Cedax Side Effects
Generic Name: ceftibuten
Note: This document contains side effect information about ceftibuten. Some of the dosage forms listed on this page may not apply to the brand name Cedax.
Some side effects of Cedax 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 ceftibuten: oral capsule, oral powder for suspension
Along with its needed effects, ceftibuten (the active ingredient contained in Cedax) 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 ceftibuten:Rare
- Burning while urinating
- decreased urination
- difficult or labored breathing
- difficult or painful urination
- dry mouth
- increase in heart rate
- rapid breathing
- shortness of breath
- sunken eyes
- tightness in the chest
- unusual tiredness or weakness
- wrinkled skin
- Abdominal or stomach cramps or tenderness
- back, leg, or stomach pains
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloody or cloudy urine
- bloody, black, or tarry stools
- chest pain
- clay-colored stools
- cloudy urine
- cough or hoarseness
- coughing up blood
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- diarrhea, watery and severe, which may also be bloody
- difficulty with breathing or swallowing
- fast heartbeat
- feeling of discomfort
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- feeling, seeing, or hearing things that are not there
- fever with or without chills
- general body swelling
- general feeling of tiredness or weakness
- high fever
- increased menstrual flow or vaginal bleeding
- increased thirst
- inflammation of the joints
- joint or muscle pain
- loss of appetite
- lower back or side pain
- muscle aches
- nausea or vomiting
- noisy breathing
- pale skin
- problems with speech or speaking
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or black, tarry stools
- red or dark brown urine
- red skin lesions, often with a purple center
- red, irritated eyes
- severe mood or mental changes
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden decrease in the amount of urine
- swollen lymph glands
- swollen or painful glands
- unpleasant breath odor
- unusual behavior
- unusual bleeding or bruising
- unusual weight loss
- vomiting of blood
- yellowing of the eyes or skin
Some side effects of ceftibuten 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
- Acid or sour stomach
- loose stools
- stomach discomfort, upset, or pain
- bad, unusual, or unpleasant (after) taste
- bloated, full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- cracks in the skin at the corners of the mouth
- dry mouth
- excess air or gas in the stomach or intestines
- feeling unusually cold
- full feeling
- hives or welts
- increase in the body movements
- itching of the vagina or genital area
- pain during sexual intercourse
- passing gas
- redness of the skin
- sleepiness or unusual drowsiness
- soreness or redness around the fingernails and toenails
- stuffy nose
- thick, white vaginal discharge with no odor or with a mild odor
- trouble with sleeping
- unable to sleep
- weight loss
For Healthcare Professionals
Applies to ceftibuten: oral capsule, oral powder for reconstitution
Ceftibuten (the active ingredient contained in Cedax) 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.
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 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 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 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 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 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 side effects have included dysuria, hematuria, and vaginitis in less than less than 1% of patients.
Other side effects have included taste perversion in less than 1% of patients.
Dermatologic side effects have included pruritus, rash, diaper rash, and urticaria in less than 1% of patients.
Respiratory side effects have included dyspnea and nasal congestion in less than 1% of patients.
Psychiatric side effects have included reports of psychosis during postmarketing experience.
More about Cedax (ceftibuten)
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