78/100 · Elevated
Manufactured by Viatris Specialty LLC
Gabapentin Adverse Events: High Seriousness and Diverse Reactions
710,782 FDA adverse event reports analyzed
Last updated: 2026-05-12
GABAPENTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 710,782 FDA adverse event reports, GABAPENTIN 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 GABAPENTIN include DRUG INEFFECTIVE, FATIGUE, NAUSEA, PAIN, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GABAPENTIN.
Gabapentin 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 710,782 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 63.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a significant portion related to respiratory and neurological issues.
A wide variety of reactions are reported, indicating a complex safety profile. The most common reactions include fatigue, nausea, and pain, which are frequently reported.
Patients taking Gabapentin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Gabapentin can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and the risk of respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Gabapentin received a safety concern score of 78/100 (high concern). This is based on a 63.3% serious event ratio across 351,586 classified reports. The score accounts for 710,782 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: 210,598, Male: 113,456, Unknown: 759. The most frequently reported age groups are age 60 (5,881 reports), age 61 (5,866 reports), age 58 (5,738 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 351,586 classified reports for GABAPENTIN:
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.
Gabapentin can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and the risk of respiratory issues.
If you are taking Gabapentin, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, pain, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the medication without medical advice. 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.
Gabapentin is subject to strict monitoring by the FDA due to its high number of serious adverse events. Healthcare providers should be vigilant about patient monitoring and management.
The FDA has received approximately 710,782 adverse event reports associated with Gabapentin. 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 Gabapentin include Drug Ineffective, Fatigue, Nausea, Pain, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (28,916 reports), Fatigue (24,398 reports), Nausea (21,942 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Gabapentin.
Out of 351,586 classified reports, 222,645 (63.3%) were classified as serious and 128,941 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 Gabapentin break down by patient sex as follows: Female: 210,598, Male: 113,456, Unknown: 759. 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 Gabapentin adverse events are: age 60: 5,881 reports, age 61: 5,866 reports, age 58: 5,738 reports, age 62: 5,649 reports, age 65: 5,596 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 Gabapentin 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 Gabapentin include: Diarrhoea, Headache, Dizziness, Fall, Dyspnoea. 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 Gabapentin 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.
Gabapentin 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. The majority of adverse events are serious, with a significant portion related to respiratory and neurological issues.
Key safety signals identified in Gabapentin's adverse event data include: High number of serious adverse events (222,645 out of 351,586, or 63.3%).. Multiple neurological and respiratory issues are frequently reported, including falls, dyspnea, and pneumonia.. Drug ineffectiveness and overuse are also significant concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Gabapentin can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and the risk of respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Gabapentin.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the medication without medical advice.
Gabapentin has 710,782 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating a complex safety profile. The volume of reports for Gabapentin reflects both the drug's usage level and the vigilance of the reporting community.
Gabapentin is subject to strict monitoring by the FDA due to its high number of serious adverse events. Healthcare providers should be vigilant about patient monitoring and management. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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