Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Icatibant acetate
Drug ID BADD_D01123
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 6918172
TTD Drug ID D04ZBT
NDC Product Code 55463-0033; 59651-363; 63415-0526; 32861-0004; 41524-0008; 55111-994; 60505-6214; 62147-0277; 54092-702; 68462-828; 35207-0008; 66529-0002; 69766-014
UNII 325O8467XK
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 C61H93N19O15S
CAS Registry Number 138614-30-9
SMILES CC(=O)O.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(CCC N=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)
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Body temperature increased13.15.01.001--Not Available
Dermatitis23.03.04.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Injection site reaction12.07.03.015; 08.02.03.014--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Transaminases increased13.03.04.036--Not Available
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