Medication approval journey
citalopram (Celexa)
Approved for Major depressive disorder in adults
page first published · last updated
Also answers to “the original pressing” — its codename in our videos and posts. The full codebook
How this page reads
The page as written, with the clinical terms
Plain language uses the same facts, the same numbers and the same caveats. It does not leave anything out. Quotes from the FDA label are never reworded in either setting.
Before you stop or change your citalopram dose
Stopping abruptly causes withdrawal effects that can be severe
Stopping or reducing an SSRI too fast commonly causes withdrawal symptoms — dizziness, electric-shock sensations, insomnia, agitation. These are often more severe and far longer-lasting than the "one to two weeks" many people are told. Any change should be a slow, prescriber-supervised taper.
what the citalopram warnings mean
label facts below are read from the citalopram tablets FDA label on DailyMed, set id 625a78b2-4751-4ca5-91b6-7c85fd9f8c2e, version 5, effective august 27, 2026. the section numbers in brackets are the label’s own. every source is linked at the end of this section. last checked 2026-10-05.
citalopram was approved for depression in 1998, and about 2.9 million americans filled a prescription for it in 2024 [meps]. it is the parent molecule of escitalopram, and it is the one ssri whose label sets a hard maximum dose because of the heart. the label carries one boxed warning and nine further warnings. this section says what each means in plain words, what the approval trials measured and for how long, which side effects the label counts and how often, and what independent research has found since, in both directions. every number is from the label or from a study in the library, and each source is linked at the end.
this is information to take to a prescriber. nothing here is a reason to start, stop or change a dose on your own; the label itself says stopping suddenly is the thing to avoid.
the boxed warning: suicidal thoughts and behaviors, by age
the boxed warning says antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults in short-term studies, that everyone on the drug should be watched for worsening, and that citalopram is not approved for anyone under 18 [label, boxed warning and 5.1].
the numbers come from pooled placebo-controlled trials of antidepressants covering about 77,000 adults and 4,500 children. per 1,000 people treated, the difference against placebo was: under 18, 14 additional people with suicidal thoughts or behaviors; 18 to 24, 5 additional; 25 to 64, 1 fewer; 65 and older, 6 fewer [label 5.1, table 1]. the label adds that the absolute risk was highest in people treated for depression, and that whether the risk extends beyond four months is unknown.
so the warning is specific: thoughts and behaviors, not deaths; the first months; and above age 24 the pooled trials showed no increase [label 5.1; age-ceiling row]. for someone under 25 the question is who is watching and for what. for someone over 65 the number runs the other way, and for citalopram the over-60s have a second, separate reason to read on: the dose ceiling.
the heart-rhythm warning, and why the maximum dose is 40 mg
citalopram is the only ssri whose label limits the dose on cardiac grounds. warning 5.2 says it "causes dose-dependent QTc prolongation", a lengthening of one interval on the ecg that has been linked to torsade de pointes, ventricular tachycardia and sudden death, all of which have been seen in post-marketing reports. because the lengthening grows with dose, the label says not to give more than 40 mg a day, and 20 mg a day is the maximum for people over 60, people with liver impairment, people who are cyp2c19 poor metabolisers, and anyone taking a cyp2c19 inhibitor such as cimetidine [label 5.2, 2.1, 2.3, 2.4].
the label also says to avoid citalopram in people with congenital long qt syndrome, slow heart rate, low potassium or magnesium, a recent heart attack or uncompensated heart failure, and in people taking other drugs that lengthen the interval (it names quinidine, procainamide, amiodarone, sotalol, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin, pentamidine and methadone, among others); to check potassium and magnesium in people at risk; to consider an ecg in those groups; and to stop the drug if the qtc stays above 500 milliseconds [label 5.2]. pimozide is contraindicated outright [dose-ceiling].
the history matters for anyone on an older dose. the trial that established efficacy worked at 40 and 60 mg; the label now calls 60 mg “1.5 times the maximum recommended daily dosage” and the ceiling is 40 mg [label 14; dose-ceiling]. a 2013 review in the library adds the honest limit: qtc prolongation is "an established, though imperfect, risk marker" for the dangerous rhythm, no well-controlled study has counted the rhythm deaths themselves, and most people on psychiatric drugs have few qt risk factors [qt-review]. the warning is real, it is about a marker, and it matters most for people who already have a risk factor.
the other eight warnings, in plain words
the rest of the warnings section, 5.3 to 5.10, matches the other ssri labels. none is boxed.
- serotonin syndrome [5.3]: too much serotonin signalling, which can be life-threatening. the risk rises with other serotonergic drugs (triptans, tricyclics, fentanyl, lithium, tramadol, meperidine, methadone, buspirone, amphetamines, st john’s wort) and the combination with an maoi is contraindicated. symptoms were noted in 0.1% of depression-trial patients on citalopram. signs are agitation or confusion, racing heart, sweating, fever, tremor, muscle jerking and overactive reflexes.
- bleeding [5.4]: drugs that block serotonin reuptake make platelets less effective. aspirin, nsaids such as ibuprofen and naproxen, and blood thinners add to the risk, and ssri use in the month before delivery has been linked to a less than twofold rise in postpartum bleeding.
