{
 "query": "ciprofloxacin",
 "ingredient": "ciprofloxacin",
 "slug": "ciprofloxacin",
 "rxcui": "2551",
 "brands": [
  "Ciloxan",
  "Cipro",
  "Cetraxal",
  "Proquin"
 ],
 "names": [
  "ciprofloxacin",
  "ciprofloxacin hydrochloride",
  "ciprofloxacin lactate"
 ],
 "classes": [
  {
   "id": "J01MA",
   "name": "Fluoroquinolones"
  },
  {
   "id": "S01AE",
   "name": "Fluoroquinolones"
  },
  {
   "id": "S02AA",
   "name": "Antiinfectives"
  },
  {
   "id": "S03AA",
   "name": "Antiinfectives"
  }
 ],
 "alternatives": [
  "acetic acid",
  "aluminum acetotartrate",
  "besifloxacin",
  "boric acid",
  "chloramphenicol",
  "chlorhexidine",
  "clioquinol",
  "delafloxacin",
  "enoxacin",
  "fleroxacin",
  "fosfomycin",
  "gatifloxacin",
  "gemifloxacin",
  "gentamicin",
  "grepafloxacin",
  "hexamidine",
  "hydrogen peroxide",
  "levofloxacin",
  "lomefloxacin",
  "miconazole",
  "moxifloxacin",
  "neomycin",
  "nitrofurazone",
  "norfloxacin",
  "ofloxacin",
  "pefloxacin",
  "polymyxin b",
  "rifamycin sv",
  "sparfloxacin",
  "temafloxacin",
  "tetracycline",
  "trovafloxacin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 131,
   "OPHTHALMIC": 25,
   "AURICULAR (OTIC)": 19,
   "INTRAVENOUS": 4
  },
  "boxed_warning": "WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including ciprofloxacin, 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 ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 - 5.16) ], reserve ciprofloxacin for use in patients who have ...",
  "indications_and_usage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Infectious Diarrhea ( 1.4 ) Typhoid Fever (Enteric Fever) ( 1.5 ) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Chronic Bacterial Prostatitis ( 1.9 ) Lower Respiratory Tract Infections ( 1.10 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11 ) Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13 ) 1.1 Skin and Skin Structure In...",
  "contraindications": "Known hypersensitivity to ciprofloxacin or other quinolones ( 4.1 , 5.6 , 5.7 ) Concomitant administration with tizanidine ( 4.2 ) 4.1 Hypersensitivity Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7) ]. 4.2 Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7) ].",
  "warnings_and_cautions": "Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin. Discontinue ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1 , 5.6 , 5.7 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. ( 5.8 ) Clostridioides difficile -associated diarrhea: Evaluate if colitis occurs. ( 5.11 ) QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. ( 5.12 , 7 , 8.5 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin, 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, perip...",
  "warnings": "",
  "adverse_reactions": "The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [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) ] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions (5.10) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.11) ] Prolongation of the QT Interval [see Warnings and Precautions (5.12) ] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.13) ] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.14) ] Dev...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration, Important Administration Instructions ( 2.1 ) 11/2021",
  "information_for_patients": "Advise the patient to read the FDA -approved patient labeling (Medication Guide) Serious Adverse Reactions Advise patients to stop taking ciprofloxacin 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 ciprofloxacin 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 ciprofloxacin tablets and may occur together in the same patient. Inform patients to stop taking ciprofloxacin 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 r...",
  "spl_medguide": "Medication Guide Ciprofloxacin Tablets, USP for oral use (sih-proe-FLOX-ah-sin) Read this Medication Guide before you start taking ciprofloxacin tablets and each time you get a refill. There may be new information. This information 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 ciprofloxacin tablets? Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). Tendon problems can happen in people of all ages who take ciprofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: pain swelling tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites. The risk of getting tend...",
  "clinical_studies": "14.1 Complicated Urinary Tract Infection and Pyelonephritis\u2013Efficacy in Pediatric Patients Ciprofloxacin administered intravenously and/or orally was compared to a cephalosporin for treatment of cUTI and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 \u00b1 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety. Patients were evaluated for clinical success and bacteriological eradication of the baseline organism(s) with no new infection or superinfection at 5 to 9 days post-therapy (Test of Cure or TOC). The Per Protocol population had a causative organism(s) with protocol specified colony count(s) at baseline, no protocol violation, and no premature discontinuation or loss to follow-up (among other criteria). The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between ciprofloxacin and the comparator group as shown below. Table 12: Clinical Success and ...",
