Index of reports
> Life Threatening Events (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tobi (Tobramycin Inhalation) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Tobi side effects in male
Reported by a physician from Germany on 2012-07-25
Patient: male, weighing 58.0 kg (127.6 pounds)
Reactions: Post Procedural Complication, Bronchial Disorder, Cough, Epistaxis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Azithromycin; Albuterol Sulfate; Spiriva; Symbicort
Possible Tobi side effects in male
Reported by a physician from Germany on 2012-07-13
Patient: male
Reactions: Bronchial Disorder, Post Procedural Complication, Cough
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tobi
Possible Tobi side effects in 78 year old female
Reported by a physician from Canada on 2012-04-20
Patient: 78 year old female
Reactions: LIP Swelling, Pruritus, Rash Generalised, Angioedema, Hypotension, Immunodeficiency, Febrile Neutropenia, Swollen Tongue, Pyrexia, Neuropathy Peripheral, Feeling Hot, Dermatitis Bullous, Neutropenia, Dermatitis Exfoliative, Rash Maculo-Papular
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
Dosage: unk
Indication: Febrile Neutropenia
Start date: 2010-11-04
End date: 2010-11-05
Lenalidomide
Dosage: 25 mg, qd
Administration route: Oral
Indication: Myelodysplastic Syndrome
Start date: 2010-10-29
Ancef
Dosage: unk
Start date: 2010-11-04
End date: 2010-11-05
Other drugs received by patient: Velcade
Possible Tobi side effects in male
Reported by a pharmacist from Ireland on 2012-04-02
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Renal Impairment, Nephropathy Toxic, Dehydration, Oedema, Rash, Toxicity To Various Agents, Blood Creatinine Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Neoral
Dosage: 150 mg, bid
Indication: Rheumatoid Arthritis
Prograf
Neoral
Indication: Transplant
Tacrolimus
Dosage: 1 df, variable dose target trough 10-12
Start date: 2011-07-14
Tacrolimus
Dosage: 1 df, variable dose target trough 10-12
Start date: 2010-10-14
Tobi
Dosage: 300 mg, bid
Indication: Pseudomonas Infection
Start date: 2011-09-06
End date: 2011-12-01
Other drugs received by patient: Myfortic; Sterimar; Magnesium; Prednisolone; Alfacalcidol; Furosemide; Micera; Lansoprazole; Alendronate Sodium; Nystatin; Azithromycin; Symbicort; Vitamin D; Septin; Folic Acid; Fungizone; Bicarbonate; Chlorhexidine Gluconate; Atorvastatin; Calcium Carbonate; Immunosuppressants
Possible Tobi side effects in male
Reported by a pharmacist from Ireland on 2012-02-13
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Renal Impairment, Nephropathy Toxic, Dehydration, Oedema, Toxicity To Various Agents, Rash, Blood Creatinine
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Neoral
Dosage: 150 mg, bid
Indication: Rheumatoid Arthritis
Tacrolimus
Tobi
Dosage: 300 mg, bid
Indication: Pseudomonas Infection
Start date: 2011-09-06
End date: 2011-12-01
Other drugs received by patient: Prednisolone; Vitamin D; Furosemide; Chlorhexidine Gluconate; Alendronate Sodium; Sterimar; Nystatin; Lansoprazole; Alfacalcidol; Myfortic; Calcium Carbonate; Immunosuppressants; Septin; Fungizone; Folic Acid; Azithromycin; Atorvastatin; Magnesium; Symbicort
Possible Tobi side effects in male
Reported by a pharmacist from Ireland on 2012-01-13
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Renal Impairment, Dehydration, Oedema, Rash, Blood Creatinine
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Myfortic; Prednisolone; Septin; Folic Acid; Sterimar; Magnesium; Symbicort; Lansoprazole; Nystatin; Chlorhexidine Gluconate; Furosemide; Calcium Carbonate; Azithromycin; Fungizone; Atorvastatin; Neoral; Immunosuppressants; Vitamin D; Alfacalcidol; Alendronate Sodium
Possible Tobi side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: female
