Index of reports
> Cases with Agitation (39)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Singulair (Montelukast) where reactions include agitation. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 39 Next >>
Possible Singulair side effects in
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient:
Reactions: Agitation, Cardiac Flutter, Drug Ineffective
Drug(s) suspected as cause:
Singulair
Other drugs received by patient: Propionate DE Sodium; Timolol Maleate; Pravastatin Sodium; Albuterol; Pulmicort; Fluticasone Propionate
Possible Singulair side effects in
Reported by a physician from United States on 2012-08-01
Patient:
Reactions: Agitation, Cardiac Flutter, Drug Ineffective
Drug(s) suspected as cause:
Singulair
Other drugs received by patient: Fluticasone Furoate; Pulmicort; Timolol Maleate; Pravastatin Sodium; Propionate DE Sodium; Albuterol
Possible Singulair side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23
Patient:
Reactions: Irritability, Hostility, Agitation, Educational Problem, Abnormal Behaviour, Aggression
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in
Reported by a physician from Brazil on 2012-07-11
Patient:
Reactions: Irritability, Agitation, Swelling, Convulsion
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in
Reported by a physician from Brazil on 2012-07-11
Patient:
Reactions: Irritability, Agitation, Swelling, Convulsion
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-22
Patient: male
Reactions: Agitation, TIC, Sleep Disorder, Suicidal Ideation
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in female
Reported by a physician from United States on 2012-06-19
Patient: female
Reactions: Agitation
Drug(s) suspected as cause:
Singulair
Dosage: unk
Pristiq
Dosage: 100 mg, unk
Administration route: Oral
Indication: Obsessive-Compulsive Disorder
Possible Singulair side effects in 14 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-13
Patient: 14 year old male, weighing 57.0 kg (125.4 pounds)
Reactions: Agitation, Suicidal Behaviour, Insomnia, Screaming, Aggression, Nervousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: 45 year old female, weighing 59.9 kg (131.7 pounds)
Reactions: Agitation, Anxiety, Anger, Tremor, Suicidal Ideation, Self-Injurious Ideation, Nervousness
Drug(s) suspected as cause:
Singulair
Dosage: 10 mg, once daily, po
Administration route: Oral
Indication: Inner Ear Disorder
Start date: 2012-05-01
End date: 2012-05-21
Singulair
Dosage: 10 mg, once daily, po
Administration route: Oral
Indication: Multiple Allergies
Start date: 2012-05-01
End date: 2012-05-21
Possible Singulair side effects in female
Reported by a physician from United States on 2012-06-05
Patient: female
Reactions: Agitation
Drug(s) suspected as cause:
Pristiq
Dosage: 100 mg, unk
Administration route: Oral
Indication: Obsessive-Compulsive Disorder
Singulair
Dosage: unk
Possible Singulair side effects in 4 year old male
Reported by a physician from France on 2012-06-05
Patient: 4 year old male
Reactions: Agitation, Sleep Disorder, Suicide Attempt, Abnormal Behaviour
Drug(s) suspected as cause:
Singulair
Other drugs received by patient: Fluticasone Propionate and Salmeterol Xinafoate; Mometasone Furoate
Possible Singulair side effects in 4 year old male
Reported by a physician from France on 2012-06-04
Patient: 4 year old male
Reactions: Agitation, Sleep Disorder, Suicide Attempt, Abnormal Behaviour
Drug(s) suspected as cause:
Singulair
Other drugs received by patient: Mometasone Furoate; Fluticasone Propionate and Salmeterol Xinafoate
Possible Singulair side effects in 4 year old male
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: 4 year old male, weighing 18.1 kg (39.9 pounds)
Reactions: Agitation, Anxiety, Insomnia, Anger, Mood Swings, Unevaluable Event, Aggression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in female
Reported by a pharmacist from United States on 2012-06-01
Patient: female
Reactions: Agitation, Pruritus, Hypogeusia, Contusion, Nausea, Chromaturia, Headache, Rash, Eye Pain, Palpitations, Insomnia
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in female
Reported by a physician from United States on 2012-05-17
Patient: female
Reactions: Agitation
Drug(s) suspected as cause:
Pristiq
Dosage: 100 mg, unk
Administration route: Oral
Indication: Obsessive-Compulsive Disorder
Singulair
Dosage: unk
Possible Singulair side effects in female
Reported by a physician from United States on 2012-05-14
Patient: female
Reactions: Agitation
Drug(s) suspected as cause:
Pristiq
Dosage: 100 mg, unk
Administration route: Oral
Indication: Obsessive-Compulsive Disorder
Singulair
Dosage: unk
Possible Singulair side effects in 4 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04
Patient: 4 year old male, weighing 21.0 kg (46.2 pounds)
Reactions: Off Label Use, Agitation, Abnormal Behaviour, Anger, Screaming, Oppositional Defiant Disorder, Aggression
Drug(s) suspected as cause:
Singulair
Administration route: Oral
Start date: 2012-04-23
Singulair
Administration route: Oral
Indication: Psychomotor Hyperactivity
Start date: 2011-11-15
End date: 2011-12-01
Singulair
Administration route: Oral
Start date: 2012-04-23
Singulair
Administration route: Oral
Indication: Hypersensitivity
Start date: 2011-11-15
End date: 2011-12-01
Singulair
Administration route: Oral
Start date: 2012-04-23
Singulair
Administration route: Oral
Indication: Sinusitis
Start date: 2011-11-15
End date: 2011-12-01
Possible Singulair side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-30
