Escitalopram
/api/v1/drug/escitalopramBoxed warning
SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). Escitalopram tablets are not approved for use in pediatric patients less than 7 years of age ( 8.4 ). WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant -treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Escitalopram tablets is not approved for use in pediatric patients less than 7 years of age [see Use in Specific Populations ( 8.4) ].
Mechanism of action
Sourced from openFDAThe mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
Indications
Sourced from openFDA- 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 ) Escitalopram tablets are 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.ICD-10: F32.9, F41.1
Contraindications
Sourced from openFDA- Do not use MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of stopping treatment with escitalopram. Do not use escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders.contraindicated
Dosage & administration
Sourced from openFDAIndication and Population Recommended Dosage MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily • No additional benefits were seen at 20 mg once daily ( 2.1 ) • Administer once daily, morning or evening, with or without food ( 2.3 ) • Elderly patients: recommended dosage is 10 mg once daily ( 2.4 ) • Hepatic impairment: recommended dosage is 10 mg once daily ( 2.4 , 8.6 ) • When discontinuing Escitalopram tablets, reduce dose gradually whenever possible ( 2.5 ) 2.1 Major Depressive Disorder Adults The recommended dosage of escitalopram tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies ( 14.1 )] . Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week. Pediatric Patients 12 years of age and older The recommended dosage of escitalopram tablets in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks.
Warnings & precautions
Sourced from openFDA• Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue Escitalopram and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) • Discontinuation syndrome: When discontinuing Escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3 ) • Seizures: Use with caution in patients with a history of seizure ( 5.4 ) • Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) • Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6 ) • Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk ( 5.7 ) • Interference with Cognitive and Motor Performance: Use caution when operating machinery ( 5.8 ) • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.9 ) • Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses ( 5.10 ) • Sexual Dysfunction: Escitalopram may cause symptoms of sexual dysfunction ( 5.11 ) 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, th…
Adverse reactions
Sourced from openFDAMost 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 Torrent Pharma Inc. at 1-800-912-9561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 )] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Use in specific populations
Sourced from openFDAPregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate ( 8.1 ) Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO ® (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.7 ) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage.
Pharmacokinetics
Sourced from openFDA- Metabolism
- The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day. With once-daily dosing, steady state plasma concentrations are achieved within approximately one week.
Overdosage
Sourced from openFDAThe following have been reported with escitalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in escitalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a escitalopram overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Approval history
Sourced from openFDA- Aug 14, 2002NDANDA021323Abbvie
- Mar 14, 2012ANDAANDA202227Amneal Pharms
- Apr 2, 2012ANDAANDA079062Aurobindo Pharma Ltd
- May 3, 2012ANDAANDA079121Sun Pharma Canada
- Jun 12, 2012ANDAANDA202221Hetero Labs Ltd Iii
- Sep 11, 2012ANDAANDA202389Accord Hlthcare
- Sep 11, 2012ANDAANDA078777Graviti Pharms
- Aug 29, 2025NDANDA219130Almatica
FAERS reports
- 1Fatigue9,3516.8%
- 2Nausea9,3426.8%
- 3Drug Ineffective8,7716.4%
- 4Headache7,2395.3%
- 5Diarrhoea6,8475.0%
- 6Anxiety6,5684.8%
- 7Dizziness6,2024.5%
- 8Depression6,0684.4%
- 9Off Label Use6,0094.4%
- 10Pain5,7304.2%
- 11Fall5,4704.0%
- 12Dyspnoea5,3803.9%
- 13Vomiting5,1893.8%
- 14Insomnia4,4393.2%
- 15Asthenia4,3973.2%
Literature
Recent PubMed references pinned to Escitalopram as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Adjuvant administration probiotic effects on sexual function in depressant men undergoing selective serotonin reuptake inhibitor treatment: a double-blinded randomized controlled trial.The journal of sexual medicine · 2026 · Taghavi SA, Sadri M, Hashemimohammadabad M, et al.PMID 42059569DOI 10.1093/jsxmed/qdag043
- The association between body mass index and treatment outcomes in major depressive disorder: a CAN-BIND-1 study.Journal of psychiatric research · 2026 · Kim HK, Jones BDM, Hahn MK, et al.PMID 41935494DOI 10.1016/j.jpsychires.2026.03.036
