Cedax Side Effects

Generic Name: ceftibuten

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

Cedax

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 Cedax:

Diarrhea; headache; indigestion; loose stools; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; joint pain; mental or mood changes; red, swollen, or blistered skin; seizures; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; yellowing of the eyes or skin.

Cedax 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 Cedax Suspension:

Diarrhea; headache; indigestion; loose stools; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; joint pain; mental or mood changes; red, swollen, or blistered skin; seizures; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; yellowing of the eyes or skin.

Side Effects by Body System

General

Ceftibuten is generally well tolerated. In clinical trials, 2% of patients discontinued medication due to adverse events, primarily diarrhea, nausea, or vomiting, and 0.3% discontinued due to rash or pruritus.

Gastrointestinal

If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Gastrointestinal side effects have included nausea (4%), diarrhea (3%), dyspepsia (2%), abdominal pain (1%) and vomiting (1%). Anorexia, constipation, dry mouth, eructation, flatulence, loose stools and moniliasis have been reported in less than 1% of patients. Melena has been reported during postmarketing experience. Pseudomembranous colitis has been reported in patients treated with cephalosporins.

Nervous system

Nervous system side effects have included headache in 3% of patients and dizziness in 1%. Somnolence, fatigue, agitation, hyperkinesia, irritability, insomnia, and paresthesia have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.

Hypersensitivity

Hypersensitivity side effects have included rash and pruritus in less than 1% of patients. Serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience. Cephalosporin class antibiotics have been associated with anaphylaxis, drug fever, Stevens-Johnson syndrome, and erythema multiforme.

Hematologic

Hematologic side effects have included increased eosinophils (3%), decreased hemoglobin (2%), increased or decreased platelets (less than 1%) and decreased leukocytes (less than 1%). 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 ALT (1%), increased bilirubin (1%), increased alkaline phosphatase (less than 1%), and increased AST (less than 1%). Jaundice and transient increases in LDH have been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Renal

Renal side effects have included increased BUN (1%), increased creatinine (less than 1%), and dysuria (less than 1%). Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Genitourinary

Genitourinary side effects have included dysuria, hematuria, and vaginitis in less than less than 1% of patients.

Other

Other side effects have included taste perversion in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus, rash, diaper rash, and urticaria in less than 1% of patients.

Respiratory

Respiratory side effects have included dyspnea and nasal congestion in less than 1% of patients.

Psychiatric

Psychiatric side effects have included reports of psychosis during postmarketing experience.

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