Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bilastine
Drug ID BADD_D02615
Description Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.
Indications and Usage For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older [FDA Label].
Marketing Status approved; investigational
ATC Code R06AX29; S01GX13
DrugBank ID DB11591
KEGG ID D09570
MeSH ID C445659
PubChem ID 185460
TTD Drug ID Not Available
NDC Product Code 42765-045
UNII PA1123N395
Synonyms bilastine
Chemical Information
Molecular Formula C28H37N3O3
CAS Registry Number 202189-78-4
SMILES CCOCCN1C2=CC=CC=C2N=C1C3CCN(CC3)CCC4=CC=C(C=C4)C(C)(C)C(=O)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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acne23.02.01.001--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.009--Not Available
Condition aggravated08.01.03.004--Not Available
Cough22.02.03.001--
Drug ineffective08.06.01.006--Not Available
Dry skin23.03.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypoaesthesia17.02.06.023; 23.03.03.081--Not Available
Influenza like illness08.01.03.010--
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site rash23.03.13.010; 12.07.03.032; 08.02.03.032--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Malaise08.01.01.003--
Menstruation delayed21.01.02.003; 05.05.01.010--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Nasal congestion22.04.04.001--
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