85/100 · Critical
Manufactured by Aurobindo Pharma Limited
Citalopram Hydrobromide Adverse Events: High Seriousness and Diverse Reactions
209,370 FDA adverse event reports analyzed
Last updated: 2026-05-12
CITALOPRAM HYDROBROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 209,370 FDA adverse event reports, CITALOPRAM HYDROBROMIDE has a safety score of 85 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 HYDROBROMIDE include FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE, TOXICITY TO VARIOUS AGENTS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CITALOPRAM HYDROBROMIDE.
Citalopram Hydrobromide has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 209,370 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, 82.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious adverse events, particularly suicide and overdose.
Diverse range of reactions, including neurological, gastrointestinal, and cardiovascular issues. Significant reports of depression and anxiety, indicating potential mental health risks.
Patients taking Citalopram Hydrobromide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Citalopram Hydrobromide can interact with other drugs, leading to toxicity and increased risk of adverse events. Overdose is a significant concern, and patients should be monitored closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Citalopram Hydrobromide received a safety concern score of 85/100 (high concern). This is based on a 82.2% serious event ratio across 104,249 classified reports. The score accounts for 209,370 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: 62,761, Male: 32,796, Unknown: 293. The most frequently reported age groups are age 58 (1,885 reports), age 57 (1,559 reports), age 60 (1,514 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 104,249 classified reports for CITALOPRAM HYDROBROMIDE:
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 Hydrobromide can interact with other drugs, leading to toxicity and increased risk of adverse events. Overdose is a significant concern, and patients should be monitored closely.
If you are taking Citalopram Hydrobromide, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, headache, toxicity to various agents. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and avoid self-adjustment. Inform healthcare providers about any existing conditions or medications to avoid potential interactions. 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 the safety of Citalopram Hydrobromide, particularly for serious adverse events like suicide and overdose. Regular medical check-ups are recommended for patients on this medication.
The FDA has received approximately 209,370 adverse event reports associated with Citalopram Hydrobromide. 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 Hydrobromide include Fatigue, Nausea, Drug Ineffective, Headache, Toxicity To Various Agents. By volume, the top reported reactions are: Fatigue (6,825 reports), Nausea (5,889 reports), Drug Ineffective (5,398 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 Hydrobromide.
Out of 104,249 classified reports, 85,672 (82.2%) were classified as serious and 18,577 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 Hydrobromide break down by patient sex as follows: Female: 62,761, Male: 32,796, Unknown: 293. 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 Hydrobromide adverse events are: age 58: 1,885 reports, age 57: 1,559 reports, age 60: 1,514 reports, age 55: 1,513 reports, age 65: 1,493 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 Hydrobromide 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 Hydrobromide include: Diarrhoea, Fall, Dizziness, Pain, Off Label Use. 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 Hydrobromide 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 Hydrobromide has a safety concern score of 85 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. High incidence of serious adverse events, particularly suicide and overdose.
Key safety signals identified in Citalopram Hydrobromide's adverse event data include: High number of serious adverse events (85,672 out of 104,249, 82.2%). Multiple reports of suicidal ideation and completed suicides. Frequent occurrence of drug interactions and overdose incidents. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Citalopram Hydrobromide can interact with other drugs, leading to toxicity and increased risk of adverse events. Overdose is a significant concern, and patients should be monitored closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Citalopram Hydrobromide.
Patients should strictly follow prescribed dosages and avoid self-adjustment. Inform healthcare providers about any existing conditions or medications to avoid potential interactions.
Citalopram Hydrobromide has 209,370 adverse event reports on file with the FDA. Diverse range of reactions, including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Citalopram Hydrobromide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Citalopram Hydrobromide, particularly for serious adverse events like suicide and overdose. Regular medical check-ups are recommended for patients on this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Aurobindo Pharma Limited and compare their safety profiles:
The following drugs share commonly reported adverse reactions with CITALOPRAM HYDROBROMIDE:
Drugs related to CITALOPRAM HYDROBROMIDE based on therapeutic use, drug class, or shared indications: