{ "query": "ofloxacin", "ingredient": "ofloxacin", "slug": "ofloxacin", "rxcui": "7623", "brands": [ "Ocuflox" ], "names": [ "ofloxacin" ], "classes": [ { "id": "J01MA", "name": "Fluoroquinolones" }, { "id": "S01AE", "name": "Fluoroquinolones" }, { "id": "S02AA", "name": "Antiinfectives" } ], "alternatives": [ "acetic acid", "aluminum acetotartrate", "besifloxacin", "boric acid", "chloramphenicol", "chlorhexidine", "ciprofloxacin", "clioquinol", "delafloxacin", "enoxacin", "fleroxacin", "fosfomycin", "gatifloxacin", "gemifloxacin", "gentamicin", "grepafloxacin", "hydrogen peroxide", "levofloxacin", "lomefloxacin", "miconazole", "moxifloxacin", "neomycin", "nitrofurazone", "norfloxacin", "pefloxacin", "polymyxin b", "rifamycin sv", "sparfloxacin", "temafloxacin", "tetracycline", "trovafloxacin" ], "label": { "route_mode": "OPHTHALMIC", "route_counts": { "OPHTHALMIC": 38, "AURICULAR (OTIC)": 31, "ORAL": 2 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:", "contraindications": "CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see WARNINGS ).", "warnings_and_cautions": "", "warnings": "WARNINGS NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.", "adverse_reactions": "ADVERSE REACTIONS Ophthalmic use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received. Refer to WARNINGS for additional adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Sentlss at 1--855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.", "spl_medguide": "", "clinical_studies": "Clinical Studies: Conjunctivitis: In a randomized, double-masked, multi-center clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. Corneal ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, ofloxacin ophthalmic solution treated subjects had an overall clinical success rate (complete re-epithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% ce...", "brand_name": "Ofloxacin", "manufacturer": "ARMAS PHARMACEUTICALS INC.", "application_number": "ANDA076407", "pharm_class_epc": [ "Quinolone Antimicrobial [EPC]" ], "route": [ "OPHTHALMIC" ], "effective_time": "20231023", "set_id": "07ac850b-a983-fc21-e063-6394a90a21b2", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 7641, "serious": 5887, "death": 603, "hospitalization": 2943, "primary_suspect": 7617, "top_reactions": [ [ "Acute Kidney Injury", 408 ], [ "Eye Pain", 356 ], [ "Off Label Use", 355 ], [ "Drug Ineffective", 350 ], [ "Headache", 288 ], [ "Fatigue", 281 ], [ "Pain", 264 ], [ "Nausea", 261 ], [ "Arthralgia", 256 ], [ "Diarrhoea", 255 ], [ "Chronic Kidney Disease", 207 ], [ "Anxiety", 205 ], [ "Renal Failure", 203 ], [ "Condition Aggravated", 193 ], [ "Pyrexia", 189 ] ], "by_year": { "2019": 924, "2020": 759, "2021": 698, "2022": 641, "2023": 695, "2024": 519, "2025": 525, "2026": 185 }, "by_year_primary": { "2019": 924, "2020": 758, "2021": 696, "2022": 636, "2023": 688, "2024": 513, "2025": 523, "2026": 185 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20190702", "reason": "Lack of Assurance of Sterility", "firm": "Altaire Pharmaceuticals, Inc.", "status": "Completed" } ], "recall_total": 1, "drugsfda": { "applications": 34, "nda": 4, "anda": 29, "first_approval": "19901228", "rems": false, "rems_last": "20130813", "labeling_supplements": 28, "labeling_recent": 0, "sponsors": [ "ALLERGAN", "ALTAIRE PHARMS INC", "ALVOGEN", "AMNEAL", "APOTEX INC", "BAUSCH AND LOMB", "BAUSCH AND LOMB INC", "BEDFORD" ], "unapproved": false, "first_approval_fmt": "12/28/1990" }, "trials": { "total": 472, "completed": 257, "terminated": 46, "with_results": 69, "industry": 140, "phase3": 123, "results_share": 0.26848249027237353, "terminated_share": 0.09745762711864407 }, "pubmed": { "rct": 294, "meta": 2, "recent_rct": 6, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "ofloxacin", "Ocuflox" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1475339, "beneficiaries": 1096563, "spend": 27348598.93, "by_brand": [ { "brand": "Ofloxacin", "claims": 1475266, "per_claim": 18.533552742, "is_generic": true }, { "brand": "Ocuflox", "claims": 73, "per_claim": 91.489178082, "is_generic": false } ], "per_claim": 18.537162597884283 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "ofloxacin", "matched": "ofloxacin", "stewardship": [ "KeyAccessGroup", "WatchGroup" ] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 1221, "fills": 1475339, "per_million": 827.6064009695399, "ratio": 0.29888819753288115, "median": 2768.949753790441 }, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "828 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site", "Death share in reports is near or below the FAERS average (0.9x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 41, "letter": "F", "why": [ "294 randomized trials and 2 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": 99, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 29 generic makers (-1)" ], "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 (29 applications)", "31 same-class alternatives exist" ], "weight": 0.1 } }, "total": 83, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are acute kidney injury, eye pain. 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 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.)" ] }