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 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 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 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 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 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 2012-08-21
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 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 2012-08-20
Patient: female
Reactions: Respiratory Tract Infection Bacterial, Bronchiectasis
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 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 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 2012-08-14
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 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 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 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 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 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 2012-08-07
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 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 female
Reported by a physician from United States on 2012-08-06
Patient: female
Reactions: Abdominal Pain, Pancreatitis Acute, Dysphonia, Laryngitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobi
Tobi
Dosage: 300 mg, bid, alternative 28 days
Indication: Cystic Fibrosis
End date: 2011-12-28
Other drugs received by patient: Adek; Albuterol; Pulmozyme; Morphine; Omeprazole; Creon; Prilosec; Zofran; Advair Diskus 100 / 50; Valten; Boniva
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