45/100 · Moderate
Manufactured by Bausch Health US, LLC
Chlordiazepoxide Hydrochloride and Clidinium Bromide Adverse Reactions Mostly Non-Serious
4,878 FDA adverse event reports analyzed
Last updated: 2026-05-12
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. Based on analysis of 4,878 FDA adverse event reports, CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE include DIARRHOEA, NAUSEA, FATIGUE, DRUG INEFFECTIVE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE.
Chlordiazepoxide Hydrochloride And Clidinium Bromide has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 4,878 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us, Llc.
The most commonly reported adverse events include Diarrhoea, Nausea, Fatigue. Of classified reports, 56.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reactions are non-serious, with diarrhea, nausea, and fatigue being the most common.
The majority of reports are from females, with a significant number of serious reactions. Age distribution shows a peak in reports among individuals aged 60-70.
Patients taking Chlordiazepoxide Hydrochloride And Clidinium Bromide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other sedatives or anticholinergics may increase the risk of adverse effects. Warnings are issued for patients with certain medical conditions, such as liver or kidney disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Chlordiazepoxide Hydrochloride And Clidinium Bromide received a safety concern score of 45/100 (moderate concern). This is based on a 56.5% serious event ratio across 1,900 classified reports. The score accounts for 4,878 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 1,486, Male: 349, Unknown: 4. The most frequently reported age groups are age 61 (41 reports), age 55 (37 reports), age 58 (37 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,900 classified reports for CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE:
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.
Interactions with other sedatives or anticholinergics may increase the risk of adverse effects. Warnings are issued for patients with certain medical conditions, such as liver or kidney disease.
If you are taking Chlordiazepoxide Hydrochloride And Clidinium Bromide, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, fatigue, drug ineffective, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional. 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 closely monitors these drugs due to the high number of serious adverse events reported. Healthcare providers should be cautious when prescribing these medications.
The FDA has received approximately 4,878 adverse event reports associated with Chlordiazepoxide Hydrochloride And Clidinium Bromide. 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide include Diarrhoea, Nausea, Fatigue, Drug Ineffective, Pain. By volume, the top reported reactions are: Diarrhoea (181 reports), Nausea (180 reports), Fatigue (165 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Chlordiazepoxide Hydrochloride And Clidinium Bromide.
Out of 1,900 classified reports, 1,073 (56.5%) were classified as serious and 827 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide break down by patient sex as follows: Female: 1,486, Male: 349, Unknown: 4. 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide adverse events are: age 61: 41 reports, age 55: 37 reports, age 58: 37 reports, age 64: 37 reports, age 65: 37 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide adverse event reports is Bausch Health Us, Llc. 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide include: Headache, Abdominal Pain, Dizziness, Vomiting, Asthenia. 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide 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.
Chlordiazepoxide Hydrochloride And Clidinium Bromide has a safety concern score of 45 out of 100 (moderate 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. Most reactions are non-serious, with diarrhea, nausea, and fatigue being the most common.
Key safety signals identified in Chlordiazepoxide Hydrochloride And Clidinium Bromide's adverse event data include: High incidence of gastrointestinal issues like diarrhea and nausea.. Fatigue and dizziness are frequently reported.. A notable number of serious reactions, including death and myocardial infarction.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other sedatives or anticholinergics may increase the risk of adverse effects. Warnings are issued for patients with certain medical conditions, such as liver or kidney disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Chlordiazepoxide Hydrochloride And Clidinium Bromide.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional.
Chlordiazepoxide Hydrochloride And Clidinium Bromide has 4,878 adverse event reports on file with the FDA. The majority of reports are from females, with a significant number of serious reactions. The volume of reports for Chlordiazepoxide Hydrochloride And Clidinium Bromide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these drugs due to the high number of serious adverse events reported. Healthcare providers should be cautious when prescribing these medications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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