Cefdinir Side Effects
Brand Names: Omnicef
Please note - some side effects for Cefdinir 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 Cefdinir - for the consumer
Cefdinir
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 Cefdinir: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cefdinir:
Seek medical attention right away if any of these SEVERE side effects occur when using Cefdinir: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 .
Cefdinir 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 Cefdinir Suspension: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cefdinir Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Cefdinir Suspension:Diarrhea; headache; nausea.
TopSevere 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.
For the professional
Cefdinir
Clinical Trials
Cefdinir for Oral Suspension (Pediatric Patients)In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S.) were treated with the recommended dose of Cefdinir suspension (14 mg/kg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to Cefdinir. Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with Cefdinir therapy. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 2289 (0.2%) 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 suspension in multiple-dose clinical trials (N = 1783 Cefdinir-treated patients):
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b Laboratory changes were occasionally reported as adverse events. |
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| U.S. TRIALS IN PEDIATRIC PATIENTS | ||
| (N = 1783)a | ||
| Incidence ≥ 1% | Diarrhea | 8% |
| Rash | 3% | |
| Vomiting | 1% | |
| Incidence < 1% but > 0.1% | Cutaneous moniliasis | 0.9% |
| Abdominal pain | 0.8% | |
| Leukopeniab | 0.3% | |
| Vaginal moniliasis | 0.3% of girls | |
| Vaginitis | 0.3% of girls | |
| Abnormal stools | 0.2% | |
| Dyspepsia | 0.2% | |
| Hyperkinesia | 0.2% | |
| Increased ASTb | 0.2% | |
| Maculopapular rash | 0.2% | |
| Nausea | 0.2% | |
NOTE: In both Cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The incidence of diarrhea in Cefdinir-treated patients ≤ 2 years of age was 17% (95/557) compared with 4% (51/1226) in those > 2 years old. The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients ≤ 2 years of age compared with 1% (8/1226) in those > 2 years old.
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.:
| U.S. TRIALS IN PEDIATRIC PATIENTS | ||
| (N = 1783) | ||
| Incidence ≥ 1% | ↑Lymphocytes, ↓Lymphocytes | 2%, 0.8% |
| ↑Alkaline phosphatase | 1% | |
| ↓Bicarbonatea | 1% | |
| ↑Eosinophils | 1% | |
| ↑Lactate dehydrogenase | 1% | |
| ↑Platelets | 1% | |
| ↑PMNs, ↓PMNs | 1%, 1% | |
| ↑Urine protein | 1% | |
| Incidence < 1% but > 0.1% | ↑Phosphorous, ↓Phosphorus | 0.9%, 4% |
| ↑Urine pH | 0.8% | |
| ↓White blood cells, ↑White blood cells | 0.7%, 3% | |
| ↓Calciuma | 0.5% | |
| ↓Hemoglobin | 0.5% | |
| ↑Urine leukocytes | 0.5% | |
| ↑Monocytes | 0.4% | |
| ↑AST | 0.3% | |
| ↑Potassiuma | 0.3% | |
| ↑Urine specific gravity, ↓Urine specific gravity | 0.3%, 1% | |
| ↓Hematocrita | 0.2% | |
Postmarketing Experience
The following adverse experiences and altered laboratory tests, regardless of their relationship to Cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leucopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible Cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements, and rhabdomyolysis.
Cephalosporin Class Adverse Events
The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:
Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment.
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.
TopBy body system
Gastrointestinal side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
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 side effects
Ocular adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included conjunctivitis.
Respiratory side effects
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 side effects
Adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included fever, shock, feeling of suffocation, and facial and laryngeal edema.
Cardiovascular side effects
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 side effects
Musculoskeletal adverse effects reported during postmarketing experience with cefdinir, regardless of causality, have included involuntary movements and rhabdomyolysis.
Other side effects
Geriatric patients have been reported to experience a lower rate of adverse events, including diarrhea, than younger patients.
TopMore resources:
Cefdinir - Includes detailed dosage instructions.
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