Escitalopram Side Effects: Common, Serious & FDA Warnings

Common Side Effects of Escitalopram

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for escitalopram. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

From the FDA-approved label, Section 5.1: Suicidal Thoughts and Behaviors in Adolescents and Young

Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

Show full Section 5.1See less

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1 . Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing escitalopram, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

From the FDA-approved label, Section 5.4: Seizures

Although anticonvulsant effects of racemic citalopram have been observed in animal studies, escitalopram has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product's premarketing testing. In clinical trials of escitalopram, cases of convulsion have been reported in association with escitalopram treatment. Like other drugs effective in the treatment of major depressive disorder, escitalopram should be introduced with care in patients with a history of seizure disorder.

Escitalopram Recalls

FDA enforcement actions matched to escitalopram via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).

No recalls are on record for this drug in the FDA enforcement database.

Escitalopram Shortages

FDA-listed shortages of escitalopram products. Strength and dosage-form level detail.

Is Escitalopram Safe?

Escitalopram is FDA-approved. The label's Warnings and Precautions section covers suicidal thoughts and behaviors in adolescents and young (Section 5.1), serotonin syndrome (Section 5.2), discontinuation syndrome (Section 5.3), seizures (Section 5.4), activation of mania or (Section 5.5), hyponatremia (Section 5.6), increased risk of bleeding (Section 5.7), interference with cognitive and motor (Section 5.8), angle closure (Section 5.9), use in patients with concomitant illness (Section 5.10), sexual dysfunction use of (Section 5.11).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

FDA-Approved Indications

Escitalopram is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

• Depression
• Anxiety

Escitalopram is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s Lexapro (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )

Frequently Asked Questions

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.