{
 "query": "cephalexin",
 "ingredient": "cephalexin",
 "slug": "cephalexin",
 "rxcui": "2231",
 "brands": [],
 "names": [
  "cephalexin",
  "cephalexin anhydrous",
  "cephalexin hydrochloride",
  "cephalexin monohydrate"
 ],
 "classes": [
  {
   "id": "J01DB",
   "name": "First-generation cephalosporins"
  }
 ],
 "alternatives": [
  "cefadroxil",
  "cefatrizine",
  "cefazolin",
  "cephaloridine",
  "cephalothin",
  "cephapirin",
  "cephradine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 139
  },
  "boxed_warning": "",
  "indications_and_usage": "Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Respiratory Tract Infections Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . 1.2 Otitis Media Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis . 1.3 Skin and Skin Structure Infections Cephalexin capsules USP are indicated for the treatment of skin and skin structure infe...",
  "contraindications": "Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. ( 4 ) Cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.",
  "warnings_and_cautions": "Serious hypersensitivity (anaphylactic) reactions : Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. ( 5.1 ) Clostridioides difficile -Associated Diarrhea (CDAD) : Evaluate if diarrhea occurs. ( 5.2 ) Direct Coombs' Test Seroconversion : If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia.( 5.3 ) Seizure Potential : Use lower dose in patients with renal impairment. ( 5.4 ) 5.1 Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin. Before therapy with cephalexin capsules is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cephalexin occurs, discontinue the drug and i...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity Reactions [see WARNING AND PRECAUTIONS ( 5.1 )] Clostridioides difficile -Associated Diarrhea [see WARNINGS AND PRECAUTIONS ( 5.2 )] Direct Coombs' Test Seroconversion [see WARNINGS AND PRECAUTIONS ( 5.3 )] Seizure Potential [see WARNINGS AND PRECAUTIONS ( 5.4 )] Prolonged Prothrombin Time [see WARNINGS AND PRECAUTIONS ( 5.5 )] Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS ( 5.6 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, ga...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Dosage and Administration ( 2 ) 7/2026",
  "information_for_patients": "Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin capsules, other beta-lactams (including cephalosporins) or other allergens ( 5.1 ) Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider. Antibacterial Resistance Patients should be counseled that antibacterial drugs including cephalexin capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules are prescribed to treat a bacterial infection, patients should be told that 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) decr...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Cephalexin",
  "manufacturer": "Lupin Pharmaceuticals, Inc.",
  "application_number": "ANDA065229",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260824",
  "set_id": "1d3e6d33-5dc2-498e-8efa-e3c4fca15dff",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 100",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 30869,
  "serious": 21062,
  "death": 2273,
  "hospitalization": 9347,
  "primary_suspect": 30815,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    2954
   ],
   [
    "Drug Hypersensitivity",
    2308
   ],
   [
    "Acute Kidney Injury",
    2151
   ],
   [
    "Diarrhoea",
    1956
   ],
   [
    "Renal Failure",
    1897
   ],
   [
    "Fatigue",
    1862
   ],
   [
    "Nausea",
    1709
   ],
   [
    "Rash",
    1649
   ],
   [
    "Drug Ineffective",
    1558
   ],
   [
    "Pain",
    1546
   ],
   [
    "Headache",
    1503
   ],
   [
    "Dyspnoea",
    1481
   ],
   [
    "Off Label Use",
    1480
   ],
   [
    "Urinary Tract Infection",
    1222
   ],
   [
    "Anxiety",
    1149
   ]
  ],
  "by_year": {
   "2019": 4237,
   "2020": 3286,
   "2021": 2588,
   "2022": 2032,
   "2023": 1943,
   "2024": 2008,
   "2025": 1910,
   "2026": 928
  },
  "by_year_primary": {
   "2019": 4237,
   "2020": 3286,
   "2021": 2585,
   "2022": 2018,
   "2023": 1940,
   "2024": 1984,
   "2025": 1901,
   "2026": 928
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240510",
   "reason": "Labeling: Not Elsewhere Classified: Back label states  Each contains: cephalexin monohydrate, USP equivalent to 2.5g'  instead of  Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240510",
   "reason": "Labeling: Not Elsewhere Classified: Back Label states  Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of  Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240510",
   "reason": "Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g'  instead of  Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240510",
   "reason": "Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g'  instead of  Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240510",
   "reason": "Labeling: Not Elsewhere Classified: Front label states   100 Tablets  instead of  100 ml  and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210412",
   "reason": "Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin",
   "firm": "Preferred Pharmaceuticals, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20190109",
   "reason": "CGMP Deviations; presence of extraneous material in the  was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 58,
  "nda": 4,
  "anda": 44,
  "first_approval": "19710104",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 91,
  "labeling_recent": 2,
  "sponsors": [
   "AJENAT PHARMS",
   "ALKEM LABS LTD",
   "ANDA REPOSITORY",
   "APOTHECON",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BARR",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/04/1971"
 },
 "trials": {
  "total": 120,
  "completed": 67,
  "terminated": 14,
  "with_results": 31,
  "industry": 27,
  "phase3": 15,
  "results_share": 0.4626865671641791,
  "terminated_share": 0.11666666666666667
 },
 "pubmed": {
  "rct": 93,
  "meta": 2,
  "recent_rct": 3,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cephalexin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7489860,
  "beneficiaries": 5317376,
  "spend": 57528301.4,
  "by_brand": [
   {
    "brand": "Cephalexin",
    "claims": 7489860,
    "per_claim": 7.6808246616,
    "is_generic": true
   }
  ],
  "per_claim": 7.680824661609162
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4813,
  "fills": 7489860,
  "per_million": 642.6021314150064,
  "ratio": 0.23207432006859005,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "643 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": 39,
   "letter": "F",
   "why": [
    "93 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 5 Class III across 44 generic makers (-4)",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (44 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, drug hypersensitivity, acute kidney injury, diarrhoea. How would we recognize and handle those?",
  "Why this one over cefadroxil, cefatrizine, cefazolin? 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.)"
 ]
}