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Omnicef

"For nearly a century, bacteria-fighting drugs known as antibiotics have helped to control and destroy many of the harmful bacteria that can make us sick. But in recent decades, antibiotics have been losing their punch against some types of bac"...

Omnicef

Omnicef Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Omnicef (cefdinir) is used to treat many different types of infections caused by bacteria. It is a cephalosporin antibiotic. The brand name Omnicef is discontinued in the U.S. This medication is available in generic form. Common side effects include diarrhea or nausea.

The recommended dosage of cefdinir for infections in adults and adolescents ranges from 300 mg to 600 mg, taken either once or twice daily. Duration of treatment ranges from 5 to 10 days. Cefdinir may interact with probenecid, or vitamin or mineral supplements that contain iron. Other drugs may interact with cefdinir. Tell your doctor all prescription and over-the-counter medications and supplements you use. Cefdinir should be used only when prescribed during pregnancy. This drug does not pass into breast milk. Consult your doctor before breast-feeding.

Our Omnicef (cefdinir) 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 in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Omnicef in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • chest pain;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, stomach pain, indigestion, vomiting, mild diarrhea;
  • headache, dizziness;
  • diaper rash in an infant taking liquid cefdinir;
  • mild itching or skin rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Omnicef (Cefdinir) »

What is Patient Information Overview?

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

Omnicef Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea or nausea may occur. If either of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause your stools to turn a reddish color, especially if you also take iron products. This is harmless.

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 rare but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or 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 very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, 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 Omnicef (Cefdinir)»

What is Prescribing information?

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

Omnicef FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials - OMNICEF (cefdinir) Capsules (Adult and Adolescent Patients)

In clinical trials, 5093 adult and adolescent patients (3841 US and 1252 non-US) 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 US, 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 US TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)a

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%
a 1733 males, 2108 females

The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the US:

LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES US TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)

Incidence ≥ 1% ↑Urine leukocytes 2%
↑Urine protein 2%
↑Gamma-glutamyltransferasea 1%
↓Lymphocytes, ↑Lymphocytes 1%, 0.2%
↑Microhematuria 1%
Incidence < 1% but > 0.1% ↑Glucosea 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 gravitya 0.6%, 0.2%
↓Bicarbonatea 0.6%
↑Phosphorus, ↓Phosphorusa 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 dehydrogenasea 0.2%
↑Platelets 0.2%
↑Potassiuma 0.2%
↑Urine pHa 0.2%
a N < 3841 for these parameters

Clinical Trials - OMNICEF (cefdinir) for Oral Suspension (Pediatric Patients)

In clinical trials, 2289 pediatric patients (1783 US and 506 non-US) 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 US, 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):

ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION US 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%
a 977 males, 806 females
b Laboratory changes were occasionally reported as adverse events.

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 US:

LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION US 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% ↑Phosphorus, ↓Phosphorus 0.9%, 0.4%
↑Urine pH 0.8%
↓White blood cells, ↑White blood cells 0.7%, 0.3%
↓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%, 0.1%
↓Hematocrita 0.2%
a N=1387 for these parameters

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, leukopenia, 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 (see WARNINGS).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Read the entire FDA prescribing information for Omnicef (Cefdinir) »

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Omnicef - User Reviews

Omnicef User Reviews

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

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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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