78/100 · Elevated
Manufactured by Viatris Specialty LLC
Pregabalin Adverse Events: High Seriousness and Diverse Reactions
592,151 FDA adverse event reports analyzed
Last updated: 2026-05-12
PREGABALIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 592,151 FDA adverse event reports, PREGABALIN has a safety score of 78 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 PREGABALIN include DRUG INEFFECTIVE, PAIN, FATIGUE, DIZZINESS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PREGABALIN.
Pregabalin has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 592,151 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 66.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pregabalin reports show a high percentage of serious adverse events (66.5%).
The most common reactions include pain, fatigue, and dizziness, indicating a broad range of potential side effects. Weight changes and falls are notable among the adverse events reported.
Patients taking Pregabalin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pregabalin can cause drug interactions, and patients should be aware of potential interactions with other medications. Warnings are issued for off-label use and misuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pregabalin received a safety concern score of 78/100 (high concern). This is based on a 66.5% serious event ratio across 264,046 classified reports. The score accounts for 592,151 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: 158,866, Male: 82,329, Unknown: 1,709. The most frequently reported age groups are age 60 (4,612 reports), age 64 (4,212 reports), age 65 (4,212 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 264,046 classified reports for PREGABALIN:
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.
Pregabalin can cause drug interactions, and patients should be aware of potential interactions with other medications. Warnings are issued for off-label use and misuse.
If you are taking Pregabalin, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, dizziness, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or stopping Pregabalin to discuss potential risks and benefits. Report any adverse reactions to the FDA's MedWatch program for ongoing safety monitoring. 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 Pregabalin's safety profile, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 592,151 adverse event reports associated with Pregabalin. 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 Pregabalin include Drug Ineffective, Pain, Fatigue, Dizziness, Nausea. By volume, the top reported reactions are: Drug Ineffective (26,495 reports), Pain (25,901 reports), Fatigue (15,112 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pregabalin.
Out of 264,046 classified reports, 175,530 (66.5%) were classified as serious and 88,516 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 Pregabalin break down by patient sex as follows: Female: 158,866, Male: 82,329, Unknown: 1,709. 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 Pregabalin adverse events are: age 60: 4,612 reports, age 64: 4,212 reports, age 65: 4,212 reports, age 59: 4,209 reports, age 58: 4,181 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 Pregabalin adverse event reports is Viatris Specialty 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 Pregabalin include: Off Label Use, Headache, Malaise, Somnolence, Weight Increased. 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 Pregabalin 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.
Pregabalin has a safety concern score of 78 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. Pregabalin reports show a high percentage of serious adverse events (66.5%).
Key safety signals identified in Pregabalin's adverse event data include: High percentage of serious adverse events (66.5%).. Diverse range of reactions, including neurological, gastrointestinal, and cardiovascular issues.. Reports of drug interactions and misuse are present.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pregabalin can cause drug interactions, and patients should be aware of potential interactions with other medications. Warnings are issued for off-label use and misuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pregabalin.
Consult healthcare providers before starting or stopping Pregabalin to discuss potential risks and benefits. Report any adverse reactions to the FDA's MedWatch program for ongoing safety monitoring.
Pregabalin has 592,151 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and dizziness, indicating a broad range of potential side effects. The volume of reports for Pregabalin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Pregabalin's safety profile, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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