What the label lists and what reports show
Escitalopram side effects
Escitalopram's FDA label: “The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).” FAERS holds 139,519 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (9,541 reports).
- Generic listed
- Boxed warning
Check it at the source: the escitalopram FDA label on DailyMed (effective October 1, 2023, Allergan, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Lexapro?Lexapro may cause serious side effects, including: See “What is the most important information I should know about Lexapro?” Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when Lexapro is taken with certain other medicines. See “Do not take Lexapro if you?” Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome: agitation seeing or hearing things that are not real (hallucinations) confusion coma fast heartbeat blood pressure changes sweating shaking (tremors), stiff muscles, or muscle twitching flushing dizziness seizures high body temperature (hyperthermia) nausea, vomiting, diarrhea loss of coordination Discontinuation syndrome. Suddenly stopping Lexapro may cause you or your child to have serious side effects. […]
Source: FDA drug label, NDA021323 (Abbvie), as published by Allergan, Inc., effective October 1, 2023 (SPL set 13bb8267-1cab-43e5-acae-55a4d957630a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).
TABLE 3
| Adverse Reactions | Lexapro ( N=429 ) % | Placebo ( N=427) % |
|---|---|---|
| Dry Mouth | 9% | 5% |
| Sweating Increased | 4% | 1% |
| Headache | 24% | 17% |
| Paresthesia | 2% | 1% |
| Nausea | 18% | 8% |
| Diarrhea | 8% | 6% |
| Constipation | 5% | 4% |
| Indigestion | 3% | 2% |
| Vomiting | 3% | 1% |
| Abdominal Pain | 2% | 1% |
| Flatulence | 2% | 1% |
| Toothache | 2% | 0% |
| Fatigue | 8% | 2% |
| Influenza-like Symptoms | 5% | 4% |
| Neck/Shoulder Pain | 3% | 1% |
| Somnolence | 13% | 7% |
| Insomnia | 12% | 6% |
| Libido Decreased | 7% | 2% |
| Dreaming Abnormal | 3% | 2% |
| Appetite Decreased | 3% | 1% |
| Lethargy | 3% | 1% |
| Yawning | 2% | 1% |
| Ejaculation Disorder 1,2 | 14% | 2% |
| Anorgasmia 3 | 6% | <1% |
| Menstrual Disorder | 2% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800- 678-1605, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA021323 (Abbvie), as published by Allergan, Inc., effective October 1, 2023 (SPL set 13bb8267-1cab-43e5-acae-55a4d957630a), via openFDA; the full label on DailyMed
What do FAERS reports show?
139,519 reports list escitalopram among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11,263 are coded as a death and 44,069 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Escitalopram: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions