{ "query": "levofloxacin", "ingredient": "levofloxacin", "slug": "levofloxacin", "rxcui": "82122", "brands": [], "names": [ "levofloxacin", "levofloxacin anhydrous" ], "classes": [ { "id": "J01MA", "name": "Fluoroquinolones" }, { "id": "S01AE", "name": "Fluoroquinolones" } ], "alternatives": [ "besifloxacin", "ciprofloxacin", "delafloxacin", "enoxacin", "fleroxacin", "gatifloxacin", "gemifloxacin", "grepafloxacin", "lomefloxacin", "moxifloxacin", "norfloxacin", "ofloxacin", "pefloxacin", "sparfloxacin", "temafloxacin", "trovafloxacin" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 65, "INTRAVENOUS": 10, "OPHTHALMIC": 2 }, "boxed_warning": "WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: o Tendinitis and tendon rupture ( 5.2 ) o Peripheral neuropathy ( 5.3 ) o Central nervous system effects ( 5.4 ) Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions ( 5.1 ) Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )] . Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions ( 5 ), reserve l...", "indications_and_usage": "Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). \u2022 Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) \u2022 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) \u2022 Chronic bacterial prostatitis ( 1.6 ) \u2022 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7 ) \u2022 Plague in adult and pediatric patients ( 1.8 ) \u2022 Urinary Tract Infections (UTI): Complicated ( 1.9 , 1.10 ) and Uncomplicated ( 1.12 ) \u2022 Acute Pyelonephritis ( 1.11 ) \u2022 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13 ) \u2022 Acute Bacterial Sinusitis ( 1.14 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.15 ). 1.1 Nosocomial Pneumonia Levofloxacin tablet is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureu...", "contraindications": "Known hypersensitivity to levofloxacin or other quinolones ( 4 , 5.7 ) Levofloxacin tablet is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )].", "warnings_and_cautions": "\u2022 Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) \u2022 Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) \u2022 Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) \u2022 Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) \u2022 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 ( 5.11 , 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 levofloxacin, 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, peripheral neuropathy, and ...", "warnings": "", "adverse_reactions": "The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: \u2022 Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1 )] \u2022 Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] \u2022 Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] \u2022 Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] \u2022 Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] \u2022 Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6 )] \u2022 Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] \u2022 Hepatotoxicity [see Warnings and Precautions ( 5.8 )] \u2022 Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] \u2022 Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.10 )] \u2022 Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] \u2022 Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] \u2022 Blood Glucose Disturbances [see Warnings and Precautions ( 5.13 )] \u2022 Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14 )] \u2022...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions Hypersensitivity Reactions ( 5.7 ) 06/2024", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Serious Adverse Reactions Advise patients to stop taking levofloxacin 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 levofloxacin or other fluoroquinolone use: \u2022 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 levofloxacin and may occur together in the same patient. Inform patients to stop taking levofloxacin immediately if they experience an adverse reaction and to call their healthcare provider. \u2022 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 refrain from exercise; and disco...", "spl_medguide": "MEDICATION GUIDE Levofloxacin (lee\" voe flox' a sin) Tablets, USP What is the most important information I should know about levofloxacin tablets? Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you have any of the following serious side effects while you take levofloxacin tablets, you should stop taking levofloxacin tablets immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). \u2022 Tendon problems can happen in people of all ages who take levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems include pain, swelling, tears, and swelling of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. \u2022 The risk of getting tendon problems while you take levofloxacin tablets is higher if you: \u25cb are over 60 years of age \u25cb are taking steroids (corticosteroids) \u25cb have had a kidney, heart or lung transplant. \u2022 Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets. \u2022 Other reasons that c...", "clinical_studies": "14.1 Nosocomial Pneumonia Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter, randomized, open-label study comparing intravenous levofloxacin (750 mg once daily) followed by oral levofloxacin (750 mg once daily) for a total of 7 to 15 days to intravenous imipenem/cilastatin (500 to 1,000 mg every 6 to 8 hours daily) followed by oral ciprofloxacin (750 mg every 12 hours daily) for a total of 7 to 15 days. Levofloxacin-treated patients received an average of 7 days of intravenous