Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Loteprednol etabonate
Drug ID BADD_D01324
Description Loteprednol Etabonate (LE) is a topical corticoid anti-inflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides. As a nasal spray, it can be used for the treatment and management of seasonal allergic rhinitis. Most prescription LE products, however, tend to be indicated for the treatment of post-operative inflammation and pain following ocular surgery [FDA Label]. A number of such new formulations that have been approved include Kala Pharmaceutical's Inveltys - the first twice-daily (BID) ocular corticosteroid approved for this indication, designed specifically to enhance patient compliance and simplified dosing compared to all other similar ocular steroids that are dosed four times daily [L4545]. Moreover, LE was purposefully engineered to be a 'soft drug', one that is designed to be active locally at the site of administration and then rapidly metabolized to inactive components after eliciting its actions at the desired location, thereby subsequently minimizing the chance for adverse effects [A38693].
Indications and Usage A number of prescription loteprednol etabonate ophthalmic products are specifically indicated for the treatment of post-operative inflammation and pain following ocular surgery [FDA Label].
Marketing Status approved
ATC Code S01BA14
DrugBank ID DB14596
KEGG ID D01689
MeSH ID D000069559
PubChem ID 444025
TTD Drug ID D0X6GN
NDC Product Code 55718-142; 55718-152; 55718-153; 24208-353; 68682-299; 15308-0722; 24208-299; 55718-155; 63190-0220; 81861-0027; 17478-830; 71571-121; 82260-299; 63190-0780; 81861-0028; 82260-508; 46439-8743; 46439-8744; 62756-232; 60269-287; 65089-0037; 24208-443; 71571-333; 55718-154; 24208-503; 24208-507; 24208-508; 50383-265
UNII YEH1EZ96K6
Synonyms Loteprednol Etabonate | Etabonate, Loteprednol | CEHOAC | Chloromethyl 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate | 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate, Chloromethyl | Chloromethyl 17 ethoxycarbonyloxy 11 hydroxy 3 oxoandrosta 1,4 diene 17 carboxylate | Lotemax | Loteprednol | Alrex
Chemical Information
Molecular Formula C24H31ClO7
CAS Registry Number 82034-46-6
SMILES CCOC(=O)OC1(CCC2C1(CC(C3C2CCC4=CC(=O)C=CC34C)O)C)C(=O)OCCl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Application site pain12.07.01.004; 08.02.01.0040.000922%Not Available
Burning sensation08.01.09.029; 17.02.06.0010.003688%Not Available
Cataract06.06.01.0010.000542%
Cataract subcapsular06.06.01.002--Not Available
Chills15.05.03.016; 08.01.09.0010.002305%
Condition aggravated08.01.03.0040.001844%Not Available
Conjunctival oedema06.04.01.001--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Corneal oedema06.04.02.001--Not Available
Discomfort08.01.08.003--Not Available
Drug hypersensitivity10.01.01.0010.002305%Not Available
Drug ineffective08.06.01.0060.003444%Not Available
Drug interaction08.06.03.0010.000542%Not Available
Dry eye06.08.02.0010.000732%
Erythema23.03.06.0010.000922%Not Available
Erythema of eyelid23.03.06.006; 06.04.04.003--Not Available
Eye allergy10.01.03.028; 06.04.05.0100.001383%Not Available
Eye discharge06.04.05.0010.000597%Not Available
Eye infection11.01.06.001; 06.04.05.007--
Eye irritation06.04.05.0030.007838%Not Available
Eye pain06.08.03.0020.004746%
Eye swelling06.08.03.0030.001519%Not Available
Headache17.14.01.0010.001519%
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Impaired healing08.03.02.001--Not Available
Instillation site pain12.07.01.008; 08.02.01.0080.000597%Not Available
Intraocular pressure increased13.07.04.002--Not Available
Keratitis06.04.02.002--
Lacrimation increased06.08.02.0040.000922%
Ocular hyperaemia06.04.05.0040.003688%Not Available
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