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Zyflo CR (Zileuton) - Side Effect Reports to FDA

 
 



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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