- activation of mania or hypomania [5.5]: in someone with bipolar disorder an antidepressant can tip a depressive episode into a manic one; people with bipolar disorder were excluded from the trials and mania or hypomania was still reported in 0.1% of patients. the label tells prescribers to screen for a personal or family history first.
- discontinuation syndrome [5.6]: stopping, particularly abruptly, can bring nausea, sweating, low mood, irritability, agitation, dizziness, electric-shock sensations, tremor, anxiety, confusion, headache, insomnia, tinnitus and, rarely, seizures. the label recommends gradual reduction rather than abrupt cessation whenever possible.
- seizures [5.7]: people with a seizure history were excluded from the trials. in the trials that were run, seizures occurred in 0.3% of people on citalopram and 0.5% on placebo; the label still says caution in anyone with a seizure disorder.
- angle-closure glaucoma [5.8]: the pupil dilation many antidepressants cause can trigger an attack in an eye with narrow drainage angles that has not been treated.
- low sodium [5.9]: hyponatremia, usually from the hormone syndrome siadh, with cases below 110 mmol/l reported. early signs are headache, poor concentration, confusion, weakness and unsteadiness; severe cases have included seizures and death. older people, people on diuretics and anyone dehydrated may be at greater risk.
- sexual dysfunction [5.10]: delayed or absent ejaculation, erectile dysfunction and reduced desire in men; reduced desire and delayed or absent orgasm in women. the label tells prescribers to ask before starting and to ask again during treatment, because people do not volunteer it.
what the trials measured, and for how long
the depression approval rested on two placebo-controlled trials in adult outpatients aged 18 to 66, lasting 4 to 6 weeks, with the hamilton depression scale as the outcome. study 1, a 6-week fixed-dose trial of 10, 20, 40 and 60 mg, found 40 and 60 mg effective, "no clear effect of the 10 mg and 20 mg daily doses", and 60 mg no better than 40 mg. study 2, a 4-week trial, titrated people up to as much as 80 mg, twice today’s maximum [label 14]. the label gives no enrollment per trial; 1,063 people took citalopram across the placebo-controlled depression trials [label 6.1].
then the sentence most labels do not carry: "in three additional placebo-controlled trials in patients with mdd, the difference in response to treatment between patients receiving citalopram and patients receiving placebo was not statistically significant" [label 14]. three of five registration trials did not show a difference; two positive trials was the standard for approval. two longer studies randomised responders to continue or switch to placebo, with less relapse on citalopram over six months [label 14].
the arithmetic that matters: the efficacy trials were 4 to 6 weeks, the doses that worked in the fixed-dose trial were 40 mg and above, today’s ceiling is 40 mg and the ceiling for the over-60s is 20 mg, a dose the label says showed no clear effect; the longest controlled measurement behind the approval was six months; and about 2.9 million americans a year take it. the open-questions step further down this page puts the same three points as questions.
the most common side effects, with the label’s numbers
the label pools 1,063 people on citalopram at 10 to 80 mg against 446 on placebo in depression trials of up to 6 weeks, and reports the reactions at 2% or more and above placebo: nausea 21% vs 14%, dry mouth 20% vs 14%, sleepiness 18% vs 10%, insomnia 15% vs 14%, increased sweating 11% vs 9%, diarrhea 8% vs 5%, tremor 8% vs 6%, indigestion 5% vs 4%, fatigue 5% vs 3% [label 6.1, table 3]. the only reaction at 5% or more and twice placebo was ejaculation disorder in men. the full list is in the side-effects section lower on this page.
sexual side effects in men (425 on citalopram, 194 on placebo): abnormal ejaculation, mostly delay, 6.1% vs 1%; decreased libido 3.8% vs under 1%; impotence 2.8% vs under 1%. in women the label reports decreased libido in 1.3% and anorgasmia in 1.1% of 638 patients, without a placebo comparison [label 6.1, table 4]. the label says in its own words that such estimates "may underestimate their actual incidence". people on citalopram in the trials lost about 0.5 kg; placebo patients did not change [label 6.1].
two cautions the label attaches to all of these: rates from trials cannot be compared directly with rates for other drugs, and they may not match what happens in ordinary practice.
what independent research says, in both directions
in favour. when sexual function was measured with a questionnaire across antidepressants, citalopram sat third of ten, behind sertraline and venlafaxine, so it is not the ssri with the heaviest sexual burden [serretti-2009]. the triptan interaction every ssri label lists was measured over 14 years in one health system: two definite cases of serotonin syndrome in 30,928 person-years of combined use, about 0.6 per 10,000 years, and the authors said the fda advisory should be reconsidered [orlova-2018]. serotonin toxicity itself has a seven-sign definition built from 2,222 overdoses: inducible muscle jerking, agitation, sweating, tremor, overactive reflexes, and in severe cases rigidity and fever; nausea and headache after starting a second drug are not on the list [hunter-2003].
against, or smaller than the badge suggests. the label’s own clinical-studies section is the main entry here: three of five registration trials failed to separate from placebo, and the doses that worked are at or above today’s ceiling [label 14]. the bleeding warning is real but modest: across 15 case-control and 4 cohort studies the odds of an upper-gi bleed on an ssri were 1.66 times, which is one extra bleed for roughly every 3,177 low-risk people or 881 high-risk people; with an nsaid as well the odds rose to 4.25 times [anglin-2014]. in may 2019 the european regulator’s safety committee ordered every maker of citalopram and nine related drugs to add a warning that sexual dysfunction can continue after the drug is stopped; how often is unknown, and that uncertainty cuts both ways [prac-2019].
