65/100 · Elevated
Manufactured by Accord Healthcare Inc.
Moderate Safety Concerns with Pravastatin Sodium: Common Gastrointestinal and Musculoskeletal Issues
35,900 FDA adverse event reports analyzed
Last updated: 2026-05-12
PRAVASTATIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 35,900 FDA adverse event reports, PRAVASTATIN SODIUM 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 PRAVASTATIN SODIUM include FATIGUE, DIARRHOEA, NAUSEA, DYSPNOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PRAVASTATIN SODIUM.
Pravastatin Sodium 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 35,900 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 68.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues such as fatigue, diarrhea, and nausea are commonly reported.
Musculoskeletal symptoms like myalgia and arthralgia are frequently observed. Serious adverse events, including death and acute kidney injury, are reported but less frequent. Drug interactions and off-label use are significant safety signals. The majority of reactions are non-serious, but the diversity of reactions is notable.
Patients taking Pravastatin Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pravastatin sodium may interact with other drugs, and its use in unapproved indications is a safety concern. Patients should be monitored for potential drug interactions and adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pravastatin Sodium received a safety concern score of 65/100 (elevated concern). This is based on a 68.0% serious event ratio across 18,922 classified reports. The score accounts for 35,900 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: 10,007, Male: 7,653, Unknown: 22. The most frequently reported age groups are age 73 (421 reports), age 70 (411 reports), age 76 (411 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 18,922 classified reports for PRAVASTATIN SODIUM:
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.
Pravastatin sodium may interact with other drugs, and its use in unapproved indications is a safety concern. Patients should be monitored for potential drug interactions and adverse effects.
If you are taking Pravastatin Sodium, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, dyspnoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Report any new or worsening symptoms to your healthcare provider promptly. Follow prescribed dosages and do not use the drug for unapproved indications. 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 events and managing drug interactions. Patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 35,900 adverse event reports associated with Pravastatin Sodium. 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 Pravastatin Sodium include Fatigue, Diarrhoea, Nausea, Dyspnoea, Headache. By volume, the top reported reactions are: Fatigue (1,262 reports), Diarrhoea (1,095 reports), Nausea (954 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pravastatin Sodium.
Out of 18,922 classified reports, 12,874 (68.0%) were classified as serious and 6,048 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 Pravastatin Sodium break down by patient sex as follows: Female: 10,007, Male: 7,653, Unknown: 22. 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 Pravastatin Sodium adverse events are: age 73: 421 reports, age 70: 411 reports, age 76: 411 reports, age 72: 404 reports, age 74: 399 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 Pravastatin Sodium 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 Pravastatin Sodium include: Fall, Drug Ineffective, Dizziness, Asthenia, Arthralgia. 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 Pravastatin Sodium 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.
Pravastatin Sodium 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. Gastrointestinal issues such as fatigue, diarrhea, and nausea are commonly reported.
Key safety signals identified in Pravastatin Sodium's adverse event data include: Frequent gastrointestinal issues (fatigue, diarrhea, nausea). Common musculoskeletal symptoms (myalgia, arthralgia). Serious events like death and acute kidney injury. High number of drug interactions and off-label use reports. Diverse range of reactions including neurological and cardiovascular issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pravastatin sodium may interact with other drugs, and its use in unapproved indications is a safety concern. Patients should be monitored for potential drug interactions and adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pravastatin Sodium.
Report any new or worsening symptoms to your healthcare provider promptly. Follow prescribed dosages and do not use the drug for unapproved indications.
Pravastatin Sodium has 35,900 adverse event reports on file with the FDA. Musculoskeletal symptoms like myalgia and arthralgia are frequently observed. The volume of reports for Pravastatin Sodium reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious events and managing drug interactions. Patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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