Applies to cefepime: injection powder for solution.

Serious side effects of Cefepime

Along with its needed effects, cefepime 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 cefepime:

More common

• Abdominal or stomach cramps
• back, leg, or stomach pains
• bleeding gums, nosebleeds
• confusion
• convulsions
• dark urine
• difficulty with breathing
• fever, chills
• general body swelling
• headache
• irregular heartbeats
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea or vomiting
• numbness and tingling around the mouth, fingertips, or feet
• tremor
• yellowing of the eyes or skin

Less common

• Bluish color
• pain, tenderness
• swelling of the foot or leg

Rare

• Diarrhea
• inflammation or swelling
• watery or bloody diarrhea

Incidence not known

• Agitation
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bloody, black, or tarry stools
• blurred vision
• change in consciousness
• chest pain
• cough or hoarseness
• difficult or painful urination
• difficulty with swallowing
• dizziness
• fast heartbeat
• general feeling of tiredness or weakness
• itching, hives
• muscle twitching or jerking
• paralysis
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• rhythmic movement of the muscles
• seeing, hearing, or feeling things that are not there
• seizures
• severe sleepiness
• stiff neck
• sudden decrease in the amount of urine
• swollen or painful glands
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood

Other side effects of Cefepime

Some side effects of cefepime 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

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

Rare

• Itching of the vagina or genital area
• pain during sexual intercourse
• redness of the skin
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

For Healthcare Professionals

Applies to cefepime: injectable powder for injection, intravenous powder for injection, intravenous solution.

General

The most commonly reported side effects included positive Coombs' Test (without hemolysis), localized reactions, increased ALT, and diarrhea.^[Ref]

Hematologic

Very common (10% or more): Positive Coombs' Test without hemolysis (up to 18.7%)

Common (1% to 10%): Abnormal partial thromboplastin time (PTT), abnormal prothrombin time (PT), anemia, eosinophilia, PT prolonged, PTT prolonged

Uncommon (0.1% to 1%): Decreased hematocrit, decreased neutrophils/neutropenia, decreased platelets/thrombocytopenia/transient thrombocytopenia, decreased white blood cell counts/leukopenia/transient leukopenia

Rare (0.01% to 0.1%): Transient neutropenia

Frequency not reported: Agranulocytosis, aplastic anemia, hemolytic anemia

Postmarketing reports: Pancytopenia^[Ref]

Agranulocytosis, aplastic anemia, hemolytic anemia, neutropenia, pancytopenia, thrombocytopenia, and transient leukopenia were reported with cephalosporin use.^[Ref]

Hepatic

Liver dysfunction and cholestasis were reported with cephalosporin use.^[Ref]

Common (1% to 10%): Alkaline phosphatase increased, blood bilirubin increased, increased ALT, increased AST, increased total bilirubin

Postmarketing reports: Cholestasis, liver dysfunction^[Ref]

Local

Common (1% to 10%): Infusion site reactions/local reactions, injection site inflammation, injection site pain

Uncommon (0.1% to 1%): Infusion site inflammation^[Ref]

Local reactions included inflammation, pain, phlebitis, and rash, and occurred irrespective to this drug in patients who received IV infusion.^[Ref]

Gastrointestinal

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of side effects, including diarrhea, nausea, and vomiting.^[Ref]

Common (1% to 10%): Diarrhea, nausea, vomiting

Uncommon (0.1% to 1%): Colitis, oral candidiasis, oral moniliasis, pseudomembranous colitis

Rare (0.01% to 0.1%): Abdominal pain, constipation

Frequency not reported: Clostridium difficile-associated diarrhea, gastrointestinal disorder^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash/skin rash

Uncommon (0.1% to 1%): Erythema, urticaria

Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of side effects, including rash and pruritus.

The most frequently reported side effect in pediatric patient was rash.

Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis were reported with cephalosporin use.^[Ref]

Other

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of side effects, including fever.^[Ref]

Common (1% to 10%): Fever/pyrexia

Uncommon (0.1% to 1%): Inflammation, pain

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

Cardiovascular

Common (1% to 10%): Phlebitis/infusion site phlebitis

Rare (0.01% to 0.1%): Vasodilation

Frequency not reported: Hemorrhage^[Ref]

Hemorrhage was reported with cephalosporin use.^[Ref]

Metabolic

Hypocalcemia occurred more frequently in older patients.

False positive glycosuria was reported with cephalosporin use.^[Ref]

Common (1% to 10%): Decreased phosphorus

Uncommon (0.1% to 1%): Decreased calcium, hypocalcemia, increased calcium, increased phosphorus, increased potassium

Frequency not reported: False positive glycosuria^[Ref]

Nervous system

Common (1% to 10%): Headache

Rare (0.01% to 0.1%): Convulsions, dizziness, dysgeusia, paresthesia, taste perversion

Very rare (less than 0.01%): Seizures

Frequency not reported: Altered state of consciousness/consciousness disorder, coma, encephalopathy, myoclonus, neurotoxicity, stupor

Postmarketing reports: Aphasia, nonconvulsive status epilepticus^[Ref]

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of side effects, including headache.

Encephalopathy included coma, confusion, consciousness disorder, hallucinations, and stupor.

Coma, consciousness disorder, convulsions, encephalopathy, myoclonus, and stupor were reported with cephalosporin use.^[Ref]

Respiratory

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

Renal

Uncommon (0.1% to 1%): Blood creatinine increased/increased creatinine, blood urea increased/increased blood urea nitrogen (BUN), transient increase in serum creatinine, transient increase in serum urea, transient uremia

Frequency not reported: Renal dysfunction, renal failure, toxic nephropathy^[Ref]

Renal failure and toxic nephropathy were reported with cephalosporin use.^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Vaginal infection, vaginitis

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

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema

Frequency not reported: Anaphylactic shock, anaphylaxis, hypersensitivity reactions^[Ref]

Anaphylactic shock and anaphylaxis were reported with cephalosporin use.^[Ref]

Immunologic

Rare (0.01% to 0.1%): Candidiasis, unspecified moniliasis^[Ref]

Psychiatric

Confusion and hallucinations were reported with cephalosporin use.^[Ref]

Frequency not reported: Confusion/state of confusion, hallucinations^[Ref]