on withdrawal, the uk guideline nice ng215 says coming off can take months, that medicines should not be stopped abruptly except in exceptional circumstances, and that tapers should get smaller as the dose gets lower [nice-2022]; the royal college of psychiatrists conceded in 2019 that for some people withdrawal is severe and long-lasting, while stating that antidepressant use is not dependence in the addiction sense [rcpsych-2019]. and on the heart, the review in the library is the one to hold beside warning 5.2: citalopram "appears more likely than others" among ssris to lengthen the qtc, the marker is imperfect, the rhythm deaths have never been counted in a controlled study, and monitoring should follow the person’s own risk factors [qt-review].
questions to ask your prescriber about citalopram
each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.
- given my age, which side of the boxed warning’s line am i on, and what exactly should i or the people around me watch for in the first two months?
- what dose am i on? the label’s fixed-dose trial showed no clear effect at 10 or 20 mg, and 20 mg is the ceiling for people over 60. which part of the evidence covers my dose?
- do i have any of the qt risk factors the label lists, does anything else i take lengthen the interval, and has anyone looked at an ecg or my potassium and magnesium?
- i take ibuprofen or naproxen for pain, or a blood thinner. does the bleeding warning change what i should use instead?
- the label says to ask about sexual function before starting and during treatment. can we do that now?
- if i ever want to stop, what would the taper look like, how small are the steps near the end, and how would we tell withdrawal from relapse?
- three of the five registration trials did not beat placebo. what in my own response tells us the drug is doing the work?
questions people ask
- does citalopram have a black box warning?
- yes. the fda label carries one boxed warning, on suicidal thoughts and behaviors in children, adolescents and young adults in short-term studies, and states that citalopram is not approved for anyone under 18. per 1,000 people treated, the pooled numbers are 14 additional cases under 18, 5 additional at 18 to 24, 1 fewer at 25 to 64 and 6 fewer at 65 and over. the heart-rhythm warning is a separate, non-boxed warning (5.2).
- why is the maximum dose of citalopram 40 mg?
- because the label says citalopram causes dose-dependent qtc prolongation, an ecg change linked to dangerous heart rhythms and sudden death in post-marketing reports. doses above 40 mg a day are not recommended, and the maximum is 20 mg a day for people over 60, people with liver impairment, cyp2c19 poor metabolisers and anyone on a cyp2c19 inhibitor. the trial that established efficacy worked at 40 and 60 mg, and the label now describes 60 mg as 1.5 times the maximum.
- what are the most common citalopram side effects?
- from the label’s depression trials, 1,063 people on citalopram against 446 on placebo: nausea 21% vs 14%, dry mouth 20% vs 14%, sleepiness 18% vs 10%, insomnia 15% vs 14%, increased sweating 11% vs 9%, diarrhea 8% vs 5%, tremor 8% vs 6%. in men, abnormal ejaculation was 6.1% vs 1%, decreased libido 3.8% vs under 1% and impotence 2.8% vs under 1%; in women the label reports decreased libido in 1.3% and anorgasmia in 1.1%, and says such figures may understate the true rate.
- what happens if you stop citalopram suddenly?
- the label lists a discontinuation syndrome after abrupt stopping: nausea, sweating, low mood, irritability, agitation, dizziness, electric-shock sensations, tremor, anxiety, confusion, headache, insomnia, tinnitus and, rarely, seizures, and recommends gradual reduction whenever possible. the uk guideline says coming off can take months and that tapers should get smaller as the dose gets lower. a taper plan is a conversation with a prescriber, not something to decide from a web page.
- did the citalopram trials show it works?
- two of five placebo-controlled registration trials did, at 40 mg and above; the label itself states that in three additional trials the difference from placebo was not statistically significant, and that the fixed-dose trial showed no clear effect at 10 or 20 mg. two longer studies found less relapse over six months in people who stayed on it after responding. two positive trials is the fda’s standard for approval, and the label meets it.
sources for this section
the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.
