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Adverse events occurring in a controlled trial: Adverse events reported in a 3-week clinical trial of pediatric patients treated with ADDERALL XRª or placebo are presented in the table below. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied. Text Continues Below
The following adverse reactions have been associated with amphetamine use: Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome. Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic: Urticaria. Endocrine: Impotence, changes in libido. Body System Preferred Term ADDERALL XRª (N= 374) Placebo (N= 210) General Abdominal Pain (stomachache) 14% 10%
Accidental Injury 3% 2%
Asthenia (fatigue) 2% 0%
Fever 5% 2%
Infection 4% 2%
Viral Infection 2% 0%
Digestive System Loss of Appetite 22% 2%
Diarrhea 2% 1%
Dyspepsia 2% 1%
Nausea 5% 3%
Vomiting 7% 4%
Nervous System Dizziness 2% 0%
Emotional Lability 9% 2%
Insomnia 17% 2%
Nervousness 6% 2%
Metabolic/ Nutritional Weight Loss 4% 0% Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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