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Tobramycin Adverse Events Reported to the FDA Over Time

How are Tobramycin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Tobramycin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Tobramycin is flagged as the suspect drug causing the adverse event.

Most Common Tobramycin Adverse Events Reported to the FDA

What are the most common Tobramycin adverse events reported to the FDA?

Renal Failure Acute
78 (3.2%)
Pyrexia
61 (2.5%)
Drug Ineffective
34 (1.4%)
Blood Creatinine Increased
32 (1.31%)
Nausea
30 (1.23%)
Pneumonia
29 (1.19%)
Dehydration
28 (1.15%)
Tachycardia
28 (1.15%)
Hypotension
27 (1.11%)
Diarrhoea
25 (1.03%)
Haemodialysis
25 (1.03%)
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Vomiting
24 (.98%)
Drug Hypersensitivity
23 (.94%)
Pseudomembranous Colitis
22 (.9%)
Eye Irritation
21 (.86%)
Tinnitus
21 (.86%)
Condition Aggravated
20 (.82%)
Renal Impairment
20 (.82%)
Abdominal Pain
19 (.78%)
Clostridium Difficile Colitis
19 (.78%)
Vision Blurred
19 (.78%)
Visual Acuity Reduced
19 (.78%)
Dizziness
18 (.74%)
Dyspnoea
18 (.74%)
Ocular Hyperaemia
18 (.74%)
Pseudomonas Infection
18 (.74%)
Cough
17 (.7%)
Intraocular Pressure Increased
17 (.7%)
Staphylococcal Infection
17 (.7%)
Acute Generalised Exanthematous Pus...
16 (.66%)
Eye Pain
16 (.66%)
Drug Level Increased
15 (.62%)
Hypersensitivity
15 (.62%)
Neuralgic Amyotrophy
15 (.62%)
Septic Shock
15 (.62%)
Rash
14 (.57%)
Thrombocytopenia
14 (.57%)
Headache
13 (.53%)
Pruritus
13 (.53%)
Weight Decreased
13 (.53%)
Deafness Neurosensory
12 (.49%)
Disease Progression
12 (.49%)
Arthralgia
11 (.45%)
Balance Disorder
11 (.45%)
Eosinophilia
11 (.45%)
Eye Swelling
11 (.45%)
Eyelid Oedema
11 (.45%)
Febrile Neutropenia
11 (.45%)
Malaise
11 (.45%)
Multi-organ Failure
11 (.45%)
Renal Failure
11 (.45%)
Renal Tubular Necrosis
11 (.45%)
Angle Closure Glaucoma
10 (.41%)
C-reactive Protein Increased
10 (.41%)
Colitis
10 (.41%)
Hypoacusis
10 (.41%)
Hypoxia
10 (.41%)
Post Procedural Complication
10 (.41%)
Rash Maculo-papular
10 (.41%)
Sepsis
10 (.41%)
Bronchospasm
9 (.37%)
Cystic Fibrosis Lung
9 (.37%)
Erythema Of Eyelid
9 (.37%)
General Physical Condition Abnormal
9 (.37%)
Hepatitis Toxic
9 (.37%)
Liver Injury
9 (.37%)
Lung Disorder
9 (.37%)
Rash Erythematous
9 (.37%)
Atrial Fibrillation
8 (.33%)
Blood Urea Increased
8 (.33%)
Deafness
8 (.33%)
Decreased Appetite
8 (.33%)
Drug Interaction
8 (.33%)
Erythema
8 (.33%)
Infection
8 (.33%)
Inflammation
8 (.33%)
Lacrimation Increased
8 (.33%)
Overdose
8 (.33%)
Pain
8 (.33%)
Pancytopenia
8 (.33%)
Photophobia
8 (.33%)
Respiratory Failure
8 (.33%)
Abdominal Distension
7 (.29%)
Asthenia
7 (.29%)
Dialysis
7 (.29%)
Drug Toxicity
7 (.29%)
Dysgeusia
7 (.29%)
Dyspepsia
7 (.29%)
Eye Oedema
7 (.29%)
Eye Pruritus
7 (.29%)
Haemoptysis
7 (.29%)
Increased Upper Airway Secretion
7 (.29%)
Influenza Like Illness
7 (.29%)
Ocular Hypertension
7 (.29%)
Anaemia
6 (.25%)
Anuria
6 (.25%)
Chills
6 (.25%)
Conjunctivitis
6 (.25%)
Convulsion
6 (.25%)
Disease Recurrence
6 (.25%)
Face Oedema
6 (.25%)

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This graph shows the top adverse events submitted to the FDA for Tobramycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tobramycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Tobramycin

What are the most common Tobramycin adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Tobramycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tobramycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Tobramycin According to Those Reporting Adverse Events

Why are people taking Tobramycin, according to those reporting adverse events to the FDA?

