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 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 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 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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