Reactions: Death, Respiratory Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
Indication: Bronchiectasis
Tobi
Dosage: 300 mg, bid
Indication: Obstructive Airways Disorder
Start date: 2010-11-19
Tobi
Indication: Bronchitis Chronic
Possible Tobi side effects in male
Reported by a pharmacist from Ireland on 2011-12-14
Patient: male
Reactions: Renal Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Neoral
Possible Tobi side effects in
Reported by a pharmacist from Ireland on 2011-12-12
Patient:
Reactions: Renal Failure, Toxicity To Various Agents
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Neoral
Possible Tobi side effects in female
Reported by a individual with unspecified qualification from United States on 2011-12-06
Patient: female
Reactions: Weight Decreased, Prolonged Expiration, Abdominal Pain, Night Sweats, Contusion, Pyrexia, Abdominal Discomfort, Palpitations, Ecchymosis, Oedema Peripheral, Cough, Ventricular Extrasystoles, Chest Discomfort, Haematuria, Anaemia, Dyspnoea Paroxysmal Nocturnal, Left Ventricular END-Diastolic Pressure Increased, Nasal Congestion, Delirium, Intermittent Claudication, Dehydration, Ischaemia, Renal Necrosis, Haemorrhage, Wheezing, Aortic Aneurysm, Constipation, Gastritis, Dizziness, Orthopnoea, Fluid Overload, Dyspnoea, Nausea, Haemoptysis, Diastolic Dysfunction, Blood Creatine Increased, Renal Failure, Arthralgia, Rhythm Idioventricular
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Vitamin D; Wellbutrin SR; Anusol HC; Albuterol; Pepcid; Levaquin; Flexeril; Mucinex; Carafate; Protonix; Mineral OIL Emulsion; Vicodin; Ambien; Multi-Vitamin; Lubiprostone; Magnesium Sulfate; Aspirin; Phoslo; Splenium; Nasonex; Fluoxetine; Advair Diskus 100 / 50; Nebivolol HCL; Estradiol; Promethazine; Phenergan; Lipitor; Bystolic; Flonase; Beta Blocking Agents; Percocet; Lisinopril; Spiriva; Pepcid; Metformin HCL; Fluconazole; Famotidine
Possible Tobi side effects in female
Reported by a physician from United States on 2011-11-10
Patient: female
Reactions: Death, Respiratory Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
Indication: Bronchitis Chronic
Tobi
Dosage: 300 mg, bid
Indication: Obstructive Airways Disorder
Start date: 2010-11-19
Possible Tobi side effects in female
Reported by a physician from United States on 2011-10-31
Patient: female
Reactions: Abdominal Pain, Prolonged Expiration, Night Sweats, Weight Decreased, Contusion, Pyrexia, Abdominal Discomfort, Palpitations, Oedema Peripheral, Ecchymosis, Cough, Ventricular Extrasystoles, Chest Discomfort, Dyspnoea Paroxysmal Nocturnal, Haematuria, Left Ventricular END-Diastolic Pressure Increased, Anaemia, Nasal Congestion, Delirium, Intermittent Claudication, Dehydration, Ischaemia, Renal Necrosis, Haemorrhage, Aortic Aneurysm, Wheezing, Constipation, Gastritis, Orthopnoea, Dizziness, Fluid Overload, Dyspnoea, Haemoptysis, Nausea, Diastolic Dysfunction, Blood Creatine Increased, Renal Failure, Arthralgia, Rhythm Idioventricular
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
Other drugs received by patient: Flexeril; Metformin HCL; Mineral OIL Emulsion; Advair Diskus 100 / 50; Aspirin; Mucinex; Flonase; Lubiprostone; Beta Blocking Agents; Nasonex; Estradiol; Multi-Vitamin; Carafate; Magnesium; Splenium; Fluoxetine HCL; Pepcid; Protonix; Lisinopril; Levaquin; Phoslo; Vicodin; Fluconazole; Percocet; Famotidine; Nebivolol HCL; Pepcid; Promethazine; Vitamin D; Lipitor; Bystolic; Spiriva; Wellbutrin SR; Anusol HC; Albuterol; Ambien; Phenergan HCL
Possible Tobi side effects in female
Reported by a individual with unspecified qualification from United States on 2011-10-25
Patient: female
Reactions: Renal Failure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tobi
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