{
 "query": "azithromycin",
 "ingredient": "azithromycin",
 "slug": "azithromycin",
 "rxcui": "18631",
 "brands": [
  "AzaSite",
  "Zithromax"
 ],
 "names": [
  "azithromycin",
  "azithromycin anhydrous",
  "azithromycin dihydrate",
  "azithromycin monohydrate",
  "azithromycin sodium dihydrogen phosphate"
 ],
 "classes": [
  {
   "id": "J01FA",
   "name": "Macrolides"
  },
  {
   "id": "S01AA",
   "name": "Antibiotics"
  }
 ],
 "alternatives": [
  "amikacin",
  "ampicillin",
  "bacitracin",
  "cefuroxime",
  "chloramphenicol",
  "chlortetracycline",
  "clarithromycin",
  "dibekacin",
  "dihydrostreptomycin",
  "dirithromycin",
  "erythromycin",
  "framycetin",
  "fusidic acid",
  "gentamicin",
  "josamycin",
  "kanamycin",
  "micronomicin",
  "midecamycin",
  "miocamycin",
  "natamycin",
  "neomycin",
  "netilmicin",
  "oleandomycin",
  "oxytetracycline",
  "penicillin g",
  "polymyxin b",
  "rifamycin sv",
  "roxithromycin",
  "spiramycin",
  "telithromycin",
  "tetracycline",
  "tobramycin",
  "troleandomycin",
  "tyrothricin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 135,
   "INTRAVENOUS": 11,
   "PARENTERAL": 2,
   "OPHTHALMIC": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "(azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults ( 1.1 ) Urethritis and cervicitis in adults ( 1.1 ) Genital ulcer disease in men ( 1.1 ) Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate t...",
  "contraindications": "Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. ( 4.1 ) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 ) 4.1 Hypersensitivity ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. 4.2 Hepatic Dysfunction ZITHROMAX is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.",
  "warnings_and_cautions": "Serious (including fatal) allergic and skin reactions: Discontinue ZITHROMAX if reaction occurs. ( 5.1 ) Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue ZITHROMAX immediately if signs and symptoms of hepatitis occur. ( 5.2 ) Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. ( 5.3 ) Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. ( 5.4 ) Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescrib...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ] QT Prolongation [see Warnings and Precautions (5.4) ] Cardiovascular Death [see Warnings and Precautions (5.5) ] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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, most of the reported side effects were mild to moderate in severit...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Cardiovascular Death ( 5.5 ) 11/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). General Patient Counseling ZITHROMAX tablets and oral suspension can be taken with or without food. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously. The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur. Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant. Patients should be counseled that antibacterial drugs including ZITHROMAX (azithromycin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZITHROMAX (azithromycin) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the 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...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adult Patients Acute Bacterial Exacerbations of Chronic Bronchitis In a randomized, double-blind controlled clinical trial of acute exacerbation of chronic bronchitis (AECB), azithromycin (500 mg once daily for 3 days) was compared with clarithromycin (500 mg twice daily for 10 days). The primary endpoint of this trial was the clinical cure rate at Days 21\u2013 24. For the 304 patients analyzed in the modified intent-to-treat analysis at the Days 21\u201324 visit, the clinical cure rate for 3 days of azithromycin was 85% (125/147) compared to 82% (129/157) for 10 days of clarithromycin. The following outcomes were the clinical cure rates at the Days 21\u201324 visit for the bacteriologically evaluable patients by pathogen: Pathogen Azithromycin (3 Days) Clarithromycin (10 Days) S. pneumoniae 29/32 (91%) 21/27 (78%) H. influenzae 12/14 (86%) 14/16 (88%) M. catarrhalis 11/12 (92%) 12/15 (80%) Acute Bacterial Sinusitis In a randomized, double-blind, double-dummy controlled clinical trial of acute bacterial sinusitis, azithromycin (500 mg once daily for 3 days) was compared with amoxicillin/clavulanate (500/125 mg three times a day for 10 days). Clinical response assessments were made at Day 10...",
  "brand_name": "Zithromax",
  "manufacturer": "Redpharm Drug",
  "application_number": "NDA050711",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250903",
  "set_id": "3ddecd25-dc32-a2af-e063-6294a90a526d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 82635,
  "serious": 61659,
  "death": 7354,
  "hospitalization": 29094,
  "primary_suspect": 82267,
  "top_reactions": [
   [
    "Off Label Use",
    9565
   ],
   [
    "Drug Ineffective",
