CONCERTA (Page 3 of 8)

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

The most common adverse reaction in double-blind clinical trials (>5%) in pediatric patients (children and adolescents) was abdominal pain upper. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis [see Adverse Reactions (6.1)].

The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased [see Adverse Reactions (6.3)].

The development program for CONCERTA included exposures in a total of 3906 participants in clinical trials. Children, adolescents, and adults with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies (see Table 3). Safety was assessed by collecting adverse events, vital signs, weights, and ECGs, and by performing physical examinations and laboratory analyses.

Table 3. CONCERTA Exposure in Double-Blind and Open-Label Clinical Studies
Patient Population N Dose Range
Children 2216 18 to 54 mg once daily
Adolescents 502 18 to 72 mg once daily
Adults 1188 18 to 108 mg once daily

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

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.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of CONCERTA based on the comprehensive assessment of the available adverse event information. A causal association for CONCERTA often 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 clinical trials of another drug and may not reflect the rates observed in clinical practice.

The majority of adverse reactions were mild to moderate in severity.

6.1 Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials

Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations.

Children and Adolescents

Table 4 lists the adverse reactions reported in 1% or more of CONCERTA-treated children and adolescent subjects in 4 placebo-controlled, double-blind clinical trials.

Table 4. Adverse Reactions Reported by ≥1% of CONCERTA-Treated Children and Adolescent Subjects in 4 Placebo-Controlled, Double-Blind Clinical Trials of CONCERTA
System/Organ Class Adverse Reaction CONCERTA (n=321) % Placebo (n=318) %
*
Terms of Initial insomnia (CONCERTA=0.6%) and Insomnia (CONCERTA=2.2%) are combined into Insomnia.
Gastrointestinal Disorders
Abdominal pain upper 6.2 3.8
Vomiting 2.8 1.6
General Disorders and Administration Site Conditions
Pyrexia 2.2 0.9
Infections and Infestations
Nasopharyngitis 2.8 2.2
Nervous System Disorders
Dizziness 1.9 0
Psychiatric Disorders
Insomnia * 2.8 0.3
Respiratory, Thoracic and Mediastinal Disorders
Cough 1.9 0.9
Oropharyngeal pain 1.2 0.9

The majority of adverse reactions were mild to moderate in severity.

Adults

Table 5 lists the adverse reactions reported in 1% or more of CONCERTA-treated adults in 2 placebo-controlled, double-blind clinical trials.

Table 5. Adverse Reactions Reported by ≥1% of CONCERTA-Treated Adult Subjects in 2 Placebo-Controlled, Double-Blind Clinical Trials *
System/Organ Class Adverse Reaction CONCERTA (n=415) % Placebo (n=212) %
*
Included doses up to 108 mg.
Cardiac Disorders
Tachycardia 4.8 0
Palpitations 3.1 0.9
Ear and Labyrinth Disorders
Vertigo 1.7 0
Eye Disorders
Vision blurred 1.7 0.5
Gastrointestinal Disorders
Dry mouth 14.0 3.8
Nausea 12.8 3.3
Dyspepsia 2.2 0.9
Vomiting 1.7 0.5
Constipation 1.4 0.9
General Disorders and Administration Site Conditions
Irritability 5.8 1.4
Infections and Infestations
Upper respiratory tract infection 2.2 0.9
Investigations
Weight decreased 6.5 3.3
Metabolism and Nutrition Disorders
Decreased appetite 25.3 6.6
Anorexia 1.7 0
Musculoskeletal and Connective Tissue Disorders
Muscle tightness 1.9 0
Nervous System Disorders
Headache 22.2 15.6
Dizziness 6.7 5.2
Tremor 2.7 0.5
Paresthesia 1.2 0
Sedation 1.2 0
Tension headache 1.2 0.5
Psychiatric Disorders
Insomnia 12.3 6.1
Anxiety 8.2 2.4
Initial insomnia 4.3 2.8
Depressed mood 3.9 1.4
Nervousness 3.1 0.5
Restlessness 3.1 0
Agitation 2.2 0.5
Aggression 1.7 0.5
Bruxism 1.7 0.5
Depression 1.7 0.9
Libido decreased 1.7 0.5
Affect lability 1.4 0.9
Confusional state 1.2 0.5
Tension 1.2 0.5
Respiratory, Thoracic and Mediastinal Disorders
Oropharyngeal pain 1.7 1.4
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 5.1 0.9

The majority of ADRs were mild to moderate in severity.

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