pharmacopeia
GET
/api/v1/drug/citalopram

Boxed 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 )] . Citalopram tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . 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 ) . • Citalopram tablets are not approved for use in pediatric patients ( 8.4 ) .

2D structure
1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile
SMILES CN(C)CCCC1(C2=C(CO1)C=C(C=C2)C#N)C3=CC=C(C=C3)F
InChIKey WSEQXVZVJXJVFP-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Serotonin Uptake Inhibitors.

Monoamine OxidaseSerotonin Uptake

Indications

Sourced from openFDA
  • Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .ICD-10: F32.9

Contraindications

Sourced from openFDA
  • Citalopram tablets are contraindicated in patients: • taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . • taking pimozide because of risk of QT prolongation [see Drug Interactions ( 7 )] .contraindicated

Dosage & administration

Sourced from openFDA

• Administer once daily with or without food ( 2 ) . • Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily ( 2.1 ) . • Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily ( 2.2 ) . • When discontinuing citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) . 2.1 Recommended Dosage Administer citalopram tablets once daily, with or without food, at an initial dosage of 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval of no less than one week. Dosages above 40 mg once daily are not recommended due to the risk of QT prolongation [see Warnings and Precautions ( 5.2 )] . 2.2 Screen for Bipolar Disorder Prior to Starting Citalopram Tablets Prior to initiating treatment with citalopram tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] . 2.3 Recommended Dosage for Specific Populations The maximum recommended dosage of citalopram tablets for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily [see Warnings and Precautions ( 5.2 ), Clinical Pharmacology ( 12.3 )] .

Warnings & precautions

Sourced from openFDA

• QT-Prolongation and Torsade de Pointes: Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of citalopram tablets in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia. Discontinue citalopram tablets in patients with persistent QTc measurements > 500 ms ( 5.2 , 7 ). • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue citalopram tablets and serotonergic agents and initiate supportive measures ( 5.3 ). • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs, other antiplatelet drugs, warfarin and other anticoagulants may increase this risk ( 5.4 ). • Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ). • Seizures: Use with caution in patients with seizure disorder ( 5.7 ). • Angle-Closure Glaucoma: Avoid use of citalopram tablets in patients with untreated anatomically narrow angles ( 5.8 ). • Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.9 ). • Sexual Dysfunction: Citalopram tablets may cause symptoms of sexual dysfunction. ( 5.10 ).

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity reactions [see Contraindications ( 4 )] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )] • QT-prolongation and torsade de pointes [see Warnings and Precautions ( 5.2 )] • Serotonin syndrome [see Warnings and Precautions ( 5.3 )] • Increased risk of bleeding [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Discontinuation syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.7 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.8 )] • Hyponatremia [see Warnings and Precautions ( 5.9 )] • Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Use in specific populations

Sourced from openFDA

Pregnancy: SSRI use, particularly late 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 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 ( 5.4 ) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. Published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum.

Overdosage

Sourced from openFDA

The following have been reported with citalopram 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 citalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose. Consider contacting a Poison Center (1‐800‐221‐2222) or a medical toxicologist for additional overdosage management recommendations.

Approval history

Sourced from openFDA
  • Jul 17, 1998NDANDA020822Abbvie
  • Oct 28, 2004ANDAANDA077031Aurobindo
  • Nov 5, 2004ANDAANDA077042Mylan
  • Dec 13, 2004ANDAANDA077043Hikma
  • Apr 29, 2005ANDAANDA077045Epic Pharma
  • Jun 14, 2006ANDAANDA077629Chartwell Molecular
  • Aug 28, 2006ANDAANDA077812Aurobindo Pharma
  • Jan 31, 2022NDANDA215428Almatica

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
134,746 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue9,0186.7%
  2. 2Nausea8,2796.1%
  3. 3Drug Ineffective7,3505.5%
  4. 4Headache6,7315.0%
  5. 5Diarrhoea6,2874.7%
  6. 6Pain5,9544.4%
  7. 7Dizziness5,7634.3%
  8. 8Fall5,6634.2%
  9. 9Anxiety5,4904.1%
  10. 10Dyspnoea5,3834.0%
  11. 11Off Label Use5,2563.9%
  12. 12Depression5,2433.9%
  13. 13Toxicity To Various Agents5,1243.8%
  14. 14Vomiting5,0173.7%
  15. 15Completed Suicide4,3743.2%

Literature

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

Clinical trials

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The 10 most recently updated of 721 ClinicalTrials.gov registrations naming Citalopram as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Citalopram. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Citalopram work?
Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Serotonin Uptake Inhibitors.
What is Citalopram used for?
According to FDA labeling, Citalopram carries indications including: Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Citalopram?
Citalopram 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 Citalopram?
Citalopram is marketed under brand names including Celexa.
What are the contraindications for Citalopram?
Citalopram labeling lists contraindications including: Citalopram tablets are contraindicated in patients: • taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . • taking pimozide because of risk of QT prolongation [see Drug Interactions ( 7 )] .. Always consult the full prescribing information and a clinician.
Note. Data for citalopram 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.

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