Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Avatrombopag
Drug ID BADD_D02497
Description Avatrombopag (_Doptelet_), is an orally administered, small-molecule thrombopoietin receptor (c-Mpl) agonist which increases platelet number, but not platelet activation [A33097], [L2824]. This decreases the need for blood transfusions [L2824]. Patients with thrombocytopenia and chronic liver disease (leading to thrombocytopenia) often require platelet transfusions before surgical procedures to decrease the risk of bleeding [A33095]. Thrombocytopenia (or decreased numbers of platelets) is a common complication in patients suffering from chronic liver disease, either as an immediate result of liver disease or a consequence of interferon-based antiviral therapy [F95]. Avatrombopag was approved by the FDA on May 21, 2018 for thrombocytopenia (low platelets) in adults with chronic liver disease who are scheduled to undergo a procedure [L2931]. It is administered orally as _avatrombopag maleate_, its salt form [L2927]. _Doptelet_ (Avatrombopag) is the first orally administered treatment option for patients with chronic liver disease, allowing a large population of patients to avoid a platelet transfusion before a procedure by increasing platelet counts to the optimal level of greater or equal to 50,000 per microliter [L2932].
Indications and Usage Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure [FDA label].
Marketing Status approved; investigational
ATC Code B02BX08
DrugBank ID DB11995
KEGG ID D10306
MeSH ID C533238
PubChem ID 9852519
TTD Drug ID D0W1DI
NDC Product Code Not Available
UNII 3H8GSZ4SQL
Synonyms avatrombopag | Doptelet | AKR 501 | AKR501 | AKR-501 | YM 477 | YM477 | YM-477 | E5501 compound | 1-(3-chloro-5-((4-(4-chloro-2-thienyl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)-2-pyridyl)piperidine-4-carboxylic acid
Chemical Information
Molecular Formula C29H34Cl2N6O3S2
CAS Registry Number 570406-98-3
SMILES C1CCC(CC1)N2CCN(CC2)C3=C(N=C(S3)NC(=O)C4=CC(=C(N=C4)N5CCC(CC5)C(=O)O)Cl)C6=CC(=C S6)Cl
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)
Muscular weakness17.05.03.005; 15.05.06.0010.000503%
Myalgia15.05.02.0010.001166%
Myocardial infarction24.04.04.009; 02.02.02.0070.000457%
Nausea07.01.07.0010.008116%
Neuropathy peripheral17.09.03.0030.000503%Not Available
Pain in extremity15.03.04.0100.002126%
Portal vein thrombosis09.01.06.007; 24.01.03.0030.000343%
Pruritus23.03.12.0010.001555%
Pulmonary embolism24.01.06.001; 22.06.02.0010.000572%Not Available
Pyrexia08.05.02.0030.002172%
Rash23.03.13.0010.002446%Not Available
Renal disorder20.01.02.0020.000229%Not Available
Renal vein thrombosis24.01.11.002; 20.01.07.0110.000229%Not Available
Somnolence17.02.04.006; 19.02.05.0030.001555%
Swelling08.01.03.0150.001280%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.000777%Not Available
Thrombosis24.01.01.0060.000343%Not Available
Tremor17.01.06.0020.000503%
Vision blurred17.17.01.010; 06.02.06.0070.001555%
Vomiting07.01.07.0030.002904%
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.0130.000503%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001555%Not Available
Deep vein thrombosis24.01.02.0030.000343%Not Available
Haemorrhage24.07.01.0020.000457%Not Available
Embolism24.01.01.0090.000229%
Disease progression08.01.03.0380.000617%
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000777%
Mesenteric vein thrombosis24.01.08.004; 07.15.02.0130.000229%Not Available
Illness08.01.03.0910.000892%Not Available
Therapeutic product effect decreased08.06.01.0500.001166%Not Available
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