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Accolate (Zafirlukast) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Accolate (Zafirlukast) 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 (121)
Death (5)
Life Threatening Events (4)
Disability (3)

Reports by Reaction Type

Asthma (30)Malaise (27)Drug Dose Omission (25)Dyspnoea (22)Fall (12)Chronic Obstructive Pulmonary Disease (10)Diabetes Mellitus (9)Bronchitis (9)Drug Ineffective (8)Multiple Allergies (8)Respiratory Disorder (7)Cough (7)

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

Possible Accolate side effects in 67 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 67 year old female

Reactions: Multiple Allergies

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort



Possible Accolate side effects in 73 year old female

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

Patient: 73 year old female

Reactions: Arthritis

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Symbicort



Possible Accolate side effects in 54 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 54 year old female, weighing 76.2 kg (167.6 pounds)

Reactions: DRY Mouth

Drug(s) suspected as cause:
Accolate

Other drugs received by patient: Symbicort; Loratadine



Possible Accolate side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 56 year old male

Reactions: Asthma, Diabetes Mellitus, Rectal Tenesmus, Constipation, Haemorrhoidal Haemorrhage, Hypercholesterolaemia, Chest Pain, Gouty Arthritis, Peyronie's Disease, Benign Prostatic Hyperplasia, Micturition Urgency, Anxiety, Osteoarthritis, Arthralgia, Joint Swelling, Insomnia, Painful Erection, Penis Disorder, Spinal Osteoarthritis, Essential Hypertension, Painful Defaecation

Drug(s) suspected as cause:
Accolate

Other drugs received by patient: Allopurinol; Klor-CON; HC Pram; Proctosol HC; Celebrex; Dexilant; Famotidine; Prozac; Finasteride; Nystatin; Buspirone HCL; Ambien; Terazosin HCL; Fexofenadine HCL; Oxybutynin Chloride; Diltiazem HCL; Metformin HCL; Proctofoam HCL; Hyzaar



Possible Accolate side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 58 year old female

Reactions: Insomnia, Intentional Drug Misuse

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Accolate
    Administration route: Oral



Possible Accolate side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 72 year old male

Reactions: Drug Dose Omission, Malaise, Blood Pressure Inadequately Controlled, Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Toprol-XL
    Administration route: Oral



Possible Accolate side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Malaise, Ankle Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Symbicort



Possible Accolate side effects in 90 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 90 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort
    Dosage: unknown



Possible Accolate side effects in 47 year old female

Reported by a physician from United States on 2012-08-02

Patient: 47 year old female

Reactions: Drug Dose Omission, Respiratory Disorder

Drug(s) suspected as cause:
Accolate



Possible Accolate side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 71 year old male

Reactions: Asthma, Emphysema, Diabetes Mellitus, Blood Cholesterol Increased, Intentional Drug Misuse, Chronic Obstructive Pulmonary Disease, Hypertension

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Accolate
    Administration route: Oral



Possible Accolate side effects in 61 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-31

Patient: 61 year old male

Reactions: Asthma, Night Sweats, Productive Cough, Dyspnoea, Increased Upper Airway Secretion, Chest Discomfort, Dyslipidaemia, Pyrexia, Intentional Drug Misuse, Chronic Obstructive Pulmonary Disease, Lung Disorder, Insomnia, Pulmonary Congestion, Multiple Allergies, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Accolate
    Administration route: Oral
    Indication: Asthma

Accolate
    Dosage: two per day
    Administration route: Oral

Nexium
    Dosage: two per day
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Other drugs received by patient: Ventolin HAF; Uniphyl; Combivent; Prednisone; Advair Diskus 100 / 50



Possible Accolate side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 58 year old female

Reactions: Barrett's Oesophagus, Upper Limb Fracture, Drug Ineffective, Hand Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Nexium
    Administration route: Oral

Omeprazole
    Administration route: Oral

Symbicort

Other drugs received by patient: Protonix



Possible Accolate side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 51 year old female

Reactions: Asthma, Multiple Allergies

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Nexium
    Administration route: Oral

Rhinocort

Symbicort
    Dosage: 160/4.5 mcg, daily



Possible Accolate side effects in 47 year old female

Reported by a physician from United States on 2012-07-06

Patient: 47 year old female

Reactions: Drug Dose Omission, Dyspnoea

Drug(s) suspected as cause:
Accolate



Possible Accolate side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 83 year old female

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort



Possible Accolate side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: 61 year old male

Reactions: Asthma, Intentional Drug Misuse, Multiple Allergies

Drug(s) suspected as cause:
Accolate
    Dosage: two per day
    Administration route: Oral

Accolate
    Administration route: Oral

Nexium
    Dosage: two per day
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Accolate side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 74 year old female

