Prescription Drug Information: Methylphenidate Hydrochloride (Page 3 of 8)

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 methylphenidate hydrochloride extended-release tablets treated children and adolescent subjects in 4 placebo-controlled, double-blind clinical trials.

Table 4. Adverse Reactions Reported by ≥1% of Methylphenidate Hydrochloride Extended-Release Tablets -Treated Children and Adolescent Subjects in 4 Placebo-Controlled, Double-Blind Clinical Trials of Methylphenidate Hydrochloride Extended-Release Tablets
*
Terms of Initial insomnia (Methylphenidate hydrochloride extended-release tablets =0.6%) and Insomnia (Methylphenidate hydrochloride extended-release tablets =2.2%) are combined into Insomnia

System/Organ Class

 Adverse Reaction

Methylphenidate hydrochloride extended-release tablets

(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 methylphenidate hydrochloride extended-release tablets-treated adults in 2 placebo-controlled, double-blind clinical trials.

Table 5. Adverse Reactions Reported by ≥1% of Methylphenidate Hydrochloride Extended- Release Tablets-Treated Adult Subjects in 2 Placebo-Controlled, Double-Blind Clinical Trials *
*
Included doses up to 108 mg.

System/Organ Class

 Adverse Reaction

Methylphenidate hydrochloride extended-release tablets

(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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