Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Linagliptin
Drug ID BADD_D01292
Description Linagliptin is a DPP-4 inhibitor developed by Boehringer Ingelheim for the treatment of type II diabetes [L9557]. Linagliptin differs from other DPP-4 inhibitors in that it has a non-linear pharmacokinetic profile, is not primarily eliminated by the renal system, and obeys concentration dependant protein binding[A37050]. Linagliptin was approved by the FDA on May 2, 2011[L9557].
Indications and Usage Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise[L9557]. It should not be used to treat type I diabetes or in diabetic ketoacidosis.[L9557] An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.[L11479]
Marketing Status approved
ATC Code A10BH05
DrugBank ID DB08882
KEGG ID D09566
MeSH ID D000069476
PubChem ID 10096344
TTD Drug ID D02EYG
NDC Product Code 12714-153; 62993-0808; 65862-970; 0597-0140; 64220-184; 55154-0410; 65015-854; 53104-7701; 63415-0521; 66039-908; 73309-391; 50370-0045; 69037-0008; 65727-057; 51869-0020; 55111-972
UNII 3X29ZEJ4R2
Synonyms Linagliptin | (R)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione | 1H-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)- | BI 1356 | 1356, BI | BI1356 | BI-1356 | Tradjenta | Trajenta
Chemical Information
Molecular Formula C25H28N8O2
CAS Registry Number 668270-12-0
SMILES CC#CCN1C2=C(N=C1N3CCCC(C3)N)N(C(=O)N(C2=O)CC4=NC5=CC=CC=C5C(=N4)C)C
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)
Peripheral swelling08.01.03.053; 02.05.04.0150.003009%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Dyslipidaemia14.08.04.015--Not Available
Infarction24.04.02.0170.000243%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.000825%
Genital infection female21.14.04.003; 11.01.10.011--Not Available
Hyperlipidaemia14.08.03.001--
Renal impairment20.01.03.0100.002669%Not Available
Unevaluable event08.01.03.0510.001771%Not Available
Genital infection male21.09.03.006; 11.01.19.006--Not Available
Chronic kidney disease20.01.03.0170.000946%
Bronchial hyperreactivity22.03.01.016--Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.000243%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.003009%
Anal incontinence17.05.01.021; 07.01.06.0290.000825%
Faeces pale07.01.03.0050.000243%Not Available
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