    6594
   ],
   [
    "Chronic Kidney Disease",
    5654
   ],
   [
    "Dyspnoea",
    5503
   ],
   [
    "Acute Kidney Injury",
    4567
   ],
   [
    "Pneumonia",
    4193
   ],
   [
    "Nausea",
    4013
   ],
   [
    "Cough",
    3921
   ],
   [
    "Drug Hypersensitivity",
    3730
   ],
   [
    "Diarrhoea",
    3651
   ],
   [
    "Fatigue",
    3608
   ],
   [
    "Renal Failure",
    3513
   ],
   [
    "Pain",
    3082
   ],
   [
    "Headache",
    3039
   ],
   [
    "Condition Aggravated",
    2915
   ]
  ],
  "by_year": {
   "2019": 9630,
   "2020": 12004,
   "2021": 9297,
   "2022": 6864,
   "2023": 6088,
   "2024": 5887,
   "2025": 5749,
   "2026": 2744
  },
  "by_year_primary": {
   "2019": 9623,
   "2020": 11994,
   "2021": 9261,
   "2022": 6801,
   "2023": 6046,
   "2024": 5816,
   "2025": 5683,
   "2026": 2687
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20140102",
   "reason": "Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 74,
  "nda": 10,
  "anda": 62,
  "first_approval": "19911101",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 151,
  "labeling_recent": 16,
  "sponsors": [
   "ALEMBIC",
   "AMNEAL",
   "APOTEX CORP",
   "AUROBINDO PHARMA LTD",
   "AUROBINDO PHARMA USA",
   "BIONPHARMA",
   "CARLSBAD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/01/1991"
 },
 "trials": {
  "total": 710,
  "completed": 412,
  "terminated": 116,
  "with_results": 143,
  "industry": 194,
  "phase3": 185,
  "results_share": 0.3470873786407767,
  "terminated_share": 0.16338028169014085
 },
 "pubmed": {
  "rct": 859,
  "meta": 119,
  "recent_rct": 178,
  "cochrane": [
   {
    "pmid": "38411248",
    "title": "Macrolide antibiotics (including azithromycin) for cystic fibrosis",
    "year": "2024"
   },
   {
    "pmid": "25749735",
    "title": "Azithromycin for acute lower respiratory tract infections",
    "year": "2015"
   },
   {
    "pmid": "22696367",
    "title": "Azithromycin versus penicillin G benzathine for early syphilis",
    "year": "2012"
   },
   {
    "pmid": "21975751",
    "title": "WITHDRAWN: Azithromycin for treating uncomplicated typhoid and paratyphoid fever (enteric fever)",
    "year": "2011"
   },
   {
    "pmid": "21328286",
    "title": "Azithromycin for treating uncomplicated malaria",
    "year": "2011"
   },
   {
    "pmid": "18843701",
    "title": "Azithromycin for treating uncomplicated typhoid and paratyphoid fever (enteric fever)",
    "year": "2008"
   },
   {
    "pmid": "18253999",
    "title": "Azithromycin for acute lower respiratory tract infections",
    "year": "2008"
   },
   {
    "pmid": "15497172",
    "title": "Azithromycin for acute lower respiratory tract infections",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "azithromycin",
   "AzaSite",
   "Zithromax"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 8790821,
  "beneficiaries": 6348813,
  "spend": 47294775.67,
  "by_brand": [
   {
    "brand": "Azithromycin",
    "claims": 8784697,
    "per_claim": 5.2022007851,
    "is_generic": true
   },
   {
    "brand": "Azasite",
    "claims": 5084,
    "per_claim": 309.72311172,
    "is_generic": false
   },
   {
    "brand": "Zithromax",
    "claims": 1040,
    "per_claim": 19.601673077,
    "is_generic": false
   }
  ],
  "per_claim": 5.380018051783787
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20180802",
   "title": "FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm614085.htm",
   "kind": "drug",
   "matched": "azithromycin"
  },
  {
   "date": "20130312",
   "title": "Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm341822.htm",
   "kind": "drug",
   "matched": "azithromycin"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "azithromycin",
  "matched": "azithromycin",
  "stewardship": [
   "KeyAccessGroup",
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 14186,
  "fills": 8790821,
  "per_million": 1613.728683589394,
  "ratio": 0.5827944986651874,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 79,
   "letter": "B",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2018 (-16)",
    "1,614 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 77,
   "letter": "B",
   "why": [
    "859 randomized trials and 119 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "8 independent Cochrane review(s) exist",
    "Only 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 62 generic makers (-1)",
    "16 label changes approved since 2021: the safety story is still moving (-8)",
    "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 (62 applications)",
    "35 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "In 2018 the FDA issued a safety communication about this drug (FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiot). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, dyspnoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amikacin, ampicillin, bacitracin? 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.)"
 ]
}