Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Apremilast
Drug ID BADD_D00156
Description Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as [Roflumilast] and [Crisaborole].[A181244,L7495] Initially approved in 2014, it is marketed by Celgene.[L7501] In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.[A181216]
Indications and Usage Apremilast is indicated for the treatment of adults with active psoriatic arthritis and adults with oral ulcers associated with Behcet's Disease. In addition, apremilast is indicated for the treatment of plaque psoriasis, of any severity, in adult patients who are candidates for phototherapy or systemic therapy.[L7501]
Marketing Status approved; investigational
ATC Code L04AA32
DrugBank ID DB05676
KEGG ID D08860
MeSH ID C505730
PubChem ID 10151715
TTD Drug ID D07ESC
NDC Product Code 55513-369; 53069-1040; 66406-0242; 82891-014; 55513-137; 59651-150; 65129-1383; 11722-062; 12658-0581; 47621-306; 53069-1050; 66406-0241; 70518-3155; 49187-0757; 55111-993; 58032-2030; 65372-1204; 69766-010; 69766-024; 55513-485; 53747-077; 65977-0119; 66039-934; 73309-043; 66406-0240
UNII UP7QBP99PN
Synonyms apremilast | Otezla | CC 10004 | CC10004 | CC-10004
Chemical Information
Molecular Formula C22H24N2O7S
CAS Registry Number 253168-86-4
SMILES CCOC1=C(C=CC(=C1)C(CS(=O)(=O)C)N2C(=O)C3=C(C2=O)C(=CC=C3)NC(=O)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)
Hernia08.01.04.001--Not Available
Hidradenitis23.02.03.0130.001471%Not Available
Hyperchlorhydria07.11.03.0010.004509%Not Available
Hypersensitivity10.01.03.003--
Immune system disorder10.02.01.0010.015624%Not Available
Inappropriate affect19.04.01.0050.000651%Not Available
Influenza like illness08.01.03.0100.050947%
Initial insomnia19.02.01.005; 17.15.03.0050.006679%Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Insomnia19.02.01.002; 17.15.03.0020.309130%
Irritable bowel syndrome19.24.01.003; 07.02.04.0030.024979%Not Available
Joint stiffness15.01.02.0030.024907%Not Available
Joint swelling15.01.02.004--Not Available
Judgement impaired19.05.01.009; 17.03.03.0050.000241%Not Available
Keratoacanthoma23.08.02.007; 16.03.02.0070.001061%Not Available
Lactose intolerance07.17.01.003; 14.02.02.0010.002459%Not Available
Leukaemia16.01.03.001; 01.10.03.001--
Libido increased21.03.02.007; 19.08.03.0020.001640%
Lichen planus23.03.08.0010.003689%Not Available
Liver disorder09.01.08.001--Not Available
Macule23.03.03.0370.003279%Not Available
Mass08.03.05.003--Not Available
Memory impairment17.03.02.003; 19.20.01.0030.112093%
Menstrual disorder21.01.01.0040.009259%Not Available
Migraine24.03.05.003; 17.14.02.0010.231492%Not Available
Migraine with aura24.03.05.005; 17.14.02.0020.001471%Not Available
Miliaria23.02.03.0140.002869%Not Available
Mood altered19.04.02.0070.079302%Not Available
Mood swings19.04.03.0010.048054%Not Available
Morphoea23.03.02.011; 15.06.01.008; 10.04.07.0020.000820%Not Available
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