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CONCERTA®

(methylphenidate HCl)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

CONCERTA® (methylphenidate HCl)
Medical Information

CONCERTA - Treatment Discontinuation

Last Updated: 07/09/2026

Summary

  • There are currently no recommendations for dose tapering in the event that treatment with CONCERTA is discontinued.
  • No downward tapering methods were used when subjects were crossed over to another treatment arm in the pivotal trials of CONCERTA in children, adolescents, and adults. 1-7
  • A search of the published literature failed to identify any articles or case reports regarding dose tapering or the possible adverse effects of abruptly discontinuing CONCERTA.

PRODUCT LABELING

Please refer to the following section of the enclosed Full Prescribing Information that is relevant to your inquiry1: DOSAGE AND ADMINISTRATION, Dose Reduction and Discontinuation.

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
13 February 2026.

References

Show
1 CONCERTA (methylphenidate HCl) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-edb60a5a-a794-4ed6-b7ab-758d0aa94194
2 Swanson J, Gupta S, Lam A, et al. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies. Arch Gen Psychiat. 2003;60(2):204-211.  
3 Wolraich ML, Greenhill LL, Pelham W, et al. Randomized, controlled trial of OROS methylphenidate once a day in children with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108(4):883-892.  
4 Pelham WE, Gnagy EM, Burrows-Maclean L, et al. Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics. 2001;107(6):e105-e105.  
5 Wilens TE, McBurnett K, Bukstein O, et al. Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2006;160(1):82-90.  
6 Medori R, Ramos-Quiroga JA, Casas M, et al. A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008;63(10):981-989.  
7 Adler LA, Zimmerman B, Starr HL, et al. Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2009;29(3):239-247.  

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