CONCERTA (Page 3 of 8)
6 ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
- Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1)]
- Hypersensitivity to Methylphenidate [see Contraindications (4.1)]
- Monoamine Oxidase Inhibitors [see Contraindications (4.2)and Drug Interactions (7.1)]
- Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)]
- Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)]
- Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)]
- Seizures [see Warnings and Precautions (5.5)]
- Priapism [see Warnings and Precautions (5.6)]
- Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7)]
- Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.8)]
- Potential for Gastrointestinal Obstruction [see Warnings and Precautions (5.9)]
- Hematologic Monitoring [see Warnings and Precautions (5.10)]
- Acute Angle Closure Glaucoma [see Warnings and Precautions (5.11)]
- Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.12)]
- Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.13)]
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.
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.
System/Organ Class Adverse Reaction | CONCERTA (n=321) % | Placebo (n=318) % |
---|---|---|
| ||
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.
System/Organ Class Adverse Reaction | CONCERTA (n=415) % | Placebo (n=212) % |
---|---|---|
| ||
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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