Post marketing new adverse effects of oral therapies in multiple sclerosis: A systematic review

Mult Scler Relat Disord. 2022 Dec:68:104157. doi: 10.1016/j.msard.2022.104157. Epub 2022 Sep 6.


Background: There is a lack of safety information about the post-marketing adverse effects of several disease-modifying drugs (DMDs) used to control multiple sclerosis (MS). Investigating the post-marketing side effects is required to manifest the safety of the appropriate therapy. Therefore, the present systematic review aimed to identify disease-modifying drugs used to control multiple sclerosis attacks and progress.

Methods: The Web of Science, PubMed, and Scopus databases were searched for studies published until November 2020 based on the research strategy terms. Inclusion criteria involved all full texts exploring disease-modifying drugs used to control multiple sclerosis based on case reports and case series studies. The Joanna Briggs Institute (JBI) critical appraisal checklist was used to assess the quality of case report studies.

Results: In total, 25 articles that met the criteria for inclusion were retrieved in the present systematic review. The most side effects were observed with fingolimod and teriflunomide, respectively, while dimethyl fumarate had minor side effects.

Conclusion: The oral therapies have some significant post-marketing adverse effects that have been diagnosed in numerous case reports. Some of them are serious and must be noticed by neurologists. Accordingly, in this review, we assessed the post-marketing adverse effects of oral therapies for multiple sclerosis.

Keywords: Disease-modifying drugs; Multiple sclerosis; Oral medications.

Publication types

  • Systematic Review
  • Case Reports
  • Review

MeSH terms

  • Dimethyl Fumarate / therapeutic use
  • Drug-Related Side Effects and Adverse Reactions* / drug therapy
  • Fingolimod Hydrochloride / adverse effects
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Multiple Sclerosis* / chemically induced
  • Multiple Sclerosis* / drug therapy
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy


  • Immunosuppressive Agents
  • Dimethyl Fumarate
  • Fingolimod Hydrochloride