Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Methylphenidate hydrochloride
Drug ID BADD_D01432
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 D01296
MeSH ID D008774
PubChem ID 9280
TTD Drug ID D02PPN
NDC Product Code 72865-127; 0406-1571; 17180-1724; 10147-0686; 59116-3391; 60274-949; 24478-075; 31722-926; 31722-954; 0115-1739; 0115-1801; 40032-571; 42858-077; 42858-078; 43386-572; 43386-931; 43547-486; 50268-545; 51407-528; 51991-612; 57664-230; 57664-607; 60687-543; 62175-310; 63629-1176; 70752-132; 0591-3891; 0591-3895; 71376-202; 72865-122; 72865-124; 72865-136; 72912-570; 0406-0570; 0406-2069; 11014-0083; 53834-502; 59116-3392; 59116-6850; 60274-546; 13811-711; 0093-5346; 24478-076; 24478-323; 27808-059; 0115-1738; 0115-1740; 0115-1802; 40032-572; 42291-571; 42858-076; 43386-571; 43547-488; 43602-178; 50268-529; 50268-546; 50458-588; 51407-527; 57664-228; 57664-608; 59630-750; 62037-725; 62037-734; 62175-311; 63629-1904; 63629-1919; 63629-1923; 64980-222; 0527-4581; 0527-4583; 72162-2019; 11014-0371; 59116-3394; 60274-548; 60274-946; 61960-7000; 0078-0370; 13811-707; 16714-823; 0093-5348; 24478-074; 31722-953; 40032-570; 42858-075; 42858-081; 43598-440; 50268-528; 50268-548; 51862-609; 62037-726; 63629-2461; 63629-2462; 0406-0127; 0406-1830; 68084-805; 68084-823; 70010-015; 71376-204; 71376-205; 60687-554; 60687-565; 64980-223; 65162-235; 67877-615; 67877-616; 0406-1850; 70010-043; 0527-4582; 71335-1219; 0591-3854; 0591-3902; 71930-024; 72865-126; 72865-133; 72912-585; 11014-0081; 51927-3076; 60274-547; 60274-947; 10702-102; 16714-821; 31722-927; 31722-928; 0115-1741; 0115-1800; 50268-547; 51862-614; 57664-609; 59630-755; 62175-313; 63629-1921; 63629-9472; 63629-9473; 67877-617; 0406-1144; 0406-1810; 0406-1860; 70010-014; 0591-3869; 71930-025; 0406-8335; 0792-0101; 59116-3390; 60274-948; 0078-0439; 0078-0441; 13811-700; 16729-479; 0093-5292; 42291-568; 42858-080; 43386-575; 43547-487; 43598-441; 43602-177; 50458-587; 51862-610; 63629-1920; 65162-237; 0406-1146; 0406-1445; 0406-1473; 0406-1820; 0406-1840; 0527-3313; 72865-125; 72865-135; 11014-0230; 10147-0688; 10702-101; 0078-0424; 16729-478; 0093-5296; 24478-321; 31722-174; 31722-175; 0115-1736; 43386-574; 60687-532; 63629-2459; 65162-231; 0527-4584; 70752-131; 71376-201; 71376-203; 72865-134; 72912-525; 72912-555; 0406-1335; 11014-0319; 10147-0685; 60274-542; 10702-163; 0078-0372; 13811-706; 13811-708; 0093-5293; 0093-5298; 24478-322; 24478-324; 27808-058; 42291-569; 42858-079; 43386-570; 50458-585; 51862-611; 51862-612; 62175-312; 63629-1172; 63629-1902; 63629-1922; 63629-1924; 63629-2463; 67877-602; 0406-0154; 0406-1142; 68025-084; 70010-013; 0527-3312; 0527-4580; 0591-3862; 72912-545; 11014-0082; 60274-942; 0078-0440; 13811-709; 0093-5297; 31722-173; 43598-439; 51991-611; 62037-727; 63629-1231; 63629-2460; 63629-9471; 64980-221; 65162-233; 67877-618; 70010-012; 70010-016; 0527-3310; 0527-3311; 72912-535; 38779-0851; 10147-0687; 10702-100; 67509-001; 0078-0371; 13811-710; 16714-822; 43386-930; 43598-438; 50458-586; 57664-229; 57664-606; 63629-1175; 63629-1903; 67877-603; 0406-0136; 70010-042; 0527-4579; 0591-3873; 72162-2040; 72162-2041; 72865-123; 49452-4682; 51634-0114; 59116-3393; 60274-549; 10702-164; 65267-114; 65267-115; 16729-480; 0093-5295; 0093-5347; 31722-952; 31722-955; 0115-1737; 42291-570; 43386-573
UNII 4B3SC438HI
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.ClH
CAS Registry Number 298-59-9
SMILES COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl
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)
Hepatic function abnormal09.01.02.001--Not Available
Hypersensitivity10.01.03.003--
Hypomania19.16.02.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Lethargy08.01.01.008; 19.04.04.004; 17.02.04.003--
Leukopenia01.02.02.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Migraine17.14.02.001; 24.03.05.003--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.005--Not Available
Obsessive-compulsive disorder19.06.05.002--Not Available
Palpitations02.11.04.012--
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.010--Not Available
Psychomotor hyperactivity19.11.02.003; 17.01.02.011--Not Available
Pulse abnormal13.14.04.004--Not Available
Pulse pressure decreased13.14.04.008--Not Available
Pulse pressure increased13.14.04.007--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Raynaud's phenomenon24.04.03.003--Not Available
Rhabdomyolysis15.05.05.002--
Somnolence19.02.05.003; 17.02.04.006--
Sudden death02.03.04.013; 08.04.01.003--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.003--Not Available
Tourette's disorder19.11.04.002; 17.19.02.001; 03.10.01.001--Not Available
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