Oxalate

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).

• Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) 1.1 Major Depressive Disorder Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1) ] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.ICD-10: F32.9, F41.1, G47.00

• Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets. Do not use escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders.contraindicated

Escitalopram tablets should be administered once daily, in the morning or evening, with or without food. Escitalopram tablets should generally be administered once daily, morning or evening with or without food ( 2.1 , 2.2 ). Indication Recommended Dose MDD in Adolescents (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults (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 No additional benefits seen at 20 mg/day dose (2.1) . 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment ( 2.3 ). No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment ( 2.3 ). Discontinuing Escitalopram Tablets: A gradual dose reduction is recommended ( 2.4 ). 2.1 Major Depressive Disorder Initial Treatment Adolescents The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [see Clinical Studies (14.1) ] . If the dose is increased to 20 mg, this should occur after a minimum of three weeks. Adults The recommended dose of escitalopram tablets 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) ] .

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram oxalate, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort). If such symptoms occur, discontinue escitalopram oxalate and initiate supportive treatment. If concomitant use of escitalopram oxalate with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 4 , 5.2 ). Discontinuation of Treatment with Escitalopram Oxalate: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible (5.3) . Seizures: Prescribe with care 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 SIADH (5.6) . Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation (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 ).

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. Clinical Trial Data Sources Pediatrics (6 to 17 years) Adverse events were collected in 576 pediatric patients (286 escitalopram oxalate, 290 placebo) with major depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of escitalopram oxalate in pediatric patients less than 12 years of age has not been established. Adults Adverse events information for escitalopram oxalate was collected from 715 patients with major depressive disorder who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials. An additional 284 patients with major depressive disorder were newly exposed to escitalopram in open-label trials.

Pregnancy: 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 ). 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 register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation (see Clinical Considerations) with exposure to selective serotonin reuptake inhibitors (SSRIs), including escitalopram oxalate, during pregnancy. There are risks associated with untreated depression in pregnancy (see Clinical Considerations).

Metabolism

The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day. Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of about 27 to 32 hours.

The 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 oxalate overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a escitalopram oxalate overdose. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.

• Apr 2, 2012ANDAANDA079062Aurobindo Pharma Ltd
• May 3, 2012ANDAANDA079121Sun Pharma Canada
• Jun 12, 2012ANDAANDA202221Hetero Labs Ltd Iii
• Sep 11, 2012ANDAANDA090432Aurobindo Pharma Ltd
• Sep 11, 2012ANDAANDA202210Macleods Pharms Ltd
• Sep 11, 2012ANDAANDA090939Torrent Pharms Ltd
• Sep 12, 2012ANDAANDA202280Jubilant Cadista
• Sep 16, 2014NDANDA204760Averitas

1. 1Drug Ineffective5,0206.7%
2. 2Fatigue4,6476.2%
3. 3Nausea4,5666.1%
4. 4Off Label Use4,0065.4%
5. 5Diarrhoea3,9635.3%
6. 6Headache3,8055.1%
7. 7Dizziness3,1084.2%
8. 8Drug Interaction3,0814.1%
9. 9Fall3,0794.1%
10. 10Anxiety3,0084.0%
11. 11Dyspnoea2,9404.0%
12. 12Vomiting2,8513.8%
13. 13Pain2,7833.7%
14. 14Condition Aggravated2,6623.6%
15. 15Depression2,6043.5%

Recent PubMed references pinned to Oxalate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Animal models for calcium oxalate kidney stone research.
  Zoological research · 2026 · Tuo X, Cheng C, Wen J, et al.
  PMID 42267561DOI 10.24272/j.issn.2095-8137.2025.567
• SIRT1 regulates CaOx crystal-induced exacerbation of renal mitochondrial dysfunction and fibrosis through PPAR-α in aged mice.
  Journal of molecular medicine (Berlin, Germany) · 2026 · Xu Y, Xia K, Mao X, et al.
  PMID 42209799DOI 10.1007/s00109-026-02687-5
• Metabolic origins of hyperoxaluria: the critical role of precursors and vitamin B6 status in rats.
  Urolithiasis · 2026 · Ogawa Y
  PMID 42191892DOI 10.1007/s00240-026-02009-x
• The activation of the metabolic oxaloacetate-pyruvate axis restores influenza A virus replication during impaired glycolysis.
  Virology journal · 2026 · Bojarzyn CR, Bieß N, Behrens M, et al.
  PMID 42178590DOI 10.1186/s12985-026-03201-6
• Sustainable recovery of vanadium from spent sulfuric acid catalysts using oxalic acid leaching and hydrothermal treatment.
  Environmental science and pollution research international · 2026 · Hasbaoui NE, Hadrami AE, Essifi K, et al.
  PMID 42143658DOI 10.1007/s11356-026-37830-9
• IL-6 exacerbates calcium oxalate kidney stones by promoting inflammatory responses and crystal adhesion via p38 MAPK signaling activation.
  Urolithiasis · 2026 · Liang F, Guo F, Han Z, et al.
  PMID 42133071DOI 10.1007/s00240-026-02005-1
• Cell Membrane Biogenesis: A Matter of Survival. Its Role in Renal Epithelia Restitution After Calcium Oxalate Injury.
  Journal of cellular physiology · 2026 · Parra LG, Sendyk DE, Verstraeten SV, et al.
  PMID 42093332DOI 10.1002/jcp.70187
• Identifying Potent Oxalate-Degrading LAB Strains for the Development of Low Oxalate Rhubarb-Based Juice Products.
  Journal of basic microbiology · 2026 · Vosoughi P, Habibi Najafi MB, Khosravi-Darani K, et al.
  PMID 42080253DOI 10.1002/jobm.70171

The 10 most recently updated of 172 ClinicalTrials.gov registrations naming Oxalate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 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
• Oxalate Formation From Ascorbic Acid
  Active not recruiting · Interventional · 90 enrolled · University of Alabama at Birmingham
  NCT04603898updated 2026-06-09
• Dietary Oxalate and Immune Cell Function
  Active not recruiting · Interventional · 82 enrolled · University of Alabama at Birmingham
  NCT03877276updated 2026-06-04
• Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
  Completed · Phase 4 · Interventional · 56 enrolled · Vanderbilt University Medical Center
  NCT05365477updated 2026-06-03
• Obesity and Endogenous Oxalate Synthesis
  Completed · Interventional · 58 enrolled · University of Alabama at Birmingham
  NCT03808090updated 2026-06-01
• Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease
  Recruiting · Interventional · 80 enrolled · University of Alabama at Birmingham
  NCT06989320updated 2026-05-29
• Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis
  Active not recruiting · Interventional · 28 enrolled · University of Alabama at Birmingham
  NCT06735924updated 2026-05-29
• Heterozygous Individuals for AGXT and Kidney Stones
  Not yet recruiting · Interventional · 4 enrolled · University of Alabama at Birmingham
  NCT04430426updated 2026-05-29
• Renal Metabolism of Glycolate to Oxalate
  Active not recruiting · Interventional · 15 enrolled · University of Alabama at Birmingham
  NCT04437225updated 2026-05-29
• O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
  Recruiting · Interventional · 40 enrolled · University of Alabama at Birmingham
  NCT06330246updated 2026-05-28

Frequently asked questions

How does Oxalate 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 Oxalate used for?

According to FDA labeling, Oxalate carries indications including: Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) 1.1 Major Depressive Disorder Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1) ] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Oxalate?

Oxalate labeling lists contraindications including: Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets. Do not use escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders.. Always consult the full prescribing information and a clinician.