ArticleDrug safety2013
Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Traditional Chinese medicine for diabetic peripheral neuropathy: a network meta-analysis.Frontiers in endocrinology · 2025Pooled it
- Perioperative Breast Analgesia: a Systematic Review of the Evidence for Perioperative Analgesic Medications.Current pain and headache reports · 2022Pooled it
- Possible Signals of Ocular Disorders Associated with Gabapentinoids: A Three-Arm Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Nanocomposite hydrogel acupoint therapy for sustained pregabalin delivery and long-term neuropathic pain relief.Materials today. Bio · 2026Article
- Comparative safety and health service utilization for gabapentin versus non-steroidal anti-inflammatory drugs for cervical radiculopathy: A retrospective cohort study of academic centers.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2026Article
- Article
- Drug-induced herpes zoster: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024.Frontiers in pharmacology · 2025Article
- Gabapentinoids-Related Delirium Adverse Events: A Real-World Study from 2004 to 2022 Based on FAERS.Journal of pain research · 2024Article
- The association between Gabapentin or Pregabalin use and the risk of dementia: an analysis of the National Health Insurance Research Database in Taiwan.Frontiers in pharmacology · 2023Article
- Signal Detection of Pediatric Drug-Induced Coagulopathy Using Routine Electronic Health Records.Frontiers in pharmacology · 2022Article
- Did you choose appropriate mouthwash for managing chemoradiotherapy-induced oral mucositis? The therapeutic effect compared by a Bayesian network meta-analysis.Frontiers in oral health · 2022Review
- A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring.Clinical pharmacology and therapeutics · 2021Review
- Mirogabalin-A Novel Selective Ligand for the α2δ Calcium Channel Subunit.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Gabapentinoid Abuse in France: Evidence on Health Consequences and New Points of Vigilance.Frontiers in psychiatry · 2021Article
- Respiratory concerns of gabapentin and pregabalin: What does it mean to the pharmacovigilance systems in developing countries?F1000Research · 2020Article
- Patterns of gabapentin and pregabalin use and misuse: Results of a population-based cohort study in France.British journal of clinical pharmacology · 2019Observational
- Gabapentin and Pregabalin and Risk of Atrial Fibrillation in the Elderly: A Population-Based Cohort Study in an Electronic Prescription Database.Drug safety · 2018Article
- Induction of hemangiosarcoma in mice after chronic treatment with S1P-modulator siponimod and its lack of relevance to rat and human.Archives of toxicology · 2018Article
- Serum apolipoprotein A1 and haptoglobin, in patients with suspected drug-induced liver injury (DILI) as biomarkers of recovery.PloS one · 2017Article
- Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database.Clinical drug investigation · 2016Article
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
No grant is acknowledged in the PubMed record.
Abstract
backgroundGabapentin and pregabalin are widely used as antineuropathic pain drugs. Their use is also associated with the development of adverse drug reactions (ADRs), mainly neuropsychiatric.
objectiveThe aim of this work was to study 'serious' and/or 'unexpected' adverse reactions associated with pregabalin and gabapentin. STUDY
designWe studied ADRs reported to the French Pharmacovigilance System occurring between 1995 and 2009.
main outcome measureFor each ADR associated with gabapentin or pregabalin, we noted year, patient age and sex, type of adverse reaction, as well as the imputability score. Reporting rate of serious ADRs for gabapentin and pregabalin was estimated with regard to data of use (obtained from the French National Health Insurance Fund) using the defined daily dose. A global and descriptive analysis of the adverse reactions for each drug is presented. Secondly, details of deaths and ADRs with an imputability score of at least 'probable' or 'likely' were presented.
resultsOverall, 1333 cases were recorded (725 related to gabapentin, 608 related to pregabalin), mainly neuropsychiatric ADRs. Among the 22 deaths recorded, 8 were related to gabapentin in obstetrical situations. Other less well-documented ADRs were identified, such as hepatitis associated with gabapentin and haematological ADRs associated with pregabalin.
conclusionThis study confirmed the prevalence of neuropsychiatric ADRs associated with gabapentin or pregabalin. A high rate of death occurred with gabapentin in an obstetrical context. New adverse reactions have been noted, such as haematological or hepatic adverse reactions associated with pregabalin and gabapentin, respectively.
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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.