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Singulair (Montelukast) - Agitation - Suspected Cause - Side Effect Reports

 
 



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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