{"id":"loteprednol","rwe":[{"pmid":"41774285","year":"2026","title":"Therapeutic effects of Chelidonium majus on ocular surface ınflammation and tear film homeostasis in a benzalkonium chloride-ınduced rat model of dry eye disease.","finding":"","journal":"International ophthalmology","studyType":"Clinical Study"},{"pmid":"41606966","year":"2026","title":"Postoperative Corneal Dellen Following PreserFlo MicroShunt: A Case Report.","finding":"","journal":"The American journal of case reports","studyType":"Clinical Study"},{"pmid":"41294172","year":"2025","title":"Different formulations of corticosteroid eye drops at different treatment times in the control of inflammation and prevention of cystoid macular edema after cataract surgery: randomized clinical trial.","finding":"","journal":"Arquivos brasileiros de oftalmologia","studyType":"Clinical Study"},{"pmid":"41168626","year":"2025","title":"Retraction Note: Loteprednol-Loaded Nanoformulations for Corneal Delivery by Quality-by-Design Concepts: Optimization, Characterization, and Anti-inflammatory Activity.","finding":"","journal":"AAPS PharmSciTech","studyType":"Clinical Study"},{"pmid":"40925862","year":"2025","title":"Acoltremon (Tryptyr) for dry eye disease.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"}],"_fda":{"id":"08a09440-b505-b2c9-e063-6394a90a0d76","set_id":"08a091a8-748f-acc4-e063-6394a90af4bc","openfda":{"upc":["0372485665105","0372485665150","0372485665051"],"unii":["YEH1EZ96K6"],"route":["OPHTHALMIC"],"rxcui":["311382"],"spl_id":["08a09440-b505-b2c9-e063-6394a90a0d76"],"brand_name":["Loteprednol Etabonate"],"spl_set_id":["08a091a8-748f-acc4-e063-6394a90af4bc"],"package_ndc":["72485-665-05","72485-665-10","72485-665-15"],"product_ndc":["72485-665"],"generic_name":["LOTEPREDNOL ETABONATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["LOTEPREDNOL ETABONATE"],"manufacturer_name":["ARMAS PHARMACEUTICALS INC."],"application_number":["ANDA207609"],"is_original_packager":[true]},"version":"1","warnings":["WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation."],"pregnancy":["Pregnancy Teratogenic effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period."],"description":["DESCRIPTION Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: Chemical Name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate Each mL contains: ACTIVE: Loteprednol Etabonate 5 mg (0.5%); INACTIVES: Edetate disodium, glycerin, povidone K-30, purified water sodium hydroxide and tyloxapol. Hydrochloric acid may be added to adjust the pH to 5.0 - 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%. Chemical Structure"],"precautions":["PRECAUTIONS General Information for Patients This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using loteprednol etabonate. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600 and 300 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. Pregnancy Teratogenic effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when loteprednol etabonate is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"how_supplied":["HOW SUPPLIED Loteprednol Etabonate Ophthalmic Suspension, 0.5% is supplied in a plastic bottle with a controlled drop tip and a pink cap in the following sizes: 5 mL - NDC 72485-665-05 10 mL - NDC 72485-665-10 15 mL - NDC 72485-665-15 DO NOT USE IF NECKBAND IMPRINTED WITH \"SEALED FOR YOUR PROTECTION' IS NOT INTACT. Storage: Store upright between 15°–25°C (59°–77°F). DO NOT FREEZE. KEEP OUT OF REACH OF CHILDREN. Rx Only Distributed by: Armas Pharmaceuticals, inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG Rithofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland Rev. 08/23"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20231026","nursing_mothers":["Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when loteprednol etabonate is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mmHg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo."],"contraindications":["CONTRAINDICATIONS Loteprednol etabonate, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids."],"how_supplied_table":["<table width=\"100%\"><colgroup><col width=\"98%\"/></colgroup><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">DO NOT USE IF NECKBAND IMPRINTED WITH &quot;SEALED FOR YOUR PROTECTION&apos; IS NOT INTACT.</content></paragraph></td></tr></tbody></table>"],"general_precautions":["General"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent. It is highly lipid soluble which enhances its penetration into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites. Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ 1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited (<1 ng/mL) systemic absorption occurs with loteprednol etabonate. Clinical Studies: Post-Operative Inflammation: Placebo-controlled clinical studies demonstrated that loteprednol etabonate is effective for the treatment of anterior chamber inflammation as measured by cell and flare. Giant Papillary Conjunctivitis: Placebo-controlled clinical studies demonstrated that loteprednol etabonate was effective in reducing the signs and symptoms of giant papillary conjunctivitis after 1 week of treatment and continuing for up to 6 weeks while on treatment. Seasonal Allergic Conjunctivitis: A placebo-controlled clinical study demonstrated that loteprednol etabonate was effective in reducing the signs and symptoms of allergic conjunctivitis during peak periods of pollen exposure. Uveitis: Controlled clinical studies of patients with uveitis demonstrated that loteprednol etabonate was less effective than prednisolone acetate 1%. Overall, 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cell by day 28, compared to 87% of patients treated with 1% prednisolone acetate. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%."],"indications_and_usage":["INDICATIONS AND USAGE Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery."],"information_for_patients":["Information for Patients This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using loteprednol etabonate."],"spl_unclassified_section":["Sterile Ophthalmic Suspension"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION SHAKE VIGOROUSLY BEFORE USING. Steroid Responsive Disease Treatment: Apply one to two drops of loteprednol etabonate into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS ). Post-Operative Inflammation: Apply one to two drops of loteprednol etabonate into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period."],"spl_product_data_elements":["Loteprednol Etabonate Loteprednol Etabonate WATER GLYCERIN TYLOXAPOL EDETATE DISODIUM POVIDONE K30 BENZALKONIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID LOTEPREDNOL ETABONATE LOTEPREDNOL White to Off White"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 72485-665-05 Loteprednol Etabonate Ophthalmic Suspension, 0.5% Rx only 5 mL 5 ml container label 5 ml carton label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 72485-665-10 Loteprednol Etabonate Ophthalmic Suspension, 0.5% Rx only 10 mL 10 ml container label q0 ml carton label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 72485-665-15 Loteprednol Etabonate Ophthalmic Suspension, 0.5% Rx only 15 mL 15 ml container label 15 ml carton label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600 and 300 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender."]