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Tobramycin Side Effects

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Common Tobramycin Side Effects


The most commonly reported Tobramycin side effects (click to view or check a box to report):

Renal Failure Acute (33)
Ocular Hyperaemia (16)
Eye Irritation (15)
Dyspnoea (14)
Vision Blurred (12)
Blood Creatinine Increased (11)
Nausea (9)
Dizziness (9)
Bronchospasm (9)
Eye Pain (8)
Pneumonia (8)
Eyelid Oedema (8)
Hypersensitivity (7)
Pyrexia (7)
Eye Swelling (7)
Erythema Of Eyelid (7)
Haemodialysis (6)
Infective Pulmonary Exacerbation Of Cystic Fibrosi (6)
Photophobia (6)
Lacrimation Increased (6)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Tobramycin Side Effects Reported to FDA



Tobramycin Side Effect Report#9931774
Renal Failure Acute, Dialysis, Hypoacusis, Vertigo, Tremor
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis infective,device related infection, who was treated with Tobramycin (dosage: Single Implantatio, Implanted With Knee Spacer, start time:
Nov 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute, Dialysis, Hypoacusis, Vertigo, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized and became disabled.
Tobramycin Side Effect Report#9914953
Endophthalmitis, Hypopyon, Vitritis, Ocular Hyperaemia, Photophobia, Visual Acuity Reduced, Keratitis, Corneal Oedema, Retinal Exudates
This report suggests a potential Tobramycin Endophthalmitis side effect(s) that can have serious consequences. A 27-year-old male patient (weight: NA) from SA was diagnosed with the following symptoms/conditions: conjunctivitis and used Tobramycin (dosage: NA) starting NS. After starting Tobramycin the patient began experiencing various side effects, including: Endophthalmitis, Hypopyon, Vitritis, Ocular Hyperaemia, Photophobia, Visual Acuity Reduced, Keratitis, Corneal Oedema, Retinal ExudatesAdditional drugs used concurrently:
  • Amoxicillin
  • Clavulanic Acid
  • Penicillin Nos (0.5 Miu, Every 6 Hours)
  • Gentamicin
The patient was hospitalized. Although Tobramycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Endophthalmitis, may still occur.
Tobramycin Side Effect Report#9912556
This Death problem was reported by a pharmacist from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tobramycin (dosage: Less Then 1 Month). The following drugs were being taken at the same time: NA. When using Tobramycin, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9817165
Infection
This Infection side effect was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: eye infection.The patient was prescribed Tobramycin Ophthalmic Solution Usp 0.3% (drug dosage: 1 Drop; Every 8 Hours; Right Eye), which was initiated on
Oct 21, 2013. Concurrently used drugs: NA..After starting to take Tobramycin Ophthalmic Solution Usp 0.3% the consumer reported adverse symptoms, such as: InfectionThese side effects may potentially be related to Tobramycin Ophthalmic Solution Usp 0.3%.
Tobramycin Side Effect Report#9817164
Off Label Use, Eye Irritation, Eye Pain, Ocular Hyperaemia, Rhinorrhoea, Vision Blurred
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: eye pruritus,eye discharge, who was treated with Tobramycin Ophthalmic Solution Usp 0.3% (dosage: 2 Drops In Left Eye, Three Times Per Day, start time:
Nov 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Off Label Use, Eye Irritation, Eye Pain, Ocular Hyperaemia, Rhinorrhoea, Vision Blurred after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin Ophthalmic Solution Usp 0.3% treatment in female patients, resulting in Off Label Use side effect.
Tobramycin Side Effect Report#9815764
Renal Failure Acute, Continuous Haemodiafiltration, Lung Transplant
This report suggests a potential Tobramycin Ophthalmic Solution Usp 0.3% Renal Failure Acute side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tobramycin Ophthalmic Solution Usp 0.3% (dosage: NA) starting NS. After starting Tobramycin Ophthalmic Solution Usp 0.3% the patient began experiencing various side effects, including: Renal Failure Acute, Continuous Haemodiafiltration, Lung TransplantAdditional drugs used concurrently:
  • Furosemide
  • Tacrolimus
  • Heparin
Although Tobramycin Ophthalmic Solution Usp 0.3% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Tobramycin Side Effect Report#9812545
Renal Failure Acute, Renal Tubular Necrosis
This Renal Failure Acute problem was reported by a health professional from US. A 17-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tobramycin Sulfate (dosage: NA). The following drugs were being taken at the same time:
  • Furosemide
  • Tacrolimus
When using Tobramycin Sulfate, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, Renal Tubular NecrosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure Acute, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9723232
Swelling Face, Fatigue
This Swelling Face side effect was reported by a consumer or non-health professional from US. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: eye infection viral.The patient was prescribed Tobramycin - Dexameth Ophth (drug dosage: 1 Drop 4 Times Daily Into Left Eye.?4 X Daily?drop Into Left Eye.), which was initiated on
Oct 08, 2013. Concurrently used drugs:
  • Lisinopril
  • Brimonidine Tartrate
  • Timolol
  • Aspirin
