72/100 · Elevated
Manufactured by Mylan Institutional LLC
Moderate Safety Concerns with Thiamine Hydrochloride, Riboflavin 5-Phosphate Sodium, Dexpantenol, and Niacinamide
70,501 FDA adverse event reports analyzed
Last updated: 2026-05-12
THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Mylan Institutional LLC. Based on analysis of 70,501 FDA adverse event reports, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE has a safety score of 72 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 THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE include FATIGUE, NAUSEA, DIARRHOEA, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE.
Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 70,501 adverse event reports for this medication, which is primarily manufactured by Mylan Institutional Llc.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 58.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include fatigue, nausea, and diarrhea, indicating gastrointestinal and general malaise effects.
Serious adverse events such as pneumonia, falls, and death are reported, suggesting potential severe risks. A diverse range of reactions indicates a complex safety profile, with no single issue dominating.
Patients taking Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not explicitly mentioned, but caution is advised when using this combination with other medications, especially those affecting the gastrointestinal tract or respiratory system. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide received a safety concern score of 72/100 (elevated concern). This is based on a 58.6% serious event ratio across 28,816 classified reports. The score accounts for 70,501 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: 18,233, Male: 8,984, Unknown: 13. The most frequently reported age groups are age 64 (598 reports), age 70 (539 reports), age 66 (535 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,816 classified reports for THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE:
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.
Drug interactions are not explicitly mentioned, but caution is advised when using this combination with other medications, especially those affecting the gastrointestinal tract or respiratory system.
If you are taking Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, headache, 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 unusual symptoms to their healthcare provider immediately. Follow the prescribed dosage and schedule strictly to minimize the risk of adverse reactions. 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 should continue to monitor the safety of this combination, particularly in elderly patients, and healthcare providers should be vigilant for serious adverse events.
The FDA has received approximately 70,501 adverse event reports associated with Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide. 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide include Fatigue, Nausea, Diarrhoea, Headache, Pain. By volume, the top reported reactions are: Fatigue (3,240 reports), Nausea (2,172 reports), Diarrhoea (2,138 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide.
Out of 28,816 classified reports, 16,895 (58.6%) were classified as serious and 11,921 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide break down by patient sex as follows: Female: 18,233, Male: 8,984, Unknown: 13. 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide adverse events are: age 64: 598 reports, age 70: 539 reports, age 66: 535 reports, age 67: 532 reports, age 63: 517 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide adverse event reports is Mylan Institutional 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 Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide include: Dizziness, Drug Ineffective, Dyspnoea, Arthralgia, 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 Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide 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, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide has a safety concern score of 72 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. The most common reactions include fatigue, nausea, and diarrhea, indicating gastrointestinal and general malaise effects.
Key safety signals identified in Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide's adverse event data include: Falls and death are reported as serious adverse events, indicating potential risks for elderly patients.. A wide variety of reactions, including neurological and respiratory issues, suggest a complex safety profile.. Reports of pneumonia and other infections are concerning, especially given the age distribution of the patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not explicitly mentioned, but caution is advised when using this combination with other medications, especially those affecting the gastrointestinal tract or respiratory system. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide.
Patients should report any unusual symptoms to their healthcare provider immediately. Follow the prescribed dosage and schedule strictly to minimize the risk of adverse reactions.
Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide has 70,501 adverse event reports on file with the FDA. Serious adverse events such as pneumonia, falls, and death are reported, suggesting potential severe risks. The volume of reports for Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor the safety of this combination, particularly in elderly patients, and healthcare providers should be vigilant for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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