{ "query": "chlorhexidine", "ingredient": "chlorhexidine", "slug": "chlorhexidine", "rxcui": "2358", "brands": [ "Periogard", "Bactoshield", "Betasept", "Dyna-Hex", "Exidine", "Hibiclens", "Nupro Chlorhexidine", "Oro Clense", "Paroex", "Peridex", "PerioChip" ], "names": [ "chlorhexidine", "chlorhexidine acetate", "chlorhexidine diacetate", "chlorhexidine gluconate", "chlorhexidine hydrochloride" ], "classes": [ { "id": "A01AB", "name": "Antiinfectives and antiseptics for local oral treatment" }, { "id": "B05CA", "name": "Antiinfectives" }, { "id": "D08AC", "name": "Biguanides and amidines" }, { "id": "D09AA", "name": "Medicated dressings with antiinfectives" }, { "id": "R02AA", "name": "Antiseptics" }, { "id": "S02AA", "name": "Antiinfectives" }, { "id": "S03AA", "name": "Antiinfectives" } ], "alternatives": [ "acetic acid", "acriflavine hydrochloride", "aluminum acetotartrate", "aluminum chlorohydrate", "amphotericin b", "benzalkonium", "benzethonium", "benzoxonium chloride", "boric acid", "cetrimonium", "cetylpyridinium", "chloramphenicol", "chlorquinaldol", "chlortetracycline", "ciprofloxacin", "clioquinol", "clotrimazole", "dequalinium", "dibrompropamidine", "dichlorobenzyl alcohol", "dimethyldodecylbenzylammonium", "domiphen", "doxycycline", "ethacridine lactate", "fosfomycin", "framycetin", "fusidic acid", "gentamicin", "hexamidine", "hexetidine", "hexylresorcinol", "hydrogen peroxide", "iodoform", "mandelic acid", "metronidazole", "miconazole", "minocycline", "miristalkonium", "natamycin", "neomycin", "nitrofurazone", "noxythiolin", "octenidine", "ofloxacin", "oxyquinoline", "oxytetracycline", "phenol", "phenylmercuric nitrate", "polihexanide", "polymyxin b", "polynoxylin", "povidone-iodine", "propamidine", "rifamycin sv", "sodium perborate", "sulfamethizole", "taurolidine", "tetracycline", "tibezonium iodide", "triclosan" ], "label": { "route_mode": "ORAL", "route_counts": { "TOPICAL": 105, "ORAL": 31, "DENTAL": 10, "BUCCAL": 6, "OPHTHALMIC": 4, "CUTANEOUS": 1 }, "boxed_warning": "", "indications_and_usage": "INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .", "contraindications": "CONTRAINDICATIONS Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.", "warnings_and_cautions": "", "warnings": "WARNINGS The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS .", "adverse_reactions": "ADVERSE REACTIONS The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "", "spl_medguide": "", "clinical_studies": "", "brand_name": "NUPRO Chlorhexidine Gluconate", "manufacturer": "Xttrium Laboratories, Inc.", "application_number": "ANDA077789", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250430", "set_id": "4a3b87bc-d913-6c88-e054-00144ff8d46c", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 18108, "serious": 15457, "death": 5000, "hospitalization": 8186, "primary_suspect": 18094, "top_reactions": [ [ "Rash", 4738 ], [ "Fatigue", 4606 ], [ "Joint Swelling", 4408 ], [ "Pain", 4332 ], [ "Pruritus", 4094 ], [ "Hypersensitivity", 4078 ], [ "Lower Respiratory Tract Infection", 4071 ], [ "Peripheral Swelling", 4043 ], [ "Folliculitis", 4020 ], [ "Impaired Healing", 3961 ], [ "Dyspnoea", 3932 ], [ "Stomatitis", 3929 ], [ "Arthralgia", 3915 ], [ "Weight Increased", 3901 ], [ "Confusional State", 3850 ] ], "by_year": { "2019": 1245, "2020": 1556, "2021": 2372, "2022": 1912, "2023": 1148, "2024": 2726, "2025": 2734, "2026": 794 }, "by_year_primary": { "2019": 1245, "2020": 1556, "2021": 2371, "2022": 1910, "2023": 1147, "2024": 2717, "2025": 2733, "2026": 794 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20260818", "reason": "Cross Contamination with Other Products", "firm": "Sage Products, LLC", "status": "Ongoing" }, { "class": "Class II", "date": "20170601", "reason": "CGMP Deviations", "firm": "Xttrium Laboratories Inc", "status": "Terminated" }, { "class": "Class II", "date": "20160729", "reason": "CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.", "firm": "Sage Products LLC", "status": "Terminated" }, { "class": "Class III", "date": "20160212", "reason": "Subpotent drug", "firm": "Ecolab Inc", "status": "Terminated" } ], "recall_total": 