Vantin Side Effects

Please note - some side effects for Vantin 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 Vantin - for the Consumer

Vantin

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 Vantin:

Diarrhea; headache; loose stools; nausea; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; seizures; severe diarrhea; skin rash; stomach pain/cramps; vaginal irritation or discharge.

Vantin Suspension

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 Vantin Suspension:

Diarrhea; headache; loose stools; nausea; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; seizures; severe diarrhea; skin rash; stomach pain/cramps; vaginal irritation or discharge.

Vantin Side Effects - for the Professional

Vantin

Clinical Trials

In clinical trials using multiple doses of cefpodoxime proxetil film-coated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. The percentage of cefpodoxime proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. Adverse events thought possibly or probably related to cefpodoxime in multiple-dose clinical trials (N=4696 cefpodoxime-treated patients) were:

Incidence Greater Than 1%:

Diarrhea                                                                                7.0%
Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. difficile organism or toxin in the stool.
Nausea                                                                                  3.3%
Vaginal Fungal Infections                                                        1.0%
Vulvovaginal Infections                                                           1.3%
Abdominal Pain                                                                      1.2%
Headache                                                                               1.0%

Incidence Less Than 1%: By body system in decreasing order:

Clinical Studies

Adverse events thought possibly or probably related to cefpodoxime proxetil that occurred in less than 1% of patients (N=4696)

Body - fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological tests, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, localized pain.

Cardiovascular - congestive heart failure, migraine, palpitations, vasodilation, hematoma, hypertension, hypotension.

Digestive - 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, tenesmus, dry throat, toothache.

Hemic and Lymphatic - anemia.

Metabolic and Nutritional - dehydration, gout, peripheral edema, weight increase.

Musculo-skeletal - myalgia.

Nervous - dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo.

Respiratory - asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, sinusitis.

Skin - urticaria, rash, pruritus non-application site, diaphoresis, maculopapular rash, fungal dermatitis, desquamation, dry skin non-application site, hair loss, vesiculobullous rash, sunburn.

Special Senses - taste alterations, eye irritation, taste loss, tinnitus.

Urogenital - hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginal pain.

In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly or probably related to study drug. Primarily, these discontinuations were for gastrointestinal disturbances, usually diarrhea, vomiting, or rashes.

Adverse events thought possibly or probably related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials (N=2128 patients treated with cefpodoxime) were:

Incidence Greater Than 1%:

Diarrhea                                                                             6.0%
The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%.
Diaper rash/Fungal skin rash                                               2.0% (includes moniliasis)
The incidence of diaper rash in infants and toddlers was 8.5%.
Other skin rashes                                                                1.8%
Vomiting                                                                             2.3%

Incidence Less Than 1%:

Body: Localized abdominal pain, abdominal cramp, headache, monilia, generalized abdominal pain, asthenia, fever, fungal infection.

Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis.

Hemic & Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura.

Metabolic & Nutritional: Increased SGPT.

Musculo-Skeletal: Myalgia.

Nervous: Hallucination, hyperkinesia, nervousness, somnolence.

Respiratory: Epistaxis, rhinitis.

Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash.

Special Senses: Taste perversion.

In clinical trials using a single dose of cefpodoxime proxetil film-coated tablets, 509 patients were treated with the recommended dosage of cefpodoxime (200 mg). There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

Adverse events thought possibly or probably related to cefpodoxime in single-dose clinical trials conducted in the United States were:

Incidence Greater Than 1%:
Nausea                                                                                1.4%
Diarrhea                                                                               1.2%

Incidence Less Than 1%:
Central Nervous System: Dizziness, headache, syncope.
Dermatologic: Rash.
Genital: Vaginitis.
Gastrointestinal: Abdominal pain.
Psychiatric: Anxiety.

Laboratory Changes

Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were:

Hepatic: Transient increases in AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, and LDH.

Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs' test, and prolonged PT, and PTT.

Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia.

Renal: Increases in BUN and creatinine.

Most of these abnormalities were transient and not clinically significant.

The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis.

One death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.

In addition to the adverse reactions listed above which have been observed in patients treated with cefpodoxime proxetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:

Adverse Reactions and Abnormal Laboratory Tests: Renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, serum sickness-like reaction, hemorrhage, agranulocytosis, and pancytopenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Side Effects by Body System

Hypersensitivity

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

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 disturbances such as diarrhea (7%), nausea (3.3%), and abdominal pain (1.2%) have been reported. 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, and toothache have been reported in less than 1% of patients. Adverse effects reported during postmarketing experience have included pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, and rectorrhagia with hypotension.

Hematologic

Hematologic side effects have included anemia (<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. 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 transient increases in 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 reported in less than 1% of patients have included asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, and sinusitis. Adverse effects reported during postmarketing experience have included pulmonary infiltrate with eosinophilia.

Renal

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

Dermatologic

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

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.

Other

Taste alteration and taste loss have been reported in less than 1% of patients.

Musculoskeletal

Musculoskeletal side effects have included myalgia (<1%).

Cardiovascular

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

Metabolic

Metabolic side effects reported in less than 1% of patients have included dehydration, gout, peripheral edema, and weight increase. Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia have also 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

Adverse effects affecting the body as a whole have been reported in less than 1% of patients and include 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.

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