This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zyflo CR (Zileuton) 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 (9)
Death (2)
Life Threatening Events (1)
Reports by Reaction Type
Palpitations (3),
Drug Ineffective (2),
Death (2),
Product Quality Issue (2),
Alanine Aminotransferase Increased (2),
Aspartate Aminotransferase Increased (2),
Blood Bilirubin Increased (1),
Hypersensitivity (1),
Pyrexia (1),
Fatigue (1),
Mood Altered (1),
Product Formulation Issue (1)
Possible Zyflo CR side effects in 36 year old male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 36 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Zyflo CR
Other drugs received by patient: Advair; Zolair
Possible Zyflo CR side effects in male
Reported by a physician from United States on 2012-07-02
Patient: male, weighing 123.0 kg (270.6 pounds)
Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
Drug(s) suspected as cause:
Zyflo CR
Other drugs received by patient: Symbicort; Nexium; Multi-Vitamin; Coq10; Ipratropium Bromide; Calcium; Vitamin D; Zocor; Combivent; Furosemide; Naproxen; Klor-CON; Hctz / Microzide; Fish OIL; Magnesium Sulfate; Zestril; Montelukast / Singular; Gabapentin
Possible Zyflo CR side effects in male
Reported by a physician from United States on 2012-06-04
Patient: male
Reactions: Breast Mass
Drug(s) suspected as cause:
Zyflo CR
Possible Zyflo CR side effects in male
Reported by a physician from United States on 2012-04-25
Patient: male
Reactions: Blood Bilirubin Increased, Fatigue, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Headache, Pyrexia
Drug(s) suspected as cause:
Zyflo CR
Other drugs received by patient: Proair HFA; Pulmicort; Alvesco
Possible Zyflo CR side effects in male
Reported by a individual with unspecified qualification from United States on 2012-04-11
Patient: male
Reactions: Blood Pressure Increased, Heart Rate Decreased, Palpitations
Drug(s) suspected as cause:
Zyflo CR
Other drugs received by patient: Ongliza; Metformin HCL; Singulair; Lisinopril; Zyrtec; Carvediolor; Spiriva; Lipitor; Advair Diskus 100 / 50
Possible Zyflo CR side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-24
Patient: female
Reactions: Product Quality Issue, Palpitations, Drug Ineffective
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyflo CR
Possible Zyflo CR side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-10
Patient: female
Reactions: Death, Product Quality Issue, Palpitations, Drug Ineffective
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zyflo CR
Possible Zyflo CR side effects in female
Reported by a physician from United States on 2011-12-01
Patient: female
Reactions: Angioedema, Hypersensitivity, Middle Ear Effusion, Nausea, Sinus Headache, Rhinorrhoea, Hyperhidrosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zyflo CR
Other drugs received by patient: Vitamin D
Possible Zyflo CR side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-10
Patient: 54 year old female, weighing 86.2 kg (189.6 pounds)
Reactions: Product Formulation Issue, Mood Altered, Arthralgia, Decreased Activity, Treatment Failure, Exercise Tolerance Decreased
Drug(s) suspected as cause:
Zyflo CR
Dosage: 2 tabs
Administration route: Oral
Indication: Bronchial Hyperreactivity
Zyflo CR
Dosage: 2 tabs
Administration route: Oral
Indication: Asthma
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