78/100 · Elevated
Manufactured by Mylan Pharmaceuticals Inc.
Hyoscyamine Sulfate Adverse Events Show High Serious Reaction Rate
21,511 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYOSCYAMINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Mylan Pharmaceuticals Inc.. Based on analysis of 21,511 FDA adverse event reports, HYOSCYAMINE SULFATE has a safety score of 78 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 HYOSCYAMINE SULFATE include NAUSEA, DIARRHOEA, PAIN, FATIGUE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYOSCYAMINE SULFATE.
Hyoscyamine Sulfate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 21,511 adverse event reports for this medication, which is primarily manufactured by Mylan Pharmaceuticals Inc..
The most commonly reported adverse events include Nausea, Diarrhoea, Pain. Of classified reports, 62.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, diarrhea, and abdominal pain are the most common side effects.
Serious reactions, including death and chronic kidney disease, are reported frequently. Drug ineffectiveness and off-label use are significant concerns.
Patients taking Hyoscyamine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hyoscyamine Sulfate can cause drug ineffectiveness and off-label use, which may lead to serious complications. Patients should be closely monitored, especially for serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hyoscyamine Sulfate received a safety concern score of 78/100 (high concern). This is based on a 62.7% serious event ratio across 8,855 classified reports. The score accounts for 21,511 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: 6,315, Male: 2,086, Unknown: 8. The most frequently reported age groups are age 62 (152 reports), age 58 (126 reports), age 69 (125 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,855 classified reports for HYOSCYAMINE SULFATE:
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.
Hyoscyamine Sulfate can cause drug ineffectiveness and off-label use, which may lead to serious complications. Patients should be closely monitored, especially for serious adverse events.
If you are taking Hyoscyamine Sulfate, here are important things to know. The most commonly reported side effects include nausea, diarrhoea, pain, fatigue, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider about any pre-existing conditions, especially kidney disease, before starting Hyoscyamine Sulfate. Regular monitoring and follow-up are essential to manage potential side effects. 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 Hyoscyamine Sulfate for safety concerns, particularly regarding serious reactions and chronic kidney disease. Healthcare providers should report any adverse events to the FDA.
The FDA has received approximately 21,511 adverse event reports associated with Hyoscyamine Sulfate. 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 Hyoscyamine Sulfate include Nausea, Diarrhoea, Pain, Fatigue, Dizziness. By volume, the top reported reactions are: Nausea (797 reports), Diarrhoea (687 reports), Pain (636 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hyoscyamine Sulfate.
Out of 8,855 classified reports, 5,549 (62.7%) were classified as serious and 3,306 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 Hyoscyamine Sulfate break down by patient sex as follows: Female: 6,315, Male: 2,086, Unknown: 8. 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 Hyoscyamine Sulfate adverse events are: age 62: 152 reports, age 58: 126 reports, age 69: 125 reports, age 65: 123 reports, age 52: 122 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 Hyoscyamine Sulfate adverse event reports is Mylan Pharmaceuticals 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 Hyoscyamine Sulfate include: Drug Ineffective, Headache, Abdominal Pain, Vomiting, 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 Hyoscyamine Sulfate 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.
Hyoscyamine Sulfate has a safety concern score of 78 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. Nausea, diarrhea, and abdominal pain are the most common side effects.
Key safety signals identified in Hyoscyamine Sulfate's adverse event data include: High rate of serious reactions (62.7%). Multiple reports of fatal outcomes. Significant number of chronic kidney disease cases. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hyoscyamine Sulfate can cause drug ineffectiveness and off-label use, which may lead to serious complications. Patients should be closely monitored, especially for serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hyoscyamine Sulfate.
Patients should inform their healthcare provider about any pre-existing conditions, especially kidney disease, before starting Hyoscyamine Sulfate. Regular monitoring and follow-up are essential to manage potential side effects.
Hyoscyamine Sulfate has 21,511 adverse event reports on file with the FDA. Serious reactions, including death and chronic kidney disease, are reported frequently. The volume of reports for Hyoscyamine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Hyoscyamine Sulfate for safety concerns, particularly regarding serious reactions and chronic kidney disease. Healthcare providers should report any adverse events to the FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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