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Tobramycin (Tobramycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tobramycin 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 (80)
Death (6)
Life Threatening Events (5)
Disability (2)

Reports by Reaction Type

Intraocular Pressure Increased (7)Decreased Appetite (7)Vision Blurred (7)Drug Ineffective (6)Pyrexia (6)Eye Oedema (5)Visual Acuity Reduced (5)Angioedema (5)Drug Hypersensitivity (5)Ageusia (5)Ocular Hyperaemia (5)Thrombocytopenia (4)

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

Possible Tobramycin side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Tobramycin
    Dosage: unk

Prilosec
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Prevacid
    Dosage: unk

Benadryl
    Dosage: unk

Keflex
    Dosage: unk

Demerol
    Dosage: unk



Possible Tobramycin side effects in 13 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-08-03

Patient: 13 year old female

Reactions: Aphagia, Renal Impairment, Malaise, Disseminated Intravascular Coagulation, Abnormal Behaviour, Pyrexia, Serum Sickness, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targocid
    Dosage: 400 mg (1x 1 / d)
    Indication: Hypogammaglobulinaemia
    Start date: 2012-05-28
    End date: 2012-06-11

Targocid
    Dosage: 400 mg (1x 1 / d)
    Indication: Staphylococcal Infection
    Start date: 2012-05-28
    End date: 2012-06-11

Ceftazidime
    Dosage: 4.5 g (2x 1/d)
    Indication: Staphylococcal Infection
    Start date: 2012-05-30

Tobramycin
    Dosage: 450 mg (1x 1/d)
    Indication: Staphylococcal Infection
    Start date: 2012-05-28
    End date: 2012-06-08

Other drugs received by patient: Taurine; Azithromycin; Acetaminophen; Colecalciferol; Vitamin E; Dornase Alfa; Fluticasone and Salmeterol; Pancrelipase; Albuterol Sulate; Theophylline; Omeprazole; Vitamin D; Phytonadione; Ursodiol; Vitamin A



Possible Tobramycin side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 64 year old female

Reactions: Pruritus, Ocular Hyperaemia, Swelling, Toxicity To Various Agents, Discomfort

Drug(s) suspected as cause:
Tobramycin



Possible Tobramycin side effects in male

Reported by a pharmacist from United States on 2012-07-02

Patient: male, weighing 108.0 kg (237.6 pounds)

Reactions: Dialysis, Escherichia Infection, Haemodialysis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin

Vancomycin



Possible Tobramycin side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-12

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error, Intercepted Medication Error

Drug(s) suspected as cause:
Clindamycin
    Dosage: injectable

Tobramycin
    Dosage: injectable



Possible Tobramycin side effects in female

Reported by a physician from United States on 2012-05-28

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Tobramycin
    Dosage: unk

Potassium Penicillin G
    Dosage: unk



Possible Tobramycin side effects in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23

Patient: 21 year old female

Reactions: Bartter's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin
    Dosage: 7 mg/kg, daily on hospital day 3, intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication

Rifampin
    Indication: Product Used FOR Unknown Indication

Amiloride HCL
    Dosage: 10 mg, daily
    Indication: Electrolyte Depletion



Possible Tobramycin side effects in female

Reported by a pharmacist from United States on 2012-05-16

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Tobramycin
    Dosage: twice a day
    Indication: Pseudomonas Infection

Zoledronic Acid
    Dosage: unk



Possible Tobramycin side effects in 21 year old female

Reported by a physician from United States on 2012-05-11

Patient: 21 year old female

Reactions: Pseudo-Bartter Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin
    Dosage: 7 mg/kg daily

Tobramycin

Other drugs received by patient: Rifampicin



Possible Tobramycin side effects in 55 year old male

Reported by a consumer/non-health professional from France on 2012-05-09

Patient: 55 year old male

Reactions: Grand MAL Convulsion, Overdose, Metabolic Acidosis, Hypotension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Dosage: daily dose 400 mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-22
    End date: 2009-12-23

Tobramycin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-20

Ciprofloxacin Hydrochloride
    Dosage: daily dose 400 mg
    Start date: 2009-12-26
    End date: 2010-01-01

Ciprofloxacin Hydrochloride
    Dosage: 400 mg, bid
    Start date: 2009-12-24
    End date: 2009-12-26

Imipenem and Cilastatin Sodium
    Dosage: 500 mg, bid
    Start date: 2010-01-24
    End date: 2010-01-24

Ciprofloxacin Hydrochloride
    Dosage: daily dose 200 mg
    Start date: 2010-01-02
    End date: 2010-01-21

