Page last updated: 2024-10-31

methylphenidate and Adverse Drug Event

methylphenidate has been researched along with Adverse Drug Event in 22 studies

Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.
methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.

Research Excerpts

ExcerptRelevanceReference
"Methylphenidate, modafinil, and amantadine are commonly prescribed medications for alleviating fatigue in multiple sclerosis; however, the evidence supporting their efficacy is sparse and conflicting."9.41Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. ( Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021)
"Methylphenidate, modafinil, and amantadine are commonly prescribed medications for alleviating fatigue in multiple sclerosis; however, the evidence supporting their efficacy is sparse and conflicting."5.41Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. ( Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021)
"There were more incidents of bradycardia in subjects treated with clonidine compared with those not treated with clonidine (17."5.13Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis. ( Bukstein, OG; Daviss, WB; Harris, P; McDERMOTT, MP; Palumbo, D; Patel, NC; Pelham, WE; Robb, AS; Sallee, FR, 2008)
" Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52."2.94Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study. ( Abdel-Hamid, M; Alm, B; Berger, M; Borel, P; Colla, M; Graf, E; Heßmann, P; Huss, M; Jacob, C; Jans, T; Kis, B; Lücke, C; Matthies, S; Müller, HHO; Philipsen, A; Retz, W; Rösler, M; Sobanski, E; van Elst, LT, 2020)
" Trials of amphetamines, atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil with a placebo arm and reporting data on headache as an adverse event, were included."2.82Headache in ADHD as comorbidity and a side effect of medications: a systematic review and meta-analysis. ( Banaschewski, T; Bölte, S; Buitelaar, JK; Coghill, D; Cortese, S; Häge, A; Hohmann, S; Jonsson, U; Nobel Norrman, H; Pan, PY; Şahpazoğlu Çakmak, SS, 2022)
"The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial."2.79Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate. ( Aabech, HS; Ramtvedt, BE; Sundet, K, 2014)
"The side effect profile as assessed by the SERS was similar to that of previous studies with insomnia, decreased appetite, and headaches showing significant treatment effects (p < 0."2.76Relation between therapeutic response and side effects induced by methylphenidate as observed by parents and teachers of children with ADHD. ( Bhat, V; Grizenko, N; Joober, R; Lee, J; Polotskaia, A; Sengupta, S, 2011)
" Withdrawals due to all-cause, adverse effects and lack of efficacy were defined as primary outcomes evaluating the safety of such medications."2.55An Evaluation on the Efficacy and Safety of Treatments for Attention Deficit Hyperactivity Disorder in Children and Adolescents: a Comparison of Multiple Treatments. ( Gao, J; He, S; Li, Y; Wang, Q; Zhang, Y, 2017)
"Methylphenidate is an effective first-line treatment for attention-deficit/hyperactivity disorder (ADHD)."1.91The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis. ( Kim, E; Lee, H; Oh, S; Park, S; Purja, S; Shin, H; Yuniar, CT, 2023)
"Modafinil was associated with DAAD in the total dataset (ROR, 2."1.46Sensitivity of Quantitative Signal Detection in Regards to Pharmacological Neuroenhancement. ( Connemann, BJ; Gahr, M; Schönfeldt-Lecuona, C; Zeiss, R, 2017)
" The risk of adverse drug-drug interaction(s) is present when metabolic inhibitors are combined with known or suspected substrates of a given enzyme."1.36Identification of selected therapeutic agents as inhibitors of carboxylesterase 1: potential sources of metabolic drug interactions. ( Appel, DI; Markowitz, JS; Peterson, YK; Wang, Z; Zhu, HJ, 2010)

Research

Studies (22)

TimeframeStudies, this research(%)All Research%
pre-19901 (4.55)18.7374
1990's0 (0.00)18.2507
2000's2 (9.09)29.6817
2010's11 (50.00)24.3611
2020's8 (36.36)2.80

