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Index of reports
> Cases resulting in hospitalization (208)
> Cases with Headache (21)
Below is the selection of adverse event reports related to Singulair (Montelukast) that includes cases resulting in hospitalization where reactions include headache.
Adverse event in 6 year old male receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-07-26
Patient: 6 year old male, weighing 29.0 kg (63.8 pounds)
Adverse reactions / side effects: Hallucination, Auditory, Dyskinesia, Abasia, Headache, Constipation, Feeling Cold, Malaise, Fatigue, Anger, Aura, Migraine, Nightmare, Clonus, Muscular Weakness, Flushing, Arthralgia, Hallucination, Visual, Diarrhoea, Ear Pain, Parosmia, Complex Partial Seizures, Athetosis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol
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 36 year old male receiving Singulair (Montelukast)
Reported by a physician from Germany on 2007-06-29
Patient: 36 year old male, weighing 78.0 kg (171.6 pounds)
Adverse reactions / side effects: Speech Disorder, Dysaesthesia, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol Sulfate; Budesonide
Adverse event in 11 year old male receiving Singulair (Montelukast)
Reported by a physician from France on 2007-05-24
Patient: 11 year old male
Adverse reactions / side effects: Malaise, Fatigue, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Cetirizine Hydrochloride
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 5 year old female receiving Singulair (Montelukast)
Reported by a physician from Netherlands on 2007-04-09
Patient: 5 year old female
Adverse reactions / side effects: Confusional State, Movement Disorder, Prescribed Overdose, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Fluticasone Propionate; Albuterol
Adverse event in 9 year old male receiving Singulair (Montelukast)
Reported by a physician from Poland on 2007-03-06
Patient: 9 year old male, weighing 30.0 kg (66.0 pounds)
Adverse reactions / side effects: Pain in Extremity, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2006-02-07
End date: 2006-02-09
Singulair
Administration route: Oral
Start date: 2006-02-17
End date: 2006-02-19
Adverse event in 47 year old female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-03-05
Patient: 47 year old female
Adverse reactions / side effects: Asthma, Blood Pressure Increased, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2002-01-01
Singulair
Administration route: Oral
End date: 2007-02-27
Other drugs received by patient: Advair Diskus 100 / 50
Adverse event in female receiving Singulair (Montelukast)
Reported by a consumer/non-health professional from United States on 2007-02-26
Patient: female
Adverse reactions / side effects: Osteoporosis, Musculoskeletal Pain, Headache, Joint Stiffness, Body Height Decreased, Upper Respiratory Tract Infection, Throat Irritation, Bone Density Decreased, Candidiasis, Cough
Adverse event resulted in: hospitalization
Suspect drug(s):
Advair Diskus 100 / 50
Dosage: 1puff twice per day
Indication: Chronic Obstructive Pulmonary Disease
Singulair
Other drugs received by patient: Albuterol; Nebulizer
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 36 year old male receiving Singulair (Montelukast)
Reported by a physician from Germany on 2007-02-13
Patient: 36 year old male, weighing 78.0 kg (171.6 pounds)
Adverse reactions / side effects: Speech Disorder, Dysaesthesia, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol Sulfate; Budesonide
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 44 year old male receiving Singulair (Montelukast)
Reported by a individual with unspecified qualification from France on 2007-02-07
Patient: 44 year old male, weighing 61.0 kg (134.2 pounds)
Adverse reactions / side effects: Vomiting, Hypothermia, Alanine Aminotransferase Increased, Rhinitis, Headache, Hyperhidrosis, Transaminases Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Miosis, Photophobia, Dizziness, Bradycardia, Salivary Hypersecretion, Cholinergic Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Depakene
Dosage: 500 mg, tid
Administration route: Oral
Indication: Epilepsy
Start date: 1996-01-01
Urbanyl
Dosage: 5 mg, qd
Administration route: Oral
Indication: Epilepsy
Start date: 1996-01-01
Kenzen
Dosage: 4 mg, qd
Administration route: Oral
Start date: 2004-01-01
Singulair
Dosage: 10 mg, qd
Administration route: Oral
Start date: 2004-01-01
Desloratadine
Dosage: 5 mg, qd
Administration route: Oral
Indication: Rhinitis
Start date: 2006-11-17
End date: 2006-11-23
Tegretol
Dosage: 400 mg, tid
Administration route: Oral
Indication: Epilepsy
Start date: 1996-01-01
Adverse event in 36 year old male receiving Singulair (Montelukast)
Reported by a physician from Germany on 2007-02-02
Patient: 36 year old male, weighing 78.0 kg (171.6 pounds)
Adverse reactions / side effects: Speech Disorder, Dysaesthesia, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol Sulfate; Budesonide
Adverse event in 36 year old male receiving Singulair (Montelukast)
Reported by a physician from Germany on 2007-01-30
Patient: 36 year old male, weighing 78.0 kg (171.6 pounds)
Adverse reactions / side effects: Speech Disorder, Dysaesthesia, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair (Montelukast)
Other drugs received by patient: Albuterol Sulfate; Budesonide
Adverse event in 44 year old male receiving Singulair (Montelukast)
Reported by a individual with unspecified qualification from France on 2007-01-26
Patient: 44 year old male, weighing 61.0 kg (134.2 pounds)
Adverse reactions / side effects: Hypothermia, Alanine Aminotransferase Increased, Rhinitis, Headache, Hyperhidrosis, Transaminases Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Miosis, Dizziness, Bradycardia, Salivary Hypersecretion, Cholinergic Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Depakene
Dosage: 500 mg, tid
Administration route: Oral
Urbanyl
Dosage: 5 mg, qd
Administration route: Oral
Kenzen
Dosage: 4 mg, qd
Administration route: Oral
Singulair
Dosage: 10 mg, qd
Administration route: Oral
Desloratadine
Dosage: 5 mg, qd
Administration route: Oral
Indication: Rhinitis
Start date: 2006-11-17
End date: 2006-11-23
Tegretol
Dosage: 400 mg, tid
Administration route: Oral
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
Adverse event in 44 year old male receiving Singulair (Montelukast)
Reported by a health professional (non-physician/pharmacist) from France on 2007-01-17
Patient: 44 year old male
Adverse reactions / side effects: Myositis, Vomiting, Hypothermia, Alanine Aminotransferase Increased, Headache, Transaminases Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Photophobia, Dizziness, Blood Cholinesterase Increased, Bradycardia, Salivary Hypersecretion, Cholinergic Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Singulair
Administration route: Oral
Indication: Asthma
Start date: 2004-01-01
Valproate Sodium
Administration route: Oral
Indication: Epilepsy
Start date: 1996-01-01
Carbamazepine
Administration route: Oral
Indication: Epilepsy
Start date: 1996-01-01
Clobazam
Administration route: Oral
Candesartan
Administration route: Oral
Indication: Hypertension
Desloratidine
Administration route: Oral
Indication: Rhinitis
Start date: 2006-11-17
End date: 2006-11-23
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