Celexa Side Effects

Celexa Information

Celexa Side Effects

The premarketing development program for Celexa included citalopram exposures in patients and or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient exposure years. There were in addition over 19,000 exposures from mostly open-label European postmarketing studies. The conditions and duration of treatment with Celexa varied greatly and included (in overlapping categories) open label and double- blind studies, inpatient and outpatient studies, fixed-dose and dose titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

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 tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events. The stated frequencies of side effects represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Celexa side effects Associated with Discontinuation of Treatment

Among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related( i.e., associated with discontinuation in at least 1% of CelexaTM -treated patients at a rate at least twice that of placebo) are shown below.