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This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Singulair (Montelukast). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.
Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.
All cases (402)
Cases resulting in a serious event (378)
Cases resulting in death (10)
Cases resulting in life threatening events (48)
Cases resulting in hospitalization (208)
Cases resulting in disability (45)
Cases resulting in other serious reactions (176)
Below is a sample of reports where side effects / adverse reactions may be related to Singulair (Montelukast). For a complete list and/or a specific selection of reports, please use the links in the index above.
Adverse event in 4 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: 4 year old female, weighing 27.2 kg (59.9 pounds)
Adverse reactions / side effects: Abnormal Behaviour, Anger, Aggression
Suspect drug(s):
Singulair
Indication: Asthma
Start date: 2005-08-23
End date: 2006-03-17
Singulair
Indication: Hypersensitivity
Start date: 2005-08-23
End date: 2006-03-17
Adverse event in 4 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: 4 year old female, weighing 27.2 kg (59.9 pounds)
Adverse reactions / side effects: Anger, Aggression
Suspect drug(s):
Singulair
Indication: Asthma
Start date: 2005-08-23
End date: 2006-03-17
Singulair
Indication: Hypersensitivity
Start date: 2005-08-23
End date: 2006-03-17
Adverse event in 69 year old male receiving Singulair (Montelukast)
Reported by a physician from Ireland on 2007-10-31
Patient: 69 year old male
Adverse reactions / side effects: Renal Impairment, Asthenia, Neuritis, Eosinophilia
Suspect drug(s):
Diovan
Dosage: 80 mg/d
Administration route: Oral
Indication: Hypertension
Start date: 2007-01-01
Singulair
Dosage: 10 mg/d
Administration route: Oral
Indication: Asthma
Start date: 2007-01-01
Other drugs received by patient: Symbicort; Ventolin; Amlodipine
Adverse event in 41 year old female receiving Singulair (Montelukast)
Reported by a physician from Spain on 2007-10-30
Patient: 41 year old female
Adverse reactions / side effects: OFF Label USE, Pulmonary Eosinophilia
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2000-03-01
End date: 2000-01-01
Singulair
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Singulair
Administration route: Oral
Indication: Nasal Polyps
Start date: 2000-03-01
End date: 2000-01-01
Singulair
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Other drugs received by patient: Budesonide
Adverse event in female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-30
Patient: female, weighing 16.3 kg (35.9 pounds)
Adverse reactions / side effects: Personality Change, Eyelid Oedema, Nightmare, Nausea, Stomach Discomfort, Rash, Aggression, Irritability, Pharyngeal Oedema, Anger, Pharyngolaryngeal Pain, Mood Swings, Crying
Suspect drug(s):
Singulair (Montelukast)
Adverse event in 3 year old female receiving Singulair (Montelukast)
Reported by a physician from Japan on 2007-10-30
Patient: 3 year old female, weighing 15.0 kg (33.0 pounds)
Adverse reactions / side effects: Oliguria
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Flutide; Hokunalin
Adverse event in 3 year old male receiving Singulair (Montelukast)
Reported by a physician from Japan on 2007-10-29
Patient: 3 year old male
Adverse reactions / side effects: Agitation, Convulsion in Childhood
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Ebastel
Adverse event in 2 year old male receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-29
Patient: 2 year old male
Adverse reactions / side effects: Anaphylactic Reaction
Suspect drug(s):
Allegra
Indication: Drug USE FOR Unknown Indication
Miralax
Dosage: po
Administration route: Oral
Indication: Constipation
Start date: 2006-06-01
End date: 2007-10-17
Neocate
Indication: Drug USE FOR Unknown Indication
Prevacid
Indication: Drug USE FOR Unknown Indication
Pulmicort
Indication: Drug USE FOR Unknown Indication
Singulair
Indication: Drug USE FOR Unknown Indication
Adverse event in 69 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from Ireland on 2007-10-29
Patient: 69 year old male
Adverse reactions / side effects: Renal Impairment, Asthenia, Neuritis, Eosinophilia
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2007-01-01
End date: 2007-03-01
Valsartan
Administration route: Oral
Indication: Hypertension
Start date: 2007-01-01
Other drugs received by patient: Budesonide and Formoterol Fumarate; Albuterol; Amlodipine Besylate
Adverse event in male receiving Singulair (Montelukast)
Reported by a physician from United States on 2007-10-29
Patient: male, weighing 78.0 kg (171.6 pounds)
Adverse reactions / side effects: Allergic Granulomatous Angiitis
Suspect drug(s):
Singulair (Montelukast)
Adverse event in 19 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-26
Patient: 19 year old female
Adverse reactions / side effects: Dyspnoea, Malaise
Suspect drug(s):
Advair Diskus 100 / 50
Indication: Asthma
Singulair
Indication: Asthma
Adverse event in 53 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-26
Patient: 53 year old female
Adverse reactions / side effects: Back Pain, Arthralgia, Neck Pain, Pain, Arthritis
Suspect drug(s):
Advair Diskus 100 / 50
Dosage: 1puff per day
Indication: Asthma
Start date: 2005-12-01
Singulair
Indication: Asthma
Other drugs received by patient: Lutein; Omega 3; Tylenol (Caplet); Advil; Glucosamine; Calcium
