Concerta Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of methylphenidate hydrochloride based on the comprehensive assessment of the available adverse event information. A causal relationship with methylphenidate hydrochloride cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trial data: Double-blind data - adverse reactions reported at ≥1% frequency: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations.
Pediatric patients: The safety of CONCERTA was evaluated in 639 pediatric patients (children and adolescents) with ADHD who participated in 4 placebo-controlled, double-blind clinical trials. The information presented in this section was derived from pooled data.
Adverse reactions reported by ≥1% of CONCERTA-treated children and adolescent patients in these trials are shown in Table 3. (See Table 3.)

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The majority of adverse reactions were mild to moderate in severity.
Adult patients: The safety of CONCERTA was evaluated in 905 adult patients with ADHD who participated in 3 placebo-controlled, double-blind clinical trials. The information presented in this section was derived from pooled data.
Adverse reactions reported by ≥1% of CONCERTA-treated adult patients in these trials are shown in Table 4. (See Table 4.)

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The majority of adverse reactions were mild to moderate in severity.
Open-label data - adverse reactions reported at ≥1% frequency: The safety of CONCERTA was evaluated in 3782 pediatric and adult patients with ADHD who participated in 12 open-label clinical trials. The information presented in this section was derived from pooled data.
Adverse reactions reported by ≥1% of CONCERTA-treated patients in these trials and not listed in Table 3 and 4 are shown in Table 5. (See Table 5.)

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The majority of adverse reactions were mild to moderate in severity.
Double blind and open-label data - adverse reactions reported at <1% frequency: Additional adverse reactions that occurred in <1% of CONCERTA-treated pediatric and adult patients in the double-blind and open-label clinical datasets are listed in Table 6. (See Table 6.)

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The majority of adverse reactions were mild to moderate in severity.
Postmarketing data: Adverse reactions identified during postmarketing experience with CONCERTA are included in Table 7. In this table, the frequencies are provided according to the following convention: Very common ≥ 1/10 (≥10%); Common ≥ 1/100 to < 1/10 (≥1% and <10%); Uncommon ≥ 1/1,000 to < 1/100 (≥0.1% and <1%); Rare ≥ 1/10,000 to < 1/1,000 (≥0.01 and <0.1%); Very rare < 1/10,000 (<0.01%), including isolated reports; Not known Cannot be estimated from the available data. (See Table 7.)

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