Other drugs received by patient: Nicardipine Hydrochloride; Gentamicin; Imovane; Fluconazole; Previscan



Possible Tobramycin side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-09

Patient: female, weighing 11.3 kg (24.9 pounds)

Reactions: Croup Infectious, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 6 mg, ix
    Administration route: Oral
    Start date: 2011-08-17
    End date: 2011-08-17

Tobramycin
    Dosage: code not broken
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Dexamethasone
    Dosage: 6.5 mg, die
    Administration route: Oral
    Start date: 2011-08-14
    End date: 2011-08-16

Blinded NO Treatment Received
    Dosage: code not broken
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Placebo
    Dosage: code not broken
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Epinephrine
    Dosage: 5 ml 1/600 neb prn
    Start date: 2011-08-14
    End date: 2011-08-15

Other drugs received by patient: Tempra; Vitamin E; Cephalexin; Creon; Motilium; TRI-VI-SOL; Sodium Chloride



Possible Tobramycin side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: 84 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Ocular Hyperaemia, Drug Hypersensitivity, Localised Oedema, Eye Pruritus

Drug(s) suspected as cause:
Tobramycin



Possible Tobramycin side effects in female

Reported by a physician from Hungary on 2012-04-30

Patient: female

Reactions: Neutrophil Count Increased, C-Reactive Protein Increased, Burkholderia Test Positive, Pseudomonas Infection, Sputum Discoloured, Asphyxia, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin



Possible Tobramycin side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-27

Patient: 22 year old female

Reactions: Lymphadenopathy, Drug Ineffective, Tachycardia, Rales, Pyrexia, Serum Ferritin Increased, Shift To THE Left, C-Reactive Protein Increased, Still's Disease Adult Onset, Tachypnoea, Splenomegaly, Pharyngitis, Clubbing, Procalcitonin Increased, Dyspnoea, Rash, Computerised Tomogram Abnormal, Oropharyngeal Discomfort, Candida Test Positive, Tonsillar Disorder, Increased Viscosity of Nasal Secretion, Bacterial Disease Carrier, Arthralgia, Respiratory Failure, Rhonchi, Arthritis, Aspergillus Test Positive, Inflammation

Drug(s) suspected as cause:
Tobramycin

Other drugs received by patient: Pancreatic Enzymes; Penicillin V; Clarithromycin; Colistin Sulfate; Fluticasone Propionate / Salmeterol; Tiotropium Bromide; Meropenem



Possible Tobramycin side effects in 16 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-24

Patient: 16 year old female

Reactions: Arthralgia, Oedema Peripheral, Pain, Pyrexia, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin

Other drugs received by patient: Meropenem



Possible Tobramycin side effects in female

Reported by a physician from Canada on 2012-04-23

Patient: female, weighing 11.3 kg (24.9 pounds)

Reactions: Hypertension, Croup Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Dexamethasone
    Dosage: 6 mg, ix
    Administration route: Oral
    Start date: 2011-08-17
    End date: 2011-08-17

Blinded Placebo
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Dexamethasone
    Dosage: 6.5 mg, die
    Administration route: Oral
    Start date: 2011-08-14
    End date: 2011-08-16

Epinephrine
    Dosage: 5 ml 1/600 neb prn
    Start date: 2011-08-14
    End date: 2011-08-15

Blinded NO Treatment Received
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Other drugs received by patient: Sodium Chloride; Motilium; Cephalexin; TRI-VI-SOL; Tempra; Creon; Vitamin E



Possible Tobramycin side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-04-20

Patient: 63 year old female

Reactions: Scratch, Pneumonia, Wrist Fracture, Fungal Sepsis, Fall, Malaise, Staphylococcal Infection, Septic Shock, Renal Failure Acute, Ligament Sprain, Infarction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vancomycin
    Indication: Product Used FOR Unknown Indication

Tobramycin
    Indication: Product Used FOR Unknown Indication

Tigecycline
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Crohn's Disease

Other drugs received by patient: Zoloft; Vicodin; Lomotil; Bentyl; Potassium Chloride; Soma; Norvasc; Aciphex; Bupropion HCL; Quinapril and Hydrochlorothiazide; Ambien; Bystolic; Furosemide



Possible Tobramycin side effects in 69 year old male

Reported by a pharmacist from United States on 2012-04-18

Patient: 69 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Renal Tubular Necrosis, Toxicity To Various Agents, Renal Failure Acute, Haemodialysis

