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)
Infusion site pain12.07.05.002; 08.02.05.014-Not Available
Injection site discomfort12.07.03.019; 08.02.03.018-Not Available
Major depression19.15.01.003-Not Available
Pulseless electrical activity02.03.04.020-Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001-Not Available
Injection site scar23.03.11.016; 12.07.03.050; 08.02.03.050-Not Available
Drug resistance08.06.01.005-Not Available
Neurological symptom17.02.05.010-Not Available
Adverse event08.06.01.010-Not Available
Abdominal hernia07.16.06.005-Not Available
Cardiac disorder02.11.01.003-Not Available
Inflammation10.02.01.089; 08.01.05.007-Not Available
Limb discomfort15.03.04.014-Not Available
Laryngeal disorder22.04.01.001-Not Available
Mental disorder19.07.01.002-Not Available
Ill-defined disorder08.01.03.049-Not Available
Adverse drug reaction08.06.01.009-Not Available
Nasal disorder22.04.03.004-Not Available
Sinus disorder22.04.06.002-
Unevaluable event08.01.03.051-Not Available
Poor quality sleep19.02.05.005; 17.15.04.002-Not Available
Gastrointestinal inflammation07.08.03.007-Not Available
Oral disorder07.05.01.005-Not Available
Genital swelling21.10.01.010-Not Available
Brain injury19.07.03.007; 17.11.01.003-Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.008-Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004-
Injury associated with device08.07.01.012; 12.01.08.035-Not Available
Respiratory tract oedema22.02.07.013-Not Available
Vulvovaginal swelling21.08.02.016-Not Available
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