Authors

AuthorsStudies
Liu, Z1
Shi, Q1
Ding, D1
Kelly, R1
Fang, H1
Tong, W1
Dubrall, D1
Leitzen, S1
Toni, I1
Stingl, J1
Schulz, M1
Schmid, M1
Neubert, A1
Sachs, B1
Pan, PY1
Jonsson, U1
Şahpazoğlu Çakmak, SS1
Häge, A1
Hohmann, S1
Nobel Norrman, H1
Buitelaar, JK1
Banaschewski, T1
Cortese, S2
Coghill, D1
Bölte, S1
Groom, MJ1
Akhlaque, E1
Shin, H1
Yuniar, CT1
Oh, S1
Purja, S1
Park, S1
Lee, H1
Kim, E1
Kis, B1
Lücke, C1
Abdel-Hamid, M1
Heßmann, P1
Graf, E1
Berger, M1
Matthies, S1
Borel, P1
Sobanski, E1
Alm, B1
Rösler, M1
Retz, W1
Jacob, C1
Colla, M1
Huss, M1
Jans, T1
van Elst, LT1
Müller, HHO1
Philipsen, A1
Elliott, J1
Johnston, A1
Husereau, D1
Kelly, SE1
Eagles, C1
Charach, A1
Hsieh, SC1
Bai, Z1
Hossain, A1
Skidmore, B1
Tsakonas, E1
Chojecki, D1
Mamdani, M1
Wells, GA1
Nourbakhsh, B1
Revirajan, N1
Morris, B1
Cordano, C1
Creasman, J1
Manguinao, M1
Krysko, K1
Rutatangwa, A1
Auvray, C1
Aljarallah, S1
Jin, C1
Mowry, E1
McCulloch, C1
Waubant, E1
Svendsen, K1
Halvorsen, KH1
Vorren, S1
Samdal, H1
Garcia, B1
Ramtvedt, BE1
Aabech, HS1
Sundet, K1
Li, Y1
Gao, J1
He, S1
Zhang, Y1
Wang, Q1
Gahr, M1
Connemann, BJ1
Schönfeldt-Lecuona, C1
Zeiss, R1
Zhu, HJ1
Appel, DI1
Peterson, YK1
Wang, Z1
Markowitz, JS1
Tobaiqy, M1
Stewart, D1
Helms, PJ1
Bond, C1
Lee, AJ1
Bateman, N1
McCaig, D1
McLay, J1
Lee, J1
Grizenko, N1
Bhat, V1
Sengupta, S1
Polotskaia, A1
Joober, R1
Kim, J1
Kim, M1
Ha, JH1
Jang, J1
Hwang, M1
Lee, BK1
Chung, MW1
Yoo, TM1
Kim, MJ1
Olfson, M1
Huang, C1
Gerhard, T1
Winterstein, AG1
Crystal, S1
Allison, PD1
Marcus, SC1
Duong, S1
Chung, K1
Wigal, SB1
Humphreys, C1
Garcia-Bournissen, F1
Ito, S1
Koren, G1
Daviss, WB1
Patel, NC1
Robb, AS1
McDERMOTT, MP1
Bukstein, OG1
Pelham, WE1
Palumbo, D1
Harris, P1
Sallee, FR1
Springer, NS1
Fricke, NL1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis[NCT03185065]Phase 3141 participants (Actual)Interventional2017-10-04Completed
A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED FATIGUE[NCT06064162]Early Phase 120 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD[NCT01220440]Phase 436 participants (Actual)Interventional2006-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Acceptability of Treatment as Assessed by a Single Question Questionnaire

"Participants will answer yes or no to this question: Taken into consideration the possible benefits and/or disadvantages of this medication, would you choose it, going forward to treat your MS fatigue?. The number of participants who answered Yes to this question is reported here." (NCT03185065)
Timeframe: Week 5 of each treatment period

InterventionParticipants (Count of Participants)
Placebo39
Amantadine41
Modafinil55
Methylphenidate55

Epworth Sleepiness Scale (ESS) Score

ESS score during the fifth week of treatment period. The ESS score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo9.4
Amantadine9.3
Modafinil8.3
Methylphenidate8.8

Modified Fatigue Impact Scale (MFIS) Score

MFIS score during the fifth week of treatment period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo40.6
Amantadine41.3
Modafinil39.0
Methylphenidate38.6

Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score

Neuro-QoL Item Bank - Fatigue T score during the fifth week of treatment period. T-score distributions rescale raw scores into standardized scores with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo53.1
Amantadine53.0
Modafinil52.5
Methylphenidate52.0

Reviews

7 reviews available for methylphenidate and Adverse Drug Event

ArticleYear
Headache in ADHD as comorbidity and a side effect of medications: a systematic review and meta-analysis.
    Psychological medicine, 2022, Volume: 52, Issue:1

    Topics: Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Central Nervous System Sti

2022
Current Pharmacological Treatments for ADHD.
    Current topics in behavioral neurosciences, 2022, Volume: 57

    Topics: Adolescent; Adult; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Central

2022
Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis.
    PloS one, 2020, Volume: 15, Issue:10

    Topics: Adult; Amphetamine; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Bayes

2020
An Evaluation on the Efficacy and Safety of Treatments for Attention Deficit Hyperactivity Disorder in Children and Adolescents: a Comparison of Multiple Treatments.
    Molecular neurobiology, 2017, Volume: 54, Issue:9

