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 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.
ADRs reported by ≥1% of Concerta-treated children and adolescents in these trials are shown in Table 2. (See Table 2.)

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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.
ADRs reported by ≥1% of Concerta-treated patients in these trials are shown in Table 3. (See Table 3.)

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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.
ADRs reported by ≥1% of Concerta-treated patients in these trials and not listed in Tables 2 and 3 are shown in Table 4. (See Table 4.)

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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 pediatric and adult patients in the double-blind and open-label clinical datasets are listed 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 spontaneous reporting rates: Blood and Lymphatic System Disorders: Very Rare: Pancytopenia, thrombocytopenia, thrombocytopenic purpura.
Immune System Disorders: Rare: Hypersensitivity reactions eg, angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions and exanthemas NEC.
Psychiatric Disorders: Very Rare: Disorientation, hallucinations, auditory and visual hallucinations, mania.
Nervous System Disorders: Very Rare: Convulsions, grand mal convulsions, dyskinesia.
Eye Disorders: Very Rare: Diplopia, mydriasis, visual disturbance.
Cardiac Disorders: Very Rare: Angina pectoris, bradycardia, extrasystoles, supraventricular tachycardia, ventricular extrasystoles.
Vascular Disorders: Very Rare: Raynaud's phenomenon.
Skin and Subcutaneous Tissue Disorders: Very Rare: Alopecia, erythema.
Musculoskeletal, Connective Tissue and Bone Disorders: Very Rare: Arthralgia, myalgia, muscle twitching.
General Disorders and Administration Site Conditions: Rare: Decreased therapeutic response. Very Rare: Chest pain & discomfort, decreased drug effect, hyperpyrexia.
Investigations: Very Rare: Increased blood alkaline phosphatase, blood bilirubin and hepatic enzyme, decreased platelet count, abnormal white blood cell count.
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 & 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.