- citalopram tablets prescribing information, fda label on dailymed (set id 625a78b2-4751-4ca5-91b6-7c85fd9f8c2e, version 5, effective august 27, 2026): boxed warning; sections 2.1 to 2.4, 5.1 to 5.10, 6.1 tables 3 and 4, 14
- ahrq medical expenditure panel survey, prescribed medicines public-use file 2024 (hc-254a): people with at least one citalopram purchase, weighted; computed by veisund, method on the usage section of this page
- the antidepressant suicidality warning has an age ceiling most people never hear about (fda boxed warning, read off the label) (library row)
- citalopram has a dose ceiling because of the heart, and it drops to 20 mg with certain other drugs (celexa prescribing information, sections 2.3 to 2.5, 4 and 5.2, august 2026) (library row)
- beach sr, et al. qtc prolongation, torsades de pointes, and psychotropic medications. psychosomatics 2013 (narrative review) (library row)
- serretti a, chiesa a. treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. journal of clinical psychopharmacology 2009 (library row)
- european medicines agency, pharmacovigilance risk assessment committee. recommendations on signals, 13 to 16 may 2019, section 1.3: ssris and snris, persistent sexual dysfunction after drug withdrawal (library row)
- anglin r, et al. risk of upper gastrointestinal bleeding with ssris with or without concurrent nsaid use: a systematic review and meta-analysis. american journal of gastroenterology 2014 (library row)
- orlova y, rizzoli p, loder e. coprescription of triptans and ssri or snri antidepressants and serotonin syndrome. jama neurology 2018 (library row)
- dunkley ej, et al. the hunter serotonin toxicity criteria. qjm 2003 (library row)
- national institute for health and care excellence. medicines associated with dependence or withdrawal symptoms (ng215), 2022 (library row)
- royal college of psychiatrists. position statement on antidepressants and depression (ps04/19), 2019 (library row)
claims about citalopram we went and checked
- confirmeddo 40% or more of people with depression not respond to antidepressants?said on Lex Fridman Podcast, 2026-09-21; the number holds up. in the largest real-world antidepressant study the US government funded, about half of patients did not respond to the first drug they were given, so "40 or north of 40%" is a fair, even conservative, way to put it.
every check quotes one sentence, links the original at the timestamp, and takes each assertion to the primary record. the full list: /checked.
How long the citalopram trials actually ran
The longest trial behind the citalopram approval ran 6 weeks.
The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.
People often stay on these drugs for far longer than the trials ran. The trials behind the approval ran 4 to 6 weeks.
That does not mean longer use is unsafe. It does not mean the drug stops working either. It means longer use was never the thing that got tested.
If you have been on it a long time, that is a fair thing to ask your prescriber about.
Boxed warning: suicidal thoughts and behaviors
The strongest warning the FDA puts on a label, often called a black box warning. It is reproduced below word for word, not summarised.
This is the strongest warning the FDA can put on a drug label. Some people call it a black box warning. We copied it word for word. We did not shorten it and we did not soften it.
The warning below is about suicidal thoughts. In short studies, antidepressants raised the risk of suicidal thoughts and behavior. That was in children and young adults. The label tells prescribers to watch every patient closely for this. It also tells them to watch for the illness getting worse.
The FDA’s own words follow, copied exactly.
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 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 thoughts and behaviors ( 5.1 ) . Citalopram is not approved for use in pediatric patients ( 8.4 ).
FDA label effective August 27, 2026 — read the full label on DailyMed
What citalopram is FDA approved for, and the trials behind it
Approved for major depressive disorder in adults in 1998, under application NDA 020822. Source: FDA Drugs@FDA.
The label does not report enrollment for the individual efficacy studies, and three placebo-controlled trials in the program did not show a statistically significant difference from placebo; the participant figure here is the pooled safety count from depression trials of up to 6 weeks.
Efficacy for depression was established in two placebo-controlled studies of 4 to 6 weeks in adult outpatients aged 18 to 66 — one fixed-dose study spanning 10 mg to 60 mg daily and one dose-titration study. In three additional placebo-controlled trials, the difference between citalopram and placebo was not statistically significant. Two long-term studies randomized responders to continued citalopram or placebo, with lower relapse rates on citalopram over the following 6 months.
Two gaps first. The label does not report how many people were in each of the trials that worked. And three other trials against a placebo did not show a real difference from the placebo.
The patient count here is the pooled safety count. It comes from depression trials of up to 6 weeks.
The FDA approved citalopram in 1998. The approved use was major depression in adults. The file number is NDA 020822. The source is Drugs@FDA, the FDA's own database.
Two trials against a placebo backed the depression approval. They ran 4 to 6 weeks. Everyone was an adult outpatient aged 18 to 66.
One used set doses from 10 mg to 60 mg a day. The other raised the dose over time.
Two longer studies took people who had done well, then moved some to a placebo. Fewer people on the drug got ill again over the next 6 months.
- Trials
- 2 placebo-controlled trials
- Duration
- 4 to 6 weeks
- Participants
- 1,063 patients on citalopram in the pooled placebo-controlled trials
- Compared against
- Placebo
The efficacy of citalopram 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 to 66) meeting DSM-III or DSM-III-R criteria for major depressive disorder (MDD) (Studies 1 and 2).
Verbatim from the citalopram FDA label, Clinical Studies section, effective August 27, 2026 — read the full label on DailyMed.
Side effects of citalopram in the approval trials
Incidence among 1,063 patients who received citalopram 10 mg to 80 mg daily versus 446 on placebo in placebo-controlled depression trials of up to 6 weeks. The label cautions that trial rates cannot be directly compared with rates for other drugs and may not reflect the rates observed in clinical practice.
Read the limits first. These numbers come from depression trials against a placebo that ran up to 6 weeks. 1,063 people took the drug at 10 mg to 80 mg a day. 446 took a placebo.
The label warns that you cannot line these rates up against another drug’s rates. It warns that real life may not match them either.
- Nausea (21% vs 14% on placebo)
- Dry mouth (20% vs 14%)
- Somnolence (18% vs 10%)
- Insomnia (15% vs 14%)
- Increased sweating (11% vs 9%)
- Diarrhea (8% vs 5%)
- Tremor (8% vs 6%)
- Ejaculation disorder (6% vs 1%, male patients)
- Dyspepsia (5% vs 4%)
- Fatigue (5% vs 3%)
The most common adverse reaction that occurred in citalopram-treated patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients (see Table 3 ).
