{ "query": "citalopram", "ingredient": "citalopram", "slug": "citalopram", "rxcui": "2556", "brands": [ "Celexa" ], "names": [ "citalopram", "citalopram hydrobromide" ], "classes": [ { "id": "N06AB", "name": "Selective serotonin reuptake inhibitors" } ], "alternatives": [ "escitalopram", "fluoxetine", "fluvoxamine", "paroxetine", "sertraline" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 87 }, "boxed_warning": "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 m onitor all antidepressant-treated patients for clinical worsening , and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . CELEXA is 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 though t s and behaviors ( 5.1 ) . CELEXA is not approved for use in pediatric patients ( 8.4 ) .", "indications_and_usage": "is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . CELEXA is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).", "contraindications": "is 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 )] . with known hypersensitivity to citalopram or any of the inactive ingredients in CELEXA. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 ) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI ( 4 ). Concomitant use of pimozide ( 4 ) . Known hypersensitivity to citalopram or any of the inactive ingredients of CELEXA ( 4 ).", "warnings_and_cautions": "QT-Prolongation and Torsade de Pointes : Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of CELEXA 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 CELEXA 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 CELEXA and serotonergic agents and initiate supportive measures ( 5.3 ). In cr eased 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 CELEXA in patients with untreated anatomically narrow ang...", "warnings": "", "adverse_reactions": "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 \u2265 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observe...", "drug_abuse_and_dependence": "9.1 Controlled Substance CELEXA (citalopram HBr) is not a controlled substance. 9.2 Abuse Animal studies suggest that the abuse liability of CELEXA is low. CELEXA has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with CELEXA did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, health care providers should carefully evaluate CELEXA patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).", "controlled_substance": "9.1 Controlled Substance CELEXA (citalopram HBr) is not a controlled substance.", "recent_major_changes": "Warnings and Precautions ( 5.3 , 5.4 ) 08/2023", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicid al Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions ( 5.1 )] . QT Prolongation and Torsade de Pointes Advise patients to consult their health care provider immediately if they feel faint, lose consciousness, or have heart palpitations. Instruct patients to inform their health care provider that they are taking CELEXA before taking any new medications [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of CELEXA with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John\u2019s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients ...", "spl_medguide": "MEDICATION GUIDE CELEXA \u00ae (Suh-leks-uh) (citalopram) Tablets, for oral use What is the most important information I should know about CELEXA? CELEXA may cause serious side effects, including: Increased risk of suicidal thoughts and actions. CELEXA and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed. CELEXA is not for use in children. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you hav...", "clinical_studies": "The efficacy of CELEXA as a treatment for major depressive disorder was established in two placebo-controlled studies (of 4 to 6 weeks duration) in adult outpatients (ages 18-66) meeting DSM-III or DSM-III-R criteria for major depressive disorder (MDD) (Studies 1 and 2). Study 1, a 6-week trial in which patients received fixed CELEXA doses of 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that CELEXA 40 daily and 60 mg daily (1.5 times the maximum recommended daily dosage) was effective as measured by the Hamilton Depression Rating Scale (HAMD) total score, the primary efficacy endpoint. The HAMD-17 is a 17-item, clinician-rated scale used to assess severity of depressive symptoms. Scores on the HAMD-17 range from 0 to 52, with higher scores indicating more severe depression. This study showed no clear effect of the 10 mg and 20 mg daily doses, and the 60 mg daily dose was not more effective than the 40 mg daily dose. Due to the risk of QTc prolongation and ventricular arrhythmias, the maximum recommended dosage of CELEXA is 40 mg once daily. In study 2, a 4-week, placebo-controlled trial in patients with MDD, the initial dose was 20 mg daily, followed