Reactions: Back Pain, Respiratory Disorder, Nausea, Pain, Spinal Cord Injury, Fall, Loss of Consciousness, Off Label Use, Malaise, Bladder Disorder, Memory Impairment, Spinal Deformity, Back Disorder

Drug(s) suspected as cause:
Accolate
    Administration route: Oral
    Indication: Respiratory Disorder

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastric Disorder

Symbicort
    Dosage: 160/4.5 mcg, daily
    Indication: Respiratory Disorder

Other drugs received by patient: Oxycodone HCL



Possible Accolate side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 60 year old female

Reactions: Malaise, Cough

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Crestor
    Administration route: Oral



Possible Accolate side effects in 57 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-02

Patient: 57 year old female, weighing 79.4 kg (174.7 pounds)

Reactions: Ligament Rupture, Dyspnoea, Hyperhidrosis, Anxiety, Osteoarthritis, Road Traffic Accident, Renal Impairment, Limb Discomfort, Depression, Muscle Spasms

Drug(s) suspected as cause:
Accolate
    Dosage: generic
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-05-01

Accolate
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Fluconazole; Counter Medications; Propranolol; Xanax



Possible Accolate side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: 47 year old female

Reactions: Drug Dose Omission, Dyspnoea

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Symbicort



Possible Accolate side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 59 year old female

Reactions: Emphysema, Weight Decreased, Migraine, Dyspnoea, Diverticulitis, Chronic Obstructive Pulmonary Disease, Nerve Compression, Spondylitis, Malaise, Dyspepsia, Bronchitis, Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Accolate
    Administration route: Oral
    Indication: Asthma
    Start date: 1998-01-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2007-01-01

Symbicort
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2009-01-01

Symbicort
    Indication: Emphysema
    Start date: 2009-01-01

Other drugs received by patient: Trilipix; Diazepam; Pravastatin



Possible Accolate side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: 69 year old female

Reactions: Sinus Headache

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Accolate side effects in 59 year old male

Reported by a physician from United States on 2012-06-18

Patient: 59 year old male

Reactions: Lung Neoplasm Malignant

Drug(s) suspected as cause:
Accolate

Other drugs received by patient: Albuterol Sulate; Prochlorperazine MAL; Fluticasone Propiona; Lansoprazole; Lortab; Advair Diskus 100 / 50; Fexofenadine HCL; Ventolin HFA; Dexamethasone; Lorazepam; Ciprofloxacin HCL; Amlodipine Besylate; Spiriva; Citalopram Hydrobrom



Possible Accolate side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 59 year old female

Reactions: Drug Dose Omission, Asthma, Pneumonia, Dyspnoea, Spinal Fracture, Muscular Weakness, Immunodeficiency, Lung Disorder, Gait Disturbance, Depression, Multiple Allergies

Drug(s) suspected as cause:
Accolate



Possible Accolate side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 55 year old female

Reactions: Drug Dose Omission, Dyspnoea, Memory Impairment

Drug(s) suspected as cause:
Accolate



Possible Accolate side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 65 year old female

Reactions: Drug Dose Omission, Pain, Headache, Fall, Malaise, Dizziness, Nasal Dryness, Depression, Sinusitis, Muscle Spasms, Cough, Hypersomnia, Drug Hypersensitivity, Incorrect Dose Administered, Muscular Weakness, Rhinorrhoea, Feeling Abnormal

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Atacand
    Administration route: Oral

Atacand HCT
    Dosage: 32/12.5 mg
    Administration route: Oral

Crestor
    Administration route: Oral
    Start date: 2008-09-08

Nexium
    Administration route: Oral

Rhinocort
    Dosage: two sprays per day
    Indication: Hypersensitivity

Rhinocort
    Dosage: four sprays per day

Symbicort

Other drugs received by patient: Boniva



Possible Accolate side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 74 year old female

Reactions: Back Pain, Dyspnoea, Nausea, Pain, Fall, Loss of Consciousness, Malaise, Memory Impairment, Bladder Disorder, Spinal Deformity, Back Disorder

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort

Other drugs received by patient: Oxycodone HCL



Possible Accolate side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Blood Iron Decreased, Blood Thyroid Stimulating Hormone Decreased

Drug(s) suspected as cause:
Accolate
    Administration route: Oral
    Indication: Asthma

Pulmicort Flexhaler
    Indication: Asthma
    Start date: 2012-01-24

Other drugs received by patient: Pepsidase; Lorazepam; Synthroid



Possible Accolate side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 55 year old female

Reactions: Drug Dose Omission, Respiratory Disorder, Dyspnoea

Drug(s) suspected as cause:
Accolate
    Administration route: Oral

Pulmicort Flexhaler



Possible Accolate side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: 71 year old male

Reactions: Dyspnoea, Drug Ineffective

Drug(s) suspected as cause:
Accolate

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