Concerta Adverse Reactions

Clinical Trial Data: Double-Blind Data: Adverse Drug Reactions Reported at ≥1% Frequency: Adverse drug reactions (ADRs) in either the pediatric or adult double-blind adverse drug reaction 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 drug reactions reported by ≥1% of Concerta-treated subjects in these trials are shown in Table 3.

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The majority of ADRs were mild to moderate in severity.
Adult Patients: The safety of Concerta was evaluated in 627 adult patients with ADHD who participated in 2 placebo-controlled, double-blind clinical trials. The information presented in this section was derived from pooled data.
Adverse drug reactions reported by ≥1% of Concerta-treated patients in these trials are shown in Table 4.

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The majority of ADRs were mild to moderate in severity.
Open-Label Data: Adverse Drug Reactions Reported at ≥1% Frequency: The safety of Concerta was evaluated in 3590 pediatric and adult subjects with ADHD who participated in 11 open-label clinical trials. The information presented in this section was derived from pooled data.
Adverse drug reactions reported by ≥1% of Concerta-treated subjects in these trials and not listed in Tables 3 and 4 are shown in Table 5.

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The majority of ADRs were mild to moderate in severity.
Double-Blind and Open-Label Data: Adverse Drug Reactions Reported at <1% Frequency: Additional ADRs that occurred in <1% of Concerta-treated subjects in the double-blind and open-label clinical datasets are as follows: Blood and Lymphatic System Disorders: Leukopenia.
Psychiatric Disorders: Anger, hypervigilance, altered mood, mood swings, sleep disorder, tearfulness, tic.
Nervous System Disorders: Lethargy, somnolence, psychomotor hyperactivity.
Eye Disorders: Dry eyes.
Vascular Disorders: Hypertension.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea.
Skin and Subcutaneous Tissue Disorders: Macular rash.
Reproductive System and Breast Disorders: Erectile dysfunction.
Investigations: Cardiac murmur.
The majority of ADRs were mild to moderate in severity.
Post-Marketing Data: ADRs identified during post-marketing experience with Concerta are included in the following texts. The frequencies are provided according to the following convention: Very common: ≥1/10; common ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare <1/10,000, including isolated reports.
The following ADRs are presented by frequency category based on incidence in clinical trials, when known: Blood and Lymphatic System Disorders: Not Known: Pancytopenia, thrombocytopenia, thrombocytopenic purpura.
Immune System Disorders: Uncommon: Hypersensitivity reactions eg, angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions and exanthemas NEC.
Psychiatric Disorders: Rare: Disorientation, auditory and visual hallucinations, mania. Not Known: Hallucinations.
Nervous System Disorders: Uncommon: Dyskinesia. Not Known: Convulsions, grand mal convulsions.
Eye Disorders: Rare: Diplopia, mydriasis, visual disturbance.
Cardiac Disorders: Rare: Angina pectoris, extrasystoles, ventricular extrasystoles. Not Known: Bradycardia, supraventricular tachycardia.
Vascular Disorders: Not Known: Raynaud's phenomenon.
Skin and Subcutaneous Tissue Disorders: Uncommon: Alopecia, erythema.
Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Myalgia, arthralgia, muscle twitching.
General Disorders and Administration Site Conditions: Uncommon: Chest pain and discomfort. Not Known: Decreased drug effect, hyperpyrexia, decreased therapeutic response.
Investigations: Uncommon: Increased hepatic enzyme. Rare: Increased blood bilirubin. Not Known: Increased blood alkaline phosphatase, decreased platelet count, abnormal white blood cell count.
Note: The frequency category “not known” is used for ADRs for which no valid estimate of the incidence rate can be derived from clinical trials.