Omnicef Side Effects

Generic Name: cefdinir

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

Omnicef

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 Omnicef: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Omnicef:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; change in the amount of urine produced; dark urine; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea or vomiting; severe stomach pain or cramps; unusual bleeding or bruising; vaginal irritation or discharge; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Omnicef 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 Omnicef Suspension: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Omnicef Suspension:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; change in the amount of urine produced; dark urine; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea or vomiting; severe stomach pain or cramps; unusual bleeding or bruising; vaginal irritation or discharge; yellowing of the skin or eyes.

Side Effects by Body System

Gastrointestinal

Reddish-colored stools have occurred when cefdinir was taken with iron-containing products, and may be due to the formation of non-absorbable complexes in the GI tract.

Gastrointestinal side effects have included diarrhea (15%), nausea (3%), abdominal pain (1%), dyspepsia (0.7%), flatulence (0.7%), vomiting (0.7%), anorexia (0.3%), constipation (0.3%), dry mouth (03%), abnormal stools (0.3%), moniliasis (0.2%) and pseudomembranous colitis. Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included stomatitis, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, upper GI bleed, peptic ulcer, and ileus.

Hypersensitivity

Hypersensitivity reactions associated with cephalosporin class antibiotics have included allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis. Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included anaphylaxis (with rare cases of fatality), serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Dermatologic

Dermatologic side effects have included rash (0.9%) and pruritus (0.2%). Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included exfoliative dermatitis, erythema multiforme, and erythema nodosum.

Genitourinary

Genitourinary side effects have included vaginal moniliasis (4% of women), vaginitis (1% of women), leukorrhea (0.2% of women), increased urine leukocytes (2%), increased urine protein (1%), increased microhematuria (1%), increased urine glucose (0.9%), increased urine specific gravity (0.6%), decreased urine specific gravity (0.2%), increased urine pH (0.2%). Cephalosporins as a class have been associated with false-positive tests for urine glucose.

Nervous system

Nervous system side effects have included headache (2%), dizziness (0.3%), insomnia (0.2%), asthenia (0.2%), and somnolence (0.2%). Some cephalosporins have been associated with seizures in renally impaired patients. Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included loss of consciousness.

Hematologic

Hematologic side effects have included increased lymphocytes (1%), decreased lymphocytes (0.2%), increased white blood cells (0.9%), decreased white blood cells (0.7%), increased eosinophils (0.7%), decreased hemoglobin (0.3%), increased polymorphonuclear neutrophils (0.3%), decreased polymorphonuclear neutrophils (0.2%), and increased platelets (0.2%). Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included granulocytopenia, pancytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, bleeding tendency, coagulation disorder, and disseminated intravascular coagulation. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.

Metabolic

Metabolic side effects have included increased gamma-glutamyltransferase (1%), increased alanine aminotransferase (0.7%), decreased bicarbonate (0.6%), increased phosphorus (0.6%), decreased phosphorus (0.3%), increased aspartate aminotransferase (0.4%), increased alkaline phosphatase (0.3%), increased blood urea nitrogen (0.3%), increased bilirubin (0.2%), increased lactate dehydrogenase (0.2%), and increased potassium (0.2%).

Hepatic

Hepatic side effects associated with cephalosporins as a class have included hepatic dysfunction, including cholestasis. Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, and increased amylase.

Renal

Renal side effects associated with cephalosporins as a class have included renal dysfunction and toxic nephropathy. Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included acute renal failure and nephropathy.

Ocular

Ocular adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included conjunctivitis.

Respiratory

Respiratory adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, and idiopathic interstitial pneumonia.

Other

Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included fever, shock, feeling of suffocation, and facial and laryngeal edema.

Cardiovascular

Cardiovascular adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included cardiac failure, chest pain, myocardial infarction, hypertension, and allergic vasculitis.

Musculoskeletal

Musculoskeletal adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included involuntary movements and rhabdomyolysis.

Other

Geriatric patients have been reported to experience a lower rate of adverse events, including diarrhea, than younger patients.

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