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Index of reports
> Cases resulting in other serious reactions (176)
> Cases with Headache (13)
Below is the selection of adverse event reports related to Singulair (Montelukast) that includes cases resulting in other serious reactions where reactions include headache.
Adverse event in male receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-10-18
Patient: male
Adverse reactions / side effects: Asthma, Drug Ineffective, Restlessness, Insomnia, Headache, Sinusitis
Suspect drug(s):
Advair Diskus 100 / 50
Dosage: 1puff twice per day
Indication: Asthma
Start date: 2001-01-01
Loratadine
Dosage: 10mg per day
Administration route: Oral
Indication: Multiple Allergies
Start date: 2006-07-01
Mometasone Furoate
Dosage: 2spr per day
Indication: Multiple Allergies
Start date: 2006-07-01
Singulair
Dosage: 10mg per day
Administration route: Oral
Indication: Multiple Allergies
Start date: 2006-07-01
Adverse event in 51 year old female receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2007-07-19
Patient: 51 year old female
Adverse reactions / side effects: Haemorrhage, Headache
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Fluticasone Propionate and Salmeterol Xinafoate; Cilazapril; Ipratropium Bromide; Albuterol Sulfate; Paroxetine Hydrochloride
Adverse event in 6 year old male receiving Singulair (Montelukast)
Reported by a physician from United States on 2007-07-16
Patient: 6 year old male, weighing 29.0 kg (63.8 pounds)
Adverse reactions / side effects: Hallucination, Auditory, Dyskinesia, Headache, Constipation, Feeling Cold, Fatigue, Anger, Aura, Migraine, Nightmare, Clonus, Muscular Weakness, Convulsion, Flushing, Hallucination, Visual, Diarrhoea, Arthralgia, Parosmia, Athetosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol
Adverse event in 9 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-05-17
Patient: 9 year old female, weighing 31.8 kg (69.9 pounds)
Adverse reactions / side effects: Vomiting, Nausea, Headache, Crying
Suspect drug(s):
Singulair (Montelukast)
Adverse event in 65 year old female receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-05-15
Patient: 65 year old female, weighing 86.0 kg (189.2 pounds)
Adverse reactions / side effects: Abdominal Pain, Movement Disorder, Pruritus, Bone Pain, Petechiae, Cerebrovascular Disorder, Headache, Somnolence, Generalised Oedema, Hypercholesterolaemia, Myalgia, Fatigue, Face Oedema, Chest Pain, DRY Mouth, Conjunctival Hyperaemia, Oedema Peripheral, Abdominal Distension, Dizziness, Depression, Acute Coronary Syndrome, Cough, Muscle Spasms, Back Pain, Dyspnoea, Autonomic Nervous System Imbalance, Nausea, Hypotension, Rash, Skin Tightness, Anxiety, Syncope, Arthralgia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Rhinitis Allergic
Start date: 2004-11-01
End date: 2006-06-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-11-01
End date: 2006-06-01
Other drugs received by patient: Levothyroxine Sodium; Quinapril Hydrochloride; Quinapril Hydrochloride; Ticlopidine Hydrochloride; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Ranitidine; Simvastatin; Simvastatin; Nicergoline; Perazine Dimalonate; Aspirin; Aspirin; Imipramine Hydrochloride; Metoprolol; Isosorbide Dinitrate; Simvastatin; Chlorthalidone; Prednisone; Loratadine; Fluvoxamine Maleate; Modafinil
Adverse event in 65 year old female receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-05-11
Patient: 65 year old female, weighing 86.0 kg (189.2 pounds)
Adverse reactions / side effects: Abdominal Pain, Movement Disorder, Pruritus, Bone Pain, Petechiae, Cerebrovascular Disorder, Headache, Somnolence, Generalised Oedema, Hypercholesterolaemia, Myalgia, Fatigue, Face Oedema, Chest Pain, DRY Mouth, Conjunctival Hyperaemia, Oedema Peripheral, Abdominal Distension, Dizziness, Depression, Acute Coronary Syndrome, Cough, Muscle Spasms, Back Pain, Dyspnoea, Autonomic Nervous System Imbalance, Nausea, Hypotension, Rash, Skin Tightness, Anxiety, Arthralgia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Rhinitis Allergic
Start date: 2004-11-01
End date: 2006-06-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-11-01
End date: 2006-06-01
Other drugs received by patient: Levothyroxine Sodium; Quinapril Hydrochloride; Quinapril Hydrochloride; Ticlopidine Hydrochloride; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Ranitidine; Simvastatin; Simvastatin; Nicergoline; Perazine Dimalonate; Aspirin; Aspirin; Imipramine Hydrochloride; Metoprolol; Isosorbide Dinitrate; Simvastatin; Chlorthalidone; Prednisone; Loratadine; Fluvoxamine Maleate; Modafinil
Adverse event in 10 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-03-02
Patient: 10 year old male
Adverse reactions / side effects: Irritability, Vertigo, Headache, Thirst, Aggression
Suspect drug(s):
Singulair
Indication: Asthma
Start date: 2005-09-23
End date: 2005-10-23
Singulair
Administration route: Oral
Start date: 2006-11-15
End date: 2007-02-13
Other drugs received by patient: Fluticasone Propionate; Albuterol; Salmeterol
Adverse event in 65 year old female receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-02-20
Patient: 65 year old female, weighing 86.0 kg (189.2 pounds)
