This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Escitalopram Oral Solution is the brand name for escitalopram. According to the FDA-approved label, 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. FAERS contains 136,906 submissions naming this drug from 2003 through 2026; the top three reactions cited are fatigue, nausea, and drug ineffective.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Escitalopram Oral Solution. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Escitalopram Oral Solution. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 136,906 FAERS submissions that named Escitalopram Oral Solution. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Escitalopram Oral Solution. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Escitalopram Oral Solution. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE 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 )
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [ see Warnings and Precautions (5.1) ] Serotonin syndrome [ see Warnings and Precautions(5.2) ] Discontinuation syndrome [ see Warnings and Precautions(5.3) ] Seizures [ see Warnings and Precautions (5.4) ] Activation of mania or hypomania [ see Warnings and Precautions (5.5) ] Hyponatremia [ see Warnings and Precautions (5.6) ] Increased Risk of Bleeding [ see Warnings and Precautions (5.7) ] Interference with Cognitive and Motor Performance [ see Warnings and Precautions (5.8) ] Angle-closure glaucoma [ see Warnings and Precautions (5.9) ] Use in Patients with Concomitant Illness [ see Warnings and Precautions (5.10) ] Sexual Dysfunction [ see Warnings and Precautions (5.11) ] Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia ( 6. (continues in label)
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