  "brand_name": "Ciprofloxacin Hydrochloride",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "ANDA076593",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260108",
  "set_id": "1057be77-00bb-4839-be3d-c8e11ae531a2",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 84645,
  "serious": 70760,
  "death": 7727,
  "hospitalization": 31815,
  "primary_suspect": 84146,
  "top_reactions": [
   [
    "Drug Hypersensitivity",
    5912
   ],
   [
    "Fatigue",
    5724
   ],
   [
    "Pain",
    5188
   ],
   [
    "Acute Kidney Injury",
    5130
   ],
   [
    "Diarrhoea",
    5114
   ],
   [
    "Nausea",
    5028
   ],
   [
    "Arthralgia",
    5022
   ],
   [
    "Off Label Use",
    4812
   ],
   [
    "Drug Ineffective",
    4784
   ],
   [
    "Chronic Kidney Disease",
    4659
   ],
   [
    "Dyspnoea",
    4085
   ],
   [
    "Vomiting",
    3799
   ],
   [
    "Headache",
    3638
   ],
   [
    "Anxiety",
    3473
   ],
   [
    "Pyrexia",
    3436
   ]
  ],
  "by_year": {
   "2019": 11440,
   "2020": 8345,
   "2021": 7345,
   "2022": 5364,
   "2023": 5647,
   "2024": 5379,
   "2025": 4789,
   "2026": 2040
  },
  "by_year_primary": {
   "2019": 11428,
   "2020": 8332,
   "2021": 7296,
   "2022": 5278,
   "2023": 5511,
   "2024": 5287,
   "2025": 4735,
   "2026": 2006
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250311",
   "reason": "Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241216",
   "reason": "Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240723",
   "reason": "Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190702",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Altaire Pharmaceuticals, Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20190702",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Altaire Pharmaceuticals, Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20190702",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Altaire Pharmaceuticals, Inc.",
   "status": "Completed"
  },
  {
   "class": "Class III",
   "date": "20120309",
   "reason": "Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.",
   "firm": "Pack Pharmaceuticals",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 54,
  "nda": 10,
  "anda": 39,
  "first_approval": "19871022",
  "rems": false,
  "rems_last": "20110803",
  "labeling_supplements": 173,
  "labeling_recent": 8,
  "sponsors": [
   "AIPING PHARM INC",
   "ALEMBIC THERAP",
   "ALK ABELLO",
   "ALTAIRE PHARMS INC",
   "AMNEAL",
   "AUROBINDO PHARMA",
   "BARR",
   "BAXTER HLTHCARE"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/22/1987"
 },
 "trials": {
  "total": 443,
  "completed": 274,
  "terminated": 61,
  "with_results": 75,
  "industry": 127,
  "phase3": 92,
  "results_share": 0.2737226277372263,
  "terminated_share": 0.13769751693002258
 },
 "pubmed": {
  "rct": 676,
  "meta": 20,
  "recent_rct": 24,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ciprofloxacin",
   "Ciloxan",
   "Cipro",
   "Cetraxal",
   "Proquin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4864951,
  "beneficiaries": 3547499,
  "spend": 34602813.71,
  "by_brand": [
   {
    "brand": "Ciprofloxacin HCl",
    "claims": 4856922,
    "per_claim": 6.7246056556,
    "is_generic": true
   },
   {
    "brand": "Ciloxan",
    "claims": 5419,
    "per_claim": 280.03523344,
    "is_generic": false
   },
   {
    "brand": "Cipro",
    "claims": 2197,
    "per_claim": 174.16376878,
    "is_generic": false
   },
   {
    "brand": "Cipro",
    "claims": 401,
    "per_claim": 95.735461347,
    "is_generic": false
   },
   {
    "brand": "Ciprofloxacin",
    "claims": 12,
    "per_claim": 282.4925,
    "is_generic": true
   }
  ],
  "per_claim": 7.112674662088066
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ciprofloxacin",
  "matched": "ciprofloxacin",
  "stewardship": [
   "KeyAccessGroup",
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 12028,
  "fills": 4864951,
  "per_million": 2472.378447388268,
  "ratio": 0.8928939371340365,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,472 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "676 randomized trials and 20 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 27% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 0 Class III across 39 generic makers (-6)",
    "8 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 (39 applications)",
    "32 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "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, fatigue, pain, acute kidney injury. How would we recognize and handle those?",
  "Why this one over acetic acid, aluminum acetotartrate, besifloxacin? 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.)"
 ]
}