    Topics: Adolescent; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Child; Clonidi

2017
Metabolic, toxicological, and safety considerations for drugs used to treat ADHD.
    Expert opinion on drug metabolism & toxicology, 2012, Volume: 8, Issue:5

    Topics: Amphetamines; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Central Nerv

2012
Exposure to attention deficit hyperactivity disorder medications during pregnancy.
    Canadian family physician Medecin de famille canadien, 2007, Volume: 53, Issue:7

    Topics: Abnormalities, Drug-Induced; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivit

2007
Nutrition and drug therapy for persons with developmental disabilities.
    American journal of mental deficiency, 1975, Volume: 80, Issue:3

    Topics: Anticonvulsants; Antidepressive Agents; Appetite; Dextroamphetamine; Drug-Related Side Effects and A

1975

Trials

5 trials available for methylphenidate and Adverse Drug Event

ArticleYear
Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.
    Pharmacopsychiatry, 2020, Volume: 53, Issue:6

    Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants;

2020
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.
    Journal of child and adolescent psychopharmacology, 2014, Volume: 24, Issue:3

    Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Child; Cross-Over Studies; Dextroamphetam

2014
Relation between therapeutic response and side effects induced by methylphenidate as observed by parents and teachers of children with ADHD.
    BMC psychiatry, 2011, Apr-21, Volume: 11

    Topics: Adult; Attention Deficit Disorder with Hyperactivity; Attitude to Health; Central Nervous System Sti

2011
Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis.
    Journal of the American Academy of Child and Adolescent Psychiatry, 2008, Volume: 47, Issue:2

    Topics: Adrenergic alpha-Agonists; Attention Deficit Disorder with Hyperactivity; Bradycardia; Central Nervo

2008

Other Studies

10 other studies available for methylphenidate and Adverse Drug Event

ArticleYear
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs.
    BMC pharmacology & toxicology, 2021, 10-07, Volume: 22, Issue:1

    Topics: Adolescent; Atomoxetine Hydrochloride; Child; Child, Preschool; Drug Combinations; Drug-Related Side

2021
Alice in Wonderland Syndrome as a potential side-effect in Attention Deficit Hyperactivity Disorder patients undergoing Methylphenidate treatment.
    JPMA. The Journal of the Pakistan Medical Association, 2023, Volume: 73, Issue:3

    Topics: Alice in Wonderland Syndrome; Attention Deficit Disorder with Hyperactivity; Drug-Related Side Effec

2023
The Adverse Effects and Nonmedical Use of Methylphenidate Before and After the Outbreak of COVID-19: Machine Learning Analysis.
    Journal of medical Internet research, 2023, 08-16, Volume: 25

    Topics: Attention Deficit Disorder with Hyperactivity; Bayes Theorem; Central Nervous System Stimulants; COV

2023
Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?
    European journal of clinical pharmacology, 2018, Volume: 74, Issue:4

    Topics: Adverse Drug Reaction Reporting Systems; Atorvastatin; Central Nervous System Stimulants; Databases,

2018
Sensitivity of Quantitative Signal Detection in Regards to Pharmacological Neuroenhancement.
    International journal of molecular sciences, 2017, Jan-05, Volume: 18, Issue:1

    Topics: Adrenergic Uptake Inhibitors; Adverse Drug Reaction Reporting Systems; Atomoxetine Hydrochloride; Au

2017
Identification of selected therapeutic agents as inhibitors of carboxylesterase 1: potential sources of metabolic drug interactions.
    Toxicology, 2010, Apr-11, Volume: 270, Issue:2-3

    Topics: Animals; Antipsychotic Agents; Aripiprazole; Attention Deficit Disorder with Hyperactivity; Carboxyl

2010
A pilot study to evaluate a community pharmacy-based monitoring system to identify adverse drug reactions associated with paediatric medicines use.
    European journal of clinical pharmacology, 2010, Volume: 66, Issue:6

    Topics: Adolescent; Adverse Drug Reaction Reporting Systems; Anticonvulsants; Atomoxetine Hydrochloride; Chi

2010
Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database.
    Regulatory toxicology and pharmacology : RTP, 2011, Volume: 61, Issue:2

    Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Databases, Factual; Drug-Related Side Effects

2011
Stimulants and cardiovascular events in youth with attention-deficit/hyperactivity disorder.
    Journal of the American Academy of Child and Adolescent Psychiatry, 2012, Volume: 51, Issue:2

    Topics: Adolescent; Amphetamines; Angina Pectoris; Arrhythmias, Cardiac; Attention Deficit Disorder with Hyp

2012