reports: Anaphylaxis (including anaphylactoid reactions)^[Ref]

Ocular

Rare (0.01% to 0.1%): Scleral disorder