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Background: Side effects of selective serotonin reuptake inhibitors (SSRIs), the most commonly used antidepressants, are generally underreported in clinical trials. A systematic assessment of side effects associated with SSRIs with a structured instrument in a naturalistic setting is an important design to fully understand the side effect profile of various SSRIs. We examined the frequency of side effects caused by 3 commonly used SSRIs, sertraline, escitalopram, and fluoxetine, by using a self-rating instrument designed to measure patients’ subjective symptoms in a naturalistic treatment setting.

Depression And Anxiety Medication With Least Side Effects

Methods: Subjects were outpatients recruited from the psychiatric department of a tertiary care hospital. Subjects aged ≥ 18 years; have been diagnosed with depression, anxiety spectrum disorder, adjustment disorder, hypochondriasis, or impulse control disorder accordingly

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Criteria; and using SSRI monotherapy. The assessment instrument includes 42 items and was designed using drug package insert data on the most commonly observed side effects of antidepressants released by the US Food and Drug Administration.

Results: A total of 100 patients participated in this study. Among them, 70% are women. The most common diagnosis was depression (49%). Of the patients, 53% were taking sertraline, 38% escitalopram, and 8% fluoxetine. Common side effects reported by patients are flatulence (64%), drowsiness (59%), memory impairment (51%), decreased concentration (50%), yawning (47%), fatigue (45%), dry mouth ( 45). %), weight gain (45%), dizziness (43%) and sweating (38%). Patients treated with escitalopram had a higher incidence of headache, pruritus, memory impairment, decreased concentration and dizziness. Patients treated with sertraline had significantly reduced appetite.

Conclusion: The study results highlight the prevalence and pattern of side effect profiles of 3 commonly used SSRIs and provide baseline data for comparison with other similar studies.

To cite: Anagha K, Shafeena T, Shihabudheen P, et al. Side effect profile of selective serotonin reuptake inhibitors: a cross-sectional study in a naturalistic setting.

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N. A. Uvais, MBBS, TPM, Department of Psychiatry, Iqraa International Hospital and Research Centre, Calicut, Kerala, India ([email protected]).

Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed psychotropic agents for the treatment of various psychiatric disorders. Although SSRIs have different chemical structures, they all share the same mechanism of action: selectively inhibiting the reuptake of serotonin. When compared to tricyclic antidepressants (TCAs), SSRIs have a much lower side effect profile with comparable efficacy.

SSRIs also show significantly lower discontinuation rates compared to other classes of antidepressants and can be used safely in elderly patients, children, and patients with various comorbidities.

Various side effects have been reported with its long-term use. The most commonly reported side effects are sexual dysfunction, gastrointestinal symptoms, neuropsychiatric symptoms, and constitutional symptoms. However, research also shows wide discrepancies in the rates of various side effects reported between the original placebo-controlled clinical trials and post-marketing clinical trials.

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Additionally, the SSRI side effect profile provided in the drug manufacturer’s package insert is derived from company-sponsored studies that have been reviewed by the US Food and Drug Administration (FDA) and typically fail to capture the real-world side effect profile of SSRIs.

Doses used in early clinical trials may not be sufficient to allow a full understanding of the side effect profile of SSRIs.

Furthermore, the trial design, the method for determining adverse effects, and the duration of the clinical trial may also influence the reporting of side effects.

Analyzed clinical trials on antidepressants showed that a structured and systematic side effect assessment strategy was used in only 21% of these trials, and only a few trials used an objective side effect assessment scale. Because the external validity of SSRI use side effect data from clinical trials is unknown, a systematic evaluation of side effects associated with SSRIs with a structured instrument in daily clinical practice is an important design to fully understand the side effect profile of various SSRIs.

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Patients’ subjective feelings and complaints of side effects associated with SSRIs in a naturalistic treatment setting are critical in clinical practice, as they can influence treatment continuity and good compliance.

The purpose of this study was to compare the frequency of side effects caused by 3 commonly used SSRIs, sertraline, escitalopram, and fluoxetine, using a self-assessment instrument designed to measure patients’ subjective symptoms in a naturalistic treatment setting.