From the citalopram FDA label, Adverse Reactions section, effective August 27, 2026 — DailyMed.
More from the citalopram label: drug abuse and dependence
Not a controlled substance
Citalopram is not a controlled substance. Animal studies suggest its abuse liability is low, and premarketing experience showed no drug-seeking behavior, but the label notes it has not been systematically studied in humans for abuse, tolerance, or physical dependence and advises observing patients for signs of misuse.
FDA label, Drug Abuse and Dependence section.
Discontinuation syndrome
The label lists adverse reactions after stopping serotonergic antidepressants, particularly abruptly, including nausea, sweating, irritability, dizziness, sensory disturbances such as electric shock sensations, insomnia, and seizures, and recommends a gradual reduction in dosage rather than abrupt cessation whenever possible.
FDA label, Warnings and Precautions section.
How many Americans take citalopram
Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.
These are federal survey numbers. They come out about two years late. They count prescriptions filled. They do not tell you if the drug helped.
- 12,504,000
- prescriptions in the United States (2024), refills included
- 2,876,646
- people filling them (2024), ± 506,315 (95%)
Prescriptions are down 58% from 2014 to 2024, a change larger than the survey’s margin of error. Whatever you decide about citalopram, you are deciding alongside about 2,876,646 other people in 2024.
Prescriptions by year: 2014 29,737,922 · 2015 28,069,031 · 2016 26,387,590 · 2017 24,434,272 · 2018 22,224,263 · 2019 21,546,700 · 2020 18,549,177 · 2021 18,444,406 · 2022 15,047,663 · 2023 14,769,554 · 2024 12,504,000.
Prescriptions are down 58 percent since 2014. About 2.9 million people in the United States took it in 2024.
Correction (29 September 2026). An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves. It showed 2,876,645 people and 12,500,214 prescriptions for 2024; the file gives 2,876,646 and 12,504,000.
Source: AHRQ Medical Expenditure Panel Survey (MEPS), Prescribed Medicines public-use files, 2014 (HC-168A) through 2024 (HC-254A), computed by veisund. People with at least one purchase where the Multum generic name (RXDRGNAM) equals the drug, weighted by the year’s person weight; purchases include refills. Standard errors by Taylor linearization on VARSTR/VARPSU. AHRQ’s reliability rule: a year is not shown when fewer than 60 survey respondents reported the drug or the relative standard error is over 50%. AHRQ cautions that its 2018 questionnaire redesign and the 2020–2022 pandemic years make year-to-year comparisons less certain.
What people report to the FDA about citalopram
Read this before the numbers.
Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.
Read this before the numbers.
Anyone can send a report to the FDA. Patients can. Doctors can. Drug makers can. Nobody checks that the drug caused what the report describes.
There is also no bottom number. Tens of millions of prescriptions turn into reports at a rate nobody knows. Reports go up when a drug is in the news, and that is not the same as more harm.
So these are counts of reports. They are not rates. You cannot use them to compare one drug with another. The FDA itself says not to use this data to make medical choices.
We show it because it is on the public record, and you should get to see it with its limits named.
- 106,559
- reports mentioning citalopram, all time
- 87,468
- filed as serious (a report-level flag covering every drug and outcome in the report)filed as serious. That flag covers the whole report, and one report can name more than one drug and more than one outcome.
Most-reported reactions
- Fatigue6,992
- Nausea6,019
- Drug ineffective5,543
- Headache5,146
- Toxicity to various agents5,100
- Diarrhoea4,832
- Fall4,463
- Pain4,429
- Dizziness4,424
- Off label use4,363
“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.
It is worth noticing how high “drug ineffective” ranks. A report that the drug did not help counts as an adverse event too. People file a lot of them.
Source: FDA Adverse Event Reporting System (FAERS), via openFDA, openFDA dataset refreshed 2026-07-30 (the refresh date of the query endpoint, not the date reports run through).
Drug interactions listed on the citalopram label
The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.
Below is the part of the FDA label that lists other drugs. It is copied word for word.
No list on the web can see what else you take. A pharmacist can. Ask one to check your full list.
Read the label’s interactions section
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) ]. Intervention: The maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ]. Other Serotonergic Drugs Clinical Impact: Concomitant use of citalopram and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of citalopram and/or concomitant serotonergic drugs [see Warning and Precautions (5.3) ]. Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: Concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions (5.4) ]. CYP2C19 Inhibitors : Citalopram 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors ( 5.2 , 7 ) .
FDA label for citalopram, effective August 27, 2026 — DailyMed.
Label history: when this label changes, it is recorded in What changed.
Who pays for citalopram
Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.
- Medicare Part D
- Read the under-65 group correctly before the numbers: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error. The beneficiary total sums brand-level rows, so treat it as an upper bound on distinct people. 1,422,360 beneficiaries filled 6,743,311 claims in 2024 — 1,227,120 aged 65 and over, and 195,240 under 65.
- Medicaid
- At least 2,096,752 prescriptions in 2024 — a floor, because 139 of 518 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.
