45/100 · Moderate
Manufactured by Armas Pharmaceuticals Inc.
Thiamine Hydrochloride Adverse Events Show Widespread Mild to Moderate Reactions
30,453 FDA adverse event reports analyzed
Last updated: 2026-05-12
THIAMINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Armas Pharmaceuticals Inc.. Based on analysis of 30,453 FDA adverse event reports, THIAMINE HYDROCHLORIDE 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 THIAMINE HYDROCHLORIDE include OFF LABEL USE, NAUSEA, DRUG INEFFECTIVE, DYSPNOEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for THIAMINE HYDROCHLORIDE.
Thiamine Hydrochloride 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 30,453 adverse event reports for this medication, which is primarily manufactured by Armas Pharmaceuticals Inc..
The most commonly reported adverse events include Off Label Use, Nausea, Drug Ineffective. Of classified reports, 90.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are mild to moderate in severity, with nausea and fatigue being the most common.
Serious adverse events, such as acute kidney injury and pneumonia, are less frequent but still notable. Drug interactions and product use issues are reported, indicating potential risks when used off-label. The reaction diversity is high, with over 100 distinct reactions reported, suggesting a complex safety profile.
Patients taking Thiamine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Thiamine Hydrochloride can cause drug interactions and should be used with caution, especially when administered off-label. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Thiamine Hydrochloride received a safety concern score of 45/100 (moderate concern). This is based on a 90.0% serious event ratio across 11,722 classified reports. The score accounts for 30,453 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: Male: 5,997, Female: 4,636, Unknown: 42. The most frequently reported age groups are age 40 (282 reports), age 65 (271 reports), age 63 (265 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 11,722 classified reports for THIAMINE 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.
Thiamine Hydrochloride can cause drug interactions and should be used with caution, especially when administered off-label.
If you are taking Thiamine Hydrochloride, here are important things to know. The most commonly reported side effects include off label use, nausea, drug ineffective, dyspnoea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and use Thiamine Hydrochloride only for approved indications. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring. 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 Thiamine Hydrochloride for safety, and updates will be provided as necessary.
The FDA has received approximately 30,453 adverse event reports associated with Thiamine 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 Thiamine Hydrochloride include Off Label Use, Nausea, Drug Ineffective, Dyspnoea, Diarrhoea. By volume, the top reported reactions are: Off Label Use (861 reports), Nausea (765 reports), Drug Ineffective (749 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Thiamine Hydrochloride.
Out of 11,722 classified reports, 10,555 (90.0%) were classified as serious and 1,167 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 Thiamine Hydrochloride break down by patient sex as follows: Male: 5,997, Female: 4,636, Unknown: 42. 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 Thiamine Hydrochloride adverse events are: age 40: 282 reports, age 65: 271 reports, age 63: 265 reports, age 64: 261 reports, age 54: 257 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 Thiamine Hydrochloride adverse event reports is Armas 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 Thiamine Hydrochloride include: Pain, Fatigue, Confusional State, Vomiting, Malaise. 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 Thiamine 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.
Thiamine Hydrochloride 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. The majority of reported reactions are mild to moderate in severity, with nausea and fatigue being the most common.
Key safety signals identified in Thiamine Hydrochloride's adverse event data include: Acute kidney injury and pneumonia are key serious adverse events.. Drug interactions and product use in unapproved indications are significant safety signals.. Over 100 distinct reactions reported, indicating a complex safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Thiamine Hydrochloride can cause drug interactions and should be used with caution, especially when administered off-label. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Thiamine Hydrochloride.
Always follow the prescribed dosage and use Thiamine Hydrochloride only for approved indications. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring.
Thiamine Hydrochloride has 30,453 adverse event reports on file with the FDA. Serious adverse events, such as acute kidney injury and pneumonia, are less frequent but still notable. The volume of reports for Thiamine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Thiamine Hydrochloride for safety, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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