{
 "query": "moxifloxacin",
 "ingredient": "moxifloxacin",
 "slug": "moxifloxacin",
 "rxcui": "139462",
 "brands": [
  "Vigamox",
  "Avelox"
 ],
 "names": [
  "moxifloxacin",
  "moxifloxacin hydrochloride",
  "moxifloxacin hydrochloride monohydrate"
 ],
 "classes": [
  {
   "id": "J01MA",
   "name": "Fluoroquinolones"
  },
  {
   "id": "S01AE",
   "name": "Fluoroquinolones"
  }
 ],
 "alternatives": [
  "besifloxacin",
  "ciprofloxacin",
  "delafloxacin",
  "enoxacin",
  "fleroxacin",
  "gatifloxacin",
  "gemifloxacin",
  "grepafloxacin",
  "levofloxacin",
  "lomefloxacin",
  "norfloxacin",
  "ofloxacin",
  "pefloxacin",
  "sparfloxacin",
  "temafloxacin",
  "trovafloxacin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "OPHTHALMIC": 27,
   "ORAL": 23,
   "INTRAVENOUS": 3
  },
  "boxed_warning": "WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS andEXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin tablets, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] Peripheral neuropathy [see Warnings and Precautions ( 5.3 )] Central nervous system effects [see Warnings and Precautions ( 5.4 )] Discontinue moxifloxacin tablets immediately and avoid the use of fluoroquinolones, including moxifloxacin tablets, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )]. Fluoroquinolones, including moxifloxacin tablets, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin tablets in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )]. Because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 - 5.13 )] , ...",
  "indications_and_usage": "Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Plague ( 1.5 ) Acute Bacterial Sinusitis ( 1.6 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.8 ) 1.1 Community Acquired Pneumonia Moxifloxacin tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]) , Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumonia...",
  "contraindications": "Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions ( 5.8 )] . Known hypersensitivity to moxifloxacin tablets or other quinolones ( 4 , 5.8 )",
  "warnings_and_cautions": "Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin tablets. Discontinue moxifloxacin tablets at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) Clostridioides difficile- Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.10 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including moxifloxacin tablets, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peri...",
  "warnings": "",
  "adverse_reactions": "The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions ( 5.1 )] Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] QT Prolongation [see Warnings and Precautions ( 5.6 )] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.7 )] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 )] Blood Glucose Disturbances [see Warnings and Precautions ( 5.12 )] Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.13 )] Development of Drug Resistant Bacteria [see Warnings and Prec...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Hypersensitivity Reactions ( 5.8 ) 7/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide) Serious Adverse Reactions Advise patients to stop taking moxifloxacin tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with moxifloxacin tablets or other fluoroquinolone use: Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of moxifloxacin tablets and may occur together in the same patient. Inform patients to stop taking moxifloxacin tablets immediately if they experience an adverse reaction and to call their healthcare provider. Tendinitis and Tendon Rupture: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrai...",
  "spl_medguide": "MEDICATION GUIDE Moxifloxacin (mox i flox a sin) tablets, for oral use, USP Read the Medication Guide that comes with moxifloxacin tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about moxifloxacin tablets? Moxifloxacin tablets are in a class of antibiotics called fluoroquinolones. Moxifloxacin tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin tablets 1.Tendon rupture or swelling of the tendon (tendinitis). Tendon problems can happen in people of all ages who take moxifloxacin tablets . Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), sho...",
  "clinical_studies": "14.1 Acute Bacterial Sinusitis In a controlled double-blind study conducted in the US, moxifloxacin tablets (400 mg once daily for ten days) were compared with cefuroxime axetil (250 mg twice daily for ten days) for the treatment of acute bacterial sinusitis. The trial included 457 patients valid for the efficacy analysis. Clinical success (cure plus improvement) at the 7 to 21 day post-therapy test of cure visit was 90% for moxifloxacin tablets and 89% for cefuroxime. An additional non-comparative study was conducted to gather bacteriological data and to evaluate microbiological eradication in adult patients treated with moxifloxacin tablets 400 mg once daily for seven days. All patients (n = 336) underwent antral puncture in this study. Clinical success rates and eradication/presumed eradication rates at the 21 to 37 day follow-up visit were 97% (29 out of 30) for Streptococcus pneumoniae , 83% (15 out of 18) for Moraxella catarrhalis , and 80% (24 out of 30) for Haemophilus influenzae . 14.2 Acute Bacterial Exacerbation of Chronic Bronchitis Moxifloxacin tablets (400 mg once daily for five days) were evaluated for the treatment of acute bacterial exacerbation of chronic bronchit...",
