82/100 · Critical
Manufactured by Aurobindo Pharma Limited
Citalopram Adverse Events: High Seriousness and Diverse Reactions
266,799 FDA adverse event reports analyzed
Last updated: 2026-05-12
CITALOPRAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 266,799 FDA adverse event reports, CITALOPRAM has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CITALOPRAM include FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CITALOPRAM.
Citalopram has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 266,799 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 77.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Citalopram reports are predominantly serious, with 77.1% classified as such.
The most common reactions include fatigue, nausea, and drug ineffectiveness, indicating potential efficacy issues. Serious reactions such as death, completed suicide, and cardiac arrest are reported, highlighting significant safety concerns.
Patients taking Citalopram should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Citalopram can interact with other drugs, potentially leading to toxicity or increased side effects. Patients should avoid certain medications and inform their healthcare provider of all current medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Citalopram received a safety concern score of 82/100 (high concern). This is based on a 77.1% serious event ratio across 133,479 classified reports. The score accounts for 266,799 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 83,242, Male: 40,463, Unknown: 368. The most frequently reported age groups are age 58 (2,308 reports), age 57 (2,012 reports), age 55 (1,990 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 133,479 classified reports for CITALOPRAM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Citalopram can interact with other drugs, potentially leading to toxicity or increased side effects. Patients should avoid certain medications and inform their healthcare provider of all current medications.
If you are taking Citalopram, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, headache, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any existing health conditions or medications you are taking before starting citalopram. Monitor for signs of suicidal thoughts or behaviors, especially in the first few months of treatment. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor citalopram for safety, particularly regarding serious adverse events and drug interactions. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of serious adverse reacti
The FDA has received approximately 266,799 adverse event reports associated with Citalopram. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Citalopram include Fatigue, Nausea, Drug Ineffective, Headache, Diarrhoea. By volume, the top reported reactions are: Fatigue (8,932 reports), Nausea (8,206 reports), Drug Ineffective (7,282 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Citalopram.
Out of 133,479 classified reports, 102,959 (77.1%) were classified as serious and 30,520 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Citalopram break down by patient sex as follows: Female: 83,242, Male: 40,463, Unknown: 368. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Citalopram adverse events are: age 58: 2,308 reports, age 57: 2,012 reports, age 55: 1,990 reports, age 53: 1,949 reports, age 60: 1,908 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Citalopram adverse event reports is Aurobindo Pharma Limited. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Citalopram include: Pain, Dizziness, Fall, Anxiety, Dyspnoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Citalopram to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Citalopram has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Citalopram reports are predominantly serious, with 77.1% classified as such.
Key safety signals identified in Citalopram's adverse event data include: High percentage of serious adverse events (77.1%).. Multiple reports of suicidal ideation and attempts, especially in older adults.. Cardiac issues like QT prolongation and arrhythmias are noted.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Citalopram can interact with other drugs, potentially leading to toxicity or increased side effects. Patients should avoid certain medications and inform their healthcare provider of all current medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Citalopram.
Inform your healthcare provider about any existing health conditions or medications you are taking before starting citalopram. Monitor for signs of suicidal thoughts or behaviors, especially in the first few months of treatment.
Citalopram has 266,799 adverse event reports on file with the FDA. The most common reactions include fatigue, nausea, and drug ineffectiveness, indicating potential efficacy issues. The volume of reports for Citalopram reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor citalopram for safety, particularly regarding serious adverse events and drug interactions. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of serious adverse reacti For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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