Subjects were outpatients recruited from psychiatric departments in tertiary care hospitals. Subjects were patients (aged ≥ 18 years) diagnosed with any psychiatric disorder according to

Criteria and those using SSRI monotherapy. Patients who underwent combination therapy, had comorbid physical illness, had poor drug compliance, or were unwilling to provide informed consent were excluded. The study protocol was approved by the institutional ethics committee. Informed written consent was obtained from patients prior to the study. Patient demographics, diagnosis and drug-related details (type of drug, daily dose and duration of administration) were collected from patients using a data collection form. An assessment instrument was designed using drug package insert data on the most commonly observed side effects of antidepressants (those with incidence rates ≥ 3%) released by the FDA similar to previous studies.

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This instrument contains 42 items designed to measure side effects caused by antidepressants experienced by the patient during the past month. Data analysis was conducted using

Values ​​< .05 are considered significant. SPSS 10.0 for Windows (IBM, Armonk, New York) was used for statistical analysis.

A total of 100 patients participated in the study, and 70% were women. The most common diagnosis was depression (49%), followed by panic disorder (14%) and obsessive-compulsive disorder (13%). Patient diagnoses are provided in Table 1. Of the patients, 53% were taking sertraline, 38% escitalopram, and 8% fluoxetine. SSRI prescription patterns by various psychiatric diagnoses are also provided in Table 1. There were no statistically significant differences in age, sex, or duration of SSRI administration across the 3 groups of patients taking sertraline, escitalopram, and fluoxetine. The most frequently reported side effects were flatulence (64%), drowsiness (59%), memory impairment (51%), decreased concentration (50%), yawning (47%), fatigue (45%), dry mouth (45 %). ), weight gain (45%), dizziness (43%) and sweating (38%). Patients treated with escitalopram showed a higher incidence of headache (χ

= .047). However, there were no significant differences in other side effects among the 3 groups. A comparison of side effect profiles between groups taking sertraline, escitalopram, and fluoxetine is provided in Table 2. Two patients taking sertraline reported other side effects: apathy and hair loss. Two patients taking escitalopram reported shortness of breath.

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Fluoxetine was introduced in the United States in 1988 as an alternative to TCAs with similar efficacy and a favorable side effect profile, particularly cardiac conduction abnormalities in overdose and the risk of triggering seizures.

However, questions about the safety and tolerability of SSRIs have arisen with their continued use. Very high rates of various side effects such as sexual dysfunction or hyponatremia have been reported in post-marketing clinical trials compared to the original placebo-controlled clinical trials.

Most of these results are derived from observational studies and case series submitted to regulatory authorities. Therefore, the comparative incidence rates of side effects across different antidepressant agents remain incompletely explained. Therefore, studies conducted in naturalistic settings can only compare side effect profiles of various SSRIs among users, which is a strength of our study.

In this study, we compared symptoms experienced by patients on SSRI monotherapy with escitalopram, sertraline, and fluoxetine for different psychotic conditions in a naturalistic setting. The most common diagnosis is depressive disorder, and the most commonly prescribed SSRI is sertraline. There were no statistically significant differences in age, sex, or duration of SSRI administration across the 3 groups taking sertraline, escitalopram, and fluoxetine. The most common side effects reported by users are gastrointestinal, neuropsychiatric, sexual, and constitutional in nature. In 2009, Cascade et al

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Published patient-reported side effects from a cross-section of real-world patients taking 1 of the following SSRI antidepressants: citalopram, escitalopram, fluoxetine, paroxetine, or sertraline. Thirty-eight percent of the approximately 700 patients surveyed reported experiencing 1 or more side effects from taking SSRI antidepressants. Commonly reported side effects were sexual dysfunction (56%), sleepiness/sleepiness (53%), weight gain (49%), dry mouth (19%), insomnia (16%), fatigue (14%), nausea ( 14). %), dizziness/vertigo (13%), and tremors (12%).

Commonly reported gastrointestinal symptoms in our study were flatulence, dry mouth, nausea, constipation, diarrhea, decreased appetite, and dyspepsia. Bloating and dry mouth are most commonly reported. We also found a significant reduction in appetite among patients taking sertraline. Serotonin plays a key regulatory role in motor and sensory regulation of the gastrointestinal (GI) tract affecting gastric motility.

Other commonly reported GI side effects associated with SSRI use such as GI bleeding and abdominal pain were not reported in our study. A review exploring the side effect profile of SSRIs found that GI disturbances were the most frequently reported side effects of SSRI use, significantly associated with fluvoxamine use, while escitalopram was less likely to cause GI side effects.

About half of all patients who start using this agent experience GI

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