Related Experiment Video
Updated: Feb 7, 2026

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
Published on: December 26, 2015
Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System
Ippazio Cosimo Antonazzo1, Emanuel Raschi1, Emanuele Forcesi1
1a Department of Medical and Surgical Sciences , Alma Mater Studiorum, University of Bologna , Bologna , Italy.
Background:
Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs).
Research Design And Methods:
We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period. Reporting odds ratio (ROR) for MS was calculated for each single substance. Disproportionality signals were considered when at least 10 cases were retrieved with a lower limit of the 95% confidence interval (CI) >1.
Results:
After a customized data-mining process, 3,226 reports of MS were retrieved. 'Antineoplastic and immunomodulating drugs' (33% of total reports) were the most frequently reported, with 10 disproportionality signals, including etanercept (445 cases; ROR: 2.48; 95% Cl: 2.24-2.74), adalimumab (329; 2.05; 1.83-2.30), and infliximab (119; 2.25; 1.87-2.70). We also observed signals for drugs acting on hormone balance, bone density, and central nervous system.
Conclusion:
Our findings suggest that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk.
Related Concept Videos
Local Anesthetics: Adverse Effects
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
Skeletal Muscle Relaxants: Adverse Effects
Unlike...
Insulin: Dosing Regimen and Adverse Effects
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
FDA Approved Drugs: Changes to Approved Drugs
Bioequivalence of Drugs: Drugs with Multiple Indications
Allergic Drug Reactions

