Interstitial pneumonia and other adverse events in riluzole-administered amyotrophic lateral sclerosis patients: a retrospective observational study

BMC Neurol. 2019 Apr 27;19(1):72. doi: 10.1186/s12883-019-1299-1.


Background: Riluzole is the only approved oral drug for amyotrophic lateral sclerosis (ALS). We performed a retrospective study including ALS patients treated with riluzole, focusing on adverse events.

Methods: Patients diagnosed with ALS according to the revised El Escorial criteria (World Federation of Neurology) in our center and who were administered 50 mg oral riluzole twice daily between January 2011 and September 2017 and followed up for at least 6 months from treatment initiation or until death were included. Data regarding sex, age, disease type, initial symptoms, biochemical analyses performed before and after riluzole administration, and medical history were collected. In case of withdrawal, cause of discontinuation and durations of disease and drug administration were recorded.

Results: A total of 92 cases were enrolled. Riluzole administration was discontinued in 20 cases (21.7%). The most frequent reason for discontinuation was elevated liver enzymes (n = 5, 5.4%), followed interstitial pneumonia (IP), nausea and appetite loss, dizziness, general malaise, tongue paresthesia, and urinary urgency. In two cases, administration was discontinued primarily because of progression of bulbar palsy. All adverse events occurred within 6 months from treatment initiation and improved soon after its discontinuation. Three IP cases developed severe respiratory failure and required steroid treatment.

Conclusion: Riluzole administration was discontinued in 20 cases among total of 92 cases. Careful follow-up is important for the first six months after the initiation of riluzole administration, including through interviews, chemical analyses, and chest X-rays, as required.

Keywords: Adverse events; Amyotrophic lateral sclerosis; Interstitial pneumonia; Liver dysfunction; Riluzole; Side-effect.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Amyotrophic Lateral Sclerosis / drug therapy*
  • Chemical and Drug Induced Liver Injury / epidemiology
  • Chemical and Drug Induced Liver Injury / etiology
  • Disease Progression
  • Female
  • Humans
  • Lung Diseases, Interstitial / chemically induced
  • Lung Diseases, Interstitial / epidemiology
  • Male
  • Middle Aged
  • Neuroprotective Agents / adverse effects*
  • Retrospective Studies
  • Riluzole / adverse effects*


  • Neuroprotective Agents
  • Riluzole