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Review Zyflo Safety Reports submitted to FDA

Total Zyflo reports: 15.
Zyflo FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 7.
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FDA Reported Zyflo Side Effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic enzyme increased, lethargy, hepatomegaly, chest pain, asthenia, abdominal pain, muscle twitching, influenza like illness.
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Zyflo Side Effects Report #5677954-9
Consumer or non-health professional from UNITED STATES reported ZYFLO problem on Mar 03, 2008. Female patient, weighting 180.0 lb, was diagnosed with sinusitis and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: chest discomfort, rash, wheezing. ZYFLO dosage: unknown. During the same period patient was treated with CENTRUM, OSCAL, ASPIRIN. Patient recovered.

Zyflo Side Effects Report #5642311-8
ZYFLO problem was reported by a Physician from UNITED STATES on Feb 07, 2008. Male patient, weighting 200.0 lb, was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, stevens-johnson syndrome. ZYFLO dosage: (1200 MG BID ORAL). During the same period patient was treated with SPIRIVA, SINGULAIR. Patient was hospitalized. Patient recovered.

Zyflo Side Effects Report #5601022-5
Physician from UNITED STATES reported ZYFLO problem on Jan 22, 2008. Female patient, 49 years of age, weighting 142.0 lb, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. ZYFLO dosage: 600 MG FIRST TABLET PO. Patient recovered.

Zyflo Side Effects Report #5606588-7
ZYFLO problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 09, 2008. Female patient was diagnosed with sinusitis and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: chest discomfort, rash, wheezing. ZYFLO dosage: unknown. During the same period patient was treated with CENTRUM, OSCAL, ECOTRIN. Patient recovered.

Zyflo Side Effects Report #5627238-X
Physician from UNITED STATES reported ZYFLO problem on Aug 29, 2007. Female patient, weighting 235.0 lb, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: white blood cell count decreased. ZYFLO dosage: unknown. During the same period patient was treated with ADVAIR HFA, PREVACID. Patient was hospitalized. Patient recovered.

Zyflo Side Effects Report #5627239-1
ZYFLO problem was reported by a Physician from UNITED STATES on Aug 17, 2007. Male patient was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: adverse event, hepatic enzyme increased. ZYFLO dosage: unknown. Patient recovered.

Zyflo Side Effects Report #5543732-4
Physician from UNITED STATES reported ZYFLO problem on Nov 20, 2007. Male patient, weighting 214.0 lb, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, eosinophil percentage increased, fatigue, feeling abnormal, serum ferritin increased. ZYFLO dosage: (600 MG QID ORAL). During the same period patient was treated with ALBUTEROL SULPHATE, ZYRTEC, LISINOPRIL, FLONASE, CHLORIDE, QVAR, SYMBICORT, SINGULAIR. Patient recovered.

Zyflo Side Effects Report #5513340-X
ZYFLO problem was reported by a Physician from UNITED STATES on Oct 23, 2007. Male patient, weighting 203.0 lb, was diagnosed with mastocytosis and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: condition aggravated, mastocytosis, palpitations. ZYFLO dosage: 600 MG QID ORAL. During the same period patient was treated with PAROXETINE, GASTROCROM, HYDROXYZINE, FOSAMAX, VITAMIN D. Patient was hospitalized. Patient recovered.

Zyflo Side Effects Report #5475643-7
Physician from UNITED STATES reported ZYFLO problem on Sept 13, 2007. Female patient, weighting 262.0 lb, was diagnosed with asthma, status asthmaticus, arthralgia, atrial fibrillation and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, renal failure acute. ZYFLO dosage: unknown. During the same period patient was treated with DIOVAN, BENAZEPRIL, MOBIC, COUMADIN, PREDNISONE. Patient was hospitalized. Patient recovered.

Zyflo Side Effects Report #5494557-X
ZYFLO problem was reported by a Pharmacist from UNITED STATES on Oct 05, 2007. Male patient was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: clostridial infection, white blood cell count decreased. ZYFLO dosage: unknown. Patient was hospitalized. Patient recovered.

Zyflo Side Effects Report #5501131-5
Physician from UNITED STATES reported ZYFLO problem on Oct 10, 2007. Female patient, weighting 249.0 lb, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cardiac failure congestive, cardiogenic shock, cardiomegaly, cardiomyopathy, cholecystectomy, myocardial infarction. ZYFLO dosage: (60 MG QID ORAL). During the same period patient was treated with AMIODARONE, DIGOXIN, LOVENOX, ALBUTEROL, BUDESONIDE, ATROVENT, AVELOX, PREDNISONE. Patient was hospitalized. Patient died on 08/11/2007.

Zyflo Side Effects Report #5445720-5
ZYFLO problem was reported by a Physician from UNITED STATES on Aug 17, 2007. Female patient, 33 years of age, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: asthma, cardiomyopathy. ZYFLO dosage: unknown. During the same period patient was treated with AMIODARONE, DIGOXIN, LOVENOX, ALBUTEROL, BUDESONIDE, ATROVENT, AVELOX, PREDNISONE. Patient was hospitalized. Patient died on 08/16/2007.

Zyflo Side Effects Report #5412158-6
Physician from UNITED STATES reported ZYFLO problem on July 24, 2007. Male patient, weighting 214.0 lb, was diagnosed with asthma and was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, feeling abnormal, serum ferritin increased. ZYFLO dosage: unknown. Patient recovered.

Zyflo Side Effects Report #5400911-4
ZYFLO problem was reported by a Physician from UNITED STATES on July 09, 2007. Male patient, 70 years of age, was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, hepatic enzyme increased, jaundice, pruritus. ZYFLO dosage: unknown. Patient recovered.

Zyflo Side Effects Report #5400911-4
Physician from UNITED STATES reported ZYFLO problem on July 09, 2007. Male patient, 70 years of age, was treated with ZYFLO. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, hepatic enzyme increased, jaundice, pruritus. ZYFLO dosage: unknown. Patient recovered.


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chest discomfort, rash, wheezing, hypersensitivity, stevens-johnson syndrome, supraventricular tachycardia, , was diagnosed with sinusitis and was diagnosed with asthma and was diagnosed with sinusitis and was diagnosed with asthma and