Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Copanlisib
Drug ID BADD_D02544
Description Copanlisib is a selective pan-Class I phosphoinositide 3-kinase (PI3K/Phosphatidylinositol-4,5-bisphosphate 3-kinase/phosphatidylinositide 3-kinase) inhibitor that was first developed by Bayer Healthcare Pharmaceuticals, Inc. The drug targets the enzyme that plays a role in regulating cell growth and survival. Copanlisib was granted accelerated approval on September 14, 2017 under the market name Aliqopa for the treatment of adult patients with relapsed follicular lymphoma and a treatment history of at least two prior systemic therapies. Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma that is caused by unregulated proliferation and growth of lymphocytes. The active ingredient in Aliquopa intravenous therapy is copanlisib dihydrochloride.
Indications and Usage Indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Marketing Status approved; investigational
ATC Code L01EM02
DrugBank ID DB12483
KEGG ID D10867
MeSH ID C000589253
PubChem ID Not Available
TTD Drug ID D0S5LD
NDC Product Code 50419-385
UNII WI6V529FZ9
Synonyms copanlisib | 2-amino-N-(7-methoxy-8-(3-morpholinopropoxy)-2,3-dihydroimidazo(1,2-c)quinazolin-4-yl)pyrimidine-5-carboxamide | BAY 80-6946 | Aliqopa
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1032568-63-0
SMILES Not Available
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)
Anaemia01.03.02.0010.000112%
Cardiac arrest02.03.04.0010.000112%
Death08.04.01.0010.000168%
Dehydration14.05.05.0010.000112%
Hyperglycaemia14.06.02.002; 05.06.02.0020.000336%
Hypertension24.08.02.0010.000548%
Paraesthesia23.03.03.094; 17.02.06.0050.000246%
Pneumonitis22.01.01.0060.000246%
Rash23.03.13.0010.001007%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000571%Not Available
Drug intolerance08.06.01.0130.000381%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000112%
Acute kidney injury20.01.03.0160.000112%
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