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Ceclor

Ceclor

Ceclor Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Ceclor (cefaclor) is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It is taken by mouth. Hypersensitivity reactions have been reported in about 1.5% of patients taking this drug. Other possible side effects can include diarrhea or vaginitis. This is not a complete list of possible side effects from this medication.

As with all antibiotics, it is important to take Ceclor exactly as directed and finish all the medication even if your symptoms improve. Animal studies did not show harm to a developing fetus with the administration of cefaclor, but adequate and well-controlled studies of pregnant women are lacking. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Small amounts of Ceclor (cefaclor) have been detected in human milk, so caution is advised when administering to nursing mothers.

Our Ceclor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ceclor Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach upset, headache, nausea, vomiting, or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, new signs of infection (e.g., persistent sore throat or fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), unusual joint pain, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ceclor (Cefaclor)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ceclor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse effects considered to be related to therapy with Ceclor (cefaclor) are listed below:

Hypersensitivity reactions have been reported in about 1,5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients.

Cases of serum-sickness-like reactions have been reported with the use of Ceclor (cefaclor) . These are characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. Occasionally, solitary symptoms may occur, but do not represent a serum-sickness-like reaction. While further investigation is ongoing, serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with Ceclor (cefaclor) . Such reactions have been reported more frequently in pediatric patients than in adults with an overall occurrence ranging from 1 in 200 (0.5%) in one focused trial to 2 in 8346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%) to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalization, usually of short duration ' (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported.

More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, paresthesias, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months.

Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70). Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment {see WARNINGS). Nausea and vomiting have been reported rarely. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.

Other effects considered related to therapy included eosinophilia (1 in 50 patients), genital pruritus, moniliasis or vaginitis ( about 1 in 50 patients), and, rarely, thrombocytopenia or reversible interstitial nephritis.

Causal Relationship Uncertain -

CNS - Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence have been reported.

Transitory abnormalities in clinical laboratory test results have been reported. Although they were of uncertain etiology, they are listed below to serve as alerting information for the physician.

Hepatic - Slight elevations of AST, ALT, or alkaline phosphatase values (1 in 40).

Hematopoietic - As has also been reported with other p-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia of possible clinical significance.

There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving Ceclor (cefaclor) and Coumadin® concomitantly.

Renal - Slight elevations in BUN or serum creatinine (less than 1 in 500) or abnormal urinalysis (less than 1 in 200).

Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, false positive test for urinary glucose, elevated bilirubin, elevated LDH, 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 (see DOSAGE AND ADMINISTRATION and OVERDOSAGE sections).

DRUG INTERACTIONS

Drug / Laboratory Test Interactions

Patients receiving Ceclor (cefaclor) may show a false-positive reaction for glucose in the urine with tests that use Benedict's and Fehling's solutions and also with Clinitesr tablets.

There have been reports of increased anticoagulant effect when Ceclor (cefaclor) and oral anticoagulants were administered concomitantly.

Read the entire FDA prescribing information for Ceclor (Cefaclor) »

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Ceclor - User Reviews

Ceclor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ceclor sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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