- All payers (survey estimate)
- A survey estimate from 198 respondents, which we computed from AHRQ’s MEPS 2024 Prescribed Medicines file (people with at least one purchase, weighted; purchases include refills), puts the whole country at 12,504,000 purchases and 2,876,646 people in 2024. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.
- The population nobody counts
- The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of citalopram specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.
Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.
Who has been paying for citalopram, 2019–2024
Medicare Part D
Claims, all ages — the one payer with a public per-drug series.
8,406,705 → 6,743,311 claims
Medicare under 65
Beneficiaries, not ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population. A gap is a suppressed split, not zero.
333,505 → 195,240 beneficiaries
Medicaid
A floor each year — small-cell rows are suppressed federally and excluded from the sum.
3,488,325 → 2,096,752 prescriptions (floor)
Commercially insured adults
No public dataset publishes per-drug commercial claims for any year — the absence is the finding, and it is rendered, not interpolated. The population this library most wants to inform is the one with no public per-drug series, in any year — insurers and PBMs hold that data privately. What the federal surveys do measure — how many adults take these medications at all — is on the adult-usage page.
Sources: Medicare Part D Prescribers by Geography and Drug (data.cms.gov, national rows, per data year); Medicaid State Drug Utilization Data (data.medicaid.gov, national rows). Claims, fills and beneficiaries are different units — compare each series only with itself.
The citalopram approval, step by step
Step 1
What the approval was actually based on
Which studies did the FDA rely on, how long did they run, and who was in them?
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)... In three additional placebo-controlled trials in patients with MDD, the difference in response to treatment between patients receiving CELEXA and patients receiving placebo was not statistically significant.
FDA-approved labelling, 14 CLINICAL STUDIES — read the label on DailyMed
Our reading
Five trials were run. Two worked and three did not, and the FDA made the label say so. That sentence is the single most valuable thing on this page and you will not find its equivalent in a journal article, because journals largely do not publish the trials that failed. It is also worth knowing that the winning trial showed no clear effect at 10 mg or 20 mg — the doses most people are actually prescribed — and that the 60 mg dose was no better than 40 mg. In 2011 the FDA capped the dose at 40 mg over a QT-interval risk found thirteen years after approval.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- July 17, 1998
- Application
- NDA020822
- Review
- STANDARD
- Original sponsor
- Forest Laboratories (now AbbVie)
- Holds it now
- AbbVie
- Label submissions since
- 34
Source: openFDA Drugs@FDA, original application ORIG-1
Step 3
What was added after it was on the market
Which warnings arrived only after millions of people were already taking it?
PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting, section 1.3: SNRIs and SSRIs - persistent…
21 years after approval
On 16 May 2019 the EU drug regulator's safety committee ordered every manufacturer of citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, duloxetine, venlafaxine, desvenlafaxine, and milnacipran to add this warning within two months: "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI." The patient leaflet wording is "In some cases, these symptoms have continued after stopping treatment." This is a regulator acting on case reports and pharmacovigilance data, not a prevalence study — how often it happens is still unknown, and that uncertainty cuts both ways.
Worth asking
European regulators require a label warning that sexual side effects can persist after stopping an SSRI or SNRI — how would you and I tell that apart from the depression itself if it happened to me?
Citalopram has a dose ceiling because of the heart, and it drops to 20 mg with certain other drugs
28 years after approval
Citalopram is one of the most prescribed antidepressants, and the only SSRI whose label sets a hard maximum dose because of the heart. Several of the interactions here are about that ceiling.
Significant findings
CELEXA prescribing information (Allergan, August 2026), section 5.2: "CELEXA causes dose-dependent QTc prolongation an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of which have been observed in postmarketing reports for citalopram. Because of the risk of QTc prolongation at higher CELEXA doses, it is recommended that CELEXA not be given at doses above 40 mg once daily."
Section 2.3: "The maximum recommended dosage of CELEXA for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily." Section 2.4: "The maximum recommended dosage of CELEXA when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily."
On stacking QT drugs: "CELEXA should also be avoided in patients who are taking other drugs that prolong the QTc interval. Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin)". Pimozide is contraindicated outright: coadministration "increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias."
Section 5.3 names the serotonin syndrome partners: "The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs". Symptoms of serotonin syndrome "were noted in 0.1% of MDD patients treated with CELEXA in premarketing clinical trials." MAOIs need a 14-day gap in either direction.
Worth asking
Two questions if you take citalopram. Which CYP2C19 inhibitors are on your list (the label names the mechanism; common ones include some acid reducers), and does your dose respect the 20 mg ceiling if so? And is any other drug you take on the QT list, including antipsychotics and some antibiotics? A pharmacist can answer both in a minute. The Beach 2013 row in this wave is the review of QT risk across psychiatric drugs.
The antidepressant suicidality warning has an age ceiling most people never hear about
Antidepressants carry a boxed warning about suicidal thoughts and behaviour in children, adolescents and young adults. It came from pooling 24 short-term placebo-controlled trials of nine antidepressants in more than 4,400 young patients: suicidality was reported in about 4% on drug against 2% on placebo. There were no completed suicides in those trials.
The part that usually gets lost is the age boundary, which is in the label itself. The studies did not show an increased risk above age 24, and in patients 65 and older the risk went in the other direction — it was reduced. The warning is real and it is specific, not a blanket statement about everyone who takes one.
