ArticleDrug and alcohol dependence2020
Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system.
Article in Drug and alcohol dependence, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 46 citations in OpenAlex.
- Safety signals for drug-related respiratory depression: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS).Journal of thoracic disease · 2026Article
- Possible Signals of Ocular Disorders Associated with Gabapentinoids: A Three-Arm Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- A hospital-based multi-centric observational study to explore the prevalence and correlates of non-medical use and dependence of pregabalin among the patients with substance use disorder in Punjab & Chandigarh.Substance abuse treatment, prevention, and policy · 2026Observational
- Pregabalin dependence, withdrawal, suicidality and psychosis reports: A disproportionality analysis of the Australian adverse events database.British journal of clinical pharmacology · 2026Article
- A comprehensive analysis of jurisdiction-specific laws related to scheduling or required prescription drug monitoring of gabapentin in the United States, 2016-2024.The International journal on drug policy · 2026Article
- Age-stratified signals and early onset of adverse events with pregabalin: a disproportionality analysis of the FDA adverse event reporting system.Frontiers in medicine · 2026Article
- Psychiatric and behavioural side effects of antiseizure medications in epilepsy.Journal of neurology · 2025Review
- Changing Trends in Nonmedical Gabapentin Use Among a Cohort of Rural Appalachian People Who Use Drugs: A Longitudinal Study Over the Time Period of Scheduling Changes in Kentucky.The International journal on drug policy · 2025Article
- Prescribing Patterns of Gabapentinoids in Chronic Pain Management: A Single Institution Retrospective Chart Review.Psychopharmacology bulletin · 2025Article
- Pharmacovigilance of esketamine nasal spray: an analysis of the FDA adverse event reporting system database.Frontiers in pharmacology · 2024Article
- Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis.Frontiers in pharmacology · 2024Article
- Concurrent Gabapentin and Opioid Use and Risk of Mortality in Medicare Recipients with Non-Cancer Pain.Clinical pharmacology and therapeutics · 2023Article
- Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).Pharmaceuticals (Basel, Switzerland) · 2022Article
- A Focus on Abuse/Misuse and Withdrawal Issues with Selective Serotonin Reuptake Inhibitors (SSRIs): Analysis of Both the European EMA and the US FAERS Pharmacovigilance Databases.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Dimethyl Trisulfide Diminishes Traumatic Neuropathic Pain Acting on TRPA1 Receptors in Mice.International journal of molecular sciences · 2021Article
- Editorial: Prescribing Psychotropics: Misuse, Abuse, Dependence, Withdrawal and Addiction.Frontiers in psychiatry · 2021Article
- [Pharmacotherapy of alcohol withdrawal: update and new developments].Der Nervenarzt · 2021Review
- Gabapentinoid Abuse in France: Evidence on Health Consequences and New Points of Vigilance.Frontiers in psychiatry · 2021Article
- Current Evidence on Abuse and Misuse of Gabapentinoids.Drug safety · 2020Review
- Factors Associated with Gabapentin Misuse among People Who Inject Drugs in Appalachian Kentucky.Substance use & misuse · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundAlthough there have been increasing reports of intentional gabapentin misuse, epidemiological evidence for the phenomenon is limited. The purpose of this study was to determine whether there are pharmacovigilance abuse signals for gabapentin.
methodsUsing FDA Adverse Events Reporting System reports from January 1, 2005 to December 31, 2015, we calculated pharmacovigilance signal measures (i.e., reporting odds ratio, proportional reporting ratio, information component, and empirical Bayes geometric mean) for abuse-related adverse event (AR-AE)-gabapentin pairs. Loglinear modeling assessed the frequency of concurrent reporting of abuse-related and abuse-specific AEs (AS-AEs) associated with gabapentin. Findings were compared to a positive (pregabalin) and negative (duloxetine) control.
resultsFrom 2005-2015 there were 5,951,229 unique AE reports submitted to the FDA including 99,977 for gabapentin, 73,977 for duloxetine, and 97,813 for pregabalin. Significant drug-AR-AE pair signals involving gabapentin included: drug abuser, multiple drug overdose, and substance-induced psychotic disorder. Significant drug AR-AE signals involving gabapentin and pregabalin, but not duloxetine, were: ataxia, dependence, drug abuse, increased drug tolerance, and overdose. Compared to duloxetine, gabapentin had significantly greater odds of a co-report for an AS-AE with drug withdrawal syndrome (OR: 6.55), auditory hallucinations (OR: 4.57), delusions (OR: 2.36), euphoric mood (OR: 5.45), ataxia (OR: 2.85), drug abuser (OR: 3.01), aggression (OR: 1.98), psychotic disorder (OR: 1.96), and feeling abnormal (OR: 1.31).
conclusionsWe identified abuse-related signals for gabapentin and highlighted several CNS effects that may be associated with its abuse. Gabapentin prescribers should be aware of the drug's abuse liability and effects that may accompany its use.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.