Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Beclomethasone dipropionate monohydrate
Drug ID BADD_D00220
Description Beclomethasone dipropionate is a second-generation synthetic corticosteroid agent [A179842] and a diester of beclomethasone, which is structurally similar to [dexamethasone].[L6871] It is a prodrug of an active metabolite beclomethasone 17-monopropionate (17-BMP)[A179839] which acts on the glucocorticoid receptor to mediates its therapeutic action. Beclomethasone dipropionate itself posesses weak glucocorticoid receptor binding affinity and is rapidly converted into 17-BMP upon administration.[A179839] Formulations for oral inhalation, intranasal, and topical use are available for beclomethasone dipropionate. Beclomethasone dipropionate became first available in a pressurized metered-dose inhaler in 1972 and later in a dry powder inhaler and an aqueous nasal spray.[A179839] Due to its anti-inflammatory, antipruritic, and anti-allergy properties, beclomethasone dipropionate is used in various inflammatory conditions, such as asthma, allergic rhinitis, and dermatoses to reduce symptoms. When inhaled, it is proposed that beclomethasone dipropionate remains active locally in the lung without causing significant side effects associated with systemic corticosteroids.[A180010] Compared to earlier corticosteroids such as [dexamethasone] and [prednisolone], beclomethasone dipropionate is reported to be less irritating to the nasal mucosa with a longer duration of action when administered intranasally.[A179848]
Indications and Usage Indicated for oral inhalation use in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. The aerosol form of beclomethasone diproprionate is not indicated for the relief of acute bronchospasm.[L6871] Indicated for intranasal use to relieve the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis and prevent the recurrence of nasal polyps following surgical removal.[L6880] Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.[L10782] Corticosteroid-responsive dermatoses include psoriasis, contact dermatitis (dermatitis venenata), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus, lichen planus, eczema, eczematous dermatitis), intertrigo, dyshidroses (pompholyx), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, stasis dermatitis, and anogenital and senile pruritus.[L6886]
Marketing Status approved; investigational
ATC Code R01AD01; R03BA01; A07EA07; D07AC15
DrugBank ID DB00394
KEGG ID D11572
MeSH ID D001507
PubChem ID 16052009
TTD Drug ID D07DVK
NDC Product Code 46439-8748; 0173-0388
UNII 4H7L9AI22I
Synonyms Beclomethasone | Beclometasone | Asmabec Clickhaler | Ascocortonyl | Beclamet | Beclo Asma | Beclo AZU | Beclocort | Beclomet | Bemedrex Easyhaler | Beclomethasone Dipropionate | Dipropionate, Beclomethasone | Beclorhinol | Sanasthmax | Becloturmant | Beclovent | Beconase | Becloforte | Becodisk | Becodisks | Propaderm | Becotide | Sanasthmyl | Beconase AQ | Bronchocort | Junik | Qvar | Ecobec | Beclazone | Beclazone Easy Breathe | Ventolair | Prolair | Filair | Filair Forte | AeroBec Forte | Aerobec | Nasobec Aqueous | Respocort | Vancenase | Vanceril | Aldecin | Viarin | Apo-Beclomethasone
Chemical Information
Molecular Formula C28H39ClO8
CAS Registry Number 77011-63-3
SMILES CCC(=O)OCC(=O)C1(C(CC2C1(CC(C3(C2CCC4=CC(=O)C=CC43C)Cl)O)C)C)OC(=O)CC.O
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)
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Cataract06.06.01.001--
Cautery to nose25.05.03.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry throat07.06.01.005; 22.12.03.005--Not Available
Dysgeusia17.02.07.003; 07.14.03.001--
Epistaxis24.07.01.005; 22.04.03.001--
Glaucoma06.03.01.002--
Headache17.14.01.001--
Intraocular pressure increased13.07.04.002--Not Available
Lacrimation increased06.08.02.004--
Nasal congestion22.04.04.001--
Nasal dryness22.04.03.002--Not Available
Nasal septum perforation22.04.03.003--Not Available
Nausea07.01.07.001--
Rash23.03.13.001--Not Available
Rhinorrhoea22.12.03.021--
Sneezing22.12.03.024--
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Wheezing22.03.01.009--
Growth retardation14.03.02.031; 05.03.02.007; 15.03.05.016--
Nasal mucosal disorder22.04.03.009--Not Available
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