72/100 · Elevated
Manufactured by Strides Pharma Science Limited
High Incidence of Gastrointestinal and Respiratory Symptoms with Ergocalciferol
901,191 FDA adverse event reports analyzed
Last updated: 2026-05-12
ERGOCALCIFEROL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Strides Pharma Science Limited. Based on analysis of 901,191 FDA adverse event reports, ERGOCALCIFEROL 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 ERGOCALCIFEROL include FATIGUE, NAUSEA, DIARRHOEA, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ERGOCALCIFEROL.
Ergocalciferol 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 901,191 adverse event reports for this medication, which is primarily manufactured by Strides Pharma Science Limited.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 58.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are gastrointestinal issues such as fatigue, nausea, and diarrhea, indicating potential digestive side effects.
Respiratory symptoms like dyspnea and pneumonia are also frequently reported, suggesting possible respiratory adverse effects. Serious reactions, including death and pneumonia, account for nearly 60% of all serious events, highlighting significant health risks.
Patients taking Ergocalciferol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ergocalciferol may interact with other medications affecting calcium and vitamin D metabolism, and patients should be monitored for potential drug interactions and side effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ergocalciferol received a safety concern score of 72/100 (elevated concern). This is based on a 58.7% serious event ratio across 366,199 classified reports. The score accounts for 901,191 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: 246,143, Male: 101,063, Unknown: 196. The most frequently reported age groups are age 65 (6,777 reports), age 64 (6,102 reports), age 67 (6,095 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 366,199 classified reports for ERGOCALCIFEROL:
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.
Ergocalciferol may interact with other medications affecting calcium and vitamin D metabolism, and patients should be monitored for potential drug interactions and side effects.
If you are taking Ergocalciferol, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, headache, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should take ergocalciferol as prescribed and report any new or worsening symptoms to their healthcare provider. Regular monitoring of blood levels of calcium and vitamin D is recommended to prevent adverse 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 closely monitors ergocalciferol reports, and any new or severe reactions should be reported to healthcare providers immediately.
The FDA has received approximately 901,191 adverse event reports associated with Ergocalciferol. 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 Ergocalciferol include Fatigue, Nausea, Diarrhoea, Headache, Drug Ineffective. By volume, the top reported reactions are: Fatigue (36,306 reports), Nausea (27,028 reports), Diarrhoea (25,827 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ergocalciferol.
Out of 366,199 classified reports, 214,874 (58.7%) were classified as serious and 151,325 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 Ergocalciferol break down by patient sex as follows: Female: 246,143, Male: 101,063, Unknown: 196. 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 Ergocalciferol adverse events are: age 65: 6,777 reports, age 64: 6,102 reports, age 67: 6,095 reports, age 63: 6,092 reports, age 70: 5,938 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 Ergocalciferol adverse event reports is Strides Pharma Science Limited. 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 Ergocalciferol include: Pain, Off Label Use, Dyspnoea, Arthralgia, Dizziness. 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 Ergocalciferol 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.
Ergocalciferol 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 are gastrointestinal issues such as fatigue, nausea, and diarrhea, indicating potential digestive side effects.
Key safety signals identified in Ergocalciferol's adverse event data include: Frequent reports of gastrointestinal issues (fatigue, nausea, diarrhea) and respiratory symptoms (dyspnea, pneumonia) indicate a high risk of these side effects.. A significant number of serious reactions, including death and pneumonia, suggest potential severe health risks.. The high volume of reports and diverse range of reactions indicate a need for careful monitoring and management.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ergocalciferol may interact with other medications affecting calcium and vitamin D metabolism, and patients should be monitored for potential drug interactions and side effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ergocalciferol.
Patients should take ergocalciferol as prescribed and report any new or worsening symptoms to their healthcare provider. Regular monitoring of blood levels of calcium and vitamin D is recommended to prevent adverse effects.
Ergocalciferol has 901,191 adverse event reports on file with the FDA. Respiratory symptoms like dyspnea and pneumonia are also frequently reported, suggesting possible respiratory adverse effects. The volume of reports for Ergocalciferol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors ergocalciferol reports, and any new or severe reactions should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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