Pseudomonas Infection
110
Product Used For Unknown Indication
87
Cystic Fibrosis
66
Drug Use For Unknown Indication
59
Infection
29
Eye Infection
23
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Prophylaxis
21
Conjunctivitis
21
Mycobacterium Abscessus Infection
21
Infection Prophylaxis
21
Sepsis
15
Pneumonia
14
Anti-infective Therapy
10
Postoperative Care
10
Antibiotic Therapy
9
Lung Disorder
9
Lung Infection
8
Antibiotic Prophylaxis
8
Bacterial Infection
8
Lung Infection Pseudomonal
8
Pyrexia
7
Enterococcal Sepsis
6
Staphylococcal Infection
6
Sinusitis
6
Bronchiectasis
6
Skin Ulcer
6
Febrile Neutropenia
6
Conjunctivitis Infective
6
Eye Injury
5
Blepharitis
5
Eye Oedema
5
Neutropenia
5
Diffuse Panbronchiolitis
5
Respiratory Tract Infection
5
Ocular Hyperaemia
4
Bacteraemia
4
Chronic Obstructive Pulmonary Disea...
4
Chalazion
4
Systemic Antibacterial Therapy
4
Cystic Fibrosis Lung
4
Device Related Infection
4
Eye Inflammation
4
Agranulocytosis
3
Post Procedural Infection
3
Catheter Site Infection
3
Osteomyelitis
3
Corneal Abrasion
3
Lacrimation Increased
3
Eye Irritation
3
Eye Pruritus
3
Condition Aggravated
3

Drug Labels

LabelLabelerEffective
TobramycinMajor Pharmaceuticals01-SEP-09
Tobramycin And DexamethasonePhysicians Total Care, Inc.06-OCT-10
Tobramycin And DexamethasoneBausch & Lomb Incorporated06-OCT-10
TobramycinRebel Distributors Corp01-DEC-10
Tobramycin And DexamethasoneRebel Distributors Corp26-JAN-11
TobrexAlcon Laboratories, Inc.14-JUL-11
TobradexAlcon Laboratories, Inc.18-JUL-11
Tobradex StAlcon Laboratories, Inc.18-JUL-11
Tobramycin And DexamethasoneFalcon Pharmaceuticals20-JUL-11
TobradexAlcon Laboratories, Inc.27-JUL-11
TobramycinAPP Pharmaceuticals, LLC24-AUG-11
Tobramycin And DexamethasoneH.J. Harkins Company, Inc.14-DEC-11
Tobramycin In Sodium ChlorideHospira, Inc.14-DEC-11
TobramycinHospira, Inc.15-DEC-11
TobramycinHospira, Inc.15-DEC-11
TobramycinAkorn, Inc.13-JAN-12
TobramycinH.J. Harkins Company, Inc.13-FEB-12
TobramycinPreferred Pharmaceuticals, Inc28-FEB-12
TobramycinSandoz Inc.09-MAR-12
TobramycinRebel Distributors Corp27-MAR-12
TobradexSTAT Rx USA LLC30-AUG-12
TobramycinAPP Pharmaceuticals, LLC31-AUG-12
TobramycinSTAT Rx USA LLC04-SEP-12
TobramycinFresenius Kabi USA, LLC05-SEP-12
TobramycinLake Erie Medical DBA Quaity Care Products LLC07-SEP-12
Tobramycin SulfateTeva Parenteral Medicines, Inc.11-SEP-12
BethkisCornerstone Therapeutics Inc.12-OCT-12
Tobrex Alcon Laboratories, Inc.05-NOV-12
TobramycinX-GEN Pharmaceuticals, Inc.02-JAN-13
TobramycinBausch & Lomb Incorporated03-JAN-13
ZyletBausch & Lomb Incorporated10-JAN-13
Tobi PodhalerNovartis Pharmaceuticals Corporation22-MAR-13
Tobramycin SulfatePfizer Laboratories Div Pfizer Inc04-APR-13
Tobramycin SulfatePfizer Laboratories Div Pfizer Inc04-APR-13
TobramycinFresenius Kabi USA, LLC01-MAY-13

Tobramycin Case Reports

What Tobramycin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Tobramycin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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