Patient: female, weighing 22.7 kg (49.9 pounds)
Reactions: Irritability, Agitation, Excessive Eye Blinking
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 62 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18
Patient: 62 year old female, weighing 76.2 kg (167.6 pounds)
Reactions: Agitation, Nightmare, Sleep Disorder
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 60 year old female
Reported by a physician from United States on 2012-04-11
Patient: 60 year old female, weighing 95.0 kg (209.0 pounds)
Reactions: Agitation, Hypersensitivity, Dyspnoea, Pain in Extremity, Drug Interaction, Erythema, Aggression, Irritability, Affective Disorder, Weight Increased, Ecchymosis, DRY Mouth, Oedema Peripheral
Drug(s) suspected as cause:
Pentasa
Administration route: Oral
Pentasa
Administration route: Oral
Indication: Crohn's Disease
Medrol
Administration route: Oral
Start date: 2010-11-01
End date: 2012-02-12
Elavil
Administration route: Oral
Indication: Muscle Spasms
Medrol
Administration route: Oral
Start date: 2012-02-13
Elavil
Administration route: Oral
Lyrica
Administration route: Oral
Start date: 2005-01-01
End date: 2010-07-01
Medrol
Administration route: Oral
Indication: Inflammatory Pain
Start date: 2010-01-01
End date: 2010-11-01
Lyrica
Administration route: Oral
Indication: Neuralgia
Start date: 2010-07-01
Singulair
Administration route: Oral
Indication: Asthma
Other drugs received by patient: Taxol; Oxycodone; Prozac; Omeprazole
Possible Singulair side effects in 4 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-04
Patient: 4 year old male, weighing 21.0 kg (46.2 pounds)
Reactions: Agitation, Off Label Use, Abnormal Behaviour, Anger, Aggression
Drug(s) suspected as cause:
Singulair
Administration route: Oral
Indication: Hypersensitivity
Start date: 2011-11-15
End date: 2011-12-01
Singulair
Administration route: Oral
Indication: Psychomotor Hyperactivity
Start date: 2011-11-15
End date: 2011-12-01
Possible Singulair side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-03-28
Patient: 59 year old female, weighing 136.1 kg (299.4 pounds)
Reactions: Abnormal Dreams, Anxiety, Agitation, Insomnia, Muscular Weakness
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-03-28
Patient: 68 year old female, weighing 65.8 kg (144.7 pounds)
Reactions: Agitation, Irritability, Hostility, Mood Altered, Disorientation, Depression, Tremor
Drug(s) suspected as cause:
Singulair
Dosage: 1 at night
Indication: Multiple Allergies
Start date: 2012-01-01
Singulair
Dosage: 1 at night
Indication: Asthma
Start date: 2012-01-01
Levothyroxine Sodium
Dosage: 1 a day
Start date: 2011-12-01
Possible Singulair side effects in 2 year old female
Reported by a consumer/non-health professional from United States on 2012-03-21
Patient: 2 year old female, weighing 12.7 kg (27.9 pounds)
Reactions: Irritability, Agitation, Fear, Insomnia, Abnormal Behaviour, Anger, Crying
Drug(s) suspected as cause:
Singulair
Dosage: 1, 4mg tablet
Administration route: Oral
Indication: Multiple Allergies
Start date: 2011-09-15
End date: 2011-09-16
Singulair
Possible Singulair side effects in 60 year old female
Reported by a physician from United States on 2012-03-16
Patient: 60 year old female, weighing 95.0 kg (209.0 pounds)
Reactions: Agitation, Dyspnoea, Hypersensitivity, Pain in Extremity, Drug Interaction, Erythema, Aggression, Affective Disorder, Irritability, Weight Increased, DRY Mouth, Ecchymosis, Oedema Peripheral
Drug(s) suspected as cause:
Elavil
Administration route: Oral
Indication: Muscle Spasms
Lyrica
Administration route: Oral
Start date: 2005-01-01
End date: 2010-07-01
Medrol
Administration route: Oral
Start date: 2010-11-01
End date: 2012-02-12
Medrol
Administration route: Oral
Start date: 2012-02-13
Singulair
Administration route: Oral
Indication: Asthma
Medrol
Administration route: Oral
Indication: Inflammatory Pain
Start date: 2010-01-01
End date: 2010-11-01
Lyrica
Administration route: Oral
Indication: Neuralgia
Start date: 2010-07-01
Pentasa
Administration route: Oral
Indication: Crohn's Disease
Pentasa
Administration route: Oral
Elavil
Administration route: Oral
Other drugs received by patient: Prozac; Oxycodone; Omeprazole; Taxol
Possible Singulair side effects in 4 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-05
Patient: 4 year old male, weighing 25.4 kg (55.9 pounds)
Reactions: Irritability, Agitation, Hostility, Educational Problem, Abnormal Behaviour, Aggression
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 57 year old female
Reported by a physician from United States on 2012-02-09
Patient: 57 year old female, weighing 77.1 kg (169.6 pounds)
Reactions: Personality Change, Agitation, Irritability, Screaming, Headache, Mood Swings, Depression
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 6 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-07
Patient: 6 year old male
Reactions: Agitation, Personality Disorder, Aggression
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 6 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-06
Patient: 6 year old male
Reactions: Agitation, Personality Disorder, Aggression
Drug(s) suspected as cause:
Singulair
Possible Singulair side effects in 4 year old female
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 4 year old female, weighing 15.9 kg (34.9 pounds)
Reactions: Agitation, Mood Altered, Restlessness, Insomnia, Abnormal Behaviour, Aggression, Decreased Appetite
Drug(s) suspected as cause:
Singulair
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