65/100 · Elevated
Manufactured by Hikma Pharmaceuticals USA Inc.
Dicyclomine Hydrochloride Adverse Events: Nausea, Diarrhea, and Fatigue Predominate
33,951 FDA adverse event reports analyzed
Last updated: 2026-05-12
DICYCLOMINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. Based on analysis of 33,951 FDA adverse event reports, DICYCLOMINE HYDROCHLORIDE has a safety score of 65 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 DICYCLOMINE HYDROCHLORIDE include NAUSEA, DIARRHOEA, FATIGUE, PAIN, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICYCLOMINE HYDROCHLORIDE.
Dicyclomine Hydrochloride has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 33,951 adverse event reports for this medication, which is primarily manufactured by Hikma Pharmaceuticals Usa Inc..
The most commonly reported adverse events include Nausea, Diarrhoea, Fatigue. Of classified reports, 61.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, diarrhea, and fatigue are the most common adverse events reported.
Serious adverse events, such as chronic kidney disease and acute kidney injury, are also reported but less frequently. The majority of adverse events are non-serious, but the high volume of reports indicates a significant safety concern. Reports of falls and dizziness suggest a risk of falls and accidents, especially in older adults.
Patients taking Dicyclomine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dicyclomine Hydrochloride can cause falls and dizziness, which may increase the risk of accidents, especially in older adults. It is important to monitor patients for these symptoms and adjust dosing as necessary. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dicyclomine Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 61.5% serious event ratio across 13,353 classified reports. The score accounts for 33,951 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 9,527, Male: 3,141, Unknown: 14. The most frequently reported age groups are age 63 (226 reports), age 61 (220 reports), age 62 (216 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 13,353 classified reports for DICYCLOMINE HYDROCHLORIDE:
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.
Dicyclomine Hydrochloride can cause falls and dizziness, which may increase the risk of accidents, especially in older adults. It is important to monitor patients for these symptoms and adjust dosing as necessary.
If you are taking Dicyclomine Hydrochloride, here are important things to know. The most commonly reported side effects include nausea, diarrhoea, fatigue, pain, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal impairment, especially those with pre-existing kidney conditions. Closely observe older adults for symptoms of dizziness and falls, and adjust dosing as needed. 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 Dicyclomine Hydrochloride. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 33,951 adverse event reports associated with Dicyclomine Hydrochloride. 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 Dicyclomine Hydrochloride include Nausea, Diarrhoea, Fatigue, Pain, Headache. By volume, the top reported reactions are: Nausea (1,250 reports), Diarrhoea (1,193 reports), Fatigue (1,120 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dicyclomine Hydrochloride.
Out of 13,353 classified reports, 8,215 (61.5%) were classified as serious and 5,138 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 Dicyclomine Hydrochloride break down by patient sex as follows: Female: 9,527, Male: 3,141, Unknown: 14. 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 Dicyclomine Hydrochloride adverse events are: age 63: 226 reports, age 61: 220 reports, age 62: 216 reports, age 65: 211 reports, age 57: 204 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 Dicyclomine Hydrochloride adverse event reports is Hikma Pharmaceuticals Usa Inc.. 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 Dicyclomine Hydrochloride include: Drug Ineffective, Off Label Use, Chronic Kidney Disease, Dizziness, Abdominal Pain. 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 Dicyclomine Hydrochloride 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.
Dicyclomine Hydrochloride has a safety concern score of 65 out of 100 (elevated 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. Nausea, diarrhea, and fatigue are the most common adverse events reported.
Key safety signals identified in Dicyclomine Hydrochloride's adverse event data include: Chronic kidney disease and acute kidney injury are key safety signals, indicating potential renal toxicity.. Falls and dizziness are significant safety signals, particularly in older adults.. Reports of respiratory issues, such as pneumonia and dyspnea, are also notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dicyclomine Hydrochloride can cause falls and dizziness, which may increase the risk of accidents, especially in older adults. It is important to monitor patients for these symptoms and adjust dosing as necessary. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dicyclomine Hydrochloride.
Monitor patients for signs of renal impairment, especially those with pre-existing kidney conditions. Closely observe older adults for symptoms of dizziness and falls, and adjust dosing as needed.
Dicyclomine Hydrochloride has 33,951 adverse event reports on file with the FDA. Serious adverse events, such as chronic kidney disease and acute kidney injury, are also reported but less frequently. The volume of reports for Dicyclomine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Dicyclomine Hydrochloride. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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