Citalopram Hydrobromide Medication Guide

Conditions This Medication May Treat

Based on Bridgeway's clinical use. See the FDA "Uses" section below for approved indications.

Depression

Uses (FDA Indications) (FDA source)

1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .

Dosage Forms & Strengths (FDA source)

3 DOSAGE FORMS AND STRENGTHS Citalopram tablets, USP are available as: 40 mg: White colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘7’ on other side Tablets: 40 mg, scored

Warnings & Precautions (FDA source)

5 WARNINGS AND PRECAUTIONS QT-Prolongation and Torsade de Pointes : Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of citalopram 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 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 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 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 may cause symptoms of sexual dysfunction. ( 5.10 ) . 5.1 Suicidal Thoughts and Behavior 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, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. …

Common Side Effects (FDA source)

6 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 ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 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 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. The safety for citalopram included citalopram exposures in patients and/or healthy subjects from 3 different groups of studies: 429 healthy subjects in clinical pharmacology/pharmacokinetic studies; 4,422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1,370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. …

Drug Interactions (FDA source)

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with citalopram. Table 5: Clinically Important Drug Interactions with Citalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including citalopram, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.5) , Contraindications (4) , Warnings and Precautions (5.3) ] . Pimozide Clinical Impact: Concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see Clinical Pharmacology (12.2) ]. Intervention: Citalopram is contraindicated in patients taking pimozide [see Contraindications (4) , Warnings and Precautions (5.2) ]. Drugs that Prolong the QTc Interval Clinical Impact: Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology (12.2) ]. Intervention: Avoid concomitant use of citalopram with drugs that prolong the QT interval (citalopram is contraindicated in patients taking pimozide) [see Contraindications (4) , Warnings and Precautions (5.2) ]. CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see Clinical Pharmacology (12.2) ]. …

Interactions With Other Medications We Cover

FDA label text for Citalopram Hydrobromide or a related medication mentions the following combinations. Check any two medications with our interaction tool →

• Citalopram Hydrobromide + Lithium Carbonate — Minor
• Citalopram Hydrobromide + Buspirone Hydrochloride — Minor

About this interaction data. These interactions were identified by automatically scanning FDA prescribing-label text for medications in Bridgeway's library. This is not a complete list and is not a substitute for review by your prescriber or pharmacist, who use comprehensive clinical databases. Always share your full medication list with your care team. How we source this data →

Contraindications (FDA source)

4 CONTRAINDICATIONS 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) ] . with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. 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 citalopram ( 4 ).

Use in Specific Populations (FDA source)

8 USE IN SPECIFIC POPULATIONS 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. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including citalopram, during pregnancy . …

Most-Reported Adverse Events (FAERS)

Of 106,559 adverse-event reports mentioning Citalopram Hydrobromide submitted to the FDA, the most frequently reported reactions are:

• Fatigue — 6,992 reports
• Nausea — 6,019 reports
• Drug Ineffective — 5,543 reports
• Headache — 5,146 reports
• Toxicity To Various Agents — 5,100 reports
• Diarrhoea — 4,832 reports
• Fall — 4,463 reports
• Pain — 4,429 reports
• Dizziness — 4,424 reports
• Off Label Use — 4,363 reports

Source: FDA Adverse Event Reporting System (FAERS). These are voluntary, unverified reports from patients and providers worldwide — they do not mean the medication caused the reaction, and report counts reflect how widely a drug is used as much as its safety profile.

Recent FDA Recalls

No ongoing recalls involving Citalopram Hydrobromide right now. See full medication safety feed →