Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Icatibant
Drug ID BADD_D02452
Description Icatibant (Firazyr) is a synthetic peptidomimetic drug consisting of ten amino acids, and acts as an effective and specific antagonist of bradykinin B2 receptors. It has been approved in the EU for use in hereditary angioedema, and is under investigation for a number of other conditions in which bradykinin is thought to play a significant role. Icatibant currently has orphan drug status in the United States and FDA approved on August 25, 2011.
Indications and Usage Approved for use in acute attacks of hereditary angioedema (HAE). Investigated for use/treatment in angioedema, liver disease, and burns and burn infections.
Marketing Status approved; investigational
ATC Code B06AC02
DrugBank ID DB06196
KEGG ID D04492
MeSH ID C065679
PubChem ID 6918173
TTD Drug ID D04ZBT
NDC Product Code 63323-574; 71225-114; 69097-664; 70709-013; 0093-3066; 24201-207
UNII 7PG89G35Q7
Synonyms icatibant | D-Arg(Hyp(3)-Thi(5)-D-Tic(7)-Oic(8))BK | icatibant acetate | HOE-140 | HOE140 | Firazyr | Hoechst-140 | HOE 140 | Hoechst 140 | JE 049 | JE-049 | WIN 65365 | D-Arg(Hyp(3)-Thi(5)-L-Tic(7)-Oic(8))BK | WIN-65365
Chemical Information
Molecular Formula C59H89N19O13S
CAS Registry Number 130308-48-4
SMILES C1CCC2C(C1)CC(N2C(=O)C3CC4=CC=CC=C4CN3C(=O)C(CO)NC(=O)C(CC5=CC=CS5)NC(=O)CNC(=O) C6CC(CN6C(=O)C7CCCN7C(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)N)O)C(=O)NC(CCCN=C(N)N) 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)
Hepatic cirrhosis09.01.04.001-Not Available
Hernia08.01.04.001-Not Available
Hypersensitivity10.01.03.003-
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoxia22.02.02.003-
Influenza like illness08.01.03.010-
Inguinal hernia07.16.02.001-Not Available
Injection site bruising12.07.03.042; 23.03.11.015; 08.02.03.042; 24.07.06.017-Not Available
Injection site erythema12.07.03.001; 08.02.03.001; 23.03.06.015-Not Available
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.004-Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005-Not Available
Injection site irritation08.02.03.027; 12.07.03.027-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 rash23.03.13.010; 12.07.03.032; 08.02.03.032-Not Available
Injection site reaction12.07.03.015; 08.02.03.014-
Injection site urticaria23.04.02.003; 12.07.03.029; 10.01.06.003; 08.02.03.029-Not Available
Injection site warmth12.07.03.036; 08.02.03.036-Not Available
Intestinal obstruction07.13.01.002-Not Available
Laryngeal oedema22.04.02.001; 10.01.05.003; 23.04.01.005-
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008-
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005-Not Available
Loss of consciousness17.02.04.004-Not Available
Lymphoma16.20.01.001; 01.12.01.001-Not Available
Malaise08.01.01.003-
Memory impairment19.20.01.003; 17.03.02.003--
Menstruation irregular21.01.01.005; 05.05.01.008-
Migraine24.03.05.003; 17.14.02.001-Not Available
Myocardial infarction02.02.02.007; 24.04.04.009-
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