Worth asking
Given my age, which side of that line am I on, what specifically should I or the people around me watch for in the first two months, and who do I call if it happens.
Step 4
What independent research has found since
What has been learned by people who were not selling it?
SSRIs raise the odds of a stomach bleed by about two thirds; with an NSAID as well, about fourfold
16 years after approval
Serotonin is needed for platelets to clump. Antidepressants that block its reuptake reduce the platelet store, and this meta-analysis measured what that does to the risk of bleeding from the stomach, alone and with an anti-inflammatory painkiller.
Significant findings
Anglin and colleagues (American Journal of Gastroenterology, 2014) searched to April 2013 and included "Fifteen case-control studies (including 393,268 participants) and four cohort studies". "There was an increased risk of upper GI bleeding with SSRI medications in the case-control studies (OR=1.66, 95% CI=1.44,1.92) and cohort studies (OR=1.68, 95% CI=1.13,2.50)."
The absolute numbers: "The number needed to harm for upper GI bleeding with SSRI treatment in a low-risk population was 3,177, and in a high-risk population it was 881." And the combination: "The risk of upper GI bleeding was further increased with the use of both SSRI and NSAID medications (OR=4.25, 95% CI=2.82,6.42)."
The authors' conclusion: "SSRI medications are associated with a modest increase in the risk of upper GI bleeding, which is lower than has previously been estimated. This risk is significantly elevated when SSRI medications are used in combination with NSAIDs, and physicians prescribing these medications together should exercise caution and discuss this risk with patients."
Worth asking
The number needed to harm is the one to hold on to: on an SSRI alone, one extra bleed for roughly every three thousand low-risk people, or every nine hundred high-risk. The combination with regular NSAID use is where the risk stops being modest. If you take an SSRI and buy ibuprofen or naproxen for pain, the question for the pharmacist is what the alternative is, and whether you count as high risk (prior ulcer, older age, anticoagulants, steroids).
An SSRI blocked most of MDMA's psychological effects in a placebo-controlled study of 16 volunteers
2 years after approval
"Will my antidepressant stop ecstasy from working" has a measured answer from a Swiss laboratory, and it also explains why the combination is not simply safe.
Significant findings
Liechti and colleagues (Neuropsychopharmacology, 2000) gave MDMA 1.5 mg per kilogram by mouth to 16 healthy volunteers in a double-blind, placebo-controlled study, with or without pretreatment with citalopram 40 mg intravenously.
"MDMA produced an emotional state with heightened mood, increased self-confidence and extroversion, moderate derealization, and an intensification of sensory perception. Most of these effects were markedly reduced by citalopram."
The mechanism, from the abstract: "The effect of MDMA on 5-HT release can be blocked by 5-HT uptake inhibitors such as citalopram, suggesting that MDMA interacts with the 5-HT uptake site." The finding "suggests that the psychological effects of MDMA are mediated via action at the 5-HT uptake site to increase 5-HT release through the carrier".
Worth asking
Two consequences follow, in opposite directions. The first is that a person on an SSRI who takes MDMA and feels little may take more, and the dose that goes up is the dose whose heart and temperature effects were not blocked. The second is that MDMA and an SSRI both raise serotonin, and every SSRI label lists amphetamines among the drugs that raise serotonin syndrome risk. The Vuori 2003 row in this wave is what happened when MDMA met an MAOI antidepressant. A person on an antidepressant who is going to use MDMA anyway should know that "it did nothing" is not the same as "it was safe".
Serotonin toxicity is diagnosed by seven signs, and the rules were built from 2,222 overdoses
5 years after approval
Half the labels in this wave warn about serotonin syndrome. This is the paper that defined how a clinician recognises it.
Significant findings
Dunkley and colleagues (QJM, 2003) studied "all patients admitted to the Hunter Area Toxicology Service (HATS) following an overdose of a serotonergic drug from January 1987 to November 2002 (n = 2222)." A learning set of 473 SSRI-alone overdoses was used to find which clinical features predicted a toxicologist's diagnosis of serotonin toxicity.
"Numerous clinical features were associated with serotonin toxicity, but only clonus (inducible, spontaneous or ocular), agitation, diaphoresis, tremor and hyperreflexia were needed for accurate prediction of serotonin toxicity as diagnosed by a clinical toxicologist. Although the learning dataset did not include patients with life-threatening serotonin toxicity, hypertonicity and maximum temperature > 38 degrees C were universal in such patients; these features were therefore added."
The result: "These new criteria were simpler, more sensitive (84% vs. 75%) and more specific (97% vs. 96%) than Sternbach's criteria."
Worth asking
The everyday value of this paper is the symptom list in plain words: muscle twitching or jerking that a doctor can trigger by flexing your ankle, restlessness, sweating, tremor, overactive reflexes, and in severe cases stiffness and fever. Nausea or a headache after starting a second serotonergic drug is not on the list. If you have been told to watch for serotonin syndrome, these seven signs are what to watch for, and they are a reason to seek care the same day.
QT prolongation from psychiatric drugs is a real but imperfect risk marker; the arrhythmia itself is unmeasured
15 years after approval
The interaction warnings about QT prolongation, which run through the citalopram, pimozide and paroxetine rows of this wave, rest on a marker, not on counted heart rhythm deaths. This review says so.
