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)
Skin irritation23.03.04.009-Not Available
Sleep apnoea syndrome19.02.05.002; 17.15.05.001; 22.02.01.013-
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003-Not Available
Stress19.06.02.004-Not Available
Swelling08.01.03.015-Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018-Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.003-Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008-
Synovial cyst16.18.01.004; 15.04.02.002-Not Available
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.004-Not Available
Throat tightness22.12.03.031; 19.01.02.005-Not Available
Thrombosis24.01.01.006-Not Available
Tongue oedema07.14.02.007; 23.04.01.009; 10.01.05.008-Not Available
Tooth disorder07.09.05.001-Not Available
Urticaria23.04.02.001; 10.01.06.001-
Varicose vein24.10.04.001-Not Available
Vomiting07.01.07.003--
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.030-Not Available
Musculoskeletal disorder15.03.05.025-Not Available
Poor venous access24.03.02.017-Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.013-Not Available
Peripheral swelling08.01.03.053; 02.05.04.015-Not Available
Localised oedema14.05.06.009; 02.05.04.006; 08.01.07.011-
Weight fluctuation14.03.02.002-Not Available
Muscle tightness15.05.03.007-Not Available
Intervertebral disc protrusion15.10.01.004-Not Available
Injection site discolouration12.07.03.038; 08.02.03.038; 23.03.03.046-Not Available
Eye pruritus06.04.05.006-Not Available
Musculoskeletal discomfort15.03.04.001-Not Available
Injection site swelling12.07.03.018; 08.02.03.017-Not Available
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