4, "drugsfda": { "applications": 32, "nda": 16, "anda": 16, "first_approval": "19760917", "rems": false, "rems_last": "", "labeling_supplements": 54, "labeling_recent": 7, "sponsors": [ "BAJAJ", "BECTON DICKINSON", "CAREFUSION 2200", "CHARTWELL RX", "COLGATE PALMOLIVE CO", "COLGATE-PALMOLIVE CO", "DEXCEL PHARMA", "ECOLAB" ], "unapproved": false, "first_approval_fmt": "09/17/1976" }, "trials": { "total": 1322, "completed": 826, "terminated": 80, "with_results": 181, "industry": 219, "phase3": 141, "results_share": 0.21912832929782083, "terminated_share": 0.060514372163388806 }, "pubmed": { "rct": 1028, "meta": 183, "recent_rct": 195, "cochrane": [ { "pmid": "31476022", "title": "Chlorhexidine bathing of the critically ill for the prevention of hospital-acquired infection", "year": "2019" }, { "pmid": "28362061", "title": "Chlorhexidine mouthrinse as an adjunctive treatment for gingival health", "year": "2017" }, { "pmid": "25867816", "title": "Chlorhexidine treatment for the prevention of dental caries in children and adolescents", "year": "2015" }, { "pmid": "25739381", "title": "Chlorhexidine skin or cord care for prevention of mortality and infections in neonates", "year": "2015" }, { "pmid": "25504106", "title": "Vaginal chlorhexidine during labour to prevent early-onset neonatal group B streptococcal infection", "year": "2014" }, { "pmid": "25218725", "title": "Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV)", "year": "2014" }, { "pmid": "15495077", "title": "Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV)", "year": "2004" }, { "pmid": "15266490", "title": "Vaginal chlorhexidine during labour to prevent early-onset neonatal group B streptococcal infection", "year": "2004" } ] }, "payments": { "year": "2024", "usd": 1742.36, "records": 14, "by_name": [ [ "Hibiclens", 1742.36 ] ], "names_checked": [ "chlorhexidine", "Periogard", "Bactoshield", "Betasept", "Dyna-Hex", "Exidine", "Hibiclens", "Nupro Chlorhexidine", "Oro Clense", "Paroex", "Peridex", "PerioChip" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 2604862, "beneficiaries": 1662541, "spend": 13704814.010000002, "by_brand": [ { "brand": "Chlorhexidine Gluconate", "claims": 2600933, "per_claim": 5.2602626827, "is_generic": true }, { "brand": "Periogard", "claims": 3929, "per_claim": 5.9107177399, "is_generic": false } ], "per_claim": 5.261243785659279 }, "mdl": [], "dsc": [ { "date": "20170202", "title": "FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm530975.htm", "kind": "drug", "matched": "chlorhexidine gluconate" } ], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "chlorhexidine", "matched": "chlorhexidine", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 6244, "fills": 2604862, "per_million": 2397.0559668803953, "ratio": 0.8656913920518216, "median": 2768.949753790441 }, "scores": { "safety": { "score": 80, "letter": "B", "why": [ "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2017 (-8)", "2,397 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site", "Death appears in 3.0x the share of reports seen across all of FAERS (-12)" ], "weight": 0.35 }, "evidence": { "score": 81, "letter": "B", "why": [ "1028 randomized trials and 183 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 22% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 87, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 3 Class II, 1 Class III across 16 generic makers (-5)", "7 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $1,742 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 (16 applications)", "60 same-class alternatives exist" ], "weight": 0.1 } }, "total": 86, "grade": "B", "questions": [ "In 2017 the FDA issued a safety communication about this drug (FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate). Does that risk apply to me?", "The most-reported problems in FDA's adverse event data are rash, fatigue, joint swelling, pain. How would we recognize and handle those?", "Why this one over acetic acid, acriflavine hydrochloride, aluminum acetotartrate? 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.)" ] }