Adverse reactions / side effects: Abdominal Pain, Movement Disorder, Pruritus, Bone Pain, Petechiae, Cerebrovascular Disorder, Headache, Somnolence, Generalised Oedema, Hypercholesterolaemia, Myalgia, Fatigue, Face Oedema, Chest Pain, DRY Mouth, Conjunctival Hyperaemia, Oedema Peripheral, Abdominal Distension, Dizziness, Depression, Acute Coronary Syndrome, Cough, Muscle Spasms, Back Pain, Dyspnoea, Autonomic Nervous System Imbalance, Nausea, Hypotension, Rash, Skin Tightness, Anxiety, Arthralgia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Rhinitis Allergic
Start date: 2004-11-01
End date: 2006-06-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-11-01
End date: 2006-06-01
Other drugs received by patient: Levothyroxine Sodium; Quinapril Hydrochloride; Quinapril Hydrochloride; Ticlopidine Hydrochloride; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Ranitidine; Simvastatin; Simvastatin; Nicergoline; Perazine Dimalonate; Aspirin; Aspirin; Imipramine Hydrochloride; Metoprolol; Isosorbide Dinitrate; Simvastatin; Chlorthalidone; Prednisone; Loratadine; Fluvoxamine Maleate; Modafinil
Adverse event in 65 year old female receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-02-19
Patient: 65 year old female, weighing 86.0 kg (189.2 pounds)
Adverse reactions / side effects: Abdominal Pain, Movement Disorder, Pruritus, Bone Pain, Petechiae, Cerebrovascular Disorder, Headache, Somnolence, Generalised Oedema, Myalgia, Face Oedema, Fatigue, DRY Mouth, Chest Pain, Conjunctival Hyperaemia, Oedema Peripheral, Abdominal Distension, Dizziness, Depression, Acute Coronary Syndrome, Cough, Muscle Spasms, Back Pain, Dyspnoea, Nausea, Hypotension, Rash, Skin Tightness, Anxiety, Arthralgia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Rhinitis Allergic
Start date: 2004-11-01
End date: 2006-06-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-11-01
End date: 2006-06-01
Other drugs received by patient: Levothyroxine Sodium; Quinapril Hydrochloride; Quinapril Hydrochloride; Ticlopidine Hydrochloride; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Amlodipine Besylate; Ranitidine; Simvastatin; Simvastatin; Nicergoline; Perazine Dimalonate; Aspirin; Aspirin; Imipramine Hydrochloride; Metoprolol; Isosorbide Dinitrate; Simvastatin; Chlorthalidone; Prednisone; Loratadine; Fluvoxamine Maleate; Modafinil
Adverse event in 65 year old female receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-02-09
Patient: 65 year old female, weighing 86.0 kg (189.2 pounds)
Adverse reactions / side effects: Abdominal Pain, Movement Disorder, Petechiae, Headache, Somnolence, Generalised Oedema, Myalgia, Fatigue, Chest Pain, DRY Mouth, Abdominal Distension, Dizziness, Acute Coronary Syndrome, Cough, Muscle Spasms, Back Pain, Dyspnoea, Nausea, Hypotension, Rash, Skin Tightness, Anxiety, Arthralgia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Rhinitis Allergic
Start date: 2004-11-01
End date: 2006-06-01
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-11-01
End date: 2006-06-01
Other drugs received by patient: Aspirin; Levothyroxine Sodium; Quinapril Hydrochloride; Ticlopidine Hydrochloride; Amlodipine Besylate; Ranitidine; Simvastatin; Simvastatin; Nicergoline; Perazine Dimalonate; Imipramine Hydrochloride; Metoprolol; Isosorbide Dinitrate; Simvastatin; Chlorthalidone; Prednisone; Loratadine; Fluvoxamine Maleate; Modafinil
Adverse event in 8 year old female receiving Singulair (Montelukast)
Reported by a physician from Japan on 2007-02-08
Patient: 8 year old female, weighing 26.0 kg (57.2 pounds)
Adverse reactions / side effects: Nausea, Dizziness, Thirst, Headache, Asthenia, Pallor
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Packera Aurea; Ethyl Cysteine Hydrochloride; Ambroxol Hydrochloride; Tulobuterol; Intal
Adverse event in 44 year old male receiving Singulair (Montelukast)
Reported by a physician from France on 2007-01-24
Patient: 44 year old male, weighing 61.0 kg (134.2 pounds)
Adverse reactions / side effects: Vomiting, Hypothermia, Alanine Aminotransferase Increased, Occupational Exposure TO Toxic Agent, Headache, Hyperhidrosis, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Miosis, Photophobia, Vertigo, Bradycardia, Salivary Hypersecretion, Cholinergic Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Desloratadine
Dosage: 5 mg; qd; po
Administration route: Oral
Indication: Rhinitis
Start date: 2006-11-17
End date: 2006-11-23
Depakene
Dosage: 500 mg; tid; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Tegretol
Dosage: 400 mg; tid; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Urbanyl (Clobazam)
Dosage: 5 mg; qd; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Kenzen (Candesartan Cilexetil)
Dosage: 4 mg; qd; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Singulair
Dosage: 10 mg; qd; po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Adverse event in 9 year old female receiving Singulair (Montelukast)
Reported by a physician from Belgium on 2007-01-22
Patient: 9 year old female
Adverse reactions / side effects: Balance Disorder, Abnormal Behaviour, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2003-11-05
Singulair
Administration route: Oral
Start date: 2006-11-02
End date: 2006-11-07
Other drugs received by patient: Amoxicillin and Clavulanate Potassium; Fenoterol Hydrobromide and Ipratropium Bromide
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