65/100 · Elevated
Manufactured by Kowa Pharmaceuticals America, Inc.
Moderate Safety Concerns with Pitavastatin Calcium
22,800 FDA adverse event reports analyzed
Last updated: 2026-05-12
PITAVASTATIN CALCIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kowa Pharmaceuticals America, Inc.. Based on analysis of 22,800 FDA adverse event reports, PITAVASTATIN CALCIUM 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 PITAVASTATIN CALCIUM include MYALGIA, DIARRHOEA, FATIGUE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PITAVASTATIN CALCIUM.
Pitavastatin Calcium 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 22,800 adverse event reports for this medication, which is primarily manufactured by Kowa Pharmaceuticals America, Inc..
The most commonly reported adverse events include Myalgia, Diarrhoea, Fatigue. Of classified reports, 73.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include muscle-related issues, gastrointestinal symptoms, and fatigue.
Serious adverse events, such as myocardial infarction and renal impairment, are reported but less frequent. A wide range of reactions are reported, indicating diverse safety concerns. Report volume is substantial, with over 22,800 reports, suggesting a significant safety profile.
Patients taking Pitavastatin Calcium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pitavastatin calcium can interact with other drugs, potentially leading to increased risk of muscle-related issues and liver function abnormalities. Warnings are issued for drug interactions and the need for regular monitoring of liver function and m This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pitavastatin Calcium received a safety concern score of 65/100 (elevated concern). This is based on a 73.4% serious event ratio across 9,830 classified reports. The score accounts for 22,800 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: 4,469, Male: 3,902, Unknown: 15. The most frequently reported age groups are age 68 (254 reports), age 74 (252 reports), age 72 (247 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 9,830 classified reports for PITAVASTATIN 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.
Pitavastatin calcium can interact with other drugs, potentially leading to increased risk of muscle-related issues and liver function abnormalities. Warnings are issued for drug interactions and the need for regular monitoring of liver function and m
If you are taking Pitavastatin Calcium, here are important things to know. The most commonly reported side effects include myalgia, diarrhoea, fatigue, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Regularly monitor liver function and muscle enzymes during treatment with Pitavastatin calcium. Inform your healthcare provider about any pre-existing conditions or other medications you are taking to avoid potential drug interactions. 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 Pitavastatin calcium. Healthcare providers should be vigilant about potential serious adverse events and regularly monitor patients for signs of muscle and liver issues.
The FDA has received approximately 22,800 adverse event reports associated with Pitavastatin 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 Pitavastatin Calcium include Myalgia, Diarrhoea, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Myalgia (804 reports), Diarrhoea (615 reports), Fatigue (549 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pitavastatin Calcium.
Out of 9,830 classified reports, 7,213 (73.4%) were classified as serious and 2,617 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 Pitavastatin Calcium break down by patient sex as follows: Female: 4,469, Male: 3,902, Unknown: 15. 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 Pitavastatin Calcium adverse events are: age 68: 254 reports, age 74: 252 reports, age 72: 247 reports, age 69: 241 reports, age 70: 236 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 Pitavastatin Calcium adverse event reports is Kowa Pharmaceuticals America, 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 Pitavastatin Calcium include: Arthralgia, Dizziness, Dyspnoea, Malaise, 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 Pitavastatin 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.
Pitavastatin Calcium 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 adverse reactions include muscle-related issues, gastrointestinal symptoms, and fatigue.
Key safety signals identified in Pitavastatin Calcium's adverse event data include: Muscle-related issues like myalgia and rhabdomyolysis are frequently reported.. Gastrointestinal symptoms such as nausea and diarrhea are common.. Cardiovascular events, including myocardial infarction and hypertension, are reported.. Renal impairment and liver disorders are also noted as key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pitavastatin calcium can interact with other drugs, potentially leading to increased risk of muscle-related issues and liver function abnormalities. Warnings are issued for drug interactions and the need for regular monitoring of liver function and m Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pitavastatin Calcium.
Regularly monitor liver function and muscle enzymes during treatment with Pitavastatin calcium. Inform your healthcare provider about any pre-existing conditions or other medications you are taking to avoid potential drug interactions.
Pitavastatin Calcium has 22,800 adverse event reports on file with the FDA. Serious adverse events, such as myocardial infarction and renal impairment, are reported but less frequent. The volume of reports for Pitavastatin Calcium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Pitavastatin calcium. Healthcare providers should be vigilant about potential serious adverse events and regularly monitor patients for signs of muscle and liver issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with PITAVASTATIN CALCIUM:
Drugs related to PITAVASTATIN CALCIUM based on therapeutic use, drug class, or shared indications: