Cefdinir Side Effects

ADVERSE EVENTS Clinical Trials - Cefdinir Capsules (Adult and Adolescent Patients) In clinical trials, 5093 adult and adolescent patients (3841 U.S.

and 1252 non-U.S.) were treated with the recommended dose of cefdinir capsules (600 mg/day).

Most adverse events were mild and self-limiting.

No deaths or permanent disabilities were attributed to cefdinir.

One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefdinir therapy.

The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea.

Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to cefdinir administration.

In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple-dose clinical trials (N = 3841 cefdinir-treated patients): ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES U.S.

TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) a a 1733 males, 2108 females Incidence ≥1% Diarrhea 15% Vaginal moniliasis 4% of women Nausea 3% Headache 2% Abdominal pain 1% Vaginitis 1% of women Incidence <1% but >0.1% Rash 0.9% Dyspepsia 0.7% Flatulence 0.7% Vomiting 0.7% Abnormal stools 0.3% Anorexia 0.3% Constipation 0.3% Dizziness 0.3% Dry mouth 0.3% Asthenia 0.2% Insomnia 0.2% Leukorrhea 0.2% of women Moniliasis 0.2% Pruritus 0.2% Somnolence 0.2% The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.S.: LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES U.S.

TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) a N <3841 for these parameters Incidence ≥1% ↑Urine leukocytes 2% ↑Urine protein 2% ↑Gamma-glutamyltransferase a 1% ↓Lymphocytes, ↑Lymphocytes 1%, 0.2% ↑Microhematuria 1% Incidence <1% but >0.1% ↑Glucose a 0.9% ↑Urine glucose 0.9% ↑White blood cells, ↓White blood cells 0.9%, 0.7% ↑Alanine aminotransferase (ALT) 0.7% ↑Eosinophils 0.7% ↑Urine specific gravity, ↓Urine specific gravity a 0.6%, 0.2% ↓Bicarbonate a 0.6% ↑Phosphorus, ↓Phosphorus a 0.6%, 0.3% ↑Aspartate aminotransferase (AST) 0.4% ↑Alkaline phosphatase 0.3% ↑Blood urea nitrogen (BUN) 0.3% ↓Hemoglobin 0.3% ↑Polymorphonuclear neutrophils (PMNs), ↓PMNs 0.3%, 0.2% ↑Bilirubin 0.2% ↑Lactate dehydrogenase a 0.2% ↑Platelets 0.2% ↑Potassium a 0.2% ↑Urine pH a 0.2% Clinical Trials - Cefdinir for Oral Suspension (Pediatric Patients) In clinical trials, 2289 pediatric patients (1783 U.S.