Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Omalizumab
Drug ID BADD_D01610
Description Omalizumab, manufactured by _Genentech_, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids [L4670]. Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated [L4670]. In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA [L4671].
Indications and Usage This drug is an anti-IgE antibody indicated for: 1. Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids [FDA label] 2. Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment [FDA label]
Marketing Status approved; investigational
ATC Code R03DX05
DrugBank ID DB00043
KEGG ID D05251
MeSH ID D000069444
PubChem ID Not Available
TTD Drug ID D02GEC
NDC Product Code 50242-040; 50242-215; 50242-214
UNII 2P471X1Z11
Synonyms Omalizumab | Xolair
Chemical Information
Molecular Formula Not Available
CAS Registry Number 242138-07-4
SMILES Not Available
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)
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
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.009--Not Available
Cough22.02.03.001--
Dermatitis23.03.04.002--Not Available
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Ear pain04.03.01.003--
Fatigue08.01.01.002--
Fracture15.08.02.001; 12.04.02.001--
Headache17.14.01.001--
Hypotension24.06.03.002--
Injection site bruising24.07.06.017; 12.07.03.042; 23.03.11.015; 08.02.03.042--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--Not Available
Injection site induration12.07.03.007; 08.02.03.007--Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site mass12.07.03.010; 08.02.03.009--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injection site urticaria12.07.03.029; 10.01.06.003; 08.02.03.029; 23.04.02.003--Not Available
Injection site warmth12.07.03.036; 08.02.03.036--Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Lung disorder22.02.07.001--Not Available
Lymphadenopathy01.09.01.002--Not Available
Neoplasm malignant16.16.01.001--Not Available
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