65/100 · Elevated
Manufactured by BluePoint Laboratories
Moderate Safety Concerns with Lovastatin
47,586 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOVASTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BluePoint Laboratories. Based on analysis of 47,586 FDA adverse event reports, LOVASTATIN 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 LOVASTATIN include DRUG INEFFECTIVE, FATIGUE, NAUSEA, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOVASTATIN.
Lovastatin 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 47,586 adverse event reports for this medication, which is primarily manufactured by Bluepoint Laboratories.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 56.8% 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 pain, indicating potential gastrointestinal and musculoskeletal side effects.
Serious adverse events, such as death and renal failure, account for a significant portion of reports, highlighting the need for careful monitoring. Drug interactions and dose-related issues are reported, suggesting potential risks when combined with other medications. Age distribution shows a higher incidence of adverse events in older adults, particularly those over 70 years old.
Patients taking Lovastatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lovastatin can interact with other drugs, and patients should be cautious about potential side effects, especially when the drug dose is altered. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lovastatin received a safety concern score of 65/100 (elevated concern). This is based on a 56.8% serious event ratio across 25,238 classified reports. The score accounts for 47,586 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: 13,990, Male: 10,057, Unknown: 27. The most frequently reported age groups are age 76 (550 reports), age 69 (516 reports), age 70 (511 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 25,238 classified reports for LOVASTATIN:
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.
Lovastatin can interact with other drugs, and patients should be cautious about potential side effects, especially when the drug dose is altered.
If you are taking Lovastatin, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, diarrhoea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of muscle pain, weakness, or cramps, which could indicate a serious condition like rhabdomyolysis. Report any unusual symptoms to your healthcare provider promptly, especially if they are severe or persistent. 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.
Regulatory bodies continue to monitor the safety profile of Lovastatin, with ongoing reviews to ensure patient safety.
The FDA has received approximately 47,586 adverse event reports associated with Lovastatin. 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 Lovastatin include Drug Ineffective, Fatigue, Nausea, Diarrhoea, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (1,662 reports), Fatigue (1,521 reports), Nausea (1,396 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lovastatin.
Out of 25,238 classified reports, 14,345 (56.8%) were classified as serious and 10,893 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 Lovastatin break down by patient sex as follows: Female: 13,990, Male: 10,057, Unknown: 27. 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 Lovastatin adverse events are: age 76: 550 reports, age 69: 516 reports, age 70: 511 reports, age 71: 510 reports, age 66: 493 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 Lovastatin adverse event reports is Bluepoint Laboratories. 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 Lovastatin include: Dizziness, Pain, Headache, Asthenia, Fall. 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 Lovastatin 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.
Lovastatin 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. The most common reactions include fatigue, nausea, and pain, indicating potential gastrointestinal and musculoskeletal side effects.
Key safety signals identified in Lovastatin's adverse event data include: Death and renal failure are among the most serious adverse events reported.. Drug interactions and dose-related issues are frequent, indicating potential risks when combined with other medications.. Gastrointestinal and musculoskeletal symptoms are commonly reported, affecting quality of life.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lovastatin can interact with other drugs, and patients should be cautious about potential side effects, especially when the drug dose is altered. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lovastatin.
Monitor for signs of muscle pain, weakness, or cramps, which could indicate a serious condition like rhabdomyolysis. Report any unusual symptoms to your healthcare provider promptly, especially if they are severe or persistent.
Lovastatin has 47,586 adverse event reports on file with the FDA. Serious adverse events, such as death and renal failure, account for a significant portion of reports, highlighting the need for careful monitoring. The volume of reports for Lovastatin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies continue to monitor the safety profile of Lovastatin, with ongoing reviews to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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