Concerta and Adverse Reactions - What to Know For Your Safety

The development program for CONCERTA® included exposures in a total of 2121 participants in clinical trials (1797 patients, 324 healthy adult subjects). These participants received CONCERTA® 18, 36, 54 and/or 72 mg/day. Children, adolescents, and adults with ADHD were evaluated in four controlled clinical studies, three open-label clinical studies and two clinical pharmacology studies. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

If you or your child has suffered a serious Concerta side effect, you may be entitled to compensation for your pain & suffering. You can start the process of filing a lawsuit by filling out the simple form below for a free case evaluation.

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see also:

Clinical Trials Read about Adverse Findings in Clinical Trials with CONCERTA
Concerta users: Learn more about Adverse Findings in Clinical Trials

ADHD Concerta - Learn all about ADHD
Concerta - The Drug for ADHD

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