title: Montelukast-induced adverse drug reactions: a review of case reports in the literature.
abstract: BACKGROUND
  Montelukast, a leucotriene receptor antagonist, binds the cysteinyl leucotriene type 1 receptor. Montelukast is commonly prescribed to asthma patients as add-on therapy to inhaled corticosteroids. Several clinical trials emphasized that montelukast can be considered a safe drug. However, recent evidence reconsidered the benefit/risk ratio of the use of montelukast for both paediatric and adult patients.
  
  
  CONCLUSIONS
  The present review analyzed the previous published case reports regarding montelukast-induced adverse drug reactions (ADRs). They included agitation, anxiety, depression, sleep disturbance, hallucinations, suicidal thinking and suicidality, tremor, dizziness, drowsiness, neuropathies and seizures. The immune system can be involved, in particular, cases of Churg-Strauss syndrome have been published. Furthermore, it can induce hypersensitivity reactions, including anaphylaxis and eosinophilic infiltration. In addition, hepatobiliary, pancreatic and uropoietic disorders have been observed. Some of these cases are characterized by severe prognosis (i.e. neurological deficit and fatal hepatotoxicity). Key Message: The use of montelukast can be burdened by several ADRs, of which physicians should be aware in their clinical practice. A better understanding of the mechanisms causing ADRs after using montelukast could help researchers and clinicians in defining a risk-reduction strategy aimed to lessen montelukast toxicity. More accurate epidemiological studies, in order to discover risk factors favouring montelukast-associated ADRs, are demanded.
authors.affiliation: School and Division of Allergology and Clinical Immunology, University of Messina, Messina, Italy.
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Calapai
authors.forename: Marco
authors.initials: M
authors.lastname: Casciaro
authors.forename: Marco
authors.initials: M
authors.lastname: Miroddi
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Calapai
authors.forename: Michele
authors.initials: M
authors.lastname: Navarra
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Gangemi
mesh_terms: D000085:Acetates / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D002648:Child; D003521:Cyclopropanes; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D011804:Quinolines / Q000009:adverse effects* / Q000627:therapeutic use; D012307:Risk Factors; D013440:Sulfides
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast