Table 1.

Adverse drug reactions (ADRs) after montelukast reported to the Netherlands Pharmacovigilance Center Lareb and deemed serious, for example, leading to death, hospitalisation, or life threatening condition

Adverse drug reaction	Comments	Relation with montelukast according to the Naranjo score (Naranjo et al. 1981)
Death	20‐year‐old woman with pulmonary embolism Woman of unknown age with renal failure.
Allergic granulomatous angiitis
Angioedema	4‐year‐old girl with concomitant use of pulmicort and foradil. Patient was treated with tavergil and prednisone. Montelukast was discontinued. Angioedema disappeared.	Possible
Malaise	45‐year‐old woman with concomitant use of 8 other medicines. Montelukast was discontinued and she recovered.	Possible
Epilepsy	9‐year‐old boy with no concomitant use of other medicines. Montelukast was discontinued and he recovered.	Possible
Chest pain	Man of unknown age with concomitant use of seretide. Montelukast was discontinued and he recovered.	Possible
Hallucination	13‐year‐old boy with no concomitant use of medicines. Montelukast was discontinued and he recovered.	Possible
Myalgia	47‐year‐old man with concomitant use of 5 other medicines. Montelukast was discontinued and he recovered.	Possible
Eosinophilia	66‐year‐old woman with concomitant use of seretide. Montelukast was discontinued and she recovered slowly.	Probable
Nightmare/somnambulism	72‐year‐old woman with concomitant use of 9 other medicines. Montelukast was discontinued and she recovered.	Probable
Chest discomfort	Woman of unknown age with concomitant use of 5 other medicines. Further information unknown Woman of unknown age with concomitant use of 3 other medicines. Further information unknown.	Possible Possible
Anaphylactic reaction	13‐year‐old boy with concomitant use of 4 other medicines. Montelukast was discontinued and he recovered.	Probable