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Singulair (Montelukast) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Singulair (Montelukast) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (738)
Death (31)
Life Threatening Events (80)
Disability (61)

Reports by Reaction Type

Aggression (70)Suicidal Ideation (68)Depression (57)Abnormal Behaviour (54)Allergic Granulomatous Angiitis (50)Anxiety (41)Agitation (39)Insomnia (36)Irritability (34)Nightmare (32)Asthma (31)Anger (29)

Below are a few examples of reports where side effects / adverse reactions may be related to Singulair (Montelukast). For a complete list or a specific selection of reports, please use the links above.

Possible Singulair side effects in 11 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 11 year old male, weighing 41.3 kg (90.8 pounds)

Reactions: Somnambulism

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in 64 year old female

Reported by a physician from United States on 2012-08-24

Patient: 64 year old female

Reactions: Abdominal Pain

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Vomiting, Overdose, Drug Dispensing Error

Drug(s) suspected as cause:
Singulair
    Indication: Asthma

Singulair
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hypersensitivity
    Start date: 2012-07-11
    End date: 2012-08-10



Possible Singulair side effects in 16 year old male

Reported by a physician from United States on 2012-08-24

Patient: 16 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Malaise, Fatigue, Dizziness, Headache

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 51 year old female

Reactions: Weight Increased, Hypersensitivity, Arthralgia, Insomnia, Depression, Gastric Disorder

Drug(s) suspected as cause:
Allegra

Asmanex Twisthaler
    Administration route: Oral
    Indication: Asthma

Dulera

Fluticasone Propionate

Loratadine and Pseudoephedrine Sulfate

Prednisone TAB

Pulmicort

Singulair

Symbicort

Zyrtec

Other drugs received by patient: Albuterol; Albuterol



Possible Singulair side effects in

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-24

Patient:

Reactions: Mood Altered, Abnormal Behaviour, Aggression

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Albuterol; Beclazone; Erythromycin



Possible Singulair side effects in 11 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 11 year old male, weighing 41.3 kg (90.8 pounds)

Reactions: Somnambulism

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Asthma, Fear, Delusion, Suicidal Ideation, Weight Increased, Syncope, Mental Disorder, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Dulera; Abilify; Nasonex; Vyvanse



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Drug Dose Omission, NO Adverse Event, Tablet Physical Issue

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Blood Creatine Phosphokinase Increased, Myoglobin Blood Increased

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Welchol; Centrum (Minerals (Unspecified) (+) Vitamins (Unspecified)); Fluticasone Propionate; Vitamin D



Possible Singulair side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Vision Blurred

Drug(s) suspected as cause:
Omnaris
    Dosage: unk
    Indication: Hypersensitivity
    Start date: 2012-07-20

Singulair
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-20

Other drugs received by patient: Nadolol; Nasonex; Synthroid



Possible Singulair side effects in

Reported by a physician from Spain on 2012-08-23

Patient:

Reactions: Alice in Wonderland Syndrome

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from Honduras on 2012-08-23

Patient:

Reactions: Heart Rate Decreased, Syncope, Pallor, Somnolence, Resuscitation, Loss of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Rhinorrhoea, Cough

Drug(s) suspected as cause:
Singulair
    Indication: Hypersensitivity

Singulair
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-02-01

Singulair
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Asthma

Singulair

Other drugs received by patient: Proair (Albuterol Sulfate); Zyrtec; Flonase; Allegra



Possible Singulair side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient:

Reactions: Vasculitis, Allergic Granulomatous Angiitis

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Vomiting, Overdose, Product Distribution Issue

Drug(s) suspected as cause:
Singulair
    Indication: Asthma

Singulair
    Dosage: unk mg, unk
    Administration route: Oral
    Indication: Hypersensitivity
    Start date: 2012-07-11
    End date: 2012-08-10



Possible Singulair side effects in

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Malaise

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Qvar 40; Proair (Albuterol Sulfate)



Possible Singulair side effects in

Reported by a health professional (non-physician/pharmacist) from Romania on 2012-08-23

Patient:

Reactions: Allergic Granulomatous Angiitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Fluticasone Propionate / Salmeterol



Possible Singulair side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Facial Spasm, Muscle Twitching

Drug(s) suspected as cause:
Singulair
    Indication: Wheezing

Singulair
    Indication: Cough

Singulair
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-02-03
    End date: 2012-06-20

Other drugs received by patient: Qvar 40



Possible Singulair side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from Honduras on 2012-08-23

Patient:

Reactions: Syncope, Heart Rate Decreased, Somnolence, Pallor, Loss of Consciousness, Resuscitation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from Germany on 2012-08-22

Patient:

Reactions: Off Label Use, Hepatic Function Abnormal, Allergic Granulomatous Angiitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Singulair

Other drugs received by patient: Cyclophosphamide; Corticosteroids (Unspecified); Methotrexate



Possible Singulair side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 43 year old female

Reactions: Scratch, Respiratory Disorder, Angioedema, Nasal Discomfort, Urticaria, Upper-Airway Cough Syndrome, Skin Disorder, Weight Increased, Dysphonia, Swelling, Insomnia, Urticaria Chronic, Rhinitis Perennial, Cough, Eye Pruritus

Drug(s) suspected as cause:
Neurontin
    Dosage: unk
    Indication: Bipolar Disorder

Singulair
    Dosage: unk

Zyrtec
    Dosage: unk

Other drugs received by patient: Proventil-HFA



Possible Singulair side effects in

Reported by a pharmacist from Japan on 2012-08-22

Patient:

Reactions: Allergic Granulomatous Angiitis

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient:

Reactions: Psychomotor Hyperactivity, Aggression, Suicidal Ideation

Drug(s) suspected as cause:
Singulair



Possible Singulair side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Expired Drug Administered, Pyrexia, Rash Pruritic

Drug(s) suspected as cause:
Singulair
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2007-08-01

Singulair
    Dosage: 10 mg, once
    Administration route: Oral
    Indication: Asthma



Possible Singulair side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-15

Patient:

Reactions: Drug Eruption

Drug(s) suspected as cause:
Allegra
    Dosage: unk
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2011-05-01

Fluticasone Furoate
    Dosage: unk
    Indication: Chronic Sinusitis
    Start date: 2011-05-01

Methista
    Dosage: unk
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2011-05-01

Singulair
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2011-05-01
    End date: 2011-06-01

Tranexamic Acid
    Dosage: unk
    Indication: Chronic Sinusitis
    Start date: 2011-05-01

[therapy Unspecified]
    Dosage: unk
    Indication: Chronic Sinusitis
    Start date: 2011-05-01

Other drugs received by patient: Avelox; Clarith



Possible Singulair side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male, weighing 15.4 kg (33.9 pounds)

Reactions: Screaming, Mood Swings

Drug(s) suspected as cause:
Singulair
    Dosage: 1 packet once a day po
    Administration route: Oral
    Indication: Mood Swings
    Start date: 2012-05-10
    End date: 2012-08-01

Singulair
    Dosage: 1 packet once a day po
    Administration route: Oral
    Indication: Sleep Terror
    Start date: 2012-05-10
    End date: 2012-08-01

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