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Ophthalmic","category":"route"},{"label":"Suspension/Drops","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"allergic conjunctivitis","category":"indication"},{"label":"acne rosacea","category":"indication"},{"label":"superficial punctate keratitis","category":"indication"},{"label":"herpes zoster keratitis","category":"indication"},{"label":"iritis","category":"indication"},{"label":"cyclitis","category":"indication"},{"label":"Bausch And Lomb","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"763 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"653 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"470 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"450 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"434 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"396 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"306 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"256 reports"},{"date":"","signal":"DRY EYE","source":"FDA FAERS","actionTaken":"232 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"215 reports"}],"commonSideEffects":[{"effect":"abnormal vision/blurring","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"burning on instillation","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"chemosis","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"discharge","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"dry eyes","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"epiphora","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"foreign body sensation","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"itching","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"injection","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"photophobia","drugRate":"5-15%","severity":"common","_validated":true},{"effect":"conjunctivitis","drugRate":"reported","severity":"unknown"},{"effect":"corneal abnormalities","drugRate":"reported","severity":"unknown"},{"effect":"eyelid erythema","drugRate":"reported","severity":"unknown"},{"effect":"ocular irritation/pain/discomfort","drugRate":"reported","severity":"unknown"},{"effect":"papillae","drugRate":"reported","severity":"unknown"},{"effect":"uveitis","drugRate":"reported","severity":"unknown"},{"effect":"headache","drugRate":"reported","severity":"unknown"},{"effect":"rhinitis","drugRate":"reported","severity":"unknown"},{"effect":"pharyngitis","drugRate":"reported","severity":"unknown"},{"effect":"significant elevation of intraocular pressure (≥10 mmHg)","drugRate":"2%","severity":"serious","_validated":true}],"contraindications":["Loteprednol etabonate is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis, vaccinia, and varicella.","Loteprednol etabonate is contraindicated in mycobacterial infection of the eye and fungal diseases of ocular structures.","Loteprednol etabonate is contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids."],"specialPopulations":{"Lactation":"Caution should be exercised when loteprednol etabonate is administered to a nursing woman.","Pregnancy":"Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."},"seriousAdverseEvents":[{"event":"significant elevation of intraocular pressure (≥10 mmHg)","detail":"Among patients receiving loteprednol etabonate","severity":"serious","incidence":"2% (15/901)"}]},"trials":[],"aliases":[],"company":"Bausch And Lomb","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$28.7679/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$10,500","description":"LOTEPREDNOL 0.5% OPHTHALMC GEL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LOTEPREDNOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:39:57.749424+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Loteprednol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:40:05.808501+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:40:03.265686+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:39:56.648697+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LOTEPREDNOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:40:04.767178+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:39:55.424211+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:39:55.424240+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:40:06.223403+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:05.808420+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200865/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:05.465049+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocu","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:12.770431+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:19.914550+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA207609","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:39:55.424245+00:00"}},"allNames":"loteprednol etabonate","offLabel":[],"synonyms":["Loteprednol Etabonate","LOTEPREDNOL ETABONATE"],"timeline":[{"date":"1998-03-09","type":"positive","source":"FDA Orange Book","milestone":"Alrex approved — 0.2%"},{"date":"2012-09-28","type":"positive","source":"FDA Orange Book","milestone":"Lotemax approved — 0.5%"},{"date":"2018-08-22","type":"positive","source":"FDA Orange Book","milestone":"Inveltys approved — 1%"},{"date":"2019-02-22","type":"positive","source":"FDA Orange Book","milestone":"Lotemax Sm approved — 0.38%"},{"date":"2020-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from Alcon Labs Inc to Bausch And Lomb"},{"date":"2020-10-26","type":"positive","source":"FDA Orange Book","milestone":"Eysuvis approved — 0.25%"},{"date":"20200424","type":"positive","source":"OpenFDA","milestone":"FDA approval (Alcon Labs Inc)"},{"date":"2023-04-12","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Loteprednol etabonate is a small molecule corticosteroid medication originally developed by Alcon Labs Inc and currently owned by Bausch And Lomb. It is used to treat various eye conditions, including allergic conjunctivitis, acne rosacea, and iritis. Loteprednol etabonate is available as a generic medication, with six generic manufacturers, and is off-patent. It is used to reduce inflammation and swelling in the eye. The commercial status of loteprednol etabonate is off-patent, with no active Orange Book patents.","approvals":[{"date":"20200424","orphan":false,"company":"ALCON LABS INC","regulator":"FDA"}],"brandName":"Loteprednol Etabonate","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Loteprednol etabonate is a corticosteroid that exerts its anti-inflammatory effects by inhibiting the release of pro-inflammatory mediators, such as phospholipase A2 and cyclooxygenase, and by stabilizing lysosomal membranes, thereby reducing the production of inflammatory cytokines and chemokines."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Loteprednol","title":"Loteprednol","extract":"Loteprednol is a topical corticosteroid used to treat inflammations of the eye. 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