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)
Death08.04.01.001--
Dementia19.20.02.001; 17.03.01.0010.000728%Not Available
Dermatitis23.03.04.0020.000825%Not Available
Dermatitis bullous23.03.01.0020.007134%
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diabetes mellitus05.06.01.001; 14.06.01.001--Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.002596%Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.014219%
Drug eruption08.01.06.015; 23.03.05.001; 10.01.01.0050.000825%Not Available
Dyspepsia07.01.02.0010.001893%
Dysphagia07.01.06.0030.002451%
Eczema23.03.04.0060.000825%
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.0020.001771%
Flatulence07.01.04.0020.000946%
Gallbladder disorder09.03.02.0010.000243%Not Available
Gastrooesophageal reflux disease07.02.02.0030.000946%
Gastrointestinal disorder07.11.01.001--Not Available
Gout15.01.06.001; 14.09.01.0010.002062%Not Available
Haematocrit increased13.01.05.002--Not Available
Haematoma24.07.01.001--
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000243%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.006--Not Available
Hepatic failure09.01.03.0020.000485%
Hyperglycaemia14.06.02.002; 05.06.02.0020.003907%
Hyperkalaemia14.05.03.0010.000946%
Hypersensitivity10.01.03.0030.003373%
Hypertriglyceridaemia14.08.02.001--
Hypoglycaemia14.06.03.001; 05.06.03.0010.006284%
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