.After starting to take Tobramycin - Dexameth Ophth the consumer reported adverse symptoms, such as: Swelling Face, FatigueThese side effects may potentially be related to Tobramycin - Dexameth Ophth.
Tobramycin Side Effect Report#9719146
Renal Tubular Necrosis, Renal Failure Acute, Oliguria, Blood Creatinine Increased
This is a report of a 17-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tobramycin (dosage: NA, start time: NS), combined with:
  • Tacrolimus
  • Furosemide
and developed a serious reaction and side effect(s): Renal Tubular Necrosis, Renal Failure Acute, Oliguria, Blood Creatinine Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin treatment in female patients, resulting in Renal Tubular Necrosis side effect.
Tobramycin Side Effect Report#9704297
Tinnitus
This report suggests a potential Tobramycin Tinnitus side effect(s) that can have serious consequences. A 25-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cystic fibrosis and used Tobramycin (dosage: NA) starting
Aug 10, 2011. After starting Tobramycin the patient began experiencing various side effects, including: TinnitusAdditional drugs used concurrently:
  • Ibuprofen
  • Oxycodone
  • Albuterol
  • Advair
  • Delortadine
  • Azithromycin
  • Dornase
  • Bactrim
Although Tobramycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tinnitus, may still occur.
Tobramycin Side Effect Report#9698566
Pulmonary Haemorrhage, Staphylococcal Infection, Bacterial Infection
This Pulmonary Haemorrhage problem was reported by a consumer or non-health professional from US. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: neuromyopathy. On NS this consumer started treatment with Tobramycin (dosage: Unk). The following drugs were being taken at the same time: NA. When using Tobramycin, the patient experienced the following unwanted symptoms/side effects: Pulmonary Haemorrhage, Staphylococcal Infection, Bacterial InfectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Haemorrhage, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9695112
Lung Disorder
This Lung Disorder side effect was reported by a physician from US. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tobramycin (drug dosage: 1 Df (1 Ampoule), Bid), which was initiated on
Nov 21, 2008. Concurrently used drugs: NA..After starting to take Tobramycin the consumer reported adverse symptoms, such as: Lung DisorderThese side effects may potentially be related to Tobramycin. The patient was hospitalized.
Tobramycin Side Effect Report#9691234
Heart Rate Irregular
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: eye infection,blood cholesterol increased,hypertension,prostatomegaly, who was treated with Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% (dosage: 1 Drop; Four Times A Day; Ophthalmic, start time: 2007), combined with:
  • Atorvastatin Calcium (40 Mg; Daily; Oral)
  • Quinapril (20 Mg; Daily; Oral)
  • Silodosin (Daily;oral)
  • Finasteride (Daily;oral)
  • Acetylsalicylic Acid (81 Mg; Daily; Oral)
and developed a serious reaction and side effect(s): Heart Rate Irregular after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% treatment in male patients, resulting in Heart Rate Irregular side effect.
Tobramycin Side Effect Report#9691229
Eye Irritation, Eye Pruritus, Ocular Hyperaemia
This report suggests a potential Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% Eye Irritation side effect(s) that can have serious consequences. A 48-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% (dosage: 1 Drop In Each Eye; Four Times Daily; Ophthalmic) starting
Apr 15, 2013. After starting Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% the patient began experiencing various side effects, including: Eye Irritation, Eye Pruritus, Ocular HyperaemiaAdditional drugs used concurrently: NA. Although Tobramycin And Dexamethasone Ophthalmic Suspension Usp 0.3%/0.1% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eye Irritation, may still occur.
Tobramycin Side Effect Report#9690618
Throat Irritation, Insomnia, Dysgeusia, Lymphadenopathy
This Throat Irritation problem was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: eye infection bacterial. On
Nov 08, 2013 this consumer started treatment with Tobramycin/dexamethasone (dosage: 1 Drop Once Daily Into The Eye). The following drugs were being taken at the same time: NA. When using Tobramycin/dexamethasone, the patient experienced the following unwanted symptoms/side effects: Throat Irritation, Insomnia, Dysgeusia, LymphadenopathyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Throat Irritation, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9644732
Infective Pulmonary Exacerbation Of Cystic Fibrosis
This Infective Pulmonary Exacerbation Of Cystic Fibrosis side effect was reported by a consumer or non-health professional from Country Not Specified. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: cystic fibrosis.The patient was prescribed Tobramycin (drug dosage: 300 Mg, Bid), which was initiated on
Apr 23, 2013. Concurrently used drugs: NA..After starting to take Tobramycin the consumer reported adverse symptoms, such as: Infective Pulmonary Exacerbation Of Cystic FibrosisThese side effects may potentially be related to Tobramycin. The patient was hospitalized.
Tobramycin Side Effect Report#9610954
Chronic Obstructive Pulmonary Disease, Glossodynia, Dizziness
