{
 "query": "cefdinir",
 "ingredient": "cefdinir",
 "slug": "cefdinir",
 "rxcui": "25037",
 "brands": [],
 "names": [
  "cefdinir",
  "cefdinir monohydrate"
 ],
 "classes": [
  {
   "id": "J01DD",
   "name": "Third-generation cephalosporins"
  }
 ],
 "alternatives": [
  "cefditoren",
  "cefetamet",
  "cefixime",
  "cefodizime",
  "cefoperazone",
  "cefotaxime",
  "cefpodoxime",
  "cefsulodin",
  "ceftazidime",
  "ceftibuten",
  "ceftizoxime",
  "ceftriaxone",
  "moxalactam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 66
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents Community-Acquired Pneumonia Caused by Haemophilus influenzae (including \u03b2-lactamase producing strains), Haemophilus parainfluenzae (including \u03b2-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including \u03b2-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis C...",
  "contraindications": "CONTRAINDICATIONS Cefdinir for oral suspension is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS BEFORE THERAPY WITH CEFDINIR FOR ORAL SUSPENSION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG \u03b2-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the ...",
  "adverse_reactions": "ADVERSE EVENTS 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): ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION U.S. TRIALS IN PEDIATRIC PATIENTS (N = 1783) 1 Incidence \u2265 1% Diarrhea 8% Rash 3% Vomiting 1% Incidence < 1% but > 0.1% Cutaneous moniliasis 0.9% Abdominal pain 0.8% Leukopenia 2 0.3% Vaginal moniliasis 0.3% of girls Vagi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs including cefdinir for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefdinir for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefdinir for oral suspension or other antibacterial drugs in the future. Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the antacid. Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir for oral suspension therapy, cefdinir...",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL STUDIES Community-Acquired Bacterial Pneumonia In a controlled, double-blind study in adults and adolescents conducted in the U.S., cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days post therapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained: U.S. Community-Acquired Pneumonia Study Cefdinir vs Cefaclor Cefdinir BID Cefaclor TID Outcome Clinical Cure Rates 150/187 (80%) 147/186 (79%) Cefdinir equivalent to control Eradication Rates Overall 177/195 (91%) 184/200 (92%) Cefdinir equivalent to control S. pneumoniae 31/31 (100%) 35/35 (100%) H. influenzae 55/65 (85%) 60/72 (83%) M. catarrhalis 10/10 (100%) 11/11 (100%) H. parainfluenzae 81/89 (91%) 78/82 (95%) In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, cefdinir BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days post therapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes wer...",
  "brand_name": "Cefdinir",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "ANDA065332",
  "pharm_class_epc": [
   "Cephalosporin Antibacterial [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250813",
  "set_id": "1d58b10c-b253-4925-8681-580aa2e8ae2e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7720,
  "serious": 4650,
  "death": 571,
  "hospitalization": 2361,
  "primary_suspect": 7711,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    549
   ],
   [
    "Diarrhoea",
    500
   ],
   [
    "Pneumonia",
    492
   ],
   [
    "Fatigue",
    464
   ],
   [
    "Nausea",
    405
   ],
   [
    "Renal Failure",
    398
   ],
   [
    "Acute Kidney Injury",
    384
   ],
   [
    "Sinusitis",
    355
   ],
   [
    "Headache",
    347
   ],
   [
    "Pain",
    344
   ],
   [
    "Urinary Tract Infection",
    319
   ],
   [
    "Dyspnoea",
    315
   ],
   [
    "Drug Ineffective",
    310
   ],
   [
    "Drug Hypersensitivity",
    304
   ],
   [
    "Off Label Use",
    304
   ]
  ],
  "by_year": {
   "2019": 1053,
   "2020": 980,
   "2021": 647,
   "2022": 472,
   "2023": 453,
   "2024": 551,
   "2025": 541,
   "2026": 266
  },
  "by_year_primary": {
   "2019": 1053,
   "2020": 980,
   "2021": 646,
   "2022": 471,
   "2023": 452,
   "2024": 549,
   "2025": 538,
   "2026": 265
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240508",
   "reason": "Defective container: lack of seal integrity.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20240424",
   "reason": "Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20240424",
   "reason": "Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200702",
   "reason": "Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191101",
   "reason": "Presence of Foreign substance: identified as a dead ant.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191101",
   "reason": "Presence of Foreign substance: identified as a dead ant.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190523",
   "reason": "Complaint received of metal piece identified in the product bottle prior to the reconstitution.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190102",
   "reason": "CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190102",
   "reason": "CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180327",
   "reason": "Superpotent Drug",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130226",
   "reason": "Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.",
   "firm": "Teva Pharmaceuticals USA, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 14,
  "nda": 2,
  "anda": 12,
  "first_approval": "19971204",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ABBVIE",
   "ALKEM LABS LTD",
   "ANDA REPOSITORY",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "LUPIN",
   "TEVA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/04/1997"
 },
 "trials": {
  "total": 32,
  "completed": 24,
  "terminated": 2,
  "with_results": 8,
  "industry": 19,
  "phase3": 2,
  "results_share": 0.3333333333333333,
  "terminated_share": 0.0625
 },
 "pubmed": {
  "rct": 37,
  "meta": 0,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cefdinir"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2313999,
  "beneficiaries": 1855308,
  "spend": 35355463.28,
  "by_brand": [
   {
    "brand": "Cefdinir",
    "claims": 2313999,
    "per_claim": 15.278944926,
    "is_generic": true
   }
  ],
  "per_claim": 15.278944926078188
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": null,
  "name": "cefdinir",
  "matched": "cefdinir",
  "stewardship": [
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1352,
  "fills": 2313999,
  "per_million": 584.2699154148295,
  "ratio": 0.21100777094817882,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "584 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 18,
   "letter": "F",
   "why": [
    "37 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 33% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 8 Class II, 2 Class III across 12 generic makers (-7)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (12 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, diarrhoea, pneumonia, fatigue. How would we recognize and handle those?",
  "Why this one over cefditoren, cefetamet, cefixime? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}