Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tocophersolan
Drug ID BADD_D02235
Description D-Alpha-tocopheryl polyethylene glycol 1000 succinate (Tocofersolan, Vedrop), has been developed in Europe as an orally bioavailable source of vitamin E in children suffering from cholestasis [L2371]. Cholestasis is the reduction or stoppage of bile flow, either to impaired secretion by _hepatocytes_ (liver cells) or obstruction [L2374], [L2375]. Tocofersolan is a polyethylene glycol derivative of α-tocopherol and synthetic water-soluble version of [DB11251]. Tocofersolan is an oral treatment of vitamin E deficiency due to digestive malabsorption in pediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis. It was approved by the European Medicines Agency (EMA) in June 2009 under the market name Vedrop. Moreover, the agent is capable of demonstrating antioxidant effects that make it a popular component to include in cosmetics and pharmaceuticals as well. In addition to the above, tocofersolan has been studied as a promising application as an absorption enhancer in drug delivery [MSDS].
Indications and Usage Tocofersolan is indicated in vitamin E deficiency caused by digestive malabsorption in pediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis from birth (full term newborns) up to 18 years of age [L2371].
Marketing Status approved
ATC Code A11HA08
DrugBank ID DB11635
KEGG ID D06174
MeSH ID C014225
PubChem ID 71406
TTD Drug ID D08CVC
NDC Product Code Not Available
UNII Not Available
Synonyms tocophersolan | mono-(2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-6-chromanyl) succinate polyethylene glycol monoester | poly(oxy-1,2-ethanediyl), alpha-(4-((3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-1-benzopyran-6-yl)oxy)-1,4-dioxobutyl-omega-hydroxy- | tocofersolan | tocopherol polyethylene glycol succinate | vitamin E-TPGS | TPGS | vitamine E PEG-1000-succinate | alpha-tocopheryl polyethylene glycol succinate | (+)-alpha-tocopheryl polyethylene glycol 1000 succinate | tocopheryl poly(ethylene glycol) 1000 succinate | tocophersolan, (2R-(2R*(4R*,8R*)))-isomer | tocopherol poly(ethylene glycol) 2000 succinate | alpha-D-tocopherol poly(ethylene glycol) 2000 succinate | TPGS 2K
Chemical Information
Molecular Formula C35H58O6
CAS Registry Number 30999-06-5
SMILES CC1=C(C(=C(C2=C1OC(CC2)(C)CCCC(C)CCCC(C)CCCC(C)C)C)OC(=O)CCC(=O)OCCO)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)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Asthenia08.01.01.001--Not Available
Blood potassium abnormal13.11.01.024--Not Available
Blood sodium abnormal13.11.01.025--Not Available
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Skin disorder23.03.03.007--Not Available
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