Adverse event in 67 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-25
Patient: 67 year old female
Adverse reactions / side effects: Burning Sensation, Pleuritic Pain
Suspect drug(s):
Advair Diskus 100 / 50
Dosage: 1puff twice per day
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2005-06-01
End date: 2005-12-01
Singulair
Start date: 2007-02-01
End date: 2007-04-01
Other drugs received by patient: Singulair; Norvasc
Adverse event in female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-25
Patient: female
Adverse reactions / side effects: Drug Ineffective
Suspect drug(s):
Advair Diskus 100 / 50
Singulair
Administration route: Oral
Adverse event in 63 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-25
Patient: 63 year old female
Adverse reactions / side effects: Drug Ineffective, Gastric Disorder
Suspect drug(s):
Advair Diskus 100 / 50
Indication: Asthma
Duoneb
Indication: Asthma
Prednisone
Indication: Asthma
Pulmicort
Indication: Asthma
Singulair
Indication: Asthma
Zyrtec
Indication: Asthma
Adverse event in 51 year old female receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-10-24
Patient: 51 year old female, weighing 77.0 kg (169.4 pounds)
Adverse reactions / side effects: Epilepsy
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Phenytoin; Valproate Sodium; Albuterol
Adverse event in 46 year old male receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from Spain on 2007-10-23
Patient: 46 year old male
Adverse reactions / side effects: Musculoskeletal Pain, Sensory Loss, Paraesthesia
Suspect drug(s):
Rhinocort
Dosage: 64mcg per day
Indication: Drug USE FOR Unknown Indication
Start date: 2001-01-01
Seretide
Indication: Drug USE FOR Unknown Indication
Start date: 2004-01-01
Singulair
Dosage: 10mg per day
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2007-02-26
End date: 2007-06-28
Ventolin
Indication: Drug USE FOR Unknown Indication
Start date: 2001-01-01
Adverse event in 12 year old male receiving Singulair (Montelukast)
Reported by a physician from France on 2007-10-23
Patient: 12 year old male
Adverse reactions / side effects: Cardio-Respiratory Arrest, Pharyngitis, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Budesonide and Formoterol Fumarate
Adverse event in 5 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from Portugal on 2007-10-23
Patient: 5 year old male, weighing 27.0 kg (59.4 pounds)
Adverse reactions / side effects: Dyskinesia, Petit MAL Epilepsy, Epilepsy
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2005-09-01
End date: 2006-01-01
Singulair
Administration route: Oral
Start date: 2006-01-01
End date: 2006-07-01
Other drugs received by patient: Stiripentol; Valproate Sodium
Adverse event in 32 year old male receiving Singulair (Montelukast)
Reported by a physician from Australia on 2007-10-23
Patient: 32 year old male
Adverse reactions / side effects: Ileal Perforation, Crohn's Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Adverse event in 46 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from Spain on 2007-10-23
Patient: 46 year old male
Adverse reactions / side effects: Musculoskeletal Pain, Anaesthesia, Paraesthesia
Suspect drug(s):
Albuterol Sulfate
Start date: 2001-01-01
Budesonide
Start date: 2001-01-01
Fluticasone Propionate and Salmeterol Xinafoate
Start date: 2004-01-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2007-02-26
End date: 2007-06-28
Adverse event in 77 year old female receiving Singulair (Montelukast)
Reported by a individual with unspecified qualification from Germany on 2007-10-22
Patient: 77 year old female
Adverse reactions / side effects: Gastric Cancer
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Adverse event in 5 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from Portugal on 2007-10-22
Patient: 5 year old male, weighing 27.0 kg (59.4 pounds)
Adverse reactions / side effects: Dyskinesia, Petit MAL Epilepsy, Epilepsy
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2005-09-01
End date: 2006-01-01
Singulair
Administration route: Oral
Start date: 2006-01-01
End date: 2006-07-01
Other drugs received by patient: Stiripentol; Valproate Sodium
Adverse event in 10 year old male receiving Singulair (Montelukast)
Reported by a physician from United States on 2007-10-22
Patient: 10 year old male
Adverse reactions / side effects: Death, Dyspnoea
Adverse event resulted in: death, life threatening event
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol
Adverse event in 43 year old female receiving Singulair (Montelukast)
Reported by a physician from Japan on 2007-10-19
Patient: 43 year old female, weighing 28.0 kg (61.6 pounds)
Adverse reactions / side effects: Mononeuropathy Multiplex, Hypoaesthesia, Pyrexia, Allergic Granulomatous Angiitis
Adverse event resulted in: hospitalization
Suspect drug(s):
Predonine
Administration route: Oral
Indication: Asthma
Start date: 2007-08-01
End date: 2007-08-03
Predonine
Administration route: Oral
Start date: 2007-08-04
End date: 2007-08-06
Predonine
Administration route: Oral
Start date: 2007-08-07
End date: 2007-08-07
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2007-07-20
End date: 2007-08-07
Other drugs received by patient: Theolong; Mestranol and Norethynodrel; Zolpidem Tartrate; Lendormin; Salmeterol Xinafoate; Flutide
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