72/100 · Elevated
Manufactured by Accord Healthcare Inc.
Moderate Safety Concerns with Atorvastatin Calcium
126,371 FDA adverse event reports analyzed
Last updated: 2026-05-12
ATORVASTATIN CALCIUM, FILM COATED is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 126,371 FDA adverse event reports, ATORVASTATIN CALCIUM, FILM COATED 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 ATORVASTATIN CALCIUM, FILM COATED include FATIGUE, DRUG INEFFECTIVE, DIARRHOEA, NAUSEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATORVASTATIN CALCIUM, FILM COATED.
Atorvastatin Calcium, Film Coated 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 126,371 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Fatigue, Drug Ineffective, Diarrhoea. Of classified reports, 63.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and dizziness are the most frequently reported adverse events.
Serious adverse events, such as falls and pneumonia, are common. Drug interactions and hypersensitivity reactions are also significant concerns.
Patients taking Atorvastatin Calcium, Film Coated should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Atorvastatin can interact with other drugs, and patients should be warned about potential drug interactions and hypersensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Atorvastatin Calcium, Film Coated received a safety concern score of 72/100 (elevated concern). This is based on a 63.4% serious event ratio across 65,790 classified reports. The score accounts for 126,371 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: 31,709, Male: 29,507, Unknown: 86. The most frequently reported age groups are age 65 (1,440 reports), age 71 (1,421 reports), age 75 (1,409 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 65,790 classified reports for ATORVASTATIN CALCIUM, FILM COATED:
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.
Atorvastatin can interact with other drugs, and patients should be warned about potential drug interactions and hypersensitivity reactions.
If you are taking Atorvastatin Calcium, Film Coated, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, diarrhoea, nausea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Discuss any other medications you are taking with your healthcare provider to avoid potential drug interactions. Monitor for signs of serious adverse events such as falls, pneumonia, and muscle pain. 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 oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions.
The FDA has received approximately 126,371 adverse event reports associated with Atorvastatin Calcium, Film Coated. 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 Atorvastatin Calcium, Film Coated include Fatigue, Drug Ineffective, Diarrhoea, Nausea, Dyspnoea. By volume, the top reported reactions are: Fatigue (4,361 reports), Drug Ineffective (4,158 reports), Diarrhoea (3,794 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Atorvastatin Calcium, Film Coated.
Out of 65,790 classified reports, 41,711 (63.4%) were classified as serious and 24,079 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 Atorvastatin Calcium, Film Coated break down by patient sex as follows: Female: 31,709, Male: 29,507, Unknown: 86. 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 Atorvastatin Calcium, Film Coated adverse events are: age 65: 1,440 reports, age 71: 1,421 reports, age 75: 1,409 reports, age 70: 1,408 reports, age 66: 1,355 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 Atorvastatin Calcium, Film Coated adverse event reports is Accord Healthcare 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 Atorvastatin Calcium, Film Coated include: Headache, Dizziness, Pain, Off Label Use, 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 Atorvastatin Calcium, Film Coated 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.
Atorvastatin Calcium, Film Coated 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. Fatigue, nausea, and dizziness are the most frequently reported adverse events.
Key safety signals identified in Atorvastatin Calcium, Film Coated's adverse event data include: Falls and pneumonia are among the more serious adverse events.. Drug interactions and hypersensitivity reactions are key safety signals.. Rhabdomyolysis and myocardial infarction are rare but serious adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Atorvastatin can interact with other drugs, and patients should be warned about potential drug interactions and hypersensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Atorvastatin Calcium, Film Coated.
Discuss any other medications you are taking with your healthcare provider to avoid potential drug interactions. Monitor for signs of serious adverse events such as falls, pneumonia, and muscle pain.
Atorvastatin Calcium, Film Coated has 126,371 adverse event reports on file with the FDA. Serious adverse events, such as falls and pneumonia, are common. The volume of reports for Atorvastatin Calcium, Film Coated reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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