Significant findings
Beach and colleagues (Psychosomatics, 2013) reviewed the literature on the corrected QT interval and psychiatric medication. "QTc interval prolongation is an established, though imperfect, risk marker for TdP" (torsades de pointes, the dangerous rhythm). "There are no well-controlled studies that assess the risk of TdP associated with psychotropic agents."
What the evidence supports: "There are limited data that selective serotonin reuptake inhibitors (SSRIs) as a class are linked to QTc prolongation; citalopram appears more likely than others to induce this phenomenon. Among antipsychotics, thioridazine remains the agent most associated with QTc prolongation; intravenous haloperidol also appears to carry an increased risk. Of the atypical antipsychotics, ziprasidone appears most likely to prolong the QTc interval."
And the proportion: "The majority of patients in need of psychotropic medications display few risk factors for QTc prolongation and should be considered to be at low risk for TdP. The frequency of cardiac monitoring for patients receiving psychiatric medications should be individually determined, based on the prescribed agent(s) and additional risk factors for TdP."
Worth asking
This is the review to hold beside the labels. The labels say avoid stacking QT drugs; the review says the stacking matters most for people who already have risk factors, such as heart disease, low potassium or magnesium, or a congenital long QT, and that the harm at the end of the chain has never been measured in a controlled study. If you take two drugs from the QT lists, the question is whether you have any of those risk factors and whether anyone has looked at an ECG.
Withdrawal from these medications can take months, and NICE says so
24 years after approval
NICE guideline NG215 covers safe prescribing and managed withdrawal for five groups of medication: opioids, benzodiazepines, gabapentinoids, Z-drugs and antidepressants. It is the closest thing there is to an official answer on how coming off actually goes.
It states that withdrawal can be difficult and may take several months or more, that symptoms vary widely in type and severity, that they affect both physical and mental health, and that they can be delayed in onset and can persist. Two recommendations are worth quoting to a prescriber. Do not stop a medicine abruptly except in exceptional medical circumstances. And taper using a slow, stepwise reduction proportionate to the current dose, so the decrements get smaller as the dose gets lower — not a fixed cut each time.
That last detail is the one most commonly missed. Gabapentinoids are the exception in the guideline and are reduced by a fixed amount at each step.
Worth asking
Can we write the taper down, what size are the steps near the end, and how long do I hold at each step before the next reduction.
In 2019 the Royal College of Psychiatrists changed its position on withdrawal
21 years after approval
For years people reporting long, severe antidepressant withdrawal were told it lasted a week or two. In May 2019 the Royal College of Psychiatrists published a position statement conceding the point: while withdrawal symptoms are often mild and self-limiting, there is substantial variation, and for some patients symptoms last much longer and are more severe.
It went further and asked for changes — that guidelines and patient information recognise the potential for severe and long-lasting withdrawal, that pharmacologically-informed tapering guidance be developed, that discontinuation be tapered at a rate the patient can tolerate over potentially several months, and that clinicians actively work to tell withdrawal apart from relapse.
One thing it explicitly does not say, and it is worth being accurate about: the College states that from a clinical perspective antidepressant use is not associated with dependence in the addiction sense. Withdrawal and dependence are not the same claim.
Worth asking
If I feel bad three weeks after a dose reduction, how will we decide whether that is withdrawal or my depression returning, and what do we do differently in each case.
Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis.
11 years after approval
When sexual function is actually asked about with a questionnaire rather than waited for as a spontaneous complaint, treatment-emergent sexual dysfunction ranged from 25.8% to 80.3% of patients across antidepressants, all significantly above placebo. In descending order of impact the drugs were sertraline, venlafaxine, citalopram, paroxetine, fluoxetine, imipramine, phenelzine, duloxetine, escitalopram, and fluvoxamine. Agomelatine, amineptine, bupropion, moclobemide, mirtazapine, and nefazodone showed no significant difference from placebo.
Worth asking
Where does the antidepressant I'm on sit on the sexual side-effect ranking, and is there a drug with a lower rate that would still treat my condition?
Step 5
What still is not known
Which questions you might reasonably have has nobody answered yet?
- Three of five registration trials failed. Two positive trials was the standard for approval — is it your standard?
- The trial showed no clear effect at 10 mg or 20 mg daily. If that is your dose, which part of the evidence covers it?
- The maximum dose was cut from 60 mg to 40 mg in 2011 on cardiac grounds. The trial that established efficacy used doses that are now above the limit.
The citalopram legal and safety record
Settled and adjudicated matters only, from primary sources — including the litigation that was decided for the manufacturer, and the cases this drug is verifiably not part of.
Deciding about citalopram?
- Side-effect rates from citalopram's own label — drug vs placebo, with every caveat the label attaches
- How long every medication's approval trials ran — citalopram beside every other drug in the library, from the same FDA record
- 12 questions to ask before starting a psychiatric medication — each with the study behind it
- Already on it? The 10-question annual review — including the honest case for staying
- How long every drug here was tested before approval — one chart, all medications
Open citalopram (Celexa) in veisund
The app has the full approval journey, the resources behind it, and people working through the same questions.
