45/100 · Moderate
Manufactured by Ascend Laboratories, LLC
Rosuvastatin Calcium Adverse Events: Common Mild Reactions, Serious Events Less Frequent
80,562 FDA adverse event reports analyzed
Last updated: 2026-05-12
ROSUVASTATIN CALCIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ascend Laboratories, LLC. Based on analysis of 80,562 FDA adverse event reports, ROSUVASTATIN CALCIUM has a safety score of 45 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 ROSUVASTATIN CALCIUM include DYSPNOEA, FATIGUE, DRUG INEFFECTIVE, PAIN, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROSUVASTATIN CALCIUM.
Rosuvastatin Calcium has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 80,562 adverse event reports for this medication, which is primarily manufactured by Ascend Laboratories, Llc.
The most commonly reported adverse events include Dyspnoea, Fatigue, Drug Ineffective. Of classified reports, 74.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most common reactions include dyspnea, fatigue, and pain, which are generally mild to moderate in severity.
Serious adverse events, such as pneumonia and asthma, occur less frequently but are still notable. Drug interactions and falls are reported, indicating potential risks that should be monitored. The majority of reactions are non-serious, with a serious event rate of 74% of all outcomes. Age distribution shows a higher number of reports in older adults, suggesting potential age-related risks.
Patients taking Rosuvastatin Calcium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Rosuvastatin calcium may cause drug interactions and falls, so patients should be monitored for these risks. Patients should avoid driving or operating heavy machinery if experiencing dizziness or fatigue. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Rosuvastatin Calcium received a safety concern score of 45/100 (moderate concern). This is based on a 74.0% serious event ratio across 25,338 classified reports. The score accounts for 80,562 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 12,604, Male: 10,115, Unknown: 11. The most frequently reported age groups are age 65 (845 reports), age 77 (746 reports), age 72 (657 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 25,338 classified reports for ROSUVASTATIN 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.
Rosuvastatin calcium may cause drug interactions and falls, so patients should be monitored for these risks. Patients should avoid driving or operating heavy machinery if experiencing dizziness or fatigue.
If you are taking Rosuvastatin Calcium, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, drug ineffective, pain, cough. 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 respiratory issues, such as dyspnea and asthma, especially in older adults. Be cautious of potential drug interactions and falls, particularly 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.
The FDA continues to monitor the safety of rosuvastatin calcium and has not issued any specific warnings or changes to the drug label based on this data.
The FDA has received approximately 80,562 adverse event reports associated with Rosuvastatin 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 Rosuvastatin Calcium include Dyspnoea, Fatigue, Drug Ineffective, Pain, Cough. By volume, the top reported reactions are: Dyspnoea (2,494 reports), Fatigue (2,455 reports), Drug Ineffective (2,331 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 Calcium.
Out of 25,338 classified reports, 18,754 (74.0%) were classified as serious and 6,584 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 Calcium break down by patient sex as follows: Female: 12,604, Male: 10,115, Unknown: 11. 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 Calcium adverse events are: age 65: 845 reports, age 77: 746 reports, age 72: 657 reports, age 70: 591 reports, age 66: 576 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 Calcium adverse event reports is Ascend Laboratories, Llc. 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 Calcium include: Headache, Nausea, Pneumonia, Arthralgia, Diarrhoea. 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 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.
Rosuvastatin Calcium has a safety concern score of 45 out of 100 (moderate 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. Most common reactions include dyspnea, fatigue, and pain, which are generally mild to moderate in severity.
Key safety signals identified in Rosuvastatin Calcium's adverse event data include: Pneumonia and asthma are key safety signals, indicating potential respiratory issues.. Falls and drug interactions are significant safety signals, highlighting the need for careful monitoring.. Serious adverse events like death and acute kidney injury are reported, though less frequently.. Drug hypersensitivity and rash are also notable safety signals, indicating potential allergic reactions.. Cognitive disorders and depression are reported, suggesting potential neurological effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Rosuvastatin calcium may cause drug interactions and falls, so patients should be monitored for these risks. Patients should avoid driving or operating heavy machinery if experiencing dizziness or fatigue. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Rosuvastatin Calcium.
Monitor for signs of respiratory issues, such as dyspnea and asthma, especially in older adults. Be cautious of potential drug interactions and falls, particularly in elderly patients.
Rosuvastatin Calcium has 80,562 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and asthma, occur less frequently but are still notable. The volume of reports for Rosuvastatin Calcium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of rosuvastatin calcium and has not issued any specific warnings or changes to the drug label based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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