therapy (range: 1 to 16 days); comparator-treated patients received an average of 8 days of intravenous therapy (range: 1 to 19 days). Overall, in the clinically and microbiologically evaluable population, adjunctive therapy was empirically initiated at study entry in 56 of 93 (60.2%) patients in the levofloxacin arm and 53 of 94 (56.4%) patients in the comparator arm. The average duration of adjunctive therapy was 7 days in the levofloxacin arm and 7 days in the comparator. In clinically and microbiologically evaluable patients with documented Pseudomonas aeruginosa infection, 15 of 17 (88.2%) received ceftazidime (N=11) or piperacillin/tazobacta...", "brand_name": "levofloxacin", "manufacturer": "Preferred Pharmaceuticals Inc", "application_number": "ANDA077652", "pharm_class_epc": [ "Fluoroquinolone Antibacterial [EPC]" ], "route": [ "ORAL" ], "effective_time": "20250123", "set_id": "067e260c-dc47-4957-a9ff-5a79f17b4ca0", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 82265, "serious": 68916, "death": 9647, "hospitalization": 33871, "primary_suspect": 81953, "top_reactions": [ [ "Off Label Use", 4146 ], [ "Drug Hypersensitivity", 4058 ], [ "Pneumonia", 4038 ], [ "Acute Kidney Injury", 3956 ], [ "Dyspnoea", 3914 ], [ "Nausea", 3882 ], [ "Fatigue", 3869 ], [ "Drug Ineffective", 3738 ], [ "Pain", 3696 ], [ "Chronic Kidney Disease", 3651 ], [ "Arthralgia", 3420 ], [ "Pyrexia", 3371 ], [ "Diarrhoea", 3305 ], [ "Neuropathy Peripheral", 3189 ], [ "Pain In Extremity", 2943 ] ], "by_year": { "2019": 9683, "2020": 7880, "2021": 6497, "2022": 5426, "2023": 5169, "2024": 4732, "2025": 4557, "2026": 1991 }, "by_year_primary": { "2019": 9673, "2020": 7873, "2021": 6471, "2022": 5380, "2023": 5100, "2024": 4674, "2025": 4517, "2026": 1955 } }, "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 II", "date": "20210315", "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "firm": "Cardinal Health Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20180925", "reason": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.", "firm": "Baxter Healthcare Corporation", "status": "Terminated" }, { "class": "Class III", "date": "20180801", "reason": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.", "firm": "Baxter Healthcare Corporation", "status": "Terminated" }, { "class": "Class III", "date": "20180801", "reason": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.", "firm": "Baxter Healthcare Corporation", "status": "Terminated" }, { "class": "Class III", "date": "20180801", "reason": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.", "firm": "Baxter Healthcare Corporation", "status": "Terminated" }, { "class": "Class II", "date": "20170310", "reason": "Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.", "firm": "Claris Lifesciences Inc", "status": "Terminated" } ], "recall_total": 7, "drugsfda": { "applications": 50, "nda": 5, "anda": 43, "first_approval": "19961220", "rems": false, "rems_last": "20120725", "labeling_supplements": 88, "labeling_recent": 0, "sponsors": [ "APOTEX INC", "AUROBINDO PHARMA LTD", "AVET LIFESCIENCES", "BAXTER HLTHCARE CORP", "CHARTWELL MOLECULAR", "CHARTWELL RX", "DR REDDYS LABS INC", "EUGIA PHARMA" ], "unapproved": false, "first_approval_fmt": "12/20/1996" }, "trials": { "total": 472, "completed": 257, "terminated": 46, "with_results": 69, "industry": 140, "phase3": 123, "results_share": 0.26848249027237353, "terminated_share": 0.09745762711864407 }, "pubmed": { "rct": 354, "meta": 24, "recent_rct": 41, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "levofloxacin" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 2499553, "beneficiaries": 1866045, "spend": 14922754.89, "by_brand": [ { "brand": "Levofloxacin", "claims": 2499553, "per_claim": 5.9701694223, "is_generic": true } ], "per_claim": 5.970169422292706 }, "mdl": [], "dsc": [ { "date": "20181220", "title": "FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm", "kind": "class", "matched": "fluoroquinolone" }, { "date": "20180710", "title": "FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm611032.htm", "kind": "class", "matched": "fluoroquinolone" }, { "date": "20160726", "title": "FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm", "kind": "class", "matched": "fluoroquinolone" }, { "date": "20160512", "title": "FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm", "kind": "class", "matched": "fluoroquinolone" } ], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "levofloxacin", "matched": "levofloxacin", "stewardship": [ "KeyAccessGroup", "WatchGroup" ] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 11146, "fills": 2499553, "per_million": 4459.197304478041, "ratio": 1.6104291160841053, "median": 2768.949753790441 }, "scores": { "safety": { "score": 53, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 4 Drug Safety Communication(s) about this drug's class since 2010 (-8)", "4,459 FDA reports naming it as the suspect drug per million Medicare fills, 1.6x the median drug on this site (-4)", "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": 55, "letter": "D", "why": [ "354 randomized trials and 24 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": 89, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 3 Class II, 4 Class III across 43 generic makers (-6)", "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 (43 applications)", "16 same-class alternatives exist" ], "weight": 0.1 } }, "total": 71, "grade": "C", "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, pneumonia, acute kidney injury. 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.)" ] }