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Tobradex (Tobramycin / Dexamethasone Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tobradex 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 (28)

Reports by Reaction Type

Lipogranuloma (8)Off Label Use (7)Wrong Drug Administered (3)Ulcerative Keratitis (3)Anterior Chamber Cell (3)Conjunctival Hyperaemia (3)Ocular Hyperaemia (3)Corneal Perforation (2)Diplopia (2)Corneal Opacity (2)Aqueous Humour Leakage (2)Uveitis (2)

Possible Tobradex side effects in 42 year old female

Reported by a physician from Switzerland on 2012-08-01

Patient: 42 year old female

Reactions: Endophthalmitis, Scleritis, Eye Infection Bacterial, Ulcerative Keratitis, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobradex

Other drugs received by patient: Ciprofloxacin



Possible Tobradex side effects in 65 year old female

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

Patient: 65 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Increased Insulin Requirement, Blood Glucose Increased

Drug(s) suspected as cause:
Tobradex

Other drugs received by patient: Insulin; Actrapid; Lantus



Possible Tobradex side effects in 57 year old male

Reported by a physician from Switzerland on 2012-06-25

Patient: 57 year old male

Reactions: Amniotic Membrane Graft, Conjunctival Hyperaemia, Post Procedural Complication, Ocular Hyperaemia, Ulcerative Keratitis, Anterior Chamber Cell, Anterior Chamber Fibrin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mitomycin
    Dosage: (0.2 mg/ml for 2 min intraocular)
    Indication: Surgery

Ofloxacin
    Dosage: (every 2 hours ophthalmic)
    Indication: Infection Prophylaxis

Tobradex
    Dosage: (tid ophthalmic)
    Indication: Postoperative Care

Vitamin A
    Dosage: (tid ophthalmic)
    Indication: Postoperative Care



Possible Tobradex side effects in female

Reported by a physician from Malta on 2012-06-08

Patient: female

Reactions: Corneal Perforation, Ocular Hyperaemia, Aqueous Humour Leakage, Eye Pain

Drug(s) suspected as cause:
Tobradex

Other drugs received by patient: Cyclosporine; Etanercept



Possible Tobradex side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: male, weighing 88.5 kg (194.6 pounds)

Reactions: Excoriation, Expired Drug Administered, Eye Disorder, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-05-21

Patient: 67 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Mouth Haemorrhage

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 76 year old female

Reported by a physician from Spain on 2012-05-10

Patient: 76 year old female

Reactions: Enterococcus Test Positive, Corneal Opacity, Corneal Leukoma, Infectious Crystalline Keratopathy

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-01

Patient: male, weighing 88.0 kg (193.6 pounds)

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Dosage: 5 mg, tid or prn
    Administration route: Oral
    Indication: Bipolar Disorder

Tobradex
    Dosage: unk
    Indication: Laceration
    Start date: 2012-02-01



Possible Tobradex side effects in female

Reported by a physician from Malta on 2012-05-01

Patient: female

Reactions: Corneal Perforation, Ocular Hyperaemia, Aqueous Humour Leakage, Eye Pain

Drug(s) suspected as cause:
Tobradex

Other drugs received by patient: Cyclosporine; Etanercept



Possible Tobradex side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: 70 year old female, weighing 64.5 kg (141.9 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-03-19

Patient: 28 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Night Sweats, Skin Exfoliation, Insomnia, Rash, Hallucination, Delusion

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 58 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-15

Patient: 58 year old male

Reactions: Diplopia, Vision Blurred

Drug(s) suspected as cause:
Tobradex
    Dosage: (1 gtt tid os ophthalmic)
    Indication: Postoperative Care

Tobradex ST
    Dosage: (3 gtt qd os ophthalmic), (3 gtt qd os ophthalmic)
    Indication: Postoperative Care

Tobradex ST

Other drugs received by patient: Simvastatin; Aspirin



Possible Tobradex side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-03-06

Patient: 58 year old male

Reactions: Diplopia, Vision Blurred

Drug(s) suspected as cause:
Tobradex
    Dosage: (3 gtt qd os ophthalmic) ; (3 gtt qd os ophthalmic)
    Indication: Postoperative Care

Tobradex
    Dosage: (1 gtt tid os ophthalmic)
    Indication: Postoperative Care

Tobradex

Other drugs received by patient: Aspirin; Simvastatin



Possible Tobradex side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: female, weighing 59.4 kg (130.7 pounds)

Reactions: Economic Problem, Eyelid Oedema, Erythema of Eyelid, Eyelid Bleeding

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in female

Reported by a pharmacist from Cyprus on 2012-02-16

Patient: female

Reactions: Purulence, Eye Swelling, Ulcerative Keratitis, Eye Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 55 year old female

Reported by a physician from Turkey on 2012-02-03

Patient: 55 year old female

Reactions: Device Material Issue, Hypopyon, Photophobia, Conjunctival Hyperaemia, Wrong Drug Administered, Anterior Chamber Cell, Uveitis

Drug(s) suspected as cause:
Tobradex
    Dosage: (ophthalmic)

Tobrex
    Dosage: (every 2 hours ophthalmic)



Possible Tobradex side effects in 1 month old

Reported by a physician from United States on 2012-02-03

Patient: 1 month old

Reactions: Wrong Drug Administered, Corneal Graft Rejection, Corneal Thickening, Corneal Opacity, Corneal Oedema, Disease Progression

Drug(s) suspected as cause:
Tobradex
    Dosage: daily ophthalmic

Tobrex
    Dosage: daily ophthalmic

Other drugs received by patient: Homatropine Hydrobromide



Possible Tobradex side effects in 65 year old male

Reported by a physician from Turkey on 2012-02-03

Patient: 65 year old male

Reactions: Wrong Drug Administered, Conjunctival Hyperaemia, Anterior Chamber Cell, Uveitis

Drug(s) suspected as cause:
Tobradex
    Dosage: (ophthalmic)

Tobrex
    Dosage: (every 2 hours ophthalmic)



Possible Tobradex side effects in 34 year old male

Reported by a physician from United States on 2011-12-05

Patient: 34 year old male, weighing 74.8 kg (164.7 pounds)

Reactions: Lens Disorder

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 45 year old female

Reported by a physician from China on 2011-12-02

Patient: 45 year old female

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 45 year old female

Reported by a physician from China on 2011-11-22

Patient: 45 year old female

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 57 year old male

Reported by a physician from China on 2011-11-22

Patient: 57 year old male

Reactions: Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 51 year old female

Reported by a physician from China on 2011-11-22

Patient: 51 year old female

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 60 year old male

Reported by a physician from China on 2011-11-22

Patient: 60 year old male

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 48 year old female

Reported by a physician from China on 2011-11-22

Patient: 48 year old female

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 62 year old female

Reported by a physician from China on 2011-11-22

Patient: 62 year old female

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 55 year old male

Reported by a physician from China on 2011-11-22

Patient: 55 year old male

Reactions: Off Label Use, Lipogranuloma

Drug(s) suspected as cause:
Tobradex



Possible Tobradex side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-04

Patient: 72 year old female

Reactions: Blindness Transient, Ocular Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobradex

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