72/100 · Elevated
Manufactured by Parke-Davis Div of Pfizer Inc
Atorvastatin Calcium Reports Show High Incidence of Muscle and Gastrointestinal Issues
446,126 FDA adverse event reports analyzed
Last updated: 2026-05-12
ATORVASTATIN CALCIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Parke-Davis Div of Pfizer Inc. Based on analysis of 446,126 FDA adverse event reports, ATORVASTATIN CALCIUM 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 include FATIGUE, DRUG INEFFECTIVE, NAUSEA, TYPE 2 DIABETES MELLITUS, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATORVASTATIN CALCIUM.
Atorvastatin Calcium 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 446,126 adverse event reports for this medication, which is primarily manufactured by Parke-Davis Div Of Pfizer Inc.
The most commonly reported adverse events include Fatigue, Drug Ineffective, Nausea. Of classified reports, 65.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Muscle-related issues such as myalgia and rhabdomyolysis are common, with a high incidence of serious adverse events.
Gastrointestinal symptoms like nausea and diarrhea are frequently reported, with a significant number of serious cases. There is a notable increase in serious cardiovascular events, including myocardial infarction and stroke.
Patients taking Atorvastatin Calcium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Atorvastatin calcium can cause muscle-related issues such as myalgia and rhabdomyolysis, and there are warnings about potential drug interactions, particularly with other lipid-lowering agents. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Atorvastatin Calcium received a safety concern score of 72/100 (elevated concern). This is based on a 65.3% serious event ratio across 240,066 classified reports. The score accounts for 446,126 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: 121,278, Male: 102,563, Unknown: 2,299. The most frequently reported age groups are age 65 (4,790 reports), age 70 (4,707 reports), age 71 (4,548 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 240,066 classified reports for ATORVASTATIN CALCIUM:
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 calcium can cause muscle-related issues such as myalgia and rhabdomyolysis, and there are warnings about potential drug interactions, particularly with other lipid-lowering agents.
If you are taking Atorvastatin Calcium, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, nausea, type 2 diabetes mellitus, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for muscle-related symptoms such as pain, weakness, or dark urine, which could indicate rhabdomyolysis. Be cautious with concurrent use of other lipid-lowering drugs and report any adverse events to healthcare providers promptly. 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 the safety of atorvastatin calcium and has issued warnings about potential serious adverse events, particularly in patients with pre-existing conditions.
The FDA has received approximately 446,126 adverse event reports associated with Atorvastatin Calcium. 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 include Fatigue, Drug Ineffective, Nausea, Type 2 Diabetes Mellitus, Diarrhoea. By volume, the top reported reactions are: Fatigue (13,812 reports), Drug Ineffective (12,859 reports), Nausea (12,420 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.
Out of 240,066 classified reports, 156,655 (65.3%) were classified as serious and 83,411 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 break down by patient sex as follows: Female: 121,278, Male: 102,563, Unknown: 2,299. 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 adverse events are: age 65: 4,790 reports, age 70: 4,707 reports, age 71: 4,548 reports, age 68: 4,510 reports, age 69: 4,497 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 adverse event reports is Parke-Davis Div Of Pfizer 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 include: Dyspnoea, Pain, Myalgia, Dizziness, Headache. 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 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 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. Muscle-related issues such as myalgia and rhabdomyolysis are common, with a high incidence of serious adverse events.
Key safety signals identified in Atorvastatin Calcium's adverse event data include: High incidence of myalgia and rhabdomyolysis, with 9,800 and 2,201 reports respectively.. Serious cardiovascular events, including myocardial infarction and stroke, are frequently reported.. A significant number of serious gastrointestinal issues, including nausea and diarrhea, with 9,649 and 11,035 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Atorvastatin calcium can cause muscle-related issues such as myalgia and rhabdomyolysis, and there are warnings about potential drug interactions, particularly with other lipid-lowering agents. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Atorvastatin Calcium.
Monitor for muscle-related symptoms such as pain, weakness, or dark urine, which could indicate rhabdomyolysis. Be cautious with concurrent use of other lipid-lowering drugs and report any adverse events to healthcare providers promptly.
Atorvastatin Calcium has 446,126 adverse event reports on file with the FDA. Gastrointestinal symptoms like nausea and diarrhea are frequently reported, with a significant number of serious cases. The volume of reports for Atorvastatin Calcium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of atorvastatin calcium and has issued warnings about potential serious adverse events, particularly in patients with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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