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)
Dyschezia07.02.03.0050.002170%Not Available
Spondyloarthropathy15.01.09.0030.000530%Not Available
Prostatomegaly21.04.01.0020.002821%Not Available
Rhinalgia22.12.03.0200.001640%Not Available
Ear congestion04.03.01.0100.002170%Not Available
Ear discomfort04.03.01.0050.006221%Not Available
Ear pruritus04.03.01.0110.001350%Not Available
Respiratory tract congestion22.02.07.0030.020157%Not Available
Upper respiratory tract congestion22.12.03.0330.004340%Not Available
Paranasal sinus discomfort22.12.03.0180.006148%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Epigastric discomfort07.01.02.0040.007499%Not Available
Musculoskeletal discomfort15.03.04.0010.011959%Not Available
Secretion discharge08.01.03.0190.009620%Not Available
Tonsillar disorder22.04.05.0090.000241%Not Available
Depressive symptom19.15.02.0030.011911%Not Available
Nodule08.03.05.002--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.035034%Not Available
Rectal tenesmus15.05.03.011; 07.03.03.0010.000530%Not Available
Urine odour abnormal20.02.01.0200.003930%Not Available
Paranasal sinus hypersecretion22.04.06.0040.003689%Not Available
Major depression19.15.01.003--Not Available
Reflux gastritis07.08.02.0040.001230%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001--Not Available
Dermatitis psoriasiform23.03.14.0040.000651%Not Available
Cluster headache17.14.01.0030.002580%Not Available
Infrequent bowel movements07.02.02.0110.001640%Not Available
Adverse event08.06.01.010--Not Available
Breast disorder21.05.04.0040.000723%Not Available
Cardiac disorder02.11.01.003--Not Available
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