Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cefdinir
Drug ID BADD_D00384
Description Cefdinir, also known as Omnicef, is a semi-synthetic, broad-spectrum antibiotic belonging to the third generation of the cephalosporin class. It has been proven to be effective for the treatment of common bacterial infections in the ear, sinus, throat, lungs, and skin. Cefdinir was approved by the FDA in 1997 to treat a variety of mild to moderate infections and was initially marketed by Abbvie.[A180739] Because of its chemical structure, it is effective against organisms that are resistant to first-line cephalosporin therapy due to the production of beta-lactamase enzymes.[A180724,A180727]
Indications and Usage Cefdinir is indicated to treat acute bacterial otitis media, acute maxillary sinusitis, community-acquired (CA) pneumonia, acute bacterial exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in children and adults.[L7330,A180739] The organisms susceptible to cefdinir have been listed below in addition to their associated clinical condition that may be treated with cefdinir.[L7330] Various beta-lactamase producing organisms may be treated, as indicated in certain sections below. **Respiratory** Acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis Community-acquired pneumonia caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis **Ear, nose, and throat** Acute bacterial otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae (penicillin-susceptible only) Tonsillitis caused by Streptococcus pyogenes Pharyngitis caused by Streptococcus pyogenes Acute maxillary sinusitis caused by Haemophilus pneumoniae and Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis **Skin and skin structure infections** Uncomplicated skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Marketing Status approved
ATC Code J01DD15
DrugBank ID DB00535
KEGG ID D00917; D11571
MeSH ID D000077525
PubChem ID 6915944
TTD Drug ID D0WS1X
NDC Product Code 16714-392; 43063-959; 68071-3403; 71205-183; 71205-405; 65862-177; 16714-391; 53002-1526; 67296-1448; 68001-362; 68071-2599; 68071-5145; 68788-8404; 71205-576; 72189-185; 43063-964; 50090-6417; 68071-1645; 68180-722; 68788-7987; 68788-8115; 68788-7844; 71205-224; 72189-186; 0781-6077; 0093-4136; 0093-4137; 67296-1216; 67877-548; 16714-393; 50090-2719; 50090-3723; 65862-218; 67296-0765; 68071-2975; 68071-3156; 68788-8062; 68788-8323; 71205-380; 72189-308; 0093-3160; 50090-6171; 53002-2654; 57237-099; 63187-989; 70518-2537; 72189-423; 72789-061; 0781-6078; 68071-2493; 68071-2564; 68180-723; 68788-7339; 72189-259; 72789-054; 61788-2000; 50090-1034; 63187-616; 65862-219; 67877-543; 68071-2683; 70934-062; 72189-043; 50090-1033; 50090-5811; 50090-6042; 60687-699; 61919-840; 63187-835; 63629-8968; 67877-547; 68071-2401; 68180-711; 68788-7478; 70518-3577; 0781-2176; 65862-384; 82608-012; 50090-6041
UNII CI0FAO63WC
Synonyms Cefdinir | FK 482 | FK-482 | FK482 | PD 134393 | PD-134393 | 7-(2 (2-Aminothiazol-4-yl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic acid | CI 983 | CI-983 | CI983 | Omnicef
Chemical Information
Molecular Formula C14H13N5O5S2
CAS Registry Number 91832-40-5
SMILES C=CC1=C(N2C(C(C2=O)NC(=O)C(=NO)C3=CSC(=N3)N)SC1)C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Leukopenia01.02.02.001--Not Available
Loss of consciousness17.02.04.004--Not Available
Melaena07.12.02.004; 24.07.02.013--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Nephropathy20.05.03.001--Not Available
Nephropathy toxic20.05.03.002; 12.03.01.010--Not Available
Neutropenia01.02.03.004--Not Available
Pancytopenia01.03.03.003--Not Available
Peptic ulcer07.04.07.001--Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Pseudomembranous colitis11.02.02.002; 07.19.01.003--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Renal failure20.01.03.005--Not Available
Rhabdomyolysis15.05.05.002--
Seizure17.12.03.001--
Serum sickness10.01.03.004; 12.02.08.004--
Serum sickness-like reaction10.01.03.005; 08.01.03.003--Not Available
Shock24.06.02.002--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Suffocation feeling22.12.02.014--Not Available
Thrombocytopenia01.08.01.002--Not Available
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