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Zileuton adverse events reported to FDA.

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Summary

FDA Adverse Reports: 7. View All

Zileuton FDA safety alerts: 2009

Reported deaths: 1

Reported hospitalizations: 11

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Often additional risks of using a medication, such as Zileuton, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Zileuton users, Learn more about unwanted side effects & find ways to reduce them. Browse Zileuton Adverse Reports reported to FDA and participate in Zileuton discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Zileuton. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Zileuton Adverse Effect Reports (FDA)

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4736436-9 | Blood Sodium Decreased, Dehydration, Gangrene, Insomnia, Neutropenia, Oral Intake Reduced, Thrombocytopenia
on Jul 19, 2005 Male patient from UNITED STATES , 59 years of age, weighting 163.1 lb, was diagnosed with non-small cell lung cancer and was treated with Zileuton (View Usage). Patient experienced the following unwanted or unexpected effects: blood sodium decreased, dehydration, gangrene, insomnia, neutropenia, oral intake reduced, thrombocytopenia. Zileuton dosage: 600 Mg Qid Po. During the same period patient was treated with CARBOPLATIN (729 Mg Iv) (View Carboplatin Review and Carboplatin Label ), GEMCITABINE (3690 Mg Iv) (View Gemcitabine Review and Gemcitabine Label ), CELECOXIB (10400 Mg Po) (View Celecoxib Review and Celecoxib Label ). Patient was hospitalized.

4736435-7 | Atrial Fibrillation, Cyanosis, Haemodynamic Instability, Loss Of Consciousness, Myocardial Infarction, Myocardial Ischaemia, Pericardial Effusion, Respiratory Distress, Syncope
Patient was taking Zileuton (View Usage). Patient had the following side effects: atrial fibrillation (What is atrial fibrillation?), cyanosis, haemodynamic instability, loss of consciousness, myocardial infarction, myocardial ischaemia, pericardial effusion, respiratory distress, syncope on Jul 19, 2005 from UNITED STATES Additional patient health information: Male patient , 66 years of age, weighting 150.8 lb, was diagnosed with non-small cell lung cancer and. Zileuton dosage: 600 Mg Qid Po. During the same period patient was treated with CARBOPLATIN (489 Mg Once Iv) (View Carboplatin Review and Carboplatin Label ), GEMCITABINE (1710 Mg Once Iv) (View Gemcitabine Review and Gemcitabine Label ).

4717683-9 | Asthenia, Bacteria Urine, Bacterial Infection, Decreased Appetite, Fatigue, Haemolytic Anaemia, Hypotension, International Normalised Ratio Increased, Otitis Externa
Adverse event was reported on Jun 29, 2005 by a Male patient taking Zileuton (View Usage) (Dosage: 2400 Mg Qid Po) was diagnosed with non-small cell lung cancer and. Location: UNITED STATES , 60 years of age, weighting 154.3 lb, After Zileuton was administered, patient had the following side effects: asthenia, bacteria urine, bacterial infection (What is bacterial infection?), decreased appetite, fatigue, haemolytic anaemia, hypotension, international normalised ratio increased, otitis externa. During the same period patient was treated with GEMCITABINE (1000 Mg/m2 Qwk Iv) (View Gemcitabine Review and Gemcitabine Label ), CARBOPLATIN (375 Mg Once Iv) (View Carboplatin Review and Carboplatin Label ), CELECOXIB (400 Mg Bid Po) (View Celecoxib Review and Celecoxib Label ). Patient was hospitalized.

4717682-7 | Abasia, Blood Creatine Phosphokinase Increased, Myalgia, Myositis, Nausea, Pain In Extremity, Pneumonia, Sinus Tachycardia
on Jun 29, 2005 Male patient from UNITED STATES , 52 years of age, weighting 141.3 lb, was diagnosed with non-small cell lung cancer and was treated with Zileuton (View Usage). Patient experienced the following unwanted or unexpected effects: abasia, blood creatine phosphokinase increased, myalgia, myositis (What is myositis?), nausea (What is nausea?), pain in extremity, pneumonia (What is pneumonia?), sinus tachycardia. Zileuton dosage: 600 Mg Qid Po. During the same period patient was treated with GEMCITABINE (1730 Mg Qwk Iv) (View Gemcitabine Review and Gemcitabine Label ), CARBOPLATIN (677 Mg Once Iv) (View Carboplatin Review and Carboplatin Label ). Patient was hospitalized.


4717335-5 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Platelet Count Decreased, White Blood Cell Count Decreased
on Jun 29, 2005 Male patient from UNITED STATES , 54 years of age, weighting 247.6 lb, was diagnosed with non-small cell lung cancer and was treated with Zileuton (View Usage). Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, platelet count decreased, white blood cell count decreased. Zileuton dosage: 600 Mg Qid Po. During the same period patient was treated with CARBOPLATIN (810 Mg Qday Iv) (View Carboplatin Review and Carboplatin Label ), CELECOXIB (400 Mg Bid Po) (View Celecoxib Review and Celecoxib Label ), GEMCITABINE (100 Mg/m2 Qwk Iv) (View Gemcitabine Review and Gemcitabine Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ), DOCUSATE NA (View Docusate Na Review and Docusate Na Label ), MILK OF MAGNESIA (View Milk Of Magnesia Review and Milk Of Magnesia Label ), PROCHLORPERAZINE MALEATE (View Prochlorperazine Maleate Review and Prochlorperazine Maleate Label ).

4717333-1 | Blood Albumin Decreased, Blood Sodium Decreased, Blood Urea Increased, Chills, Dehydration, Diarrhoea, Dizziness, Haematocrit Decreased
Patient was taking Zileuton (View Usage). After Zileuton was administered, patient had the following side effects: blood albumin decreased, blood sodium decreased, blood urea increased, chills, dehydration, diarrhoea, dizziness (What is dizziness?), haematocrit decreased on Jun 29, 2005 from UNITED STATES Additional patient health information: Male patient , 80 years of age, weighting 130.3 lb, was diagnosed with non-small cell lung cancer and. Zileuton dosage: 600 Mg Qid Po. During the same period patient was treated with CARBOPLATIN (352 Mg Once Iv) (View Carboplatin Review and Carboplatin Label ), GEMCITABINE (1630 Mg Qwk Iv) (View Gemcitabine Review and Gemcitabine Label ), ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (View Albuterol Sulfate And Ipratropium Bromide Review and Albuterol Sulfate And Ipratropium Bromide Label ), ATENOLOL (View Atenolol Review and Atenolol Label ), DILTIAZEM (View Diltiazem Review and Diltiazem Label ), FOSINOPRIL NA (View Fosinopril Na Review and Fosinopril Na Label ), ISOSORBIDE DINITRATE (View Isosorbide Dinitrate Review and Isosorbide Dinitrate Label ), MORPHINE (View Morphine Review and Morphine Label ). Patient was hospitalized.

4717332-X | Anaemia, Blood Urea Increased, Coagulopathy, Deep Vein Thrombosis, Dizziness, Dyspnoea, Epistaxis, Gastritis, Gastrointestinal Haemorrhage
Adverse event was reported on Jun 25, 2005 by a Male patient taking Zileuton (View Usage) (Dosage: 600 Mg Qid Po) was diagnosed with non-small cell lung cancer and. Location: UNITED STATES , 64 years of age, weighting 280.0 lb, Patient experienced the following unwanted or unexpected effects: anaemia, blood urea increased, coagulopathy, deep vein thrombosis (What is deep vein thrombosis?), dizziness (What is dizziness?), dyspnoea, epistaxis, gastritis, gastrointestinal haemorrhage. During the same period patient was treated with GEMCITABINE (1000 Mq/sqm Q3wks Iv) (View Gemcitabine Review and Gemcitabine Label ), CARBOPLATIN (960 Mg Q3wks Iv) (View Carboplatin Review and Carboplatin Label ), ATENOLOL (View Atenolol Review and Atenolol Label ), COUMADIN (View Coumadin Review and Coumadin Label ), LIPITOR (View Lipitor Review and Lipitor Label ), TRUSOPT (View Trusopt Review and Trusopt Label ), AMARYL (View Amaryl Review and Amaryl Label ), HYDROCODONE BITARTRATE (View Hydrocodone Bitartrate Review and Hydrocodone Bitartrate Label ). Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Zileuton risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Zileuton quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Zileuton use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Zileuton Reactions
Abasia
Alanine Aminotransferase Increased
Anaemia
Aspartate Aminotransferase Increased
Asthenia
Atrial FibrillationWhat is Atrial fibrillation?
Bacteria Urine
Bacterial InfectionWhat is Bacterial infection?
Blood Albumin Decreased
Blood Alkaline Phosphatase Increased
Blood Creatine Phosphokinase Increased
Blood Sodium Decreased
Blood Urea Increased
Chills
Coagulopathy
Cyanosis
Decreased Appetite
Deep Vein ThrombosisWhat is Deep vein thrombosis?
Dehydration
Diarrhoea
DizzinessWhat is Dizziness?
Dyspnoea
Epistaxis
Fatigue
Gangrene
Gastritis
Gastrointestinal Haemorrhage
Haematocrit Decreased
Haemodynamic Instability
Haemolytic Anaemia
Zileuton Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Zileuton adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!