  "brand_name": "Moxifloxacin",
  "manufacturer": "Macleods Pharmaceuticals Limited",
  "application_number": "ANDA209143",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260317",
  "set_id": "182ecd0f-714f-42f0-9b16-fb604cf15786",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 24795,
  "serious": 20878,
  "death": 2895,
  "hospitalization": 8085,
  "primary_suspect": 24711,
  "top_reactions": [
   [
    "Off Label Use",
    2560
   ],
   [
    "Drug Hypersensitivity",
    2449
   ],
   [
    "Dyspnoea",
    2376
   ],
   [
    "Drug Ineffective",
    2128
   ],
   [
    "Pneumonia",
    2128
   ],
   [
    "Pain",
    1983
   ],
   [
    "Vomiting",
    1920
   ],
   [
    "Asthma",
    1888
   ],
   [
    "Rash",
    1586
   ],
   [
    "Fatigue",
    1567
   ],
   [
    "Wheezing",
    1563
   ],
   [
    "Neuropathy Peripheral",
    1534
   ],
   [
    "Nausea",
    1531
   ],
   [
    "Malaise",
    1361
   ],
   [
    "Pyrexia",
    1324
   ]
  ],
  "by_year": {
   "2019": 2524,
   "2020": 2376,
   "2021": 1909,
   "2022": 1961,
   "2023": 2045,
   "2024": 2250,
   "2025": 2600,
   "2026": 966
  },
  "by_year_primary": {
   "2019": 2521,
   "2020": 2370,
   "2021": 1902,
   "2022": 1948,
   "2023": 2030,
   "2024": 2231,
   "2025": 2589,
   "2026": 960
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20190226",
   "reason": "Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190201",
   "reason": "Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180726",
   "reason": "Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 32,
  "nda": 6,
  "anda": 25,
  "first_approval": "19991210",
  "rems": false,
  "rems_last": "20110803",
  "labeling_supplements": 81,
  "labeling_recent": 3,
  "sponsors": [
   "ALEMBIC",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "BAYER HLTHCARE",
   "BAYER PHARMS",
   "CHARTWELL RX",
   "CROSSMEDIKA SA",
   "DR REDDYS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/10/1999"
 },
 "trials": {
  "total": 704,
  "completed": 543,
  "terminated": 54,
  "with_results": 150,
  "industry": 489,
  "phase3": 99,
  "results_share": 0.27624309392265195,
  "terminated_share": 0.07670454545454546
 },
 "pubmed": {
  "rct": 267,
  "meta": 28,
  "recent_rct": 28,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "moxifloxacin",
   "Vigamox",
   "Avelox"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1116701,
  "beneficiaries": 708017,
  "spend": 28326442.64,
  "by_brand": [
   {
    "brand": "Moxifloxacin",
    "claims": 1052157,
    "per_claim": 24.154419749,
    "is_generic": false
   },
   {
    "brand": "Moxifloxacin HCl",
    "claims": 64055,
    "per_claim": 43.605988447,
    "is_generic": true
   },
   {
    "brand": "Vigamox",
    "claims": 489,
    "per_claim": 243.39310838,
    "is_generic": false
   }
  ],
  "per_claim": 25.36618364271188
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Infectious diseases",
  "names": [
   "moxifloxacin"
  ],
  "reason": "Moxifloxacin, a fluoroquinolone antibiotic that is no more effective than other antibiotics of this class, can cause toxic epidermal necrolysis and fulminant hepatitis, and has also been linked to an increased risk of cardiac disorders ( Prescrire Int n\u00b0 62, 103, 117; Rev Prescrire n\u00b0 371). Another fluoroquinolone such as ciprofloxacin or ofloxacin is a better option. Neurology Alzheimer\u2019s disease. The cholinesterase inhibitors authorised for use in Alzheimer\u2019s disease, as well as memantine, have minimal and transient efficacy in this situation, and none has been shown to slow progression towa...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "moxifloxacin"
 },
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "moxifloxacin",
  "matched": "moxifloxacin",
  "stewardship": [
   "KeyAccessGroup",
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5780,
  "fills": 1116701,
  "per_million": 5175.9602615203175,
  "ratio": 1.8692864521773636,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "5,176 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-5)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 44,
   "letter": "F",
   "why": [
    "267 randomized trials and 28 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)",
    "Only 28% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 3 Class III across 25 generic makers (-1)",
    "3 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 (25 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are drug hypersensitivity, 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 besifloxacin, ciprofloxacin, delafloxacin? 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.)"
 ]
}