- Efficacy and Safety of Escitalopram in Alleviating Depression and Anxiety Symptoms in COPD Patients: A Randomized Double-Blind Placebo-Controlled Trial.International journal of chronic obstructive pulmonary disease · 2026 · Gao Z, Tang S, Zhang W, et al.PMID 41909477DOI 10.2147/COPD.S572465
- Effects of escitalopram on resting-state functional connectivity in comorbid depressive and anxious adolescents.Journal of affective disorders · 2026 · Shin J, Lee KH, Kim JW, et al.PMID 41812896DOI 10.1016/j.jad.2026.121567
- Melitidin alleviates escitalopram-induced sub-chronic cardiotoxicity via regulating mitochondrial fission-fusion machinery and redox signaling: A biochemical, echocardiographic, and histological study.Tissue & cell · 2026 · Wang Y, Ashfaq H, Alsaleem MA, et al.PMID 41806632DOI 10.1016/j.tice.2026.103435
- Cannabidiol reduces the latency for the behavioral effect of escitalopram in chronically stressed male mice: involvement of NAPE-PLD expressed in parvalbumin-positive interneurons and the prefrontal cortex.Neuropharmacology · 2026 · Scarante F, Lopes VD, Fusse EJ, et al.PMID 41791701DOI 10.1016/j.neuropharm.2026.110894
- Antidepressant withdrawal-induced de novo restless legs syndrome: a case report.Sleep medicine · 2026 · Balian EA, Nadryan NM, Atabekyan LG, et al.PMID 41785584DOI 10.1016/j.sleep.2026.108882
- Reversal of chronic restraint-induced HPA axis dysregulation and depressive-like behaviour by chronic escitalopram treatment in rats: involvement of SERT.Brain research · 2026 · Shanker S, Saroj N, Manjarrez-Gutiérrez G, et al.PMID 41775329DOI 10.1016/j.brainres.2026.150233
Clinical trials
The 10 most recently updated of 721 ClinicalTrials.gov registrations naming Escitalopram as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Neurobiological Mechanisms of Pathological Rumination and Effects of AripiprazoleActive not recruiting · Interventional · 108 enrolled · Central South UniversityNCT06937476updated 2026-06-12
- An Investigator-Initiated, Randomized, Double-Blind, Double-Dummy Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.Not yet recruiting · Interventional · 80 enrolled · Sichuan Credit Pharmaceutical Co., Ltd.NCT07645807updated 2026-06-12
- Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)Recruiting · Phase 4 · Interventional · 400 enrolled · Nova Scotia Health AuthorityNCT05017311updated 2026-06-11
- Pupillometry in Delayed Sleep Wake Phase DisorderRecruiting · Interventional · 220 enrolled · Northwestern UniversityNCT06949644updated 2026-06-08
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night SweatsCompleted · Observational · 999 enrolled · Astellas Pharma Global Development, Inc.NCT06049797updated 2026-06-05
- Mindfulness and Biofeedback for Anxiety DisordersCompleted · Phase 4 · Interventional · 188 enrolled · I.M. Sechenov First Moscow State Medical UniversityNCT07628153updated 2026-06-04
- Improving Outcomes in Depression in Primary Care in a Low Resource SettingActive not recruiting · Phase 3 · Interventional · 1,500 enrolled · Harvard Medical School (HMS and HSDM)NCT05944926updated 2026-05-22
- Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDDRecruiting · Phase 2 · Interventional · 400 enrolled · Vigonvita Life SciencesNCT06828887updated 2026-05-20
- Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIVRecruiting · Phase 2 · Interventional · 186 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)NCT06705478updated 2026-05-19
- Effect of XingpiJieyu Formula on Mitochondrial Energy Metabolism in Severe Liver-Stagnation and Spleen-Deficiency Depression.Completed · Phase 4 · Interventional · 150 enrolled · Peking University Sixth HospitalNCT07590609updated 2026-05-15
Pharmacogenomics
CPIC-curated drug–gene pairs for Escitalopram. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.
- COMTCPIC C (provisional)
- CYP2C19CPIC AClinPGx 1AFDA label: Informative PGx
- CYP2D6CPIC CClinPGx 3
- GRIK4CPIC C (provisional)
- HTR2ACPIC CClinPGx 3
- SLC6A4CPIC CClinPGx 4
Structural analogs
Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.
Frequently asked questions
- How does Escitalopram work?
- The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
- What is Escitalopram used for?
- According to FDA labeling, Escitalopram carries indications including: 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 ) Escitalopram tablets are 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Escitalopram?
- Escitalopram is classified as Selective serotonin reuptake inhibitors, Serotonin Reuptake Inhibitor, Monoamine Oxidase Inhibitors, Serotonin Uptake Inhibitors, Increased Central Nervous System Serotonin Activity.
- What are the brand names for Escitalopram?
- Escitalopram is marketed under brand names including Lexapro.
- What are the contraindications for Escitalopram?
- Escitalopram labeling lists contraindications including: Do not use MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of stopping treatment with escitalopram. Do not use escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders.. Always consult the full prescribing information and a clinician.
escitalopram is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.