This is a report of a 82-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Tobramycin (dosage: 300 Mg, Q12h, start time: 201207), combined with: NA. and developed a serious reaction and side effect(s): Chronic Obstructive Pulmonary Disease, Glossodynia, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin treatment in female patients, resulting in Chronic Obstructive Pulmonary Disease side effect. The patient was hospitalized.
Tobramycin Side Effect Report#9538737
Haemoptysis, Po2 Decreased, Heart Rate Increased, Fall
This report suggests a potential Tobramycin Haemoptysis side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: bronchiectasis and used Tobramycin (dosage: 1 Df, Bid) starting
Sep 15, 2013. After starting Tobramycin the patient began experiencing various side effects, including: Haemoptysis, Po2 Decreased, Heart Rate Increased, FallAdditional drugs used concurrently: NA. Although Tobramycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemoptysis, may still occur.
Tobramycin Side Effect Report#9525593
Distal Intestinal Obstruction Syndrome, Vomiting
This Distal Intestinal Obstruction Syndrome problem was reported by a physician from FR. A 13-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cystic fibrosis,pneumonia pseudomonal. On
May 10, 2013 this consumer started treatment with Tobramycin Inhalation Powder (dosage: 8 Df, Daily For Every Other Month). The following drugs were being taken at the same time: NA. When using Tobramycin Inhalation Powder, the patient experienced the following unwanted symptoms/side effects: Distal Intestinal Obstruction Syndrome, VomitingThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Distal Intestinal Obstruction Syndrome, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9496526
Increased Bronchial Secretion, Dyspnoea, Oxygen Saturation Decreased, Lung Disorder
This Increased Bronchial Secretion side effect was reported by a consumer or non-health professional from Country Not Specified. A 6.-year-old male patient (weight:NA) experienced the following symptoms/conditions: cystic fibrosis.The patient was prescribed Tobramycin (drug dosage: 300 Mg, Bid), which was initiated on NS. Concurrently used drugs:
  • Cyproheptadine (Unk Ukn, Unk)
  • Pulmozyme (Unk Ukn, Unk)
  • Hypersol B (Unk Ukn, Unk)
  • Prevacid (Unk Ukn, Unk)
  • Albuterol (Unk Ukn, Unk)
  • Bactrim (Unk Ukn, Unk)
.After starting to take Tobramycin the consumer reported adverse symptoms, such as: Increased Bronchial Secretion, Dyspnoea, Oxygen Saturation Decreased, Lung DisorderThese side effects may potentially be related to Tobramycin. The patient was hospitalized.
Tobramycin Side Effect Report#9458332
Renal Impairment
This is a report of a 37-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Tobramycin (dosage: 360 Mg, 1x/day, start time:
Aug 26, 1988), combined with:
  • Vancomycin Hcl (2 G, 1x/day)
  • Amphotericin B (20 Mg, 1x/day)
and developed a serious reaction and side effect(s): Renal Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin treatment in male patients, resulting in Renal Impairment side effect.
Tobramycin Side Effect Report#9442158
Aspiration
This report suggests a potential Tobramycin Aspiration side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: cystic fibrosis and used Tobramycin (dosage: Unk Ukn, Unk) starting NS. After starting Tobramycin the patient began experiencing various side effects, including: AspirationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Tobramycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aspiration, may still occur.
Tobramycin Side Effect Report#9431879
Ototoxicity, Tinnitus, Chest Discomfort
This Ototoxicity problem was reported by a health professional from GB. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: treatment failure. On
Jul 03, 2013 this consumer started treatment with Tobramycin (dosage: 112 Mg, Bid). The following drugs were being taken at the same time:
  • Creon (Unk)
  • Levemir (Unk)
  • Dornase Alfa (Unk)
  • Omeprazole Sodium (Unk)
  • Novorapid (Unk)
  • Seretide (Unk)
  • Salbutamol (Unk)
  • Ursodeoxycholic Acid (Unk)
When using Tobramycin, the patient experienced the following unwanted symptoms/side effects: Ototoxicity, Tinnitus, Chest DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ototoxicity, may become evident only after a product is in use by the general population.
Tobramycin Side Effect Report#9420655
Haemoptysis, Aspergilloma, Hyperplasia, Bronchial Disorder
This Haemoptysis side effect was reported by a physician from FR. A 17-year-old female patient (weight:NA) experienced the following symptoms/conditions: pseudomonas infection.The patient was prescribed Tobramycin Inhalation Powder (drug dosage: 28 Mg, Bid), which was initiated on
Oct 30, 2012. Concurrently used drugs:
  • Ventolin (Unk)
  • Antibiotics (Unk)
.After starting to take Tobramycin Inhalation Powder the consumer reported adverse symptoms, such as: Haemoptysis, Aspergilloma, Hyperplasia, Bronchial DisorderThese side effects may potentially be related to Tobramycin Inhalation Powder. The patient was hospitalized.
Tobramycin Side Effect Report#9419214
Hearing Impaired, Deafness Neurosensory
This is a report of a 27-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tobramycin (dosage: NA, start time:
Apr 22, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hearing Impaired, Deafness Neurosensory after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tobramycin treatment in female patients, resulting in Hearing Impaired side effect.


