Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Methylphenidate
Drug ID BADD_D01431
Description Methylphenidate is a central nervous system stimulant used most commonly in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and for narcolepsy. Also known as the marketed products Ritalin, Concerta, or Biphentin, methylphenidate is used with other treatment modalities (psychological, educational, cognitive behaviour therapy, etc) to improve the following group of developmentally inappropriate symptoms associated with ADHD: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. Long-acting formulations of psychostimulants such as methylphenidate, [DB01576], and [DB01255] are considered the most effective and widely used treatment for ADHD, and are considered first-line options for children, adolescents, and adults as recommended by CADDRA (Canadian ADHD Resource Alliance). [L6037] CADDRA recommends the use of methylphenidate due to long term studies, of over twenty years in duration, which show methylphenidate is safe and effective.
Indications and Usage Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.
Marketing Status approved; investigational
ATC Code N06BA04
DrugBank ID DB00422
KEGG ID D04999
MeSH ID D008774
PubChem ID 4158
TTD Drug ID D02PPN
NDC Product Code 0781-2363; 0378-8263; 0574-2420; 0406-7654; 70165-200; 0378-8261; 68968-5552; 68968-5555; 70165-100; 0781-2362; 0781-2364; 0378-8262; 0574-2410; 0574-2430; 0574-2415; 68968-5553; 70165-300; 68968-5554; 0781-2361; 0378-8260
UNII 207ZZ9QZ49
Synonyms Methylphenidate | Metadate | Equasym | Methylin | Concerta | Phenidylate | Ritalin | Ritaline | Ritalin-SR | Ritalin SR | Tsentedrin | Centedrin | Daytrana | Methylphenidate Hydrochloride | Hydrochloride, Methylphenidate
Chemical Information
Molecular Formula C14H19NO2
CAS Registry Number 113-45-1
SMILES COC(=O)C(C1CCCCN1)C2=CC=CC=C2
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)
Apnoea22.02.01.0010.000103%
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.0050.005674%-
Application site irritation08.02.01.003; 12.07.01.0030.003655%-
Application site oedema08.02.01.020; 12.07.01.0200.000210%-
Application site pain08.02.01.004; 12.07.01.0040.001838%-
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.0040.003355%-
Application site rash08.02.01.016; 12.07.01.016; 23.03.13.0080.002117%-
Application site reaction08.02.01.006; 12.07.01.006---
Application site ulcer08.02.01.007; 12.07.01.007; 23.07.03.0100.000140%-
Arrhythmia02.03.02.0010.000391%-
Arteriospasm coronary02.02.02.005; 12.02.01.031; 24.04.04.0050.000062%-
Arteritis24.12.02.0010.000041%-
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Asthenopia06.01.01.002---
Asthma10.01.03.010; 22.03.01.0020.000325%-
Athetosis17.01.01.004---
Atrioventricular block first degree02.03.01.0040.000041%
Atrioventricular block second degree02.03.01.0050.000062%
Auricular swelling04.01.01.002---
Autoimmune hepatitis09.01.07.019; 10.04.09.0010.000090%-
Back pain15.03.04.005--
Benign hepatic neoplasm09.04.01.001; 16.06.01.0010.000041%-
Binge eating19.09.01.0010.000090%-
Bipolar I disorder19.16.01.0020.000041%-
Blindness06.02.10.003; 17.17.01.0030.000123%-
Blindness transient06.02.10.006; 17.17.01.0040.000041%-
Blindness unilateral06.02.10.007; 17.17.01.0160.000062%-
Blister12.01.06.002; 23.03.01.001---
Blood bilirubin increased13.03.04.018--
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ADReCS-Target
Drug Name ADR Term Target
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