Cefpodoxime Side Effects

Some side effects of cefpodoxime 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 cefpodoxime: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking cefpodoxime: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• fever, chills, body aches, flu symptoms;

• unusual bleeding or bruising;

• cough, wheezing, chest tightness, trouble breathing;

• fast or pounding heartbeats;

• feeling like you might pass out;

• seizure (convulsions);

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• swelling, rapid weight gain, feeling short of breath (even with mild exertion); or

• increased thirst, loss of appetite, urinating less than usual or not at all.

Less serious side effects of cefpodoxime may include:

• nausea, vomiting, stomach pain, mild diarrhea, bloating, gas, constipation;

• stiff or tight muscles;

• back pain, muscle pain;

• headache, tired feeling;

• anxiety, nervousness, feeling restless or hyperactive;

• numbness or tingly feeling, warmth or redness under your skin;

• dizziness, spinning sensation;

• strange dreams, nightmares;

• stuffy nose;

• dry mouth, unusual or unpleasant taste in your mouth;

• white patches or sores inside your mouth or on your lips;

• diaper rash in an infant taking liquid cefpodoxime

• mild itching or skin rash; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to cefpodoxime: oral powder for reconstitution, oral tablet

Hypersensitivity

Hypersensitivity side effects have included rash and urticaria. Cross-reactivity in penicillin-allergic patients may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, serum sickness-like reactions, and anaphylactic shock have been reported during postmarketing experience.

Gastrointestinal

Diarrhea and loose stools may be dose-related and has been reported in 10.4% of patients taking 800 mg cefpodoxime per day, compared to 5.7% of patients taking 200 mg per day. Ten percent of these patients tested positive Clostridium difficile organisms or toxins.

C difficile was isolated in six of six volunteers given cefpodoxime for 10 days compared with one of six volunteers given placebo. The symptoms associated with C difficile were mild and did not result in withdrawal from the study. The excretion of C difficile in the stool was not statistically associated with the passage of loose stools and none of the subjects went on to develop pseudomembranous colitis.

In postmarketing experience reports, one death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.

Gastrointestinal side effects have included diarrhea (7%), nausea (3.3%), and abdominal pain (1.2%). Pseudomembranous colitis, vomiting, dyspepsia, dry mouth, flatulence, decreased appetite, constipation, oral moniliasis, anorexia, eructation, gastritis, mouth ulcers, gastrointestinal disorders, rectal disorders, tongue disorders, tooth disorders, increased thirst, oral lesions, stomatitis, tenesmus, dry throat, toothache, taste alteration, and taste loss have been reported in less than 1% of patients. Pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, and rectorrhagia with hypotension have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (less than 1%), leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, lymphocytopenia, thrombocythemia, neutropenia, thrombocytopenia and eosinophilia, positive Coombs' test, and prolonged PT and PTT. Most of these effects were transient and clinically insignificant. Easy bleeding or bruising has been reported. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.

Hepatic

Hepatic side effects have included increased AST, ALT, GGT, alkaline phosphatase, bilirubin, and LDH. These changes have generally been transient and clinically insignificant. Acute liver injury has been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Respiratory

Respiratory side effects have included asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, and sinusitis in less than 1% of patients. Pulmonary infiltrate with eosinophilia has been reported during postmarketing experience.

Renal

Renal side effects have included increased BUN and creatinine. These changes have generally been transient and clinically insignificant. Purpuric nephritis has been reported during postmarketing experience. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Dermatologic

Dermatologic side effects have included urticaria, rash, pruritus, diaphoresis, maculopapular rash, diaper rash, fungal dermatitis, acne, exfoliative dermatitis, desquamation, dry skin, hair loss, vesiculobullous rash, and sunburn in less than 1% of patients. Eyelid dermatitis has been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (1%). Dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo, tinnitus, hallucination, hyperkinesia, syncope, and somnolence have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.

Genitourinary

Genitourinary side effects have included vaginal fungal infections (1%) and vulvovaginal infections (1.3%). Hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginitis, and vaginal pain have been reported in less than 1% of patients. Change in quantity of urine has been reported.

Musculoskeletal

Musculoskeletal side effects have included myalgia (less than 1%).

Cardiovascular

Cardiovascular side effects have included congestive heart failure, palpitations, vasodilation, hematoma, migraine, hypertension, and hypotension in less than 1% of patients.

Metabolic

Metabolic side effects have included dehydration, gout, peripheral edema, and weight increase in less than 1% of patients. Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia have been reported. These changes have generally been transient and clinically insignificant.

Ocular

Ocular side effects have included eye irritation in less than 1% of patients.

Other

Other side effects have included fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological test, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, and localized pain in less than 1% of patients.

Endocrine

Endocrine side effects have included galactorrhea with cefpodoxime-associated hyperprolactinemia.

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