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The appearance of Tobramycin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Tobramycin Side Effects for Women?

Women Side EffectsReports
Renal Failure Acute 16
Ocular Hyperaemia 11
Blood Creatinine Increased 8
Dizziness 8
Dyspnoea 8
Eye Irritation 8
Vision Blurred 7
Bronchospasm 6
Eye Swelling 6
Eyelid Oedema 6

What are common Tobramycin Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 17
Eye Irritation 7
Dyspnoea 6
Erythema Of Eyelid 5
Neuralgic Amyotrophy 5
Ocular Hyperaemia 5
Vision Blurred 5
Dialysis 4
Eye Pain 4
Haemodialysis 4

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Tobramycin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Tobramycin Safety Alerts, Active Ingredients, Usage Information

    NDC0069-0088
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTobramycin Sulfate
    NameTOBRAMYCIN SULFATE
    Dosage FormINJECTION
    RouteINTRAMUSCULAR; INTRAVENOUS
    On market since20110510
    LabelerPfizer Laboratories Div Pfizer Inc
    Active Ingredient(s)TOBRAMYCIN SULFATE
    Strength(s)40
    Unit(s)mg/mL
    Pharma ClassAminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]

    Tobramycin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 239

    Tobramycin safety alerts: No

    Reported deaths: 11

    Reported hospitalizations: 69

    Latest Tobramycin clinical trials