Drug(s) suspected as cause:
Tobramycin



Possible Tobramycin side effects in 78 year old female

Reported by a physician from Canada on 2012-04-18

Patient: 78 year old female

Reactions: Neuropathy Peripheral, Angioedema, Febrile Neutropenia, Rash Maculo-Papular

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tobramycin
    Indication: Febrile Neutropenia
    Start date: 2010-11-04
    End date: 2010-11-05

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Myelodysplastic Syndrome
    Start date: 2010-10-29
    End date: 2010-11-09

Ancef
    Indication: Febrile Neutropenia
    Start date: 2010-11-04
    End date: 2010-11-05

Other drugs received by patient: Velcade



Possible Tobramycin side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-18

Patient: female, weighing 11.3 kg (24.9 pounds)

Reactions: Hypertension, Croup Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Blinded NO Treatment Received
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Dexamethasone
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Start date: 2011-08-14
    End date: 2011-08-16

Epinephrine
    Dosage: 5 ml 1/600 neb prn
    Start date: 2011-08-14
    End date: 2011-08-15

Dexamethasone
    Dosage: 6 mg, ix
    Administration route: Oral
    Start date: 2011-08-17
    End date: 2011-08-17

Placebo
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2010-06-11
    End date: 2010-07-08

Other drugs received by patient: Vitamin E; Sodium Chloride; Tempra; Motilium; Creon; TRI-VI-SOL



Possible Tobramycin side effects in female

Reported by a physician from Canada on 2012-04-18

Patient: female, weighing 5.9 kg (13.1 pounds)

Reactions: Pseudomonas Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Placebo
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2011-04-19
    End date: 2011-05-04

Placebo
    Dosage: double blinded
    Start date: 2011-05-05
    End date: 2011-05-09

Placebo
    Dosage: double blinded
    Start date: 2011-05-09
    End date: 2011-05-19

Tobramycin
    Dosage: double blinded
    Start date: 2011-05-09
    End date: 2011-05-19

Tobramycin
    Dosage: double blinded
    Start date: 2011-05-05
    End date: 2011-05-09

Blinded NO Treatment Received
    Dosage: double blinded
    Start date: 2011-05-09
    End date: 2011-05-19

Blinded NO Treatment Received
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2011-04-19
    End date: 2011-05-04

Tobramycin
    Dosage: double blinded
    Indication: Pseudomonas Infection
    Start date: 2011-04-19
    End date: 2011-05-04

Blinded NO Treatment Received
    Dosage: double blinded
    Start date: 2011-05-05
    End date: 2011-05-09



Possible Tobramycin side effects in 66 year old female

Reported by a physician from United States on 2012-04-11

Patient: 66 year old female

Reactions: Corneal Thinning, Ulcerative Keratitis, Corneal Epithelium Defect, Pseudomonas Test Positive, Corneal Infiltrates, Hypopyon, Keratitis Bacterial, Corneal Oedema, Iritis, Keratitis

Drug(s) suspected as cause:
Prednisolone Acetate
    Dosage: (every 2 hours ophthalmic)

Ceftazidime
    Dosage: (50 mg/ml qid)

Tobramycin
    Dosage: (14 mg/ml every 30 minutes), (four times a day)



Possible Tobramycin side effects in female

Reported by a consumer/non-health professional from Canada on 2012-04-02

Patient: female

Reactions: Eye Infection, Laser Therapy, Eye Pain

Drug(s) suspected as cause:
Xalatan
    Dosage: 1 drop in each eye daily
    Indication: Glaucoma

Azarga
    Dosage: unk
    End date: 2011-06-01

Tobramycin
    Dosage: 1 gtt, 4x/day
    Indication: Eye Infection



Possible Tobramycin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30

Patient: 68 year old female

Reactions: Drug Ineffective, Cataract Operation Complication, Eye Oedema, Intraocular Pressure Increased, Vision Blurred, Polyarthritis

Drug(s) suspected as cause:
Celebrex
    Dosage: 200 mg; qd
    Indication: Polyarthritis

Acetazolamide
    Dosage: 125 mg;qd
    Indication: Eye Oedema

Ketorolac Tromethamine
    Dosage: oph
    Indication: Eye Oedema

Tobramycin
    Dosage: oph
    Indication: Eye Oedema
    End date: 2011-10-01

Omnipred
    Dosage: oph
    Administration route: Oral
    Indication: Eye Oedema