by titration to the maximum tol...", "brand_name": "Celexa", "manufacturer": "Allergan, Inc.", "application_number": "NDA020822", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20231009", "set_id": "4259d9b1-de34-43a4-85a8-41dd214e9177", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 96190, "serious": 73540, "death": 12841, "hospitalization": 31773, "primary_suspect": 95665, "top_reactions": [ [ "Fatigue", 7109 ], [ "Nausea", 6021 ], [ "Drug Ineffective", 5847 ], [ "Headache", 5066 ], [ "Off Label Use", 4856 ], [ "Diarrhoea", 4751 ], [ "Toxicity To Various Agents", 4506 ], [ "Pain", 4276 ], [ "Dizziness", 4196 ], [ "Fall", 4174 ], [ "Dyspnoea", 3838 ], [ "Anxiety", 3727 ], [ "Vomiting", 3419 ], [ "Malaise", 3283 ], [ "Depression", 3269 ] ], "by_year": { "2019": 10565, "2020": 8703, "2021": 7110, "2022": 5781, "2023": 5650, "2024": 3575, "2025": 5641, "2026": 2401 }, "by_year_primary": { "2019": 10541, "2020": 8685, "2021": 7076, "2022": 5668, "2023": 5508, "2024": 3525, "2025": 5569, "2026": 2353 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20220126", "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.", "firm": "CARDINAL HEALTHCARE", "status": "Terminated" } ], "recall_total": 1, "drugsfda": { "applications": 37, "nda": 4, "anda": 33, "first_approval": "19980717", "rems": false, "rems_last": "", "labeling_supplements": 32, "labeling_recent": 5, "sponsors": [ "ABBVIE", "ALMATICA", "AMNEAL PHARMS NY", "APOTEX", "AUROBINDO", "AUROBINDO PHARMA", "AUROBINDO PHARMA LTD", "BIOVAIL LABS INTL" ], "unapproved": false, "first_approval_fmt": "07/17/1998" }, "trials": { "total": 726, "completed": 475, "terminated": 84, "with_results": 197, "industry": 219, "phase3": 125, "results_share": 0.4147368421052632, "terminated_share": 0.11570247933884298 }, "pubmed": { "rct": 331, "meta": 18, "recent_rct": 21, "cochrane": [ { "pmid": "22786497", "title": "Citalopram versus other anti-depressive agents for depression", "year": "2012" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "citalopram", "Celexa" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 6745805, "beneficiaries": 1422944, "spend": 51156213.19, "by_brand": [ { "brand": "Citalopram HBr", "claims": 6741609, "per_claim": 7.2088306694, "is_generic": false }, { "brand": "Celexa", "claims": 4196, "per_claim": 609.41264776, "is_generic": false } ], "per_claim": 7.583411199997628 }, "mdl": [], "dsc": [ { "date": "20120328", "title": "Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm297391.htm", "kind": "drug", "matched": "citalopram hydrobromide" }, { "date": "20110824", "title": "Celexa (citalopram hydrobromide)- Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm269086.htm", "kind": "drug", "matched": "citalopram hydrobromide" } ], "settlements": [], "prescrire": { "section": "Haematology", "names": [ "citalopram", "escitalopram" ], "reason": "Citalopram and escitalopram are \u201cselective\u201d serotonin reuptake inhibitor (SSRI) antidepressants that expose patients to a higher incidence of QT prolongation, torsade de pointes and sudden death than other SSRIs, as well as worse outcomes in the event of overdose ( Prescrire Int n\u00b0 170, 174, 221; Rev Prescrire n\u00b0 369).", "edition": "2026", "qualifier": null, "qualified": false, "matched": "citalopram" }, "eml": { "listed": true, "status": "AddedToEml", "name": "citalopram", "matched": "citalopram", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 11447, "fills": 6745805, "per_million": 1696.9064477849568, "ratio": 0.6128339618521592, "median": 2768.949753790441 }, "scores": { "safety": { "score": 39, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2012 (-16)", "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)", "1,697 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site", "Death share in reports is near or below the FAERS average (1.5x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 55, "letter": "D", "why": [ "331 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)", "1 independent Cochrane review(s) exist", "Only 41% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 86, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 33 generic makers (-1)", "5 label changes approved since 2021: the safety story is still moving (-8)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (33 applications)", "5 same-class alternatives exist" ], "weight": 0.1 } }, "total": 65, "grade": "C", "questions": [ "In 2012 the FDA issued a safety communication about this drug (Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhy). Does that risk apply to me?", "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?", "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over escitalopram, fluoxetine, fluvoxamine? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }