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Tobi (Tobramycin Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tobi (Tobramycin Inhalation) 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 (745)
Death (196)
Life Threatening Events (13)
Disability (7)

Reports by Reaction Type

Death (157)Infective Pulmonary Exacerbation of Cystic Fibrosis (87)Upper Respiratory Tract Infection (72)Dyspnoea (66)Cough (58)Pneumonia (54)Pseudomonas Infection (42)Lung Infection (37)Cystic Fibrosis (36)Pulmonary Function Test Decreased (30)Dysphonia (28)Infection (26)

Below are a few examples of reports where side effects / adverse reactions may be related to Tobi (Tobramycin Inhalation). For a complete list or a specific selection of reports, please use the links above.

Possible Tobi side effects in

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-08-27

Patient:

Reactions: Vomiting, Haemoptysis, Cough

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a physician from Germany on 2012-08-27

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Pulmonary Haemorrhage, Dysphonia, Haematuria, Tachypnoea, Pyrexia, Gynaecomastia, Oxygen Saturation Decreased, Infective Pulmonary Exacerbation of Cystic Fibrosis

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Creon; Vitamin E; Kanavit; Cotrim DS; Atrovent; Singulair; Colistin; Spiriva; Vitamin K TAB; Cotrim DS; Pulmicort; Vitamin A; Fluticasone Propionate / Salmeterol; Pulmozyme; Nexium; Zithromax; Ambisome; Cetirizine; Bosul; Bosul; Creon; Urso Falk; Escitalopram; Prednisone TAB; Insulin; Bosul; Mirtazapine; Vitamin D



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Cystic Fibrosis, Pseudomonas Infection, Condition Aggravated

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in 32 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 32 year old female

Reactions: Pulmonary Haemorrhage

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: male, weighing 100.5 kg (221.1 pounds)

Reactions: Chest Discomfort, Bronchospasm

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Pneumonia, Blood Potassium Decreased, Dehydration, Pulmonary Oedema, Blood Sodium Decreased, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Lisinopril; Aspirin; Sodium Bicarbonate; Potassium Chloride; Lasix; Warfarin Sodium; Metformin



Possible Tobi side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Small Intestinal Obstruction, Pseudomonas Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Tracheal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male

Reactions: Infective Pulmonary Exacerbation of Cystic Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in 71 year old female

Reported by a physician from United States on 2012-08-21

Patient: 71 year old female, weighing 98.9 kg (217.5 pounds)

Reactions: Pseudomonas Infection, Sjogren's Syndrome, Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi
    Dosage: 300 mg, bid, 28 days on and 28 days off
    Indication: Sjogren's Syndrome
    Start date: 2011-01-06

Tobi
    Dosage: 300 mg, bid
    Start date: 2012-02-02

Other drugs received by patient: Nexium; Albuterol; Pulmicort



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Respiratory Tract Infection Bacterial, Bronchiectasis

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Chronic Lymphocytic Leukaemia, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Chemotherapeutics NOS



Possible Tobi side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female

Reactions: Dysphonia, Wrist Fracture, Pain, Hearing Impaired

Drug(s) suspected as cause:
Tobi
    Dosage: 5 ml, bid
    Start date: 2012-04-16

Tobi
    Dosage: 300 mg, bid
    Indication: Bronchitis

Tobi
    Dosage: 5 ml, bid
    Indication: Lung Disorder
    Start date: 2012-06-01

Other drugs received by patient: Fluticasone Propionate



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Malaise, Fungal Infection, Intestinal Malrotation, Blood Glucose Increased, Pulmonary Function Test Decreased, Infective Pulmonary Exacerbation of Cystic Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Saline; Vitamin TAB; Pancrelipase; Pulmozyme; Cayston; Albuterol



Possible Tobi side effects in 73 year old female

Reported by a physician from United States on 2012-08-15

Patient: 73 year old female

Reactions: Dyspnoea, Anaphylactic Reaction

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Xopenex



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 65.9 kg (145.0 pounds)

Reactions: Swelling Face, Malaise, Vena Cava Thrombosis, Pneumothorax, Hearing Impaired, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi
    Dosage: 300 mg, bid
    Indication: Cystic Fibrosis
    Start date: 2012-02-03
    End date: 2012-04-03

Tobi
    Indication: Bronchiectasis

Other drugs received by patient: Tikosyn; Atacand; Aspirin; Symbicort; Spirma; Singulair



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Metoprolol; Symbicort; Flovent; Primidone; Plavix; Xanax; Tamsulosin HCL; Prednisone TAB; Albuterol; Azithromycin; Sertraline Hydrochloride; Omeprazole; Dexilant; Bactrim; Aspirin; Cardizem; Mucinex; Nystatin



Possible Tobi side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male

Reactions: Death, Syncope, Dizziness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-08-13

Patient: male

Reactions: Malaise, Device Issue, Coagulopathy, Gait Disturbance, Cardiac Disorder

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13

Patient: female

Reactions: Cough, Lower Respiratory Tract Infection

Drug(s) suspected as cause:
Tobi
    Dosage: 112 mg, bid
    Indication: Cystic Fibrosis
    Start date: 2012-06-21
    End date: 2012-06-28

Tobi
    Indication: Cough

Tobi
    Indication: Pseudomonas Infection

Other drugs received by patient: Colistin Sulfate; Pulmozyme; Combivent



Possible Tobi side effects in female

Reported by a physician from Netherlands on 2012-08-13

Patient: female

Reactions: Nausea, Deafness, Dizziness

Drug(s) suspected as cause:
Tobi
    Dosage: 1 df, bid
    Indication: Bronchiectasis
    Start date: 2012-08-03

Tobi
    Dosage: 4 df, once daily



Possible Tobi side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi

Other drugs received by patient: Cardizem; Aspirin; Sertraline Hydrochloride; Nystatin; Symbicort; Tamsulosin HCL; Primidone; Dexilant; Albuterol; Bactrim; Metoprolol Tartrate; Flovent; Prednisone TAB; Mucinex; Plavix; Omeprazole; Xanax; Azithromycin



Possible Tobi side effects in 8 year old male

Reported by a physician from United States on 2012-08-09

Patient: 8 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-08-07

Patient: female

Reactions: Cystic Fibrosis, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Respiratory Tract Congestion, Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female

Reactions: Chest Discomfort, Tinnitus, Dysphonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi



Possible Tobi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Gastric Cancer Stage IV

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobi

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