82/100 · Critical
Manufactured by AstraZeneca Pharmaceuticals LP
Rosuvastatin Adverse Events: High Seriousness and Diverse Reactions
362,440 FDA adverse event reports analyzed
Last updated: 2026-05-12
ROSUVASTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 362,440 FDA adverse event reports, ROSUVASTATIN has a safety score of 82 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 ROSUVASTATIN include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DYSPNOEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROSUVASTATIN.
Rosuvastatin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 362,440 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 67.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Rosuvastatin reports show a high percentage of serious adverse events, particularly related to muscle and kidney issues.
The most common reactions include fatigue, nausea, and muscle pain, indicating a broad range of potential side effects. Serious reactions such as acute kidney injury, rhabdomyolysis, and myocardial infarction are notable concerns.
Patients taking Rosuvastatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Rosuvastatin can cause drug interactions, particularly with other statins and certain antibiotics, leading to increased risk of muscle toxicity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Rosuvastatin received a safety concern score of 82/100 (high concern). This is based on a 67.7% serious event ratio across 194,670 classified reports. The score accounts for 362,440 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 95,340, Male: 85,364, Unknown: 754. The most frequently reported age groups are age 65 (4,976 reports), age 72 (4,369 reports), age 70 (4,357 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 194,670 classified reports for ROSUVASTATIN:
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.
Rosuvastatin can cause drug interactions, particularly with other statins and certain antibiotics, leading to increased risk of muscle toxicity.
If you are taking Rosuvastatin, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, dyspnoea, 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 symptoms like pain, weakness, or dark urine, which could indicate rhabdomyolysis. Regularly check liver function and kidney function, especially in elderly patients. 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 Rosuvastatin for safety, with ongoing reviews of its cardiovascular benefits versus risks.
The FDA has received approximately 362,440 adverse event reports associated with Rosuvastatin. 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 Rosuvastatin include Fatigue, Nausea, Drug Ineffective, Dyspnoea, Diarrhoea. By volume, the top reported reactions are: Fatigue (11,695 reports), Nausea (10,037 reports), Drug Ineffective (9,220 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Rosuvastatin.
Out of 194,670 classified reports, 131,877 (67.7%) were classified as serious and 62,793 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 Rosuvastatin break down by patient sex as follows: Female: 95,340, Male: 85,364, Unknown: 754. 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 Rosuvastatin adverse events are: age 65: 4,976 reports, age 72: 4,369 reports, age 70: 4,357 reports, age 68: 4,300 reports, age 71: 4,214 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 Rosuvastatin adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Rosuvastatin include: Myalgia, Off Label Use, Pain, Headache, 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 Rosuvastatin 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.
Rosuvastatin has a safety concern score of 82 out of 100 (high 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. Rosuvastatin reports show a high percentage of serious adverse events, particularly related to muscle and kidney issues.
Key safety signals identified in Rosuvastatin's adverse event data include: Acute kidney injury and rhabdomyolysis are key safety signals, indicating potential severe renal and muscle toxicity.. Myocardial infarction and hypertension are also significant, suggesting cardiovascular risks.. Death and chronic kidney disease are critical signals, highlighting the severity of adverse outcomes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Rosuvastatin can cause drug interactions, particularly with other statins and certain antibiotics, leading to increased risk of muscle toxicity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Rosuvastatin.
Monitor for muscle symptoms like pain, weakness, or dark urine, which could indicate rhabdomyolysis. Regularly check liver function and kidney function, especially in elderly patients.
Rosuvastatin has 362,440 adverse event reports on file with the FDA. The most common reactions include fatigue, nausea, and muscle pain, indicating a broad range of potential side effects. The volume of reports for Rosuvastatin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies continue to monitor Rosuvastatin for safety, with ongoing reviews of its cardiovascular benefits versus risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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