Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sarecycline
Drug ID BADD_D02501
Description Sarecycline is a semi-synthetic derivative of tetracycline that was initially discovered by Paratek Pharmaceuticals from Boston, MA but then licensed to Warner Chilcott of Rockaway, NJ in July of 2007 [A40005]. After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris [A39993, A39994] the US Food and Drug Administration approved Barcelona based Almirall, S.A.'s Seysara (sarecylcine) as a new first in class narrow spectrum tetracycline derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older [L4814]. Seysara (sarecycline) was originally part of Allergan's US Medical Dermatology portfolio, before Almirall acquired the portfolio in the second half of 2018 as a means of consolidating and reinforcing the dermatology-focused pharmaceutical company's presence in the United States [L4815]. Acne vulgaris itself is a common chronic skin condition associated with the blockage and/or inflammation of hair follicles and their accompanying sebaceous glands [L4814]. The acne often presents physically as a mixture of non-inflammatory and inflammatory lesions mainly on the face but on the back and chest as well [L4814]. Based upon data from Global Burden of Disease studies, the acne vulgaris condition affects up to 85% of young adults aged 12 to 25 years globally - with the possibility of permanent physical and mental scarring resulting from cases of severe acne [L4814]. Subsequently, while a number of first line tetracycline therapies like doxycycline and minocycline do exist for treating acne vulgaris, sarecycline presents a new and innovative therapy choice because it exhibits the necessary antibacterial activity against relevant pathogens that cause acne vulgaris but also possesses a low propensity for resistance development in such pathogens and a narrower, more specific spectrum of antibacterial activity, resulting in fewer off-target antibacterial effects on endogenous intestinal flora and consequently fewer resultant adverse effects associated with diarrhea, fungal overgrowth, etc.
Indications and Usage Sarecycline is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older [FDA Label].
Marketing Status approved; investigational
ATC Code J01AA14
DrugBank ID DB12035
KEGG ID D10666
MeSH ID C000629276
PubChem ID 54681908
TTD Drug ID D0T6EI
NDC Product Code Not Available
UNII 94O110CX2E
Synonyms sarecycline | (4S,4aS,5aR,12aS)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-((methoxy(methyl)amino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-2-tetracenecarboxamide | Seysara
Chemical Information
Molecular Formula C24H29N3O8
CAS Registry Number 1035654-66-0
SMILES CN(C)C1C2CC3CC4=C(C=CC(=C4C(=C3C(=O)C2(C(=C(C1=O)C(=O)N)O)O)O)O)CN(C)OC
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)
Anxiety19.06.02.0020.000248%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.000437%
Headache17.14.01.0010.000578%
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.000049%-
Oesophageal ulcer07.04.05.0020.000049%
Palpitations02.11.04.0120.000107%
Photosensitivity reaction23.03.09.0030.000248%
Rash23.03.13.0010.000330%-
Seizure17.12.03.0010.000131%
Tooth discolouration07.09.02.0010.000165%
Urticaria10.01.06.001; 23.04.02.0010.000248%
Vertigo04.04.01.003; 17.02.12.0020.000165%
Vision blurred06.02.06.007; 17.17.01.0100.000544%
Decreased appetite08.01.09.028; 14.03.01.0050.000049%
Liver injury09.01.07.022; 12.01.17.0120.000073%-
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