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citalopram

Sold as Celexa. Class: Selective serotonin reuptake inhibitors. First FDA approval 07/17/1998: 28 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (65/100)

Safety ×35%
F
Evidence ×25%
D
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
A

Safety: 39

Evidence: 55

Regulatory history: 86

Money & lawsuits: 100

Options: 100

FDA 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 ) .

Independent reviews and post-approval warnings

FDA Drug Safety Communications

Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.

Prescrire: drug to avoid

Citalopram and escitalopram are “selective” 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° 170, 174, 221; Rev Prescrire n° 369).

Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Haematology) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

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 precautions

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...

Adverse reactions (label)

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 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...

Recent major label changes

Warnings and Precautions ( 5.3 , 5.4 ) 08/2023

Source: FDA SPL label for Celexa (Allergan, Inc.), effective 20231009. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

96,190reports that mention this drug
95,665of those blame this drug, not another one the person was taking
76%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
13.3%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Fatigue · 7,109Nausea · 6,021Drug Ineffective · 5,847Headache · 5,066Off Label Use · 4,856Diarrhoea · 4,751Toxicity To Various Agents · 4,506Pain · 4,276Dizziness · 4,196Fall · 4,174Dyspnoea · 3,838Anxiety · 3,727Vomiting · 3,419Malaise · 3,283Depression · 3,269

Reports per year

20192020202120222023202420252026
10,5658,7037,1105,7815,6503,5755,6412,401

1,697 reports blaming this drug for every million Medicare prescriptions filled, which is 0.6× the typical drug on this site. (11,447 reports in 2024–2026, against 6,745,805 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

1recall actions on file
4 / 33brand / generic applications
5label changes since 2021
NoREMS program
DateClassFirmReason
01/2022Class IICARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

331randomized trials (PubMed)
18systematic reviews
726registered trials
41%of completed trials posted results
12%terminated or withdrawn
30%industry-funded

Independent Cochrane reviews

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

1,422,944Medicare Part D patients (2024)
6,745,805prescriptions filled
$8average cost per fill
$51Mtotal Medicare spend
ProductFills$/fill
Citalopram HBr6,741,609$7
Celexa4,196$609

Same-class alternatives

2 drugs in the same class grade a letter or more higher than citalopram on this site. Worth asking whether one of them would do the same job for you.

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. 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?
  2. 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?
  3. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
  4. The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. How would we recognize and handle those?
  5. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  6. Why this one over escitalopram, fluoxetine, fluvoxamine? What would make you pick one of those instead?
  7. What result are we expecting, by when, and what is the plan if it does not happen?
  8. 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.)