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)
Nasal congestion22.04.04.001-
Nephrolithiasis20.04.01.002-
Nephrotic syndrome20.05.01.002-
Nervousness19.06.02.003-Not Available
Nonspecific reaction08.01.03.040-Not Available
Obesity14.03.02.009-
Pancreatitis07.18.01.001-
Pericarditis02.06.02.001-
Periorbital oedema10.01.05.010; 06.08.03.017; 23.04.01.002-
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.016-Not Available
Pregnancy18.08.02.004-Not Available
Premature delivery18.07.01.006-
Pruritus23.03.12.001-
Pulmonary embolism24.01.06.001; 22.06.02.001-Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003-
Pulmonary thrombosis24.01.06.002; 22.06.02.003-Not Available
Pyrexia08.05.02.003-
Rash macular23.03.13.003-Not Available
Rash pruritic23.03.13.030-Not Available
Raynaud's phenomenon24.04.03.003-Not Available
Rebound effect08.06.02.009-Not Available
Respiratory disorder22.02.07.002-Not Available
Respiratory distress22.02.01.012-Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Rheumatoid arthritis15.01.03.001; 10.04.06.001-Not Available
Rotator cuff syndrome12.01.07.018; 15.01.08.002-
Seizure17.12.03.001-
Shock24.06.02.002-Not Available
Skin discolouration23.03.03.005-Not Available
Skin exfoliation23.03.07.003-Not Available
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