Adderal XR Side Effects & Drug Interactions - Amphetamine Mixed Salts

[Amphetamine Mixed Salts]

ADVERSE EVENTS

The premarketing development program for ADDERALL XRª included exposures in a total of 685 participants in clinical trials (615 patients, 70 healthy adult subjects). These participants received ADDERALL XRª at daily doses up to 30 mg. The 615 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and one single-dose clinical pharmacology study (N= 20).

Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.

In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events. 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.

Adverse events associated with discontinuation of treatment: In two placebo-controlled studies of up to 5 weeks duration, 2.4% (10/ 425) of ADDERALL XRª treated patients discontinued due to adverse events (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/ 259) receiving placebo. The most frequent adverse events associated with discontinuation of ADDERALL XRª in controlled and uncontrolled, multiple-dose clinical trials (N= 595) are presented below. Over half of these patients were exposed to ADDERALL XRª for 12 months or more.

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.