Cefaclor Side Effects

ADVERSE REACTIONS Clinical Trials There were 3272 patients treated with multiple doses of cefaclor extended-release tablets in controlled clinical trials and an additional 211 subjects in pharmacology studies.

There were no deaths in these trials thought to be related to toxicity from cefaclor extended-release tablets.

Treatment was discontinued in 1.7% of patients due to adverse events thought to be possibly or probably drug-related.

The following adverse clinical and laboratory events were reported during the cefaclor extended-release tablets clinical trials conducted in North America at doses of 375 mg or 500 mg BID;

however, relatedness of the adverse events to the drug was not assigned by clinical investigators during the trials (see TABLES 4 and 5 ).

Table 4: ADVERSE CLINICAL EVENTS - CEFACLOR EXTENDED-RELEASE TABLETS MULTIPLE DOSE DOSING REGIMENS CLINICAL TRIALS - NORTH AMERICA (n = 1400) Incidence Equal to or Greater Than 1% Event Incidence Headache 4.9% Rhinitis 3.9% Diarrhea 3.8% Nausea 3.4% Vaginitis n = 934 for these events (subset of female participants).

2.4% Vaginal Moniliasis 2.2% Abdominal Pain 1.6% Cough Increased 1.5% Pharyngitis 1.4% Pruritus 1.4% Back Pain 1.0% Adverse reactions occurring during the clinical trials with cefaclor extended-release tablets with an incidence of less than 1% but greater than 0.1% included the following (listed alphabetically): Accidental injury, anorexia, anxiety, arthralgia, asthma, bronchitis, chest pain, chills, congestive heart failure, conjunctivitis, constipation, dizziness, dysmenorrhea, dyspepsia, dysuria, ear pain, edema, fever, flatulence, flu syndrome, gastritis, infection, insomnia, leukorrhea, lung disorder, maculopapular rash, malaise, menstrual disorder, myalgia, nausea and vomiting, neck pain, nervousness, nocturia, otitis media, pain, palpitation, peripheral edema, rash, respiratory disorder, sinusitis, somnolence, surgical procedure, sweating, tremor, urticaria, vomiting.

NOTE: One case of serum-sickness-like reaction was reported among the 3272 adult patients treated with cefaclor extended-release tablets during the controlled clinical trials.

These reactions have also been reported with the use of cefaclor in other oral formulations and are seen more frequently in pediatric patients than in adults.

These reactions are characterized by findings of erythema multiforme, rash, 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.