Propylene Glycol
    Dosage: oph
    Indication: Eye Oedema

Naproxen
    Indication: Polyarthritis
    End date: 2011-12-01

Simvastatin
    Indication: Blood Cholesterol Increased
    End date: 2011-10-01

Cortisone
    Dosage: qid
    Indication: Eye Oedema
    Start date: 2011-05-01

Lipitor
    Dosage: 20 mg;qd;po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-10-01

Pred Forte
    Dosage: oph
    Indication: Eye Oedema

Other drugs received by patient: Thiazide; Levoxyl



Possible Tobramycin side effects in female

Reported by a physician from United States on 2012-03-23

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine
    Dosage: unk

Gemfibrozil
    Dosage: unk

Timoptic
    Dosage: unk

Minitran
    Dosage: unk

Ergomar
    Dosage: unk

Alphagan
    Dosage: unk

Celexa
    Dosage: unk

Velocef
    Dosage: unk

Tobramycin
    Dosage: unk

Valium
    Dosage: unk

Phenergan HCL
    Dosage: unk

E.E.S.
    Dosage: unk

Tetanus Toxoid
    Dosage: unk

Ciprofloxacin
    Dosage: unk

Azopt
    Dosage: unk

Lipitor
    Dosage: unk

Vicodin
    Dosage: unk

Darvon
    Dosage: unk



Possible Tobramycin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient: 68 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Drug Ineffective, Pain, Eye Oedema, Intraocular Pressure Increased, Visual Acuity Reduced, Vision Blurred

Drug(s) suspected as cause:
Pred Forte
    Indication: Eye Oedema

Tobramycin
    Indication: Eye Oedema

Propylene Glycol
    Indication: Eye Oedema

Naproxen
    Indication: Arthritis
    End date: 2011-12-01

Simvastatin
    Indication: Blood Cholesterol Increased
    End date: 2011-10-01

Lipitor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Naproxen
    End date: 2011-12-01

Celebrex
    Indication: Polyarthritis

Acetazolamide
    Indication: Eye Oedema

Ketorolac Tromethamine
    Indication: Eye Oedema

Omnipred
    Indication: Eye Oedema

Cortisone Acetate
    Indication: Eye Oedema
    Start date: 2011-05-01

Other drugs received by patient: Thiazide; Levoxyl



Possible Tobramycin side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-16

Patient: 53 year old female

Reactions: Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Tobramycin
    Start date: 2011-12-24
    End date: 2012-01-12

Vancomycin
    Start date: 2011-12-19
    End date: 2012-01-12

Ceftazidime
    Start date: 2011-12-24
    End date: 2012-01-12

Cancidas
    Start date: 2011-12-27
    End date: 2012-01-12

Ambisome
    Start date: 2012-01-04
    End date: 2012-01-12

Other drugs received by patient: Prednisone TAB; Aspirin; Atorvastatin; Propranolol; Ramipril; Insulin; Clonazepam



Possible Tobramycin side effects in 69 year old male

Reported by a pharmacist from United States on 2012-03-15

Patient: 69 year old male, weighing 139.5 kg (306.9 pounds)

Reactions: Chemical Eye Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobramycin



Possible Tobramycin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-14

Patient: 68 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Drug Ineffective, Visual Impairment, Intraocular Pressure Increased, Eye Oedema, Vision Blurred, Eye Disorder, Cataract Operation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Tobramycin
    Indication: Oedema

Simvastatin
    Indication: Blood Cholesterol Increased

Systane [macrogol,propylene Glycol]
    Indication: Oedema

Pred Forte
    Indication: Oedema

Celebrex
    Dosage: 200 mg, qd
    Indication: Polyarthritis

Naproxen Sodium
    Indication: Polyarthritis

Acetazolamide
    Dosage: 125 mg, qd
    Indication: Oedema

Lipitor
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Ketorolac Tromethamine
    Indication: Oedema

Other drugs received by patient: Thiazide Derivatives; Levoxyl



Possible Tobramycin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-09

Patient: female, weighing 90.8 kg (199.8 pounds)

Reactions: Drug Ineffective, Eye Oedema, Visual Impairment, Intraocular Pressure Increased, Vision Blurred, Eye Disorder, Cataract Operation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lipitor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Ketorolac Tromethamine
    Indication: Oedema

Simvastatin
    Indication: Blood Cholesterol Increased

Tobramycin
    Indication: Oedema

Acetazolamide
    Indication: Oedema

Celebrex
    Indication: Polyarthritis

Naproxen
    Indication: Polyarthritis

Pred Forte
    Indication: Oedema

Propylene Glycol
    Indication: Oedema

Other drugs received by patient: Levoxyl; Thiazide

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